Routledge Handbook of Global Health Rights 2020053762, 2020053763, 9780367276393, 9780429297021, 9781032004600

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ROUTLEDGE HANDBOOK OF GLOBAL HEALTH RIGHTS

This book examines the idea of a fundamental entitlement to health and healthcare from a human rights perspective. The volume is based on a particular conceptual reasoning that balances critical thinking and pragmatism in the context of a universal right to health. Thus, the primary focus of the book is the relationship or contrast between rights-based discourse/jurisprudential arguments and real-life healthcare contexts.The work sets out the constraints that are imposed on a universal right to health by practical realities such as economic hardship in countries, lack of appropriate governance, and lack of support for the implementation of this right through appropriate resource allocation. It queries the degree to which the existence of this legally enshrined right and its application in instruments such as the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the Universal Declaration of Human Rights (UDHR) can be more than an ephemeral aspiration but can, actually, sustain, promote, and instil good practice. It further asks if social reality and the inequalities that present themselves therein impede the implementation of laudable human rights, particularly within marginalised communities and cadres of people. It deliberates on what states and global bodies do, or could do, in practical terms to ensure that such rights are moved beyond the aspirational and become attainable and implementable. Divided into three parts, the first analyses the notion of a universal inalienable right to health(care) from jurisprudential, anthropological, legal, and ethical perspectives. The second part considers the translation of international human rights norms into specific jurisdictional healthcare contexts. With a global perspective it includes countries with very different legal, economic, and social contexts. Finally, the third part summarises the lessons learnt and provides a pathway for future action. The book will be an invaluable resource for students, academics, and policymakers working in the areas of health law and policy, and international human rights law. Clayton Ó Néill, LLB (Ulster), LLM (Dub), BCL (Oxon), PhD (Durham), FHEA, is a Lecturer in Law at Queen’s University Belfast, Northern Ireland. He has published a monograph, titled Religion, Medicine and the Law (Routledge 2018). Charles Foster is a Visiting Professor at the University of Oxford, UK, a fellow of Green Templeton College, Oxford, a Senior Research Associate at the Uehiro Institute for Practical

Ethics, Oxford, and a Research Associate at the Ethox Centre and the HeLEX Centre at the University of Oxford. Jonathan Herring is the DM Wolfe-Clarendon Fellow in Law at Exeter College, UK, and a Vice Dean and Professor of Law at the University of Oxford, UK. John Tingle is a Lecturer in Law at the University of Birmingham, UK, and a qualified Barrister. His research interests are in the areas of global and English patient safety, nursing law, and universal health coverage. He is a Visiting Professor of Law at Loyola University School of Law in Chicago, Illinois, USA.

ROUTLEDGE HANDBOOK OF GLOBAL HEALTH RIGHTS

Edited by Clayton Ó Néill, Charles Foster, Jonathan Herring, and John Tingle

First published 2021 by Routledge 2 Park Square, Milton Park,Abingdon, Oxon OX14 4RN and by Routledge 605 Third Avenue, New York, NY 10158 Routledge is an imprint of the Taylor & Francis Group, an informa business © 2021 selection and editorial matter, Clayton Ó Néill, Charles Foster, Jonathan Herring and John Tingle; individual chapters, the contributors The right of Clayton Ó Néill, Charles Foster, Jonathan Herring and John Tingle to be identified as the authors of the editorial material, and of the authors for their individual chapters, has been asserted in accordance with sections 77 and 78 of the Copyright, Designs and Patents Act 1988. All rights reserved. No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data Names: Ó Néill, Clayton, editor, author. | Foster, Charles, 1962-, editor, author. | Herring, Jonathan, editor, author. | Tingle, John, editor, author. Title: Routledge handbook of global health rights / edited by Clayton Ó Néill, Charles Foster, Jonathan Herring and John Tingle. Description: Milton Park,Abingdon, Oxon ; New York, NY : Routledge, [2021] | Includes bibliographical references and index. Identifiers: LCCN 2020053762 (print) | LCCN 2020053763 (ebook) | ISBN 9780367276393 (hardback) | ISBN 9780429297021 (ebook) Subjects: LCSH: Right to health. | Human rights. Classification: LCC K3260.3 .R68 2021 (print) | LCC K3260.3 (ebook) | DDC 344.03/21--dc23 LC record available at https://lccn.loc.gov/2020053762 LC ebook record available at https://lccn.loc.gov/2020053763 ISBN: 978-0-367-27639-3 (hbk) ISBN: 978-1-032-00460-0 (pbk) ISBN: 978-0-429-29702-1 (ebk) Typeset in Bembo by Deanta Global Publishing Services, Chennai, India

CONTENTS

Table of cases Table of agreements Table of secondary legislation Table of statutes List of contributors

viii xii xiii xiv xvi

PART A

International human rights and the right to health 1 An introduction to health rights as they apply in a global landscape Clayton Ó Néill 2 Universal Declaration of Human Rights, part 1:Articles 1, 2, 3, 5, and 6 Charles Foster 3 Universal Declaration of Human Rights, part 2:Articles 7, 12, 16, 18, 19, and 25 Jonathan Herring 4 A global right to health amid global health emergencies Clayton Ó Néill 5 Global health rights in the Inter-American Court of Human Rights: On the doctrine of the minimum core obligations and a co-responsibility to care Thana C de Campos-Rudinsky

v

1 3 11

23 47

62

Contents PART B

Health Rights across the temporal stages in specifc countries

79

Beginning of life and children

81

6 Assisted reproductive technologies in Uganda: Law and practice Zahara Nampewo 7 Abortion and conscience:A crossroads for Northern Ireland Clayton Ó Néill 8 The standard of care and implications for paediatric decision-making: The Swedish viewpoint Santa Slokenberga Middle of life

83 102

122

153

9 The right to health in Hong Kong: Incorporation, implementation, and balancing Edward Lui

155

10 ‘Dignity’ in the adjudication of healthcare rights in India Sushant Chandra

168

11 Universal health coverage and the right to health in Nigeria Cheluchi Onyemelukwe

180

12 Realising the right to health in Kenya: Connecting health governance outcomes to patient safety perspectives Naomi N Njuguna

205

13 Developing an intrinsic patient safety culture in health systems:The NHS experience John Tingle

227

14 Clinical negligence litigation procedure, policy, and practice in England:The product of a legal cycle rather than an application of a right to health? Stephen King 15 Patient safety and human rights Helen Hughes

244 259

vi

Contents

16 Fundamental rights to health care and charging overseas visitors for NHS treatment: Diversity across the United Kingdom’s devolved jurisdictions Jean V McHale and Elizabeth M Speakman

279

17 Public reporting, transparency, and patient autonomy in the province of Quebec Lara Khoury

299

End of life

315

18 Human tissue, human rights, and humanity Jesse Wall

317

19 Autonomy and the right to (end one’s?) life:A German perspective Carsten Momsen and Mathis Schwarze

332

20 Voluntary assisted dying law reform in Australia and New Zealand Ian Freckelton

348

21 Comparative perspectives on medical aid in dying:The United States and Canada Barbara A Reich

367

PART C

The application of a universal right to health in practice

387

22 A right to health:A right granted and agreed, but limited or denied? Clayton Ó Néill and Charles Foster

389

Index

401

vii

TABLE OF CASES

A, B and C v. Ireland [2011] 53 EHRR 13, ................................................................. 109n18 AB v. Minister of Social Development (CCT155/15) [2016] ZACC 43; 2017 (3) BCLR (CC); 2017 (3) SA 570 (CC) (29 November 2016) [313], ................................... 84 Adeyinka Badejoh and others v. Federal Ministry of Education and others, ............................ 188n50 A G Ondo State v.A G Federation, ............................................................................. 189, 199 Al-Skeini v. United Kingdom (Application No 55721/07), ............................................. 263n14 Alyne da Silva v. Brazil, ....................................................................................................... 30 Andhra Kesari Education Society v. Director of School Education (1988) 4 SC 431(India), ....... 169n15 Archbishop Olubunmi Okogie and others v.Attorney General of Lagos (1981) 2 NCLR 331, ........................................................................................................ 188n50 Asiye Genc v.Turkey App no 24109/07, .......................................................... 126n26, 159n37 Associated Provincial Picture Houses Ltd v.Wednesbury Corporation [1948] 1 KB 223, 234, ....................................................................................................... 159n41 Attorney General v. X, ....................................................................................................... 109 Azubike v.Attorney General of the Federation [2004] Suit No. FHC/PH/CS/679/2003 (Nigeria), .................................................................................................................... 193 Bandhua Mukti Morcha v. Union of India (1984) AIR SC 802 (India), ............... 169n17, 173n50 Bank Mellat v. HM Treasury (No 2) [2014] AC 700, ....................................................... 164n82 Bataliny v. Russia,App no 10060/07, ........................................................................... 126n22 Baxter v. Montana, 2009 MT 449, ................................................................................ 372n24 Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582, .............................. 256n20 Bolitho v. Hackney Health Authority [1998] AC 232, ...................................................... 257n21 Bugdaycay v. Secretary of State for the Home Department [1987] AC 514, 531, ................... 159n42 Calvelli and Ciglio v. Italy,App no 32967/96, ............................................................... 126n27 Cantoni v. France,App no 17862/91, .......................................................................... 147n185 Carter v. Canada (Attorney General), 2012 BCSC 886; [2015] SCC 5; [2015] 1 SCR 33; [2015] 1 SCR 331, ......................................................... 349n5, 359–360, 374n37, 374n39 Case of Centre for Legal Resources on behalf of Valentin Câmpeanu v. Romania, App no 47848/08 (ECtHR, 17 July 2014), ............................................................. 125n19 Cathay Pacific Airways Flight Attendants Union v. Director-General of Civil Aviation [2007] 2 HKC 393, ................................................................................................ 159n40 viii

Table of cases

Catholic Diocese of Hong Kong v. Secretary for Justice [2007] 4 HKLRD 483, .................... 158n28 Centre for Reproductive Medicine v. Mrs U [2002] EWCA Civ, 565, [2002] I FLR 927, ........... 89 Chan Mei Yee v. Director of Immigration [2000] HKCFI 1521, ......................................... 160n44 Chan To Foon v. Director of Immigration [2001] 3 HKLRD 109; (n 44) 133, ....... 160n44, 160n45 Chirstine Kidha v. Nairobi Womens Hospital (2016) eKLR, ............................................... 208n8 Christopher John Wake and Djiniyinni Gondarra v. Northern Territory of Australia and The Honourable Keith John Austin Asche AC,The Administrator of the Northern Territory of Australia, ............................................................................................................... 350n8 Chung Kwok Man v.The Hong Kong Housing Authority [2016] 3 HKLRD 592, ............. 159n39 Clean Air Foundation Ltd v.The Government of the HKSAR [2007] HKCFI 757, ............ 160n48 Comilang Milagros Tecson v. Director of Immigration (2019) 22 HKCFAR 59, ...... 156n14, 157n20 Consumer Education Research Society v. Union of India (1995) 3 SCC 42 (India), ........................................................... 169n12, 169n14, 171n33, 173n41 Cuscul Pivaral et al. v. Guatemala, ................................................................... 62–63, 69–75, 77 D v. United Kingdom (1997) 24 EHRR 423, ....................................................................... 20 David Tracey v. University Hospitals Cambridge NHS Foundation Trust and Secretary of State for Health (2014) EWCA Civ 33, ................................................................ 271n53 Dermit Barbato v. Uruguay, communication No. 84/1981, ............................................... 17n31 Dickson v. United Kingdom, ................................................................................................. 84 Drolet v. Parenteau [1991] RJQ 2956, ........................................................................... 309n86 Edwards v. United Kingdom [2002] ECHR 303, .............................................................. 17n33 Erdinç Kurt and Others v.Turkey,App no 50772/11, ............................. 20n58, 126n29, 127n30 Evans v.Amicus Healthcare [2004] EWCA Civ 727, ............................................................. 89 Evans v. the United Kingdom, ............................................................................................... 84 Femi Falana v.Attorney General of the Federation FHC/IKJ/CS/M59/2010, ................... 193n73 Fernandes De Oliveira v. Portugal App no 78103/14, ......................................... 126n26, 127n31 Fok Chun Wa v. Hospital Authority [2008] HKCFI 1143, ............................................... 158n28 Francis Coralie Mullin v.Administrator of Delhi AIR 1981 SC 746, .................................. 169n14 GA v. Director of Immigration (2014) 17 HKCFAR 60, ....................... 156n14, 157n18, 157n23 Georgi Ivanov Elchinov v. Natsionalna zdravnoosiguritelna kasa, ......................................... 127n33 Georgina Ahamefule v. Imperial Medical Centre, .................................................................... 192 Geraets-Smits v. Stichting Ziekenfonds VGZ, ................................................................... 130n53 Gideon Kilundo & Daniel Kilundo Mwenga v. Nairobi Women’s Hospital (Petition No. 242 of 2018) (2018) eKLR, .................................................................... 208 Gonzales v. Oregon, 546 US 243 (2006), ....................................................................... 372n22 González et al. (“Cotton Field”) v. Mexico, ....................................................................... 17n28 Greater Glasgow Health Board v. Doogan and Another [2014] UKSC 68, .................... 115, 393n3 Harksen v. Lane No 1998 (1) sa 300 (cc), ...................................................................... 176n68 Hernández v. Argentina, .................................................................................................. 69n27 Hopp v. Lepp [1980] 2 SCR 192, ......................................................................... 210, 309n86 Hospice New Zealand v.Attorney-General [2020] NZHC 1356, ...................................... 362n56 Hristozov v. Bulgaria, ...................................................................................................... 21n61 Human Fertilization and Embryology Authority ex parte Blood (1997) 2 WLR 807, .................. 89 Hysan Development Co Ltd v.Town Planning Board (2016) 19 HKCFAR 372, ................ 156n10 In re an Application by Wong Chun-sing and Ng Fook-yiu for Judicial Review [1984] HKLR 71, 74–75, .................................................................................................. 157n22 International Planned Parenthood Federation – European Network (IPPF EN) v. Italy, .......... 129n46 Janaway v. Salford Area Health Authority [1989] AC 537 (HL), ..................... 115, 119n48, 393n2 ix

Table of cases

Jonah Gbemre v. Shell Petroleum Development Company Nigeria Limited and others Suit No: FHC /B/SC/53/05, ..................................................................................... 189 JOO (also known as JM) v.Attorney General & 6 Others (2018) eKLR, ........................... 216n38 Joseph Odafe and Others v.Attorney-General of the Federation and Others, ............................... 193 Kesavananda Bharati v. State of Kerala AIR 1973 SC 1461(India), .................................. 170n20 Kokkinakis v. Greece,App no 14307/88, ..................................................................... 147n183 Kwok Wing Hang v. Chief Executive in Council [2020] 1 HKLRD 1, ............................. 162n62, 162n63, 163n70 Lantsova v. Russian Federation (CCPR/C/74/D/763/1997), .......................................... 17n32 Laxmi Mandal v. Deen Dayal Hospital Harinagar WP (C) Nos 8853 of 2008, .................. 174n51 LC v. Peru CEDAW/C/50/D/22/2009 (2011), ................................................................. 27 Lee v. Oregon, 107 F3d 1382 (9th Cir 1997), ................................................................ 371n19 Legal Defence and Assistance Project (LEDAP) GTE & LTD v. Federal Ministry of Education & Anor (2017w), Suit No FHC/ABJ/CS/978/15, .................................... 190n57 Leung Kwok Hung v. HKSAR (2005) 8 HKCFAR 299, ............................................... 165n88 Leung Kwok Hung v. Secretary for Justice [2020] HKCA 192, .......................................... 163n71 Liivik v. Estonia,App no 12157/05, ........................................................................... 147n186 Lopes de Sousa Fernandes v. Portugal, App no 56080/13; (2018) 66 EHRR 28, ............................................................................. 125n19, 126n25, 159n35 Maneka Gandhi v. Union of India (1978) AIR SC 597 (India), ....................................... 178n77 MAO & Another v.AG & 4 Others (2015) eKLR, ........................................................... 208n9 McGlinchey v. UK App No 50390/99, 37 EHRR 41 (2003), .............................................. 21 Medical Decision-Making on Behalf of Children Post-Great Ormond Street Hospital v. Gard (Hart Publishing 2019) 191–206, .............................................................................. 123n8 Mehmet Şentürk and Bekir Şentürk v.Turkey (2013) 60 EHRR 4 (2015) 60 EHRR 4, ............................................................................................. 159n36, 281n10 Mellet v. Ireland (CCPR/C/116/D/2324/2013), ........................................................... 19n48 Minister of Justice and Correctional Services v. Estate Late James Stransham-Ford [2017] 1 All SA 354; 2017 (3) SA 152 (SCA), .................................................................... 359n46 Miranda Cortez et al. v. El Salvador, ................................................................................. 43n76 Mohd Ahmed (minor) v. Union of India (2014) 6 HCC (del) 118, ........... 168n4, 170n18, 170n22, 170n23, 170n25, 171n32, 175, 176n68, 176n70 Montgomery v. Lanarkshire Health Board [2015] UKSC 11, ............................................. 257n22 Ng Ka Ling v. Director of Immigration (1999) 2 HKCFAR 4, 25, ...................................... 156n4 Ng Siu Tung v. Director of Immigration (2002) 5 HKCFAR 1, ......................................... 159n39 No FHC/ABJ/CS/978/15, ....................................................................................... 190n57 Odafe and Others v.Attorney-General and Others Suit No. FHC/PH/CS/680/2003; (2004) AHRLR 205 (NgHC 2004) (2004) AHRLR 205 at 211; (2005) CHR 309, ............................................................................................................. 193n72 Pagtama,Victorina Alegre v. Director of Immigration [2016] HKCFI 34, ............................. 160n44 Parmanand Katara v. Union of India (1989) 4 SCC 286(India), .......................... 170n22, 171n32 Paschim Bagga Mazdoor Khet Samiti Khet v. State of West Bengal (1996) 4 SCC 37, ........ 171n34, 174n51, 174n56 Peerbooms v. Stichting CZ Groep Zorgverzekeringen, ........................................................ 130n53 Poblete Vilches y otros v. Chile, ......................................................................................... 69n25 Pretty v.The United Kingdom (2002) 3(10) German Law Journal E4, .................................. 349 R v. Barnet London Borough Council, Ex parte Shah [1983] 2 AC 309, ............................ 284n30 x

Table of cases

Ramji Tiwari v. State of UP and others (1997)1UPLBEC 690, ......................................... 169n15 Reibl v. Hughes [1980] 2 SCR 880, 884, ...................................................................... 309n86 Republic v.Transition Authority & Ano Ex parte Kenya Medical Pharmacists and Dentists Union and 2 Others, ................................................................................................ 213n26 R (Nicklinson) v. Ministry of Justice [2014] UKSC 38, ...................................................... 18n42 Rõigas v. Estonia (Application no. 49045/13), ............................................................... 126n28 R (on the application of Nicklinson and another) v. Ministry of Justice [2014] UKSC 38, ...... 108n15 Scialaqua v. Italy (1998) 26 EHRR 164, ....................................................................... 281n11 Seales v. Attorney-General [2015] 3 NZLR 556; [2015] NZHC 1239, .............. 359n44, 360n47 SH v. Austria [2011] ECHR 1878, ..................................................................................... 37 Snehlata v. State of UP PIL NO. 14588 of 2009 (Allahabad High Court) (India), ......... 170n24, 170n27, 177n75 Song Rai v.The Coroner of Hong Kong [2011] 2 HKLRD 245, ...................................... 159n34 State of Maharashtra v.Vikas Sahebrao Roundale (1992) 5 SC 175(India), ......................... 169n15 State of Punjab v. Mohinder Singh Chawla (1997) 2 SCC 83, ............................. 171n34, 174n51 State of Punjab v. Ram Lubhaya Bagga (1998) 4 SCC 118; (1998) 1 SCR 1120, ............ 170n21, 171n34, 174n51 Stransham-Ford v. Minister of Justice and Correctional Services [2017] 1 All SA 354; 2017 (3) SA 152 (SCA), .............................................................................................. 359 Sudhir Jaiswal v. State of UP Writ No 1568 of 2017 (Allahabad High Court) (India), ..... 177n74 SW v.The Secretary for Justice [2019] 1 HKLRD 768, ................................................... 159n34 SWK & 5 Others v. Medecins Sans Frontier France & 10 others (Petition No. 605 of 2014), ..................................................................................... 209n11 Toussaint v. Canada (CCPR/C/123/D/2348/2014), ..................................................... 17n36 Tryphosa Jebet Kosgey v. Eldogn View Hospital (2016) eKLR, ............................................ 208n8 Ubamaka Edward Wilson v. Secretary for Security (2012) 115 HKCFAR 743, ................... 156n14 Unnikrishnan v. State of AP (1993) 1 SCC 645 (India), ................................................. 170n20 Vacco v. Quill, 521 US 793 (1997), ............................................................................... 371n16 Vasileva v. Bulgaria,App no 23796/10 (ECtHR, 17 March 2016), ................................. 125n19 Vasyukov v. Russia,App no 2974/05, ........................................................................... 126n20 Veronica Nyangai v. Nairobi West Hospital Ltd (2017) eKLR, ............................................ 208n8 Vo v. France (2004) 40 EHRR 12, .................................................................................... 108 Washington v. Glucksberg, 521 US 702 (1997), ............................................................... 371n16 Ximenes Lopes v. Brazil, ...................................................................................... 62–63, 74–77 Zhumbaeva v. Kyrgyzstan (CCPR/C/102/D/1756/2008), ............................................. 17n31

xi

TABLE OF AGREEMENTS

Convention against Torture (CAT), ................................................................................... 11 Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), ................................. 4–5, 11, 13, 27, 30, 38, 41, 51, 102–103, 105–109, 111–112, 115, 117, 119–120, 184, 279n1 Convention on the Elimination of All Forms of Racial Discrimination (CEAFRD), .......... 11 Convention on the Rights of the Child, .............................................................................. 5 European Convention on Human Rights (ECHR), ................... 4, 11, 17n33, 18, 20–21, 102, 107–108, 112, 114, 117–118, 126, 147–148, 262–264, 271, 281–282, 395 International Covenant on Civil and Political Rights (1966) (ICCPR), ............ 11–16, 19–21, 49–51, 125n15, 126, 156, 159–160, 166, 348 International Covenant on Economic, Social and Cultural Rights (1966) (ICESCR), .................................... 4–9, 11, 13, 16, 40–41, 42, 43, 48–51, 58, 62–65, 69, 77, 125n1, 127, 137, 156–160, 162, 185, 191, 197, 219, 247, 261, 348, 390–392, 394–396 Prohibition on Face Covering Regulation (Hong Kong), ................................................ 161 Prohibition on Group Gathering Regulation (Hong Kong), ............................................ 163 UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, ...................................................................................... 263n16 UN Convention on Rights of the Child (1989) (CRC), ............................................ 11, 122 UN Convention on the Rights of Persons with Disabilities (CRPD), ............... 11, 13–14, 17, 20n53, 28, 29n24 Universal Declaration of Human Rights (1948) (UDHR), .......... 4–5, 7, 9, 11–17, 19–22, 38, 44, 48–50, 125, 157, 208, 247, 367, 390

xii

TABLE OF SECONDARY LEGISLATION

Abortion (Northern Ireland) Regulations 2020, .............................................................. 106 African Commission on Human and Peoples’ Rights,‘Guidelines, ................. 191n62, 192n66 Constitution of the Federal Republic of Nigeria, 1999, ...................................... 188n49, n51 Constitution of the Republic of Nigeria 1999, ........................................................... 188n48 Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) OJ L 117, 5.5.2017, 1–175, ..................................................................................... 131n60 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001, ................................................................................................. 131n60 Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, ...................................................................................................... 131n60 Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005, ................................................................................................. 131n62 Directive 98/79/EC and Commission Decision 2010/227/EU, .................................. 131n60 National Health Service (Charges to Overseas Visitors) (Amendment) (Wales) Regulations 2009, ...................................................................................... 292n85 National Health Service (Charges to Overseas Visitors) (Scotland) Regulations 1989, .................................................................................................. 292n86 Northern Ireland Assembly Committee for Health, Social Services and Public Safety, 2014, ........................................................................................................... 291n77 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2015, ........................................................................................ 293n90 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, .......................................................................................................... 131n60 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, .......................................................................................................... 131n60

xiii

TABLE OF STATUTES

Abortion Act 1967 (GB), ......................................................................................... 104, 120 s 1, ....................................................................................................................... 104n6 s 4, ............................................................................................................ 114, 115, 118 African Charter Act Art 16, .................................................................................................................... 193 Assisted Suicide Prevention Restriction Act of 1997 (US), ............................................... 371 Canada Health Act of 1984, ............................................................................................ 368 Child Rights Act (NG), .................................................................................................. 197 Crimes Act 1961 (NZ), ................................................................................................... 359 Criminal Justice Act (NI) 1945 s 25(1), ................................................................................................................... 107 Death with Dignity Act (OR, US), .......................................................................... 337, 371 Death with Dignity Bill 2003 (NZ), ................................................................................ 359 Death with Dignity Bill 2016 (SA), ................................................................................. 351 Discrimination against Persons with Disabilities (Prohibition) Act 2018 (NG), .......... 200–201 End of Life Choice Act 2019 (NZ), .......................................................................... 348, 362 End of Life Choice Bill 2019 (NZ), ......................................................................... 351, 360 End-of-Life Choices (Voluntary Assisted Dying) Bill 2020 (TAS), .................................... 351 Equality Act 2010 (UK), .......................................................................................... 262–263 European Communities Act 1972, ................................................................................... 247 Euthanasia Laws Act 1997 (Cth), ..................................................................................... 350 Health Act 2017 (KE), .................................................................................................... 210 Health and Medical Care Act (SE), .................................................................................. 136 s 6, .......................................................................................................................... 137 s 7, .......................................................................................................................... 137 Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, ........ 286n49 Health (Regulation of Termination of Pregnancy) Act 2018 (IRL), .................................. 102 s 9, .......................................................................................................................... 110 s 12(1), .................................................................................................................... 110 Human and Peoples’ Rights (Ratification and Enforcement) Act 1983 (NG), ................... 190 Human Rights Act 1998 (UK), .......................................................... 155, 246, 262, 282, 294 xiv

Table of statutes

Immigration Act 2014 (UK) s 39, ........................................................................................................................ 285 Life During Pregnancy Act 2013 (IRL), .......................................................................... 109 Mental Capacity Act 2005 (UK), ................................................................................ 285n43 Mental Health Act 1983 (UK), ................................................................................... 285n43 Montana’s Terminally Ill Act (MT, US), ........................................................................... 372 National Health Act 2014 (NG), ............................................................... 187, 197–200, 393 s 3(1), ...................................................................................................................... 198 s 11, ........................................................................................................................ 198 National Health Insurance Scheme Act (NG), ................................................................. 194 National Health Service (Scotland) Act 1978, .................................................................. 283 New Zealand Bill of Rights Act 1990, ............................................................................. 359 NHS Act 1977 (UK), ...................................................................................................... 283 s 121, ................................................................................................................. 283n20 NHS Act 2006 (UK) s 1, .......................................................................................................................... 246 Northern Ireland (Executive Formation etc) Act 2019, ............................................. 104, 119 s 9, ............................................................................................................ 105, 106, 111 s 9(1), ...................................................................................................................... 106 s 9(2), ...................................................................................................................... 106 s 9(3), ...................................................................................................................... 106 s 9(4), ...................................................................................................................... 106 s 9(5), ...................................................................................................................... 106 s 9(6), ...................................................................................................................... 106 s 9(7), ...................................................................................................................... 106 s 12, ........................................................................................................................ 120 Offences Against the Person Act 1861 (UK) s 58, ...................................................................................................... 104, 104n5, 107 s 59, ................................................................................................................. 104, 107 Patient Act 2014 (SE), .............................................................................................. 136, 138 Patient Protection and Affordable Care Act (ACA) (US), ................................................. 368 Patient Safety Act 2010 (SE), .................................................................................... 136, 138 Prisons Act (NG) s 7, .......................................................................................................................... 193 s 8, .......................................................................................................................... 193 Republic of Ireland Miscellaneous Provisions Act 2019, ................................................... 287 Rights of the Terminally Ill Act 1995 (NT), ..................................................................... 349 Transition to Devolution Act 2012 (NG), ........................................................................ 213 Voluntary and Natural Death Bill 1993 (ACT), ............................................................... 349 Voluntary Assisted Dying Act 2017 (Vic), ................................................................. 348, 351 Voluntary Assisted Dying Act 2019 (WA), ........................................................................ 348 Voluntary Assisted Dying Bill 2017 (NSW), ..................................................................... 351 Voluntary Assisted Dying Bill 2019 (WA), ....................................................................... 357

xv

CONTRIBUTORS

Sushant Chandra is an Associate Professor and Assistant Director of the Clinical Law Programme at Jindal Global Law School, India. Chandra graduated from Gujarat National Law University in 2011 with 7 Gold Medals and Best Outstanding Student Award, after which he pursued the BCL at the University of Oxford, UK. He takes keen interest in public law and legal philosophy. He is particularly interested in the development of administrative law in India. He has published widely in various academic and non-academic journals. He assists in directing the Center on Clinical Programme at the Jindal Global Law School. He is also a full-time member of the Global Alliance for Justice Education and takes keen interest in its work. Thana C de Campos-Rudinsky is a Research Fellow at the Princeton Institute for International and Regional Studies, Princeton, New Jersey, USA; and an Assistant Professor at the School of Government, Pontifical Catholic University of Chile. Her publications include The Global Health Crisis: Ethical Responsibilities (Cambridge University Press 2017) and The Philosophical Foundations of Medical Law (co-edited with Andelka Phillips and Jonathan Herring). Charles Foster is a Visiting Professor at the University of Oxford, UK; a fellow of Green Templeton College, Oxford; a Senior Research Associate at the Uehiro Institute for Practical Ethics, Oxford; and a Research Associate at the Ethox Centre and the HeLEX Centre at the University of Oxford. He is also a practising Barrister. He has been involved in some of the leading English medical law cases, such as Nicklinson v Ministry of Justice, Purdy v DPP, and An NHS Trust v Y. Some of his publications include Human Thriving and the Law (with Jonathan Herring) (Springer 2018); Identity, Law and Personhood (with Jonathan Herring) (Springer 2017); Human Dignity in Bioethics and Law (Hart 2012); and Choosing Life, Choosing Death – The Tyranny of Autonomy in Medical Law and Ethics (Hart 2009). Ian Freckelton, QC, is a practising Barrister at Castan Chambers, Melbourne, Australia. He is also a Professorial Fellow in Law and Psychiatry at the University of Melbourne; an Adjunct Professor of Forensic Medicine at Monash University, Melbourne; and an Adjunct Professor at Johns Hopkins University in Baltimore, Maryland, USA. He is a judge of the Supreme Court in Nauru. He is the Editor of the Journal of Law and Medicine and the founding Editor of Psychiatry, Psychology and Law. He has been a Commissioner at the Victorian Law Reform Commission. xvi

Contributors

Amongst his publications are the following: Pandemics, Public Health Emergencies and Government Powers (edited with Belinda Bennett) (Federation Press 2021). Expert Evidence: Law, Practice and Procedure (6th edn Thomson Reuters 2019); Expert Evidence and Criminal Jury Trials (with Jane Goodman-Delahunty, Jacqueline Horan and Blake McKimmie) (Oxford University Press 2016); Scholarly Misconduct (Oxford University Press 2016); Tensions and Traumas in Health Law (edited with Kerry Petersen) (Federation Press 2016); Coercive Care: Rights and the Law (edited with Bernadette McSherry) (Routledge 2013). Jonathan Herring is the DM Wolfe-Clarendon Fellow in Law at Exeter College, UK; and a Vice Dean and Professor of Law at the University of Oxford, UK. He has written extensively in the areas of medical law and ethics, care law, elder law, family law, criminal law, and law and vulnerability. Some of his publications include Medical Law and Ethics (8th edn Oxford University Press 2020);Law and the Relational Self (Cambridge University Press 2019);Vulnerability, Childhood and Law (Springer 2018); Vulnerable Adults and the Law (Oxford University Press 2016); Altruism, Welfare and Law (with Charles Foster) (Springer 2015); Domestic Abuse and Human Rights (Intersentia 2020); Criminal Law (10th edn Oxford University Press 2020); and Older People in Law and Society (Oxford University Press 2009). Helen Hughes is the Chief Executive of Patient Safety Learning, a charity and independent voice for improving patient safety. Helen’s passion for improved patient safety is informed by personal family insight into the impact of unsafe care and the ineffectiveness of organisational responses to learn from error. Helen is an experienced leader in organisational effectiveness and transformational change. She has held leadership roles in healthcare in the UK and the World Health Organisation, the National Patient Safety Agency, Equality and Human Rights Commission, Parliamentary Health Services Ombudsman, and the Charity Commission. Lara Khoury, AdE (Quebec Bar), LLB (Sherb), BCL (Oxon), DPhil (Oxon), is an Associate Professor at the Faculty of Law, Co-Director of the McGill Research Group on Health and Law, Associate Member of the Institute for Health and Social Policy and of the Biomedical Ethics Unit, all at McGill University, Montreal, Quebec. She is a permanent member of the Paul-André Crépeau Center for Private and Comparative Law. Stephen King is a Partner at Mills & Reeve LLP solicitors, Norwich, UK. King is a dispute resolution lawyer/advocate. He acts on insurance coverage disputes/malpractice defence/ healthcare-related risks. Clients include insurers, government bodies, healthcare professionals, and corporates involved in healthcare provision including telemedicine and diagnostic services. Insurer clients include professional indemnity, accident and health, critical illness, regulatory, and management liability risks. Edward Lui is a BCL Candidate at Magdalen College, University of Oxford, UK. His research interests lie mainly in medical law and public law. Jean V McHale is a Professor of Health Care Law at the University of Birmingham, UK. She is Director of the Centre for Health Law, Science and Policy. Her recent books include The Regulation of Cosmetic Procedures: Legal, Ethical and Practical Challenges (with Melanie Latham) (Routledge 2020); European Health Law:Themes and Implications (with Tamara Hervey) (Cambridge University Press 2015); Routledge Handbook of Complementary and Alternative Medicines: Perspectives from Social Science and Law (edited with Nicola Gale) (Routledge 2015); and Principles of Medical Law (edited with Judy Laing) (4th edn Oxford University Press 2017). xvii

Contributors

Carsten Momsen heads the Department of Comparative Criminal Law, Criminal Procedure Law, White Collar/ Economic and Environmental Criminal Law at Freie Universität Berlin. Since 2019, he is the ongoing visiting scholar at John Jay College of Criminal Justice (City University of New York), New York, USA. Among other positions, in 2012 he was Visiting Professor at Symbiosis University in Pune, India, and at the University of Toronto, Canada, in 2016 and 2019. He holds a position as scholar in residence at New York Law School, New York, USA. Momsen is a founding member and PI of the Berlin-based Einstein Center Digital Future, and a permanent member of the Program Committee of the international conference series SADFE – Systematic Approaches on Digital Forensic Engineering. In addition to various compliance issues, current projects are focused on corporate responsibility for human rights violations, comparative whistle-blower protection, and assessment of wrongful convictions and miscarried investigations. Research includes the related data protection issues, digital evidence, and digital forensics. Of interest are discriminatory effects of predictive policing based on the use of big data and artificial intelligence (AI) in particular and the impact on human rights. Zahara Nampewo is a Ugandan lawyer, academic, and human rights practitioner teaching at Makerere University School of Law, Kampala, Uganda. She also heads the Human Rights and Peace Centre (HURIPEC), a research and advocacy centre of Makerere University. Nampewo’s areas of interest and expertise include human rights, health justice, gender, and transitional justice. She is Managing Editor of the East African Journal on Peace and Human Rights, an international, peer-reviewed, bi-annual scholarly publication of HURIPEC. Nampewo was winner of the 5th Women in Law Award for ‘Female Lawyer Academic,’ awarded in 2019 by the Uganda Law Society on 7 March 2019. Naomi N Njuguna is a Lecturer at the University of Nairobi, Kenya, and is also an Advocate of the High Court of Kenya. Her areas of specialisation and research are in Labour Law, Medical Law and Ethics and Health Law and Policy and has engaged in several research projects and written scholarly papers in these areas. She has keen interest in health rights, patient safety and occupational safety and health of healthcare workers in low- and middle-income countries. Clayton Ó Néill, LLB (Ulster), LLM (Dub), BCL (Oxon), PhD (Durham), FHEA, is a Lecturer in Law at Queen’s University Belfast, Northern Ireland. He has published a monograph, titled Religion, Medicine and the Law (Routledge 2018). He has also edited a book called Global Patient Safety: Law, Policy and Practice (Routledge 2018) (with John Tingle and Morgan Shimwell). He has a particular interest in medical law and ethics, and the application of human rights. He is also concerned with the interconnection between the manifestation of religious belief and the exercise of autonomy. He has published related material in journals such as Medical Law International, Medical Law Review, and European Journal of Health Law. Cheluchi Onyemelukwe is an Associate Professor in Health Law and Policy at Babcock School of Law and Security Studies at Babcock University in Nigeria. She is also a partner at Health Ethics and Law Consulting in Nigeria. She has written a monograph titled Health Research Governance in Africa: Law, Ethics and Regulation (Routledge 2018). Barbara A Reich is a Professor of Law at Western New England University School of Law, Springfield, Massachusetts, USA. She teaches torts and a variety of medical law subjects, including biomedical ethics and end-of-life law. She received her JD from Harvard Law School, Cambridge, Massachusetts, USA. She then spent two years in private practice in Washington, xviii

Contributors

DC, specializing in pharmaceutical and medical device law. Her research interests include legal and ethical issues in end-of-life decision-making, comparative end-of-life law, paediatric health issues; racial disparities in the delivery of health care, clinical research ethics, and the impact of politics in science and medicine. Mathis Schwarze is a PhD candidate and Research Assistant at Freie Universität Berlin, Germany. He holds a law degree from Freie Universität Berlin and an MSc in Criminology and Criminal Justice from the University of Oxford, UK. His research interests include criminal law, criminology, and sentencing. Santa Slokenberga is a Senior Lecturer in Administrative Law at Uppsala University, Sweden. Her research focuses on regulating the standards of medical care and scientific uncertainty in paediatric medicine. Her other research interests include the governance of new and emerging genomic technologies, scientific research regulation, and public health challenges to democratic values and structures. Elizabeth M Speakman is a Research Fellow at the School of Health and Social Care, Edinburgh Napier University, Scotland. John Tingle is a Lecturer in Law at the University of Birmingham, UK, and a qualified Barrister. His research interests are in the areas of global and English patient safety, nursing law, and universal health coverage. He is a Visiting Professor of Law at Loyola University School of Law, Chicago, Illinois, USA. His publications include Global Patient Safety: Law, Policy and Practice (co-edited with Clayton Ó Néill and Morgan Shimwell); Law and Nursing (with Jean McHale); and Nursing Law and Ethics (co-edited with Alan Cribb). Jesse Wall is a Senior Lecturer at the University of Auckland, New Zealand. His publications include Being and Owning:The Body, Bodily Material, and the Law (Oxford University Press 2015); Landmark Cases in Medical Law (edited with Jonathan Herring) (Hart 2015); and Law, Ethics, and Medicine: Essays in Honour of Peter Skegg (edited with Mark Henaghan) (Thomson Reuters 2016). He has also published articles in leading journals, such as the Oxford Journal of Legal Studies and the Journal of Medical Ethics.

xix

PART A

International human rights and the right to health

1 AN INTRODUCTION TO HEALTH RIGHTS AS THEY APPLY IN A GLOBAL LANDSCAPE Clayton Ó Néill

Introduction We are born.We live.We die.There will be two dates on our gravestone – the date of our birth and the date of our death – and a hyphen will interlink the two.That hyphen encompasses our lived lives, all the joys, sorrows, triumphs, disappointments, high days and holidays, low days and sadnesses that we have experienced. Most of us live lives according to some form of precepts, some unwritten rules that have been laid out by our parents, our church, our own moral compass.Within those precepts we find factors that contribute to the wellness of our lives and that of the community in which we live: responsibilities and rights. In order to live mature and wellbalanced lives, we assume responsibility for ourselves and, in some cases, for others and for the planet that nourishes and sustains us.And, then, there are the rights that we possess, and it is these rights, as they pertain to health, that form the substance of this book.

Rights: phainomena and endoxa The possession of rights has long been a hallmark of citizenship. From the time of Aristotle, Plato, and Socrates, there has been a shift to recognising that the state assumes responsibility for the protection of some of the rights of its citizens. Human rights, as we know them, have evolved from the earliest formulation of the Imago Dei. They have been the subject of consideration in centuries-long cogitation on the links between natural law and individual rights. According to Jonathan Crowe, ‘[n]atural law theories, whether they are understood in a broad or narrow sense, rely on the idea that human life is directed towards certain intrinsic goods.’1 Howard P Kainz states that ‘[t]he task of natural-law theory can be interpreted as arguing that there do exist some supervening meta-laws, or as working towards a clarification of such laws, or as the specification of just what the laws are.’2 The interconnection between societal forces and individual consciousness has seen the evolution of human rights through the eyes of Locke and to the conceptualisation of rights as being linked to life, liberty, and property, as reflected in the

1 Jonathan Crowe, Natural Law and the Nature of Law (Cambridge University Press 2019). 2 Howard P Kainz, Natural Law:An Introduction and Re-Examination (Open Court 2004).

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Clayton Ó Néill

slogan of the French revolution liberté, égalité, fraternité. Many of the French revolutionaries were also motivated by Rousseau whose imprint is felt on the language of rights. Most ethical persuasions, from the most rational to the most liberal, from those that prioritise autonomy to those that value community relationships above and beyond individual determination, assume that citizens have rights and that these rights are universal, and can be universally applied and can be universally assertible.We can accept the idea that having a right means having a claim that has a legal or moral justification that allows an individual to possess something, to obtain something, or to act in a particular way that helps to assert the identity of the individual. A right to health that exists within and of itself is almost powerless unless it corresponds to other rights that help and promote the proper, fair, and equitable application of a right to health.This is Rousseau’s social contract working in a health landscape; this is Locke’s classical liberalism striving for equality, choice, and equal division of resources.3 This is Aristotle’s phainomena, the appearance of the right, and his endoxa, the credible opinions that surround the appearance of those rights.4 The philosophical problem that is explored in this book centres on the problem that is created when there is a lack of translation from the phainomena of rights to the actualisation of rights.Aristotle describes puzzles such as this as aporiai.5 This book will seek to solve the aporiai that are created when this mismatch exists. In so doing, this Handbook will show how the creation of a universal right to health that is universally applied involves reaching Aristotle’s eudaimonia – the flourishing that applies to a life that is lived well and happily.6 The preamble to the Universal Declaration of Human Rights (UDHR) recognises ‘the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world’ and ‘it is essential, if man is not to be compelled to have recourse, as a last resort, to rebellion against tyranny and oppression, that human rights should be protected by the rule of law.’7 Thus, the UN General Assembly set out the UDHR as a common standard of achievement for all peoples and all nations, to the end that every individual and every organ of society, keeping this Declaration constantly in mind, shall strive by teaching and education to promote respect for these rights and freedoms and by progressive measures, national and international, to secure their universal and effective recognition and observance, both among the peoples of Member States themselves and among the peoples of territories under their jurisdiction.8 In the international context, rights are provided for under international treaties, such as the UDHR and the International Covenant on Economic, Social and Cultural Rights (ICESCR), as well as the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), inter alia. At a European level, the main mechanism for the protection of human rights is the European Convention on Human Rights (ECHR).The right to health can be seen both overtly and covertly. For example, the specific right to health is found within Article 12

3 Jean-Jacques Rousseau, The Social Contract (Wordsworth Classics of World Literature 1998, translated by HJ Tozer). See, for example,Vere Chappell (ed), The Cambridge Companion to Locke (Cambridge University Press 1994). 4 Jonathan Barnes (ed), The Complete Works of Aristotle: The Revised Oxford Translation (vols 1 and 2) (Princeton University Press 1984). 5 See ‘Aristotle’, Stanford Encyclopaedia of Philosophy (25 September 2008, revised 29 July 2015). 6 ibid. 7 Preamble, UDHR www.un.org/en/universal-declaration-human-rights/ accessed 30 June 2020. 8 ibid.

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An introduction to health rights

ICESCR and Article 25 UDHR, but the right to health does not exist in a vacuum. It is connected to other rights, such as the right to education and the right to housing.There are different elements to the right to health.The Office of the United Nations High Commissioner for Human Rights (OHCHR)/World Health Organization (WHO) in Fact Sheet 31 state that the right to health is ‘inclusive’ and that it contains both ‘freedoms’ and ‘entitlements.’9 In relation to the inclusivity of the right, they link the right to health to availability of healthcare and creation of hospitals as well as other factors, such as safe water, nutrition, housing, safe environments, and gender equality.10 This approach is also taken by the Committee on Economic, Social and Cultural Rights, which is responsible for supervising the rights under the ICESCR. In relation to freedoms, in Fact Sheet 31, the OHCHR/WHO refers to freedoms, such as freedom from medical treatment that is non-consensual and freedom from torture, or treatment that is degrading or inhuman.11 In the context of entitlements, focus is placed on ensuring the right to equal opportunities in order to ensure that every person can have access to the best possible level of health, a right to the ‘prevention, treatment and control of diseases,’ availability of necessary drugs, and appropriate reproductive health, amongst others.12 Fact Sheet 31 also states that there is no place for discrimination in the facilitation of health services and goods, and these services ‘must be available, accessible, acceptable and of good quality.’13 Fact Sheet 31 refers to misconceptions pertaining to the right to health. It states that a difference exists between the right to health and the right to be healthy.This right is not simply ‘a programmatic goal to be attained in the long term’ and a nation’s financial demands do not release it from its obligations to strive for the realisation of the right to health.14 It is clearly recognised that rights that protect people from discrimination (e.g. International Covenant on the Elimination of All Forms of Racial Discrimination), protect women (CEDAW, Articles 10(2) and 12), protect children (Article 25, Convention on the Rights of the Child), and protect people with disabilities (Convention on the Rights of Persons with Disabilities) are also relevant. This, therefore, seems to be a simple, non-problematic issue; health rights exist and are historically and philosophically bound to human rights. Significant protections are in place to support the manifestation of these rights.Why do we need to consider the issue of global health at all? There is, in my view, a gap between the right to health as it exists and the way it is applied or not applied at a global level. The mismatch between legal underpinning and practical reality forms the cornerstone of much of the debate in this Handbook.The need to translate the rights that are described and justified under international treaties and the failure of states and individuals to assume responsibility for the practical application of these rights lies at the centre of the anomalies that exist in different jurisdictions. Health-related rights and health rights have a symbiotic relationship. It is difficult to achieve physical and mental wellness through access to appropriate healthcare that is mandated by a right to health without also being able to draw upon the well of rights that supports the provision of education, a home, safe water, sanitation and work.That ensures that freedoms exist within a safe and non-discriminatory environment. This Handbook will meander through the intersection of these rights and lay bare some of the

9 The Office of the United Nations High Commissioner for Human Rights (OHCHR)/World Health Organization, ‘The Right to Health: Fact Sheet No. 31’ 3. www.ohchr.org/Documents/Publications/Factshee t31.pdf accessed 23 October 2020. 10 ibid 3–4. 11 ibid 4. 12 ibid 3. 13 ibid 4. 14 ibid 5.

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inequalities that prevent the full manifestation of a right to health.The final chapter will set forth a pathway towards the global achievement of this goal.

A local impact and a global reach? The human world is one that is both local and global. It is local in the sense that individuals live their lives in a small community and, no matter how far the travel and how wide the repertoire of geographical adventures, it is in the nature of the human spirit to find ease and sustenance at home, in one location, in a place where there is love, human contact, and human relationships. The interactions created and nurtured by people are primarily local. That local experience is, however, intrinsically linked to the global connections that are made and to the global context that is created.This book has a particularly global reach in so far as it attempts to show that the issue of health rights may be experienced differently in different contexts and jurisdictions, but the same rights remain irrespective of their iterations and their apparel. What happens at a local level is, thus, influenced by a global identity and by global happenings.This pertains, particularly, to the context of health. Part of the remit of this book is to look at health rights as they exist within different jurisdictions and to try to draw parallels within these jurisdictions on a thematic basis. But, aligned to health rights is the concept that we also have parallel responsibilities. In the book, we will look at the idea that, while health rights exist within themselves and of themselves, unless they are aligned with a real acceptance of the responsibilities that belong to both individuals and governments, then those rights, in fact, cannot be vivified. The focus of the book is, thus, on the idea that there are global health rights, but problems exist in both local and global application of these rights. In order to ensure that we had a wide global reach, the authors of this book extend from Ireland to England to Australia to Hong Kong to India to America and other places in between. It was impossible to ensure that every jurisdiction was accounted for, but we tried to ensure that there was a balance between the various continents and a balance, also, between the thematic consideration of some of the areas that are addressed within the book.We aim to highlight what is happening in different jurisdictions, but this is not just a textbook telling the reader ‘this is the health rights’ situation in Uganda or Kenya or in the United Kingdom. Instead, the book attempts to analyse, to critique, and to criticise positions that have been taken by respective governments and respective legal systems in terms of health rights.We have tried to link an analysis of health rights in geographical areas, as they apply to topical issues, to the core question of whether the right to health is applied appropriately within the global landscape.The analysis of specific areas pertaining to health rights is aligned to themes that transcend particular jurisdictional borders.

Scope of the Handbook: aporiai The book attempts to answer one key question: Does a universal right to health exist in practice? In posing that question there is almost a presumption that that one question is the finite one but, of course, the idea of health rights is much more complex than that.The answers to one question cannot, in any way, begin to encompass the complexities and the pluralities that exist within this whole area, but they provide the conduit through which several sub-questions can be addressed. Underneath that core question, there are a number of allied sub-questions, which could include things like the following: •

If a right exists within one country, does that right automatically exist within other countries or should it exist? 6

An introduction to health rights

• • • •

Are there other factors that would preclude the existence of the operationalising of that right on a cross-jurisdictional basis? What practical steps can be taken to ensure that there is a marriage of two minds between health rights and health-related rights? How are health rights balanced with other rights and responsibilities at both the national and transnational level? What is the role of the individual in the manifestation of health rights?

These questions and others will be explored throughout the practical examples described and analysed in Part B, and conclusions in respect of them will be drawn in Part C.

Structure The book is divided into three parts. In Part A we consider the legal backdrop to the right to health, Part B looks at what happens to health rights within different jurisdictions, and Part C provides answers to the core question relating to the universality of health rights.

Part A: International human rights and the right to health Part A sets the scene. It delineates the specific rights that are currently ascribed to health from within the context of international human rights law. As such, it provides a link between the relevant international treaties and the specific right to health. In Chapters 2, 3, and 4, we will set out the main rights that protect the right to health, particularly through the lens of the UDHR and the ICESCR.The primary focus of Charles Foster’s and Jonathan Herring’s chapters is on the connection between the UDHR and the right to health. Clayton Ó Néill analyses the role of the ICESCR in relation to the right to health and links this discussion to health emergencies, such as the current COVID-19 pandemic, and the wider conceptual issues of justice and globalisation.Thana C de Campos-Rudinsky considers global health rights in the context of the Inter-American Court of Human Rights. This part of the book describes the protections that are in place to support health rights, and connections are drawn to concepts such as justice, dignity, and globalisation.The emerging urgency of health rights in the context of global emergencies is scrutinised.Thus, Part A involves a broad brushstroke approach to health rights. It provides the legal backdrop for the deeper consideration of how these health rights are applied or not applied in specific jurisdictions, which is explored in Part B.

Part B: Health rights across the temporal stages in specifc countries Part B considers the chronological continuum of pertinent issues pertaining to health at different stages of life: (i) the beginning of life, (ii) the middle of life, and (iii) the end of life.

Beginning of life The beginning of life section considers issues such as abortion and assisted reproduction. Zahara Nampeow discusses assisted reproductive technologies in Uganda as they pertain to law and practice. Clayton Ó Néill explores abortion and conscientious objection in Northern Ireland. Santa Slokenberga brings to life the interplay between a child’s right to health and bodily integrity/paediatric decision-making in Sweden. 7

Clayton Ó Néill

Middle of life The middle of life section covers a wide range of issues, ranging from the cost of healthcare, the regulation of human tissue, children’s rights in health contexts, and the issue of patient safe and quality of care. Edward Lui writes about the health rights issue in Hong Kong. Sushant Chandra considers the vexed question of dignity in the adjudication of health rights in India. Cheluchi Onyemelukwe considers the arguments surrounding universal health coverage and the right to health in Nigeria. Naomi N Njuguna discusses the relationship between health governance and patient safety in Kenya. Stephen King, John Tingle, and Helen Hughes address patient safety from different perspectives. Jean V McHale and Elizabeth M Speakman provide an analysis of the mythically ephemeral, but real, concept of ‘visitors’ and charging for NHS services. Lara Khoury positions her discourse on public reporting, transparency, and patient autonomy in Quebec.

End of life The end of life section predominately focuses on euthanasia and assisted dying.These chapters all share common themes: the right to self-determination and bodily integrity, as well as the concept of respect for the dignity of human beings. Jesse Wall analyses the issue of human tissue, human rights, and humanity. Carsten Momsen and Mathis Schwarze refer to the German perspective on autonomy and the right to (end one’s) life. Ian Freckelton contextualises health rights from the perspective of end-of-life issues in Australia and New Zealand. Barbara A Reich considers the issue of medical aid in dying in the United States and Canada

Part C: The application of a universal right to health in practice In Part C, Clayton Ó Néill and Charles Foster join the individual threads that have been woven throughout Part B and bring us towards a summary/synthesis where the actual question of ‘Does a universal right to health apply in practice in a global landscape?’ is addressed and answered. Part C analyses the intersection between rights and responsibilities, and positions rights and responsibilities as co-dependent within the area of health rights and related rights. It answers the question as to whether a right to health is applied practically throughout different jurisdictions and offers some solutions towards a more enduring pathway to the realisation of this right. Thus, the spectrum of life is contained within the book – beginning, middle, and end – and many of the infinite commas and apostrophes that exist within the balance of life.

Conclusion: eudaimonia This Handbook does not sit on a philosophical fence. It is unapologetically partisan in the sense that the contributors, in almost all instances, advocate for equity in terms of sharing resources and knowledge.They also support proportionality in the use of medical regulations and in the procedures that govern patient safety.They recommend investing the attributes of liberté, égalité, fraternité in the global application of a right to health. Health rights, as a social justice issue, is the primary refrain of the lyrics of the book. Let us return for one minute to the hyphen that encompasses our lives – for many people, their life will be whole, hearty, and healthy, but, for others, that life may be consumed by illhealth and by the necessity to spend considerable amounts of time in hospitals and in healthcare contexts.The book points to anomalies, injustices, and disproportionate delivery of healthcare 8

An introduction to health rights

within particular countries, and it juxtaposes these provisions with a right to health that we consider to be universal.The journey along which we hope you will travel with us is one that will take us through many different jurisdictions, and will address different health needs and different health rights and responsibilities. But, in the end, as the journey comes to a conclusion, we hope that we will be able to say, ‘Yes, there is a right to health.Yes, it is universal.Yes, it has universal applicability.’ So, come with us and share the journey.

References ‘Aristotle’, Stanford Encyclopedia of Philosophy (25 September 2008, revised 29 July 2015). Chappell,Vere (ed), The Cambridge Companion to Locke (Cambridge University Press 1994). Crowe, Jonathan, Natural Law and the Nature of Law (Cambridge University Press 2019). Jonathan, Barnes (ed), The Complete Works of Aristotle: The Revised Oxford Translation (1 and 2) (Princeton University Press 1984). Kainz, Howard P, Natural Law:An Introduction and Re-Examination (Open Court 2004). Preamble,‘UDHR’ www.un.org/en/universal-declaration-human-rights/ accessed 30 June 2020. Rousseau, Jean-Jacques, The Social Contract (Wordsworth Classics of World Literature 1998, translated by HJ Tozer). The Office of the United Nations High Commissioner for Human Rights (OHCHR)/World Health Organization, ‘The Right to Health: Fact Sheet No. 31’ 3 www.ohchr.org/Documents/Publications/ Factsheet31.pdf accessed 23 October 2020.

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2 UNIVERSAL DECLARATION OF HUMAN RIGHTS, PART 1 Articles 1, 2, 3, 5, and 6 Charles Foster

Introduction The Universal Declaration of Human Rights (1948) (UDHR) has several effects. It expresses the overwhelming international consensus on how human beings should be treated, and accordingly helps to declare, enshrine, and perpetuate an ethos. That ethos is itself powerful: it acts as an inhibition to human violations and a spur to better treatment. It seeps, often unnoticed, into many political, legal, and other deliberations. This chapter, though, is concerned with the more formal effects of the UDHR.There is a debate, which is outside the scope of this book, about whether or not the UDHR forms part of customary international law. But it is not disputed that the UDHR underpins (by whatever legal mechanism) a number of international instruments which are binding (to varying degrees and by varying mechanisms) on states that ratify them. Instruments such as the International Covenant on Civil and Political Rights (1966) (ICCPR); the International Covenant on Economic, Social and Cultural Rights (1966) (ICESCR); the UN Convention on Rights of the Child (1989) (CRC); the Convention on the Elimination of All Forms of Racial Discrimination (CEAFRD); the Convention on the Elimination of All Forms of Discrimination Against Women (CAFDAW); the Convention on the Rights of Persons with Disabilities (CRPD); the Convention against Torture (CAT); and many others all give real force to the principles of the UDHR.This chapter looks particularly at the embodiment in the ICCPR, the ICESCR, and the CRC of those UDHR principles that relate to human health. It does not detail the procedures for enforcement or their efficacy. Many of the provisions of the UDHR overlap significantly with those of other instruments of rather different genealogy. The obvious example is the European Convention on Human Rights (ECHR). It is tempting to use Strasbourg jurisprudence as a lens through which to view the UDHR and its derivative instruments, but one should be careful about this – notably because the doctrine of the margin of appreciation applied when construing the demands of the ECHR has a legal life of its own, and while the UDHR-derived instruments are interpreted with a sensitivity to the national context that is analogous in some ways to the way that the margin of appreciation operates, the analogy is not perfect.

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Charles Foster

Article 1 Article 1: All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood. This most sonorous of the UDHR’s declarations is, historically, a creature of the notion of the Imago Dei. If all human beings are made in the image of God, there are two broad consequences. First, since God deserves to be honoured, creatures bearing his stamp deserve to be respected. And second, since all humans bear this stamp and share the same divine origins, no one is entitled to more or less respect than any other. The Imago Dei is the most profoundly egalitarian declaration. The ‘brotherhood’ spoken of in Article 1 is not, though, the very first biblical example of brotherhood (the first brothers were Cain and Abel, and Cain murdered Abel): it is instead an aspirational extrapolation from the asserted fact of the Imago Dei: if humans really are those sorts of creatures, one should behave to them like truly functional brothers. If the article were taken seriously, there would be nothing else for the UDHR or its legal offspring to do. Its other articles, and those of (for instance) the ICCPR and the ICESCR can be regarded as exposition of Article 1. As elsewhere in comparable international declarations, there is no attempt to define its key ideas – such as dignity.The UDHR was signed in the immediate aftermath of the Second World War: its context was Auschwitz. Whatever dignity was, it was clear that it had been violated there. Whatever the source of rights, they had not been respected. It was no time for jurisprudential niceties.The broad outline of the lessons learned was clear: it had to be etched in stone before memories faded.The detail could be added later. In the article, the birth of a human marks a new start: a new story, to be told according to the principles of the Declaration. Children are distinct from their parents.1 A child born to a (rightly) imprisoned mother is free.The Declaration gets rather carried away with its own rhetoric. It is not true, for instance, that an anencephalic child (which is certainly a human being), is ‘endowed with reason,’ or, presumably, conscience. And one must be careful about concluding from the article that humans possess dignity and rights because they have reason and/or conscience.That would exclude from the protection of the UDHR many of the humans who most needed that protection: the very young, the unconscious, and the otherwise mentally uncapacious. The spirit of Article 1, then, infuses and informs all the other articles of the UDHR. In the context of health, because ‘dignity’ and ‘rights’ are not self-defining, and because it is not self-evident what ‘dignity’ and ‘rights’ entail for health, the real work of Article 1 is delegated to other UDHR articles and to other instruments.

Article 2 Article 2: Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national of social origin, property, birth, or other status. Furthermore, no

1 CRC Article 3(1), for instance, provides that ‘in all actions concerning children, whether undertaken by public or private social welfare institutions, courts of law, administrative authorities or legislative bodies, the best interests of the child shall be a primary consideration.’The best interests of the child may, but may not, coincide with the interests of the parents or the views of the parents about how the child should be treated.

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distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation or sovereignty. This is clear enough: it is a corollary of the egalitarian component of Article 1.Whatever health rights and freedoms human beings should have, must be had by all. Its words are repeated many times elsewhere.2 In the CRC, for instance,Article 2(1) provides that States Parties shall respect and ensure the rights set forth in the present Convention to each child within their jurisdiction without discrimination of any kind, irrespective of the child’s or his or her parent’s or legal guardian’s race, colour, sex, language, religion, political or other opinion, national, ethnic or social origin, property, disability, birth or other status. The circumstances in which discrimination in a healthcare context might be invoked are infinitely various. Under CRPD Article 5, for instance, an applicant suffered a number of complex health issues following a discectomy. She sought a number of types of treatment and rehabilitation, and contended that the United Kingdom discriminated against her in a number of ways in failing to provide them, and that this discrimination was, inter alia, a result of her disability.3

Article 3 Article 3: Everyone has the right to life, liberty and security of person.

Introduction The fullest expression of Article 3, insofar as it relates to the right to life, is contained in ICCPR Article 6.4 Much of Article 6 relates to the death penalty (which is not considered in this chap-

2 See too ICCPR Articles 2(1), 14, 24, 25, and 26; ICESCR Article 2.2; CERD Articles 1, 2, 4, and 5; CEDAW Articles 2, 3, 4, and 15; CRPD Articles 3, 4, 5, and 12. In the CAT, if treatment is discriminatory, that is a factor in it being ‘degrading.’ 3 CRPD:Application 27/2015.The case was framed in a number of ways:Articles 5 and 25 were particularly important.The application was ruled inadmissible. 4 The full text of Article 6 of the ICCPR reads: 1. Every human being has the inherent right to life.This right shall be protected by law. No one shall be arbitrarily deprived of his life. 2. In countries which have not abolished the death penalty, sentence of death may be imposed only for the most serious crimes in accordance with the law in force at the time of the commission of the crime and not contrary to the provisions of the present Covenant and to the Convention on the Prevention and Punishment of the Crime of Genocide.This penalty can only be carried out pursuant to a final judgement rendered by a competent court. 3. When deprivation of life constitutes the crime of genocide, it is understood that nothing in this article shall authorize any State Party to the present Covenant to derogate in any way from any obligation assumed under the provisions of the Convention on the Prevention and Punishment of the Crime of Genocide. 4. Anyone sentenced to death shall have the right to seek pardon or commutation of the sentence.Amnesty, pardon or commutation of the sentence of death may be granted in all cases. 5. Sentence of death shall not be imposed for crimes committed by persons below eighteen years of age and shall not be carried out on pregnant women. 6. Nothing in this article shall be invoked to delay or to prevent the abolition of capital punishment by any State Party to the present Covenant.

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ter) but Article 6(1) is of more general application. It provides: ‘1. Every human being has the inherent right to life.This right shall be protected by law. No one shall be arbitrarily deprived of his life.’ The CRC has a corresponding provision,5 as does the CRPD6 and the African Charter on Human and Peoples’ Rights.7 The most authoritative statement of the meaning of the right to life provisions of ICCPR Article 6, and thus of the right to life provisions of UDHR Article 3, is in a General Comment by the UN Human Rights Committee.8 ‘Liberty and security of person’ under ICCPR Article 6 has its own General Comment.9

An absolute right to life? The comment explains that The right to life is the supreme right from which no derogation is permitted, even in situations of armed conflict and other public emergencies that threaten the life of the nation. The right to life has crucial importance both for individuals and for society as a whole. It is most precious for its own sake as a right that inheres in every human being, but it also constitutes a fundamental right, the effective protection of which is the prerequisite for the enjoyment of all other human rights and the content of which can be informed by other human rights.10 The observation about the right to life being a ‘prerequisite’ to the enjoyment of other rights might sound like a statement of the biologically obvious: the dead do not (or we do not know that they do) exercise (for instance) a right to self-determination.Yet in other legal domains (and notably under the ECHR) many debates are framed as competitions between the right to life and other rights.We return to this issue in the context of assisted suicide. Despite this start, the comment soon makes it clear that the right is not absolute. It is not just a right to ‘be free from acts and omissions that are intended to be or may be expected to cause their unnatural or premature death,’ but also (since the right ‘should not be interpreted narrowly’) a right ‘to enjoy life with dignity.’11 It is this wider construction, perhaps ironically, that dilutes the absolute nature of the right. This is made clear later in the comment:‘Although it inheres in every human being, the right to life is not absolute.’12 The right is repeatedly described as a right not to be arbitrarily deprived of one’s life.13 This formulation does not sit happily with the way that the right is explained elsewhere in the comment where, for instance, the right is said to concern ‘the entitlement of

5 CRC Article 6(1):‘Every human being has the inherent right to life.This right shall be protected by law. No one shall be arbitrarily deprived of his life.’ 6 CRPD Article 10:‘States Parties reaffirm that every human being has the inherent right to life and shall take all necessary measures to ensure its effective enjoyment by persons with disabilities on an equal basis with others.’ 7 Article 4:‘Human beings are inviolable. Every human being shall be entitled to respect for his life and the integrity of his person. No one may be arbitrarily deprived of this right.’ 8 GC 36 (CCPR/C/GC/36) 30 October 2018. 9 GC 35 (CCPR/C/GC/35) (2014). 10 GC 36 1(2). 11 GC 36 1(3). 12 GC 36 II(10). 13 See GC 36 1(4), 1(7), II(10).

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individuals to be free from acts or omissions that are intended to or may be expected to cause their unnatural or premature death.’14 Intentional deaths may very well be frighteningly nonarbitrary.The existence of a well-drafted set of criteria setting out the circumstances in which a state might consider that deaths are justified will mean that deaths that meet the criteria are non-arbitrary. The General Comment deals unsatisfactorily with the question of what amounts to arbitrary deprivation of life. Such deprivation will be ‘as a rule, arbitrary if it is inconsistent with international law or domestic law.’15 This is an unhelpful and non-reassuring observation in a document whose purpose is to enshrine the ethos, if not the letter, of the relevant part of international humanitarian law.The comment seems not to recognize this worry insofar as international law is concerned, but it does address it in relation to domestic law.‘The notion of “arbitrariness” is not to be fully equated with “against the law”’ (it says),‘but must be interpreted more broadly to include elements of inappropriateness, injustice, lack of predictability and due process of law,16 as well as elements of reasonableness, necessity and proportionality.’This observation is expounded primarily in terms of the boundaries of the doctrine of self-defence – the paradigm case, in the eyes of the authors of the comment, of potentially non-arbitrary deprivation of life. It is not necessary that a life is actually lost for Article 6 to be violated: the creation of a situation that could cause a life to be lost will be caught by the article,17 as would the failure to take the necessary legislative or administrative steps to avoid loss of life or to investigate any relevant failures. The comment further provides that ‘Deprivation of life involves intentional or otherwise foreseeable and preventable life-terminating harm or injury, caused by an act or omission. It goes beyond injury to bodily or mental integrity or a threat thereto.’18

‘Liberty and security of person’ This, the second part of UDHR, finds its expression in Article 9 of ICCPR, which is interpreted by a lengthy General Comment.19 It is primarily concerned with arrest and detention.The comment does make observations of wider application, however. It states that ‘[s]ecurity of person concerns freedom from injury to the body and the mind, or bodily and mental integrity’20 and ‘[t]he right to security of person protects individuals against intentional infliction of bodily or mental injury, regardless of whether the victim is detained or non-detained.’21 The comment sees Article 9 as supplementing the right to life under ICCPR Article 3:‘The right to personal security may be considered broader [than that protected by Article 3] to the extent that it also addresses injuries that are not life-threatening.’22 That said, in the realm of health rights,Article 9 has little to add to the other articles that are considered in more detail in this book.

14 GC 36 1(3). 15 GC 36 II(12). 16 Gorji-Dinka v Cameroon (CCPR/C/83/D/1134/2002), para. 5.1; Van Alphen v Netherlands, communication No. 305/1988, para 5.8. 17 GC 36(1)(7). 18 GC 36(6). 19 GC 35 (16 December 2014). 20 GC 35 1(3). 21 GC 35 1(9). 22 GC 35 VII(55). See too ICCPR Article 10(1), which provides: ‘All persons deprived of their liberty shall be treated with humanity and with respect for the inherent dignity of the human person.’

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A right to health? It would have been possible for a general right to health to have been fashioned from Article 6 of ICCPR. In fact, that work was left to Article 12 of ICESCR, which deals with the matter expressly.23 Article 12 ICESCR is best seen as related to the UDHR via UDHR Article 25, which is dealt with in the next chapter.

The scope of the concomitant duties Rights entail duties.We have seen already that there is a right not to be ‘arbitrarily’ deprived of one’s life.There is, then, a duty on states parties to ‘refrain from engaging in conduct resulting in arbitrary deprivation of life’ and to ensure the right to life and exercise due diligence to protect the lives of individuals against deprivations caused by persons or entities whose conduct is not attributable to the State.24 The obligation of States parties to respect and ensure the right to life extends to reasonably foreseeable threats and life-threatening situations that can result in loss of life. States parties may be in violation of Article 6 even if such threats and situations do not result in loss of life.25 Article 6(1)’s requirement that the right of life ‘be protected by law’ imposes an obligation to establish a legal framework to give effect to the right – including laws or other measures to protect life ‘from all reasonably foreseeable threats.’26 It is not enough for technically satisfactory laws to be on the statute book: the state must ensure full compliance with all of the relevant legal provisions. Investigations of alleged breaches of the article must be independent, impartial, prompt, thorough, effective, credible, and transparent.27 The duty to protect by law the right to life also requires States parties to organize all State organs and governance structures through which public authority is exercised in

23 Article 12 of ICESCR provides: 1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness. This article is the subject of its own detailed General Comment: GC 14 (2000). 24 UN Human Rights Committee, General Comment No 31,The nature of the general legal obligation imposed on States parties to the Covenant (2004), para 8. See also European Court of Human Rights, Osman v United Kingdom (case No. 87/1997/871/1083), judgment of 28 October 1998, para. 116. 25 GC 36 1(7). 26 GC 36 III(18). 27 See GC 36 III(28).

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a manner consistent with the need to respect and ensure the right to life,28 including establishing by law adequate institutions and procedures for preventing deprivation of life, investigating and prosecuting potential cases of unlawful deprivation of life, meting out punishment and providing full reparation.29 Individuals with disabilities must have special protection, enabling them to enjoy their right to life ‘on an equal basis with others.’This must include the provision of reasonable accommodation when such provision is necessary to ensure the right to life: the comment cites particularly the need to ensure access to essential facilities and services.30 Individuals deprived by the state of their liberty are subject to a particularly strenuous duty of care: assume the responsibility to care for their lives31 and bodily integrity, and they may not rely on lack of financial resources or other logistical problems to reduce this responsibility.32 The same heightened duty of care attaches to individuals held in private incarceration facilities operating pursuant to an authorization by the State.The duty to protect the life of all detained individuals includes providing them with the necessary medical care and appropriate regular monitoring of their health, shielding them from inter-prisoner violence,33 preventing suicides and providing reasonable accommodation for persons with disabilities.34,35 The General Comment frames the duty very widely: States parties should take appropriate measures to address the general conditions in society that may give rise to direct threats to life or prevent individuals from enjoying their right to life with dignity. These general conditions may include high levels of criminal and gun violence, pervasive traffic and industrial accidents, degradation of the environment … deprivation of indigenous peoples’ land, territories and resources, the prevalence of life-threatening diseases, such as AIDS, tuberculosis and malaria, extensive substance abuse, widespread hunger and malnutrition and extreme poverty and homelessness. The measures called for to address adequate conditions for protecting the right to life include, where necessary, measures designed to ensure access without delay by individuals to essential goods and services such as food, water, shelter, health care,36 electricity and sanitation, and other measures designed to promote and facilitate adequate general conditions, such as the bolstering of effective emergency health services, emergency response operations (including firefighters, ambulance services and police forces) and social housing programmes. States parties should also develop

28 Inter-American Court of Human Rights, González et al. (“Cotton Field”) v Mexico, judgment of 16 November 2009, para 236. 29 GC 36 III(19). 30 GC 36 III(24). 31 Zhumbaeva v Kyrgyzstan (CCPR/C/102/D/1756/2008), para 8.6; Human Rights Committee, Dermit Barbato v Uruguay, communication No. 84/1981, para 9.2. 32 Lantsova v Russian Federation (CCPR/C/74/D/763/1997), para 9.2. 33 European Court of Human Rights, Edwards v United Kingdom [2002] ECHR 303 (Application No 46477/99), para 60. 34 See CRPD,Article 14. 35 GC 36 III(25). 36 Toussaint v Canada (CCPR/C/123/D/2348/2014), para. 11.3. See also CCPR/C/ISR/CO/4, para 12.

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strategic plans for advancing the enjoyment of the right to life, which may comprise measures to fight the stigmatization associated with disabilities and diseases, including sexually transmitted diseases, which hamper access to medical care;37 detailed plans to promote education for non-violence; and campaigns for raising awareness of genderbased violence38 and harmful practices,39 and for improving access to medical examinations and treatments designed to reduce maternal and infant mortality.40 Furthermore, States parties should also develop, when necessary, contingency plans and disaster management plans designed to increase preparedness and address natural and man-made disasters that may adversely affect enjoyment of the right to life, such as hurricanes, tsunamis, earthquakes, radioactive accidents and massive cyberattacks resulting in disruption of essential services.41

Assisted suicide and euthanasia The classic example of tension between the right to life and autonomy rights relates to assisted suicide.This tension has been explored particularly in the context of the provisions of the ECHR. A typical ECHR debate about assisted suicide is framed like this:42 The applicant asserts that she wants to decide where, when, and in what circumstances she lives, and accordingly where, when, and in what circumstances she die (a contention under ECHR Article 8(1) – the most elastic of the ECHR Articles, within which Strasbourg’s conceptions of autonomy and dignity are accommodated).43 She wants assistance in dying, and contends that unless she gets it, her Article 8(1) right will be breached. She recognises, typically – and for instance in England – that there is a national law that says that she cannot get that assistance, and that that law is an expression of the state’s obligations under Article 2, the right to life under the ECHR. But, she contends,Article 2 should give way to Article 8. The respondent typically replies that the Article 2 obligation is absolute – not qualified like Article 8(1) (Article 8(2) balances the 8(1) rights of the individual against the interests and rights of all society), and that it should always prevail over Article 8. The state, the respondent says, must look not only to the interests of the applicant, but to everyone’s interests.Then comes an empirical claim: If the assisted dying law is relaxed to allow the result sought by the applicant, vulnerable people’s lives are likely to be lost. People might be pressured into dying because they are made to feel that they are a burden, for instance. Article 2 therefore insists that the assisted dying legislation remains unchanged. Article 8(2), notes the respondent, means that the

37 CCPR/C/JAM/CO/3, para 9. 38 CCPR/CO/71/UZB, para 19. 39 Committee on the Elimination of All Forms of Discrimination Against Women and Committee on the Rights of the Child, Joint General Recommendation No. 31 of the Committee on the Elimination of Discrimination against Women/ general comment No. 18 of the Committee on the Rights of the Child on Harmful Practices (2014), para 56. 40 Human Rights Committee, General Comment No. 6:Article 6 (Right to Life), para 5; CCPR/C/COD/CO/3, para 14. 41 GC 36 III(26). 42 R (Nicklinson) v Ministry of Justice [2014] UKSC 38. 43 ECHR Article 8 provides: 1. Everyone has the right to respect for his private and family life, his home and his correspondence. 2. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.

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autonomy interests of all society must be taken into account. If the assisted dying law is relaxed, the autonomy interests of people other than the applicant will be adversely affected. At least if the empirical claim is made out, the ‘prerequisite’ observation in the General Comment (see earlier) might seem to decide such a debate, if convened under the ICCPR, for the respondent, and it would seem to be arguable that even without an empirical claim in relation to the interests of third parties, Article 6 of the ICCPR, if read consistently with this part of the comment, is inconsistent with assisted suicide or euthanasia. But the comment does not stop there. It goes on to dilute this initial statement about the absolute nature of the article, recognising the need for some accommodation between the right to life and autonomy rights – at least at the end of life. While acknowledging the central importance to human dignity of personal autonomy, States should take adequate measures, without violating their other Covenant obligations, to prevent suicides, especially among individuals in particularly vulnerable situations,44 including individuals deprived of their liberty. States parties that allow medical professionals to provide medical treatment or the medical means to facilitate the termination of life of afflicted adults, such as the terminally ill, who experience severe physical or mental pain and suffering and wish to die with dignity,45 must ensure the existence of robust legal and institutional safeguards to verify that medical professionals are complying with the free, informed, explicit and unambiguous decision of their patients, with a view to protecting patients from pressure and abuse.46

Termination of pregnancy There is no discussion in the General Comment on ICCPR Article 6 of the possibility that the embryo or fetus might itself have a right to life falling within the article. Instead, the focus is very much on the protection of the Article 6 rights of the mother.47 Where pregnancy or childbirth might risk the ‘life and health’ of the mother or where ‘carrying a pregnancy to term would cause the [mother] substantial pain or suffering, most notably where the pregnancy is the result of rape or incest or where the pregnancy is not viable’ safe, legal, and effective access to abortion must be provided.48 In all other cases, says the comment, abortion must not be regulated ‘in a manner that runs contrary to their duty to ensure that women and girls do not have to resort to unsafe abortions.’49 Any measure or practice that compels resort to unsafe abortion should be removed.‘States parties should remove existing barriers to effective access by women and girls to safe and legal abortion, including barriers caused as a result of the exercise of conscientious objection by individual medical providers, and should not introduce new barriers.’50 This presumably cannot amount to a direction to abolish the right of conscientious objection (except possibly in the case of abortion which is needed in order to save the mother’s life), since such abolition would offend other fundamental principles of the UDHR.

44 CCPR/C/79/Add.92, para 11. 45 Committee on Economic, Social and Cultural Rights, CESCR General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art. 12) (2000) (20). 46 CCPR/C/NLD/CO/4, para 7. 47 See GC 36 1(8). 48 Mellet v Ireland (CCPR/C/116/D/2324/2013), paras 7.4–7.8; CCPR/C/IRL/CO/4, para 9. 49 Human Rights Committee, GC 28(10) (2000) on the equality of rights between men and women. See also, e.g., CCPR/C/ARG/CO/4, para 13. 50 GC 36 1(8).

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Article 5 Article 5: No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. UDHR Article 5’s main expression is through ICCPR Article 7, which provides that ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.’ There is a short but comprehensive General Comment.51 There is a comparable provision in the CRC52 and the CRPD,53 and the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment and Punishment deals in detail with this area. Article 7 is absolute. It cannot be limited or qualified in any way,54 and protects both physical and mental integrity.55 The provision of most relevance to this chapter is that prohibiting non-consensual medical or scientific experimentation.The Second World War heredity is obvious. Where valid consent cannot be given (and in particular where the subject is detained in any way) the General Comment mandates special protection.56 It goes on to note that ‘[s]uch persons should not be subjected to any medical or scientific experimentation that may be detrimental to their health.’57 Consent procedures (and indeed philosophical accounts of what constitutes adequate consent) vary widely between jurisdictions.This is particularly true when the patient lacks capacity, and decisions about treatment have to be made on their behalf.There is no developed jurisprudence under the ICCPR about how the adequacy of consent should be determined.58 The stricture in the General Comment to Article 7 barring experiment if the experimental treatment proposed may be detrimental to the patient’s health is surely ripe for review in the event of lastditch, potentially life-saving experimental treatment of an otherwise doomed patient. There has been very little consideration by the UN Human Rights Committee or comparable bodies of the provisions of Article 7 outside the context of detention, and for indications as to how the jurisprudence of Article 7 might evolve, it is useful to look at the way that ECHR Article 3 has been handled by the Strasbourg Court. Much attention in that jurisdiction has been given to whether Article 3 might be breached by returning a patient from a contracting state to another where the standards of medical care are such that suffering will result.The law is now clear: thus in D v United Kingdom59 an HIV-positive patient could not be returned to their state of origin where the available treatment was inadequate. A breach of Article 3 ECHR (and no doubt of Article 7 ICCPR) does not require an act: the articles are directed at the consequences, and accordingly an omission that results in the pro-

51 Human Rights Committee GC 20 (1992). 52 See CRC Article 37(a). For commentary, see Committee on the Rights of the Child, GC 8(11) (2006) – The Right of the Child to Protection from Corporal Punishment and Other Cruel or Degrading Forms of Punishment. 53 CRPD Article 15. 54 GC 20(3). 55 GC 20(2). 56 GC 20(7). 57 ibid. 58 For an illustration of these difficulties in an ECHR context, see Erdinc Kurt v Turkey (2017) Application no. 50772/11 59 (1997) 24 EHRR 423

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scribed consequences is likely to amount to a breach.Thus there was a breach of ECHR Article 3 in McGlinchey v UK, where a vomiting, dehydrated prisoner was not properly monitored.60 ECHR Article 3 has been (and ICCPR Article 7 would no doubt be) less successful in establishing that states have obligations to provide treatment, absent which the applicant will suffer. Thus, failure to provide potentially life-saving cancer therapy did not amount to a breach of Article 3.61

Article 6 Article 6: Everyone has the right to recognition everywhere as a person before the law. In the healthcare context this should be read together with UDHR Article 1 (see earlier), Article 2 (non-discrimination)62 and Article 7 (equality before the law).63 Article 16 of the ICCPR is in identical terms, and there are variants in the International Convention on the Protection of the Rights of All Migrant Workers and Members of Their Families,64 the African Charter on Human and Peoples’ Rights,65 and the Convention on the Rights of Persons with Disabilities.66

60 App No 50390/99, 37 EHRR 41 (2003). 61 Hristozov v Bulgaria,Applications nos. 47039/11 and 358/12. 62 ‘Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. Furthermore, no distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation of sovereignty.’ 63 ‘All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.’ 64 Article 24: ‘Every migrant worker and every member of his or her family shall have the right to recognition everywhere as a person before the law.’ 65 Article 5:‘Every individual shall have the right to the respect of the dignity inherent in a human being and to the recognition of his legal status. All forms of exploitation and degradation of man particularly slavery, slave trade, torture, cruel, inhuman or degrading punishment and treatment shall be prohibited.’ 66 Article 12: 1. States Parties reaffirm that persons with disabilities have the right to recognition everywhere as persons before the law. 2. States Parties shall recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life. 3. States Parties shall take appropriate measures to provide access by persons with disabilities to the support they may require in exercising their legal capacity. 4. States Parties shall ensure that all measures that relate to the exercise of legal capacity provide for appropriate and effective safeguards to prevent abuse in accordance with international human rights law. Such safeguards shall ensure that measures relating to the exercise of legal capacity respect the rights, will and preferences of the person, are free of conflict of interest and undue influence, are proportional and tailored to the person’s circumstances, apply for the shortest time possible and are subject to regular review by a competent, independent and impartial authority or judicial body. The safeguards shall be proportional to the degree to which such measures affect the person’s rights and interests. 5. Subject to the provisions of this article, States Parties shall take all appropriate and effective measures to ensure the equal right of persons with disabilities to own or inherit property, to control their own financial affairs and to have equal access to bank loans, mortgages and other forms of financial credit, and shall ensure that persons with disabilities are not arbitrarily deprived of their property.

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As noted earlier, the embryo or fetus is not regarded as being a person with an enforceable right under these instruments, and indeed any rights that future persons might be thought to have would seem to have to give way to any rights under these provisions that are vested in a living person.

Conclusion Article 1 of the UDHR has the potential for extraordinary legal and ethical fecundity. Some of that potential has been realised. Its spirit (a spirit informed by the Imago Dei) has informed and infused all the other articles of the UDHR and the instruments that are parasitic on the UDHR. But its influence has been piecemeal.As we have seen, the nearest that the UDHR gets to conferring a right to health is through Article 25 (working through ICESCR Article 12), which is the subject of the next chapter. Article 1 of the UDHR could have been and could be used more than it has been in advocating and fashioning such a right. If humans are equal in dignity and rights, and should act towards one another as mutually supportive sisters and brothers, it is an outrage for humans in Manhattan to expect healthcare provision orders of magnitude better than that available to humans in sub-Saharan Africa. The jurisprudence of the UDHR and its associated instruments has failed to deal in any nuanced way with the foundational question:‘What is health?’The literature on this question is vast and complex,67 but it tends towards a holistic conception of health as human thriving – a conception which itself depends on an account of the sort of creatures that humans are perceived to be. UDHR Article 1 is clear about what we are, and therefore has a potent contribution to make to the debate about global health rights. Dignity, too, the conception at the heart of UDHR Article 1, needs to be pressed more urgently into front-line service than it has been. Dignity appears, undefined, as a placeholder, in the post-Second World War declarations. It is time for it to be given some hard-edged meaning, and to start doing some real work.

References Committee on Economic, Social and Cultural Rights, CESCR General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art. 12). Committee on the Elimination of All Forms of Discrimination Against Women and Committee on the Rights of the Child, Joint General Recommendation No. 31 of the Committee on the Elimination of Discrimination against Women/general Comment No. 18 of the Committee on the Rights of the Child (2014). Foster, Charles and Herring, Jonathan ‘What Is Health?’ in Law and Global Health: Current Legal Problems (Oxford University Press 2014) 23–36. Human Rights Committee, General Comment No. 6:Article 6 (Right to Life). UN Human Rights Committee, General Comment No. 31, The Nature of the General Legal Obligation Imposed on States Parties to the Covenant (2004).

67 For a survey, see Charles Foster and Jonathan Herring, ‘What Is health?’ in Law and Global Health: Current Legal Problems (OUP 2014) 23–36.

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3 UNIVERSAL DECLARATION OF HUMAN RIGHTS, PART 2 Articles 7, 12, 16, 18, 19, and 25 Jonathan Herring

Introduction This chapter will explore the relevance of Articles 7, 12, 16, 18, 19, and 25 of the Universal Declaration of Human Rights (UDHR) to a claim to a right to health. The basic claim for a human right to health is straightforward: health is core to a person’s well-being. As the High Commission for Human Rights1 puts it: Regardless of our age, gender, socio-economic or ethnic background, we consider our health to be our most basic and essential asset. Apart from life itself, health is a prerequisite for much that we consider good in life. If interests deserve to be protected by rights, one of our primary interests must be in health. As Matthew Liao2 argues, the most plausible basis for human rights is to determine what are the ‘fundamental conditions for pursuing a good life.’ He explains these are The fundamental conditions comprise various goods, capacities, and options that human beings qua human beings need, whatever else they qua individuals might need, in order to pursue certain basic activities, such as deep personal relationships with one’s partner, friends, parents, children; knowledge of the workings of the world, of oneself, and of others; active pleasures such as creative work and play; and passive pleasures such as appreciating beauty.

1 Office of the United Nations High Commissioner for Human Rights, The Right to Health (United Nations 2019). 2 Matthew Liao,‘Human Rights and Public Health Ethics’ in Anna Mastroianni, Jeffrey Kahn and Nancy Kass (eds) The Oxford Handbook of Public Health Ethics (Oxford University Press 2019).

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Those things that inhibit such a flourishing life can be regarded as ill health.3 In saying that, I do not agree that everything currently regarded as an illness is ill health, but that is an argument for another time.4 The next stage of the analysis must be that not every cause of inequality justifies a right. One key reason why health does is that it is beyond the reach of an individual on their own.This is all the more so when it is accepted that health includes not just access to healthcare, but protection from unhealthy environmental issues and other causes of ill health.5 Clearly a citizen cannot take their own steps to produce these. From this starting point many questions arise. What exactly is meant by health? What is required of a state if it is protect health? How are rights to health to be balanced against other rights? In this chapter, I will explore how the articles under consideration can assist in answering such questions. Despite the seeming obvious importance of health, it is notable that a right to health is not explicitly protected in the UDHR, although subsequent international rights documents have included it. For example, Article 12 of the International Covenant on Economic, Social and Cultural Rights protects the right to the highest attainable standard of health.The United Nations Committee on Economic, Social and Cultural Rights (CESCR) in General Comment 14 explains that right in this way: health is a fundamental human right indispensable for the exercise of other human rights. … The right to health is closely related to and dependent upon the realization of other human rights, as contained in the International Bill of Rights, including the rights to food, housing, work, education, human dignity, life, non-discrimination, equality, the prohibition against torture, privacy, access to information, and the freedoms of association, assembly and movement. These and other rights and freedoms address integral components of the right to health. So, while there is a lively debate as to whether it is appropriate to claim a right to health, it will be argued in this chapter that a right to health is a key aspect of all the rights to be discussed. It would be impossible to protect the rights of equality, for example, without also protecting a right to health. This makes it implausible there is not a right to health. Or, putting it another way, if there is no human right to health, it is not clear there can be a human right to anything.6

Article 7 Article 7:All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.

3 Jason Eberl, Eleanor Kinney and Matthew Williams, ‘Foundation for a Natural Right to Health Care’ (2011) 36 Journal of Medicine and Philosophy 537. 4 Charles Foster and Jonathan Herring, ‘What is Health?’ in M Freeman, S Hawkes and B Bennett (eds) Law and Global Health (Oxford University Press 2014). 5 For concern that extending a right to health beyond a right to health care services is too broad, see Kristen Hessler and Allen Buchanan,‘Equality, Democracy, and the Human Right to Health Care’ in Rosamond Rhodes, Margaret Battin, and Anita Silvers (eds) Medicine and Social Justice: Essays on the Distribution of Health Care (Oxford University Press 2012). 6 Nicole Hassoun,‘The Human Right to Health’ (2015) 10 Philosophy Compass 275.

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It will be argued here that a failure to provide health will inevitably involve a breach of the right to equal protection and freedom from discrimination. An inherent part of ensuring equality is to ensure access to health services. Before developing that point we need to examine the wording of Article 7. The first sentence in Article 7 focuses on equality before the law and the second on equal protection of the law.7 Article 2 is wider, recognising a general right to non-discrimination to all rights under the UDHR: Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. Furthermore, no distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation of sovereignty. Clearly there is a potential overlap between Articles 2 and 7. Article 7 is wider in two respects. First,Article 2 is restricted to discrimination in respect of the rights and freedoms in the UDHR. Article 7 is wider and requires equality before the law in all issues, not just in relation to the rights in the UDHR. Second, Article 7 focuses on the idea of equality, rather than discrimination (at least in the first sentence).This is significant because the concept of equality can be seen as wider than discrimination. A failure to remedy a profound inequality between two people may not discriminate (it is a failure to act after all), but it might not ensure equality between the law.This point will be developed below. Significantly for now, however, I emphasise the requirement to promote equality before the law will obligate the state to act positively. If in the ‘natural’ social environment one group is not equal before the law because of disadvantages caused by distributions of social resources, then equality can only be achieved by state intervention.This is why equality has played an important role in seeing human rights as creating positive obligations on the state to intervene and not just to inhibit state action. As the late Professor Sir Bob Hepple8 put it: The shift of focus from negative duties not to discriminate, harass or victimise, to positive duties to advance equality, justify the re-invention of this branch of the law as equality law, of which discrimination law is an essential but not exclusive part. Some of the different forms of inequality will now be discussed.

Sex inequality Health rights are essential to combat sex discrimination.9 This is for two reasons. First, that women have particular health needs, which are different from men, and if not met they perpetuate disadvantage against women. Second, other causes of disadvantage against women put

7 Dimitrina Petrova, Article 7: The Equality and Non-Discrimination Provision Appendix E to the Report of the Global Citizenship Commission (United Nations 2018). 8 Bob Hepple, Equality:The New Legal Framework (Hart Publishing 2011) 1. 9 Included within this is discrimination based on trans status. See Maciej Szydlowski,‘Gender Recognition and the Rights to Health and Health Care: Applying the Principle of Self-Determination to Transgender People’ (2016) 17 International Journal of Transgenderism 199.

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them in a position that they are less able to access healthcare resources or respond to health challenges.While health treatment will not ‘make right’ the wrongs of patriarchy, it will at least prevent its impact being exacerbated.The issues of gender inequality in health go wider. Alicia Yamin10 sets out some of the broader issues that arose from the Beijing Platform for Action in relation to health: poor quality and lack of responsiveness of health services; gender-specific barriers; gender inequality in preconditions to health such as nutrition; sexual- and gender-based violence, including physical and psychological abuse; HIV and other sexually transmitted diseases; mental disorders related to marginalization, powerlessness, and poverty, along with overwork and stress and the growing incidence of domestic violence as well as substance abuse; health concerns of older women; environmental health hazards and differential susceptibility; need for statistical data disaggregated by gender; and the need for clinical trials and health research on women. Some of these examples will now be developed in a little more detail. Violence against women is a major cause of inequality.This includes sexual assault, domestic abuse and sexual harassment.11 The United Nations12 states: It is estimated that 35 per cent of women worldwide have experienced either physical and/or sexual intimate partner violence or sexual violence by a non-partner (not including sexual harassment) at some point in their lives. However, some national studies show that up to 70 per cent of women have experienced physical and/or sexual violence from an intimate partner in their lifetime. Evidence shows that women who have experienced physical or sexual intimate partner violence report higher rates of depression, having an abortion and acquiring HIV, compared to women who have not. Domestic abuse is perpetrated primarily against women13 and causes severe physical and psychological injuries which, if untreated, can be severe.The abuse itself can create serious barriers to women accessing treatment for the impact of these forms of violence and so a safe, efficient, easy access health service is essential. Gender discrimination in employment and higher rates of poverty are severe in most countries. In even the wealthiest Organization for Economic Cooperation and Development (OECD) countries, there are significant pay gaps, which can be magnified when intersecting factors are taken into account.14 Without there being an acknowledged right to health, citizens will be expected to meet their own health needs. Those in poverty will have less access to healthcare needs and resulting ill health will exacerbate their poverty. Further, poverty is closely connected to impacts on people’s psychological and emotional well-being.15

10 Alicia Yamin,‘Women’s Health and Human Rights: Struggles to Engender Social Transformation’ in José Zuniga, Stephen Marks, and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013). 11 Herring, Human Rights and Domestic Abuse (Intersentia, 2020). 12 UN Women, Facts and Figures: Ending Violence against Women (United Nations 2020). 13 Herring, Human Rights and Domestic Abuse (n 11) ch 3. 14 Organization for Economic Cooperation and Development, Inequality (OECD 2020). 15 Yamin (n 10).

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Gender can also result from the different needs for people in relation to their bodies. Pregnancy care, childbirth provision, healthcare post birth, and contraceptive provision are all key elements of the health of many women and people of other genders having uteruses. Without the provision of that healthcare, there will be inequality because of the burden of these issues falls disproportionately on women.16 To deny both men and women access to abortion may be to treat them without discrimination, but it would not promote equality between them. The Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW) committee in 2011 heard the case of Alyne da Silva v Brazil17 in which Alyne da Silva Pimentel died in Brazil following pregnancy complications due to a woeful lack of care for the pregnancy and childbirth. The CEDAW committee concluded that the general failure to provide maternal health services caused gender inequality.To ensure women’s equality it was necessary for the state to ensure there were sufficient resources to enjoy health. In 2011 in LC v Peru18 the CEDAW applied similar reasoning to require access to abortion, at least in cases of rape and sexual assault, or when a woman’s life or health is in danger.

Race discrimination Race discrimination is a worldwide problem.As Dimitrina Petrova19 explains: Discrimination based on race, ethnicity, color of skin, and similar characteristics is pervasive, and most ethnic minorities in the world today suffer various forms of discrimination and exclusion. Institutionalized discrimination against Haitians in the Dominic Republic keeps persons of Haitian descent from registering their children as citizens, shutting the children out of schooling and health care. People of African descent are discriminated against on the basis of their skin color throughout South America, as well as in Egypt and Sudan, while Roma remain to date the most disadvantaged and systematically excluded minority throughout Europe. And she goes on to list many other examples. As they indicate, racial prejudice is widespread, leading to poverty and economic exclusion. Again, without there being a right to healthcare, the disadvantages flowing from poverty and economic exclusion will be further exacerbated, perhaps making it even harder to find employment to improve the person’s financial situation. Even in developed countries, such as the UK, there are distinct health disadvantages connected to race.As Victor Adebowlae,20 incoming chair of the NHS Confederation, and Professor Mala Rao write: Ethnic minority doctors and patients still face too many injustices in the NHS … from the fivefold higher maternal mortality among black women than among white women in the UK to the gap in performance between white and ethnic minority students and doctors and the increased likelihood of disciplinary procedures against ethnic minority doctors.

16 17 18 19 20

ibid. CEDAW/C/49/D/17/2008. CEDAW/C/50/D/22/2009 (2011). Petrova (n 7). Victor Adebowlae,‘It’s Time to Act on Racism in the NHS’ (2020) 368 BMJ 568.

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Lillian Anekwe writes of the situation in the US: Data from the US show that there is a clear racial gap in health – at the age of 25, the average white American can expect to live five years longer than the average black person. The gap by education is larger: even the better off black person with a college degree or higher level of education has a lower life expectancy than a white high school graduate.21 This extends beyond physical health to mental health. Harding et al. found that ‘unlike other measures of adversity, perceived racism was consistently associated with poorer psychological wellbeing across gender, ethnicity, and age.’22

Disability discrimination It has been estimated that around 15% of the world’s population is affected by disability discrimination.23 Some disabled people require support and accommodation for medical needs connected with their disability, and for them to achieve equal access equipment, treatment, or surgery may be required. Without a right to health access these will be denied. Even if there are no specific healthcare needs connected to the disability, the disability may impede access to healthcare services, and without a right of healthcare there will be further disadvantage flowing from that. The importance of access to health is recognised in Article 25 of the United Nations Convention on the Rights of Persons with Disabilities, which reads: States Parties recognize that persons with disabilities have the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability. States Parties shall take all appropriate measures to ensure access for persons with disabilities to health services that are gender-sensitive, including health-related rehabilitation. In particular, States Parties shall: (a) Provide persons with disabilities with the same range, quality and standard of free or affordable health care and programmes as provided to other persons, including in the area of sexual and reproductive health and population-based public health programmes; (b) Provide those health services needed by persons with disabilities specifically because of their disabilities, including early identification and intervention as appropriate, and services designed to minimize and prevent further disabilities, including among children and older persons; (c) Provide these health services as close as possible to people’s own communities, including in rural areas; (d) Require health professionals to provide care of the same quality to persons with disabilities as to others, including on the basis of free and informed consent by, inter alia, raising awareness of the human rights, dignity, autonomy and needs of

21 Lillian Anekwe ‘Harnessing the Outrage: It’s Time the NHS Tackled Racial Bias’ (2020) 368 BMJ 341. 22 Seeromani Harding, Ursula Read, Oarabile Molaodi et al.,‘The Determinants of Young Adult Social Well-Being and Health (DASH) Study: Diversity, Psychosocial Determinants and Health’ (2015) 50 Social Psychiatry and Psychiatric Epidemiology 1173. 23 WHO, World Report on Disability (WHO 2011).

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persons with disabilities through training and the promulgation of ethical standards for public and private health care; (e) Prohibit discrimination against persons with disabilities in the provision of health insurance, and life insurance where such insurance is permitted by national law, which shall be provided in a fair and reasonable manner; (f) Prevent discriminatory denial of health care or health services or food and fluids on the basis of disability. The Convention also includes some more specific rights, such as Article 19, protecting rights to independent living and being included in the community and Article 26 which requires states to ‘take effective and appropriate measures, including through peer support, to enable persons with disabilities to attain and maintain maximum independence, full physical, mental, social and vocational ability, and full inclusion and participation in all aspects of life.’ It should be added that these rights can apply to mental health issues as well as physical health issues.24 These claims are all the stronger if the social model of disability is adopted. Penny Weller25 explains: The social model of disability addresses the environmental constraints that limit the ability of people with disabilities to engage in community life. It draws attention to the relationship between stigma, discrimination, structural inequalities, inadequate service provision and deficits in health. Even if the social model is only accepted as a partial explanation of the consequences of disabilities, because it means the state contributes to certain bodies being disabled, by the allocation and form of social provision, the state has a particularly heavy obligation to mitigate those.

Using equality to develop a broader perspective on the right to health There is, however, more to be said about equality than simply to say that disadvantaged groups will be further disadvantaged without access to health. Dimitrina Petrova26 explains that the development of the notion of equality is significant because it leads to a move from an approach that is individualistic and defensive to one that is collectivistic and proactive; from a patchwork of norms to a unitary (unified, integrated) framework; from regulation of contractual relations in employment and other areas to a human rights approach; clarifying the definitions of discrimination, harassment, and victimization and applying them consistently across all protected characteristics; widening the circumstances in which positive action (affirmative action) is allowed; increasing focus on the interconnectedness of the different types of inequalities and disadvantages; expanding positive duties on public sector bodies to advance equality in respect of all

24 Andrew Molas, ‘Defending the CRPD: Dignity, Flourishing, and the Universal Right to Mental Health’ (2016) 20 The International Journal of Human Rights 1264. 25 P Weller,‘The Right to Health:The Convention on the Rights of Persons with Disabilities’ (2010) 35 Alternative Law Journal 66. 26 Petrova (n 7).

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protected characteristics; and the beginning of attempts to relate status equalities with socio-economic equality. This chapter will next develop two of these themes in particular: moving to a collective understanding of health and the importance of positive duties to promote health. Individualistic to collective

International understandings of equality rights have moved from an individualist to a collective understanding of rights. In other words, the focus is not particularly on whether the individual has been the victim of discrimination (although that is an important issue) but whether the society is promoting equality between women. If we go back to the case of Alyne da Silva v Brazil, an individual approach would have focused on whether or not the denial of pregnancy health treatment was in the case of the particular woman an interference in her rights or whether she could show she was discriminated against. That might have been a hard case to make. A collective approach, as undertaken by the CEDAW committee, looked at whether the provisions of health services to pregnant women and women in labour were generally appropriate. From that perspective it was relatively easy to be able to find that as a whole, pregnancy services were inadequate and her case was a manifestation of that. It can enable an approach which recognises the wrong both to the group of women and to the particular woman in question.27 It can be beneficial to an individual claimant because it may be hard to establish that, in their particular case, they were discriminated against. However, it may be much easier to show a whole class of people (of which one is a member) were discriminated against. Some have used this approach to deny rights to health. Gopal Sreenivasan28 argues that, because public health involves public goods, individuals cannot claim a right to the promotion of their health. He gives the example of developing herd immunity to diphtheria through vaccination. That might be seen as a public good for health, but no one can claim a right to her immunity. No one individual can compel another person to be vaccinated against their will.This is not a convincing argument. All it shows is that there cannot be an absolute right to health through public goods. It does not mean there cannot be a right to have a programme of voluntary vaccination.While we cannot compel vaccination in the name of other’s rights to health (at least generally), that does not mean that there is no right to health, just that it can be trumped by other people’s right to bodily integrity, for example. The importance of collective rights is particularly important when we look beyond claims to a failure to provide health services to broader challenges to health such as environmental pollution. There it may be particularly difficult for an individual to demonstrate that their health issues were caused by the pollution. However, statistics might readily demonstrate that the collective health of a group was impacted by a polluted environment. There is a broader truth here too. If we want to achieve health we must focus on producing a healthy society.29 Human identity is found in relationship with others, from our beginning to our end and beyond – in the memories we have and other legacies we leave.As COVID-19 has visibly demonstrated, a healthy person in an unhealthy society will not remain well for long. There is great wisdom in the National Aboriginal Health Strategy Working Party:

27 Rakesh Chandra, ‘Collective Rights v Individual Rights’ (2017) 4 International Journal of Multidisciplinary Research and Development 51. 28 Gopal Sreenivasan,‘A Global Right to Health: Some Inconclusive Scepticism’ (2012) 86 Aristotelian Society 239. 29 Foster and Herring,‘What Is Health?’ (n 4).

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Aboriginal health is not just the physical wellbeing of an individual but is the social, emotional and cultural wellbeing of the whole community in which each individual is able to achieve their full potential thereby bringing about the total wellbeing of their community. It is a whole-of-life view and includes the cyclical concept of life-deathlife.30 All bodies have needs. Our society has built up a wide range of structures and forms of assistance which disguise our mutual dependence. It highlights the needs of some bodies and disguises the needs of others. Indeed we are forced by a wide range of societal pressures to disguise or mitigate our vulnerability so that we can behave in an acceptable way in the public realm. In a powerful article, Kate Lindemann31 contrasts the emphasis on ‘accommodations’ made to assist disabled people, with the lack of appreciation of how much accommodation there is for the able-bodied: Colleagues, professional staff members, and other adults are unconscious of the numerous accommodations that society provides to make their work and life style possible. ATM’s, extended hours in banks, shopping centres and medical offices, EZpass, newspaper kiosks, and elevators are all accommodations that make contemporary working life possible.There are entire industries devoted to accommodating the needs of adult working people. Fast food, office lunch delivery, day time child care, respite care, car washing, personal care attendants, interpreters, house cleaning, and yard and lawn services are all occupations that provide services that make it possible for adults to hold full time jobs. As this quote indicates, much is made of the assistance given to help the disabled, but the reality is we are all dependent on a huge range of resources.Able-bodied people need the provision of stairs to get to the first floor as much as the wheelchair user needs the lift.Yes, it is the provision of the lift for which we pat ourselves on the back for making such excellent provision for the disabled. In fact, we all depend on a wide range of social provisions to live in our society, from sewerage to supermarkets; from banks to buses. Our self-sufficiency is a myth. So, it is not just that a failure to meet the health needs of the ‘disadvantaged’ perpetuates disadvantage and so we need a right to health for all. It is that in a societal allocation of resources we have created some whose health needs are met and rendered some disabled. The equality of healthcare provision requires a far bigger imagining than simply ensuring everyone can see a doctor. It requires a recognition of the multiple ways bodies are ‘abled’ or ‘disabled’ by a wide range of societal provision. Positive duties

The right to equality requires action. As argued earlier, in a situation where the ‘natural’ position is inequality, then a failure to intervene will mean the inequality will be perpetuated. For people to be equal, there need to be interventions by the state to remedy existing inequalities and health is an obvious example of where basic health needs must be met if equality is to be promoted.32

30 Quoted in Paula Boddington and Ulla Raisanen, ‘Theoretical and Practical Issues in the Definition of Health: Insights from Aboriginal Australia’ (2009) 34 Journal of Medicine and Philosophy 49, 51. 31 Kate Lindemann,‘The Ethics of Receiving’ (2003) 24 Theoretical Medicine and Bioethics 501, 507. 32 Sandra Fredman, Comparative Human Rights Law (Oxford University Press 2018), ch 8.

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The contrasting view is that human rights should only be about stopping the state interfering in people’s liberty. From that perspective, ill health is a result of natural events and so is not the responsibility of the state. The state must not harm people’s health, but it has no positive obligation to intervene. Nowadays such a limited understanding of human rights would be rejected as being outdated. Increasingly, human rights are seen as imposing obligations on the state to ‘facilitate freedom and advance substantive equality.’33 A state which does not provide health treatments and this produces inequality cannot wash its hands on the basis that it is not responsible for that inequality. Take, for example, air pollution. The state can choose whether or not to regulate air pollution.There is no ‘neutral’ position. Either the state does not regulate and thereby permits air pollution, with the resulting ill health; or it does regulate it, with the resulting health benefit. If we are to ensure that people have the essential requirements to a minimum standard of well-being the state must provide healthcare facilities and intervene where environments are healthy. The CESCR explained that to meet a right to health, healthcare facilities had to be available, accessible, acceptable, and of good quality.34 Availability refers to not just to health services and treatments but also underlying necessities of health (e.g. clean water).The accessibility requirements require that the provisions are available ‘without discrimination, physically accessible, economically accessible (i.e. affordable), and accessible health-related information.’35 The acceptability requirement refers to the fact that it be provided in a way which respects cultural sensitivities and is in line with medical ethics. The quality of care requires that the treatments be medically appropriate and given by skilled personnel and in line with scientific advice.All of these require positive actions by the state to ensure they are not provided they will result in inequality. More precisely, the CESCR36 (para 45) has set out some ‘core minimum’ that is needed: (1) to ensure the right of access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups; (2) to ensure access to the minimum essential food which is sufficient, nutritionally adequate and safe, to ensure freedom from hunger to everyone; (3) to ensure access to basic shelter, housing and sanitation, and an adequate supply of safe and potable water; (4) to provide essential drugs, … defined by WHO’s Action Programme on Essential Drugs; (5) to ensure equitable distribution of all health facilities, goods and services; [and] (6) to adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population. Without the provision of these, inequalities will inevitably result. The list, however, seeks to impose obligations which are manageable for all states and do not depend on the particular economic position of individual countries.37

33 ibid. 34 Stephen Marks,‘The Emergence and Scope of the Human Right to Health’ in José Zuniga, Stephen Marks and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013). 35 ibid. 36 Committee and Economic Social and Cultural Rights, The Right to the Highest Attainable Standard of Health (CESCR 2000), para 45. 37 Benjamin Mason and Lawrence Gostin,‘Framing Human Rights in Global Health Governance’ in José Zuniga, Stephen Marks, and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013).

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Paul Hunt38 highlights a further important aspect of ensuring equality through healthcare when he states a human rights-based approach requires that special attention be given to disadvantaged individuals and communities; it requires the active and informed participation of individuals and communities in policy decisions that affect them; and it requires effective, transparent and accessible monitoring and accountability mechanisms. The combined effect of these is to empower disadvantaged individuals and communities. This points to the importance of working with communities to ensure healthcare provision is met. This is particularly important given the widespread rejection of paternalistic forms of medicine where doctors determine the appropriate treatment for patients and an individual is expected simply to accept their expert view. Instead, doctors and patients are expected to work together to forge an appropriate response.39 In any event it is simply a matter of effectiveness. Healthcare interventions which do not chime with the value or culture of a community simply will not work.

Conclusions on Article 7 It has been argued in this section that the rights to equality in Article 7 can only be met if there is a right to health. This right to health must be understood as a collective right as well as an individual right if it is to combat inequality. Further, it must be seen as a positive right: not just a right not be discriminated in the health context, but requiring state action.

Article 12 Article 12: No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks. At first sight, Article 12 does not look a promising start for a right to health because it seems that the right is primarily a negative one preventing the state from interfering in an individual’s life. Indeed, if anything it seems most relevant as providing the basis of a right to refuse treatment. However, I will argue that a deeper understanding of the right to privacy can make it more progressive. Before developing that argument, however, I want to say a little more about the right to refuse treatment, a breach of which would infringe Article 12.That right is an important aspect of the right to health. At first that might seem a surprising claim, because the right to refuse treatment might look like a right not to have health, rather than a right to have health. But, in support of the claim, I would emphasise that good medical treatment is found in a dialogue between the patient and the doctor. The doctor needs to inform the patient of the different options available and the patient needs to inform the doctor of what values and outcomes are

38 UN Special Rapporteur on Health, The Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health (United Nations 2006). 39 Jonathan Herring, Bill Fulford, and Ashok Handa,‘Elbow Room for Best Practice? Montgomery, Patients’Values in Balanced Decision-Making in Person-Cantered Clinical Care’ (2017) 25 Medical Law Review 582.

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important to them. It is only with the contributions of both parties and the ensuing dialogue that good medical treatment is offered. If a patient has no right to refuse treatment and the doctor simply decides what is best and imposes it, counterproductive treatments will be given.The patient may refuse to take the required medication or the outcome will be seen as disastrous by the patient, even though most people would have been happy.The right to refuse treatment is, therefore, an important aspect of the right to good health. Turning next to explore how the right to privacy can generate a more general right to health: to gain a good understanding of privacy we need to appreciate what is the value that underpins privacy. At its heart, privacy is commonly thought to be about being left alone, but why? Elizabeth Schneider,40 in a seminal article, argues that underpinning privacy is the right to be left to flourish as a person.That is why we need private space to be able to develop our relationships and understandings of ourselves. John Eekelaar has written of the need for a ‘privileged sphere’: that love itself demands such a space if it is to sustain a lifelong partnership.The value of the privileged sphere lies in the freedom to engage in unregulated activity irrespective of the inherent capacity of the activity to advance the well-being either of the actors or of others.41 That is why there is more to privacy than being left alone. Being lonely is not in itself a value, particularly if one does not want to be alone. It is being left alone, so that we are able to engage in those core human activities of building relationships and contemplating our lives. Once we understand that this is the value underpinning it we can develop what Schneider calls a more ‘affirmative concept of privacy.’42 Privacy becomes about giving someone the ability to express and develop themselves in terms of their relationships and self-understandings. It is true that in some cases the primary role of the government in enabling this will be to keep out of people’s lives. However, there will be other cases where a person needs government intervention to enable their relationships to flourish and to inspect their lives. We do already acknowledge this in the case of disability where a person may need resources and support to enable them to develop relationships. But this may be true in far more cases than those traditionally labelled ‘disabled people.’ This approach to privacy has been accepted by the courts in domestic abuse cases, where rather than privacy being used as a reason for why the state should not intervene to protect a victim of domestic abuse, it has been used as a justification requiring intervention.43 Only by intervening and freeing a person from an abusive relationship can they enjoy the goods which rest at the heart of privacy. But there is no reason to limit this kind of thinking to domestic abuse cases. Ill health can inhibit a person’s ability to experience relationships and flourish. Hence, privacy generates a right to health. Article 12 also speaks of protection from honour or reputation. A modern version of the UNHR would probably use the word dignity rather than honour. Many influential accounts of dignity have referred to the idea of honour.44 Dignity is about showing due honour the status

40 41 42 43 44

Elizabeth Schneider,‘The Violence of Privacy’ (1991) 23 Conn L Rev 973. John Eekelaar, Family Law and Personal Life (Oxford University Press 2006), ch 2. Schneider (n 40). Herring, Human Rights and Domestic Abuse (n 11) ch 3. Jeremy Waldron, Dignity, Rank, and Rights (Oxford University Press 2006).

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that all persons have.A person who is not treated as having that equal worth and honour due to a human being is denied the respect necessary to engage as a human being. For a person with an illness or disability for which they seek health provision, if that is denied it can lead to them not being recognised as having the equal value.45 While difficult to define,46 Ronald Dworkin has claimed that the very idea of human rights depends upon ‘the vague but powerful notions of human dignity.’47 Nussbaum48 claims that if we accept a person has ‘a life that is worthy of … dignity’ then they are entitled to the resources necessary for basic engagement with the world.To fail to provide these would be to disrespect the honour due to that life. She asserts that there is an obligation on the state to nurture the human life so that inherent capabilities can be developed. She lists ten, but Alicia Yamin49 highlights three that are closely tied to health: • • •

Life: being able to live to the end of a human life of normal length, i.e., not dying prematurely or having a life so reduced as to be not worth living; Bodily health: being able to have good health, including reproductive health, to be adequately nourished; and to have adequate shelter; Bodily integrity: being able to move freely from place to place; to be secure against assault, including sexual assault and domestic violence; having opportunities for sexual satisfaction and for reproductive choice.

Even if one did not agree with the details of Nussbaum’s capabilities approach, asking what healthcare is needed so a person can receive the honour they ought to receive as a person, that they may be treated in a dignified way, can be a helpful way of considering what a right to health requires.50

Article 16 Article 16: (1) Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family.They are entitled to equal rights as to marriage, during marriage and at its dissolution. (2) Marriage shall be entered into only with the free and full consent of the intending spouses. (3) The family is the natural and fundamental group unit of society and is entitled to protection by society and the State. Under Article 16, it is the right to found a family which is key to Article 16. Few would now claim that the right to marry and to found a family are bound together. Indeed, even using standard rules of interpretation the repeated ‘to’ indicates the right to marry and the right to found a family are two separate claims so they will be treated as such.This section will explore what this right to found a family may involve.

45 46 47 48 49

Marks (n 34). For an excellent discussion see Charles Foster, Human Dignity in Bioethics and the Law (Hart 2011). Ronald Dworkin, Taking Rights Seriously (Gerald Duckworth 1977) , 198. Martha Nussbaum, Women and Human Development:The Capabilities Approach (Cambridge University Press 2000). Alicia Yamin,‘Women’s Health and Human Rights: Struggles to Engender Social Transformation’ in José Zuniga, Stephen Marks, and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013). 50 Sridhar Venkatapuram, Health Justice:An Argument from the Capabilities Approach (Wiley 2011).

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Reproductive rights: access to assisted conception It might well be argued that the right to found a family provides a right of access to assisted reproduction. I take it that it is uncontroversial that Article 16 would prohibit the state from actively preventing fertile couples from producing children by, for example, involuntary sterilisation. Similarly, I take that for the state to prohibit access to assisted conception would be in breach of the article.The question more relevant for this chapter is whether it grants a positive right of access to assisted reproduction. Article 16 was, no doubt, drafted without thought of assisted reproduction and the reference to ‘a right to found a family’ is sufficiently vague as to not determine the question. There are two primary ways that a case of access to assisted reproduction may be made.The first is to draw an analogy with discrimination law and argue that there should be no disadvantage suffered by those who are infertile as compared to fertile couples.This principle leads John Harris to argue: It seems invidious to require that people who need assistance with procreation meet tests to which those who need no such assistance are not subjected. If we are serious that people demonstrate their adequacy as parents in advance of being permitted to procreate, then we should license all parents. Since we are evidently not serious about this, we should not discriminate against those who need assistance with procreation.51 Some commentators draw a link with disability and argue that just as in other areas of life we seek to make accommodations for disabled people so they can enjoy the same aspects of life as other people, we should, at least prima facie, offer assisted reproduction to those ‘disabled through infertility.’ For example, the Report of the Committee of Inquiry into Human Fertilisation and Embryology argued: an inability to have children is a malfunction and should be considered in exactly the same way as any other. Furthermore infertility may be the result of some disorder which in itself needs treatment for the benefit of the patient’s health. … In summary, we conclude that infertility is a condition meriting treatment.52 There are, however, difficulties with drawing such a direct link to health. It is not clear that the inability to have a child is a health issue, per se. Not least because often infertility is a relational thing (this couple cannot produce a child), rather than necessarily the issue resting in one person’s body.This causes Hane Maung53 to argue that we should avoid the analogy with a disease and simply consider the harms associated with involuntary childlessness, including suffering and the thwarting of valued life projects, as well as the social, cultural and economic factors that contribute to these harms.

51 John Harris, ‘Rights and Reproductive Choice’ in John Harris and Soren Holm (eds), The Future of Human Reproduction (Oxford University Press 1998). 52 Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilisation and Embryology (Her Majesty’s Stationary Office 1984) 9–10. 53 Hane Maung,‘Is Infertility a Disease and Does It Matter?’ (2019) 33 Bioethics 43.

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This argument seems closer to an autonomy, rather than a discrimination-based argument.This is the argument that, while generally the government is under no obligation to enable someone to meet their dreams (there is no right to the holiday in the Seychelles, however strong your desire!), there may be some decisions which are so closely tied to identity, and which a person cannot be expected to provide for themselves, where the state should have a duty to make provision, particularly where the outcome will be socially beneficial. If, as I would suggest is correct, the autonomy argument is the stronger, this creates a right to assisted reproduction, but a weaker one than would be generated by a disability discrimination claim.This seems to reflect the approach taken in the European Court of Human Rights. In SH v Austria,54 the court acknowledged that ‘the right of a couple to conceive a child and to make use of medically assisted procreation for that purpose is also protected by Article 8, as such a choice is an expression of private and family life.’ However, the court went on to state that, under Article 8(2), a state may be able to provide good reasons to interfere in that right, and where it did, the court would, given the controversial nature of the issue, respect the margin of appreciation. While a state may well have good reasons to deny access to IVF in certain cases, the restrictions had to be justified.

Reproductive rights: contraception and abortion Two challenges may be made to the claim that under Article 16 we can find a right to contraception and abortion as part of the right to health. First, it might be said that these are not health matters. Second, that the most natural reading of Article 16 is that it is a right to found a family, not a right to prevent a child from being born. In relation to the first issue, however, nowadays sexual and reproductive health are seen as health issues. The World Health Organization (WHO) explains that sexual and reproductive health (SRH) is predicated on the ability of men and women to have a Responsible, satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide if, when and how often to do so. Implicit in this are the rights of men and women to be informed of and to have access to safe, effective, affordable and acceptable methods of fertility regulation of their choice, and the right of access to appropriate health care services that will enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant.55 Once we accept that health goes beyond physical well-being to include emotion and mental health, it seems inevitable that sexual relationships come under the ambit of health.As the PanAmerican Health Organization (PAHO) and WHO put it: Sexual health is the experience of the ongoing process of physical, psychological and, socio-cultural well being related to sexuality. Sexual health is evidenced in the free and responsible expressions of sexual capabilities that foster harmonious personal and social wellness, enriching individual and social life. It is not merely the absence of dys-

54 [2011] ECHR 1878. 55 WHO, Sexual Health (WHO 2012).

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function, disease and/or infirmity. For sexual health to be attained and maintained it is necessary that the sexual rights of all people be recognized and upheld.56 Such claims are enhanced by equality provision. If men and women are to have equal access to sexual well-being, then this requires that women, in particular, have access to abortion and contraception. Even if these points are found unconvincing, every year around 70,000 women die from complications connected to unsafe abortion.57 So access to safe abortion and contraception is clearly a health matter. Indeed, human rights to sexual health have been recognised in the treaties which were generated from the UDHR, such as the CEDAW and the Convention on the Rights of the Child (CRC).58 As to the second point, I would argue that contraception and abortion are key to the right to found a family.Women’s reasons for abortion often relate to their wish to care for other family members or a child they will have in the future. Sherwin reports from her analysis of women’s abortion reasons that the explanations involve ‘her feelings about her foetus, her relationship with her partner, other children she may have, and her various obligations to herself and others – contextually defined considerations that reflect her commitments to the needs and interests of everyone concerned.’59 One woman has explained her reasoning behind an abortion in these terms: I was 22 when I found out I was pregnant. I had just qualified as a teacher but was yet to find my first teaching position. My partner had a decent job but he was recovering from a prolonged period of severe depression and while he lived with his elderly mother, I was caring for my grandmother who had been diagnosed with a degenerative illness.Although we were very much in love and hoped to have children one day, our finances and living arrangements meant we were not equipped to raise a child.We would want to give our children the very best possible start in life and, at that time, we didn’t have the opportunity to do so.60 Here we can see the abortion decision is connected to the right to found a family. It is about the timing and circumstances in which the case can be offered.61 The right to abortion can, therefore, be seen as an aspect of the right to found a family.

Articles 18 and 19 Article 18: Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in

56 PAHO and WHO, Sexual Health (WHO 2000). 57 Christina Zampas and Jaime Gher, ‘Abortion as a Human Right: International and Regional Standards’ (2008) Human Rights Law Review 2. 58 Eszter Kismödi and Laura Ferguson, ‘Celebrating the 70th Anniversary of the UDHR, Celebrating Sexual and Reproductive Rights’ (2018) 26 Reproductive Health Matters 52. 59 Susan Sherwin, No Longer Patient (Temple University Press 1992). 60 ‘Post 15’ (My Body, My Choice) http://mybody-mylife.org/user-submitted-post-15/ accessed 14 November 2020. 61 Jonathan Herring,‘Ethics of Care and the Public Good of Abortion’ (2019) 2 Oxford Human Rights Hub Law Journal 1.

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UDHR Articles 7, 12, 16, 18, 19, and 25

community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance. Article 19: Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers. Articles 18 and 19 will be treated together.These rights are, of the ones considered in this chapter, perhaps the most tangential to a right to health.The most significant issue may be the right to freedom of conscientious objection.This is not the place to offer a complete analysis of that right.62 In outline, the right states that a medical professional can maintain their perceived moral integrity by voicing a conscientious objection to providing a particular kind of treatment. In such a case, forcing them to provide the treatment would be in breach of their human rights. The classic, and most common, scenario would be where a professional has moral objections to abortion. In such a case, it would be in breach of their rights to freedom of conscience to force them to be involved in such a procedure or to penalise them for following their conscientious. The strongest argument in favour of this right is that we should respect people’s ‘moral integrity.’As Mary Neal63 puts it: we accept that it is sometimes necessary for a professional to be able to extract herself from involvement in something she considers to be seriously wrong and thereby protect herself from sharing in moral responsibility for serious wrongdoing (as she sees it). To compel a medical professional to act in such a way would be seriously wrong them. There are other reasons too. Few patients would wish to be treated by a professional who thought the treatment was morally wrong. It also helps contribute to a diverse workforce. There are a few commentators who reject the whole basis of conscientious objection. Julian Savulescu bluntly states that ‘[i]f people are not prepared to offer legally permitted, efficient, and beneficial care to a patient because it conflicts with their values, they should not be doctors.’64 That, however, seems to ask too much of doctors. Earlier reference was made to the modern approach to medicine being a dialogue between doctor and patients, a more relational model. Just as a patient should not be given treatment contrary to their views, that the doctor should, at least prima facie, not be required to provide treatment they do not wish. So most commentators seek some kind of compromise view. That conscientious objection should be protected unless doing so will mean a patient is denied treatment. It considers that, if the respect for conscience means a loss of access to healthcare rights to a patient, the rights of the patient will win out.That sounds the obvious solution in theory, but there are difficulties in practice. Udo Schuklenk and Ricardo Smalling65 argue that a health system cannot know when

62 Christina Lamb (2016) ‘Conscientious Objection: Understanding the Right of Conscience in Health and Healthcare Practice’ (2016) 22 The New Bioethics 33. 63 Mary Neal, ‘Conscientious Objection, “Proper Medical Treatment” and Professionalism: The Limits of Accommodation for Conscience in Healthcare’ in John Adenitire (ed) Religious Beliefs and Conscientious Exemptions in a Liberal State (Hart 2019). 64 Julian Savulescu,‘Conscientious Objection in Medicine’ (2006) 332 BMJ 294. 65 Udo Schuklenk and Ricardo Smalling, ‘Why Medical Professionals Have No Moral Claim to Conscientious Objection Accommodation in Liberal Democracies’ (2017) 43 JME 234.

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a member of staff may raise an objection and that ‘[a]ny society that grants medical professionals a conscientious objection-based opt-out will have to accept suboptimal health outcomes with regard to procedures that are considered at that point in time part and parcel of good professional healthcare practice in those societies.’The only way we can guarantee high quality healthcare is to not permit conscientious objection.That may well be challenged.66 It is not clear that, for example, allowing sick leave or compassionate leave does not likewise challenge this. Whether the highly speculative possibility that healthcare will be impeded justifies the inevitable harm of requiring a person to act in breach of conscience may well be questioned, at least without clear evidence patients are losing out on access to healthcare.

Article 25 Article 25: Everyone has the right to a standard of living adequate for the health and well- being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. This broad ranging right covers food; clothing; housing; medical care; and necessary social services, including ‘security’ (by which is meant financial and practical support).These topics can be seen as built on two key concepts. The first is the concept of dignity. Without these rights being met, there is unlikely to be human dignity.The list of requirements in Article 25 set out the core needs for a flourishing life.The second clear link between these topics is health.Article 25 highlights some of the essentials a person needs and without which they would be very likely to suffer ill-health: food, clothing, and housing. Access to treatment for illness is of little use if the person’s living standards are such that they will simply fall ill again. Indeed, any concept of a right to health must include not only the right of access to treatments, but the right to be prevented from falling ill in the first place.As General Comment 14 to the International Covenant on Economic, Social and Cultural Rights (ICESR) puts it: the right to health embraces a wide range of socio-economic factors that promote conditions in which people can lead a healthy life, and extends to the underlying determinants of health, such as food and nutrition, housing, access to safe and potable water and adequate sanitation, safe and healthy working conditions, and a healthy environment. Unsurprisingly, given their basic nature, the rights in Article 25 are also found in many other international agreements. For example, under Article 11, the ICESCR states that: The States Parties to the present Covenant recognize the right of everyone to an adequate standard of living for himself and his family, including adequate food, clothing and housing, and to the continuous improvement of living conditions. Article 27 of the UN Convention on the Rights of the Child states: ‘States Parties recognise the right of every child to a standard of living adequate for the child’s physical, mental, spiritual,

66 Neal (n 63).

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UDHR Articles 7, 12, 16, 18, 19, and 25

moral and social development.’ From Article 14 CEDAW:‘States Parties shall take all appropriate measures to eliminate discrimination against women in rural areas […] to ensure […] the right […] to enjoy adequate living conditions, particularly in relation to housing, sanitation, electricity and water supply, transport and communications.’ In terms of Europe, in Article 4(1) European Social Charter, the contracting parties undertake ‘to recognise the right of workers to remuneration such as will give them and their families a decent standard of living.’67 A key issue in the interpretation of this rights is how far these concepts can be understood. Does the right demand no more than the bare minimum to survive? Are these rights in danger of simply overwhelming a government of limited means? Before exploring those questions, a brief outline of the key concepts in the right will be provided.

Food In General Comment 12 on the ICESCR it is explained that the right to adequate food requires the food to be available, sufficient in terms of nutritional quality, safe, acceptable given the cultural or religious concerns of consumers, and accessible.68 These seem essential requirements when it is recalled that the rights are designed to promote health and dignity. Another way of addressing this might be to frame the right in terms of a right to freedom from hunger.69 It is the element of accessibility which is problematic, particularly in so far as that is read to include economic accessibility. It is this which is most likely to be the major challenge for many governments.70 It is generally assumed that the right to food includes the right to water. Although Article 25 does not specifically mention it, there is specific mention of the right to water in General Comment 15 on the ICESCR: The right to water contains both freedoms and entitlements.The freedoms include the right to maintain access to existing water supplies necessary for the right to water, and the right to be free from interference, such as the right to be free from arbitrary disconnections or contamination of water supplies. By contrast, the entitlements include the right to a system of water supply and management that provides equality of opportunity for people to enjoy the right to water.

Housing This right too combines elements of both dignity and health. The United Nations estimates that 100 million people have nowhere to live and more than a billion people have inadequate housing.71 It is clear that a lack of or inadequate housing is linked to health. Using even England and Wales, a developed country with a moderate climate, the statistics are striking:

67 The European Social Charter includes in Article 31 a right to housing. 68 The Committee on Economic, Social and Cultural Rights has issued detailed General Comments explaining the components of this right. 69 Asbjørn Eide,‘The Human Right to Adequate Food and Freedom from Hunger’ (United Nations) https://digital library.un.org/record/277522?ln=en. 70 Juanjuan Sun,‘On Right to Adequate Food and Relevant Concepts from the Legal Perspective’ (2017) 16 Journal of Human Rights 256. 71 Habitat for Humanity,‘World Habitat Day’ www.habitat.org/volunteer/build-events/world-habitat-day accessed 11 November 2020.

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The mean age at death was 45 years for males and 43 years for females in 2018; in the general population of England and Wales, the mean age at death was 76 years for men and 81 years for women.72 General Comments 4 and 7 of the Committee on Economic, Social and Cultural Rights help clarify what the right to adequate housing should include: security of tenure; affordability; habitability; accessibility; cultural adequacy and location (being sited to permit access to employment, schools, etc.).Again, these comments are designed to ensure that the housing offered will promote the health and dignity of citizens.

Clothing This right too is linked with a number of more basic rights. Clearly it offers warmth and is important to health in that way, but it has dignity, cultural, and religious dimensions. Notably, it is less articulated in the General Comments, although particular mention is made of older people and disabled people who need particular kinds of clothing to promote their health.73

Medical care As mentioned earlier, the right to health can be broadly understood to include the right to protected from challenges to health and the requirements for health.This provision specifically reflects a right to medical care. It is here that the issue of the extent of the right is most clear. While there is unlikely to be a broad range of views over what might be a basic need in terms of food, there will be more disputes in terms of medicine. Even if it is taken at a basic level, it is clear it is often breached. According to the World Bank and World Health Organization, in 2017 at least half of the world’s population (some 3.8 billion people) is too poor to get essential healthcare services.74

Social services and security General Comment 19 on the ICESR explains: The right to social security encompasses the right to access and maintain benefits, whether in cash or in kind, without discrimination in order to secure protection, inter alia, from (a) lack of work-related income caused by sickness, disability, maternity, employment injury, unemployment, old age, or death of a family member; (b) unaffordable access to health care; (c) insufficient family support, particularly for children and adult dependents. Social security, through its redistributive character, plays an important role in poverty reduction and alleviation, preventing social exclusion and promoting social inclusion.

72 Office of National Statistics, Deaths of Homeless People in England and Wales: 2018 (ONS 2019). 73 General Comments 5 and 6. 74 Office of the High Commissioner,‘Universal Declaration of Human Rights at 70: 30 Articles on 30 Articles’ www .ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=23970&LangID=E accessed 11 November 2020.

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The significance of this lies particularly in the fact that without the provision of social security a person may be driven to dangerous or undignified means of providing for themselves or their family, such as prostitution or begging. The references to services makes it clear that on occasion, services rather than money may be required.This may be particularly relevant in relation to personal care services for those unable to meet those needs themselves.

The extent of the right The great challenge here is to define an adequate standard of living, which is the base level of these rights.As Onora O’Neill asks: Is this right only a right to the standard of health that a person can attain with locally available and affordable treatment – however meagre that may be? Or is it a right to the highest standard available globally – however expensive that may be? The first is disappointingly minimal, and the latter barely coherent (how can everyone have a right to the best?).75 There is general agreement that the extent of the required provision must depend upon the particular circumstances of the country. ICESCR General Comment 12 finds that what is ‘adequate’‘is to a large extent determined by prevailing social, economic, cultural, climatic, ecological and other conditions.’ However, there is also agreement that there must be an absolute minimum, which is likely to involve where a person’s basic health with be affected.A common way of understanding this issue is that there is ‘progressive realisation’: that states seek to protect the rights to the extent to which resources are available, and as resources increase so the extent of protection increases.76 The Icelandic Human Rights Centre77 explains that states parties are required to continuously take steps forward in order to achieve the full realisation of the rights recognised in the instruments.This obligation is immediately applicable and is not subject to limitation. Hence, it is not merely an obligation to take action at some time in the future. States, regardless of their level of development, must take steps immediately to achieve the full realisation of the rights. Adopting this approach, there has been much effort at establishing a ‘minimal set of basic goods.’78 These might be the lowest level that are seen as acceptable for any country.The focus on defining these is, perhaps, an acknowledgement of the difficulty in challenging a government which states that it cannot provide a higher level of provision. In seeking to identify this we encounter is defining in respect of what the minimal level is. Norman Daniels79 writes:

75 Onora O’Neill,‘The Dark Side of Human Rights’ (2005) 81 International Affairs 427, 429. 76 This found approval in the Inter-American Commission on Human Rights (e.g. Miranda Cortez et al. v El Salvador (Case 11.670)). 77 Icelandic Human Rights Centre, ‘The Right to an Adequate Standard of Living’ www.humanrights.is/en/hum an-rights-education-project/human-rights-concepts-ideas-and-fora/substantive-human-rights/the-right-to-an -adequate-standard-of-living accessed 11 November 2020. 78 Kenneth Reinert, No Small Hope:Towards the Universal Provision of Basic Goods (Oxford University Press 2018) 79 Norman Daniels,‘Justice, Health, and Health Care’ (2001) 1 American Journal of Bioethics 2.

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Meeting health needs in order to keep people close to normal functioning preserves for people their ability to participate in the political, social, and economic life of their society. It sustains them as fully participating citizens – normal collaborators and competitors – in all spheres of social life. This very much puts citizenship at the heart of the basic needs. Others emphasise the importance of autonomy and hence David Copp refers the basic needs to be things that are needed in order to achieve and maintain one's status as an autonomous and rational agent.80 One can imagine other approaches and different aspects of what it means to have a flourishing life such as being able to participate in caring relationships81 or reaching a base level of happiness. Even with agreement as to the level being sought, there may be disagreement over the extent to which individuals should be expected to contribute to their own well-being. For example, Rutger Claassen argues in favour of A reciprocity principle, according to which agents should contribute to the realization of their own subsistence capabilities as far as they are able to and be entitled to receive them from others as far as they are unable.82 Not everyone would accept that principle and even among those that do there will be considerable dispute as to its application.83

Conclusion This chapter has explored the relevance of Articles 7, 12, 16, 18, 19, and 25 UDHR on the right to health. It has been argued that they all support and give clarity to the right to health. As the 1991 Vienna Declaration of the World Conference on Human Rights states:‘[a]ll human rights are universal, indivisible and interdependent and interrelated.’84 That has been a theme of this chapter.We cannot promote equality without ensuring there is access for all to health; cannot protect privacy, properly understood, without a right to health; we cannot recognise rights to family life, without a right to health.This should not, however, be seen in individual terms: as producing a land populated by healthy bodies.We should be seeking to produce a healthy society. That is one where society seeks to promote the equality of all; to recognise the value and dignity of every human being; that enables relationships to flourish.That is true health.

References Adebowlae,Victor,‘It’s Time to Act on Racism in the NHS’ (2020) 368 BMJ 568. Anekwe, Lillian,‘Harnessing the Outrage: It’s Time the NHS Tackled Racial Bias’ (2020) 368 BMJ 341.

80 David Copp, ‘The Right to an Adequate Standard of Living: Justice, Autonomy and the Basic Needs’ (1992) 9 Social Philosophy & Policy 231–261. 81 Charles Foster and Jonathan Herring, Welfare,Altruism and the Law (Springer 2015). 82 R Claassen, Capabilities in the Just Society (Cambridge University Press 2016). 83 For a very helpful discussion, see Thana de Campos, The Global Health Crisis (Cambridge University Press 2017). 84 Vienna Declaration and Programme of Action 1991,Article 5.

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UDHR Articles 7, 12, 16, 18, 19, and 25 Appendix E to the Report of the Global Citizenship Commission (United Nations 2018). Boddington, Paula and Raisanen, Ulla,‘Theoretical and Practical Issues in the Definition of Health: Insights from Aboriginal Australia’ (2009) 34 Journal of Medicine and Philosophy 49. Claassen, R, Capabilities in the Just Society (Cambridge University Press 2016). Chandra, Rakesh,‘Collective Rights v Individual Rights’ (2017) 4 International Journal of Multidisciplinary Research and Development 51. Committee and Economic Social and Cultural Rights, The Right to the Highest Attainable Standard of Health (CESCR 2000), para 45. Copp, David, ‘The Right to an Adequate Standard of Living: Justice, Autonomy and the Basic Needs’ (1992) 9 Social Philosophy & Policy 231–61. Daniels, Norman,‘Justice, Health, and Health Care’ (2001) 1 American Journal of Bioethics 2. de Campos, Thana, The Global Health Crisis (Cambridge University Press 2017). Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilisation and Embryology (Her Majesty’s Stationary Office, 1984), 9–10. Dworkin, Ronald, Taking Rights Seriously (Gerald Duckworth 1977). Eberl, Jason, Kinney, Eleanor, and Williams, Matthew, ‘Foundation for a Natural Right to Health Care’ (2011) 36 Journal of Medicine and Philosophy 537. Eekelaar, John, Family Law and Personal Life (Oxford University Press 2006). Eide, Asbjørn, The Human Right to Adequate Food and Freedom from Hunger (United Nations) https://digital library.un.org/record/277522?ln=en accessed 14 November 2020. Foster, Charles, Human Dignity in Bioethics and the Law (Hart 2011). Foster, Charles, and Herring, Jonathan,‘What is Health?’ in M Freeman, S Hawkes and B Bennett (eds) Law and Global Health (Oxford University Press 2014). Foster, Charles, and Herring, Jonathan, Welfare,Altruism and the Law (Springer 2015). Fredman, Sandra, Comparative Human Rights Law (Oxford University Press 2018). Habitat for Humanity, ‘World Habitat Day’ www.habitat.org/volunteer/build-events/world-habitat-day accessed 11 November 2020. Harding, Seeromani, Read, Ursula, Molaodi, Oarabile et al., ‘The Determinants of Young Adult Social Well-Being and Health (DASH) Study: Diversity, Psychosocial Determinants and Health’ (2015) 50 Social Psychiatry and Psychiatric Epidemiology 1173. Harris, John,‘Rights and Reproductive Choice’ in John Harris and Soren Holm (eds) The Future of Human Reproduction (Oxford University Press 1998). Hassoun, Nicole,‘The Human Right to Health’ (2015) 10 Philosophy Compass 275. Hepple, Bob, Equality:The New Legal Framework (Hart Publishing 2011). Herring, Jonathan,‘Ethics of Care and the Public Good of Abortion’ (2019) 2 Oxford Human Rights Hub Law Journal 1. Herring, Jonathan, Fulford, Bill, and Handa,Ashok,‘Elbow Room for Best Practice? Montgomery, Patients’ Values in Balanced Decision-Making in Person-Cantered Clinical Care’ (2017) 25 Medical Law Review 582. Herring, Jonathan, Domestic Abuse and Human Rights (Intersentia, 2020). Hessler, Kristen, and Buchanan, Allen, ‘Equality, Democracy, and the Human Right to Health Care’ in Rosamond Rhodes, Margaret Battin and Anita Silvers (eds) Medicine and Social Justice: Essays on the Distribution of Health Care (Oxford University Press 2012). Kismödi, Eszter, and Ferguson, Laura,‘Celebrating the 70th Anniversary of the UDHR, Celebrating Sexual and Reproductive Rights’ (2018) 26 Reproductive Health Matters 52. Lamb, Christina, ‘Conscientious Objection: Understanding the Right of Conscience in Health and Healthcare Practice’ (2016) 22 The New Bioethics 33. Liao, Matthew, ‘Human Rights and Public Health Ethics’ in Anna Mastroianni, Jeffrey Kahn, and Nancy Kass (eds) The Oxford Handbook of Public Health Ethics (Oxford University Press 2019). Lindemann, Kate,‘The Ethics of Receiving’ (2003) 24 Theoretical Medicine and Bioethics 501, 507. Marks, Stephen, ‘The Emergence And Scope of the Human Right to Health’ in José Zuniga, Stephen Marks, and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013). Mason, Benjamin, and Gostin, Lawrence, ‘Framing Human Rights in Global Health Governance’ in José Zuniga, Stephen Marks and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013). Maung, Hane,‘Is Infertility a Disease and Does it Matter?’ (2019) 33 Bioethics 43.

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Jonathan Herring Molas, Andrew, ‘Defending the CRPD: Dignity, Flourishing, and the Universal Right to Mental Health’ (2016) 20 The International Journal of Human Rights 1264. Neal, Mary, ‘Conscientious Objection, “Proper Medical Treatment” and Professionalism: The Limits of Accommodation for Conscience in Healthcare’ in John Adenitire (ed) Religious Beliefs and Conscientious Exemptions in a Liberal State (Hart 2019). Nussbaum, Martha, Women and Human Development:The Capabilities Approach (Cambridge University Press 2000). Office of National Statistics, Deaths of Homeless People in England and Wales: 2018 (ONS 2019). Office of the High Commissioner, ‘Universal Declaration of Human Rights at 70: 30 Articles on 30 Articles’ www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=23970&LangID=E accessed 11 November 2020. Office of the United Nations High Commissioner for Human Rights, The Right to Health (United Nations 2019). O’Neill, Onora,‘The Dark Side of Human Rights’ (2005) 81 International Affairs 427. Organization for Economic Cooperation and Development, Inequality (OECD 2020). PAHO and WHO, Sexual Health (WHO 2000). Petrova, Dimitrina, Article 7:The Equality and Non-Discrimination Provision (United Nations 2016). ‘Post 15’ (My Body, My Choice) http://mybody-mylife.org/user-submitted-post-15/ accessed 14 November 2020. Reinert, Kenneth, No Small Hope: Towards the Universal Provision of Basic Goods (Oxford University Press 2018). Savulescu, Julian,‘Conscientious Objection in Medicine’ (2006) 332 BMJ 294. Schneider, Elizabeth,‘The Violence of Privacy’ (1991) 23 Connecticut Law Review 973. Schuklenk, Udo, and Smalling, Ricardo,‘Why Medical Professionals Have No Moral Claim to Conscientious Objection Accommodation in Liberal Democracies’ (2017) 43 JME 234. Sherwin, Susan, No Longer Patient (Temple University Press 1992). Sreenivasan, Gopal, ‘A Global Right to Health: Some Inconclusive Scepticism’ (2012) 86 Aristotelian Society 239. Sun, Juanjuan,‘On Right to Adequate Food and Relevant Concepts from the Legal Perspective’ (2017) 16 Journal of Human Rights 256. Szydlowski, Maciej,‘Gender Recognition and the Rights to Health and Health Care:Applying the Principle of Self-Determination to Transgender People’ (2016) 17 International Journal of Transgenderism 199. UN Special Rapporteur on Health, The Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health (United Nations 2006). UN Women, Facts and Figures: Ending Violence against Women (United Nations 2020). Venkatapuram, Sridhar, Health Justice:An Argument from the Capabilities Approach (Wiley 2011). Waldron, Jeremy, Dignity, Rank, and Rights (Oxford University Press 2006). Weller, P, ‘The Right to Health: The Convention on the Rights of Persons with Disabilities’ (2010) 35 Alternative Law Journal 66. WHO, Sexual Health (WHO 2012). WHO, World Report on Disability (WHO 2011). Yamin, Alicia, ‘Women’s Health and Human Rights: Struggles to Engender Social Transformation’ in José Zuniga, Stephen Marks, and Lawrence Gostin (eds) Advancing the Human Right to Health (Oxford University Press 2013). Zampas, Christina, and Gher, Jaime, ‘Abortion as a Human Right: International and Regional Standards’ [2008] Human Rights Law Review 2.

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4 A GLOBAL RIGHT TO HEALTH AMID GLOBAL HEALTH EMERGENCIES Clayton Ó Néill

Introduction This chapter deals with the connection between global rights and global health, and casts a particular eye on global health emergencies, including the COVID-19 pandemic. It focuses specifically on the effectiveness or otherwise of global responses to crises, and considers the disconnect that can exist between national and international action/advice. The COVID-19 pandemic quickly engulfed many corners of the world.We have responded in various ways: with fear, anger, acceptance, trepidation, and hope for the remodelled world that may emerge.The pandemic makes it important to consider whether and to what degree a unified global response can or should be put in place in a manner that recognises that all people have a right to health, and have a right to have equal and equitable access to health knowledge and health resources. This chapter is divided into two sections.The first section deals with ideas and interpretations pertaining to a right to health. It sets out some of the legal instruments designed to give a global protection to this right and that have not been considered in the previous chapters by Herring and Foster.The second section looks specifically at how and whether a right to health operates within the landscape of COVID-19. It assesses the degree to which current legal instruments and the international organisations which support the application of a right to health have been successful in achieving their aims in this context. It proposes an approach to the attainment of a universal right to health that encompasses justice, fairness, and equity.

A universal right to health in the COVID-19 context There has long been a universal consensus (bar the protestations of a few ascetics and deviants) that health is intimately connected to human thriving. The concept of a right to health has roots in many ages, regions, and philosophies. There are traces of it in the Golden Age of Greece, in the view of autonomy articulated at the Enlightenment, in the reaction against the commodification of humans that occurred at the Industrial Revolution, in the international response to the Holocaust, and in the Liberation

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theology of Latin America.1 The right is related to the principle that states must take action to safeguard citizens’ health.2 World War II acted as a catalyst for states to cooperate with one another and to form the United Nations.The Universal Declaration of Human Rights (UDHR) was adopted shortly afterwards. In the immediate aftermath of World War II, the right to health was not perceived, according to Tobin,‘as a noble aspiration or utopian goal – a perception that characterizes its contemporary understanding.’3 Instead he says that ‘it was intimately linked, more so than other economic and social rights, with maintaining peace and security and was therefore considered to be of significant instrumental value.’4 Tobin makes reference to Franklin D Roosevelt’s famous Presidential State of the Union address in 1941 where Roosevelt discussed freedoms, including ‘freedom from want – which, translated into world terms, means economic understandings which will secure to every nation a healthy peacetime life for its inhabitants – everywhere in the world.’5 The pursuit of health for citizens was seen as an essential element of social, economic and cultural rights – and if those rights were to be legally protected, so, it followed, should a right to health. But what is ‘health’ for these purposes? It is not defined in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR).The Committee on Economic, Social and Cultural Rights (CESCR) refers to the preamble of the World Health Organization’s (WHO) Constitution which describes health as ‘a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.’6 When the WHO’s Constitution was ratified in 1948, the goal of ‘Health for All’ was a central facet. According to Ruger, the WHO’s vision of achieving ‘Health for All’ has not been fulfilled and the efforts of the WHO, to date, have mostly been rhetorical.7 As this chapter demonstrates, there is a good deal more rhetoric than substance in the recent history of the idea of a universal right to health. The most significant endorsement of a global right to health is found in Article 12 ICESCR, which states: 1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness.

John Tobin, The Right to Health in International Law (Oxford University Press 2012) 9. ibid 9. ibid 15. ibid 15. Franklin D Roosevelt,The State of the Union Address to Congress 6 January 1941, in Samuel Rosenman (ed),The Public Papers and Addresses of Franklin D Roosevelt (Random House, 1938–1950) 672. See Tobin (n 1) 24–25. 6 OHCHR, CESCR General Comment No. 14 www.ohchr.org/Documents/Issues/Women/WRGS/Health/GC14 .pdf accessed 22 October 2020. 7 Jennifer Prah Ruger, ‘Normative Foundations of Global Health Law’ (2008) 96(2) Georgetown Law Journal 423–443. 1 2 3 4 5

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The provision within Article 12 2(c) of a constituent element that specifies the need to prevent, treat, and control epidemics gives a very clear endorsement to the efforts that are currently being made to prevent the spread of COVID-19.The attendant rights within this article, including aiming towards a highest standard of health, realisation of rights, improvement in services, hygiene, and the development of the child sit alongside the prevention, treatment, and control of epidemics.This recognises the fact that the right to health in terms of the prevention of the spread of epidemics is not held within a vacuum, but is aligned with broader rights that run in parallel with and transcend emergency health measures. In respect of the provisions within the ICESCR, Gostin contends that, although the right to health sets out a ‘critical framework for national and global responsibilities for health,’ there are a number of shortcomings, as follows: (1) the right to health has goals, but the obligations are insufficiently structured with detail in order to make them prone to thorough scrutinising and enforcement; (2) the CESCR, which oversees the ICESCR, has very limited powers to enforce states to comply with the ICESCR other than studying reports written by the states on their implementation of the ICESCR, as well as formulating recommendations; (3) the ICESCR necessitates that states act on the promises made ‘progressively,’ instead of immediately. Gostin argues that this means that the path towards full realisation is ‘staggered and uncertain’; (4) it is the states themselves, and not the international community, that hold the legal duty to ensure that sufficient health services exist, even if the particular state does not have many resources and has inadequate capacity.8 Thus, the fact that a right to health is encapsulated within the ICESCR and is deliberated on by the CESCR does not necessarily lead to any form of automatic application. A right to health is incorporated within economic, social, and cultural rights.These rights are protected in international law under the International Covenant on Civil and Political Rights (ICCPR), while economic, social, and cultural rights are safeguarded under the ICESCR. Civil and political rights are often regarded as more important and more concrete than abstract economic, social, and cultural rights. Both treaties came into force in 1976 and together with the UDHR form the International Bill of Human Rights. Indeed, both categories of rights are ‘universal, indivisible and interrelated’ and they are both looked upon in a ‘fair and equal manner, on the same footing and with the same emphasis.’Article 2(1) ICESCR says: Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures. Ssenyonjo contends that it has been indefensibly recognised that economic, social, and cultural rights are insufficiently concrete and that they ought to be reviewed at national level rather than at an international level, due to the lack of justiciability.9 However, according to Article 2 ICESCR, steps must be taken by states in order to achieve, as far as possible, the full realisation of these rights. In 2008, an Optional Protocol was introduced (and came into force in 2013), which allows for explicit breaches of economic, social, and cultural rights to be adjudicated upon. Citizens or organisations are now able to complain to the CESCR if there has been a vio-

8 Lawrence O Gostin, Global Health Law (Harvard University Press 2014) 20. 9 Manisuli Ssenyonjo, Economic, Social and Cultural Rights in International Law (Hart 2016).

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lation of the ICESCR. In order to make this complaint, the domestic remedies must have been exhausted and the applicant(s) must show harm or prove that their application, according to Article 4 ICESCR,‘raises a serious issue of general importance.’10 In discussing substantive issues pertaining to the implementation of Article 12 ICESCR, the CESCR recognised the fact that health is ‘a fundamental human right indispensable for the exercise of other human rights.’ Every person is entitled to enjoy the ‘the highest attainable standard of health conducive to living a life in dignity.’11 This can be realised through differing approaches, such as WHO programmes or particular legal instruments.The CESCR links the right to health to other international instruments, such as Article 25.1 UDHR.According to the CESCR the normative context of Article 12 ICESCR includes both entitlements and obligations.The CESCR states: The freedoms include the right to control one’s health and body, including sexual and reproductive freedom, and the right to be free from interference, such as the right to be free from torture, non-consensual medical treatment and experimentation. By contrast, the entitlements include the right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.12 The CESCR points to the following as essential elements of the right to health: availability, physical and economic accessibility, acceptability, and quality. The healthcare facilities must be physically available for all citizens within a state and that these facilities must not be delivered a discriminatory manner.13 Medical ethics and culture must be given appropriate respect, and science and medicine must be of sufficient quality to ensure adequacy of safe treatment.This means that healthcare professionals must be properly trained; medicines must be scientifically approved; and there must be safe and effective equipment, sanitation, and drinking water.14 The International Covenant on Civil and Political Rights (ICCPR) is also relevant, especially Article 6 – the right to life. Like the CESCR, the Human Rights Committee exists which focuses on state accountability. However, Gostin argues that both mechanisms are inadequately rigorous because of the non-binding nature of their decisions.15 The respective committees make recommendations instead of judgements that must be followed. In relation to the ICESR, states only need to give the recommendations made by the CESCR ‘urgent consideration.’ In the context of the ICCPR, the Human Rights Committee can only tell states ‘whether interim measures may be desirable to avoid irreparable damage to the victim of the alleged violation.’16 Gostin explains that both of these international treaties differ in relation to acceptable limitations of rights.17 He contends that the ICCPR guarantees particular rights that are so important that they could never be denied by a state in a public health crisis. States cannot derogate from

10 ibid 252.Also see Amrei Müller,‘Limitations to Derogations from Economic, Social and Cultural Rights’ (2009) 9(4) Human Rights Law Review 557–601. 11 Committee on Economic, Social and Cultural Rights, ‘Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights’ (12 May, 2000) http://docstore.ohchr.org/ SelfServices/FilesHandler.ashx?enc=4slQ6QSmlBEDzFEovLCuW1AVC1NkPsgUedPlF1vfPMJ2c7ey6PAz2q aojTzDJmC0y%2B9t%2BsAtGDNzdEqA6SuP2r0w%2F6sVBGTpvTSCbiOr4XVFTqhQY65auTFbQRP WNDxL accessed 22 October 2020. 12 ibid para 8. 13 ibid. 14 ibid para 11. 15 Gostin, Global Health Law (n 8). 16 Rules of Procedure, Rule 92 (earlier rule 86). 17 Gostin, Global Health Law (n 8) 256.

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these rights, but other rights can be limited. For example, freedom of expression in the ICCPR can be limited if ‘provided by law and are necessary (a) for respect of the rights or reputations of others; (b) for the protection of national security or of public order (ordre public), or of public health or morals.’18 The ICESR does not include specific limitations within the articles themselves. Instead,Article 4 ICESCR states: The States Parties to the present Covenant recognize that, in the enjoyment of those rights provided by the State in conformity with the present Covenant, the State may subject such rights only to such limitations as are determined by law only in so far as this may be compatible with the nature of these rights and solely for the purpose of promoting the general welfare in a democratic society. These provisions provide a substantive legal backbone to the philosophical idea that a right to health exists and that this right has global application. Some additional international treaties that endorse a right to health are relevant, but are outside the remit of this chapter. It is, however, worth noting that the right to health is apparent in the following provisions: • • • • • • •

Article 5 (e)(iv), International Convention on the Elimination of All Forms of Racial Discrimination (CERD); Articles 11.1 (f) and 12 of the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW); Article 24 of the Convention on the Rights of the Child (UNCRC); Article 11, European Social Charter; Article 16,African Charter on Human and Peoples’ Rights; Article 10 of the Additional Protocol to the American Convention on Human Rights; and Article 25 UDHR (discussed by Jonathan Herring in Chapter 3).

Thus, there is a significant body of legal instruments which supports or endorses or defends a right to health. For this right to be vivified in practice, however, international organisational defence is required.

The role of the WHO in the context of epidemics The WHO, whose advice purports to transcend action at individual country level, is a body that provides leadership on critical issues pertaining to health and sets up partnerships where joint action is required.19 The WHO is the main international body tasked with responding to an epidemic, such as Ebola. McInnes has stated that the WHO has ‘[t]he operational ability to act in a crisis is noticeable by its omission.’20 The WHO also disseminates knowledge, sets the research agenda and the norms/standards, monitors the execution of these standards and norms, and formulates policy options based on relevant evidence and ethics. Additionally, the WHO

18 Article 19(3) ICCPR. 19 WHO,‘About WHO’ www.who.int/about/role/en/ accessed 22 October 2020. 20 Colin McInnes, ‘WHO’s Next? Changing Authority in Global Health Governance after Ebola’ (2015) 91 (6) International Affairs 91 1299–1316.

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oversees health trends, offers technical support, and acts as a catalyst for change.According to the Office of the High Commissioner for Human Rights (OHCHR) and the WHO: Regardless of our age, gender, socio-economic or ethnic background, we consider our health to be our most basic and essential asset. Ill health, on the other hand, can keep us from going to school or to work, from attending to our family responsibilities or from participating fully in the activities of our community. By the same token, we are willing to make many sacrifices if only that would guarantee us and our families a longer and healthier life. In short, when we talk about well-being, health is often what we have in mind.21 Furthermore, the WHO’s preamble asserts that ‘[t]he enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.’22 Therefore, the attainment of health is something that deserves significant attention at an international level. The work of the WHO has not always been universally affirmed. In response to the Ebola epidemic, it was stated in The Lancet that ‘incredibly weak health systems, with few staff, little equipment, and poor facilities’ made ‘disease surveillance, isolation, and supportive care virtually impossible without external assistance.’23 Ruger discusses how many cultural factors, such as governmental mistrust and burial practices, ‘confounded efforts to find and treat the ill.’24 Pharmaceutical companies were criticised for their response to the Ebola epidemic.25 Ruger cites evidence in The Lancet, where it was argued that ‘a vaccine would probably exist if Ebola affected a large number of people in high-income countries, making research and development financially attractive to drug companies.’26 Without doubt, the WHO was widely criticised for its response to the epidemic. Clare Wenham considers these criticisms and states that there was ‘a general consensus in the global health community that it fell short of its leadership responsibilities.’27 The WHO recognised its own shortcomings: The initial response was slow and insufficient, we were not aggressive in alerting the world, our surge capacity was limited, we did not work effectively in coordination with other partners, there were shortcomings in risk communication, and there was confusion of role and responsibilities.28 Wenham refers to the operational and normative roles of the WHO. She claims that during the Ebola epidemic, from a normative perspective, the WHO reacted by producing technical

21 OHCHR and WHO,‘The Right to Health: Fact Sheet No 31’ 1 www.ohchr.org/Documents/Publications/Fac tsheet31.pdf accessed 22 October 2020. 22 WHO, Constitution of the World Health Organization (4th ed 2006) 1 www.who.int/governance/eb/who_const itution_en.pdf accessed 22 October 2020. 23 ‘Ebola:A Failure of International Collective Action’ (2014) 384 The Lancet 637. 24 Jennifer Prah Ruger, Global Health Justice and Governance (Oxford University Press 2018) 4. 25 ibid 4. 26 ‘Ebola:A Failure of International Collective Action’ (n 23). 27 Clare Wenham, ‘What We Have Learnt about the World Health Organization and the Ebola Outbreak’ (2017) 372 (1712) Philosophical Transactions of the Royal Society of London Series B Biological Sciences https://royalsociety publishing.org/doi/10.1098/rstb.2016.0307 accessed 22 October 2020. 28 WHO,‘Leadership Statement on the Ebola Response and WHO Reforms’ (WHO 2012) www.who.int/csr/dise ase/ebola/joint-statement-ebola/en/ accessed 2 April 2020.

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advice, engaging with communities, sharing epidemiological data, and supporting the training of healthcare works and worked on a vaccine. Nevertheless, she argues that these normative responses have been overlooked due to the criticisms of the WHO’s operational response. According to her, a mismatch exists between the WHO’s expectations and what this organisation is authorised and able to do.29 She claims that the WHO does not have the ability to deliver significantly on either its normative or operational roles.30 Following the Ebola epidemic, the WHO has created the Health Emergencies Programme, with the aim of having ‘one programme, with one workforce, one budget, one set of rules and processes and one clear line of authority.’31 The creation of this programme and recognition by the WHO of its shortfalls in the response to the Ebola epidemic is a positive step forward in the realisation of a proper global health agenda.The WHO has made efforts to ensure that the Health Emergencies Programme can actually respond to the criticisms that the WHO lacks the normative and operational abilities to tackle a global health emergency. The response at this organisational level to epidemics has, therefore, had both positive and questionable features.What has the response been at the national governmental level within the global landscape?

Global responses to COVID-19 The coronavirus pandemic is now travelling through towns, cities, countries, and continents at great speed and with calamitous effect on diverse populations. It appears to be immune to colour, creed, race, ethnicity, status, and global geographic location, although in the developed world there is some evidence that black ethnic monitories are disproportionately affected.There are nuances of difference in the way in which curves are being flattened, social distancing is being imposed or being enjoyed, governments are reacting, people are reacting.These nuances are not insignificant, and the rates of death certainly seem to be aligned to factors which, at the time of writing, are sometimes ambiguous.The only certain thing in February 2021 is that this is a pandemic that is casting its shadow with global zeal and global consequence. Responses to the virus have differed from jurisdiction to jurisdiction, with differing results. Many of the developing countries hit by coronavirus are poorly equipped to deal with this global pandemic, but the invidious reach of it is yet to be calibrated. India, at one stage, locked down its 1.4 billion inhabitants. For many of the poorer citizens of this country, the problem will not be social distancing or hand sanitising, but in finding a place to lay a head and food to sustain a weakening self. France, Spain, and Italy were ravaged by this pandemic, which is still spreading despite concerted efforts on the part of governments, citizens, and medical teams.The

29 Wenham (n 27). 30 Also see WHO, Report of the Ebola Interim Assessment Panel (WHO 2015) www.who.int/csr/resources/publicati ons/ebola/report-by-panel.pdf?ua=1 accessed 22 October 2020. 31 WHO, WHO’s New Health Emergencies Programme (WHO 2016) www.who.int/about/who_reform/emergency -capacities/emergencies-accessed22October 2020/programme2016.pdf?ua=1 accessed 04 April 2020; WHO, ‘WHO Health Emergencies Programme’ www.who.int/westernpacific/about/how-we-work/programmes/ who-health-emergencies-programme accessed 22 October 2020.The WHO states that the programme attempts to ‘minimize the health consequences of outbreaks and emergencies.’ It does this by ‘helping countries to strengthen capacities to detect, prevent and respond to health emergencies’; ‘mitigating the risk of high threat diseases and infectious hazards’; ‘detecting and assessing emergency health threats and informing public health decision-making’;‘responding rapidly and effectively to emergencies under a coordinated incident management system; and ‘ensuring WHO’s work in emergencies is effectively managed, sustainably financed, adequately staffed and operationally ready to fulfil its mission.’

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somewhat draconian measures adopted by China may have arrested the spread of the disease in Asia. As I write in February 2021, in today’s news coronavirus deaths in the world have passed 2.3 million: COVID-19 is a global pandemic requiring a local response. Much of this response will come from the fair and equitable immunisation of populations, using vaccines such as those produced by Pfizer-BioNTech and Moderna. Some positive trends in respect of vaccines on a country-specific basis are currently visible. It remains to be seen, however, to what degree an appropriate sharing of vaccine resources will apply globally. It is hoped that COVAX will act as a global solution to the problem posed by inequity in terms of distribution of vaccines. COVAX aims to ensure that all people are provided with vaccines, including those who live in counties that lack economic resources.32 From a European Union (EU) perspective, a common European response to the virus has been commissioned by the European Commission to alleviate the socio-economic impact as well as to strengthen its public health sectors.33 The European Commission’s president, Ursula von der Leyen, has created a coronavirus response team to manage the response to the virus. The aims of this response team are to enhance the supply of protective personal equipment and medical supplies (such as ventilators), making the EU’s fiscal rules more flexible, establishing the Coronavirus Response Investment Initiative to help small businesses and the health workers/ organisations, stop unnecessary travel to the EU, and set out guidelines for member states on procedures that can be taken to safeguard the health of citizens while allowing for the traffic of necessary goods.34 However, aspects of the EU’s response to the COVID-19 crisis have been heavily criticised, particularly in relation to the perceived tardiness of actions taken at EU level to procure and distribute vaccines. The differences in the global reaction to coronavirus are not, strangely enough, wholly based upon either economic or medical variables. For example, the UK, which has a ‘rich’ arsenal of advanced medical knowledge, history, and know-how, had originally adopted fairly laissez-faire testing procedures. It had missed opportunities to purchase much needed medical protective equipment for its staff and it has not consistently complied with the WHO’s advice to ‘test, test, test.’ Hospitals were built to cope with a huge population of critically ill patients, but, to date, are underused, but as the third wave is striking, may yet form significant pillars in the fight against the virus. In an effort to inhibit the spread of COVID-19, many governments throughout the world implemented guidance that told older people (70-plus) and those with underlying health conditions to shield away from the general public for prolonged periods. In Ireland, for example, this was called ‘cocooning.’ In addition to this, visits by relations to residents in nursing homes were severely limited or forbidden altogether, leading many of these residents bereft of company, isolated, lonely, and alone. In the legitimate attempt to ensure that the health of these older and more vulnerable people was protected, there may have been an unwritten and unheralded cost – the well-being, mental health, and flourishing of these people may have been compromised to such a degree that there was an inequity between cure and disease, and, in effect, the isolating treatment may, for some, have been worse than the actual contracting of the dreaded disease. For some relatives whose loved ones died in hospital alone and were buried almost alone or without

32 See Seth Berkley, ‘COVAX explained’ (Gavi, 3 September 2020) https://www.gavi.org/vaccineswork/covaxexplained accessed 11 February 2021.Also see WHO,‘COVAX:Working for global equitable access to COVID19 vaccines’ https://www.who.int/initiatives/act-accelerator/covax accessed 11 February 2021. 33 European Commission, ‘Coronavirus Response’ https://ec.europa.eu/info/live-work-travel-eu/health/coronav irus-response_en accessed 22 October 2020. 34 European Commission,‘European Commission’s Response Team’ https://ec.europa.eu/info/live-work-travel-eu /health/coronavirus-response/european-commissions-action-coronavirus_en accessed 22 October 2020.

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fanfare, then, once again, the treatment may have been more psychologically invidious than the disease. It may be worth perusing the legal question as to whether the right of an older person to health, as protected under the various legal instruments mentioned earlier, was actually compromised, or was it a case that, in a pandemic situation, these rights are limited by the emergency measures that must be taken to protect public health. Logically, the latter scenario is probably the one that would sway the judgement. But, at a human level and at a human rights level, it may well be argued into the future that there was a deprivation of liberty, that there was a derogation of rights and the principles of the human rights instruments were not used in the spirit by which they were intended when making freedom-limiting policies for older and vulnerable people. In the United States (US), a White House Coronavirus Task Force has been established by the US Department of State. A multi-trillion financial rescue package been signed into law by President Trump, which was endorsed by both Republicans and Democrats. From an international perspective, the US has set out a significant budget to help other countries in their hour of need. USAID has authorised the use millions of dollars to purchase protective equipment in over 25 countries, inter alia.35 The US, another ‘wealthy’ state initially, at the highest level, denied that the virus would take off in the manner in which it has. Many states were tardy in their initial response to the spread of the virus.The former leader of the US had been infected with a virus that was originally dismissed by him as a hoax.There is disquiet in some quarters that this one person was the recipient of extensive medical intervention, while many people in the US and beyond have difficulty accessing the most basic healthcare.This is a key issue in the assertion of a right to health: does the possession of wealth or power guarantee a right to health and, equally, does the lack of wealth or power limit and minimise the opportunities that exist for others to exercise the same right? The inequity in treatment and healthcare provision given to those in power and those without power is not confined to America: the same injustices apply, in many cases, globally.The reality is that there is a direct correlation between poor health provision and the economic status of particular countries. If the right to health is a universal and inalienable human right, it is unacceptable that differences in the provision of care exist, in many instances, between developed and developing countries. What are the principles that promote a right to health and that need to be applied in practice as COVID-19 and other health emergencies continue to dominate the agenda of global health?

Justice, fairness, and equity and the moral compass of the global response to COVID-19 Global health law involves a hybrid of human rights law, international humanitarian law, international trade/labour law, international environmental law, inter alia.36 Thana de Campos in her book The Global Health Crisis discusses the moral value of health and responsibilities that global stakeholders hold in response to a global health crisis.37 She contends that wealthy states, pharmaceutical companies, and wealthy people have moral duties to those who are less privileged. Her argument that these stakeholders must, as a starting point, respect everyone’s basic human right to health is laudable.38 Equally, her argument that the concept of justice is central

35 US Department of State, ‘Coronavirus Disease 2019 (COVID-19) www.state.gov/coronavirus/ accessed 22 October 2020. 36 David P Fidler, International Law and Public Health: Material on and Analysis of Global Health Jurisprudence (2000); and Ruger,‘Normative Foundations of Global Health Law’ (n 7). 37 Thana de Campos, The Global Health Crisis: Ethical Responsibilities (Cambridge University Press 2017). 38 ibid 263.

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to the vindication of health rights is one that is closely aligned to the discursive journey taken by the contributors here.39 De Campos contends that lack of medical innovation/research and development represents the ‘crux’ of the crisis. Thus, she claims that, in order to try to remedy the problem, the first pivotal issue to be resolved is ‘access to medical knowledge’ – what she describes as ‘scientific and technical medical progress indispensable to meeting basic health needs.’40 This, therefore, necessitates the need for pharmaceutical companies to be involved in resolving the crisis.This is not simply a matter of benevolence: justice is a central component of any exploration of a remedy. Her conclusion that pharmaceutical companies are duty bound to disclose medical patents is surely sensible. De Campos’s description of a health crisis predated the current global health emergency where the number of people afflicted by the COVID-19 virus is multiplying exponentially at an alarming degree. Her advice is all the more relevant in this context. Justice, medical knowledge, response from big pharma, moral duties, research, and innovation – attention to all of these areas in a unified manner could put the moral duty to protect all at the centre of the health agenda, and in protecting all, it is likely that individual countries would, themselves, be better protected against global health emergencies. De Campos argues that there are two conceptions of the right to health: the first is the ‘well-being conception.’This conception links health to overall well-being.The right to health is defined as ‘a right to the highest attainable level of a person’s complete physical, mental and social capacities.’41 This includes socio-economic conditions and ranges from ‘basic human needs’ (e.g. shelter, sanitation, water) to more contextualised socio-economic conditions (e.g. healthy workplace, a healthy environment). She claims that this conception of health is too broad and too all-encompassing because health is just one factor within a range of relevant factors within the context in which a person is living. An alternative conception of health, according to de Campos, is related to the idea of basic health needs. De Campos states that ‘basic human needs are basic, as opposed to nonbasic, because they are indispensable to one’s survival – they are vital to any human life because without them the basic human goods of life and health would be threatened and violated.’42 She defines basic health needs as ‘moral and normative premises that can justify universal moral requirements – that is, prima facie stringent (yet not absolute) duties on others.These universal moral requirements will take the form of duties of justice and of reasons for benevolence.’43 Thus, the assumptions that underpin basic health needs provide reasons for ‘benevolent conduct’ and also supply a rationale that justifies the duties of justice that imposed upon others.44 In the context of the global health crisis, she prioritises basic health needs over non-basic health needs: basic health needs are at the core of a health emergency.They have moral relevance because they are the objects of both particular basic rights and even stronger duties.These rights and duties are more compelling than non-basic rights and duties that might be aligned to overall well -being.45 A right to health, if is not coupled with a just and equitable division of health resources, will be limited in its ability to have an impact upon people who are suffering the effects of a pandemic.Thus, a global response to this pandemic must be framed within and emanate from an agreed principle of equity.

39 40 41 42 43 44 45

ibid 264. ibid 212. ibid 29. ibid 31. ibid 36. ibid. ibid 39.

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Friedman and Gostin extend the concept of justice as comprising the foundation upon which a right to health is built.46 According to them, the goal of global health law must be to create a legal framework that achieves and sustains that kind of transformation.47 They state that, historically, global health has actually been about protecting richer countries from pathogens originating in poorer countries.48 This has moved to a situation where it is recognised that global health threats can start anywhere and that global health security is about the protection of everybody’s health, notwithstanding the fact that a disparity still exists between richer and poorer countries.49 Friedman and Gostin contend that three sets of conditions are needed for public good, i.e. public care, public health, and social determinants of health.50 They believe that public health services are tilted toward prevention instead of treatment and that public health action has been focused primarily on the health of populations instead of on the health of individuals.51 For Friedman and Gostin, fairness is a key component of global health with justice. In a perfect system, no matter how rich or poor a country is, no matter how much education a person has received, all will have analogous healthcare results. In this perfect state, everyone would have long and healthy lives.52 They claim that universal health coverage could go a long way to achieving greater fairness and justice.The reality is that those with the most money go to better schools, are paid more money, and work in safer environments and, thus, Friedman and Gostin argue that, without a collaborative endeavour, inequalities that are apparent in social systems will affect public health systems.53 The laudable struggle to provide a vaccine for COVID-19 that can meet the challenges of mutation or to provide state-of-the-art steroids that will combat the worst effects of the disease is not, in itself, enough to guarantee a right to health in developing countries where COVID-19 is weaving its way through the population. For example, let us look at the position of Sierra Leone.At this country, the rate of death from COVID-19 is low.That is not as positive a finding as it might appear.The worst effects of COVID-19 are to be seen in older and infirm people. According to the WHO, life expectancy in the WHO African region is 61.2 years in comparison to 77.5 in the WHO European region.54 The average lifespan in Sierra Leone is 54.55 The lack of an ageing population there means that COVID-19 does not strike with as virulent a force as in countries with older populations. Sierra Leone’s early death toll is linked to extreme poverty, malnutrition, and grave and untreated childhood illnesses, diseases that are often preventable and curable, but may have found insufficient popular appeal. This example points to the idea that using resources in an almost exclusive fight against COVID-19 could have the unfortunate consequence of supporting an inequitable approach to the application of a right to health. The articulation of this right to health in all international legal instruments is not always clear-cut and can meander into euphemistic and aspirational zones. But this articulation is well-

46 Eric A Friedman and Lawrence O Gostin, ‘Imagining Global Health with Justice: In Defence of the Right to Health’ (2015) 23 Health Care Analysis 308–29. 47 ibid 310. 48 ibid. 49 ibid. 50 ibid 311. 51 ibid. 52 ibid 312. 53 ibid 313. 54 WHO, ‘Life Expectancy’ www.who.int/gho/mortality_burden_disease/life_tables/situation_trends_text/en/ accessed 22 October 2020. 55 The World Bank,‘Life Expectancy At Birth – (Total) Years – Sierra’ Leone’ https://data.worldbank.org/indicator /SP.DYN.LE00.IN?locations=SL accessed 22 October 2020.

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meaning. Foster and Herring talk about the need to move beyond the narrow confines of our understanding of health towards a view of human thriving that is connected to social context and social expectations.56 In terms of global health justice, Ruger has argued that the duty of society to preserve and enhance health lies with the ethical concept of ‘human flourishing or human capability.’57 She states that national states have the primary role in promoting fairness and equity, but global institutions have an important ‘secondary role’ in rectifying the problems of inequality and the lack of fairness. Global organisations and global actors ought to support developing countries in order to allow them to enhance and promote health.58 A world that struggles to combat health emergencies needs to do so in a way that is mindful and protective of other less-newsworthy diseases, illnesses, and malaises that threaten defenceless populations. It is possible, for example, that far more will die of malaria than of COVID-19 in Sierra Leone. Ssenyonjo refers to a number of factors that adversely impact upon economic, social, and cultural rights in Africa.59 They include corruption, failure to comply with national court rulings, poverty, and lack of respect for the rule of law and international bodies.60 He claims that, in order to improve the ICESCR’s impact, a dramatic range of legal/economic/educational policies is required, including ensuring that national legislation complies with the ICESCR; politicians, lawyers, civil servants, and students are educated about the role of the covenant and the justiciability of economic, social, and cultural rights; ensuring that there are proper strategies adopted in order to reduce rates of poverty; and a need for greater transparency in the organisation of public money and the actions of those in authority. He argues that the Optional Protocol to the ICESCR must be ratified by far more states and these states need to be far less tardy in submitting reports to the CESCR.61 The sad reality is that corruption lies at the centre of some of the interventions that are being put in place to stop the spread of COVID-19.There seems to be political will to try to fight COVID-19, but I am not sure if the same will exists to fight inequity, injustice, and lack of fairness as they apply to the ‘smaller’ diseases that threaten the health of many people. The fact that legal instruments exist to protect a right to health is, of course, positive, but the patchy implementation and lack of visibility in the enforcement of these rights leads to a reality where a right to health is not high on the agenda of those who might have the power to ascribe and apply such a right.Widdows and Gostin have engaged in theoretical debate about the weighting that is ascribed to community and individual needs as they apply to health rights.62 What is now required is a practical approach that is both communal

Charles Foster and Jonathan Herring, Human Thriving and the Law (Springer 2018). Ruger,‘Normative Foundations of Global Health Law’ (n 7). ibid. Manisuli Ssenyonjo, ‘The Influence of the International Covenant on Economic, Social and Cultural Rights’ (2017) 64 Netherlands International Law Review 259–89. 60 ibid. 61 ibid. 62 See Heather Widdows,‘Global Health Justice and the Right to Health’ (2015) 23 Health Care Analysis 391–400, 391; see Gostin, Global Health Law (n 8) 121. Heather Widdows responds to Gostin’s argument in Global Health Law that global health is communal and is intrinsically linked to other concerns of justice, which would involve ‘all-of-society’ or ‘health-in-all’ policies and the need to focus on basic/communal health goods instead of individual and high-tech health goods. She queries whether this broad communal version of global health justice is ‘best served by making the right to health central to the project.’ She argues that rights are intrinsically individualistic and works best in relation to ‘single issue campaigns’ (391).Widdows claims that Gostin’s alternative approaches, that are less rights-focused, and, instead, focus on ‘global public goods and health security’ might be more deliverable, while ‘avoiding the problems of rights-talk’ (391). Gostin is of the view that health/health law/ health ethics must be global and that these ethics should directly correlate with justice.Widdows does not challenge this view of ‘health-for all.’ Instead, she queries the manner in which this can be attained. Specially,‘Gostin’s 56 57 58 59

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and individualistic. Resources should be shared with communities and should also be targeted to individuals who have most need of them. Where justice comes into play is in ensuring that richer countries share their access to health knowledge as well as health resources and that they do so with generous enthusiasm.This generosity of spirit cannot be mandated by the WHO, but it can be encouraged at societal and governmental level.There are currently shoots of this sharing of practice and sharing of knowledge. From the very earliest stage in the coronavirus pandemic, the genomes to the virus were shared with the international community and efforts to produce a vaccine have been carried out with collaboration between nations. It appears that the fight against this global virus is producing a global response. Notwithstanding this, individual countries are responding in an individual way: some are shutting borders, some are instigating social distancing, some have complete lockdowns, some have instituted draconian practices to inculcate social obedience. Many are now imposing severe travel restrictions and some quarantine systems have been put in place. Most countries are mindful of the recommendations of the WHO, but the disparate response at the level of the individual country will probably, in hindsight, not have helped control the spread of the disease.When countries act unilaterally, with the aim of protecting that individual country, they forget that the virus knows no borders and that unified, agreed action is probably the best response to this emerging pandemic.

Conclusion Much has been said in the media about the uniqueness of the COVID-19 phenomenon, the unprecedented nature of this disease, the challenging times in which we live, suggesting, in a way, that never was society so challenged by an invidious disease. Of course, the reality is that the penetration of a pandemic to multiple corners of the world is not unique to COVID-19. In fact, the COVID-19 mortality rates would barely have got a mention in other ages – the bubonic plague, for example, may have killed as much as 40% of the population.What is unique and what is illuminating and what is questionable is the societal response to this pandemic and its diverse formats. There are many explanations at different psychological and political levels for these diverse responses, but in some way, at the heart of the response are different iterations of the same desire to protect a given population from this new disease.What unites countries, broadly speaking, is a commitment to this endeavour, but what divides them are the resources that they have at their disposal and the medical treatments that are available and applied. Divergence also exists in the political leadership that attaches itself to the stewardship or otherwise of the pandemic.Why can one country have a ‘Zero-COVID’ approach and others a ‘herd immunity’

broadly communal vision of global health justice is well served by making the right to health so central to the project.’ She claims that ‘Gostin’s use of the right to health is in some tension with his broader global vision, and as such it might be better for Gostin to abandon or play-down rights-talk and focus less on the ‘right to health’ and more on other approaches. She argues that Gostin’s additional focus on global public goods and health security could be substituted for the right to health analysis. She states (392): This would deliver many—and perhaps all—of the health goods which Gostin includes in his vision of global health and avoid many of the problems of rights-talk.To do this would change the form rather than the substance of Gostin’s claims. It would not affect what individuals receive, or substantially change his construction of health. It would change the language from one of rights to one of goods. In addition it would remove a source of tension in Gostin’s GHL [Global Health Law], making his broadly communal vision of global health more robust.

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approach and still others a ‘living with COVID’ approach? The right to health is sometimes subverted by political actions that compromise the promotion of public health. Gostin asks a number of salient questions: Under a right to health, what are the crucial services/goods that are guaranteed to everyone?63 What health-related obligations do states owe to their citizens?64 What are the obligations held by the international community for advancing the health of people, particularly in low-/middle-income countries?65 These questions have relevance for the struggle to prevent the spread of COVID-19, and this chapter has found some answers to these questions. If a right to health can be considered to be a service or a consumer good, then I have tried to show here that a right to health is, indeed, guaranteed to everyone. There are obligations on states to their citizens in terms of the application of these rights, which is underpinned by a number of international instruments that are, however, insufficiently robust in terms of enforcement.We have seen how developing countries do not have the same resources to combat this virus as other countries. Developed countries have an obligation to assist developing nations in reducing the spread of COVID-19, but action in this regard cannot only be confined to pandemic relief because other health rights and necessities are often more pertinent or, at the very least, exist in parallel in these contexts.The global governance mechanisms that, according to Gostin, are ‘required to ensure that all states live up to their mutual responsibilities for improving health’66 need to be founded upon aligning a right to health with broader human rights. It now appears that the WHO and the legal instruments that underpin healthcare and access to it can say all they like, can infer all they like, can promise all they like about health and its associated rights, but unless there is just and global application in practice, then these asserted rights are founded on rocky ground and are toothless in the face of pandemics and day-to-day illnesses alike. All citizens should have a just and equal opportunity to have access to the most valid preventative and treatment measures. Accordingly, approaches to the implementation of a right to health have to be underpinned by the principles of justice, fairness and equity. At the heart of such procedures should be the sharing of knowledge, resources, and personnel. The future thought and action of those concerned with promoting the application of a right to health should be embraced by a shared commitment to the principles that underpin this right.

References Berkley,Seth,‘COVAX Explained’(Gavi,3 September 2020) www.gavi.org/vaccineswork/covax-explained accessed 11 February 2021 Committee on Economic, Social and Cultural Rights, Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights (12 May 2000) http://docstore.ohchr.org /SelfServices/FilesHandler.ashx?enc=4slQ6QSmlBEDzFEovLCuW1AVC1NkPsgUedPlF1vfPMJ2 c7ey6PAz2qaojTzDJmC0y%2B9t%2BsAtGDNzdEqA6SuP2r0w%2F6sVBGTpvTSCbiOr4XVF TqhQY65auTFbQRPWNDxL accessed 22 October 2020. de Campos, Thana, The Global Health Crisis: Ethical Responsibilities (Cambridge University Press 2017). ‘Ebola:A Failure of International Collective Action’ (2014) 384 The Lancet 637. European Commission,‘Coronavirus Response’ https://ec.europa.eu/info/live-work-travel-eu/health/co ronavirus-response_en accessed 22 October 2020.

63 64 65 66

Gostin, Global Health Law (n 8) 22. ibid 25. ibid 27. ibid 29.

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A global right to health European Commission, ‘European Commission’s Response Team’ https://ec.europa.eu/info/live-work -travel-eu/health/coronavirus-response/european-commissions-action-coronavirus_en accessed 22 October 2020. Fidler, David P, International Law and Public Health: Material on and Analysis of Global Health Jurisprudence (Transnational Publishers 2000). Foster, Charles and Herring, Jonathan, Human Thriving and the Law (Springer 2018). Friedman, Eric A and Gostin, Lawrence O,‘Imagining Global Health with Justice: In Defence of the Right to Health’ (2015) 23 Health Care Analysis 308–329. Gostin, Lawrence O, Global Health Law (Harvard University Press 2014). McInnes, Colin, ‘WHO’s Next? Changing Authority in Global Health Governance after Ebola’ (2015) 91(6) International Affairs 1299–1316. Müller,Amrei,‘Limitations to Derogations from Economic, Social and Cultural Rights’ (2009) 9(4) Human Rights Law Review 557–601. OHCHR, ‘CESCR General Comment No. 14’ www.ohchr.org/Documents/Issues/Women/WRGS/ Health/GC14.pdf accessed 22 October 2020. OHCHR and WHO,‘The Right to Health: Fact Sheet No 31’ 1 www.ohchr.org/Documents/Publication s/Factsheet31.pdf accessed 22 October 2020. Roosevelt, Franklin D,‘The State of the Union Address to Congress 6 January 1941’ in Samuel Rosenman (ed), The Public Papers and Addresses of Franklin D Roosevelt (Random House 1938–1950). Ruger, Jennifer Prah, ‘Normative Foundations of Global Health Law’ (2008) 96(2) Georgetown Law Journal 423–443. Ruger, Jennifer Prah, Global Health Justice and Governance (Oxford University Press 2018). Ssenyonjo, Manisuli, Economic, Social and Cultural Rights in International Law (Hart 2016). Ssenyonjo, Manisuli, ‘The Influence of the International Covenant on Economic, Social and Cultural Rights’ (2017) 64 Netherlands International Law Review 259–289. The World Bank,‘Life Expectancy at Birth – (Total) Years – Sierra’ Leone’ https://data.worldbank.org/ind icator/SP.DYN.LE00.IN?locations=SL accessed 22 October 2020. Tobin, John, The Right to Health in International Law (Oxford University Press 2012). US Department of State, ‘Coronavirus Disease 2019 (COVID-19)’ www.state.gov/coronavirus/ accessed 22 October 2020. Wenham, Clare, ‘What We Have Learnt about the World Health Organization and the Ebola Outbreak’ (2017) 372 Philosophical Transactions of the Royal Society of London Series B Biological Sciences 1712 https://royalsocietypublishing.org/doi/10.1098/rstb.2016.0307 accessed 22 October 2020 WHO, Constitution of the World Health Organization (4th edn 2006) 1 www.who.int/governance/eb/who_ constitution_en.pdf accessed 22 October 2020. WHO, Leadership Statement on the Ebola Response and WHO Reforms (WHO 2012) www.who.int/csr/dise ase/ebola/joint-statement-ebola/en/ accessed 02 April 2020. WHO, Report of the Ebola Interim Assessment Panel (WHO 2015) www.who.int/csr/resources/publications /ebola/report-by-panel.pdf?ua=1 accessed 22 October 2020. WHO,‘About WHO’ www.who.int/about/role/en/ accessed 22 October 2020. WHO,‘COVAX:Working for Global Equitable Access to COVID-19 Vaccines’ www.who.int/initiatives/ act-accelerator/covax accessed 11 February 2021. WHO, ‘Life Expectancy’ www.who.int/gho/mortality_burden_disease/life_tables/situation_trends_text/ en/ accessed 22 October 2020. WHO, WHO’s New Health Emergencies Programme (WHO 2016) www.who.int/about/who_reform/e mergency-capacities/emergencies-accessed 22 October 2020/programme2016.pdf?ua=1 accessed 04 April 2020;WHO,‘WHO Health Emergencies Programme’ www.who.int/westernpacific/about/how -we-work/programmes/who-health-emergencies-programme accessed 22 October 2020. Widdows, Heather, ‘Global Health Justice and the Right to Health’ (2015) 23 Health Care Analysis 391–400.

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5 GLOBAL HEALTH RIGHTS IN THE INTER-AMERICAN COURT OF HUMAN RIGHTS On the doctrine of the minimum core obligations and a co-responsibility to care Thana C de Campos-Rudinsky

Introduction As an economic, social, and cultural right (ESCR), the human right to health grounds two types of state duties, namely duties of immediate realisation (also called minimum core obligations) and duties of progressive realisation. The conceptualisation of these two types of duties has been widely debated in the field of global health rights, with scholars such as Chapman, Hunt, Tasioulas, and Tobin providing a comprehensive analysis of the applicable international legal instruments in determining the scope of these two duties.These legal instruments include, for example, the International Covenant of Economic, Social and Cultural Rights (ICESCR), as well as General Comments 3 and 14 of the United Nations Committee on Economic, Social and Cultural Rights. However, the distinct scope of each of these two types of duties remains unclear, leading to what I have called ‘the conflation problem,’ where moral confusion about different types of health realities and of health duties engender practical confusion in political deliberation and legal adjudication. Global health rights scholars have not adequately examined how these state duties (imprecisely distinguished and therefore conflated in international legal instruments) have been discussed in regional human rights courts. Here, I will examine how state duties of immediate and progressive realisation have (or have not) been further clarified, defined, and specified in recent right-to-health cases, decided by the Inter-American Court of Human Rights (IACHR) of the Organisation of American States (OAS).1 I will look closely at two IACHR cases: 2018 Cuscul Pivaral et al. v Guatemala and 2006 Ximenes Lopes v Brazil.The former involves a right-to-

1 The IACHR was established in 1979 by the Organization of American States (OAS) to enforce and interpret the American Convention on Human Rights (or Pact of San Jose, adopted in 1969). Its two main functions are to adjudicate cases of human rights violations and to advise OAS member states on legal interpretations related to those human rights violations.

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health litigation involving vulnerable HIV patients.The latter involves a right-to-health litigation involving a vulnerable mentally ill patient. In both cases, the respective states were charged in light of their duty to progressively realise the right to health in their jurisdiction.The critical examination of these two cases will show that, in deriving their analysis of states’ duties directly from international legal documents (i.e. ICESCR and General Comments 3 and 14) while also invoking regional legal instruments (e.g. American Convention of Human Rights) for further characterisation of OAS member states’ duties, the IACHR ends up perpetuating the conflation problem that originated in the international legal documents, passing the conflation problem on to the regional legal system. The upshot of this critical examination of the IACHR jurisprudence and its inherited conflation problem will be the suggestion of a new understanding of what the minimum core obligations of the right to health, within the OAS reality and considering the IACHR precedents, should prescribe. I will argue that one specific duty of immediate realisation that all OAS state members bear is the duty to care for the most vulnerable within their jurisdiction, through adequate regulation and supervision of local healthcare institutions, private and public alike. I contend that this should be interpreted as an obligation of conduct and, therefore, a duty of immediate (rather than progressive) realisation. More specifically, this obligation of conduct (or duty of immediate realisation) should entail the state’s duty to design a normative framework to create accountability, transparency, and information-sharing mechanisms to both scrutinise and assist healthcare institutions directly entrusted with the care of patients. States, healthcare institutions, and other social actors share a general duty to care for patients.While states care for patients by discharging their immediate duty to regulate and supervise healthcare institutions under their jurisdiction, healthcare institutions care for patients by discharging their progressive duty – in cooperation with states and others social actors – to gradually achieve the result of highest attainable standards of physical, mental, and social well-being for all patients entrusted to their care (as prescribed by the human right to health). A state’s duty to regulate and supervise local healthcare institutions (private and public) is, I contend, an immediate duty because the state is uniquely placed to realise such duty, which, generally speaking, does not need to depend on a large allocation of resources.The conduct of regulation and supervision can and should be immediately implemented. Conversely, the duty to directly care for patients and strive to achieve adequate standards of physical, mental, and social well-being for all is, I suggest, a progressive coresponsibility, contingent upon the economic and political circumstances.This progressive duty is shared by all in that society because it depends on a shared intention to allocate significant efforts and resources. To put this normative argument forth, I first provide a conceptual analysis of the duties of immediate and progressive realisation, explaining how they create what I have called the conflation problem. Then, to examine how this conflation problem that originated in international human rights documents has been passed on to regional human rights instruments and regimes, I will introduce to the discussion two IACHR cases (i.e. 2018 Cuscul Pivaral et al. v Guatemala and 2006 Ximenes Lopes v Brazil).Their close analysis demonstrates that the IACHR perpetuates the conflation problem between immediate and progressive duties.This finding should be relevant to those interested in the human right protection mechanism not only of the OAS, but also of other regional regimes, in that it can provide insights on how the conflation problem might be perpetuated in other jurisdictions too. In synthesising a body of literature not yet put together (i.e. doctrine of minimum core obligations and IACHR jurisprudence), this chapter expands the debates within the field of global health rights by offering a new direction on how duties of immediate and progressive realisation should be interpreted, particularly when they fall on developing states (such as Guatemala and Brazil and other Latin American nations), which 63

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may be equally committed to the full realisation of the human right to health, but may struggle in their reality of scarce resources. My proposed interpretation of a co-responsibility to care for vulnerable patients, which includes a state’s immediate duties and the whole community’s shared progressive duties, makes sense of a confusing array of theoretical issues on the doctrine of the minimum core obligations, while proposing a practically feasible plan of action on a legal issue on the human right to health.

Duties of immediate and progressive realisation related to right to health: the confation problem The distinction between ‘duties of progressive realisation’ and ‘duties of immediate realisation’ (also called ‘the minimum core obligations’) is seminal to the definition of ESCR, among which the human right to health is included.The distinction was introduced to accommodate the fact that the full realisation of ESCR is a long process. It cannot be achieved overnight, especially because the fulfilment of ESCR depends on the design of institutions, which take time, effort, and resources to materialise.2 Traditionally, the distinction between these two types has been introduced to differentiate ESCR, which ground duties of progressive realisation, from civil and political rights (CPR), which presumably ground duties of immediate realisation.Although this division between ESCR and CPR has been abandoned by international human rights scholars, who now admit that both ESCR and CPR require the design of costly institutions to be fully realised, the distinction between duties of progressive realisation and duties of immediate realisation is still acknowledged as a useful one in the context of ESCR.

Duties of progressive realisation: obligations of result Article 2(1) of the ICESCR defines duties of progressive realisation. It establishes that state parties should strive to ‘take steps, individually and through international assistance and cooperation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realisation’ of ESCR, such as the right to health. Duties of progressive realisation are, generally speaking, defined as obligations of result – a result which is to be achieved gradually, as states progressively take steps towards the end goal of full realisation of ESCR. General Comment 3 (on ‘The Nature of State Parties’ Obligations’) by the United Nations Committee on Economic, Social and Cultural Rights, in its paragraph 9, further clarifies the duties of progressive realisation as obligations of result in this way: The principal obligation of result reflected in article 2 (1) is to take steps “with a view to achieving progressively the full realization of the rights recognized” in the Covenant. The term “progressive realization” is often used to describe the intent of this phrase. The concept of progressive realization constitutes a recognition of the fact that full realization of all economic, social and cultural rights will generally not be able to be achieved in a short period of time. In this sense the obligation differs significantly from that contained in article 2 of the International Covenant on Civil and Political Rights which embodies an immediate obligation to respect and ensure all of the relevant rights. Nevertheless, the fact that realization over time, or in other words progressively, is foreseen under the Covenant should not be misinterpreted as

2 Onora O’Neill, Towards Justice and Virtue:A Constructive Account of Practical Reasoning (CUP 1996) 131.

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depriving the obligation of all meaningful content. It is on the one hand a necessary flexibility device, reflecting the realities of the real world and the difficulties involved for any country in ensuring full realization of economic, social and cultural rights. On the other hand, the phrase must be read in the light of the overall objective, indeed the raison d’être, of the Covenant which is to establish clear obligations for States parties in respect of the full realization of the rights in question.3 To qualify a certain duty in the category of progressive realisation does not – and should not – deplete it of content and force. Quite the contrary, its progressive realisation allows for flexibility, as stated in General Comment 3, which is necessary for and conducive to a feasible full realisation of the duty.True, the full realisation of this duty is somehow delayed in time. However, its full realisation is still required, and the reason why it is (or has to be) delayed is the fact that there are real-world constraints in resources and other practical contingencies that impede the immediate full realisation of all duties correlated to ESCR, such as the right to health.4 Although delay is somehow justified, state parties to the ICESCR cannot delay the full realisation of ESCR indefinitely, and progress combined with non-regression ought to be demonstrated periodically.5

Duties of immediate realisation: minimum core obligations of conduct In addition to duties of progressive realisation, General Comment 3 also establishes certain duties of immediate effect correlated to ESCR, also called ‘minimum core’ obligations. Chapman has highlighted the immediacy component of minimum core obligations.6 She argues that the minimum core obligations should be primarily interpreted as obligations of conduct (to be immediately implemented), rather than obligations of results (to be progressively implemented).7 Hunt, the former special rapporteur on the right to health, echoes Chapman’s conception in his latest report: the right to health imposes overlapping obligations of immediate effect on States.They include (…) the core obligation to ensure the minimum essential levels of the right. Immediate obligations are outside the ambit of the article 2(1) of the ICESCR. Core

3 UN Committee on Economic, Social and Cultural Rights, General Comment 3 – ‘The Nature of State Parties’ Obligations’ 14 December 1990 (UN Doc UN E/1991/23) (emphasis added). 4 I have put this argument forth in Thana C de Campos,‘Justice and Responsibility: A Deontological Approach to Medical Law’ in A Philips,T C de Campos, and J Herring, Philosophical Foundations of Medical Law (OUP 2019) 97. 5 Take, for example, the Universal Period Review undertaken by the UN Human Rights Council. It provides the opportunity for each state to disclose the steps they have taken to improve the situations of both ESCR and CPR in their countries in fulfilling their human rights obligations. See: www.ohchr.org/EN/HRBodies/UPR/Pages/ UPRMain.aspx 6 For a thorough discussion on the concept of minimum core obligations related to the human right to health, see for example Lisa Forman, Luljeta Caraoshi, Audrey R Chapman, and Everaldo Lamprea, ‘Conceptualizing Minimum Core Obligations under the Right to Health: How Should We Define and Implement the “Morality of the Depths”’(2016) 20(4) The International Journal of Human Rights 531–48. 7 Audrey R Chapman,‘Core Obligations Related to the Right to Health’ in Audrey R Chapman and Sage Russell (eds), Core Obligations: Building a Framework for Economic, Social and Cultural Rights (Intersentia 2002) 185–215 (emphasis added). For a contrary view, see for example Katherine G Young,‘The Minimum Core of Economic and Social Rights:A Concept in Search of Content’ (2008) 33 Yale Journal of International Law 117–18.

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obligations are the minimum essential level of a right and are not progressively realized.8 In a similar vein, Tasioulas defines the minimum core obligations as the sub-set of obligations associated with socio-economic rights that must be immediately complied with in full (obligations of ‘immediate effect’) and hence to which the doctrine of progressive realisation is inapplicable.9 Tasioulas adds that there are three elements of minimum core obligations:‘(a) immediacy: they demand immediate compliance, (b) completeness: they must be fully complied with at any given time, and (c) universality: they bind all states (presumably all state parties to the Covenant) irrespective of variations in wealth and other resources.’10 While these right-to-health scholars have centred their conceptualisation of minimum core obligations around the idea of immediacy, paragraph 10 of General Comment 3 establishes a test that would help determine if a state cannot feasibly meet the minimum core requirement immediately.This test involves the state demonstrating ‘that every effort has been made to use all resources that are at its disposition in an effort to satisfy, as a matter of priority, those minimum obligations.’11 There are two main purposes in defining the minimum core obligation. First, the theoretical purpose is to establish the minimum essentials of what constitutes each ESCR (such as the human right to health). These minimum essentials ought to be realised immediately and as a matter of priority.When it comes to the human right to health in particular, General Comment 3 establishes that its minimum core obligations are ‘essential primary health care.’12 Second, the practical purpose of distinguishing the minimum core obligations (to be immediately realised, as a matter of priority) from the remaining duties of progressive realization is feasibility.The doctrine of the minimum core obligation aims at practicality, by helping define immediate priorities in the process of allocation of scarce resources. Both theoretical and practical purposes of distinguishing minimum core obligations from the remaining duties of progressive realisation are key in regard to human right to health, because healthcare resources are especially scarce and many practical contingencies (such as the lack of sufficiently available, accessible, acceptable, and appropriate medical treatments worldwide)13 apply.14

The confation problem Although theoretically and practically justified, the distinction between duties of progressive realisation and duties of immediate realisation is not sufficiently clear in the context of the human right to health. General Comment 14 (on ‘The Right to the Highest Attainable Standard of Health’) has a special section, comprising paragraphs 43 and 44, dedicated to defining ‘core obligations.’ These paragraphs should arguably specify the minimum core of the human right to health, by further defining what ‘essential primary health care,’ as first mentioned in General

8 Paul Hunt, ‘The Right of Everyone to the Enjoyment of the Highest Attainable Standard of Health’ 11 August 2014 (UN Doc A/69/150), para 10). 9 John Tasioulas, The Minimum Core of the Right to Health (World Bank 2017) 1. 10 ibid 12. 11 UN Committee (n 3) para10. 12 ibid. 13 OHCHR and WHO, The Right to Health – Fact Sheet No. 31, 4.Available at: www.ohchr.org/Documents/Public ations/Factsheet31.pdf accessed 12 November 2020. 14 de Campos (n 4) 99.

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Comment 3, means. One would therefore expect paragraphs 43 and 44 to more precisely define which health-related core obligations should immediately be realised as a matter of priority. However, instead of explaining the content of the core duties and their duty-bearers, paragraphs 43 and 44 merely repeat some possible items or components of a right to essential primary health care.15 Paragraph 43 merely lists several items comprising the minimal essential of healthcare provision.These include, inter alia: ‘right of access to health facilities, goods and services on a nondiscriminatory basis, especially for vulnerable or marginalized groups; (…) access to minimum essential food; (…) access to basic shelter, housing, sanitation, and potable water.’16 In trying to specify what ‘essential primary health care’ means, paragraph 43 of General Comment 14 lists some components of what constitutes the minimal essential of healthcare provision. Some of them, like essential food and basic shelter, are not exclusive components of the right to health. They are components of other human rights as well, like the right to food and the right to housing. On the one hand this is understandable, since all human rights are interdependent and the realisation of one specific human right depends on the realisation of the other human rights. On the other hand, this conceptualisation of the right to health as the most fundamental of all human rights – meaning the human right on which all other human rights depend – causes confusion. Although the right to health is a basic human right, all other human rights cannot be simply reduced to the right to health, because they often need to be addressed in particular ways. Health, housing, and potable water are certainly interrelated, and equally basic. But they ground separate rights that require specific duties. So, the conflation of these rights in paragraph 43 of the General Comment 14 causes confusion about what needs to be done first in order to feasibly attain health. Paragraph 43 is silent about who has the duty to do what. Similarly, paragraph 44 goes on to simply list several other items of ‘comparable priority’17 within the context of a right to essential primary health care.These include, for example: ‘reproductive, maternal (pre-natal as well as postnatal) and child health care; (…) immunisations against major infectious diseases (…); measures to prevent, treat and control epidemic and endemic diseases; (…) education and access to information; (…) education on health and human rights.’18 While the first three items on the list are components of the right to health, the last two items on the list could be claimed as components of a separate human rights, namely the right to education. This conflation, again, leads to confusion about what should be done immediately and as a matter of priority, as well as what can be feasibly done. Here again paragraph 44 is silent about the duties and duty-bearers. The lists displayed in paragraphs 43 and 44 of General Comment 14, containing some items of what would constitute ‘essential primary health care,’ are troublesome for several reasons. First, and as already mentioned, the conflation of different rights that, in reality, require different duties, are all reduced to the right to health.This conflation leads to confusion about what should really be immediately and feasibly prioritised in a context of scarce resources. Secondly, the minimum core obligations, which should have been specified in paragraphs 43 and 44, are not given any helpful specification, since these two paragraphs simply list certain components of the right to health or other human rights. Nothing substantial is said about the

15 ibid. 16 United Nations Committee on Economic, Social and Cultural Rights, General Comment 14 – ‘The Right to the Highest Attainable Standard of Health’ 11 August 2000 (UN Doc E/C.12/200/4), para 43 (a)–(c). 17 ibid para 44. 18 ibid para 44 (a)–(e).

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core duties that correspond to the right to health.As O’Neill puts it,‘obligations have to specify not only what is to be accorded, but which obligation-bearers are going to have to do what for whom and at what cost.’19 And the lists provided in paragraphs 43 and 44 say very little – if anything – about the minimum core obligations spurring from the human right to health.20 The lists say nothing about the key conditions for the immediate priority or feasibility of minimum core duties. Although paragraphs 43 and 44 are under the title ‘core obligations’ in General Comment 14, their focus is not on the immediate priority and the feasibility of these obligations. Instead of specifying obligation, the focus in these paragraphs is actually on rights – more precisely on the claim-rights that a right to essential primary health care allegedly entails. These claim-rights are the entitlements that victims of the violations of said right are supposed to receive.21 Nothing is articulated about the specific duties and the specific duty-bearers. Neither the immediacy question nor the feasibility question is addressed. In short, the fact that paragraphs 43 and 44 (which were supposed to explain (i) what is to be accorded as ‘core obligations,’ and (ii) which duty-bearers should do what for whom and for what cost) merely provide a list of claim-rights to be demanded as entitlements related to right to health. Third, these claim-rights that paragraphs 43 and 44 of General Comment 14 demand of state parties are overly burdensome, which renders any possible obligation that they might ground unfeasible.This defeats the two main purposes of the minimum core obligations, namely (i) the theoretical purpose to establish the minimum essentials that ought to be realised immediately and as a matter of priority, and (ii) the practical purpose of feasibility.As Tasioulas puts it:‘These [claimrights] seem overly demanding to be feasibly conceived as obligations of immediate effect incumbent on all states, especially on an invariant reading of the Minimum Core Doctrine.’22 In a similar vein,Tobin argues that the vision of the minimum core obligations of states under the right to health, as advanced by the ESC Committee, is dissociated from the capacity of states to realize this vision. It simply does not offer a principled, practical, or coherent rationale which is sufficiently sensitive to the context in which the right to health must be operationalized.23 In summary, this section has provided a conceptual analysis of the ‘duties of progressive realisation’ and ‘duties of immediate realisation’ in the context of the human right to health. I have explained how their difference is obscured, by way of conflation with other rights.This defeats the purpose of the distinction. In the next section, I will investigate whether this conflation problem between these two types of duties that originated in international human rights documents is transmitted to regional human rights instruments and regimes. My analysis will focus on the IACHR system.

The confation problem in the IACHR jurisprudence The human rights protection mechanism of the OAS is composed of the Inter-American Commission on Human Rights (IAcHR) and the Inter-American Court of Human Rights

19 20 21 22 23

Onora O’Neill, Bounds of Justice (CUP 2000) 97, 100. de Campos (n 4) 99. ibid. Tasioulas (n 9) 8. John Tobin, The Right to Health in International Law (OUP 2012) 340.

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(IACHR or the Court).The latter, on which I will focus my analysis, is tasked with the mandate to (i) adjudicate cases of OAS member states human rights violations, and (ii) to advise OAS member states on legal interpretations related to those human rights violations. Importantly, the IACHR rules on whether an OAS member state is guilty of human rights violation: the Court does not rule on whether individuals are guilty of human rights violation. The IACHR has discussed state violations of the human right to health in several cases. There is, in fact, a significant body of jurisprudence on the right to health.24 This jurisprudence has interpreted the human right to health, by ‘deriving’25 it from the legal instruments of several bodies: • •

•

the international level (e.g. the 1948 Universal Declaration of Human Rights [art 25.1]; the 1966 ICESCR [art 12]; the 2000 General Comment 14); the regional level (e.g. the 1948 Charter of the OAS, the 1948 American Declaration of Rights and Duties of Man/Bogota Declaration [art XI]; the 1969 American Convention of Human Rights/Pact of San Jose [art 26]; and the 1988 Additional Protocol to the American Convention on Human Rights in the Area of ESCR/Protocol of San Salvador Protocol [art 10]); and the national level (e.g. various OAS member states have established the human right to health as a constitutional right, including Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Haití, Honduras, Mexico, Nicaragua, Panamá, Paraguay, Perú, Dominican Republican, Surinam, Uruguay, and Venezuela).26

Through the interpretation and application of these international, regional, and national legal instruments to the cases brought to the IACHR, it has established the human right to health as an ‘autonomous right,’27 which grounds state duties.The most thorough discussion of these state duties is found in the 2018 Cuscul Pivaral et al. v Guatemala case.

2018 Cuscul Pivaral et al. v Guatemala In this case, the state of Guatemala was found guilty of violating the human right to health of 49 HIV patients, by way of state omission. More specifically, Guatemala was condemned for inaction in not discharging the duties of progressive realisation of this vulnerable population’s right to health, violating Article 26 of the American Convention of Human Rights/Pact of San Jose.28 In order to explain what these state duties consist of, the IACHR recalled, in paragraph 141 of the decision, that there are two types of duties applicable to the human right to health,

24 OAS IACHR, Cuadernillo de Jurisprudencia de La Corte Interamericana de Derechos Humanos N. 28: Derecho a La Salud, San Jose, Costa Rica, 2020. 25 OAS IACHR, Poblete Vilches y otros v Chile, 2018. 26 ibid. 27 OAS IACHR Poblete Vilches y otros v Chile, 2018; Cuscul Pivaral y otros v Guatemala, 2018; and Hernández v Argentina, 2019. 28 American Convention of Human Rights/Pact of San Jose,Article 26 Progressive Development: The States Parties undertake to adopt measures, both internally and through international cooperation, especially those of an economic and technical nature, with a view to achieving progressively, by legislation or other appropriate means, the full realisation of the rights implicit in the economic, social, educational, scientific, and cultural standards set forth in the Charter of the Organization of American States.

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namely the duties of immediate realisation and the duties of progressive realisation.The progressive character of the latter, which the IACHR highlighted referring back to Article 26 of the American Convention of Human Rights/Pact of San Jose, has the purpose of offering flexibility to states so that they can feasibly attain the full realization of ESCR (such as the right to health) over time. In doing so, the IACHR clearly (though not explicitly) echoes the understanding of General Comment 3 of the UN Committee on Economic, Social and Cultural Rights, discussed earlier, according to which the two purposes of the duties progressive realisation are (i) definition of immediate priorities and (ii) feasibility. In elaborating on the concept of flexibility as the key feature of duties of progressive realisation and obligations of result, the IACHR clarifies that there is no particular time frame to achieve such result.29 Neither is there a specific means of attaining such a result.30 States have, therefore, leeway to decide which steps to take and when to take them towards full realisation of ESCR, depending on their economic reality and other practical contingencies.31 However, the IACHR reiterates that, in being an obligation of result, the duties of progressive realisation necessitate that something is in fact done.32 Action, in other words, is required; inaction is prohibited.33 And this action ought to be continually executed.34 That is to say, non-regression is obligatory.35 In placing the state in a ‘special position of guarantor with greater care and responsibility,’36 it seems that the IACHR convicted the state of Guatemala for not discharging its duty to care for the vulnerable HIV population under its jurisdiction. By care, here, I mean a twofold duty, encompassing: (i) an action of care for the vulnerable under the state’s jurisdiction – a continually executed action, to be more precise; and (ii) a conduct of care to be immediately implemented as a priority. In this way, I am conceptualising duty of care here in general terms, as entailing (i) an obligation of result, to be progressively realised, and (ii) an obligation of conduct, to be immediately realised.While the former allows flexibility (in being contingent to economic and political circumstances), the latter does not (in demanding a clear definition of the immediate priorities of care and the feasibility of such care). Presumably, the former, in being more costly in its execution, can be justifiably delayed, whereas the latter cannot accommodate excuses. Although the 2018 Cuscul Pivaral et al. v Guatemala decision does not explicitly use the term ‘duty of care’ in the specific sense that I am using it, the decision did aim at discussing the state obligations for ‘caring for people living with HIV.’37 So, my definition of ‘duty of care’ is reflected in this decision. In finding Guatemala internationally responsible for failing to provide the appropriate care for their most vulnerable HIV populations, the IACHR charged Guatemala with three main obligations of result, all of which to be gradually executed, viz. (i) duty to regulate and supervise local healthcare institutions, (ii) duty to educate their population on health and human rights matters, and (iii) duty to provide access to HIV testing and medical treatment for their HIV population.

29 30 31 32 33 34 35 36 37

OAS IACHR, Poblete Vilches y otros v Chile, 2018, para 142. ibid para 142. ibid para 147. ibid para 142. ibid para 146. ibid para 146. ibid para 143. ibid para 132. ibid para 147.

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First, the IACHR determined that Guatemala has a duty to regulate and supervise local healthcare institutions. The Court established that Guatemala should discharge this obligation by focusing on attaining three main results: (a) Not only to implement the legislative measures and public policies that Guatemala had already adopted to combat the HIV epidemic,38 but also to implement effective mechanisms for periodic supervision and monitoring of its public hospitals to ensure that they are providing comprehensive healthcare to people living with HIV, in keeping with both domestic and international laws.39 (b) To set up an information system on the scope of their HIV epidemic.40 The Court further defined such system thus: it should contain statistical information on the patients (including their sex, age, ethnicity, language and socio-economic status of patients), and on the local healthcare institutions (including their geographical location and infrastructure).41 (c) To design a mechanism to ensure the accessibility, availability, and quality of antiretroviral drugs, diagnostic tests, and health services for people living with HIV.42 Second, the IACHR determined that Guatemala has a duty to educate their population and provide access to information on health and human rights matters. The Court established that Guatemala should discharge this obligation by focusing on attaining three main results: (a) To implement a training program for health system officials who work in hospitals and healthcare centres that treat people with HIV in Guatemala.This would serve the purpose of educating officials about the international standards and domestic laws regarding people living with HIV.43 (b) To design a publication or a booklet on HIV transmission and prevention.44 (c) To conduct a national awareness-raising campaign, aimed at combating the stigma as well as lack of information about the people living with HIV.45 Third, the IACHR determined that Guatemala has a duty to provide access to HIV testing and medical treatment for their HIV population.The Court established that Guatemala should discharge this obligation by focusing on attaining two main results: (a) To provide periodic monitoring for pregnant women living with HIV, coupled with adequate HIV testing and medical treatment to avoid vertical transmission of the virus.46 (b) To directly provide medical treatment to ensure the right to health of the HIV population, rather than entrusting their care to non-governmental organisations.47

38 39 40 41 42 43 44 45 46 47

ibid para 224. ibid para 225. ibid para 225. ibid para 225. ibid para 226. ibid para 227. ibid para 228. ibid para 229. ibid para 228. ibid para 147.

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The IACHR defines all of these as duties of progressive realisation. The Court determined specific results that Guatemala should execute over time. In other words, for the IACHR, (i) the duty to regulate and supervise local healthcare institutions, (ii) the duty to educate their population on health and human rights matters, and (iii) the duty to provide access to HIV testing and medical treatment for their HIV population are all duties of progressive realisation or obligations of result. But should all of them be so classified? Would some of them not fall under the category of duties of immediate realisation or obligations of conduct? In order to answer this question, it is worth returning to the distinction between duties of immediate realisation and duties of progressive realisation.The division between the two types of state duties, has been, as argued earlier in the chapter, blurred: there is a conflation problem. The difference in scope between duties of progressive realisation and duties of immediate realisation is not sufficiently clear in the international legal context of the human right to health. A further investigation of the traditional distinction between obligations of conduct and obligations of result might be helpful here. Originally a Roman law concept, the idea of obligations of conduct (or means) and obligations of result is typical of civil law systems. This concept was introduced to international law and has been discussed by both Roberto Ago and James Crawford, special rapporteurs for the International Law Commission on State Responsibility.48 Accordingly, there are two kinds of international obligations: state’s obligations of conducts (or means) and state’s obligations of result. The typical example of obligations of conduct in Roman law is the debtor, who, as a duty-bearer, promises to use all the possible means and to exercise the necessary diligence to perform the contractual obligation.49 Here the duty-bearer does not commit to performing the contractual obligation per se.That is, the duty-bearer does not commit to achieving a particular result. Instead, the content of his promise is in taking all necessary measures and all appropriate means, and doing all that is in his power. A healthcare-related example of an obligation of conduct is the healthcare professional.50 She has an obligation (of conduct) to be diligent and to do everything that is possible to cure the patient and to restore his health. However, the specific result of cure and health are outside of the scope of the doctor’s obligation of conduct, because the doctor cannot guarantee such desirable results.51 Obligations of result, on the other hand, aim at a particular outcome to be delivered.The desired outcomes ought to be delivered, unless a force majeure exception can justify the breach of the obligation.52 The IACHR, in the 2018 Cuscul Pivaral et al. v Guatemala decision, adjudicates that Guatemala has three main international obligations to discharge: (i) the duty to regulate and supervise local healthcare institutions, (ii) the duty to educate their population on health and human rights matters, and (iii) the duty to provide access to HIV testing and medical treatment for their HIV population. For the Court, these are all duties of progressive realisation or obligation of result, and the IACHR has prescribed specific results to be attained by Guatemala under each of these three categories. Although all of these three categories fall under the general theme of ‘duties of care,’ there are significant theoretical and practical differences among them that should be clarified: first, not all

48 Constantin P Economides,‘Content of the Obligation: Obligations of Means and Obligations of Result’ in James Crawford, Alain Pellet, Simon Olleson, Kate Parlett, The Law of International Responsibility (OUP 2010) ch 26, 371–81, 375. 49 ibid. 50 ibid. 51 ibid. 52 ibid.

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of them seem to fall under the obligations of result type; also, not all of them seem to belong to those classes of duties grounded on the human rights to health. Take the first category (i.e. the duty to regulate and supervise local healthcare institutions), for example. The duty to regulate and supervise responds to the state inaction and lack of due diligence. In this sense, it is an obligation of conduct: the state’s conduct (of regulating and supervising local institutions) should be evaluated on the basis of whether or not it has taken all necessary measures and all appropriate means, and it has done all that is in its power to regulate and supervise local healthcare institutions. Accordingly, (a) implementing legislative measures and public policies that Guatemala had already adopted to combat the HIV epidemic,53 and implementing effective mechanisms for periodic supervision and monitoring of its public hospitals to ensure that they are providing comprehensive health care to people living with HIV, in keeping with both domestic and international laws54 qualifies as an obligation of conduct, and should, therefore, be evaluated according to the criterion of due diligence. Similarly, (b) setting up a statistical information system on the scope of its HIV epidemic55 is also an obligation of conduct that should be evaluated according to Guatemala’s disposition to take all the necessary measures to succeed, rather than to successful results themselves.Although the IACHR classifies all of these as obligations of result, demanding therefore specific successful outcomes, it should not be so. The Court not only creates confusion by conflating duties of immediate realisation and duties of progressive realisation, but it also charges Guatemala with an unfeasible international obligation to obtain successful results that are beyond Guatemala’s power and control. Were these duties rightly classified as obligations of conduct, then Guatemala would be correctly assessed according to its disposition and due diligence. However, in being classified as obligations of result, Guatemala is assessed according to unpredictable standards of success. Now, take the second category (i.e. the duty to educate their population on health and human rights matters).This duty seems to more appropriately belong to the human right to education than to the human right to health. As argued earlier in the chapter, the conflation of different rights which, in reality, require different duties, is problematic in that it reduces different human rights to the human right to health.This conflation leads, I suggested, to confusion about what should really be immediately and feasibly prioritised in a context where resources to fully realise all ESCR are scarce. An objector here may want to claim that it matters very little whether the duty to educate a population on health and human rights should be theoretically linked to the right to education or to the right to health.This theoretical grounding of the duty, my opponent would argue, say nothing about the practicalities on whether or not this duty should be immediately prioritised or not.This is a valid claim. In fact, if the practical purpose of duties of immediate realisation is (as I have argued) feasibility, it might be less practically relevant to dispute whether the duty to educate the population on health and human rights is based on the right to education or on the right to health. However, the conflation problem, as I also argued, is a theoretical problem with tangible effects in real-world deliberations: the theoretical foundations of the duty to educate the population on health and human rights (that is to say, whether it is based on the right to education or on the right to health) will affect how and by whom the duty will be practically discharged.This is because the scarce resources for the realisation of this duty will have to come either from the right-to-education–related budget or the right-to-health–related budget. The duty bearers of a right-to-education–based duty and the duty bearers of a right-to-health–based

53 ibid para 224. 54 ibid para 225. 55 ibid para 225.

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duty are not exactly the same: although there is some overlap (i.e. the government generally speaking), the civil society actors directly involved in the realisation of each of these rights will be different.As an obligation of result, the duty to educate the population on health and human rights is a duty of progressive realisation, shared among various social actors. Lack of clarity on whether this duty is based on the right to education or on the right to health will cause practical confusion about who is actually in charge of what to gradually execute this duty. The conflation between different human rights and between different types of duties has therefore important practical implications. Last, take the third category (i.e. the duty to provide access to HIV testing and medical treatment for their HIV population). Like the previous duty (i.e., the duty to educate the population), this duty is also an obligation of result to be gradually executed with the participation of all in the society. It is, in this sense, a shared co-responsibility of progressive realisation of certain results.The results that the IACHR specified under the duty to provide access to HIV testing and medical treatment for the HIV population were two: (a) the provision of periodic monitoring for pregnant women living with HIV, as well as (b) the provision of adequate HIV testing and medical treatment for other patients.56 The success of these results is contingent upon Guatemala’s economic and political circumstances. This means that the Guatemalan society would have to be commonly committed to achieving these goals, so that the IACHR could later more accurately assess the compliance of the state of Guatemala against the criterion of Guatemala’s progress and nonregression on the duty to provide access to HIV testing and medical treatment for their HIV population. I have discussed so far in this section, the IACHR conviction of the state of Guatemala for not discharging its duty to care for the vulnerable HIV population under its jurisdiction. I conceptualised the duty of care here as a twofold duty, encompassing (i) an action of care for the vulnerable under the state’s jurisdiction – a continually executed action, to be more precise; and (ii) a conduct of care to be immediately implemented as a priority. I have, therefore, conceptualised duty of care here in general terms, as a state duty entailing (i) an obligation of result, to be progressively realised, and (ii) an obligation of conduct, to be immediately realised. And I have demonstrated that, in the 2018 Cuscul Pivaral et al. v Guatemala decision, the IACHR conflates these two different obligations and realities of care.This conflation problem has practical consequences. It causes confusion in deliberating how the state of Guatemala is to discharge those three specific duties of care (i.e., (i) duty to regulate and supervise local healthcare institutions, (ii) duty to educate their population on health and human rights matters, and (iii) duty to provide access to HIV testing and medical treatment for their HIV population).There is lack of certainty as to who exactly in Guatemala should be in charge of each of these duties. It is also unclear how the IACHR is to justly assess Guatemala’s progress or failure in relation to the realisation of these three duties in particular, and the right to health in general. Although my idea of states’ duty to care for the vulnerable patients under their jurisdiction is certainly central in human right-to-health litigations, the exact term ‘duty to care’ is not typical in the global health rights literature.There is, however, one recent IACHR case where the term ‘duty to take care’ is explicitly used in the context of the right to health. Next I will analyse the 2006 Ximenes Lopes v Brazil as to how it interprets the Brazilian state’s duty to take care of its vulnerable mental health patients. I have constructed my interpretation of states’ duty of care so far in general terms, following the ethics of care literature here in interpreting care broadly.57 I will also further specify what the state’s duty of care, encompassing both obligations

56 ibid para 228. 57 In the Ethics of Care tradition, see for example, Jonathan Herring, Caring and the Law (Hart 2013).

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of immediate conduct and obligations of progressive results, means in the context of the human right to health.

2006 Ximenes Lopes v Brazil On 1 October 1999, Damião Ximenes Lopes, a 30-year-old patient suffering a severe mental condition, was admitted to the psychiatric clinic Guararapes Rest House.This clinic provided healthcare for patients eligible under Brazil’s public healthcare system, known as the Unified Health System (or Sistema Unico de Saude [SUS]). On the day of admission, Ximenes Lopes showed no signs of bodily injury. However, only three days later, on 4 October, Ximenes Lopes was found with several signs of grave injuries: he was bleeding, had bruises all over his body, had his hands tied back, showed difficulty in breathing, and was wearing torn clothes with excrement on them.The clinic explained that Ximenes Lopes had an episode of aggressive attack and had to be subjected to physical restraint by the healthcare personnel as a matter of security. Ximenes Lopes was found dead on the same day, 4 October, approximately two hours after being medicated by the director of the clinic. No medical assistance was provided to Ximenes Lopes before its death. Although his relatives filed a criminal charge as well a civil complaint for damages against the owner of the psychiatric clinic, no further investigations were carried out. The case was then brought to the Inter-American Commission on Human Rights and later to the IACHR’s attention. In its final decision, the IACHR established that states have two main duties regarding patients with mental illnesses: (i) the duty to take care; and (ii) the duty to regulate, supervise, and investigate healthcare institutions. The IACHR explained the duty to take care in terms of the state’s ‘special position as guarantor in regard to persons who are in its custody or under its care.’58 That is to say, because of states’ special position or mandate, they have the duty to take care of all those entrusted to them. Not much more is said about state’s duty to take care, except that it is a ‘positive duty to provide the necessary conditions to lead a decent life.’59 This positive duty applies particularly in relation to ‘persons who are under health treatment,’60 given their particular vulnerability.Among these individuals, the positive duty to take care applies in an even more stringent way to ‘patients with mental illness, given their [greater] vulnerability when they are admitted to psychiatric institutions.’ 61 Nothing is said about the nature of this ‘duty to take care.’ The IACHR does not define whether it is an obligation of conduct or an obligation of result. Neither does it mention how immediately or progressively the state is to discharge this ‘duty to take care.’This underspecified discussion of the ‘duty to take care’ can perhaps be further refined by an analysis of the Court’s discussion of the duty to regulate, supervise, and investigate, which applies to both private and public institutions providing healthcare services.62 The duty to regulate, supervise, and investigate can be interpreted in the 2006 Ximenes Lopes v Brazil case as a specific way in which the state can care for vulnerable populations.The state is uniquely placed to provide regulation, supervision, and investigation mechanisms. By regulating, supervising, and investigating healthcare institutions, the state ultimately guarantees not only

58 59 60 61 62

OAS IACHR, Ximenes Lopes v Brazil Case, 2006, para 138. ibid para 138. ibid para 139. ibid para 140. On the greater vulnerability of psychiatric patients, see also para 106. ibid para 90, 141.

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that patients are adequately treated, but also that healthcare institutions ‘provide the necessary conditions [for patients] to lead a decent life.’63 The IACHR specifies the duty to regulate, supervise and investigate as follows. It includes, inter alia, (a) an obligation to create an appropriate legal framework, defining the standards of healthcare treatment and hospitalisation, against which healthcare institutions are to be scrutinised;64 and (b) an obligation to create mechanisms for inspection, which both investigate and solve complaints, by taking appropriate disciplinary or judicial actions related to professional misconduct or violation of a patient’s right.65 More precisely, the latter consists of an obligation to adopt health surveillance measures,‘understood as a set of policies aimed at preventing health risks and taking action to control and monitor healthcare services, products, and substances.’66 Although it seems that the IACHR qualifies these duties and obligations as progressive duties, whose results are to be gradually executed by the state of Brazil, it would be more accurate, I contend, to qualify them as duties of immediate realisation or obligations of conduct. This is because the IACHR is in actuality requiring the state of Brazil to take all appropriate means to care for psychiatric patients, by doing all that is in its power to regulate, supervise, and investigate healthcare institutions. In this sense, the state of Brazil should, I suggest, be assessed against its due diligence in complying with the IACHR directives regarding the creation of (a) an appropriate normative framework, and (b) appropriate accountability, transparency, and information-sharing mechanisms to both scrutinise and assist healthcare institutions directly entrusted with the care of patients. The state is uniquely placed to discharge its duty to regulate, supervise, and investigate local healthcare institutions (private and public alike). Also, the conduct of regulation, supervision, and investigation of local institutions is prima facie and ceteris paribus less contingent upon a large allocation of resources, compared to the full realisation of the right to health (as an adequate standard of physical, mental, and social well-being for all). Therefore, the conduct of regulation, supervision, and investigation can and should be immediately implemented by states. Conversely, the duty to directly care for patients by striving to achieve adequate standards of physical, mental, and social well-being for all cannot be a duty of immediate realisation. Its progressive nature necessitates time, effort, and resources. In fact, the achievement of such a result (i.e. the full realisation of the right to health for all individuals) could only be achieved through a shared, collective enterprise.The state alone cannot feasibly achieve such a goal. For this reason, the duty of progressive realisation of the right to health is more accurately conceptualised, I contend, as a co-responsibility, shared by states, healthcare institutions, and other actors (such as civil society organizations, churches, neighbours, and families).This progressive duty is shared by all in a certain society because it depends on a shared intention to allocate a significant amount of time, effort, and resources to its realisation. To summarise, states, healthcare institutions, and other actors share a general duty to care for vulnerable patients. While states care for patients by discharging their immediate duty to regulate, supervise, and investigate healthcare institutions under their jurisdiction, healthcare institutions – in cooperation with states and others actors – care for patients by discharging their progressive duty to gradually achieve the result of adequate standards of physical, mental, and social well-being for all patients entrusted to their care.This proposed interpretation of a social

63 64 65 66

ibid para 138. ibid para 98. ibid para 99. ibid para 142.

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co-responsibility to care for vulnerable patients, including the state’s immediate duties and the whole community’s shared progressive duties, is practically reasonable. It presents a feasible plan of action for the realisation of the human right to health, by more clearly differentiating different duties and realities of health that had been conflated and obscured in legislations and courts’ interpretations. My proposed interpretation differentiates, on the one hand, between those immediate, minimum core priorities (e.g., the specific obligations contained under the category the duty to regulate, supervise and investigate), and on the other hand, the remaining duties of care that cannot be implemented immediately, given that they are more contingencies-dependent.

Conclusion This chapter has first provided a conceptual analysis of the duties of immediate and progressive realisation, explaining how they create what I have called ‘the conflation problem.’ Then, to examine how this conflation problem, which originated in international human rights documents, has been passed on to regional human rights instruments and regimes, the chapter introduced two IACHR cases (i.e. 2018 Cuscul Pivaral et al. v Guatemala and 2006 Ximenes Lopes v Brazil).Their close analysis demonstrated that the IACHR perpetuates the conflation problem between immediate and progressive duties, and this conflation problem has serious practical implications. The analysis of key global health rights instruments (i.e. the ICESCR and the General Comments 3 and 14 of the United Nations Committee on Economic, Social and Cultural Rights), coupled with the analysis of the IACHR case law on global health rights showed that neither the instruments nor the case law support the actual realisation of the right to health. More specifically, by causing practical confusion in political deliberation and legal adjudication, the conflation problem hinders the feasible realisation of the right to health in the global context. The outcome of this critical examination was the suggestion of a more specific interpretation of the duties of immediate realisation (i.e. minimum core obligations of the right to health) within the OAS reality and considering the IACHR precedents. I argued that one specific duty of immediate realisation that all OAS state members should bear is the duty to care for the most vulnerable within their jurisdiction, through adequate regulation, supervision, and investigation of local healthcare institutions, private and public alike. I contended that this should be interpreted as an obligation of conduct and therefore a duty of immediate (rather than progressive) realisation. More specifically, this obligation of conduct (or duty of immediate realisation) should entail the state’s duty to design a normative framework to create accountability, transparency, and information-sharing mechanisms to scrutinise and assist healthcare institutions directly entrusted with the care of patients.The proposed specification of the minimum core obligations of the right to health within the OAS reality and considering the IACHR precedents is relevant not only to those interested in the human right protection mechanism of the OAS, but also to those interested in global health rights in general, because it provides insights on how the conflation problem has been perpetuated in different jurisdictions and how the duties of immediate realisation, though universal, can also be tailored according to the realities of each legal context.

References Chapman,Audrey R,‘Core Obligations Related to the Right to Health’ in Audrey R Chapman and Sage Russell (eds), Core Obligations: Building a Framework for Economic, Social and Cultural Rights (Intersentia 2002) 185–215.

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Thana C de Campos-Rudinsky de Campos,Thana C,‘Justice and Responsibility:A Deontological Approach to Medical Law’ in A Philips, T C de Campos, and J Herring, Philosophical Foundations of Medical Law (Oxford University Press 2019). Economides, Constantin P, ‘Content of the Obligation: Obligations of Means and Obligations of Result’ in James Crawford, Alain Pellet, Simon Olleson, and Kate Parlett, The Law of International Responsibility (Oxford University Press 2010). Forman, Lisa, Caraoshi, Luljeta, Chapman, Audrey R, and Lamprea, Everaldo,‘Conceptualizing Minimum Core Obligations under the Right to Health: How Should We Define and Implement the “Morality of the Depths”’(2016) 20(4) The International Journal of Human Rights 531–48. Hunt, Paul, ‘The Right of Everyone to the Enjoyment of the Highest Attainable Standard of Health’ 11 August 2014 (UN Doc A/69/150). OHCHR and WHO, ‘The Right to Health – Fact Sheet No. 31’ 4 www.ohchr.org/Documents/Public ations/Factsheet31.pdf accessed 12 November 2020. O’Neill, Onora, Towards Justice and Virtue:A Constructive Account of Practical Reasoning (Cambridge University Press 1996). O’Neill, Onora, Bounds of Justice (Cambridge University Press 2000). Tasioulas, John, The Minimum Core of the Right to Health (World Bank 2017). Tobin, John, The Right to Health in International Law (Oxford University Press 2012). UN Committee on Economic, Social and Cultural Rights, ‘General Comment 3 – “The Nature of State Parties” Obligations’ 14 December 1990 (UN Doc UN E/1991/23). United Nations Committee on Economic, Social and Cultural Rights, ‘General Comment 14 – ‘The Right to the Highest Attainable Standard of Health’ 11 August 2000 (UN Doc E/C.12/200/4). Young, Katherine G, ‘The Minimum Core of Economic and Social Rights: A Concept in Search of Content’ (2008) 33 Yale Journal of International Law 117–18.

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PART B

Health Rights across the temporal stages in specifc countries

Beginning of life and children

6 ASSISTED REPRODUCTIVE TECHNOLOGIES IN UGANDA Law and practice Zahara Nampewo

Reproduction, infertility, and ART: a snapshot of Africa and beyond It is the desire of many couples the world over to marry and found a family.This desire is significant and has received international recognition and protection as a human right.The Universal Declaration of Human Rights 1948 in Article 16 indicates that men and women of full age, without any limitation due to race, nationality, or religion, have the right to marry and found a family.1 This principle is reflected in Article 31 of Uganda’s constitution. However, it is not always possible for healthy adults to reproduce at the time when they choose to, resulting in a situation of involuntary childlessness.2 This is mostly due to infertility, a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse.3 Infertility is recognised by the World Health Organization (WHO) as a disease and as a disability because of its potential to impair reproductive function.4 The main causes of infertility are blockage of the fallopian tube (tubal stenosis) in women and sperm duct (oligoasthenospermia) in men.5 These two conditions are primary consequences

1 Article 16 Universal Declaration of Human Rights, Article 23(2) International Covenant on Civil and Political Rights, General Comment No 5. See also other references in Article 8(1) European Convention for the Protection of Human Rights and Fundamental Freedoms, Article 18 African Charter on Human and Peoples Rights, and Article 16(1)(e) of the UN Convention on Elimination of all Forms of Discrimination against Women. 2 Involuntary childlessness is the inability to fulfil the desire to have a biologically related child. Such physical inability can be caused by one’s reproductive dysfunction (e.g. low sperm count or blocked fallopian tubes) or the reproductive dysfunction of one’s partner. 3 F Zegers-Hochschild et al., ‘International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary of ART Terminology’ (2009) 92(5) Fertility and Sterility. Here, infertility is defined to include infecundity, meaning the inability to conceive or to impregnate, and pregnancy wastage, meaning failure to carry a pregnancy to term through spontaneous abortion and still birth. See also Ibraheem O Tajudeen, ‘The Need for Legal Regulation of Assisted Reproductive Technology in Nigeria’ (2014) 20(1) East African Journal of Peace and Human Rights 155. 4 WHO, Sexual and Reproductive Health (WHO 2020) www.who.int/reproductivehealth accessed 14 October 2020. 5 Gwet-Bell et al.,‘The 5 Main Challenges Faced in Infertility Care in Cameroon’ (2018) 3(16) Global Reproductive Health Journal. www.gieraf.org/assets/images/article_39/01The_5_main_challenges_faced_in_infertility_care_ in.99986.pdf accessed 14 October 2020.

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of infections, largely due to sexually transmitted diseases. In Uganda, about 10%–15% of couples cannot have children due to infertility.6 Reproductive advancements are now well recognised throughout the world. The WHO defines assisted reproductive technology (ART) as all treatments or procedures that include the in vitro handling of both human oocytes, sperm, and embryos for the purpose of establishing a pregnancy.7 ART methods include but are not limited to in vitro fertilisation (IVF), embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, intracytoplasmic sperm injection, tubal embryo transfer, gamete and embryo cryopreservation, oocyte and embryo donation, and gestational surrogacy. Today, globally, almost two million ART cycles are performed every year and nearly four million babies have been born through this assisted reproduction technique.8 ART has received support as a human right through law: courts across the world have sought to protect this right in different but interesting ways. In Dickson v United Kingdom,9 the European Court of Human Rights found that a person’s right to use artificial insemination falls within the ambit of Article 8 of the European Convention on Human Rights, which protects the right to respect for family and private life.The courts have further interpreted this right expansively. A 2007 case before the European Court of Human Rights, Evans v the United Kingdom,10 asserts that the right to reproduce includes both coital and non-coital means of reproduction. Courts have further emphasised this right to include respect for decisions on whether persons intend to become or not to become parents.11 In the United States, infertility is taken very seriously and is considered a major life activity and, therefore, a disability under the Americans with Disabilities Act.12 On the African continent, there is limited legal attention to ART. South Africa’s jurisprudence includes, for example, the case of AB v Minister of Social Development,13 where an applicant sought an order declaring a section of the Children’s Act inconsistent with the constitution on the basis that it prohibited her from using surrogacy as a means of becoming a parent and,

6 Interview with Dr Robert Busingye, senior obstetrician and gynaecologist, 18 December 2019, Kampala. Dr Busingye further states that about 75% of these cases are due to sexually transmitted infections.To emphasise this aspect of infertility, the doctor recalled an example when one of the pioneer facilities in the country was just opened in 2004 and the president offered a donation of free ART services, many people turned up for assessments. Of these, over 50% of them were actually infertile. 7 Zegers-Hochschild et al. (n 3). 8 BBC News, ‘Birthday Honours: Test Tube Baby Pioneer Knight’ (BBC News, June 10 2011) www.bbc.co.uk/ news/health-13727900 accessed 14 October 2020. 9 Dickson v the United Kingdom,Application No 44362/04 of 4 December 2007 para 66. 10 Application No 6339/05 of 10 April 2007 para 71. See also Costa & Pavan v Italy (Application No. 54270/10 of 28th August 2012) and SH & Ors v Austria (Application no. 57813/00 of 3rd November 2011 para 82) where the court considered the right of the couples to make use of medically assisted procreation.The former case involved an Italian couple who were healthy carriers of cystic fibrosis and wanted, with the help of medically assisted procreation and genetic screening, to avoid transmitting the disease to their offspring.The court held that there had been a violation of Article 8.The latter case also held that Article 8 should allow for the making of reproductive choices an expression of private and family life. 11 See, generally, C Van Niekerk, ‘Assisted Reproductive Technologies and the Right to Reproduce under South African Law’ (2017) 20 PER/PELJ 1–31. 12 Bragdon v Abbott, 524 US Supreme Court 624 (1998). See ‘Workplace Rights for Those Suffering from Infertility’ (The Spiggle Law Firm) www.spigglelaw.com/employment-blog/workplace-rights-for-those-suffering-from -infertility/ accessed 14 October 2020. 13 AB and Another v Minister of Social Development, (CCT155/15) [2016] ZACC 43; 2017 (3) BCLR (CC); 2017 (3) SA 570 (CC) (29 November 2016) [313]; www.saflii.org/za/cases/ZACC/2016/43.html accessed 14 October 2020.

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therefore, violated her rights to privacy, reproductive autonomy, dignity, equality, and access to health care. The court considered these rights and found for the applicant, affirming that reproductive autonomy includes non-coital reproduction.14 Africa has been slower at catching up with this contemporary development going by country statistics. South Africa was the first country on the continent to have a successful IVF birth in 1984, followed by Nigeria in West Africa in 1989,15 Uganda in 2004,16 and Kenya in 2006.17 Since the continent constitutes 16% of the world’s population, it would be expected that its share of ART would be reflective of its significant demographic dimension. Surprisingly, however, the use of ART is much less than its expected fair share of 320,000 cycles per year. In the World Report on Assisted Reproductive Technology, data from Africa represented only 1% of global ART activity.18 This is even more surprising given the prevalence of infertility is highest in low-resource countries, particularly in sub-Saharan Africa. It has been estimated that 8% to 12% of couples worldwide are infertile with 9% currently cited as the global average.19 On the other hand, in some areas of sub-Saharan Africa, infertility has been recorded as high as 30%.20 In these circumstances, the demand for ART should, therefore, be high in this part of the world and, resultantly, its use.This, however, is not the case.21 One explanation given for the low continental representation of ART is the widespread belief that infertility is not a pressing problem in poor developing countries with several justifications to this, one being that Africa is already overpopulated and second that infertility is a low priority when confronted with competition from other healthcare demands such as malaria and HIV. In fact, in Uganda, the national total fertility rate is still quite high at 5.4 and was even higher in previous years.22 The other reasoning is based on an argument of limited resources, stating that the expensive techniques required under ART cannot be justified in countries where poverty is still an important issue. In Uganda, where the right to health is not expressly provided for in the constitution, but rather in the National Objectives and Directive Principles of State Policy,23 arguing for access to ART as part of the right to health makes for a weak argument. It can also be claimed that Uganda is still contending with basic developmental issues like poverty, high unemployment, high proportion of ill health in the populace, overpopulation, and poor infrastructure.

14 This decision was however later overturned by the constitutional court on the basis that the section in contention (S.294) did not violate the applicant’s right to reproductive autonomy as the right contained in S.12(2)(a) pertains to an individual’s own body and not that of another woman. 15 Tajudeen (n 3) 155. 16 ibid. 17 Thiankolu Muthoni, ‘Towards a Legal Framework on Assisted Human Reproduction in Kenya; Some Thoughts on the Law,Technology and Social Change’ (2007) 9. 18 See W Ombelet and J Onofre, ‘IVF in Africa: What Is It All About?’ (2019) 11(1) Facts,Views, and Vision in ObGyn 65–76. 19 ibid. 20 Robert Nachtigall, ‘International Disparities in Access to Infertility Services’ (2006) 85(4) Fertility and Sterility 871–75. 21 It is documented that in sub-Saharan Africa the utilisation of ART in 2010 was 87 cycle/mppy compared with 474 cycle/mppy and 900 cycle/mppy for global and Europe utilisation, respectively. In 2014 the contribution of Africa to the 1,647,777 ART cycles reported globally was only 1%.The minimal optimal need of the 1.25 billion (16% of global population) inhabitants in Africa is 1,875000 cycles.These figures reflect the huge shortage of ART services for infertile couples in Africa. See, further, Gamal I Serour et al., ‘The Place of ART in Africa’ (2019) 4(2) Global Reproductive Health e27. 22 Uganda Demographic and Health Survey 2016, 13.The fertility rates for previous years were higher at 6.2 (2011), 6.7 (2006), and 7.4 (1988/9). 23 Principles 14 and 20.

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Consequently, there are many reasons that states can pick on to deny access to expensive hightechnology treatments for infertile couples. Infertility care through ART has been included as an integral part of reproductive healthcare highlighted in the WHO’s Sustainable Development Goals (SDG).The aim of SDG 3.7 is ‘to ensure universal access to sexual and reproductive health care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programs by 2030.’And the following words ring true to this: In a world that needs vigorous control of population growth, concerns about infertility may seem odd, but the adoption of a small family norm makes the issue of involuntary infertility more pressing. If couples are urged to postpone or widely space pregnancies, it is imperative that they should be helped to achieve pregnancy when they so decide, in the more limited time they will have available. (Mahmoud Fathalla, Director Special Programme of Research, Development and Research Training in Human Reproduction)

Religious, moral, and cultural attitudes on ART in Uganda In most African countries, there is a high socio-cultural value attached to procreation. Children are important for many reasons, including social status, identity, and continuity of lineage. Consequences of involuntary childlessness are usually much more pronounced in Africa than in other countries from the West, often coming with social stigma, isolation, and abandonment. Additionally, because of the patriarchal nature of the majority of African societies, women are often blamed in cases of infertility. According to Gamal Serour, infertility in Africa is a grave medico-socio-cultural problem.24 Women can be punished for failing to bear children. The repercussions include, and are not limited to, divorce or abandonment by husbands, loss of economic security and social support, fewer rights to property, becoming the subject of rumours, as well as physical, mental, and social abuse. In this discussion, specific focus is placed on the perception of ART as a means of redress against infertility, and reactions to it from the religious and cultural angles, all of which set perceived morally acceptable standards.The subject of study is the Baganda, the biggest ethnic group in Uganda,25 selected for its representative perceptions for other parts of the country.The data here was generated through interaction with Islamic and Christian religious leaders and cultural leaders from different subgroups within the Ganda community. Just as in other parts of the country, the ability to procreate for the Baganda is significant because it is the basis for the continuity of patrilineal bloodlines through the clan systems.26 The Baganda are socially organised under a patriarchal model supported by a patrilineal line of descent. Every Muganda belongs to a clan and this comes with social identity, roles in society, access to property and even burial grounds.27 As a patriarchal culture, men are at the top of the

24 Serour et al. (n 21). 25 Uganda Bureau of Statistics, National Population and Housing Census (Uganda Bureau of Statistic 2014), www.ubos .org/ accessed 14 October 2020. 26 Martha N Mukasa, ‘Ethical and Sociocultural Considerations for Use of Assisted Reproductive Technologies Among the Baganda of Uganda’ (thesis, Georgia State University 2013) https://scholarworks.gsu.edu/anthro_t heses/78 accessed 14 October 2020. 27 In Buganda, particular clans play specific roles in society and members of the Ganda community take particular pride in whatever clan they belong to. For instance, the Nkima (monkey) clan is tasked with the special role of

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social hierarchy and their status in adulthood is linked to the quality of children produced, with male children being the most desired outcomes from pregnancy.28 Children are also important for the economic health of family units, often providing much needed labour in gardens, and as caregivers for younger siblings.Additionally, succession is through the eldest male child. Because of the attachment to continuity of lineage, family security, and link to property, there is a lot of social pressure on couples to reproduce, and often this social anxiety is suffered by women.Therefore, just as in other parts of Africa, the inability to procreate in Buganda comes with stigmatisation, isolation, ostracisation, and disinheritance. Cases of neglect of women by their husband’s families or abandonment by partners are common.29 Many women also shared stories of physical and psychological violence, economic deprivation, and denial by partners as well as polygamy.30 Owing to the social pressure to procreate, ART has become one of the attractive means to address involuntary childlessness. However, it is not without controversy. Our engagement with respondents from the religious and cultural members of society in Buganda during this study indicate that, against the background of increased and fast-paced medical and scientific developments making childbearing possible for infertile couples, ART is a sensitive ethical and moral issue. For those toeing the religious line, most contended that childbearing is the work of God and only the supreme being has power to give children, arguing that scientists should not be allowed to take part in this responsibility and play god.They agreed with the official view of the Roman Catholic Church, strongly opposing all kinds of IVF or artificial conception.The position of the church posits that IVF is unnatural.31 According to this group, insemination through artificial means separates the conjugal act from the procreative act, thus threatening the institution of family and the dignity of the human person.The church advocates for adoption as an acceptable option to assisted reproduction.32 This school of thought further expressed concern about the ownership and legal status of the embryo in the event of divorce or death of either of the couple. Other than the Sunni and Shia Islamic sects, which are in support of assisted reproduction in general, with differences of opinion on issues such as third-party gamete donation and surrogacy, the religious segments are generally not in favour of ART. On cultural moral grounds, ART is still a subject of suspicion. Because of the strong association with clans in Buganda, questions were often posed to the researchers during this study regarding where children born of ART would be buried in case of death or whether they should inherit from the family.These suspicions were on the basis that through ART, you could never truly tell the identity of a child especially when there had been gamete donations.This tendency was particularly pronounced in instances of sperm donations on grounds that men would have no corporeal bond with the child (while women using donor eggs would have such a connection to the offspring through pregnancy). At the same time, because Buganda is a patrilineal

28 29 30 31

32

adorning the king with his robe on coronation day, while the Nte (cow) clan are the official royal iron workers for the king.They make the royal hoe used in the last funeral rites of a deceased king. Abasi Kiyimba, ‘Gendering Social Destiny in the Proverbs of the Baganda: Reflections on Boys and Girls Becoming Men and Women’ (2005) 17(2) Journal of African Cultural Studies 253–70. Ombelet and Onofre (n 18). Interview with Nansa (not real name), 4 October 2019. Haas John,‘Begotten Not Made:A Catholic View of Reproductive Technology’ www.usccb.org/issues-and-actio n/human-life-and-dignity/reproductive-technology/begotten-not-made-a-catholic-view-of-reproductive-t echnology accessed 14 October 2020. ibid.

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society, every child automatically takes on their father’s clan at birth, leading to uncertainty about what clan a child born out of ART really belongs to. Also, according to the customs of the Baganda, one is not supposed to marry into one’s clan or that of their mother’s.This type of system is referred to as being exogamous.33 Similarly, one is not supposed to eat the totem of one’s clan or that of the mother’s clan.34 Some members of the Baganda community asked questions on how these questions could be resolved when one could not really ascertain where a particular child begotten from ART really belonged. This need to pass on ethnic identity through male bloodlines makes ART socially problematic and, as such, less acceptable to the community. There were concerns voiced that children born from such processes could stand a higher chance of being shunned in families and clans. Furthermore, according to one source, it was a matter of contention as to why single women who are not married ‘properly’ as required by Ganda cultural norms or even persons of different sexual orientation should have children through ART. According to them, marriage is central in the making of families and therefore, extending reproductive rights through ART to persons who are not perceived to conform to societal norms is a threat to the continuation and preservation of family lines and Ganda culture. Another interesting cultural phenomenon is the attitude towards twins in Buganda. Twins are highly desired in Buganda and are regarded as a blessing, attracting special names for them and their siblings as well as their parents. Bearing twins in Buganda requires the performance of certain rituals which reinforce the unique special position of these children in society. But once people know they were conceived under ART, then they become suspect.35 This matter was raised in view of the fact that ART often comes with multiple pregnancies and implying that twins conceived in this manner were perhaps not ‘authentic.’ Gender dynamics were also highlighted as an offshoot of ART for the obvious preference of male children in patriarchal societies such as Buganda. It was, therefore, questioned whether ART would not heighten genetic gender selections in preference for sons, and in so doing promoting ‘artificial’ sons for that matter. Finally, let me highlight an interesting comment made by one respondent to what he felt was the socially inappropriate process of ART, especially on the side of men. According to him, masturbation as a means to generating samples of male gametes for use during ART was repulsive of social and cultural norms, and that rather than resort to this, men should be allowed to choose other fertile partners.36 From this, it can be deduced that, culturally, ART is yet to succeed as a fully acceptable mode of procreation especially with clan heads interested in continuity of clan lineages.

Law and policy on ART For the longest time, science and technology in the area of reproduction and specifically involving ART has been way ahead of the law. In fact, the law has mostly been playing catch up, attempting to address particular scenarios after they have occurred. It should be noted that, even where states are willing, the issue of regulating ART services is not an easy one.

33 34 35 36

‘The Clans of Buganda’ www.buganda.com/ebika.htm accessed 14 October 2020. ibid. Mukasa (n 26). Interview with M Nsobya, Kampala 12 March 2020. Similar feelings on this issue exist in other parts of Africa. See Ayodele Jegede and Adetona Fayemiwo,‘Cultural and Ethical Challenges of Assisted Reproductive Technologies in the Management of Infertility among the Yoruba of South Western Nigeria’ (2010) 14(22) African Journal of Reproductive Health, 115–127, 121.

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In Uganda, despite the first successful IVF birth in 2004, there is no law to regulate the conduct of this new technology and neither is there a specific enforcement mechanism to oversee the same. An ever-increasing need for clarity and consistency in the area of reproductive law is needed in order to keep up with the scientific advances mandated by ART.What is in existence is the general Uganda Medical and Dental Practitioners Council, which licences the ART facilities and medical practitioners, just as it does for any other medical field.37 The council is guided by the major principles and norms of medical practice such as the ‘do no harm/safe practice’ principle and prioritising the best interests of the patient. Some of the grey areas requiring regulation in Uganda include specifications for donor eggs, donor sperm or donor embryos; limits to maximum number of embryos that can be transferred into a woman’s uterus; consent to use and storage period of gametes; and use of surplus gametes, embryo freezing, and rights arising from surrogacy. Failure to regulate an aspect of human life as important as IVF is so grave because of the potential for conflict as well as the need to stipulate rights and duties for all those concerned. Many ART-related cases in other parts of the world have already been the subject of legal interpretation and judicial dispute resolution.The English case of Evans v Amicus Healthcare38 is a clear example of a conflict arising out of the controversies raised by ART. In this case, Natalie Evans wished to have an embryo implanted that had been created from her eggs and the sperm of the man from which she had subsequently separated.These embryos were created just before she had a hysterectomy.39 Her only chance to have a genetically related child was to have the embryo implanted. The man had written to the clinic to notify it of the separation between himself and Natalie and requested that the embryos be destroyed.40 Natalie challenged this position, but was not successful on grounds that the embryos had not been used because they were not yet implanted in her and that she did not have the consent of the donor to use them. Such a decision is interesting under law because it highlights aspects of consent to embryos. Similar cases on this matter include Centre for Reproductive Medicine v Mrs U,41 where consent was revoked by the male donor after initially agreeing to the posthumous use of his sperm to treat his wife, and that of Human Fertilization and Embryology Authority ex parte Blood42 regarding the right to infertility treatment of the applicant with the sperm of her dead husband.The sperm had been taken from Mr Blood as he lay in a coma shortly before his death from meningitis.43 Such cases are important as they illustrate the need for the law to come in quickly to regulate aspects of ART that are already happening in fact. As stated earlier, no regulation exists in Uganda on ART and, yet, it is a growing medical practice in the country. There is a mushrooming of ART centres in the country but with no clear guidelines on standard operating procedures required of this specialised field outside of those provided under general medical practice in Uganda. Therefore, aspects such as

37 In an interview with Dr Busingye, it was revealed that the council licenses ART facilities as well as ART practitioners (reproductive specialists) on an annual basis. A license is issued pursuant to meeting the minimum set requirements. An example of such requirements for the specialists is the proof of attendance of a minimum of 48 hours of an accredited continuous professional training in the preceding year, in one’s area of specialisation. The council is able to obtain data of trainings attended from the relevant hospitals offering it across the country. 38 Evans v Amicus Healthcare [2004] EWCA Civ 727. 39 This means the removal by operation of a person’s ovaries. 40 Jegede and Fayemiwo (n 36). 41 Centre for Reproductive Medicine v Mrs U [2002] EWCA Civ, 565, [2002] I FLR 927. 42 Human Fertilization and Embryology Authority ex parte Blood (1997) 2 WLR 807. 43 Jegede and Fayemiwo (n 36).

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specifications of medical personnel to work in this field, level of infrastructure required to ensure safety of patients or gametes, and the like are undefined. The lack of a specific legislation also comes with absence of a regulatory framework.Without this, a licensed medical doctor working in reproductive rights can generally practise in the field of ART.The approach being followed in Uganda is a kind of self-regulation, one which presents a lot of discretion to the healthcare service provider to work with flexibility minus accountability from an overarching specialised oversight body. Subsequently, critical aspects in ART practice such as consent or its withdrawal to engage in ART or donate gametes, recruitment of, and compensation of gamete donors (to avoid the same donors donating in different places) and surrogates, are left to the general law of medical practice, law of contract, and individual professional standards, thus affecting quality and standardisation. Similarly, matters of rights and duties remain in the grey, for example rights of surrogates, third-party reproduction, infertility treatment insurance benefits, and pre-implantation genetics gender selection. The absence of a relevant law on ART treatment has grave and negative social implications arising from the lack of checks by government to monitor the activities of medical personnel. In a country such as Uganda with high poverty levels44 and fairly high illiteracy levels,45 especially on the subject of ART, it is possible for ART service providers to use this predicament of absence of standards to take advantage of unsuspecting and desperate members of the public in ill-equipped and unlicensed fertility clinics. It is clear that there is a glaring gap in the area of regulating ART. It is imperative for the government to adopt a harmonised, comprehensive regulatory framework that conforms with international best practices in the administration of ART. Lessons can be taken from Kenya, which has a specialised ART department within its medical professionals council, or the United Kingdom, which has an enforcement agency set up just for this. Interestingly, Kenya was slightly behind Uganda in the early days of ART, only having recorded its first IVF baby in 2006, two years after Uganda. The latter now seems to be ahead in terms of regulating this issue which points to faster progress on its end.The draft ART regulation spearheaded by the Uganda Medical and Dental Practitioners Council addresses most of the aspects needed for a comprehensive regulation of ART practice in Uganda. The draft regulation is generally aimed to ensure safe and quality standards and punish misconduct, and it states in its preamble that it was prompted by malpractices in IVF clinics resulting in harm to patients. Sec 9(2) of the draft ART regulations defines ‘fertility services’ to mean medical, surgical, gynaecological, or obstetric services provided for the purpose of assisting women to carry children. Of particular importance to note in the draft regulation are the following: emphasis on patient empowerment through information sharing and consent; emphasis of counselling for all parties involved in the process; regulation of aspects such as embryo and sperm safety, preservation and disposal of gametes, pre-implantation genetic diagnosis, pre-implantation sex selection, protection of surrogate (in relation to doctor-recommended interventions such as therapeutic termination of pregnancy, evacuation of intra-uterine fetal death, multiple pregnancy, caesarean section delivery, etc.); specification of age of persons involved in ART technologies as 18 years and above; and status of mother, father, and child.

44 World Bank, Uganda Poverty Assessment 2016: Fact Sheet, www.worldbank.org accessed 4 April 2020.According to this report, the proportion of the Ugandan population living below the national poverty line was 19.7% in 2013. 45 Uganda Bureau of Standards, Education Monograph Report, www.ubos.org/. The literacy rate for the country is given as 72.2% for the population aged 10 years and above.

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Its categorisation of types of mother is interesting. It specifies four categories of ‘mother’: (1) A ‘genetic mother’ – a woman who carries a child as a result of the placing in her of an embryo. (2) A ‘birthing mother’ – a women who carried a child as a result of placing in her of an embryo. (3) A ‘surrogate mother’ – a woman who carries a child in pursuance of a notarised surrogacy agreement. (4) A ‘commissioning or intended mother’ – a woman ‘A’ who enters into a surrogacy agreement with another woman to have the embryos supplied by her, to be placed in the surrogate who carries the pregnancy and delivers the child to her as the mother with parental responsibilities of the child gestated and delivered. The draft ART regulation is not only strong with regard to the procedural aspects of ART, but also takes care of human rights and governance matters for persons involved. It also deals with penalties as well as grant or revocation of licence. Consequently, it provides remedies to persons for wrongs that may be committed. The passing of this regulation would be a new dawn for ART practice in Uganda because it would outline permitted procedures, stipulate rights and duties of parties involved, and create a non-questioned oversight role for a regulating agency.

The practice of ART within Uganda’s current health sector: realities and experiences As stated earlier, there are high levels of infertility in Uganda. According to a renowned ART practitioner, about 75% of infertility cases in Uganda are due to sexually transmitted infections, which leads to blockage of the fallopian tube in women and sperm duct among men.46 This section highlights findings on the state of ART as practised in Uganda. The data was availed through formal interviews and casual conversations with ART practitioners, donors, and surrogates, as well as women and men who sought or had used ART services in Uganda. Experiences and views about ART, surrogacy and donation, quality of service, and the impact on their lives were probed. In terms of economic positioning, it should be noted that the patients were mostly middle to upper class, while the donors and surrogates came from poor economic and educational backgrounds. It was, however, not easy to get this data. Most of the clinics operate on a ‘no information’ basis, pleading patient confidentiality.The study team made many appointments to speak with practitioners that were not honoured. Recipients of ART services were also nervous about sharing information, due to stigma attached to infertility in society. It can already be concluded that the practice of ART in Uganda is generally shrouded in silence and secrecy both on the side of the providers and the beneficiaries. To set the context for ART practice in Uganda, it is important to note from the onset that Uganda is a developing country with the majority of the population living below the poverty line47 and with no recognisable minimum wage.48 Unfortunately, in such a poor economic state,

46 Interview with Dr Busingye (n 6). 47 World Bank (n 44). 48 Attempts to enact a minimum wages bill were rejected by the president. Having a law on minimum wages would have enabled the government to fix minimum wages for workers in various sectors. It also provided for annual revisions. See further URN, ‘Museveni Rejects Minimum Wages Bill’ The Observer (27 August 2019) https:// observer.ug/news/headlines/61776.

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the right to health is not specified in the constitution and the health system does not offer public social security. As such, health is not a priority issue as evidenced by the low level of resources allocated to it in the national budget.49 Likewise, infertility is placed further lower in the gradient of public health issues of concern in the country. In this state of affairs, ART as a remedy to persons suffering infertility is only accessible through the private sector, and couples have to bear the full cost of their treatment.This is in contrast to the practice in many European countries where a specific number of cycles of IVF treatment are reimbursed by their governments.50 Thus, because of the prohibitive cost and lack of government support, not many people can afford ART. Due to these and other factors, Uganda has seen less development in ART in recent decades than in other parts of the world.51

Infrastructure and operation The pioneer ART clinic was established in Uganda in 2004 and the first successful IVF baby delivered in the same year. As such, the practice of ART in the country is still fairly new. From our engagement with practitioners in this field, we learnt that there are several factors impeding the successful practice of ART, first being the high start-up costs. Just like other specialised medical practices, establishing ART centres relies on expensive imported equipment. All of the companies involved in the setting up of new IVF centres are based in foreign countries and even after successful setup, practitioners regularly face problems with high maintenance costs due to the need to bring in experienced service technicians and engineers from abroad.There is also lack of a reliable local supply of good quality drugs, culture media, and other important consumables.Aligned to this is the unstable power supply and frequent outages. In these conditions, successful ART programmes require standby generators and electricity converters to guarantee optimal laboratory conditions,52 which further push up the costs of operation. Additionally, there is a lack of well-trained fertility specialists such as reproductive endocrinologists, embryologists, and IVF nurses.53 Most of the specialists are general medical practitioners and while the country requires a minimum of 12 embryologists, at least 2 in each region, the country’s existing capacity at the moment lies between 2 and 3 of these.54 As such, many of the clinics have to co-opt more experienced and trained international staff, both on a parttime and full-time basis. In view of this, transnational networks of skilled personnel, particularly those from Europe and a few from Nigeria, have been essential for the successful establishment of ART clinics in Uganda.Thus, because of the aforementioned hardships, many agree that it is not as easy to do IVF in Africa as in Europe.55 On a positive side, Uganda has a relatively fair supply of gynaecologists, currently producing an average of 50 newly trained ones coming out of medical school every year.These only need

49 For the FY 2019/2020 health was allocated 7.9% of the total national budget and 7.8% in 2020 (2020/2021 National Budget Framework paper, Uganda). 50 JO Fadare and AA Adeniyi, ‘Ethical Issues in Newer Assisted Reproductive Technologies: A View from Nigeria’ (2015) 18 Nigerian Journal of Clinical Practice, S57–S61. 51 Compare this to the situation in Israel, which boasts one million IVF cycles per capita. 52 RK Adageba, ET Maya, and FJ Damialie,‘Setting Up and Running a Successful IVF Program in Africa: Prospects and Challenges’ (2015) 65(3) Journal of Obstetrics and Gynecology of India 155–57. 53 Viola Hörbst, ‘You Cannot Do IVF in Africa as in Europe’ (2016) 2 Reproductive BioMedicine and Society 108–115 www.sciencedirect.com/science/article/pii/S240566181630020X accessed 14 October 2020. 54 Interview with Dr Busingye (n 6). 55 Hörbst (n 53).

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two years’ additional training in order to become specialised reproductive practitioners. But even with this shortage in personnel, many ART clinics have been established in Uganda.This study found that there are six such clinics, although the figure seems to be growing by the day.What is certain for a fact is that all these specialised clinics are located in the capital city in Kampala, bringing about a disparity in ART services between the urban and rural parts of the country. Also, just from observation of site visits, it was clear that fertility clinics are at different levels of expertise, implying that there is a disparity in the services available to patients.56 Furthermore, because of the difficulty in gauging the scope of ART services available, it is nearly impossible to generate a population-level database that accurately defines the burden of infertility, need for ART, recording, auditing, and difficulties in access to ART services. In fact, when asked how they learnt about the ART services, patients replied that they were referred by previous patients or general gynaecologists. It is important to mention here that Uganda is in the process of establishing a state-funded centre for ART. Mulago National Referral Hospital will be the first public health facility to provide ART to enable infertile women to bear children.57 According to Dr Robert Busingye, a senior consultant in obstetrics and gynaecology at Mulago hospital who doubles as the president of the newly launched Uganda Fertility Society, ‘the 320-bed capacity Women’s Hospital will have an IVF facility and will benefit from new technologies from WHO which will help bring down the costs of offering IVF.’58 He further states that 15 doctors and nurses at the hospital have benefitted from specialised ART training in India. He also called upon the government to waive taxes on medicines used in ART in order to make services affordable in the private sector. Since its completion in 2017, however, the hospital is yet to commence offering services.

Regulation Even as ART services grow in Uganda, the issue of regulation remains outstanding. Regulation is vital for quality assurance, compliance with standards as well as protection of patients and other parties involved. Some of the critical elements that require regulation include condition of clinics, standardisation of common medical practices in this field, qualifications of health workers, cost, information, and consent. In the absence of a specific regulation on ART, there are so many unknowns about the practice of ART in Uganda. From our engagement with the health practitioners, much of the medical and ethical management of ART service provision is the responsibility of the director of each clinic. On the one hand, directors are guided in this aspect by their understanding of biomedical ethics and by their entrepreneurial considerations, and on the other hand, by their religious convictions and their reputation among patients and the wider society. As shared by one embryologist,59 the processes undertaken at their clinic are premised on ‘borrowed or assumed law’, best practices of what other leading countries in the field are doing and medical ethics generally, including conscience.When ethical questions arise, in the absence of law ‘one can only act on what they believe is right by their conscience.’ According to him, practices such as surrogacy and egg donation require regulation because they have the highest

56 The team visited three clinics and one could observe just from the infrastructure that some clinics were far ahead of other newer and just established ones. 57 Emmanuel Ainebyoona,‘Mulago to Start Low Cost Infertility Treatment’ Monitor Newspaper (27 February 2017) 6. 58 ibid. 59 Interview with Dr Maurice Eluba, senior embryologist, Women’s Hospital International and Fertility Centre, Kampala, 5 February 2020.

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potential of being commercialised and as such lead to exploitation of the people seeking the services. Genetic analysis and gender selection are other such areas. Per the embryologist: Some clients come and they want to eliminate any chances of giving birth to a child who has a deformity. Because this is an area that is not regulated, even where someone has a 10% chance of giving birth to a child with a disability and they have the money, they are willing to spend on the procedure (which is extremely expensive).The doctors cannot stop them from accessing the service they want. On the aspect of gender selection, it is never the intention of the analysis but because the technology allows the person to examine all the chromosomes, one ends up getting the gender from the XY chromosome.This has however been outlawed in most European countries and can only be accepted in cases of a gender related genetic disease. Another aspect of concern is preservation of surplus gametes and embryos. It is uncertain for how long fertility clinics should store such and at what conditions, keeping in mind that power supply is a problem in Uganda. Studies from developed countries have shown that the viability of the frozen embryos reduces with longer storage time.60 In view of the discussion, ART practice in Uganda is very much still in a free-for-all and a lot is left to the discretion and professional standards of each practitioner. Most clinics make their own rules and follow varied standards.Therefore, quality assurance of the procedures remains an important factor because of the potential for abuse.There is, therefore, need for regulation and especially guidance on some of the controversial aspects of ART practice.

General trends and patterns Currently, ART is carried out in the private sector. All the centres are owned and operated by Ugandan doctors, some with technical collaborative support from individuals and institutions from the Western world. The first cycle of IVF is often unsuccessful, and depending on financial capacity, many patients may have to follow this with a second and even a third trial.61 Regrettably, each of these cycles has to be financed privately by the patients, and there is no arrangement for nocost repetition of the procedure in the event that the initial one fails. At the same time, conceptions following assisted reproduction are high-risk pregnancies and may be followed by obstetric complications including extrauterine complications, tubal ectopic pregnancies, spontaneous abortions, multiple pregnancies, high perinatal mortality, preterm deliveries, and low birth weight babies.62 Accordingly, pregnancy and childbearing through ART, even when successful, is not always easy. With increasing sophistication and fine-tuning of the procedure, however, fertility specialists are now able to transfer more than one embryo with very good outcomes. According to one gynaecologist:

60 Fadare and Adeniyi (n 50) 161. 61 Interview with Dr Mark Muyingo, Kampala, 8 April 2020. See also, generally, LJ Noreh, O Tucs, CB SekaddeKigondu and JA Noreh, ‘Outcomes of Assisted Reproductive Technologies at the Nairobi In Vitro Fertilisation Centre’ (2009) 86(4) East African Medical Journal 156–161 at 158. 62 Noreh et al. (n 61).

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One of the major challenges that arises with ART services is managing expectations. Notably, the chances of failure are more than chances of success.Yet, failure to conceive usually brings feelings of grief and sadness.This however is managed through counselling where by the patients are informed about the probabilities. In an era where the market is very competitive, some facilities may paint a picture that they have a very high success rate. This is hard to validate because Uganda currently does not have a database indicating the performance of different centres. This is distinct from other countries with either voluntary or compulsory submission of data relating to ART results.As such, clinics are encouraged to make it clear to their clients that the process does not guarantee 100% success for giving birth.63 It should be noted that the practice of ART in Uganda is generally shrouded in secrecy.There is little data on cases managed or success rate, and little information available for interested parties to refer to, for example to guide selection of particular practitioners over others. In our view, a patient just has to trust their instincts and rely on recommendations from other patients, many of whom are unwilling to discuss their reproductive challenges publicly. One of the respondents to the research (HN) stated: I was asked by the doctor how many children I wanted to have and I said I wanted 2. They decided to put five embryos because normally not all of them successfully develop and the target was that I could get either one child, or two or a maximum of three children. This is normal clinical practice to insert more embryos to avoid disappointment, because when my procedure was done, we were around 14 women but only 6 of us conceived.64

Cost Private practitioners set up fertility clinics in their respective countries, driven by humanitarian and biomedical motives, hoping to increase accessibility to high-tech solutions for their sub-Saharan African patients.65 Yet, however humanitarian their reasons may be, ART services are very costly. More than 98% of the population in Africa cannot afford IVF because it is too expensive.66 The case of Uganda is no different. Charges for IVF for instance range from $6500 for a single IVF cycle, while surrogacy procedures range from $6000 to $10000.67 Many couples are unable to undergo IVF because of those high expenses and in fact, 50% of the couples that consult at ART clinics cannot afford the treatment.68 Part of the reason for the high costs is the

63 Interview with Dr Busingye (n 6). 64 Interview with HN,Women’s Hospital International and Fertility Centre, Kyotera, Masaka, Uganda, 6 February 2020. HN conceived five babies through IVF. 65 Hörbst (n 53). 66 UNFPA State of the World Population, Worlds Apart: Reproductive Health and Rights in an Age of Inequality, (2017, UNFPA) https://esaro.unfpa.org/en/publications/worlds-apart-reproductive-health-and-rights-age-inequality accessed 14 October 2020. 67 Interview Dr Maurice Eluba (n 59). A patient we talked to during the study put the cost of an IVF cycle at 24 million Uganda shillings ($6400). 68 ibid.

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financial constraint incurred by the physicians to import and maintain the necessary equipment, but also the high costs of international personnel involved in the procedures. According to a calculation made by Huyser, the average percentage of the major cost-drivers of an IVF cycle in South Africa in 2012 were the following: 8% for clinic fees, 28% to medication, 29% to clinicians’ fees and consultations, and 35% for laboratory fees (for use of equipment and the laboratory, disposables, culture media, and staff expenditures).69 Another reason for the high costs of the procedures in Uganda is the piecemeal mode of payment for the different services. For instance, costs for initial laboratory tests are billed separately from those of ovarian stimulation retrieval of eggs for IVF, fertilisation and culture of eggs and embryos, and maternity costs. It should be noted that the bulk of these costs are met by women.This originates from the gendered pressures that childlessness imposes on women more than men.As a fact, most patients at ART clinics are women. Husbands and other male partners are rarely supportive in these ventures, reflected by their reluctance to attend clinics or even pay for the required procedures.70 HN also stated: I first realised that I could not have children normally after I had tried traditional methods and visited very many hospitals that could not find any problem with me. My husband went ahead and got children from another woman and that was how I confirmed that I had a problem. My in laws were very concerned about my inability to give birth and so was my mother because even my younger sisters had given birth before me. However, the money needed for the IVF process was a lot, in fact, one may need to sell their property and also ask from relatives. I was scared about the money so I did not go back for more than six months but after I got some money I went back to try. These services are not affordable, considering the number of women out there who are struggling with infertility.The treatment is very expensive because even after conceiving there are extra costs you incur. For example, after conceiving you visit after every two weeks, you must have more than Sh. 700,000 ($200) per visit. Even antenatal care is very expensive because it costs $350. They should be made a bit cheaper, to reduce on the money they charge for the services. Because for one to start the process you must have about Sh. 20 million (USD 2500) which is a very huge amount for an average Ugandan. If there is a way to make this cheaper, it should be explored because infertility is not a condition among the rich only.71 Thus, in Uganda where there is no social security in the healthcare system; couples must cover the full expenses by themselves, which creates a major barrier to access quality treatment for a large majority of infertile couples. Even then, the clinics still get many clients, some from neighbouring East African countries (Kenya, Tanzania, Rwanda, Congo, Sudan, Somalia, and Ethiopia) who cannot afford to go to South Africa, Europe, or the United States, since the costs in Uganda are relatively low in comparison to the former.

69 C Huyser, L Boyd.‘ART in South Africa:The Price to Pay’ Facts Views Vis ObGyn (2013) 5(2) 91–99. 70 Interview with Ann Marie (not real name), patient, Neogenesis Clinic, Kampala, 27 October 2019. 71 Interview with HN (n 64).

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The practice, however, seems profitable to practitioners.Within a few years of commencing practice, most are able to buy off their office buildings or construct new facilities. Dr Eluba contends: We are constructing a three storey building adjacent to the existing building. In the near future, we will move the IVF unit to the new building, and we will have a maternity unit, operation theatre and neonatal care unit; the latter is very important as neonatal care services in Uganda are scarce and we have a multiple pregnancy rate of 20%.We are doing our best to lower this high rate of multiple pregnancies, but it is very difficult due to the pressure of the patients; most of them will be able to afford only one treatment cycle in their entire life, so a single embryo transfer is difficult for them to accept, as it is in all health systems, where the patient has to pay for the full treatment themselves.72 The clinics are, however, trying to mitigate the high costs of treatment through egg sharing, transfer of a higher number of embryos, training of local personnel, collaboration between centres in Africa to purchase consumables in bulk, and local manufacturing of some of the equipment through local craftsmen.73 There is hope that with time, the costs for ART will lower and more couples in need will be able to access the much-needed service.

Donors and surrogates Surrogacy and egg donation are contentious matters, as raised earlier in both the cultural religious perspectives but also in law, and is proposed as one of the areas requiring regulation.While egg donation is becoming more familiar and accepted as an inevitable part of ART, surrogacy on the other hand is taking a while longer. Nevertheless, because of the high poverty rates and the high unemployment rate in Uganda’s labour market,74 egg donation and surrogacy, in particular, are gaining ground as a remunerative opportunity, particularly for young women without much educational and professional training. That however does not stop the questioning of moral uprightness and ambivalences of the practice by both the surrogates as well as the patients, mostly around the use of third-party gametes (selling gametes) or offering ‘wombs for rent.’ Given the extreme poverty that countless suffer in the country, many women finally conclude that surrogacy or donating is a morally acceptable way of earning money to achieve a better future for themselves and their families. As one of them says:‘I think in the end [to be a donor or a surrogate] is better than prostitution.’75 Of course, some countries with legislation on ART prohibit surrogacy for commercial gain and also go as far as to state that surrogacy agreements/arrangements are illegal and as such unenforceable at law.76 It can, however, be argued that surrogacy for commercial gain is necessary as it helps two parties achieve their goals: the birth mother gets a child, while the surrogate

72 Interview with Dr Eluba (n 59). 73 Dr Eluba gave an example of the ICSI stabilisation table at WHI, which was made locally for $50. 74 According to the Uganda Bureau of Statistics, the national unemployment rate stands at 9% of the working age population. See UBOS International Labour Day Book, www.ubos.org/wp-content/uploads/2019. 75 Interview with Mary (not real name), 22 October 2019. 76 See section 33 Human Fertilisation and Embryology Act, UK 2008, which criminalises both intermediary and parties involved in such an arrangement and irrespective of the intermediary demanding a fee or not for his/her services.The regulation is meant to limit surrogacy to cases where there are such close ties that no intermediary

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mother gets money for sustenance.The proposed ART bill in Uganda makes room for surrogacy. As a practice, however, we learnt that candidates for donation and surrogacy are subjected to health checks and clinical tests for infectious diseases (e.g. HIV, hepatitis B and C) as part of the screening process. Furthermore, criteria such as age, previous deliveries, and marital status are also considered. In general, we discovered that patient demand for donors is higher than for surrogates, but most of the candidates would prefer to act as surrogates than egg donors because surrogacy is far more lucrative.77 Ultimately, the need for regulation of this issue cannot be underscored because of the centrality that surrogacy and gamete donation play in ART.There is urgency to do away with the silence and secrecy surrounding these two and instead aim to protect all the parties concerned through legislation.

Knowledge and awareness Knowledge and awareness of ART services as an option to treat infertility is generally poor. Questions asked to our respondents during this study indicate that many did not believe in ART and said ‘only God gives babies,’ while others just did not know about the existence of this field of medicine.This of course is not helped by the fact that there is limited information on the existence of ART services. Potential clients need to be guided on the scope of services offered by particular clinics and their specialities as well as their success rates. Such information can make all the difference between whether one will or will not use the service or whether they will or will not ultimately have a baby. There is also missing information at a wider community level of the magnitude of infertility, its impact on health and quality of life, and its prevention and treatment.Therefore, the planned law on ART should not only aim to regulate the specifics of the medical practice of ART but also enhance community education and sensitisation on reproductive health.

Conclusion Many families in African societies substantially depend on children for social status. Because of the prominence of childbearing, failure to have children has always been the subject of scorn. Often it is the women much more than the men who have borne the brunt of childlessness. Therefore, involuntary childlessness in Africa also takes on a gendered face. The position in Uganda is no different.The example given of the Baganda in central Uganda shows the crucial role that children play in holding families together. Science and technology through ART have gained ground as a method of assisting childless couples to reproduce. In recent years, there has been a sprouting of medical clinics and health centres in Uganda with the intention of assisting couples in this cause.The practice of ART has generated widespread controversy along religious, cultural, and moral lines. Similarly, the practice of IVF is associated with prohibitive high costs of treatment, inadequately trained physicians in reproductive health technology as well as unclear law and policy on reproductive health. However, despite the devastating social, psychological, economical, and personal consequences of being childless, the government of Uganda fails to prioritise the right to health and,

is needed. See Dennis Odigie and Florence Iyasere, ‘In-Vitro Fertilization in Developing Countries: Emerging Issues’, (2018) 24(1) East African Journal of Peace and Human Rights, 108–119, 114. 77 Interview with Nasimolo, Kampala, 19 October 2019.

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thus, does not enable equitable access to healthcare through a public health scheme.Therefore, childless couples can only access ART, which is currently very expensive, through private means. Unfortunately, while people are desperate to have children and are often tempted to do anything for this, they are also very vulnerable and can very easily be manipulated and exploited. This is because practice of IVF in Uganda is largely unregulated, and its occurrence often happens behind closed doors. For instance, it is not clear what remedies a couple who have spent millions of shillings would be entitled to in case of failure of conception. It is also not known what the repercussions would be if one utilised previously frozen reproductive gametes which resulted in a baby with disabilities as a result of poor storage facilities.Additionally, because ART is a relatively new frontier in reproductive technology, widespread controversy about its use has been generated along religious, cultural, and moral lines. It is clear that there is lack of full community support for it. This chapter examined the existing law in Uganda surrounding this area of medicine and found that there is a gap with regard to regulation.There is no law to comprehensively cover the practice of ART in Uganda.A key message is that childlessness is not only a social or individual medical problem but also a public health issue.We, thus, strongly support the inference in SDG 3.7 of universal access to sexual and reproductive healthcare services, including family planning, information and education, and the integration of reproductive health into national strategies and programs, to include ART.Thus, it is important for Uganda as a country to aspire to improve both the medical standards in ART in order to enhance availability, affordability, and effectiveness, as well as to address institutional and infrastructural deficiency through purpose-driven legislation for the administration and regulation of ART treatment, backed by enforcement and sanction for breach. This should come together with a regulatory framework for monitoring performance of medical personnel and compliance with the law. Furthermore,ART does not operate in a vacuum.There should be emphasis placed on public educational programmes about the advantages of ART as an alternative to natural reproduction.These would change the negative mindset and disposition to the treatment. Having these in place would help to further promote the human right for all men and women of full age to marry and found a family without any limitation as guaranteed under the Universal Declaration of Human Rights and Article 31 of Uganda’s constitution.

Acknowledgements The funds that supported this research and field study were generously given by Nottingham Trent University, to which I am grateful. I also acknowledge and appreciate the research and fieldwork, provided by the team of Mr Brian Kibirango, Ms Maxine Twijukye, and Ms Rehemah Twine, all of Makerere University in Kampala, Uganda.

Glossary78 Embryo donation: the transfer of an embryo resulting from gametes that did not originate from the recipient and her partner. Full surrogacy: this is where the surrogate mother has no genetic link to the child.The surrogate mother only gestates the embryo, which is usually created from the eggs and sperm of the intended parents.

78 Zegers-Hochschild et al. (n 3).

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Gamete intrafallopian transfer (GIT): the procedure in which both gametes (oocytes and spermatozoa) are transferred to the fallopian tube. Intracytoplasmic sperm injection (ICSI): this is the procedure in which a single spermatozoon is injected into the oocyte cytoplasm. If fertilisation is successful, a fertilised ovum (or several ova) is either transferred to the mother’s or a surrogate mother’s body for normal development in the uterus, or frozen for later implantation. Mitochondrial donation: this allows women to produce genetically related offspring without transferring genetic defects. It involves the removal of deoxyribonucleic acid (DNA) from a patient’s egg or embryo containing unhealthy mitochondria to a donor’s egg or embryo containing healthy mitochondria. Partial surrogacy: this is where the surrogate mother provides the egg and the sperm from the intended father is placed into the surrogate mother’s reproductive tract, through artificial insemination, to achieve fertilisation. Posthumous reproduction (PHR): this arises where a party has donated his/her gametes prior to death and a recipient would like to use them thereafter or where a deceased child has donated their gametes to their parents and the parents wish to use the gametes to create grandchildren. Pre-implantation genetic diagnosis: this is the analysis of polar bodies from oocytes, zygotes, or embryos for the detection of specific genetic, structural, or chromosomal alterations. Surrogacy: an agreement in which one woman agrees to bear a child for another woman or a couple (intended parents) and surrender it at birth. Zygote intrafallopian transfer (ZIFT): this is the procedure where the zygote(s) is transferred into the fallopian tube.

References Adageba, RK, Maya, ET and Damialie, FJ, ‘Setting Up and Running a Successful IVF Program in Africa: Prospects and Challenges’ (2015) 65(3) Journal of Obstetrics and Gynecology of India 155–57. BBC News,‘Birthday Honours:Test Tube Baby Pioneer Knight’ (BBC News, 10 June 2011) www.bbc.co .uk/news/health-13727900 accessed 14 October 2020. Fadare, JO and Adeniyi, AA, ‘Ethical Issues in Newer Assisted Reproductive Technologies: A View from Nigeria’ (2015) 18 Nigerian Journal of Clinical Practice S57–S61. Gwet-Bell et al., ‘The 5 Main Challenges Faced in Infertility Care in Cameroon’ (2018) 3(3) Global Reproductive Health Journal e16. Haas, John, ‘Begotten Not Made: A Catholic View of Reproductive Technology’ www.usccb.org/issues -and-action/human-life-and-dignity/reproductive-technology/begotten-not-made-a-catholic-view -of-reproductive-technology accessed 14 October 2020. Hörbst,Viola,‘You Cannot Do IVF in Africa as in Europe’ (2016) 2 Reproductive BioMedicine and Society 108–15 www.sciencedirect.com/science/article/pii/S240566181630020X accessed 14 October 2020. www.gieraf.org/assets/images/article_39/01The_5_main_challenges_faced_in_infertility_care_in.99 986.pdf accessed 14 October 2020. Huyser, C, and Boyd, L,‘ART in South Africa:The Price to Pay’ (2013) 5(2) Facts Views Vision in ObGyn 91–99. Kiyimba, Abasi,‘Gendering Social Destiny in the Proverbs of the Baganda: Reflections on Boys and Girls Becoming Men and Women’ (2005) 17(2) Journal of African Cultural Studies 253–70. Mukasa, Martha N,‘Ethical and Sociocultural Considerations for Use of Assisted Reproductive Technologies Among the Baganda of Uganda’ (thesis, Georgia State University 2013) https://scholarworks.gsu.edu/a nthro_theses/78 accessed 14 October 2020. Muthoni, Thiankolu, ‘Towards a Legal Framework on Assisted Human Reproduction in Kenya; Some Thoughts on the Law,Technology and Social Change’ (2007) 1–23. Nachtigall, Robert, ‘International Disparities in Access to Infertility Services’, (2006) 85(4) Fertility and Sterility 871–75.

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Assisted reproductive technologies Noreh, LJ,Tucs, O, Sekadde-Kigondu, CB and Noreh, JA,‘Outcomes of Assisted Reproductive Technologies at the Nairobi In Vitro Fertilisation Centre’ (2009) 86(4) East African Medical Journal 156–61. Odigie, Dennis, and Iyasere, Florence, ‘In-Vitro Fertilization in Developing Countries: Emerging Issues’ (2018) 24(1) East African Journal of Peace and Human Rights 108–19. Ombelet, W, and Onofre, J, ‘IVF in Africa: What Is it All About?’ (2019) 11(1) Facts,Views, and Vision in ObGyn 65–76. Serour, Gamal I, et al.,‘The Place of ART in Africa’, (2019) 4(2) Global Reproductive Health e27. Tajudeen, Ibraheem O,‘The Need for Legal Regulation of Assisted Reproductive Technology in Nigeria’ (2014) 20(1) East African Journal of Peace and Human Rights 155. UBOS International Labour Day Book, www.ubos.org/wp-content/uploads/2019. Uganda Bureau of Standards, Education Monograph Report, www.ubos.org/. Uganda Bureau of Statistics, National Population and Housing Census (Uganda Bureau of Statistic 2014) www.ubos.org/ accessed 14 October 2020. UNFPA State of the World Population, Worlds Apart: Reproductive Health and Rights in an Age of Inequality (UNFPA 2017) https://esaro.unfpa.org/en/publications/worlds-apart-reproductive-health-and-rights -age-inequality accessed 14 October 2020. URN,‘Museveni Rejects Minimum Wages Bill’ The Observer (27 August 2019) https://observer.ug/news/ headlines/61776. Van Niekerk, C, ‘Assisted Reproductive Technologies and the Right to Reproduce under South African Law’ (2017) 20 PER/PELJ 1–31. WHO, Sexual and Reproductive Health (WHO 2020) www.who.int/reproductivehealth accessed 14 October 2020. World Bank, Uganda Poverty Assessment 2016: Fact Sheet www.worldbank.org accessed 4 April 2020. Zegers-Hochschild, F, et al., ‘International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary of ART Terminology’ (2009) 92(5) Fertility and Sterility 1520–24.

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7 ABORTION AND CONSCIENCE A crossroads for Northern Ireland Clayton Ó Néill

Introduction On every medical law syllabus, students undertake study in relation to abortion and reproductive health. They question the legitimacy of abortion from particular ethical perspectives, the moral status of the fetus, and, indeed, the relationship between the right to an abortion and human rights law/jurisprudence. Abortion is not an easy topic – it is not black and white. Even within the ‘pro-choice’ and ‘pro-life’ camps there are nuances of arguments in relation to what ought to be permissible or impermissible. But, broadly speaking, the orthodox argument in favour of abortion is that respect ought to be given primarily to the bodily integrity and autonomy of the woman. On the other side of the coin is the argument that abortion is an infringement of the sanctity or inviolability of life, which echoes the idea of ‘God gives, and God takes away.’The purpose of this chapter, however, is not to question or support the ethical validity of abortion and/or contested reproductive health practices. Instead, the chapter will analyse the changing law in Northern Ireland (NI) from a human rights perspective with a view to assessing the appropriateness of the law, particularly as it applies to conscientious objection. The chapter responds to the very recent implementation of the Abortion (Northern Ireland) Regulations 2020. It also questions the reply given by the UK government to the consultation process concerning conscientious objection to abortion that preceded these Regulations. The chapter concludes that, while the Regulations comply with the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), they also fail to endorse an approach to conscientious objection that is fully reflective of the principles and spirit of Article 9 of the European Convention on Human Rights (ECHR). The island of Ireland has two legal jurisdictions: Ireland (Éire) (hereafter the Irish Republic) and NI.The Irish Republic has recently changed its laws on abortion, following a nationwide referendum where the controversial 8th Amendment to the Irish Constitution, Bunreacht na hÉireann, was repealed and replaced by the 36th Amendment, which endorsed legislative reform of the law in the form of the subsequent Health (Regulation of Termination of Pregnancy) Act 2018. This change may be linked to two sociological variables: on one hand, there has been a radical sea change in the attitudes of Irish people towards abortion and reproductive rights and, on the other hand, there has been a weakening of support of religious authority, such as that of the Catholic Church.The success of the Repeal campaign has led to many activists calling for a 102

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change in the law in NI, using the slogan ‘The North is Next.’ In the absence of a functioning NI Assembly at Stormont, the Westminster government imposed new legislation on NI for the widening of the law on abortion so that it was aligned with human rights norms in accordance with obligations imposed upon it by CEDAW. The same intervention happened in respect of same-sex marriage. The chapter is divided into two sections. The first section will set out the historical and legal context of abortion as it pertains to NI.The latter section will explore the related issue of conscientious objection.

The pathway to change Social and political context While debates for and against development in laws relating to abortion have raged with quiet intensity in many states, in NI there is an acute alignment between religious belief and political affiliation that renders debate relating to abortion particularly contentious. Traditionally, Catholicism has been associated with Nationalism/Republican perspectives and Protestantism has been connected to Unionism. In this jurisdiction, political thought and persuasion is often guided and formed by religious affiliation, which is linked to tribal or ethnic branding. Entire schooling processes are primarily tunnelled through one religious channel or the other. Ethnicity itself is largely proclaimed on the basis of religious tradition.1 As indicated, religion has played a significant role in the attitudes of citizens towards abortion.2 Many entrenched anti-abortion political and social arguments have been made by those who purport to have strong religious convictions. It is not surprising that the abortion debate is addressed with the greatest ferocity from those who hold strong religious beliefs.The usually opposing factions of Unionism and Nationalism had traditionally been aligned in an anti-abortion stance. Or so it was.What is surprising is that the traditional Catholic voice has been changing: younger Catholics and even older ones have shifted their perspectives. This may be reflective of the process to amend the constitution of the Irish Republic that had given an explicit protection to the ‘unborn child.’ In 1983, the 8th Amendment was introduced to the Irish constitution. It stated: The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable, by its laws to defend and vindicate that right. This solidified a position in the constitution that regarded the fetus as having constitutional status. De Londras and Enright state that that the notion of ‘life’ was restrictively interpreted and ‘[r]ather than recognise the 8th Amendment as protecting life in all its richness and depth, successive courts and governments have been content to assume that it only protects the bare condition of being alive.’3 A Repeal the 8th campaign that aimed to remove the 8th Amendment placed a significant emphasis on the compassion and care rather than on the moral status of the fetus. It is noteworthy that Sinn Féin (the main Republican party with parliamentary represen-

1 See, for example, Jennifer Todd, Identity, Change after Conflict: Ethnicity, Boundaries and Belonging in the Two Irelands (Palgrave Macmillan 2018). 2 See Clayton Ó Néill, Religion, Medicine and the Law (Routledge 2018), particularly chapter 8. 3 Fiona de Londras and Máiréad Enright, Repealing the 8th (Policy Press 2018) 2.

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tation on both sides of the border) has advocated for this change in the law. Sinn Féin played a significant role in the South in canvassing for the 8th Amendment to be repealed.4 Equally, one of the main Nationalist parties, the Social Democrat and Labour Party (SDLP) describes itself as ‘pro-life,’ but this is not the position of many of its prominent members.Thus, the (Catholic) Nationalist voice holds many positions and does not provide a united perspective on this issue. The more entrenched viewpoint in this debate comes from the Protestant traditions of which there are many. They include Reformed Presbyterians, Free Presbyterians, and various Evangelical groups, such as Plymouth Brethren. Major NI Unionist political parties, such as the Democratic Unionist Party (DUP), the Ulster Unionist Party (UUP), the Progressive Unionist Party (PUP), and the Traditional Unionist Voice (TUV), whose members are often aligned to these religious groupings, are against the legalisation of abortion.The leader of the largest party (the DUP), Arlene Foster, has steadfastly shown her opposition to the change in the law. It is unlikely that their viewpoints are likely to change, and they will certainly disagree with the content of the new abortion Regulations, which were implemented on 31 March 2020.

The road to change The main focus of this section is on legal developments pertaining to abortion in NI, which was in a political impasse for almost three years. During this lengthy period, the Stormont institution had been left politically vacant. However, this lacuna gave Members of Parliament (MPs) in Westminster the opportunity to decide that it was time to change the law on abortion in NI. Prior to the introduction of the Northern Ireland (Executive Formation etc) Act 2019, abortion was a crime: the law in NI was primarily governed by Sections 58 and 59 of the Offences Against the Person Act 1861.5 The Abortion Act 1967, which applies to England, Scotland, and Wales (GB), was not extended to NI.6 All this was to change.

4 This has actually caused a split in Sinn Féin, where a number of members left the party and formed the Aontú party (which is an all-Ireland political party that opposes abortion). 5 According to the now repealed section 58 every woman, being with child, who, with intent to procure her own miscarriage, shall unlawfully administer to herself any poison or other noxious thing, or shall unlawfully use any instrument or other means whatsoever with the like intent, and whosoever, with intent to procure the miscarriage of any woman, whether she be or be not with child, shall unlawfully administer to her or cause to be taken by her any poison or other noxious thing, or shall unlawfully use any instrument or other means whatsoever with the like intent, shall be guilty of felony, and being convicted thereof shall be liable… to be kept in penal servitude for life. Section 58 of the 1861 Act stated: Whosoever shall unlawfully supply or procure any poison or other noxious thing, or any instrument or thing whatsoever, knowing that the same is intended to be unlawfully used or employed with intent to procure the miscarriage of any woman, whether she be or be not with child, shall be guilty of a misdemeanor, and being convicted thereof shall be liable … to be kept in penal servitude. 6 Under section 1 of the Abortion Act 1967, in GB, abortion is permissible when there is a threat to the life of the pregnant woman or in order to prevent grave permanent injury to the physical/mental health of the pregnant mother or where there is a risk of injury to the pregnant woman or her children (up to 24 weeks gestation) or where there is a significant risk that, if the child were born, he or she would ‘suffer from such physical or mental abnormalities as to be seriously handicapped.’

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Northern Ireland (Executive Formation etc) Act 2019 and the CEDAW report The introduction of the Northern Ireland (Executive Formation etc) Act 2019 by the Westminster government, in the absence of a functioning Stormont Executive, changed the law of abortion in NI. Section 9 of the Act is particularly important because it fundamentally states that the NI Secretary of State must make sure that paragraphs 85 and 86 of the CEDAW report are implemented.7 Before considering section 9 in more detail, let us consider the specific recommendations made in the CEDAW report.

Paragraphs 85 and 86 of CEDAW’s Report Paragraph 85 recommended that sections 58 and 59 of the Offences against the Person Act 1861 must be repealed so that no criminal charge could be brought against a woman or a girl who has an abortion or against healthcare professionals who assist or provide an abortion.The report recommended that legislation should be implemented to allow for the legalisation of abortion in NI in cases where there is a threat to the physical or mental health of the woman ‘without conditionality of long-term or permanent effects,’ incest and rape, and severe fetal impairment. It was recommended that a mechanism ought to be introduced to promote the rights of women, and improvements were required in relation to data-sharing between the Police Service of Northern Ireland (PSNI) and the Department of Health, Social Services and Public Safety in relation to self-induced abortions. CEDAW also made a number of recommendations in relation to rights and services connected to sexual and reproductive health.These include: • •

• •

• •

Provide non-biased, scientifically sound and rights-based counselling and information on sexual and reproductive health services, including on all methods of contraception and access to abortion; Ensure accessibility and affordability of sexual and reproductive health services and products, including on safe and modern contraception, including oral and emergency, long term or permanent and adopt a protocol to facilitate access at pharmacies, clinics and hospitals; Provide women with access to high quality abortion and post-abortion care in all public health facilities, and adopt guidance on doctor-patient confidentiality in this area’; Make age-appropriate, comprehensive and scientifically accurate education on sexual and reproductive health and rights a compulsory curriculum component for adolescents, covering early pregnancy prevention and access to abortion, and monitor its implementation; Intensify awareness-raising campaigns on sexual and reproductive health rights and services, including on access to modern contraception; Adopt a strategy to combat gender-based stereotypes regarding women’s primary role as mothers; and

7 Committee on the Elimination of All Forms of Discrimination Against Women, Report of the Inquiry concerning the United Kingdom of Great Britain and Northern Ireland under article 8 of the Optional Protocol to the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW/C/OP.8/GBR/1) published on 6 March 2018 https://tbinternet.ohchr.org/Treaties/CEDAW/Shared%20Documents/GBR/INT_CEDAW_ITB_GBR_ 8637_E.pdf accessed 1 April 2020.

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•

Protect women from harassment by anti-abortion protestors by investigating complaints, prosecuting and punishing perpetrators.8

Section 9 Northern Ireland (Executive Formation etc) Act 2019 It is interesting that the 2019 Act stated that all of the preceding recommendations ‘must’ be implemented (section 9(1)). In line with paragraphs 85 and 86 of CEDAW’s report, section 9 of the Act states that: • • • • • •

Sections 58 and 59 Offences Against the Person Act 1861 are repealed (section 9(2)); No criminal proceeding or investigation may be brought in relation to any of the offences set out under sections 58 or 59 of the 1861 Act, as they applied to NI (section 9(3)); Whatever other changes (regulations) which are both necessary and proportionate in order to comply with the implementation of CEDAW’s recommendations are required to the law in NI must be made by the Secretary of State (section 9(4)); These Regulations must, specifically, allow for the regulation of abortion in NI, e.g. in relation to when abortion may or may not be permitted (section 9(5)); These Regulations had to be introduced by 31 March 2020 (section 9(6)); The duties which are imposed on the Secretary of State by section 9 must be carried out quickly, given the important impact of the change of law on women’s human rights (section 9(7)).

The Abortion (Northern Ireland) Regulations 2020 Following a consultation process, to be considered in more detail later, the Abortion (Northern Ireland) Regulations 2020 were implemented on 31 March 2020. Here is a snapshot of the main aspects of these Regulations:9 • • • • • • • •

Abortion on demand is available up to 12 weeks of gestation (section 3); Where there is a risk to the physical or mental health of the woman, abortion is permitted up to 24 weeks gestation (section 4); No time limit exists for access to abortion in the case of severe/fatal fetal abnormality (section 7); No time limit exists for access to abortion when there is a risk to the life or grave permanent injury of the pregnant woman (section 6); An abortion may be performed where it is ‘immediately necessary … to save the life, or to prevent grave permanent injury to the physical or mental health, of the pregnant woman’ (section 5); An abortion must be performed by a registered ‘medical professional’ (section 2); Terminations can take place in the premises of GPs, clinics and hospitals provided by the Health and Social care trust and women’s homes in ‘where the second stage of early medical terminations may be carried out.’ Further places may be added in the future (section 8); In the case of a termination undertaken within 12 weeks, a certificate must be signed by a medical professional indicating that the pregnancy has not gone past the 12-week limit or

8 ibid para 86. 9 ibid 10 and 11.

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• •

that it is immediately essential for the abortion to be performed. In relation to the other grounds, two medical professionals will need to sign the certificate that one of the relevant grounds is met (section 9); The medical professional must notify the Chief Medical Officer when an abortion has been performed (section 10); A conscience clause has been included, meaning that medical professionals can conscientiously object to the abortion (section 12). (The suitability of this provision will be discussed in more detail later in the chapter.)

It is important to consider the seminal Supreme Court case of In the Matter of an Application by the Northern Ireland Human Rights Commission for Judicial Review (Northern Ireland) (NIHRC).10 This case paved the way towards the introduction of the 2019 Act.

Human rights and health: NIHRC Supreme Court case The introduction of the legislation in Westminster came as a response to the judgment of the Supreme Court in NIHRC.This case acted as a catalyst for change in the law.The nature of this book is to consider whether a universal right to health exists and to examine specific instances that relate to health and human rights in different jurisdictions.The judgment in NIHRC was one that relied heavily on the language and ethos of human rights, particularly the ECHR and CEDAW.The following is a brief synopsis of the case facts. In this case, the court considered sections 58 and 59 of the Offences Against the Person Act 1861, as well as section 25(1) of the Criminal Justice Act (NI) 1945, which made abortion illegal.The Northern Irish Human Rights Commission (NIHRC) challenged these provisions by relying on Articles 3 (prevention of torture, inhuman and degrading treatment), 8 (respect for private and family life), and 14 (protection from discrimination) ECHR, and it sought a declaration under section 4 (declaration of incompatibility) and section 6 (Acts of Public Authorities) of the Human Rights Act 1998 (HRA). Prior to reaching the Supreme Court, the High Court in NI had held that the NIHC had sufficient standing to bring the proceedings without an applicant. Horner J held that the law on abortion breached Article 8 ECHR because the 1861 Act made abortion a criminal act even in instances of fatal fetal abnormality, rape, and incest. He used section 4 HRA to make a declaration of incompatibility. However, when the case was appealed to the Court of Appeal in NI, it was held that sections 58 and 59 of the 1861 Act did not breach the ECHR.At the Supreme Court, it was decided by the majority that the NIHRC did not have standing to bring the case and, therefore, the Supreme Court could not issue a declaration of incompatibility. However, ultimately, the majority were of the opinion that the law in NI represented a breach of Article 8 ECHR due to its prohibition of abortion in the case of fatal fetal abnormality, pregnancy following rape, and pregnancy as a consequence of incest. They considered that the prohibition of abortion under the 1861 Act did not breach Article 3 ECHR. I will not consider the issue of standing in detail in this case. Instead, I will focus my analysis on the Supreme Court’s approach to the ECHR (particularly given the focus of this book on [global] health rights). Lady Hale made reference to the recent CEDAW report on the UK’s compliance or non-compliance with Article 8 of the Optional Protocol to CEDAW.11 Article 8

10 In the Matter of an Application by the Northern Ireland Human Rights Commission for Judicial Review (Northern Ireland) [2018] UKSC 27. 11 Lady Hale NIHRC (n 10) [9].

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of this Optional Protocol states that, if reliable information is received by the Committee on the Elimination of Discrimination against Women, which indicates ‘grave or systematic violations’ by a state signed up to CEDAW of Convention rights, an inquiry may be conducted by the committee and recommendations shall be made to the relevant state, based on the results of the findings.The report discussed the ‘chilling effect’ upon doctors, who fear discussing the option of abortion in case this might be seen as aiding, abetting, counselling, or procuring the unlawful act of abortion in NI.12 The committee found that, even though abortion was permitted in extremely limited situations, de facto limitations meant that abortion was ‘virtually impossible.’13 For example, the report highlighted the limitation of services from the point of view of geography, lack of clarity in relation to when abortion was permissible, and refusal of healthcare professionals to carry out abortions as a result of intimidation or conditions which were ‘hostile’ due to the potential for prosecution, inter alia.When considering whether there was a breach of Article 8 ECHR, the Supreme Court had to ask whether the law achieved a legitimate aim and if this aim was proportionate and necessary in a democratic society. The majority in the Supreme Court agreed that the law at the time represented a legitimate aim. For example, Lady Hale stated: the community undoubtedly does have a moral interest in protecting the life, health and welfare of the unborn – it is that interest which underlies many areas of the law, including the regulation of assisted reproduction, and of the practice of midwifery, as well as of the termination of pregnancy. But the community also has an interest in protecting the life, health and welfare of the pregnant woman – that interest also underlies the regulation of assisted reproduction, of midwifery and of the termination of pregnancy. And pregnant women are undoubtedly rights-holders under…both the Convention and domestic law with autonomy as well as health and welfare rights.The question, therefore, is how the balance is to be struck between the two. Also, the court pointed out that a right to life does not exist for the unborn child, as supported by the judgment of the European Court of Human Rights in Vo v France.14 Many would, however, say that Vo v France cannot simply be summarised by saying ‘Pre-birth: no Article 2,’ and they contend that this case leaves the door open for an argument that, with increasing gestation, there’s an incremental accrual of Article 2 rights. Interestingly, the majority in the NIHRC case discussed opinion polls that had been published in the media which indicated that most people in NI were in favour of a change in the law, particularly in relation to fatal fetal abnormality and pregnancy due to rape/incest. However, they said that the main issue in this case was not whether or not the aim was legitimate, but instead whether the breaches of women’s Article 8 rights could be necessary in a democratic society by correctly balancing the rights of the pregnant woman with the interests of the fetus. Specific attention was given to the court’s judgment in Nicklinson.15 This case involved consideration of the issue of assisted suicide and whether or not the law breached Article 8 ECHR.At the Supreme Court, the appeal was unsuccessful: the majority held that this was an issue for Parliament and that no breach of Article 8 existed due to the application of the wide margin of appreciation.To return to NIHRC, it was determined

12 13 14 15

CEDAW report (n 7) 5.Also see NIHRC (n 10), Lady Hale [9].Also see section 5, Criminal Law Act (NI) 1967. ibid 5. Vo v France (2004) 40 EHRR 12.Also see NIHRC (n 10), Lord Mance [94]. R (on the application of Nicklinson and another) v Ministry of Justice [2014] UKSC 38.

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there that one could not differentiate between Nicklinson and the present case because, even though the potential of a fetus must be respected, it is not legally a person. In the context of fatal fetal abnormality, rape, and incest, the majority held that the law was disproportionate and, therefore, breached Article 8.The court also held that there was no breach of Article 3 ECHR, a finding that was disputed by McMahon and Ní Ghráinne.16 The point to all of this is that the position on abortion adopted in NI at that time was seen to represent a breach of human rights and action was called for to ensure that NI was compliant with CEDAW. In NIHRC, the discussion of the incompatibility was obiter because of the fact that the court did not have standing.The majority held that the courts did not have jurisdiction to make a declaration of incompatibility. Even though the court did not have standing, it is clear that the court strongly endorsed the need to consider changing the law.According to Lord Mance: I am in short satisfied that the present legislative position in Northern Ireland is untenable and intrinsically disproportionate in excluding from any possibility of abortion pregnancies involving fatal foetal abnormality or due to rape or incest. My conclusions about the Commission’s lack of competence to bring these proceedings means that there is however no question of making any declaration of incompatibility. But the present law clearly needs radical reconsideration. Those responsible for ensuring the compatibility of Northern Ireland law with the Convention rights will no doubt recognise and take account of these conclusions, at as early a time as possible, by considering whether and how to amend the law, in the light of the ongoing suffering being caused by it as well as the likelihood that a victim of the existing law would have standing to pursue similar proceedings to reach similar conclusions and to obtain a declaration of incompatibility in relation to the 1861 Act.17 The intense criticism of NI practice meted out by the Supreme Court meant that immediate action was needed and was a legal requirement.This gave fuel to Members of Parliament and to human rights organisations to push for legislative change.

Development of the law on abortion in the Irish Republic It is also important to understand the context of the approach to abortion on the island. In the key case of Attorney General v X, a test was created for when an abortion could be procured, which was (many years) later set out in the Life During Pregnancy Act 2013.18 Under this legislation, an abortion could only be performed if the life and not the health is at risk.19

16 Ní Ghráinne and McMahon assess the Supreme Court’s decision in relation to its compliance with international law.They argue that the court was correct to find that the prohibition of abortion in the context of rape, incest, and fatal fetal abnormality was a breach of Article 8 ECHR, but they are of the opinion that the court should have held that there was a breach of Article 3 of the European Convention (in relation to the ban on abortion in the case of rape or incest, but not fatal fetal abnormality). They also contend that insufficient attention was given to international law. For example, they claim that the Supreme Court erred in not considering UN Human Rights Committee’s views. See Bríd Ní Ghráinne and Aisling McMahon,‘Abortion in Northern Ireland and the European Conventions on Human Rights: Reflections from the UK Supreme Court’ (2019) 68(2) International and Comparative Law Quarterly 477–94. 17 Lord Mance NIHRC (n 10) [135]. 18 Attorney General v X [1992] 1 IR 1; PP v HSE [2014] IEHC 622.Also see A, B and C v Ireland [2011] 53 EHRR 13, which provided the impetus for the introduction of the 2013 Act. 19 See De Londras and Enright (n 3) 4.

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Thus, prior to the repealing of the 8th Amendment, it was a crime to have an abortion unless it was permitted by the test under the 2013 Act, i.e. where there was a ‘real and substantial risk’ to the life of the woman and where this risk could only be avoided by the facilitation of an abortion.20 As we know, however, the law on abortion is now regulated by the Health (Regulation of Termination of Pregnancy) Act 2018 and the 2013 Act has been repealed. According to section 9 of the 2018 Act, an abortion may be undertaken where two medical professionals (an obstetrician and an ‘appropriate medical practitioner’) are ‘of the reasonable opinion formed in good faith’ that (a) a risk to life or serious harm to the pregnant woman, (b) ‘the foetus has not reached viability,’ and (c) it is appropriate to carry out the abortion in order to prevent the risk to the life or health of the pregnant woman. Section 12(1) states that an abortion may be undertaken where the healthcare professional is of the reasonable opinion that the woman has not been pregnant for more than 12 weeks. A three days’ waiting period must exist before a termination is permitted. The legislation, however, has been criticised by many Repeal campaigners who argue that the new law falls short of the demand for ‘free, safe, legal’ abortion in Ireland.21 How did the abortion legislation in the Irish Republic come to being in face of many differing perspectives, and how were the dissenting voices listened to and arbitrated upon? A central vehicle in the pre-referendum deliberative process was the use of a Citizens’Assembly, which was made up of representatives from a wide cohort of Irish society.The Assembly was established in 2016 to consider the position of abortion from a constitutional perspective. Over a period of 18 months divisive, discursive, and collaborative discussions took place and responses from various stakeholders were tabulated and considered prior to providing recommendations.The work of the Assembly was broadly welcomed. It was seen as being an important step on the pathway towards social and, ultimately, constitutional change.This description of the context of reform in the Irish Republic situates the analysis of the Northern Irish reform within this context of changing perspectives and developments on the island. It highlights the benefits attached to undertaking a consultative forum that was based upon a discursive process that encompassed the voices of many factions of Irish society.The discussion will now focus specifically on NI where this type of forum did not happen in advance of change in the law.

Consultation process in NI A consultation on the framework for abortion services in NI was set up in November 2019.22 This involved consultation with the Royal Colleges in NI and other relevant parties. The closing date for responses was 16 December 2019. The purpose of the consultation was to allow members of the public to share their opinions on the proposed changes in the law pertaining to abortion services. Over 21,000 people responded to the consultation, which lasted six weeks. Feedback has now been reviewed. Consideration was to be given to the

20 ibid 6. 21 Máiréad Enright, ‘“The Enemy of the Good”: Reflections on Ireland’s New Abortion Legislation’ (2018) 8 (2) feminists@law https://journals.kent.ac.uk/index.php/feministsatlaw/article/view/658/1333 accessed 30 March 2020. 22 HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal Duty under section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 UK (4 November 2019) www.gov .uk/government/consultations/a-new-legal-framework-for-abortion-services-in-northern-ireland accessed 31 March 2020.

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views and values of citizens but, ultimately, it was concluded that the Abortion (Northern Ireland) Regulations 2020 would need to be consistent with section 9 of the 2019 Act and paragraphs 85 and 86 of the CEDAW report.The Minister of State to the Northern Ireland Office, Robin Walker, has stated: In considering the consultation responses, we have sought to balance the range of views against our legal obligations, and taken pragmatic decisions informed by evidence, in order to bring forward a new legislative framework that will be operationally sound, that works best for Northern Ireland and that delivers on the Government’s duty.23 The consultation document was set out in a modular fashion in order to allow for a focused response. The answers were assessed from both quantitative and qualitative analytical lens. The government contends that the yes/no responses were qualitatively analysed and that the specific responses were considered from a quantitative perspective. The government stated that key opinions that emerged were noted via a series of ‘tags’ corresponding to major themes set out in the consultation and emerging issues arising from stakeholder engagement.This methodology helped to draw out useful themes emerging from the consultation and the reasons behind each of them.24 Interestingly, 79% of the submissions opposed any change of the law in NI.25 Nevertheless, the government cited the need to comply with its legal obligations under section 9 of the 2019 Act in a manner that complies with the CEDAW report.Thus, it is clear that the new abortion framework, although legally necessary, following the 2019 Act, flies in face of a very significant sector of NI’s population. The 2020 Regulations represent an enormous sea change in the law pertaining to abortion and women’s health rights. But this is not the end of the story.A key question emerges: to what degree do or should these Regulations support and defend the right to conscientiously object to participation in abortion provision?

Can I say no? Conscientious objection to abortion Conscientious objection involves a healthcare professional abstaining from particular medical procedures as a consequence of acting in accordance with belief. In medical terms, conscientious objection is mainly used in the context of abortion.Acting in accordance with conscience can be interpreted in different ways: from those who believe that conscience is acting in accordance with duty, to those who refuse to believe that conscience exists. For those with religious beliefs, however, even greater gravitas is brought to the question.There is no one defined

23 HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal Duty under Section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 UK Government Consultation Response (March 2020) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/ file/875380/FINAL_Government_response_-_Northern_Ireland_abortion_framework.pdf accessed 31 March 2020. 24 ibid 8. 25 ibid 9.

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Christian perspective but, interestingly, most Christian religious see conscience as being in some way related to an individual response to an individual situation. Even the most rigid of Catholic dogma allows for action in accordance with conscience where the development of conscience is related to the formation of an informed judgement.26 All sorts of ‘moral good’ can come from the exercise of conscience. We can think about what we do and do not with an incisive and, maybe, insightful eye. We can subject our actions to a process of personal moral discernment. Conscience can provide an extra tool to gauge whether action is good or not. Let us see how conscience works for a practising Catholic. Prior to going to confession, Catholics are asked to review their conscience, to personally interrogate the self.Thus, the sacrament of confession is a dual process between priest and penitent. In effect, the penitent needs, through the interrogation of conscience, to identify his own sins.The same is true of the Catholic who prepares to receive Communion. She examines her conscience to determine, if, by her actions and thoughts, she is worthy. At a religious level, in Catholicism, the exercise of conscience is part and parcel of faith formation and faith development. But conscience has limits. If conscience goes amiss, then a terrible state could be borne: killing could be justified on the basis of conscience, torture and inhumane treatment could be put into play because some form of conscience permitted it. So, conscience needs to have limits. Catholicism has provided its own limits in the form of ‘the holy will of God.’ If conscience gives rise to will (potential action), then what is willed by the person within Catholicism is always going to be trumped by the holy will of God.Thus, we act in accordance with conscience, in line with our will, but, also according to traditional Catholic values. In general, from an overall Christian perspective, we must infer that the person who conscientiously objects has consciously questioned and queried the matter to which he/she is objecting. This means that the exercise of conscience is not a frivolous, light-hearted exercise, but is one which commits people to a serious interrogation of the act to which they are objecting and deep examination of the legal or moral arguments around that. Those who are drafting legislation in relation to conscientious objection will need to consider that, for some who hold deeply felt religious beliefs, any participation in abortion, direct or indirect, will infringe upon their conscience. In 2019, a special edition of The New Bioethics, edited by Mary Neal, Sara Fovargue, and Stephen W Smith, focused on conscience in healthcare. Neal and Fovargue ask a pertinent question: ‘is conscientious objection incompatible with healthcare professionalism?’27 They refer to the minority of writers who agree that this is the case but, ultimately, Neal and Fovargue argue in favour of conscientious objection. They critique the claim that conscientious objection is ‘fundamentally incompatible’ with proper healthcare professionalism because the attitude of the conscientious objector exists in opposition to the disposition (attitudes and underlying character) that we should expect from a ‘good’ healthcare professional and conclude that this is not the case.This, then, is the ethical dilemma and paradox that applies to conscientious objection: if, as a healthcare professional, I am to be true to my conscience then I cannot participate in abortion.This is my right under Article 9 ECHR.Alternatively, if, as a healthcare professional, I am to be true to the wishes of my patient then I cannot deprive her of the healthcare that she requests and that is her right and entitlement under CEDAW. Balancing these two rights in a jurisdiction where religious belief is often at the cornerstone of political and legislative action

26 See Ó Néill, Religion, Medicine and the Law (n 2). 27 Mary Neal and Sara Fovargue, ‘Is Conscientious Objection Incompatible with Healthcare Professionalism?’ (2019) 3 The New Bioethics 221–35.

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will be a challenge.The right to conscientiously object is not, of course, confined to the medical arena. Indeed, Oderberg has demonstrated how medical conscience, from a matter of principle, is no different to other types of conscience, but from a practical viewpoint, it continues to be a pivotal driver in the conscientious objection debate.28 Savulescu’s seminal opposition to the right to conscientiously object bears consideration. He recognises that deeply held religious beliefs can conflict, at times, with medical practice. He argues that healthcare professionals cannot ‘make moral judgments on behalf of patients’29 and makes reference to Shakespeare who said that ‘[c]onscience is but a word cowards use, devised at first to keep the strong in awe’ (Richard III V.iv.1.7).30 Savulescu contends that ‘[i]f people are not prepared to offer legally permitted, efficient, and beneficial care to a patient because it conflicts with their values, they should not be doctors.’31 He further argues that conscientious objection prioritises religious values over secular values and so ‘discriminates unfairly against the secular.’32 He suggests that the protection of patients’ health is the main goal of healthcare and outlines a number of constraints necessary to ensure that healthcare is legal, equitable, and efficiently delivered.These constraints include the fact that patients are entitled to be aware of a full range of available treatments, conscientious objectors must ensure that they do not compromise the patient’s access to care, and a doctor who compromises the delivery of medical services to patients due to their conscientious objection must be punished by removing their medical licence.33 Savulescu contends: Values are important parts of our lives. But values and conscience have different roles in public and private life. They should influence discussion on what kind of health system to deliver. But they should not influence the care an individual doctor offers to his or her patient.The door to ‘value-driven medicine’ is a door to a Pandora’s box of idiosyncratic, bigoted, discriminatory medicine. Public servants must act in the public interest, not their own.34 Savulescu hits an awkward and ethically challenging nerve, which has been explored previously by me in Religion, Medicine and the Law.The nerve that is sensitised is the moral dilemma that exists when there is a need to balance the rights of the conscientious objector with the rights of the patient. The only remedy that I see is to suggest that neither right can be negated and the force of law must walk an ethically challenging tightrope where both rights are balanced, precariously or otherwise.While Savulescu is correct in naming the ethical dilemma, recognising the rights of a conscientious objector does not constitute the opening of a Pandora’s box to discriminatory medicine. In fact, the opposite would be true were such rights to be annulled. The box that is opened when rights are balanced resembles more an Iliad-like journey that needs to be taken by all the travellers on the quest for righteousness in this cause. But conscience is not a silent walker!

28 29 30 31 32 33 34

David S Oderberg,‘How Special Is Medical Conscience?’ (2019) 3 The New Bioethics 207–20. Julian Savulescu,‘Conscientious Objection in Medicine’ (2006) 332 BMJ 294–97. ibid 294. ibid 294. ibid 295. ibid. ibid 297.

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Let us now revert to the less abstract arena where this moral question where an attempt is made to resolve this conundrum in a practical way. The UK government’s recent report, the 2020 framework for abortion in NI, stated that this framework will mirror the same statutory protection as under the Abortion Act 1967, meaning no person shall be under any duty, whether by contract or by any statutory or other legal requirement, to participate in any treatment authorised by the Regulations to which the person has a conscientious objection.The only exception will be where the participation in treatment is necessary to save the life or to prevent grave permanent injury to the physical or mental health of a pregnant woman or girl.35 The UK government notes in its response to the consultation process that the majority of people endorsed the provision of a conscience clause.36 The government cites the fact that a large number of organisations wanted the conscience clause to be consistent with GB and that this approach would ‘strike a reasonable balance between allowing health professionals who do not wish to provide these services to opt out, whilst still enabling proper service provision and patient care.’ Proponents of this approach, for the most part, argued that the new law should be supported by professional guidance and that the conscience clause should not cause any adverse impact to the women seeking an abortion.37 The government notes that some respondents felt that they would not want conscientious objection to be extended to include administrative or managerial staff. It also contends that some respondents disagreed with the implementation of a narrow approach to conscientious objection and that a wide approach would be consistent with Article 9 ECHR. The government refers to the fact that [a] few respondents also voiced concern that healthcare workers with a conscientious objection could face being discriminated against in the workplace without stronger protections, with some respondents particularly concerned that this could potentially leave some employees leaving their job, and that adequate protections and support should also be in place for these employees.38 Ultimately, the UK government has concluded that the same approach to section 4 of the Abortion Act 1967 would be taken in NI, meaning no person shall be under any duty, whether by contract or by any statutory or other legal requirement, to participate in any treatment authorised by the Regulations to which the person has a conscientious objection.The only exception will be where the participation in treatment is necessary to save the life or to prevent grave permanent injury to the physical or mental health of a pregnant woman or girl.39

35 ibid 11. 36 HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal Duty under Section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 UK Government Consultation Response (March 2020) (n 23) 33. 37 ibid 32. 38 ibid 33. 39 ibid 33.

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They say that anyone can opt out of participation in treatment of abortion services to which they have a conscientious objection, but that this protection does not extend to the ancillary, administrative and managerial tasks that might be associated with that treatment.40 The government claims that the conscientious objection must be restricted to the narrow interpretation endorsed by the Supreme Court in Greater Glasgow Health Board v Doogan and Others (Doogan).41 The precursor to Doogan was Janaway v Salford Health Authority (Janaway), which dealt with a secretary who was assigned administrative duties, including referral letters for abortion, that she felt interfered with the exercise of her conscience. At the House of Lords, it was held that this was not the case because section 4 of the Abortion Act 1967 only covered those who have a direct participation in the abortion and could not be extended to those with administrative roles.42 Broadly, speaking, this finding was reiterated in Doogan. Midwives took a case where they argued that the new rostering and administrative duties imposed upon them, due to the fact that abortion services were offered in the units in which they worked, were an infringement of section 4 of the 1967 Act.The Supreme Court stated that the ancillary roles of midwives were insufficiently direct or hands-on, and that application of the ordinary meaning of ‘participate’ meant that section 4 could not be extended to include them. Much of the debate around Doogan and the exercise of conscience has centred on the narrow definition of ‘participate.’ If a broader definition of ‘participate’ were accepted, it is, however, probable that an infringement of the right to exercise conscientious objection would have existed. The UK government also argues that, if the conscience clause were widened, it would have practical implications and undermine the provision of abortion in NI. It argued that if a wide interpretation were in place, ‘fewer people providing ancillary services in relation to abortion could result in fewer appointments and longer waiting times, creating de facto barriers to access, and almost certainly adversely impacting the quality of care and standard of services.’The UK government says that the approach in section 4 of the 1967 Act in GB is ‘human rights compliant,’ ‘works satisfactorily in practice,’ and ‘is therefore appropriate to apply in Northern Ireland to the provision of abortion services.’43 Let us return to the actual questionnaire.Two questions relating to conscientious objection were included in the survey that was conducted as a primary vehicle to gauge public opinion about the new legislation.44 This action served to gauge public opinion and to ensure that the legislation, while complying with CEDAW, reflected as closely as possible a breadth of community voice.A number of questions should now, I believe, be asked:Was the consultative approach engaged in following the 2019 Act a suitable vehicle to engage with the question of conscien-

40 ibid 33. 41 Greater Glasgow Health Board v Doogan [2014] UKSC 68. I have analysed the Doogan judgment in the following case review: Clayton Ó Néill,‘Conscientious Objection in Greater Glasgow Health Board v Doogan [2014] UKSC 68’ (2015) 15(4), Medical Law International 246–54. 42 See Ó Néill, Religion, Medicine and the Law (n 2) 181. 43 HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal duty under Section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 UK Government Consultation Response (March 2020) (n 23) 33. 44 HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal Duty under Section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 (n 22).

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tious objection from a human rights perspective? If not, what sort of consultative approach would have been better? While this consultative process in the North does allow for voices to be heard on different sides of this contentious debate, there remain problems with this approach. The starting point for this was one that was thrust upon participants because of the fact that Stormont was not operating and that this legislation was imposed upon the jurisdiction of NI, without support from many of its public representatives. A perception of forcing the hand was shared amongst people of all political beliefs. In theory, a better starting point for this action would have been the conducting of a Citizens’Assembly, as in the Irish Republic, prior to deciding upon a change in the law. However, it must also be stated that it is possible that, given the divisive and sometimes corrosive nature of aspects of Northern Irish political life, such an Assembly might not have ever worked and the whole idea of legislative change could have hijacked by the Orange/Green political divide, much as happened to the COVID-19 debate pertaining to school closure at an early point in the pandemic.45 It is not sufficient to just conduct surveys and analyse answers to questionnaires. This does not give voice to those who agitate for the rights of women and, equally, for those whose concern is for the unborn. Neither, in my view, was given an equitable chance in this consultation process to give this issue the solemnity and seriousness that it deserves. The timeframe for response to the survey was far too limited. Roughly one month was given for citizens to respond.This period contrasts with the allocated 18-month period, which had been extended from one year, in the Republic, as part of the Citizens’ Assembly. This leads to the conclusion that the survey approach used was problematic and should have been broadened to include an open forum consultative process. The questions posed pertaining to conscientious objection in this survey were as follows: Question 11: Do you agree that the proposed conscientious objection provision should reflect practice in the rest of the United Kingdom, covering participation in the whole course of treatment for the abortion, but not associated ancillary, administrative or managerial tasks? This broadly asks whether NI should adopt practice vindicated in the Doogan judgment of allowing for the narrow interpretation of participation in abortion. Question 12: Do you think any further protections or clarification regarding conscientious objection is required in the regulations? In order to illustrate the difficulties involved in achieving consensus about conscientious objection, the answers to questions 11 and 12 from two ideologically diverging organisations are now considered, i.e. Catholic Bishops of NI and Amnesty International. Not surprisingly, the Catholic Bishops of NI were very unhappy about the change in the law and regard it as an ‘unjust law.’They argued that ‘[a]s a consequence, no one is obliged in conscience to cooperate with any action permitted by this law which directly and intentionally leads to the killing of an unborn child. Indeed, everyone is morally obliged to oppose this law by conscientious objec-

45 See, for example, Michael McHugh, ‘Michelle O’Neill Calls for Northern Ireland Schools to Close Over Coronavirus’ (Belfast Telegraph, 13 March 2020) www.belfasttelegraph.co.uk/news/northern-ireland/michelle -oneill-calls-for-northern-ireland-schools-to-close-over-coronavirus-39042109.html accessed 31 March 2020.

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tion.’ The Catholic Bishops placed a strong focus on the concept of conscientious objection and argued that all healthcare professionals (including pharmacists) and ancillary staff should have the ‘right to refuse to participate’ in anything to do with abortion procedures.This position is wider than the approach taken to conscientious objection by the UK Supreme Court in Doogan.The Catholic Bishops recognise the narrow definition accepted in Doogan, but state that this applied to the Abortion Act 1967 and falls outside the context of NI.They said that a conscientious objection clause should be much wider and should reflect the stronger views in NI.They claimed that this would comply with Article 9 ECHR – freedom of religion, thought, and conscience.The Catholic Bishops also argued that [r]eferral to another health professional who does not have a conscientious objection to abortion services, is not an option for a health provider who is a Christian, since in those circumstances, he or she would still be co-operating in the process to access abortion services. Therefore, the New Regulatory Framework needs to make provision for an alternative referral procedure when health professionals with a conscientious objection to abortion find themselves in a situation where the woman has decided that she wants access to abortion services.46 This approach vindicates fully the right of the medical professional to consciously object to abortion. It calls for a widening of the application of ‘participate’ beyond the scope of Doogan and, indeed, this will be shown later in this chapter to be a valid call. However, the lack of commitment by the Catholic Bishops to referral services goes too far. It is a wholly impractical stance and includes a complete failing in the duty to refer. Amnesty International has provided diverging answers to questions 11 and 12, as posed in the consultation.47 When asked if NI should follow the approach taken in England, Scotland, and Wales, which would involve a very narrow definition of participation (thus, excluding ancillary/administrative staff from conscientious objection), Amnesty International argued that if there is a conscience clause, that it should follow the narrow definition provided for in Doogan. Ultimately, Amnesty International is not very pro-conscientious objection and claims that the term ‘conscience-based refusal to provide care’ ought to be used instead.Amnesty International refers to CEDAW, General Recommendation No 24 (Article 12 of the Convention (Women and Health), para 11): Measures to eliminate discrimination against women are considered to be inappropriate if a health-care system lacks services to prevent, detect and treat illnesses specific to women. It is discriminatory for a State party to refuse to provide legally for the performance of certain reproductive health services for women. For instance, if health service providers refuse to perform such services based on conscientious objection, measures should be introduced to ensure that women are referred to alternative health providers.

46 Response to the Consultation on ‘A New Legal Framework for Abortion Services in Northern Ireland’ from the Catholic Bishops of Northern Ireland (17 December 2019) www.catholicbishops.ie/2019/12/17/response-to-the-consultati on-on-a-new-legal-framework-for-abortion-services-in-northern-ireland-from-the-catholic-bishops-of-northe rn-ireland/ accessed 30 March 2020. 47 Amnesty International, Response to Northern Ireland Office: A New Legal Framework for Abortion Services in Northern Ireland (December 2019) www.amnesty.org.uk/files/Amnesty%20International%20Response%20to%20NIO %20Dec%202019.pdf accessed 30 March 2019.

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While Amnesty International’s response supports the autonomous rights of women in accordance with human rights, it fails to grasp the central importance of conscientious objection as a human right. Acting in accordance with conscience manifests an intrinsic belief that is integral to personhood and self, and cannot be negated in the simplistic fashion that is proposed here. These two sets of responses to the same questions serve to illustrate the points of view that might be found on each extreme of this perspective.There will be many healthcare professionals who have no objection to being directly or indirectly involved in the provision of abortion services in NI. They will hold fast to their view that a woman has a right to make decisions for herself about herself.There are other healthcare professionals, however, who, often because of their religious belief, do not wish to participate in the provision of abortion.The Abortion Act 1967 allows such people who have a direct role in abortion provision to conscientiously object in GB, as long as they fulfil referral procedures.The Doogan judgment did not allow for the extension of conscientious objection to indirect provision. In light of the societal context of NI, I suggest that a broader interpretation of ‘participate’ should have been adopted in the Abortion (Northern Ireland) Regulations 2020, along the lines of that requested, but refused, in the Doogan case.This would have allowed for those with both direct and indirect roles in the provision of abortion services to conscientiously object and for that conscientious objection to be upheld. The right to conscientiously object would, however, need to be supplemented by an obligation to refer to a suitably qualified practitioner. This duality of approach would have ensured that two rights are protected. There is no compulsion upon the legislature in NI to follow Doogan because Doogan related to section 4 of the Abortion Act, which does not apply in NI. At a practical level, there is, thus, no need to hold by the precepts of Doogan. On a principled level, there is a need to ensure that the scope of conscientious objection is widened: those who have a direct or indirect connection to abortion provision should be allowed to exercise their conscience if their right to freedom, conscience and religion, as protected under Article 9 ECHR, is infringed. As I have previously argued, the use of Article 9 in Doogan was insufficiently applied but should now be at the cornerstone of the new legislation. Article 9(1) ECHR is a right that quite obviously includes the right to manifest religion or belief in ‘practice and observance.’The freedom to act in accordance with religious belief in healthcare practice and in the ‘observance’ of healthcare procedures is given visible protection here, and the right to conscientiously object to participation, even at a remover, in abortion is surely protected here.This protection is, however, qualified by the limitations that apply to Article 9(2), namely that the manifestation of religious belief ‘shall be subject only to such limitations as are prescribed by law and are necessary in a democratic society, in the interests of public safety, for the protection of public order, health or morals, or for the protections of the rights and freedoms of others.’This limitation leads to the conclusion that a duty to refer should also apply in this legislation.This provision would balance the right of the medical practitioner to conscientiously object with the equally grave obligation to act for the patient. This duty to refer counters any argument that conscientious objection is limited by Article 9(2). Even if an argument were articulated that conscientious objection involves an infringement of the rights and freedoms of others, that position is counterbalanced by the pragmatism associated with the duty to refer.The same argument applies to those who contest that the duty of a doctor to a patient trumps any conscientious objection.This argument also negates the importance of conscientious objection as a freedom within society that is valued and valuable as a constant that affirms the right of a human being to act in accordance with an informed conscience. Surely, this right should be one that is not confined to those who participate in an abortion from a

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narrow perspective.The arguments in favour of conscientious objection in Janaway48 were lost, as was the case in Doogan. The legislative context should not be an impediment to the decisionmaking process but should support the duality of rights – those of the conscientious objector and those of the patient. Of course, there will always be that allegation that ‘conscience does make cowards of us all’ and that acting in accordance with conscience means deviating from duty to the patient.49 But there is also the parallel argument that if we cannot in accordance with our conscience, then we cannot act at all. Using Doogan as a vindication of supporting the narrow interpretation of participation in abortion is actually incorrect. It is important to state here quite categorically that the Doogan judgment focused on the interpretation of ‘participate’ within section 4 of the Abortion Act 1967. That was the only scope envisaged within this judgment. The 1967 Act does not apply to NI and, therefore, the findings of Doogan are, equally, inapplicable, except by indirect extension. Deciding who should be allowed to act in accordance with their conscience should, thus, not be aligned be with this judgment, but should be aligned to other legal and societal realities that pertain to the jurisdiction of NI. Given that 79% of the population who responded to the consultation were opposed any change in the law, it is likely that many of the staff who are not involved directly with abortion provision, but will have an indirect connection to it would likely want to conscientiously object.The UK government looked for consistency between the approach to conscientious objection between NI and GB. However, the NI jurisdiction is not the same as that of GB in many practical and historical ways, and many of its practices differ.The fact that very many people in NI attest to having a religious belief that is explicitly anti-abortion in its reasoning is one factor of difference between NI and GB, and it is not unreasonable to expect that religious belief should be given some additional weight in determining who can conscientiously object. There is a discernible gap between the opinions voiced by very many respondents in the consultative process and the Abortion (Northern Ireland) Regulations 2020 that have come into being.This relates, in particular, to the issue of conscientious objection. It is not clear the degree to which the weight of opinions in the consultation surveys was considered. What appears to be more likely is that the government acted in accordance with CEDAW, but manifestly gave insufficient consideration to the fact that NI’s citizens would value a broader interpretation of participation in abortion than was decided upon and implemented in the Regulations. The fact that the government might have done so because of a desire to comply with the Supreme Court’s findings in a case that was not directly relevant in this jurisdiction is regrettable. This may have been the simpler option for the UK government, but it does negate the desire of many healthcare professionals to extend the conscience clause beyond a very limited few.

Conclusion It is timely now to summarise the main points of this chapter.We are now at a crossroads in NI. A new Act of Parliament, the Northern Ireland (Executive Formation) Act 2019, was instigated

48 Janaway v Salford Health Authority [1989] AC 537. This was a precursor House of Lords case to Doogan (n 41), where ‘participate’ in abortion in Section 4 of the Abortion Act 1967 was given a narrow interpretation, where participation was confined to those who had a hands-on role in the abortion.This, therefore, excluded a secretary who refused to write a referral letter as she claimed that it adversely interfered with her conscience. 49 William Shakespeare, edited by Roma Gill, Hamlet (1601) Act 3, Scene 1 (Oxford University Press 1992) 68.

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by the British government in the absence of a functioning Executive in NI. In order to comply with the CEDAW report, the provisions of the 2019 Act and the resulting future Northern Irish legislation significantly widen the scope of abortion services in NI.The decision, made in Westminster, to change the law on abortion found support amongst some. However, broadly speaking, it was introduced against the wishes of many members of Northern Irish political parties and the societies represented by them. Some of those working in healthcare settings might now have to become involved in practical managerial tasks and administrative roles connected to abortion provision that could impinge upon their religious beliefs, which inform their conscience. This chapter looked specifically at the issue of conscientious objection and provided guidance for the drafters of legislation as to how provisions to support the exercise of conscience could be included in the forthcoming legislation in a manner that is compliant with human rights norms and laws. The research drew upon the recent experience of the Irish Republic in terms of the repeal of the 8th Amendment of the Constitution. It criticises the surveybased consultative forum that was adopted by the Secretary of State for NI as the primary basis of engaging with society, with a view to finding commonalities of perspective in relation to this issue. I argue that the approach taken to the exercise of conscience in UK Supreme Court in Doogan is inappropriate in NI because the issue adjudicated on in this case related to the Abortion Act 1967, which does not apply in NI. Using the narrow version of participation in relation to conscientious objection is, equally, inappropriate given the deeply held religious belief of a large sector of the population. Section 12 of the Abortion (Northern Ireland) Regulations 2020 has, as a consequence, the potential to constitute a derogation of freedom of religion, thought, and conscience. While this chapter has dealt with the issue of conscientious objection as it applies primarily in the island of Ireland, it is, nonetheless, a question that has application and implication in the global contexts where this right is questioned, derided, accepted, and applied according to the strength of political, legal, and medical support that is given to this right, and the force of religious beliefs or comprehensive values that underpin or do not underpin governance.The fact that conscientious objection may not be seen in some jurisdictions to have primacy of importance does not mean that this right is valueless. Surely, if a right to health is something that is prized and to be supported, then what must also be supported is the individual right to object to medical provision that flies in the face of individual conscience. If the right of the individual is denied, then there is a dilution of the concept of a right to health and that dilution would, itself, become a Pandora’s box where the accoutrements of the box would comprise of derogation of a right, lack of respect for the views and values of healthcare professionals and staff, and the consequent ultimate compromising of justice itself.

References Amnesty International, Response to Northern Ireland Office: A New Legal Framework for Abortion Services in Northern Ireland (December 2019) www.amnesty.org.uk/files/Amnesty%20International%20Resp onse%20to%20NIO%20Dec%202019.pdf accessed 30 March 2019. de Londras, Fiona and Enright, Máiréad, Repealing the 8th (Policy Press 2018). Enright, Máiréad,‘“The Enemy of the Good”: Reflections on Ireland’s New Abortion Legislation’ (2018) 8(2) feminists@law https://journals.kent.ac.uk/index.php/feministsatlaw/article/view/658/1333 accessed 30 March 2020. HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal Duty under Section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 UK (4 November 2019) www.gov.uk/government/consultations/a-new-legal-framework-for-abortion-services-in-northern -ireland accessed 31 March 2020.

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Abortion and conscience HM Government, A New Legal Framework for Abortion Services in Northern Ireland: Implementation of the Legal Duty under Section 9 of the Northern Ireland (Executive Formation etc.) Act 2019 UK Government Consultation Response (March 2020) https://assets.publishing.service.gov.uk/government/uploads/syste m/uploads/attachment_data/file/875380/FINAL_Government_response_-_Northern_Ireland_ab ortion_framework.pdf accessed 31 March 2020. McHugh, Michael, ‘Michelle O’Neill Calls for Northern Ireland Schools to Close Over Coronavirus’ (Belfast Telegraph, 13 March 2020) www.belfasttelegraph.co.uk/news/northern-ireland/michelle-on eill-calls-for-northern-ireland-schools-to-close-over-coronavirus-39042109.html accessed 31 March 2020. Neal, Mary and Fovargue, Sara,‘Is Conscientious Objection Incompatible with Healthcare Professionalism?’ (2019) 3 The New Bioethics 221–35. Ní Ghráinne, Bríd and McMahon,Aisling,‘Abortion in Northern Ireland and the European Conventions on Human Rights: Reflections from the UK Supreme Court’ (2019) 68(2) International and Comparative Law Quarterly 477–94. Ó Néill, Clayton, ‘Conscientious Objection in Greater Glasgow Health Board v Doogan [2014] UKSC 68’ (2015) 15(4), Medical Law International 246–54. Ó Néill, Clayton, Religion, Medicine and the Law (Routledge 2018). Oderberg, David S,‘How Special Is Medical Conscience?’ (2019) 3 The New Bioethics 207–20. Committee on the Elimination of All Forms of Discrimination Against Women, Report of the Inquiry Concerning the United Kingdom of Great Britain and Northern Ireland under Article 8 of the Optional Protocol to the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW/C/OP.8/ GBR/1) published on 6 March 2018 https://tbinternet.ohchr.org/Treaties/CEDAW/Shared%20Do cuments/GBR/INT_CEDAW_ITB_GBR_8637_E.pdf accessed 01 April 2020. Response to the Consultation on ‘A New Legal Framework for Abortion Services in Northern Ireland’ from the Catholic Bishops of Northern Ireland (17 December 2019) www.catholicbishops.ie/2019/12/17/response -to-the-consultation-on-a-new-legal-framework-for-abortion-services-in-northern-ireland-from-the -catholic-bishops-of-northern-ireland/ accessed 30 March 2020. Savulescu, Julian,‘Conscientious Objection in Medicine’ (2006) 332 BMJ 294–97. Shakespeare, William, Hamlet (1601) Act 3, Scene 1 (Oxford University Press 1992, edited by Roma Gill). Todd, Jennifer, Identity, Change after Conflict: Ethnicity, Boundaries and Belonging in the Two Irelands (Palgrave Macmillan 2018).

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8 THE STANDARD OF CARE AND IMPLICATIONS FOR PAEDIATRIC DECISION-MAKING The Swedish viewpoint Santa Slokenberga

Why the standard of care and paediatric decisionmaking is a right-to-health concern One of the fundamental elements of the right to the highest attainable standard of health (right to health) is healthcare that meets the availability, accessibility, and acceptability standard and is of appropriate quality.1 However, whether and how this standard can be met greatly depends on a number of circumstances that stretch well beyond the traditional resource dimension which accepts the gradual realisation of the right.2 It is based first and foremost on the question of what is the medical care that is scientifically possible and legally permissible to be made available to specific patient groups and individual patients in need. Children are often described as a vulnerable and diverse population group which requires particular protection under the United Nations Convention on the Rights of the Child (CRC).3 Regarding health, Article 24 of the CRC requires that ‘the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health’ shall

1 See, for example, UN Committee on Economic, Social and Cultural Rights (CESCR), General Comment No 14: The Right to the Highest Attainable Standard of Health (Art 12 of the Covenant), 11 August 2000, E/C.12/2000/4, at paras 12, 19, 35; UN Committee on the Rights of the Child, General Comment No 15: On the Right of the Child to the Enjoyment of the Highest Attainable Standard of Health (Art 24), 2013, CRC/C/GC/15, at para 116. 2 See Article 2 ICESCR and CESCR, General Comment No 3:The Nature of States Parties’ Obligations (Art 2, para 1, of the Covenant), 14 Dec 1990. See also UN Committee on Economic, Social and Cultural Rights, General Comment No 14: The Right to the Highest Attainable Standard of Health (Art 12 of the Covenant), 11 August 2000, E/C.12/2000/4, at para 30. 3 See Article 1 of the Convention on the Rights of the Child (adopted 20 November 1989, entered into force 2 September 1990) 1577 UNTS 3. However, as argued by Herring using the universal vulnerability theory, children are not the only vulnerable group in cases of complex medical decision-making. Jonathan Herring,‘Vulnerability and Medical Decisions Concerning Children’ in Imogen Goold, Jonathan Herring and Cressida Auckland (eds), Parental Rights, Best Interests and Significant Harms: Medical Decision-Making on Behalf of Children Post-Great Ormond Street Hospital v Gard (Hart Publishing 2019) 191–206.

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be recognised for children. Despite this call for recognition, which from the international law perspective is a treaty obligation on the CRC’s parties, children as a class across the globe often lack scientifically appropriate medical care. Consequently, they risk being exposed to risky interventions, such as those related to off-label medicinal products.4 That applies to interventions that range from intensive care unit treatments to outpatient care and is a problem that many, if not all, countries around the world face.5 A central challenge to such medical care that has not been adequately scientifically tested and recognised as appropriate for a paediatric patient group relates to decision-making. First, it relates to decisions that lie with medical professionals who are in a position to make clinical decisions about a particular case with due regard to the applicable standards that steer professional decision-making. Second, it relates to decisions about a child who is in need of medical care and whose integrity thereby is at stake. Generally, many groups of children do not have the capacity to decide what is in their best interests and make legally binding decisions about their own medical care. Moreover, they might have highly limited capacity to form views and express them, due to their young age or medical condition, thereby making themselves adequately heard.6 From both the medical as well as legal perspective, arguably, the most vulnerable in this regard are critically ill infants.7 Parents as primary carers have a duty to care for a child and make decisions regarding a child’s medical care, subject to some public control to ensure that the child’s rights are safeguarded.8 At the same time, others also involved in the care shall ensure that ‘best interests’ are followed. However, what is in the best interests of such children, in particular, seriously ill children, is not easy to answer. Not only is the notion of best interests difficult to settle upon in each case, but its susceptibility to interpretation creates considerable room for conflicts to emerge.9 While there are straightforward medical decision-making cases, there are also complex ones that require careful assessment of the provided medical information and balance of risks the child can be subjected to for a certain chance to get the intended medical benefit. In either case, the concepts of informed consent/assent to medical care heavily rely on the information provided by the

4 In 2007, the EU introduced a paediatric investigation plan.This plan, however, covers drugs only.The recent assessment shows improvement in the development of new paediatric drugs and new paediatric indications. See https ://ec.europa.eu/health/sites/health/files/files/paediatrics/2016_pc_report_2017/ema_10_year_report_for_co nsultation.pdf, 10–17, accessed 4 August 2020. 5 Joana Magalhães and others, ‘Use of Off-Label and Unlicenced Drugs in Hospitalised Paediatric Patients: A Systematic Review’ (2015) 71 European Journal of Clinical Pharmacology 1. See also Eva Skovslund Nielsen and others, ‘Off-Label Prescribing of Psychotropic Drugs in a Danish Child and Adolescent Psychiatric Outpatient Clinic’ (2016) 25 European Child & Adolescent Psychiatry 25. 6 See UN General Assembly, Convention on the Rights of the Child, 20 November 1989, United Nations,Treaty Series, vol 1577, p 3, art 12. 7 See Elin Kimland and Viveca Odlind,‘Off-Label Drug Use in Pediatric Patients’ (2012) 91 Clinical Pharmacology & Therapeutics 796, 799. 8 Under the CRC, in accordance with Article 3 the standard is the child’s best interests. As follows from Article 5, the responsibilities, rights, and duties of parents shall be respected.This means that a state is expected to intervene when parents do not act in the best interests of their children. However, in scholarship in regard to this state intervention, a significant harm threshold has also been discussed. See Douglas Diekema,‘Parental Refusals of Medical Treatment:The Harm Principle as Threshold for State Intervention’ (2004) 25 Theoretical Medicine and Bioethics 243. For more recent analysis see Imogen Goold, Jonathan Herring, and Cressida Auckland (eds), Parental Rights, Best Interests and Significant Harms: Medical Decision-Making on Behalf of Children Post-Great Ormond Street Hospital v Gard (1st edn, Hart Publishing 2019). 9 For example, LM Kopelman, ‘The Best-Interests Standard as Threshold, Ideal, and Standard of Reasonableness’ (1997) 22 The Journal of Medicine and Philosophy 271.

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respective medical professional, and thus the available knowledge, thresholds of disclosure, and standard of care.10 There is a thick layer of legal instruments safeguarding the right to health. However, there are neither internationally binding requirements regarding the standard of care that shall be made available to children, nor commonly agreed guidelines on what medical care meets the standard, nor is there consensus about what constitutes adequate quality of medical care to be offered to patients. In 2017, the Council of Europe (CoE) undertook an in-depth examination of how the existing medical practices and new biomedical interventions challenge children’s rights.11 Although it resulted in some important outcomes12 and is part of the CoE focus for 2020–2025,13 a comprehensive response to governing paediatric medical care has not yet materialised. In the absence of such standards, the national legal orders have considerable discretion in making these decisions. Sweden is an example of a country that has assumed a number of international commitments in this area whilst also clearly ignoring them.14 The national law prescribes the standard of care that must be met in order for medical interventions to be offered to children and thereby steer medical decision-making. However, the nature of the care that meets the standard is rather ambiguous. This could have far-reaching implications for the protection of a child’s integrity and validity of consent to medical care as a central component in enabling lawful medical care. This chapter takes a Swedish viewpoint and examines the governance of standard of care and its implications in paediatric decision-making. It begins by examining the interplay between health and integrity from the human rights and European Union (EU) law perspective. As both international human rights law and Swedish law emphasise the importance of professional standards, prior to providing detailed insights into the Swedish national law the chapter considers the medical profession’s approach to setting the standard of medical care.Then it moves on to analysing how Sweden has addressed the question of standard of care for children and paediatric decision-making. It sheds light on the limited role that parents have as primary carers in medical decision-making under the best interests standard and argues for the need to establish clear mechanisms for reviewing the standard of medical care, thus adopting a transparent and verifiable approach to protecting integrity.

10 For insights into the information obligation from a Swedish perspective, see Elisabeth Rynning, ‘Samtycke till Medicinsk Vard Och Behandling: En Rattsvetenskaplig Studie’ (Uppsala University 1994) 185–276, in particular, 197–238. For analysis under the current legislation, see Jameson Garland, On Science, Law, and Medicine:The Case of Gender-‘Normalizing’ Interventions on Children Who Are Diagnosed as Different in Sex Development (Uppsala University 2016) 293–322. 11 See Kavot Zillén, Jameson Garland, and Santa Slokenberga,‘The Rights of Children in Biomedicine: Challenges Posed by Scientific Advances and Uncertainties’ (Council of Europe 2017). Ton Liefaard, Aart Hendriks, and Daniella Zlotnik, ‘From Law to Practice: Towards a Roadmap to Strengthen Children’s Rights in the Era of Biomedicine’ (Council of Europe 2017). 12 Arguably, the most important is Parliamentary Assembly Resolution 2191 (2017) Promoting the human rights of and eliminating discrimination against intersex people. 13 Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020–2025), Adopted by the Committee on Bioethics at its 16th meeting (19–21 November 2019) https://rm.coe.int/strategic-action-plan -final-e/16809c3af1. See further, Laurence Lwoff,‘New Technologies, New Challenges for Human Rights? The Work of the Council of Europe’ (2020) 1 European Journal of Health Law 1. 14 Arguably, the most explicit case is gender assignment surgeries on intersexed infants. See Jameson Garland and Santa Slokenberga, ‘Protecting the Rights of Children with Intersex Conditions from Nonconsensual GenderConforming Medical Interventions:The View from Europe’ (2019) 27 Medical Law Review 482.

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When civil and political rights meet social and economic rights On the interplay between civil and political and social and economic rights For many good reasons, human rights, at least to some degree, have drifted away from the traditional dichotomy of civil and political rights on the one hand, and social and economic and cultural rights on the other that can be found in international and regional human rights regimes.15 Instead, the focus is on the indivisibility, interdependence and interrelatedness of these rights, which are reflected, for example, in the CRC,16 and can be linked back to how human rights were handled under the Universal Declaration of Human Rights (UDHR).Also, the EU, at least on the surface, has taken a similar approach and the Charter of Fundamental Rights of the European Union (CFREU) sets forth both of these groups of rights, while at the same time steering their implementation through specific norms and requirements.17 Although it is not an easy task to escape the politically motivated distinctions between the two groups of human rights, bodies within the United Nations (UN)18 as well as the CoE have found ways to create synergies between provisions requiring protection for health as part of the social and economic rights, and provisions safeguarding integrity as part of the civil and political rights.19 Analysis of the requirements relevant to paediatric medical care that stem from these treaties, as well as insights into the requirements that are set forth in EU law, could offer a valuable basis for exploring how Sweden’s international requirements govern the standard of paediatric care.

How do external actors shape internal health obligations? Protection of integrity is commonly expressed through the provisions of right to life, the prohibition from torture, and protection of privacy or private life, all of which could be said to be anchored on the principle of human dignity. Between the prohibition of torture and medicine is a rather complex relationship that is beyond the limits of this contribution. It suffices to note, as follows from European Court of Human Rights (ECtHR) case law, that only exceptionally does the question of medical care trigger the application of Article 3 of the European Convention

15 International Covenant on Civil and Political Rights (ICCPR) and International Covenant on Economic, Social and Cultural Rights (ICESCR) in the UN system, as well as ECHR and (revised) European Social Charter (ESC) in the Council of Europe system. However, early on the CESCR had already drawn attention to challenges related to this split. See CESCR, Draft general comment No. 9: The domestic application of the Covenant, E/C.12/1998/24, 3 December 1998, para 10. 16 However, for the sake of accuracy it has to be noted that it was adopted before the 1993 Vienna Declaration of the World Conference on Human Rights. Audrey R Chapman, ‘The Divisibility of Indivisible Human Rights’ (University of Connecticut, Human Rights Institute 2009). See also Eibe Riedel, Gilles Giacca, and Christophe Golay,‘The Development of Economic, Social, and Cultural Rights in International Law’ in Eibe Riedel, Gilles Giacca and Christophe Golay (eds), The Development of Economic, Social, and Cultural Rights in International Law (Oxford University Press 2014) 6. 17 Here it suffices to note two peculiarities. First, as can be derived from Article 51.1 of the CFREU, it applies only in so far as the EU law applies. Second, the same provision mandates ‘respecting’ rights and ‘observing’ principles. However, which provisions contain rights and which contain principles remains somewhat ambiguous. 18 For example, Human Rights Committee, General Comment No 36, Article 6: right to life, 3 September 2019, CCPR/C/GC/36. 19 See Vasileva v Bulgaria,App no 23796/10 (ECtHR, 17 March 2016) [63]. See also Case of Centre for Legal Resources on behalf of Valentin Câmpeanu v Romania,App no 47848/08 (ECtHR, 17 July 2014) [130]. See also Lopes de Sousa Fernandes v Portugal, App no 56080/13 (ECtHR, 10 December 2017) [165].

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on Human Rights (ECHR).20 A similar approach could be said to relate to the text and historical development of Article 7 of the International Covenant on Civil and Political Rights (ICCPR).21 However, at the same time one should acknowledge that the interplay between prohibition of torture, inhuman and degrading treatment, and substandard medical care has not been adequately explored. Nonetheless, under the ECHR as well as the ICCPR, involvement in scientific research without valid consent is a clear violation of this prohibition.22 Human rights standards place obligations on the national legal orders not only to refrain from actions that interfere with the enjoyment of the right to privacy and life but also to take measures to ensure that these rights are protected.The Human Rights Committee, in regard to Article 6 ICCPR which ensures protection of life, has emphasised the need for medical care to be an element of the state’s obligation to ensure this right.23 The ECtHR has been reluctant to grant rights to access certain care that a state has not committed to provide24 and to engage substantive limbs of the ECHR provisions in cases that it classifies as ‘mere’ malpractice cases, as elaborated in the case of Lopes de Sousa Fernandes v Portugal.25 However, it has been firm in mandating that adequate mechanisms are put in place to safeguard the rights that are protected under the convention, and this also applies to the area of medical care.26 In a number of cases, the ECtHR has emphasised that principles stemming from Article 2 ECHR apply in the public health sphere too and that states are required to make regulations that compel hospitals, whether public or private, to adopt appropriate measures for the protection of their patients’ lives.27 As the ECtHR already indicated early on in the admissibility decision of William and Anita Powell against the United Kingdom and continues to reiterate, this obligation includes that ‘a Contracting State has made adequate provision for securing high professional standards among health professionals and the protection of the lives of patients.’28 These principles also apply to obligations stemming from Article 8 ECHR29 and include assessment of the existence of a framework that

20 For example, lack of adequate care when the state was responsible to provide it when a person has been in custody. See, for example, Vasyukov v Russia,App no 2974/05 (ECtHR, 5 April 2011). 21 Preparatory works to the covenant considerably focus on the experimentation. See Marc J Bossuyt and John P Humphrey, Guide to the ‘Travaux Preparatoires’ of the International Covenant on Civil and Political Rights (M. Nijhoff 1987). However, at the same time, the General Comment notes that ‘article 7 protects, in particular, children, pupils and patients in teaching and medical institutions.’ UN Human Rights Committee (HRC), CCPR General Comment No 20: Article 7 (Prohibition of Torture, or Other Cruel, Inhuman or Degrading Treatment or Punishment), 10 March 1992, para 5. 22 For a violation of Article 3 ECHR, see Bataliny v Russia, App no 10060/07, judgment 23 July 2015, para 90. For a conflict with Article 7 ICCPR, see UN Human Rights Committee (HRC), CCPR General Comment No 20: Article 7 (Prohibition of Torture, or Other Cruel, Inhuman or Degrading Treatment or Punishment), 10 March 1992, para 7. 23 See Human Rights Committee, General Comment No 36, Article 6: right to life, 3 September 2019, CCPR/C/ GC/36, paras 25–26. 24 See, for example, Valentina Pentiacova and Others against Moldova, App no 14462/03 (ECtHR, admissibility decision, 4 January 2005). 25 See Lopes De Sousa Fernandes v Portugal, App no 56080/13 (ECtHR, 17 December 2019), paras 185–96, in particular paras 191–94. 26 Under Article 2, see Fernandes De Oliveira v Portugal, App no 78103/14 (ECtHR, 31 January 2019), para 192. Under Article 8, see Asiye Genç v Turkey,App no. 24109/07 (ECtHR, 27 January 2015) [67], [74]–[87]. 27 Calvelli and Ciglio v Italy, App no 32967/96 (ECtHR, 17 January 2002) [49]. See also Vo v France, App no 53924/00 (ECtHR, 8 July 2004) [88]. 28 William and Anita Powell against the United Kingdom App no 45305/99 (ECtHR, admissibility decision 4 May 2000), p 18. For a more recent application see, for example, Rõigas v Estonia (Application no. 49045/13), 12 September 2017, [101]. 29 See, for example, Erdinç Kurt and Others v Turkey,App no 50772/11 (ECtHR, 6 June 2017) [51].

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protects patients’ physical integrity and whether the respective legislative and statutory frameworks have been properly implemented.30 To date, the ECtHR has not required that care be of a specific standard, and where the question of the standard has been at the core of a case brought before the court, it has successfully escaped tackling this question in greater detail.31 EU law cannot be said to place more comprehensive obligations either. Given the economic origins of the EU, the content of Article 168.7 Treaty on the Functioning of the European Union (TFEU) is hardly a surprise to anyone.32 It declares that the EU shall respect the responsibilities of the member states for the definition of their health policy and for the organisation and delivery of health services and medical care. Among the responsibilities that the member states retain is the management of health services and medical care and the allocation of the resources. Throughout the case law, the Court of Justice of the European Union (CJEU) has persistently affirmed this liberty and intervened only when a member state is not providing the care it had committed to provide, including when the quality of care has been the issue.33 Furthermore, even though the first sentence of Article 35 of the CFREU states,‘[e]veryone has … the right to benefit from medical treatment,’ this obligation, as acknowledged in the same sentence, is subject to ‘the conditions established by national laws and practices.’34 Nonetheless, as elaborated in the following regarding quality, this does not mean that the EU has not contributed to shaping rules relevant for the provision of care.

Quality matters, but what is quality? Quality as part of the highest attainable standard of health

The right to the highest attainable standard of health is set forth in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) and can be found in groupspecific human rights treaties, including the already noted Article 24 of the CRC. One of the key components of this right is quality of medical care.35 In legal scholarship on the right to health, quality is commonly addressed as one of the four key components of the right to health. However, there seems to be rather limited consideration on how to approach this requirement or its constituting elements that are elaborated in General Comment 14 under Article 12 ICESCR.36 In contrast, scholars in medicine, health and health policy have attempted to

30 Erdinç Kurt and Others v Turkey,App no 50772/11 (ECtHR, 6 June 2017) [59]. 31 For example, in the case of Erdinç Kurt and Others v Turkey the court emphasised investigation and motivation of violation, but did not provide any tools to the assessment of lege artis, apart from indicating need for a proper analysis to assess whether the care was such to meet the standard. See Erdinç Kurt and Others v Turkey, App no 50772/11 (ECtHR, 6 June 2017) [68]. In the case of Rõigas v Estonia, it indicated that ‘medical expert opinions are very likely to carry a crucial weight in the courts’ assessment of highly complex issues of medical negligence.’ Rõigas v Estonia, App no 49045/13 (ECtHR, 12 September 2017) [115]. In the case of Fernandes De Oliveira v Portugal, the ECtHR emphasised the need to carry out concrete assessment in that regard. See Fernandes De Oliveira v Portugal,App no 78103/14 (ECtHR, 31 January 2019) [107]. 32 Consolidated version of the Treaty on the Functioning of the European Union, OJ C 326, 26.10.2012, 47–390. 33 For example, C-173/09, Georgi Ivanov Elchinov v Natsionalna zdravnoosiguritelna kasa, ECLI:EU:C:2010:581. 34 Charter of Fundamental Rights of the European Union OJ C 326, 26.10.2012, 391–407. 35 Committee on the Rights of the Child, General Comment No. 15 (2013) on the right of the child to the enjoyment of the highest attainable standard of health (art 24), 17 April 2013, CRC/C/GC/15, paras 113 and 116. CESCR, General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art 12 of the Covenant), 11 August 2000, E/C.12/2000/4, para 12. 36 For example, Brigit Toebes,‘Towards an Improved Understanding of the International Human Right to Health’ (1999) 21 Human Rights Quarterly 661, 667. See also, Aart Hendriks and Brigit Toebes, ‘Towards a Universal

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clarify the issue,37 putting forward definitions and assessable components.38 Although it could be perceived as a deficiency in legal scholarship, one must acknowledge that defining quality of medical care is not easily done.39 It is a concept that is approached differently depending on the perspectives that it is intended to capture and interests that it is intended to further.40 From a legal perspective, it could be argued to be a concept that touches upon multiple aspects of medical care that are subject to legal requirements, and both these aspects and the legal requirements evolve. Likewise, it is a concept that calls for taking account of multiple perspectives, key being those at the core of medical care: the healthcare provider (person and institution) and the patient. General Comment 14 states: As well as being culturally acceptable, health facilities, goods and services must also be scientifically and medically appropriate and of good quality. This requires, inter alia, skilled medical personnel, scientifically approved and unexpired drugs and hospital equipment, safe and potable water, and adequate sanitation. What is understood by the requirement that goods and services must be scientifically and medically appropriate and of good quality is not further elaborated, apart from indicating the need to have scientifically approved, unexpired drugs and hospital equipment.41 General Comment 15 on the right of the child to the enjoyment of the highest attainable standard of health adopted under the CRC also acknowledges the aforementioned two elements, and emphasises the need to ensure their appropriateness for children and to carry out regular quality-of-care assessments.42 Regarding medical interventions, it specifies that the quality element includes a requirement that ‘treatments, interventions and medicines are based on the best available evidence.’43 It also requires that ‘medical personnel are skilled and provided with adequate training on maternal and children’s health, and the principles and provisions of the Convention.’ Similar to General Comment 14, it also includes a requirement regarding drugs and adds that drugs shall be scientifically approved and shall not have expired. Furthermore, it states that the medical interventions shall be child-specific (when necessary) and be monitored for adverse reactions. However, no further guidance regarding the question of ‘best available evidence’ for treatments, interven-

37

38 39

40 41 42 43

Definition of the Right to Health’ (1998) 17 Medicine and Law 319.Tony Evans,‘A Human Right to Health?’ (2002) 23 Third World Quarterly. Steven D Jamar, ‘The International Human Right to Health’ (1994) 22 Southern University Law Review 1. Some depth to this question is given by Rui Nunes, Sofia B Nunes and Guilhermina Rego,‘Health Care as a Universal Right’ (2017) 25 Zeitschrift Fur Gesundheitswissenschaften 1. Grant E Steffen, ‘Quality Medical Care: A Definition’ (1988) 260 Jama 56. Avedis Donabedian, ‘The Quality of Medical Care’ (1978) 200 Science (New York, N.Y.) 856. Philip Caper,‘Defining Quality in Medical Care’ (1988) 7 Health Affairs 49. SM Campbell, MO Roland, and SA Buetow, ‘Defining Quality of Care’ (2000) 51 Social Science & Medicine 1611. See, for example, Caper (n 37). See an acknowledgement made early on by James Todd, senior deputy executive vice president of the American Medical Association, in which he states that ‘quite honestly, the medical profession is groping to try to come up with an understandable definition of quality.’ Federation of American Health Systems Review, May/June 1986, p 22, quoted in Steffen (n 37). See Caper (n 37). CESCR, General Comment No 14:The Right to the Highest Attainable Standard of Health (Art 12 of the Covenant), 11 August 2000, E/C.12/2000/4, para 12. Committee on the Rights of the Child, General Comment No 15 (2013) on the right of the child to the enjoyment of the highest attainable standard of health (Art 24), 17 April 2013, CRC/C/GC/15, para 116. Committee on the Rights of the Child, General Comment No. 15 (n 42) para 116.

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tions, and medicines is provided. In terms of the exact standards that are followed, these are for the national legal orders to decide with due regard to their external commitments in the field. In the case of Sweden, those commitments include membership in the EU and the CoE, and accession to specific CoE treaties addressing the question of quality of care. Quality as part of social rights, biology, and medicine requirements within the CoE

Within the CoE, two sets of legal instruments are of relevance for considering the standard of care: first, treaties addressing social rights as well as the area of biology and medicine; second, soft law tools, such as recommendations and resolutions. Under Article 11.1 of the (revised) European Social Charter,44 with a view to ensuring the effective exercise of the right to protection of health, states have a duty to remove as far as possible causes of ill-health. It has been argued that it places on states positive and negative obligations to further health. The European Committee of Social Rights has emphasised that it includes ensuring the best possible state of health for the population ‘in line with the available knowledge.’45 Elsewhere, it has emphasised the necessity for ‘appropriate’ care.46 However, thus far it does not seem that the European Committee of Social Rights would have provided more precise guidance on its view on assessing the body of existing knowledge or determining appropriateness in terms of standard of care. Arguably, one of the most explicit treaty requirements for the standard of care is Article 3 of the Biomedicine Convention, which mandates that care shall be of appropriate quality, along with Article 4, which requires that it is carried out in such a way that it is in line with relevant professional obligations and standards.47 However, unlike many other members of the Council of Europe, Sweden has only signed the Biomedicine Convention and not ratified it. Consequently, the importance of these provisions for Sweden is limited to not defeating the object and purpose of the convention as required under Article 18 of the Vienna Convention on the Law of the Treaties.48 Substantially, however, these provisions rely on the field of medicine as informed by the state of the art and relevant professional obligations and standards to decide on the treatment that shall be offered to a patient. Several Committee of Ministers recommendations have elaborated on the requirement of appropriate quality or requirements relevant for the quality of health care. For example, by 1997 it had already been emphasised that ‘health care should be improved by applying methods of

44 European Social Charter (revised), ETS No 163. 45 European Committee of Social Rights, Conclusions XV-2 (2001), Denmark. 46 European Committee of Social Rights, International Planned Parenthood Federation – European Network (IPPF EN) v Italy, Complaint No 87/2012, Decision on the merits of 10 September 2013, para 66. 47 See Explanatory Report to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, ETS 164, paras 24, 30, and 32. 48 However, it is uncertain to what extent Articles 3 and 4 fall within the remit of ‘object and purpose’ of the Biomedicine Convention. On the one hand, one could take Article 1 of the Biomedicine Convention as a starting point and argue for the protection of the dignity and identity of everyone, as well as the guarantee of integrity and other rights and fundamental freedoms for everyone, without discrimination. On the other hand, one could take the rights and obligations enshrined in those articles from which signatories may not contemplate derogations and argue that they reflect the nucleus of the convention.Those are specified in Article 26.2 of the convention and are as follows: Articles 11, 13, 14, 16, 17, 19, 20, and 21. It could be argued that limiting the core of the convention to non-derogable rights is unsatisfactory from the perspective of the intention of the convention, and therefore, the former approach shall be preferred. However, it is then unclear what the exact expectations are of a signatory state and how much leeway it has in regulating medical care and setting standards therein.

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evidence-based medicine and utilising the results of technology assessment in decision making, directing appropriate attention to laboratory quality assurance.’49 A recommendation in 2006 stated the need for standardisation as an essential element of managing patient safety.50 Also, a recommendation in 2012 emphasised medical health care technology that has been scientifically proven to be beneficial to be an example of good practice.51 Detailed requirements have been adopted relating to particular interventions, for example, haemophilia therapies, that have the ability to shape the standard of medical care.52 Quality of medical care and EU law

The EU is no different from other legal orders in acknowledging the importance of quality in medical care.Already in 2001, in a preliminary ruling in the Smiths and Peerbooms case, the CJEU emphasised such considerations as the existing scientific literature and studies, and authorised opinions of specialists as relevant considerations for assessing whether a particular medical treatment is sufficiently tried and tested.53 Constrained by the principle of conferral, in Article 4 of the Patients’ Rights Directive it defers considerably to national law to ensure cross-border healthcare is provided. From Article 4.1.b it can be derived that standards and guidelines on quality and safety rules fall within the national competences, whereas from Article 4.1.c that safety standards can also be adopted by the EU.54 The directive sets out a health technology assessment network (cooperation system) to support the work of member states,55 which could be reshaped in the near future.56 However, further work with these standards at the national level remains within the competence of the national legal orders. Building on the principles of mutual trust and recognition, the EU has left a highly limited possibility for member states to doubt the quality of medical care in another member state.57 The Patients’ Rights Directive is not the only legal act of the EU that is relevant for shaping the practice of medical care. Specifically in regard to medicinal products, already for more than a decade a specific framework for ‘ensur[ing] that medicines are regularly researched, developed and authorised to meet the therapeutic needs of children’58 has been in place, albeit it has not led

49 Council of Europe: Committee of Ministers, Recommendation No R (97) 17 of the Committee of Ministers to Member States on the Development and Implementation of Quality Improvement Systems (qis) in Health Care, 30 September 1997, Appendix, II.9. 50 Council of Europe: Committee of Ministers, Recommendation Rec (2006)7 on Management of Patient Safety and Prevention of Adverse Events in Health Care. 51 Council of Europe, Committee of Ministers, Recommendation CM/Rec (2012)8 of the Committee of Ministers to Member States on the Implementation of Good Governance Principles in Health Systems, 12 September 2012, Attribute No 8.4. 52 Council of Europe, Committee of Ministers, Resolution CM/Res (2017)43 on Principles Concerning Haemophilia Therapies (replacing Resolution CM/Res (2015)3) (Adopted by the Committee of Ministers on 13 December 2017). 53 C-157/99, B.S.M. Geraets-Smits v Stichting Ziekenfonds VGZ and H.T.M. Peerbooms v Stichting CZ Groep Zorgverzekeringen, ECLI:EU:C:2001:404, [97]–[98]. 54 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ L 88, 4.4.2011, 45–65. 55 ibid Art 15. 56 See Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM (2018) 51 final 2018/0018 (COD). 57 Directive 2011/24/EU (n 54),Art 8.2. 58 Marjolein Weda, Joëlle Hoebert, Marcia Vervloet, Carolina Moltó Puigmarti, Nikky Damen, Sascha Marchange, Joris Langedijk, John Lisman, Liset van Dijk for the European Commission, Study on Off-Label Use of Medicinal Products in the European Union, EU 2019, p 32.

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to the elimination of off-label use of drugs.59 Although not necessarily perfect, it has resulted in the delivery of increased medicines. However, to date a comparable strategy for medical devices and in vitro medical devices has not been implemented. For these three classes of products of importance to medical care (medical devices, in vitro diagnostic medical devices, and medicinal products) standards are set forth for their placing on the market or putting into service, and transparency is furthered through the provision of information regarding intended use (e.g. labelling).60 Therefore, although the EU prescribes product requirements, it does not set forth detailed requirements relating to their use.61 Furthermore, although professional qualifications are of central importance to quality of medical care, further quality conditions or mechanisms are not set down therein.62

Insights from the medical profession What standard? Medical decision-making is complex and a brief insight into the field cannot adequately portray the daily challenges healthcare professionals face in practising medicine or do justice to the immense amount of scholarship and implemented legal and policy solutions in the field. However, a brief insight can give a sense of its sophistication, traditions, and internal transitions, as well as the controversies in the field, and illustrate the elusive nature of the standard of medical care that the international and EU law refers to and that national law needs to capture, both as a right-to-health obligation and as an integrity-protecting measure. The current dominant standard in medical care is evidence-based medicine (EBM). Its origins date back to the second half of the last century, when a paradigm shift occurred and the focus switched from the ‘art of medicine’ to data derived from clinical research and their incorporation in the practice of medicine;63 however, the term EBM was coined only in 1992.64 At the core of the art of medicine was a belief that ‘each physician always thought the right thoughts and did the right things,’65 which rested on the assumption that each ‘physician would synthesize all of the important information about the patient, relevant research, and experiences

59 ibid 38–83. 60 See Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, 67–128; Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) OJ L 117, 5.5.2017, 1–175. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) OJ L 117, 5.5.2017, 176–332. 61 As acknowledged by the CJEU, the EU rules on pharmaceutical products do not prohibit off-label prescription. Regulating the use of medicinal products is a competence of the national legal orders. C-179/16, F. Hoffmann-La Roche and Others, EU:C:2018:25 [59]. 62 See Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, OJ L 255, 30.9.2005, 22–142. 63 Ronald L Koretz,‘Assessing the Evidence in Evidence-Based Medicine’ (2019) 34 Nutrition in Clinical Practice 60. 64 Evidence-Based Medicine Working Group, ‘Evidence-Based Medicine. A New Approach to Teaching the Practice of Medicine’ (1992) 268 JAMA 2420. (Gordon Guyatt and others, ‘Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine’ (1992) 268 JAMA 2420. Gordon H Guyatt, ‘Evidence-Based Medicine’ (1991) 114 ACP Journal Club A16. 65 David M Eddy,‘Evidence-Based Medicine:A Unified Approach’ (2005) 24 Health Affairs 9, 9–10.

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with previous patients to determine the best course of action.’66 However, this approach proved to contain major flaws, perhaps most obviously exemplified by two experts arriving at different conclusions in their clinical judgements.67 Today, EBM is regarded as the gold standard for decision-making in medical practice and health policy.68 As pointed out by Garland, it coexists with other approaches,69 for example, science-based medicine, which, according to its proponents, seeks to tackle the shortcomings of EBM.70 However, it is questionable to what extent it is an approach on its own. EBM ‘is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.’71 The goal of EBM is to integrate ‘individual clinical expertise with the best available external clinical evidence from systematic research.’72 To achieve this goal, several steps need to be taken. First, assessment of clinical efficacy of an intervention needs to be made, which is achieved through a systematic and rigorous assessment and categorisation of the available evidence. EBM requires that the available evidence is thoroughly scrutinised in terms of design, methodology, and validity of conclusions, and then graded into a level of evidence. Second, specific guidelines, standards, options, and recommendations may be developed and distributed. Finally, the findings are integrated with clinical expertise to make treatment decisions. Whether or not specific guidelines, standards, options, and recommendations are developed and distributed depends on many considerations, including established frameworks governing the practice of medicine in a particular country. In either case, it could be said that step two can be part of health policy measures or they can be approached in terms of steps an individual healthcare provider is taking in order to identify the best medical care for the patient. Despite its prominent status, EBM is not without its shortcomings. Critics of EBM make a number of claims directed at the very core of EBM – evidence – including on the content of the evidence generally,73 the quality of evidence generated through randomised clinical trials, and the challenges regarding interpreting the results, selectivity in reporting, and quality of the studies.74 As shown from scholarly discussions, EBM scholars are not blind to this reality. Ioannidis in his reflection on EBM and his professional and personal experiences summarised the situation thus:‘As EBM became more influential, it was also hijacked to serve agendas different from what

66 ibid. 67 ibid. Beginning in the early 1970s, however, two major flaws began to appear in this fundamental assumption. 68 Ana Fernandez and others,‘Evidence-Based Medicine: Is It a Bridge Too Far?’ (2015) 13 Health Research Policy and Systems 66. 69 Garland, On Science, Law, and Medicine:The Case of Gender-‘Normalizing’ Interventions on Children Who Are Diagnosed as Different in Sex Development (n 10) 206–14. 70 Central claims are particularly regarding the scope of ‘science’ EBM relies upon (reliance on clinical science as opposed to all available scientific evidence, including from other disciplines), not how it tackles prior probability.‘About SBM’ https://sciencebasedmedicine.org/about-science-based-medicine/ accessed 5 July 2020.‘Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”’ https://sciencebasedmedicine .org/prior-probability-the-dirty-little-secret-of-evidence-based-alternative-medicine-2/ accessed 5 July 2020. 71 David L Sackett,‘Evidence-Based Medicine’ (1997) 21 Seminars in Perinatology 3. 72 ibid. 73 Alvan R Feinstein and Ralph I Horwitz,‘Problems in the “Evidence” of “Evidence-Based Medicine”’ (1997) 103 The American Journal of Medicine 529. 74 Susanna Every-Palmer and Jeremy Howick,‘How Evidence-Based Medicine Is Failing Due to Biased Trials and Selective Publication’ (2014) 20 Journal of Evaluation in Clinical Practice 908. Michel Accad and Darrel Francis, ‘Does Evidence Based Medicine Adversely Affect Clinical Judgment?’ (2018) 362 BMJ: British Medical Journal (Online).

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it originally aimed for.’75 This points to the industry and funders, as well as market pressure and individual clinicians (including those yielding to market temptations and pressures, and those adhering to eminence-based medicine principles) as being among those who have had a role to play in exploiting the vulnerability of the mechanism.76 As Ioannidis himself elsewhere observed, there is increasing concern that in modern research false findings may be the majority or even the vast majority of published research claims.77 Thus, although it can be said to be the dominant current standard in the field of medical decision-making, which allows identifying the best way to treat a particular patient and determine medical cause, when practising EBM one should be mindful of its vulnerabilities.

Grading evidence A central component in EBM is the assessment of evidence for a particular clinical application.78 Since the first proposal in the 1970s about how evidence can be categorised, other approaches have emerged.79 Although there are differences in these models and they have evolved over time into better versions of themselves, it is generally agreed that randomised clinical trials and systematic reviews of randomised clinical trials have the most credibility, whereas expert opinion has the least.80 A system that was put forward in 2004 called Grading of Recommendations Assessment, Development and Evaluation (GRADE), and which has since been refined,81 has been widely accepted (including in a Swedish context)82 for the purpose of assessing not only the quality of evidence but also the strength of recommendations.83 This approach involves five key steps: •

First, to localise the source in the ranking of evidence between ‘high’ for randomised controlled trials and ‘low’ for observational studies.

75 John PA Ioannidis,‘Evidence-Based Medicine Has Been Hijacked:A Report to David Sackett’ (2016) 73 Journal of Clinical Epidemiology 82. 76 ibid. 77 John PA Ioannidis,‘Why Most Published Research Findings Are False’ (2005) 2 PLoS Medicine e124. 78 At its core,‘EBM advocates want patients, practitioners, health care managers and policy makers to pay attention to the best findings from health care research that meet the dual requirements of being both scientifically valid and ready for clinical application.’ R Brian Haynes,‘What Kind of Evidence Is It That Evidence-Based Medicine Advocates Want Health Care Providers and Consumers to Pay Attention To?’ (2002) 2 BMC Health Services Research 3. 79 Patricia B Burns, Rod J Rohrich, and Kevin C Chung, ‘The Levels of Evidence and Their Role in EvidenceBased Medicine’ (2011) 128 Plastic and Reconstructive Surgery 305. 80 ibid. 81 Peter C Wyer, ‘From MARS to MAGIC: The Remarkable Journey through Time and Space of the Grading of Recommendations Assessment, Development and Evaluation Initiative’ (2018) 24 Journal of Evaluation in Clinical Practice 1191. 82 See Brian P Kavanagh, ‘The GRADE System for Rating Clinical Guidelines’ (2009) 6 PLoS Medicine (9) e1000094. In the Swedish context, see the National Board of Health and Welfare and SBU, see Socialstyrelsen, ‘Nationella Riktlinjer. Metodbeskrivning’ www.socialstyrelsen.se/globalassets/sharepoint-dokument/doku ment-webb/nationella-riktlinjer/nationella-riktlinjer-metodbeskrivning.pdf. However, EBM importance in day-to-day practice and in assessment with the compliance with the Swedish standards on science and proven experience is unexplored. Prima facie, the Medical Responsibility Board (Hälso- och sjukvårdens ansvarsnämnd), accounts for it implicitly in such cases as considering whether guidelines of the National Board of Health and Welfare have been followed. 83 Gordon H Guyatt and others,‘GRADE: An Emerging Consensus on Rating Quality of Evidence and Strength of Recommendations’ (2008) 336 BMJ 924. For an insight into acceptance, see Kavanagh (n 82).

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• • • •

Second, to ‘downgrade’ or ‘upgrade’ the initial ranking through analysing the facts that could affect the quality of the studies, for example, if they suffer from bias. Third, to assign a final grade for the quality of evidence as ‘high,’ ‘moderate,’ ‘low,’ or ‘very low’ for all the critically important outcomes. Fourth, to consider other factors that influence the strength of a recommendation for a course of action. Finally, to make a recommendation within the binary scale of a strong or weak recommendation.84

Just as EBM has faced criticism, so too have evidence-grading techniques been subjected to scrutiny.85 However, they are an integral part of the development of scholarly thought and can help to improve the responsiveness of the mechanism to the challenges that time, decay, and evolving practices bring.A recent criticism that GRADE has faced is that it does ‘not expressly recognize the high risk of bias when the producers of evidence have an invested interest in the result.’86 Others have pointed to disagreements in assigning a final grade for the quality of evidence as ‘high,’‘moderate,’‘low,’ or ‘very low’ for all the critically important outcomes, which then risks affecting the reliability of conclusions.87 Yet another reproval is that GRADE is not fit for assessing risk and causality, establishing risk thresholds, or assessing animal studies, and there are challenges in accommodating qualitative data.88

Integrating evidence into medical care In clinical decision-making, assessment of evidence is only one step to arrive at a clinical decision. EBM has been presented as consisting of five steps: the first one relates to converting information that is needed into answerable questions; the second to finding the evidence with which to answer the questions; the third to critically appraising it; the fourth to applying the results of the appraisal into the clinical practice; and the final one to evaluating the performance.89 In the five-step EBM model described by Akobeng, the patient perspective is integrated in step 4, within which a recommendation is given on the evidence that can be applied to the patient. The patient’s own values and circumstances are of importance in this, as well as factors that shape what care can be delivered in a particular case, such as costs and availability of a particular treatment option. One should also be mindful of the link between different steps, in particular, steps 3 and 4. As illustrated by Jones and Sagar,‘when one treatment is shown to be better than another on a population basis this does not mean that it is the best treatment for the patient.’They draw on Charlton’s earlier work90 and argue that ‘only when we cannot reliably predict which patient

84 Gabrielle Goldet and Jeremy Howick,‘Understanding GRADE:An Introduction’ (2013) 6 Journal of EvidenceBased Medicine 50. 85 On critique, see Wyer (n 81). 86 Every-Palmer and Howick (n 74). 87 Susan L Norris and Lisa Bero, ‘GRADE Methods for Guideline Development: Time to Evolve?’ (2016) 165 Annals of Internal Medicine 810. 88 ibid. 89 Anthony K Akobeng,‘Principles of Evidence Based Medicine’ (2005) 90 Archives of Disease in Childhood 837. 90 See Bruce G Charlton, ‘Mega-Trials: Methodological Issues and Clinical Implications’ (1995) 29 Journal of the Royal College of Physicians of London 96.

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will benefit from each treatment option should we take the general conclusion for the population and apply it to the individual patient.’91 EBM as a mechanism allows finding answers to those questions that are open to its techniques.92 However, it does not provide answers to the question of how to manage a patient’s medical needs when there is no suitable evidence to address the challenge.93 Examples of this are rare diseases or where there are ethical concerns which make it difficult to carry out the necessary research.94 Paediatrics is one such area. Diringer has argued that for some EBM scholars absence of proof is proof of absence, namely, ‘if a therapy has not been proven to improve clinical outcome in a randomized controlled trial, it should not be used.’As he suggests,‘this approach is especially problematic in situations in which there are almost no quality data and can lead to inaction and therapeutic nihilism.’ He urges his readers to look behind the reasons for the lack of randomised controlled trials (including ethical) and acknowledge the complex reality in clinics, particularly intensive care units, which require rapid decisions to be made without high-quality data. In delivering this conclusion, he contrasts scientists with doctors, where the former ‘have the luxury of making decisions based on high-quality data.’95 Although it is not explicitly mentioned in the paper, one could argue that it implies both the time that is necessary to rigorously follow EBM steps and the time to advance science in the field. Thus, when considering complex medical realities, it could be argued that there will be situations that have better preconditions for practising EBM, and there will be situations when the possibilities to practice EBM could sometimes be limited.These limitations could be attributed to various considerations, e.g. lack of adequate evidence on best treatment options when several medical conditions coexist or medical urgency that precludes the possibility of undertaking thorough research and instead require acting on the knowledge and skills at the disposal of the healthcare professional.The question of lack of adequate evidence is of particular importance to the area of paediatric medical care and considerations under which research involving children as a class or as specific paediatric population groups may be carried out. If EBM does not lead to clear answers on the care given, then the question is whether there is anything that can be done about the specific medical condition in the given case. This is precisely the area in which the importance of national approaches to managing standards of care and responsibility of healthcare providers kicks in and there is a need for answers to emerge.

Insights from Sweden: the nature of care for children Some remarks on the governance of the standard of care and decision-making In Sweden, the question of the (medico-)legal standard of quality and paediatric care decisionmaking triggers two overlapping and interacting sets of legal requirements. First, those regulating the standard of care. Second, those regulating the child’s integrity, and medical and parental

91 Glenn W Jones and Stephen M Sagar, ‘Evidence Based Medicine: No Guidance Is Provided for Situations for Which Evidence Is Lacking’ (1995) 311 BMJ 258. 92 ibid. 93 ibid. 94 Michael N Diringer, ‘Evidence-Based Medicine: What Do You Do When There’s No Evidence?’ (2003) 31 Critical Care Medicine 659. 95 ibid.

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decision-making.At the nucleus of the former is the healthcare regulatory framework, whereas at the nucleus of the latter are both healthcare and family law frameworks. Constitutionally, Sweden is a dualist country.Therefore, despite that Sweden is a signatory of several international human rights treaties that are relevant to the standard of care and paediatric decision-making, their effect depends on several circumstances, arguably key being whether a particular legal act is implemented in the Swedish law.96 However, one of the four Swedish constitutions, the Instrument of Government, offers protection to a number of internationally recognized rights that are at the core of the questions of interest.97 To manage the relationship between the national law and international law, the national courts have operationalised a principle of treaty-conforming interpretation, which requires interpreting Swedish law in so far as possible in harmony with international law.98 The area of health and medical care is steered by several central laws that are adopted by Parliament. Key acts of Parliament on matters relating to paediatric medical care and decisionmaking are the Health and Medical Care Act,99 the Patient Safety Act,100 the Patient Act,101 and the Code on Parents and Children.102 In exploring the legislator’s intention and obtaining insights into the dialogue that occurred with the stakeholders regarding the formation of particular provisions travaux preparatoires are of particular value.103 During the development of an act, various public documents are generated that belong to the broader category of preparatory works, including inquiry reports104 and bills of the government,105 which are considered in this chapter. These bills belong to a later phase of development of a legal act and could be said to closer reflect the intention of the legislature at the time the law was adopted. Having introduced some essentials of the Swedish legal system, this section proceeds by analysing the question of quality of health care.Thereafter, it analyses the protection of bodily integrity and decision-making by taking account of the constitutional perspectives and health and family laws. It then addresses their interplay.

On standards of paediatric care Legal requirements for quality of care

From a constitutional perspective, the most relevant norms steering the standard of paediatric care are the ones that provide protection to the protection of the right to health. However, other norms could be also relevant, for example, the ones protecting integrity that are reviewed in the next section.

96 On the complex relationship, see Lena Marcusson,‘Det Offentliga Uppdraget Och de Mänskliga Rättigheterna’ in Anna-Sara Lind and Elena Namli (eds), Mänskliga rättigheter i det offentliga Sverige (Studentlitteratur 2017) 33. Maria Grahn-Farley,‘Fördragskonform tolkning av MR-traktat’ [2018] Svensk Juristtidning 423. 97 In particular, Chapter 1 Article 2 and Chapter 2 of the Instrument of Government. 98 Bull Thomas and Fredrik Sterzel, Regeringsformen – en kommentar (4th edn, Studentlitteratur AB 2019) 89. On treaty conforming interpretation, see Grahn-Farley (n 96). 99 Hälso- och sjukvårdslag, SFS 2017:30. 100 Patientsäkerhetslag, SFS 2010:659. 101 Patientlag, SFS 2014:821. 102 Föräldrabalk, SFS 1949:381. 103 See Åke Frändberg,‘Interpretation of Statutes – the Use and Weight of Travaux Préparatoires in Sweden’ [1999] Anglo-Swedish Studies in Law 11, 212–15. 104 Statens offentliga utredningar, abbrevierad as SOU, as well as Departementsserie, abbreviated as Ds. 105 Proposition, abbreviated as Prop.

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In Chapter 1 Article 2 of the Instrument of Government, the right to health is enshrined as a goal that public institutions should promote.106 Similarly, as in many other constitutional legal orders, this provision could be said to echo the socio-economic nature of the right to the highest attainable standard of health and is a non-enforceable right.107 Consequently, although treaty-conforming interpretation allows paying due regard to Article 12 ICESCR and Article 24 CRC, Chapter 1 Article 2 of the Instrument of Government in itself does not offer protection to a minor patient in claiming access to qualitative medical care. Nonetheless, if interpreted in conformity with international law, this provision allows the international deference to professional standards to be brought down to the national level.The detailed content of this right, however, remains to be elaborated by the acts of Parliament in the field. The three key acts in Sweden that are of particular relevance for the standards of care and were introduced earlier establish a somewhat circular mechanism in ensuring quality of medical care.To begin with, Chapter 5 section 1 of the Health and Medical Care Act requires that healthcare activities be conducted in a way that ‘the requirements for good care are met.’108 Healthcare providers have a particular responsibility to plan, manage, and control the respective care provider (institution) to ensure that this requirement is fulfilled.109 In the Patient Act, the principle of good care is not set forth expressis verbis.110 Nonetheless, Chapter 1 sections 6 and 7 echo provisions of the Health and Medical Care Act and set forth the goal of healthcare by stating that it ‘is good health and care on equal terms for the entire population.’ Each ‘patient shall receive competent and diligent healthcare that is of good quality and which is in accordance with science and proven experience.’ As can be derived from the preparatory works, this provision has strong links with the Patient Safety Act which sets forth science and proven experience as a steering principle for professional performance of healthcare personnel,111 as well as the provision of the Health and Medical Care Act which sets forth the requirement of good care.112 What the principle of ‘good care’ entails and consequently its implications in paediatric care is only generally elaborated in Chapter 5 section 1 of the Health and Medical Care Act, but it suffices to assert that quality of medical care is one of its elements, along with a requirement that the care is easily accessible and meets the patient’s need for security, continuity, and safety. However, as elaborated in detail later, the nature of care that meets the criterion of science and proven experience is surrounded by a degree of ambiguity and has fuelled considerable research in the field.113 What is well established, however, is that some interventions are exempted from

106 Kungörelse om beslutad ny regeringsform, SFS 1974:152, Chapter 1 Article 2. 107 See Anna-Sara Lind,‘The Right to Health in Sweden’ in Aeyal Gross and Colleen M Flood (eds), The Right to Health at the Public/Private Divide:A Global Comparative Study (Cambridge University Press 2014) 53. However, as argued by Anna-Sara Lind, the requirement of social rights to be genuine and effective contributes to closing the gap of non-enforceability of these rights. Anna-Sara Lind,‘Sociala Rättigheter i Förändring: En Konstitutionellrättslig Studie’ (PhD thesis, Juridiska institutionen 2009) 439. 108 Hälso- och sjukvårdslag (n 99). 109 ibid Chapter 3 section 1. 110 See Patientlag (n 101). 111 Prop 2016/17:43, En ny hälso- och sjukvårdslag. 112 See Prop 2013/14:106, s 112. In regard to the repealed Health and Medical Care Act section 2a, para 1, which is now Chapter 5 section 1 of the Health and Medical Care Act. 113 Among recent scholarly contributions are Garland. See Jameson Garland, ‘Testing the Bounds of Lawful Medicine in Sweden:Vetenskap Och Beprövad Erfarenhet as a Legally Enforceable Standard of Care’ [2019] Nordisk socialrättslig tidskrift 79. Lena Wahlberg, ‘Rätten till Ersättning För Gränsöverskridande Våd Och Kravet På Vetenskap Och Beprövad Erfarenhet’ [2018] Förvaltningsrättlig tidskrift 789. Lena Wahlberg and Johannes Persson, ‘Importing Notions in Health Law: Science and Proven Experience’ (2017) 24 European

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this requirement, for example research114 and homeopathy (an alternative to treatment).115 At the same time, it is also known that some grey areas regarding medical care, on the one hand, and scientific research, on the other, exist, and therefore the question of the application of unproven methods emerges.116 Some of the key points relevant to unpacking the notion, and thereby identifying what level of health and medical care may (or shall, depending on circumstances) be offered to children, are considered next. Quality of medical care in terms of standards

The legal frameworks that are considered here are relatively modern, namely, the Patient Safety Act adopted in 2010 and the Patient Act adopted in 2014. However, the requirement of science and proven experience in Swedish medical law has been known since the 1890s117 and has been part of health regulations since 1960.118 Moreover, it was an ethical standard adopted by the Swedish Medical Association119 and is also known in other fields, such as education.120 Despite this considerable history and medico-legal nature, to date the content of this standard is surrounded by a degree of ambiguity,121 which leads to uncertainty about the standard of care that is offered to patients. In the preparatory works for two relatively old and repealed laws, namely, the Act for the Qualification to Practice Medicine and the Quackery Act, the principle of science and proven experience is contrasted with medical or healing art.As acknowledged therein, it ‘has obviously little coverage in the practitioner’s profession’ in our days ‘when this (medical) treatment is determined by science and proven experience.’122 Since 1994, this obligation formally extends to all healthcare workers,123 initially under the Act on the Duties of Health Care Personnel,124 which was annulled and then replaced by the Patient Safety Act.125 However, neither of the legal acts that refer to this notion defines it. Furthermore, as insights from the preparatory works in the following show, close to nothing was done to define it there either.126

114 115 116 117 118 119

120 121 122 123 124 125 126

Journal of Health Law 565. Lena Wahlberg and Nils-Eric Sahlin,‘Om Icke Vedertagna Behandlingsmetoder Och Kravet På Vetenskap Och Beprövad Erfarenhet’ [2017] Förvaltningsrättslig tidskrift 45. SOU 1989:60,Alternativmedicin, 59. ibid 184. Rynning (n 10) 134. D M Pontin, Författningar m.m. angående medicinalväsendet i Sverige, omfattande år 1890 (Norstedt & Söner 1891) § 59, quoted in Wahlberg and Persson (n 113) 570. See Kungl.Ma:t’s proposition nr.141 år 60, p 34. See The Act for the Qualification to Practice Medicine, SFS 1960:408 and the Quackery Act, SFS 1960:409. It is not merely a legal requirement, but also an ethical one. Läkaren ska handla i enlighet med vetenskap och beprövad erfarenhet. Läkarförbundets etiska regler, available https://slf.se/rad-och-stod/etik/lakarforbundets-e tiska-regler/ accessed 13 July 2020. See Skollag, SFS 2010:800, Chapter 1 section 5. Indeed, it is nothing new that the concept is difficult to grasp and it is ambiguous. www.sbu.se/sv/publikation er/vetenskap-och-praxis/beprovad-erfarenhet-behover-omprovas/ See Kungl.Ma:t’s proposition nr.141 år 60, p 34, www.riksdagen.se/sv/dokument-lagar/dokument/proposition /kungl-majts-proposition-nr-hl-ar-1960_EL30141/html. As argued by Rynning, in practice this principle has already applied to other healthcare professionals prior to this enactment. See Rynning (n 10) 128. Lag om åligganden för personal inom hälso- och sjukvården, SFS 1994:953 (repealed). Wahlberg and Persson (n 113) 570. An argument for the absence of legal content in this provision was put forward in a case before the Medical Responsibility Board, but it had no impact on the outcome. See Medical Responsibility Board, decision of 2 September 2009 No HSAN 2008/4114:B4.

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In Sweden, there is no legal definition of science. However, from section 2 paragraph 2 of the Ethical Review Act127 one can infer that there is a close link between scientific work and research. In a bill of a different act, science is conceptualised as knowledge that has been obtained systematically and methodologically within a specific area.The bill indicates that the decision of what constitutes science in a particular field must be based on all available science.128 However, this does not help to set the level of ‘science’ required under the science and proven experience standard. As scientific research in Sweden is regulated under a different framework, which includes the Ethical Review Act, one could argue that (at least prima facie) the medical care framework relates to the status quo of the science. This could be supported by the aforementioned argument that research is exempt from compliance with the requirements of science and proven experience.129 However, at the same time, given the developments in the area of scientific research, this does not necessarily lead to the conclusion that an intervention that is subjected to research cannot meet the standard of ‘science.’ Generally, science can be approached in broad and narrow terms. The narrow approach to science focuses on the respective field and specific questions addressed therein. Such an approach could be said to relate to the GRADE approach to assessing medical evidence. Namely, through an accepted methodology it is ascertained how the science stands on an issue. However, this approach rests on the assumption that science is defined by the elements covered by the respective mechanism. In their work, both of the Swedish authorities, namely, the National Board of Health and Welfare, and the Swedish Agency for Health Technology Assessment and Assessment of Social Services, use GRADE. As explained by Wahlberg, the national guidelines, as well as other forms of knowledge support in the field adopted by either of the authorities, can give insightful information on the nature of care that could be said to fulfil the criterion of science and proven experience.130 Such an approach, however, embraces not only the science limb of the principle but also the proven experience limb. A more general perspective of science allows integrating the previously discussed EBM criticism and accommodating the core argument put forward by the science-based medicine group. From the Swedish perspective, one could argue that other disciplines could even have an impact on the field of medicine and challenge the validity of results. While this approach could offer advantages as it enables other evidence to be taken into account (e.g. other scientific disciplines) and medical scientific findings to be assessed in light of other findings, it carries with it uncertainty about the types of disciplines and evidence, as well as how much evidence is needed in order for the requirement to be met. The assessment of ‘experience’ has been built into the GRADE system and seems to require documentation of the experience that the GRADE system tools can take into account. In the Swedish context, one of the fundamental questions related to the science and proven experience standard is whether the requirement of ‘experience’ relates to the respective medical professional’s experience or to experience within the medical profession more generally. Likewise, what is unclear is how much experience is enough in order for the ‘proven experience’ aspect

127 Lag om etikprövning av forskning som avser människor, SFS 2003:460. 128 Prop 2012/13:150, Patientrörlighet i EU – förslag till ny lagstiftning, 52.This approach can be compared with that of UNESCO, which in its Recommendation on Science and Scientific Researchers recommendation addresses science as a process as well as a fact or state. See para 1(a)(i). 129 See Wahlberg and Sahlin (n 113) 48. 130 See Wahlberg (n 113) 739.

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to be met, and how this experience should be assessed.131 While the requirement for individual experience could be seen as setting a higher standard (that experience needs to be obtained prior to an intervention), it would also create questions about how this experience could and should be obtained and whether there are adequate mechanisms in place for this to happen, for example, through the research avenue. Likewise, there is also a risk that individual experience as a criterion in some contexts might be inappropriate from a patient perspective due, for example, to risks of non-consensual scientific experimentation. Under the Swedish standard of care, the notion of science coexists with the notion of experience through a conjunction, which literally means ‘and.’The way one sees this conjunction is decisive in how science interplays with experience. Preparatory documents which can be used as guidance on the originally intended content of this concept are not available, and the preparatory works of the laws of 1960 do not elaborate on it in detail.The preparatory works of 1989 indicated that already by 1976 the National Board of Health and Welfare had provided guidance, stating that the word implies ‘both’ and not ‘either or.’ It elaborates: The requirement consists in the demand that the medical doctor, in the exercise of his or her profession, is bound to take account of both science and proven experience. The legal text thus implies an ‘and’ – not an ‘either … or.’At the time, for example, at which a new method is introduced, proven experience of it is trivially lacking, and the scientific evidence has to suffice for the decision to accept the method. … At other times, long clinical experience might be the dominant evidence in favour of accepting the medical treatment, whereas theoretical and/or experimental evidence for its effectiveness might be lacking.132 Given the age of this statement and the significant advances in regard to EBM, Wahlberg and Sahlin have argued that this explanation should be treated with caution.133 They have found the support in the National Board’s referral response to a different national law in regard to which the authority places primary emphasis on the science, leaving proven experience as a secondary criterion.134 However, at the same time the approach does not imply that science could be separated from experience, and experience relates to the ‘practice’ and ‘skills’ of the healthcare provider concerned rather than being an accepted practice in the field. In scholarly discussions, more measured approaches than the one suggested by the National Board of Health and Welfare have emerged. One is when only one of the criteria are met in a case ‘either or but not in conflict between the two’ could suffice.135 Such an approach sets rather clear but broad borders for the professional freedom of the medical profession. While there is room for further analysis of the requirement of science and proven experience, it suffices to note that while in some cases it can be rather easily established what meets this standard and consequently what medical care a child can be subjected to, in other cases it will rather be difficult to establish.This uncertainty has several far-reaching implications, including on the question of liability of healthcare providers and the actual nature of the care offered to an

131 See Johannes Persson and Lena Wahlberg, ‘Vår erfarenhet av beprövad erfarenhet’ [2005] Läkartidningen 112:DR6A. 132 SOU 1989:60 (n 114) 59. 133 Wahlberg and Sahlin (n 113) 62–63. 134 ibid 63. 135 Johannes Persson, Sten Anttila and Nils-Eric Sahlin,‘Hur Förstå ’och’ i ’vetenskap Och Beprövad Erfarenhet’?’ [2018] Filosofisk tidskrift.

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individual patient for her medical needs.At the most extreme, if there is no common verifiable understanding of what care meets the standard of science and proven experience, then care that is offered to an individual could differ depending on who is making the decision. If this happens the Swedish standard risks landing in the initial challenges the field of medicine faced when medicine was considered to be art.This, however, could risk resulting in liability. Operationalisation of this principle

The National Board of Health and Welfare has been tasked with ensuring in part that health care is provided in accordance with science and proven experience.This should happen through knowledge support and regulations.136 The Swedish Agency for Health Technology Assessment and Assessment of Social Services has been tasked with evaluating the scientific support for applied and new methods in health care.137 The latter produces checklists and assessments, which are its key tools for meeting the objective,138 whereas the former issues recommendations regarding the provision of medical care and adopts regulations that clarify the obligations set forth in the laws, thus contributing to clarifying the standard.The same also applies to regulations adopted by the Medical Products Agency.139 They could be said to shape what constitutes science and proven experience in the matters these instruments cover or allow to assess.140 However, where these guidelines are lacking, medical decision-making regarding what care should be offered to children again lands back on the principle of science and proven experience. In the absence of greater certainty, more than two decades ago Rynning had already explored the ambiguity over when exactly a new method can be regarded as being in line with the requirement of science and proven experience, and how it relates to exceptional cases. In that regard, she indicated that the room for manoeuvre for applying unestablished methods is considerably constrained.141 Relatively recently Wahlberg and Sahlin have labelled these non-conventional methods and have argued that in order for them to apply under the science and proven experience criterion, inter alia, sufficient evidence of their safety and effectiveness should exist.142 By doing so, they implicitly seem to argue against interventions that lack adequate scientific foundations. For over a decade already the application of new diagnoses or methods that have implications for human dignity or integrity are required to be assessed in terms of individual and social or societal ethical aspects.143 In essence, this means an external review prior to implementation in clinical practice. Although a broad interpretation could lead to a conclusion that almost any method in healthcare has relevance for integrity and dignity and thus be subject to review, in the preparatory works to this reform it is indicated that the concepts of ‘integrity’ and ‘dignity’

136 Förordning med instruktion för Socialstyrelsen, SFS 2015:284, section 4 para 1. 137 Förordning med instruktion för Statens beredning för medicinsk och social utvärdering, SFS 2007:1233, section 1. 138 See SBU,‘Method’ www.sbu.se/en/method/ accessed 22 July 2020. 139 The Medical Products Agency (Läkemedelsverket), Förordning med instruktion för Läkemedelsverket, SFS 2020:57. 140 See SOU 1989:60 (n 114) p 59. See, for example, decision of the Health and Social Welfare Inspectorate of 3 September 2015, Dnr 8.2-29040/2013. See also Medical Responsibility Board, decision of 5 February 2020 No 24.1 -20457/2019. 141 Rynning (n 10) 128–34. 142 Wahlberg and Sahlin (n 113) 65. 143 Hälso- och sjukvårdslag (n 99), Chapter 5 section 3.

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shall be narrowly interpreted.The preparatory works also indicate that focus should be on the methods that relate to existential questions about the beginning and end of life. Other methods could also be covered, but not, for example, elderly and home healthcare.144 It is clear that this requirement is not intended to be treated as mandatory, and uncertainties about whether a method should or should not be subjected to review could emerge. Moreover, it means that methods that are not subject to this review can be introduced into healthcare. Finally, it will be for each healthcare provider to decide on a particular intervention and whether it meets the requirement of science and proven experience. However, whether the care is such that it meets the standard will ultimately be decided by those entrusted with ensuring oversight of the field.145 This could have differing and far-reaching implications, which I shall consider in the concluding part of this chapter.

Child integrity and best interests Protection of bodily integrity

Matters relating to a child’s rights and personal integrity rest on several constitutional provisions. Firstly, an objective that is set forth in the Instrument of Government is to safeguard a child’s rights,146 along with the objective to protect each individual’s right to privacy and family life.147 Secondly, bodily integrity falls under the individual rights block of the constitution. In accordance with Chapter 2 Article 6, paragraph 1 of the Instrument of Government, everyone is ‘protected in their relations with the public institutions against any physical violation.’ Furthermore, paragraph 2 of the same provision safeguards ‘against significant invasions of their personal privacy, if these occur without their consent and involve the surveillance or systematic monitoring of the individual’s personal circumstances.’148 These protections can be limited if the conditions set forth in Chapter 2 Article 20 of the Instrument of Government are fulfilled. In particular, this means that a law, i.e. an act of Parliament, is necessary in order for a limitation to be considered permissible. As can be derived from the preparatory works to the Patient Act, Chapter 2 Article 6, paragraph 1 of the Instrument of Government is of particular importance.149 It sets out that healthcare seeks to protect individuals from forced actions taken by public authorities. This covers invasive and non-invasive medical interventions carried out within publicly organised healthcare.150 However, interventions that are not regarded as forced do not fall under this constitu-

144 145 146 147

Prop 2009/10:83, Etisk bedömning av nya metoder i vården, 26–27. Rynning (n 10) 130. Kungörelse om beslutad ny regeringsform, SFS 1974:152 Chapter 1 Article 2. Kungörelse om beslutad ny regeringsform (n 146) Chapter 1 Article 2. See Johanna Schiratzki,‘Children’s Right to Family Life and the Swedish Constitution’ in Trude Haugli and others (eds), Children’s Constitutional Rights in the Nordic Countries (Brill Nijhoff 2019). 148 According to Litins’ka, paragraph 2 aims to strengthen these protections and safeguards against significant interventions without informed, voluntary, and explicit consent. Although this protection is conditioned on the existence of surveillance or systematic monitoring of the individual’s personal circumstances.As argued by her, it cannot be precluded that collection of data about a patient falls within the scope of application of this provision, and in case of overlaps the one offering stronger protection shall prevail.Yana Litins’ka, ‘Assessing Capacity to Decide on Medical Treatment: On Human Rights and the Use of Medical Knowledge in the Laws of England, Russia and Sweden’ (Uppsala University 2018) 463. 149 Prop 2013/14:106 (n 112) 56. 150 See Prop 1973:90, Kungl. Maj:ts proposition med förslag till ny regeringsform och ny riksdagsordning m. m., p 242.The notion of public authorities shall be interpreted broadly and in accordance with Chapter 12 Article 4

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tional protection.151 For example, Rynning has emphasised that there should be at least reason to assume that the person concerned would have opposed the intervention, namely, the presence of a hypothetical opposition.152 Following the adoption of the Patient Act, Kindström-Dahlin emphasised the importance of legally binding consent as an important criterion in determining whether a constitutional provision has been violated.153 However, neither of the scholars seems to imply that in all cases absence of valid consent amounts to a violation of the constitution. On the contrary, for example, Rynning has argued that ‘it can hardly be argued that an intervention has been imposed in situations where the individual has agreed to commitments because of having not received complete information regarding, for example, the risks of the measure.’154 Given the evolution in integrity protection from a human rights perspective, one could question whether a more expansive interpretation of this constitutional protection should be given. Protection of integrity under the Patient Act: information and consent

The Swedish Patient Act does not expressis verbis entail a right to informed consent. Nonetheless, it requires that the patient’s self-determination rights and integrity shall be respected. Furthermore, it states that care may not be given unless the patient’s consent is received, except when there is a legal basis to provide medical care without such consent.155 This also applies to children. Regarding children, the law does not set a statutory consent age. Instead, it states that ‘when the patient is a child, the child’s attitude to the current care or treatment should be clarified as far as possible.The child’s attitude should be given importance in relation to his or her age and maturity.’156 The preparatory works to the Patient Act indicate that it drew on other areas where the age of 15 was seen as an age of empowerment to set the presumption threshold there. In accordance with this threshold, for children under the age of 15 the presumption of incompetence applies, while after the age of 15 presumption of competence applies.157 However, in either case, an individual assessment needs to be made.158 It can therefore be stated that in some situations children will be regarded as competent to make decisions about their own healthcare. Parental authority is addressed in the Parental Code. Generally, if a child is under the custody of one parent, that parent decides on the child’s personal matters, including on health.159 However, if the child is under the custody of both parents, they both decide.160 Exceptions apply

151 152 153 154 155

156 157 158 159 160

para 2 of the Instrument of Government covers even situations where delegation of powers is given to private subjects. See review made by Litins’ka (n 148) 456. Moa Kindström-Dahlin,‘Att Tvinga Ett Barn–Om Barns Rättigheter i Hälso-Och Sjukvården Och Behovet Av En Tydligare Tvångsvårdslagstiftning’ (2016) 2 Förvaltningsrättslig tidskrift 245, 260. Rynning (n 10) 107–108. Kindström-Dahlin (n 151) 206. Rynning (n 10) 107. Patientlag (n 101) Chapter 4 section 2. On the challenges and tensions relating to the informed consent and the rights discourse, see Jameson Garland,‘Informed Consent as a Right: Regulatory Challenges in the Swedish Legal Framework’ (2018) 2 Förvaltningsrättslig tidskrift 233. On challenges in the application of the informed consent, see Jameson Garland, ‘Informed Consent in Clinical Practice in Sweden: Challenges in Protecting Patients’ Rights through Medical Science and Law’ (2019) 1 Förvaltningsrättslig tidskrift 49. Patientlag (n 101) Chapter 4 section 3. Prop 2013/14:106 (n 112) 65–67. ibid at 66. See also Parliamentary Ombudsman decision of 23 November 2018 dnr. 3153–2016. Föräldrabalk (n 102) Chapter 6 section 13 para 1. ibid Chapter 6 sections 2 and 11. In the event that only one of the two parents agree to medical care, social services may be involved to give decision on behalf of a child. See Föräldrabalk (n 102) Chapter 6 section 13a.

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when one of the parents is prevented from participating in decision-making because of, for example, absence, unless the question relates to something that is of considerable importance to the child’s future or the principle of best interests requires otherwise.161 Decisions that are less intrusive into the child’s integrity can be made by one guardian, if the circumstances so require.162 Likewise, if a child herself is deemed competent to decide, she may do so.163 Under the Parental Code, the custodian must, as the child’s age and development increases, take greater account of the child’s views and wishes. On this basis, the parents are empowered to assert the child’s interests in a particular case with due regard to the views of the child.164 Before consent to medical care is obtained, relevant information that is adjusted to the age, maturity, experience, language background, and other relevant elements must be provided to a patient, which enables her to make an informed decision.165 Chapter 3 sections 1 and 2 of the Patient Act set forth detailed information obligations of the care provider. For the purposes of this analysis, it suffices to note only the most relevant ones: first, the methods available for examination, care, and treatment;166 second, the expected course of care and treatment;167 and third, information regarding significant risks of complications and side effects.168 Whether it is the child who consents to medical care or the guardians, in addition to the child receiving information, the guardians must also receive it unless exceptions relating to confidentiality apply.169 The key question is to what extent do the existing requirements on informed consent ensure that the patient (and the decision-maker when the decision is not made by the patient) is informed about the medical care being offered. While on the surface the requirement to disclose methods available for examination, care, and treatment could also enable the disclosing of the limitations of these foundations from the science and proven experience perspective, the preparatory works indicate that the starting point is the existence of methods that meet the standard. As stated therein, the intended meaning of the phrase ‘expected course of care and treatment’ is ‘a description of what the patient can normally expect in relation to the offered care, and as a result of this care.’ Moreover, the phrase ‘information regarding significant risks of complications and side effects’ ‘refers to risks that are not negligible.’170 As explained further in the preparatory works, the duty of information cannot be considered to cover all possible risks and complications that an intervention can lead to, for example, very rare complications. However, if a side effect of a treatment is relatively uncommon but very serious, it may be considered a significant risk to the patient about which he or she should be informed. The requirement for information in this section must be proportionate to the planned treatment.’171

161 Föräldrabalk (n 102) Chapter 6 section 13 para 2. Exception to this applies when a child is under the custody of both parents but one of them is permanently prevented from exercising the custody. See Föräldrabalk, SFS1949:381, Chapter 6 section 8a. 162 Prop 1975/76:170, om ändring i föräldrarbalken, m.m., 178. 163 See Parliamentary Ombudsman decision of 23 November 2018 dnr. 3153–2016. 164 Prop1981/82:168, om vårdnad och umgänge m.m., p 24. 165 Patientlag (n 101) Chapter 3 Section 6 and Chapter 3 sections 1 and 2. 166 ibid Chapter 3 section 1 para 2. 167 ibid para 5. 168 ibid para 6. 169 ibid section 3. 170 Prop 2013/14:106 (n 112) 114. 171 ibid.

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In other words, the legal requirements offer guidance regarding the disclosure, but the judgement on the relevant information to disclose remains with the particular care provider, with due regard to the individual patient in focus.These requirements seem to be open to accommodate the disclosure of various limitations associated with medical care, including scientific uncertainty.

Interplay of the applicable requirements Neither of the acts that expressis verbis requires taking into consideration the child’s best interests in medical care elaborates172 the meaning of the child’s best interests in health care. In the preparatory works to the Patient Act, it is indicated that ‘the healthcare staff must take into account science and proven experience and, depending on the child’s age and maturity, obtain evidence from the guardians.’When necessary, information from other sources can be obtained. Additionally, in line with Article 12 of the CRC, the child’s views must be considered. This indicates that ‘the starting point of the child’s best interests is respect for the child’s full human dignity and integrity.’173 Although the preparatory works to the Health and Medical Services Act implicitly endorse this approach,174 as the earlier analysis on standard of care shows, the requirement of science and proven experience is conceptualised in terms of ‘must take into account.’ This hardly allows any room to deviate from this standard.Therefore, it could be said that it is left to the care providers, in the first place, to decide what care can be offered to a child. It is only then, from these alternatives, that there is a choice for the child’s parents (or if the child can consent, the child) to decide on. One could question how the fact that the best interests consideration is intertwined with the requirement of science and proven experience could affect parental authority and responsibility for the child’s personal matters. In one scenario, shared decision-making could take place thus enhancing the parental participation and role. In another scenario, as decision-making is only vaguely addressed in the preparatory works, it could be a care provider that has reached the decision about care and what is then left is to obtain a rather formal consent in order for it to be carried out, unless an emergency requires a non-consensual intervention175 or there are several alternatives to choose from that are compliant with science and proven experience and best interests. However, even obtaining that rather formal consent might not be challenge free and cases of parental disagreement176 or neglect of the duty of care177 could trigger the interven-

172 173 174 175 176

Chapter 5 section 6 of the Health and Medical Care Act and Chapter 1 section 8 of the Patient Act. Prop 2013/14:106 (n 112) 63. See Prop 2016/17:43 (n 111) 97–98. Interventions carried out in the absence of consent are regulated under Chapter 4 section 4 of the Patient Act. An illustrative case for addressing the parental disagreement in the case of use of medicine and the standard of care is HFD 2015 ref 5. In the cases of parental disagreement for a Social Welfare Board to consent to care, it is necessary that the intervention is from the child’s best interests perspective.That requires the Social Welfare Board to obtain adequate information to identify the necessity for such care, including second opinion, and, if needed to assess the guardian’s objections, a complementary assessment of an independent doctor. Whether a guardian’s objections can be considered to have such weight that there is reason to obtain a supplementary medical assessment should also be decided with regard to how well substantiated the investigation that already exists is judged to be.Additionally, according to the court, the nature of the intervention and continuity could have an importance on the best interests analysis. Finally, should the Social Welfare Board approve the care, the decision shall meet the requirements prescribed by the principle of legal certainty in a particular case. HFD 2015 ref 5. 177 Pernilla Leviner, ‘Who Has the Final Word? On Trust and Legal Uncertainty within the Swedish Healthcare System’ in Imogen Gools, Cressida Auckland, and Jonathan Herring (eds), Medical Decision-Making on Behalf of Young Children.A Comparative Perspective (Hart 2020), 155–66.

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tion of the Social Welfare Board to ascertain the best interests and make a decision, should that be needed. As was previously established, bodily integrity is protected under the Swedish constitution and requires a legal basis for an intervention. One such basis is the research framework, another is the healthcare framework, although admittedly there is considerable interplay between the two, and there are interventions that relate to neither of them.The healthcare framework does not permit substandard care, but at the same time it does not provide tools to establish the type or level of care that meets the standard. This uncertainty has far-reaching implications. First, the question arises about what, if any, is the standard that society and individual patients can rely on when seeking healthcare. Second, just how ‘established’ should novel interventions be under the requirement of science and proven experience to be able to offer them to a child. Further inquiries into the assessments of healthcare quality could shed some light on this matter. However, already here it can be noted that some resistance has emerged about accepting relatively recent interventions that are intended for a condition that is not accompanied by a code in the Swedish disease classification.178 In addition to the fact that there is uncertainty about the types of interventions children may be subjected to, there is related uncertainty regarding what, if any, of these interventions lead to risks of liability for the care provider associated with substandard care. A broad interpretation of the science and proven experience concept could risk creating considerable room for new interventions, and require considering when care is medical care and when it can be considered an impermissible scientific experimentation. A narrow interpretation could risk setting a very high standard for an intervention to enter into medical practice and therefore potentially create an obstacle to innovative care.

Tying up the loose ends: standard of care and decisionmaking perspectives in paediatric care There is a considerable layer of international human rights law, EU law, and national Swedish law that requires medical care generally and paediatric care specifically to be of appropriate quality. This requirement is of central importance in Sweden in regulating what care can be offered to a paediatric patient and what care the patient or her parents can consent to. However, there is ambiguity about what exactly quality is, what care falls within the standard of science and proven experience, and how to verify it.As was previously discussed, in some cases medical decision-making will be straightforward as there is sufficient data and adequate preconditions to operationalise them. However, in other cases, it can be problematic as adequate data are lacking and it is difficult to carry out the necessary research.This ambiguity and uncertainty casts doubt over the protection of integrity that human rights and Swedish constitutional law grants to a child in need of medical care. Both international human rights standards and Swedish national law defer to the medical profession in defining what quality of medical care is.The medical profession, at least from the EBM perspective, offers a functional approach in assessing evidence and transposing it into clinical practice, but at the same time is aware of its shortcomings – for example, regarding existence of evidence, quality of evidence, and resources that are necessary for assessing the evidence and

178 In one case, it was provided to a child by a doctor without paediatric speciality. It is unclear what bearing this fact had on the decision of the board.The Medical Responsibility Board (Hälso- och sjukvårdens ansvarsnämnd), Förordning med instruktion för Hälso- och sjukvårdens ansvarsnämnd, SFS 2011:582, para 1.

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transposing it to medical decision-making. In Sweden, quality is ensured through the notion of science and proven experience: a notion that transplants medical knowledge in the legal discipline and as such brings along challenges,179 as well as a notion that fails to provide tools to verify when an intervention that is not yet well established, either generally or for a particular patient group specifically, may be offered to patients in clinical care. Challenges associated with this uncertainty could, to some degree, be overcome if relevant mechanisms were put in place to control the entry of methods into clinical care. However, in Sweden, this control is an exception that applies to a narrow group of interventions rather than a rule for all new interventions. This can be contrasted with approaches other countries have taken in requiring a method to be registered prior to it being implemented in practice.180 In the absence of such a control, the question emerges about the type of legal tools needed to ensure quality of care. Uncertainty about the standard of care and challenges to setting boundaries allows questioning how difficult it will be to anticipate when a medical professional is deviating from the standard.While the advantages of granting such considerable leeway to the medical profession are clear, challenges could emerge from the perspective of patient integrity protection, more specifically, how the requirement of informed consent can be met. In the Swedish context, the requirement of ‘information’ prior to consent being acquired requires disclosure of risks that are not negligible.This spills over into the question of what interventions children can be subjected to and how this uncertainty affects the assessment of the child’s best interests. Singer has rightly claimed that medical care that does not meet the standard of science and proven experience can hardly be seen as compatible with the principle of the child’s best interests.181 However, this lack of clarity risks rendering cumbersome identification of situations when these violations occur. One could argue that effective implementation of the principle of best interests would require that the standard of care was clarified. From the human rights perspective, this situation allows questioning whether the science and proven experience requirement and the difficulty in establishing the content of this notion meet the requirements of the existence of ‘law’ that are relevant for both integrity protection provisions182 and the prohibition of a punishment without law under Article 7 ECHR. Moreover, it is unclear whether it offers adequate foreseeability of the standard and risks for the parties involved. It is well established that ‘the need to avoid excessive rigidity and to keep pace with changing circumstances means that many laws are inevitably couched in terms which, to a greater or lesser extent, are vague.’183 It is precisely this approach that has been coined as the vessel approach in the Swedish law-making technique.184 Previously, the ECtHR has appeared to be tolerant of the existence of grey areas that can be attributed to legislative technique.185 However, one should also be mindful of the risks associated with the use of overly vague concepts and criteria,186 and the need for adequate mechanisms to be in place for ensuring patient

179 See Wahlberg and Persson (n 113). 180 For example, Latvia. See section 91 of the Medical Treatment Law, Latvijas Vēstnesis, 167/168, 01.07.1997. However, at the same time it is an open question whether non-registered methods could be used in medical care. 181 Anna Singer, Barnets Bästa: Om Barns Rättsliga Ställning i Familj Och Samhälle (Norstedts Juridik AB 2019) 380. 182 Garland (n 113) 89. 183 Kokkinakis v Greece,App no 14307/88 (ECtHR, 25 May 1993) [40]. 184 Jane Reichel,‘European Legal Method from a Swedish Perspective: Rights, Compensation and the Role of the Courts’ in Ulla Neergaard and Ruth Nielsen (eds), Towards a European Legal Method: Synthesis or Fragmentation? (DJØF 2011) 248–51. 185 Cantoni v France,App no 17862/91 (ECtHR 15 Nov 1996) [32]. 186 Liivik v Estonia,App no 12157/05 (ECtHR, 25 June 2009) [96]–[104].

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protections.187 One can question whether persistent disregard of uncertainty at the national level is excusable under the ECHR standard which tolerates some ambiguity, regardless of whether the situation is assessed from the integrity, liberty, or punishment point of view, or whether the mechanism could risk collapsing should stronger human rights voices emerge.A deeper inquiry from the human rights perspective is necessary to test the viability of this ambiguous standard. In either case, for a matter to be tried at the ECtHR not only should the national remedies fail to deliver justice in the cases of violation but the case should also pass the threshold of ‘mere’ negligence set by the ECtHR in the malpractice cases. The principle of a child’s best interests requires that they are considered in all matters relating to children. In the Swedish context, the care providers have been placed in the position of offering care that is in the best interests of children, whilst taking into account a number of perspectives. Swedish healthcare can therefore be argued to have made the transition from parental decision-making to medical decision-making, where the care providers are required to assess all relevant circumstances in order to arrive at a medical decision that is in the child’s best interests. While this approach, at least on the surface, means that everyone acts in the child’s best interests, it also means that parental authority has to some degree been transformed into the binary response of either ‘accepting’ or ‘refusing’ care that has been offered, or where several alternatives exist, choosing from these, whereby the latter is subject to a potential public intervention. In the Swedish context this situation allows questioning whether parental consent is nothing more than a formality of keeping the parents informed and maintaining a false feeling of control over their children as part of their duty to care. In this complex environment, paediatrics is an area that could be receptive to shared decision-making practices. However, whether adequate preconditions are in place for it to happen and whether and to what extent it is practised is another question that remains to be explored elsewhere. In either case, in Sweden, the healthcare regulatory standard makes no room for the provision of medical care that does not meet the standard of science and proven experience. However, at the same time, if it is difficult to establish what the standard is, one can question how the standard interplays with a scientific research regulatory framework and the internationally recognised prohibition of non-consensual scientific experimentation. Likewise, it is unclear how to classify interventions that do not meet the standard and whether there is an adequate mechanism in place that allows the standard to be expanded in both emergency and non-emergency settings. From a human rights perspective, inquiries are needed into the interplay between science and clinical care expressed through the right to benefit from scientific progress and its applications, prohibition of illegal and unethical scientific experimentation, and the right to health and integrity, as well as its implications for the area of family law.

Acknowledgements I would like to thank LL.D.Yana Litins’ka for insightful comments on an earlier draft of the manuscript and Susan Cleary for the proofreading. This contribution has been possible with the generous support of the Swedish Research Council (Vetenskapsrådet) for the project ‘Beslutsfattande för barn vid medicinsk behandling med ovissa resultat,’ project-id: 2017-02992.

187 See discussion in the section titled ‘Quality matters, but what is quality?’

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Santa Slokenberga Garland, Jameson,‘Testing the Bounds of Lawful Medicine in Sweden:Vetenskap Och Beprövad Erfarenhet as a Legally Enforceable Standard of Care’ [2019] Nordisk socialrättslig tidskrift 79. Garland, Jameson, and Slokenberga, Santa, ‘Protecting the Rights of Children with Intersex Conditions from Nonconsensual Gender-Conforming Medical Interventions: The View from Europe’ (2019) 27 Medical Law Review 482. Goldet, Gabrielle, and Howick, Jeremy, ‘Understanding GRADE: An Introduction’ (2013) 6 Journal of Evidence-Based Medicine 50. Goold, Imogen, Herring, Jonathan, and Auckland, Cressida (eds), Parental Rights, Best Interests and Significant Harms: Medical Decision-Making on Behalf of Children Post-Great Ormond Street Hospital v Gard (1st edn, Hart Publishing 2019). Guyatt, Gordon, and others, ‘Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine’ (1992) 268 JAMA 2420. Grahn-Farley, Maria, ‘Fördragskonform Tolkning av MR-Traktat’ [2018] Svensk Juristtidning 423. Guyatt, Gordon H,‘Evidence-Based Medicine’ (1991) 114 ACP Journal Club A16. Guyatt, Gordon H, and others, ‘GRADE: An Emerging Consensus on Rating Quality of Evidence and Strength of Recommendations’ (2008) 336 BMJ 924. Haynes, R Brian, ‘What Kind of Evidence Is It That Evidence-Based Medicine Advocates Want Health Care Providers and Consumers to Pay Attention To?’ (2002) 2 BMC Health Services Research 3. Hendriks, Aart, and Toebes, Brigit, ‘Towards a Universal Definition of the Right to Health’ (1998) 17 Medicine and Law 319, 10–17 https://ec.europa.eu/health/sites/health/files/files/paediatrics/2016_ pc_report_2017/ema_10_year_report_for_consultation.pdf accessed 4 August 2020. Human Rights Committee, General Comment No 36,Article 6: Right to Life, 3 September 2019, CCPR/C/ GC/36, paras 25–26. Ioannidis, John PA,‘Why Most Published Research Findings Are False’ (2005) 2 PLoS Medicine e124. Ioannidis, John PA,‘Evidence-Based Medicine Has Been Hijacked: A Report to David Sackett’ (2016) 73 Journal of Clinical Epidemiology 82. Jamar, Steven D,‘The International Human Right to Health’ (1994) 22 Southern University Law Review 1. Jones, Glenn W and Sagar, Stephen M,‘Evidence Based Medicine: No Guidance Is Provided for Situations for Which Evidence Is Lacking.’ (1995) 311 BMJ 258. Kavanagh, Brian P, ‘The GRADE System for Rating Clinical Guidelines’ (2009) 6(9) PLoS Medicine e1000094. Kimland, Elin, and Odlind, Viveca, ‘Off-Label Drug Use in Pediatric Patients’ (2012) 91 Clinical Pharmacology 796–801. Kindström-Dahlin, Moa, ‘Att Tvinga Ett Barn–Om Barns Rättigheter i Hälso-Och Sjukvården Och Behovet Av En Tydligare Tvångsvårdslagstiftning’ (2016) 2 Förvaltningsrättslig tidskrift 245. Kopelman, LM, ‘The Best-Interests Standard as Threshold, Ideal, and Standard of Reasonableness’ (1997) 22 The Journal of Medicine and Philosophy 271. Koretz, Ronald L, ‘Assessing the Evidence in Evidence-Based Medicine’ (2019) 34 Nutrition in Clinical Practice 60. Leviner, Pernilla,‘Who Has the Final Word? On Trust and Legal Uncertainty within the Swedish Healthcare System’ in Imogen Gools, Cressida Auckland and Jonathan Herring (eds), Medical Decision-Making on Behalf of Young Children:A Comparative Perspective (Hart 2020) 155–66. Liefaard, Ton, Hendriks, Aart, and Zlotnik, Daniella, From Law to Practice:Towards a Roadmap to Strengthen Children’s Rights in the Era of Biomedicine (Council of Europe 2017). Lind, Anna-Sara, ‘The Right to Health in Sweden’ in Aeyal Gross and Colleen M Flood (eds), The Right to Health at the Public/Private Divide:A Global Comparative Study (Cambridge University Press 2014). Litins’ ka, Yana, Assessing Capacity to Decide on Medical Treatment: On Human Rights and the Use of Medical Knowledge in the Laws of England, Russia and Sweden (Uppsala University 2018) 463. Magalhães, Joana, and others,‘Use of Off-Label and Unlicenced Drugs in Hospitalised Paediatric Patients: A Systematic Review’ (2015) 71 European Journal of Clinical Pharmacology 1. Marcusson, Lena, ‘Det Offentliga Uppdraget Och de Mänskliga Rättigheterna’ in Anna-Sara Lind and Elena Namli (eds), Mänskliga rättigheter i det offentliga Sverige (Studentlitteratur 2017) 33. Nielsen, Eva Skovslund, and others, ‘Off-Label Prescribing of Psychotropic Drugs in a Danish Child and Adolescent Psychiatric Outpatient Clinic’ (2016) 25 European Child & Adolescent Psychiatry 25. Norris, Susan L, and Bero, Lisa, ‘GRADE Methods for Guideline Development:Time to Evolve?’ (2016) 165 Annals of Internal Medicine 810.

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Paediatric care decision-making Nunes, Rui, Nunes, Sofia B, and Rego, Guilhermina, ‘Health Care as a Universal Right’ (2017) 25 Zeitschrift Fur Gesundheitswissenschaften 1. Persson, Johannes and Wahlberg, Lena, ‘Vår erfarenhet av beprövad erfarenhet’ [2005] Läkartidningen 112:DR6A. Pontin, DM, Författningar m.m. angående medicinalväsendet i Sverige, omfattande år 1890 (P.A. Norstedt & Söner 1891). Riedel, Eibe, Giacca, Gilles, and Golay, Christophe, ‘The Development of Economic, Social, and Cultural Rights in International Law’ in Eibe Riedel, Gilles Giacca, and Christophe Golay (eds), The Development of Economic, Social, and Cultural Rights in International Law (Oxford University Press 2014). Rynning, Elisabeth, Samtycke Till Medicinsk Vard Och Behandling: En Rattsvetenskaplig Studie (Uppsala University 1994) 185–276, in particular, 197–238. Sackett, David L,‘Evidence-Based Medicine’ (1997) 21 Seminars in Perinatology 3. SBU,‘Method’ www.sbu.se/en/method/ accessed 22 July 2020. Schiratzki, Johanna, ‘Children’s Right to Family Life and the Swedish Constitution’ in Trude Haugli and others (eds), Children’s Constitutional Rights in the Nordic Countries (Brill Nijhoff 2019). Singer, Anna, Barnets Bästa : Om Barns Rättsliga Ställning i Familj Och Samhälle (Norstedts Juridik AB 2019). Socialstyrelsen, ‘Nationella Riktlinjer. Metodbeskrivning’ www.socialstyrelsen.se/globalassets/sharepoin t-dokument/dokument-webb/nationella-riktlinjer/nationella-riktlinjer-metodbeskrivning.pdf accessed 14 November 2020. Steffen, Grant E,‘Quality Medical Care:A Definition’ (1988) 260 JAMA 56. Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020–2025), Adopted by the Committee on Bioethics at its 16th meeting (19–21 November 2019), https://rm.coe.int/strategic-a ction-plan-final-e/16809c3af1. See further Laurence Lwoff, ‘New Technologies, New Challenges for Human Rights? The Work of the Council of Europe’ (2020) 1 European Journal of Health Law 1. Thomas, Bull, and Sterzel, Fredrik, Regeringsformen – en kommentar (4th edn Studentlitteratur AB 2019) 89. Toebes, Brigit,‘Towards an Improved Understanding of the International Human Right to Health’ (1999) 21 Human Rights Quarterly 661. UN Committee on Economic, Social and Cultural Rights, General Comment No 3: The Nature of States Parties’ Obligations (Art 2, para 1, of the Covenant), 14 Dec 1990. UN Committee on Economic, Social and Cultural Rights, General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant), 11 August 2000, E/C.12/2000/4. UN Committee on the Rights of the Child, General Comment No 15 (2013) on the Right of the Child to the Enjoyment of the Highest Attainable Standard of Health (Art. 24), CRC/C/GC/15. Wahlberg, Lena, ‘Rätten Till Ersättning För Gränsöverskridande Våd Och Kravet På Vetenskap Och Beprövad Erfarenhet’ [2018] Förvaltningsrättlig tidskrift 789. Wahlberg, Lena and Persson, Johannes,‘Importing Notions in Health Law: Science and Proven Experience’ (2017) 24 European Journal of Health Law 565. Wahlberg, Lena, and Sahlin, Nils-Eric,‘Om Icke Vedertagna Behandlingsmetoder Och Kravet På Vetenskap Och Beprövad Erfarenhet’ [2017] Förvaltningsrättslig tidskrift 45. Weda, Marjolein, Joëlle, Hoebert, Marcia, Vervloet, Carolina, Moltó, Nikky Damen, Puigmarti, Sascha Langedijk, Marchange, Lisman, Joris, and van Dijk, John, Liset for the European Commission, Study on OffLabel Use of Medicinal Products in the European Union, EU 2019. Wyer, Peter C, ‘From MARS to MAGIC: The Remarkable Journey Through Time and Space of the Grading of Recommendations Assessment, Development and Evaluation Initiative’ (2018) 24 Journal of Evaluation in Clinical Practice 1191. Zillén, Kavot, Garland, Jameson, and Slokenberga, Santa, The Rights of Children in Biomedicine: Challenges Posed by Scientific Advances and Uncertainties (Council of Europe 2017).

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9 THE RIGHT TO HEALTH IN HONG KONG Incorporation, implementation, and balancing Edward Lui

Introduction In 2000, the United Nations (UN) Committee on Economic, Social and Cultural Rights adopted its General Comment No 14 on the right to health. It began by saying that ‘health is a fundamental human right indispensable for the exercise of other human rights. Every human being is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity.’1 These words highlight the importance of the right to health as an international human right.This chapter adds onto the work in the earlier chapters, by examining how this fundamental right operates in Hong Kong.The analysis will proceed in two parts. First, it will be contended that only a small portion of the right to health is incorporated into Hong Kong law. The majority of it is excluded from the corpus of constitutional rights. Nor is the right sufficiently protected by the common law principles in Hong Kong. Second, two recent government policies on health and public assemblies will be examined. In those policies, we see the government has attempted to balance the right to health with other conflicting rights and policy aims.While this effort is commendable, its balancing exercise is often contestable.

Incorporation: the right to health as a constitutional right? Hong Kong is a common law jurisdiction that exists within China.The Basic Law2 – its constitutional document – creates within Hong Kong a system of constitutional rights. Unlike the English position under the Human Rights Act 1998,3 a constitutional right under the Basic Law is overriding: if primary legislation is found incompatible with it, the courts may directly strike

1 Committee on Economic, Social and Cultural Rights, CESCR General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art. 12) (11 August 2000) [1]. 2 The Basic Law of the Hong Kong Special Administrative Region of the People’s Republic of China. 3 Edward Lui and Michelle Yik Yu Wong, ‘Subordinating Subordinate Legislation under the Human Rights Act 1998’ (2020) 136 LQR 354, 356.

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it down.4 There are two sources of constitutional rights under the Basic Law. The first source of constitutional rights is from the body of the Basic Law itself. Chapter III of the Basic Law is titled ‘Fundamental Rights and Duties of the Residents.’5 It contains an array of rights, such as the right to equality,6 the right to vote,7 the freedom of assembly,8 and the freedom of speech.9 There are other some rights which can be found from other chapters of the Basic Law,10 such as the right to property.11 The second source of constitutional rights is the Hong Kong Bill of Rights.12 Article 39(1) of the Basic Law provides that The provisions of the International Covenant on Civil and Political Rights [ICCPR], the International Covenant on Economic, Social and Cultural Rights [ICESCR] … as applied to Hong Kong shall remain in force and shall be implemented through the laws of the Hong Kong Special Administrative Region.13 This may create the impression that the Basic Law thereby incorporates the ICCPR and ICESCR within Hong Kong’s framework of constitutional rights. This impression must be resisted. The article only relates to the covenants ‘as applied to Hong Kong.’ This reflects the dualist principle: obligations in international law do not form part of the domestic law, unless and until the obligations are incorporated by domestic legislation. As a result, only the parts of the ICCPR and ICESCR that are incorporated by local legislation will form part of the constitutional rights in Hong Kong. The contrary is also true: if they are not so incorporated, they will not become constitutional rights – whether or not this involves a breach of the treaty obligations in international law.14 This is where the Hong Kong Bill of Rights15 comes into play. It implements by local legislation the ICCPR rights to Hong Kong.16 Accordingly, such rights also form part of the constitutional rights in Hong Kong. Let us apply this approach to the ICESCR. It is true that China – Hong Kong’s sovereign – is a party to the ICESCR.17 But per Article 39(1) of the Basic Law (and the dualist principle which it embodies), the ICESCR is not thereby incorporated within Hong Kong.There must be additionally a piece of implementing legislation in Hong Kong for the ICESCR rights to achieve constitutional status. It is clear that in Hong Kong, there is no comprehensive incorpora-

4 Ng Ka Ling v Director of Immigration (1999) 2 HKCFAR 4, 25; Kemal Bokhary, ‘Judicial Striking-Down of Unconstitutional Legislation’ (2020) 50(1) Hong Kong Law Journal 77, 80–81. 5 Dinusha Panditaratne, ‘Basic Law, Hong Kong Bill of Rights and the ICCPR’ in Johannes Chan and CL Lim (eds), Law of the Hong Kong Constitution (2nd edn, Sweet & Maxwell 2015) [16.032], [16.054]. 6 The Basic Law (n 2) Art 25. 7 ibid Art 26. 8 ibid Art 27. 9 ibid. 10 Hysan Development Co Ltd v Town Planning Board (2016) 19 HKCFAR 372 [33]. 11 Basic Law (n 2) Arts 6, 105. 12 Panditaratne (n 5) [16.054]. 13 Basic Law (n 2) Art 39(1). 14 Ubamaka Edward Wilson v Secretary for Security (2012) 115 HKCFAR 743 [43]; GA v Director of Immigration (2014) 17 HKCFAR 60 [58]; Comilang Milagros Tecson v Director of Immigration (2019) 22 HKCFAR 59 [74]. 15 Contained in the Hong Kong Bill of Rights Ordinance (Cap 383). 16 Bokhary (n 4) 78, 80. But see Panditaratne (n 5) [16.018] for some qualifications to this position, which are not here relevant. 17 Michael Ramsden and Luke Marsh, ‘Refugees in Hong Kong: Developing the Legal Framework for SocioEconomic Rights Protection’ (2014) 14 Human Rights Law Review 267, 268.

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tion of the ICESCR into a single piece of domestic legislation.18 This means that the rights in the ICESCR – including the right to health – do not generally form part of the constitutional rights in Hong Kong. Comilang illustrates this. In this case, the applicants were respectively mothers (with no right to abode in Hong Kong) and children (with a right to abode in Hong Kong).The Director of Immigration refused to grant the mothers an extension of permission to remain in Hong Kong and take care of their children.The applicants applied for judicial review and partly relied on Article 10(1) of the ICESCR, which stipulates that ‘the widest possible protection and assistance should be accorded to the family, which is the natural fundamental group unit of society.’19 The court rejected their application based on the ICESCR: The appellants’ reliance on ICESCR 10 is unsustainable for the simple reason that the ICESCR is an international treaty and under the common law dualist principle is not self-executing. Unless and until made part of Hong Kong domestic law by legislation, the provisions of such a treaty do not confer or impose any rights or obligations on individual citizens.20 The same point applies to the right to health embodied by the Universal Declaration of Human Rights (UDHR).There is a debate as to whether the UDHR is merely soft law (i.e. creating no international legal obligations) or has been incorporated as part of customary international law (thus creating international legal obligations).21 Regardless of this debate, since the rights under the UDHR were not incorporated by local legislation, they do not form part of the constitutional rights in Hong Kong.22 There is, therefore, no general recognition of the right to health as a constitutional right within Hong Kong. This analysis is, however, subject to three possible exceptions – all of which were deficient to incorporate the right to health into Hong Kong law.The first exception is that there can be an ‘incorporation of individual provisions of the [ICESCR] by different statutes.’ If there is an individual statute that incorporates the right to health, it can still form part of the constitutional right in Hong Kong.23 This however only offers limited help to enforce the right to health in Hong Kong for two reasons.The first reason is that the right to health covers a broad range of matters. It extends beyond healthcare, and covers a wide range of socio-economic factors that promote conditions for a healthy life, such as food and nutrition, housing, water, sanitation, working conditions, and the environment.24 Unless there is a statute that simply incorporates the right to health in its entirety, it is rather unlikely that individual statutes can manage to cover the whole range of matters protected by the right to health.The second reason is that this method is dependent upon the legislative process in Hong Kong: there must be an implementing legislation for the right to health. By Hong Kong’s constitutional system, this would require the Chief Executive’s (the head of the government) consent for such a legislative bill to be initiated.25 It

18 19 20 21 22 23 24 25

GA v Director of Immigration (n 14) [60]. ICESCR Art 10(1). Comilang Milagros Tecson v Director of Immigration (n 14) [74]. See, e.g., Li-Ann Thio, ‘Reading Rights Rightly:The UDHR and Its Creeping Influence on the Development of Singapore Public Law’ [2008] Singapore Journal of Legal Studies 264, 282–83. In re an Application by Wong Chun-sing and Ng Fook-yiu for Judicial Review [1984] HKLR 71, 74–75. GA v Director of Immigration (n 14) [60(1)]. John Tobin, The Right to Health in International Law (OUP 2012) 126–30. The Basic Law (n 2) Art 74; Benny Tai, ‘The Chief Executive’ in Johannes Chan and CL Lim (eds), Law of the Hong Kong Constitution (2nd edn, Sweet & Maxwell 2015) [7.159]–[7.166].

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would also require the majority support in the Legislative Council of Hong Kong (LegCo), which has historically always been pro-government.26 In other words, for the right to health to be implemented by legislation, the government must willingly impose this burden upon itself. This is not impossible but is far from a satisfactory way to guarantee the right to health. The second exception is that the right to health may be partly recognised as a constitutional right through the Basic Law and the Hong Kong Bill of Rights. Let us first examine the Basic Law. Article 138 of the Basic Law provides that ‘the Government of the Hong Kong Special Administrative Region shall, on its own, formulate policies to develop Western and traditional Chinese medicine and to improve medical and health services.’27 This somewhat provides a restriction towards the government’s healthcare policies. It requires the government to develop and maintain an effective public healthcare system that responds to changing social, economic, and public needs. It also forbids the government from making changes to the healthcare policies that are ‘not a development and improvement based on the existing system.’28 The critic may argue that this suffices to recognise a right to health in Hong Kong.The issue with this argument is threefold. First, Article 138 only requires the government to ‘improve.’ It neither sets out an end-goal to be achieved by the government, nor does it formulate itself as a fundamental right for the citizens. This is to be contrasted with Article 12 of the ICESCR. It makes clear that it is the ‘right of everyone’ to have the ‘enjoyment of the highest attainable standard of physical and mental health.’29 Without even delving into the specifics, Article 12 already has a better edge in protecting the right to health. Second, Article 12 provides much more specific protections for the right to health. The critic may immediately retort by saying that Article 2(1) of the ICESCR provides that ICESCR rights are to be progressively realised; that is no less vague than what Article 138 states.30 This criticism is false.As the UN Committee on Economic, Social and Cultural Rights explains: The progressive realization of the right to health over a period of time should not be interpreted as depriving States parties’ obligations of all meaningful content. Rather, progressive realization means that States parties have a specific and continuing obligation to move as expeditiously and effectively as possible towards the full realization of article 12.31 The critic’s claim is further refuted by Article 12(2) of the ICESCR. It helpfully specifies the steps which states parties must take to achieve the full realisation of the right to health, such as ‘the prevention, treatment and control of epidemic, endemic, occupational and other diseases.’ By doing so, it provides specific guarantees to the right to health – a matter which the Basic Law has failed to achieve.32 Third, Article 12 has a broader scope than Article 138. Article 138 only

26 Po Jen Yap,‘Twenty Years of the Basic Law: Continuity and Changes in the Geoffrey Ma Court’ (2019) 49 Hong Kong Law Journal 209, 213. 27 The Basic Law (n 2) Art 138 (emphasis added). 28 Catholic Diocese of Hong Kong v Secretary for Justice [2007] 4 HKLRD 483 [122]; Fok Chun Wa v Hospital Authority [2008] HKCFI 1143 [103], [104]. 29 ICESCR Art 12(1). 30 This line of the argument on the vagueness of Art 12 is prevalent: see, e.g. David P. Fidler, International Law and Infectious Diseases (OUP 1999) 197; Onora O’Neill,‘The Dark Side of Human Rights’ (2005) 81(2) International Affairs 427, 428, 433–34. 31 Committee on Economic, Social and Cultural Rights (n 1) [31]. 32 Michael Ramsden,‘Using the ICESCR in Hong Kong Courts’(2012) 42 Hong Kong Law Journal 839, 842.

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deals with the improvement of healthcare services.As explained earlier, the right to health under Article 12 extends beyond the mere provision of healthcare services. For these reasons, the Basic Law’s provision on healthcare services is miles apart from the right to health. Let us then turn to the Hong Kong Bill of Rights. As explained earlier, it confers constitutional status on the ICCPR rights.This provides a partial – albeit limited – recognition of the right to health in Hong Kong. For instance, the Hong Kong Bill of Rights recognises the right to life.33 It has been held that this replicates the Article 2 (right to life) jurisprudence under the European Convention on Human Rights.34 If so, the Hong Kong government will have a duty to take appropriate steps to safeguard the lives of those within its jurisdiction.35 In the context of healthcare, it will preclude the government from denying life-saving emergency treatment where it is known a patient’s life is in danger.36 It will also require the government to take necessary steps to avoid a systemic failure of hospital services – by having appropriate regulatory measures in place – if the failure may deprive patients of life-saving emergency treatment.37 It is not disputed that this gives partial effect to the right to health. But this is far from sufficient to cover the many important matters under the right to health. The third exception is the principles of administrative law: these common law principles may still be receptive of the rights in ICESCR, although these rights do not qualify as constitutional rights in Hong Kong. Ramsden and Marsh have suggested two such possibilities. The first is the principle of legitimate expectation.They suggested that since Hong Kong is bound by the ICESCR, the applicants may argue that they have a ‘legitimate expectation that the government would respect their rights under these instruments.’38 If so, this expectation must be taken into account by the government in its decisions.39 And if the government wishes to depart from the expectation, it must offer its reasons for doing so.40 The second is the doctrine of anxious scrutiny.Typically, the court may only find a decision irrational if it is ‘so unreasonable that no reasonable authority could ever come to it.’41 Per this doctrine, the court may apply a more rigorous form of rationality review ‘according to the gravity of the issue which the decision determines.’42 Ramsden and Marsh suggested that the fact that the matter concerns an ICESCR right may engage the doctrine.43 The problem with their argument is a lack of support in the positive law. It assumes a judicial attitude that is willing to give effect to the ICESCR rights – a willingness that is only precluded by a lack of implementation in Hong Kong. So that when it comes to the common law,

33 The Hong Kong Bill of Rights (n 15) Art 2(1). 34 Song Rai v The Coroner of Hong Kong [2011] 2 HKLRD 245 [20]; SW v The Secretary for Justice [2019] 1 HKLRD 768 [44]. 35 Elizabeth Wicks, Human Rights and Healthcare (Hart 2007) 18; William A. Schabas, The European Convention on Human Rights:A Commentary (OUP 2015) 122; Lopes de Souza Fernandes v Portugal (2018) 66 EHRR 28 [164]. 36 Lopes (n 35) [191]; see, e.g. Mehmet Senturk v Turkey (2015) 60 EHRR 4. 37 Lopes (n 35) [192]; Aleydis Nissen, ‘A Right to Access to Emergency Health Care: The European Court of Human Rights Pushes the Envelope’ (2017) 26(4) Medical Law Review 693, 696; see, e.g. Asiye Genc v Turkey App no 24109/07 (ECHR, 27 April 2015). 38 Ramsden and Marsh (n 17) 287. 39 Ng Siu Tung v Director of Immigration (2002) 5 HKCFAR 1 [94], [351]; Chung Kwok Man v The Hong Kong Housing Authority [2016] 3 HKLRD 592 [56]. 40 Cathay Pacific Airways Flight Attendants Union v Director-General of Civil Aviation [2007] 2 HKC 393 [37]; Chung (n 39) [56]. 41 Associated Provincial Picture Houses Ltd v Wednesbury Corporation [1948] 1 KB 223, 234. 42 Bugdaycay v Secretary of State for the Home Department [1987] AC 514, 531. 43 Ramsden and Marsh (n 17) 287.

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the courts will seize the opportunity and give effect to such rights. This assumption is highly contestable. The prevailing judicial view in Hong Kong law is that the ICESCR is merely ‘promotional’ and ‘aspirational.’ It only reflects ‘what it is hoped to be achieved in the future.’44 Unlike the ICCPR, it does not create ‘immediate and absolute rights.’The suggestion that ‘the ICESCR creates legitimate expectation’ has, therefore, been described as ‘artificial.’45 Ramsden recognised this impediment to his argument.46 His response is to criticise this view.As he rightly pointed out, the prevailing judicial review has misunderstood the nature of the ICESCR (e.g. it also contains immediate duties).47 But this does not detract from the reality of the prevailing judicial view in Hong Kong: that the rights in ICESCR are ‘aspirational’ only. It is perforce unlikely that the Hong Kong courts will assume a contrary attitude in the area of administrative law – and thereby provide strong protections to the right to health. The lukewarm judicial reception of the ICESCR rights, including the right to health, is evidenced by Clean Air.48 In this case, the applicant argued that the government has failed to take sufficient steps to combat air pollution in Hong Kong. This includes a broad range of allegations, such as a failure to rationalise bus routes and a failure to regulate the use of diesel fuels.The applicant relied in part on the right to health under Article 12 of the ICESCR.The court rejected the application. Its reasoning is simple.The measures to combat air pollution (e.g. the regulation of diesel fuels) is a matter of government policy. Such policy decisions engage social and economic factors.And the court must not go into the merits of the policies adopted by the government.49 The court made this point without invoking the argument that ICESCR rights are not directly enforceable in Hong Kong. Its point is simply that the nature of the matter covered within the right to health is not for the courts to adjudicate upon. This reflects what Karen Kong observed as a ‘strong judicial attitude that the courts should not be used as a forum to discuss socioeconomic policies.’50

Implementation and balancing: the right to health in government policies Despite the problems with incorporating the right to health into Hong Kong law, this may not be the end of the story. Even if the judicial remedies are not available, administrative remedies may still be available to give effect to the right to health.51 In other words, the right to health can be implemented through various government policies without the corresponding judicial recognition. Recognising the right to health through implementation alone is in principle possible. In Hong Kong, a large part of its right to health depends upon recognition through the Hong Kong government’s policies, rather than through the application of public law by the courts. But such a way of recognising the right to health in Hong Kong faces two hurdles. First, it requires

44 Chan To Foon v Director of Immigration [2001] 3 HKLRD 109, 133 (emphasis original). See also Chan Mei Yee v Director of Immigration [2000] HKCFI 1521 [45]–[46]; Pagtama, Victorina Alegre v Director of Immigration [2016] HKCFI 34 [112]–[115]. 45 Chan To Foon v Director of Immigration (n 44) 133. 46 Michael Ramsden, ‘Judging Socio-Economic Rights in Hong Kong’ (2018) 16(2) International Journal of Constitutional Law 447, 457. 47 ibid. 48 Clean Air Foundation Ltd v The Government of the HKSAR [2007] HKCFI 757. 49 ibid [28], [30], [32], [39], [41], [43]. 50 Karen Kong, ‘Adjudicating Social Welfare Rights in Hong Kong’ (2012) 10(2) International Journal of Constitutional Law 588, 589. 51 Xiao Pan, ‘Realising the Right to Health: A Comparative Study of South Africa, the United States and China’ (2015) 45 Hong Kong Law Journal 517, 524, 544.

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the government to act – on its own initiative – upon its international obligations, although there is no mechanism within the domestic law to compel this. Consequently, the government may be disincentivised to give effect to the right to health. But as we shall see, this is not the case with the Hong Kong government. Second, despite a good faith effort, the government may find it difficult to balance the right to health with other conflicting rights and policy aims. In this section, we will examine two government policies, both being subordinate legislation, that relate to the right to health in the context of public assemblies. Both policies feature an interesting conundrum: the government is required to balance the right to health with other rights and policy aims. On both occasions, the government’s balancing effort is commendable, although its balancing exercise remains contestable.

The Prohibition on Face Covering Regulation On 4 October 2019, the Chief Executive in Council enacted the Prohibition on Face Covering Regulation.52 The following sections are here relevant. Section 3(1) provides that ‘a person must not use any facial covering that is likely to prevent identification’ in an ‘unlawful assembly,’ ‘unauthorized assembly,’ ‘public meeting,’ or a ‘public procession.’53 These are some technical terms which we will not delve into here. In essence, the prohibition covers every public assembly, whether or not it is lawfully held. A ‘facial covering’ means ‘a mask or any other article of any kind … that covers all or part of a person’s face.’54 A person who contravenes section 3(1) will commit an offence, which is punishable by imprisonment.55 Section 4(1) provides that a person will have a defence if he has ‘lawful authority’ or ‘reasonable excuse’ for using a facial covering.56 And a reasonable excuse includes – but is not limited to – the use of facial covering for a ‘pre-existing medical or health reason.’57 Section 5 further provides if a person is using a facial covering in a public place that a ‘police officer reasonably believes is likely to prevent identification,’ the police officer may stop the person and require him to remove the facial covering.58 And if the person fails to comply with the police officer’s requirement, he will commit an offence punishable by imprisonment.59 The officer is thereupon empowered to forcibly remove the facial covering.60 The Face Covering Regulation was enacted as a response to Hong Kong protests since June 2019,61 which have grown increasingly violent.The government’s reasoning is that violent protesters are facilitated by wearing facial coverings. First, facial covering ‘emboldens’ protesters to ‘engage in violent or unlawful acts which they may not otherwise perform without concealment.’ The Face Covering Regulation therefore helps to curb the violence and to ensure ‘peaceful protests

52 53 54 55 56 57 58 59 60 61

Prohibition on Face Covering Regulation (Cap 241K). ibid s 3(1)(a)–(d). ibid s 2. ibid s 3(2). ibid s 4(1). ibid s 4(3)(c). ibid s 5(1), (2)(a). ibid s 5(3). ibid s 5(2)(b). For the protests, see the discussion in Johannes Chan, ‘Ten Days That Shocked the World: The Rendition Proposal in Hong Kong’ (2019) 49(2) Hong Kong Law Journal 431; Cora Chan, ‘Demise of “One Country, Two Systems”? Reflections on the Hong Kong Rendition Saga’ (2019) 49(2) Hong Kong Law Journal 447; Albert HY Chen, ‘A Perfect Storm: Hong Kong-Mainland Rendition of Fugitive Offenders’ (2019) 49(2) Hong Kong Law Journal 419.

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and demonstrations will stay that way.’62 Second, facial covering makes it difficult for the protesters to be ‘identified, arrested and successfully prosecuted.’The Facial Covering Regulation therefore assists in law enforcement, such as police arrests and identification via eyewitness and closed-circuit television (CCTV) evidence.63 The policy aim of the government thus requires prohibiting the wearing of facial coverings, including face masks, in public assemblies. This may however have implications for the right to health. As Meier and Mori suggested, achieving the highest attainable standard of health necessarily requires states to prevent, treat, and control diseases, for the simple reason that they may affect the general health of the population.64 The modern and well-known example is, of course, COVID-19. If the government prohibits the wearing of face masks in public assemblies, it will undermine the efforts of disease control and increase the risks of spreading COVID-19. Indeed, it is the government’s own advice that citizens should wear face masks in the outdoors.65 This advice is particularly true for the public assemblies that may amass large crowds in close proximity. The critic may perforce find it tempting to criticise the Face Covering Regulation for its lack of regard for the right to health.Yet the matter is more nuanced, for three reasons. First, it must be remembered that the Face Covering Regulation does not prohibit the wearing of face masks in public generally. It only targets public assemblies. Therefore, its impact on the right to health is limited. Second, the Face Covering Regulation was enacted in October 2019. COVID-19 was not at the time an issue: the first confirmed case of COVID-19 in Hong Kong was on 23 January 2020.66 So, judging the matter at the time of October 2019, the health risk that the Face Covering Regulation may pose is much lower than that at present. Third, despite this, the Face Covering Regulation has made provisions for health concerns. Section 4 permits the wearing of facial coverings if a ‘reasonable excuse’ exists.The wearing of face masks for a ‘pre-existing medical or health reason’ is expressly specified as one such excuse.67 This excuse is obviously inserted for public health reasons and displays an acute awareness by the government of implications that the Face Covering Regulation may have on the right to health.The definition of ‘reasonable excuse’ in section 4 is also non-exhaustive. It has been suggested that, in light of the present situation, the wearing of face masks to avoid contracting COVID-19 constitutes a ‘reasonable excuse.’68 Indeed, the government has so conceded in a judicial challenge against the Face Covering Regulation.69

62 Kwok Wing Hang v Chief Executive in Council [2020] 1 HKLRD 1 [133]; Security Bureau, ‘Legislative Council Brief: Emergency Regulations Ordinance (Cap. 241) Prohibition on Face Covering Regulation’ (October 2019) [2]–[3] www.sb.gov.hk/eng/antimask/LegCo%20Brief%20(Eng)%20(4.10.2019)%20Final.pdf accessed 28 June 2020. 63 Kwok Wing Hang v Chief Executive in Council (n 62) [134]. 64 Benjamin Mason Meier and Larisa M. Mori, ‘The Highest Attainable Standard: Advancing a Collective Human Right to Public Health’ (2005) 37 Columbia Human Rights Law Review 101, 102, 113–15, 117–18, 121–25, 127; ICESCR,Art 12(2)(c). 65 The Government of the Hong Kong Special Administrative Region, ‘Health Advice’ www.coronavirus.gov.hk/ eng/health-advice.html accessed 28 June 2020. 66 Elizabeth Cheung,‘China Coronavirus: Death Toll Almost Doubles in One Day as Hong Kong Reports Its First Two Cases’ South China Morning Post (Hong Kong, 22 January 2020) www.scmp.com/news/hong-kong/he alth-environment/article/3047193/china-coronavirus-first-case-confirmed-hong-kong accessed 28 June 2020. 67 Face Covering Regulation (n 52) s 4(1), (3)(c). 68 SCMP Editorial,‘Suspending Mask Ban Should Be Considered during the Epidemic’ South China Morning Post (Hong Kong, 10 April 2020) www.scmp.com/comment/opinion/article/3079450/suspending-mask-ban-shoul d-be-considered-during-pandemic accessed 28 June 2020. 69 Alvin Lum and Chris Lau,‘What Happens If Hong Kong Court Upholds Mask Ban Amid Coronavirus Pandemic’ South China Morning Post (Hong Kong, 8 April 2020) www.scmp.com/news/hong-kong/politics/article/30788 51/remember-mask-ban-what-happens-if-hong-kong-court-upholds accessed 28 June 2020.

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This shows that, despite a lack of incorporation into Hong Kong law, the government is willing to give effect to the right to health. It has chosen not to relentlessly pursue its policy aim and has, instead, balanced it with the right to health.This is so, although no judicial review may lie for the government’s failure to implement the right to health.While the government should be commended for doing so, its balancing exercise within the Face Covering Regulation is contestable.The primary candidate for criticism is section 5. It confers a wide power on the police officer: as long as he reasonably believes that the facial covering is likely to prevent identification, he may ask that a face mask be taken off. It is not limited to a public assembly (it applies to every person in a public place), it is not necessary for the officer to suspect that the person is committing any crime, and it is not necessary for the person to intend to conceal his identity by wearing the facial covering.70 As the Court of Appeal suggested, ‘section 5 confers power to the police to make a request to remove facial coverings in an entirely uneventful situation.’71 It permits a curtailment of the right to health, i.e. the health risks posed by the removal of face masks, where the policy aim underlying the Face Covering Regulation is not engaged. Criticism may also be laid against section 4.The government has now accepted that wearing face masks to prevent contracting COVID-19 constitutes a ‘reasonable excuse.’ But this concession is likely due to the seriousness of the COVID-19 crisis. It is unclear if section 4 also exonerates the wearing of face masks to prevent contracting diseases generally (e.g. the flu).This is unlikely to be so, for two reasons. First, section 4 only specifically exonerates ‘pre-existing’ medical causes (e.g. if the person has already been infected). Had the government intended to exclude ‘potential’ medical causes as well, it could have easily said so. Second, the excuse that ‘I was only wearing the mask not to contract the flu’ is too convenient. It can easily remove the chances of a successful prosecution under section 3 altogether. If this analysis is correct, the Face Covering Regulation will have had limited regard to disease prevention generally, beyond the context of COVID-19. But the right to health is not just about the latter, but the former as well.72

The Prohibition on Group Gathering Regulation Then we turn to the Prevention and Control of Disease (Prohibition on Group Gathering) Regulation (hereinafter the Group Gathering Regulation).73 It was enacted by the Chief Executive in Council on 29 March 2020. The following sections are here relevant. Section 3(1) specifies that ‘no group gathering may take place in any public place during a specified period.’74 At the time of enactment, ‘group gathering’ means a ‘gathering of more than 4 persons.’75 This general prohibition does not apply to ‘exempt group gatherings specified in Schedule 1.’76 Schedule 1, at the time of enactment, contains 12 exceptions. They include, for instance, group gatherings ‘at a place of work for the purposes of work’ and ‘for the conduct of proceedings in a court.’77 What is notable is that the Group Gathering Regulation contains no exceptions for public assemblies. So public assemblies – insofar as they constitute a ‘group gathering’ – are entirely

70 71 72 73 74 75 76 77

Kwok Wing Hang v Chief Executive in Council (n 62) [185]. Leung Kwok Hung v Secretary for Justice [2020] HKCA 192 [268]. ICESCR Art 12(2)(c). Prevention and Control of Disease (Prohibition on Group Gathering) Regulation (Cap 599). ibid s 3(1). ibid s 2. ibid s 3(2). ibid sch 1, paras 4, 7.

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prohibited. This point deserves highlighting, since the Hong Kong protests (which led to the Face Covering Regulation) did not cease in 2020. So the practical effect of the Group Gathering Regulation is that these protests cannot lawfully continue.This inevitably constitutes a restriction of the freedom of assembly. On the other hand, the government has explained that the Group Gathering Regulation was intended to implement social distancing and thereby effect disease control over COVID-19.78 And disease control is, as explained earlier, required by the right to health.There is thus a conflict between the right to health and the freedom of assembly which underlies the Group Gathering Regulation. Tobin argued that, in relation to ‘public health regulations such as quarantining of persons with infectious diseases,’ the human rights treaty monitoring bodies have ‘tended to overlook the potential for conflicting rights to exist in such contexts and, as a consequence, have failed to provide states with any substantive guidance as to how to resolve such conflicts.’79 An exception is General Comment No 14.There, the UN Committee explained that ‘issues of public health are sometimes used by States as grounds for limiting the exercise of other fundamental rights’. In such a case, the states have the burden to justify such limitations, which [M]ust be in accordance with the law, including international human rights standards, compatible with the nature of the rights protected by the Covenant, in the interest of legitimate aims pursued, and strictly necessary for the promotion of the general welfare in a democratic society.80 Similarly,Tobin argues that ‘legislative measures designed to protect health must not impose an unreasonable limitation on other rights to which individuals are entitled under international law.’ Any such limitations must ‘pursue a legitimate aim’ and be ‘proportionate’ to achieve that aim.81 This reflects the proportionality test which is widely used in UK and Hong Kong law.82 At first blush, the Group Gathering Regulation may be criticised as ignoring the freedom of assembly altogether. McCrudden, for instance, has argued that ‘the [COVID-19] crisis has been used an excuse’ by the Hong Kong Government to ‘introduce authoritarian measures restricting embarrassing or threatening political dissent.’83 This conclusion perhaps goes too far. As McCrudden acknowledges, social distancing in protests is at best difficult and inevitably gives rise to a significant risk of COVID-19 infections.84 In the UK, for instance, Boris Johnson has opposed the Black Lives Matter protests for the reason that they flout social distancing.85 Hong Kong’s Group Gathering Regulation is undoubtedly motivated, at least in part, by public health

78 Food and Health Bureau, ‘Legislative Council Brief: Prevention and Control of Disease Ordinance (Cap.599); Prevention and Control of Disease (Requirement and Directions) (Business and Premises) Regulation; Prevention and Control of Disease (Prohibition on Group Gathering) Regulation’ (March 2020) [9]. www.legco.gov.hk/yr1 9-20/english/subleg/brief/2020ln031_032_brf.pdf accessed 28 June 2020. 79 Tobin (n 24) 180–81. 80 Committee on Economic, Social and Cultural Rights (n 1) [28]. 81 Tobin (n 24) 181–82. 82 See, e.g. Bank Mellat v HM Treasury (No 2) [2014] AC 700 [20]; Hysan (n 10) [52]–[53]. 83 Christopher McCrudden,‘Democracy, Protests, and COVID-19: The Challenge of (and for) Human Rights’ (UK Constitutional Law Association, 19 June 2020). https://ukconstitutionallaw.org/2020/06/19/christopher-mccru dden-democracy-protests-and-covid-19-the-challenge-of-and-for-human-rights/ accessed 28 June 2020. 84 ibid. 85 Vincent Wood, ‘Boris Johnson Calls for End to Black Lives Matter Protesters “Flouting Social Distancing”’ The Independent (London, 8 June 2020) www.independent.co.uk/news/uk/politics/protests-social-distancing-boris -johnson-coronavirus-black-lives-matter-uk-a9555486.html accessed 28 June 2020.

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concerns. Indeed, as the COVID-19 numbers have lessened in Hong Kong, the government has relaxed the restrictions under the Group Gathering Regulation.The number of participants allowed in a group gathering was increased to 8 in May 202086 and further increased to 50 the next month.87 This is inconsistent with a claim that the Group Gathering Regulation was solely enacted to quash political dissent. But the government’s balancing exercise under the Group Gathering Regulation is not faultless either. In Hong Kong, the freedom of assembly is judicially recognised as a ‘fundamental right.’ It lies ‘at the foundation of a democratic society,’ and is of ‘cardinal importance for the stability and progress of society.’88 In particular, this involves a ‘positive duty on the part of the Government … to take reasonable and appropriate measures to enable lawful assemblies to take place peacefully.’89 Under the Group Gathering Regulation, the government takes a binary approach: if there are more than 50 participants, the assembly is prohibited, but if not, the assembly is permitted.90 The existence of 50 participants defines the level of health risks that may be tolerated.This, however, ignores the positive role that the government may play in facilitating a public assembly with more than 50 participants, by introducing measures to further alleviate the health risks involved. For instance, the Group Gathering Regulation may be amended to permit assemblies with more participants, provided the assemblies take place in a more ventilated route and all participants wear face masks throughout. This may mean that the current restriction on the freedom of assembly is not ‘strictly necessary’ to advance the right to health, which the General Comment No 14 requires.91

Conclusion In conclusion, this chapter has examined how the right to health operates in Hong Kong. In terms of its incorporation, Hong Kong has fared poorly: the right to health is not incorporated as a constitutional right, and the common law has done little to help. The Hong Kong courts are generally reluctant to recognise ICESCR rights, including the right to health. In term of its implementation, the Hong Kong government has demonstrated a willingness to give effect to the right to health, despite a lack of judicial enforcement. However, its balancing exercise is on occasion contestable. Two explanations are possible for this. The first explanation is that both policies we have examined were made on an urgent basis, in the face of a contingency that required immediate redress.The second explanation is that the government is not properly equipped to balance the right to health with conflicting rights and policy aims. This is something which the courts are more readily equipped to do92 by way of judicial review.93 If the latter explanation is sound, it will be necessary to give effect to the right to health not only through

86 Prevention and Control of Disease (Prohibition on Group Gathering) (Amendment) (No. 2) Regulation 2020, s 3; Food and Health Bureau,‘Legislative Council Brief: Prevention and Control of Disease Ordinance (Cap. 599); Prevention and Control of Disease (Prohibition on Group Gathering) (Amendment) (No. 2) Regulation 2020’ [12] www.legco.gov.hk/yr19-20/english/subleg/brief/2020ln059_brf.pdf accessed 28 June 2020. 87 Prevention of Control of Disease (Prohibition on Group Gathering) (Amendment) (No. 5) Regulation 2020, s 3. 88 Leung Kwok Hung v HKSAR (2005) 8 HKCFAR 299 [1]–[2]. 89 ibid [22]. 90 The latter point is subject to the other requirements in the Public Order Ordinance (Cap 245), which is beyond the scope of this chapter. 91 Committee on Economic, Social and Cultural Rights (n 1) [28]. 92 NW Barber,‘Self-Defence for Institutions’ (2013) 72(3) CLJ 558, 573. 93 Philip Sales,‘Partnership and Challenge:The Courts’ Role in Managing the Integration of Rights and Democracy’ [2016] PL 456, 468.

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administrative measures but also through judicial enforcement. Doing so would offer a much stronger recognition of the right to health in Hong Kong. This chapter also lays the foundation for how the right to health may be advanced in Hong Kong.This follows from the foregoing analysis as to the current flaws of the right. One of these flaws is a judicial reluctance to give effect to the right to health by way of human rights and administrative law, and thus an apt remedy is judicial activism. By way of example, Lord Kerr has suggested that ‘the time has come for the exception to the dualist theory in human rights conventions … to be openly recognised.’94 If this exception is adopted by the Hong Kong courts, it will qualify the aforementioned position in Comilang and allow the right to health to be ‘an enforceable right in domestic law.’95 An alternative route is via the Hong Kong government and the historically pro-government LegCo. If there can be a piece of implementing legislation for the right to health – just as what the Hong Kong Bill of Rights does for the ICCPR rights – the right to health can be incorporated as a constitutional right.This will, as explained earlier, have to be done on the government’s own initiative. By contrast, the role for the general citizens of Hong Kong is relatively limited.They have no direct means to alter judicial attitudes, or to compel the government to incorporate the right to health. And without either of these events happening, the citizens can unlikely resort to judicial review to recognise the right to health. Clean Air illustrates this. Accordingly, the most realistic way out for general citizens is through generating widespread public support for the right to health in Hong Kong.The reality, however, remains cruel: unless the courts or the government nod their heads, a general right to health in Hong Kong remains only an aspiration.96

References Barber, NW,‘Self-Defence for Institutions’ (2013) 72(3) CLJ 558. Bokhary, Kemal, ‘Judicial Striking-Down of Unconstitutional Legislation’ (2020) 50(1) Hong Kong Law Journal 77. Chan, Cora, ‘Demise of “One Country, Two Systems”? Reflections on the Hong Kong Rendition Saga’ (2019) 49(2) Hong Kong Law Journal 447. Chan, Johannes,‘Ten Days That Shocked the World:The Rendition Proposal in Hong Kong’ (2019) 49(2) Hong Kong Law Journal 431. Chen, Albert HY,‘A Perfect Storm: Hong Kong-Mainland Rendition of Fugitive Offenders’ (2019) 49(2) Hong Kong Law Journal 419. Cheung, Elizabeth, ‘China Coronavirus: Death Toll Almost Doubles in One Day as Hong Kong Reports Its First Two Cases’ South China Morning Post (Hong Kong, 22 January 2020) www.scmp.com/news /hong-kong/health-environment/article/3047193/china-coronavirus-first-case-confirmed-hong-kon g accessed 28 June 2020. Committee on Economic, Social and Cultural Rights, CESCR General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art 12) (11 August 2000). Fidler, David P, International Law and Infectious Diseases (Oxford University Press 1999). Food and Health Bureau, ‘Legislative Council Brief: Prevention and Control of Disease Ordinance (Cap.599); Prevention and Control of Disease (Requirement and Directions) (Business and Premises) Regulation; Prevention and Control of Disease (Prohibition on Group Gathering) Regulation’ (March 2020) 9 www.legco.gov.hk/yr19-20/english/subleg/brief/2020ln031_032_brf.pdf accessed 28 June 2020. Kong, Karen, ‘Adjudicating Social Welfare Rights in Hong Kong’ (2012) 10(2) International Journal of Constitutional Law 588.

94 R (SG) v Secretary of State for Work and Pensions [2015] 1 WLR 1449 [254]. 95 ibid [255]. 96 Chan To Foon v Director of Immigration (n 44) 133.

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The right to health in Hong Kong Lui, Edward, and Wong, Michelle Yik Yu,‘Subordinating Subordinate Legislation under the Human Rights Act 1998’ (2020) 136 LQR 354. Lum, Alvin, and Lau, Chris, ‘What Happens if Hong Kong Court Upholds Mask Ban Amid Coronavirus Pandemic’ South China Morning Post (Hong Kong, 8 April 2020) www.scmp.com/news/hong-kong /politics/article/3078851/remember-mask-ban-what-happens-if-hong-kong-court-upholds accessed 28 June 2020. McCrudden, Christopher, Democracy, Protests, and COVID-19: The Challenge of (and for) Human Rights (UK Constitutional Law Association 19 June 2020) https://ukconstitutionallaw.org/2020/06/19/ch ristopher-mccrudden-democracy-protests-and-covid-19-the-challenge-of-and-for-human-rights/ accessed 28 June 2020. Meier, Benjamin Mason, and Mori, Larisa M, ‘The Highest Attainable Standard: Advancing a Collective Human Right to Public Health’ (2005) 37 Columbia Human Rights Law Review 101, 102, 113–15, 117–18, 121–25, 127. Nissen, Aleydis, ‘A Right to Access to Emergency Health Care: The European Court of Human Rights Pushes The Envelope’ (2017) 26(4) Medical Law Review 693. O’Neill, Onora,‘The Dark Side of Human Rights’ (2005) 81(2) International Affairs 427, 428. Pan, Xiao, ‘Realising the Right to Health: A Comparative Study of South Africa, the United States and China’ (2015) 45 Hong Kong Law Journal 517. Panditaratne, Dinusha, ‘Basic Law, Hong Kong Bill of Rights and the ICCPR’ in Johannes Chan and CL Lim (eds), Law of the Hong Kong Constitution (2nd edn, Sweet & Maxwell 2015). Prevention and Control of Disease (Prohibition on Group Gathering) (Amendment) (No. 2) Regulation 2020, s 3; Food and Health Bureau,‘Food and Health Bureau,‘Legislative Council Brief: Prevention and Control of Disease Ordinance (Cap. 599); Prevention and Control of Disease (Prohibition on Group Gathering) (Amendment) (No. 2) Regulation 2020’ www.legco.gov.hk/yr19-20/english/subleg/brief /2020ln059_brf.pdf accessed 28 June 2020. Ramsden, Michael,‘Using the ICESCR in Hong Kong Courts’ (2012) 42 Hong Kong Law Journal 839. Ramsden, Michael, ‘Judging Socio-Economic Rights in Hong Kong’ (2018) 16(2) International Journal of Constitutional Law 447. Ramsden, Michael and Marsh, Luke, ‘Refugees in Hong Kong: Developing the Legal Framework for Socio-Economic Rights Protection’ (2014) 14 Human Rights Law Review 267. Sales, Philip, ‘Partnership and Challenge: The Courts’ Role in Managing the Integration of Rights and Democracy’ [2016] PL 456. Schabas, William A., The European Convention on Human Rights: A Commentary (Oxford University Press 2015) 122. SCMP Editorial, ‘Suspending Mask Ban Should Be Considered during the Epidemic’ South China Morning Post (Hong Kong, 10 April 2020) www.scmp.com/comment/opinion/article/3079450/ suspending-mask-ban-should-be-considered-during-pandemic accessed 28 June 2020. Tai, Benny, ‘The Chief Executive’ in Johannes Chan and CL Lim (eds), Law of the Hong Kong Constitution (2nd edn, Sweet & Maxwell 2015) 7.159–7.166. The Basic Law of the Hong Kong Special Administrative Region of the People’s Republic of China.The Government of the Hong Kong Special Administrative Region,‘Health Advice’ www.coronavirus.gov. hk/eng/health-advice.html accessed 28 June 2020. Thio, Li-Ann,‘Reading Rights Rightly:The UDHR and Its Creeping Influence on the Development of Singapore Public Law’ [2008] Singapore Journal of Legal Studies 264. Tobin, John, The Right to Health in International Law (Oxford University Press 2012). Wicks, Elizabeth, Human Rights and Healthcare (Hart 2007). Wood,Vincent,‘Boris Johnson Calls for End to Black Lives Matter Protesters “Flouting Social Distancing”’ The Independent (London, 8 June 2020) www.independent.co.uk/news/uk/politics/protests-socialdistancing-boris-johnson-coronavirus-black-lives-matter-uk-a9555486.html accessed 28 June 2020. Yap, Po Jen,‘Twenty Years of the Basic Law: Continuity and Changes in the Geoffrey Ma Court’ (2019) 49 Hong Kong Law Journal 209.

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10 ‘DIGNITY’ IN THE ADJUDICATION OF HEALTHCARE RIGHTS IN INDIA Sushant Chandra

Theoretical foundation of right to health in India Human dignity has its root in the Kantian ethical philosophy.The Kantian categorical imperative requires that human beings should never be treated merely as a means, but simultaneously as an end.1 Kant uses the term Wurde that translates to dignity, and refers to the term 16 times in Groundwork to the Metaphysics of Morals.2 Kant uses dignity to mean ‘unconditional, incomparable value.’3 It is, in this sense, that human dignity is ‘non-derogable’ – a phrase that the Indian courts have started applying in adjudicating healthcare claims.4 Kant grounded dignity in autonomy and stated, ‘autonomy is therefore the ground of the dignity of human nature and of every rational nature.’5 It is accepted that not everyone would agree to this approach to dignity and other understandings are available.6 It is this idea of autonomy that attributes ‘human beings as agents capable of making moral choices.’7 Martha Nussbaum expands upon this by stating: The core idea is that of the human being as a dignified free being who shapes his or her own life in cooperation and reciprocity with others, rather than being passively shaped or pushed around by the world in the manner of a ‘flock’ or ‘herd’ animal. A life that is really human is one that is shaped throughout by these human powers of practical reason and sociability.8

Immanuel Kant, Groundwork of the Metaphysics of Morals edited by Mary Gregor (Cambridge University Press 1997). ibid; also see Michael Mosen, Dignity: It’s History and Meaning (Harvard University Press 2012). Kant (n 1). Mohd Ahmed (minor) v Union of India (2014) 6 HCC (del) 118 (India). Kant (n 1) 43. See, for example, Charles Foster, Human Dignity in Bioethics and Law (Hart 2011). Martha Nussbaum, Women and Human Development:The Capabilities Approach (Cambridge University Press 2000). See, for example, Amartya Sen,‘Capabilities and Well-Being’ in Martha Nussbaum and Amartya Sen, The Quality of Life (Clarendon 1993) 30–53. 8 Nussbaum (n 7) 72.

1 2 3 4 5 6 7

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The capability approach, as devised by Sen and contributed to by Nussbaum, provides for holding states accountable to provide access to fundamental basic necessities.9 The theoretical framework derives its flesh and blood from human dignity grounded in autonomy – ascribing sacredness to the moral choices each individual has in creating the life of their choice.10 These capabilities have special status in enabling individuals to pursue the choices they might make. Which sets of capabilities are emphasised depends on what a given society considers as valuable. It is contested whether a common list of capabilities can be made, due to the difficulty ‘in seeing how the exact lists and weights would be chosen without appropriate specification of the context of their use (which could vary).’11 In explicating the content of ‘social minimum,’ the Supreme Court has held that ‘such facilities and opportunities’12 that enable individuals to reach ‘minimum standards of health and civilized living’13constitutes social minimum. The concept of ‘social minimum’14 or ‘intellectual capability’15 that Indian courts have devised in responding to socio-economic claims pertaining to healthcare and education are consistent with theoretical framework espoused by the capability approach.16 For example, the Indian courts have acknowledged reaching ‘intellectual capability’ as one of the minimum standards required. Further, in expanding on ‘social minimum,’ Indian courts have also reflectively engaged with the Directive Principles of State Policies17 and General Comment No 3 issued by the United

9 ibid 6. 10 ibid 6. 11 See K Van Marle, ‘“The Capabilities Approach”, “The Imaginary Domain”, and “Asymmetrical Reciprocity”: Feminist Perspective on Equality and Justice’ (2003) 11 Feminist Legal Studies, 255–78, 272–73. 12 Consumer Education Research Society v. Union of India (1995) 3 SCC 42 (India) [18]. 13 ibid. 14 See Consumer Education Research Society v. Union of India (1995) 3 SCC 42 (India) [18]; Francis Coralie Mullin v. Administrator of Delhi AIR 1981 SC 746 (India). Initially, the scheme of the state was to simply safeguard life, but that was changed to ‘dignified life.’ It altered the obligations of the state too to maintain dignified life of individuals. One of the ways of doing it is developing ‘condition precedent’ to securing a dignified life. The ‘condition precedent’ to dignified life also referred to as ‘social minimum’ has its foundations in ‘bare minimum expression of human self ’ (Francis Carolie Mullin v Administrator of Delhi) and autonomy of individuals. In Carolie, though obiter, the court ruled: the question which arises is whether the right to life is limited only to protection of limb or faculty or does it go further and embrace something more.We think that the right to life includes the right to live with human dignity and all that goes along with it, namely the bare necessaries of life such as adequate nutrition, clothing and shelter and facilities for reading, writing and expression oneself in diverse forms, freely moving about and mixing and commingling with fellow human beings. Of course, the magnitude and content of the components of this right would depend upon the extent of the economic development of the country, but it must, in any view of the matter, include the right to the basic necessities of life and also the right to carry on such functions and activities as constitute the bare minimum expression of self. 15 Ramji Tiwari v State of UP and others (1997)1UPLBEC 690 (India).The Allahabad High Court granted equal pay to teachers teaching in unaided primary school. It grounded its reasoning in teachers playing a pivotal role in developing ‘intellectual capability’ in students. It also referred to the Supreme Court’s judgments in Andhra Kesari Education Society v Director of School Education (1988) 4 SC 431(India) and State of Maharashtra v Vikas Sahebrao Roundale (1992) 5 SC 175(India). 16 Nussbaum’s approach is compatible with a range of different theories about the degree of material equality that should be guaranteed in a just society from complete egalitarianism, a Rawlsian difference principle, and a focus on an ample social minimum for all. See Sandra Liebenberg,‘The Value of Human Dignity in Interpreting SocioEconomic Rights’ (2005) 21 South African Journal of Human Rights 10. 17 Bandhua Mukti Morcha v Union of India,AIR 1984 SC 802 (India): [T]his right to live with human dignity enshrined in article 21 derives its life breath from the directive principles of state policy and particularly clauses (e) and (f) of Article 39 and Articles 41 and 42 and, at

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Nations Committee on Economic, Social and Cultural Rights.18 The courts have not simply borrowed the principles from these instruments, but engaged reflectively and applied the reasoning that Sen employs in resolving issues concerning access to capabilities.19 The courts have held that a harmonious interpretation between Part III and Part IV can be found by reference to the dignity inherent in an individual.20 The courts, while laying down social minima, have not only engaged reflectively with Directive Principles in Part IV and the General Comment, but have taken into account their institutional limitations in deciding policy issues;21 the urgency of the claims before them; and impact of denying claims.22 In developing ‘social minima,’ courts have also been mindful of issues of inadequate budgetary allocation towards healthcare claims;23 improper utilisation of already allocated budgets;24 and inadequate policy measures affecting important capabilities and thereby impacting choices made by people.25 In adjudicating social rights cases, there is a growing trend, in locating important interests within autonomy rights that demand constitutionalisation of socio-economic rights – which were earlier considered to be non-justiciable.26 In engaging with issues related to judicial legitimacy and institutional competence in devising ‘social minimum,’ the courts have employed dignity to justify demanding explanations for the use of allocated budget on a given entitlement.27 For example, in Snehlata v State of UP28 the court directed the state to provide an explanation for its inability to spend the allocated budget on the healthcare when individual healthcare interest infractions were rampant in the state.29 The South African Constitutional Court applied this method of engagement in establishing systemic social rights.30 This remedy is particularly welcome, because it respects the principles of separation of powers and the institutional limitations of the judiciary

18

19 20

21 22 23 24 25 26 27 28 29 30

the least, therefore, it must include protection of the health and strength of workers men and women, and of the tender age of children against abuse, opportunities and facilities for children to develop in a healthy manner and in conditions of freedom and dignity, educational facilities, just and humane conditions of work and maternity relief.These are the minimum requirements which must exist in order to enable a person to live with human dignity and no state – neither the central government nor any state government – has the right to take any action which will deprive a person of the enjoyment of these basic essentials. Mohd Ahmed (minor) v Union of India (n 4) [43]. (The committee, in General Comment No 3, confirmed that states parties have a core obligation to ensure the satisfaction of, at the very least, minimum essential levels of each of the rights enunciated in the covenant, including essential primary healthcare.) Sen (n 7). Unnikrishnan v. State of AP (1993) 1 SCC 645 (India).‘[B]oth parts III and IV… have to be balanced and harmonized then alone the dignity of the individual can be achieved.They (fundamental rights and directive principles) were meant to supplement each other’ (quoting J Shelat and J Grover in Kesavananda Bharati v State of Kerala AIR 1973 SC 1461(India)). State of Punjab v Ram Lubhaya Bagga (1998) 4 SCC 118. Parmanand Katara v Union of India (1989) 4 SCC 286(India); Mohd Ahmed (minor) v Union of India (n 4). Mohd Ahmed (minor) v Union of India (n 4) [52]. Snehlata v State of UP PIL NO. 14588 of 2009 (Allahabad High Court) (India). Mohd Ahmed (minor) v Union of India (n 4) [52]. See Cecile Fabre, Social Rights Under the Constitution 101 (2000), where she argues that such rights protect the vital interest individuals have in autonomy and well-being. Snehlata v State of UP, PIL No. 14588 of 2009 (Allahabad High Court) (India). ibid. ibid. Madhav Khosla, ‘Making Social Rights Conditional – Lessons from India’ (2010) International Journal of Constitutional Law, https://academic.oup.com/icon/article/8/4/739/667097 accessed 19 October 2020.

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in designing social policies.31 It is interesting how dignity, grounded in autonomy, when used as a constitutional value can demand, and obtain, beneficial outcomes, while respecting institutional competence.

Odyssey of healthcare adjudication in India: understanding the role of ‘dignity’ The judgments of the Supreme Court are finely layered when it comes to applying dignity in the adjudication of healthcare claims.The method employed in this part in developing Indian courts’ engagement with the concept of dignity is twofold: first, the nature of dispute and the degree of intervention expected from the court in seeking the desired outcome will be explained. Second, it will examine how the courts apply the value of dignity in adjudicating healthcare claims. This chapter argues that the courts’ engagement with dignity as a foundational value in developing health rights’ jurisprudence is most strongly influenced by the fact, that the court is required to either expand on an existing healthcare interest provided by the executive or to develop a new one. It has been observed, while analysing the judgments of the Indian courts, that the courts’ engagement with the concept of dignity have been strongest when they are asked to expand an existing healthcare interest or develop a new one. The Supreme Court’s focus on dignity also alludes to an effort on the part of the court to legitimise the outcome in expanding or developing a new right by deriving support from dignity. While looking at the conspectus of cases contested before the Supreme Court in the last four decades, the following categories of healthcare cases could be chiselled out: (1) The first category comprises of those set of cases where a claim for expanding or developing the healthcare claim has been brought before the Court in the absence of any legal instrument providing for the healthcare claim sought.32 (2) The second category comprises of those set of cases where existing legal instruments insufficiently responded to the healthcare claim, and hence the indulgence of the Court is sought to fill in the gap.33 (3) The third category comprises of those set of cases where the Court is asked to interpret or enforce an existing legal instrument covering healthcare claims.34

First category In the first category, Indian courts exhibit two extreme approaches. It is seen that the courts were conservative until the late 1980s and refrained from employing a rights-based discourse in interpreting healthcare claims.The well-established principle of separation of power injuncted the courts from creating new rights in name of interpretivism. In Pt Parmanand Katara, a social activist filed a social action litigation before the Supreme Court to direct the Union of India, state governments, and union territories to provide immediate medical assistance to

31 Mark Tushnet, Weak Courts, Strong Rights: Judicial Review and Social Welfare Rights in Comparative Constitutional Law (Princeton University Press 2008). 32 Parmanand Katara v Union of India (1989) 4 SCC 286; Mohd Ahmed (minor) v Union of India (n 4). 33 Consumer Education Research Society v. Union of India (1995) 3 SCC 42. 34 Paschim Banga Mazdoor Khet Samiti v. State of West Bengal, (1996) 4 SCC 37; State of Punjab v Mohinder Singh Chawla (1997) 2 SCC 83; State of Punjab v Ram Lubhaya Bagga, (1998) 4 SCC 118.

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road accident victims.35 The petitioner appended a news report from the Hindustan Times that mentioned the case of a person riding a scooter who was knocked down by a speeding car.36 A Good Samaritan took the injured to the nearest hospital where the doctor refused to treat him on the ground of medico-legal formalities.37 He was asked to take the injured to another hospital that was 20 km away, and while the injured was rushed to the suggested hospital, he died.38 The Supreme Court’s engagement with Article 21 in this case was inadequate. Article 21 states that ‘[n]o person shall be deprived of his life or personal liberty except according to procedure established by law.’ In fact, the Court refers to Article 21 only once in the entire judgment.39 The Court acted in a conservative way and refrained from engaging with a rights-based discourse. Its abstention from engaging with the liberty clause (Article 21) led to no interaction with dignity jurisprudence.The Court, rather, chose to navigate in the safer tides of the professional obligations of the doctors.40 Justice Mishra, after emphasising Clauses 10 and 13 of the Code of Medical Ethics, which reaffirms doctors’‘obligations to the sick,’ held: A doctor at the Government hospital positioned to meet this State obligation is, therefore, duty bound to extend medical assistance for preserving life. Every doctor whether at a Government hospital or otherwise has the professional obligation to extend his services with due expertise for protecting life. The recognition of an ethical duty in constituting legal obligation to provide immediate medical attention forms the basis of Court’s judgment.The judgment is full of ‘professional obligations’ of doctors and there is a mindful abstention from engaging with an approach based on the right to health. As tersely mentioned at the beginning of this section, the Court refrained from dealing with issues concerning the executive or legislature due to the principle of separation of powers, and avoided a rights discourse even in those areas where no legal instrument existed. The methods adopted by the Court in dealing with the issue is also reflected in the remedy that it offered in the present case.The Court offered a weak remedy and ordered a wider circulation of its judgment so that doctors could understand their professional obligations with utmost sincerity. However, the judgment consciously evaded any discussion of sanctions in cases of violations. The magic that it expected from the Medical Council of India in spelling out and enforcing the sanctions was just a charade. The way in which the Indian courts have engaged with the first category of cases has undergone a significant change recently as the courts have become more active. In the sequence of development purely based on time of occurrence, it is imperative to discuss the second and third categories before we move to see the transition in the approach of the courts under the first category – those cases where legal instruments don’t cover the healthcare claims. Hence, this discussion of the first category of cases will continue after discussing the second and third categories of cases.

35 36 37 38 39 40

Parmanand Katara v Union of India (1989) 4 SCC 286 [1]. ibid. ibid. ibid. ibid. ibid.

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Second category The second category highlights a trend wherein existing legal instruments were insufficient to respond to healthcare claims brought by the claimants, and hence the indulgence of the court was sought to fill in the vacuum.41 In Consumer Education and Research Council v Union of India,42 a public interest litigation (PIL) was filed before the Supreme Court to address the health concerns of employees working in asbestos industries. In 74 asbestos industries across nine states, about 11,000 employees were working. Many of them suffered from asbestosis, a condition that may lead to lung cancer and other forms of cancer, that occurred primarily due to exposure to asbestos.The petition sought directions from the Supreme Court to ensure that industries adopt membrane filter tests and that continuous monitoring of health of employees is undertaken for 40 years from the date of joining service or for 10 years after retiring, whichever is later, among other remedies.43 The Supreme Court expanded on the constitutional commitment to social justice.44 The Court referred to dignity 17 times in its entire judgment, but refrained from expanding on the concept.45 Although there has been a significant attempt on the part of the Court to develop a jurisprudence on the right to life under Article 21, and in its view, it invokes concepts such as social justice,46 social democracy,47 and foundational values, such as liberty, equality, and fraternity,48 its engagement with dignity is rather casual. Dignity has been used in three senses: first, as a constitutional goal, it is important to safeguard the dignity of individuals. The Court observed in paragraph 18: Social justice is a dynamic device to mitigate the sufferings of the poor, weak, dalits, tribals and deprived sections of the society and to elevate them to the level of equality to live a life with dignity of person. In its effort to develop the concept of social justice, the Court clarified that the state must not only provide dignity to individuals but also sustain it.49 Second, dignity has been promoted as an interpretive right under Article 21. The Court developed the right to dignity from Article 38 and Article 39 of the Indian Constitution. It is not new for the Indian courts to develop jurisprudence under Article 21 from the principles enunciated under directive principles of state policy.50 The Supreme Court observed:

41 42 43 44 45 46 47 48 49

Consumer Education Research Society v Union of India (1995) 3 SCC 42 (India). ibid. ibid [1]. ibid [18] ibid [18]–[26]. ibid [18]. ibid. ibid. ibid [20]:

The jurisprudence of personhood or philosophy of the right to life envisaged under Article 21, enlarges its sweep to encompass human personality in its full blossom with invigorated health which is a wealth to the workman to earn his livelihood, to sustain the dignity of person and to live a life with dignity and equality. 50 Bandhua Mukti Morcha v Union of India (1984) AIR SC 802 (India).

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The right to human dignity, development of personality, social protection, right to rest and leisure are fundamental human rights to a workman assured by the Charter of Human Rights, in the Preamble and Articles 38 and 39 of the Constitution. Finally, the Court used dignity as constitutional principle demanding respect of individuals due to their inner worth.At paragraph 28, the Court observed: Therefore, it must be held that the right to health and medical care is a fundamental right under Article 21 read with Articles 39(e), 41 and 43 of the Constitution and make the life of the workman meaning and purposeful with dignity of person. To sum up, dignity is a constitutional goal; a desired state for individuals that the state must provide for and sustain; an interpretive right drawing its content from directive principles of state policy; and a constitutional principle demanding respect for each individual on the grounds of their inner moral worth, including acceptance of a right to healthcare.These constituents do not operate in watertight compartments and significantly overlap with one another. In the second category of cases, the Court’s engagement with dignity is conspicuous but there is no effort on the part of the Court in theorising the principle and explicating its application.

Third category The third category of cases comprises those where a legal instrument already covers a healthcare claim, and the issues pertaining to its interpretation, enforcement, or legality has appeared before the Court.51 In such cases, the Supreme Court has not engaged with the constitutional value of dignity at all. Mohinder Singh Chawla52 and Ram Lubhaya Bagga53 are both cases pertaining to the interpretation of government policy regarding reimbursement claims in cases of treatment in private hospitals. In Mohinder Singh Chawla, the Court was asked to adjudicate if the treatment in the referred hospital would include expenses incurred on room, diet, and attendants.The Court answered the question in the affirmative and did not engage with dignity jurisprudence at all. However, in Ram Lubhaya Bagga the question before the Court concerned the reimbursement of additional expenses incurred during treatment when the government policy provided for reimbursement at the government rate.54 The Supreme Court gave utmost deference to government policy and agreed to ‘financial constrain’ as a legitimate reason in the realisation of the right to health.55 The Court again, like in Mohinder Singh Chawla, did not engage with dignity, and the only place where it referred to it, did so as a constitutional principle. The most celebrated case under the third category is Paschim Banga Mazdoor Khet Samity,56 where Hakim Sheikh fell from a train and suffered serious head injuries and brain haemorrhage. It was contended by the petitioner that Hakim Sheikh was taken to seven public hospitals where he was refused treatment either due to unavailability of beds or lack of requisite

51 State of Punjab v. Mohinder Singh Chawla (1997) 2 SCC 83; State of Punjab v Ram Lubhaya Bagga (1998) 1 SCR 1120; Paschim Bagga Mazdoor Khet Samiti Khet v State of West Bengal (1996) 4 SCC 37; Laxmi Mandal v Deen Dayal Hospital Harinagar WP (C) Nos 8853 of 2008. 52 (1997) 2 SCC 83. 53 (1998) 4 SCC 118. 54 ibid [2]. 55 ibid [29]. 56 Paschim Banga Mazdoor Khet Samity (1996) 4 SCC 37.

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facilities.57 Finally, Hakim Sheikh was admitted into a private hospital where he incurred Rs. 17,000 on treatment.58 The inquiry committee that was set up by the Court found that in one hospital capacity to offer him treatment existed; in another, the register maintaining records of patients had not been maintained; and in Medical College Hospital, Calcutta the junior doctor should have consulted the senior doctor immediately before refusing Hakim Sheikh.59 The Court held that the government hospitals run by the State and medical officers employed therein are duty-bound to extend medical assistance for preserving human life. Failure on the part of a government hospital to provide timely medical treatment to a person in need of such treatment results in violation of his right to life guaranteed under Article 21.60 It ruled in favour of Hakim Sheikh by awarding him a compensation of Rs. 25,000. It would have been interesting to observe the order of the Court had the committee not found the public hospitals negligent in providing treatment to Hakim Sheikh. This case was the first in which the Supreme Court stated that financial reasons cannot be cited as justifying limiting access to healthcare.61 The case has subsequently been referred to in many cases in support of this proposition.62 But this is not an unqualified observation.This was a case where doctors and the state were duty bound under the existing legal framework to provide medical treatment to patients taken to public hospitals. Paschim Banga Mazdoor Khet Samiti further shows no interaction with dignity in expanding on the reasoning and remedy. The Court did not refer to dignity even once. It simply crafted the remedy locating healthcare claims under Article 21.

First category We, again, come back to the first category. We have already highlighted how the courts acted conservatively until the 1980s and viewed healthcare claims through a duty-/obligation-oriented approach. In Parmanand Katara the Supreme Court, while alluding to professional obligations of doctors, ensured that patients must receive appropriate medical attention, irrespective of the private or public nature of the hospital. It was also stated that the Court’s deference to the executive in policymaking and advertent abstention from grappling with a rights-based discourse justified taking the conservative approach in the 1980s. However, the Court’s engagement with the constitutional value of dignity has increased with time and courts have been shifting towards a stronger form of interpretivism in creating new forms of rights. This can be seen in the way the courts crafted remedies by adhering to a duty-/obligation-oriented approach in the 1980s, but over the years they have shifted to a rights-based discourse with the advent of judicial activism and a stronger interpretivism.63 This was particularly conspicuous in a 2014 verdict by the Delhi High Court in Mohd Ahmed (minor) v Union of India.64

57 58 59 60 61 62 63 64

ibid [2]. ibid. ibid [7]. ibid [9]. ibid [16]. See Mohd Ahmed (minor) v Union of India (n 4). The second category mentioned earlier helps in showing the transition. Mohd Ahmed (minor) v Union of India (n 4).

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In Mohd Ahmed, a seven-year-old boy suffered from lysosomal storage disorder (Gaucher) where his body was unable to process fat and fat got deposited on various body organs which may have led to his premature demise. Treatment of this disorder is available and costs around USD 9000 per month. The father of the patient was a rickshaw puller and could not pay for Ahmed’s treatment.This significant judgment develops the dignity jurisprudence of the courts in three ways: first, it holds a ‘non-derogable minimum core’ of the right to healthcare which cannot be compromised. It admits the difficulty in defining the ‘minimum core’ but says that at least ‘minimum decencies of life consistent with human dignity’ must be provided.65 Second, it holds that the ‘right to adequate healthcare flows from the sanctity of human life and dignity that belongs to all persons.’66 This is significant because the court locates the right to healthcare in the constitutional value of dignity and attempts to provide it content. Unlike the second category of cases mentioned, where dignity is only invoked as a general principle, here it is seen as a constitutional value. Finally, the court, by providing content to the constitutional value of dignity, marks the shift from a conservative approach to an activist one.The court employs dignity as part of liberty clause (Article 21) and equality clause (Article 14).67 The expansion of dignity jurisprudence alongside equality jurisprudence holds the key to view societal disadvantages from a more humane lens.The dignity in equality jurisprudence attributes equal moral worth to each individual and hence provides for treatment as an equal as opposed to equal treatment. The Constitutional Court of South Africa has immensely contributed to developing the theoretical foundations of dignity under equality jurisprudence. There are three important attributes to reading dignity under the equality jurisprudence: Firstly, it demands that the social or economic disadvantage that some members of society suffer as a result of gender and historical prejudice must be acknowledged by the adjudicating bodies. Secondly, members of groups and individuals68 who are marginalised must be treated differently from others in order to promote substantive equality. That is because substantive equality demands treatment as equals and not equal treatment. Finally, while offering them special treatment, urgency considerations and the consequence in not providing the claim must be evaluated by the adjudicating authority while deciding the case.69 The Delhi High Court referred to Article 14 (right to equality before the law) infraction in its concluding paragraph. It held: To conclude, today, on account of lack of Government planning, there is ‘pricing out’ of orphan drugs for rare diseases and chronic diseases, like Gaucher.The enzyme replacement therapy is so expensive that there is a breach of constitutional obligation of the Government to provide medical aid on fair, reasonable, equitable and affordable basis. By their inaction, the Central and the State Governments have violated Articles 14 and 21 of the Constitution.70

65 ibid [67]. 66 ibid [65]. 67 Article 14 states that ‘[t]he State shall not deny to any person equality before the law or the equal protection of the laws within the territory of India’; see Leslie Meltzer Henry, The Jurisprudence of Dignity (University of Pennsylvania Law Review 2011). 68 Mohd Ahmed (minor) v Union of India (n 4); see also Harksen v Lane No 1998 (1) sa 300 (cc). (Regan J dissenting: ‘such patterns of discrimination can occur where people are treated without the respect that individual human beings deserve and particularly where treatment is determined not by the needs or circumstances of particular individuals but by their attributes and characteristics, whether biologically or socially determined.’) 69 David Bilchitz,‘Giving Socio-Economic Rights Teeth:The Minimum Core and Its Importance’ (2002) 118 SALJ 484, 490–91. 70 Mohd Ahmed (minor) v Union of India (n 4) [85] (emphasis added).

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The Delhi High Court, without using the term in as many words, applies all three attributes of dignity under equality jurisprudence in its judgment. It held: Just because someone is poor, the State cannot allow him to die. In fact, Government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases, like Gaucher especially when the prognosis is good and there is a likelihood of the patient leading to normal life.After all, health is not luxury and should not be the sole possession of a privileged few.71 The Delhi High Court’s judgment in Ahmed’s case holds the key to opening the doors for exploring the possibilities of situating dignity within equality jurisprudence under the Indian Constitution. Some may view this argument as inherently limiting due to the institutional incapacity of the judiciary.72 A more interventionist approach of the courts may deny the executive the authority to design and enforce healthcare policies – something which they are most adept to deal with.73 Further, the South African Constitutional Court applies dignity in equality jurisprudence in engaging dialogically with the state. The Constitutional Court in South African does not create strong remedies while applying this strand of dignity in healthcare.The Indian Courts may adopt a middle ground, especially in view of judgments of the Allahabad High Court in Sudhir Jaiswal v State of UP74 and Snehlata v State of UP.75 In Snehlata, a woman had a fistula in her bladder and could not be provided proper treatment in public healthcare facilities. While adjudicating her claim, the court asked the executive to file an affidavit explicating the budgetary allocation on healthcare facilities in the state. The court observed that a substantial part of the budget for the years 2016–17 and 2017–18 remained unspent.The court chastised the state and directed it to use the budget in a more efficacious manner.The courts may explore developing a jurisprudence of providing relief to claimants from the unspent budget as the Allahabad High Court devised in the educational case of Sudhir Jaiswal.This may allay the concerns of judicial activism amounting to tampering of budgetary layout, a concern that became prominent after Brazil’s example came to the world stage.76 Besides this, a systemic engagement between the court and the executive is desirable, on the lines of reasonableness model in South Africa for strengthening institutional framework on healthcare.

71 ibid [86]. 72 See Daniel Wang, Right to Healthcare Litigation in Brazil: The Problem and The Institutional Response (2015) 15 Human Rights Law Review 617–41. 73 ibid. 74 Writ No 1568 of 2017 (Allahabad High Court) (India): [A]s regard filling of 25 percent seats in private unaided schools, the rule provided that only those students within a vicinity of 1 km could seek admission.The rule was made in view of ensuring that no transportation difficulties are faced by children from economically weaker section and disadvantaged category.A son of a laborer who lived beyond 1 km neighborhood applied for admission in a prestigious private school in Allahabad and was denied admission on the ground of 1 km rule.The court held when the school had unfilled seats under 25 percent category then 1 km criteria should be relaxed.The access to education is the primary goal that state is trying to achieve and it should not be dispensed with in view of 1 km rule. 75 Snehlata v State of UP PIL No 14588 of 2009 (Allahabad High Court) (India). 76 Wang (n 72).

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Conclusion Traditionally, courts’ engagement with dignity in healthcare claims has been abysmal in cases where a legal instrument is already in place.Then the courts have simply used dignity to provide legitimacy to the rationality of its own reasoning and outcome.The courts, in view of their own institutional limitation due to separation of power, have refrained from developing a rightsbased discourse to healthcare claims as part of the liberty clause. But towards the end of 1970s courts started developing jurisprudence that enabled them to expand the liberty clause under Article 2177 and started to engage with the constitutional value of dignity in healthcare cases. It’s the common person’s plight that constituted the centrality of dignity jurisprudence. It is evident from the judgments of the courts that the following features of dignity are now key: (1) The idea of a dignified life demands a stronger obligation on the part of the state to provide for healthcare claims. (2) The constitutional value of a dignified life is grounded in the value of autonomy, which accepts each individual as the creator of her own destiny due to her inner worth and attributes sacred value to her choice/s in creating a desired life. (3) The idea of dignified life presupposes human beings as ends and not as means. (4) The dignity jurisprudence demands a ‘social minimum’ that is compliant with the capability approach. (5) The dignity jurisprudence also alludes to the possibilities of situating dignity within equality jurisprudence and reflects on the institutional role it could play in mitigating material inequality. Despite courts’ significant engagement with dignity, and attempts to employ it as a cardinal constitutional value in adjudicating socio-economic claims, there are multiple murky areas which need further clarity.These are: (1) Courts have simply invoked dignity in justifying the concept of ‘social minimum’ while adjudicating healthcare claims. Courts have not engaged with drawing the contour of ‘social minimum’ and its constituents. In viewing the ‘social minimum,’ there is enormous possibility in developing a contextual theoretical framework. (2) Courts have sporadically referred to the relationship between autonomy and dignity. However, the courts’ jurisprudence is unclear and smudged on the relationship between the two. It is the Kantian idea of dignity grounded in autonomy that provides a framework by suggesting the relationship between the two. Courts need to neatly lay down their relationship and clearly suggest their interaction. (3) There are, again, sporadic instances where courts locate dignity within equality jurisprudence, but refrain from clearly sketching their relationship. This strand of dignity jurisprudence has the potential of opening a new way of viewing dignity within the Indian constitutional law framework and demanding more accountability on the part of the executive.

77 Maneka Gandhi v Union of India (1978) AIR SC 597 (India).

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References Bilchitz, David, ‘Giving Socio-Economic Rights Teeth: The Minimum Core and Its Importance’ (2002) 118 SALJ 484, 490–91. Foster, Charles, Human Dignity in Bioethics and Law (Hart 2011). Kant, Immanuel, Groundwork of the Metaphysics of Morals (Cambridge University Press 1997, edited by Mary Gregor). Khosla, Madhav, ‘Making Social Rights Conditional – Lessons From India’ (2010) International Journal of Constitutional Law https://academic.oup.com/icon/article/8/4/739/667097 accessed 19 October 2020. Mosen, Michael, Dignity: It’s History and Meaning (Harvard University Press 2012). Nussbaum, Martha, Women and Human Development:The Capabilities Approach (Cambridge University Press 2000). Sen, Amartya, ‘Capabilities and Well-Being’ in Martha Nussbaum and Amartya Sen, The Quality of Life (Clarendon 1993) 30–53. Tushnet, Mark,Weak Courts, Strong Rights: Judicial Review and Social Welfare Rights in Comparative Constitutional Law (Princeton University Press 2008). Van Marle, K,‘“The Capabilities Approach”,“The Imaginary Domain”, and “Asymmetrical Reciprocity”: Feminist Perspective on Equality and Justice’ (2003) 11 Feminist Legal Studies 255–78 and 272–73. Wang, Daniel, ‘Right to Healthcare Litigation in Brazil: The Problem and The Institutional Response’ (2015) 15 Human Rights Law Review 617–41.

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11 UNIVERSAL HEALTH COVERAGE AND THE RIGHT TO HEALTH IN NIGERIA Cheluchi Onyemelukwe

Introduction Nigeria is Africa’s most populous nation with about 200 million people. It has considerable influence on the continent. However, healthcare indices in the country are poor.The country has some of the highest rates of human immunodeficiency virus (HIV), with a prevalence rate of 1.5% of persons between the ages of 15 and 64.1 Maternal mortality rates are very high: 522 per 100,000 live births.2 Nigeria also experiences a significant number of infectious diseases, some of which yield epidemics annually. Infant mortality as a result of malnutrition is also high and many children die before their fifth birthday from childhood diseases. Nigeria has the highest estimated burden of childhood pneumococcal diseases in Africa3 and the second highest in the world.4 Non-communicable diseases are also becoming a cause for concern, with increasing rates of cancers, hypertension, and diabetes, in part due to lifestyle changes. Limited access to mental health services as well as its associated stigma continue to be a significant challenge, while many living with a disability have little access to essential services. These statistics are made grimmer by the limited number of persons who have access to healthcare services and high out-of-pocket expenses for healthcare,5 with some estimates placing them at 90%.6 Disparities in access exist between rural and urban areas, with rural areas

1 Federal Ministry of Health and National Agency for AIDS Control (NACA), ‘Nigeria HIV/AIDS Indicator and Impact Survey’ (2019) www.naiis.ng/resource/factsheet/NAIIS%20PA%20NATIONAL%20FACTSHEET %20FINAL.pdf accessed 14 October 2020. 2 National Population Commission, Nigeria and ICF, Nigeria Demographic and Health Survey (2018) https://dhsprog ram.com/pubs/pdf/FR359/FR359.pdf accessed 14 October 2020. 3 IMO Adetifa,AL Adamu,A Karani, M Waithaka, KA Odeyemi, CAN Okoromah, MM Bello, IS Abubakar,V Inem, and JAG Scott,‘Nasopharyngeal Pneumococcal Carriage in Nigeria:A Two-Site, Population-Based Survey’ (2018) 8(1) Scientific Reports 3509. 4 Agnese Juliano et al.,‘The Burden and Risks of Pediatric Pneumonia in Nigeria:A Desk-Based Review of Existing Literature and Data’ (2020) 55(1) Pediatric Pulmonology S10–S21. 5 BS Aregbeshola and SM Khan, ‘Out-of-Pocket Payments, Catastrophic Health Expenditure and Poverty among Households in Nigeria 2010’ (2018) 7(9) International Journal of Health and Policy Management 798–806. 6 CS-SUNN and PACFAH,‘Budgeting for Health and Nutrition in Nigeria’ https://ptcij.org/wp-content/upload s/2015/12/Budgeting-for-Health-and-Nutrition-in-Nigeria.pdf accessed 14 October 2020.

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being where more people live having fewer healthcare facilities, poor patient safety,7 a significant amount of brain drain of healthcare professionals and the resulting low patient-to-healthprofessional ratio (1 to about 3000),8 poor and dilapidating infrastructure, and a considerable degree of health illiteracy. Despite these challenges, budgetary allocations to healthcare hover around 5% or less of the annual budget,9 well below the commitment of the country in the Abuja Declaration of 2001.Accountability is, therefore, a key issue. To address these issues, the concept of universal health coverage (UHC) has become increasingly suggested as a solution in Nigeria.This movement follows the drive in international policy circles towards the concept of UHC, championed by the World Health Organization and other international development organisations.This concept, defined briefly as ensuring that all people obtain essential health services they need without suffering financial hardship,10 has found currency not only in Nigeria but in other African countries and countries around the world. While the concept appears to hold promise for improving access to basic, quality healthcare services, what are the legal foundations for UHC? In this regard, scholars have analysed the close relationship between UHC and the right to health, as articulated in the International Covenant on Economic, Social and Cultural Rights. The relationship between universal health coverage and the right to health has also been explored by the WHO, noting that the right to health is based on the WHO Constitution of 1948.11 More relevant for the purpose of this chapter: what rights do Nigerians have to UHC? The Constitution of the Federal Republic of Nigeria (1999), like the constitutions that preceded it, does not specifically provide for the right to health as conceived in international human rights instruments.These include, in particular, the International Covenant on Economic, Social and Cultural Rights,12 and also regional instruments such as the African Charter on Human and Peoples’ Rights.13 Yet the right to health is not specifically articulated in the Constitution. Instead, it provides for a non-justiciable duty to ensure occupational safety and medical and health services for all.14 Much has been written on the justiciability of the right to health and other socio-economic rights in Nigeria,15 which seemingly makes the legal foundations of UHC somewhat shaky. However, this chapter examines the universal health coverage and the right to health as currently articulated in Nigeria’s body of legislation. It argues that, while the right to health is non-justiciable in its purest form, in the years since the Constitution came into force, there has been a steady, though slow, movement towards enshrining the right to health and providing a

7 See Cheluchi Onyemelukwe,‘Patient Safety in Nigeria:An Emergent Concept’ in John Tingle, Clayton Ó Neill, and Morgan Shimwell (eds), Global Patient Safety: Law, Policy and Practice (Routledge 2018). 8 FMOH, 2018 National Health Work Force Profile, 2019. 9 Aworinde Tobi,‘2020 Budget: Health, Education in Familiar Territory of Neglect’ Punch Newspaper (20 October 2019) https://punchng.com/2020-budget-health-education-in-familiar-territory-of-neglect/ accessed 14 October 2020. 10 WHO, ‘What Is Universal Health Coverage?’ www.who.int/news-room/q-a-detail/what-is-universal-health-co verage accessed 14 October 2020. 11 ibid. 12 Cheluchi Onyemelukwe,‘Access to Anti-Retroviral Drugs as a Component of the Right to Health: Examining the Application of the Right in Nigerian Jurisprudence’ (2008) 7 African Human Rights Law Journal 446. 13 ibid. 14 Constitution of Nigeria, 1999, section 17(3)(d)(e). 15 See, for example, Onyemelukwe, ‘Access to Anti-Retroviral Drugs’ (n 12) 446; and Nnamuchi Obiajulu, ‘Rethinking Justiciability of Socioeconomic Rights in Nigeria: A Critique of the Dominant Position’ (20 December 2012) https://ssrn.com/abstract=2191914 accessed 14 October 2020.

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legal foundation for UHC in other pieces of legislation. It is further contended that these pieces of legislation can be employed to ensure or give teeth to the laudable idea of universal health coverage in Nigeria.

Universal health coverage and the right to health Universal health coverage is not a new concept. It may be argued to have begun long before the 20th century. From the 19th century, different countries have worked to establish systems that aim to provide universal health coverage.16 These attempts evolved from the Otto von Bismarck national social health insurance scheme in Germany and then to the 20th-century countries, with national health systems in the United Kingdom and Canada. Various ideas have drawn from the idea of UHC such as the primary health care concept enshrined in the 1978 Alma Ata Declaration and later on in several World Health Assembly declarations.17 However, the concept has recently come into more prominence and is now being championed by the most important international development organisations, including the WHO and the World Bank, encouraging less wealthy and resource-constrained countries to adopt it as well. Thus in 2012, the United Nations adopted a resolution which recognised amongst other things, ‘the responsibility of Governments to urgently and significantly scale up efforts to accelerate the transition towards universal access to affordable and quality health-care services’ and acknowledged that universal health coverage implies that all people have access, without discrimination, to nationally determined sets of the needed promotive, preventive, curative and rehabilitative basic health services and essential, safe, affordable, effective and quality medicines, while ensuring that the use of these services does not expose the users to financial hardship, with a special emphasis on the poor, vulnerable and marginalized segments of the population.18 Three years later, in 2015, the concept was also adopted in the Sustainable Development Goals (SDGs), a set of programmatic goals set by the United Nations for the achievement of a sustainable future and expected to be achieved by all countries by 2030.19 SDG 3 requires the achievement of the goal of ensuring healthy lives and promoting well-being for all at all ages and within that goal the goal of achieving universal health coverage.20 On 12 December 2017, the UN by a resolution adopted by the General Assembly declared 12 December to be Universal Health Coverage Day.21 Further, a high-level meeting on universal health coverage was held on 23

16 Eswan Swan, ‘Universal Health Coverage: An Illustrated History’ Financial Times (19 September 2018) www.ft .com/content/34084366-dadb-11e9-8f9b-77216ebe1f17 accessed 14 October 2020. 17 Gilbert A Abiiro and Manuela De Allegri, ‘Universal Health Coverage from Multiple Perspectives: A Synthesis of Conceptual Literature and Global Debates’ (2015) 17 BMC International Health and Human Rights https:/ /bmcinthealthhumrights.biomedcentral.com/articles/10.1186/s12914-015-0056-9 accessed 14 October 2020. 18 UNGA 67th Session on Global Health and Foreign Policy, adopted 12 December 2012. 19 See www.un.org/sustainabledevelopment/sustainable-development-goals/; T Bärnighausen and R Sauerborn, ‘One Hundred and Eighteen Years of the German Health Insurance System:Are There Any Lessons for Middleand Low-Income Countries?’ (2002) 54 Social Science & Medicine 1559–87. 20 SDG 3.8. 21 UN, ‘International Universal Health Coverage Day, 12 December’ www.un.org/en/observances/universal-heal th-coverage-day accessed 14 October 2020.

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September 2019, where political leaders from UN member states declared their commitment to achieving universal health coverage.22 Universal health coverage has been defined as ‘all people and communities, having access to the basic health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship.’23 In essence, the components of UHC include improved access to needed, effective services while protecting users of healthcare systems from financial ruin/hardship. The services contemplated under universal health coverage are basic, essential, and comprehensive health services – promotive, preventive, curative, rehabilitative, and palliative. It also includes the key concepts of ‘equity, shared responsibility, and quality healthcare delivery irrespective of ability to pay.’24 According to the WHO, objectives of UHC are thus threefold: • • •

equity in access to health services – everyone who needs services should get them, not only those who can pay for them; the quality of health services should be good enough to improve the health of those receiving services; and people should be protected against financial risk, ensuring that the cost of using services does not put people at risk of financial harm.25

The key questions that UHC seeks to answer are:Who is covered? What services are covered? What is the level of quality of these services? How are the services paid for? In this regard, the concept envisages that health systems should be strong, efficient, well-organised and managed in order to meet the health needs of all persons in line with their priorities.Thus, all persons in a country are covered at least to some degree. In terms of coverage of services, the health system is not only expected to be curative, it should also be preventive, providing room for the prevention of common illnesses, including infectious diseases. It should also be promotive, promoting good health practices, providing information on how people can stay healthy, and incentives and encouragement to adopt healthy practices and lifestyles. It should also be rehabilitative, for example providing support for substance abuse management. Importantly, it must address cost. Coverage must not depend on who can afford to pay. In the context of Nigeria, this is a crucial matter. In a country where the majority live below the poverty line, access to health care is often dependent on affordability, that is whether one can pay for health services. Cost also includes delivering a system of financing that provides for these needs to be met, including the costs of health providers; essential medicines; and technologies, research, and information systems. In the context of UHC, this is an aspect that must be addressed through appropriate health financing arrangements. Quality of services must also be addressed: this means that there needs to be measures in place to ensure qualified persons, good equipment, quality essential medicines, high-quality information, addressing of issues such as waiting times, etc. Quality is crucial in

22 IISD, ‘UN High-Level Meeting Adopts Historic Declaration on Universal Health Coverage’ (24 September 2019) https://sdg.iisd.org/news/un-high-level-meeting-adopts-historic-declaration-on-universal-health-cove rage/ accessed 14 October 2020. 23 WHO, ‘Universal Health Coverage’ www.who.int/healthsystems/universal_health_coverage/en/ accessed 14 October 2020. 24 WHO,‘African Union Universal Health Coverage in Africa: From Concept to Action’ (WHO 2014) 1–7 www.w ho.int/health_financing/policy-framework/auc-who-2014-doc1-en.pdf accessed 14 October 2020. 25 WHO, ‘Health Financing’ www.who.int/health_financing/universal_coverage_definition/en/ accessed 14 October 2020.

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part because it affects health outcomes and determines whether health services are of value for the money, but also because it has an impact on trust, perception, and ultimately uptake of the services. As important as universal health coverage might be, as noted elsewhere, there are domestic political debates,26 including those concerning financing mechanisms, which must be held. These debates and ones concerning legal issues about the necessary legal steps to entrench UHC will offer an opportunity to those involved in healthcare provision and policy-making to engage with this pivotal issue. As the WHO notes, the law is an important enabler of UHC because it can help guarantee the goals of UHC, namely equity, quality, health security, and financial risk protection; establish the legal mandate for access to health services for all; establish and enforce fair rules and incentives to ensure that for actors towards achieving UHC; and provide one means for realising UHC policies and programmes and supporting efforts to strengthen health systemss.27 In addition, it provides sustainability that is likely to ensure that policies outlast governments and become institutionalised. With these in mind, I turn now to a key question: what is the legal foundation for universal health coverage? How can governments be held legally accountable for providing universal health coverage? These questions can be answered in a domestic context by examining the domestic legal frameworks in place and assessing how well they meet the imperative of an entitlement to universal health coverage and its expected outcomes.With respect to this entitlement, a rights-based analysis offers a good basis for assessment of these laws. From a human rights perspective, these questions are often answered by looking at the connections and linkages between the right to health and UHC. Many scholars have attempted to draw these linkages, as have international organisations, making reference to key international instruments.The Universal Declaration of Human Rights, for example, declares that ‘[e]veryone has the right to a standard of living adequate for the health and well-being of himself and his family.’28 This provision clearly resonates in our understanding of UHC.The right to health is also acknowledged in the International Convention on the Elimination of All Forms of Racial Discrimination of 1965,29 the Convention on the Elimination of All Forms of Discrimination against Women of 1979,30 Convention on the Rights of the Child of 1989,31 the Convention on the Rights of Persons Living with Disabilities,32 and the International Convention on Migrant Workers.33 At a regional level, the African Charter on Human and Peoples’ Rights also provides for the right to health, declaring:‘Every individual shall have the right to the best attainable state of physical and mental health.’34More recently, one of the key issues developed for deliberations prior to the UN High-Level Meeting on Universal Health Coverage in 2019 as an ‘Ask’ was the need to regulate and legislate UHC, that is to

26 Jesse B Bump,‘The Long Road to Universal Health Coverage: Historical Analysis of Early Decisions in Germany, the United Kingdom, and the United States’ (2015) 1(1) Health Systems and Reform 28. 27 WHO,‘Creating Enabling Legal Environments for Universal Health Coverage’ www.who.int/health-laws/univer sal-health-coverage/en/ accessed 14 October 2020. 28 Universal Declaration of Human Rights,Article 25. 29 Article 5(e)(iv). 30 Articles 11.1(f) and 12 of the Convention on the Elimination of All Forms of Discrimination against Women of 1979. 31 Article 24 of the Convention on the Rights of the Child of 1989. 32 Article 25 of the Convention on the Rights of Persons Living with Disabilities. 33 Article 28. 34 Article 16.

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Create a strong, enabling regulatory and legal environment responsive to people’s needs. UHC requires a sound legal and regulatory framework and institutional capacity to ensure the rights of people and meet their needs. Governments are the primary duty bearer under the International Covenant on Economic, Social and Cultural Rights, even in cases when they rely on private providers.35 The International Covenant on Economic, Social and Cultural Rights (ICESCR) provides for a number of socio-economic rights, including the right to health. It states: ‘The States Parties recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.’36 General Comment Number 1437 has helped expatiate on the normative contents of right to health, establishing the minimum core obligations of States. General Comments are considered soft rather than hard law and are not legally binding. However, they are highly persuasive and generally receive compliance in international law.38 The General Comment notes that ‘The realization of the right to health may be pursued through numerous, complementary approaches, such as the formulation of health policies, or the implementation of health programmes developed by the World Health Organization (WHO), or the adoption of specific legal instruments.’39 In this regard, UHC may be regarded as one approach to realising the right to health, alongside the adoption of legal instruments to strengthen that approach. The General Comment emphasises the interdependency of human rights and that other rights such as the rights to food, housing, work, education, human dignity, life, non-discrimination, equality, the prohibition against torture, privacy, and access to information, and the freedoms of association, assembly, and movement.40 Beyond that, the General Comment observes that while the right to health comes in various forms, in all its forms it comprises the following elements: (a) Availability – This includes functioning public health and healthcare facilities, goods, and services, as well as programmes, have to be available in sufficient quantity within the country along with the determinants of health including water that is safe and suitable for drinking and adequate sanitation facilities; hospitals, clinics, and other health-related buildings; trained medical and professional personnel receiving domestically competitive salaries; and essential drugs, as defined by the WHO Action Programme on Essential Drugs. (b) Accessibility – This requires that health facilities, goods, and services have to be accessible to everyone without discrimination within the country.This has four intersecting aspects, including non-discrimination, physical accessibility, and affordability (in which equity is embedded and in which poor households are not to be disproportionately burdened with healthcare costs). Each of these is linked to the requirements of UHC as discussed earlier.

35 UHC2030, ‘Key Asks from the UHC Movement UN High-Level Meeting on Universal Health Coverage’ www.uhc2030.org/fileadmin/uploads/uhc2030/Documents/UN_HLM/UHC_Key_Asks_final.pdf> accessed 14 October 2020. 36 CESCR,Article 12. 37 Committee on Economic, Social and Cultural Rights, General Comment No 14:The Right to the Highest Attainable Standard of Health (Twenty-Second Session Geneva, 25 April–12 May 2000). 38 Lottie Lane, ‘The Horizontal Effect of International Human Rights Law in Practice’ (2018) 5(1) European Journal of Comparative Law and Governance 5–88. 39 Article 1 of the General Comment. 40 Article 3 of the General Comment.

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(c) Acceptability – The right to health requires that all health facilities, goods, and services shall respect medical ethics and must be culturally appropriate, gender-sensitive, and sensitive to life-cycle requirements, respect confidentiality, and improve the health status. (d) Quality – The right also requires that health facilities, goods, and services must also be scientifically and medically appropriate and of good quality. This necessarily requires that there be sufficient numbers of the key elements of healthcare: skilled medical personnel, scientifically approved and unexpired drugs and hospital equipment, safe and potable water, and adequate sanitation. The General Comment also addresses the need for rehabilitative care, in particular for older adults, and the right to a framework for preventing infectious diseases. Countries are required to ensure the minimum levels of the right as enunciated in the core normative content. The right includes both positive and negative elements, requiring states to undertake active steps to provide health facilities and access, while refraining from discrimination, for example. From the preceding discourse, the key elements of UHC, such as affordability, financial risk protection, and quality, are embedded within the right to health, even though the right operates within the parameters of progressive realisation, which allows room for a country, including resource-constrained countries like Nigeria, to work towards realising, protecting, and fulfilling the right to health. In essence, the right to health provides legal foundation for the right of all to have access to available, accessible, acceptable, qualitative health care, and requires the existence of a legal framework that assures such care. However, the right to health with the core requirements of progressive realisation, non-discrimination, the requirement to meet minimum core obligations, and its clear commitment to addressing the social determinants of health as well as healthcare services, and the requirement not only to rely on a country’s resources but also on international cooperation and assistance, is arguably broader than the focus on UHC. This is an argument worth exploring and which has been considered to some degree in the literature.41 It is, however, not the focus of this chapter. This chapter focuses instead on the grounds upon which UHC may claim a legal foundation which will entitle citizens to make a claim on the government.

Universal health coverage and the justiciability of the right to health in Nigeria UHC has become a major imperative in Nigeria, especially in light of its poor health indices as cited in the Introduction. In 2014, a Presidential Summit on Universal Health Coverage took place in Abuja.This heralded an official embrace of the concept in Nigeria, with the key points highlighted in a Presidential Summit on Universal Health Coverage Declaration.42 The

41 See, for example, Gorik Ooms et al., ‘Is Universal Health Coverage the Practical Expression of the Right to Health Care?’ (2014) BMC International Health and Human Rights; see also Lisa Forman, ‘What Could a Strengthened Right to Health Bring to the Post-2015 Health Development Agenda?: Interrogating the Role of the Minimum Core Concept in Advancing Essential Global Health Needs’ (2013) 48 BMC International Health and Human Rights 13 https://bmcinthealthhumrights.biomedcentral.com/articles/10.1186/1472-698X-14-3 accessed 14 October 2020; Gilbert A Abiiro and Manuela De Allegri,‘Universal Health Coverage from Multiple Perspectives: A Synthesis of Conceptual Literature and Global Debates’ (2015) 17 BMC International Health and Human Rights https://bmcinthealthhumrights.biomedcentral.com/articles/10.1186/s12914-015-0056-9 accessed 14 October 2020. 42 ‘Presidential Summit on Universal Health Coverage Declaration (Abuja, 10 March, 2014)’ www.msh.org/sit es/msh.org/files/presidential_summit_declaration_on_universal_health_coverage_in_nigeria.pdf accessed 14 October 2020.

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Declaration affirmed that ‘health is a fundamental human right’ and that the government has the responsibility to assure the health of its people.43 This is particularly important because, as discussed later, the Nigerian Constitution does not clearly recognise the right to health as a fundamental right.The Declaration also recognised that UHC ‘holds the key to unlocking the door for equitable, qualitative and universally accessible healthcare for all Nigerians without suffering financial hardship.’44 The Declaration also recognised the challenges that hinder UHC in Nigeria, namely ‘sub-optimal health system characterized by budgetary constraints, inadequate financial protection for the poor, shortage and mal-distribution of human resources for health, uneven quality of health care services, challenges in the provision of health commodities, poor coordination, and weak referral system and the uneven utilization of health services.’45 It, then, listed several steps that were to be taken towards achieving UHC. Several of these included health financing steps but also steps for the purpose of managing quality: • • • • • • • • • •

Institutionalising mandatory health insurance in Nigeria, with contributions from all income earners (formal and informal) and special funds to cover the poor; Increasing budgetary allocation to health at federal, state, and local government with a proportion earmarked for UHC priority interventions; Providing alternative, innovative, and sustainable sources of funding for UHC; Pooling these funds into a Universal Health Coverage Fund at all levels; Strengthening and expanding financial risk protection mechanisms for the poor and vulnerable groups as part of the broader social protection efforts in the country; Defining a standard benefit package of essential health services that address priority healthcare needs of Nigerians; Providing the standard benefit package through ensuring adequate physical infrastructure, skilled human resource, medicines and other life-saving commodities, and equitable distribution of same Providing policy and regulatory instruments for the institutionalisation of systems and mechanisms that ensure quality of care and satisfaction for consumers of healthcare services; Exploring the establishment of an Independent Health Quality Commission to ensure standards and compliance; Building an organised referral system that guarantees each citizen access to functional primary health care facility, which shall be the first point of contact in the national health system.46

While the Declaration is not a legal document and does not carry any weight in law, it demonstrates government understanding of the existing challenges and the need to take steps towards UHC in Nigeria. Since the Declaration, the government has taken several steps, including enactment of the National Health Act and the establishment of state health insurance schemes. The National Health Policy 2016 reiterates the government’s commitment towards universal health coverage by declaring the vision of the policy, an umbrella document which provides the

43 44 45 46

Article 1 of the Declaration. Article 3 of the Declaration. Article 6 of the Declaration. Articles 10 to 19 of the Declaration.

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overall government policy on the wide range of health issues and which is expected to last ten years,‘Universal Health Coverage (UHC) for all Nigerians.’47 Clearly, therefore, the Nigerian government has declared its commitment to the ideals of UHC. However, the situation of health access and quality in the country makes it plain that it is very far from achieving the objectives of UHC – limiting financial hardship in accessing basic healthcare services and provision of services of good quality, and by so doing addressing issues of equity, service provision, etc. The question then may be whether there is a supportive legal framework for UHC which may be drawn upon to enforce this practice. For this purpose, I next consider the right of health and its justiciability in a Nigerian context. The right to health is not one of the fundamental rights provided in Chapter Four of the Constitution, although other rights provided therein have significance for the right to health such as the right to life, the right to dignity and freedom from degrading and cruel treatment, right to freedom of religion and conscience, and the right to privacy. Instead the closest idea to a right to health is found in Chapter Two of the Constitution. Chapter Two provides for the Fundamental Objectives and Directive Principles of State Policy. Section 17(3)(c) and (d) provides for the obligation to provide for occupational health and safety and medical facilities: The State shall direct its policy towards ensuring that: (c) the health, safety and welfare of all persons in employment are safeguarded and not endangered or abused; (d) there are adequate medical and health facilities for all persons. However, this provision, like other provisions in Chapter Two are unenforceable as constitutional provisions. In this regard, section 6(6)(c) of the Constitution ousts the jurisdiction of the courts to enforce the obligations and directive principles set out in Chapter Two of the Constitution, stating that the judicial powers vested in the judiciary48 shall not except as otherwise provided by this Constitution, extend to any issue or question as to whether any act of omission by any authority or person or as to whether any law or any judicial decision is in conformity with the Fundamental Objectives and Directive Principles of State Policy set out in Chapter II of this Constitution.49 The courts have adopted a restrictive interpretation of section 6(6)(c) of the Constitution in several cases.50 In this regard, a consideration of section 13 of the Constitution may be helpful: It shall be the duty and responsibility of all organs of government, and of all authorities and persons, exercising legislative, executive or judicial powers, to conform to, observe and apply the provisions of this Chapter of this Constitution.51 Yet this, by itself, as apparent in early decisions, does not override section 6(6)(c) which ousts or removes the jurisdiction of the courts to enforce.52 On the basis of this, many scholars have

47 48 49 50

Federal Ministry of Health, National Health Policy, 2016. Constitution of the Republic of Nigeria,1999, section 6. Constitution of the Federal Republic of Nigeria, 1999, section 6 (6)(c). See, for example, Archbishop Olubunmi Okogie and others v Attorney General of Lagos (1981) 2 NCLR 331; Adeyinka Badejoh and others v Federal Ministry of Education and others. 51 Constitution of the Federal Republic of Nigeria, 1999, section 13. 52 ibid section 6.

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argued that the right to health is not justiciable in Nigeria and proposed ways of ensuring that this right becomes justiciable, including amending the Constitution, adopting the Indian approach to linking fundamental objectives to fundamental rights (for example, there can be no right to life without a right to basic health care), investigating whether the enforceable fundamental rights have been violated by making reference to the fundamental objectives.53 However, a close look at the opening phrase, the ousting clause, of section 6(6)(c), ‘except as otherwise provided by this Constitution’ suggests that the matter is not as straightforward as it would appear from the early decisions.When read in conjunction with section 13, as quoted earlier, it is arguable that the ouster ought not to be effective. Some of these arguments appear to have had an impact on other socio-economic rights. In Jonah Gbemre v Shell Petroleum Development Company Nigeria Limited and others,54 for instance, a case in which the plaintiff challenged the flaring of gas and the resulting destruction of the environment as a violation of their right to life, the court held that the right to life included the right to a clean, healthy environment. In reaching this decision, the court relied on the provisions in the African Charter on Human and Peoples’ Rights, which has been domesticated and is now municipal law.This suggests a progressive movement by the courts in Nigeria to a recognition of socio-economic rights. However, another way to potentially ensure the enforceability of the right to health, alongside other socio-economic and cultural rights, is the enactment of standalone legislation. In this regard, the courts in Nigeria have now held on the basis of section 13 that while enforceability in the courts may, strictly speaking, not be permitted under the Constitution, the same Constitution requires the executive arm and other arms of government to undertake the application of Chapter Two, including the right to medical services, making it an obligation, albeit an unenforceable one.Thus, in the case of A G Ondo State v A G Federation, the Supreme Court declared that non-compliance with the provisions of Chapter Two would amount to a failure of duty and responsibility, though unenforceable by legal process. However, the Court went on to declare that ‘the Directive Principles (or some of them) can be made justiciable by legislation.’55 Further, Justice Uwaifo in that case stated aptly: We do not need to seek uncertain ways of giving effect to the Directive Principles in Chapter II of our Constitution. The Constitution itself has placed the entire chapter II under the Exclusive Legislative list. By this, it simply means that all the Directive Principles need not remain mere or pious declarations. It is for the Executive and the National Assembly, working together, to give expression to anyone of them through appropriate enactment … the National Assembly can well legislate if in its wisdom it considers it necessary.56 In other words, the government can choose to ensure enforceability by passing legislation to give effect to the provisions of Chapter Two, in which case that legislation can be enforced by the courts.This includes legislation which provides for universal health coverage or for the right

53 Onyemelukwe, ‘Access to Anti-Retroviral Drugs’ (n 12); C Obiagwu and CA Odinkalu, ‘Nigeria: Combating Legacies of Colonialism and Militarism’ in AA An-Na’im, Human Rights under African Constitutions: Realising the Promise for Ourselves (2003) 226; Edoba Omoregie and Daud Momodu, ‘Justifying the Right to Health Care in Nigeria: Some Comparative Lessons’ (2014) 12 Nigerian Juridical Review 13. 54 Jonah Gbemre v Shell Petroleum Development Company Nigeria Limited and ors Suit No: FHC /B/SC/53/05. 55 A G Ondo State v A G Federation (2002) 9 NWLR (Pt. 772) 222 (SC) per Uwaifo, JSC at p. 382 paras A–D. 56 ibid 382 paras F–H (emphasis added).

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to health, including the right to medical services as specified in the Constitution.This approach has been adopted by the Nigerian courts in recent cases such as Legal Defence and Assistance Project (LEDAP) GTE & LTD v Federal Ministry of Education & Anor57 where the right to universal basic education, as provided under the Compulsory Universal Basic Education Act, was held to be enforceable by the court under that Act. As I have argued elsewhere, the right to medical facilities as provided under the Constitution is narrower than the right to health. It does not make provision for the underlying determinants of health or for the normative content of the right to health as identified in the General Comment.58 Enacting legislation can help address those other missing aspects outside the Constitution while rendering them justiciable so that an aggrieved Nigerian who believes their rights to be violated can seek redress for such violation under the legislation. At this time, the right to health has been implemented, albeit to a limited degree in various pieces of legislation. These pieces of law indicate that universal health coverage is not merely a policy issue but a matter in which the law can be used for the purposes of accountability. I examine these pieces of legislation in the subsequent sections.

Recent legal developments with implications for the right to health and universal health coverage The African Charter on Human and Peoples’ Rights The African Charter on Human and Peoples’ Rights (hereafter the African Charter) is a regional human rights instrument established by the Organisation of African Unity, now the African Union, and adopted in 1981 and came into force on 21 October 1986, for the purpose of promoting and protecting human rights and basic freedoms in Africa. The Constitution of Nigeria entrenches a dualist system which requires that international law be domesticated before it is enforceable in Nigerian courts.According to the Constitution: ‘No treaty between the federation and any other country shall have the force of law except to the extent to which any such treaty has been enacted into law by the National Assembly.’59 Nigeria has ratified and domesticated the African Charter, the first country in Africa to do so.60 Thus the African Charter on Human and Peoples’ Rights (Ratification and Enforcement) Act 198361 is now municipal law enforceable before Nigerian courts. The African Charter provides for a number of socio-economic rights, including the right to health.Article 16 states: (1) Every individual shall have the right to enjoy the best attainable state of physical and mental health. (2) State Parties to the present Charter shall take the necessary measures to protect the health of their people and to ensure that they receive medical attention when they are sick.

57 Legal Defence and Assistance Project (LEDAP) GTE & LTD v Federal Ministry of Education & Anor (2017w), Suit No FHC/ABJ/CS/978/15, https://nigerialii.org/ng/judgment/high-court-fct-nigeria/2018/2 accessed 14 October 2020. 58 Onyemelukwe,‘Access to Anti-Retroviral Drugs’ (n 12) 446. 59 Constitution of the Federal Republic of Nigeria, 1999, section 12. 60 African Commission on Human and Peoples’ Rights,‘State Parties to the African Charter’ www.achpr.org/statep artiestotheafricancharter accessed 14 October 2020. 61 African Charter on Human and Peoples’ Rights (Ratification and Enforcement) Act, 1983 Cap A10 Laws of the Federation of Nigeria, 2004.

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The first part of the right to health, underscoring all persons’ rights to the best attainable state of physical and mental health, are reminiscent of the provisions in other instruments, including the WHO Constitution, the Convention on the Rights of the Child, and the ICESCR. The normative content is set out in the Principles and Guidelines on the Implementation of Economic, Social and Cultural Rights in the African Charter on Human and Peoples’ Rights articulated by the African Commission on Human and Peoples’ Rights (hereafter Principles and Guidelines).62 Like General Comment No 14 on the right to health in the ICESCR, the Principles and Guidelines are soft law, which, however, is of considerable significance in understanding the rights articulated in the African Charter.They define the scope of the right and the key principles that undergird the right, including minimum core obligations, the principle of non-discrimination, obligations to take immediate steps, and presumption against retrogressive steps as well as progressive realisation. Progressive realisation is not specifically provided in the African Charter. However, while recognising this, the Principles and Guidelines also state that the concept is well recognised in international law and applicable in the context of the African Charter to require states to continue to work towards the realisation of the rights provided therein through a reasonable and measurable plan.63 With this recognition, it seems fairly clear that the General Comment on the ICESCR has utility in defining the content of the right to health as articulated in the African Charter. Importantly, the Principles and Guidelines emphasise the domestic enforceability of socioeconomic rights including the right to health, providing: All rights recognised in the African Charter must be made effective under national legal systems. Violation of economic, social and cultural rights protected under the African Charter must entitle affected individuals and peoples to effective remedies and redress under domestic law.A rigid classification of economic, social and cultural rights which puts them, by definition, beyond the reach of the courts would be incompatible with the principle that human rights are indivisible and interdependent. International remedies are ultimately only supplementary to effective national remedies.64 As stated earlier, Nigeria has adopted the African Charter as domestic law, making it directly enforceable in Nigerian law.What this means is that the right to health is, or at least ought to be, enforceable in Nigerian courts. The Principles and Guidelines also require that national plans, policies, indicators, timeframes, and benchmarks should be articulated, with emphasis on vulnerable persons and groups, and be employed for measuring the progress of states towards the actualisation of socio-economic rights. The contents of the right to health are set out in the Principles and Guidelines.The Principles and Guidelines note that the right is an inclusive right encompassing both healthcare and the underlying determinants of health.Amongst other things, it requires an effective and integrated health system, responsive to national and local priorities, and accessible to all; the determinants of health including access to safe and potable water and adequate sanitation, an adequate supply of safe food, nutrition, housing, and healthy occupational and environmental conditions; and

62 African Commission on Human and Peoples’ Rights, ‘Guidelines on the Implementation of Economic, Social and Cultural Rights in the African Charter on Human and Peoples’ Rights’ www.achpr.org/public/Document/ file/English/achpr_instr_guide_draft_esc_rights_eng.pdf accessed 14 October 2020. 63 Principles and Guidelines, sections 13 and 14. 64 ibid section 22.

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effective access to health-related education and information, including on sexual and reproductive health freedoms such as control over one’s own body and health and freedom from interference including non-consensual medical treatment, experimentation, forced sterilisation, and inhuman and degrading treatment.The minimum core obligations include access to health facilities, goods, and services on a non-discriminatory basis, especially for vulnerable or marginalised groups; provision of essential drugs to all those who need them, as periodically defined under the WHO Action Programme on Essential Drugs, and particularly anti-retroviral drugs; universal immunisation against major infectious diseases; measures to prevent, treat, and control epidemic and endemic diseases; and education and access to information concerning the main health problems in the community, including methods of preventing and controlling them. It also requires the adoption of national policies that provide a holistic approach to individuals’ healthcare needs; and comprehensive strategy and action plans that address basic and primary health care, and which provide specific measures for the coverage of all age groups including persons in marginalised areas whether urban or rural. It also requires that governments set a target of allocating at least 15% of their annual budget to the improvement of the health sector.This echoes the Abuja Declaration which made a similar requirement.65 Action plans must ensure access to emergency treatment, that is, adequate medical care and treatment in the event of sickness or accident. Amongst other things, it also emphasises gender issues, including the need for a gender perspective in developing health policies and plans, and criminalisation of harmful traditional practices such as female genital mutilation.66 There are clear similarities with the General Comment, but also a definite effort to address key issues that are peculiar to many African countries and to be as practical as possible, hence the emphasis on policies, action plans, and measurable targets; and the focus on malaria, tuberculosis, and HIV, as well as the focus on the marginalised and vulnerable. In terms of UHC, the provisions of the Principles and Guidelines to a significant degree overlap with the components of availability and affordability, with the focus on health insurance, particularly for the vulnerable, and on access to medical facilities, and to provision of care throughout the lifecycle. Thus, the right to health in the African Charter can be argued to provide a legal basis for UHC in African countries. The Principles and Guidelines do not focus specifically on quality, although this may be argued to be embedded within its concerns. Given key challenges with patient safety and quality, however, emphasis on this would have been helpful guidance for domestic policymakers and adjudicatory bodies. At any rate, it remains to be seen how much the Principles and Guidelines will inform the interpretation of the right to health and UHC in domestic courts especially given the poor health indices of many African countries.67 In Nigeria, several cases have been brought on the basis of the right as entrenched in the African Charter. In Georgina Ahamefule v Imperial Medical Centre the court found for the plaintiff, holding that the defendant hospital’s denial of medical care to the plaintiff on grounds of her HIV positive status constitutes ‘a flagrant violation of her right to health guaranteed her under Article 16 of the African Charter on Human and Peoples’ Rights Ratification and Enforcement Act Cap 10 and the Article 12 of the International Covenant on Economic and Socio-Cultural

65 Abuja Declaration On HIV/Aids, Tuberculosis and other Related Infectious Diseases (2001) www.eldis.org/document /A19768 accessed 11 November 2020. 66 African Commission on Human and Peoples’ Rights (n 62) 27. 67 For some of the decisions by the African Commission and within the practice of some African countries, see Giuseppe Pascale, ‘The Human Right to Health under the African Charter on Human and Peoples’ Rights: An Evaluation of Its Effectiveness’ (federalism.it 2016)

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Rights ratified by Nigeria in 1999.’68 This case is also relevant for its pronouncement on the illegality of discrimination on the basis of HIV status.69 In Azubike v Attorney General of the Federation70 and others, the appellants having been previously sentenced to death were awaiting execution. In the intervening period, they developed mental health challenges.They argued that continued detention in light of their health conditions violated their rights to dignity and was, therefore, unconstitutional.They also argued that failure to provide them with medical treatment infringed upon their right to medical treatment as provided under the now repealed Prisons Act.71 Section 7 of the Prisons Act provided that where a convict is suspected of being of unsound mind, the person is to be provided with medical treatment, and the sentence only to be executed after it has been determined that the convict is of sound mind. Section 8 of the Prisons Act also provided that in the event of serious illness of a prisoner confined in a prison in which there is not suitable accommodation for him, the comptroller-general (or, in an emergency, the superintendent) may direct that the prisoner be sent to a hospital for treatment.Although they were unsuccessful on their claims with respect to the right to dignity, the court found that their right to health had been infringed upon and that they had the right to receive medical treatment prior to the execution of the sentence imposed on them. More directly, in Joseph Odafe and Others v Attorney-General of the Federation and Others it was held that the right to health was justiciable pursuant to Article 16 of the African Charter Act.72 In that case, the applicants who were awaiting trial, inmates at the Port Harcourt prison, developed HIV. They were denied treatment by the prison authorities and they brought action on the basis that this denial, amongst other things, violated their right to medical care as guaranteed under Article 16 of the act.The court found in their favour and held that denial of treatment for HIV was a violation of their right to health. In Femi Falana v Attorney-General of the Federation, the Federal High Court rejected an application to uphold the right to health on grounds of lack of locus standi,73 suggesting that the person seeking a declaration must show a direct impact. In essence, the African Charter provides a strong legal foundation for the right to health in Nigeria, rendering that right justiciable as is obvious from the cases cited. Universal health coverage provides an avenue for practical programmes to realise the right to health, with the backing of the African Charter. It seems fairly clear from the few cases that have been decided on this point, however, that not enough use is currently being made of the African Charter to push forward the goals of UHC. In the absence of research, one can speculate on why, and reasons may include the length of time it takes to obtain judgment in Nigerian courts (the Ahamefule case cited earlier, for example, took over ten years), the expenses involved, and perhaps a lack of education on the breadth of this right under the African Charter.

68 Per Idowu J. 69 See Cheluchi Onyemelukwe,‘Discrimination on the Basis of HIV Status: An Analysis of Recent Developments in Nigerian Law and Jurisprudence’ (2017) 17(3) International Journal of Discrimination and the Law, 160–79. 70 Azubike v Attorney General of the Federation [2004] Suit No. FHC/PH/CS/679/2003 (Nigeria) (unreported judgment of Justice RO Nwodo). 71 The Prisons Act has now been repealed and replaced by the Nigeria Correctional Services Act, 2019. 72 Odafe and Others v Attorney-General and Others Suit No. FHC/PH/CS/680/2003; (2004) AHRLR 205 (NgHC 2004) (2004) AHRLR 205 at 211; (2005) CHR 309. 73 Femi Falana v Attorney General of the Federation FHC/IKJ/CS/M59/2010.

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The National Health Insurance Scheme Act and state health insurance schemes One of the key goals of UHC is the prevention of undue financial hardship.This is captured in the normative content on the right to health as affordable. Especially in the Nigerian context, affordability often dictates who gets healthcare and what quality of care they receive.This also raises the issue of equity, where only those who can afford healthcare receive care. Hospital detentions occur, where healthcare providers detain patients for failure to pay for care received,74 despite the violation of several rights outside the right to health, including the right to movement and the right to dignity. Similarly, failures of health care facilities to provide emergency care in several cases in recent years,75 due in part to concerns about payment, underline the importance of mechanisms to prevent non-accessibility to care due to requirement for payment at point of care. In Nigeria, the majority of persons obtain healthcare via payment of user fees or out-ofpocket payment. This is not only highly inefficient, but it often means that many go without the care they need and others have catastrophic expenses that adversely affect every aspect of their lives.76 Although previously, the government funded healthcare including through ‘free’ health programs, this has been unsustainable, leaving many at risk of financial hardship. Health insurance allows the pooling of funds through the contribution of affordable premiums, and the distribution of healthcare risks across a wide range of people where some subsidise others, reducing the individual risks of each person.While private health insurance can be priced out of the reach of the general populace, social health insurance schemes with essential services coverage supported by the government can be a good path for low-income countries.77 It is recognised that an effective health insurance system would not only act as a safety net, preventing many from falling into undue financial hardship, but would help improve health outcomes by increasing demand, that is, encouraging individuals to seek the care they need and in a timely fashion. The Principles and Guidelines in providing the normative content for the right to health under the African Charter require that national health insurance be established where necessary to ensure that individuals, particularly vulnerable and disadvantaged persons, ‘are not prevented from accessing health care services and goods.’78 In 1999, many decades after the idea was first conceived in Nigeria, the National Health Insurance Scheme Act was passed (hereafter the Scheme).The Scheme, a form of social health insurance, became operational in 2005. The precepts of UHC and the right to health are key considerations in this legislation, though not expressly stated. A review of the objectives of the Act bears this out and they are to ensure that every Nigerian has access to good healthcare services as well as to protect families from the financial hardship of huge medical bills. Further, limits in the rise in the cost of healthcare services and equitable distribution of healthcare costs among differ-

74 R Yates and T Brookes, ‘Whitaker E Hospital Detentions for Non-Payment of Fees: A Denial of Rights and Dignity’ (Chatham House 2017) www.chathamhouse.org/sites/default/files/publications/research/2017-12-06 -hospital-detentions-non-payment-yates-brookes-whitaker.pdf accessed 14 October 2020. 75 ibid 9. 76 Aregbeshola and Khan (n 5). 77 Shops Plus,‘Integrating Family Planning into Universal Health Coverage Efforts’; Ole Doetinchen, Guy Carrin, and David Evans,‘Thinking of Introducing Social Health Insurance? Ten Questions’ (WHO 2009). www.who.in t/health_financing/documents/pb_e_09_04-10qshi.pdf?ua=1 accessed 14 October 2020; Guy Carrin and Chris James, Reaching Universal Coverage via Social Health Insurance: Key Design Features in the Transition Period (WHO 2004) https://apps.who.int/iris/bitstream/handle/10665/69018/EIP_FER_DP_04.2.pdf?sequence=1 accessed 14 October 2020. 78 Article 67(bb).

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ent income groups ensure equitable patronage of all levels of healthcare.With regard to quality, the objectives include the aim of maintaining a high standard of healthcare delivery services within the scheme ensure the availability of funds to the health sector for improved services. In terms of accessibility, the objective of the Scheme is to ensure adequate distribution of health facilities within the federation.79 The Scheme is responsible for registering health maintenance organisations and healthcare providers under the Scheme.80 Health maintenance organisations (HMOs) are given the responsibility of collecting contributions to persons covered under the Scheme, the payment of capitation fees to healthcare providers, and establishing a quality assurance system.81 Contributions are to be made by employers of ten or more employees and other voluntary organisations. With its laudable objectives, it would appear that Nigeria is on the path to UHC. Unfortunately, the Scheme has been beset with many challenges in the decade and a half since it became operational.This includes rate of coverage, the manner of operations, and the impact on health outcomes in Nigeria.With regard to coverage, at inception, a phased approach to covering persons was undertaken.The government began by covering employees of the federal public service and paying a portion of the contributions, in part to obtain buy-in.The state public sector was expected to follow, but the states (with the exception of two states) did not become part of the Scheme. Further, 15 years after operations began, many in the informal sector, where the majority of people work, are still not covered.82 There is no official data on coverage; however, most research on the matter puts the coverage of Nigerians at less than 5%.83 Some analyses indicate that this may be because of the voluntary nature of the Scheme, where persons may choose to be covered or not.84 Moreover, the use of HMOs for the collection of contributions and payment of healthcare providers has raised a number of issues. HMOs typically act as middle brokers in the process, receiving risk-free monies and paying capitation fees to healthcare providers on behalf of the Scheme.This process has been criticised as inefficient and corruption ridden. Health care providers often complain about delayed payments. Moreover, the National Health Insurance Scheme (NHIS), the organisation charged with overseeing the health insurance contributions, has also not acted effectively as regulators of the HMOs giving room for speculation on regulatory capture. Further, key provisions relating to provider payment mechanisms in the act, in particular those relating to capitation. have also been criticised for being inefficient and being prone to corruption.85 The result is that the Scheme has not delivered on the promise of UHC.

79 80 81 82

See National Insurance Scheme Act, 1999, section 5. ibid section 6. ibid section 20. BSC Uzochukwu, ‘Health Care Financing in Nigeria: Implications for Achieving Universal Health Coverage’ (2015) 18(4) Nigerian Clinical Journal of Practice 437 www.njcponline.com/article.asp?issn=1119-3077;year =2015;volume=18;issue=4;spage=437;epage=444;aulast=Uzochukwu accessed 14 October 2020. 83 See, for example, O Onwujekwe, K Hanson K, B Uzochukwu,‘Examining Inequities in Incidence of Catastrophic Health Expenditures on Different Healthcare Services and Health Facilities in Nigeria’(2013) 5(2) Journal of Public Health and Epidemiology 51–5; Luminous Jannamike,‘Nigeria’s 5% NHIS Enrollment in 15yrs Shameful – NMA’ Vanguard (26 August 2019) www.vanguardngr.com/2019/08/nigerias-5-nhis-enrollment-in-15yrs-s hameful-nma/ accessed 14 October 2020. 84 David A Adewole et al.,‘Payment for Health Care and Perception of the National Health Insurance Scheme in a Rural Area in Southwest Nigeria’ (2015) 93(3) The American Journal of Tropical Medicine and Hygiene 648–54. 85 Cheluchi Onyemelukwe,‘Re-Positioning the NHIS for Success:A To-Do List for the Executive Secretary’ https ://nigeriahealthwatch.com/re-positioning-the-nhis-for-success-a-to-do-list-for-the-executive-secretary/# .Xs7TTG5FzmQ accessed 14 October 2020; Aidogie Osamuyimen, Retsepile Ranthamane, and Wu Qifei,

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As a result of the gaps and challenges in the operation and utilisation of the Scheme, a number of steps have been taken in recent years. One of these steps is the enactment of state health insurance laws.These laws typically establish state health insurance schemes which address health insurance at the state level. These laws also typically make health insurance mandatory for all residents in the state for the purpose of providing expanding coverage towards achieving UHC. An example of such laws is the Lagos State Health Management Agency Law (2015).The law provides for mandatory insurance, requiring all residents of the state to be covered by health insurance. It also provides the state to pay contributions for the vulnerable. Further, the National Health Insurance Commission Bill is currently awaiting passage at the National Assembly. The intent of the bill is to address recent occurrences in the health insurance landscape in Nigeria, for instance, recognition of the state health insurance schemes, and to reposition the NHIS as a regulator and minimise its role as a provider of health insurance. It remains to be seen how effective these steps will be in the pursuit of UHC.As things stand today, however, user fees/out-of-pocket payments continue to be the primary avenue for many. As a consequence, access to healthcare remains inequitable, with poor people, other vulnerable persons, and many in rural areas unable to receive the care that they need without undue financial hardship. The mandatory nature of health insurance in the emergent states’ health insurance schemes also provides room for accountability in the courts, especially with regard to the provisions requiring states to contribute towards the care of the vulnerable.This creates an obligation that can ground right-to-health arguments before the courts.The question of justiciability becomes moot, because as noted in the cases cited earlier, the health insurance legislation is a standalone legislation that has provided grounds for such actions.At this time, no claims have been brought before the court on the limited coverage provided under the NHIS on the grounds of the right to health. Such a claim would, no doubt, expand the jurisprudence on health insurance as a core component of UHC and the right to health, and also support access to quality healthcare in Nigeria.

The Child Rights Act Although this is true generally, it is particularly true in the case of children that the right to health is a precursor to the enjoyment of all other rights.The Convention on the Rights of the Child (CRC) provides for the right of a child to ‘the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health.’86 This right also includes the requirements to ensure that no child is deprived of access to healthcare services, and the requirement for states to take measures to prevent infant and child mortality, ensure provision of necessary healthcare with emphasis on primary health care; ensure measures to combat disease and malnutrition and provision of adequate nutritious food and clean drinking water; ensure appropriate prenatal and postnatal care for mothers; and ensure access to education on child care, including the benefits of breastfeeding, hygiene, environmental sanitation, and measures to prevent accidents; and develop preventive health care and family planning education.87

‘Analysis of Nigeria Health Insurance Scheme: Lessons from China, Germany and United Kingdom’ (2017) 22(4) IOSR 33. 86 Convention on the Rights of the Child,Article 24. 87 ibid Article 24(2).

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In addition, other international instruments including the ICESCR’s and the African Charter’s provisions on the right to health also apply to children. More specifically, the African Charter on the Rights and Welfare of the Child also provide that ‘every child shall have the right to enjoy the best attainable state of physical, mental and spiritual health.’88 It goes on to reproduce the requirements set out in the CRC, but also requires the ‘meaningful participation of non-governmental organizations, local communities and the beneficiary population in the planning and management of basic service programmes for children.’89 Nigeria ratified the CRC in 1991 and domesticated it in 2003, enacting the Child Rights Act.The Child Rights Act is thus enforceable in Nigeria. Under the Child Rights Act, a child is defined as a person below the age of 18.90 The right to health of a child is captured in section 13, which clearly states:‘Every child is entitled to enjoy the best attainable state of physical, mental and spiritual health’ in line with the CRC. It similarly reproduces all the requirements of the right to health provided in the CRC as stated earlier.These include the right to access healthcare services and the determinants of health including clean drinking water, food, etc. In addition to those provisions, it makes the immunisation of a child under the age of 2 compulsory, failure of which constitutes a criminal offence.91 It is important to note that the rights of a child under the Child Rights Act are in addition to all other rights conferred by the Constitution92 and other legislation. There is no doubt that the right of health of a child can be enforced under the Child Rights Act. Justiciability is, thus, not in issue. In reality, Nigeria has some of the world’s highest rates of infant and child mortality, including from malnutrition, and childhood and vaccine-preventable diseases.Violence against children, including female genital mutilation and child marriage, continue to be challenges that have significant adverse impacts on the health of children in Nigeria. UHC remains illusory given the continuing challenges of access to healthcare. As a result, children under 5 are covered under most state health insurance schemes as part of the vulnerable groups for whom the states make contributions. But this is far from sufficient in covering all children, especially those between the ages of 6 and 18.While the Child Rights Act makes vaccination compulsory on pain of criminal sanction, thus placing an obligation on parents and guardians of children, it does not place a similar obligation on the government to ensure the accessibility of such vaccines.93 The right to health of a child and its practical manifestation in universal health coverage has not been litigated in Nigeria. But, clearly, the law provides a mechanism for holding the government accountable to address these issues within the framework of the right to health.

The National Health Act The National Health Act is now recognised as the primary statutory enactment on health service delivery in Nigeria. Enacted in 2014 after many years of advocacy, the Act sets out the several key provisions in relation to the organisation of the health system and with regard to matters ranging from quality and human resources for health to patients’ rights. It also makes

88 89 90 91 92 93

African Charter on the Rights and Welfare of the Child,Article 14. ibid Article 14(2)(j). Child Rights Act 2003, section 277. ibid section 13(4). ibid section 3. See Cheluchi Onyemelukwe, ‘Can Legislation Mandating Vaccination Solve the Challenges of Routine Childhood Immunisation in Nigeria?’ Oxford University Commonwealth Law Journal (Forthcoming); Oxford Legal Studies Research Paper, https://ssrn.com/abstract=2717479 (accessed 14 October 2020).

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some key financial provisions. For the first time, the law recognises the basic outlines of the health system. Arguably, it does not specify the responsibilities of the three tiers of government in a clear enough manner; one of the key reasons why the Act was necessary in the first place. What it does do with respect to universal health coverage, however, is to provide an entitlement to a basic minimum package of services, increase funding to primary health, and set out the rights of patients, thus addressing quality concerns. It also provides legal authority for key governance mechanisms such as the National Council on Health, which has the authority to approve the National Health Policy.94 In this way, it gives indirect legal force to the provisions in the National Health Policy. (It will be recalled that the vision of the extant National Health Policy is the achievement of universal health coverage.95) In essence, the National Health Act outlines the health system recognising federal, state, and local government levels; governance structures; and quality mechanisms in part to achieve UHC in Nigeria. Specifically, the National Health Act provides that every person is entitled to a basic minimum package of services stating: ‘Without prejudice to the prescription by the Minister in section 3(1) of this Act, all Nigerians shall be entitled to basic minimum package of health services.’96 A basic minimum package of health services, also referred to as an essential package of health services especially in a low-income setting is defined as ‘a limited list of public health and clinical interventions which will be provided at primary and/or secondary level care.’97 It aims to provide a minimum package that the state will provide typically through a social health insurance scheme or tax-based financing for healthcare. Its main goal is to provide equity, ensuring that everyone, regardless of income level can access basic healthcare at a cost that is affordable, thus actualising the concept of universal health coverage. From the provision of the National Health Act, this will apply to all Nigerians without exception. The basic minimum package of services is to be funded from the Basic Health Care Provision Fund, an intervention fund established under section 11 of the National Health Act.The Basic Health Care Provision Fund (BHCPF) is also expected to fund certain specified primary health care services as provided under the National Health Act. BHCPF is to be funded from the federal government annual grant of not less than 1% of its Consolidated Revenue Fund; grants by international donor partners; and funds from any other source. Money from the Fund is required under the Act to be employed to finance the following: (a) 50% of the Fund shall be used for the provision of basic minimum package of health services to citizens, in eligible primary or secondary health care facilities through the National Health Insurance Scheme (NHIS); (b) 20 per cent of the Fund shall be used to provide essential drugs, vaccines and consumables for eligible primary health care facilities; (c) 15 per cent of the Fund shall be used for the provision and maintenance of facilities, equipment and transport for eligible primary healthcare facilities; and (d) 10 per cent of the Fund shall be used for the development of human resources for primary health care;

94 95 96 97

National Health Act, section 4. National Health Policy, 2016, xiv. Section 3(3) of the National Health Act. WHO,‘Essential Health Packages:What Are They For? What Do They Change? Technical Brief no 2, 2008’ www .who.int/healthsystems/topics/delivery/technical_brief_ehp.pdf accessed 14 October 2020.This is in contrast to developed countries where the package often is more extensive and what is provided is typically a list of exclusions.

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(5) 5 per cent of the Fund shall be used for emergency medical treatment to be administered by a Committee appointed by the National Council on Health. The preceding provision breaks down the manner in which the monies shall be spent.The use of the word ‘shall’ throughout that section indicates peremptoriness, a mandatory obligation. The Fund cannot be disbursed otherwise.This minimum basic package, discussed earlier, shall be provided through the health insurance scheme, specifically the National Health Insurance Scheme (NHIS). The National Primary Health Care Development Agency (NPHCDA) is required to disburse the funds for subsection 3(b), (c), and (d) of this section through state and federal capital territory primary healthcare boards for distribution to local government and area council health authorities through a grant process. The Act also makes mandatory the provision of counterpart funding by states and local governments.The provisions of the Compulsory Universal Basic Education Act are similar, requiring counterpart funding from states. In practice, states have been either unable or unwilling to provide the counterpart funding, with the result that billions of naira in funding for education have not been accessed with consequent adverse outcomes for education in the country.98 The NPHCDA is given the responsibility of developing guidelines for the administration, disbursement, and monitoring of the Fund with the approval of the Minister of Health. As set out in the National Health Act, the BHCPF is being disbursed through three gateways, namely through the NPHCDA Gateway, National Health Insurance Scheme (NHIS Gateway), and Federal Ministry of Health (for emergency care). However, although the money has been inserted in the budget since 2018 from the Consolidated Revenue Fund, with support from entities such as the Bill and Melinda Gates Foundation, there have been ongoing debates amongst the key stakeholders involved in defining guidelines. Unfortunately, the National Health Act does not define the services which comprise a basic minimum package of care. The process of developing a basic minimum package of services is thus ongoing, along with the guidelines for the disbursement of the BHCPF. There are many things to take into consideration: the economic constraints of the country as well as the basic healthcare needs of all Nigerians.The promise of the National Health Act, with respect to universal health coverage, is, therefore, yet to be fulfilled for Nigerians. Can the entitlement to a basic minimum package be considered to be a right enforced in Nigerian courts, thereby requiring governments to provide a basic minimum package of care? The short answer is yes. Going by the Supreme Court decision in A G Ondo State v. A G Federation as discussed earlier, this provision is enforceable on its own before the courts. In addition, the language of the provision, using the words ‘shall’ and ‘entitlement’ requires mandatory execution of the provision by the government. However, an examination of the National Health Act does not provide a clear enforcement procedure for this provision.This poses a problem, but, perhaps, not an insurmountable one.While no clear mechanism for enforcement is provided, the constitutional authority of the High Court in Nigeria, as provided under the Constitution, will allow it to hear matters on a breach of this entitlement.What is not clear is what sort of remedy it would be able to provide given the lack of clarity of the National Health Act. It is expected that human rights organisations will bring action in Nigerian courts in a not too distant time. It is, therefore, appropriate that the federal government implements the provision entitling all to a

98 Anibueze et al., ‘Counterpart funding of the Universal Basic Education in Nigeria: Implication for Counseling’ (2013) 17(2) IOSR Journal of Humanities and Social Science 11–16.

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basic minimum package by establishing the basic minimum package and providing it as required by the National Health Act. Apart from the financing aspects of the National Health Act, provisions are also made relating to quality.These provisions include establishment of several institutional structures to ensure quality such as the National Tertiary Institutions Committee, which is required to establish standards through the issuance of a Certificate of Standards. Unfortunately, the Act does not set out the basic requirements for qualification of the Certificate of Standards. In the over five years of enacting the act, the guidelines or regulations for obtaining this certificate have yet to be provided.The National Health Act also, for the first time in legislation, set out several rights a patient or user of a health facility is entitled to (thus laying the foundation for the Patients’ Bill of Rights,99 which though not law itself, captures the various rights of patients as found in the National Health Act and other pieces of legislation). The Act provides for the right to emergency treatment,100 the right to informed consent,101 and the right to confidentiality.102 It also requires each healthcare facility to place a statement of these rights in a conspicuous place in the health facility.103 Apart from patients’ right, it also provides the right of healthcare providers to protection from abuse by patients,104 and from occupational hazards and potential for contracting infectious diseases.105 The National Health Act, thus, sets out a framework for financing, governance, and quality, which, if effectively implemented, will support and promote universal health coverage. It is likely that the courts will have a reasonable opportunity to develop the jurisprudence and enhance the right to health for Nigerians through progressive interpretations of the right to the basic minimum package and of the rights of users of healthcare facilities.

Discrimination against Persons with Disabilities (Prohibition) Act, 2018 Aside from the legislation whose core focus is the implementation of universal health coverage, and, therefore, to a significant extent, the right to health, the Discrimination against Persons with Disabilities (Prohibition) Act, 2018, which provides for non-discrimination, also addresses other aspects of universal health coverage. In this regard, it provides for the right to unfettered access to adequate healthcare without discrimination on the basis of disability.106 This clearly applies to both private and public health facilities. Further, it provides for the right of persons with mental disabilities to free healthcare in all public facilities.107 These provisions, while commendable, are also problematic to a degree. It is not quite clear what is meant by ‘unfettered access.’ Does it mean provision of infrastructure for accessibility, hearing aids, and other equipment and support for persons living with a disability? In my view, the answer is in the affirmative. Non-discrimination is a core tenet of both the right to health and universal health coverage, emphasising the need for universality, equality, and dignity. But what about user fees, a key barrier for persons living with a disability? The section is

99 100 101 102 103 104 105 106 107

National Health Act, sections 23, 26, and 29. ibid section 20. ibid section 23. ibid section 26. ibid section 24(e). ibid section 21(2)(a). ibid section 21(2)(b). Discrimination against Persons with Disabilities (Prohibition) Act, 2018, section 21(1). ibid section 21(2).

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seemingly couched in such a manner as to preclude government responsibility in this regard. This view is bolstered by the clear meaning of the accompanying provision which provides free care for persons living with mental disability in public facilities.The provision, thus, does not meet the standards for the right to health (which requires health provision for persons living with a disability) when read on its own. However, read in conjunction with the provisions in the National Health Act, the government is obliged to provide the minimum package of service that persons living with a disability require. A progressive and broad interpretation of these provisions by courts in Nigeria is essential to ensure that persons living with disability enjoy the right to health. This is the only way to put meaning into the word ‘universal’ in universal health coverage.

Conclusion It is apparent that there is a nexus between universal health coverage and the right to health. One may be tempted to argue that the right to health is a broader framework, but it is clear that the right to health provides the human rights and legal basis for universal health coverage. Nigeria, like many countries around the world, with the support of international development organisations has adopted universal health coverage as the vision for improving the country’s poor health indices.This is even more firmly embedded with the SDGs framework, also adopted by Nigeria. One key question that this chapter sought to answer was whether there was a legal foundation for the concept of universal health coverage, especially in light of the non-justiciability of socio-economic rights, including the right to medical facilities for all in the Nigerian Constitution. This chapter has examined the legal foundations for universal health coverage, analysing the enforceability of the right to health in Nigeria. Although socio-economic rights are generally not justiciable, an exploration of Nigeria’s jurisprudence and legislation has shown a clear movement towards justiciability. This is emphasised in the legislation that has been enacted since the current democratic dispensation, including the African Charter on Human and Peoples’ Rights in 1983, the National Health Insurance Scheme in 1999, the Child Rights Act in 2003, the National Health Act in 2014, and the Discrimination against Persons with Disabilities (Prohibition) Act in 2018, and emergent state health insurance schemes. However, while the legal framework is laudably progressive, implementation is lagging. At present, few cases have been brought on the basis of the emerging legal framework for universal health coverage in Nigeria. But, it is clear that there are legal obligations imposed on the government to implement universal health coverage to the maximum extent allowed by law.This is not simply a moral or ethical obligation but a legal obligation, enforceable under Nigeria’s international legal obligations and within the domestic courts.These laws also provide an advocacy instrument for civil society organisations and for human rights advocates to demand accountability and to build upon the progress that has resulted in the enactment of these laws. Each of the emergent laws has potential to deepen universal health coverage.The National Health Act, in particular, provides a robust foundation for the expansion of the jurisprudence on the right to health in Nigeria. Much more engagement is required to extend the conversation around basic minimum packages of care and to expand the package in line with need and economic realities but also the human right to health. Moreover, an argument could be made that there is need for more robust laws, for example, with respect to coverage for persons with disability. But this can only be fruitfully engaged with when there is significant implementation of the already existing laws to protect, fulfil, and promote the right to health in Nigeria. 201

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References Abiiro, Gilbert A, and De Allegri, Manuela, ‘Universal Health Coverage from Multiple Perspectives: A Synthesis of Conceptual Literature and Global Debates’ (2015) 17 BMC International Health and Human Rights https://bmcinthealthhumrights.biomedcentral.com/articles/10.1186/s12914-015 -0056-9 accessed 14 October 2020. Abuja Declaration On HIV/Aids, Tuberculosis and Other Related Infectious Diseases (2001) www.eldis.org/ document/A19768 accessed 11 November 2020. Adetifa, IMO,Adamu,AL, Karani,A,Waithaka, M, Odeyemi, KA, Okoromah, CAN, Bello MM,Abubakar, IS, Inem V, and Scott JAG.‘Nasopharyngeal Pneumococcal Carriage in Nigeria:A Two-Site, PopulationBased Survey’ (2018) 8(1) Scientific Reports 3509. Adewole, David A, et al., ‘Payment for Health Care and Perception of the National Health Insurance Scheme in a Rural Area in Southwest Nigeria’ (2015) 93(3) American Journal of Tropical Medicine and Hygiene 648–54. African Commission on Human and Peoples’ Rights, ‘Guidelines on the Implementation of Economic, Social and Cultural Rights in the African Charter on Human and Peoples’ Rights’, www.achpr.org/p ublic/Document/file/English/achpr_instr_guide_draft_esc_rights_eng.pdf accessed 14 October 2020. Anibueze et al., ‘Counterpart Funding of the Universal Basic Education in Nigeria: Implication for Counseling’ (2013) 17(2) IOSR Journal of Humanities and Social Science 11–16. Aregbeshola, BS, and Khan, SM, ‘Out-of-Pocket Payments, Catastrophic Health Expenditure and Poverty among Households in Nigeria 2010’ (2018) 7(9) International Journal of Health and Policy Management 798–806. Bärnighausen, T and Sauerborn, R, ‘One Hundred and Eighteen Years of the German Health Insurance System: Are There Any Lessons for Middle- and Low-Income Countries?’ (2002) 54 Social Science & Medicine 1559–87. BSC Uzochukwu, ‘Health Care Financing in Nigeria: Implications for Achieving Universal Health Coverage’ (2015) 18(4) Nigerian Clinical Journal of Practice 437 http://www.njcponline.com/article.asp ?issn=1119-3077;year=2015;volume=18;issue=4;spage=437;epage=444;aulast=Uzochukwu accessed 14 October 2020. Bump, Jesse B, ‘The Long Road to Universal Health Coverage: Historical Analysis of Early Decisions in Germany, the United Kingdom, and the United States’ (2015) 1(1) Health Systems and Reform 28. Committee on Economic, Social and Cultural Rights, General Comment No 14: The Right to the Highest Attainable Standard of Health (Twenty-Second Session Geneva, 25 April-12 May 2000). CS- SUNN and PACFAH,‘Budgeting for Health and Nutrition in Nigeria’ https://ptcij.org/wp-content /uploads/2015/12/Budgeting-for-Health-and-Nutrition-in-Nigeria.pdf accessed 14 October 2020. Federal Ministry of Health and National Agency for AIDS Control (NACA),‘Nigeria HIV/AIDS Indicator and Impact Survey’ (2019) https://www.naiis.ng/resource/factsheet/NAIIS%20PA%20NATIONAL %20FACTSHEET%20FINAL.pdf accessed 14 October 2020. Forman, Lisa,‘What Could a Strengthened Right to Health Bring to the Post-2015 Health Development Agenda?: Interrogating the Role of the Minimum Core Concept in Advancing Essential Global Health Needs’ (2013) 48 BMC International Health and Human Rights 13 https://bmcinthealthhumrights.biome dcentral.com/articles/10.1186/1472-698X-14-3 accessed 14 October 2020. IISD UN High-Level Meeting Adopts Historic Declaration on Universal Health Coverage, https://sd g.iisd.org/news/un-high-level-meeting-adopts-historic-declaration-on-universal-health-coverage/ accessed 14 October 2020. Jannamike, Luminous, ‘Nigeria’s 5% NHIS Enrollment in 15yrs Shameful – NMA’ (Vanguard Newspaper, August 26, 2019), https://www.vanguardngr.com/2019/08/nigerias-5-nhis-enrollment-in-15yrs-sha meful-nma/ accessed 14 October 2020. Juliano,Agnese, et al,‘The Burden and Risks of Pediatric Pneumonia in Nigeria:A Desk-Based Review of Existing Literature and Data’ (2020) 55(1) Pediatric Pulmonology 10–21. Lane, Lottie,‘The Horizontal Effect of International Human Rights Law in Practice’ (2018) 5(1) European Journal of Comparative Law and Governance 5–88. National Population Commission, Nigeria and ICF, Nigeria Demographic and Health Survey (2018) https:// dhsprogram.com/pubs/pdf/FR359/FR359.pdf accessed 14 October 2020. Obiagwu, C and Odinkalu, CA, ‘Nigeria: Combating Legacies of Colonialism and Militarism’ in AA An Na’Naim’ Human Rights under African Constitutions: Realising the Promise for Ourselves (2003).

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Right to health in Nigeria Obiajulu, Nnamuchi, ‘Rethinking Justiciability of Socioeconomic Rights in Nigeria: A Critique of the Dominant Position’ (20 December 2012). https://ssrn.com/abstract=2191914 accessed 14 October 2020. Omoregie, Edoba and Momodu, Daud,‘Justifying the Right to Health Care in Nigeria: Some Comparative Lessons’ (2014) 12 Nigerian Juridical Review 13. Onwujekwe, O, Hanson, K and Uzochukwu, B,‘Examining Inequities in Incidence of Catastrophic Health Expenditures on Different Healthcare Services and Health Facilities in Nigeria’(2013) 5(2) Journal of Public Health and Epidemiology 51–55. Onyemelukwe, Cheluchi, ‘Access to Anti-Retroviral Drugs As a Component of the Right to Health: Examining the Application of the Right in Nigerian Jurisprudence’ (2008) 7 African Human Rights Law Journal 446. Onyemelukwe, Cheluchi,‘Discrimination on the Basis of HIV Status:An Analysis of Recent Developments in Nigerian Law and Jurisprudence’ (2017) 17(3) International Journal of Discrimination and the Law, 160–79. Onyemelukwe, Cheluchi, ‘Patient Safety in Nigeria: An Emergent Concept’ in John Tingle, Clayton Ó Neill and Morgan Shimwell (eds), Global Patient Safety: Law, Policy and Practice (Routledge 2018). Onyemelukwe, Cheluchi,‘Re-Positioning the NHIS for Success:A To-Do List for the Executive Secretary’ https://nigeriahealthwatch.com/re-positioning-the-nhis-for-success-a-to-do-list-for-the-executive-se cretary/#.Xs7TTG5FzmQ accessed 14 October 2020. Onyemelukwe, Cheluchi, ‘Can Legislation Mandating Vaccination Solve the Challenges of Routine Childhood Immunisation in Nigeria?’ Oxford University Commonwealth Law Journal (Forthcoming); Oxford Legal Studies Research Paper, https://ssrn.com/abstract=2717479 accessed 14 October 2020. Ooms, Gorik, et al, ‘Is Universal Health Coverage the Practical Expression of the Right to Health Care?’ (2014) 14(3) BMC International Health and Human Rights. Osamuyimen, Aidogie, Ranthamane, Retsepile and Qifei, Wu, ‘Analysis of Nigeria Health Insurance Scheme: Lessons from China, Germany and United Kingdom’ (2017) 22(4) IOSR 33. Pascale, Giuseppe,‘The Human Right to Health under the African Charter on Human and Peoples’ Rights: An Evaluation of Its Effectiveness’ (federalism.it, 2016) Presidential Summit on Universal Health Coverage Declaration, (Abuja, March 10, 2014) https://ww w.msh.org/sites/msh.org/files/presidential_summit_declaration_on_universal_health_coverage_in_n igeria.pdf accessed 14 October 2020. Shops Plus, ‘Integrating Family Planning into Universal Health Coverage Efforts’ in Ole Doetinchen, Guy Carrin and Evans David (eds), Thinking of Introducing Social Health Insurance? Ten Questions (WHO 2009). https://www.who.int/health_financing/documents/pb_e_09_04-10qshi.pdf?ua=1 accessed 14 October 2020; Guy Carrin and Chris James, Reaching Universal Coverage via Social Health Insurance: Key Design Features in the Transition Period (WHO 2004) https://apps.who.int/iris/bitstream/handle/10665 /69018/EIP_FER_DP_04.2.pdf?sequence=1 accessed 14 October 2020. Swan, Eswan, ‘Universal Health Coverage: An Illustrated History’ (Financial Times, September 19, 2018) https://www.ft.com/content/34084366-dadb-11e9-8f9b-77216ebe1f17 accessed 14 October 2020. Tobi, Aworinde, ‘2020 Budget: Health, Education in Familiar Territory of Neglect’ (Punch Newspaper, October 20, 2019); https://punchng.com/2020-budget-health-education-in-familiar-territory-of-n eglect/ accessed 14 October 2020. UHC2030,‘Key Asks from the UHC Movement UN High-Level Meeting on Universal Health Coverage’ www.uhc2030.org/fileadmin/uploads/uhc2030/Documents/UN_HLM/UHC_Key_Asks_final.pdf accessed May 28, 2020 UN,‘International Universal Health Coverage Day 12 December’ https://www.un.org/en/observances/u niversal-health-coverage-day accessed 14 October 2020. UNGA 67th Session on Global Health and Foreign Policy, adopted 12 December 2012. WHO, African Union Universal Health Coverage in Africa-From Concept to Action. Addis Ababa:World Health Organization (WHO 2014) 1–7 https://www.who.int/health_financing/policy-framework/auc-who -2014-doc1-en.pdf accessed 14 October 2020. WHO, ‘Essential Health Packages: What Are They For? What Do They Change? Technical Brief no 2, 2008’, https://www.who.int/healthsystems/topics/delivery/technical_brief_ehp.pdf accessed 14 October 2020. WHO, ‘Health Financing’ https://www.who.int/health_financing/universal_coverage_definition/en/ accessed 14 October 2020.

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Cheluchi Onyemelukwe WHO, ‘Universal Health Coverage’ https://www.who.int/healthsystems/universal_health_coverage/en/ accessed 14 October 2020. WHO, ‘What is Universal Health Coverage?’ https://www.who.int/news-room/q-a-detail/what-is-u niversal-health-coverage accessed 14 October 2020. WHO, Creating Enabling Legal Environments for Universal Health Coverage, https://www.who.int/health-law s/universal-health-coverage/en/ accessed 14 October 2020. Yates, R and Brookes, T, Whitaker E Hospital Detentions for Non-Payment of Fees: A Denial of Rights and Dignity (Chatham House 2017). https://www.chathamhouse.org/sites/default/files/publications/res earch/2017-12-06-hospital-detentions-non-payment-yates-brookes-whitaker.pdf accessed 14 October 2020.

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12 REALISING THE RIGHT TO HEALTH IN KENYA Connecting health governance outcomes to patient safety perspectives Naomi N Njuguna

In early March of 2018, Kenya awakened to one of the biggest medical error scandals to hit the headlines. It involved the largest national referral hospital in Kenya and in East Africa – the Kenyatta National and Referral Hospital. A patient who had been admitted with a swelling on the head, and who only required nursing and medication, was wheeled into theatre to have brain surgery. It was only hours into the surgery that the neurosurgeon discovered that there was nothing wrong with the brain of the patient, and the mistake was discovered – they had the wrong patient.1 In a clear case of patient identity mix-up, the incident demonstrated the systemic failures of the admission procedures, record-keeping, patient identification, and patient monitoring within the hospital, which seriously compromised patient safety.The hospital was dogged the same year with other major scandals involving sexual assault on female patients in the maternity wards as well as baby stealing sagas. Following the suspension of the neurosurgeon and the assisting team (two nurses and the anaesthetist), a strike was called by the union protesting his suspension for the systemic failures of the hospital, which included poor working conditions for doctors, such as heavy workloads, leading to fatigue and stress. Medical errors and adverse events are not uncommon in public health facilities in Kenya, bringing into sharp focus the quality of health services in light of the constitutionalised right to health. The journey to realising the right to the highest attainable standard of health in Kenya begun partly by including the right within the Constitution of Kenya 2010 and partly by adopting a governance model that devolved health services to county governments. Other policy initiatives such as universal health coverage are also part of this journey. Patient safety is an integral component of both the right to health and of health systems governance. In integrating patient safety within these two thematic concepts, a discussion and

1 See Betty Njeru,‘KNH on the Spot after Brain Surgery Is Performed on Wrong Patient’ Standard Media (2 March 2018) www.standardmedia.co.ke/nairobi/article/2001271660/knh-on-the-spot-after-brain-surgery-is-perfo rmed-on-wrong-patient accessed 14 October 2020.

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interrogation of issues beyond what occurs at the clinic or health facility level is needed. It implies going beyond an examination of the relational aspects of patient safety and moving to consider the hierarchical aspects of governance and how those aspects interact with each other in order to influence the perceptions of the concept of harm to patients. The purpose of this chapter therefore is to discuss how the concept of patient safety can be understood in the context of the wider considerations that the country has to take into account in health governance and service delivery in the public sector health facilities. Particular attention will be placed on the outcomes of devolution of health services and how this has affected patient safety. Harm reduction is thus construed in a way refocuses attention from the clinical relationship of the healthcare provider and the patient, and to the regulatory, policy, and governance framework that affects this relationship, particularly in government-run health facilities in Kenya. The discussion is centred on the public sector because more patients seek the more affordable services in public sector health facilities in the country, although its implications can be translated for use by the private sector.2 Patient safety perspectives and reforms in the public sector are thus bound to affect a greater percentage of the populace in Kenya. Health service delivery and patient safety are multifaceted issues and therefore an integrative approach is needed to comprehensively deal with the factors that compromise patient safety in public sector hospitals in Kenya.

Understanding patient safety in Kenya: expanding the concept of patient harm In 2013, a survey was conducted by the Ministry of Health in Kenya, in conjunction with partners – the World Health Organization, the IFC World Bank Group, Safe Care, and UKaid – to assess the levels of patient safety in Kenyan hospitals.3 The intention was to roll out the Kenya Quality Model for Health initiative. Five areas of risk were considered, namely leadership process and accountability; competent and capable workforce; safe environment for staff and patients; clinical care of patients; and improvement of quality and safety. Most facilities scored poorly with overall compliance for public hospitals at 0.26% and scores for non-public hospitals at 1.87%. A simple definition of patient safety is ‘the avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare.’ It is the prevention of adverse events and mistakes or errors that can take place within the healthcare setting.The World Health Organization (WHO) has defined patient safety as aiming ‘to prevent and reduce risks, errors and harm that occur to patients during provision of healthcare.’4 In Kenya, the most common medical errors consist of diagnostic errors, where there are failures to order the correct or appropriate tests as well as correct application of the test results. Other common errors are medication errors, hospital-acquired infections, delays in diagnosis and treatment, and failure to monitor and follow-up with the patient after diagnosis and prescription. Errors also occur as a result of the lack of competency and the recklessness of healthcare professionals.

2 See Juliet Atellah,‘Where Do Kenyans Seek Medical Treatment?’ (Elephant) www.theelephant.info/data-stories/2 019/02/08/where-do-kenyans-seek-medical-treatment/?print=pdf accessed 14 October 2020. 3 See An Assessment of Patient Safety Standards in Kenya: Summary Report of Patient Safety Survey (2013) https://ua singishureproductivehealth.files.wordpress.com/2015/08/kenya-patient-safety-survey-report-2014.pdf accessed 14 October 2020. 4 See WHO, ‘Patient Safety’ www.who.int/news-room/fact-sheets/detail/patient-safety (WHO, 13 September 2019) accessed 14 October 2020.

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According to Vincent, ‘patient safety however is a broad endeavour that requires thinking beyond the individual patient to consider the characteristics of the whole system of healthcare.’5 A systemic consideration of patient safety requires an analysis of the underlying determinants of medical errors. In public health facilities, these underlying determinants affect the decisionmaking processes and actions of health facility managers as well as healthcare workers as they deal with patients. Many of the errors and adverse events are not as a result of carelessness or recklessness, or incompetence of the health professionals, but are due to macro factors that are beyond their control. Focusing on error minimisation may fail to highlight broader conceptions and perceptions of harm to patients. Current discourse on patient safety needs to take into account the context within which it is being applied. Understanding of the factors that may undermine patient safety is essential. Factors in low- and middle-income countries (LMICs) may be fundamentally different from those in high-income countries.The concept of harm therefore takes on an expanded meaning beyond the making of medical errors in the hospital. Harm reduction should not merely be limited to medically related harm. Patient safety therefore needs to be considered beyond therapeutic interventions within the clinical setting to broader macro factors that are influenced by decision-makers at the governmental level.This means taking into account policies, programmes, governance models, and other regulatory interventions. Issues such as politics, corruption, lack of accountability and transparency, misinformation, disputes, mismanagement, unsafe working conditions for healthcare workers, unethical conduct, and human rights violations all contribute towards the adverse events and harm that take place within healthcare settings. A more integrated and system-based view of the concept of safety is needed within healthcare facilities in order to reduce the nature and types of harm that patients face. A causality analysis needs to be conducted particularly in LMICs in order to determine the various underlying and root causes of the factors that can cause patient harm. Similarly, there needs to be an identification of policy gaps and assessment of the healthcare contexts in order to formulate effective evidence-based policy measures for patient safety. Patient safety ‘should form the foundation for the strengthening of healthcare systems.’ Developing a culture of safety needs to be done taking into account patient perspectives on the one hand and healthcare worker perspectives on the other.Wagner et al. argue that the psychosocial working conditions of healthcare workers, as well as leadership, and patient safety and occupational safety climates are all interrelated facets within the conversation of patient safety that need to be holistically considered.6

Possible perceptions of harm by patients in public hospitals in Kenya and the underlying causes Harm as a result of medical detention over unpaid hospital bills The practice of many hospitals of detaining patients who have received treatment and are due for discharge has resulted in many patients feeling anxious, depressed, and distressed, even if they have been treated for their physical ailments. There is significant mental and emotional harm

5 Charles Vincent, ‘The Essentials of Patient Safety’ (2011) adapted from his book Patient Safety (2nd edn WileyBlackwell 2010) 4. 6 Anke Wagner et al.,‘Healthcare Professionals’ Perspectives on Working Conditions, Leadership and Safety Climate: A Cross-Sectional Study’ (2019) 19 BMC Health Services Research 53.

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that occurs as a result of medical detention due to unpaid hospital bills. Patients may feel like prisoners. The continued stay in a hospital setting also increases the risk of hospital-acquired infections. Mothers who have just delivered and their infants are particularly vulnerable, as well as patients who have recovered from COVID-19, and who may be detained in hospitals due to unpaid hospital bills. Patients who are detained often feel that their human rights are being violated by the very same people who should be protecting their rights. And, indeed, their human rights are being violated.Various international provisions come into play, including Article 13 of the Universal Declaration of Human Rights (UDHR),Articles 9 and 11 of the International Covenant on Civil and Political Rights, and Article 6 of the African Charter on Human and Peoples’ Rights (ACHPR). The Constitution of Kenya also has provisions which are violated when a patient is detained over unpaid medical bills.7 The courts in Kenya have declared it unconstitutional and illegal for a patient to be detained over unpaid medical bills. One such case is Gideon Kilundo & Daniel Kilundo Mwenga v Nairobi Women’s Hospital,8 where the senior Kilundo, after being involved in a serious car accident, was treated and made a full recovery at the Nairobi Women’s Hospital. He incurred a medical bill of Kshs. 1,033,196, which was unsettled at the time of discharge. The hospital then opted to detain him until he paid the bill prompting the constitutional petition.The court had to engage in a balancing act between protecting the hospitals rights to property in the form of monetary payment and the petitioner’s right to liberty. In the end, the court made a declaration that the detention was illegal and that the hospital could recover the unpaid debt in court rather than violate the patient’s human rights. Hospital detentions harm the dignity of the patient and may cause more harm and complications to the patient than they came in with. The case of MAO & Another v AG & 4 Others9 is a case in point. The petitioners were patients at Pumwani Maternity Hospital where they had been admitted, and as a result of their indigence they were unable to pay and hence were detained by the hospital for more than 21 days.Their case showed the kind of harm that patients would face at the hands of health professionals and also due to weak hospital systems.They were spoken to rudely when they sought assistance, had to share beds with other detained patients, and even sometimes had to sleep on the cold floor to allow their infants to use the bed.They had to purchase their own cups, plates, cotton wool, and other items needed in their management before they received any treatment.The bed had only one light blanket.The ward in which they were detained was near a flooding toilet that was hardly cleaned.They were not attended to or examined by the attending doctor. Detained patients were always fed last and therefore the food was never adequate. For nursing mothers, this led to stress as they did not have enough nutrition to breastfeed their infants.Their detention caused anxiety as they had other children at home. They were not even allowed to go outside to get fresh air and sunshine due to the fear that they would escape.The first petitioner, upon discharge, discovered that she had contracted pneumonia as a result of the numerous nights sleeping on a cold hospital floor next to a flooded toilet. The second petitioner was rushed to the hospital because she had developed complications, and upon arrival was told to sleep on the floor as all the beds were occupied. Upon discharge, she was not shown an itemised bill but was given a figure to pay, which she could not afford.The

7 Constitution of Kenya 2010,Articles 28, 29, and 39. 8 (Petition No. 242 of 2018) (2018) eKLR; see also Veronica Nyangai v Nairobi West Hospital Ltd (2017) eKLR; Chirstine Kidha v Nairobi Womens Hospital (2016) eKLR; and Tryphosa Jebet Kosgey v Eldogn View Hospital (2016) eKLR. 9 MAO & Another v AG & 4 Others (2015) eKLR.

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type of harm suffered by these patients may not be the typical errors and adverse events that have been the focus of patient safety discussions, but are nevertheless harms that compromise patient safety, particularly in LMICs. The underlying causes of hospital detentions can be traced to weak financing systems for access to health services that leave patients with no option but to incur out-of-pocket expenses to access healthcare. Medical detention is evidence of failed universal health coverage (UHC). Patients who are poor and are unable to pay for health services are the ones who should benefit the most from UHC, but ironically are the ones who end up suffering violations of their rights because they cannot afford to pay. UHC will be discussed later in the chapter. Hospital detentions can also be attributed to weak governance and monitoring systems that allow for these violations of patient rights.

Harm as a result of disrespectful and unethical conduct by health professionals It is not uncommon in public health facilities to hear of patients’ complaints concerning the level of disrespect and abuse they have undergone at the hands of the health professionals handling them. The disrespect comes in the form of verbal and physical abuse, neglect, abandonment, discriminatory action, breach of confidentiality and privacy, and non-consensual treatment.The effect of this kind of treatment is fear by patients of accessing health services where they will be mistreated and mishandled. Pregnant women particularly face this kind of fear, contributing to high rates of maternal and infant morbidity and mortality, as birth complications cannot be adequately handled by unskilled local midwives. A report by FIDA Kenya and Centre for Reproductive Rights showed that women in labour would often face mistreatment such as the pinching of thighs, slapping, and beating.10 Unlike Western jurisdictions where the patient’s views and consent are considered central in the treatment process, in Kenya cultural perceptions render the patient in subservience to the views of the health professional. ‘Doctor knows best’ seems to be the order of the day, and any questioning of this may lead to tension between the patient and health professional, with the latter being disrespectful to the patient. Medical paternalism is thus used to abuse and disrespect patients. Impoliteness and disrespect impede other human rights, for instance the right to dignity and autonomy (self-determination). As a result of the cultural perception of doctor knows best, health professionals are many times unwilling to share decision-making authority with patients. Treatment can then be done without consent and proper information being shared with the patient.This generates feelings of isolation, exclusion, and intimidation in the patients, who may then suffer more harm as a result of these feelings. Lack of respect for the autonomy of the patient includes the lack of recognition of the cultural beliefs or personal beliefs or value system of the patient, and for the right to proper and full information concerning the course and procedures of their treatment.The case of forced sterilisation of mothers living with HIV illustrates this point.11 Disrespect and abuse are now deemed public health issues which need to be addressed using multi-component interventions beyond the clinical setting. Relying on the findings of the

10 FIDA Kenya and Centre for Reproductive Rights, Failure to Deliver:Violation of Women’s Human Rights in Kenyan Health Facilities (2007) www.reproductiverights.org/sites/default/files/documents/pub_bo_failuretodeliver.pdf accessed 11 November 2020. 11 SWK & 5 Others v Medecins Sans Frontier France & 10 others (Petition No 605 of 2014).

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Heshima Project conducted between 2011 and 2014,Abuya et al.12 propose interventions at three levels – the facility level, the community level, and the contextual level. It is the third level that is of concern for this chapter.The context under which these health services are offered is important – the devolution of health services and the introduction of free maternity services in public health facilities and implications this had for human resources for health.The shortages of health workers lead to heavy workloads, fatigue, stress, and burnout.This is turn leads to the indifferent, impersonal, and dehumanised feelings that health workers have towards their patients. Despite the National Patients’ Rights Charter, the different codes of conduct for the different health professionals, and the enactment of the Health Act, it seems that the harm that patients suffer as a result of disrespect, abuse, and unethical conduct is far from quelled in public hospitals in Kenya.

Harm as a result of denial of emergency medical treatment and poor referral systems Sometime in 2015, a casual labourer by the name Alex Madaga was involved in a tragic road accident that left him with serious head injuries. He spent 18 hours in an ambulance waiting to be admitted to Intensive Care Units in four different hospitals. Each of the hospitals did not offer him emergency medical services. Eventually he was admitted at the Kenyatta National Hospital, when an ICU bed became available, but he succumbed to his injuries shortly thereafter, in a case that exposed the glaring weakness in the implementation of the Constitutional right to emergency medical treatment.Article 43(2) of the Constitution of Kenya, 2010 provides: A person shall not be denied emergency medical treatment. This has been reiterated in the Health Act 2017. Emergency medical treatment has been defined in various documents in Kenya. In the Health Policy it has been given a comprehensive definition as including First aid treatment of ambulatory patients and those with minor injuries; public health information on emergency treatment, prevention and control; and administrative support, including maintenance of vital records and providing for a conduit of emergency health funds across government. It also provides that Emergency health services shall be a part of the referral services and shall be provided by the nearest health facility, regardless of ownership (both public and private). The Health Act 2017 provides that Emergency treatment refers to necessary immediate health care that must be administered to prevent death or worsening of a medical condition.

12 Timothy Abuya, Charity Ndwiga, Julie Ritter, Lucy Kanya et al.,‘The Effect of a Multi-Component Intervention on Disrespect and Abuse During Childbirth in Kenya’ (2015) 15 BMC Pregnancy and Childbirth 224.

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The National Patients’ Rights Charter contains similar provisions that seek to guarantee the right to emergency medical treatment. Despite these lofty provisions of law, there are serious challenges faced in public health facilities in offering emergency medical treatment for patients.13 The challenges occur in three main ways: firstly, there is failure to admit patients in order that they may receive appropriate emergency medical care. Many facilities are managed by clinical officers or senior nurses or even interns straight from university who have minimal experience in resuscitation and stabilisation of a patient in need of emergency care. Secondly, there are many facilities that do not have the appropriate systems and are not well designed to accommodate patients requiring emergency medical treatment. The COVID-19 pandemic has demonstrated the weakness in the public health sector in the country. In a recent study conducted to assess the surge capacity of the Kenyan health system as a result of the increased infections, it was found that only 22 out of the 47 counties in the country had at least one intensive-care unit.14 This situation has compromised the safety of patients who seek emergency treatment, particularly in public health facilities as they are often turned away due to lack of bed space.15 Thirdly, there are referral systems that do not work efficiently and effectively. The referral system in Kenya is overburdened because patients bypass the primary health facilities and seek treatment directly at referral institutions, even for minor ailments.The referral system is meant to ensure that there is continuity of care and management of the patient from the lower-level facilities to the higher-level facilities. It is intended to ensure that where there are no ‘locally’ available resources in the facilities, the patient can then be referred to another facility where the resources are available. However, the system as it is in Kenya would actually cause the patient more harm than good.The referral hospitals in Kenya are overcrowded, which means that at any one given time, there are no beds available to cater for inpatients. In many instances, patients have to sleep on the floor or share beds. In 2019, the Parliamentary Health Committee released a report which showed the deplorable conditions of four national referral hospitals that compromised the safety of patients. There was a total lack of plant and equipment maintenance and replacement. At the Kenyatta National Hospital, there were weekly deaths of up to 80 babies in the newborn unit.The facilities were dilapidated with leaks and cracks, as well as poor sanitation. There was an understaffing of nurses with a ratio of 50 patients to 1 nurse.The daily inpatient volume was up to 2093 patients, but the bed capacity was only 1800.The Mathari Teaching and Referral Hospital, which is the only mental hospital in the country, has a paltry staff of 386 against the recommended international levels of 1077. There is overcrowding of patients in the facility which makes it difficult to monitor and treat them.The facilities are also rundown and dilapidated.The same story resonates at the Moi Teaching and Referral Hospital, which serves the whole western region of the country – a population of about 25 million. Each of these hospitals has bad debts and waivers, as well as lack of reimbursement from the National Hospital Insurance Fund (NHIF), the national insurer, for patients who have paid using the insurance scheme.They have also faced budgetary constraints.

13 Morgan C Broccoli, Emilie J B Calvello, Alexander P Skog, Benjamin Wachira, and Lee A Wallis, ‘Perceptions of Emergency Care in Kenyan Communities Lacking Access to Formalised Emergency Medical Systems: A Qualitative Study’ (2015) BMJ Open 1; B Wachira and IBK Martin ‘The State of Emergency Care in the Republic of Kenya’ (2011) 1 African Journal of Emergency Medicine 160. 14 Edwine W Barasa, Paul O Ouma, and Emelda A Okiro, ‘Assessing the Hospital Surge Capacity of the Kenyan Health System in the Face of the COVID-19 Pandemic’ (2020) 15(7) PloS ONE 1. 15 The government of Kenya has recently rolled out the Protocol on Home Based Care for COVID-19 patients due to the lack of capacity to manage them in the hospitals. See Ministry of Health, Home Based Isolation and Care Guidelines for Patients with COVID-19 (Ministry of Health June 2020).

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For example, the budget for Mathari hospital was reduced from Kshs. 114 million to 92 million, and faced a lack of reimbursement from NHIF of Kshs. 104 million. Another study conducted to bring out the challenges faced in the referral systems in Kenya16 showed that there was lack of ambulatory services for emergency cases, lack of skill for health workers in dealing with referrals, lack of standard referral documents so that even emergency cases would likely be missed or ignored, and lack of sufficient budgetary allocations for referrals. There is, therefore, underinvestment in the referral hospitals as well as primary facilities, which should be able to absorb and act as a filter for patients so that attention can be given to emergency treatment.

Health governance outcomes that have an adverse impact on patient safety Health governance can be understood in two ways: governance at the clinical level, which is relational in nature; and governance at the macro level, which is hierarchical in nature. Bodolica, Spraggon, and Tofau have defined hierarchical governance as ‘the macro level policy framing and coordination efforts, which occur through administrative top-down decision making, resource allocation, and controlled planning and administration’ and relational governance as ‘associated with micro-level mechanisms aimed at facilitating interactions via reciprocity, trust, altruism, solidarity and shared norms that are embedded in patient–physician relationships.’17 They argue that these two levels of governance have traditionally been considered separately from each other. However, in order for patient safety to be enhanced, the interactions and interrelationship between the two levels of governance need to be synchronised. A unified and holistic governance structure needs to be developed.The implications of this approach are that decisions that are made at the macro governance level have to be sensitive to the decisions that are bound to be made at the micro governance level. Similarly, it also implies that the challenges at the micro governance level can be attributed to challenges faced at the macro governance level. A good illustration would be in the area of resource allocation and distribution in health care. Resources are needed within the hospital setting to enhance patient safety. Governments have traditionally been resource allocators and distributors. However, if the government does not allocate adequate or sufficient resources to health facilities, this would hamper patient safety efforts. I argue that overemphasis on the relational aspects of governance at the expense of hierarchical aspects, may fail to address the root causes of harm within hospital settings in Kenya. One major disadvantage of the hierarchical governance approach is that there can be a detachment from the micro-level challenges for the physician–patient relationship. For example, patient preferences and views may not be taken into account.18 It also may fail to take into account the effect of policies, allocation decisions, budgeting, etc. on relational governance issues.

16 Kariri James Kamau, Ben Onyango-Osuga, and Susan Njuguna,‘Challenges Facing Implementation of Referral System for Quality Health Care Services in Kiambu County, Kenya’ (2017) 4(1) Health Systems and Policy Research 48. 17 Virginia Bodolica, Martin Spraggon, and Gabriela Tofan,‘A Structural Framework for Bridging the Macro-Micro Divide in Health-Care Governance’ (2016) 19(4) Health Expert 790–804, 791. 18 ibid 791.

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Challenges of devolution as a governance framework to quality service delivery and patient safety in public health facilities in Kenya The Constitution of Kenya 2010 introduced a decentralised mode of governance that created two levels of government – the national government and county governments19– which were meant to be ‘distinct and interdependent and shall conduct their mutual relations on the basis of consultation and cooperation.’20 The objects of devolution are mainly to enhance self-governance and participation of the citizens in the decisions that affect them. Devolution is intended to enhance access to services as well as the quality of service delivery.21 It is also intended to increase transparency, accountability, and citizen participation. The Fourth Schedule of the Constitution sets out the functions of both the national government and county governments. When it comes to health, the county governments are in charge of ‘county health facilities and pharmacies,’‘ambulance services,’ and ‘promotion of primary care.’22 The national government is to be in charge of national referral health facilities and formulation of health policy.23 The intentions of increased access to services and enhancing the quality of service delivery, noble as they may have been, have faced numerous challenges due to assumptions that were made about devolution and service delivery, and the manner in which devolution has been implemented. Health services were devolved to the counties in 2013, in a move that can be deemed to be more politically motivated than aimed at efficient delivery of service to the people.A seven-year transition was provided for in the Constitution from the time of its promulgation in 2010. However, the President declared functions devolved in June 2013. If the criteria in the Transition to Devolution Act24 are anything to go by, the counties do not seem to have been prepared for the full devolution of health services. In order for any function to be devolved, there needed to be an existing legislative framework for the function, a framework for service delivery in order to implement the function, the prior undertaking of a capacity assessment, evaluation of whether there is adequate infrastructure and financial systems in place, and an approved plan.25 This was not adequately done when health services were devolved, prompting litigation on the issue.26 There were no guidelines on the structures, roles, and mandates of the county government health sector management; the county health management teams did not have the necessary capacity and skills to conduct their roles, such as strategic planning and drawing up of budgets; there were conflicts between the national government and county governments; the appointment of officials was largely dominated by nepotism, ethnicity, and intense lobbying; and there was lack of clarity of the roles of the county health management team and the other county government departments such as county treasuries and county public service boards.27

19 20 21 22 23 24 25 26 27

There are 47 county governments as specified in the First Schedule of the Constitution of Kenya, 2010. Constitution of Kenya, 2010 Article 6(2). Constitution of Kenya 2020,Articles 174 and 175. Fourth Schedule, Part 2(2)(a) to (c), Constitution of Kenya 2010. Fourth Schedule, Part 2(23) and (28), Constitution of Kenya 2010. Transition to Devolution Act No 1 of 2012. See section 24 of the Transition to Devolution Act 2012. Republic v Transition Authority & Ano Ex parte Kenya Medical Pharmacists and Dentists Union and 2 Others. KEMRI Policy Brief,‘Early Experiences and Effects of Health Sector Devolution in Kenya’ (February 2018) https ://resyst.lshtm.ac.uk/resources/early-experiences-and-effects-of-health-sector-devolution-in-kenya accessed 14 October 2020.

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Aspects affected by devolution that are bound to affect patient safety The management and working conditions of healthcare workers One specific area that the devolution of health services significantly affected is the human resources for health. Health workers are an essential component of any health system. Their well-being and safety in the workplace have a direct and significant effect on the manner in which they treat patients, deliver health services, and ensure patient safety. Studies have been conducted that link the working conditions of healthcare workers with patient care.28 Hickam et al. explain working conditions as entailing ‘workforce staffing, workflow design, personal/ social factors, physical environment and organisational factors.’29 The health sector is a ‘high-risk, high-demand, high-stress industry.’30 Health workers are subjected to ‘fast paced environments which have high physical work demands and require constant mental astuteness to oversee the needs of fragile, complex, compromised, very ill people, often in unpredictable settings.’31 Sokas et al. argue that a safety culture where the health and well-being of healthcare workers and patients are integrated would enhance patient safety by creating ‘savings in workers’ compensation costs, lower staff turnover, improved staff morale, increased patient satisfaction and fewer patient adverse events.’32 The work environment must be conducive33 for the health worker to be able to deliver quality services that will enhance patient safety and reduce any form of harm to the patient. Conductivity also goes to such issues such as collegiality with other workers, a participatory approach to decision making, adequate supervision from supervisors, objective performance appraisals, and promotion based on merit and skill. In Kenya, the prioritisation of the demand side of health services has been the traditional focus. Investments and resources have been made with patients in mind. The interests and the needs – both physiological and especially psychosocial – of healthcare workers have largely been sidelined.This has had a profound effect on patient safety.The COVID-19 pandemic has reopened the discussion on the interlinkage between healthcare worker safety and patient safety in Kenya. Preliminary studies at the onset of the COVID-19 pandemic showed that properly used and quality-tested personal protective equipment by healthcare workers can effectively safeguard them from getting infected with COVID-19.This will in turn enable them to prevent infection to patients.34 By the beginning of August, Kenya had recorded over 250 cases of health workers in public hospitals who had contracted the virus, with the Ministry of Health attributing these numbers to the high number of patients who were also testing positive for the virus.35

28 DH Hickam et al., ‘The Effect of Health Care Working Conditions on Patient Safety: Summary’ (2003) www .ncbi.nlm.nih.gov/books/NBK11929/ accessed 2 June 2020; see, also,Wagner et al. (n 6). 29 Hickam et al. (n 28). 30 Joseline Sikorski,‘Connecting Worker Safety to Patient Safety:A New Imperative for Healthcare Leaders’ (2009) Ivey Business Journal https://iveybusinessjournal.com/publication/connecting-worker-safety-to-patient-safety -a-new-imperative-for-health-care-leaders/ accessed 14 October 2020. 31 ibid. 32 Rosemary Sokas et al., ‘Frontline Hospital Workers and the Worker Safety/Patient Safety Nexus’ (2013) 39(4) The Joint Commission Journal on Quality and Patient Safety 185, 186. 33 ibid. 34 Kangqi, Ng et al., ‘COVID-19 and the Risk to Health Care Workers: A Case Study’ (2020) Annals of Internal Medicine L20-1075 www.ncbi.nlm.nih.gov/pmc/articles/PMC7081171/ accessed 15 October 2020. 35 See Kjoki Kihiu,‘186 Health Care Workers Positive for COVID-19 in Kenya’ www.capitalfm.co.ke/news/2020/ 07/186-health-care-workers-positive-for-covid-19-in-kenya/ (Capital FM, 1 July 2020) accessed 14 October 2020; see, also, Felix Tih,‘Kenya: 250 health works infected with COVID-19’ AA (8 July 2020) www.aa.com.tr/ en/africa/kenya-257-health-workers-infected-with-covid-19/1903926 accessed 14 October 2020. At Pumwani

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However, health workers have complained that they do not have adequate personal protective equipment (PPE) or that the ones that are supplied are of a substandard quality, putting both the healthcare workers and the patients’ safety in jeopardy. The stress and strain to healthcare workers has further been exacerbated by the corruption in the procurement of the PPEs and the manner in which money allocated to strengthen measures to combat the COVID-19 pandemic in Kenya has been utilised. In order to meet the shortfall of healthcare workers, the Ministry of Health planned to recruit an additional 5000 healthcare workers. However, even this move has caused conflict between the Council of Governors and the Ministry of Health, with the former arguing that the counties are legally meant to be the ones to conduct the recruitment exercise.This meant that the recruitment was put on hold, leaving the already fragile, overworked, and overloaded public health sector workers at risk of fatigue and burnout. The regulatory and policy framework in Kenya that seeks to protect working conditions of workers needs to take an integrative and collaborative approach that will take into account issues related to the occupational safety and health of workers. In this case, the regulatory and policy framework for healthcare workers needs to take into account the interrelationship between worker safety and well-being on the one hand and patient safety and well-being on the other. The occupational safety and health of healthcare workers needs to cover all facets of their wellbeing, including their psychosocial well-being, which is currently neglected.Work-related stress and burnout amongst healthcare workers are not currently receiving the priority within policy frameworks as they should. Apart from the lack of proper equipment and infrastructure in their working environment, healthcare workers have also faced challenges in remuneration.According to McCoy et al.,‘pay and income have been described as hygiene factors that affect motivation, performance, morale, and the ability of employers to attract and retain staff.’36 They argue that when healthcare workers are not remunerated adequately, they would moonlight and even extort money from patients and engage in other corrupt practices, such as theft of medical supplies and medication to sell privately. In Kenya, issues of remuneration and collective bargaining processes have been an ongoing challenge leaving health workers feeling demotivated and frustrated.The delays in salaries, as well as in the conclusion of collective bargaining processes, have led to strikes or threats of strikes. The feelings of dissatisfaction have in many cases eventually led to health worker migration to better-paying jobs and this in turn causes a shortage in health facilities.The ripple effect that this has is that patients do not have the benefit of quality attention by the overworked and overloaded and stressed healthcare workers. The stress, fatigue, and burnout as a result of overwork can cause healthcare workers to have compassion fatigue and indifference towards

Maternity Hospital, the largest public maternity hospital in the country, 41 healthcare workers tested positive for COVID-19 in mid-July. 36 David McCoy et al., ‘Salaries and Incomes of Health Workers in Sub-Saharan Africa’ (2008) 371(9613) The Lancet 675–81.

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patients37 resulting in patient harm. Health workers are thus bound to be rude, unsympathetic, and neglectful towards patients, leading to litigation around human rights violations of patients38. The improvement of working conditions (infrastructure, equipment, medical supplies, and organisation structure) and remuneration of health workers in public health facilities is a hierarchical governance issue.There are decisions, policies, and programmes that have to be developed and implemented at a macro level in order to influence the working conditions at the micro level.The failure to address these issues leads to consequences that have a significant bearing on patient safety in those health facilities. One such consequence is industrial action by healthcare workers. Since the promulgation of the Constitution of Kenya in 2010, the country has experienced some of the worst and most prolonged strikes by public sector healthcare workers in the country’s history.The promises that the Constitution and devolution made were simply that – promises. But the delivery of the same was not felt, especially by healthcare workers.The threat of strikes still continues even with the current COVID-19 pandemic with healthcare workers protesting the lack of protective equipment, testing kits, risk allowances, and psychosocial support. Other issues that have led to strikes among healthcare workers in Kenya since the devolution of health services took place include failed collective bargaining processes, inadequate and delayed remuneration, high workload and overwork, lack of equipment, infrastructure and supplies, lack of promotions, failure to manage their retirement benefits and plans, and lack of managerial autonomy.

Health fnancing, planning, budgeting, and allocation The macro processes of financing, planning, budgeting, and allocation may not at first glance, seem to have anything to do with patient safety. However, a closer scrutiny of how these processes affect the working environment and operational culture within health facilities would lead to an understanding of the connectivity between macro decisions and micro decisions and processes at the health facility level. Upon devolution, challenges were encountered in aligning the planning and budgeting processes.There were also delays in undertaking routine tasks due to the recentralisation of financial management functions. This led to the frustrations of frontline workers who could not access funds for needed supplies which had run out.Also, user fees which were collected at the health facility level now have to be deposited in the County Consolidated Revenue Account. Health facilities do not have ready access to those and have to wait for disbursements for recurrent expenditure, leading to delays and frustrations for health facility managers and health workers who may urgently need supplies to attend to patients.The new operational structure also meant that there was lack of clarity of roles in terms of who was responsible for the welfare of healthcare workers, and who was responsible for their in-house training and career progression as well as intercounty transfers, again leading to frustration and dissatisfaction among workers.This affects the quality of services rendered to patients.

37 Donald A Kokonya, John M Mburu, Dammas M Kathuku, DM Ndetei et al., ‘Burnout Syndrome Among Medical Workers at Kenyatta National Hospital’ (2014) 17 Journal of Psychiatry 6; Rael Wahu Gichara,‘Burnout in Nurses at a Referral Hospital in Western Kenya (2017) 7(11) International Journal of Academic Research in Business and Social Sciences, 1; Benyam W Dubale, Zeina Chemali, John Denninger et al., ‘Systematic Review of Burnout Among Health Providers in Sub-Saharan Africa’ (2019) 19 BMC Public Health 1247; DM Ndetei, M Pizzo, H Maru, FA Ongecha, LI Khasakhala,V Mutiso, DA Kokonya ‘Burnout in Staff Working at the Mathari Psychiatric Hospital’ (2008) African Journal of Psychiatry 199. 38 JOO (also known as JM) v Attorney General & 6 Others (2018) eKLR.

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Another aspect that has been affected by planning, budgeting, and allocation under devolution is essential medicines and medical supplies (EMMS) management. Before devolution, health facilities were the procuring agents of EMMS. Under devolution, the county governments are now the procuring agents.This has led to challenges in the turnaround time for orders resulting in long periods of time for commodity stock-outs. Stock-outs have also been caused by refusal by the Kenya Medical Supplies Agency (KEMSA) to supply medicines and medical supplies to counties as a result of the high debts owed by the counties.39 Some county governors have failed to prioritise EMMS and have instead chosen to focus on the acquisition of assets which will give them political mileage, such as ambulances.The crisis of constant stock-outs of medical supplies and medicines has led to patients being referred to private chemists and pharmacies which are too expensive and unaffordable for many of them.This compromises their safety and health. The quality of service delivery and patient safety in public health facilities depends largely on the amount of resources (including financial resources) that are allocated to them.This will determine, among many things, the number of personnel that can be hired, the medical equipment and infrastructure, opportunities for training, how much investment is made, and how priorities are set in the health sector and matters of patient safety. As stated earlier in this section, devolution as a model of governance was intended to enhance the quality of service delivery.The implication of this is that citizens could expect better patient safety outcomes. However, the manner in which devolution has been implemented has created room for adverse patient safety outcomes. The next section will discuss the manner in which taking a human rights governance approach to patient care can advance the patient safety agenda in Kenya.

Human rights–based approach to patient care as a governance model in public health facilities The concept of adverse events within healthcare settings can be construed in a wider way to embrace violations of patients’ health and health-related rights, which in turn compromise their safety. Patient safety, as discussed earlier in the chapter, is a concept that moves beyond the avoidance of errors in the clinical setting and considers the holistic well-being of the patient. Upholding the dignity of the patient improves their overall well-being. The question is: How does the protection of the human rights of patients enhance their safety? Peled-Raz makes an argument for a ‘human rights in patient care’ approach to patient safety. This approach is proposed in order to provide remedies for the systemic and underlying causes of patient harm and mistreatment. She defines patient care as ‘the prevention, treatment and management of illness and the preservation of physical and mental well-being through services offered by health professionals (or non-professionals under their supervision).’40 Good care is not merely about skilled and competent care by health professionals; it is also about respecting the human rights of patients.

39 Joan Kariuki, Mercy Karimi Njeru, Watu Wamae, Maureen Mackintosh, ‘Local Supply Chains for Medicines and Medical Supplies in Kenya: Understanding the Challenges’ (2015) African Centre for Technology Studies Inclusive Bioeconomy Programme Working Paper No. 001/2015; see Collins Omulo,‘Nairobi Faces Crisis over Shortage of Medicines’ Business Daily (27 March 2019) www.businessdailyafrica.com/news/counties/Nairobifaces-crisis-over-shortage-of-medicines/4003142-5045100-vqfe1p/index.html accessed 14 October 2020. 40 Maya Peled-Raz, ‘Human Rights in Patient Care and Public Health – A Common Ground’ (2017) 38 Public Health Reviews 29.

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Human rights in patient care can be seen as a viable alternative to the patient rights movement, which embraces a more consumerist ethos and perhaps is narrower in its scope, to provide adequate remedies for patient harm.The patient rights movement bases obligations to patients on the law of contract and tort, a breach of which could lead to civil action.Whereas these have had and still do have a place in the promotion of the interests of patients and have even led to the development of protocols to enhance patient safety in the private sector, their utility in the public sector is not felt as much. Indeed, the law of tort, where a medical negligence claim would be brought under, serves a corrective justice function which is intended to compensate the patient and restore them to their original position before the injury complained about. It serves a deterrence function. However, whether medical negligence and malpractice claims would enhance patient safety is debatable.41 As a result of the potential threat of litigation, healthcare providers are bound to practice defensive medicine, defined as ‘departing from normal medical practice as a safeguard from litigation.’ Defensive medicine exposes patients either to too many unnecessary diagnostic, testing, and treatment procedures (positive defensive medicine) or avoids risky treatments which may otherwise be beneficial to patients in order to reduce the chances of litigation (negative defensive medicine). Apart from that, it also has the potential to increase healthcare costs for the patients who have to pay more for tests and hospital admissions42 and also for the healthcare providers whose premiums may go up thus causing them to charge more for services provided for patients. For patients with insurance cover in Kenya, the risk of being admitted unnecessarily in hospital is very high.43 This not only harms the patient psychologically but also economically, as their premiums are bound to increase.The fear of litigation may cause heightened levels of anxiety and depression amongst health professionals due to the reputational damage that court cases can have. It can also deter health professionals from disclosing and recording errors. Peled-Raz sets out two major limitations of the patients’ rights approach. Firstly, it focuses too much on patients and leaves out the other stakeholders who also contribute towards the safety of the patient (e.g. healthcare workers). Secondly, it focuses on the clinical relationship between the patient and the healthcare provider, which hinders the consideration of other elements outside of that relationship which may influence or even cause violations of the rights of the patient. She argues that when the (healthcare) system is designed – deliberately or not – in a way that is set to infringe on human rights, the patients’ rights doctrine will provide no assistance. A patient cannot claim an infringement on his right as a patient when he is not receiving equal care, due to lack of a nationally funded health plan, nor can he protest his patients’ rights breached when a state law requires the physician to notify the authorities of his medical condition.

41 See Michelle M Mello, Michael D Frakes, Erik Blumenkranz, and David M Studdert,‘Malpractice Liability and Health Care Quality: A Review’ (2020) Clinical Review and Education 352;Toyen A Brennan and Michelle M Mello,‘Patient Safety and Medical Malpractice:A Case Study’ (2003) 139(4) Annals of Internal Medicine 267–73; M Sonal Sekhar and N Vyas ‘Defensive Medicine: A Bane to Healthcare’ (2013) 3(2) Annals of Medical Health Science Research 295. 42 Hospitals may have a tendency to carry out positive defensive medicine on patients with insurance coverage, which would also raise the premiums for the patients concerned. 43 See the scandal concerning The Nairobi Womens Hospital that had a policy of having a daily quota admission for patients, even when it was not necessary in order to gain more profits.

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A human rights to patient care approach enables multiple stakeholders and their roles to be considered in the discussion about patient safety and quality of care. It also seeks to address the systemic causes of mistreatment of patients that lead to a violation of patient safety. A rightsbased approach to patient safety in Kenya would be hinged on the constitutional provision of the right to the highest attainable standard of health.

Situating patient safety within the right to health framework The ultimate responsibility for ensuring patient safety lies with the state.This is the import of constitutionalising the right to health within the Bill of Rights of the Constitution of Kenya 2010 and of the ratification of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The right to the highest attainable standard of health as set out in the ICESCR has been constitutionalised within the Bill of Rights of the Constitution of Kenya, 2010.44 This effectively makes it a judicially enforceable right that would invoke sanctions should it be violated.45 One of the most authoritative interpretations provided of the right to health is as set out by the Committee on Economic Social and Cultural Rights.46 The committee, in setting out the meaning of the right to health, has expressed that any interpretation of the right to health must take into account its inclusive nature and that it has integrated other rights within its framework. It also entails freedoms and entitlements, for example, freedom from violations that may compromise patient safety such as non-consensual treatment, torture, inhuman and degrading treatment, as well as discrimination.47 Patient safety from the lens of the right to health also entails the social and underlying determinants of health.48 These have been defined as ‘the non-medical factors that can affect a person’s overall health and health outcomes.’49 The Commission on Social Determinants has also defined them as ‘the conditions in which people are born, grow, work, live, age, and the wider set of forces and systems shaping the conditions of daily life.’ Daniel, Bernstein, and Kane posit that social determinants are an ‘important component of the physician’s role as an advocate for patients and a steward of medical care’50 and therefore patients should be screened for the underlying determinants that could be affecting their health, and those that would affect their ability to access healthcare and to continue seeking healthcare services.The underlying determinants that are likely to have an impact on patient safety are access to clean and safe water, sanitation, safe and healthy working conditions, and socio-economic conditions. The right to health also entails the availability, accessibility, acceptability, and quality (AAAQ) framework. Patient safety can then be evaluated in light of this framework. a. Availability entails that a state should have functioning healthcare facilities with sufficient goods, services and programmes that will serve patients. There must also be a

44 Article 12 of the ICESCR. 45 The Constitution of Kenya 2010 in article 20(1) provides that the ‘Bill of Rights applies to all law and binds all State organs and all persons.’ 46 General Comment No 14 on the Right to the Highest Attainable Standard Health. 47 ibid para 8. 48 ibid para 11. 49 Hilary Daniel, S Bernstein, and Gregory C Kane, ‘Addressing Social Determinants to Improve Patient Care and Promote Health Equity: An American College of Physicians Perspective’ (2018) 168(8) Annals of Internal Medicine 577–78. 50 ibid.

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sufficient supply of essential medicines, trained, competent and professional health personnel who are motivated in their work. The underlying determinants of health, such as safe water, good sanitation, nutritious food, etc., should also be available in adequate amounts. In Kenya, this aspect of the right to health faces a number of challenges, particularly upon devolution of health services. Many health facilities are operating with very little autonomy and funds to carry out daily operations. Many are in debt, without amenities such as electricity and water, and there is poor sanitation and hygiene. The lack of these basic amenities increases the risk of hospital-acquired infections for patients, compromising their safety. There are also shortages of essential medicines, with patients being referred to private pharmacies to acquire even the most basic of drugs. The inflation of medication in some public hospitals has also contributed to the non-availability of this essential aspect that should enhance patient safety. A recent study showed that patients suffering from noncommunicable diseases are especially vulnerable. Many of these essential medicines are not available in government facilities, where they would be cheaper. Patients end up being referred to specific private pharmacies where the cost of the medication may be restrictive for them. Since the inception of devolution of health services in 2013, there has been a human resource challenge at the county level, in terms of capacity, and conflicts between the roles of county and national governments in governing health personnel. The unsafe working conditions, coupled with the dissatisfaction among health workers as to their remuneration, allowance, and promotion packages have led to a myriad of strikes in the health sector. Since independence, there have never been as many strikes as there have been since devolution.These strikes have had a profoundly negative effect on patient safety, with patients dying or suffering significant irrecoverable harm to their health as a result of not being attended to.The COVID-19 pandemic has made the situation worse for patients, particularly those who are suspected of having the coronavirus and who are not being attended to upon arrival at health facilities due to healthcare workers not having the necessary personal protective equipment (PPE). Public health facilities also have challenges in infrastructure and medical equipment. A recent deal that was entered into for the procurement and distribution to the counties of medical equipment has not yielded the desired results.This is because the deal was shrouded in corruption and secrecy, leading to escalated costing of items.A needs assessment was not carried out per county resulting in some counties receiving equipment that they do not need, or not having the requisite personnel to handle or operate the equipment.This means that patients do not get the benefit of better-quality services. The global COVID-19 pandemic has exposed the weaknesses that plague the public health sector in Kenya and how patients can then have their safety compromised.An audit of the health system reveals that testing kits, isolation units in hospitals, beds, ICU beds and equipment, and PPE for healthcare workers are in very low supply.There are instances where patients have been turned away from public facilities as a result of a lack of available space or treatment kits. b. Accessibility means that health facilities, goods, and services together with the social and underlying determinants of health should be accessible to patients in a manner that meets the following criteria: (i) It must be without discrimination.

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Discrimination can be based on several social, economic, and even political factors. Health services should be available to the marginalised and vulnerable and socially excluded such as transgendered patients, intersex, and patients of same-sex orientation.There should be no discrimination on any prohibited ground.This aspect is a core obligation of the state that is not resource-dependent. (ii) It must be physically accessible. Health facilities should be within safe reach for patients, especially for those who are marginalised, vulnerable, of ethnic minority, living with disabilities, adolescents, older persons, and persons living with HIV.The accessibility of the health facility is not merely about geographical distance, but also about the infrastructure that allows access to that health facility. It means that the state of roads and the means of transport also need to be accessible. Many Kenyans, in both urban informal settlements and rural areas, depend on public transportation to get to their destinations.Access to public transportation may not be as much as a challenge to the urban dweller as it may be for many patients in rural areas.51 Some investments by the counties in properly fitted and functioning ambulances need to be done.These factors will determine whether patients will seek services within health facilities or will seek alternative means of treatment, e.g. traditional healers. Some patients unfortunately die or even have their health irreversibly damaged as a result of the delays in getting to a health facility.The challenge that has been faced by Kenya is the corruption in the procurement processes that diverts much needed financial resources to private use. There also should be access to the underlying determinants of health, as well as proper access to buildings and amenities. Specific inclusive programmes and strategies need to be put in place for persons with disabilities.These strategies will be dependent on which model of disability is being considered, i.e. the medical model or the social model. Both, it is argued, should be borne in mind when formulating these plans and programmes for persons with disabilities. In low- and middle-income countries in sub-Saharan Africa, children living with disabilities are among the vulnerable groups that need questions of access to healthcare addressed.52 (iii) There should be economic accessibility. The rising cost of healthcare in Kenya has rendered many households bankrupt or in dire financial straits. However, in order to enhance patient safety, there must be equity and affordability of health services, where poor households are not ‘disproportionately burdened with health expenses as compared to richer households.’ For Kenya, the question of economic accessibility is to be addressed by way of universal health coverage (UHC), which is part of the Big Four Agenda of the government, as well as the government blueprint for development – the Vision 2030.

51 Veronica Escamilla, Lisa Calhoun, Nobert Odero, and Ilene S Speizer,‘Access to Public Transportation and Health Facilities Offering Long-Acting Reversible Contraceptives among Residents of Formal and Informal Settlements in Two Cities in Kenya’ (2019) 16 Reproductive Health 161. 52 Molalign B. Adugna, Fatima Nabbouh, Selvia Shehata, and Setareh Ghahari, ‘Barriers and Facilitators to Healthcare Access for Children with Disabilities in Low and Middle Income Sub-Saharan African Countries: A Scoping Review’ (2020) 20 BMC Health Services Research 15.

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The definition of UHC is That all people and communities can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship.53 The three main tenets of UHC are equity, quality, and affordability. Kenya decided to use some counties as flagship counties for the roll-out of the UHC programme. However, despite the noble intention of the government in having this programme that would benefit its citizens, especially the poor and marginalised, several teething problems have emerged. Mbau et al.54 highlight some of these issues.There have been upward revisions of premiums without the knowledge and prior notification of patients. Therefore, patients arrive at health facilities but cannot receive treatment or obtain services and are referred back to the NHIF offices.The affordability of the new rates for the urban and rural poor is a significant challenge. Some key patient populations have suffered harm as a result of not receiving the information about which facilities they should seek treatment from or the revised rates of premiums.These populations are the elderly, patients with disabilities, the illiterate, the poor in rural and marginalised areas, and the unemployed. They had poor access to media platforms where communication on the essential benefits package and where they can access these services could be relayed.The UHC roll-out in Kenya, noble though it may be, has not seen an increase in resources, infrastructure and equipment, healthcare workers particularly specialists, medicines. and medical supplies.This may further discourage patients from seeking services in health facilities where they will not get the services they need. (iv) There should be information accessibility. As part of patient safety, health information should be readily accessible. It is the right of the patient to seek, receive, and impart information and ideas concerning health issues.55 Accessibility of information is dependent on effective and efficient storage and retrieval methods. The ethical principle of veracity (truthfulness) and confidentiality should be adhered to.The adherence to these principles encourages patients to seek medical services with confidence knowing that their dignity and autonomy will be protected. Access to information also ensures the proper management of patients by the health team. It reduces medication and diagnostic errors, and improves patient monitoring and evaluation as the patient recovers. c. Acceptability entails the respectful use of medical ethics as the use of culturally appropriate methods of attending to patients. Adherence to the principles of medical ethics, i.e. autonomy, confidentiality, justice, beneficence, and non-maleficence, among many other contemporary ones, significantly enhances patient confidence in seeking health services.

53 See WHO, ‘Health Financing’ www.who.int/health_financing/universal_coverage_definition/en/ accessed 14 October 2020. 54 Rahab Mbau, Evelyn Kabia, Ayako Honda, Kara Hanson, and Edwine Barasa, ‘Examining Purchasing Reforms Towards Universal Health Coverage by the National Hospital Insurance Fund in Kenya’ (2020) 19 International Journal for Equity in Health 19. 55 The Constitution of Kenya, 2010, in Article 35(1) provides for the right to access information that is held by another person and required for the exercise of protection of any right or fundamental freedom.

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Culture has been described as ‘personal identification, language, thoughts, communications, actions, customs, beliefs, values and institutions that are often specific to ethnic, racial, religions, geographic or social groups.’56 Culturally appropriate healthcare involves culture competence, which enhances patient engagement and communication. For instance, it may be considered culturally inappropriate in some cultures for a female to be attended to by a male doctor. It would also mean taking into account different aspects of social identity such as sexual orientation, disability, and socio-economic status.Therefore, acceptability and patient safety means that healthcare workers need to be culturally sensitive to their patients. d. Quality means that health practitioners are using scientifically and medically appropriate methods to treat patients. Patient safety is enhanced when there is no malpractice or negligence involved. Quality also means that other determinants of health need to be considered and made accessible in the provision of health services. For instance, hygiene and good sanitation, potable water, food, and nutrition. Health facilities need to be regularly audited and assessed to ensure that they keep within set standards of quality assurance.57

Conclusion It is important that patient safety and quality health services be on the agenda of health policies, programmes, and governance.58 Environments where patients face harm affect the public health burden and also affect the reputational value of the public health sector, with many patients preferring to seek alternative health services, even if they are far from them. Public perception of health facilities is influenced by how ‘safe’ patients feel in those facilities. Patient safety and quality are important in shaping the delivery of health services in low- and middle-income countries. There should be a move from a mindset of mere access to health services to a mindset of quality and safety using a multi-sectoral approach to examine the ‘underlying systemic issues affecting patient safety, to share experiences in addressing barriers and creating solutions to strengthen systems and improve practices.’59 Situating patient safety within a right to health framework entails holding the state responsible for governance outcomes that influence patient safety.The Constitution of Kenya provides that ‘The State shall take legislative, policy and other measures, including the setting of standards to achieve the progressive realisation of the rights guaranteed under Article 43.’60

56 Patient Safety Network, Cultural Competence and Patient Safety (Patient Safety Network, 27 December 2019) https ://psnet.ahrq.gov/perspective/cultural-competence-and-patient-safety accessed 24 June 2020. 57 Kenya has developed a Joint Health Inspections Checklist (2014) as part of checking quality of health facilities in order to enhance patient safety. 58 WHO ‘Universal Health Coverage and Patient Safety and Quality: Understanding the Central Role of PSQ in UHC through Practical Experience in Low and Middle Income Countries’ (WHO 2014) www.wonca.net/s ite/DefaultSite/filesystem/documents/resources/UHC-PSQ%20Learning%20Lab%20Doc_Final%20Issued.pdf accessed 14 October 2020. 59 WHO ‘Global action on patient safety for achieving effecting universal health coverage’ (Seventy-first World Health Assembly side event) available at https://www.who.int/patientsafety/SummaryReport_WHA71_PSU-si de-event.pdf accessed 14th October 2020. It should also be noted that when the social and underlying determinants of health are taken into account in ensuring patient safety, a multi-sectoral approach to regulation, policy, practices, and programmes, is inevitable.The stakeholders concerned are country leaders, policy makers, experts, civil society, and NGOs as well as patient advocacy bodies. 60 Constitution of Kenya 2010,Article 21(2).

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The state, in respecting, protecting, promoting and fulfilling the right to health61 should be held accountable for the following: (i) Effective planning, budgeting and distribution of resources that affect the operational culture of health facilities which influence patient safety. (ii) The hiring of more health personnel, particularly specialists, and training them on how to effectively manage all facets of patient safety. (iii) Putting into place policy frameworks and laws that will enhance patient safety. (iv) Ensuring transparency, accountability and public participation in the management of health facilities and management processes. (v) Ensuring access to judicial remedies beyond damages for medical malpractice and negligence.The remedies should seek to address the underlying causes of the errors and adverse events in health facilities. By using a human rights–based approach, the view of patient harm is seen beyond the making of clinical errors and seen from the lens of violations of patient rights in hospital settings.These violations are as a result of various macro aspects of governance which are not managed properly. By dealing with these macro issues, the positive outcomes can influence patient safety perspectives and outcomes at the clinical level.

References Abuya, Timothy, Ndwiga, Charity, Ritter, Julie, Kanya, Lucy et al., ‘The Effect of a Multi-Component Intervention on Disrespect and Abuse During Childbirth in Kenya’ (2015) 15 BMC Pregnancy and Childbirth 224. Adugna, Molalign B, Nabbouh, Fatima, Shehata, Selvia, and Ghahari, Setareh ‘Barriers and Facilitators to Healthcare Access for Children with Disabilities in Low and Middle Income Sub-Saharan African Countries:A Scoping Review’ (2020) 20 BMC Health Services Research 15. An Assessment of Patient Safety Standards in Kenya: Summary Report of Patient Safety Survey (2013) https:// uasingishureproductivehealth.files.wordpress.com/2015/08/kenya-patient-safety-survey-report-2014. pdf accessed 14 October 2020. Atellah, Juliet, Where Do Kenyans Seek Medical Treatment? (Elephant) www.theelephant.info/data-stories/2 019/02/08/where-do-kenyans-seek-medical-treatment/?print=pdf accessed 14 October 2020. Barasa, Edwine W, Ouma, Paul O, and Okiro, Emelda A, ‘Assessing the Hospital Surge Capacity of the Kenyan Health System in the Face of the COVID-19 Pandemic’ (2020) 15(7) PloS ONE 1. Bodolica, Virginia, Spraggon, Martin, and Tofan, Gabriela, ‘A Structural Framework for Bridging the Macro-Micro Divide in Health-Care Governance’ (2016) 19(4) Health Expert 790–804, 791. Brennan,Toyen A, and Mello, Michelle M, ‘Patient Safety and Medical Malpractice: A Case Study’ (2003) 139(4) Annals of Internal Medicine 267–73. Broccoli, Morgan C, Calvello, Emilie JB, Skog, Alexander P, Wachira, Benjamin, and Wallis, Lee A, ‘Perceptions of Emergency Care in Kenyan Communities Lacking Access to Formalised Emergency Medical Systems:A Qualitative Study’ [2015] BMJ Open 1. Daniel, Hilary, Bernstein, S, and Kane, Gregory C, ‘Addressing Social Determinants to Improve Patient Care and Promote Health Equity:An American College of Physicians Perspective’ (2018) 168(8) Annals of Internal Medicine 577–78. Dubale, Benyam W, Chemali, Zeina, Denninger, John et al.,‘Systematic Review of Burnout Among Health Providers in Sub-Saharan Africa’ (2019) 19 BMC Public Health 1247.

61 Constitution of Kenya 2010,Article 21(1).

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Realising the right to health in Kenya Escamilla,Veronica, Calhoun, Lisa, Odero, Nobert, and Speizer, Ilene S, ‘Access to Public Transportation and Health Facilities Offering Long-Acting Reversible Contraceptives among Residents of Formal and Informal Settlements in Two Cities in Kenya’ (2019) 16 Reproductive Health 161. FIDA Kenya and Centre for Reproductive Rights, Failure to Deliver:Violation of Women’s Human Rights in Kenyan Health Facilities (2007) www.reproductiverights.org/sites/default/files/documents/pub_bo_f ailuretodeliver.pdf accessed 11 November 2020. Gichara, Rael Wahu,‘Burnout in Nurses at a Referral Hospital in Western Kenya’ (2017) 7(11) International Journal of Academic Research in Business and Social Sciences 1. Hickam, DH et al., ‘The Effect of Health Care Working Conditions on Patient Safety: Summary’ (2003) www.ncbi.nlm.nih.gov/books/NBK11929/ accessed 2 June 2020. Kamau, Kariri James, Onyango-Osuga, Ben, and Njuguna, Susan, ‘Challenges Facing Implementation of Referral System for Quality Health Care Services in Kiambu County, Kenya’ (2017) 4(1) Health Systems and Policy Research 48. Kangqi, Ng et al.,‘COVID-19 and the Risk to Health Care Workers:A Case Study’ (2020) Annals of Internal Medicine L20–1075 www.ncbi.nlm.nih.gov/pmc/articles/PMC7081171/ accessed 15 October 2020. Kariuki, Joan, Njeru, Mercy Karimi, Wamae, Watu, and Mackintosh, Maureen, ‘Local Supply Chains for Medicines and Medical Supplies in Kenya: Understanding the Challenges’ (2015) African Centre for Technology Studies Inclusive Bioeconomy Programme Working Paper No. 001/2015. KEMRI Policy Brief, ‘Early Experiences and Effects of Health Sector Devolution in Kenya’ (February 2018) https://resyst.lshtm.ac.uk/resources/early-experiences-and-effects-of-health-sector-devolutionin-kenya accessed 14 October 2020. Kihiu, Kjoki, ‘186 Health Care Workers Positive for COVID-19 in Kenya’ www.capitalfm.co.ke/news/ 2020/07/186-health-care-workers-positive-for-covid-19-in-kenya/ (Capital FM, 1 July 2020) accessed 14 October 2020. Kokonya, Donald A, Mburu, John M, Kathuku, Dammas M, Ndetei, DM et al.,‘Burnout Syndrome Among Medical Workers at Kenyatta National Hospital’ (2014) 17 Journal of Psychiatry 6. Mbau, Rahab, Kabia, Evelyn, Honda, Ayako, Hanson, Kara, and Barasa, Edwine, ‘Examining Purchasing Reforms Towards Universal Health Coverage by the National Hospital Insurance Fund in Kenya’ (2020) 19 International Journal for Equity in Health 19. McCoy, David et al., ‘Salaries and Incomes of Health Workers in Sub-Saharan Africa’ (2008) 371(9613) The Lancet 675–81. Mello, Michelle M, Frakes, Michael D, Blumenkranz, Erik, and Studdert, David M, ‘Malpractice Liability and Health Care Quality:A Review’ [2020] Clinical Review and Education 352. Ndetei, DM, Pizzo, M, Maru, H, Ongecha, FA, Khasakhala, LI, Mutiso,V, and Kokonya, DA, ‘Burnout in Staff Working at the Mathari Psychiatric Hospital’ [2008] African Journal of Psychiatry 199. Njeru, Betty, ‘KNH on the Spot after Brain Surgery Is Performed on Wrong Patient’ (Standard Media (2 March 2018) www.standardmedia.co.ke/nairobi/article/2001271660/knh-on-the-spot-after-brain-s urgery-is-performed-on-wrong-patient accessed 14 October 2020. Omulo, Collins, ‘Nairobi Faces Crisis over Shortage of Medicines’ Business Daily (27 March 2019) www .businessdailyafrica.com/news/counties/Nairobi-faces-crisis-over-shortage-of-medicines/4003142-50 45100-vqfe1p/index.html accessed 14 October 2020. Patient Safety Network, ‘Cultural Competence and Patient Safety’ Patient Safety Network (27 December 2019) https://psnet.ahrq.gov/perspective/cultural-competence-and-patient-safety accessed 24 June 2020. Peled-Raz, Maya, ‘Human Rights in Patient Care and Public Health – A Common Ground’ (2017) 38 Public Health Reviews 29. Sekhar, M Sonal, and Vyas, N, ‘Defensive Medicine: A Bane to Healthcare’ (2013) 3(2) Annals of Medical & Health Sciences Research 295. Sikorski, Joseline,‘Connecting Worker Safety to Patient Safety: A New Imperative for Healthcare Leaders’ (2009) Ivey Business Journal https://iveybusinessjournal.com/publication/connecting-worker-safety-to -patient-safety-a-new-imperative-for-health-care-leaders/ accessed 14 October 2020. Sokas, Rosemary et al., ‘Frontline Hospital Workers and the Worker Safety/Patient Safety Nexus’ (2013) 39(4) The Joint Commission Journal on Quality and Patient Safety 185, 186. Tih, Felix,‘Kenya: 250 Health Works Infected with COVID-19’ AA (8 July 2020) www.aa.com.tr/en/afr ica/kenya-257-health-workers-infected-with-covid-19/1903926 accessed 14 October 2020. Vincent, Charles, ‘The Essentials of Patient Safety’ (2011) adapted from his book Patient Safety (2nd edn, Wiley-Blackwell 2010).

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Naomi N Njuguna Wachira, B, and Martin, IBK, ‘The State of Emergency Care in the Republic of Kenya’ (2011) 1 African Journal of Emergency Medicine 160. Wagner, Anke et al.,‘Healthcare Professionals’ Perspectives on Working Conditions, Leadership and Safety Climate:A Cross-Sectional Study’ (2019) 19 BMC Health Services Research 53. WHO, Universal Health Coverage and Patient Safety and Quality: Understanding the Central Role of PSQ in UHC through Practical Experience in Low and Middle Income Countries (WHO 2014) www.wonca.net/ site/DefaultSite/filesystem/documents/resources/UHC-PSQ%20Learning%20Lab%20Doc_Final%2 0Issued.pdf accessed 14 October 2020. WHO, Patient Safety (WHO 13 September 2019) www.who.int/news-room/fact-sheets/detail/patient-s afety accessed 14 October 2020. WHO,‘Health Financing’ www.who.int/health_financing/universal_coverage_definition/en/ accessed 14 October 2020.

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13 DEVELOPING AN INTRINSIC PATIENT SAFETY CULTURE IN HEALTH SYSTEMS The NHS experience John Tingle

It is disingenuous for any country to say that its citizens have a human right to health and then to provide poor quality and unsafe care. A key component of the right to health is that it must be safe and effective and does no harm, otherwise the right can be seen to be negative and hollow. An important measure of a country’s commitment to health rights is the safety and quality of the healthcare services delivered. A right to health cannot exist in the abstract: viewing the country’s environment and context of healthcare delivery is fundamental to ascertaining whether there is an effective right to health. It is easy for a country to say ‘we recognise a right to health,’ but when it comes down to actual delivery of services, and patients cannot access them or they are delivered unsafely, then the right is called into question. The World Health Organization (WHO) states that ‘quality is a key component of Universal Health Coverage and includes the experience as well as the perception of health care.’This focus on quality includes ensuring that health services are both safe (‘avoiding injuries to people for whom the care is intended’) and effective (‘providing evidence-based healthcare services to those who need them’).1 A human right to health is meaningless if safe and quality healthcare is not viewed as a core component of it.

Global patient safety Today, the importance of countries incorporating effective patient safety policies and practices into health systems has become a fundamentally important global issue and goal. The WHO has helped drive a global patient safety policy agenda and provided leadership and tools to this effect.2 The WHO patient safety mission is described as follows:

1 WHO, ‘Human Rights and Health’ (WHO, 29 December 2017) www.who.int/news-room/fact-sheets/detail/ human-rights-and-health accessed 14 October 2020. 2 WHO,‘Patient Safety:About Us’ www.who.int/patientsafety/about/en/ accessed 14 October 2020.

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to coordinate, facilitate and accelerate patient safety improvements around the world by being a leader and advocating for change; generating and sharing knowledge and expertise; supporting Member States in their implementation of patient safety actions.3 WHO patient safety has embarked upon and delivered several important initiatives, which include several publications, training, education, campaigns, tools, and conferences. Global activity on patient safety has included the Multi-Professional Patient Safety Curriculum Guide,4 the Safe Childbirth Checklist5 and the Surgical Safety Checklist.6 The WHO has also created ‘world patient safety day’ as an annual event celebrated every 17 September to create a global awareness of patient safety and to encourage commitment to it.7 Global patient safety activity sits alongside the established and developing practices and policies of individual countries. Clearly, not all countries are the same in terms of health capacity and resources. There are going to be obvious differences in a country’s ability to incorporate and develop WHO guidance and universal health coverage (UHC) effectively and sustainably. The patient safety work of WHO has propelled the issue onto many countries’ health systems’ agendas and it is now a hard topic to ignore. Awareness of the patient safety issue is only the first stage in developing an ingrained systemic patient safety culture. The implementation and outcome of this culture are the next fundamental stages.This chapter will look further at WHO global patient safety policies and practices and the link to UHC. The United Nations (UN) strategic development goal (SDG) number three on health (‘[e]nsure healthy lives and promote well-being for all at all ages’) has also given a boost to the patient safety agenda which will be explored further in this chapter. How does the SDG impetus sit with patient safety initiatives and the drive for health quality?8 Additionally, the patient safety experiences of the National Health Service (NHS) England will be discussed.The NHS has been working on developing a patient safety culture for at least 20 years, since from the publication of the seminal NHS patient safety report An Organisation with a Memory.9 With this wealth of experience and activity, the NHS is a useful prism from which to view patient safety developments, policies, and practices. The fundamental question

3 ibid. 4 WHO, ‘Patient Safety Curriculum Guide Multi-Professional Edition’ (WHO 2011) www.who.int/patientsafety/ education/mp_curriculum_guide/en/ accessed 20 October 2020. 5 WHO,‘Before Birth:WHO Safe Childbirth Checklist’ https://apps.who.int/iris/bitstream/handle/10665/199179 /WHO_HIS_SDS_2015.26_eng.pdf;jsessionid=9BE29599068A424F744EFCBC643DFFA8?sequence=1(WHO 2015) accessed 20 October 2020. 6 WHO, Surgical Safety Checklist (WHO 2009) https://apps.who.int/iris/bitstream/handle/10665/44186/97892 41598590_eng_Checklist.pdf?sequence=2 accessed 20 October 2020. 7 World Patient Safety Day (WHO 2020) https://www.who.int/patientsafety/world-patient-safety-day/en/ accessed 11 February 2021. Also see WHO and Patient Safety, Global Patient Safety Action Plan:Towards Eliminating Avoidable Harm in Health Care (Third Draft, 2021) https://cdn.who.int/media/docs/default-source/integrated-hea lth-services-(ihs)/psf/gpsap/global-patient-safety-action-plan-2021-2030_third-draft_january-2021_web.pdf?sfvr sn=6767dc05_13 accessed 11 February 2021. 8 WHO,‘Patient Safety Curriculum Guide: Multi-Professional Edition’ (WHO 2011) www.who.int/patientsafety/ education/mp_curriculum_guide/en/ accessed 20 October 2020. 9 Department of Health, An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer (TSO 2000) https://webarchive.nationalarchives.gov.uk/2013010 5105027/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/ DH_4065083 accessed 20 October 2020.

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that can be asked is whether a sophisticated health delivery system, such as the NHS in England, can be said to have successfully developed an ingrained patient safety system? It is important to discuss the magnitude of the challenges all countries face when trying to develop an ingrained patient safety culture.The experiences of the NHS in England can help identify these challenges and the opportunities that lie ahead for developing, transitioning countries as well as developed countries.

The global patient safety agenda The case for global patient safety is made by the WHO and the arguments made are compelling.10 Commendable goals are set by this organisation, but their realism can be challenged when applied to developing and transitioning countries who are doing their best in the most challenging of circumstances.The goals create commendable pressures to do the right thing, but without technical help and funding, these goals may remain merely ambitions and aspirations for some countries. The WHO contends that approximately two-thirds of global adverse events happen in lowand middle-income countries.11 The WHO states that there have been limited systemic improvements in the safety of health care globally, and in some situations, efforts made have been unsustained and uncoordinated. In many countries, health services, where they are available, are of poor quality, thus endangering the safety of patients, compromising health outcomes, and this leads to lack of trust of the population in health services.12 The WHO argues that, in order to deal with this issue, there is a need to maintain clear policies, organizational leadership capacity, and data to drive safety improvements.The WHO also declares that skilled healthcare professionals are needed.There is also a need for effective involvement of patients in their care. This, the WHO contends, would go some way to producing sustainable and significant improvements in the safety of healthcare. The WHO and the Organization for Economic Cooperation and Development (OECD) have jointly argued that poor quality health services are holding back progress on improving health in countries at all income levels.13 They argue that quality of care is fundamental to the implementation of UHC: But universal health coverage should not be discussed and planned, let alone implemented, without a focus on quality. It is essential to ensure that care is effective, safe, and in keeping with the preference and needs of the people and communities being served.14

10 WHO, ‘Patient Safety Fact File, Patient Safety and Risk Management Service Delivery and Safety September’ (WHO 2019) www.who.int/features/factfiles/patient_safety/patient-safety-fact-file.pdf?ua=1 accessed 20 October 2020. 11 ibid. 12 ibid 2. 13 WHO, OECD, and International Bank for Reconstruction and Development/The World Bank, Delivering Quality Health Services:A Global Imperative for Universal Health Coverage’ (2018) https://apps.who.int/iris/bitstream/handle /10665/272465/9789241513906-eng.pdf?ua=1 accessed 20 October 2020. 14 ibid 18.

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UHC and health quality There are difficulties here with the concept of UHC and health quality in developing countries. Care quality may be poor, but it might be the only care available in remote regions where travel is difficult. Clearly, if health facilities are causing more harm than good, they must be closed. If they are, however, providing safe and effective care, but not of the best quality, and they are the only caregiver in an area, then adjustments to what is meant by ‘quality’ should be made.The benchmark is safe and effective healthcare that does not cause harm.To deprive a remote village or area from essential healthcare facilities is a step that should not be taken lightly.There should be a global focus on health quality, but what we mean by ‘quality’ needs to be tempered to suit the context of different countries and their stages of development.The WHO and OECD deliver, arguably, a hard-line message that developing countries may find particularly challenging: Quality is not a prerogative of high-income countries. If countries can afford to provide any health care – and even the poorest can and should do so – they must provide care of good quality.The alternative – poor-quality care – is not only harmful but also wastes precious resources that can be invested in other important drivers of social and economic development to improve the lives of citizens. Billions of dollars are spent on the consequences of poor-quality care – money that can fund schools, social services and infrastructure. And poor quality can also undermine the trust of the population in the benefits of modern medicine. Seen this way, universal health coverage without quality of care is a job half done.15

Handling the information and research There is an impressive array of WHO global patient safety policy guidance for countries to consider, as well as other international research.We have the information on the need for quality and, in turn, patient safety, but this information seems, in the case of some countries, to sit mainly in the top echelons of the health system, at the central management level, and has not permeated properly down to the workplace. My experiences of healthcare in remote clinics in East Africa is that clinical staff are willing to consider changes in structure to facilitate greater quality of care and patient rights, but their efforts are often compromised and frustrated by not having enough physical resources such as disposable gloves, proper building infrastructure, and adequate water supply. At a government level, there is, often, in my experience, knowledge, acceptance, and understanding of the WHO patient safety policy agenda and the need for good quality care. A difficulty that I have witnessed is that governments in some health ministries in developing countries need assigned staff to unpick the data and cascade the policy down into local health systems. It is, primarily, a staff resource issue. A factor also to consider is that in terms of global patient safety and health quality, even in developed countries such as England, the quantity of research is unmanageable, and so an even greater challenge exists in this regard in developing countries.16

15 ibid. 16 CQC, Opening the Door to Change: NHS Safety Culture and the Need for Transformation (CQC 2018) www.cqc.org .uk/sites/default/files/20181224_openingthedoor_report.pdf accessed 20 October 2020.

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The experience of England: a food of patient safety policy and implementation papers? According to the Care Quality Commission (CQC): Trusts receive too many safety-related messages from too many different sources.The trusts we spoke to said there needed to be better communication and coordination between national bodies, and greater clarity around the roles of the various organisations that send these messages.17 How key patient safety and health quality information is distilled across health systems is clearly an important global issue. Patient safety and health quality is now an important and large global service industry with many non-governmental organisations (NGOs) and international organisations maintaining agendas and offering services/advice. Suggested solutions to this problem and others may be found in the NHS Patient Safety Strategy18 with advances such as The NHS National Patient Safety Syllabus and patient safety specialists in hospitals and elsewhere.The clarification of a specific patient safety remit by such specialists and as described within this syllabus will provide practical tools to support a safer environment. Equally, there is much that the NHS can learn from practices in developed and developing countries in terms of innovation and use of resources.19 Education and training are fundamental prerequisites to developing an ingrained patient safety culture in a health system which also puts the patient first. Culture change cannot, however, be mandated. Sustainable changes in a health system’s culture take time to evolve and it is an incremental process. NHS England and NHS Improvement state: Culture change cannot be mandated by strategy, but its role in determining safety cannot be ignored.‘Just cultures’ in the NHS are too often thwarted by fear and blame.A consistent message in the consultation responses was that fear is too prevalent across NHS staff, particularly in relation to involvement in patient safety incidents.20 In discussing global patient safety, health quality, patient rights, and global health systems, it is important to look for commonalties. It is to be accepted that different countries will have different approaches to issues, practices, and policies.There are systemic differences in the delivery of healthcare services, for example, in the United States (US) and the NHS in England.This book explores several countries’ approaches to important health care issues and looks for commonalties. A practical benefit of a comparative approach to patient safety, health quality, and human rights is that what works well in one country could well be viewed as a prospective policy for another country.

17 ibid 6. 18 NHS England, NHS Improvement, The NHS Patient Safety Strategy: Safer Culture, Safer Systems, Safer Patients (July 2019) https://improvement.nhs.uk/documents/5472/190708_Patient_Safety_Strategy_for_website_v4.pd f accessed 11 November 2020. 19 See John Tingle, Clayton Ó Néill, and Morgan Shimwell, Global Patient Safety: Law, Policy and Practice (Routledge 2018). 20 ibid 7.

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The concept of ‘Never Events’ A good illustration of this patient safety–health quality country alignment can be seen in the context of ‘Never Events’: The term ‘Never Event; was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors – such as wrong-site surgery – that should never occur. Over time, the term’s use has expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable.21 Never Events in patient safety and healthcare are events in healthcare treatment and care that should never occur. In the NHS, Never Events are defined as ‘serious, largely preventable patient safety incidents that should not occur if healthcare providers have implemented existing national guidance or safety recommendations.’22 The concept originated in the US and was imported into the NHS.The Never Events concept was introduced in High Quality Care For All in 2008.23 According to this report: In some parts of the United States, events that are serious and largely preventable such as ‘wrong-site’ surgery have been designated ‘Never Events’, and payment withheld when they occur. The NPSA [National Patient Safety Agency] will work with stakeholders in this country to draw up its own list of ‘Never Events’. From next year, PCTs [primary care trusts] will choose priorities from this list in their annual operating plan.24 There is an NHS list of Never Events and a policy framework,25 which is regularly updated. Never Events are reported by NHS England and NHS Improvement monthly, and there are yearly overviews of trends.26 In considering the differences between Never Events in the US and in the NHS, there is a punitive context to Never Events in the US in that, if one occurs, there can be no payment made to the provider of the service.27 This type of payment restriction was also imported into

21 Agency for Healthcare Research and Quality (AHRQ), PS Net (Patient Safety Network, Patient Safety Primer, ‘Never Events’ (September 2019) https://psnet.ahrq.gov/primer/never-events accessed 14 October 2020. 22 NHS England, NHS Improvement, Provisional Publication of Never Events Reported as occurring between 1 April and 30 April 2020, (NHS England, NHS Improvement 2020), https://improvement.nhs.uk/documents/6639/Pro visional_publication_-_NE_1_April_2020_-_30_April_2020_FINAL.pdf accessed 20 October 2020. 23 Department of Health, High Quality Care For All, NHS Next Stage Review Final Report (TSO 2008) https:// assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/228836/7432.pdf accessed 20 October 2020. 24 ibid 45. 25 NHS Improvement, Never Events Policy and Framework (NHS Improvement, 2018) https://improvement.nhs .uk/documents/2265/Revised_Never_Events_policy_and_framework_FINAL.pdf accessed 20 October 2020. 26 The current Never Events list 2018 includes wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route, overdose of insulin due to abbreviations or incorrect device, overdose of methotrexate for non-cancer treatment, mis-selection of high strength midazolam during conscious sedation. 27 Agency for Healthcare Research and Quality (AHRQ), PS Net (Patient Safety Network),‘Patient Safety Primer: Never Events’ (September 2019). https://psnet.ahrq.gov/primer/never-events accessed 14 October 2020.

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the NHS, but was subsequently removed, as the view was taken that it reinforced the concept of a blame culture: One of the key changes we have made in response to what you told us is to remove the option to impose financial sanctions associated with Never Events.We heard that allowing commissioners to impose financial sanctions following Never Events reinforced the perception of a ‘blame culture’. Our removal of financial sanctions should not be interpreted as a weakening of effort to prevent Never Events. It is about emphasising the importance of learning from their occurrence, not blaming.28 The NHS has had a Never Events policy since 2008, and there has been a creditable transparency by the NHS in relation to when these happen and what is being done to reduce their incidence. It is doubtful, however, whether it is a realistic proposition to say that, in the future, health systems can totally avoid Never Events occurring.Work can be done to minimise their occurrence, but given that medical and nursing care is delivered by humans for humans, error will always be possible; nobody is infallible.The best we can do is to try to minimise the occurrence of Never Events by effective risk management strategies. Given that we have had well over a decade trying to deal with Never Events, it is worrying to hear from the CQC that they are continuing to occur at a worryingly high level: Despite this preventability, the number of Never Events has not fallen.About 500 times each year we are not preventing the preventable.That means that around 500 patients are suffering unnecessary harm.This failure to reduce the number of Never Events is sending us an important message.29 Never Events are a rough barometer of the safety culture in an organisation as they can point to serious defects in an organisation’s safety culture.These events should not be happening on the scale that they are, particularly after over a decade of the NHS formulating policy and actions over the Never Events problems.The fact that they are continuing to occur in a repeated fashion, with the level not falling, is an acute problem for patients and NHS staff.The nature of the Never Events works to sadly compound the nature of the patient safety cultural problem in the NHS.

The NHS journey to develop an intrinsic patient safety culture The experiences of the NHS with respect to Never Events constitutes an instructive global lesson in the challenges and opportunities involved in developing an ingrained patient safety

28 NHS Improvement, Never Events Policy and Framework (n 25). 29 CQC, Opening the Door to Change (n 16). www.england.nhs.uk/wp-content/uploads/2021/01/Provisional-pu blication-NE-1-April-30-November-2020.pdf Note that 226 Serious Incidents appeared to meet the definition of a Never Event in the Never Events list 2018 (published 31 January 2018) (see NHS Involvement, Never Events List 2018 (NHS Involvement 2018) https://improvement.nhs.uk/documents/2266/Never_Events_ list_2018_FINAL_v5.pdf accessed 11 February 2021 and had an incident date between 1 April 2020 and 30 November 2020; this number is subject to change as local investigations are completed. See NHS England, NHS Improvement, Provisional Publication of Never Events Reported as Occurring between 1 April and 30 November 2020 (14 January 2021) www.england.nhs.uk/wp-content/uploads/2021/01/Provisional-publication-NE-1-April-30-N ovember-2020.pdf accessed 11 February 2021.

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culture in a health system. There have been successes in the NHS patient safety journey and there is an effective regulator of health and social care in the CQC.30 NHS Resolution can be viewed as a success story in professionalising the NHS litigation environment.31 The National Reporting and Learning System (NRLS), which is the central database of patient safety incident reports, can also be viewed as a success story in enabling the NHS to track and learn from adverse health events.32 There are many other NHS patient safety successes but, sadly, there is also a litany of tragic failures.The NHS has developed well-crafted patient safety policies and strategies since at least the year 2000 with the publication of the seminal report An Organisation with a Memory.33 The reports, policies, and initiatives are all too often eclipsed by crises, such as the Bristol Heart Surgery crisis,34 the Mid Staffordshire crisis,35 the Morecambe Bay crisis,36 the Shrewsbury, the Telford crisis,37 and the harrowing events chronicled in the very recent Cumberlege review.38 These events show that, regardless of well-crafted NHS patient safety policies and reports, there remain endemic and seemingly insoluble safe care culture development problems in the NHS which have survived years of attempts at resolution. To begin the historical path analysis, it is worth reflecting on the words and sentiments expressed in An Organisation with a Memory in 2000,39 and whether the same can be said today over two decades later about NHS patient safety problems.This was a report of an expert group on learning from adverse events in the NHS, chaired by the chief medical officer of the time, Sir Liam Donaldson.The report set the scene for the development of patient safety policies and procedures in the NHS and laid the foundation stones. It also identified chronic patient safety issues and conceptualised them: The time is right for a fundamental re-thinking of the way that the NHS approaches the challenge of learning from adverse health care events.The NHS often fails to learn the lessons when things go wrong and has an old fashioned approach in this area compared to some other sectors.40

30 CQC, About Us:What We Do and How We Do It www.cqc.org.uk/sites/default/files/20170504_CQC_About-us.pdf accessed 20 October 2020. 31 NHS Resolution,‘About NHS Resolution’ https://resolution.nhs.uk/about/ accessed 20 October 2020. 32 See NRLS, ‘Welcome to NRLS Reporting’ https://report.nrls.nhs.uk/nrlsreporting/ accessed 11 November 2020. 33 Department of Health, An Organisation with a Memory (n 9). 34 Ian Kennedy, The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995: Learning from Bristol https://webarchive.nationalarchives.gov.uk/20090811143822/http:/www.bristol-inquiry. org.uk/final_report/the_report.pdf accessed 20 October 2020. 35 Robert Francis QC, The Mid Staffordshire NHS Foundation Trust Public Inquiry (TSO 2013) https://assets.publi shing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947.pdf accessed 20 October 2020. 36 Bill Kirkup, The Report of the Morecambe Bay Investigation (TSO 2015) https://assets.publishing.service.gov.uk/ government/uploads/system/uploads/attachment_data/file/408480/47487_MBI_Accessible_v0.1.pdf accessed 20 October 2020. 37 Jane Dalton,‘Shrewsbury Maternity Scandal: More than 900 Cases of Potential Poor Care Identified at Hospital’ The Independent (15 January 2020) www.independent.co.uk/news/health/shrewsbury-maternity-scandal/sh rewbusy-maternity-scandal-nhs-hospital-babies-mother-a9285571.html accessed 20 October 2020. 38 Baroness Cumberlege, First Do No Harm:The Report of the Independent Medicines and Medical Devices Safety Review (2020) www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf accessed 20 October 2020. 39 Department of Health, An Organisation with a Memory (n 9). 40 ibid xi.

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The report made ten recommendations, which included introducing a mandatory reporting scheme for adverse health care events and specified near misses, encourage a reporting and questioning culture in the NHS, introduce a single overall system for analysing and disseminating lessons from adverse health care events and near misses, and act to ensure that important lessons are implemented quickly and consistently.41 An Organisation with a Memory42 was also published around the same time as the seminal US patient safety publication To Err is Human, which set the patient safety agenda in the US.43 Both publications were influential change agents, creating an impetus and trajectory for reform in the area of patient safety policy development in both countries.The publications can be viewed as representing foundation stones of contemporary patient safety policy development. Early NHS NRLS policy thinking can be seen in this report, but, unfortunately, lessons remain to be learnt in relation to adverse patient safety incidents and implementing change. Even though An Organisation with a Memory was published over two decades ago, it is as relevant today as it was then in capturing current NHS patient safety problems that still require urgent resolution. Numerous well-reasoned and researched NHS patient safety reports have been regularly published by the NHS organisations and other health quality and patient safety stakeholders. Reports often contain the same themes, including trends of improving learning from adverse events, developing a perspective that does not focus on individual fault, encouragement of reporting, and advancing systems theory to the management of error. Systems theory, which is described in An Organisation with a Memory , is, today, the most favoured directing patient safety policy development and practice approach.According to the Department of Health: Whilst those committed to the person approach tend to allocate the bulk of their resources to trying to make individuals less fallible, the system approach aims for a comprehensive programme directed simultaneously at people, teams, tasks, workplaces and institutions. There is no single solution which can be applied in every circumstance. Since serious adverse events rarely have a single, isolated cause, attempts to prevent or mitigate adverse events need to address not just single event chains, but systems.44

NHS patient safety timeline An Organisation with a Memory was followed by the report Building a Safer NHS for Patients, Implementing an Organisation with a Memory in 2001.45 This report set out the government’s plans for promoting patient safety. The report heralded the creation of the National Patient Safety Agency (NPSA) which was, subsequently, abolished in 2012, with its functions transferring to the now defunct NHS Commissioning Board.The NRLS was set up in 2003 and it still exists

41 ibid. 42 ibid. 43 Institute of Medicine, To Err Is Human: Building a Safer Health System (The National Academies Press 2000) https://doi.org/10.17226/9728 accessed 14 October 2020. 44 Department of Health, An Organisation with a Memory (n 9). 45 Department of Health, Building a Safer NHS for Patients: Implementing an Organisation with a Memory, (Department of Health 2002) https://webarchive.nationalarchives.gov.uk/20070403120932/http://www.dh.gov.uk/en/ Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/Browsable/DH_4097460 accessed 20 October 2020.

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today in a more developed form. It was developed by the NPSA, along with several other patient safety tools and publications. In 2006, the Department of Health published Safety First,46 which found that progress was slow in implementing patient safety change. Managers, leaders, and others were too focused on other matters. In 2006, systemic failings were found in the NHS attitude to developing an ingrained patient safety culture. A seminal focus of key leaders and managers was financial. Staff were making insufficient use of patient safety data and effecting change. There was no cultural change. The criticisms made in 2006 can be said largely still to apply today. Some progress has been made, but it cannot be regarded as seismic progress by any account. Incremental progress has been made and many of the problems identified in 2000 and 2006 persist today. In terms of the NHS patient safety environment, over time, this became over-engineered and too complex. Today, patient safety falls within, arguably, a confusing array of different NHS organisations, which include NHS England, NHS Improvement NHS Resolution, the CQC, and the Healthcare Safety Investigation Branch (HSIB). The fact that so many interconnected organisations exist and function in parallel can create the risk of contradictory messages being given or gaps beginning to emerge.

A confusing NHS patient safety landscape Since the publication of An Organisation with a Memory,47 NHS health quality, patient safety, and regulatory organisations have changed regularly. The landscape has been in a constant state of flux with many organisations having competitions? Competing is a better word and changing remits and agendas.This has led to healthcare staff confusion over patient safety organisational remits, a point forcibly made by the CQC: Arm’s-length bodies, including CQC, royal colleges and professional regulators, have a substantial role to play within patient safety, but the current system is confused and complex, with no clear understanding of how it is organised and who is responsible for what.This makes it difficult for trusts to prioritise what needs to be done and when.48 Today, patient safety is a big global service industry, with lots of competing stakeholders and organisations, nationally and globally.This has led to a current flood of research and publications on patient safety, which has led some NHS staff to complain about managing all this and working out which information is a priority to action.The CQC found: Trusts receive too many safety-related messages from too many different sources.The trusts we spoke to said there needed to be better communication and coordination between national bodies, and greater clarity around the roles of the various organisations that send these messages.49

46 Department of Health, Safety First:A Report for Patients, Clinicians and Healthcare Managers (Department of Health 2006) https://webarchive.nationalarchives.gov.uk/20130105032616/http://www.dh.gov.uk/prod_consum_dh/ groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_064159.pdf accessed 20 October 2020. 47 Department of Health, An Organisation with a Memory (n 9). 48 CQC, Opening the Door to Change (n16) 6. 49 ibid 6.

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The NHS running to stand still on patient safety As indicated, there has been a multitude of papers dealing with NHS patient safety and health quality regulatory reports saying largely the same thing and pointing out largely the same problems. In many ways, the NHS can, over the last decade, be seen to have been running to stand still.The publications that have been discussed so far have all been well written and researched, and the same can be said of more contemporary reports, such as Opening the Door to Change by the CQC.50 The messages in all of them remain constant: change is not happening fast enough, there are still inexcusable errors, and channels of communication need to be improved.There is a need to take patient safety more seriously and to improve lesson-learning skills.We must put the patient at the centre of care and be less defensive when complaints are made. The recent Cumberlege review sends very strong signals here about the need for all this to happen to improve patient safety in the NHS.51 The patient safety reports that have been published regularly and continue to be published must also be seen within the context of major NHS patient safety crises, which have happened all too regularly. The events call into question whether NHS staff have learnt from the sea of reports published over the last 20 years or so, and whether the NHS will ever be able to develop an ingrained patient safety culture.Three patient safety crises will be discussed, and conclusions will be drawn on the most recent government efforts to develop a safe NHS patient safety culture.

The NHS’s darkest hour: The Mid Staffordshire crisis The terrible patient safety and care failings that took place in Mid Staffordshire have left an indelible mark on the NHS and how it cares for patients.A significant number of patient deaths occurred in the words of the inquiry chairman, Sir Robert Francis QC,52 ‘[b]etween 2005 and 2008 conditions of appalling care were able to flourish in the main hospital serving the people of Stafford and its surrounding area.’53 The lapses in care revealed by the report shook the nation and the NHS: The first inquiry heard harrowing personal stories from patients and patients’ families about the appalling care received at the Trust. On many occasions, the accounts received related to basic elements of care and the quality of the patient experience. These included cases where: Patients were left in excrement in soiled bed clothes for lengthy periods; Assistance was not provided with feeding for patients who could not eat without help; Water was left out of reach; In spite of persistent requests for help, patients were not assisted in their toileting; Wards and toilet facilities were left in a filthy condition; Privacy and dignity, even in death, were denied; Triage in A&E was undertaken by untrained staff; Staff treated patients and those close to them with what appeared to be callous indifference.54

50 51 52 53 54

ibid. Cumberlege (n 38). Francis (n 35). ibid 7. ibid 13.

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The Francis Report55 was published in 2013, and several other reports followed it. The Morecambe Bay scandal56 was another terrible and shocking patient safety crisis which again rocked the NHS.This inquiry report57 was published in 2015 with Dr Bill Kirkup as the inquiry chair. Shocking patient safety failings in maternity care were revealed. In the words of Dr Kirkup: This Report details a distressing chain of events that began with serious failures of clinical care in the maternity unit at Furness General Hospital, part of what became the University Hospitals of Morecambe Bay NHS Foundation Trust. The result was avoidable harm to mothers and babies, including tragic and unnecessary deaths.58 The report chronicles the nature and severity of the patient safety and governance failures that occurred.Worrying findings included the poor working relationship that existed between some staff, the dysfunctional nature of the maternity unit, poor adverse incident investigation processes, and poor clinical governance systems. Problems of poor clinical competence, insufficient recognition of risk, inappropriate pursuit of normal childbirth and failures of team-working were also identified: Many of the reactions of maternity unit staff at this stage were shaped by denial that there was a problem, their rejection of criticism of them that they felt was unjustified (and which, on occasion, turned to hostility) and a strong group mentality amongst midwives characterised as ‘the musketeers’. We found clear evidence of distortion of the truth in responses to investigation, including particularly the supposed universal lack of knowledge of the significance of hypothermia in a newborn baby, and in this context events such as the disappearance of records, although capable of innocent explanation, concerned us.59

Patient safety scandals at Shrewsbury and Telford In 2020, the NHS is again facing high-profile maternity care patient safety crises which echo the failings in the Morecambe Bay crisis.This is all post Mid Staffordshire and Morecambe Bay, raising the point that the NHS does have manifest problems in learning the lessons from past NHS patient safety crises.These crises also compound the fact that there are systemic problems in the NHS, which are making it difficult to effect a positive patient safety culture change which puts the patient first. An internal report leaked to The Independent last year shows repeated care failings and clinical malpractice going unchecked since the 1970s.60 The investigation is continuing and at the time of writing, Matthew Weaver of The Guardian reported that the police are now investigating maternity care at the Shrewsbury and Telford NHS Hospital Trust.61

55 56 57 58 59 60

ibid. Kirkup (n 36). ibid. ibid 5. ibid 8. Dalton, (n 37). According to Dalton,‘[d]ozens of babies and three mothers died, and more than 50 children also suffered permanent brain damage after being deprived of oxygen during birth, the investigation discovered.’ 61 Matthew Weaver,‘Police Investigate Maternity Care at Shropshire NHS Trust’ The Guardian (30 June 2020) www .theguardian.com/society/2020/jun/30/police-investigate-maternity-care-at-shrewsbury-and-telford-nhs-trust accessed 20 October 2020. According to Weaver, ‘[a]n initial inquiry into about 250 cases found that at least

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The CQC Opening the Door to Change report The best modern-day statements of where the NHS is currently at with patient safety is the Opening the Door to Change,62 which looked at NHS safety culture, how matters can be improved, and the need for a culture transformation.63 Problems, challenges, and opportunities were explored, and several recommendations were given. The report’s focus was on Never Events, which are stubbornly persistent in the NHS.The report paints a realistic picture of what needs to happen in order to develop a patient safety culture in the NHS and to reduce the incidence of Never Events.64 Issues discussed in the report include the ability of NHS trusts to learn from incidents locally and at a wider level. This is hampered, according to the report, by slow and unresponsive reporting processes that can discourage staff from reporting incidents: Trusts cultures can also create barriers to sharing information. With no national systems in place to support this, trusts are not incentivised to collaborate with each other and act together to learn from incidents that have happened.65 In terms of patient safety, education, and training, this is a confusing and complex area with many different stakeholders and agendas. In the foreword to the Opening the Door to Change report, Professor Ted Baker, Chief Inspector of Hospitals at the CQC, drew attention to what can be regarded as an underlying weakness in the safety culture of the NHS which urgently requires fixing. There is an apparent mismatch between or contradiction between NHS cultural perceptions of patient safety and risk and those of individual staff members: There is a contradiction between how health care culturally thinks about patient safety and the experience of individual members of staff. Staff know that what they do carries risk, but the culture in which they work is one that considers itself as essentially safe. We have repeatedly highlighted in our inspection reports that staff are often unwilling or unable to raise safety concerns. Raising concerns challenges the cultural norms of the workplace and the dichotomy between the safety reality and the safety culture may be the reason why this has proved such an intractable problem.’66

A deep dive into NHS patient safety The recent Cumberlege review, which looked into issues such as informed consent, patient rights, the relationship between health carers and patients, and health carers and system defensiveness along with other matters, is a deep dive into NHS patient safety, the health system, and the context of healthcare delivery. It does not make for easy reading and discusses some sad and harrowing patient stories and does, to some extent, dent the reader’s confidence and trust in the

62 63 64 65 66

42 babies and three mothers may have died unnecessarily and more than 50 newborns suffered avoidable brain damage at the trust. Since then hundreds more cases have emerged.The details of some of these cases, involving deaths of babies and some mothers, will now be passed to the police.’ CQC, Opening the Door to Change (n 16). ibid. CQC, Opening the Door to Change (n 16). ibid 32. ibid 4.

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NHS patient safety system: ‘[w]hat follows will not make comfortable reading for many who have dedicated their lives with the best of intentions to delivering high-quality and compassionate treatment and care.’67 It is a seminal and salutary contemporary report on NHS patient safety and should be read by everyone concerned with the issues. In her review publication introductory letter to the Secretary of State for Health and Social Care, Baroness Cumberlege articulates what has been the central theme of this chapter: We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.68 The review covered and reported on several overarching themes which included informed consent, redress, complaints, and duty of candour.

The new NHS Patient Safety Strategy The new NHS Patient Safety Strategy was published on 2 July 2019, and it maintains an excellent potential to further the development of an ingrained patient safety culture into the NHS.69 The proposals in the report will help address many of the systemic NHS patient safety problems discussed in this chapter. However, it is fair to say that cultures don’t change overnight as the report recognises, and much will depend on how many resources are given to implement the proposals in the NHS strategy and how seriously this strategy is taken by the NHS. As previously stated, history has not served the NHS well when it has come to NHS patient safety policies driving sustainable changes in NHS attitudes and practices.

Conclusion The NHS is on a long journey to developing an ingrained patient safety culture, and it has made excellent efforts in producing policies and reports.There must, in general, be more recognition by NHS staff and those that manage them that the patient is always going to be the weaker party in the care equation. Close application of the relatively new duty of candour is a necessary ingredient in advancing the quality of the dialogue between the patient and the healthcare professional/provider.The NHS has had, since at least the year 2000, a long and bumpy journey on the road to developing an ingrained patient safety culture, and it is still trying hard. There are systemic problems that need to be solved and patient safety crises still seem to regularly rock the NHS. The words of the Cumberlege review sum up well the patient safety situation with

67 Cumberlele (n 38). 68 ibid i–ii. 69 NHS England, NHS Improvement, The NHS Patient Safety Strategy (n 18).

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the NHS and the challenges to be met. It is also worth reflecting whether the patients in the Cumberlege review had effective and recognised rights to health. If they did, their rights were seriously compromised. We heard about a system that does not work in a joined-up fashion, and that lacks the leadership to deliver coherent and fully integrated patient safety policy directives and standards. Mistakes are perpetuated through a culture of denial, a resistance to noblame learning, and an absence of overall effective accountability. This culture has to change, starting at ground level while being encouraged and supported from the top.70 Research is critical in designing sustainable patient safety and health quality systems. More research is needed into issues such as how to respond to patients’ complaints in a way that avoids litigation. The development of effective patient safety tools is also an important research need and there are many others. The NHS patient safety strategy holds out a lot of promise to greatly improve the NHS in England. A failure to keep patient safety at the cornerstone of practice, of innovation, and of review means that the right of the patient to healthcare that meets individual needs is compromised. At a global level, much can be done to ensure that, when patients enter the portals of a hospital, all is done to ensure that, at the very least, their safety is not compromised but is prioritised. If this is done, then one small but important step in the realisation of a right to health is taken. Patient safety is today a global priority for all countries. A right to health brings with it an implied right to safe and secure healthcare treatment.The fact that the NHS and its healthcare systems have, in many instances, failed to deliver on patient safety means that, ultimately, they have failed to ensure that the right to health is applied and protected. Only one context has been outlined here, but the same concern applies globally. If we wish to ensure that a right to health is acted upon and applied in practice, then healthcare providers and the governmental systems that underpin this provision need to ensure that the healthcare that is delivered meets appropriate safety and quality standards.There is evidence that aspects of patient safety are being improved, but, equally, there is also evidence that much more needs to be done. A right to health is one that we cherish and wish to see in operation. But it can only exist when appropriate candour, adverse-incidents reporting, and effective overarching governance are evident alongside.

References Agency for Healthcare Research and Quality (AHRQ), PS Net (Patient Safety Network), ‘Patient Safety Primer: Never Events’ (September 2019). https://psnet.ahrq.gov/primer/never-events accessed 14 October 2020. CQC, Opening the Door to Change NHS Safety Culture and the Need for Transformation (CQC 2018) www.cqc .org.uk/sites/default/files/20181224_openingthedoor_report.pdf accessed 20 October 2020. CQC, About Us:What We Do and How We Do It www.cqc.org.uk/sites/default/files/20170504_CQC_Ab out-us.pdf accessed 20 October 2020. Cumberlege, Baroness, First Do No Harm:The Report of the Independent Medicines and Medical Devices Safety Review (2020) www.immdsreview.org.uk/downloads/IMMDSReview:Web.pdf accessed 20 October 2020. Dalton, Jane, ‘Shrewsbury Maternity Scandal: More Than 900 Cases of Potential Poor Care Identified at Hospital’ The Independent (15 January 2020) www.independent.co.uk/news/health/shrews

70 Cumberlege (n 38) 7.

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John Tingle bury-maternity-scandal/shrewbusy-maternity-scandal-nhs-hospital-babies-mother-a9285571.html accessed 20 October 2020. Department of Health, An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer (TSO 2000) https://webarchive.nationalarchives .gov.uk/20130105105027/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publica tionsPolicyAndGuidance/DH_4065083 accessed 20 October 2020. Department of Health, Building a Safer NHS for Patients: Implementing an Organisation with a Memory (Department of Health 2002) https://webarchive.nationalarchives.gov.uk/20070403120932/http:// www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/Browsab le/DH_4097460 accessed 20 October 2020. Department of Health, Safety First: A Report for Patients, Clinicians and Healthcare Managers (Department of Health 2006) https://webarchive.nationalarchives.gov.uk/20130105032616/http://www.dh.gov .uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_064159.pdf accessed 20 October 2020. Department of Health, High Quality Care For All, NHS Next Stage Review Final Report (TSO 2008) https:/ /assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/228836 /7432.pdf accessed 20 October 2020. Francis, QC, Robert, The Mid Staffordshire NHS Foundation Trust Public Inquiry (TSO 2013) https://assets. publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947 .pdf accessed 20 October 2020. Institute of Medicine, To Err Is Human: Building a Safer Health System (National Academies Press 2000) doi:10.17226/9728 accessed 14 October 2020. Kennedy, Ian, The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995, Learning from Bristol, https://webarchive.nationalarchives.gov.uk/20090811143822/http:/ www.bristol-inquiry.org.uk/final_report/the_report.pdf accessed 20 October 2020. Kirkup, Bill, The Report of the Morecambe Bay Investigation (TSO 2015) https://assets.publishing.service.gov .uk/government/uploads/system/uploads/attachment_data/file/408480/47487_MBI_Accessible_v0 .1.pdf accessed 20 October 2020. NHS England, NHS Improvement, The NHS Patient Safety Strategy Safer Culture, Safer Systems, Safer Patients (NHS England, NHS Improvement 2019) https://improvement.nhs.uk/documents/5472/190708_P atient_Safety_Strategy_for_website_v4.pdf accessed 20 October 2020. NHS England, NHS Improvement, The NHS Patient Safety Strategy: Safer Culture, Safer Systems, Safer Patients (July 2019) https://improvement.nhs.uk/documents/5472/190708_Patient_Safety_Strategy_for_web site_v4.pdf accessed 11 November 2020. NHS England, NHS Improvement, Provisional Publication of Never Events Reported as Occurring between 1 April and 30 April 2020 (NHS England, NHS Improvement 2020) https://improvement.nhs.uk/doc uments/6639/Provisional_publication_-_NE_1_April_2020_-_30_April_2020_FINAL.pdf accessed 20 October 2020. NHS England, NHS Improvement, Provisional Publication of Never Events Reported as Occurring between 1 April and 30 November 2020 (14 January 2021) www.england.nhs.uk/wp-content/uploads/2021/01/ Provisional-publication-NE-1-April-30-November-2020.pdf accessed 11 February 2021. NHS Improvement, Never Events Policy and Framework (NHS Improvement 2018) https://improvement. nhs.uk/documents/2265/Revised_Never_Events_policy_and_framework_FINAL.pdf accessed 20 October 2020. NHS Involvement, Never Events List 2018 (NHS Involvement 2018) https://improvement.nhs.uk/doc uments/2266/Never_Events_list_2018_FINAL_v5.pdf accessed 11 February 2021. NHS Resolution,‘About NHS Resolution’ https://resolution.nhs.uk/about/ accessed 20 October 2020. NRLS, ‘Welcome to NRLS Reporting’ https://report.nrls.nhs.uk/nrlsreporting/ accessed 11 November 2020. Tingle, John, Ó Néill, Clayton, and Shimwell, Morgan, Global Patient Safety: Law, Policy and Practice (Routledge 2018). Weaver, Matthew, ‘Police Investigate Maternity Care at Shropshire NHS Trust’ Guardian (30 June 2020) www.theguardian.com/society/2020/jun/30/police-investigate-maternity-care-at-shrewsbury-and -telford-nhs-trust accessed 20 October 2020. WHO, Surgical Safety Checklist (WHO 2009) https://apps.who.int/iris/bitstream/handle/10665/44186/ 9789241598590_eng_Checklist.pdf?sequence=2 accessed 20 October 2020.

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An intrinsic patient safety culture WHO, Patient Safety Curriculum Guide Multi-Professional Edition (WHO 2011) www.who.int/patientsafety /education/mp_curriculum_guide/en/ accessed 20 October 2020. WHO, Human Rights and Health (WHO 29 December 2017) www.who.int/news-room/fact-sheets/detail /human-rights-and-health accessed 14 October 2020. WHO, OECD and International Bank for Reconstruction and Development/The World Bank, Delivering Quality Health Services:A Global Imperative for Universal Health Coverage (2018) https://apps.who.int/iris /bitstream/handle/10665/272465/9789241513906-eng.pdf?ua=1 accessed 20 October 2020. WHO, World Patient Safety Day (WHO 2020) https://www.who.int/patientsafety/world-patient-safety-da y/en/accessed 11 February 2021. WHO, Before Birth: WHO Safe Childbirth Checklist https://apps.who.int/iris/bitstream/handle/10665/1 99179/WHO_HIS_SDS_2015.26_eng.pdf; jsessionid=9BE29599068A424F744EFCBC643DFFA8?s equence=1 (WHO 2015) accessed 20 October 2020. WHO, Patient Safety Fact File, Patient Safety and Risk Management Service Delivery and Safety (WHO 2019) www.who.int/features/factfiles/patient_safety/patient-safety-fact-file.pdf?ua=1 accessed 20 October 2020. WHO,‘Patient Safety:About Us’ www.who.int/patientsafety/about/en/ accessed 14 October 2020.

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14 CLINICAL NEGLIGENCE LITIGATION PROCEDURE, POLICY, AND PRACTICE IN ENGLAND The product of a legal cycle rather than an application of a right to health? Stephen King

Introduction This chapter has two functions: (1) it offers another perspective on patient safety and rights to healthcare in England that complements and develops the arguments of John Tingle (Chapter 13) and Helen Hughes (Chapter 15); and (2) it differs from many other chapters, being practicefocused and derived from my experience as a solicitor dealing with medical negligence for over 30 years. The perspective offered is one of practice in England, but my caution and proposed solutions might be applied within a global context as the issue of patient safety is one that exists in all geographical contexts. Equally, the chapter does not address in detail the issue of a right to health, but asserts that much of the legal work that centres on negligence claims does not evolve from consideration of human rights but rather from a tortuous legal cycle that often, unfortunately, is of little benefit to either claimant or system.The lack of consideration of human rights in the litigious process is, perhaps, a salient gap. Patient safety and patient outcomes are at the heart of healthcare provision.They are extensively monitored and measured, and those details published. This allows healthcare providers to be audited; compared; occasionally censured or penalised, or put into ‘special measures’; challenged; and possibly improved. A lot of work has gone into improving patient outcomes. The analysis of statistical norms and ‘outliers’ reveals much about the effectiveness of medical practice.These statistics have proved useful in managing change in how healthcare is delivered. For example, the ‘Getting It Right First Time’ (GIRFT) project, is an example where it has been demonstrated that identifying outliers and requiring the concentration of particular healthcare resources nurtures best practice and improves patient outcomes.1

1 GIRFT www.gettingitrightfirsttime.co.uk accessed 9 November 2020.

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Improving outcomes is essentially about cost control. Not so much cost control of the here and now and the treatment being offered today, but future treatment and costs. Better outcomes equal fewer ongoing treatment episodes and ultimately less cost.2 Despite initiatives like GIRFT, the annual cost of malpractice is growing, inexorably some suggest. If the problem is the cost of malpractice, there are signs the United Kingdom (UK) government is interested in fixing it. It has completed a consultation about managing escalating costs by imposing costs caps.3 It has completed another consultation on whether discretionary, noncontractual, unregulated, unenforceable indemnity arrangements (which historically have made up the majority of indemnity arrangements for medical practitioners outside their National Health Service [NHS] practice, and left some injured patients without redress) should change. The outcomes of those consultations have yet to emerge.4 It is public knowledge that the cost of dealing with medical malpractice is ever increasing. In his commentary in the most recent NHS Resolution (NHSR) annual report, the NHSR Chairman reported that in relation to one of its schemes, the Clinical Negligence Scheme for Trusts (CNST): The cost of harm for CNST in 2019/20 is estimated to be £8.3 billion, which for the first time is clearly shown in our accounts.This is slightly lower than the c£9 billion we reported last year, again largely due to lower inflation expectations … The number of new claims has risen this year by 6% in secondary care.5 The cost of poor patient outcomes is substantial, and not just in the NHS.

Who pays? England has a public healthcare service called the NHS. Healthcare from the NHS is free – or free at the point of delivery.The patient does not pay (save in some exceptional circumstances such as prescription charges) for the care available. Although free to the patient, the healthcare provided is not cheap. This difficulty of resolving a seemingly impossible problem of increasing costs may be why the citizen has no enforceable right to healthcare in the NHS. Public healthcare is organised by laws and rules that require it to be in place to serve the population. Organisations such as the National Institute for Health and Care Excellence (NICE), and local funding arrangements, NHS contracting, and other contractual or non-contractual ‘pacts’ not generally visible within the organisational structure of the NHS, ensure that decisions about the availability of healthcare resources are removed from the people using them.

2 NHS England, NHS Five Year Forward View (2014) www.england.nhs.uk/wp-content/uploads/2014/10/5yfv -web.pdf accessed 9 November 2020. 3 Paul Fenn, Fixed Costs for Clinical Negligence Claims: A Cost Analysis Approach (2018) https://assets.publishing.serv ice.gov.uk/government/uploads/system/uploads/attachment_data/file/681388/Professor_Fenn_s_Report_in_ DH_Template.pdf accessed 9 November 2020. 4 Department of Health and Social Care, Appropriate Clinical Negligence Cover (Department of Health and Social Care 2019) www.gov.uk/government/consultations/appropriate-clinical-negligence-cover accessed 9 November 2020. 5 NHS Resolution, Annual Report and Accounts 2019/20 (NHS Resolution 2020) https://assets.publishing.service .gov.uk/government/uploads/system/uploads/attachment_data/file/901086/nhs-resolution-2019-20-annual-re port-and-accounts-print-version.pdf accessed 9 November 2020.

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Of course, one sees challenges by way of judicial review to decisions about healthcare resource provision. Usually they centre on a costly treatment regime – often medications – where NICE have decided not to offer it, that ignites a challenge to that decision by the patient wanting it. These are emotive, often political cases. Occasionally, the decisions are reversed or reconsidered, and treatment is provided. Such cases could be perceived as demonstrating a right to treatment that the patient has protected by their challenge. But that is not the case.All the patient has done is challenge the rationale of the decision to withhold treatment.They may have gained access to a treatment by their challenge, but they have not established a right to it. Section 1 of the NHS Act 2006 requires that the Secretary of State for health must continue the promotion in England of a comprehensive health service designed to secure improvement: (a) in the physical and mental health of the people of England, and (b) in the prevention, diagnosis and treatment of physical and mental illness. (2) For that purpose, the Secretary of State must exercise the functions conferred by this Act so as to secure that services are provided in accordance with this Act. (3) The Secretary of State retains ministerial responsibility to Parliament for the provision of the health service in England. (4) The services provided as part of the health service in England must be free of charge except in so far as the making and recovery of charges is expressly provided for by or under any enactment, whenever passed.6 This creates duties for the Secretary of State for Health. Decisions around the exercise of those duties can be judicially reviewed. Such ‘rights’ as a citizen might have to challenge such decisions are subject to the laws imposing the duties not being repealed. So, a right to healthcare is a flimsy concept.That said, the Human Rights Act 1998 does oblige public bodies (including the NHS) to comply with rights enshrined in the European Convention on Human Rights, which mostly have an impact on the protection of vulnerable patients, and medical care in prisons/detention facilities.7 Additionally,Article 35 of the Charter of Fundamental Rights of the European Union (2000) specifically says: Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.8 This was implemented into European Union (EU) law when the Treaty of Lisbon came into force in 2009 and is, therefore, directly applicable. However, whatever rights it provides will be lost as a result of the UK leaving the EU. Richard Horton, the Editor in Chief of The Lancet, wrote about how best to overcome this loss by the creation of a moral contract between the medical professions and society in his article in March 2019.9

6 7 8 9

National Health Service Act 2006 (emphasis added). Human Rights Act 1998. Charter of Fundamental Rights of the European Union, 2012/C 326/02. Richard Horton,‘Offline: UK Citizens Are Losing the Right to Health – Who Cares?’ (2019) 393 The Lancet 860.

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A ‘right to health’ exists under in the Universal Declaration of Human Rights of 1948 (UDHR), which is a core United Nations (UN) document. It is a non-binding resolution, but the foundation of customary international law.According to Article 25(1) UDHR: (1) Everyone has the right to a standard of living adequate for the health and wellbeing of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. Finally, we have the right to health in the International Covenant on Economic, Social and Cultural Rights of 1966 (ICESCR) (in force since 1976).This is a multilateral UN treaty ratified by 171 parties, including the UK.Article 12 ICESCR states: (a) The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. (b) The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness. The ICESCR is monitored by the UN Committee on Economic, Social and Cultural Rights (CESCR), which receives five-yearly reports by states. It operates on the principle of ‘progressive realisation,’ i.e. what a state can do at that time with its available resources.There are very few mechanisms for actual enforcement. There is an Optional Protocol giving CESCR more enforcement tools, but the UK has not ratified it.The role of these for the CESCR as well as the international treaties are discussed in more detail by Foster, Herring, and Ó Néill in Chapters 2, 3 and 4, respectively, of this book.

So where does this leave the UK? The UK has a ‘dualist’ system with regard to international treaties. Treaties place legal obligations on the government (which can then create implementing legislation, e.g. European Communities Act 1972), but they are not legislation and cannot alter UK domestic law. They do not create rights that individuals can enforce in UK courts.The NHS may be viewed as one single entity, but the organisation of the NHS is complex. It can be confusing and seem inconsistent in its approach to resource management and the delivery of healthcare. There are many different interests within the NHS, some more commercial than others. These interests often work collaboratively, but are sometimes in competition, and can appear to users as inconsistent. Healthcare on offer in one location may not be on offer or may be more limited in another.There are more private than public markets that operate out of sight.There are some shared resources and infrastructures and other scenarios where different healthcare pathways operate to provide care without ‘speaking’ to each other and sharing information. 247

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Providing a free service for 66 million people requires careful husbandry of resources. For that reason, while the NHS exists to provide free care, neither I nor you has a right to it. My access to NHS healthcare is limited by the resources that are available, by the population that needs them, and our respective healthcare priorities. It may be partly because the NHS is not a single organism that problems arise, errors are made, and people are injured (and die). It is why costly claims arise that are becoming more unaffordable. Alongside the NHS, which provides the majority of healthcare episodes in the UK, is an active, commercially viable, and growing independent and charitable healthcare sector. More and more people, even those without health insurance, elect to pay for what is often referred to as private healthcare, as they perceive they have more choice about who they see and when they see them. In a world where the culture of entitlement rings out loudly, going private and not having to wait for the care the NHS can provide is seen as an acceptable choice for those who can afford to make it.

Relationships? A patient receiving treatment from the NHS has one relationship – with the NHS.All the people the patient sees are employed by the NHS. If something goes wrong, in common with settled law, the employer carries the liability for the errors and omissions of its staff.The employer is, as we say, vicariously liable.The NHS may contract with external third-party providers to provide part of the care package – diagnostic testing is a good example. But the patient injured will still be able to seek redress against the NHS. If the NHS wants to recover its outlay from the thirdparty provider and its insurer it can do so. In the independent or private sector, relationships are more complex. In the majority of cases where patients see doctors in the independent sector, the patient may not know exactly what their relationship is with the doctor. Few patients ask about it, and most never need to as their treatment episode is incident free. Doctors in the independent sector are typically not employed by the organisation owning the bricks and mortar (i.e. the clinic or hospital) where the patient is actually seen.The doctor will, typically, have a relationship with a private/independent hospital (referred to as practising privileges) and be able to see their private patients there alongside NHS patients who use the ‘choose and book’ arrangements allowing private hospitals to carry out treatments on NHS patients and be paid a fee for doing so.The private hospital takes a fee for the provision of the buildings, the equipment used, and the consumables expended (bandages for example).The doctor takes a separate fee for their time and experience.The patient, the health insurer, or the NHS might pay those fees for the private treatment provided on tariffs that are agreed in advance. When something goes wrong in the independent sector, the patient has to establish from whom they are seeking redress and consider taking action against the doctor, the hospital or clinic, or the nursing staff.This can lead to a culture of blame and cause delays until it has been clarified who ought to respond to the claim. Typically, a patient making a claim for redress against the NHS relies on the tort of negligence. The patient of the private/independent provider relies on contract or tort, though the law of contract adds nothing of substance to their claim in tort. Rarely will patients rely on their human rights in seeking redress. In those relatively rare cases where human rights might be invoked, in my experience, the patient has usually died, often at their own hand, and the grieving family are looking for more than money.They are seeking recognition that something went tragically wrong and want it declared that the patient or deceased was let down.The issue

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pertaining to declaring fault is interesting as many patients who have suffered injury report that their main objective in raising a complaint or claim is not to seek monetary compensation (which is all a court can offer), but to draw attention to failings and ensure that learning emerges from the episode such that future events of a similar nature are avoided or the risk of them occurring is mitigated.10

Indemnity issues Establishing who the right target (or defendant) should be is important for an injured patient. The patient needs to be able to identify the culpable or liable person or entity. More importantly, the defendant named needs to be able to cover the award made against them. Personal wealth rarely features in such investigations as usually the individual or entity named as defendant is indemnified or insured. The General Medical Council (GMC) and the NHS require that providers of healthcare should have adequate and appropriate indemnity in place – to provide patients who are injured with an effective means of redress.11 If the healthcare was provided by the NHS, selecting the right defendant is usually straightforward. In the independent sector it can be more complicated and made even more complicated by unforeseen developments. Take the case of Ian Paterson, the disgraced and imprisoned surgeon who injured many of his patients. Some of his patients were injured while being treated by him on the NHS. In those cases, the NHS carried the liability for his errors and omissions.The argument against the NHS was that it was either directly culpable for allowing Paterson to continue to do what he did, or it was vicariously liable for his actions while he was employed by the NHS.12 NHS organisations typically pay a membership fee or contribution to an indemnity scheme managed by a special health authority created by statute. That organisation, initially known as the NHS Litigation Authority is now called NHS Resolution (NHSR). In return for its membership contribution, NHSR takes on the responsibility for managing claims made against the NHS in all its forms – more or less.The NHS organisation indemnified under the rules of the scheme it belongs to has no legal right to an indemnity, as the schemes are discretionary.That is to say that as long as the NHSR exercises its discretion to offer an indemnity, it will be provided.The schemes seem to work well enough, there being a firm expectation that redress will be provided in the NHS, which it generally is, once the claim is established. Again, the injured patient has no right to demand redress against the NHS. Rather, the NHS is required to ensure redress is available. In some ways, this discretionary scheme arrangement is not ideal. One might detect an abdication of responsibility by the NHS Trusts and Foundation Trusts that are members of these discretionary indemnity schemes.An NHS Trust might be the correct legal defendant to a claim made against it by an injured patient, but the NHS Trust will have paid NHSR its annual contribution and expects the NHSR to take over and manage, and hopefully resolve, the claims against

10 Action against Medical Accidents, The Draft Health Service Safety Investigations Bill and “Safe Space” (Action against Medical Accidents 2017) www.avma.org.uk/?download_protected_attachment=HSSIB-briefing-19.10.17.pdf accessed 9 November 2020. 11 ‘Insurance indemnity and medico-legal support’ General Medical Council gmc-uk.org. 12 The Right Reverend Graham James, Report of the Independent Inquiry into the Issues Raised by Paterson (2020) https ://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issuesraised-by-paterson-independent-inquiry-report-web-accessible.pdf accessed 9 November 2020.

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it.What does the NHS Trust care about how NHSR do that or what outcome is achieved? If the NHS Trust leaves the management of the claims for redress against it to a third party, what has it invested in risk management, or better patient outcomes, to ensure the same injury is not caused to another patient? To return to the example of Paterson, he also injured many of his private patients.The claims of those private patients were initially made against him and passed by him to his private practice indemnity provider, the Medical Defence Union (MDU). It also managed a discretionary indemnity scheme and exercised its discretion to decline to offer Paterson an indemnity, as it was entitled to.That decision, which left Paterson without indemnity, left a group of injured patients without effective redress. So, they looked to the independent hospitals where Paterson had operated, seeing them and potentially their respective insurers as a deep pocket able to provide redress. Those hospitals would traditionally not have employed Paterson but have allowed him practising privileges, requiring him to carry appropriate and adequate indemnity against such claims. Accordingly, the independent hospitals would have felt protected from such lawsuits as might emerge from the antics of a ‘rogue’ practitioner. However, when the indemnity provider of Paterson declined cover, the independent providers faced potential claims that they either allowed an incompetent person to operate on their premises in a way that injured his patients and were directly liable for that, or that they were vicariously liable for his actions.

Pricing and contracting That model of expecting the doctor in private healthcare practice to carry the risk of malpractice is a reason why some providers of healthcare may not have effectively indemnified themselves to cover the malpractice of the doctors (or other self-employed clinical staff) who practise at their hospitals and clinics.As far as they are concerned, they could divert any claims for redress to the doctor and his indemnity scheme or insurer. Of course, what has happened with Paterson and other situations where, for one reason or another, the doctor has found indemnity declined, is that the courts have been asked to look at the gap in the availability of redress, at least in the independent sector.The courts have been quick to clarify and develop the law around both vicarious liability and a non-delegable duty of care, which may fix a clinic or health provider with liability for the negligence of the surgeon, even if they are described by and contracted to the clinic or provider as ‘self-employed.’ But the law on this issue is not entirely clear and, even now, there are instances where healthcare providers are facing claims which they never imagined they would be held responsible for and where they did not carry insurance or indemnity for the claim they are facing. In an extreme case, if liability is established, the provider may become insolvent and the claimant left with only partial or possibly no effective redress. For this reason, the government consulted on changing the indemnity arrangements in the UK to scrap discretionary schemes and bring in a regulated and contractually enforceable arrangement akin to commercial insurance.Yet, even with insurance, there can be circumstances where, if the insured doctor or hospital has failed to comply with the conditions of their insurance, which is a contract after all, the insurer may decline cover and again leave the injured patient without effective redress. There is no legal right to redress. Contracts may be written to provide for it. Regulators may insist healthcare providers arrange to respond to demands for redress, but in the end, redress may be illusory – depending on the exercise of discretion or the failure of the provider to comply with the terms of their indemnity agreement. 250

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The process of seeking redress Having tried to briefly expose the organisational aspects of healthcare provision and indemnity that will provide for redress when things go wrong, I want to turn to the process of redress. In this jurisdiction, we use the tort of negligence. Someone who owes the patient a duty of care has done something or omitted something that means the standard of healthcare was below that reasonably expected. Someone has been injured as a consequence of that lapse, and can prove a causal connection between their injury (and other losses) and the negligence about which they complain.There are two important points to bear in mind here.The first is the duty of candour and the second is the role of a complaints process. The duty of candour, which emerged from a public inquiry into the events at Mid Staffordshire Hospitals, and the recommendations of Robert Francis QC who chaired that inquiry, is now embodied both in law and professional practice.13 The duty requires that when something has gone wrong and someone is injured as a consequence, the healthcare provider must both explain to the patient what happened and why and apologise for the injury they have suffered.The ethos is not about giving the patient rights to insist on candour or take action if candour is lacking, but about healthcare providers being transparent and owning up to mistakes. If they do not, a patient might not know that candour has been denied them. Healthcare providers generally identify when things go wrong. They log it on their risk management system and undertake a serious untoward incident report or root cause analysis, which in many cases they will share with the patient or their family.Those investigations often (but not always) uncover the reasons or series of reasons, why something went wrong, and can be used to ensure lessons are learned and healthcare improved in the future.All that information is disclosable and can form the body of evidence to support a claim for redress. Even if the incident or injuries were not sufficiently serious to invoke the duty of candour, a healthcare provider will have a formal complaints process that can be used to uncover facts and establish an explanation for care that has been sufficiently lacking (in the experience of the patient). Again, this process will allow for a period of reflection and may produce information that establishes someone is at fault. It may also settle in the patient’s mind what actually happened until a potential claim loses momentum. It surprises me how often the first time a healthcare provider gets to know about a legal claim is when they receive a formal letter of claim (which will be discussed later). Even where the healthcare provider knows something has gone wrong and has written up their risk management and serious incident reports, they may just file them. If they do, they will miss the opportunity to approach the patient and try to resolve a simmering problem before it escalates. Equally, the patient often never returns to the provider to raise their concern. Instead, they respond to the wealth of media advertising to make a claim.They can become a bystander in a claim brought in their name but which in many cases looks more like a claim the purpose of which is the pursuit of legal fees.

Pre-action protocol An injured patient does not have to wait for the apology and explanation the duty of candour or complaints process requires. If an injured patient wants to bring a legal claim for compensation against the healthcare provider – and compensation is all they can get from a legal claim as a

13 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20

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patient cannot invoke a right to, and a court cannot order, apologies or explanations – then they must comply with the pre-action protocol for the resolution of clinical disputes, which is now part of the Civil Procedure Rules.These are the court rules that set out how to make a claim.14 The protocol is a process that requires the claimant to set out in detail why they think they have a claim.Who do they hold liable, and why? To be able to produce a protocol compliant letter of claim, the patient/claimant will usually need a lawyer equipped to collect their various healthcare records and instruct an appropriate independent expert able to offer a view on whether the care the patient received fell below the standard to be expected.Very importantly, the claimant has to find a lawyer who will fund the case (to be discussed). The claimant will have to demonstrate a causal link between their injury and the negligent error of the healthcare provider. It seems obvious to say this, but patients are usually seeing doctors because there is something wrong with them. Not always of course, if one considers the very many people who elect to have plastic surgery for cosmetic reasons. But generally, most patients have a pre-existing problem which has led them to seek healthcare. Some have very many overlapping and complex pre-existing problems.The question therefore is, Has the error or omission of the doctor which the patient can prove made things worse? Or is the original problem that caused the patient to see the doctor in the first place the reason for the outcome and injury.This need to prove a causal link is often the reason why such claims fail. Often the letter of claim is insufficiently detailed to comply with the protocol. That deficiency can sometimes be the inexperience of the claimant lawyer, but not always. If the letter of claim is complete, the recipient healthcare provider will know the claim they have to respond to and will also know, in general terms, that the allegations and arguments set out in the letter of claim are supported by an independent opinion from a doctor practising in the same specialty as the one accused of negligence.What I mean is that by the time the letter of claim lands on the mat of the healthcare provider, a lot of effort (and expense) has been invested in demonstrating there is a claim to answer. On receipt of a letter of claim, the healthcare provider has four months from the date they receive it to respond to it with their letter of response. Again, it is surprising how often the protocol letter of claim comes out of the blue. It is particularly surprising if the incident about which the complaint is being made was particularly serious. Was it investigated earlier and, if so, what was the outcome? Was the duty of candour applied? Even if an opportunity to investigate the matter earlier has been lost, four months is usually a reasonable time to investigate and decide on a response.After such an investigation, the outcome may be that the claim is valid, admissions are made, and efforts are directed to resolution and redress. In other cases, the claim is not sustainable, at least not on the opinions of the experts who were asked to offer a view by the healthcare provider. In those cases, the provider will have to deliver a formal response to the letter of claim.That might be part admission and an acceptance of some of the consequences alleged to have arisen from the breach of duty. It might be an admission of breach of duty but a rejection of the causation case. If the letter of claim set out the losses suffered, those losses might be accepted or accepted in part, or rejected. The purpose behind the introduction of the pre-action protocol was to bring the parties to the table, let the claimant reveal their case, and allow the defendant to challenge it.The purpose was to make litigation the last resort. Importantly, a purpose of the protocol was to reduce the cost of such claims. Sadly, it has not achieved that aim.

14 Pre-Action Protocol for the Resolution of Clinical Disputes www.justice.gov.uk/courts/procedure-rules/civil/ protocol/prot_rcd accessed 9 November 2020.

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Once the letter of response has been served, the claimant can decide whether to negotiate, back off, or litigate. The protocol exchange might identify scope for a compromise that stops short of court action. If not, the claimant can issue legal proceedings.Were the claimant to issue proceedings before invoking the protocol, or if they pay lip service only to the protocol, they might well be penalised by the court even if successful in their claim.Typically, in my experience, a claimant does not make an offer of settlement when they send their letter of claim. Quite often the letter of claim is silent as to aspects of the claim that are supposed to be included in the letter of claim such as the value of the claim or the damages sought. If the protocol were actually used to try to resolve claims, rather than allow a box to be ticked before legal costs (already high at that stage) start building exponentially, it just might be that claims would be resolved more quickly. One wonders whether the process is an exercise in obtaining redress or maximising legal fees. I said earlier that I did not consider the pre-action protocol had made litigation a last resort.The effort behind doing that was to simplify the process for obtaining redress and reduce the cost of malpractice claims. Instead what has happened is that the claimant is now encouraged to investigate and launch their claim, often where the defendant is ignorant of the developing claim. By the time they get to know about it, the defendant may well find the costs have eclipsed many times the actual and proportionate value of the claim. As Adrian Zuckerman put it, the excessive cost of malpractice claims lies not in the complexity of the procedure, the pre-action protocol, and the introduction of the Civil Procedure Rules (which were meant to allow the courts to manage litigation), but in the incentives that lawyers have to complicate litigation. Lawyers are typically paid by the hour and have no direct incentive to economise in the provision of services. So, one finds that a natural desire to maximise reward leads to forensic practices designed to increase profits rather than secure effective redress.15

Litigation and mediation – offers Once the protocol process is complete, the parties will know if they can resolve matters. If they cannot legal proceedings start and at this point the court takes over the management of the timetable towards resolution. The parties exchange pleaded cases (though these are usually a more formal recasting of the pre-action protocol correspondence, supported by the opinions of the independent experts the respective parties to the claim have engaged) and ask the court to fix directions for the phased development and eventual resolution of the claim. Along the way, there will be disclosure, where the parties share evidence about their case, though often this has mostly been done in the pre-action protocol phase save for the evidence supporting the losses that might not have been available at that time. Statements of witnesses will be prepared and exchanged. Expert reports, so secretively withheld pre-action, will now be flourished and the authors of those reports will be asked to meet or discuss their opinions following an agenda that is meant to be agreed (but often is not) by the parties.That this might have happened much earlier remains a glaring gap in the effectiveness of the pre-action protocol. In some cases, the breach of duty is easy to identify and can be admitted or partially admitted.That allows the parties to focus on causation and loss. Some cases that proceed to trial only deal with causation and loss, or possibly only with causation as it may have been possible for the parties to agree the value of the claim depending on what points are proven to the judge.

15 Adrian Zuckerman, ‘Lord Woolf ’s Access to Justice: Plus ça Change…’ (1996) 59(6) The Modern Law Review 773–96.

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At times, the breach of duty will be worth sorting out early on and so an interim hearing might take place on the preliminary issue of breach of duty or limitation. Limitation can be tricky in malpractice cases, as problems caused by malpractice may lie dormant for some time. By the time a claimant realises they have a claim, the primary limitation period may have expired. Even so, that period may be extended by a later date of knowledge which delays the start of the limitation clock or the court may exercise its discretion to disapply the limitation period and allow the claim to proceed if the claim looks to have merits, if the delay can be explained, and if a fair trial can still be held. Legal aid is only available in relatively few cases involving vulnerable claimants, such as minors. The court is expected to manage the costs expenditure so costs budgets will be prepared, revealing the eye-watering sums the lawyers have already spent and expect to spend on the claim. Eventually the claim will either resolve because the parties reach common cause, or there is a mediation which allows a compromise to be worked out. In the relatively very few cases that are fought, a judge will decide who wins and who loses. If a case gets to court, no one really wins.There are a number of devices that parties can engage to try to resolve the claim or to test the resolve of the opponent. Within the Civil Procedure Rules, Part 36 allows a party to make an offer which is kept from the court until it needs to be revealed.The purpose of making a Part 36 offer is to put on the table an offer to pay or a willingness to accept a sum of compensation. If the party to whom the offer is made decides to reject the offer and ultimately recovers less than the sum offered, they will typically suffer a penalty. So, the incentive is to pitch an offer that is likely to be accepted, but in the knowledge that if it is not, the party rejecting it is at risk. Mediation is another device or process that is commonly used to resolve malpractice claims. Whilst it is often the case that parties can negotiate a resolution, sometimes they reach an impasse and what is needed is a neutral third party or mediator to break down the obstacles to resolution. Mediations are extremely productive processes in my experience. First, the parties have to agree to the process and who to appoint as mediator.The skill of the mediator is in the process, rather than the subject matter of the dispute.The role of the mediator is not to act as arbitrator or evaluator, but to challenge each party about their case and seek out the redress they are prepared to accept or offer. The mediation process is private and confidential. A typical mediation agreement requires the parties not to rely on anything disclosed within the process of the mediation in future litigation (assuming the mediation does not result in resolution). A mediation can be as short or as long as the parties are prepared to commit to.The court will expect (but not impose on) litigating parties to try some form of alternative dispute resolution (ADR), and mediation tends to be the most used in malpractice cases. If a resolution is reached, it can be embodied in a court order or agreement that becomes legally enforceable. It is an elegant form of resolution and far easier on the parties (patient and doctor), as it is usually held in a private location that is relatively informal. To revert to the cost of dispute resolution, in the last ten years the costs of dealing with medical malpractice has soared. A National Audit Office 2017 Report found that in 61% of cases (involving the NHS), the claimant’s legal costs of pursuing a claim were greater than the value of the damages the claimant recovered.16 One reason cited for such high costs is the length of time it typically takes to resolve a dispute – in 2016/2017 the average time was 426

16 National Audit Office, Managing the Costs of Clinical Negligence in Trusts (National Audit Office 2017) www.nao.or g.uk/report/managing-the-costs-of-clinical-negligence-in-trusts/ accessed 9 November 2020.

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days, compared with only 300 days in 2010/2011.The reason for these delays is unclear. Some commentators suggest the delay is caused by defence lawyers taking an unreasonably defensive stance even when liability is established. However, the introduction of qualified one-way costs shifting (QOCS) is also cited as a potential cause. Although the rules used to be that the losing party paid the costs of the successful party, this is no longer the case. Following the introduction of QOCS in 2013, it is unlikely (unless the claimant’s case is struck out or involves fraud) that the defendant will obtain (if they win) an enforceable costs order against a claimant in a claim involving medical malpractice.17 As such, logic would suggest that a claimant, often on a no-win-no-fee type arrangement, has less incentive, or nothing to gain, in settling the claim early and at a sensible figure, as there is no cost penalty if they do not.Whilst the defence can make an offer to settle, bear in mind this will usually be after the injury has been done, the lawyers instructed, and all their efforts have gone into ensuring that, at the point in time that the claim is actually presented to the hapless defendant (and their indemnifier or insurer), a relatively large sum in legal costs has already been incurred. It has not helped that for many claims that arise from NHS treatment, there has been little or insufficient incentive or resource aimed at tackling early resolution. An NHS body may know something has gone wrong, they may have undertaken their investigations and come clean, as the duty of candour requires, and do little but then wait until they are presented with a claim, when the smart thing would have been to offer redress, early. Logically, this entire approach (sit back and wait for the claim to arrive) must inflate both the sum required to settle a claim and the claimant’s legal costs. It also plays to the regular complaint that the NHS does not proactively investigate and deal with medical errors, unless they arise from a potentially hugely expensive obstetric claim. The NHS Resolution CEO, Helen Vernon, talks about the ‘robust’ approach to challenging claims, whilst acknowledging that the number of claims remains the same, and has done so for over a decade. She speaks of the beneficial impact of the early notification scheme in maternitytype cases, and so identifies a clear link between early action and better, i.e. at least less costly, outcomes.18 Many healthcare organisations do not effectively learn from their past mistakes.They do not invest enough in training and risk management, dispute resolution, or better patient outcomes. That is the real problem. Whilst that problem remains, it is pointless tinkering with the cost of claims, for example with capped costs, which is what the government has said it intends to introduce. An announcement by the Department of Health on 30 January 2017 stated: The government intends to impose a new, fixed cap on all clinical negligence cases up to £25,000 to prevent rising litigation costs within the NHS.There are numerous examples of lawyers who profit from the NHS by charging more than 80 times the amount awarded to the victims in minor claims. In one case, lawyers claimed £83,000 in legal costs for a case in which the patient was awarded £1,000.These costs contributed to a total bill for the NHS of £1.5 billion in financial year 2015 to 2016.

17 Civil Procedure Rules 44.13 to 44.17. 18 NHS Resolution, NHS Resolution Annual Report and Accounts 2018 to 2019 www.gov.uk/government/publicat ions/nhs-resolution-annual-report-and-accounts-2018-to-2019

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Currently, there is no limit on legal costs that can be recouped and the money claimed by lawyers takes vital funds away from NHS trusts. It is expected the new cap will help the NHS save up to £45 million a year. But that consultation hit the long grass, and there it has stayed, or as the Law Society Gazette reported in October 2019:‘Claimant and defendant sides fail to agree clin neg fixed costs levels.’ I detect no real interest in fixed costs.Whilst capping costs would reduce the overall spending on medical malpractice, it does seem a little bit like shutting the door after the horse has bolted. Why not then try something even more radical, like preventing negligent errors and omissions happening in the first place? Not an original thought.We have come part of the way with the duty of candour. Could we go the extra mile and consider no-fault redress? Capped costs of the type being considered by the government will impact access to redress, as fewer lawyers will find the return on investment of the time and effort they expend acceptable relative to the capped costs on offer for the work.The reduction in legal aid budgets severely limited access to redress, and capping costs is likely to have a similar impact. Also, a policy of capping costs, on its own, will look like is a rather mean policy which allows errors to continue to happen, whilst stealing away from responsibility for investing in better patient outcomes and pointing a finger at the very people the hapless patients and clinicians (now claimants and defendants) turn to for assistance.Whilst no doubt the government will at some point change the rules to try to cap costs, because it can, I cannot see that move having any useful purpose in solving the greater problem of stopping the errors happening in the first place.That needs investment.

Reducing claims and costs A starting point is, of course, to ensure high clinical standards which reduce the incidents of malpractice arising. Clinicians should also show empathy and ensure patients understand decisions made about their treatment.This may actually protect clinicians from having a claim made against them. Early and active intervention is required when errors are made. Early proactive intervention and redress will reduce the cost of claims, and learning from those events, if applied properly, will reduce the number of future errors. Earlier this year in the Journal of Patient Safety and Risk Management, author Albert Wu wrote about the ‘golden moment after an adverse event.’19 I know exactly what he means.

The legal tests: breach of a duty of care? Having spoken about the organisation of healthcare and indemnity and the process of finding redress, I ought to cover the tests the courts apply in determining whether a healthcare provider is liable or not. Few cases dominate legal analysis around liability for medical malpractice. One is generally referred to as Bolam or the ‘Bolam test.’20 That case decided that a doctor is not guilty of negligence if they have acted in accordance with a practice accepted as proper by a responsible body of doctors. That test is augmented by the latter case referred to as Bolitho, which required the

19 Albert W Wu, ‘The Golden Moment after an Adverse Event’ (2019) 24(5) Journal of Patient Safety and Risk Management 179–80. 20 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.

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body of opinion that Bolam speaks about, to be reasonable, responsible, and able to stand a logical analysis and scrutiny of risks and benefits.21 But what is the ‘responsible body’ of opinion at the moment? COVID-19 has delivered novel times. For doctors acting outside their specialism or using a different method of assessing patients, such as a virtual/remote consultation, will the courts apply a different test? History suggests not, so for example, the less experienced doctor undertaking a particular healthcare task will be judged according to the expectations of a doctor expected to be reasonably proficient in the task they undertake. In other words – no ‘dabbling.’ This begs the question as to what is reasonable and responsible as set out in Bolitho in such exceptional circumstances? Some commentators have suggested a new legal test would have to be formulated, as has happened to some extent in consent cases where the Montgomery test has effectively made the Bolam test redundant when assessing whether a patient has been appropriately advised of the material risks before consenting to treatment.22 Could the present crisis result in a further move away from Bolam?

Causation Proving breach of duty, whatever the test is, is only part of the story. Many claims fail because causation cannot be proved. Unlike a road accident causing injury where a driver may be held to blame, people having treatment usually have an underlying condition that requires them to have that treatment,so one is always looking to see what would have happened anyway,even if negligence is proved.

Conclusion Where we seem to be is that patients can expect healthcare to be available, but will find that funding decisions and resource management means that for some the healthcare they need will not be available.That public healthcare exists is down to the existence of laws that require it. How it is provided can be inconsistent.Accessing healthcare that a patient needs and is denied is difficult, and may involve seeking to challenge the decision-making process through the courts. Once healthcare is provided, errors might result in injury.Whilst many changes have come along to try to manage the ever-increasing cost of seeking redress, there are just too many commercial interests, and possibly little effective government interest, to change things sufficiently to make the difference required. It is clear that the medical profession as a whole, and the NHS in particular (and of course the wider interested public), cannot afford the continuation of the current situation. It would be good to see less partisan support for the status quo and the lip service paid to change, or less tinkering with peripheral issues that do not address fundamental problems, and see real collaboration on better patient outcomes and a no fault process that provides effective redress. This approach would ensure that a process exists that is reasonably free from the contention that applies to medical negligence litigation as revealed by Lord Woolf as long ago as 2006 that: it was the area of medical negligence that the civil justice system was failing most conspicuously to meet the needs of litigants.23 This could allow for improved application of a right to safe healthcare.

21 Bolitho v Hackney Health Authority [1998] AC 232. 22 Montgomery v Lanarkshire Health Board [2015] UKSC 11. 23 Lord Woolf, Access to Justice – Final Report (2006) https://webarchive.nationalarchives.gov.uk/20060213223540/ http://www.dca.gov.uk/civil/final/contents.htm accessed 9 November 2020.

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References Action Against Medical Accidents, The Draft Health Service Safety Investigations Bill and “Safe Space” (Action Against Medical Accidents 2017) www.avma.org.uk/?download_protected_attachment=HSSIB-br iefing-19.10.17.pdf accessed 9 November 2020. Department of Health and Social Care, Appropriate Clinical Negligence Cover (Department of Health and Social Care 2019) www.gov.uk/government/consultations/appropriate-clinical-negligence-cover accessed 9 November 2020. Fenn, Paul, Fixed Costs for Clinical Negligence Claims: A Cost Analysis Approach (2018) https://assets.publi shing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/681388/Professor _Fenn_s_Report_in_DH_Template.pdf accessed 9 November 2020. GIRFT, www.gettingitrightfirsttime.co.uk accessed 9 November 2020. Horton, Richard, ‘Offline: UK Citizens Are Losing the Right to Health – Who Cares?’ (2019) 393 The Lancet 860. National Audit Office, Managing the Costs of Clinical Negligence in Trusts (National Audit Office 2017) www .nao.org.uk/report/managing-the-costs-of-clinical-negligence-in-trusts/ accessed 9 November 2020. NHS England, NHS Five Year Forward View (2014) www.england.nhs.uk/wp-content/uploads/2014/10 /5yfv-web.pdf accessed 9 November 2020. NHS Resolution, NHS Resolution Annual Report and Accounts 2018 to 2019 www.gov.uk/government/pub lications/nhs-resolution-annual-report-and-accounts-2018-to-2019. NHS Resolution, Annual Report and Accounts 2019/20 (NHS Resolution 2020) https://assets.publishing .service.gov.uk/government/uploads/system/uploads/attachment_data/file/901086/nhs-resolution -2019-20-annual-report-and-accounts-print-version.pdf accessed 9 November 2020. Woolf, Lord, Access to Justice – Final Report (2006) https://webarchive.nationalarchives.gov.uk/2006021 3223540/http://www.dca.gov.uk/civil/final/contents.htm accessed 9 November 2020. Wu, Albert W, ‘The Golden Moment after an Adverse Event’ (2019) 24(5) Journal of Patient Safety and Risk Management 179–80. Zuckerman, Adrian, ‘Lord Woolf ’s Access to Justice: Plus ça Change…’ (1996) 59(6) The Modern Law Review 773–96.

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15 PATIENT SAFETY AND HUMAN RIGHTS Helen Hughes

Introduction One of the earliest maxims in healthcare emphasises the importance of patient safety, ‘First, do no harm.’Yet avoidable harm is a persistent theme in healthcare systems worldwide, with the need to significantly improve patient safety in all countries, whatever their stage of economic development. While there is a wealth of literature on patient safety as a discipline and its practical implications for healthcare, how this relates to the right to health and human rights is a relatively underexplored area. In this chapter, we will focus on patient safety and human rights, providing case studies showing where patients’ human rights are not being honoured. First, I will explain what we mean by patient safety and set out the current global scale of unsafe care, before demonstrating how the right to health also gives people a right to safe care. I will then look at the relationship between patient safety and human rights, using the legal framework in the United Kingdom (UK) as a basis and drawing on several examples of where we, and others, consider patient safety to be a human rights issue. Finally, I will return to the broader issue of avoidable harm, addressing why this continues to persist and what action needs to be taken to create a patient safety future.

What is ‘patient safety’? Patient safety is the absence of preventable harm to a patient during the process of healthcare, and the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum. An ‘acceptable minimum’ refers to the collective notions of given current knowledge, resources available, and the context in which care was delivered, weighed against the risk of non-treatment or other treatment.1 As a discipline, patient safety has emerged with the evolving complexity of healthcare systems and the resulting rise of avoidable patient harm. It aims to identify and reduce the risk of harm to patients.

1 WHO,‘Patient Safety’ www.who.int/patientsafety/en/ accessed 29 October 2020.

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The global scale of unsafe care Unsafe care is an issue that impacts healthcare provision across the world. The World Health Organization (WHO) estimates that adverse events resulting from unsafe care are one of the ten leading causes of death and disability worldwide.2 A recent Organization for Economic Cooperation and Development (OECD) report assessed the health burden of patient harm at 64 million disability-adjusted life years a year, comparable to the global disease burden of HIV/AIDS.3 The human impact of unsafe care is stark: • • •

In high-income countries, the WHO estimates as many as one in ten patients is harmed while receiving care in hospital.4 It is estimated that in the UK, Canada, and the Netherlands around 5% of hospital deaths are due to preventable safety issues.5 In low- and middle-income countries, it is estimated that one in four hospitalisations result in harm, resulting in 2.6 million deaths annually.6

As well as the tragic loss of life and long-term impact of patients’ health and well-being, there is also a huge financial burden associated with unsafe care.The direct cost of unsafe care in developed countries is estimated at 12.6% of health expenditure.7 When excluding errors that may not be preventable, this figure is 8.7% of health expenditure, which still represents a staggering $606 billion annually.8 While these figures focus on direct costs, the broader economic impact is potentially far greater. A study by Charles Andel et al. noted that, in 2008, the cost of medical errors in the United States cost around $19.5 billion, with 87% of this directly associated with additional medical costs.9 When taking into account the wider economic impact, applying quality-adjusted life years, they estimated that the total cost was perhaps $1.1 trillion annually.10 Unsafe care also comes with consequences that are considerably more difficult to quantify, such as: • •

The physical and psychological discomfort of patients who experience remedial treatment, longer hospital stays, or disability because of avoidable harm; Diminished trust in the healthcare system and professionals by patients; and

2 WHO, ‘Patient Safety Fact File’ (WHO, 2019) www.who.int/features/factfiles/patient_safety/patient-safety-fact -file.pdf?ua=1 accessed 29 October 2020. 3 OECD and Saudi Patient Safety Centre (SPSC), ‘The Economics of Patient Safety: From Analysis to Action’ (OECD and SPSC October 2020) www.oecd.org/health/health-systems/Economics-of-Patient-Safety-Oc tober-2020.pdf accessed 2 November 2020. 4 WHO, Global Patient Safety Action Plan 2021–2030 (WHO 2020) www.who.int/docs/default-source/patient-safety /1st-draft-global-patient-safety-action-plan-august-2020.pdf?sfvrsn=9b1552d2_4 accessed 2 November 2020. 5 H Hogan, R Zipfel, J Neuburger, A Hutchings, A Darzi, and N Black, ‘Avoidability of Hospital Deaths and Association with Hospital-Wide Mortality Ratios: Retrospective Case Record Review and Regression Analysis’ (2015) 351 h3239 BMJ www.bmj.com/content/bmj/351/bmj.h3239.full.pdf accessed 2 November 2020. 6 OECD and SPSC (n 3); National Academies of Sciences, Engineering, and Medicine, Crossing the Global Quality Chasm: Improving Health Care Worldwide (National Academies of Sciences 2018) www.nap.edu/catalog/25152/ crossing-theglobal-quality-chasm-improving-health-careworldwide accessed 2 November 2020. 7 OECD and SPSC (n 3). 8 ibid. 9 C Andel, SL Davidow, M Hollander, and DA Moreno, ‘The Economics of Health Care Quality and Medical Errors’ (2012) 39(1) Journal of Health Care Finance https://pubmed.ncbi.nlm.nih.gov/23155743/ accessed 2 November 2020. 10 ibid.

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•

Loss of morale and impact on well-being on healthcare workers who are not able to provide the best care possible and may be unfairly blamed for system errors.

Taken together, the human and economic case for tackling unsafe care and improving patient safety is indisputable and urgent.

Is the right to healthcare, the right to safe care? Having established that unsafe care is a major global health challenge, it is important to also consider how this is positioned within the wider context of the right to health.A human rights– based approach to health provides a set of clear principles for setting and evaluating health policy and service delivery, targeting discriminatory practices and unjust power relations that are at the heart of inequitable health outcomes.11 In pursuing a rights-based approach, the WHO states that health policy, strategies, and programmes should be designed explicitly to improve the enjoyment of all people to the right to health, prioritising those most in need. The former United Nations High Commissioner for Human Rights, Mary Robinson, has stated: The right to health does not mean the right to be healthy … but it does require governments and public authorities to put in place policies and action plans which will lead to available and accessible healthcare for all in the shortest possible time.To ensure that this happens is the challenge facing both the human rights communities and public health professionals.12 But does the right to health give people the right to safe care? The right to health (Article 12 of the International Covenant on Economic, Social and Cultural Rights [ICESCR]) includes the following core components: availability, accessibility, acceptability, and quality.13 Quality is a key component of universal health coverage and includes the experience as well as the perception of healthcare. Quality health services should be: • • • • • • •

Safe – avoiding injuries to people for whom the care is intended; Effective – providing evidence-based healthcare services to those who need them; People-centred – providing care that responds to individual preferences, needs, and values; Timely – reducing waiting times and sometimes harmful delays; Equitable – providing care that does not vary in quality on account of gender, ethnicity, geographic location, and socio-economic status; Integrated – providing care that makes available the full range of health services throughout the life course; and Efficient – maximising the benefit of available resources and avoiding waste.

Therefore, when looking at issues of unsafe care, we need to ask:When health and social care systems fail to prevent avoidable harm, do they fail to provide the right to health?

11 WHO, ‘Human Rights and Health’ (WHO, 29 December 2017) www.who.int/news-room/fact-sheets/detail/ human-rights-and-health accessed 2 November 2020. 12 DP Evans, ‘You Have the Right to … Health?’ (Medscape, 3 March 2005) www.medscape.com/viewarticle /499688#vp_2 accessed 2 November 2020. 13 UN Committee on Economic, Social and Cultural Rights (CESCR), General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant) (11 August 2000, E/C.12/2000/4).

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Patient safety as a human rights issue The application of human rights in health and patient safety is, to a great extent, dependent on the domestic legislation in a country. In this chapter, I will draw on examples showing the relationship between patient safety and human rights specifically in the UK. Before looking at these examples in more detail, I will establish the existing legal framework around human rights and healthcare in the UK.

Legal framework in the UK Human Rights Act 1998

All public authorities in the UK, including National Health Service (NHS) England and NHS Improvement (NHSE&I) and individual NHS trusts (and bodies exercising publication functions such as private healthcare providers) must comply with obligations under the Human Rights Act 1998 (HRA) and the Equality Act 2010. Under the HRA, public authorities such as NHSE&I and NHS trusts must act in accordance with the European Convention on Human Rights (ECHR), including • • •

The right to life (Article 2); Freedom from torture and inhuman or degrading treatment (Article 3); and Protection from discrimination in respect of the enjoyment of these rights and freedoms (Article 14).

The Equality and Human Right Commission (EHRC), the non-departmental public body in England and Wales responsible for the promotion and enforcement of equality and nondiscrimination laws, states that, in a medical context, Article 2 ECHR requires public authorities, such as NHSE&I and NHS trusts, to have effective administrative and regulatory systems in place to protect patients from professional incompetence which results in death.Where there is a real and immediate risk of a patient committing suicide,Article 2 ECHR also requires public authorities to do all they reasonably can to prevent the patient doing so. Under Article 3 ECHR, public authorities must not subject patients to treatment that is inhuman or degrading.They should also do all they reasonably can to protect patients who are at a real and immediate risk of self-harm or of being harmed by others. Under Article 14 ECHR, public authorities are required to ensure that the rights and freedoms set out in the Convention, including those listed earlier, are enjoyed by everyone without discrimination on the basis of sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth, or other status. Articles 2 and 3 ECHR also place an obligation on the state and its agencies to ensure that an independent official body carries out an effective public investigation into any death for which the state might be responsible and into any incident where there are clear indications that serious ill treatment may have occurred. Case law makes it clear that there should not only be a ‘lack of hierarchical or institutional connection but also a practical independence’ between the investigator and investigatee.14

14 Al-Skeini v United Kingdom (Application No 55721/07) https://hudoc.echr.coe.int/fre#%7B%22itemid %22:[%22001-105606%22]%7D.

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The Equality Act 2010 protects individuals with protected characteristics from discrimination and promotes a fair and more equal society. Section 149 of the Equality Act 2010 requires public authorities and those exercising a public function to comply with a general duty to have due regard to the need to eliminate unlawful discrimination, harassment, and victimisation; advance equality of opportunity between different groups; and foster good relations between different groups. In order to have due regard to the general duty, public authorities, such as NHSE&I and NHS trusts, must collect and publish information on people who share protected characteristics and who are affected by their policies and practices.15 United Nations Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment

The EHRC suggests that NHSE&I should be particularly mindful of the obligations under Article 14 of the United Nations Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment that requires the state (including its agencies) to ensure that victims of torture or ill-treatment have a right to obtain redress. The Committee against Torture has clarified that the right to obtain redress includes the right to satisfaction and guarantees of non-repetition.16

Human rights and healthcare How does this legal framework on human rights in the UK apply to health and social care services in practice? Citizens Advice, a network of advice charities, identifies Articles 2, 3, 5, 8, and 14 ECHR as potentially applicable for accessing health or care services.17 Public bodies must respect these rights when commissioning, planning, and providing individuals with health or care services. Here we will consider how three of these may impact on the planning and provision of services. Article 2 ECHR – the right to life

This is the right that means nobody can try to end your life and that you have a right to be protected when your life is at risk. Healthcare providers should consider this when they make decisions that may affect an individual’s life expectancy. Examples of where this may become relevant could be where a patient in hospital has a do not attempt resuscitation (DNAR) form placed on their file without their consent or where an individual has died as a result of neglect or mistreatment.

15 The Equality Act 2010 (Specific Duties and Public Authorities) Regulations 2017 www.legislation.gov.uk/uk dsi/2017/9780111153277/contents accessed 4 November 2020.This specifies that Monitor and the NHS Trust Development Authority may jointly comply with the obligations imposed by these Regulations as if they were a single public authority. 16 UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, General Comment No 3 to the Committee against Torture. Implementation of Article 14 by States Parties (19 November 2012). 17 Citizens Advice, ‘Protecting Your Human Rights When Using Health and Care Services’ www.citizensadvice .org.uk/health/discrimination-in-health-and-care-services/taking-action-about-discrimination-in-health-andcare-services/protecting-your-human-rights-when-using-health-and-care-services/ accessed 2 November 2020.

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Helen Hughes Article 3 ECHR – the right not to be tortured or treated in an inhuman or degrading way

This right is intended to provide protection against serious harm and degrading treatment. In a healthcare context, an example where Article 3 has been violated could be cases where patients have received very poor care and treatment in a hospital or any other care setting. Article 5 ECHR – the right to liberty and security

This article focuses on a person’s right not to be detained against their will unless it is allowed by law. In healthcare, this can have salience where patients have mental health issues, where they may have been unduly restrained or secluded, or where the reasons for detention have not been properly reviewed or followed.

Equality and healthcare As noted, the legal framework in the UK incorporates not only human rights but related legislation focused on preventing discrimination because of the Equalities Act 2010.This has been an area of increasing focus for patient safety in the UK in recent years. Despite this increased focus, the EHRC states that NHS organisations still do not systematically collect or publish patient safety equality information that would allow understanding of whether unsafe care is systematically biased and discriminatory of those with protected characteristics under the Equality Act 2010.Without this, we are therefore reliant on specialist reports and the voice of campaigners to identify evidence of inequality and avoidable harm. Patient Safety Learning,18 the charity of which I am chief executive, has collated examples from patient groups and formal reports where there appears to be systematic bias in the access to safe care for many patients. Learning disabilities and autism

Patients with learning disabilities, autism, or both, can encounter difficulties when accessing NHS services and have much poorer experiences than the general population. Many inquiries and investigations have found that some NHS trusts are failing to adequately respect and protect people’s rights, with devastating consequences for them and their families. This issue is exacerbated by a skills deficit in the healthcare workforce, meaning that people’s needs are sometimes being misunderstood or responded to inappropriately. As a result of these failings, people with learning disabilities or autism can be put at risk of preventable, premature death and a grossly impoverished quality of life.19

18 See www.patientsafetylearning.org/. Patient Safety Learning is a charity and independent voice for patient safety. It harnesses the knowledge, enthusiasm, and commitment of healthcare organisations, professionals, and patients for system-wide change and the reduction of harm. Patient Safety Learning believes that patient safety is not just another priority; it is a core purpose of health and social care. Patient safety should not be negotiable. 19 NHSE&I, The Learning Disability Improvement Standards for NHS Trusts (NHSE&I June 2018) www.england.nhs .uk/wp-content/uploads/2020/08/v1.17_Improvement_Standards_added_note.pdf accessed 02 November 2020; National Quality Board, ‘National Guidance on Learning from Deaths’ (updated 5 February 2018) https ://www.england.nhs.uk/publication/national-guidance-on-learning-from-deaths/ accessed 2 November 2020.

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There are a range of well-known and documented patient safety risks for people experiencing mental health difficulties, such as suicide and serious harm within adult mental healthcare pathways, and falls, violence, and aggression within dementia care pathways.20 A recent review by Bethan Thibaut et al. found that there is a lack of research on what is required to make patient safety improvements at a system level in mental healthcare, in contrast to that in physical healthcare.21 They also noted that there has been a lack of focus on managing the physical health of people living with serious mental health conditions. It was also noted by them that the latter were twice as likely to die prematurely and much more likely to develop long-term conditions or become disabled, compared to those without serious mental illness.22 Race and ethnic background

There is also an increasing number of concerns being raised that highlight the intersection between race, ethnic background, and patient safety.23 A recent prominent example of this has emerged from the COVID-19 pandemic. In the first wave in the UK, black people were found to be 1.9 times more likely to die from COVID than white people.The reasons for this appear to be a complex mix of socio-economic determinants of health, with Public Health England reporting that structural racism could also play a part: Historic racism and poorer experiences of healthcare or at work may mean that individuals in BAME [Black,Asian, and minority ethnic] groups are less likely to seek care when needed or as NHS staff are less likely to speak up when they have concerns about Personal Protective Equipment (PPE) or risk.24 Another issue that has received more recent interest is disparities in maternal mortality rates, with black women in the UK five times more likely than white women to die during pregnancy or childbirth.25 The campaign group Fivexmore has been at the forefront of raising awareness of this disparity and opened an official UK Government and Parliament petition calling for more research into this and for steps to be taken to urgently improve healthcare for black women.26

20 The Health Foundation, Safer Care Pathways in Mental Health Services: Hertfordshire Partnership NHS Foundation Trust www.health.org.uk/improvement-projects/safer-care-pathways-in-mental-health-services accessed 27 October 2020. 21 B Thibaut, LH Dewa, SC Ramtale et al.,‘Patient Safety in Inpatient Mental Health Settings:A Systematic Review’ (2019) 9 e030230 BMJ Open https://bmjopen.bmj.com/content/9/12/e030230 accessed 2 November 2020. 22 ibid. 23 Hysterical Women, ‘Introducing Black Women’s Health Matters’ (Hysterical Women, 30 September 2020) https:/ /hystericalwomen.co.uk/2020/09/30/introducing-black-womens-health-matters/ accessed 2 November 2020. 24 Public Health England, Beyond the Data: Understanding the Impact of COVID-19 on BAME Groups (Public Health England 2020) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/ file/892376/COVID_stakeholder_engagement_synthesis_beyond_the_data.pdf accessed 2 November 2020. 25 Maternal, Newborn and Infant Clinical Outcome Review Programme,‘Saving Lives, Improving Mothers’ Care’ (MBRRACE-UK, November 2018) www.npeu.ox.ac.uk/assets/downloads/mbrrace-uk/reports/MBRRACE -UK%20Maternal%20Report%202018%20-%20Web%20Version.pdf accessed 2 November 2020. 26 Fivexmore, ‘Black Women in the UK Are Five Times More Likely to Die in Pregnancy and Childbirth’ www .fivexmore.com/ accessed 2 November 2020; UK Government and Parliament Petitions, Improve Maternal Mortality Rates and Health Care for Black Women in the UK https://petition.parliament.uk/petitions/301079 accessed 30 October 2020

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The relationship between patient safety and human rights: practical examples There is clearly a close relationship between reducing avoidable harm and upholding human rights, specifically the right not to be tortured or treated in an inhuman or degrading way, the right to liberty, and the right to life. Having highlighted this, I will now focus on some current issues in UK healthcare where the failure to address patient safety can be seen to be as a failure to meet human rights obligations. These examples sit within the broader context of the NHS and its five-year Patient Safety Strategy.27 In its initial response to the consultation on this strategy, the EHRC stated: Complying with obligations under equality and human rights law is not only a matter of legal compliance; it will help NHSI ensure that its Strategy focuses on improving patient safety in a truly transparent and accountable way that respects the rights of patients and of their families/carers.28 The EHRC said that increased transparency and accountability would go some way to ensure that concerns raised by families and patients are not ignored and provide a way for the government to ensure that patients’ rights to obtain redress in accordance with the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment are upheld.29 The EHRC referred specifically to the case of Gosport Memorial Hospital, where the Secretary of State for Health and Social Care stated that ‘more than 100 families raised concerns over more than two decades, [who] were ignored and patronised.’

Failing to learn and act on that learning Sir Liam Donaldson, author of the seminal report into learning from adverse events in the NHS, An Organisation with a Memory, stated that ‘to err is human, to cover up is unforgiveable and to fail to learn is inexcusable.’30 The tragedy of the last 20 years since the publication of this report is that, although healthcare systems now pay more attention to patient safety, there are still shockingly large numbers of patients dying or suffering avoidable harm.31 Healthcare organisations are failing to act on learning from investigations into unsafe care. Healthcare systems are incredibly complex and,

27 NHS England and NHS Improvement, The NHS Patient Safety Strategy: Safer Culture, Safer Systems, Safer Patients (NHS England and NHS Improvement July 2019) https://improvement.nhs.uk/documents/5472/190708_P atient_Safety_Strategy_for_website_v4.pdf accessed 2 November 2020. 28 EHRC, Our Response to the NHS Improvement Consultation on Developing a Patient Safety Strategy (EHRC February 2019) www.equalityhumanrights.com/sites/default/files/consultation-response-nhs-improvement-national-patie nt-safety-strategy.docx accessed 2 November 2020. 29 House of Commons, Gosport Independent Panel (Volume 649, 21 November 2018) https://hansard.parliament .uk/Commons/2018-11-21/debates/50E27409-872C-411A-BC37-C86CF039EF45/GosportIndependentPan el accessed 2 November 2020. In the case of Gosport Memorial Hospital, the Secretary of State for Health and Social Care stated that ‘more than 100 families raised concerns over more than two decades, but they were ignored and patronised.’ 30 Liam Donaldson, An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer (2000) https://webarchive.nationalarchives.gov.uk/20130105144251/ht tp://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4065 086.pdf accessed 2 November 2020. 31 WHO,‘Patient Safety Fact File’ (WHO, September 2019) www.who.int/features/factfiles/patient_safety/patient -safety-fact-file.pdf?ua=1 accessed 2 November 2020.

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many would argue, not been designed for safety in the way that other safety-critical industries have developed. There are many requirements for healthcare providers to undertake investigations into serious incidents, to identify causal factors, to act for service improvement, and to prevent avoidable harm.There is evidence that • • •

These requirements are inadequate in identifying the underlying causal factors that lead to unsafe care. It is not sufficient to identify what happened and by whom; we need to understand why to inform action for improvement.32 The recommendations from these inquiries, reports, research, and investigations, even when accepted, do not lead to action that is applied consistently across the whole healthcare system. Learning from incidents is not widely applied, thereby preventing action being taken in other areas to prevent harm.33

If it is to act on its commitment and adherence to human rights legislation and patient safety good practice, the NHS should urgently and demonstrably implement the recommendations of the many regular and specifically commissioned reports into unsafe care.These include: • • • • • • • •

Reports from the Healthcare Safety Investigation Branch; Serious incident investigation reports conducted by NHS organisations; Coroners’ Prevention of Future Deaths reports; Regulatory reports by the Care Quality Commission (CQC); Independent reviews by professional bodies such as the Royal Colleges; Parliamentary and Health Service Ombudsman reports; Inquiries commissioned by the Secretary of State for Health and Social Care, such as Mid Staffordshire, Morecambe Bay, Gosport, Cumberlege Review, and Paterson Inquiry;34 and Inquiries commissioned by the Secretary of State that are still pending publication, such as Liverpool Community Health, Shrewsbury and Telford, and East Kent.

32 Parliamentary and Health Service Ombudsman, A Review into the Quality of NHS Complaints Investigations (Parliamentary and Health Service Ombudsman) www.ombudsman.org.uk/sites/default/files/A_review_into_ the_quality_of_NHS_complaints_investigations_where_serious_or_avoidable_harm_has_been_alleged.pdf accessed 2 November 2020; NHS Improvement, The Future of NHS Patient Safety Investigation (NHS Improvement March 2018) https://improvement.nhs.uk/documents/2525/The_future_of_NHS_patient_safety_investigat ions_for_publication_proofed_5.pdf accessed 2 November 2020. 33 Parliamentary and Health Service Ombudsman, A Review into the Quality of NHS Complaints Investigations (Parliamentary and Health Service Ombudsman) www.ombudsman.org.uk/sites/default/files/A_review_into_ the_quality_of_NHS_complaints_investigations_where_serious_or_avoidable_harm_has_been_alleged.pdf accessed 2 November 2020. 34 Robert Francis QC, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry (The Stationary Office 2013) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/2791 24/0947.pdf accessed 2 November 2020; Bill Kirkup, The Report of the Morecambe Bay Investigation (2015) https:// assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/408480/47487_M BI_Accessible_v0.1.pdf accessed 2 November 2020;The Right Reverend James Jones KBE, Gosport War Memorial Hospital:The Report of the Gosport Independent Panel (The Stationary Office 2018) www.gosportpanel.independ ent.gov.uk/media/documents/070618_CCS207_CCS03183220761_Gosport_Inquiry_Whole_Document.pdf accessed 2 November 2020.;The Independent Medicines and Medical Devices Safety Review, First Do No Harm (8 July 2020) www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf accessed 02 November 2020.

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In the UK, the number of deaths resulting from patient safety incidents annually is estimated at 11,000.35 In failing to learn from these incidents and not fully implementing the recommendations stemming from investigation reports, how much serious harm could have been avoided? In this context, a failure to act on this evidence could be considered a breach of a patient’s human rights, where such action would have prevented death, serious harm, and/or future avoidable harm.

Failing to listen to patients and act on their concerns Patients’ experiences are a vital source of insight that can be used to help identify patient safety problems, better understand their causes, and inform remedial measures to prevent harm from recurring. However, a recurring theme of patient safety scandals is that patients’ views are too often overlooked or disregarded. One example of this is in the findings of the Independent Medicines and Medical Devices Safety (IMMDS) Review, published in July 2020.This report examined how the healthcare system in England responded to reports about the harmful side effects from medicines and medical devices.36 It focused on safety issues relating to three medical interventions: hormone pregnancy tests, sodium valproate, and pelvic mesh implants. The review’s findings highlighted a shocking scale and severity of avoidable harm over a period of several decades.The inquiry chair, Baroness Julia Cumberlege, stated that that she and members of her team had never encountered anything like this before – the intensity of suffering, the fact that it has lasted for decades, and the sheer scale of harm.The exact numbers of those affected by safety issues from these interventions is not known but is estimated to be in the tens of thousands. Baroness Cumberlege also commented that if the physical, developmental, and emotional harm were not enough, these families had to fight to be listened to and to be taken seriously. A theme running throughout the review findings was a healthcare system – which includes the NHS, private providers, regulators and professional bodies, manufacturers, and policymakers – that was disjointed, siloed, unresponsive, and defensive. A serious consequence of this is that patients are not adequately recognised as the sole purpose of the system, with a failure to listen to their concerns. A second less high-profile example of a failure to listen to patient concerns, that has been raised directly with Patient Safety Learning, is women who experience painful hysteroscopy procedures.37 In these cases, women are suffering avoidable harm where good practice is not being implemented consistently and where patient harm is not being prevented or recorded. The existing system in the UK provides incentives that result in a reduction in access to anaesthesia for painful procedures, and women often find that they are not given information that enables them to make informed decisions. Despite years of work, many groups campaigning for pain-free hysteroscopies say they are not being listened to, that women continue to experience avoidable extreme pain, and that, despite questions to Parliament and numerous efforts to promote their cause, they are yet to receive an official acknowledgement, response, and action from the NHS.

35 NHS England and NHS Improvement, The NHS Patient Safety Strategy (n 27). 36 The Independent Medicines and Medical Devices Safety Review (n 34). 37 Patient Safety Learning’s the hub, Painful hysteroscopy www.pslhub.org/forums/topic/68-painful-hysteroscopy/ accessed 2 November 2020.

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In both the cases covered by the IMMDS review and the experiences of women who have had painful hysteroscopy procedures, the common link is of patients not being listened to and action not being taken to address unsafe care. Responsible parties who knew, or should have known, about the scale of avoidable harm should have taken immediate action. But they did nothing, for years. Is that not a breach of human rights?

Restrictive practice and people with learning disabilities and/or autism Too often, people with learning disabilities and/or autism receive poor care while in hospital, which is, at times, undignified and inhumane. An example of this from a patient safety and human rights perspective is the issue of restrictive practice, highlighted in a recent report by the health and social care regulator, the CQC, in 2020.This was prompted by a BBC Radio programme in 2018 which highlighted the increased use of restraints on adults with learning disabilities in hospital units.38 This was not the first time such issues have been highlighted, with the Mansell Report having highlighted issues of restrictive practice back in 2008 and, more recently in 2019, the high-profile case of abuse and undue use of restraints at Wholton Hall Hospital.39 The CQC report found cases where physical restraint was a normal part of the culture, with cases of patients secluded or segregated for 13 years.40 This review shows that, for some people who need complex care, the system let them down: People told us that when they were restrained it could often re-traumatise them and have a lasting impact on their mental health.They told us that it felt like they were at times not seen as human or equal because they were completely powerless.41 In 2015, Public Health England reported that every day in England 30,000 to 35,000 people with a learning disability are prescribed psychotropic medicines when they do not have a mental health condition.42 The CQC found in its review that several types of chemical restraints were used to control people’s behaviour. Such actions run contrary to good practice guidance, such as the principles of STOMP (stopping over medication of people with a learning disability,

38 BBC News,‘“Shameful” use of restrains on disabled patients’ BBC News (2 October 2018) www.bbc.co.uk/news /uk-45652339 accessed 2 November 2020. 39 J Mansell, ‘Services for People with Learning Disabilities and Challenging Behaviour or Mental Health Needs’ (October 2007) https://webarchive.nationalarchives.gov.uk/20130124041359/http://www.dh.gov.uk/prod _consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_080128.pdf accessed 2 November 2020.; BBC News,‘Whorlton Hall: Hospital “Abused”Vulnerable Adults’ BBC News (22 May 2019) www.bbc.co .uk/news/health-48367071 accessed 2 November 2020. 40 CQC, Out of Sight – Who Cares? A Review of Restraint, Seclusion and Segregation for Autistic People, and People with a Learning Disability and/or Mental Health Condition (CQC October 2020) www.cqc.org.uk/sites/default/files/ 20201023_rssreview_report.pdf 41 ibid. 42 Public Health England, Prescribing of Psychotropic Medication for People with Learning Disabilities and Autism (Public Health England July 2015) https://webarchive.nationalarchives.gov.uk/20160704152031/https://www.improv inghealthandlives.org.uk/publications/1248/Prescribing_of_psychotropic_medication_for_people_with_le arning_disabilities_and_autism accessed 2 November 2020.

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autism or both with psychotropic medicines) and STAMP (supporting treatment and appropriate medication in paediatrics).43 The report notes that these issues are ‘potential abuses of human rights’ and the inappropriate placements people have been suffering in are not a newly emerging problem.44 While there is guidance available as to what good care looks like, this is not consistently followed, and when things do go right for an individual in care it is ‘too often despite the system not because of it.’45 There is a clear need in these cases for the government, NHS organisations, and local authorities to come together to remove the barriers that have stopped people from getting the care they need for too long. There have clearly been missed opportunities to improve the lives of people with autism and people with a learning disability and/or mental health condition and of those whose behaviour others find challenging. Immediate action is needed to put an end to the abuses in human rights that are evident from this review.This action must be owned and led from the top by government, delivered by local systems working together, and involve people and their families to ensure the needs of individuals are met.

Private hospitals not meeting patient safety standards In the UK, there is a significant independent acute healthcare sector which provides a range of healthcare services, some of which are self-funded by patients through medical insurance and others directly commissioned by the NHS.Where there are deficiencies in safety in these services, can they be held accountable as breaching human rights issues? In a recent inspection, the CQC found that two-fifths of private hospitals in the UK were not meeting basic patient safety standards, giving 30% of the 206 private hospitals it inspected a ‘requires improvement’ rating.46 The main areas of concern the CQC cited were around safety and leadership. Issues noted by the inspection report included: • • • •

Lack of a culture of learning from incidents; Weaknesses in safety incident reporting; Lack of formalised governance procedures; and In some hospitals, lack of oversight and monitoring of consultants working under practising privileges.

Commenting on the report, the not-for-profit human rights organisation Each Other has highlighted several key human rights issues in relation to private healthcare, patient safety, and human rights.47 Each Other notes that it may be difficult to act on these issues as a breach of human

43 NHS England and NHS Improvement, Stopping Over Medication of People with a Learning Disability,Autism or Both (STOMP), www.england.nhs.uk/learning-disabilities/improving-health/stomp/ accessed 2 November 2020. 44 CQC, Out of Sight – Who Cares? (n 40). 45 Stephen Bubb, Winterbourne View – Time for Change: Transforming the Commissioning of Services for People with Learning Disabilities and/or Autism (2014) www.england.nhs.uk/wp-content/uploads/2014/11/transforming-c ommissioning-services.pdf accessed 2 November 2020. 46 CQC, The State of Care in Independent Hospitals (CQC April 2018) www.cqc.org.uk/sites/default/files/state-care -independent-acute-hospitals.pdf accessed 2 November 2020. 47 Each Other, ‘40% of Private Hospitals Failing Patient Safety Standards – Can Human Rights Help?’ (11 April 2018) https://eachother.org.uk/health-watchdog-reports-concerns-about-patient-care-and-safety-in-private-h ospitals/ accessed 2 November 2020.

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rights because the HRA in the UK generally only applies to public bodies, but where such organisations are providing NHS services and performing public functions, this may be applicable. In its inspection role, Each Other notes that the CQC can address human rights issues through its own powers or by referral to the EHRC.48 While this CQC report focuses on the independent sector more broadly, another highprofile example of issues of unsafe care in the private setting was the malpractice of surgeon Ian Paterson, a breast surgeon who was jailed for 20 years in 2017 after being convicted of wounding with intent.49 The inquiry into this case took evidence from more than 200 patients, and it is estimated that Paterson could have harmed more than 1000 patients.The inquiry stated that this was ‘the story of a healthcare system which proved itself dysfunctional at almost every level when it came to keeping patients safe, and where those who were the victims of Paterson’s malpractice were let down time and time again.’50 Analysing the inquiry’s findings in February 2020, Patient Safety Learning highlighted concerns that this may become yet another report of unsafe care where sympathetic noises are made but no real learning and change occurs.51 Eight months on from the report’s publication, the government has yet to provide a formal response to the report and its recommendations. As stated earlier, how can the public be assured that there will not be future harm if there are repeated failures to learn from patient safety incidents? As the inquiry chair said,‘it is wishful thinking that this could not happen again.’52 Could this failure to act, and prevent possible future harm, again be seen as a potential breach of a patient’s right to safe care?

Do not resuscitate forms and patient consent Earlier in this chapter, I considered Article 2 of the Human Rights Act, the right to life, providing an example of the use of DNAR forms without the patient’s or family member’s consent. This has been clearly been established as a human rights issue in the UK, with the case David Tracey took to the High Court and Court of Appeal after his wife, Janet, who had terminal lung cancer, had a do not attempt cardiopulmonary resuscitation (DNACPR) notice put in her records by her hospital without consultation. The appeal court declared in 2014 that this had violated her rights under Article 8 ECHR in failing to involve her in the process.53 The court held that the patient must be involved unless the doctor thinks that this would cause distress and that the distress might cause the patient harm.54 DNAR forms and consent have re-emerged as a major issue in the UK during the first wave of the COVID-19 pandemic, specifically in relation to care home residents.A survey of care staff carried out by the Queen’s Nursing Institute International Community Nursing Observatory

48 CQC, Human Rights Approach to Regulation www.cqc.org.uk/sites/default/files/20180205%20Human%20rights %20approach%20infographic%20REVISED%20FINAL.pdf accessed 2 November 2020. 49 Jones (n 34). 50 ibid. 51 Patient Safety Learning, The Paterson Inquiry:Are There Any New Lessons for Patient Safety? Will There Be Any Action? (11 February 2020) www.patientsafetylearning.org/blog/the-paterson-inquiry-are-there-any-new-lessons-for -patient-safety accessed 2 November 2020. 52 James (n 34). 53 David Tracey v University Hospitals Cambridge NHS Foundation Trust and Secretary of State for Health (2014) EWCA Civ 33 www.bailii.org/ew/cases/EWCA/Civ/2014/33.html accessed 2 November 2020. 54 ibid.

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found that a major concern for staff was being told that they had to accept patients from hospitals without knowing patients’ COVID-19 statuses, as well as not being consulted when plans were made not to resuscitate residents (without residents or their families being consulted either). The survey revealed that a decision had been made at a high level, asking UK care homes to automatically label all their residents with DNAR forms. Disability activists have raised concerns about the discriminatory aspect of these, stating that these type of blanket decisions would never have been commissioned for a group of able-bodied people.55 Health and social care staff anonymously have noted they found this blanket decision to be challenging, both ethically and professionally. Such DNAR decisions are reported as being made for elderly residents without any discussion with the patient, their families, or even care home staff who know them. Concerns about this have now been escalated to the legislative level, being highlighted as an issue at the hearings for the All-Party Parliamentary Group (APPG) for Coronavirus.56 The CQC has been asked by the Department of Health and Social Care to investigate these concerns.57 The CQC has stated that it is unacceptable for advance care plans, with or without DNAR form completion, to be applied to groups of people of any description; decisions must be made on an individual basis, according to need. It will be of significant interest to see whether this review will consider that blanket DNAR measures are a breach of human rights. In a recent report, the Joint Committee on Human Rights (JCHR) in Parliament appears to strongly support this position, stating: The blanket imposition of DNACPR notices without proper patient involvement is unlawful.The evidence suggests that the use of them in the context of the COVID-19 pandemic has been widespread.58

Treatment of children in secure healthcare settings The UK is under international and domestic legal obligations to ensure that children are not subject to cruel, inhuman, or degrading treatment. It must comply with obligations and ensure that children in detention are not subject to solitary confinement or unnecessary or disproportionate uses of restraint. In its report looking at human rights issues during the COVID-19 pandemic, the JCHR expressed its concerns about the rights of people in various types of detention.59 It referred to a number of different settings, including those in secure healthcare settings, such as mental health units.The JCHR concluded that the use of solitary confinement breaches the rights of children in detention, and where it is prolonged, the rights of adults. It noted that there are risks the

55 Open Access Government, Care Homes Told to Label Residents as Do Not Resuscitate (Open Access Government 24 August 2020) www.openaccessgovernment.org/do-not-resuscitate/93223/ accessed 2 November 2020. 56 All-Party Group on Coronavirus, Oral Evidence Session 3 (12 August 2020) https://d3n8a8pro7vhmx.cloudfront .net/marchforchange/pages/344/attachments/original/1597776197/239125_APPG_on_Coronavirus_Session_ 3_TSC.pdf?1597776197 accessed 2 November 2020. 57 CQC, CQC to Review the Use of DNACPR during Pandemic (CQC 2020) www.cqc.org.uk/news/stories/cqc-rev iew-use-dnacpr-during-pandemic accessed 2 November 2020. 58 Joint Committee on Human Rights, The Government’s Response to COVID-19: Human Rights Implications (14 September 2020) https://committees.parliament.uk/publications/2649/documents/26914/default/ accessed 2 November 2020. 59 ibid.

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measures taken during lockdown and beyond that have breached the right to family life of both those detained and of their loved ones. This is not a new issue for the JCHR, which in 2019 highlighted concerns about subjecting children to pain-inducing restraints in young offender institutions and solitary confinement for more than 22 hours a day, stating that these should be made illegal.60 Painful restraints and isolation cause physical distress and psychological harm in the short and long term, and are not compliant with human rights standards.61 The United Nations (UN) special rapporteur on torture and leading child health experts have stated that the UK government’s policy of allowing children in detention in England and Wales to be locked alone in their cells for up to 23 hours a day under emergency COVID-19 measures is ‘extreme and inhumane’ and could lead to lifelong mental health damage.62 Since March 2020, facilities have been able to keep children as young as 12 confined alone in their cells for all but around 40 minutes a day.The measures, which were put in place to stop potential COVID-19 outbreaks, affect around 500 under 18-year-olds in youth detention and another 4000 18- to 21-year-olds held in adult prisons. Professor Nils Melzer, the UN special rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, told the Guardian that solitary confinement is so damaging to children that it should never have been seen as a reasonable response to the threat of COVID-19 infections.‘Its use should be exceptional, and, in most cases, there should be different measures to stop the spread of COVID. These kinds of stress factors are likely to affect this young generation for decades to come. If they spend a year like this it could affect their whole life.’ Dr Alison Steele is a consultant paediatrician and officer for child protection at the Royal College of Paediatrics and Child Health (RCPCH), which, alongside the British Medical Association, has called for an end to the solitary confinement of children in detention.‘It is very clear that solitary confinement is harmful to children and young people,’ she said. ‘It damages their health and increases the risk of self-harm and suicide.’ The justice minister,Wendy Morton, said at the time:‘It is difficult to read this report and not conclude that we are failing some of the children in our care – that is completely unacceptable and I am determined it will not continue.’63

Tackling unsafe care Improving patient safety is a critical global health challenge.As I have highlighted from the different examples in this chapter, when health and social care systems fail to address unsafe care and avoidable harm, there is a strong case to be made that this could be considered a breach of a patient’s human rights. What can be done to address the issue of unsafe care? As mentioned earlier, the scale of this challenge is recognised by international bodies such as the WHO and OECD. Recognising this, the WHO, in August 2020, published the first draft of a Global Patient Safety Action Plan

60 Owen Bowcott,‘End “Pain-Inducing” Restraints on Child Offenders, MPs Urge’ The Guardian (19 April 2019) www.theguardian.com/society/2019/apr/19/end-pain-inducing-restraints-on-child-offenders-mps-urge accessed 2 November 2020. 61 ibid. 62 Bowcott (n 60). 63 James Grierson, ‘Children in Solitary Confinement for 23 Hours a Day, Says Report’ The Guardian (21 January 2020) www.theguardian.com/society/2020/jan/21/children-solitary-confinement-prisons-england-wales accessed 2 November 2020.

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2021–2030. It sets out a vision of a ‘world in which no patient is harmed in healthcare, and everyone receives safe and respectful care, every time, everywhere,’ and outlines a set of strategic objectives and actions to help achieve this.64 While this global call for action is welcome, to tackle unsafe care we need to understand why this problem stubbornly continues, despite an increased interest and focus on patient safety, particularly from the 1990s onwards.65

Why does unsafe care persist? The provision of health and social care is complex, with failures in patient safety being a systemic issue where • • • • • • • • •

Patient safety is often not regarded as a core purpose of health and social care by leaders, but merely one priority of many that is negotiable; Organisations do not take ‘all reasonable and practical steps’ to improve patient safety; There are no organisational standards for patient safety, with approaches to improvement often being insufficient and inconsistent; We focus too much on responding to, and mitigating the risk of, harm rather than designing healthcare to be safe for patients and for the staff who work within it; We do not learn well enough or share or act on that learning for patient safety; Staff working in healthcare are not ‘suitably qualified and experienced’ for patient safety and are not properly supported by leaders and specialists in safety design and human factors; Patients are not sufficiently engaged in their safety during care and after harm, patients need to be part of the team; We do not have good ways of measuring and improving performance for safe care; and A culture of blame and fear undermines our ambitions to design and deliver safer care.

Taken together, these underlying issues translate into a recurring range of practical patient safety failures in healthcare, such as diagnostic errors, medication errors, insufficient infection control, unsafe surgery, and risks to staff safety that themselves create patient safety issues.66 An increased focus on patient safety encourages learning from good practice as well as investigations into unsafe care. We should understand risk and share knowledge to implement improvement initiatives. However, if we are to tackle the wider systemic causes, we need to think and act differently to make the transformational change needed to realise a patient-safe future and reduce avoidable harm.

Creating a patient-safe future In health and social care, patient safety is often considered as one of several potential competing strategic priorities.These priorities are weighed against others, with organisations and individu-

64 WHO, Global Patient Safety Action Plan 2021–2030:Towards Zero Patient Harm in Health Care – First Draft (WHO August 2020) www.who.int/docs/default-source/patient-safety/1st-draft-global-patient-safety-action-plan -august-2020.pdf?sfvrsn=9b1552d2_4 accessed 2 November 2020. 65 Institute of Medicine (US) Committee on Quality of Health Care in America; LT Kohn, JM Corrigan, and MS Donaldson (eds), To Err Is Human: Building a Safer Health System (National Academies Press (US) 2000) www.ncbi .nlm.nih.gov/books/NBK225182/ accessed 2 November 2020. 66 Patient Safety Learning, ‘Why Is Staff Safety a Patient Safety Issue?’ (Patient Safety Learning, 3 September 2020) www.patientsafetylearning.org/blog/why-is-staff-safety-a-patient-safety-issue accessed 2 November 2020.

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als then deciding which take precedence.This approach to patient safety results in patient safety becoming a matter of choice. In A Blueprint for Action, Patient Safety Learning makes the case that patient safety cannot simply be just another priority of health and social care; patient safety needs to be core to the purpose of health and social care, reflected in everything that it does.67 To help achieve this, Patient Safety Learning has identified six foundations of safer care that should be used to ensure that patient safety is a core purpose of health and social care. Each foundation is accompanied by practical actions: 1) Shared learning – organisations should set and deliver goals for learning from patient safety, report on progress and share their insights widely. 2) Leadership – there should be an emphasis on the importance of overarching leadership for patient safety across the health and social care system. 3) Professionalising patient safety – standards and accreditation for patient safety need to be developed and implemented. These need to be used by regulators to inform their assessment of safe care, with all staff trained and competent to manage risk and deliver safe care. 4) Patient engagement – organisations should encourage and support the actions necessary to ensure patients are valued and engaged in their care and in patient safety improvement. 5) Data and insight – we need better measuring, reporting, and assessing of patient safety performance, quantitative as well as qualitative data. 6) Just culture – health and social care organisations should develop programmes and publish goals to eliminate blame and fear, introduce or deepen a just culture, and measure and report their progress. By focusing on designing and delivering healthcare as a safe system in this way, I believe that we can make a significant leap forward in patient safety and the right to safe care.

Delivering the right to safe care At the beginning of this chapter, I noted that how patient safety relates to the right to health and human rights is a relatively underexplored issue. I have sought to investigate this more closely, drawing on examples from the UK to demonstrate where patient safety can be a seen as human rights issue.These examples are all within the UK context – a high-income country, where the public healthcare is predominantly free at the point of delivery. How we consider the interaction of patient safety and human rights may differ considerably in low- and middle-income countries, where healthcare priorities and challenges substantially differ and with different legislative contexts. Further research is needed on the relationship between patient safety and human rights in a wider range of countries. Patient Safety Learning believes the right to healthcare is a right to safe care, and that, in order to provide patients with this right, healthcare systems need to place patient safety at the core of their purpose, reflected in everything they do. The WHO’s Global Patient Safety Action plan provides a good foundation for this at a global level, but individual countries also need to have in place system-wide leadership, culture, and

67 Patient Safety Learning, ‘The Patient-Safe Future: A Blueprint For Action’ (Patient Safety Learning 2019) https ://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=20190701 143409 accessed 2 November 2020.

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governance frameworks to design, deliver, and share improvements in patient safety. Without this, will we really be delivering people’s right to safe care?

References All-Party Group on Coronavirus, Oral Evidence Session 3 (12 August 2020) https://d3n8a8pro7vhmx.cl oudfront.net/marchforchange/pages/344/attachments/original/1597776197/239125_APPG_on_ Coronavirus_Session_3_TSC.pdf?1597776197 accessed 2 November 2020. Andel, C, Davidow, SL, Hollander, M, and Moreno, DA, ‘The Economics of Health Care Quality and Medical Errors’ (2012) 39(1) Journal of Health Care Finance https://pubmed.ncbi.nlm.nih.gov/231 55743/ accessed 2 November 2020. BBC News,‘“Shameful” Use of Restrains on Disabled Patients’ BBC News (2 October 2018) www.bbc.co .uk/news/uk-45652339 accessed 2 November 2020. BBC News,‘Whorlton Hall: Hospital “Abused”Vulnerable Adults’ BBC News (22 May 2019) www.bbc.co .uk/news/health-48367071 accessed 2 November 2020. Bowcott, Owen,‘End “Pain-Inducing” Restraints on Child Offenders, MPs Urge’ The Guardian (19 April 2019) www.theguardian.com/society/2019/apr/19/end-pain-inducing-restraints-on-child-offenders -mps-urge accessed 02 November 2020. Bubb, Stephen, Winterbourne View – Time for Change:Transforming the Commissioning of Services for People with Learning Disabilities and/or Autism (2014) www.england.nhs.uk/wp-content/uploads/2014/11/tran sforming-commissioning-services.pdf accessed 2 November 2020. Citizens Advice,‘Protecting Your Human Rights When Using Health and Care Services’ www.citizensadv ice.org.uk/health/discrimination-in-health-and-care-services/taking-action-about-discrimination -in-health-and-care-services/protecting-your-human-rights-when-using-health-and-care-services/ accessed 2 November 2020. CQC, The State of Care in Independent Hospitals (CQC April 2018) www.cqc.org.uk/sites/default/files/ state-care-independent-acute-hospitals.pdf accessed 2 November 2020. CQC, CQC to Review the Use of DNACPR During Pandemic (CQC 2020) www.cqc.org.uk/news/stories/ cqc-review-use-dnacpr-during-pandemic accessed 2 November 2020. CQC, Out of Sight – Who Cares? A Review of Restraint, Seclusion and Segregation for Autistic People, and People with a Learning Disability and/or Mental Health Condition (CQC October 2020) www.cqc.org.uk/sites/ default/files/20201023_rssreview:report.pdf. CQC, Human Rights Approach to Regulation, www.cqc.org.uk/sites/default/files/20180205%20Human %20rights%20approach%20infographic%20REVISED%20FINAL.pdf accessed 2 November 2020. Donaldson, Liam, An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer (2000) https://webarchive.nationalarchives.gov.uk/20 130105144251/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/do cuments/digitalasset/dh_4065086.pdf accessed 2 November 2020. Each Other, ‘40% of Private Hospitals Failing Patient Safety Standards – Can Human Rights Help?’ (11 April 2018) https://eachother.org.uk/health-watchdog-reports-concerns-about-patient-care-and-safe ty-in-private-hospitals/ accessed 2 November 2020. EHRC, Our Response to the NHS Improvement Consultation on Developing a Patient Safety Strategy (EHRC February 2019) www.equalityhumanrights.com/sites/default/files/consultation-response-nhs-improv ement-national-patient-safety-strategy.docx accessed 2 November 2020. Evans, DP,‘You Have the Right to … Health?’ Medscape (3 March 2005) www.medscape.com/viewarticle /499688#vp_2 accessed 2 November 2020. Fivexmore, ‘Black Women in the UK Are Five Times More Likely to Die in Pregnancy and Childbirth’ www.fivexmore.com/ accessed 2 November 2020; UK Government and Parliament Petitions, Improve Maternal Mortality Rates and Health Care for Black Women in the UK https://petition.parliament.uk/peti tions/301079 accessed 30 October 2020. Francis QC, Robert, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry (Stationary Office 2013) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data /file/279124/0947.pdf accessed 2 November 2020. Grierson, James, ‘Children in Solitary Confinement for 23 Hours a Day, Says Report’ The Guardian (21 January 2020) www.theguardian.com/society/2020/jan/21/children-solitary-confinement-prisons-en gland-wales accessed 2 November 2020.

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Patient safety and human rights Hogan, H, Zipfel, R, Neuburger, J, Hutchings, A, Darzi, A, and Black, N, ‘Avoidability of Hospital Deaths and Association with Hospital-Wide Mortality Ratios: Retrospective Case Record Review and Regression Analysis’ (2015) 351 BMJ h3239 www.bmj.com/content/bmj/351/bmj.h3239.full.pdf accessed 2 November 2020. House of Commons, Gosport Independent Panel (Volume 649, 21 November 2018) https://hansard.parl iament.uk/Commons/2018-11-21/debates/50E27409-872C-411A-BC37-C86CF039EF45/Gospor tIndependentPanel accessed 2 November 2020. Hysterical Women, ‘Introducing Black Women’s Health Matters’ (Hysterical Women, 30 September 2020) https://hystericalwomen.co.uk/2020/09/30/introducing-black-womens-health-matters/ accessed 2 November 2020. Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn, LT, Corrigan, JM, and Donaldson, MS (eds), To Err Is Human: Building a Safer Health System (National Academies Press (US) 2000) www.ncbi.nlm.nih.gov/books/NBK225182/ accessed 2 November 2020. Joint Committee on Human Rights, The Government’s Response to COVID-19: Human Rights Implications (14 September 2020) https://committees.parliament.uk/publications/2649/documents/26914/def ault/ accessed 2 November 2020. Jones,The Right Reverend James, Gosport War Memorial Hospital:The Report of the Gosport Independent Panel (Stationary Office 2018) www.gosportpanel.independent.gov.uk/media/documents/070618_CCS207 _CCS03183220761_Gosport_Inquiry_Whole_Document.pdf accessed 2 November 2020. Kirkup, Bill, The Report of the Morecambe Bay Investigation (2015) https://assets.publishing.service.gov.uk/ government/uploads/system/uploads/attachment_data/file/408480/47487_MBI_Accessible_v0.1.pdf accessed 02 November 2020; Mansell, J, ‘Services for People with Learning Disabilities and Challenging Behaviour or Mental Health Needs’ (October 2007) https://webarchive.nationalarchives.gov.uk/20130124041359/http://www.dh .gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_080128 .pdf accessed 2 November 2020. Maternal, Newborn and Infant Clinical Outcome Review Programme,‘Saving Lives, Improving Mothers’ Care’ (MBBRACE-UK, November 2018) www.npeu.ox.ac.uk/assets/downloads/mbrrace-uk/repo rts/MBRRACE-UK%20Maternal%20Report%202018%20-%20Web%20Version.pdf accessed 2 November 2020. NHS England and NHS Improvement, The NHS Patient Safety Strategy: Safer Culture, Safe Systems, Safer Patients (NHS England and NHS Improvement July 2019) https://improvement.nhs.uk/documents /5472/190708_Patient_Safety_Strategy_for_website_v4.pdf accessed 2 November 2020. NHS England and NHS Improvement, Stopping Over Medication of People with a Learning Disability, Autism or Both (STOMP), www.england.nhs.uk/learning-disabilities/improving-health/stomp/ accessed 2 November 2020. NHS Improvement, The Future of NHS Patient Safety Investigation (NHS Improvement March 2018) https ://improvement.nhs.uk/documents/2525/The_future_of_NHS_patient_safety_investigations_for_pu blication_proofed_5.pdf accessed 2 November 2020. NHSE&I, The Learning Disability Improvement Standards for NHS Trusts (NHSE&I June 2018) www.englan d.nhs.uk/wp-content/uploads/2020/08/v1.17_Improvement_Standards_added_note.pdf accessed 2 November 2020; National Quality Board, ‘National Guidance on Learning from Deaths’ (updated 5 February 2018) www.england.nhs.uk/publication/national-guidance-on-learning-from-deaths/ accessed 2 November 2020. OECD and Saudi Patient Safety Centre (SPSC), ‘The Economics of Patient Safety: From Analysis to Action’ (OECD and SPSC October 2020) www.oecd.org/health/health-systems/Economics-of-Pa tient-Safety-October-2020.pdf accessed 2 November 2020. Open Access Government, Care Homes Told to Label Residents as Do Not Resuscitate (Open Access Government 24 August 2020) www.openaccessgovernment.org/do-not-resuscitate/93223/ accessed 2 November 2020. Parliamentary and Health Service Ombudsman, A Review into the Quality of NHS Complaints Investigations (Parliamentary and Health Service Ombudsman). www.ombudsman.org.uk/sites/default/files/A_re view:into_the_quality_of_NHS_complaints_investigations_where_serious_or_avoidable_harm_has _been_alleged.pdf accessed 2 November 2020. Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action (Patient Safety Learning 2019) https:/ /s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=201 90701143409 accessed 2 November 2020.

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Helen Hughes Patient Safety Learning, Why is Staff Safety a Patient Safety Issue? (Patient Safety Learning, 3 September 2020) www.patientsafetylearning.org/blog/why-is-staff-safety-a-patient-safety-issue accessed 2 November 2020. Patient Safety Learning, The Paterson Inquiry:Are There Any New Lessons for Patient Safety? Will There Be Any Action? (11 February 2020) www.patientsafetylearning.org/blog/the-paterson-inquiry-are-there-anynew-lessons-for-patient-safety accessed 2 November 2020. Patient Safety Learning’s the Hub, Painful Hysteroscopy, www.pslhub.org/forums/topic/68-painful-hyster oscopy/ accessed 2 November 2020. Public Health England, Prescribing of Psychotropic Medication for People with Learning Disabilities and Autism (Public Health England July 2015) https://webarchive.nationalarchives.gov.uk/20160704152031/ht tps://www.improvinghealthandlives.org.uk/publications/1248/Prescribing_of_psychotropic_medicat ion_for_people_with_learning_disabilities_and_autism accessed 2 November 2020. Public Health England, Beyond the Data: Understanding the Impact of COVID-19 on BAME Groups (Public Health England 2020) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/ attachment_data/file/892376/COVID_stakeholder_engagement_synthesis_beyond_the_data.pdf accessed 2 November 2020. The Health Foundation, Safer Care Pathways in Mental Health Services: Hertfordshire Partnership NHS Foundation Trust, www.health.org.uk/improvement-projects/safer-care-pathways-in-mental-health -services accessed 27 October 2020. The Independent Medicines and Medical Devices Safety Review, First Do No Harm (8 July 2020) www.i mmdsreview.org.uk/downloads/IMMDSReview:Web.pdf accessed 2 November 2020. Thibaut, B, Dewa, LH, Ramtale, SC, et al.,‘Patient Safety in Inpatient Mental Health Settings:A Systematic Review’ (2019) 9 BMJ Open e030230 https://bmjopen.bmj.com/content/9/12/e030230 accessed 2 November 2020. UN Committee on Economic, Social and Cultural Rights (CESCR), General Comment No. 14:The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant) (11 August 2000, E/C.12/2000/4). UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, General Comment No 3 to the Committee Against Torture. Implementation of Article 14 by States Parties (19 November 2012). WHO, Human Rights and Health (WHO 29 December 2017) www.who.int/news-room/fact-sheets/detail /human-rights-and-health accessed 2 November 2020. WHO, Patient Safety Fact File (WHO 2019) www.who.int/features/factfiles/patient_safety/patient-safety -fact-file.pdf?ua=1 accessed 29 October 2020. WHO, Patient Safety Fact File (WHO September 2019) www.who.int/features/factfiles/patient_safety/pati ent-safety-fact-file.pdf?ua=1 accessed 2 November 2020. WHO, Global Patient Safety Action Plan 2021–2030 (WHO 2020) www.who.int/docs/default-source/pat ient-safety/1st-draft-global-patient-safety-action-plan-august-2020.pdf?sfvrsn=9b1552d2_4 accessed 2 November 2020. WHO, Global Patient Safety Action Plan 2021–2030:Towards Zero Patient Harm in Health Care – First Draft (WHO August 2020) www.who.int/docs/default-source/patient-safety/1st-draft-global-patient-safety -action-plan-august-2020.pdf?sfvrsn=9b1552d2_4 accessed 2 November 2020. WHO, Patient Safety, www.who.int/patientsafety/en/ accessed 29 October 2020.

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16 FUNDAMENTAL RIGHTS TO HEALTH CARE AND CHARGING OVERSEAS VISITORS FOR NHS TREATMENT Diversity across the United Kingdom’s devolved jurisdictions Jean V McHale and Elizabeth M Speakman

Introduction Human rights are considered as universal, yet, as the debates in this book all too clearly illustrate, respect for such rights is far from universal across the globe, or across continents or even, at times, within specific jurisdictions. Human rights in relation to health and healthcare can be particularly problematic.The right to health and respect for healthcare rights are part of fundamental human rights declarations.They can be constructed through traditional civil and political rights such as the right to life or the right to privacy or they may be included as a specific right to health or to healthcare.1 The challenge in asserting such rights relates to their definition and scope.What constitutes ‘health’ is something which remains highly contested.The World Health Organization (WHO) definition of health is that Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.2

1 See the 1965 International Convention on the Elimination of All Forms of Racial Discrimination,Article 5(e)(iv); International Covenant on Economic, Social and Cultural Rights 1966,Article 12; Convention on the Elimination of All Forms of Discrimination against Women, Articles 11(1)(f), 12, and 14 (2)(b); Convention on the Rights of the Child 1989, Article 24; Convention on the Rights of Persons with Disabilities (2006), Article 25; CESCR General Comment No 14:The Right to the Highest Attainable Standard of Health (Art. 12) (11 August 2000); J Tobin, The Right to Health in International Law (OUP 2015); B Toebes, ‘Towards an Improved Understanding of the International Right to Health’ (1999) 21 Human Rights Quarterly 261. 2 Preamble to WHO Constitution 1948.

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This can be seen as both aspirational and unclear.3 What constitutes ‘complete mental and social well-being’ is something which is, in itself, critically relative across time and place – something so subjective that its full complexity can be very difficult to delineate.A narrower approach than that of the WHO is that of seeing ‘health’ as centrally focused upon the illness of the individual, something which is essentially that of an ‘engineering model,’ which is concerned with repairing the defective human machine.4 What is ‘illness’ itself may be disputed. As Kennedy noted, illness, A central concept of medicine, is not a matter of objective scientific fact. Instead it is a term used to describe deviation from a notional norm.5 Consequently, this can be a highly subjective assessment by the medical profession. Moreover, such an engineering model necessarily avoids the engagement with broader questions which make the machine ‘defective’ in the first place.This brings us back to the broader definition of health. Foster and Herring see health as having a social and relational dimension.6 They have suggested that it would be wrong to regard individuals merely as ‘atomistic, static entities.’7 A multitude of factors external to the individual themselves can have an impact on health, as Hervey and McHale have argued there may be dangers in straying too far from that focus. An individual may be, or feel, separated from potentially relevant communities. Conceptualization of relations between individuals, and between an individual and various communities, may be exceedingly fluid.The fact that individuals may not always operate in an isolated fashion does not necessarily require us to depart entirely from a conception of ‘health’ that is based on individuals.8 While a right to health can be seen as something where it is difficult to achieve effective protection, it can be argued that a right to healthcare may be seen as something which can be more effectively upheld. Healthcare may be thought to be something which has an accepted meaning at least in relation to the provision of day-to-day healthcare. Such certainty can be deceptive. The boundaries of what constitutes healthcare can still remain highly disputed.An operation to replace bones shattered in a road traffic accident, intravenous antibiotics given to a patient with sepsis, or kidney dialysis would generally be seen to be the provision of ‘healthcare.’ In contrast, in vitro fertilisation in the case of someone who sought conception but was not infertile or ‘cosmetic’ surgery are examples of medical procedures where there may be dispute as to whether these fall under the category of healthcare.9

3 See D Callahan,‘The WHO Definition of “Health”’ (1973) 1(3) The Hastings Center Studies 77–88. 4 J Montgomery, ‘Recognising a Right to Health’ in R Beddard and DM Hill (eds), Economic, Social and Cultural Rights: Progress and Achievement (Macmillan 1992); and see the discussion in J Montgomery, Health Care Law (OUP 2002) 2–4. 5 I Kennedy, The Unmasking of Medicine (Allen and Unwin 1981) 7–8. 6 C Foster and J Herring,‘What Is Health?’ in M Freeman, S Hawkes, and B Bennett (eds), Law and Global Health: Current Legal Issues,Volume 16 (OUP 2014). 7 ibid. 8 TK Hervey and JV McHale, European Union Health Law: Themes and Implications (Cambridge University Press 2015). 9 See further M Latham and JV McHale The Regulation of Cosmetic Procedures: Legal, Ethical and Practical Challenges (Routledge 2020)

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A right to healthcare as a socio-economic right is one which is to be found in more recent human rights declarations. The assertion of such a right inevitably raises what can be acutely difficult issues concerning questions of resources. This has also been evident in cases where traditional civil and political rights have been used to bring claims concerning the right to healthcare. In terms of basic emergency care provision, the European Convention on Human Rights (ECHR) has held that failure to provide such care may constitute a breach of fundamental human rights in the context of the right to life.10 But the ECHR has never upheld a right to demand a specific treatment whether by a citizen or by a person visiting another country seeking treatment.11 It is also the case that the real tensions in the nature of access to healthcare and the consequent level of discretion given to member states in the implementation of such rights is reflected in the drafting of rights to healthcare which are contained in fundamental rights declarations. So, for example, Article 3 of the European Convention on Human Rights and Biomedicine provides: Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.12 Article 35 of the European Union Charter of Fundamental Rights and Freedoms states: Everyone has the right of access to preventive health care and the right to benefit from Medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all the Union’s policies and activities. To extrapolate from this what constitutes a right to healthcare services again is highly context dependent. The Biomedicine Convention makes reference to ‘equitable access to health care,’ the Charter of Fundamental Rights to access to healthcare ‘under the conditions established by national laws and practices.’ Such statements recognise that member states have discretion. In making a decision to allocate treatment to one person, the consequence of funding a particular operation or innovative drug is likely to be that another person or group of persons is denied access to such resources. Unless the approach taken is inequitable or disproportionate, then states are given a discretion in relation to the operation of access to and delivery of healthcare. This extends to enabling states to exclude some persons such as those who are not, for example, habitually resident or who are not part of some form of social insurance scheme from access to healthcare resources. But what should be ‘equitable access to healthcare’? To what extent should individuals be excluded from automatic access to healthcare resources because they are not ‘ordinarily’ resident in a particular jurisdiction? How can compassion and care and concern for an equitable right to healthcare be effectively squared with charging vulnerable visitors for treatment? Furthermore, how far should this concern with resource allocation extend? 10 Mehmet Şentürk and Bekir Şentürk v Turkey (2013) 60 EHRR 4: Asiiye Genç c Turquie (Application no 24109/07), Judgment of 27 January 2015;A Nissen,‘Right to Access Emergency Healthcare.The European Court of Human Rights Pushes the Envelope’ (2018) 26(4) Medical Law Review 693. 11 Scialaqua v Italy (1998) 26 EHRR 164. 12 It should of course be noted that the UK is not a signatory to the convention, although the convention has been used by the European Court of Human Rights in relation to specific case law.

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If healthcare itself is a universal right, then who should be excluded from access by cost of care, who should be charged and when? This is a particularly controversial question when the charging in question concerns those who are not residents of the country.These are particularly challenging in the context of the United Kingdom (UK). The UK is not a signatory to the Biomedicine Convention nor is it now a member of the European Union (EU). It is a signatory to the ECHR, and provisions of the ECHR are enforceable in domestic law through the Human Rights Act 1998. This, as we shall see, makes actually challenging resource allocation decisions concerning healthcare and migrants and ‘overseas visitors’ problematic. But that does not mean that these issues can or should be ignored. Put bluntly, in an increasingly globalised world, to what extent is it justifiable to charge those overseas visitors to the UK who seek treatment in a National Health Service (NHS) system free at the point of delivery? What practical problems may arise when a healthcare system established with the precise aim that healthcare should be free at the point of delivery is told to charge a specific group of patients who happen to be ‘overseas visitors’? In enforcing a charging system, what is the impact on the equitable and proportionate delivery of healthcare? And, indeed, do the ‘harms’ of refusing treatment on the lack of ability, to pay justify the costs? These are the issues we explore in this chapter.We take as our case study the charging of overseas visitors in the NHS in the context of the changing landscape in the devolved jurisdictions. The extent to which overseas visitors should be charged for NHS care is something which has been a matter of controversy for many decades.13 The continual financial and staffing pressures facing the NHS are well known. In the never-ending struggle to save costs and balance budgets, use of the NHS by overseas visitors has become a highly contentious issue in England, often linked to political positions on immigration.14 However, it is administratively challenging and risks inequity, sometimes being presented as an example of the ‘hostile environment’ (the Conservative government policy to deter unlawful migrants).15 In 2015 and again in 2017 the approach to charging overseas visitors in England was radically tightened by the Conservative government.16 However, some 30 years since comprehensive NHS charging regulations were introduced in 1989, statistics for the number of overseas visitors treated, cost recovery, and administrative costs remain limited, undermining attempts to undertake an accurate cost-benefit assessment. Moreover, while the whole question of charging and the legitimacy of the approach taken in England has generated considerable media engagement and controversy, there has not been the same level of media or indeed academic focus on this issue in Scotland,Wales, or Northern Ireland. Nonetheless, the last few years have led to a push to re-evaluate the approach taken from what was a notably more generous approach in relation to Scotland and Wales at least. In the next section the chapter compares and contrasts the different rules currently in place across the jurisdictions with the UK.

13 See JV McHale and EM Speakman, "Charging ‘overseas visitors’ for NHS treatment, from Bevan to Windrush and beyond." Legal Studies 40.4 (2020): 565-588. 14 Home Office,‘Enforcing the Rules.A Strategy to Ensure and Enforce Compliance with Our Immigration Laws’ Home Office March 200713-14. 15 C Jayanetti, ‘NHS Denied Treatment for Migrants Who Can’t Afford Upfront Charges’ The Guardian (13 November 2018). 16 The NHS (Charges to Overseas Visitors) Regulations 2015, as amended 2017.

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Charging overseas visitors for healthcare: divided nation(s) For the first few decades of its existence, the NHS had no comprehensive system for charging overseas visitors.17 When charging regulations were eventually introduced in 1982, this was against a backdrop of claims that the administrative process required to collect payment was likely to be complex, possibly racist, and would put undue pressure on NHS staff.18 Moreover, it was argued the low numbers of chargeable visitors were unlikely to make that process costeffective. But, as the financial pressures on the NHS increased over time, views began to change. The reasons for that financial strain were multifactorial, including straitened political budgets, the increased demands of an ageing population, and expensive new drugs and medical technology. It is unclear to what extent the use of the NHS by overseas visitors drew on healthcare resources, but it is beyond doubt that the number of overseas visitors to England in particular has greatly increased over the years.Also, as charging foreign visitors for healthcare was standard practice in other countries (including those charging British citizens needing treatment abroad), it was argued that this would simply bring the UK into line with the rest of the world.19 The NHS Act 1977 gave the government power to make regulations to charge non-resident patients in England and Wales,20 and these powers were established in Scotland by section 98 of the National Health Service (Scotland) Act 1978.The regulations were finally introduced by the Conservative government in the 1980s. Although the legal duty to charge overseas visitors for healthcare applies UK-wide, the precise mechanisms for charging are implemented via secondary legislation and, thus, the governments of Scotland,Wales, and Northern Ireland have been able to apply their own policy approaches to charging.This has led to an increasing divergence between England and the devolved jurisdictions. The tougher approach taken in England to charging third-country visitors was introduced under the former Secretary of State for Health, Jeremy Hunt, in 2015. It has been linked to the party’s hostile environment policy on immigration and as an attempt to counter allegations of exploitation of the NHS by ‘foreigners.’21 This policy is still relatively recent and was reported as initially leading to much higher cost recovery – from £73 million in 2012–2013 to £289 million in 2015–2016 (although this included £164 million from the new health surcharge).22 However, it has also been highly controversial with accusations of administrative complexity, excessive pressure on NHS staff, and inequity.23 The denial of healthcare to many from the ‘Windrush’ generation resulted in an expensive compensation scheme.24 Some reports suggest that the more restrictive regulations in England have deterred vulnerable migrants from access-

17 18 19 20 21 22

H Carty,‘Overseas Visitors and the NHS’ (1983) 5 Journal of Social Welfare and Family Law 258. HC Deb 17 March 1982,Vol 20, cols 411–52. ibid. National Health Service Act 1977, s 121. C. Jayanetti,‘Upfront Fees “Deterring Immigrants from Seeking NHS Care”’ The Guardian (18 April 2019). National Audit Office, Department of Health, Recovering the Cost of NHS Treatment for Overseas Visitors (28 October 2016). 23 L Hiam and M McKee,‘Upfront Charging of Overseas Visitors Using the NHS’ (2017) BMJ j4713. 24 The Windrush generation is a term related to the arrival of migrants from the Caribbean on the boat the Empire Windrush in 1948 and in the period to 1970. Controversy arose in relation to threats and steps taken as part of the hostile environment to deport such persons from the UK.The steps taken by the Home Office ultimately led to the resignation of the then Home Secretary Amber Rudd and to the establishment of a compensation scheme. https://www.gov.uk/apply-windrush-compensation-scheme. See A Gentleman, The Windrush Betrayal: Exposing the Hostile Environment (Guardian Faber, 2019); A Gentleman, ‘UK to Pay up to £200m in Compensation to Windrush Victims’ The Guardian (3 April 2019).

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ing necessary medical treatment.25 There have been calls for charging to be abandoned due to its adverse impacts.Although the government had promised to release reliable statistics on costrecovery and cost-benefit, these are still not forthcoming. Today, a series of separate statutory instruments operate across the devolved jurisdictions. In England the current applicable regulations are the NHS (Charges to Overseas Visitors) Regulations 2015 further amended in 2017. In Scotland and Wales, the relevant regulations are the National Health Service (Charges to Overseas Visitors) (Scotland) Regulations 1989 and the National Health Service (Charges to Overseas Visitors) Regulations 1989. In contrast to England, both sets of regulations have since 1989 only been subject to minor amendments, the most recent in 2014 and 2009 for Scotland and Wales, respectively.26 In Northern Ireland the Health Services (Persons Not Ordinarily Resident in Northern Ireland) Regulations (Northern Ireland) were passed in 1970. These were more restrictive than those in other jurisdictions in the UK as they applied not only to hospital services but also extended charging to primary care. Charging exemptions were generally limited to persons who fell within the categories of international agreements with the UK.27 The regulations were reformed in 2005,28 and then, after a review in 2014, new regulations were produced in 2015.29 While there are some similarities with the other jurisdictions in the UK, as we shall see, Northern Ireland has some distinctive elements. In all parts of the UK, emergency care is free to all, however, once an overseas visitor leaves accident and emergency care, then their care may become chargeable. Access to free secondary healthcare is residency not citizenship based.This means that the person may be charged unless they can prove that they are ‘ordinarily resident’ in the UK or unless they fall into one of the categories which are excepted under the legislation.The meaning of ‘ordinary residence’ is that which was established in the case of R v Barnet London Borough Council, Ex parte Shah:30 Ordinary residence is established if there is a regular habitual mode of life in a particular place ‘for the time being’,‘whether of short or long duration’, the continuity of which has persisted apart from temporary or occasional absences.The only provisos are that the residence must be voluntary and adopted ‘for a settled purpose’ … Ordinary residence is proven more by evidence of matters capable of objective proof than by evidence as to state of mind.31

25 K O’Donnell, ‘Transparency Is Needed on NHS Charges for Migrants and Data Sharing Agreements’ (thebmjopinion, 13 May 2013) https://blogs.bmj.com/bmj/2019/05/13/creating-a-hostile-environment-for-migrants -transparency-is-needed-on-nhs-charges-and-data-sharing-agreements-in-nhs-england/#:~:text=Transparency %20is%20needed%20on%20NHS%20charges%20for%20migrants%20and%20data%20sharing%20agreements ,May%2013%2C%202019&text=Timely%20access%20to%20healthcare%20depends,and%20individuals%20w hich%20provide%20it accessed 20 October 2020. 26 The National Health Service (Charges to Overseas Visitors) (Scotland) Amendment Regulations 2014, No 70; The National Health Services (Charges to Overseas Visitors) (Amendment) Regulations 2009, No 1512. 27 Northern Ireland Human Rights Commission (2011), Access Denied – Or Paying When You Shouldn’t (January 2011). 28 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2005 SI 2005 No 551. 29 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2015 SI 2105 No 7. 30 [1983] 2 AC 309. 31 UK Visas and Immigration, ‘Guidance. Ordinary Residence’ (5 January 2011) https://assets.publishing.service .gov.uk/government/uploads/system/uploads/attachment_data/file/258236/ordinaryresidence.pdf accessed 20 October 2020.

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Section 39 of the Immigration Act 2014 further clarified that the fact that a person has indefinite leave to remain (ILR) ‘on its own is not sufficient since that person may no longer be, for example, residing in the UK on a properly settled basis, and may only be visiting.’32 Since 2015, visitors from non-European Economic Area (EEA) countries33 who want to stay in the UK for limited periods (for example to work, study, or for family reasons) were required to pay an ‘immigration health surcharge’ of £400 per year at the time of their visa application.34 Once paid, this gives individuals access to free NHS treatment. If an individual cannot establish that they are ordinarily resident, they may still be exempt from charge, either because of their own status or that of their treatment. In terms of the length of time for ordinary residence, this has been suggested as a period of 6 months in Scotland.35 In contrast, in Northern Ireland, a period of ordinary residence is seen as 12 months.36 Although there are different regulations across the devolved jurisdictions there are also some similarities.Across all the jurisdictions, individuals who are exempt from charging include, while the UK is in the transition period from leaving the EU, those from EEA member states and also countries with which the UK has reciprocal health agreements, a group known as ‘vulnerable patients,’ prisoners, UK government employees, and war pensioners.37 ‘Vulnerable patients’ are a broad group. They include refugees,38 asylum seekers,39 and failed asylum seekers and their dependants (but in England this only applies if they are receiving support such as accommodation or care from the Home Office or a local authority),40 children who are looked after by a local authority, victims and suspected victims of modern slavery,41 where there are exceptional humanitarian reasons,42 and anyone receiving compulsory treatment under a court order or who is detained in a hospital or deprived of their liberty are also included.43

32 Department of Health and Social Care, Guidance on Implementing the Overseas Visitor Charging Regulations, February 2020, para 3.10. 33 EEA countries are member states of the European Union, Iceland, Liechtenstein, and Norway. Switzerland is not a member of the EU or EEA but is also included in this group under special arrangements. 34 This health charge was introduced by the Immigration (Health Charge) Order 2015 No 792. 35 Scottish Government, ‘“Overseas Visitors” Liability to Pay charges for NHS Care and Services’ CE 09, April 2010, para 5. Also see UK Visas and Immigration (n 31) para 11.15 in relation to the discussion of the ‘baseline questions.’ 36 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2015, Part 1, para 5. 37 UK Visas and Immigration (n 31) 54–55 and 15. 38 Those granted asylum, humanitarian protection, or temporary protection under the immigration rules and their dependants. 39 Those applying for asylum and humanitarian protection whose claims, including appeals, have not yet been determined, and their dependants. 40 Receiving support under section 4(2) of the 1999 act from the Home Office or those receiving support from a local authority under Part 1 (care and support) of the Care Act 2014 or section 35 or 36 of the Social Services and Well-Being (Wales) Act 2014, by the provision of accommodation. 41 As determined by a designated competent authority, such as the UK Human Trafficking Centre or the Home Office.This includes their spouse/civil partner and any children under 18, provided they are lawfully present in the UK. 42 An overseas visitor who has been granted leave to enter the UK outside the immigration rules in whose case the Secretary of State for Health determines there to be exceptional humanitarian reasons to provide a free course of treatment.This exemption will also apply to their child and/or companion who is authorised to travel with them, for whom the exemption is limited to treatment, the need for which arose during the visit, and cannot await until they can reasonably be expected to leave the UK. 43 For example, under the Mental Health Act 1983 or the Mental Capacity Act 2005.

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Apart from emergency care, other medical treatments which are exempt from charging across the jurisdictions of the UK include family planning services (although not termination of pregnancy) and treatment of certain specified infectious diseases, including pandemic influenza, COVID-19,44 and sexually transmitted diseases.45 However, maternity care, other than in the context of emergency treatment, is chargeable across the jurisdictions. An attempt in 2020 by a woman in England who had been subject to female genital mutilation to bring a judicial review action claiming that the impact of the current charging regime for migrants has the effect of delaying or totally deterring or stopping pregnant women, women giving birth, or those who need postnatal treatment, and who was charged £10,636 for her own maternity care which she is currently repaying at a rate of £10 per month, was unsuccessful.46 All jurisdictions are required to abide by the Human Rights Act 1998 and the Equality Act 2010 in avoiding any discrimination or inequality in implementing the charging regulations. So, for example, they cannot refuse treatment on grounds of race, gender, age, religion, or sexual orientation.47 They must also avoid discrimination in the process of identifying whether or not patients might be chargeable. One common – and controversial – feature is that the government in each jurisdiction is expected to inform the Home Office of any unpaid healthcare debts of £500 or more.48 This may then be grounds for refusing entry or a stay in the UK in the future, until the debt is paid. In addition, currently, EU citizens are specifically exempted from charge in the NHS Charging Regulations applicable in each of the four jurisdictions due to the UK as a result of the continuation of existing rights under the transition period. Post the transition period, unless an EU national is lawfully in the UK, for example because they have acquired what is known as settled status and is ordinarily resident, then they will become liable to be charged under the respective overseas visitors charging regulations. However, if bilateral agreements are obtained, then the position will change.The new Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 provides a legal framework for implementing bilateral healthcare arrangements with an individual EEA state, Switzerland, or the EU if these are agreed. It provides power to fund healthcare provided within those countries and powers to give effect to healthcare arrangements and healthcare agreements. It also provides the Secretary of State with the power to process necessary healthcare data for those arrangements.49 The devolved governments were consulted during the passage of this legislation and the act incorporates a legal obligation to continue to do so in the future.50 The legal requirement to consult with the devolved jurisdictions which has been incorporated in the new legislation, together with the decision to limit the act to EEA visitors rather than all third-country nationals, mean that alignment and consistency will be ensured at least at the outset. In this case at least, a UK-wide approach will be followed, with little evidence of divergence. There has been particular concern to safeguard reciprocal rights to healthcare between Northern Ireland and the Republic of Ireland, which is a feature of the Common Travel Area

44 See, for example, The Provision of Health Services to Persons Not Ordinarily Resident (Amendment). Regulations (Northern Ireland) 2020 No 25. 45 Part 3(c). 46 D Taylor,‘Woman Loses Legal Challenge to NHS Charges for Pregnant Migrants’ The Guardian (1 July 2020). 47 UK Visas and Immigration (n 31), ss 2.8–2.14. 48 The Scottish Parliament Health and Sport Committee (2019). The current and future operation of reciprocal healthcare schemes. SP Paper 468, 3rd Report, 2019 (Session 5) 9, s 59. 49 Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, Explanatory Notes, Overview). 50 2019 Act, s 5.

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(CTA). Concerns as to the impact of Brexit on citizens resident in Ireland led to emergency legislation being passed in the Republic of Ireland Miscellaneous Provisions (Withdrawal of the United Kingdom from the European Union on 29 March 2019) Act 2019, which includes safeguards in relation to health care.This has now been superseded by the Withdrawal Agreement between the UK and the EU.A Memorandum of Understanding signed on 8 May 2019 between the UK and Irish government states that the CTA affords British citizens residing in Ireland and Irish citizens residing in the UK the right to access emergency, routine and planned publicly funded health services in each other’s state, on the same basis as citizens of that state.51 Although this is a memorandum of understanding and not a treaty provision and thus not binding in international law, any attempt to resile from this could have considerable implications for patients on both sides of the border. While there are some common features between the jurisdictions in relation to charging overseas visitors, some distinct differences do exist, and we turn next to explore them.The differences reflect, first, the rationale for the regulations and the concerns around health ‘tourists’; second, the organisations which are required to charge; and, third, the nature of the charging process itself.

The rationale for charging: a matter of ‘health tourism’? While charging regulations applicable in England have been revised many times since 1989, becoming progressively more stringent until the current iterations in 2015 and 2017,52 the situation in the devolved jurisdictions is somewhat more complex.The Welsh regulations were initially identical to those in England and, even today, they represent a gradual evolution rather than a radical change in approach.This is also the case in Scotland, where the provisions of the original 1989 regulations largely still apply. Over time, there have been calls for changes in both those jurisdictions due to concern regarding ‘health tourism,’ but these concerns, as we shall see, have been very different in dimension and in scale to those of England. In contrast, in Northern Ireland, separate regulations have been in force since the 1970s and, although there are some similarities, there is also some divergence.53 Differences in the approach taken across the four jurisdictions are due to both a considerable difference in visitor numbers (and, therefore, far fewer potentially chargeable overseas visitors) as well as a difference in political approach. In Northern Ireland, the issue of overseas visitor charging was discussed during debate in the Northern Ireland Assembly prior to the issue of the 2015 regulations.54 The debate indicated concern about the risk of being overgenerous which

51 UK Government and the Government of Ireland, Memorandum of Understanding between the Government of the United Kingdom of Britain and Northern Ireland and the Government of Ireland (8 May 2019) para 9. 52 The NHS (Charges to Overseas Visitors) Regulations 2015, SI 2015/238 as amended by The National Health Service (Charges to Overseas Visitors) (Amendment) Regulations 2017, SI 2017/756. 53 Health Services (Persons Not Ordinarily Resident in Northern Ireland) Regulations (Northern Ireland) 1970. Northern Ireland Assembly Committee for Health, Social Services and Public Safety, ‘Official Report on Provision of Health Services to Persons Not Ordinarily Resident (Amendment) Regulations (Northern Ireland) 2014 and the Health and Personal Social Services (General Medical Services Contracts) (Amendment No 1) Regulations (Northern Ireland) 2014: DHSSPS Officials’ (17 September 2014). 54 Northern Ireland Assembly Committee for Health, Social Services and Public Safety (2014).

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might encourage ‘health tourism,’ particularly from the Republic of Ireland.55An official from the Department of Health, Social Services and Public Safety confirmed that this was being monitored: There is an access to health care team in the BSO [Business Services Organisation], which was set up to look at not just the guidance and at making sure that health care service staff are fully aware of who has a right to access health care but at how they identify and manage people who are coming in who maybe do not have health care. However, the team also looks at how we identify people who are potentially accessing health care either fraudulently or illegally.The whole culture change in the health service is a bigger aspect. 56 In 2016, the former Northern Ireland Health Minister, Edwin Poots, raised concerns about the cost of health tourism in the jurisdiction.57 The charging of overseas visitors in Northern Ireland has an added political dimension in light of Brexit and with questions raised as to the continued entitlements of citizens on either side of the border to access to healthcare (see later). In contrast, both the Scottish and Welsh governments have resisted attempts to portray ‘health tourism’ as a major problem.58 For example, a Sunday Times report from 2016 on a £2 million unpaid debt from foreign nationals with the headline ‘Scotland “needs experts to fight health tourism”’ was rebutted by the Scottish health secretary, Shona Robison, who argued that most bills are paid, procedures were in place for debt recovery, and the amount owed was ‘a very small proportion’ of the total Scottish health budget of £12 billion.59 Similarly, in 2017 the Welsh government planned to review its overseas visitors charging regulations, but the Welsh health secretary,Vaughan Gething, said that this was a ‘marginal area’ and Really, when you’re talking about the central funding of the health service, with the big challenge that we face, the actual conversation about charging people from abroad is an absolute distraction.60 For many years, the majority party in Scotland has been either Labour or the Scottish National Party, and they have repeatedly restated an intention to offer a welcoming environment to foreign visitors, whether tourists or migrants.The subject of charging overseas visitors for healthcare has only very occasionally arisen in the Scottish parliament. In a debate in 2005, the Scottish Executive stated that it does not keep records of overseas visitors who have been refused free NHS treatment under the Scottish regulations.61 In another parliamentary debate

55 ibid 8. 56 ibid. 57 C McCullough, ‘DUP’s Poots Blasts “Health Tourism” as NHS Translators Cost NHS £9.3m in Three Years in Northern Ireland’ Belfast Telegraph (28 November 2016). 58 T Martin, ‘Foreign Health Patients Saddle Scottish NHS with £3m Bill’ Express (11 February 2019) https ://www.express.co.uk/news/uk/1085564/foreign-health-patients-leave-scottish-NHS-3m-bill-latest-scotland (Express, 11 February 2019) https://www.express.co.uk/news/uk/1085564/foreign-health-patients-leave-sco ttish-NHS-3m-bill-latest-scotland accessed 20 October 2020. 59 M Macaskill,‘Scotland “Needs Experts to Fight Health Tourism”’ The Times (10 January 2016). 60 BBC News,‘NHS Foreign Visitor Charges Reviewed by Vaughan Gething’ BBC News (1 March 2017). 61 The Scottish Parliament Written Answers Wednesday 2 November 2005, Mr Andy Kerr: S2W-19910.

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on 6 November 2013, the Conservative MP Alex Johnstone queried a potential cost recovery of £200 million per year. In reply, the SNP Minister for Public Health, Michael Matheson, stated: The number of migrants … in England is different from that in Scotland. We view migrants as an important part of the Scottish economy.They are provided with healthcare in the same way as other individuals in Scotland are. … The figure that Alex Johnstone referred to is probably pretty excessive. There is no evidence whatever of such a level of expenditure in Scotland and no indication from any of our boards of difficulties that have resulted from the number of migrants who use healthcare services. It is important to treat people equally and fairly when they are in Scotland.We should not try to use our healthcare system to manage immigration and migration.62 In March 2017 a charity, Maternity Action, identified that women with insecure immigration status requiring maternity care might not meet the ‘ordinary residence’ test and this was risking the health of the women and their babies. A debt of £500 or more would be notifiable to the Home Office and risk any future immigration applications: Recent research by Maternity Action found that vulnerable migrant women are avoiding maternity care or skipping some scans and appointments in order to reduce their debt to the NHS.This puts the health of mother and baby at risk and exacerbates existing health inequalities.63 This evidence was submitted to a Scottish government Equalities and Human Rights Committee inquiry with a plea that the Scottish government retain its exemption of healthcare charging for failed asylum seekers. In response to a parliamentary question in a debate on 7 January 2019, the Scottish government confirmed64 that it did not hold information centrally on how many non-EU citizens have (a) presented, (b) been treated, and (c) been charged for NHS treatment in the last 12 months, nor how much each NHS board has received for providing this treatment. In 2018–2019, the Scottish Parliament Health and Sports Committee undertook a review of healthcare for overseas visitors.65 This was prompted by the passage of the new Healthcare (International Arrangements) Bill introduced in the light of Brexit to regulate reciprocal healthcare arrangements post Brexit.The bill was subsequently limited to focus on the arrangements with EEA countries, renamed and passed as the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019. However, the Health and Sport Committee debated the question before the bill was amended including access to care for non-EEA visitors. Paul Gray, the outgoing director general for health and social care and chief executive of NHS Scotland, made clear the less stringent approach taken in Scotland. For example, there is no obligation placed on GPs to identify or report a patient’s country of origin:

62 The Scottish Parliament, The Scottish Parliament Official Report, Meeting of the Parliament, col 24042 (6 November 2013). 63 Maternity Action, Submission to the Equalities and Human Rights Committee Inquiry into Destitution, Asylum and Insecure Immigration Status in Scotland (March 2017). 64 Scottish Government Debate, Constitution and External Affairs, 17 January 2019, S5W-20837: Response to question from Kezia Dugdale (Scottish Labour). 65 The Scottish Parliament Health and Sport Committee (2019).The Current and Future Operation of Reciprocal Healthcare Schemes. SP Paper 468, 3rd Report, 2019 (Session 5).

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we encourage GPs to establish a person’s country of origin but we do not wish to deprive people of primary healthcare services, so we have not so mandated.66 Also, that the culture of the NHS in Scotland is to provide care to people who need it and to ask questions later. I am not ashamed of that.We should recover money when we legitimately can and we should observe the regulations and provisions that are in place.67 The Committee endorsed an approach which would be more rigorous in improving cost recovery, while taking the position that ‘our best foot forward is to treat the person who presents with a need, and to seek the recovery afterwards.’68 In February 2019, the Scottish Parliament Health and Sport Committee published its review: ‘The Current and Future Operation of Reciprocal Healthcare Schemes.’69 This reports an accumulated debt (over the previous five years) of around £3 million for healthcare provided to third-country nationals.With regard to EEA visitors, it was noted that, although such patients had received treatment in Scotland, not all Scottish health boards were participating in the European Health Insurance Card (EHIC) incentive scheme which would give them a payment from central UK government for each such patient treated. Some health boards stated that they did not currently identify EEA citizens ‘because it was not cost effective to gather this data.’70 This suggests very small numbers of applicable patients.The review recommended a more consistent approach across Scottish health boards (including participation in the EHIC incentive scheme) and more efficient efforts at cost recovery. However, there is no mention of any intention to restrict eligibility in future. Parliamentary debates do indicate an awareness among the devolved jurisdictions that their more generous policy might risk ‘health tourism’ within the UK, whereby overseas visitors might cross the border to have healthcare more easily and/or cheaply than in England because of the tighter regulations operating there. But while all jurisdictions have been monitoring this risk, they have each reported little evidence of such health tourism actually occurring.71 Yet, if there is such little evidence for health tourism, then this raises the question as to whether a detailed charging regime can be seen as an effective proportionate approach to restricting access by overseas visitors to what can be seen as a fundamental human right.We return to this later.

The NHS organisations which are required to charge for services A further notable difference between England and the devolved jurisdictions relates to which organisations providing NHS services are obliged to charge. In England, the 2017 amended regulations now place responsibility for charging patients on all organisations that provide NHS

66 The Scottish Parliament Health and Sport Committee (2018). Official Report, Health and Sport Committee, 32nd Meeting 2018, Session 5 (11 December 2018) 31. 67 ibid 10. 68 The Scottish Parliament Health and Sport Committee (2018) 11. 69 The Scottish Parliament Health and Sport Committee (2019),‘The Current and Future Operation of Reciprocal Healthcare Schemes,’ SP Paper 468, 3rd Report, 2019 (Session 5), 11 F. 70 ibid 4, para 10. 71 The Scottish Parliament Health and Sport Committee, 2019, p 6, para 33; Northern Ireland Assembly Committee for Health, Social Services and Public Safety, 2014.

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services, not simply on NHS bodies themselves.72 The charging system also applies to private and voluntary sector providers. Secondary care services provided outside of a hospital setting, such as community health services, are also no longer exempt. In contrast, these services remain exempt across the devolved jurisdictions. England has, however, introduced exemptions for palliative care services, services provided as part of the NHS111 telephone advice line (a service only currently available in England), and treatment required for a physical or mental condition caused by torture, female genital mutilation, domestic violence, or sexual violence.73 None of these is a specified exempt category in the devolved jurisdictions, although, for example if a patient presented requiring treatment for a violent injury it is likely that this would fall within the category of ‘exceptional humanitarian grounds’ recognised in the devolved jurisdictions, and, therefore, still be exempt from charge. Currently, primary care is exempt from charge for overseas visitors in most of the UK.This is reflective of the different contractual status of GPs and the different operational structures of primary care as opposed to hospital medicine. However, over the last few years the NHS in England has considered extension of charging to GP services.74 Initial consultation feedback was, however, that this was unpopular with GPs and, furthermore, there were also concerns expressed on public health grounds that charging will dissuade people from accessing necessary medical care.75 In contrast, in Northern Ireland, GP services are only available free of charge to persons who are ordinarily resident (defined as 12 months or more).76 The 2015 regulations extended this to include those categories of visitors who are exempt from charge for secondary care.77 Thus, overseas visitors who are not ordinarily resident, as defined by the Northern Ireland regulations or otherwise within an exempt category, for example those living in the Republic of Ireland or on a temporary visit to Northern Ireland, may be charged for GP services.This represents a far tougher restriction on primary care than that in the rest of the UK.78 Interestingly, however, while GP services are not chargeable in Scotland, guidance given to GPs is again indicative of a tightening of the system.The guidance provides that it is for GP practices to exercise their discretion as to whether to register an overseas visitor or to treat them privately.79 It is unclear to date how this is operating in practice. In Wales, GPs have also been exempt.While these differences in approach between primary and secondary charging can be seen as part of the historical legacy of distinct service provision, the inconsistent approach is notable. Overseas

72 The NHS (Charges to Overseas Visitors) Regulations 2015 (n 16). 73 National Health Service (Charges to Overseas Visitors) Regulations 2015 No. 258, Part 3, 9(f). 74 Department of Health, ‘Making a Fair Contribution. Government Response to the Consultation on the Extension of Charging Overseas Visitors and Migrants Using the NHS in England’ (February 2017) 5. 75 ibid. 76 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2015, Part 1, para 5. 77 Northern Ireland Assembly Committee for Health, Social Services and Public Safety, 2014; Provision of Health Services to Persons Not Ordinarily Resident Regulations (Northern Ireland) 2015, Part 3, s 24. 78 It is notable that in the Republic of Ireland upfront charges are required in relation to primary care; charges vary and may be between 45 and 65 euros unless they fall within a specific category, e.g. they have a medical card due to low income, and also in relation to accident and emergency care of 100 euros unless the patient falls into a specific exempt category such as having been referred to hospital by their GP. https://www.citizensinformatio n.ie/en/health/health_services/gp_and_hospital_services/hospital_charges.html accessed 13 November 2020. 79 3 para 4.

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visitors can see a GP for an emergency, and they can also be temporarily registered. However the fact that an individual may not get charged once registered does not mean that they will automatically be registered by a GP, although GPs cannot refuse to do so for ‘discriminatory reasons.’80

The charging process itself As we saw earlier, while there are core elements in relation to exemptions from charging which exist across the jurisdictions, there are also some differences which exist between England and the other devolved jurisdictions. Across the devolved jurisdictions, there are several groups of people who are exempt from charging who would, if they were in England, be subject to charge. So, for example, in Scotland and Wales employed persons and self-employed persons who have started their own business are exempt and are not required to prove they are ‘ordinarily resident’ in order to be exempt from NHS charges for secondary care.81 Exemptions also apply to full-time students in Scotland,Wales, and Northern Ireland. In Wales and Northern Ireland, the course of study must be of at least six months’ duration or else ‘substantially funded’ by the UK government.82 No course time limit is applied in Scotland, where the charging exemption also applies to postgraduate students.83 The devolved jurisdictions have also taken a notably different position to England in relation to failed asylum seekers. In all the jurisdictions of the UK, asylum seekers are exempt from charges, whether or not the asylum application is pending, refused, or under appeal. However, in England, amendments made in 2004 and 2011 established that asylum seekers whose applications were refused were not ordinarily resident and no longer exempt from charges (although this could be imposed gradually if the patient was in the midst of treatment; known as ‘easement’). Failed asylum seekers are, however, exempt from charge if they are receiving support from the Home Office or a local authority, as explained earlier.84 The 2004 amendments were also applied in Wales. However, as a result of lobbying by refugee support organisations, these were removed in 2009.85 In contrast, in Scotland the 1989 Charging Regulations exempted from charge from the outset anyone who had made an application.86 In 2010, the Scottish government issued guidance confirming that the exemption applied to all applicants, whether successful or not: Anyone who has made a formal application for asylum, whether pending or unsuccessful, is entitled to treatment on the same basis as a UK national who is ordinarily resident in Scotland while they remain in the country.87

80 See https://www.nhs.uk/using-the-nhs/nhs-services/visiting-or-moving-to-england/how-to-access-nhs-servic es-in-england/ accessed 13 November 2020. 81 UK Visas and Immigration (n 31). 82 NHS Wales, Implementing the Overseas Visitors Hospital Charging Regulations, Guidance for Hospitals in Wales (7 December 2009) 25, para 6.14; Provision of Health Services to Persons Not Ordinarily Resident Regulations (Northern Ireland) 2015, Part 2, s 6. 83 The Scottish Government Healthcare Policy and Strategy Directorate, 2010, 8 para 27. 84 See UK Visas and Immigration (n 31). 85 National Health Service (Charges to Overseas Visitors) (Amendment) (Wales) Regulations 2009, No 1512. 86 National Health Service (Charges to Overseas Visitors) (Scotland) Regulations 1989, s 4(c). 87 (n 32) 9, para 32.

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In Northern Ireland, under the 2005 regulations, free health services were available to those with a pending asylum application, but this did not extend to failed asylum seekers who were not in receipt of Home Office support.88 During debate in the Northern Ireland Assembly the Stormont government revealed that in the course of one year there were only 28 failed asylum seekers not in receipt of Home Office support.89 Following lobbying, the position was amended in 2015. Failed asylum seekers are now exempt from charge for healthcare.90 What is also notable in Scotland is that there is a clear statement that the process of charging is seen as separate from immigration. The Scottish government states explicitly on its website that The Scottish Government decide how healthcare is provided in Scotland.This is not linked to immigration control, which is a matter for the Home Office.’91 Furthermore, the website goes on to state that NHS Scotland does not pass patient details to the Home Office for the purpose of immigration enforcement.92 This is in sharp contrast with the controversy in England regarding data sharing about immigration status with the Home Office.93 In 2017, following the intervention of the Chair of the Health Select Committee, the government agreed that data sharing arrangements between the NHS and the Home Office for identification of illegal migrants should be removed.94 However, in 2019, press reports indicated that Home Office immigration officers were contracted to work within public service organisations to facilitate checks on immigration status and this service was offered to NHS trusts.95 A further notable difference between England and the devolved jurisdictions is that the 2015 regulations provide that NHS trusts in England should apply an enhanced tariff, charging for treatment at 150% of NHS rates. This does not apply in the devolved jurisdictions where the same treatment would be charged at the standard NHS tariff.This may represent a difference in liability of hundreds, if not thousands, of pounds for an individual patient. Furthermore, while the regulations had always required trusts to establish eligibility to pay before providing second-

88 See Law Centre NI,‘Refused Asylum Seekers and Access to Free Secondary Healthcare’ https://www.lawcentr eni.org/component/content/article/63-policy-briefings/865-refused-asylum-seekers-and-access-to-free-secon dary-healthcare.html accessed 13 November 2020. 89 Northern Ireland Assembly Committee for Health, Social Services and Public Safety (2014). 90 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2015, Part 1, para 9. 91 NHS Inform, ‘Healthcare for Overseas Visitors’ https://www.nhsinform.scot/care-support-and-rights/health-ri ghts/access/healthcare-for-overseas-visitors accessed 13 November 2020. 92 ibid. 93 See McHale and Speakman (n 13). 94 D Campbell, ‘NHS Will No Longer Have to Share Immigrants’ Data with Home Office’ The Guardian (9 May 2018) https://www.theguardian.com/society/2018/may/09/government-to-stop-forcing-nhs-to-share-patients -data-with-home-office accessed 20 October 2020. For further background on data sharing L Hiam, S Steele, and M McKee,‘Creating a ‘Hostile Environment for Migrants’:The British Government’s Use of Health Service Data to Restrict Immigration Is a Very Bad Idea’ (2018) Health Economics Policy and Law 107. 95 M Savage and C Cadwalladr,‘Revealed: How Home Office Hires Out Staff to Hunt Immigrants’ The Guardian (16 February 2019) https://www.theguardian.com/uk-news/2019/feb/16/home-office-hires-out-staff-hunt -migrants-hostile-environment accessed 20 October 2020.

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ary care, since 2017 NHS trusts in England have been required to charge non-exempt patients upfront before providing care (except in an emergency). It is a matter of clinical judgement whether the patient’s need is urgent.The English guidance does, however, state that Relevant bodies must also ensure that treatment which clinicians consider to be immediately necessary or urgent is provided to any patient, even if they have not paid in advance. Failure to provide immediately necessary treatment may be unlawful under the Human Rights Act 1998. Urgent treatment should also always be provided to any person, even if deposits have not been secured. Non-urgent treatment must not be provided unless the estimated full charge is received in advance of treatment.96 In Scotland, there is also a requirement to ascertain liability for care, and the guidance on Healthcare for Holidaymakers from overseas states that NHS staff will need to see some documents to make sure you can get NHS care. • NHS staff may need to see documents that show where you live, for example your driving licence or other documents to prove you are registered for work or health care in your own country. • If you don’t have the documents they ask for, NHS staff will not be able to treat you as an NHS patient.You may need to pay for any care you receive.97 However, the guidance in Scotland is that Where an overseas visitor is liable to charging this should be explained to them from the outset and they should be asked to sign an undertaking that they agree to this ideally before treatment commences. There will, however, be instances when this is not feasible in the interests of the patient’s immediate health or wellbeing.98 Thus, while visitors will still be liable for charges, this does not mean that treatment itself will be denied – simply that charging is not required upfront.

Refections on the experience in England and the devolved jurisdictions Although the cost of overseas visitors using the NHS is a major political issue in England as we have seen, it has not been a matter of significant controversy or debate in the devolved jurisdictions (with the exception of Northern Ireland) until recently.While this may be due to a combination of fewer visitor numbers and a completely different political environment, it has allowed the devolved jurisdictions to avoid aspects of the debate in England.This debate has contained allegations of inequity and has focused on the relationship which can be drawn between charging of visitors and the hostile environment.99 There are some clear differences between England

96 Provision of Health Services to Persons not Ordinarily Resident Regulations (Northern Ireland) 2015 (n 29) para 8.32. 97 https://www.nhsinform.scot/media/1124/health-care-for-holidaymakers-from-overseas-v5-2016.pdf accessed 13 November 2020. 98 Scottish Government (n 35) 3, para 6. 99 See A Shaves,‘Austerity or Xenophobia? The Causes and Costs of the “Hostile Environment” in the NHS’ (2019) Healthcare Analysis 202.

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and the devolved jurisdictions in relation to charging overseas visitors for healthcare, with the latter offering more generous healthcare provision. There is no statistical evidence that this more generous approach has been exploited by ‘health tourists’ crossing over the borders from England. However, as England’s trajectory of increasingly stringent overseas visitor charging has continued, the devolved jurisdictions are starting to engage far more with this issue. The English experience following the 2015 reforms, with a litany of inaccurate application of the provisions,100 the rise of concern and disquiet amongst patients and professionals alike,101 and the absence to date of definitive statistics illustrating that a tougher approach is empirically evidenced, provides a very cautionary tale. Concerns have been expressed in England as to the adverse impact of charging on the delivery of healthcare and the fact that this can deter individuals seeking treatment.102 Any attempt to radically change the approach in the devolved administrations needs to be necessarily seen in that context.The fact also that healthcare professionals are involved in the charging process remains a matter of controversy. In England clinicians have expressed grave concern regarding their involvement in determining eligibility for free treatment and its impact on the professional–patient relationship.103 Is the approach taken in England the inevitable trajectory for the rest of the UK longer term, or does engagement with human rights and global health law provide a possible change in approach in the future?

Conclusion The issue of charging overseas visitors highlights what are, perhaps, inevitable tensions in expectations regarding rights concerning healthcare. While health can be seen as a universal ‘right,’ what health and healthcare means and how rights can be utilised to safeguard them are challenging questions.This is exemplified in the context of those seeking healthcare in a country where they are ‘visitors.’ It is interesting that the sole reference to date to the question of human rights in this context across England and the devolved jurisdiction in relation to charging of overseas visitors appears to be that in the 2020 Department of Health Guidance in England which makes reference to the fact that failure to provide ‘immediately necessary treatment’ may be unlawful under the Human Rights Act 1998, but does not engage further with this issue.104 Nonetheless, while claims of rights to healthcare help to inform the debate at the same time, they do not always provide straightforward solutions to what are challenging socio-economic questions. In the early years of the NHS, it was almost a badge of honour not to have to be seen to charge overseas visitors for treatment.105 In an era of today’s cash-strapped NHS in which there are major concerns relating to the demands on resources, then such an approach may be seen as fundamentally idealistic and, perhaps, unrealistic.Today, when there are continual pressures to

100 S Wollaston, Letter from Dr Sarah Wollaston MP, Chair of Health Committee to Jeremy Hunt (21 July 2017); L PashaRobinson, ‘Pregnant British Woman Ordered by NHS to Prove She Is from UK to Receive Free Treatment’ Independent (21 October 2017);A Gentleman,‘Londoner Denied NHS Cancer Care:‘It’s Like I’m Being Left to Die’ The Guardian (10 March 2018). 101 A Rimmer ‘Royal Colleges Call for End to Charges for Overseas Patients’ (2018) 363 BMJ k5413. 102 A Gentleman,‘Crackdown on Migrants Forces NHS Doctors to “Act as Border Guards”’ The Guardian (20 April 2017) https://www.theguardian.com/uk-news/2017/apr/20/crackdown-migrants -nhs-doctors-border-guards-immigration-undocumented-migrants accessed 13 November 2020. 103 See e.g. M Weaver ‘Doctors Threaten to Boycott Plan for Patients to Show ID at Hospitals’ The Guardian (22 November 2016) https://www.theguardian.com/society/2016/nov/22/doctors-threaten-to-boycott-plan-forpatients-to-show-id-for-nhs-care accessed 13 November 2020. 104 ibid 32. 105 See McHale and Speakman (n 13).

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find savings, the recent heightened discussion of charging across the devolved jurisdictions is, perhaps, to be expected, but it is suggested that any major reforms should not be implemented without very careful consideration ensuring that lessons are learnt from the problematic implementation of policy in England. Such changes must be clearly evidence-based and implemented in a way which does not undermine the fundamental ethos of the NHS itself of care free at the point of delivery. To date, in the UK as a whole and, in particular, in England the charging system has been too often driven by reports of concerns regarding cost without a wholly comprehensive engagement with the relative costs of operating such a charging system against the potential costs incurred. But the question of paying for treatment is not simply a question for those visiting the UK, but for UK citizens travelling abroad, and this same issue is reflected across different jurisdictions.There is an ongoing international recognition of health as a global concern through the work of organisations such as the WHO,106 and, indeed, COVID-19 has thrown into sharp relief how disease is no respecter of borders. If, at the international level, there is real engagement with rights to health and healthcare as a matter of global justice and global health governance, then, as part of this, charging visitors for treatment should be addressed.107 In a world of increasing global travel and employment, reciprocal agreements between states to cover the cost of healthcare of their own citizens while in other member states would provide an obvious solution.108 This could be seen as a fundamental part of a drive towards an acceptance of universal health coverage.109 That, of course, though is someway removed given the diversity and disparity of healthcare provision currently across member states themselves. Furthermore, in developing such a global approach, there would need to be engagement with what universal health coverage should contain in that context and whether it should extend to cover costs of those individuals specifically travelling with the aim of receiving treatment rather than those who are in the country for travel or tourism and then fall ill while present, something which goes beyond the scope of the current chapter.110 In the absence of such an extensive global approach, it is suggested that, at the domestic level, a cautious approach needs to be taken before charging patients for services in a healthcare system which would normally be free at the point of delivery.What should be critical in developing such a policy across jurisdictions is to ensure that it is based on a transparent principled approach which is equitable and is proportionate. Without this, there is always a very serious risk that health policy may be driven more by headlines and political agendas rather than clear evidence.

Acknowledgements The authors gratefully acknowledge the support of ESRC grant number ES/R002053/1.

106 See M Cueto,T M Brown, and E Fee, The World Health Organization: A History (CUP 2019); and LO Gostin, Global Health Law (Harvard 2014), ch 4. 107 See, generally, Gostin (n 106), and BM Meier and LO Gostin ‘Framing Human Rights in Global Health Governance’ in BM Meier and LO Gostin (eds), Human Rights in Global Health (OUP 2018). 108 In the context of the EU, health policy has evolved to facilitate such coverage of reciprocal healthcare for EU citizens, see TK Hervey and JV McHale, European Health Law:Themes and Implications (CUP 2015), ch 4. 109 This it should be noted is very different than addressing the question of elective health procedures in the context of non-therapeutic procedures, e.g. some forms of cosmetic surgery. 110 See IG Cohen, Patients with Passports (OUP 2014).

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References BBC News,‘NHS Foreign Visitor Charges Reviewed by Vaughan Gething’ BBC News (1 March 2017). Callahan, D,‘The WHO Definition of ‘Health’ (1973) 1(3) Hastings Center Studies 77–88. Campbell, D,‘NHS Will No Longer Have to Share Immigrants’ Data with Home Office’ The Guardian (9 May 2018) https://www.theguardian.com/society/2018/may/09/government-to-stop-forcing-nhs-to -share-patients-data-with-home-office accessed 20 October 2020. Carty, H,‘Overseas Visitors and the NHS’ (1983) 5 Journal of Social Welfare and Family Law 258. CESCR, General Comment No 14:The Right to the Highest Attainable Standard of Health (Art. 12) Office of the High Commissioner of Human Rights; Adopted at the Twenty-Second Session of the Committee on Economic, Social and Cultural Rights, on 11 August 2000 (contained in Document E/C.12/2000/4). Cohen, IG, Patients with Passports (Oxford University Press 2014). Cueto, M, Brown,TM, and Fee, R, The World Health Organization: A History (Cambridge University Press 2019) Department of Health, ‘Making a Fair Contribution. Government Response to the Consultation on the Extension of Charging Overseas Visitors and Migrants Using the NHS in England’ (February 2017). Department of Health and Social Care, Guidance on Implementing the Overseas Visitor Charging Regulations (February 2020). Foster, C, and Herring, J,‘What Is Health?’ in M Freeman, S Hawkes, and B Bennett (eds), Law and Global Health: Current Legal Issues,Volume 16 (Oxford University Press 2014). Gentleman,A,‘Crackdown on Migrants Forces NHS Doctors to “act as Border Guards”’ The Guardian (20 April 2017) https://www.theguardian.com/uk-news/2017/apr/20/crackdown-migrants-nhs-doctors -border-guards-immigration-undocumented-migrants accessed 13 November 2020. Gentleman, A, ‘Londoner Denied NHS Cancer Care: ‘It’s Like I’m Being Left to Die’ The Guardian (10 March 2018). Gentleman, A, ‘UK to Pay up to £200m in Compensation to Windrush Victims’ The Guardian (3 April 2019). Gentleman, A, The Windrush Betrayal: Exposing the Hostile Environment (Guardian Faber 2019). Gostin, LO, Global Health Law (Harvard 2014). Hervey, TK and McHale, JV, European Union Health Law: Themes and Implications (Cambridge University Press 2015). Hiam, L, and McKee, M,‘Upfront Charging of Overseas Visitors Using the NHS’ [2017] BMJ j4713. Hiam, L, Steele, S, and McKee, M,‘Creating a ‘Hostile Environment for Migrants’:The British Government’s Use of Health Service Data to Restrict Immigration Is a Very Bad Idea’ [2018] Health Economics, Policy and Law 107. Home Office,‘Enforcing the Rules.A Strategy to Ensure and Enforce Compliance with Our Immigration Laws’ Home Office March 200713-14. https://www.citizensinformation.ie/en/health/health_services /gp_and_hospital_services/hospital_charges.html accessed 13 November 2020. Jayanetti, C, ‘NHS Denied Treatment for Migrants Who Can’t Afford Upfront Charges’ The Guardian (13 November 2018). Jayanetti, C,‘Upfront Fees “Deterring Immigrants from Seeking NHS Care”’ The Guardian (18 April 2019). Kennedy, I, The Unmasking of Medicine (Allen and Unwin 1981). Law Centre NI, Refused Asylum Seekers and Access to Free Secondary Healthcare https://www.lawcentreni.o rg/component/content/article/63-policy-briefings/865-refused-asylum-seekers-and-access-to-freesecondary-healthcare.html accessed 13 November 2020. Macaskill, M,‘Scotland “Needs Experts to Fight Health Tourism”’ The Times (10 January 2016). Martin,T,‘Foreign Health Patients Saddle Scottish NHS with £3m Bill’ Express (11 February 2019) https ://www.express.co.uk/news/uk/1085564/foreign-health-patients-leave-scottish-NHS-3m-bill-latestscotland accessed 20 October 2020. Maternity Action, Submission to the Equalities and Human Rights Committee Inquiry Into Destitution, Asylum and Insecure Immigration Status in Scotland (March 2017). McCullough, C, ‘DUP’s Poots Blasts “Health Tourism” as NHS Translators Cost NHS £9.3m in Three Years in Northern Ireland’ Belfast Telegraph (28 November 2016). McHale, JV, and Speakman, EM,‘NHS Overseas Visitors Regulations from Bevan to Windrush and Beyond’ (2020) Legal Studies (online first). Meier, BM, and Gostin, LO,‘Framing Human Rights in Global Health Governance’ in BM Meier and LO Gostin (eds), Human Rights in Global Health (Oxford University Press 2018).

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Jean V McHale and Elizabeth M Speakman Montgomery, J, ‘Recognising a Right to Health’ in R Beddard and DM Hill (eds), Economic, Social and Cultural Rights:Progress and Achievement (Macmillan 1992);and see the further discussion in Montgomery, J, Health Care Law (Oxford University Press 2002). National Audit Office, Department of Health, Recovering the Cost of NHS Treatment for Overseas Visitors (28 October 2016). NHS Inform, ‘Healthcare for Overseas Visitors’ https://www.nhsinform.scot/care-support-and-rights/ health-rights/access/healthcare-for-overseas-visitors accessed 13 November 2020. Nissen, A, ‘Right to Access Emergency Healthcare. The European Court of Human Rights Pushes the Envelope’ (2018) 26(4) Medical Law Review 693. O’Donnell, K,‘Transparency Is Needed on NHS Charges for Migrants and Data Sharing Agreements’ (The BMJ Opinion, 13 May 2013) https://blogs.bmj.com/bmj/2019/05/13/creating-a-hostile-environme nt-for-migrants-transparency-is-needed-on-nhs-charges-and-data-sharing-agreements-in-nhs-englan d/#:~:text=Transparency%20is%20needed%20on%20NHS%20charges%20for%20migrants%20and%2 0data%20sharing%20agreements,May%2013%2C%202019&text=Timely%20access%20to%20healthc are%20depends,and%20individuals%20which%20provide%20it accessed 20 October 2020. Pasha-Robinson, L,‘Pregnant British Woman Ordered by NHS to Prove She Is from UK to Receive Free Treatment’ Independent (21 October 2017). Rimmer,A,‘Royal Colleges Call for End to Charges for Overseas Patients’ (2018) 363 BMJ k5413. Savage, M, and Cadwalladr, C, ‘Revealed: How Home Office Hires Out Staff to Hunt Immigrants’ The Guardian (16 February 2019) https://www.theguardian.com/uk-news/2019/feb/16/home-officehires-out-staff-hunt-migrants-hostile-environment accessed 20 October 2020. Scottish Government,‘Overseas Visitors’ Liability to Pay Charges for NHS Care and Services’ CE 09,April 2010. Shaves, A, ‘Austerity or Xenophobia? The Causes and Costs of the “Hostile Environment” in the NHS’ [2019] Health Care Analysis 202. Taylor, D, ‘Woman Loses Legal Challenge to NHS Charges for Pregnant Migrants’ The Guardian (1 July 2020). The Scottish Parliament, The Scottish Parliament Official Report, Meeting of the Parliament, col 24042 (6 November 2013). The Scottish Parliament Health and Sport Committee, Official Report, Health and Sport Committee (32nd Meeting 2018, Session 5) (11 December 2018). Tobin, J, The Right to Health in International Law (Oxford University Press 2015). Toebes, B, ‘Towards an Improved Understanding of the International Right to Health’ (1999) 21 Human Rights Quarterly 261. UK Government and the Government of Ireland, Memorandum of Understanding between the Government of the United Kingdom of Britain and Northern Ireland and the Government of Ireland (8 May 2019). UK Visas and Immigration,‘Guidance. Ordinary Residence’ (5 January 2011) https://assets.publishing.serv ice.gov.uk/government/uploads/system/uploads/attachment_data/file/258236/ordinaryresidence.pdf accessed 20 October 2020. Weaver, M, ‘Doctors Threaten to Boycott Plan for Patients to Show ID at Hospitals’ The Guardian (22 November 2016) https://www.theguardian.com/society/2016/nov/22/doctors-threaten-to-boycott -plan-for-patients-to-show-id-for-nhs-care accessed 13 November 2020. Wollaston, S, Letter from Dr Sarah Wollaston MP, Chair of Health Committee to Jeremy Hunt (21 July 2017).

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17 PUBLIC REPORTING, TRANSPARENCY, AND PATIENT AUTONOMY IN THE PROVINCE OF QUEBEC Lara Khoury

Introduction Today, open communication and transparency with patients and the broader population are thought to play a central role in guaranteeing patient safety in healthcare.1 Indeed, for many, a culture of prevention requires open and honest disclosure of all incidents that endanger patients.2 The idea behind this is that identifying errors, recognising them, and discussing them may reveal the systemic roots of these errors and allow for their correction in the future.3 The proposition that the disclosure of medical adverse events and transparency in the healthcare sector can improve patient safety is not new. In Canada, a 2001 report on the safety of the healthcare system in the province of Quebec famously stated, Reducing the incidence rate of avoidable accidents—since this must be the goal—can only be achieved through a profound change in the culture of the entire system. Any progress in this direction will only be possible through a new culture of transparency, open communication and open discussion.4

1 Excellent Care for All Act, LO 2010, c 14 (Ontario), preamble. 2 Joan M Gilmour, Patient Safety, Medical Error and Tort Law:An International Comparison (Health Canada 2006) 3, 13; Canadian Patient Safety Institute (CPSI), Disclosure Working Group, Canadian Disclosure Guidelines: Being Open with Patients and Families (CPSI 2011) 10. 3 Gilmour (n 2) 3, 13; William Lahey, ‘Medicare and the Law: Contours of an Evolving Relationship’ in Jocelyn Downie, Timothy Caulfield, and Colleen M Flood (eds), Canadian Health Law and Policy (4th edn, Lexis Nexis 2011) 16. 4 Quebec, Ministère de la Santé et des Services sociaux, La gestion des risques, une priorité pour le réseau: rapport du comité ministériel (Rapport Francoeur) (MSSS 2001).

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The province of Quebec, one of Canada’s most populous provinces,5 has been at the cutting edge of the movement to disclose medical mishaps. In April 2001, its Minister of Health and Social Services (Minister of Health) mandated a special ministerial committee to inquire into the occurrence of avoidable accidents in the healthcare sector in Quebec. The committee produced the aforementioned report (the Francoeur Report), which concluded that while the nature, seriousness, and frequency of the occurrence of avoidable medical accidents was no different in Quebec than elsewhere, these accidents were a significant cause of morbidity and deserved special attention.6 The report led to the adoption of a province-wide strategy to limit the occurrence of such mishaps, a plan which included a disclosure and reporting system. The commission was of the opinion that it was a priority to address the culture of ‘discomfort, embarrassment and false modesty’ that was obscuring the phenomenon of preventable medical accidents.7 Thereafter, in 2002, Quebec became the first Canadian province to adopt groundbreaking legislation that promotes disclosure and transparency within the healthcare system, with the aim of improving safety. It should also be noted though that Quebec’s healthcare institutions had already taken action in this respect even before legislative initiatives were in place. As early as 1989, hospitals affiliated with McGill University were among the first in Canada to have a protocol for the disclosure of medical errors.They also started keeping a ‘house’ registry.8 This chapter therefore centres on Quebec’s leading experience with transparency in healthcare. Disclosure of medical adverse events to institutional risk management committees and to patients is the cornerstone of the Quebec disclosure system. However, a more recent movement extends transparency to the public at large, grounded on the patient’s right to information as a cornerstone of patient autonomy.9 Influenced by American developments, demands for the public reporting of quality of care indicators – including data related to patient safety – is spreading across Canada. South of the Canadian border, legislative public reporting developments in the United States were provoked by a major campaign launched in 2003 by Consumer Union, a pro-consumer lobby associated with Consumer Reports.This campaign – likely influenced by publication of the Institute of Medicine’s report To Err Is Human10 – called on American states to pass laws

5 Canada has ten provinces and three territories. Private law matters are governed by the common law throughout, except in the province of Quebec where the civil law tradition is in effect. 6 Rapport Francoeur (n 4) 1. 7 ibid (my translation). 8 ‘The MUHC Becomes One of the First Canadian Health Centres to Adopt a Disclosure Policy’ (McGill University News and Events (Channels), 19 November 2001) www.mcgill.ca/channels/news/muhc-becomes-one-first-cana dian-health-centres-adopt-disclosure-policy-1850 accessed 25 December 2019.The MUHC accidents and incidents registry dates from 1994: MUHC,‘Patient Safety Learning’ (CUSM) https://legacy.muhc.ca/royalvic/page /patient-safety-learning accessed 8 January 2020. 9 Patrick A Molinari,‘Émergence et structuration du droit de la santé : du colloque singulier à la théorie des droits sociaux’ in Institut de droit de la santé, Droit de la santé : Fondements et perspectives,Actes de la 10e Journée de droit de la santé (Université de Neuchâtel 2004) 1617 (discussing patients’ access to their health records). 10 Implicit in Jan Odom-Forren and Ellen J Hahn, ‘Mandatory Reporting of Health Care-Associated Infections: Kingdon’s Multiple Streams Approach’ (2006) 7 Policy Politics Nursing Practice 64, 66. In 1999, the American Institute of Medicine produced its famous report To Err Is Human in which it concluded that most of the harm suffered by patients is the result of systemic problems that can be prevented: Linda T Kohn, Janet M Corrigan, and Molla S Donaldson (eds), To Err Is Human: Building a Safer Health System (National Academy Press 2000).This report strengthened the patient safety movement, which emphasises systemic analysis, in particular, as a way to reduce errors and harms in healthcare.This movement identifies a number of measures as being vital to protecting

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requiring hospitals to publicly report infection rates.11 These lobbying efforts led to the adoption of numerous legislative texts requiring such reporting. Controversy sparked thereafter as to the validity of the information disclosed, its effect on the quality and safety of care, and on the free choice of patients.12 This chapter comments briefly on the issue of the public reporting of safety indicators13 from the perspective of Quebec, the Canadian province that has shown the most legislative leadership in disclosure initiatives. Across Canada, public healthcare system transparency is evolving,14 but without national cohesion.15 Some provinces and territories publicly disclose quality indicators, while others do not, and Canadian commentators describe the indicators as variable and even ‘chaotic.’16 More uniform national reporting has been occurring since 2004, however.17 Hence, while Canada as a whole does not offer the best model in respect of transparency, the Quebec experience offers an interesting case study of long-term efforts at building bridges with the population through the disclosure of information related to patient safety.

Public reporting of patient safety indicators in Quebec The patient safety movement emphasises the importance of openly disclosing medical adverse events, particularly those that have had or could have negative consequences for the patient.18 Patients themselves desire such open communication. Indeed, according to the Canadian Patient Safety Institute (CPSI), when harm occurs, patients want to know: what happened, what measures will be taken to reduce the harm they suffered, that the healthcare professional and the institution are sorry for what happened, and what they will do so that the situation does not happen again.19 Safety and transparency are thus foundational values in several healthcare systems, including the Quebec system. Quebec’s Act Respecting Health Services and Social Services (AHSSS) entrenches these values, affirming the importance of the safety of healthcare services in its very first provisions20 as well as the importance of the participation of ‘individuals and groups of

11 12 13 14 15

16 17

18 19 20

patient safety, including the creation of an environment in which errors can be exposed and analysed without fear of individual blame or responsibility. Rachel L Stricof et al., ‘Lessons Learned While Implementing Mandatory Health Care-Associated Infection Reporting in New York State’ (2013) 19(4) Journal of Public Health Management & Practice 294. See Lara Khoury,‘La transparence dans le réseau de la santé’ in Vincent Gautrais, Catherine Régis and Laurence Largenté (eds), Mélanges Molinari (Éditions Thémis 2018). This chapter does not comment on the public reporting of broader healthcare system performance or healthcare quality indicators. Tom Archibald, ‘Health Law Efficiency and the Pursuit of Patient Safety’ (2017) 54(3) Alta Law Review 697, para 3. Jessica Giesbrecht, A Study of Publicly-Reported Acute-Care Quality Indicators Across Canada (School of Public Administration, University of Victoria 2016) ii. See also Health Council of Canada, Progress Report 2012: Health Care Renewal in Canada (HCC 2012) 18–19. Giesbrecht (n 15). Health Council of Canada (n 15) 19. See e.g. Canadian Institute for Health Information (CIHI) National System for Incident Reporting,‘Access Data and Reports’ (CIHI) www.cihi.ca/en/access-data-and-reports accessed 24 December 2019. See e.g. Martin A Makary and Michael Daniel, ‘Medical Error – The Third Leading Cause of Death in the US’ (2016) 353(2139) BMJ 1. CPSI (n 2) 10. See also Charles Vincent et al.,‘Why Do People Sue Doctors? A Study of Patients and Relatives Taking Legal Action’ (1994) 343(8913) Lancet 1609. Act Respecting Health Services and Social Services (AHSSS), CQLR c S-4.2 (Quebec), ss 2(8.1) and 5.

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individuals in the selection of orientations and in the setting up, improvement, development and management of services.’21 Since 2002, the AHSSS has also formally entrenched the right of those using healthcare services to, be informed, as soon as possible, of any accident having occurred during the provision of services that has actual or potential consequences for the user’s state of health or welfare and of the measures taken to correct the consequences suffered, if any, or to prevent such an accident from recurring.22 Reporting systems for medical accidents and incidents, and for healthcare-associated infections, complements this duty to openly communicate with patients.These reporting systems facilitate the gathering of data which the state then shares with the public at large.

Public reporting of medical accidents and incidents In the province of Quebec,23 public reporting pertains to three types of patient safety indicators: accidents and incidents related to healthcare delivery, and healthcare-associated infections.The AHSSS defines an accident as an ‘action or situation where a risk event occurs which has or could have consequences for the state of health or welfare of the user, a personnel member, a professional involved or a third person.’24 An incident is an action or situation that does not have ‘consequences for the state of health or welfare of a user, a personnel member, a professional involved or a third person, but the outcome of which is unusual and could have had consequences under different circumstances.’25 The AHSSS obliges every healthcare institution to create risk management committees.26 These committees are tasked with identifying and analysing the risk of incidents and accidents in order to ensure patient safety.27 In carrying out this mission, the institution must create a local register of incidents and accidents. The purpose of the local register is so that the committee may analyse the potential causes of incidents and accidents ‘and recommend to the board of directors of the institution measures to prevent such incidents and accidents from recurring and any appropriate control measures.’28 Every healthcare institution’s employees as well as any other

21 ibid s 2(1). 22 ibid s 8. 23 For other Canadian examples, see CIHI (Your Health System) yourhealthsystem.cihi.ca/hsp accessed 24 December 2019; Ontario, ‘Hospital Patient Safety’ (Health Quality Ontario) www.hqontario.ca/System-Performance/Hosp ital-Patient-Safety accessed 24 December 2019; Nova Scotia, ‘Public Reporting on Patient Safety’ (Nova Scotia) novascotia.ca/dhw/hsq/public-reporting/ accessed 24 December 2019. Other public disclosure sites offer more technical information that is probably addressed at actors of the healthcare system rather than the public, see e.g. CIHI’s National System for Incident Reporting,‘Access Data and Reports’ (n 17); Canadian Medication Incident Reporting and Prevention System, ‘What Is CMIRPS?’ (CMIRPS) www.cmirps-scdpim.ca/?p=14 accessed 24 December 2019. 24 AHSSS (n 20) s 8. 25 ibid s 183.2. 26 ibid s 183.1. 27 ibid s 183.2. The risk management committee’s reports are provided to the institution’s ‘watchdog committee’ (ibid s 181.0.1), a subcommittee of the board of directors: Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2018–2019 sur les incidents et accidents survenus lors de la prestation de soins de santé et de services sociaux au Québec (MSSS 2019) 20. 28 AHSSS (n 20) s 183.2. Other Canadian provinces have also instituted internal disclosure systems, e.g. in Ontario: Hospital Management, RRO 1990, Regl 965, s 2(4) (Public Hospitals Act, RSO 1990, c P-40); in Manitoba:

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persons providing services to users on behalf of an institution must report incidents and accidents.29 Healthcare institutions must also provide the information collected in the local register to the Ministry of Health.30 The Minister of Health must then establish and maintain a national register of incidents and accidents based on the content of the local registers. Similar to the local register, the national register’s the purpose is to allow the appropriate bodies to monitor and analyse the causes of incidents and accidents, and to ensure their prevention through the implementation of control measures.31 Once per year, the Ministry of Health publicly discloses the information gathered in the national register through its website,32 stressing that it does so in order to be transparent with the population.33 Prior to the summer of 2014, the ministry actually reported its data publicly every six months; the publication is now annual to ensure that the data and analysis are ‘more complete and conclusive,’ since it gives institutions more time to report to the ministry and allows the ministry to analyse, rather than simply communicate, the data.34 In my opinion, the presentation of the information makes it fairly accessible.The reports include data tables, with the most complex being located in the annexes. In the main text, the information is analysed in an intelligible manner. The reports offer clear definitions of key concepts, as well as context and interpretation of the data to allow a clearer understanding of the statistics. For instance, the Ministry of Health provides the yearly numbers of surgeries, ER visits, medical consultations in healthcare institutions, and days of housing in long-term care homes alongside the number and types of medical accidents and incidents.35 The report also notes areas that are improving as well as those worsening.36 A final example of the contextualisation provided as part of the report is the fact that it clearly explains why some regions of the province have worse results than others (e.g. high concentration of healthcare institutions, providing specialised and super-specialised care).37

Public reporting of healthcare-associated infections Another set of data disclosed publicly by the state in Quebec concerns healthcare-associated infections (HAIs). Originally, the need to publicly disclose rates of HAIs was not agreed on unanimously by actors of the healthcare system in Canada. In 2006, the Association of Medical Microbiology and Infectious Disease Canada (AMMI) and the Community and Hospital

29 30 31 32

33 34 35 36 37

Regional Health Authorities Act, SM 2005, c 24, ss 53.1–53.4; in Saskatchewan:The Regional Health Services Act, SS 2002, c R-8.2, s 58(2); in New Brunswick: Health Quality and Patient Safety Act, RSNB 2016, c 2, ss 2(2)–2(3), 3(1)(2), 3(1)(4).These systems may also impose a duty to disclose to patients (e.g. Hospital Management, RRO 1990, Regl 965, s.2(4); Manitoba Regional Health Authorities Act, SM 2005, c 24, s 53.2(2)(a); Health Quality and Patient Safety Act, RSNB 2016, c 2, ss 3(1) and 4). AHSSS (n 20) s 233.1. ibid. ibid s 431. Quebec, Ministère de la Santé et services sociaux (MSSS), ‘Publications du ministère de la Santé et services sociaux’ (MSSS) publications.msss.gouv.qc.ca/msss/recherche/?txt=Registre+national+des+incidents+et+a ccidents&rechercher=Lancer+la+recherche&msss_valpub= accessed 25 December 2019. Canadian provinces also report hospital data to the Canadian Institute for Health Information (CIHI) which makes aggregate data available publicly on its website: CIHI,‘Access Data and Reports’ (n 17). Quebec, Rapport 2018–2019 (n 27) 3, 37. Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2014–2015 des incidents et accidents survenus lors de la prestation des soins et services de santé au Québec (MSSS 2015) 7. Quebec, Rapport 2018–2019 (n 27) 3. E.g. ibid 4. ibid 15.

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Infection Control Association of Canada (CHICA) produced a joint position paper arguing against the use of infection rates reported by individual hospitals as a means of classifying them.38 However, around the same time, others were decrying the weakness of Canadian disclosure obligations.39 Data concerning HAIs is collected through a surveillance system called the Programme provincial de prévention et contrôle des infections (PCI) (provincial program for infection prevention and control). It obliges healthcare institutions to declare the incidence of seven different kinds of infection to the Quebec National Public Health Institute (Institut national de santé publique du Québec or INSPQ). These are hospital-wide nosocomial bacteraemia, central-line-associated nosocomial bacteraemia in intensive care units, bacteraemia associated with haemodialysis vascular access, methicillin-resistant staphylococcus aureus bacterial infections, Clostridium difficile diarrhoea, carbapenemases producing gram-negative bacillus infections, and vancomycin-resistant enterococcus infections. Institutions collect the data locally through their infection prevention and control teams (équipes en PCI). Nationally, the data is gathered via the information system for the surveillance of nosocomial infections (Système d’information pour la surveillance des infections nosocomiales or SI-SPIN). The SI-SPIN data is not directly accessible to the public. However, the Quebec Nosocomial Infection Committee (Comité sur les infections nosocomiales du Québec or CINQ), a subcommittee of the INSPQ, produces, analyses, and disseminates annually to the public the results of each monitoring program.The CINQ publicly releases an annual general report on its website, with information tailored to the general public.40 It also publishes special reports for each of the seven monitored infections. The general report is relatively simple to understand. For each type of infection, it provides simple statistical data accompanied by an analysis.The report then offers national and international comparisons, and straightforward recommendations based directly on the data collected for each of the seven HAIs monitored.41 The special reports (‘surveillance results’) are much more detailed in terms of statistical data and, therefore, much more difficult for the neophyte to read and understand.They detail incidence rates and their evolution, and describe individual cases. They also contain a microbiology section and include detailed data for each healthcare establishment.42

Promotion of patient autonomy through public reporting The public reporting of patient safety indicators is thought of as, first and foremost, a measure to promote patient safety. Commentators believe that promoting a culture of prevention in healthcare requires the open and honest disclosure of patient safety adverse events, accompanied

38 Association of Medical Microbiology and Infectious Disease Canada (AMMI–CHICA), Public Reporting and InterHospital Comparison of Healthcare-Acquired Infections, Position paper (IPAC Canada 2006) ipac-canada.org/photos/ custom/OldSite//pdf/AMMIposition.pdf accessed 7 January 2019. 39 Canadian Union of Public Employees (CUPE), Healthcare Associated Infections: A Backgrounder (CUPE 2009) 15, cupe.ca/sites/cupe/files/healthcare-associated-infections-cupe-backgrounder.pdf accessed 25 December 2019. 40 Quebec, INSPQ, Surveillance provincial des infections nosocomiales: faits saillants, discussions et recommandations 2017– 2018 (INSPQ 2019). 41 E.g. the latest general report: ibid. 42 E.g. the latest surveillance results for clostridium difficile infections: Quebec, INSPQ, Diarrhées associées au Clostridium difficile: résultats de surveillance 2018–2019 (INSPQ 2019) www.inspq.qc.ca/infections-nosocomiales/spin/dacd/ surveillance-2018-2019 accessed 29 December 2019.

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by efforts to learn useful lessons from past mistakes.43 However, the literature notes the paucity of evidence supporting the effectiveness of public error reporting systems for improving patient safety,44 although some studies have established an association between the two.45 Others observe adverse effects on health outcomes (e.g. gaming), but describe them as minimal.46 Some believe that, beyond safety, the public reporting of patient safety indicators is necessary to promote patients’ autonomy and free choice in determining their preferred healthcare institution.47 These types of arguments have been mainly advanced, and analysed, in the United States where the healthcare system is built on a ‘consumerist model.’48 Indeed, one may argue that patients have a ‘right to know’ about quality indicators49 and that patient autonomy is the source of obligations of transparency toward the public. For example, American authors argue that the ability to compare infection rates at each healthcare institution allows the patient to make an informed choice50 before ‘purchasing’ healthcare, such as a consumer would do when purchasing a product that carries inherent risks. American authors also maintain that healthcare purchasers want to obtain information on the performance of establishments in order to become better purchasers of health services over time.51 Of course, in the United States, where private industry largely dominates the healthcare system, consumer choice is a major issue. Patient choice takes on a different meaning, however, in systems like the Canadian one where healthcare is publicly financed52 and the patient has limited choice as to where to receive the services. Moreover, there are even American commentators who critique arguments based on patients’ autonomy.53 From a Canadian perspective, such criticism may rest on four grounds: problems with the quality of the data, the possible unintelligibil-

43 Gilmour (n 2) 3, 13; CPSI (n 2) 10. 44 In the context of HAIs: AMMI–CHICA (n 38); Thomas Haustein et al., ‘Use of Benchmarking and Public Reporting for Infection Control in Four High-Income Countries’ (2011) 11 Lancet Infectious Diseases 471, 475. Generally, regarding quality indicators: Anne C Wojtak, ‘How Can We Evaluate and Enhance the Impact of Third-Party Public Reporting on Quality Improvement for Health Care in the Province of Ontario, Canada?’ (D.P.H. thesis, University of North Carolina at Chapel Hill, 2016) iv; R Hamblin et al., ‘Public Reporting of Health Care Performance Data: What We Know and What We Should Know’ (2016) 129(1431) New Zealand Medical Journal 7, 11, and studies cited. 45 E.g. in Canada: Nick Daneman et al.,‘Reduction in Clostridium Difficile Infection Rates after Mandatory Hospital Public Reporting: Findings from a Longitudinal Cohort Study in Canada’ (2012) 9(7) PLoS Medicine. Also Wojtak (n 44) 7, 21–22, 24–25, and studies cited, including Damien Contandriopoulos et al., ‘The Multiple Causal Pathways between Performance Measures’ Use and Effect’ (2014) 71(1) Medical Care Research & Review 3; Giesbrecht (n 15) (studies cited). 46 Wojtak (n 44) 25–26 and studies cited. On balance, it appears to have more benefits than harm especially with regard to institutional behaviour, however: ibid, 29. 47 Zackary D Berger et al.,‘Can Public Reporting Impact Patient Outcomes and Disparities? A Systematic Review’ (2013) 93 Patient Education & Counselling 480; Marjan Faber et al.,‘Public Reporting in Health Care: How Do Consumers Use Quality-of-Care Information? A Systematic Review’ (2008) 47(1) Medical Care 1. 48 Berger et al. (n 47) 481. 49 E.g. sources cited by Odom-Forren and Hahn (n 10) 68. 50 Julie Reagan and Carl Hacker, ‘Laws Pertaining to Healthcare-Associated Infections: A Review of 3 Legal Requirements’ (2012) 33(1) Infection Control & Hospital Epidemiology 75, 79. 51 Edward S Wong et al., ‘Public Disclosure of Healthcare-Associated Infections: The Role of the Society for Healthcare Epidemiology of America’ (2005) 26(2) Infection Control & Hospital Epidemiology 210, 210. 52 It is funded publicly at the level of 70% and made accessible to patients without financial barriers. 53 E.g. the ability to choose patients is limited by insurers or managed care organizations, physician’s admission privileges, and their location in sectors where competition between hospitals is limited: Jill A Marsteller,Yea-Jen Hsu, and Kristina Weeks,‘Evaluation the Impact of Mandatory Public Reporting on Participation and Performance in a Program to Reduce Central Line-Associated Bloodstream Infections: Evidence from a National Patient Safety Collaborative’ (2014) 42 American Journal of Infection Control S209, S213; Michael B Edmond and Gonzalo

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ity of the information, the absence of evidence that public reporting has an effect on patient decision-making, and the doubtful usefulness of public reporting within the informed consent process.

Data quality The first concern relates to problems with the quality of the data collected and shared by the state that may limit its potential for reliably transmitting information to the public in a way that can truly promote patient autonomy. For patients to trust the data, for it to be useful to them, and for it not to mislead them, the data communicated must be of high quality. (Note that this quality is also necessary for systems to use the data to promote safety.) Systems for collecting and sharing data obviously need to continuously improve in this respect. A rich and very prolific literature raises problems with how data is collected and analysed in Quebec as elsewhere. In Quebec, interestingly, the Ministry of Health itself reflects on the issue of the quality of its data in the context of the reporting of medical accidents and incidents through its national register, on which we draw for the purposes of our analysis. When asked by the media to explain an increase in the number of deaths alongside a decrease in the number of accidents and incidents, as shown in the 2014–2015 Report of the National Registry, a spokesperson was unable to provide an explanation.To justify the absence of explanation, she invoked failures of the reporting system, including, according to her, institutions’ failure to communicate their data to the registry, difficulties in analysing and comparing the data, underreporting, and technical difficulties in entering data into the system.54 In its three most recent public reports, the Quebec Ministry of Health notes a similar array of problems. These include disparities in the way institutions collect data55 and the communication of incomplete declarations which the ministry must therefore exclude from the national data reporting.56 A recurring problem is the fact that institutions tend to report data promptly after the adverse event has occurred.They thus do so before they can complete a full analysis of the event, of its severity, and of its causes,57 leading to incomplete declarations of incidents and accidents. The ministry also observes difficulties with the continuous feeding of the national register before the ministry’s deadline and the fact that some institutions use a ‘house’ register in contravention of the law.58 The ministry also advises against using the reported data to compare institutions, since each institution has a distinct mission and serves the needs of different territories and clienteles.59 In an older document from 2014, the Ministry of Health notes an additional series of issues.These include underreporting (poor compliance with disclosure obligations); the fact that the data collected reveals variation in the analysis tools used; and in the number, expertise,

54 55 56

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ML Bearman, ‘Mandatory Public Reporting in the USA: An Example to Follow?’ (2007) 65(S2) Journal of Hospital Infection 182, 183. Cited in Tommy Chouinard, ‘Incidents dans le réseau de la santé: 316 morts en un an’ La Presse (Montreal, 8 January 2016), reporting on the 2014–2015 report of the Régistre national des incidents et des accidents. Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2016–2017 sur les incidents et accidents survenus lors de la prestation de soins de santé et de services sociaux au Québec (MSSS 2017) 35. Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2017–2018 sur les incidents et accidents survenus lors de la prestation de soins de santé et de services sociaux au Québec (MSSS 2018) 4 (11 out of 137 institutions); Quebec, Rapport 2018–2019 (n 27) 4 (4 out of 139 institutions). Quebec, Rapport 2016–2017 (n 55) 3, 4. Quebec, Rapport 2018–2019 (n 27) 4. Quebec, Rapport 2016–2017 (n 55) 4. Quebec, Rapport 2016–2017 (n 55) 3, 4; Quebec, Rapport 2018–2019 (n 27) 4.

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and authority of risk managers.60 It also observes that events having no adverse consequences for the patient (incidents) are rarely analysed.61 Authors have also observed that variations from year to year in the number of accidents and incidents cannot be reasonably relied upon; they are more closely related to how institutions respond to the disclosure process than to real increases or decreases in rates of occurrence.62 Finally, initiatives to improve data quality are stressed in the latest 2018–2019 report.63 A full, albeit brief, section is devoted to the subject64 and announces measures to improve data quality in the future.65 Despite acknowledging problems and taking action to improve the quality of the data it reports, the Ministry of Health notes that surveillance is a local responsibility66 and ascribes most of the lacuna observed in its report to local institutions’ failings. In its annual reporting of HAI rates, the CINQ does not undertake a similar reflection on the quality of its data. Reporting tends, at least as far as the general report is concerned, to remain at a very general level. However, the international literature raises many problems concerning the quality of publicly disclosed data concerning HAIs and the methodology for gathering such data.67 Therefore, data quality issues likely exist with regard to Quebec HAI reporting as well. This may militate in favour of the CINQ engaging in open self-reflection with a view to not only improve outcomes related to HAIs prevalence, but also its own surveillance system. Given the absence of such publicly available analysis, we look briefly at some of the issues the North American literature raises in this respect. The American and Canadian literature raise numerous methodological and data quality issues with regard to the public reporting of HAI rates, probably fuelled particularly by the extensive experience with it in the United States. Commentators worry about flaws in the data communicated to the public, and its potential to be misleading, misinterpreted, or misunderstood.68 Authors emphasise the need to standardise and risk adjust the data for differences in population or range and type of medical procedure,69 risk of infection inherent to the patient, and complexity of care offered at each hospital. Authors also raise the need for uniform definitions and

60 The Canadian literature observes also a need for more consistent methods of public performance reporting: Giesbrecht (n 15) 21, citing J Veillard, B Tipper, and S Allin, ‘Health System Performance Reporting in Canada: Bridging Theory and Practice at Pan-Canadian Level’ (2015) 58(1) Canadian Public Administration 15. 61 Quebec, Ministère de la Santé et des Services sociaux (MSSS), Améliorer la prévention des chutes et incidents et accidents liés à la médication: de la stratégie à l’action.Volet: incidents et accidents liés à la médication (MSSS 2014) 35. 62 Jean-François Bussières and Denis Lebel, ‘Des soins sans incidents ni accidents!’ (2011) 58(5) Québec Pharmacie 39, 41. 63 Quebec, Rapport 2018–2019 (n 27) 11. 64 ibid 35. 65 In this latest report, the ministry announces a revamping of its guidelines to address differences in the ‘disclosure culture’ and in the interpretation of guidelines, which may explain regional variations in the data: ibid 22 and 35. 66 Quebec, Rapport 2018–2019 (n 27) 36. 67 E.g. Haustein et al. (n 44) 471. See also Centers for Disease Control and Prevention (CDC) and National Nosocomial Infections Surveillance System, ‘Nosocomial Infection Rates for Inter Hospital Comparison: Limitations and Possible Solutions’ (1991) 12(10) Infection Control & Hospital Epidemiology 609, 610; CMAJ, ‘Public Reports of Infection Rates Urged’ (2009) 181(9) Canadian Medical Association J 573, 574; Brett G Mitchell et al., ‘Healthcare-Associated Infections: Getting the Balance Right in Safety and Quality v. Public Reporting’ (2012) 36 Australian Health Review 365, 366; Odom-Forren and Hahn (n 10) 67; Stricof et al. (n 11) 294;Wong et al. (n 51) 210. 68 Wong et al. (n 51) 210; Haustein et al. (n 44) 475. 69 Haustein et al. (n 44) 471. See also more generally Mark W Friedberg and Cheryl L Damberg, ‘A Five-Point Checklist to Help Performance Reports Incentivize Improvement and Effectively Guide Patients’ (2012) 31(3) Health Affairs 612.

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surveillance methods.70 Other objections to public reporting include cost, variations in surveillance practices among reporting hospitals, underreporting, and issues with the comparability of data from each reporting hospital.71 The quality of the data publicly communicated to the population is crucial to the promotion of patient autonomy in making healthcare choices, to the extent that these choices exist, of course.Where issues in data quality or methodology create the risk of misleading the public, creating confusion, or resulting in misinterpretation or lack of understanding,72 one could argue that public reporting is a disservice to patient’s autonomy.This should not lead to rejecting public disclosure in our opinion, but rather to striving to address data quality issues and to improve the reporting system alongside the healthcare system (quality of the first perhaps assisting in improving the quality of the second).

Accessibility and literacy Beyond data quality, the way the information is presented can also have an effect on patients’ ability to act on the information. Providing data to the public is insufficient if not accompanied by an interpretation that allows it to be understood. Long-term investments in education as a means to develop sufficient health literacy in the population may also be necessary to promote a clear understanding of this information by patients.73 Canadian calls in favour of educating the users of healthcare indicator information ‘to ensure meaningful and accurate use’ are therefore warranted.74 This is especially so in light of American studies that have shown poor healthcare choices increase with the number of options available and the complexity of the information (e.g. the number of performance metrics).75 This means that providing more information may lead to the conundrum of communicating data that is at once more accurate, but less intelligible or less impactful. Even more concerning is the fact that publicly disclosed data may exacerbate inequalities given that those with lesser health literacy are likely to be those the system already disadvantages.76 Indeed, it has been shown that patients have a poor understanding of quality of care indicators, and that this is particularly the case for socially and economically disadvantaged patients.77 Our own exploration of Canadian websites through which the public reporting of safety data takes place convinces us that a certain level of health literacy and knowledge of statistical science is often necessary to fully understand the information.While the state displays a real effort in Quebec to make the information intelligible to the public, the data provided is sometimes opaque and complex. For instance, the specific reports of the CINQ transmit information that is difficult to absorb and makes one wonder whether the CINQ might intend this information for the healthcare community rather than for the general public. In contrast, the CINQ’s general

70 71 72 73

74 75 76 77

ibid 471. Stricof et al. (n 11) 294;Wong et al. (n 51) 210. Raised in the US and the UK:Wong et al. (n 51) 210; Haustein et al. (n 44) 475. See more generally Giesbrecht (n 15) 23, referring to K Morris and J Zelmer,‘Public Reporting of Performance Measures in Health Care’ (2005) 4 Canadian Policy Research Networks, 11–12 and R Hader,‘Public Reporting’ (2006) 37(4) Nursing Management 88. Giesbrecht (n 15) iv. Mark Schlesinger et al.,‘Complexity, Public Reporting and Choice of Doctors: A Look Inside the Blackest Box of Consumer Behavior’ (2014) 71(5) Medical Care Research & Review Suppl to 2014 38, 41–43. Hamblin et al. (n 44) 10. Edmond and Bearman (n 53) 183; Hamblin et al. (n 44) 10.

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reports display efforts at communicating in a straightforward and unambiguous manner, and to provide not only data but also a clear analysis of it.

Effect on decision-making processes Citizens desire information and want to be involved in quality of care conversations. However, empirical studies – mostly from the United States – show that the public reporting of health safety data has little effect on decision-making processes.78 Citizens make limited or no use of quality of care information,79 are often unaware of its availability,80 and do not understand it.81 Their motivations when making healthcare-related choices are also simply difficult to identify.82 Moreover, American authors observe that the prevalent US consumerist model itself has flaws: ‘[w]hile information might lead to greater knowledge in some groups, other less advantaged groups might not be able to take advantage of the information as quickly or reliably for their benefit.’83 Referring to American research, Edmond and Bearman report that only 19% of patients used quality information to make healthcare decisions.84 When asked what sources of information about quality of care they were most likely to use, 65% of the participants answered family, friends, or work colleagues, doctors or nurses; and 37% said they would consult a website, 20% a leaflet, 18% a state administrative entity, and 16% a newspaper or magazine. When asked if they would prefer a hospital they were familiar with or a hospital with a better quality score, 61% favoured familiarity.85 The authors note, however, that these results could change as patients become better informed and better educated on these issues. Most studies demonstrating the limited role quality reports play in health-related decision-making were conducted in the United States, however.

Importance in obtaining informed consent A last issue pertains to whether patient safety data needs to become part of seeking an individual patient’s informed consent before treatment. In Canada, healthcare professionals must disclose, among other things, the ‘material risks’ of the treatment proposed. Materiality is a function of the probability of the risk arising and the severity of its consequences.86 The evaluation of materiality is closely dependent on the nature of the treatment itself and of the individual patient’s

78 Wojtak (n 44) 22, 38, and studies cited (healthcare system performance indicators in general). Berger et al. (n 47) 482, 485 report mixed results (they also note the evidence is of low quality in general). Faber et al. (n 47) 6 report limited evidence of the effectiveness of quality information on consumer choice. 79 C Shuker et al.,‘Progress in Public Reporting in New Zealand since the Ombudsman’s Ruling, and an Invitation’ (2017) 130(1457) New Zealand Medical Journal 11, 16 (citing American studies); Hamblin et al. (n 44) 10; Faber et al. (n 47) 1 and 2ff (and studies cited and analysed). 80 Faber et al. (n 47) 7. 81 ibid. 82 Hamblin et al. (n 44) 10. Moreover, Faber et al. observe that “[a]ge, gender, health status, education level, and income of the consumer/patient are assumed to be important factors influencing the effectiveness of public reporting” (Faber et al. (n 47) 6). 83 Berger et al. (n 47) 481. 84 Edmond and Bearman (n 53) 183. See also studies noted by Wojtak (n 44) 4. 85 ibid 183. 86 Hopp v Lepp [1980] 2 SCR 192, 210 and Reibl v Hughes [1980] 2 SCR 880, 884 (common law); Drolet v Parenteau [1991] RJQ 2956 (Que CA) (Quebec civil law).

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situation. One question is, therefore, whether promoting patient autonomy and making it the centre of healthcare decision-making would require doctors to disclose to the patient any systemic risks that may affect the quality of the care proposed.These systemic risks could be identified according to safety data associated with, for instance, the particular physician undertaking the medical treatment, extending to relevant safety data concerning the institution as a whole. However, the quality issues from which this data may suffer and difficulties in understanding it entail a very real risk of misleading the patient87 and of promoting confusion instead of autonomy.This militates against disclosing such information in the context of seeking informed consent.

Conclusion From the perspective of patients’ rights, transparency may be seen as leading to more autonomy for the patient, a reduction in the patient’s vulnerability, and the availability of a more active role for the patient in healthcare improvement. Predominantly, however, the target of publicly reporting healthcare safety indicators has been improving safety as well as the quality of healthcare delivery, not patient autonomy. While informed free choice, open disclosure of risks and accidents, and communication aimed at improving quality of care are undoubtedly positive developments for patients, autonomy is, in my opinion, a doubtful foundation for arguing in favour of the public reporting of patient safety data. The doubts expressed flow mostly from problems regarding the quality of the data that is publicly communicated, as well as its intelligibility.The promotion of autonomy through public reporting needs to be accompanied by analysis of the data as well as reflection on the quality and trustworthiness of the reporting system itself – which Quebec seems to engage with as far as the disclosure of accidents and incidents is concerned – and by subsequent efforts at improving the quality of the data and its accessibility.While improvement of the quality and efficiency of the Quebec HAI reporting system is not discussed by the relevant public bodies, the North American literature shows that efforts at maintaining quality data in this area are warranted as with regard to incidents and accidents.This may, in turn, require long-term efforts at improving the population’s health literacy so that its members may be true partners of the healthcare system and fully involved in decisions about their own health, as well as decisions about ways in which the system may promote their safety. Overall, it is doubtful whether public reporting of patient safety indicators improves the autonomy of patients and their ability to make informed choices. In addition to the question of whether the patient has a real freedom of choice in publicly funded healthcare systems, informed or not, we have raised the variableof intelligibility of available information for the average patient.As a counter-example, the annual reports of the Quebec Ministry of Health and the main annual report of the CINQ do appear to non-expert eyes to be the result of a true effort at intelligibility and accuracy despite the failings that have been noted in the accidentand incident-reporting system. But even the most intelligible data, of the best quality, may not participate in promoting autonomous choices on the part of patients if the latter do not rely on it, as the American literature seems to suggest is the case. It therefore seems that, at this moment, the main attraction of the public reporting of safety indicators is to allow healthcare establishments to change their priorities and to take measures

87 Hamblin et al. (n 44) 10.

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to improve quality of care – which, in itself, is very positive – rather than to strengthen patient autonomy.

Acknowledgements This research was funded by the Fondation du Barreau du Québec and the Fonds de recherche du Québec, Société et Culture.The author wishes to thank Rebecca Schur, JD/BCL candidate (McGill University) for the assistance provided in the preparation of this text.

References Archibald, T, ‘Health Law Efficiency and the Pursuit of Patient Safety’ (2017) 54(3) Alta Law Review 697. Association of Medical Microbiology and Infectious Disease Canada (AMMI – CHICA), Public Reporting and Inter-Hospital Comparison of Healthcare-Acquired Infections, Position paper (IPAC Canada 2006) ipaccanada.org/photos/custom/OldSite//pdf/AMMIposition.pdf accessed 7 January 2019. Berger, ZD et al. Can Public Reporting Impact Patient Outcomes and Disparities? A Systematic Review’ (2013) 93 Patient Education & Counselling 480. Bussières, J-F, and Lebel, D,‘Des Soins Sans Incidents ni Accidents!’ (2011) 58(5) Québec Pharmacie 39. Canadian Institute for Health Information (CIHI), Your Health System, yourhealthsystem.cihi.ca/hsp accessed 24 December 2019. Canadian Institute for Health Information (CIHI), ‘Access Data and Reports’ (CIHI) www.cihi.ca/en/ access-data-and-reports accessed 24 December 2019. Canadian Medication Incident Reporting and Prevention System, ‘What is CMIRPS?’ (CMIRPS) www .cmirps-scdpim.ca/?p=14 accessed 24 December 2019. Canadian Patient Safety Institute (CPSI), Disclosure Working Group, Canadian Disclosure Guidelines: Being Open with Patients and Families (CPSI 2011). Canadian Union of Public Employees (CUPE), Healthcare Associated Infections: A Backgrounder (CUPE 2009) 15 cupe.ca/sites/cupe/files/healthcare-associated-infections-cupe-backgrounder.pdf accessed 25 December 2019. Centers for Disease Control and Prevention (CDC) and National Nosocomial Infections Surveillance System,‘Nosocomial Infection Rates for Inter Hospital Comparison: Limitations and Possible Solutions’ (1991) 12(10) Infection Control & Hospital Epidemiology 609. Chouinard,T,‘Incidents dans le réseau de la santé : 316 morts en un an’ La Presse’ (Montreal, 8 January 2016). CMAJ, ‘Public Reports of Infection Rates Urged’ (2009) 181(9) CMAJ: Canadian Medical Association Journal 573. Contandriopoulos, D et al., ‘The Multiple Causal Pathways between Performance Measures’ Use and Effect’ (2014) 71(1) Medical Care Research & Review 3. Daneman, N et al., ‘Reduction in Clostridium Difficile Infection Rates after Mandatory Hospital Public Reporting: Findings from a Longitudinal Cohort Study in Canada’ (2012) 9(7) PLoS Medicine. Edmond, MB, and Bearman, GML, ‘Mandatory Public Reporting in the USA: An Example to Follow?’ (2007) 65(S2) Journal of Hospital Infection 182. Faber, M et al.,‘Public Reporting in Health Care: How Do Consumers Use Quality-of-Care Information? A Systematic Review’ (2008) 47(1) Medical Care 1. Friedberg, MW, and Damberg, CL, ‘A Five-Point Checklist to Help Performance Reports Incentivize Improvement and Effectively Guide Patients’ (2012) 31(3) Health Affairs 612. Giesbrecht, J, A Study of Publicly-Reported Acute-Care Quality Indicators Across Canada (School of Public Administration, University of Victoria 2016). Gilmour, JM, Patient Safety, Medical Error and Tort Law:An International Comparison (Health Canada 2006). Hader, R,‘Public Reporting’ (2006) 37(4) Nursing Management 88. Hamblin, R et al., ‘Public Reporting of Health Care Performance Data: What We Know and What We Should Know’ (2016) 129(1431) New Zealand Medical Journal 7. Haustein, T et al., ‘Use of Benchmarking and Public Reporting for Infection Control in Four HighIncome Countries’ (2011) 11 Lancet Infectious Diseases 471. Health Council of Canada, Progress Report 2012: Health Care Renewal in Canada (HCC 2012).

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Lara Khoury Khoury, L, ‘La transparence dans le réseau de la santé’ in Vincent Gautrais, Catherine Régis and Laurence Largenté (eds), Mélanges Molinari (Éditions Thémis 2018). Kohn, LT, Corrigan, JM, and Donaldson, MS (eds), To Err Is Human: Building a Safer Health System (National Academy Press 2000). Lahey, W, ‘Medicare and the Law: Contours of an Evolving Relationship’ in Jocelyn Downie, Timothy Caulfield, and Colleen M Flood (eds), Canadian Health Law and Policy (4th edn, Lexis Nexis 2011) 16. Makary, MA, and Daniel, M, ‘Medical Error – The Third Leading Cause of Death in the US’ (2016) 353(2139) BMJ 1. Marsteller, JA, Hsu,Y-J, and Weeks, K,‘Evaluation the Impact of Mandatory Public Reporting on Participation and Performance in a Program to Reduce Central Line-Associated Bloodstream Infections: Evidence from a National Patient Safety Collaborative’ (2014) 42 American Journal of Infection Control S209. Mitchell, BG et al., ‘Healthcare-Associated Infections: Getting the Balance Right in Safety and Quality v. Public Reporting’ (2012) 36 Australian Health Review 365. Molinari, PA,‘Émergence et structuration du droit de la santé : du colloque singulier à la théorie des droits sociaux’ in Institut de droit de la santé, Droit de la santé : Fondements et perspectives,Actes de la 10e Journée de droit de la santé (Université de Neuchâtel 2004) 1617. Morris, K, and Zelmer, J,‘Public Reporting of Performance Measures in Health Care’ (2005) 4 Canadian Policy Research Networks. MUHC, ‘Patient Safety Learning’ (CUSM) https://cusm.ca/patient-safety/node/39731 accessed 20 June 2016. Nova Scotia,‘Public Reporting on Patient Safety’ (Nova Scotia) novascotia.ca/dhw/hsq/public-reporting/ accessed 24 December 2019. Odom-Forren, J, and Hahn EJ, ‘Mandatory Reporting of Health Care-Associated Infections: Kingdon’s Multiple Streams Approach’ (2006) 7 Policy Politics Nursing Practice 64. Ontario, ‘Hospital Patient Safety’ (Health Quality Ontario) www.hqontario.ca/System-Performance/Hosp ital-Patient-Safety accessed 24 December 2019. Quebec, INSPQ, Diarrhées associées au Clostridium difficile: résultats de surveillance 2018–2019 (INSPQ 2019) www.inspq.qc.ca/infections-nosocomiales/spin/dacd/surveillance-2018-2019 accessed 29 December 2019. Quebec, INSPQ, Surveillance provincial des infections nosocomiales : faits saillants, discussions et recommandations 2017–2018 (INSPQ 2019). Quebec, Ministère de la Santé et des Services sociaux (MSSS), La gestion des risques, une priorité pour le réseau – Rapport du comité ministériel (Rapport Francoeur) (MSSS 2001). Quebec, Ministère de la Santé et des Services sociaux (MSSS), Améliorer la prévention des chutes et incidents et accidents liés à la médication : de la stratégie à l’action.Volet: incidents et accidents liés à la médication (MSSS 2014). Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2014–2015 des incidents et accidents survenus lors de la prestation des soins et services de santé au Québec (MSSS 2015). Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2016–2017 sur les incidents et accidents survenus lors de la prestation de soins de santé et de services sociaux au Québec (MSSS 2017). Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2017–2018 sur les incidents et accidents survenus lors de la prestation de soins de santé et de services sociaux au Québec (MSSS 2018). Quebec, Ministère de la Santé et des Services sociaux (MSSS), Rapport 2018–2019 sur les incidents et accidents survenus lors de la prestation de soins de santé et de services sociaux au Québec (MSSS 2019). Quebec, Ministère de la Santé et des Services sociaux (MSSS),‘Publications du ministère de la Santé et services sociaux’ (MSSS) publications.msss.gouv.qc.ca/msss/recherche/?txt=Registre+national+des+inci dents+et+accidents&rechercher=Lancer+la+recherche&msss_valpub= accessed 25 December 2019. Reagan, J, and Hacker, C, ‘Laws Pertaining to Healthcare-Associated Infections: A Review of 3 Legal Requirements’ (2012) 33(1) Infection Control & Hospital Epidemiology 75. Shuker, C et al., ‘Progress in Public Reporting in New Zealand since the Ombudsman’s Ruling, and an Invitation’ (2017) 130(1457) New Zealand Medical Journal 11. Stricof, RL et al., ‘Lessons Learned While Implementing Mandatory Health Care-Associated Infection Reporting in New York State’ (2013) 19(4) Journal of Public Health Management & Practice 294. ‘The MUHC Becomes one of the First Canadian Health Centres to Adopt a Disclosure Policy, (McGill University News and Events (Channels), 19 November 2001) www.mcgill.ca/channels/news/muhc-be comes-one-first-canadian-health-centres-adopt-disclosure-policy-1850 accessed 25 December 2019.

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18 HUMAN TISSUE, HUMAN RIGHTS, AND HUMANITY Jesse Wall

I doubt that there is a human right to have posthumous control over your own body. I also doubt that there is a human right to determine how the body of a deceased loved one is treated, and I doubt that there is a human right to benefit therapeutically from the use of the bodily material of a deceased person. What I do not doubt is that – inevitably – someone will claim that one of these human rights arises under the Universal Declaration of Human Rights (or some domestic variant thereof). Rather than explaining my scepticism, in this chapter I explore two more global concerns with human rights in this context. First, I explore why it is always possible to formulate human rights-based claims. I explain how such claims are plausible because of the ‘malleability’ of human rights reasoning. Second, I suggest that human rights-based claims mischaracterise our relationship to our own bodily material and the bodily material of others. Such claims structure our thinking about the use and control of bodily material in a way that promotes individualism and self-reliance at the expense of interdependence and social solidarity. I conclude that no one has a human right to posthumous bodily material insofar as no one person occupies the normative position to pursue his or her own interests without consideration of the interests of others.The implication is that it is preferable that we avoid discussion of global health rights in bodily material.

Human tissue Before we consider our ethereal human rights, let us start with our tangible human bodies. As embodied beings, upon death we leave behind bodily material: cells, tissue, gametes, marrow, blood, organs, cadavers, and so on.All of this bodily material can be extracted and put to therapeutic, scientific, and educational use. This posthumous use of bodily material, at face value at least, engages three distinct sets of people: the progenitor (the person from whom the bodily material originates), the family of the progenitor, and the beneficiary of the potential use of the bodily material. Most jurisdictions give primacy to the progenitor’s interest in determining what happens to his or her body after the progenitor’s death, either as an express requirement of consent, or presuming consent unless otherwise indicated.Whether this is an interest that deserves respect is contested. For some, the very ‘notion of interests surviving death is incoherent’ on the basis that

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‘there is no one who can be harmed at the point that any wrongful setback of interests occurs.’1 If ‘respect for persons has two distinct dimensions: 1. respect for autonomy; and 2. concern for welfare,’2 then these bases of respect are not applicable to deceased persons.As Harris explains:3 autonomy involves the capacity to makes choices, it involves acts of the will, and the dead have no capacities—they have no will, no preferences, wants nor desires, the dead cannot be autonomous and so cannot have their autonomy violated. For others, ‘when we commit to respecting the interests of the living we are also committing to respecting the dead.’4 We may have reasons to respect the wishes of the progenitor since ‘[t] he concerns we may have with what is done with our bodies after death should not simply be dismissed as irrational.’5 And even if they are irrational, McGuiness and Brazier argue:‘to demand rationality in death is to some extent to misunderstand the nature of the processes involved.’6 There is disagreement, therefore, as to whether there is a duty to respect the wishes of the deceased with regard to his or her body. Legal schemes can differ in terms of the extent to which the family of the deceased can determine whether the body of the deceased is used for therapeutic, scientific, or educational purposes. It is also contestable whether this familial interest ought to be assigned any normative weight. On one view, since we are embodied beings, our relationships with other people are mediated through our bodies. Upon death, our posthumous body remains as the medium of our relationships.7 Hence, in very visceral and yet commonplace scenarios:8 the dead infant, the wife succumbing to breast cancer at 35, the elderly father dying suddenly of a heart attack, do not change their nature for their mother, husband or daughter.They remain Susannah, Lucy and Dad. Those closest to us – such as our partner, children, parents, siblings, long-standing friends – therefore have an interest in determining what happens to our posthumous bodies.The control over the bodily material represents an extension of the embodied relationship with the deceased person. According to a competing view, ‘[t]he consent of parents, other relatives or friends to postmortem retention and use of tissue and organs’ represents a non-person-affecting interest.9 It then follows that the10

1 E Partridge, ‘Posthumous Interests and Posthumous Respect’ (1981) 91 Ethics 243; see also D Price, ‘Property, Harm and the Corpse’ in B Brooks-Gordon (ed) Death Rites and Rights (Hart 2007) 199–217. 2 J Harris,‘Law and Regulation of Retained Organs: the Ethical Issues’ (2002) 22 Legal Studies 527, 530. 3 ibid 531. 4 M Brazier and S McGuiness, ‘Respecting the Living Means Respecting the Dead Too’ (2008) 28(2) Oxford Journal of Legal Studies 297, 316. 5 ibid. 6 ibid. 7 J Wall, Being and Owning (Oxford University Press 2015) 64; T Carman, Merleau-Ponty (The Routledge Philosophers, Routledge, 2008) 141. 8 JC Callahan, ‘On Harming the Dead’ (1987) 97 Ethics 341–352; M Brazier and S McGuiness, ‘Respecting the Living Means Respecting the Dead Too’ (2008) Oxford Journal of Legal Studies 297, 305. 9 Harris (n 2) 546. 10 ibid.

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consent of parents or other relatives to organ retention or use is not required where more important person-affecting interests of others conflict… if consent is sought and acted upon, this is more like extending a courtesy than respecting a right. Similar to disagreement as to our respect for the posthumous person, the relative strength of the familial interest in bodily material is contestable. It may be a ‘relatively weak’ and non-‘personaffecting’ interest, or it may be an indispensable aspect of the way we relate to one another. The third set of interests are the interests of the beneficiaries of the posthumous use of bodily material.With regard to organ donation, it is the organ recipient’s chance at a prolonged life. For assisted reproduction, it might be the recipient’s chance at biological or gestational parenthood. In other contexts, the therapeutic interest may be more diffused.We may all benefit, for instance, from the medical advances enabled by scientific research on bodily material. As with the posthumous and relational interest, the normative weight of this societal interest is contested. For some, the posthumous use of bodily material is ‘morally obligatory’ on the basis that any ‘individualistic considerations’ ought to ‘give way to utility in the interests of social and political morality.’11 In accordance with the ‘principle of sufficiency,’12 Fabre argues that13 if the materially needy have a right against the well-off that the latter transfer some of their income to them, then the medically needy have a right against the healthy that the latter transfer some of their body parts to them. It therefore follows that ‘the needs of the sick should, in principle at least, be met by the confiscation of organs from the dead and even from the living.’14 For others, it is praiseworthy but not obligatory. By itself, the mere ability to benefit another – through the provision of bodily material (or any other ‘surplus resource’) – may only create a gift relationship. Not a relationship of obligation. Hence, there is disagreement as to how to calibrate the normative weight of the broader therapeutic interest in the posthumous use of bodily material. The point to which I am trying to triangulate is that any view on the posthumous use of bodily material must calibrate the relative strength of these three sets of interests. Moreover, any legislative scheme that governs the use and control of bodily material is necessarily premised upon a particular calibration of these interests.The global trend is to give primacy to the progenitors’ wishes, where expressed.An increasing number of jurisdictions are presuming consent to procedures, such as organ donation, in the absence of the progenitors’ expressed objection.The motivation behind the presumed consent is the therapeutic benefit of the availability of transplantable organs. Whether or not consent on behalf of the progenitor is presumed or required, secondary consideration is often given to the views of the immediate family. Both the requirement of familial consent in the absence of express progenitor consent or the power of the family to rebut the presumption in favour of consent are at the expense of the greater availability of human tissue for therapeutic, scientific, and educational use. In contrast, a scheme of conscription would give no consideration to the views of the deceased or the wishes of the immediate

11 A Cronin and J Harris, ‘Authorisation, Altruism and Compulsion in the Organ Donation Debate’ (2010) 36 Journal of Medical Ethics 627. 12 C Fabre,‘Reply to Wilkinson’ (2008) 14 Res Publica 137, 140. 13 ibid. 14 TM Wilkinson,‘The Confiscation and Sale of Organs’ (2007) 13 Res Publica 327, 327.

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family and would be motivated by sole concern for the therapeutic benefit or broader social benefit in the use of the bodily material. Regardless of how the interests under the legislative scheme are calibrated, all these schemes represent ‘informal’ schemes.They are ‘informal’ in the sense that, where the underlying interests conflict, there is no particular form or structure to the way the law addresses the conflicting interests.The law prohibits some activities whilst enabling others on the basis of certain preconditions being satisfied. Individuals are asked to exercise legal powers, either permitting extraction and use for particular or general purposes, or refusing permission.There are no rights to be claimed or infringed, no duties to be imposed, performed, or breached. An alternative is to view these interests in the posthumous use of bodily material as giving rise to human rights. For instance, Article 3 of the Universal Declaration of Human Rights guarantees that ‘everyone has the right to life, liberty and security of person.’15 Every person may therefore have a right to the ‘security’ of his or her posthumous body. Article 22 guarantees everyone ‘the economic, social and cultural rights indispensable for his dignity and the free development of his personality.’16 Every person may therefore have ‘social and cultural rights’ to determine how the body of a loved one is treated as an ‘indispensable’ aspect of his or her dignity or personality. Article 25(1) guarantees everyone ‘the right to a standard of living adequate for the health and well-being of himself ’ or herself ‘including …medical care.’17 Every person may therefore have a right to have his or her life prolonged through the transplantation of bodily material (or otherwise be a beneficiary of medical care through the use of bodily material). If these rights apply, then the interests in the posthumous use of bodily material have a particular form. They are rights. Moreover, they are human rights. In what follows, I will consider how unhelpful it is to apply these formal structures to the use and control of bodily material.

Human rights On the face of it, there is nothing wrong with these human rights claims. Specific claims can fall under the ambit of general rights guarantees. In order to formulate these specific claims, human rights guarantees provide us with a shared language for identifying the values that are at stake, which triggers a particular institution- or discipline-specific way of reasoning about these values. These human rights provide us with a starting point (or, as will become more apparent, two starting points). I focus here on the ease with which human rights claims can be formulated. But first, in order to frame what we mean by ‘human rights,’ I adopt John Tasioulas’ three hallmarks, according to which, human rights represent:18 (1) The idea of each and every individual human being as an ultimate focus of moral concern;

15 The Universal Declaration of Human Rights 1948, Article 3: Everyone has the right to life, liberty, and security of person. 16 The Universal Declaration of Human Rights 1948,Article 22: Everyone, as a member of society, has the right to social security and is entitled to realisation, through national effort and international co-operation and in accordance with the organisation and resources of each state, of the economic, social, and cultural rights indispensable for his dignity and the free development of his personality. 17 The Universal Declaration of Human Rights 1948, Article 25(1): Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing, and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age, or other lack of livelihood in circumstances beyond his control. 18 J Tasioulas,‘Towards a Philosophy of Human Rights’ (2012) 65 Current Legal Problems 1, 4.

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(2) The concern [for the individual human being] should… take the form of recognising moral duties that are directly owed to these individual human beings, who have corresponding rights to their performance; (3) In virtue of our standing as human beings… we each possess certain rights, independently of whether or not they are actually enforced or even recognised socially. In this section, I explain how the relationship between the three hallmarks creates a ‘malleability’ that human rights discourse relies upon.The malleability of human rights, I will argue, enables a discourse without enabling a constructive analysis.

Grounding the right The first hallmark places the focus on ‘every individual human being,’ and specifically, the interests of ‘the putative right-holder, interests that are universal in the sense that all human beings have them simply as human beings.’19 The second hallmark introduces a structural feature.That is, human rights – as rights – impose corresponding duties. It then follows that to formulate a human right requires two distinct stages: grounding the right and imposing the duty. The first stage of grounding the right ‘takes into account only those individualistic values (status and interests) of the putative rights-holder that are supposed to ground the existence of the rights.’20 For instance, if we accept that a person has an interest in controlling how his or her posthumous body is used, and since every person has this interest ‘by virtue of their humanity,’21 then Article 3 ‘right to security of person’ can be grounded in the status and interests of the putative rights-holder. Equally, if we accept that a person has an interest in controlling how the body of a deceased loved one is used, that each person has thus interest ‘by virtue of their humanity,’ then (again) Article 22 ‘entitlement to social and cultural rights’ is engaged. And if we accept that each person has an interest in a prolonged life, by virtue of his or her humanity, then Article 25(1) ‘right to medical care’ is engaged. At this initial stage, we ask whether ‘in the case of all human beings, it is “possible” to serve the underlying values through a duty with the proposed content.’22 It is possible for each putative right – the right to posthumous control, the right to familial control, the right to therapeutic use – to protect the moral properties that each person has by virtue of his or her humanity. However, these implications can be difficult to sustain. Recall that the very question of whether, after his or her death, there is a ‘person’ for the purposes of Article 3, is contestable. Similarly, it is difficult to specify why a family member ought to exercise control over the body of a deceased person pursuant to Article 22.To claim that an implication of Article 25(1) is that a person has a right to bodily material is just as unstable, as it is predicated on resources being owed to a person, by way of some kind of obligation. Articles 3, 22, and 25(1) are ‘unstable’ in the sense that the rights cannot be connected to any particular implication (as to the use and control of bodily material, in this case) without specifying a range of further details about the content of the rights themselves. In specifying these details, ‘we find that we have committed ourselves to the description of an entire [normative] order’23 about personhood, the develop-

19 ibid 7. 20 ibid 15. 21 J Tasioulas,‘On the Nature of Human Rights’ in G Ernst and J-C Heilinger (eds), The Philosophy of Human Rights: Contemporary (De Gruyter 2012) 26. 22 Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 15. 23 M Tushnet,‘An Essay on Rights’ (1984) 62(8) Texas Law Review 1363, 1379.

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ment of a socialised personality, or standards of adequate healthcare. It is in this way, our rights here are unstable. Disagreements about the details of the normative order – disagreements about ‘persons,’ ‘social rights,’ ‘standards of health’ – ‘can make it difficult to sustain the claim that a right remains implicated.’24 We might then seek to avoid the specification of rights at the point of formulating the claim and just presume that such claims can be grounded as ‘rights.’That is, we might allow the specific claims to become human rights claims simply by virtue of the specific claims falling under the general ambit of Articles 3, 22, and 25(1). If so, we have merely delayed the process of specification.We encounter the same need to specify a normative order about personhood, personality, and standards of healthcare, when we consider whether such rights can be subject to justified limitations or – as is inevitable with regard to Articles 3, 22, and 25(1) – when we consider which right has priority over the other conflicting rights. However, human rights are only unstable (in the above sense) when we seek to connect a practical implication with ‘the underlying values’ that the right serves. An alternative way of ‘grounding the right’ is to approach human rights as a standard that requires interpretation and application. The first task of grounding the right then becomes more institutionally confined. Where the institution is law, the analysis follows a certain discipline-specific mode of legal reasoning. Hence, when we specify the contents of an institutionalised right in law, our rights guarantees represent a set of standards the practical implications of which can be drawn from the legal standards themselves. The reasoning goes that: because the drafters of the Universal Declaration of Human Rights were ‘not in a position to be specific,’ it falls to adjudicators (broadly construed) ‘to give substance to abstract categorizations,’25 since ‘determining the undetermined is one of the standard functions of adjudication.’26 Since Articles 3, 22, and 25 rely on abstract concepts (‘dignity,’ ‘personality,’ ‘liberty,’ ‘security’), general categories (‘person,’ ‘social and cultural,’ ‘health and wellbeing’), and broad standards (‘indispensable,’ ‘adequate,’ ‘realization’), grounding the right is a task of specifying what practical implications fall within the ambit of the application of these concepts, categories, and standards. Rather than connecting the rights-claim with the underlying values that the rights guarantees seek to protect, a different set of institutionally defined techniques are employed to interpret and specify what these concepts, categories, and standards can be understood to require. In the institutional setting, grounding the right requires the interpretation of legal materials. Outside of the institutional setting, grounding the right requires the description of a normative order. As we shall now turn to consider, the same duality between outside and inside the institutional setting can be found when we consider the duties that logically follow from the grounding of rights.

Imposing the duty The second stage of human rights ‘takes into account the implications of affirming the right for other values and other persons, especially would-be duty-bearers.’27 At this stage, we need to be able to show that ‘the underlying individualistic considerations of moral status and universal interests suffice to generate duties with the same content.’28 That is, we need to show that the

24 ibid 1363. 25 T Endicott, ‘Legal Interpretation’ in Andrei Marmor (ed), Routledge Companion to Philosophy of Law (Routledge 2012) 114. 26 ibid 112. 27 Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 15. 28 ibid.

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putative right-holder’s interest (in posthumous autonomy, embodied relationships, or health and wellbeing) is sufficiently important to justify ‘the imposition of the self-same duties as being owed to all human beings.’29 As the second hallmark alludes, human rights – as rights – have a particular structure. It is this structure that differentiates rights from other norms, such as ‘interests,’ ‘goals,’ ‘values,’ or ‘considerations.’ In particular, human rights impose correlative duties.These duties represent ‘reasons for action of a special kind.’30 The duties that follow from observing a right are ‘categorial’ in the sense ‘that their application to the duty-bearer, and their weight or stringency, is independent of the latter’s motivation.’31 The duties that follow are ‘exclusionary’ in that the duties represent reasons for action that ‘exclude at least some of the latter from bearing on what all-things-considered the duty-bearer should do.’32 Finally, a breach of the duties that follow from observing a right ‘typically justifies a distinctive range of moral responses.’33 It follows, therefore, for Tasioulas, that the ‘distinguishing feature of human rights is to erect powerful, if not absolutely insurmountable, barriers against trade-off[s].’34 Raz presses this point further: the ‘rights’ (and correlative duties) in human rights ‘mark out a normatively exceptional domain’ where such rights ‘deserve protection even if that requires exceptional measures.’35 Failure to engage in this second stage of rights reasoning ignores ‘the possibility of believing that certain conditions are essential to our life, and even of striving to secure such conditions, without either claiming or having a right to them.’36 The concern here is that, if we assign human rights with the task of marking out a normatively exceptional domain, then human rights can only perform that task ‘if people do not have human rights to everything which will or may improve the quality of their life.’37 Whilst our putative right-holder may have an interest in posthumous autonomy, embodied relationships, or health and wellbeing, the interest needs to be sufficiently important to generate duties (reasons for action of a special kind) on others to enable the exercise of posthumous autonomy, the expression of embodied relationships, or access to healthcare resources. In an institutional setting, this second stage of imposing duties is burdensome. To start, to impose a duty is to identify a duty-bearer. In the context of rights to bodily material, this is most likely to be a public healthcare provider, who may be under a duty to obtain consent for posthumous use of bodily material, or obtain bodily material without consent (depending on which right is being engaged). Imposing a duty also requires an account of why the duties owed to the rights-bearer ought to amount to exclusionary and categorial reasons, and a distinctive range of remedial responses ought to be available to the adjudicator. In the context of bodily material, we need to account for why a public healthcare provider ought to act on one set of reasons – either acting out of respect for the progenitor’s posthumous interests, the familial interest, or the therapeutic interests – to the exclusion of the other applicable reasons. Finally, imposing a duty requires some kind of remedial response to failure to perform the duty. Once

29 30 31 32 33 34 35

ibid 14. Tasioulas,‘On the Nature of Human Rights’ (n 21) 27. ibid 27. ibid. ibid. Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 8. J Raz,‘Human Rights Without Foundation’ in S Besson and J Tasioulas (eds), The Philosophy of International Law (Oxford University Press 2010) 321, 329. 36 ibid 321, 325. 37 ibid 321, 326.

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we understand what it means to impose a duty in an institutional setting, we can begin to appreciate the gap between something being valuable (and having reasons to strive towards the standard) and an individual having a right to it (and thereby imposing a special set of reasons for action on a duty-bearer). Outside of an institutional setting, the reasoning can be more aspirational than practical. Whilst we may affirm a right, and thereby implicate duties, such ‘duties’ can represent general reasons for ‘striving to secure the conditions’ that enable the exercise of the right. As ‘outside rights,’ where human rights represent aspirational values, the duties that they generate are ‘reasons’ to respect the human right. Inside the institutional setting,‘inside’ human rights represent standards, the duties that they generate are categorial, exclusionary, and remedial reasons to respect the human right. In this way, human rights represent either a moral standard that institutions ought to translate into a practical setting or a moral value that institutions ought to aspire to adhere to. Human rights – and duties – are therefore configured differently, depending on whether they are inside or outside an institutional setting.

The malleability of human rights As I have already implied, human rights guarantees – such as the Universal Declaration of Human Rights – have a double life. ‘For lawyers,’ Tasioulas explains, human rights are a set of principles that ‘possess… a legal-institutional embodiment’ that favours ‘standards that can be applied without extensive reliance on the exercise of moral judgment.’38 In comparison, for philosophers,‘the principles form part of the broader web of propositions that comprises a theory of morality or some segment of it.’39 The problem that I will highlight here is that this double life enables human rights discourse to be malleable.That is, each human rights guarantee mediates – goes back and forth between – being a set of values (or ‘outside rights’) and a set of standards (or ‘inside rights’). It is this ambiguity between human rights as values (or ‘outside rights’) and human rights as standards (or ‘inside rights’) that enables the human right to be malleable, moulded, and manipulated. In our reasoning about bodily material, a human rights guarantee can either be a value external to the legal system that legal standards ought to aspire towards or a standard internal to the legal system, depending on what suits the human rights protagonists. Let us start with human rights as ‘values’ (or ‘outside rights’).There is an important sense in which human rights represent something greater than the legal system that the rights belong to, whilst still being able to guide our reasoning within that legal system.This follows from the third hallmark of human rights, that each person has rights ‘in virtue of our standing as human beings’ which we ‘each possess certain rights, independently of whether or not they are actually enforced or even recognised socially.’40 By protecting the moral properties that each person has by virtue of his or her humanity, human rights ‘follow from values that are neither arbitrary or subjective because they are universal.’41 They are, therefore, ‘“universal” in the sense that they derive from needs and values or preferences that every person shares or ought to share’ independently of the institutions that may seek to uphold and protect human rights.42 In this way, human rights facilitate for us ‘a relatively objective, rational, determinative discussion of how

38 39 40 41

Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 4. ibid 4. ibid. D Kennedy, ‘The Critique of Rights in Critical Legal Studies’ in Wendy Brown and Janet Halley (eds), Left Legalism/Left Critique (Duke University Press 2002) 178, 185. 42 ibid.

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[human rights] ought to be instantiated in social or legal rules.’43 In our legal reasoning, these rights sit ‘outside’ an institutional practice – such as law – in the sense that whether or not a legal system recognises a particular human right, it remains the case that the law ought to give effect to the right. Human rights reasoning, where the rights are ‘outside’ rights, is then an exercise of translation; ‘translating the pre-existing natural entity or concept into particular legal rules by examining its implications in practice.’44 At the same time, human rights are ‘standards’; they are rights ‘inside’ the legal system. By virtue of the Universal Declaration of Human Rights, or by virtue of the domestic enactment of these human rights, each legal system acknowledges the existence of a legal right (to personal security, cultural rights, medical care, and so on). Moreover, ‘once you acknowledge the existence of the right, then you have to agree that its observance’ has implications for the legal system.45 Human rights form part of the canon of legal materials that we are required to interpret and apply. In our legal reasoning, human rights are ‘inside rights’ in the sense that faithful application of the law includes fidelity to the human rights guarantees, and this ‘interpretative fidelity’ requires observance of the implications that follow from the human rights guarantees.46 Human rights guarantees therefore ‘occupy an ambiguous status in legal discourse, because they can be either rules or reasons for rules.’47 To be clear, the distinction between values and standards is commonplace to legal reasoning. Legal rights can justify the interpretation of other legal rules and legal rights can constitute legal reasons for developing legal rules in a certain way.48 Put another way, human rights as reasons and human rights as standards form part of the interpretative materials, notwithstanding the distinction between reasons and standards. They add to the body of materials that are internal to the legal system whilst also providing values external to the legal system that the body of materials ought to adhere to. However, the criticism here is that any given human rights–based claim can move back and forth between these two states or modes of reasoning.As Kennedy explains:49 On one side, the argument from [human] rights is legal, because it is based on one of the enacted rules of the legal system … on the other, it is normative or political, because it is in the form of an assertion about how an outside right should be translated into law. Human rights discourse can therefore trade on this ambiguity. By arguing that an implication follows from the observance of a right, the argument can simultaneously draw upon the internal membership of the right to the legal system and the external moral value that the legal system ought to promote or adhere to. To formulate a rights-based argument, the human rights protagonist can ground the right as an internal (institutional) standard. Since the existence of the right is grounded in an institutional context, the protagonist avoids the ‘instability of the right.’That is, he or she avoids having to specify the normative order that the rights-claim is presumed upon. Instead, the protagonist

43 44 45 46 47 48 49

ibid. ibid 178, 186. ibid 178, 185. ibid. ibid. J Raz,‘Legal Rights’ in J Raz (ed), Ethics in the Public Domain (Clarendon Press 2001) 265. Kennedy (n 44) 178, 187.

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can rely on the right as a standard that has a set of implications that follow from interpretative fidelity to the standard.At the same time, the protagonist can ground the duty as something that is outside of the institutional setting, as duty that should be translated into law, thereby avoiding the three-fold burden of grounding a duty in an institutional context. Consider how the rights in our three rights-based claims have to move between being an outside value and an inside standard: The problem with the Article 3 claim is that the right itself is unstable; it is difficult to sustain the contention that a deceased person remains a ‘person’ to whom we owe duties of respect. However, we can avoid the instability of the right by approaching the question of ‘person’ (under Article 3) as an institutional question of legal interpretation. The problem with the Article 22 claim is that whilst we can accept we have reasons to respect the interest of the grief-stricken in controlling the posthumous body, it is difficult to ground such reasons as exclusionary reasons; excluding the consideration of countervailing interests (such as the progenitors wishes or the therapeutic benefit). However, we can avoid the burden of the duty by approaching the human right as a value; something that healthcare providers ought to promote. The problem with the Article 25(1) claim is that the respect of the right requires exclusionary reasons for the healthcare provider to obtain bodily material; reasons that exclude consideration of the progenitor’s or the family’s wishes. We can nonetheless formulate the human rights claim by approaching the right as a standard (or inside right) and approaching the correlative duty as a value (or outside right). More broadly, the implication here is that carving out a ‘normatively exceptional domain’ – grounding stable rights and imposing burdensome duties – is (as it should be) exceptional. It follows that there ought to be very few global health rights, and none of them should concern bodily material. However, because of the malleability of human rights, having a double life of being inside and outside rights, there are no barriers to entry into formulating human rights claims to bodily material. Whilst we ought to write about our shared ideas on global health rights, in order to concretise our ethereal aspirations, we need to consider whether the human rights discourse accurately prescribes how we ought to think about what we owe one another. In the next section, I suggest that, with regard to bodily material, human rights do not.

Humanity Perhaps a human rights protagonist will be willing to concede ‘that human rights morality is not, in the first place, a code, but a distinctive moral sensibility,’50 and suggest that the translation of the moral sensibility into an institutional practice is a difficult but laudable goal. Moreover, the protagonist may nonetheless persist that ‘there is the value that consists in the equal basic moral status of all human beings’ and this value has ‘implications for a variety of agents and contexts.’51 We should, the argument goes, approach human rights (and, perhaps, global health rights) as a ‘distinctive moral sensibility’ that affirms (1) ‘each and every individual human being as an ultimate focus of moral concern,’ that (2) recognises ‘moral duties that are directly owed to these

50 Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 4. 51 ibid 26.

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individual human beings, who have corresponding rights to their performance,’ (3) ‘in virtue of our standing as human beings.’52 The fallback position here is that human rights guarantees provide a way to structure our analysis, and to focus our discourse, around individual human beings, their rights to bodily material, and the duties that such rights entail. In this section, I argue against this fallback position.This human rights ‘sensibility,’ I argue, misrepresents our relationship with our own bodily material and the bodily material of others. Articles 3, 22, and 25(1) guarantee individual human rights. An individual has a right to the security of his or her person, an individual has the right to exercise the social and cultural rights that are indispensable for his or her dignity, and an individual has the right to medical care.Through the implementation of the right, each individual rights-holder can further his or her own interests and preferences without any concern for how their interests and preferences impact the position of others.The human rights (and duties) that are implemented carve out the normative spaces where individuals can ‘legitimately’ pursue their own self-interest.The ‘value that consists in the equal basic moral status of all human beings’ quickly becomes the ‘value of self-interested individuals pursuing their own interests.’We are motivated to respect the human rights of others because of our shared standing ‘as human beings,’ even where the exercise of those human rights demonstrates no concern for our shared humanity. If implemented under Article 3, a person is granted the power to exercise posthumous control over his or her bodily material, for whatever reason (or for no reason at all), without consideration of the interests of others. Similarly, under Articles 22 and 25(1), the right to exercise social or cultural rights and the right to medical care, if they are implemented as human rights, allow the pursuit of selfinterest. The aspiration is that, if we can make ‘a sharp distinction between one’s interests and those of others, combined with the belief that a preference in conduct for one’s own interests is legitimate’, then human rights rules will ‘make it possible to coexist with others similarly selfinterested.’53 This structures our reasoning in favour of individualism and self-reliance. We can legitimately pursue our self-interest, the reasoning goes, by imposing duties that are owed to us by others, ‘without being dependent on them or asking sacrifices of them.’54 This is at the expense of altruism and the inclination to ‘make sacrifices, to share, and to be merciful.’55 In some contexts, this individualistic sensibility may be warranted. The individualistic sensibility is, however, the antithesis of the sensibility that we ought to adopt with regard to posthumous bodily material. Let us therefore contrast the human rights sensibility with a ‘solidarity’ sensibility that we ought to adopt. We can understand the right to security of persons as preserving a person’s exclusive use and control over his or her embodied existence at any given point of time, where the body is ‘the medium through which we exercise our autonomy, experience preference satisfaction, and form relationships (or however our subjectivity is expressed).’56 Independent of this condition, where the body is not ‘the vehicle of being in the world,’57 there is nothing individualistic about our bodies.As Herring and Chau have explained:58

52 53 54 55 56 57 58

ibid 4. D Kennedy,‘Form and Substance in Private Law Adjudication’ (1976) 89 Harvard Law Review 1685. ibid. ibid. Wall, Being and Owning (n 7) 183. M Merleau-Ponty, Phenomenology of Perception (C Smith, trans), (Routledge 2003) 94. J Herring and P-L Chau,‘My Body,Your Body, Our Bodies’ (2007) 15 Medical Law Review 34, 51.

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our bodies are often in a state of dependency on other bodies… our bodies are constantly interacting and reacting with the world around us… our bodies are not immutable entities, but are constantly changing and recreating themselves.We need to move away from a vision of a society of bodies which are only of concern to ourselves and recognise that to a significant degree, our bodies depend on other bodies and the world around us for their meaning and survival. There is a subtlety in the human body; bodies are exclusively ours whilst still being connected to others.These are overlapping states.Whilst our current body is the vehicle for ‘being in the world,’ our bodies are also connected with, and dependent upon, others. For instance, the current state of our bodies is (in part) determined by a genetic code that we inherit and pass on, the fruits of medical research that other bodies have contributed to, the sharing of bodily material between people, and a physical environment that other people and other organisms contribute to. Our bodies are exclusively ours when the body is integrated with our subjectivity; at the same time, our bodies are shared in the sense that an individual ‘always contains a trace of the other.’59 There are also important instances where the overlap ends, such as where the body is no longer the way in which we engage and experience the world, but the interconnectedness of the body remains.The key point is that the individualistic sensibility of human rights is too blunt to appreciate this subtlety. If the Article 3 right to security of person is extended posthumously, the body remains within the exclusive domain of the rights-holder. The same is true for the purposed Article 22 right. Our bodies provide a ‘medium of social perception,’60 that is a medium ‘common to myself and others’61 where ‘certain unique ways of moving, gesturing, speaking, laughing, and so forth, express my bodily being.’62 For friends and family, a body may continue to represent this bodily being posthumously in a meaningful way, and the social and cultural practices around the treatment of a deceased body may be indispensable to the development of the personality of the grief-stricken. Nonetheless, the social and cultural practices around the respectful treatment of deceased persons are not static. Nor do social and cultural practices necessarily require exclusive use and control of the body. It is possible for such practices to develop in a way that is more facilitative of the posthumous use of bodily material.There is, again, a subtlety in the body of another continuing to represent the deceased person and being the medium of social experience, and the organs and tissue of the deceased person not performing a social or cultural task but potentially performing a therapeutic or scientific role. Social and cultural practices can adapt around this subtlety, where the subtlety is translated as a call for altruism in light of overlapping interests and needs.The subtlety does not translate well into the individualistic sensibility of human rights, where it is translated into a sensibility of self-reliance and the pursuit of self-interest. If the Article 22 right is extended to social and cultural rites over the body of the deceased person, the right has exclusionary force, its structure excludes the needs of others. At the same time, if a potential therapeutic beneficiary has a right to the medical care, the right implicates categorial and exclusive reasons on the part of the individual progenitor or the

59 I Karpin, ‘Genetics and the Legal Conception of Self ’ in M Shildrick and R Mykitiuk (eds), Ethics of the Body (MIT Press 2005); Herring and Chau (n 58) 34, 49. 60 T Carman, Merleau-Ponty (The Routledge Philosophers, Routledge 2008) 141. 61 ibid. 62 SK Toombs, ‘What Does it Mean to Be Somebody?: Phenomenological Reflections and Ethical Quandaries’ in MJ Cherry (ed), Persons and Their Bodies: Rights, Responsibilities, Relationships (Kluwer Academic Publishers 1999) 79, 82.

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grief-stricken to confer the therapeutic benefit.This misrepresents the relationship between the progenitor or family member and the potential therapeutic beneficiary.The potential therapeutic benefit may provide reasons to donate human tissue. Ordinarily, such a reason ought to be weighed against competing reasons. However, if there is a right to human tissue, the correlative duty has the normative effect of excluding countervailing reasons.The wishes of the deceased, or his or her family members, are excluded from consideration by the duty-bearer (healthcare provider) by virtue of individual rights-based sensibility. Human bodies therefore possess subtle layers of meaning. Bodies are the way in which we experience and engage in the world, they are the way in which others interact with us, and our bodies belong to the shared project of humanity, where our wellbeing has always been dependent upon others.The sources of meaning require ordering. In practice, the law must facilitate a decision-making process with regard to the use and control of bodily material, that ultimately elevates certain interests over others. My contention here is that this task of ordering preferences and interests is better performed by informal structures. Our embodied, physical and emotional wellbeing is always dependent on others. It relies on others making sacrifices for us, and vice versa.The use and control of bodily material ought to be premised upon the same of altruism and the inclination to ‘make sacrifices, to share, and to be merciful.’63 A legal structure that seeks permission to use bodily material and asks individuals to consider the interest of others is a closely aligned legal iteration of this altruistic inclination. In comparison, this task is performed poorly by formal structures, such as human rights. If we take ‘each and every individual human being as an ultimate focus of moral concern’ then we construct a tension between three ostensible rights-holders, all of whom are ‘the focus of moral concern.’64 If we recognise ‘these individual human beings… have corresponding rights to their performance,’65 then we structure this tension by the ‘making of a sharp distinction between one’s interests and those of others combined with the belief that a preference in conduct for one’s own interests is legitimate.’66 Our relationship with our body and the bodies of others is a state of dependence, connectedness, and sharing.The human rights sensibility is the antithesis of our embodied state. Allow me to summarise with reference to a strained analogy. One explanation for the demise of the Neanderthal and the rise of Homo sapiens is that the latter were able to identify with a much larger network or community.67 In the event of conflict, regardless of the tools at hand, access to resources, or physical prowess, a community of 500 will defeat an extended family of 60. Human rights structure our thinking like that of the Neanderthal, an individual (and his or her family) claims the right to posthumous control.An individual (and his or her family) claims a right to bodily material as part of his or her right to medical care. Beating our chests we assert these rights.With sharpened spears we attempt to impose duties.Whereas, we need to identify with humanity. Our bodies are not mere surplus resources, nor are our bodies exclusively ours, nor are they the sole domain of our family we leave behind. Rather, we belong to something greater. Informal legal structures enable this evolution in our thinking, away from individualism and self-reliance and in favour of altruism and the inclination to make sacrifices and to share.

63 64 65 66 67

Kennedy,‘Form and Substance in Private Law Adjudication’ (n 53). Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 4. ibid. Kennedy,‘Form and Substance in Private Law Adjudication’ (n 53). A Gat,‘Social Organization, Group Conflict and the Demise of Neanderthals’ (1999) 39(4) Mankind Quarterly 437.

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Human rights–based structures extinguish this thinking. We ought therefore to reject human rights discourse when it is contrary to how we aspire to live and relate to one another.

Conclusion In the background of this chapter has been a fabricated conversation between two great (but generally opposing) theorists of rights: John Tasioulas and Duncan Kennedy. In this chapter, I have sought to deflate the utility of human rights discourse by demonstrating how the discourse can shift between non-institutional and institutional settings in a way that suits the human rights protagonist. This enables rhetoric without analysis. Tasioulas and Kennedy might both have constructive responses. Tasioulas might respond by suggesting that we can ‘find support from any eligible ordering of the basic interests that are the components of a good human life’ without having to link ‘human rights conceptually with particular institutional arrangements or roles.’68 Kennedy might also explain that when we try to link human rights with institutional arrangements, we can ‘manipulate the plastic substance of legal reason to achieve the results that are correct in terms of outside rights.’69 For both responses, the answer rests on ‘the basic interests that are the components of a good human life’ that are ‘outside’ any ‘particular institutional arrangement.’ I have argued here that the informal legal structures of human tissue legislation identify and prioritise the basic interests in the use and control of bodily material in a manner preferable to formal human rights structures. Furthermore, no one can have a moral right to posthumous bodily material since no one person occupies the normative position to pursue his or her own interests without the consideration of the interests of others. Given that no moral – or ‘outside’ – human right exists, there is no need to institutionalise any human right to bodily material. Even further, in the context of bodily material, where the subtle layers of meaning supervene on the body, the Universal Declaration of Human Rights and ‘human rights sensibility’ are regressive. Perhaps even Neolithic.

References Brazier, M and McGuiness, S, ‘Respecting the Living Means Respecting the Dead Too’ (2008) 28(2) Oxford Journal of Legal Studies 297. Callahan, JC,‘On Harming the Dead’ (1987) 97 Ethics 341–352. Carman, T, Merleau-Ponty (The Routledge Philosophers, Routledge 2008). Cronin, A and Harris, J,‘Authorisation, Altruism and Compulsion in the Organ Donation Debate’ (2010) 36 Journal of Medical Ethics 627. Endicott, T, ‘Legal Interpretation’ in Andrei Marmor (ed), Routledge Companion to Philosophy of Law (Routledge 2012). Fabre, C,‘Reply to Wilkinson’ (2008) 14 Res Publica 137. Gat, A, ‘Social Organization, Group Conflict and the Demise of Neanderthals’ (1999) 39(4) Mankind Quarterly 437. Harris, J,‘Law and Regulation of Retained Organs:The Ethical Issues’ (2002) 22 Legal Studies 527. Herring, J and Chau, P-L,‘My Body,Your Body, Our Bodies’ (2007) 15 Medical Law Review 34. Karpin, I, ‘Genetics and the Legal Conception of Self ’ in M Shildrick and R Mykitiuk (eds), Ethics of the Body (MIT Press 2005). Kennedy, D,‘Form and Substance in Private Law Adjudication’ (1976) 89 Harvard Law Review 1685.

68 Tasioulas,‘Towards a Philosophy of Human Rights’ (n 18) 29. 69 Kennedy,‘The Critique of Rights in Critical Legal Studies’ (n 41) 178, 209.

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Human tissue, human rights, and humanity Kennedy, D,‘The Critique of Rights in Critical Legal Studies’ in Wendy Brown and Janet Halley (eds), Left Legalism/Left Critique (Duke University Press 2002). Merleau-Ponty, M, Phenomenology of Perception (Routledge 2003, translated by C Smith). Partridge, E,‘Posthumous Interests and Posthumous Respect’ (1981) 91 Ethics 243. Price, D,‘Property, Harm and the Corpse’ in B Brooks-Gordon (ed), Death Rites and Rights (Hart 2007). Raz, J,‘Legal Rights’ in J Raz (ed), Ethics in the Public Domain (Clarendon Press 2001). Raz, J,‘Human Rights Without Foundation’ in S Besson and J Tasioulas (eds), The Philosophy of International Law (Oxford University Press 2010). Tasioulas, J,‘On the Nature of Human Rights’ in G Ernst and J-C Heilinger (eds), The Philosophy of Human Rights: Contemporary (De Gruyter 2012). Tasioulas, J,‘Towards a Philosophy of Human Rights’ (2012) 65 Current Legal Problems 1. Toombs, SK, ‘What Does it Mean to Be Somebody?: Phenomenological Reflections and Ethical Quandaries’ in MJ Cherry (ed), Persons and Their Bodies: Rights, Responsibilities, Relationships (Kluwer Academic Publishers 1999). Tushnet, M,‘An Essay on Rights’ (1984) 62(8) Texas Law Review 1363. Wall, J, Being and Owning (Oxford University Press 2015) 64. Wilkinson, JC,‘The Confiscation and Sale of Organs’ (2007) 13 Res Publica 327.

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19 AUTONOMY AND THE RIGHT TO (END ONE’S?) LIFE A German perspective Carsten Momsen and Mathis Schwarze

Recent years have been marked by major developments in the legal situation surrounding assisted suicides (AS) in Germany. Most notably, in 2015 a law was passed to criminalise the ‘business-like’ provision of assistance with suicide (§ 217 Strafgesetzbuch1), aiming to ban socalled ‘right-to-die organisations.’ A little over four years later, in February 2020, the German constitutional court (Bundesverfassungsgericht) declared the offence unconstitutional – the very first time the court annulled an offence under the core penal code. Interestingly, the centrepiece of the reasons given both for the law’s passing in the first place and for its subsequent annulment was the protection of autonomy at the end of life. The legislator, on one side, emphasised the (alleged) dangers of free access to ‘business-like’ AS services on autonomy, invoking the state’s duty to uphold the right to life and human dignity.The constitutional court, on the other side, was concerned with the practical consequences the criminalisation of ‘right-to-die organisations’ had on those individuals wishing to carry out an autonomously derived end-of-life decision. In its landmark ruling, the court developed a constitutional ‘right to a self-determined death’ – which the new § 217 had violated. What, then, are ‘right-to-die organisations’ really – a threat to autonomy or indispensable helpers in exercising autonomous end-of-life decisions? This chapter aims to make sense of autonomy’s place between the right to life and the newly created right to a self-determined death. The chapter maps out the recent tumultuous developments in the realm of organised assistance with suicide and re-examines the debate that surrounded its criminalisation.

Overview This chapter is divided into four parts. First, the general legal framework surrounding AS in Germany as it was in force before the introduction of § 217 (and as applicable again after its annulment) is outlined. Second, the offence’s parliamentary history, nature, and official justifica-

1 In citing legislation, we use the German style of legal citation;‘§’ is the symbol for ‘section,’ see Michael Bohlander, Principles of German Criminal Law (Bloomsbury 2008) 4. All sections mentioned have reference to the German penal code (Strafgesetzbuch).

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tion are defined.Third, the Bundesverfassungsgericht’s ruling is outlined and questions concerning the reach of legislative discretion are touched on. Finally, an overview on the debate surrounding the criminalisation of organised assistance with suicide in Germany is offered and some of its most common arguments – the ‘slippery slope argument,’ the argument from human dignity, the danger of conflicts of interest, and the role of mental disorders – are critically evaluated.

The legal framework surrounding assisted suicides in Germany Completing suicide (or attempting to) is not a criminal offence in Germany – the actus reus of both manslaughter (Totschlag, § 212) and murder (Mord, § 211) requires the intentional killing of another person (other than might be implied by the still commonly used term Selbstmord [‘selfmurder’]2). Due to the dependence of the German accessory liability on a principal offence, the impunity of suicide itself generally also excludes criminal liability for a person intentionally aiding and abetting (Beihilfe) or instigating (Anstiftung) the suicide. Different from most European states, no specific offence for aiding a suicide existed before the introduction of § 217 either.3 This – formally derived – impunity of assistance with suicide is traditionally justified with the principle of personal responsibility4 and the criminal law’s purpose to protect legal goods5 (on which, see section titled ‘The “doctrine of legal goods” [Rechtsgutslehre]’).Taking one’s own life does not harm the legal goods of others, and assisting with a suicide does not harm the legal goods of the person voluntarily ending his or her life. However, following a classic ‘soft’ paternalistic rationale, this is only accepted to the extent that the end-of-life decision was formed autonomously. If liberty is understood to consist of ‘doing what one desires,’6 it is not an infringement of liberty to prevent non-voluntary self-inflicted harm. Consequently, assisting the suicide of a legally incompetent individual is a criminal offence in Germany. If acting intentionally regarding the suicidal person’s lack of legal competence, the assisting party is liable as a ‘principal by proxy’ (mittelbarer Täter) for the offences of manslaughter or murder, or if acting negligently, for involuntary manslaughter (fahrlässige Tötung, § 222). On this theoretical basis, the impunity of AS is attached to two key criteria – the presence of an autonomous end-of-life decision and the fact that the death was a ‘genuine’ suicide (and not a homicide committed by a third party). Both criteria are contested in their scope and sometimes imprecise application.The leading approach to determining autonomy is to apply the principle of consent and ask whether the suicidal person could have validly consented to being harmed by someone else.7 This is particularly difficult when the suicidal individual suffers from mental disorders (as is mostly the case, see section titled ‘The role of undiagnosed and diagnosed mental disorders’), is a child or adolescent, or when coercion or errors in motivation have been involved. The second aspect seems self-explanatory, but the distinction between suicides and homicides

2 Cf Dagmar Fenner, Suizid – Krankheitssymptom oder Signatur der Freiheit? Eine medizinethische Untersuchung (Alber 2008) 9, who rightly points out that ‘vitalists’ often use the term to emphasise the purported moral reprehensibility of suicides; A Bahr,‘Between “Self-Murder” and “Suicide”:The Modern Etymology of Self-Killing’ (2013) 46 Journal of Social History 620. 3 E.g. Article 151 of the Polish Criminal Code (Kodeks karny): ‘Whoever, by incitement or by providing assistance, induces a human to make an attempt on his own life, is subject to the penalty of deprivation of liberty for between 3 months and 5 years.’ 4 E.g. Ulfrid Neumann, ‘Die Strafbarkeit der Suizidbeteiligung als Problem der Eigenverantwortlichkeit des “Opfers”’ [1987] Juristische Arbeitsblätter 244. 5 E.g. Dorothea Magnus, Patientenautonomie im Strafrecht (Mohr Siebeck 2015) 244. 6 John Stuart Mill, On Liberty (Ticknor and Fields 1863) 186. 7 BGH NStZ 2012, 319.

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is not always clear-cut either. In a famous case decided by the German Federal Supreme Court (Bundesgerichtshof), the defendant convinced his blindly trusting victim that he was an inhabitant of the star Sirius.8 He persuaded the victim to end her ‘present life’ by letting a hairdryer fall into the bathtub (aiming to profit from her life insurance).The victim proceeded as she was told, but believed that she would awaken again in a new body on Lake Geneva. Here, the victim did not form a decision to die in the first place, and the control over the fatal act (Tatherrschaft) lay with the defendant. Apart from the difficult questions of detail the application of these criteria can raise, the general framework surrounding AS provides for a simple distinction: Being the principal of a homicide offence is punishable, but merely aiding a suicide is possible with impunity.

‘Business-like’ assistance with suicide – § 217 In December 2015, however, the general impunity of assisting the suicide of a competent individual was overturned by the introduction of § 217 – assistance with suicide was now a criminal offence if conducted in a ‘business-like’ manner (geschäftsmäßige Förderung der Selbsttötung). The law was passed after years of fierce public and political debate, kindled by the beginning emergence of ‘right-to-die organisations’ in Germany. In 2005, the Swiss organisation ‘Dignitas’ opened a branch office in Germany to mediate their AS services offered in Switzerland. In 2008, Hamburg’s former secretary of justice, Roger Kusch, founded an organisation called ‘Sterbehilfe Deutschland e.V.’ that offered AS services for the first time in Germany.The objective was to spare concerned individuals the journey to Switzerland, allowing them to die at home. The authorities soon revoked the commercial permission of ‘Sterbehilfe Deutschland,’9 but it resumed activities under the roof of an association based in Switzerland (‘Verein StHD’). Together, the two organisations assisted with 77 suicides between 2010 and 2012.10 Moreover, a small number of individuals reportedly performed assistance with suicide independently. For instance, the explanatory notes on § 217 mention a Berlin physician who had supposedly assisted in 200 cases of suicide in the last 20 years.11 Based on the legal situation outlined above, the practice of assisting the suicides of legally competent individuals – ‘business-like’ or not – was not a criminal offence. The lawmakers felt this was a ‘regulatory gap.’12 In the legislative process, four competing bills were introduced and the obligation to follow the party whip was suspended, allowing MPs to make a conscience-based decision. The proposed legislation ranged from explicitly permitting AS through a provision in the civil code,13 to the criminalisation of all forms of AS.14 Ultimately, a bill that criminalised the ‘business-like’ (geschäftsmäßige) provision of assistance with suicide was adopted. The criterion of ‘business-like conduct’ simply defined assistance with suicide being offered repeatedly (or with the intention thereof)15; the conduct did not have to be ‘commercial’

8 BGHSt 32, 38; see discussion in Markus D Dubber and Tatjana Hörnle, Criminal Law: A Comparative Approach (Oxford University Press 2014) 583–87. 9 VG Hamburg MedR 2009, 550. 10 Henning Rosenau and Igor Sorge, ‘Gewerbsmäßige Suizidförderung als strafwürdiges Unrecht? Kritische Anmerkungen zum Regierungsentwurf über die Strafbarkeit der gewerbsmäßigen Förderung der Selbsttötung (§ 217 StGB-E)’ (2013) 25 Neue Kriminalpolitik 108. 11 BT-Drs. 18/5373, 9. 12 ibid. 13 BT-Drs. 18/5374. 14 BT-Drs. 18/5376. 15 BT-Drs. 18/5373, 2.

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or ‘for-profit’ (gewerbsmäßig) as proposed by a competing bill.16 This low threshold was supposed to extensively cover the work of ‘right-to-die organisations’ which usually operated on a nonprofit basis. According to the explanatory memorandum, the offence was intended to counteract the negative consequences the spread of AS services might have on personal autonomy.The legislator saw a danger of conflicts of interest where assistance with suicide was provided for-profit, and also in the (more realistic) cases of non-profit conduct. Further, it was feared that the existence of ‘right-to-die organisations’ would foster the ‘acceptance’ or ‘normalisation’ of assisted suicides in society, and that eventually even a ‘social demand for completing suicide’ could be the result.17

The Bundesverfassungsgericht’s ruling After § 217 came into force, the organisations affected by the offence as well as a number of individuals filed complaints of unconstitutionality with the Bundesverfassungsgericht. In February 2020, the court decided that § 217 was indeed unconstitutional and annulled the offence.18 It ruled that the general right of personality includes the ‘right to a self-determined death.’ This right also extends to every individual’s decision to end his or her life by his or her own hand, and includes the search for and use of outside help in completing suicide.Thus, the court created a constitutional right to (assisted) suicide.19

Constitutional proportionality (Verhältnismäßigkeit) As § 217 encroached on this newly developed right by criminalising certain forms of AS, the court had to scrutinise the law as to its constitutional proportionality (Verhältnismäßigkeit). Proportionality is the standard constitutional test applied by the Bundesverfassungsgericht in determining that a law, judicial decision, or administrative act is in accordance with the rule of law.20 The proportionality test is a four-step procedure: the state measure in question must have a legitimate objective (1); it must be both suitable (2) and necessary (3) to achieve this objective; and it must satisfy the requirement of adequacy (or ‘proportionality in the narrow sense’) (4). The Bundesverfassungsgericht regularly affirms the idea of the criminal law as an ultima ratio that should be used ‘very cautiously.’21 All the same, the court usually applies the proportionality test to criminal offences in such a reserved manner that legislative discretion remains largely untouched.22 Specifically, the legislator is given free rein in its choice of a policy goal as long as this goal is itself constitutional,23 and the court only reviews (criminal) legislation as to whether it is manifestly unsuitable, unnecessary, or inadequate.24 This stance has resulted, for example, in a decision in which the court found the German incest offence (§ 173) to be constitutional

16 17 18 19 20 21 22 23 24

BT-Drs. 18/5375. BT-Drs. 18/5373, 2. BVerfG NJW 2020, 905. Volker Boehme-Neßler,‘Das Grundrecht auf Suizid’ (2020) Neue Zeitschrift für Verwaltungsrecht 1012. E.g. Grzeszick,‘GG Art. 20’ in Theodor Maunz and Günter Dürig (eds), Grundgesetz-Kommentar (90th edn, CH Beck 2020) marginal numbers 107ff. BVerfGE 39, 1, marginal number 162. Claus Roxin and Luís Greco, Strafrecht Allgemeiner Teil, vol I (CH Beck 2020) 75. Grzeszick (n 20) marginal number 111. Cf Roxin and Greco (n 22) 75.

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despite serious questions on the offence’s purpose aside from enforcing a culturally conveyed sexual moral.25 Of course, the judicial self-restraint shown by the court is in principle to be welcomed in a democracy under the rule of law, where the separation of powers is a central value. However, the degree to which judicial self-restraint is warranted is highly contested. For instance, the Bundesverfassungsgericht was widely criticised for having left too much leeway to the legislator in the aforementioned ‘incest case,’ and one justice, the late Winfried Hassemer, dissented26 (a rare event in German constitutional jurisprudence).

The ‘doctrine of legal goods’ (Rechtsgutslehre) More circumscribed requirements for the exercise of legislative discretion are formulated by the ‘doctrine of legal goods’ (Rechtsgutslehre), advanced by many German criminal law scholars27 but expressly rejected by the Bundesverfassungsgericht.28 According to the doctrine, which has its roots in liberal criminal theory and shares many similarities with the ‘harm principle,’29 only the protection of legal ‘goods’ (Rechtsgüter) may justify the use of the criminal law.There is no consensus as to what precisely constitutes legal goods. Claus Roxin and Luís Greco, for example, derive their concept from the criminal law’s purpose and define legal goods as ‘given conditions, or purposes which are necessary for the free development of individuals, the realisation of their fundamental rights, or the functioning of the state based on these goals.’30 Despite the doctrine’s conceptual vagueness (in which it does not differ greatly from the principle of constitutional proportionality), its main function is a negative and a critical one by identifying areas of overcriminalisation. For example, the concept’s proponents share their opposition to ‘legal moralism’ and the passing of offences for mere symbolic reasons. Judged by these criteria, § 217 is an evident example of overcriminalisation, as we shall see below. Indeed, this was also the Bundesverfassungsgericht’s conclusion. Why did the court decide to take the historically bold step to annul § 217 this time, thereby approximating the spurned ‘doctrine of legal goods’? The court justified the comparatively high degree of scrutiny it subjected the legislator’s discretion to with the fact that the offence interfered with a fundamental right of ‘existential importance’ – the right to a self-determined death it had just created.31 This rationale is convincing from a liberal perspective on criminal law which, like the ‘doctrine of legal goods,’ puts the individual and human dignity at the centre. Importantly, it is not limited to the criminalisation of assisted suicides. Precisely those offences that protect ‘moral values’ encroach

25 BVerfGE 120, 224. 26 BVerfGE 120, 224, marginal numbers 73ff. 27 E.g. Winfried Hassemer, ‘Grundlinien einer personalen Rechtsgutslehre’ in Arthur Kaufmann, Lothar Philipps and Heinrich Scholler (eds), Jenseits des Funktionalismus: Arthur Kaufmann zum 65. Geburtstag (Decker & Müller 1989); Roxin and Greco (n 22) 26. 28 BVerfGE 120, 227. 29 Cf Andrew von Hirsch, ‘Der Rechtsgutsbegriff und das “Harm Principle”’ in Roland Hefendehl, Andrew von Hirsch and Wolfgang Wohlers (eds), Die Rechtsgutstheorie: Legitimationsbasis des Strafrechts oder dogmatisches Glasperlenspiel? (Nomos 2003); Winfried Hassemer, ‘The Harm Principle and the Protection of “Legal Goods” (Rechtsgüterschutz): A German Perspective’ in AP Simester and others (eds), Liberal Criminal Theory: Essays for Andreas von Hirsch (Hart Publishing 2014). 30 Roxin and Greco (n 22) 26; translation by Tatjana Hörnle, ‘Theories of Criminalization’ in Markus D Dubber and Tatjana Hörnle (eds), The Oxford Handbook of Criminal Law (Oxford University Press 2014) 687. 31 BVerfG NJW 2020, 905, marginal number 266; as opposed to the more general rights to freedom of action, freedom of movement, and the right not be sanctioned, which are affected by any kind of criminalisation.

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on different facets of the right of personality (e.g. sexual autonomy), and therefore deserve closer scrutiny than was previously the case.32

Legitimate objective of § 217 The Bundesverfassungsgericht first stated that the protection of autonomy at the end of life constituted a legitimate governmental objective for introducing § 217.33 The court confirmed that the legislator reasonably assessed the dangers to autonomy emanating from unrestricted access to organised assistance with suicide. It highlighted the risk of unrecognised mental disorders and the dangers arising from insufficient information and advice provided to suicidal persons.The court also accepted the legislature’s worry of a social normalisation of AS and corresponding social pressures to be sufficiently well founded. It based this assessment on two main points: first, it referred to the experiences in the Netherlands and the US state of Oregon, where AS has become ‘entrenched in the care and health systems’ – systems which are subjected to increasing cost pressures. It highlighted the example of Oregon, where participation in the Death with Dignity Act is fully reimbursed by health insurance whereas certain therapy methods for the terminally ill are not. Second, the court mentioned research on the motivation of end-of-life decisions, according to which a common motive is the wish not to be a burden to relatives.The court argued that these aspects together raise substantial concerns that elderly individuals could be induced to end their life prematurely. An evaluation of the matter is offered in the section titled ‘The empirical slippery slope argument.’

Suitability and necessity Further, the court argued that, as a criminal provision, § 217 was a suitable instrument for the protection of legal goods.34 Subsequently, it normally determines whether the chosen form of intervention is necessary to fulfil its purpose – in the present context whether or not there were no less intrusive, but equally effective means available to protect the autonomy of end-of-life decisions.This aspect, in criminal law literature often discussed as the ‘principle of subsidiarity,’35 is closely connected to the idea of the criminal law as an ultima ratio. Criminal law should only be applied if the legal goods in question cannot be protected effectively by other branches of the law, e.g. by administrative provisions. In the realm of organised AS, non-criminal legislative alternatives to protect autonomy are readily conceivable. It is not surprising, therefore, that the Bundesverfassungsgericht indicated doubts as to the necessity of § 217. Ultimately, however, it left the question open and turned directly to the offence’s adequacy.36

Adequacy The proportionality test’s last step, adequacy, requires that the state measure’s adverse effects are not disproportionate in relation to its benefits.37 In weighing the restriction of the right to a self-determined death resulting from § 217 against its (supposed) benefits for the protection of

32 33 34 35 36 37

Cf BVerfGE 120, 227, Dissenting Opinion of Justice Hassemer, marginal number 128. BVerfG NJW 2020, 905, marginal numbers 227–59. BVerfG NJW 2020, 905, marginal numbers 260–62. E.g. Roxin and Greco (n 22) 86–90. BVerfG NJW 2020, 905, marginal number 263. Grzeszick (n 20) marginal number 117.

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autonomy, the court found the offence to be disproportionate.While the high rank of the legal goods ‘autonomy’ and ‘life’ could legitimise the use of criminal law in principle, its legitimate use reaches a limit where free choice is no longer protected but made impossible, the court argued. Factually, due to the offence’s existence there was no guarantee that suicidal individuals would still have access to assistance with suicide. In the absence of ‘right-to-die organisations,’ patients were dependent on the willingness of individual physicians to assist with a suicide, at the very least in the prescription of the necessary substances. Realistically, however, physicians’ willingness could only be expected in exceptional circumstances. Therefore, the right to suicide as a manifestation of the right to a self-determined death was de facto voided – it left no room for the individual to exercise his or her constitutionally protected freedom.

Revisiting the debate preceding the introduction of § 217 The Bundesverfassungsgericht’s ruling is a salutary development, which underlines the paramount importance of autonomy. In the form § 217 was passed, the legislator turned the protection of autonomy into its opposite. Its aim to set a high threshold for professional assistance with suicide was perfectly legitimate. Few will disagree that there are dangers to the autonomy of end-of-life decisions. However, the blanket criminalisation of all ‘business-like’ assistance with suicide was not a suitable solution to these issues.The remaining sections of this chapter contain a short overview on the ethical and legal debate that preceded the criminalisation of organised assistance with suicide and a critical analysis of its most common arguments.

The ‘slippery slope’ argument As stated above, the main argument for introducing § 217 was to counteract a ‘social normalisation’ and ‘acceptance’ of AS which would potentially result in ‘social pressures’ to complete suicide. Moreover, it was feared that tolerating the work conducted by ‘right-to-die organisations’ would set a dangerous precedent in other issues, such as assistance with the suicides of children and disabled persons, and euthanasia.38 This line of reasoning amounts to the ‘slippery slope’ (or in German: Dammbruch39) argument.As Douglas Walton described this type of argument: A slippery slope argument is a kind of argument that warns you if you take a first step, you will find yourself involved in a sticky sequence of consequences from which you will be unable to extricate yourself, and eventually you will wind up speeding faster and faster towards some disastrous outcome.40 The argument is common in the medico-ethical debate, particularly on issues such as abortion, assistance with suicide, euthanasia, and pre-natal diagnostics. In the parliamentary debate preceding the introduction of § 217, 21 of 67 speeches given by MPs contained one or more versions of a slippery slope argument.41 They all have in common the warning that the unregu-

38 E.g. Michael Friesner MP:‘Now we speak of assisted suicide. But at some point, when assisted suicide becomes the norm, the doctor will have to go from being an assistant to being the perpetrator’ (parliamentary protocol 18/66 [2014] – our translation). 39 Meaning the ‘bursting of a dam.’ 40 Douglas Walton, Slippery Slope Arguments (Oxford University Press 1992) 1. 41 Lukas Rhiel,‘Das Dammbruch- oder Slippery-Slope-Argument in der Debatte zur Sterbehilfe’ (2015) vorgänge 163, 165.

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lated offer of organised assistance with suicide would compromise autonomy. Frequently, the selection between ‘worthy’ and ‘unworthy’ lives is described as the final outcome in an unstoppable sequence of ever worsening consequences, and a parallel is drawn to the horrors of the Nazi regime.42 Even in the current debate,Wolfgang Thierse, a former president of the German parliament, was so outraged by the Bundesverfassungsgericht’s ruling of February 2020 that he compared the judges involved to the Nazi judiciary.43 An exemplary argument could go as follows: Once assistance with suicide is legalised, it becomes very easy to recommend euthanasia for mentally retarded persons, or anyone who requires inconvenient or costly treatment or support. Now we all know from the experience of Nazi Germany, it is a short step from there to elimination of any ‘socially undesirable’, i.e. politically dissident persons.44 The official justification given for the passing of § 217 did not go quite as far, yet moved in a similar direction.The notion of ‘social pressures’ implies a danger that end-of-life decisions will no longer be made by the individual but by third parties according to their measures of what constitutes a ‘worthy’ life. Is this a legitimate worry that justifies the use of the criminal law? The sorites slippery slope argument45

One of the problems with the ‘slippery slope’ type of argument is that it exploits the vagueness of the terms used.When exactly can we speak of a ‘social normalisation’ of suicides? How is ‘autonomy’ defined? At which point do the ‘social pressures’ become so strong that one can safely say that personal autonomy is impaired or suspended? Leaving these questions open clouds the view in determining the merits of the actual argument. For example, if ‘normalisation’ were simply to be defined as a reduction of suicide stigma in the community, this would warrant a more differentiated view than suggested by lawmakers. Stigma can have a preventive function against suicide (serving the sociological functions of ‘norm enforcement’ and ‘disease avoidance’46). But for acutely suicidal persons, stigma can also serve as a barrier against seeking help,47 and ‘suicide can appear to be the best solution for a stigmatised individual.’48 The empirical slippery slope argument49

Moreover, insofar as the ‘slippery slope’ type of argument implies a causal effect (‘domino theory’), it is dependent on empirical evidence to back up the postulated causal chain.The threat of a ‘social normalisation’ of suicides was substantiated with reference to the rising numbers of

42 Edward W Keyserlingk, Sanctity of Life: Or, Quality of Life in the Context of Ethics, Medicine, and Law:A Study (Law Reform Commission of Canada 1979) 23; Dagmar Fenner, ‘Ist die Institutionalisierung und Legalisierung der Suizidbeihilfe gefährlich?: Eine kritische Analyse der Gegenargumente’ (2007) 19 Ethik in der Medizin 200, 204. 43 Wolfgang Thierse,‘Die ethischen Grundfeste erschüttert’ Frankfurter Allgemeine Zeitung (29 February 2020). 44 Walton (n 40) 161–62. 45 On this type of argument, see ibid 37, 160. 46 Jo Phelan, Bruce G Link and John F Dovidio, ‘Stigma and Prejudice: One Animal or Two?’ (2008) 67 Social Science & Medicine 358. 47 N Oexle, L Mayer and N Rüsch,‘Suizidstigma und Suizidprävention’ (2020) 91 Nervenarzt 779. 48 M Pompili, I Mancinelli and R Tatarelli, ‘Stigma as a Cause of Suicide’ (2003) 183 The British Journal of Psychiatry 173. 49 Walton (n 40) 69ff.

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AS in Switzerland, Belgium, and the Netherlands (and the platitude ‘supply creates demand’).50 Apart from the question as to what extent these numbers were in fact attributable to foreigners,51 the usefulness of this measure is questionable. It is likely that suicides assisted by ‘right-to-die organisations’ simply replaced suicides which would have been carried out anyway (and by less safe methods). Thus, a more relevant measure seems to be the overall suicide rate, which decreased or remained relatively stable in these jurisdictions over the last decades.52 In fact, there are indications that the existence of (responsibly acting) ‘right-to-die organisations’ or individuals offering assistance with suicide can have a preventive effect against suicide. The Swiss organisation Dignitas reports that a considerable quota – 86% – of the individuals applying for assistance with suicide never come through with their initial request after receiving the provisional ‘green light,’ and that only 3% of their members eventually use assistance with suicide.53 Similarly, an individual ‘professionally’ conducting assistance with suicide since 2005 reported that in six out of seven cases, his job consisted of providing ‘life support.’54 It is possible that the mere knowledge of having access to a dignified way of dying can have a relieving effect on concerned individuals – a mechanism, however, that requires further research. Irrespective of this, keeping the number of suicides low should not be an end in itself. In view of the right to a self-determined death, the yardstick should be to uphold personal autonomy as well as possible – while at the same time protecting the right to life of individuals incapable of making end-of-life decisions.55 What about the points accepted by the Bundesverfassungsgericht to substantiate the legislator’s concerns? The reference to the common wish not to be a burden to relatives56 implies the (false) suspicion that end-of-life decisions with altruistic motives cannot be autonomous.This would amount to a very narrow understanding of autonomy according to which only very specific reasons for end-of-life decisions (e.g. terminal illness, severe suffering) are acceptable. However, the principle of ‘self-determination’ also extends to the motives for end-of-life decisions.The second point, which concerned cost pressures in the care and health systems in foreign countries,57 is not representative of the situation in Germany where universal health insurance is in place. More importantly, however, it is not convincing as a justification for criminalisation, but should rather be understood as a call for appropriate reforms in health legislation. The precedent slippery slope argument58

Lastly, when opponents express their fear that tolerating organised AS would set a dangerous precedent in other issues, they often fail to provide an explanation of why this would be so wrong.The court’s ruling will indeed have consequences beyond the ‘standard case’ of compe-

50 Speech of Michael Brand MP (parliamentary protocol 18/66 [2014] 6117 B). 51 Cf BVerfG NJW 2020, 905, marginal number 255. 52 Between 1995 and 2009, the rate decreased by 10.3, 12.4, and 18.3% in the Netherlands, Belgium, and Switzerland, respectively, see OECD, ‘Health at a Glance’ (2011) 35 www.oecd.org/dataoecd/6/28/49105858 .pdf accessed 11 October 2020. 53 Dignitas,‘Klinik Schönberg: Skript in Ergänzung zu Referat und Fragerunde’ (18 May 2020) www.dignitas.ch/ images/stories/pdf/diginpublic/referat-klinik-schoenberg-18052020.pdf accessed 11 October 2020. 54 Claudia Krieg,‘Interview mit dem Sterbebegleiter Peter Puppe’ (2015) vorgänge 201. 55 Ulfrid Neumann,‘Autonomie durch Heteronomie? Kategoriale Ver(w)irrungen im aktuellen Medizinstrafrecht’ (2017) Zeitschrift für Medizinstrafrecht 141, 145. 56 E.g. speech of Kerstin Griese MP (parliamentary protocol 18/66 [2014] 6134 C–D). 57 E.g. speech of Hubert Hüppe MP (parliamentary protocol 18/66 [2014] 6132 D). 58 Walton (n 40) 115.

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tent adults.As a universal right, the right to a self-determined death applies to everyone, including minors and disabled people. Of course, determining the maturity and legal competence necessary for end-of-life decisions is a particularly difficult task within these groups of individuals. However, these difficulties should not be taken as a reason for generally excluding them from access to AS – this would amount to that same flawed line of reasoning originally advanced in favour of the introduction of § 217. Moreover, the nature of the right to a self-determined death as a universal right (i.e. that of being open to everyone) also means that the court’s ruling could have consequences for euthanasia. As opposed to assistance with suicide, euthanasia is currently a criminal offence in Germany (Tötung auf Verlangen, § 216, punishable by up to five years imprisonment). One explanation offered for this distinction is that, from a soft paternalistic standpoint, only a suicide sufficiently proves the presence of an autonomous will to die. In the case of euthanasia, on the other hand, it cannot be ruled out afterwards whether the suicidal person had been persuaded to demand an act she or he would not have performed herself or himself.59 Regardless of how convincing this distinction really is, the scope of § 216 must be re-evaluated in light of the right to a self-determined death.While most people can realise their constitutional right by completing suicide (possibly supported by a ‘right-to-die organisation’), there are some individuals who are physically unable to perform the fatal act themselves. For this limited group of people, the prohibition of active euthanasia violates the constitutional right to a self-determined death and is likely unconstitutional.60

Autonomy and human dignity: A right to die or a duty to live? Related to the ‘slippery slope’ argument is the argument from human dignity.Tolerating (assistance with) suicide is incompatible, argue the critics, with the holy or absolute nature of human dignity.This view has religious as well as philosophical foundations: the three revealed religions argue that life is God’s gift and property; therefore, humans are not permitted to dispose of it.61 From a Christian view of humankind, the ‘commandment of love’ demands the protection of all human life – ‘if necessary even from harm caused by the person herself.’62 A similar strand of thinking can be found in philosophy. Pioneered by Aristotle who rejected (some forms of) suicide as an injustice to the polis, the thought was taken up again by German enlightenment philosophers such as Samuel Pufendorf63 and Immanuel Kant.64 Kant saw suicide as a violation of the moral duty to preserve oneself and as an attack on the dignity we possess as rational beings. Further, as autonomy and rationality are inherently human, he believed using a rational

59 Claus Roxin, ‘Tötung auf Verlangen und Suizidteilnahme. Geltendes Recht und Reformdiskussion’ (2013) Goltdammer’s Archiv für Strafrecht 313. 60 E.g. Josef F Lindner, ‘Verfassungswidrigkeit des Verbotes aktiver Sterbehilfe?’ (2020) Neue Zeitschrift für Strafrecht 505, who proposes the insertion of an exception in § 216 for legally competent individuals who are unable to perform the fatal act themselves. 61 Hartmut Kreß, ‘Suizid und Suizidbeihilfe in existenzieller, religiöser und kultureller Hinsicht’ in Ferdinand von Schirach, GOTT. Ein Theaterstück (Luchterhand 2020) 123. 62 Rolf Dietrich Herzberg, Die Unterlassung im Strafrecht und das Garantenprinzip (de Gruyter 1972) 266. 63 Samuel von Pufendorf, De jure naturae et gentium libri octo (Sumptibus Friderici Knochii 1684) book 2, chapter 4, § 19. 64 Immanuel Kant, Die Metaphysik der Sitten (Friedrich Nicolovius 1797) part II, § 6.

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choice to terminate one’s existence – thus terminating rationality and autonomy – would be self-contradictory.65 When autonomy becomes normatively charged in this way, the decision to die can never be autonomous – autonomy and decisions against life are mutually exclusive.This would amount to a total rejection of a ‘right to die’ and, consequently, the establishment of a ‘duty to live.’66 But to whom should this duty apply? In a liberal, pluralistic society, neither god nor the state itself has the authority to impose moral values on the individual.This is particularly true considering the fact that in 2020, over two-thirds of the German population agreed that doctors should be allowed to provide assistance with suicide, and 81% agreed at least with respect to terminally ill patients.67 Therefore, a moral ‘duty to live’ has no backing in society. Irrespective of this, human dignity should not be used as a smokescreen for justifying legal moralism. The human dignity argument is a knockout one because every violation of human dignity is unconstitutional.68 To avoid a dilution of human dignity, the concept’s very core as a defensive guarantee against degradation by the state ought to be strictly distinguished from a culturally and morally charged view of humankind. Furthermore, it must be acknowledged that life and autonomy are closely related facets of human dignity, and there is no hierarchy between them.Therefore, as the Bundesverfassungsgericht rightly notes, the ‘protection of life at the cost of autonomy contradicts the self-understanding of a community in which human dignity is the central value.’69

The danger of conficts of interest Another argument in the explanatory memorandum of § 217 was to counteract potential conflicts of interests. The memorandum stated that even non-profit ‘right-to-die organisations’ would take great interest in ‘providing services as frequently and effectively as possible.’70 This premise alone is questionable – organisations such as Dignitas emphasise that their primary purpose is ‘counselling in respect to questions on the end of life and in difficult life situations,’71 and not to perform as many assisted suicides as possible. It is likely that there is a lower chance that assistance with suicide conducted by a ‘right-to-die organisation’ is subject to conflicts of interest than if performed by a relative, in which case complex emotional and personal issues might play a role. This is not to say that conflicts of interest, particularly of a financial nature, are completely negligible. One approach to this awareness could be the introduction of a specific offence that criminalises ‘selfish’ forms of assistance with suicide – similar to the framework in Switzerland. Article 115 of the Swiss penal code reads:

65 ibid; Neumann, ‘Autonomie durch Heteronomie? Kategoriale Ver(w)irrungen im aktuellen Medizinstrafrecht’ (n 55) 143. 66 Michael Köhler,‘Die Rechtspflicht gegen sich selbst’ (2006) 14 Jahrbuch für Recht und Ethik 425. 67 Ulrich Neumann, ‘Umfrage: Mehrheit befürwortet ärztliche Sterbehilfe’ tagesschau.de (25 May 2020) www.tagess chau.de/investigativ/report-mainz/sterbehilfe-197.html accessed 11 October 2020. 68 Eric Hilgendorf, ‘Die missbrauchte Menschenwürde – Probleme des Menschenwürdetopos am Beispiel der bioethischen Diskussion’ (1999) 7 Jahrbuch für Recht und Ethik 137, 157. 69 BVerfG NJW 2020, 905, marginal number 277. 70 BT-Drs. 18/5373, 11. 71 Dignitas, ‘Was bietet DIGNITAS’ www.dignitas.ch/index.php?option=com_content&view=article&id=6 &Itemid=47&lang=de accessed 11 October 2020; Christian Rath, ‘Dignitas-Chef übers Sterben: “Gute Arbeit soll bezahlt werden”’ Die Tageszeitung: taz (16 August 2012) https://taz.de/!5086327/ accessed 11 October 2020.

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Any person who for selfish motives incites or assists another to commit or attempt to commit suicide is, if that other person thereafter commits or attempts to commit suicide, liable to a custodial sentence not exceeding five years or to a monetary penalty.72 Other proposals along these lines include the criminalisation of assistance with suicide for reasons of ‘greed’73 or the ‘exploitation of a predicament for the purpose of enrichment.’74 Such a narrowly tailored offence would certainly be preferable to the blanket criminalisation of organised AS. However, it will be difficult to define a reasonable threshold for the relevant criterion. For example, the offence should not cover well-trained helpers such as doctors merely on the grounds that these persons (partly) earn their living from providing AS.The more serious danger, however, is the possibility that anyone who was in a position to take advantage of the suicidal person’s death – particularly potential heirs and legatees – could face the risk of prosecution. However, these persons in particular tend to enjoy the suicidal person’s special trust. To place relatives or close friends under a general suspicion of ‘greediness’ would potentially discourage them from taking part in AS and thus compromise the right to a self-determined death. From a strict autonomy-oriented perspective, such an offence is not even necessary. The most ethically reprehensible cases of conflicts of interest concern assistance with the suicide of incompetent individuals for selfish reasons or on grounds of self-enrichment. This, however, is already a punishable offence under current (and long-standing) German law. On the other hand, the presence of a conflict of interest does not change the validity of the assistance provided for a legally competent adult.Therefore, conflicts of interest have no direct bearing on the legal good ‘autonomy.’

The role of undiagnosed and diagnosed mental disorders The impunity of assistance with suicide is based on the premise that suicides are (or at least: can be) voluntary (volenti non fit iniuria).This ‘voluntary suicide’ hypothesis is embodied in the work of Jean Améry: Those who leap have not necessarily fallen into delusion, they are not even ‘disturbed’ or ‘deranged’ in all circumstances.The inclination to voluntary death is not a sickness of which one has to be cured as one is cured of measles.75 However, a central argument advanced against the legitimacy of assistance with suicide is that ‘voluntary’ or ‘free’ suicides do not actually exist (or are very rare).76 Particularly problematic is the fact that suicidality is a symptom of certain psychological disorders (such as the major depression disorder, F 32.2 ICD-10). This prompts the circular argument: ‘the deceased was suicidal; thus, the suicide was pathological.’

72 English translation available at www.admin.ch/opc/en/classified-compilation/19370083/202007010000/311.0 .pdf accessed 11 October 2020. 73 Heinz Schöch and Torsten Verrel, ‘Alternativ-Entwurf Sterbebegleitung (AE-StB) mit dem Entwurf eines Sterbebegleitungsgesetzes’ (2005) Goltdammer’s Archiv für Strafrecht 553, 581–82. 74 Ulrich Schroth,‘Sterbehilfe als strafrechtliches Problem’ (2006) Goltdammer’s Archiv für Strafrecht 549, 570. 75 Jean Améry, On Suicide:A Discourse on Voluntary Death (Indiana University Press 1999) 30. 76 Gerd Geilen,‘Suizid und Mitverantwortung’ (1974) 29 Juristenzeitung 145, 148; Peter Bringewat,‘Die Strafbarkeit der Beteiligung an fremder Selbsttötung als Grenzproblem der Strafrechtsdogmatik’ (1975) 87 Zeitschrift für die gesamte Strafrechtswissenschaft 623, 632–33; Magnus (n 5) 441.

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Modern psychological research paints a more differentiated picture, but still estimates that 90–95% of individuals who completed suicide suffered from psychological disorders.77 In absolute numbers, affective disorders are the most common cause for suicides, causing an estimated 40–60% of all suicides.78 A large proportion of suicidal thoughts are only of a temporary nature, and suicide attempts are often intended as a ‘cry for help.’79 This can partly be explained by the episodic pattern of affective disorders. A particular danger in the context of assistance with suicide is, however, that psychological disorders remain completely undiagnosed. What can be concluded from these findings? First, that a demonstrable – albeit small – portion of suicides that can safely be classified as ‘voluntary’ actually exists. Second, the necessity to closely scrutinise end-of-life decisions from a medical and psychiatric standpoint. Appropriate regulatory mechanisms to ensure the autonomy and permanence of end-of-life decisions should be put in place, rather than the blanket criminalisation of ‘business-like’ AS.Third, the assumption that the presence of a psychological disorder is tantamount to the absence of autonomy is false.The broad concept of mental illness adopted by the ICD-1080 as well as the fluid borders between a ‘rational’ reaction to acute life crises and pathological disorders warrants a differentiated view. If the psychological disorder does not impair cognition (as do psychoses), the main indicator for an autonomous end-of-life decision should be the decision’s permanence, which can be the case particularly in patients resistant to psychiatric treatment. It must be recognised that suffering from chronic psychiatric disorders can be equally severe as suffering from serious physical illness; thus, a form of rationality can be seen in those patients’ desire to die.

Conclusion and outlook The annulment of § 217 is a positive and historically unprecedented development.The offence was not suitable to protect autonomy. The arguments advanced in the legislative process do not survive empirical scrutiny, rendering § 217 a ‘symbolic’ offence and thus an example of overcriminalisation. The offence gave the Bundesverfassungsgericht the opportunity, however, to develop the new constitutional right to a self-determined death, which strengthens autonomy in end-of-life decisions. The court’s ruling has had immediate practical implications – ‘rightto-die organisations’ can take up their work and suicidal persons can avail themselves of their services again.Thereby, the ruling provides a realistic and legal perspective for every competent individual wanting to end his or her life in a humane way. Apart from this direct effect, the court’s decision has rekindled public debate on important questions concerning the end of life, questions which might affect all of us at some point. A successful German writer even authored a play in which he lets his viewers vote on the ethical permissibility of AS.81 The public debate might indeed have contributed to a normalisation of suicides, but in a positive, destigmatising way. From an academic point of view, the court’s ruling

77 Clemens Cording and Henning Saß, ‘Die Freiverantwortlichkeit der Entscheidung für einen assistierten Suizid’ (2020) Neue Juristische Wochenschrift 2695. 78 Georg Fiedler and Hannah Müller-Pein, ‘Suizidalität – die Dimension eines Phänomens’ (2020) 36 Forum der Psychoanalyse 141; M Wolfersdorf,‘Suizidalität’ (2008) 79 Der Nervenarzt 1319. 79 Geilen (n 76) 148. 80 The ICD-10 also covers ‘non-pathological’ crises such as the ‘acute stress reaction’ (F 43.0), the ‘posttraumatic stress disorder’ (F 43.1), and ‘adjustment disorders’ (F 43.2) – reactions to exceptional psychological stress that would cause despair in almost anyone, see Fenner (n 2) 264–65. 81 Ferdinand von Schirach, GOTT. Ein Theaterstück (Luchterhand 2020).

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is intriguing because of its historically unprecedented intervention in the legislator’s discretion in passing criminal law. The ruling will once again ignite debate on the limits of the criminal law. Moreover, it will give rise to hopes that other potentially superfluous offences will undergo the same scrutiny, and that this ruling was a first step towards incorporating the ‘doctrine of legal goods’ into the court’s jurisprudence. Now, the ball is back in the legislator’s court.As a response to the ruling, the legislator should set up a framework for a responsible AS practice. After all, the state does have a duty to protect the ‘fragile’ autonomy and the life of suicidal citizens. However, the legislator will have to make sure to leave sufficient room for the right to a self-determined death in any new attempt to regulate organised AS.The Bundesverfassungsgericht itself listed various potential regulatory mechanisms: a legal duty to provide information and counselling and an obligatory waiting period – a concept comparable to the regulations on abortion; licensing requirements that ensure the reliability of ‘right-to-die organisations;’ and prohibitions of ‘particularly dangerous’ forms of suicide assistance (such as ‘selfish’ or ‘greedy’ behaviour, see above). Considering the fact that, as the court itself stated, there is as yet little empirical knowledge on the different approaches to AS and the field of suicide assistance in general, the legislative process should be informed by a balanced panel of experts including representatives of ‘right-to-die organisations.’ However, not only on the legislative front is there a need for action. A key aspect of any autonomy-oriented regulatory framework will be to ensure that the psychological competence of suicidal individuals and the permanence of their end-of-life decision are professionally evaluated. Doctors (particularly psychiatrists) are indispensable in performing these tasks, and it must be ensured that they can do so legally. As of yet, most of the state medical associations’ professional codes prohibit or discourage every ‘participation’ in a suicide.An important step in implementing the new ruling will therefore be for the medical associations to revise their standards. The president of the German Federal Medical Association has already signalled his intention to move in this direction.82 Returning to the question raised at the beginning of this chapter, it can be concluded that ‘right-to-die organisations’ assume an important task in upholding self-determination at the end of life, and there is no evidence that their sheer existence has adverse effects on autonomy. Therefore, § 217 was a misguided and dispensable offence, and the Bundesverfassungsgericht’s ruling constitutes a positive development in several respects. However, it can only be a first step in the process towards finding a responsible and balanced societal approach to dealing with the end of life, and many issues remain to be discussed.

References Améry, Jean, On Suicide:A Discourse on Voluntary Death (Indiana University Press 1999). Bahr,A,‘Between “Self-Murder” and “Suicide”:The Modern Etymology of Self-Killing’ (2013) 46 Journal of Social History 620. Boehme-Neßler,Volker,‘Das Grundrecht auf Suizid’ (2020) Neue Zeitschrift für Verwaltungsrecht 1012. Bohlander, Michael, Principles of German Criminal Law (Bloomsbury 2008) 4. Cording, Clemens and Saß, Henning, ‘Die Freiverantwortlichkeit der Entscheidung für einen assistierten Suizid’ (2020) Neue Juristische Wochenschrift 2695. Dignitas,‘Klinik Schönberg: Skript in Ergänzung zu Referat und Fragerunde’ (18 May 2020) www.dignit as.ch/images/stories/pdf/diginpublic/referat-klinik-schoenberg-18052020.pdf accessed 11 October 2020.

82 Cornelia Schmergal, ‘Ärzteverbände wollen Verbot der Suizidbeihilfe kippen’ DER SPIEGEL (29 September 2020) 52.

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Carsten Momsen and Mathis Schwarze Dignitas,‘Was bietet DIGNITAS’ www.dignitas.ch/index.php?option=com_content&view=article&id=6 &Itemid=47&lang=de accessed 11 October 2020. Dubber, Markus D and Hörnle, Tatjana, Criminal Law: A Comparative Approach (Oxford University Press 2014). Fenner, Dagmar,‘Ist die Institutionalisierung und Legalisierung der Suizidbeihilfe gefährlich?: Eine kritische Analyse der Gegenargumente’ (2007) 19 Ethik in der Medizin 200. Fenner, Dagmar, Suizid – Krankheitssymptom oder Signatur der Freiheit? Eine medizinethische Untersuchung (Alber 2008). Fiedler, Georg and Müller-Pein, Hannah,‘Suizidalität – die Dimension eines Phänomens’ (2020) 36 Forum der Psychoanalyse 141. Wolfersdorf, M,‘Suizidalität’ (2008) 79 Der Nervenarzt 1319. Geilen, Gerd,‘Suizid und Mitverantwortung’ (1974) 29 Juristenzeitung 145. Hassemer,Winfried,‘Grundlinien einer personalen Rechtsgutslehre’ in Arthur Kaufmann, Lothar Philipps and Heinrich Scholler (eds), Jenseits des Funktionalismus: Arthur Kaufmann zum 65. Geburtstag (Decker & Müller 1989). Hassemer, Winfried, ‘The Harm Principle and the Protection of “Legal Goods” (Rechtsgüterschutz): A German Perspective’ in AP Simester and others (eds), Liberal Criminal Theory: Essays for Andreas von Hirsch (Hart Publishing 2014). Herzberg, Rolf Dietrich, Die Unterlassung im Strafrecht und das Garantenprinzip (de Gruyter 1972). Hilgendorf, Eric, ‘Die missbrauchte Menschenwürde – Probleme des Menschenwürdetopos am Beispiel der bioethischen Diskussion’ (1999) 7 Jahrbuch für Recht und Ethik 137. Kant, Immanuel, Die Metaphysik der Sitten (Friedrich Nicolovius 1797). Keyserlingk, Edward W, Sanctity of Life: Or, Quality of Life in the Context of Ethics, Medicine, and Law:A Study (Law Reform Commission of Canada 1979). Köhler, Michael,‘Die Rechtspflicht gegen sich selbst’ (2006) 14 Jahrbuch für Recht und Ethik 425. Kreß, Hartmut,‘Suizid und Suizidbeihilfe in existenzieller, religiöser und kultureller Hinsicht’ in Ferdinand von Schirach (ed), GOTT. Ein Theaterstück (Luchterhand 2020). Krieg, Claudia,‘Interview mit dem Sterbebegleiter Peter Puppe’ (2015) vorgänge 201. Lindner, Josef F, ‘Verfassungswidrigkeit des Verbotes aktiver Sterbehilfe?’ (2020) Neue Zeitschrift für Strafrecht 505. Maunz,Theodor and Dürig, Günter (eds), Grundgesetz-Kommentar (90th edn, CH Beck 2020). Neumann, Ulfrid, ‘Die Strafbarkeit der Suizidbeteiligung als Problem der Eigenverantwortlichkeit des “Opfers”’ (1987) Juristische Arbeitsblätter 244. Neumann, Ulfrid, ‘Autonomie durch Heteronomie? Kategoriale Ver(w)irrungen im aktuellen Medizinstrafrecht’ (2017) Zeitschrift für Medizinstrafrecht 141. Neumann, Ulrich, ‘Umfrage: Mehrheit befürwortet ärztliche Sterbehilfe’ tagesschau.de (25 May 2020) www.tagesschau.de/investigativ/report-mainz/sterbehilfe-197.html accessed 11 October 2020. OECD,‘Health at a Glance’ (2011) 35 www.oecd.org/dataoecd/6/28/49105858.pdf accessed 11 October 2020. Oexle, N, Mayer, L and Rüsch, N,‘Suizidstigma und Suizidprävention’ (2020) 91 Nervenarzt 779. Phelan, Jo, Link, Bruce G and Dovidio, John F, ‘Stigma and Prejudice: One Animal or Two?’ (2008) 67 Social Science & Medicine 358. Pompili, M, Mancinelli, I and Tatarelli, R, ‘Stigma as a Cause of Suicide’ (2003) 183 British Journal of Psychiatry 173. Rath, Christian,‘Dignitas-Chef übers Sterben:“Gute Arbeit soll bezahlt werden”’ Die Tageszeitung: taz (16 August 2012) https://taz.de/!5086327/ accessed 11 October 2020. Rhiel, Lukas, ‘Das Dammbruch- oder Slippery-Slope-Argument in der Debatte zur Sterbehilfe’ (2015) vorgänge 163. Roxin, Claus,‘Tötung auf Verlangen und Suizidteilnahme. Geltendes Recht und Reformdiskussion’ (2013) Goltdammer’s Archiv für Strafrecht 313. Schmergal, Cornelia, ‘Ärzteverbände wollen Verbot der Suizidbeihilfe kippen’ DER SPIEGEL (29 September 2020). Schöch, Heinz and Verrel,Torsten,‘Alternativ-Entwurf Sterbebegleitung (AE-StB) mit dem Entwurf eines Sterbebegleitungsgesetzes’ (2005) Goltdammer’s Archiv für Strafrecht 553, 581–582. Schroth, Ulrich,‘Sterbehilfe als strafrechtliches Problem’ (2006) Goltdammer’s Archiv für Strafrecht 549. Thierse,Wolfgang,‘Die ethischen Grundfeste erschüttert’ Frankfurter Allgemeine Zeitung (29 February 2020).

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20 VOLUNTARY ASSISTED DYING LAW REFORM IN AUSTRALIA AND NEW ZEALAND Ian Freckelton

Introduction A distinctive jurisprudence and reforms to the common law have developed in Australia and New Zealand on end-of-life issues. Until the Voluntary Assisted Dying Act 2017 (Vic), the Voluntary Assisted Dying Act 2019 (WA), and the End of Life Choice Act 2019 (NZ), the focus of legal analyses and courts’ decision-making in both countries was on entitlements to withhold and withdraw treatment from persons desirous of bringing their life to an end.1 Inevitably, this took place against the backdrop of the broader community debate about physician-assisted suicide and euthanasia.2 No global or human rights treaties explicitly identify a ‘right to die.’ However, debates in relation to euthanasia issues emanate from community, as well as bioethical debates about entitlements to autonomy of decision-making by persons with serious illnesses; human dignity, including the dignity of choice;3 and respect for the wishes of persons who are ill or dying. In addition, they clearly engage a number of well-recognised human rights, including the right to life (ICCPR, Article 6), the right to freedom from torture, cruel, inhuman, and degrading treatment (ICCPR, Article 7), and the right to respect for private life (ICCPR, Article 17) as well as, arguably, the right to the enjoyment of the highest attainable standard of physical and mental health (ICESR, Article 12). However, in many authoritative human rights decisions by

1 See e.g. B White, L Willmott, E Close and J Downie, ‘Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?’ in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (Federation Press 2017), 454–478; B White et al.,‘The Role of Law in Decisions to Withhold and Withdraw LifeSustaining Treatment from Adults Who Lack Capacity: A Cross-Sectional Study’ (2016) 43 Journal of Medical Ethics 327; I Freckelton,‘Patients’ Decisions to Die:The Emerging Australian Jurisprudence’ (2011) 18 Journal of Law and Medicine 427; L Bartels and M Otlowski,‘A Right to Die? Euthanasia in Australia’ (2010) 17 Journal of Law and Medicine 532; M Otlowski, Voluntary Euthanasia and the Common Law (Clarendon Press 1997). 2 See e.g. R Syme, ‘Necessity to Palliate Pain and Suffering as a Defence to Medical Homicide’ (2009) 17 Journal of Law and Medicine 439. 3 See C Bauer,‘Dignity in Choice: A Terminally Ill Patient’s Right to Choose’ (2018) 44(3) Mitchell Hamline Law Review 1025; S Nalley,‘Euthanasia – The Right to Choose’ (2003) 1 Essai Article 28.

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courts, the ‘right to die’ has not been acknowledged. In Pretty v The United Kingdom,4 for instance, the European Court of Human Rights held that the right to life does not equate to a right to die ‘nor can it create a right to self-determination in the sense of conferring on an individual the entitlement to choose death rather than life.’ By contrast, in the internationally influential judgement of Carter v Canada,5 the Supreme Court of Canada concluded that:‘The prohibition on physician-assisted dying infringes the right to life, liberty and security of the person in a manner that is not in accordance with the principles of fundamental justice.’ However, in many countries, including Australia and New Zealand, the ultimate decision on the lawfulness and the ethics of physician-assisted suicide has been regarded as so fundamental a community issue that it has been left to the legislature. The emergent (and ongoing) efforts directed towards law reform in relation to voluntary euthanasia (VE) have generated a new generation of debate about the human rights issues involved in enabling patients themselves and on occasion through their health practitioners to exercise active choice as to the timing and circumstances of their death. This chapter reviews the legislative developments in Australia and New Zealand and the controversies that have been generated in these countries by law reform initiatives in relation to dying with dignity. The issues traversed include whether the legislative enactments have not gone far enough in alleviating suffering and giving patients autonomy, and whether they have gone too far in compromising doctor–patient relationships, protecting the beneficent culture of medicine, and ensuring that end-of-life decision-making involving health practitioners is sufficiently accountable.

The Northern Territory initiative Attempts at euthanasia law reform in Australia are conventionally dated from 1995, the year of the Rights of the Terminally Ill Act 1995 (NT), although the first voluntary euthanasia bill that was introduced into an Australian parliament was the Voluntary and Natural Death Bill 1993 (ACT). The 1995 legislation has particular historical significance because the Northern Territory was the first jurisdiction in the world to have operative legislation enabling voluntary assisted dying (VAD). It permitted a doctor to comply with a request from a terminally ill, competent adult patient to receive assistance to end their life (section 4) where, among other things, the patient was experiencing ‘pain, suffering and/or distress to an extent unacceptable to the patient’ (section 4) and there were no palliative care options to alleviate this to a level acceptable to the patient. A psychiatrist had to confirm the patient was not suffering from a ‘treatable clinical depression,’ the patient had to have received information from a palliative care specialist, and there were two ‘cooling-off ’ periods (section 7). However, from the outset the enactment was extremely controversial,6 and it existed in an area of Australia with a high level of indigenous

4 App No 2346/02 (2002) 35 Eur HR Rep 1 at [39]. See S Milns,‘Death, Dignity and Discrimination:The Case of Pretty v United Kingdom’ (2002) 3(10) German Law Journal E4. 5 [2015] 1 SCR 331 at [56]. 6 See e.g. PE Mullen, ‘Euthanasia: An Impoverished Construction of Life and Death’ (1995) 3 Journal of Law and Medicine 121; H Kuhse and P Singer, ‘Active Voluntary Euthanasia, Morality and the Law’ (1995) 3 Journal of Law and Medicine 129; D Mendelson, ‘The Northern Territory’s Euthanasia Legislation in Historical perspective’ (1995) 3 Journal of Law and Medicine 136; G Gillett,‘Ethical Aspects of the Northern Territory Euthanasia Legislation’ (1995) 3 Journal of Law and Medicine 145; M Ashby,‘Hard Cases, Causation and Care of the Dying’ (1995) 3 Journal of Law and Medicine 152; J Buchanan,‘Euthanasia:The Medical and Psychological Issues’ (1995) 3 Journal of Law and Medicine 161; D Ranson,‘The Coroner and the Rights of the Terminally Ill Act 1995 (NT)’ (1995) 3 Journal of Law and Medicine 19.

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population.7 A challenge to the legislation in the Northern Territory Supreme Court resulted in a split decision (by a majority of two to one) to uphold the law.8 The Northern Territory Act functioned for literally a few weeks before it was overturned by Commonwealth legislation, the Euthanasia Laws Act 1997 (Cth), an avenue that was open to the federal government because of the status of the jurisdiction as only a territory of Australia, not a state.The Northern Territory legislation was utilised on a small number of occasions.9 The principal points of contention in relation to the 1995 initiative were whether it was workable, given the few psychiatrists available (generally on a fly-in, fly-out basis); whether it was going to work adversely to the interests of Aboriginal people; whether it was compliant with Australia’s human rights obligations;10 whether it failed to come to terms with the availability and efficacy of palliative care services; whether persons who were mentally ill would be able to take advantage of the option;11 whether it was appropriate for non-residents to avail themselves of the legislation; whether it would place pressure on persons to use the option of voluntary assisted dying; and whether it would erode the culture of care within the medical profession. A high level of legislative activity has continued since that Commonwealth overturning of the Northern Territory initiative, with over 50 bills for voluntary euthanasia being tabled in Australian parliaments between 1995 and 2016.12 They have varied between voluntary euthanasia bills, physician-assisted suicide legislation, and hybrid forms of legislation. A further series of bills has been tabled from the beginning of 2016.While the bills can be divided among permissive, defence, and penalty mitigation models, the permissive bills were the most popular and tended to have the following features: 1. Power: power is conferred on treating medical practitioners to administer VE to certain eligible patients; 2. Immunity: immunity against civil, criminal, or disciplinary liability is conferred on any persons assisting in the administration of VE in good faith; 3. Safeguards: protective procedures are generally prescribed to require competent requests, to provide information, and to obtain psychiatric assessments; these and other safeguards are

7 See JI Fleming, ‘Death, Dying, and Euthanasia: Australia Versus the Northern Territory’ (2000) 15(3) Issues Law Medicine 291; P Quirk,‘Euthanasia in the Commonwealth of Australia’ (1998) 13(4) Issues Law Medicine 425; G Williams,‘Voluntary Euthanasia Legislation: Practicalities of the Northern Territory’s Rights of the Terminally Ill Act of 1995’ (1996) 9(3) Australian Critical Care 92. 8 Christopher John Wake and Djiniyinni Gondarra v Northern Territory of Australia and The Honourable Keith John Austin Asche AC,The Administrator of the Northern Territory of Australia, unreported, Full Court of the Supreme Court of the Northern Territory (Martin CJ,Angel J and Mildren J), 24 July 1996. 9 See P Nitschke (with P Corris), Damned If I Do (Melbourne University Press 2013). The Commonwealth law prevented the ACT, the NT and Norfolk Island from passing laws permitting euthanasia for 25 years but a lobby has emerged to change this: see N Fuller, ‘ACT Should Have Right to Vote on Euthanasia Politicians Argue’ (5 March 2021) Canberra Weekly https://canberraweekly.com.au/act-should-have-right-to-vote-on-euthanasiapoliticians-argue/. 10 See G Zdenkowski, ‘Human Rights and Euthanasia’, Occasional Paper of the Australian Human Rights and Equal Opportunity Commission (December 1996) www.humanrights.gov.au/sites/default/files/content/pdf/ human_rights/euthanasia.pdf 11 See C Ryan, ‘Australasian Psychiatry and Euthanasia: RANZCP Section of Consultation-Liaison Psychiatry's Working Group on Euthanasia’ (1996) 4(6) Australasian Psychiatry 307. 12 See L Willmott, B White, C Stackpoole, K Purser and A McGee, ‘(Failed) Voluntary Euthanasia Law Reform in Australia: Trends, Models and Politics’ (2016) 39(1) University of New South Wales Law Journal 1; Australian Human Rights Commission, Euthanasia, Human Rights and the Law, Issues Paper, May 2016 https://humanrights. gov.au/our-work/age-discrimination/publications/euthanasia-human-rights-and-law#fn122.

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conditions precedent to exercising the relevant VE power or benefiting from the granted legal and disciplinary immunity (the safeguards are discussed further below); 4. Conscientious objections: a conscientious objections clause enables medical practitioners and institutions to decline to administer VE; 5. Avoidances: miscellaneous provisions to prevent contingency clauses in contracts, wills, insurance, and annuities from adversely affecting the person’s entitlements on the basis of a request for VE; and 6. Oversight: various mechanisms are established for systematic oversight of the regime, for example a commission or committee that reviews deaths and/or reporting to parliament about how the legislation is being used. Some bills only operated if the patient suffered from a terminal illness, or even the ‘terminal phase’ of a terminal illness, while others adopted a broader conceptualisation of the illnesses, including, for example, incurable and other chronic illnesses. The bills that have been tabled over more recent years have come close to passing the relevant parliamentary chamber (or chambers) where they have been tabled and are indicative of the level of ambivalence within the Australian community about the legislative initiatives.These bills include the Victorian bill that ultimately became law; the Death with Dignity Bill 2016 (SA), which was defeated by one vote in the House of Assembly (with the Speaker’s casting vote against the bill); and the Voluntary Assisted Dying Bill 2017 (NSW), which was also defeated by a single vote in the legislative council.At the Commonwealth level, the Restoring Territory Rights (Assisted Suicide Legislation) Bill 2015, a bill designed to allow territories to legislate on VAD, was defeated in the senate by two votes in August 2018. An independent upper house member has introduced the End-of-Life Choices (Voluntary Assisted Dying) Bill 2020 (Tas)13 into the Tasmanian parliament. In New Zealand, the End of Life Choice Bill 2019 (NZ) was passed by the national parliament and was then the subject of a vote in favour of its implementation in a referendum held in October 2020.

The Victorian initiative On 19 June 2019, the Voluntary Assisted Dying Act 2017 (Vic) came into force. Its genesis lay in a 2016 report to the legislative council of the Victorian parliament by the parliament’s Legal and Social Issues Committee14 which received 1,037 submissions, 925 from individuals in a private capacity and 112 from organisations.The key findings of the report were that • • •

As a society, we are hesitant to talk about death, which is considered a taboo subject.This inhibits planning for end-of-life care, and may result in a person’s end-of-life wishes not being followed. Although most people in Victoria wish to die at home, in reality most of them will die in hospital. Demand for palliative care is steadily increasing, and is expected to continue to do so. At the same time, the diseases and needs of palliative care patients have increased in complexity. As such,Victoria’s palliative care sector is overburdened and needs better support from government.

13 www.parliament.tas.gov.au/lc/gaffney/EOL.pdf accessed 11 November 2020. 14 Inquiry into End of Life Choices: Final Report www.parliament.vic.gov.au/file_uploads/LSIC_pF3XBb2L.pdf accessed 11 November 2020.

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• • • • •

• • • • •

Despite Victoria having good palliative care services available, those who could benefit the most, often receive care too late. Carers and the volunteer workforce are integral to Victoria’s palliative care system. Although the advance care planning process has proven benefits, there are low awareness and implementation rates for advance care plans in Victoria and Australia. Existing end-of-life care legislation is confusing in many ways, and causes uncertainty, particularly for health practitioners. The legal framework for advance care planning spans several statutory provisions and some legal issues may rely on common law rulings. Substitute decision-making provisions are confusing and poorly understood by doctors. In addition, the law does not provide certainty that a person’s wishes detailed in an advance care plan will be carried out when they lose capacity. Prohibition of assisted dying is causing some people great pain and suffering. It is also leading some to end their lives prematurely and in distressing ways. Instances of assisted dying are rare, even in jurisdictions where it is legal.Assistance in dying is, in the vast majority of cases, provided to people in what would otherwise be the final weeks of their lives. Government support and funding of palliative care have not declined when assisted dying frameworks have been introduced. Courts invariably impose lenient penalties without jail time on people who assist a loved one to end their life.This is true in Australia and in similar overseas jurisdictions. Everyone’s end-of-life care needs differ. It is important that Victoria has a system in place to cater for the needs of individuals, whilst ensuring that there are safeguards in place to protect vulnerable people.

The committee recommended that the Victorian government introduce a legislated framework for voluntary assisted dying and also develop a holistic, evidence-based, interdisciplinary framework for palliative care services.The government accepted 44 of the report’s 49 recommendations15 and established a Ministerial Advisory Panel to provide advice on implementation issues. It provided its report in July 201716 and shortly afterwards legislation was introduced into and passed by both houses of the Victorian parliament. The Victorian regime is avowedly conservative and contains 68 safeguards directed towards giving the community confidence that the legislation will not be abused.17 A person is able to access voluntary assisted dying if (a) The person has made a first request; and (b) The person has been assessed as eligible for access to voluntary assisted dying by (i) The co-ordinating medical practitioner for the person; and (ii) A consulting medical practitioner for the person;

15 Government Response to the Legal and Social Issues Committee Inquiry into End of Life Choices Final Report (8 December 2016) www.health.vic.gov.au/about/legislation/voluntary-assisted-dying-bill/end-of-life-choices accessed 11 November 2020. 16 Ministerial Advisory Panel on Voluntary Assisted Dying, Final Report (July 2017) www.google.com/url?sa=t&rct =j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwjI2JLgwPfmAhWlwzgGHcB9CHYQFjAAegQIAhAC &url=https%3A%2F%2Fwww2.health.vic.gov.au%2FApi%2Fdownloadmedia%2F%257BA27EEE2F-02DE-44 BF-8347-C901CF20B7E5%257D&usg=AOvVaw3_nBorqc9RG9BJhWerVL9r accessed 11 November 2020. 17 See J Rutherford,‘Doctors and the Voluntary Assisted Dying Act 2017 (Vic): Knowledge and General Perspectives’ (2020) 27 Journal of Law and Medicine 952.

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(c) (d) (e) (f)

The person has made a written declaration; and The person has made a final request to the co-ordinating medical practitioner; and The person has appointed a contact person; and The co-ordinating medical practitioner has certified in a final review form that the request and assessment process has been completed as required by this act; and (g) The person is the subject of a voluntary assisted dying permit.18 ‘Voluntary assisted dying’ is defined to mean ‘the administration of a voluntary assisted dying substance and includes steps reasonably related to such administration.’19 The capacity of a person to participate in the regime is closely regulated. It is provided that a person has decision-making capacity in relation to voluntary assisted dying if the person is able to (a) Understand the information relevant to the decision relating to access to voluntary assisted dying and the effect of the decision; and (b) Retain that information to the extent necessary to make the decision; and (c) Use or weigh that information as part of the process of making the decision; and (d) Communicate the decision and the person’s views and needs as to the decision in some way, including by speech, gestures, or other means.20 For these purposes, a person is presumed to have decision-making capacity unless there is evidence to the contrary and is taken to understand information relevant to a decision if the person understands an explanation of the information given to the person in a way that is appropriate to their circumstances, whether by using modified language, visual aids, or any other means.21 In determining whether or not a person has decision-making capacity, it is required that regard be had to the following: (a) A person may have decision-making capacity to make some decisions and not others; (b) If a person does not have decision-making capacity to make a particular decision, it may be temporary and not permanent; (c) It should not be assumed that a person does not have decision-making capacity to make a decision: (i) On the basis of the person’s appearance; or (ii) Because the person makes a decision that is, in the opinion of others, unwise; (d) A person has decision-making capacity to make a decision if it is possible for the person to make a decision with practicable and appropriate support.22 A registered health practitioner who has a conscientious objection to voluntary assisted dying has the right to refuse to (a) Provide information about voluntary assisted dying;

18 19 20 21 22

Voluntary Assisted Dying Act 2017 (Vic), s6. ibid s3. ibid s4(1). ibid s3(2)–(3). ibid s4(4).

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(b) (c) (d) (e) (f)

Participate in the request and assessment process; Apply for a voluntary assisted dying permit; Supply, prescribe, or administer a voluntary assisted dying substance; Be present at the time of administration of a voluntary assisted dying substance; and Dispense a prescription for a voluntary assisted dying substance.23

For a person to be eligible for access to voluntary assisted dying: (a) They must be aged 18 years or more; and (b) They must: (i) Be an Australian citizen or permanent resident; and (ii) Be ordinarily resident in Victoria; and (iii) At the time of making a first request, have been ordinarily resident in Victoria for at least 12 months; and (c) They must have decision-making capacity in relation to voluntary assisted dying; and (d) They must be diagnosed with a disease, illness, or medical condition that (i) Is incurable; and (ii) Is advanced, progressive, and will cause death; and (iii) Is expected to cause death within weeks or months, not exceeding six months; and (iv) Is causing suffering to the person that cannot be relieved in a manner that the person considers tolerable.24 If the person is diagnosed with a disease, illness, or medical condition that is neurodegenerative, that disease, illness, or medical condition must be expected to cause death within weeks or months, not exceeding 12 months.25 Access to voluntary assisted dying is predicated upon a series of requests by the patient, and assessments, declarations, and reviews by the assessing and co-ordinating medical practitioner. The medical practitioner is obliged to apply for either a self-administration permit for the patient or a practitioner administration permit, the latter requiring additional administrative steps. Controversy remains about whether the Victorian legislation is achieving its stated goals, with some contending that the legislation fails to adequately respect patients’ autonomy, to alleviate human suffering, and to facilitate open discussions about end-of-life issues,26 while others argue that the legislation risks eroding the culture of care amongst health practitioners and creating a risk that patients will feel under pressure to avail themselves of voluntary assisted dying.Another issue under the legislation is its complexity with a requirement for at least three formal requests for voluntary assisted dying and four when it is a health practitioner who will administer the substance causing death.As White et al. have observed: A process that is described as rigorous could be experienced as onerous … This may complicate, or even frustrate, the policy goals of respecting autonomy and alleviating

23 24 25 26

ibid s7. ibid s9(1). ibid s9(4). See B White, K Del Villar, E Close and L Wilmott, ‘Does the Voluntary Assisted Dying Act 2017 (Vic) Reflect its Stated Policy Goals?’ (2020) 43(2) University of New South Wales Law Journal 23; see also C Johnston and J Cameron,‘Discussing Voluntary Assisted Dying’ (2018) 26(2) Journal of Law and Medicine 454.

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suffering by precluding, or at least delaying, eligible persons’ access to VAD.These persons – who by definition must be suffering and generally be expected to die within six months – may find the process overwhelming and too difficult to navigate and consequently choose not to proceed.27 Others have argued that the legislation is too restrictive and contains too many checks and balances, thereby depriving persons of meaningful access to dying with dignity who do not have the requisite terminal illnesses, or who have a comorbid psychiatric condition, or who cannot locate medical practitioners who will assist them, or who are under the age of 18 years. A significant percentage of palliative medicine doctors have expressed concern about the impact on their specialty flowing from the implementation of VAD.28 Others have questioned the prioritisation of self-administration, with some arguing that this unreasonably inhibits patient autonomy. Issues of access to the legislation, particularly those living outside the metropolitan area of Melbourne, remain.29 A difficult aspect of the regime is the preclusion under section 8 on a registered health practitioner initiating discussion with a person ‘that is in substance about voluntary assisted dying’ or in substance suggests voluntary assisted dying to the person. Platt30 has lambasted the limitation as ‘significantly paternalistic’ and asserted that it creates an unreasonable impediment to a discussion taking place on the subject between a doctor and a patient unless the patient unequivocally and expressly initiates it. The Victorian legislation came into force on 19 June 2019. From that date until 30 June 2020, 201 people were approved for a self-administration permit and 30 for a practitioner administration permit. Medications were dispensed for self-administration to 154 patients. Medication was self-administered by 104 patients and was administered to 20 patients.31 Thus, the first observation that must be made is that, in spite of the notoriety of the legislation and the degree of community engagement in its passage, only a very modest number of people availed themselves of its options in the first months of its operation.This constitutes something of a contrast to the much more significant uptake of the Canadian legislation.32 A Melbourne oncologist who sits on the board of Dying with Dignity and has assisted a significant number of patients to obtain permits, has asserted that the biggest red-tape hurdle to many of his patients has been in identifying a specialist doctor who has undertaken the mandatory assisted dying training.33 In particular, there has been a shortage of haematologists who have undertaken the required training although 365 doctors had completed the training by the end of 2019, a third of them based in regional Victoria.

27 B White, K Del Villar, E Close and L Wilmott, ‘Does the Voluntary Assisted Dying Act 2017 (Vic) Reflect its Stated Policy Goals?’ (2020) 43(2) University of New South Wales Law Journal 23 at 32. 28 Rutherford (n 17). 29 See BP White, L Willmott and E Close,‘Victoria’s Voluntary Assisted Dying Law: Clinical Implementation as the Next Challenge’ (2019) 210(5) Medical Journal of Australia 1. 30 H Platt,‘The Voluntary Assisted Dying Law in Victoria – A Good First Step but Many Problems Remain’ (2020) 27 Journal of Law and Medicine 535. 31 Voluntary Assisted Dying Review Board, Report of Operations January–June 2020 https://apo.org.au/sites/ default/files/resource-files/2020-09/apo-nid308083.pdf accessed 11 November 2020. 32 See Government of Canada, Fourth Interim Report on Medical Assisted Dying in Canada, www.canada.ca/en/health -canada/services/publications/health-system-services/medical-assistance-dying-interim-report-april-2019.html accessed 11 November 2020. 33 M Cunningham, ‘Five Applications to Die Lodged Each Week Under State’s Euthanasia Laws’ (26 December 2019) The Age www.theage.com.au/national/victoria/five-applications-to-die-lodged-each-week-under-state-s -euthanasia-laws-20191226-p53mxr.html accessed 11 November 2020.

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A potential check and balance on the legislation is the Voluntary Assisted Dying Review Board which (under section 93), amongst other things, has the function of monitoring matters related to voluntary assisted dying in Victoria, reviewing functions and powers under the act, promoting compliance with the act, and referring any issues it identifies to relevant persons, including the chief commissioner of police and the state coroner. Thus, the role of the board is not itself to investigate compliance with the act but, where it encounters anomalies, to refer them to other entities for follow-up. As yet, the board has not publicly released any analysis of the categories of patients who have sought or obtained permits, nor of those who have self-administered a substance to bring about their death, or have received a health practitioner’s assistance to do so. It has stated that it has identified potential ways to improve the operation of the voluntary assisted dying process and updated the resources available to health professionals and those people wanting to access it.These insights were gained from case reviews, evidence, feedback from individuals, medical practitioners and nominated contact people, as well as letters from the Victorian public. We share what we learn with DHHS and other agencies involved to improve the ongoing operation of the Act.34 However, its analysis of these issues has not been made public, rendering public evaluation of the operation of the legislation and the effectiveness of the board as an oversighting mechanism very difficult.

The Western Australian initiative The Western Australian government established a voluntary assisted dying ministerial panel which published its final report in 2019.35 It recommended a voluntary assisted dying regime and that to access such a scheme a person should have to meet all of the following eligibility criteria: 1. Be an adult, aged 18 years or over; and 2. Be an Australian citizen or permanent resident and have been ordinarily resident in Western Australia for 12 months at the time of making the request; and 3. Have decision-making capacity in relation to a decision about voluntary assisted dying; and 4. Be diagnosed with an eligible condition, where an eligible condition is an illness, disease, or medical condition that a. Is advanced, progressive, and will cause death; and b. Is causing suffering to the person that cannot be relieved in a manner the person considers tolerable; and 5. Death is reasonably foreseeable for the person within a period of 12 months.

34 Voluntary Assisted Dying Review Board, Report of Operations, June to December 2019 (2020) www.bettersafer care.vic.gov.au/sites/default/files/2020-02/VADRB_Report%20of%20operations%202019-2020.pdf accessed 11 November 2020. 35 Ministerial Expert Panel on Voluntary Assisted Dying, Final Report (2019) www.health.wa.gov.au/~/media/ Files/Corporate/general%20documents/Voluntary%20assisted%20dying/PDF/voluntary-assisted-dying-final-r eport.pdf accessed 11 November 2020.

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It also proposed a residency requirement but that the State Administrative Tribunal be able to dispense with this in exceptional circumstances on compassionate grounds. On 10 December 2019, the Voluntary Assisted Dying Bill 2019 (WA) was passed by the Western Australian parliament. It has most features in common with the Victorian legislation, but some distinctive characteristics.There will be an 18-month implementation period led by the Department of Health.The key features of the Western Australian voluntary assisted dying scheme, as ultimately enacted, are as follows.To access voluntary assisted dying, a person must be independently assessed as eligible by two medical practitioners: the co-ordinating practitioner and the consulting practitioner.36 These medical practitioners must meet certain requirements and have undergone mandatory training. They may also refer the person for additional assessments if required. During the process, the person must make three separate requests for voluntary assisted dying: a first request, a written declaration, and a final request.The written declaration must be witnessed by two people (who meet specific requirements). The eligibility requirements require that the person is diagnosed with at least one disease, illness, or medical condition that (i) Is advanced, progressive, and will cause death; and (ii) Will, on the balance of probabilities, cause death within a period of six months or, in the case of a disease, illness, or medical condition that is neurodegenerative, within a period of 12 months; and (iii) Is causing suffering to the person that cannot be relieved in a manner that the person considers tolerable.37 Voluntary assisted dying may be through self-administration or practitioner administration of the voluntary assisted dying substance – this is a decision made in consultation with the coordinating medical practitioner. If self-administration, the person must appoint a contact person who has designated responsibilities, including return of any unused substance. If practitioner administration this may be done by a medical practitioner or by a nurse practitioner (who meet nominated requirements). The death certificate must not include any reference to voluntary assisted dying. Throughout the process, the person must be informed of many different aspects relating to voluntary assisted dying, as well as their treatment and palliative care options. Fundamental to the process is that it remains voluntary and free from coercion. The person can withdraw or revoke their involvement at any stage. Health practitioners are also able to refuse to participate in voluntary assisted dying for any reason (including conscientious objection). Healthcare workers must not initiate discussion about, or suggest, voluntary assisted dying to a person to whom they are providing health or professional care services. However, an exception to this is medical practitioners or nurse practitioners if, at the same time, they also inform the person about treatment and palliative care options available to them and the likely outcomes of that care and treatment. The legislation was controversial, with the head of the Australian Medical Association in Western Australia, Dr Miller, contending that it was vital that state spending on palliative care be

36 Voluntary Assisted Dying Act 2019 (WA), s15. 37 ibid s16(1)(c).

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substantially increased as part of the initiatives:‘Palliative care is a human right.There must be a significant increase in funding for proper palliative care as part of the debate over VAD.’38 In the biggest ever survey conducted among Western Australian doctors, more than 1,500 expressed concerns about the legislation placed before parliament.39 The survey demonstrated that a large majority of doctors believed that at least one of the two doctors involved in the VAD process should be an up-to-date specialist in the area of the patient’s disease, in Victoria; while 91% agreed that some groups of doctors should be exempt from all responsibilities to perform acts under the VAD bill, such as doctors in training, administrators, or those who are never involved in end-of-life care. Of the doctors surveyed, 78% believed there should be a permit approval process before accessing VAD, as is the case in Victoria; while 55% believed a referral to a psychiatrist for mental health and/or capacity assessment should be mandatory before accessing VAD. Large majorities also expressed concern about the proposed legislation when it came to the storage of VAD substances at home and what time should elapse before a patient should be reassessed; while 90% of doctors surveyed wanted measures that would prevent euthanasia business models that generated large profits.

Queensland developments In May 2020, with a state election scheduled for October, the Queensland premier, Annastacia Palaszczuk, rejected a recommendation from the government’s health committee that voluntary assisted dying be debated in parliament following an inquiry which had extended over the better part of a year.40 Instead, although the committee had drafted a bill as part of its report, she proposed to refer the issue of voluntary assisted dying to the Queensland Law Reform Commission, which would report some six months after the election. The committee received nearly 5,000 submissions and recommended that the government implement legislation based largely on the Victorian model, limited to persons aged 18 years or older who are ordinarily resident in Queensland. It proposed that eligibility for access require a person to have been diagnosed by a medical practitioner as having an advanced and progressive terminal, chronic, or neurodegenerative medical condition that cannot be alleviated in a manner acceptable to the person, and that the condition will cause death. It recommended that a voluntary assisted dying scheme not incorporate precise time frames for a person’s anticipated date of death with which voluntary assisted dying could be accessed due to ‘the complex, subjective and unpredictable nature of the prognosis of terminal illness.’41 The committee recommended that a person not be rendered ineligible only because the person has a mental health condition, provided that they have decision-making capacity, and proposed a review body similar to that existing in Victoria. By November 2020 the law Reform Commission had published a legal framework consultative document.42

38 AMA Western Australia,‘Changes to Voluntary Assisted Dying Bill Vital’ (8 October 2019) www.amawa.com.au/ news/changes-to-voluntary-assisted-dying-bill-vital/. 39 ibid. 40 Queensland Parliament, Health, Communities, Disability Services and Domestic and Family Violence Prevention Committee,Voluntary Assisted Dying, Report No 34, March 2020 www.parliament.qld.gov.au/Documents/Tabl eOffice/TabledPapers/2020/5620T490.pdf accessed 11 November 2020. 41 ibid, recommendation No 5. 42 Queensland Law Reform Commission, A Legal Framework for Voluntary Assisted Dying, WP No 79 (November 2020) https://www.qlrc.qld.gov.au/__data/assets/pdf_file/0003/658506/qlrc-wp-79-2020.pdf (accessed 7 March 2021).

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The New Zealand initiative New Zealand has seen significant attempts to reform its legislative preclusions on physicianassisted suicide. In the aftermath of the Northern Territory’s legislation, a private member of parliament, Michael Laws, joined forces with a fellow parliamentarian, Cam Campion, who was then terminally ill with cancer, and together they promoted the Death with Dignity Bill 1995. Mr Campion’s plight generated considerable sympathy. The bill was proposed to come into force only after a national referendum to be held at the time of the 1996 general election. The bill was voted down (not to be introduced into the House and sent to a select committee) by 61:29. In 2003, the deputy leader of the New Zealand Party, Peter Brown, introduced the Death with Dignity Bill 2003 (NZ). It was very similar to the earlier proposed legislation: it would have allowed persons with a terminal illness or who were incurably ill to request a medically qualified person to end their lives in a ‘humane and dignified way – and to provide for that to occur after medical confirmation, a psychiatric assessment, counselling and personal reflection.’ The bill did not proceed after first reading on 30 July 2003 following a personal vote of 60:58 with one abstention. The Labour MP, Maryan Street, introduced an End of Life Choice Bill in July 2012 but withdrew it as a general election was approaching and she was concerned that it would not receive the analysis it deserved.At the request of the Labour leader, she did not reintroduce the bill after the 2014 election. The role of a dying human rights lawyer, Lecretia Seales, ultimately proved integral to the impetus towards dying with dignity legislation in New Zealand.43 Ms Seales (1973–2015) was diagnosed at the age of 38 with a brain tumour. She received brain surgery, chemotherapy, and radiotherapy to little avail and placed a case before the New Zealand High Court seeking a declaration that her general practitioner could lawfully assist her to terminate her life by administering a fatal drug with her consent or providing to her such a drug in the knowledge of how she would use it.44 She also sought declarations that the homicide and aiding and abetting provisions in the Crimes Act 1961 (NZ) were incompatible with the ‘right not to be deprived of life’ and the right not to be ‘subjected to cruel, degrading, or disproportionately severe treatment’ under Articles 8 and 9 of the New Zealand Bill of Rights Act 1990 (NZBORA). Her case was heard by Collins J, one of New Zealand’s leading medical lawyers.45 The decisions of the Supreme Court of Canada in Carter v Canada46 and of Fabricius J in Stransham-Ford v Minister of Justice and Correctional Services47 were urged upon Collins J as persuasive precedents. He accepted that palliative care cannot necessarily provide relief from suffering in all cases and that Ms Seales’

43 See A Geddis and C Gavaghan,‘Aid in Dying in New Zealand: Recent Legal Developments’ (2016) 23 Journal of Law and Medicine 849; J Young and A Geddis,‘Vox Populi,Vox Dei? Previewing New Zealand’s Public Decision in Assisted Dying’ (2020) 27 Journal of Law and Medicine (in press). 44 See G Gillett, ‘Lecretia Seales and Aid in Dying in New Zealand’ (2015) 23 Journal of Law and Medicine 308; I Freckelton, ‘Medically Assisted Suicide: Recent Jurisprudence and the Challenges for Law Reform’ (2016) 23 Journal of Law and Medicine 735. 45 Seales v Attorney-General [2015] 3 NZLR 556; [2015] NZHC 1239. 46 [2015] SCC 5. 47 [2015] 3 All SA 109, later overturned by the Supreme Court of Appeal in Minister of Justice and Correctional Services v Estate Late James Stransham-Ford [2017] 1 All SA 354; 2017 (3) SA 152 (SCA).

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perception of her pain was ‘unimpeachable’48 and that her circumstances were such that palliative care may not ameliorate her physical pain or her psychological and emotional suffering.49 Collins J concluded that Ms Seales’ case engaged four human rights principles: sanctity of life; respect for human dignity; respect of individual autonomy; and protection of the vulnerable. He found that Ms Seales would commit suicide if she took a fatal drug supplied to her by her doctor and die from it – thus her doctor could be convicted of assisting her suicide. However, he found that New Zealand’s legislative framework was relevantly different from that in Canada and declined to conclude that the Crimes Act overreached its objective in its provisions precluding the provision of assistance in suicide. He also found the objective of its provisions to be proportionate because it achieved its ‘fair objective of protecting all life.The connection between the impact of the law and its object are within the norms accepted in New Zealand society.’50 He noted that the Canadian Supreme Court in Carter v Canada and the European Court of Human Rights had concluded that persons in the circumstances of Ms Seales were not subjected to ‘treatment’ because they were unable lawfully to enlist the services of others to assist them end their own lives. He pointedly emphasised: By focusing upon the law it may appear that I am indifferent to Ms Seales’ plight. Nothing could be further from the truth. I fully acknowledge that the consequences of the law against assisting suicide as it currently stands are extremely distressing for Ms Seales and that she is suffering because that law does not accommodate her right to dignity and personal autonomy.51 In the aftermath of Lecretia Seales’ loss in court and death a short time later, her husband maintained her advocacy by publishing in 2016: Lecretia’s Choice: A Story of Love, Death and Law.52 Lecretia became the public face of New Zealand’s dying with dignity campaign that flowered in the End of Life Choice Bill which was passed in November 2019 and received Royal Assent on 16 November 2019.A poll in 2019 suggested that 72% of New Zealanders supported some form of assisted dying.53 Moreover, shortly after the high court’s decision a petition was presented to parliament requesting that ‘the House of Representatives investigate fully public attitudes towards the introduction of legislation which would permit medically-assisted dying in the event of a terminal illness or an irreversible condition which makes life unbearable.’The petition was referred to the parliament’s Health Committee which received 21,981 written submissions. The End of Life Choice Bill 2019 (NZ) was introduced into parliament by David Seymour, a man of Maori descent on his mother’s side, and leader of ACT New Zealand, a right-wing neoliberal party. Its explanatory note stated that it proposed to give ‘people with a terminal illness or a grievous and irremediable medical condition the option of requesting assisted dying.’

48 49 50 51 52 53

Seales v Attorney-General [2015] 3 NZLR 556; [2015] NZHC 1239 at [38]. ibid at [47]–[48]. ibid at [190]. ibid [192]. M Vickers, Lecretia’s Choice:A Story of Love, Death and Law (Text Publishing 2016). See M Sherman and A Whyte, ‘Strong Support for Legalising Euthanasia in 1 NEWS Colmar Brunton Poll, as MPs Set to Thrash Out Details’ (30 July 2019) 1 News www.tvnz.co.nz/one-news/new-zealand/strong-support -legalising-euthanasia-in-1-news-colmar-brunton-poll-mps-set-thrash-details accessed 11 November 2020. See also J Young and A Geddis,‘Vox Populi,Vox Dei? Previewing New Zealand’s Public Decision in Assisted Dying’ (2020) 27 Journal of Law and Medicine 937.

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It passed its first and second readings, the latter in June 2019 by a vote of 70:50.The outcome of the vote was that at the 2020 national election there would be a referendum on the issue,54 together with a second referendum on the legalisation of recreational cannabis. Section 4 of the act defines ‘assisted dying’ as (a) The administration by an attending medical practitioner or an attending nurse practitioner of medication to the person to relieve the person’s suffering by hastening death; or (b) The self-administration by the person of medication to relieve their suffering by hastening death. It provides that a person who is eligible for assisted dying must be a New Zealand citizen or permanent resident of 18 years or older who • • • •

Suffers from a terminal illness that is likely to end the person’s life within six months; and Is in an advanced state of irreversible decline in physical capability; and Experiences unbearable suffering that cannot be relieved in a manner that the person considers tolerable; and Is competent to make an informed decision about assisted dying. (section 5(1))

A person is not ineligible for assisted dying by reason only that the person is suffering from any form of mental disorder or mental illness; or has a disability of any kind; or is of advanced age (section 5(2)). A person is stipulated to be competent to make an informed decision about assisted dying if they are able to • • • •

Understand information about the nature of assisted dying that is relevant to the decision; and Retain that information to the extent necessary to make the decision; and Use or weigh that information as part of the process of making the decision; and Communicate the decision in some way. (section 6)

A health practitioner is stated not to be under any obligation to assist a person who wishes to exercise the option of receiving assisted dying if they have a conscientious objection to providing the assistance (section 8(1)). As in Victoria, a health practitioner who provides any health service to a person must not, in the course of providing that service to the person: (a) Initiate any discussion with the person that, in substance, is about assisted dying under this act; or (b) Make any suggestion to the person that, in substance, is a suggestion that the person exercise the option of receiving assisted dying under this act. (section 10(1)) A person seeking assistance in dying must inform the attending medical practitioner of their wish, who, in turn, must give the person information about the prognosis for their terminal illness, the irreversible nature of assisted dying, and the anticipated impacts of assisted dying (sec-

54 New Zealand Government, ‘End of Life Choice Referendum’ www.referendums.govt.nz/endoflifechoice/ index.html?gclid=Cj0KCQjwuJz3BRDTARIsAMg-HxUSzZEBqxptWMEWJcLXSsBv1-vcwDzmQrmnqs7 6mFXQ5cUx3v-kSYIaAlgzEALw_wcB.

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tion 11(2)(a)). The minister is obliged to appoint an end-of-life review committee, consisting of a medical ethicist and two health practitioners, one of whom must practice in the area, to consider assisted death reports; to report to the registrar (assisted dying) (see section 27) whether it considers that the information contained in an assisted death report shows satisfactory compliance with the requirements of the act; and to direct the registrar to follow up on any information contained in an assisted death report that the review committee considers does not show satisfactory compliance with the requirements of the act (section 26(1)–(2)). On 17 October 2020, New Zealanders voted in a binding referendum (at the same time as their national election) to determine whether the End of Life Choice Act 2019 (NZ) should come into force. Lively debate preceded the vote with diverse views being expressed.The disability rights commissioner, Paula Tesoriero, opposed the legalisation of dying with dignity, maintaining that it undermined years of work to change the perception of New Zealanders with disabilities.55 Hospice New Zealand also raised reservations about the proposed change to the law56 and took action in the high court to seek declarations in respect of the ramifications of the legislation. It was partially successful and obtained the following declaratory relief: (a) The End of Life Choice Act does not require hospices or other organisations to provide assisted dying services.They are entitled to choose not to provide these services.This does not depend on a hospice or other organisation having a conscientious objection, although that may often be the reason, and allowing hospices or other organisations not to offer assisted dying services is consistent with the right to freedom of conscience under section 13 of NZBORA. (b) Hospices or other organisations that choose not to offer assisted dying services may employ or engage health practitioners on the basis that these services are not provided by the hospices or organisations, but it will also be necessary to have arrangements for how health practitioners can comply with their objections under the End of Life Choice Act if a request is made of them by a person in the hospice or organisation’s care. (c) The End of Life Choice Act does not exclude the operation of the code, except to the extent that it is expressly overridden by the act or cannot apply alongside the requirements of the act. (d) The End of Life Choice Act does not exclude the professional obligations of health practitioners as set out by the Medical Council and the Nursing Council. Health practitioners required to take steps under the End of Life Choice Act may only do so if they have the competence to do so in accordance with their professional standards.The ‘attending medical practitioner’ is the patient’s medical practitioner, whose scope of practice permits them to provide the services required of them under the act and who has the necessary competence to provide those services. (e) The right to conscientiously object encompasses its usual meaning in medical practice. It will encompass when a doctor or nurse holds a deeply felt belief that it is wrong for them to provide the assistance for personal, moral reasons, internal to them.57

55 See L Walters,‘Disability Rights Commissioner Opposes Assisted Dying Bill’ (7 March 2018) Stuff www.stuff.co .nz/national/politics/102046196/disability-rights-commissioner-opposes-assisted-dying-bill?rm=a accessed 11 November 2020. 56 Hospice New Zealand, ‘End of Life Choice Act’ www.hospice.org.nz/resources/end-of-life-choice-act-our -concerns/high-court-action-by-hospice-nz/ accessed 11 November 2020. 57 Hospice New Zealand v Attorney-General [2020] NZHC 1356 at [214] per Mallon J.

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Ultimately, the vote in favour of legalising assisted dying was emphatic with 65.1% of New Zealand voters supporting the change to the law.58 The result is that the legislation will come into force on 6 November 2021.

Conclusion It is apparent that recent years have seen a groundswell of public support in Australia and New Zealand in favour of voluntary assisted dying. However, the issues relating to legislation authorising the lawful administration of a substance prescribed by a medical practitioner to enable death to take place remain contentious within both the general community and the medical profession. Ensuring well-funded palliative care services which in many scenarios will reduce the need for such legislative options is increasingly being recognised as important. The legislative initiatives in Australia and New Zealand, commencing with the Voluntary Assisted Dying Act 2017 (Vic), have been highly conservative by international standards. The movement towards such reforms to the law has been gradualist and tentative, as exemplified by the institution of a referendum in New Zealand even after parliamentary passage of legislation, and by the deferral of a vote on legislation until after a state election in Queensland. In addition, the legislation passed and prefigured throughout Australia and New Zealand is particularly demanding in terms of eligibility criteria and is characterised by the incorporation of multiple checks and balances.This has gone a considerable way towards alleviating community concern and towards neutralising opposition from professional associations representing doctors, nurses, and pharmacists.An outcome has been only a very modest uptake of the voluntary assisted dying option over the early period of its availability in Victoria. The legislative schemes in Australia and New Zealand have incorporated confinement of eligibility for voluntary assisted dying to adults resident in the relevant jurisdiction (to prevent death tourism59), persons with a terminal condition likely to lead to death within a relatively short time frame, a requirement that a concomitant of the condition is suffering that is unendurable to them, and requiring clear indicia of capacity to provide informed consent. In most jurisdictions, constraints have been imposed upon health practitioners raising the subject of voluntary assisted dying with patients in an effort to avoid the imposition of pressure or perceptions that pressure is being exerted or encouragement given to patients to end their lives. As in other countries, the legislation already passed and likely to be passed will require close evaluation to determine whether it is achieving its objective of allowing patients to make their own decisions to end their suffering at a time and in circumstances that they choose. Oversighting committees and boards internationally have had only modest levels of success in making the voluntary assisted dying processes accountable.60 However, the role, powers, and transparency of external and independent reviews of deaths taking place under voluntary assisted dying regimes are perhaps the most important checks and balances over the legislation.

58 Electoral Commission of New Zealand,‘Referendum Results’ (6 November 2020) www.electionresults.govt.nz /electionresults_2020/referendums-results.html accessed 11 November 2020. 59 See C Yu, J Wen and F Meng, ‘Defining Physician Assisted Suicide Tourism and Travel’ (2020) 44(4) Journal of Hospitality and Tourism Research 694; DS Miller and C Gonzalez,‘When Death if the Destination:The Business of Death Tourism – Despite Legal and Social Implications’ (2013) 7(3) International Journal of Culture Tourism and Hospitality Research 293. 60 See I Freckelton, ‘Assisted Dying: Learning from the International Experience’ in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (Federation Press 2017) 511–533.

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Assessment of diffuse effects upon the doctor–patient relationship and upon whether the legislative provisions are being deployed inappropriately, including whether patients are experiencing subtle forms of pressure to bring their lives to an end, will not be easy. Nor will it be straightforward to evaluate whether checks and balances are succeeding in achieving their objectives. High-quality, rigorous research (including comparative research) evaluating the legislative regimes, their implementation, and how they are perceived both within the general community and amongst health practitioners will be very important. For those jurisdictions in Australia and New Zealand which have recently implemented such schemes, international experience demonstrates that there will be ongoing debate about contentious issues under the threshold and procedural aspects of the legislative provisions.These will include the criteria for eligibility to the schemes, preclusions on doctors raising the topic with their patients, how capacity to take assisted dying decisions is to be measured, the extent of the disentitling role of mental illness, and whether persons younger than 18 should be allowed to utilise the provisions. The Australian and New Zealand dying with dignity schemes that have enabled self-initiated and physician-assisted dying for persons with terminal illnesses will function, amongst other things, as socio-medical laboratories for the human rights issues that are involved.The three legislative reforms in Victoria,Western Australia, and New Zealand have achieved popular acceptance by avowedly being conservative options. Undoubtedly, they will evolve on the basis of data, experience, and ongoing changes in community attitudes. Experience gained in their implementation will constitute a useful component in the international corpus of information that will enable comparative evaluation of physician-assisted dying, side by side with the schemes in Europe, Canada, the United States, and Colombia. At their heart are conceptualisations of the relevant human rights.Analysis of how these are affected by the legislative reforms should lie at the heart of whether the Australian and New Zealand initiatives are emulated internationally.

References AMA Western Australia, ‘Changes to Voluntary Assisted Dying Bill Vital’ (8 October 2019) www.amawa. com.au/news/changes-to-voluntary-assisted-dying-bill-vital/. Ashby, M,‘Hard Cases, Causation and Care of the Dying’ (1995) 3 Journal of Law and Medicine 152. Buchanan, J,‘Euthanasia:The Medical and Psychological Issues’ (1995) 3 Journal of Law and Medicine 161. Australian Human Rights Commission, Euthanasia, Human Rights and the Law, Issues Paper, May 2016 https://humanrights.gov.au/our-work/age-discrimination/publications/euthanasia-human-rights-and -law#fn122. Bartels, L and Otlowski, M, ‘A Right to Die? Euthanasia in Australia’ (2010) 17 Journal of Law and Medicine 532. Bauer, C, ‘Dignity in Choice: A Terminally Ill Patient’s Right to Choose’ (2018) 44(3) Mitchell Hamline Law Review 1025. Cunningham, M,‘Five Applications to Die Lodged Each Week Under State’s Euthanasia Laws’ The Age (26 December 2019) www.theage.com.au/national/victoria/five-applications-to-die-lodged-each-week -under-state-s-euthanasia-laws-20191226-p53mxr.html accessed 11 November 2020. Electoral Commission of New Zealand, ‘Referendum Results’ (6 November 2020) www.electionresults. govt.nz/electionresults_2020/referendums-results.html accessed 11 November 2020. Fleming, JI,‘Death, Dying, and Euthanasia:Australia Versus the Northern Territory’ (2000) 15(3) Issues Law Medicine 291. Freckelton, I,‘Patients’ Decisions to Die:The Emerging Australian Jurisprudence’ (2011) 18 Journal of Law and Medicine 427. Freckelton, I, ‘Medically Assisted Suicide: Recent Jurisprudence and the Challenges for Law Reform’ (2016) 23 Journal of Law and Medicine 735. Freckelton, I,‘Assisted Dying: Learning from the International Experience’ in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (Federation Press 2017).

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Voluntary assisted dying law reform Fuller, N, ‘ACT Should Have Right to Vote on Euthanasia Politicians Argue’ (5 March 2021) Canberra Weekly https://canberraweekly.com.au/act-should-have-right-to-vote-on-euthanasia-politicians-argue/. Geddis, A and Gavaghan, C, ‘Aid in Dying in New Zealand: Recent Legal Developments’ (2016) 23 Journal of Law and Medicine 849. Gillett, G, ‘Ethical Aspects of the Northern Territory Euthanasia Legislation’ (1995) 3 Journal of Law and Medicine 145. Gillett, G,‘Lecretia Seales and Aid in Dying in New Zealand’ (2015) 23 Journal of Law and Medicine 308. Government of Canada, Fourth Interim Report on Medical Assisted Dying in Canada www.canada.ca/en/hea lth-canada/services/publications/health-system-services/medical-assistance-dying-interim-report-apri l-2019.html accessed 11 November 2020. Government Response to the Legal and Social Issues Committee Inquiry into End of Life Choices Final Report (8 December 2016) www.health.vic.gov.au/about/legislation/voluntary-assisted-dying-bill/ end-of-life-choices accessed 11 November 2020. Hospice New Zealand, ‘End of Life Choice Act’ www.hospice.org.nz/resources/end-of-life-choice-act -our-concerns/high-court-action-by-hospice-nz/ accessed 11 November 2020. Inquiry into End of Life Choices: Final Report www.parliament.vic.gov.au/file_uploads/LSIC_pF3XBb 2L.pdf accessed 11 November 2020. Johnston, C and Cameron, J, ‘Discussing Voluntary Assisted Dying’ (2018) 26(2) Journal of Law and Medicine 454. Kuhse, H and Singer, P, ‘Active Voluntary Euthanasia, Morality and the Law’ (1995) 3 Journal of Law and Medicine 129. Mendelson, D,‘The Northern Territory’s Euthanasia Legislation in Historical Perspective’ (1995) 3 Journal of Law and Medicine 136. Miller, DS and Gonzalez, C, “When Death is the Destination: The Business of Death Tourism – Despite Legal and Social Implications’ (2013) 7(3) International Journal of Culture, Tourism, and Hospitality Research 293. Milns, S, ‘Death, Dignity and Discrimination:The Case of Pretty v United Kingdom’ (2002) 3(10) German Law Journal E4. Ministerial Advisory Panel on Voluntary Assisted Dying, Final Report (July 2017) www.google.com/url ?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwjI2JLgwPfmAhWlwzgGHcB9CH YQFjAAegQIAhAC&url=https%3A%2F%2Fwww2.health.vic.gov.au%2FApi%2Fdownloadmedi a%2F%257BA27EEE2F-02DE-44BF-8347-C901CF20B7E5%257D&usg=AOvVaw3_nBorqc9R G9BJhWerVL9r accessed 11 November 2020. Ministerial Expert Panel on Voluntary Assisted Dying, Final Report (2019) www.health.wa.gov.au/~/me dia/Files/Corporate/general%20documents/Voluntary%20assisted%20dying/PDF/voluntary-assisted -dying-final-report.pdf accessed 11 November 2020. Mullen, PE, ‘Euthanasia: An Impoverished Construction of Life and Death’ (1995) 3 Journal of Law and Medicine 121. Nalley, S,‘Euthanasia – The Right to Choose’ (2003) 1 Essai Article 28. New Zealand Government, ‘End of Life Choice Referendum’ www.referendums.govt.nz/endoflifech oice/index.html?gclid=Cj0KCQjwuJz3BRDTARIsAMg-HxUSzZEBqxptWMEWJcLXSsBv1-vcw DzmQrmnqs76mFXQ5cUx3v-kSYIaAlgzEALw:wcB. Nitschke, P (with Corris, P), Damned If I Do (Melbourne University Press 2013). Otlowski, M, Voluntary Euthanasia and the Common Law (Clarendon Press 1997). Platt, H,‘The Voluntary Assisted Dying Law in Victoria – A Good First Step but Many Problems Remain’ (2020) 27 Journal of Law and Medicine 535. Queensland Law Reform Commission, A Legal Framework for Voluntary Assisted Dying, WP No 79 (November 2020) https://www.qlrc.qld.gov.au/__data/assets/pdf_file/0003/658506/qlrcwp-79-2020.pdf (accessed 7 March 2021). Queensland Parliament, Health, Communities, Disability Services and Domestic and Family Violence Prevention Committee, Voluntary Assisted Dying, Report No 34, March 2020 www.parliament. qld.gov.au/Documents/TableOffice/TabledPapers/2020/5620T490.pdf accessed 11 November 2020. Quirk, P,‘Euthanasia in the Commonwealth of Australia’ (1998) 13(4) Issues Law Medicine 425. Williams, G, ‘Voluntary Euthanasia Legislation: Practicalities of the Northern Territory’s Rights of the Terminally Ill Act of 1995’ (1996) 9(3) Australian Critical Care 92.

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Ian Freckelton Ranson, D, ‘The Coroner and the Rights of the Terminally Ill Act 1995 (NT)’ (1995) 3 Journal of Law and Medicine 19. Rutherford, J, ‘Doctors and the Voluntary Assisted Dying Act 2017 (Vic): Knowledge and General Perspectives’ (2020) 27 Journal of Law and Medicine 952. Ryan, C,‘Australasian Psychiatry and Euthanasia: RANZCP Section of Consultation-Liaison Psychiatry’s Working Group on Euthanasia’ (1996) 4(6) Australasian Psychiatry 307. Sherman, M and Whyte, A, ‘Strong Support for Legalising Euthanasia in 1 NEWS Colmar Brunton Poll, as MPs Set to Thrash Out Details’ (News, 30 July 2019) 1 www.tvnz.co.nz/one-news/new-zealand/ strong-support-legalising-euthanasia-in-1-news-colmar-brunton-poll-mps-set-thrash-details accessed 11 November 2020. Syme, R, ‘Necessity to Palliate Pain and Suffering as a Defence to Medical Homicide’ (2009) 17 Journal of Law and Medicine 439. Voluntary Assisted Dying Review Board, Report of Operations, June to December 2019 (2020) 9 www .bettersafercare.vic.gov.au/sites/default/files/2020-02/VADRB_Report%20of%20operations%20201 9-2020.pdf accessed 11 November 2020. Voluntary Assisted Dying Review Board, Report of Operations January–June 2020 https://apo.org.au/s ites/default/files/resource-files/2020-09/apo-nid308083.pdf accessed 11 November 2020. Walters, L,‘Disability Rights Commissioner Opposes Assisted Dying Bill’ (Stuff, 7 March 2018) www.stuff. co.nz/national/politics/102046196/disability-rights-commissioner-opposes-assisted-dying-bill?rm=a accessed 11 November 2020. White, B, Del Villar, K, Close, E and Wilmott, L,‘Does the Voluntary Assisted Dying Act 2017 (Vic) Reflect its Stated Policy Goals?’ (2020) 43(2) University of New South Wales Law Journal 23. White, B,Willmott, L and Close, E, ‘Victoria’s Voluntary Assisted Dying Law: Clinical Implementation as the Next Challenge’ (2019) 210(5) Medical Journal of Australia 1. White, B,Willmott, L, Close, E and Downie, J,‘Withholding and Withdrawing Potentially Life-Sustaining Treatment:Who Should Decide?’ in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (Federation Press 2017). White, B, et al.,‘The Role of Law in Decisions to Withhold and Withdraw Life-Sustaining Treatment from Adults Who Lack Capacity:A Cross-Sectional Study’ (2016) 43 Journal of Medical Ethics 327. Willmott, L,White, B, Stackpoole, C, Purser, K and McGee,A,‘(Failed) Voluntary Euthanasia Law Reform in Australia:Trends, Models and Politics’ (2016) 39(1) University of New South Wales Law Journal 1. Young, J and Geddis, A, ‘Vox Populi, Vox Dei? Previewing New Zealand’s Public Decision in Assisted Dying’ (2020) 27 Journal of Law and Medicine (in press). Yu, C,Wen, J and Meng, F,‘Defining Physician Assisted Suicide Tourism and Travel’ (2020) 44(4) Journal of Hospitality and Tourism Research 694. Zdenkowski, G, ‘Human Rights and Euthanasia’ Occasional Paper of the Australian Human Rights and Equal Opportunity Commission (December 1996) www.humanrights.gov.au/sites/default/files/co ntent/pdf/human_rights/euthanasia.pdf.

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21 COMPARATIVE PERSPECTIVES ON MEDICAL AID IN DYING The United States and Canada Barbara A Reich

The United States and Canada share a border, but there are stark differences in the two countries’ healthcare systems and cultural attitudes towards ethically complex medical practices. A country’s health insurance system speaks volumes about how its culture prioritises egalitarian access to healthcare. And access to healthcare is indisputably one important constituent piece of life, liberty, and the security of the person.1 Within the broader context of health and human rights, it is interesting to consider whether and how a country’s culture also impacts practices and laws relating to controversial medical practices such as voluntary euthanasia and other forms of medical aid in dying (MAiD). This chapter will review the autonomy and human rights underpinnings of these practices as they are available and utilised in the United States and Canada, and will consider how cultural differences affect the general availability and specific contours of MAiD and euthanasia. The Universal Declaration of Human Rights (UDHR), Article 3, states that ‘Everyone has the right to life, liberty, and security of person.’Article 12 says that ‘No one shall be subjected to arbitrary interference with his privacy.’Article 29(2) states that In the exercise of his rights and freedoms, everyone shall be subject only to such limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society.2 All of these parts of the UDHR are potentially relevant to the ethical principle of patient autonomy which includes the right of patients to receive appropriate care at the end of life that reflects their wishes, promotes dignity, and minimises suffering.

1 Joseph C D’Oronzio, ‘A Human Right to Healthcare Access: Returning to the Origins of the Patients’ Rights Movement’ (2001) 10 Cambridge Quarterly of Healthcare Ethics 285–298. 2 United Nations, Universal Declaration of Human Rights, www.un.org/en/universal-declaration-human-rights/ accessed 18 October 2020.

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As a start, a brief comparison of the two health insurance systems is instructive.The United States spends the most as a percentage of its gross domestic product on healthcare compared with other high-wealth nations,3 though some of this spending is driven by the higher pricing of healthcare goods and services in the United States than elsewhere.Yet, even with all of this spending, not every resident has insurance coverage. Medicare, the universal healthcare entitlement programme in the United States, only provides coverage to individuals aged 65 and over. A number of other federal insurance programmes, including Medicaid and the Veterans Affairs Tricare programme, also cover various populations, but there is no government-sponsored guaranteed coverage of individuals aged 18–64. President Obama’s 2010 Patient Protection and Affordable Care Act (ACA) sought to extend coverage to uninsured individuals via expansion of the Medicaid programme and to make the individual purchase of insurance more affordable. It succeeded in these goals, but not to the point of universal coverage. Just before the ACA went into effect at the end of 2010, over 16% of US residents (49.9 million people) had no health insurance. By 2016, five years in, the ACA had resulted in historic lows in uninsured people, with 10% of Americans aged 18–64 lacking insurance and a total uninsured rate of 8.6% for all Americans. From that point, given the changing priorities of the Republican administration that succeeded President Obama, the trend has been less encouraging. By 2018, 10.4% of individuals who were not yet eligible for Medicare were uninsured, an uptick of almost half a million people compared with 2017. Overall, the ACA has led to significant increases in both Medicaid and private insurance coverage, with almost 20 million more people insured than before,4 yet the United States still has a substantial number of uninsured residents. These relatively improved levels of coverage in the United States pale in comparison to other wealthy countries in which nearly all residents enjoy the benefit of reliable and equitable access to affordable healthcare. In every other high-wealth country, access to healthcare for all residents is considered the responsibility of a just society, not a privilege for the more fortunate.The role of government in ensuring this access is not seriously questioned in countries other than the United States. In Canada, the National Health Insurance programme provides universal coverage and is funded by general taxes.The system is called ‘Medicare,’ but unlike US Medicare, the term refers to a universal coverage system for residents of all ages.The federal government sets and administers national standards for the healthcare system through the Canada Health Act of 1984, and provides funding. Under the Canada Health Act, each province or territory administers its own plan and must provide comprehensive coverage to all residents, but each of the provincial and territorial plans varies.5 Although private insurance coverage for services covered under provincial and territorial plans is illegal, most Canadians purchase private supplementary insurance to cover items and services, such as prescription drugs and dental care, which are not covered under the provincial and territorial plans.6 By making the purchase of private insurance for services covered by Medicare illegal, the Canadian government built in a bulwark against the potential for inequality of healthcare based on wealth.To be sure, many inequalities remain in the system,

3 OECD Statistics, National Center for Health Statistics, www.oecd.org/els/health-systems/health-data.htm accessed 14 October 2020. 4 Kaiser Family Foundation, Jennifer Tolbert et al., ‘Key Facts About the Uninsured Population’, www.kff.org (kkf, 2019). 5 Sara Allin and David Rudoler,‘The Canadian Health Care System’ (Commonwealth Fund) https://international .commonwealthfund.org/countries/canada/ accessed 18 October 2020. 6 Goran Ridic et al., ‘Comparisons of Health Care Systems in the United States, Germany, and Canada’ (2012) 24 Materia Socio Medica 112–120.

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but this provision at least prevents the development of a satellite private-pay system of potentially superior care for those with higher incomes. A country’s health insurance system is not the only influence on access to care and quality of care. In the United States, there are a number of state laws governing medical practice and patients’ rights. Each of the 50 states has implemented its own laws addressing end-of-life care and decision-making, and each state has its own common law addressing these matters. In Canada, there are various provincial and territorial statutes, notably in Ontario7 and British Columbia,8 addressing matters such as informed consent and substitute decision-making for incapacitated patients, along with common law decisions that add to the body of healthcare law. Although major structural reform to end-of-life care poses challenges in any country, the US structure makes reform particularly difficult because of the 50 state governments and the lack of an overarching federal statute or healthcare plan that reaches all patients prior to Medicare eligibility. When discussing MAiD and related practices more specifically, it is important to point out that terminology matters, both because language reflects cultural values, and because the use of the term ‘MAiD’ differs between Canada and the United States. First, it is worth noting that the evolution of the terminology in the literature reflects the development of more nuanced understanding of the practice.What began as ‘physician-assisted suicide’ later evolved to ‘physician aid in dying’ and to the most current terms,‘medical aid in dying’ and ‘medical assistance in dying.’ The term ‘therapeutic dying’ has appeared in the literature but, in the opinion of this author, this is a case where euphemism crosses the line into oxymoron.When public debate about MAiD in the United States began, it was common to see the practice referred to as ‘physician-assisted suicide.’The term ‘assisted suicide’ causes confusion because, under US state laws, even in states where MAiD has been legalised, assisting in a suicide remains a criminal offense. The same is true in Canada – assisting in a suicide remains a crime when it occurs outside the scope of permitted aid in dying by medical professionals. Many of the US state statutes legalising MAiD explicitly distinguish the practice from assisting in a suicide,9 both because only physicians can participate in the practice, and the option is limited to patients who are terminally ill. In Canada, the use of the term ‘medical assistance in dying’ rather than ‘physician assistance’ makes even more sense because Canadian law allows both physicians and nurse practitioners to engage in the practice (except in Québec). In the United States, in states where it is legally permitted, MAiD refers only to a process in which physicians write prescriptions for a lethal dose of medication at the request of a terminally ill patient, who then must himself or herself ingest the medication, usually in liquid form. No state permits a physician to administer a lethal medication to the patient directly, with the patient’s express consent. In the United States and elsewhere, this latter practice is generally referred to as ‘voluntary euthanasia.’ Despite the fact that voluntary euthanasia is illegal in the United States, it does occur.10 Although, as explained below, some commentators may argue that

7 Ontario Health Care Consent Act 1996, www.ontario.ca/laws/statute/96h02 accessed 18 October 2020. 8 British Columbia Health Care (Consent) and Care Facility (Admission) Act, www.bclaws.ca/EPLibraries/bcla ws_new/document/ID/freeside/00_96181_01 accessed 18 October 2020. 9 For example, the Oregon statute states that ‘Nothing in [the Act] shall be construed to authorize a physician or any other person to end a patient’s life by lethal injection, mercy killing or active euthanasia. Actions taken in accordance with [the Act] shall not, for any purpose, constitute suicide, assisted suicide, mercy killing or homicide, under the law.’ Oregon Death with Dignity Act Chapter 127.880. 10 Ezekiel J Emanuel et al., ‘Attitudes and Practices of Euthanasia and Physician-Assisted Suicide in the United States, Canada, and Europe’ (2016) 316(1) Journal of the American Medical Association 79–90.

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the distinctions between assisted dying and euthanasia are mainly semantic, the US law attempts to draw a firm line between the two. By contrast, the term MAiD as used in Canada is a broader term that includes both the self-ingestion option and voluntary euthanasia. The heterogeneity of American culture and the divisiveness of its politics make issues at the intersection of life, death, and medicine particularly challenging. There is no consensus in the United States about the ethical propriety of, for example, the death penalty or abortion at the other end of human life, and it is therefore unsurprising that Americans disagree about MAiD as well. A 2005 Pew Research Center poll illustrates a deep division, finding that 46% of those surveyed supported laws legalising medical aid in dying while 45% opposed such laws.11 More recent polling indicates much stronger support for euthanasia, which remains illegal across the United States, and slightly less but still strong support for MAiD. In a 2018 Gallup poll, a total of 72% of Americans supported the legalisation of euthanasia for terminally ill patients while, somewhat oddly, only 65% of those surveyed believed that physicians should be permitted by law to assist in a dying patient’s suicide.12 For some, the requirement that the patient ingest the medication may be perceived as preferable to euthanasia because it emphasises the volition of the patient, with the physician merely facilitating the patient’s autonomous decision by prescribing the medication whereas, in voluntary euthanasia, the physician may be perceived as the prime mover in ending the patient’s life. For others, the act of or even the word ‘suicide’ may be viewed as more troubling than a direct intervention from a physician to end a patient’s suffering at that patient’s request.When asked about the morality of both practices, support fell, with only 54% of those surveyed saying that physician-assisted suicide is morally acceptable.13 This polling data thus indicates that some Americans, at least, are reluctant to outlaw a practice, even when they believe it is morally wrong, which is consistent with the general ambivalence that many may experience regarding these end-of-life practices. Polling data in Canada demonstrates consistently high support for broad access to MAiD, with a recent poll finding that 86% of Canadians support the practice.14 As the discussion that follows illustrates, both Canada and the United States continue to struggle with ethical and implementation questions subsequent to the legalisation of MAiD. The public discourse in the United States on these matters sometimes does little to advance the debate, in part because some of those opposed to MAiD do not fully understand the details of the laws which they find objectionable. Even those who are well informed about the law, however, express valid concerns about its implementation and its effects on patient care and the physician–patient relationship. A comparative review of MAiD legislation in the United States and Canada through the lens of each country’s culture reveals some commonalities and some striking differences.

11 Pew Research Center for the People and the Press, ‘More Americans Discussing and Planning End-of-Life Treatment: Strong Public Support for Right to Die’ (Pew Research Center, 5 January 2006) www.people-press .org/2006/01/05/strong-public-support-for-right-to-die/ accessed 18 October 2020. 12 Megan Brenan, ‘Americans’ Strong Support for Euthanasia Persists’ (Gallup, 31 May 2018) https://news.gallup. com/poll/235145/americans-strong-support-euthanasia-persists.aspx. 13 ibid. 14 Jim Bronskill, ‘Majority of Canadians Surveyed Support Broader Assisted Dying Law: Leger Poll’ (Global News, Canadian Press, 23 February 2020) https://globalnews.ca/news/6454314/leger-survey-assisted-dying-law/ accessed 14 October 2020.

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Legal status in the United States In order to understand the complexities of the MAiD debate in the United States, it is necessary to become familiar with several different layers of legal and ethical influence, including federal constitutional law, state law, and the underlying ethical arguments. At the federal level, the US Supreme Court has declined to find a constitutional right to medical aid in dying. In two companion cases decided in 1997, the Court considered constitutional challenges to the validity of state laws forbidding ‘assisted suicide’ which were interpreted to include MAiD. In its opinions, the Court concluded that neither the Equal Protection Clause nor the Due Process Clause of the Fourteenth Amendment guarantees the right of physician assistance in ending a patient’s life.15 Moreover, the Court opined that the complexity of ethical issues made the question of MAiD more appropriate for consideration by state legislatures.16 The US Supreme Court also recognised a constitutionally protected right to palliative care.A majority of the justices opined that it would be unconstitutional for any state to interfere with access to effective palliative care, especially pain relief, at the end of life.This additional language was surprising, because it was unnecessary to resolve the questions before the Court, but it has played a significant role in building support for palliative care, including the liberal use of pain medications, at the end of life.17 Criminal law does not recognise consent as a defence to homicide, so physicians who participate in assisted dying can only do so and be safe from prosecution in states where there is an explicit exception to laws that otherwise prohibit assisting suicide.To this end, several states took up the Supreme Court’s invitation to address the question via legislation.The first state to permit MAiD was Oregon, which enacted the Death with Dignity Act18 via voter referendum in 1994 (before the Supreme Court had even decided the companion cases), although legal challenges prevented its implementation until 1997.19 The Oregon law generated enormous controversy and was challenged by a variety of groups including persons with disabilities. In many states, the implementation of new MAiD legislation is challenged by physician and disability rights groups, claiming that the practice is inconsistent with the role of the physician as healer and expressing concern about potential abuse of the practice with disabled patients, but none of these challenges has so far succeeded in invalidating legislation.20 The federal government also stepped in to interfere with the implementation of the law, enacting the ‘Assisted Suicide Prevention Restriction Act of 1997’ which forbade any federal funding to support MAiD.21 The law therefore prohibits Medicare, Medicaid, and other federal programmes from paying for MAiD – i.e. the physician care and the drugs themselves. Patients must instead rely on state funding, private insurance, or must pay out of pocket. The US Department of Justice (DOJ) also attempted to prevent the implementation of the law

15 The relevant part of the Fourteenth Amendment to the US Constitution provides: ‘No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.’ 16 Washington v Glucksberg, 521 US 702 (1997); Vacco v Quill, 521 US 793 (1997). 17 Robert A Burt,‘The Supreme Court Speaks: Not Assisted Suicide But a Constitutional Right to Palliative Care’ (1997) 337 New England Journal of Medicine 1234. 18 Or Rev Stat §§ 127.800–127.897. 19 Lee v Oregon, 107 F3d 1382 (9th Cir 1997) (denying challenges to the Oregon law by various groups based on lack of standing). 20 Alan Meisel et al., The Right to Die (3rd ed, 2020) §12.06[B]. 21 HR 1003; 105th Congress (1997–1998), PL No 105-12.

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by threatening to revoke the license to prescribe controlled substances of any physician who participated in MAiD under the Oregon law. The attorney general at the time, John Ashcroft (who was, interestingly, the former governor of Missouri at the time of the Nancy Cruzan litigation), adopted the position that the use of controlled substances for aid in dying was not a legitimate medical purpose.The legal challenge to this position and planned DOJ enforcement action succeeded with the US Supreme Court ultimately ruling in favour of the Oregon law.22 Federal efforts to invalidate MAiD laws have continued periodically but none of these efforts has succeeded. As of this writing, MAiD has been legalised via statute in nine states and the District of Columbia. It is permitted by statute in the following jurisdictions: California, Colorado, District of Columbia, Hawai’i, Maine, New Jersey, Oregon,Vermont, and Washington. Interestingly, all of these jurisdictions are coastal; as of now (2021), with the exception of Colorado, there is no statutorily authorised MAiD in any of the interior states, including the Deep South and the Midwest.This pattern of legalisation appears to reflect the political and cultural leanings of the states in question – states on the East and West coasts of the United States tend to lean liberal while southern and interior states are mainly (though not entirely) more conservative. In addition, the state of Montana now permits MAiD, although the recognition of a right to physician aid in dying in that state, and the related protection of physicians from prosecution, arose via a different legal mechanism – a state Supreme Court decision. In the original lawsuit, Robert Baxter, a terminally ill resident of Montana, several physicians, and the public interest group Compassion and Choices, asked the state court to recognise a right to medical aid in dying.They based the request on Montana’s constitution, which includes provisions recognising individual dignity and the right to privacy. Although the state’s attorney argued that no such interest existed in the constitution, the lower court agreed that the constitutional provisions were written broadly enough to encompass a right to die with dignity, including with the aid of a physician. It further concluded that physicians who provided such assistance would not be subject to criminal charges or actions against their license to practice medicine.23 On appeal, the state’s Supreme Court held that it was unnecessary to reach the constitutional question as the state’s public policy did not forbid medical aid in dying for terminally ill, mentally competent adults.24 Finding ‘no indication in Montana statutes that physician aid in dying is against public policy,’ the Montana Supreme Court added that, because the terminally ill patient initiates the request for the lethal medication, and because state law does not forbid suicide, such requests are consistent with the public policy and statutes of Montana that promote a patient’s right to die as they wish.As the court explained, Montana’s Terminally Ill Act confers on terminally ill patients a right to have their end-of-life wishes followed, even if it requires direct participation by a physician through withdrawing or withholding treatment. …Nothing in the statute indicates it is against public policy to honor those same wishes when the patient is conscious and able to vocalise and carry out the decision himself with self-administered medicine and no immediate or direct physician assistance.25

22 Gonzales v Oregon, 546 US 243 (2006). 23 Memorandum and Order, Montana First Judicial District Court (5 December 2008) https://compassionandchoi ces.org/wp-content/uploads/2018/06/081205-Decision-and-Order-wm.pdf. 24 Baxter v Montana, 2009 MT 449. 25 ibid (emphasis supplied by author).

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Note that the Court’s language carefully limits the physician’s role to supplying medication for a patient to ingest – voluntary euthanasia is not permitted in the United States. Since the state Supreme Court’s decision, the issue of MAiD – both its ethical and legal status – remains the subject of serious controversy in the state,26 with several bills submitted to the state legislature to ban the practice.The Court’s interpretation of the relevant end-of-life statutes remains valid for now and physicians can, if they choose, honour a terminally ill, competent patient’s request for lethal medication without fear of criminal prosecution. The Oregon law is reasonably representative of the other state laws and, in fact, served as the model on which most of the statutes are based.The procedural safeguards are daunting – commentators have noted that the legislation in the various states is ‘so carefully crafted, so narrowly drawn, and so laden with procedural safeguards that it may well demand more energy and fortitude to comply with it than some terminally ill people are likely to have.’27 Oregon’s Death with Dignity Act allows a narrowly defined category of patients to request a prescription for lethal medication from their physician in order to hasten death.To be eligible under the law, the patient must (1) be an adult aged 18 or older; (2) have decisional capacity, defined as ‘the ability to make and communicate health care decisions to providers’; (3) be a resident of Oregon; and (4) have a terminal disease, defined as ‘an incurable and irreversible disease that has been medically confirmed and will, within reasonable medical judgment, produce death within six months.’28 In addition to the preliminary eligibility requirements, Oregon’s Death with Dignity Act requires that the patient make an oral request and a written request in a form specified by the statute and witnessed by at least two individuals who can attest that the patient is signing voluntarily. At least one of the witnesses must be a person who is not a relative, a legatee under the patient’s will, or an owner or employee of the healthcare facility treating the patient.After a waiting period of at least 15 days after the initial request, the patient must restate the oral request to his or her physician.29 The patient’s attending physician is required, among other things, to refer the patient to another physician for confirmation of the prognosis and of the patient’s decisional capacity. Naturally, the patient must also receive information about the effect of taking the medication, and has the right to rescind the request at any time.30 Finally, the law requires physicians to inform patients about alternative palliative care options.31 All of the states’ MAiD laws contain varying safeguards to ensure that the patient requesting assistance in dying is not suffering from depression that impairs judgement. In Oregon and other states, the physician must also refer the patient for counselling if there is any evidence of a psychiatric or psychological disorder, including depression, that might impair the patient’s judgement or ability to make voluntary decisions.32 Hawai’i has taken further steps to ensure that the patient’s decision is not impacted by severe depression or other psychological problems. In Hawai’i, when a patient makes a request for MAiD, the statute requires that the patient be assessed by a licensed mental health professional to ensure that the patient has decisional capacity and is not suffering from depression or other psychological conditions that might impair

26 John Robinson, ‘Baxter and the Return of Physician-Assisted Suicide’ (2010) 40 Hastings Center Rep 15–17 (2010). 27 Alan Meisel et al., The Right to Die (3rd ed 2020) §12.06[A]. 28 Oregon Revised Statute § 127.805. 29 Oregon Revised Statute § 127.840. 30 Oregon Revised Statute §§ 127.815; 127.845. 31 ibid § 127.815. 32 ibid § 127.825.

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judgement.33 It is worth noting that, because Montana’s pathway to legalisation does not involve legislation, physicians in that state who provide lethal medication to patients do not have to follow the procedural and substantive safeguards required by the rest of the states. Washington was the second state to legalise medical aid in dying, enacting a statute very similar to Oregon’s Death with Dignity Act. The Washington law arose from a voter ballot initiative in 2008, and was codified and became effective in 2009.34 As with the Oregon statute, Washington’s Death with Dignity Act applies only to eligible adults who are terminally ill, have decisional capacity, and make the requisite oral and written requests.The statute, like Oregon’s act, requires physicians to inform requesting patients of available palliative options, including hospice care and pain control.35 From the initial legislative actions in these two states, the rest of the jurisdictions followed, some as recently as 2019, and it appears that the idea of legalising MAiD has gained significant momentum in recent years. Legislation to legalise the practice is currently under consideration in well over a dozen other states.36

Legal status in Canada MAiD is now expressly permitted throughout Canada. After a judge in British Columbia concluded that the Canadian Criminal Code’s prohibition of assisted suicide violated the Canadian Charter of Rights and Freedoms,37 the Carter v Canada case was appealed to the Supreme Court of Canada. That court unanimously concluded that the law banning assisted suicide violates section 7 of the charter, which states:‘Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice.’38 The supreme court concluded that the prohibition, as applied to competent adults who consent to the termination of life and have a ‘grievous and irremediable medical condition (including an illness, disease, or disability) that causes enduring suffering that is intolerable to the individual’ was inconsistent with section 7.39 This 2012 decision is obviously very different from the US Supreme Court’s 1997 refusal to recognise inconsistency between the criminal statute against assisting a suicide, and the protections of the Due Process and Equal Protection clauses. On the basis of its interpretation of the charter’s language, the court declared that the relevant provision of the criminal code was invalid. Section 241 of the Canadian Criminal Code states (1) Everyone is guilty of an indictable offence and liable to imprisonment for a term of not more than 14 years who, whether suicide ensues or not (a) counsels a person to die by suicide or abets a person in dying by suicide; or (b) aids a person to die by suicide.40

33 Haw Laws 2018,Act 2 §§1, 6. 34 Washington State Department of Health, Death with Dignity Act www.doh.wa.gov/YouandYourFamily/Illnessa ndDisease/DeathwithDignityAct accessed 14 October 2020. 35 Revised Code of Washington 70.245. 36 Compassion and Choices,‘In Your State’, https://compassionandchoices.org/take-action/in-your-state/ accessed 14 October 2020. 37 Carter v Canada (Attorney General), 2012 BCSC 886. 38 Canadian Charter of Rights and Freedoms, section 7, https://laws-lois.justice.gc.ca/eng/const/page-15.html accessed 18 October 2020. 39 Carter v Canada [2015] 1 SCR 33. 40 Canadian Criminal Code, RSC 1985 § 241.

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The court’s declaration of the invalidity of this section was suspended for a year in order to allow the federal, provincial, and territorial governments to revise their laws accordingly. Two additional extensions were also granted to allow provinces and territories further time to adapt their laws to the holding of the case. The Canadian federal government was left with a weighty task and a number of unanswered questions: Should the legislation make access to MAiD broader than what the Supreme Court of Canada envisioned? What procedural safeguards would be appropriate and what sort of oversight system should exist to track the use of MAiD? How should the right of patients under the charter be reconciled with physicians’ rights to refuse to participate on the basis of conscience? What should be the impact of this new right on access to palliative care or on the existing right to withholding and withdrawing life-prolonging treatment?41 The process by which new legislation was adopted reflects careful deliberation and included significant opportunity for various stakeholders to participate in the legislative process. Professional organisations, including the Provincial and Territorial Colleges of Physicians and Surgeons, have also developed their own guidelines for the provision of MAiD. In response to the supreme court decision, the federal criminal code was amended to provide a legal process for assistance in dying. In the summer of 2015, the federal government appointed an Expert Panel on Options for a Legislative Response. The reports of other expert panels and committees followed.42 The current version of the federal criminal code, section 241, has the following additional provision: ‘Exemption for medical assistance in dying (2) No medical practitioner or nurse practitioner commits an offence under paragraph (1)(b) if they provide a person with medical assistance in dying in accordance with section 241.2.’The revised code also contains exemptions from liability for those aiding the medical practitioner, for pharmacists dispensing drugs, for persons aiding patients to self-administer drugs, and various professionals who provide information about MAiD to patients.43 In the federal criminal code, the term ‘medical assistance in dying’ includes both voluntary euthanasia and prescribing or providing a medication that will enable the patient to end his or her life via self-ingestion.44

MAiD in the United States and Canada: a comparative overview of provisions The MAiD legislation in US jurisdictions and in Canada differs in multiple significant dimensions.This brief overview highlights several differences, but does not provide a complete discussion of similarities and differences. In addition to the general statutory features mentioned above, the statutes legalising MAiD in various US jurisdictions share several common features: • •

Patients must be ‘terminally ill’ which is defined as having a survival prognosis of six months or less.The medical opinion must be confirmed by another physician. Only a physician may prescribe medication to end a patient’s life.

41 Jocelyn Downie,‘After Carter v. Canada’ (National Magazine, 24 February 2015) Available at SSRN: https://ssrn .com/abstract=2670834 accessed 14 October 2020. 42 For a detailed picture of the process by which the new legislation was developed and the public participation in the details of the law and implementing legislation in the territories and provinces, see Martha Butler and Marlisa Tiedemann, Carter v. Canada:The Supreme Court of Canada’s Decision on Assisted Dying (Pub No 2015-47-E, Library of Parliament, 29 December 2015). 43 Canadian Criminal Code, section 241(4), (5), (5.1). 44 Canadian Criminal Code, section 241.1.

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• •

Voluntary euthanasia is not permitted; patients must be able to ingest the medication independently. US statutes provide for a 15-day waiting period between the time of the patient’s request for the medication and the time that the prescription is written.

The Canadian criminal statute includes the following features (with variations in the Québec legislation noted): •

• • • •

Patients must have a ‘grievous medical condition’ which is defined as meeting all of the following criteria: (a) they have a serious and incurable illness, disease, or disability; (b) they are in an advanced state of irreversible decline in capability; (c) that illness, disease, or disability or that state of decline causes them to endure physical or psychological suffering that is intolerable to them and that cannot be relieved under conditions that they consider acceptable; and (d) their natural death has become reasonably foreseeable, taking into account all of their medical circumstances, without a prognosis necessarily having been made as to the specific length of time that they have remaining.The medical opinion must be confirmed by another physician or nurse practitioner (and only by another physician in Québec). Pending legislation would remove the requirement of ‘reasonable foreseeability’ of the patient’s death.45 Physicians and nurse practitioners may prescribe medication to end a patient’s life (with the exception of Québec, which only allows physician prescribers). Patients may elect either voluntary euthanasia or to ingest the medication independently (with the exception of Québec, which only allows voluntary euthanasia). The original legislation required a 10-day waiting time between the patient’s signed request and the day on which the medical assistance in dying is provided.This provision would be revised to require instead that patients give a ‘final consent’ just prior to receiving MAiD. The new legislation would create two tracks – one for patients whose deaths are reasonably foreseeable and another, with additional safeguards for patients whose natural deaths are not reasonably foreseeable.46

The US statutes require a finding that the patient is terminally ill with a predicted survival of six months or less, and this prognosis must be verified by another physician. By contrast, the qualification for MAiD in Canada is both more detailed and more open-ended.At no point does the statute require a specific survival prognosis of six months or less; currently, physicians must only verify that the patient’s ‘natural death has become reasonably foreseeable’ (and this provision may be revised as explained above).Although it is often challenging to estimate prognosis accurately and

45 At the time of this writing, the Canadian federal government was working to revise the statute to remove the requirement that the patient’s death be ‘reasonably foreseeable’ and is considering the removal of other statutory safeguards. Department of Justice, ‘Proposed Changes to Canada’s Medical Assistance in Dying Legislation’ (Department of Justice, 2020) www.justice.gc.ca/eng/csj-sjc/pl/ad-am/index.html accessed 18 October 2020. The government of Québec recently revised its MAiD laws to be more consistent with those in the rest of the country. Government of Québec,‘Medical Aid in Dying’, www.quebec.ca/en/health/health-system-and-services /end-of-life-care/medical-aid-in-dying/ accessed 14 October 2020. 46 Department of Justice,‘Proposed Changes to Canada’s Medical Assistance in Dying Legislation’ www.justice.gc. ca/eng/csj-sjc/pl/ad-am/index.html accessed 14 October 2020.

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physicians often overestimate expected survival,47 the current Canadian statute gives more flexibility to physicians in determining that a particular patient is eligible for MAiD. In fact, the statute expressly states that physicians need not estimate how long the patient has to live, a provision that reflects the inherent clinical uncertainty in most prognostic estimates.48 The latest revisions to the statute, as explained above, would also permit MAiD for patients whose natural death is not foreseeable due to their condition, further expanding the range of patients eligible for MAiD. The US statutes and the legislation in Québec limit prescribing to physicians only, rather than permitting other clinicians such as nurse practitioners to prescribe. This has the effect, at least potentially, of limiting access to MAiD in medically underserved areas. On the other hand, restricting the provision of MAiD, in whatever form, to physicians avoids concerns about midlevel providers – that they are less well-trained and may not have the same level of experience and concomitant medical judgement that should, at least in theory, accompany more rigorous education. For those who worry about abuses in MAiD – coercion, non-compliance with the boundaries of which patients qualify, and the like – the restriction to physicians as providers makes good sense.The fact that most of Canada permits both physicians and nurse practitioners to provide MAiD reflects the desire to ensure that the option is readily available to all patients who qualify and who desire it. It may also reflect a level of comfort with the procedure, despite clearly acknowledging its gravity and finality, which does not exist in the United States. The broader definition of MAiD in Canada, which includes both voluntary euthanasia and the self-ingestion option, makes it likely that more patients will be able to elect voluntary euthanasia later in the disease process, when they are perhaps no longer able to manage a glass or straw or to swallow medication. One criticism of the self-ingestion requirement in the US statutes is that it may ‘force’ some patients to take the medication sooner than they might otherwise wish to do so; this is a particular concern for patients with neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS, also known as motor neuron disease). Nearly all Canadian patients who elect MAiD choose voluntary euthanasia over the self-ingestion option.49

Ethical debate: a brief discussion Despite significant differences in legislative approach to MAiD between the United States and Canada, scholars and health policy experts in both the United States and Canada recognise the complexity of the ethical arguments for and against permitting MAiD, however defined. The implementation of MAiD in both countries proceeds against a background of serious debate about the ethical appropriateness of the practice, given the profound implications of ending human life for any reason. There are two essential layers of ethical debate. First, physicians, ethicists, lawyers, and others debate whether it is ever ethically appropriate to hasten a patient’s death with the provision

47 Nicholas A Christakis and Elizabeth B Lamont, ‘Extent and Determinants of Error in Doctors’ Prognoses in Terminally Ill Patients’ (2000) 320 British Medical Journal 469–473 (finding that, in predicting patients’ remaining life expectancies, physicians were correct only 20% of the time and were over-optimistic 63% of the time and concluding that a closer doctor–patient relationship was associated with over-optimistic predictions). 48 Barbara A Noah and René Reich-Graefe, Rational Patient Apathy (2019) 49 Seton Hall Law Review 535, 563– 573 (providing a detailed discussion, with a case example, of the operation and effects of clinical uncertainty on complex medical decision-making). 49 Health Canada, Fourth Interim Report on Medical Assistance in Dying in Canada (2019) www.canada.ca/c ontent/dam/hc-sc/documents/services/publications/health-system-services/medical-assistance-dying-interimreport-april-2019/medical-assistance-dying-interim-report-april-2019-eng.pdf accessed 14 October 2020.

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of lethal medication (either via self-ingestion or voluntary euthanasia).Those who support the practice believe that it is appropriate if the conditions described above are met, i.e. that the patient is terminally ill with limited life expectancy, that the patient has decisional capacity and voluntarily requests the lethal medication, and that the physician has received the requisite requests and documentation and is willing to participate.Those who adopt this view consider carefully regulated access to aid in dying as one of a variety of options available to physicians to alleviate suffering at the end of life, and as an important choice for patients who value autonomy and dignity in their last days. Some argue that such a practice is never appropriate because the physician’s role is always to care for the patient, and hastening a patient’s death suggests giving up on the patient rather than caring for him or her.50 Although physicians have the option of conscientious objection and no physician can be compelled to provide the medication under any of these laws, those of this view believe that it is never appropriate for any physician to hasten a patient’s death in this way.51 The American Medical Association (AMA) has, on this basis, consistently opposed death with dignity initiatives. In a recent survey of American physicians, 58% of those surveyed agreed that MAiD should be made legal.52 In an older survey of AMA member physicians, 69% opposed physician-assisted dying.53 Many physicians who object to the practice also point out that a variety of effective tools are now available to alleviate the suffering of terminally ill patients. Continuous palliative sedation to unconsciousness, for example, provides an option to reduce physical suffering in patients at the very end of life,54 thus rendering MAiD unnecessary (though patients who wish to avoid this degree of suffering will likely disagree). Moreover, modern medicine offers excellent symptom management techniques to manage pain, dyspnoea, nausea, anxiety, and other common causes of patient suffering. Critics of legalising the practice worry that giving patients the option to determine the timing of their own deaths will diminish the quality of the palliative care available to them.This concern has not been borne out in practice, according to data compiled in Oregon and other states which have legalised MAiD. Most of these jurisdictions (but not all) receive high marks for their palliative care programmes.55 In addition to physician objections based on their healing role, policy analysts and ethicists have expressed concern that legalising medical aid in dying will result in either self-imposed or familial pressure on lower-income individuals to take this option in order to avoid additional costs to themselves or to their families. Critics have also questioned whether patients can truly

50 Leon Kass,‘Neither for Love Nor Money:Why Doctors Must Not Kill’ (1989) 94 Public Interest 25–46. 51 Willard Gaylin et al.,‘Doctors Must Not Kill’ (1988) 259 Journal of the American Medical Association 2139–2140 (‘[I]f physicians become killers or are even merely licensed to kill, the procession – and, therewith, each physician – will never again be worthy of trust and respect as healer and comforter and protector of life in all its frailty.’). 52 Keith L Martin,‘Medscape Ethics Report 2018: Life, Death, and Pain’ www.medscape.com/slideshow/2018-eth ics-report-life-death-6011014?faf=1 accessed 14 October 2020. 53 Farr A Curlin et al., ‘To Die, to Sleep: U.S. Physicians’ Religious and Other Objections to Physician-Assisted Suicide,Terminal Sedation, and Withdrawal of Life Support’ (2008) 25 American Journal of Hospice and Palliative Care 112–120. 54 Julian JZ Prokopetz and Lisa Soleymanai Lehmann, ‘Redefining Physicians’ Role in Assisted Dying’ (2012) 367 New England Journal of Medicine 97. For more on palliative sedation as an aggressive measure at the end of life, see Timothy E Quill,‘Dying and Decision Making: Evolution of End-of-Life Options’ (2004) 350 New England Journal of Medicine 2029–2032. 55 The Center to Advance Palliative Care grades all 50 states on the availability of palliative and hospice care. Oregon and Washington states both receive an ‘A’ grade. Center to Advance Palliative Care,‘State-by-State Report Card’ https://reportcard.capc.org/ accessed 14 October 2020.

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make a free and informed choice when they are suffering from a severe illness.56 Others fear a slippery slope that will lead to the inclusion of patients with chronic rather than terminal disease, and more vulnerable groups including patients with intellectual disabilities or dementia and patients with serious physical disabilities.57 From there, the argument goes, it is only a further short slip down the slope to the practice of imposing this option on people who do not wish it, including physically and intellectually disabled individuals.The statistical evidence of 22 years of experience in Oregon should go a long way towards addressing these concerns, but they persist among some in the disability community. Likewise, it should be of some comfort that there has been no effort, either through the legislature or otherwise, to broaden the class of patients for whom the option is available or otherwise to stretch the boundaries of the law as it was originally implemented. In fact, the data from the US states do not suggest that any of the above concerns are valid. In Oregon, based on the accumulated data of over two decades of experience with the Death with Dignity Act, there is no evidence of abuse of the law in the form of coercion of dying patients or overutilisation by patients suffering from serious psychological impairment. Nor has there been an avalanche of medically aided deaths following the law’s implementation. As the latest data from Oregon indicate, the number of patients who utilise this end-of-life option remains low. During the most recent year for which data are available, 290 patients received a prescription after following the law’s requirements. Of these, 188 (including 18 patients who received the medication the previous year) died after taking the medication prescribed under the Oregon act.The data also indicate that a growing number of physicians choose to provide this option for their terminally ill patients. In the most recent report, 112 physicians wrote prescriptions. In the 22 years that the Oregon act has been in effect, physicians have written a total of 2,518 prescriptions and 1,657 patients in total (66%) have taken the medication.58 Overall, in both Oregon and more recently Washington state, only about 1 out of 1,000 deaths are the result of taking the lethal medication permitted under the states’ laws.The vast majority of Oregonians who chose MAiD were above the state average for both income and education levels, and there have been no reported cases of coercion. In the United States, 53% of patients overall who elected MAiD were men.59 Although the data cannot capture all abuses and irregularities (for example, evaluating the quality and thoroughness of a psychiatric evaluation required under the statute in some cases), the overall picture of the law’s implementation is very positive. Although pain control was an important concern for many patients who utilised the assisted dying option, the vast majority of these patients expressed concern about loss of control at the end of life, being forced to live on beyond the point where they found pleasure in life, loss of autonomy, and preservation of dignity.60 For these underlying reasons, many patients indicated that they elected the option because they wished to die at home rather than in hospital. And, each year, a significant number of patients go through the process of requesting the medication but choose not to take it and die instead from their underlying illness, suggesting that the sense of increased control derived from having the option available itself provides a benefit.

56 Kass (n 50). 57 Yale Kamisar,‘Some Non-Religious Views Against Proposed “Mercy Killing”’ (1958) 42 Minnesota Law Review 969; Kass (n 50). 58 Oregon Death with Dignity Act, 2019 Annual Report, www.oregon.gov/oha/PH/PROVIDERPARTN ERRESOURCES/EVALUATIONRESEARCH/DEATHWITHDIGNITYACT/Documents/year22.pdf accessed 14 October 2020. 59 ibid. 60 ibid.

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In Canada, preliminary reports indicate similar patterns of utilisation and no evidence of abuse. The average age of patients receiving MAiD is 72 years, with patients nearly equally divided between men and women, and cancer is the most common underlying medical condition, followed by neurodegenerative diseases. The data suggest that only about 1.12% of the total deaths in Canada resulted from MAiD. Most (93%) medically assisted deaths were provided by physicians rather than nurse practitioners, and these deaths mainly occurred in hospitals and patients’ homes.61 In the United States, a second layer of ethical debate asks whether, if MAiD is ethically acceptable (as well as legal), there is any logical or ethical reason to distinguish between MAiD and voluntary euthanasia (which, unlike in Canada, remains illegal in the United States). Similarly, is there any logical or ethical distinction between withdrawing life-sustaining treatment (which does not involve the administration of a lethal causal agent) and death from ingestion of lethal medication? A thorough answer to these questions is beyond the scope of this chapter, but it is worth acknowledging that MAiD is just one of many options that might be available to a dying patient.62 Other end-of-life options also hasten death. Physicians routinely withhold or withdraw life-sustaining treatment such as ventilator support or dialysis from terminally ill patients, and adhere to do-not-resuscitate orders when patients go into cardiac arrest. Similarly, they respect patients’ decisions to stop eating or drinking and so do not resort to artificial nutrition and hydration. Moreover, palliative sedation, discussed above, is an accepted practice for which there has been no evidence of abuse.63 Despite the fact that deep sedation coupled with the withholding of artificial nutrition and hydration (at the patient’s request or at the request of the patient’s surrogate decision-maker) will certainly and inevitably result in the patient’s death, most commentators agree that it is an ethically appropriate (and legally permitted) measure to manage the otherwise intractable suffering of a dying patient.64 Taken in context with other end-of-life interventions such as these, MAiD is one of a number of options that are available to alleviate suffering at the very end of life – one that is more carefully regulated than many of the other options. Those who defend the practice of MAiD as it is defined in the United States argue that the line between death from the patient’s voluntary ingestion of a lethal medication and voluntary euthanasia is well defined and that state laws which permit medical aid in dying will hold against a slippery slope to voluntary (or coerced) euthanasia. A closer look at this claim suggests that the ethical arguments about the propriety of various end-of-life practices blur the boundaries of these practices – but, so far, the line has held.Although US law in a few states permits MAiD and no state permits voluntary euthanasia, many of the ethical arguments in support of medically assisted dying and other end-of-life practices provide similar support for the practice of voluntary euthanasia. Moreover, other end-of-life practices, such as palliative sedation, have a

61 Health Canada, Fourth Interim Report on Medical Assistance in Dying in Canada (April 2019) www.canada .ca/content/dam/hc-sc/documents/services/publications/health-system-services/medical-assistance-dying-int erim-report-april-2019/medical-assistance-dying-interim-report-april-2019-eng.pdf accessed 14 October 2020. 62 For a thorough treatment of the moral and ethical issues embedded in a range of end-of-life interventions, see David Orentlicher, Matters of Life and Death (Princeton University Press 2001). 63 ibid 49. 64 Bernard Lo and Gordon Rubenfeld, ‘Palliative Sedation in Dying Patients’ (2005) 294 Journal of the American Medical Association 1810–1816.

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similar practical effect – hastening the patient’s death – with far less legal oversight.65 All of these practices nevertheless benefit from clinical criteria and guidelines to assist physicians with decision-making and practice in caring for the dying.66 Among those who support MAiD, some advocate an expansion of the category of patients who can request and receive such assistance, suggesting that more end-of-life choices are always better than fewer. For pragmatic reasons, however, those who believe that there is no ethical difference between a physician’s providing a patient with a lethal dose of medication which the patient then ingests and injecting the patient with a lethal dose of medication should nevertheless recognise that legalising the latter action will be far more problematic than the former. Unless a patient clearly has decisional capacity, the slippery slope concerns described above become arguably more pronounced with voluntary euthanasia because the last, volitional act of the patient no longer exists to serve as a bulwark between the physician’s action and the patient’s wishes. The informed consent of the patient, documented in writing and witnessed (as required by Canadian law), would be an essential safeguard. On the other hand, the selfadministration requirement of the Oregon law and other US MAiD laws impacts the ability of those with degenerative neurological conditions such as ALS to utilise the assisted dying option because these patients may have difficulty swallowing the medication. For this reason, the selfadministration requirement creates, for some patients, the unwelcome choice between taking the medication ‘early,’ before they really wish to end life and risking that they will have to forego the option entirely later. All of these distinctions among various end-of-life options, whether well-defined and ethically distinguishable or not, illuminate the broader and far more important question, which is how physicians can respect the needs and wishes of each individual patient at the end of life. There is, of course, no uniform answer to this question, and it becomes yet more difficult when one considers that physicians have varying moral and religious views about their appropriate role in caring for dying patients and alleviating suffering. Public debate in the United States about MAiD outside the realm of experts tends to reflect a very limited understanding of the applicable laws and their limits and therefore tends to oversimplify the issues. Some citizens argue that more choices or more control at the end of life is always better, while others take the position that it is always wrong to hasten death, commit suicide, or otherwise interfere with nature, or divine will. In fact, there is far more nuance to end-of-life choices than the public generally appreciates (or than physicians necessarily think about explicitly).As both the United States and Canada have learned, legal rules only begin to address (and quite inadequately) the complexity of end-of-life choices. Even so, one might reasonably conclude that regulation of such practices, out in the open, is preferable to unregulated, silently tolerated assisted dying or voluntary euthanasia. One survey suggests that at least 6% of US physicians have complied with requests for assisted suicide or voluntary euthanasia at least once.67 The fact that some physicians are willing to accede to such requests even when not permitted by law is troubling, but unsurprising. Further public debate and legalisation of practices which have the support of citizens and healthcare providers make good sense under the circumstances – it is the only means in a democratic society to allow all voices to be heard, to try to establish some form of consensus and

65 David Orentlicher, ‘The Supreme Court and Physician-Assisted Suicide: Rejecting Assisted Suicide but Embracing Euthanasia’ (1997) 337 New England Journal of Medicine 1236–1239. 66 For example, David Orentlicher et al.,‘Clinical Criteria for Physician Aid in Dying’ (2016) 19 Journal of Palliative Medicine 259–262. 67 Diane E Meier et al., ‘A National Survey of Physician-Assisted Suicide and Euthanasia in the United States’ (1998) 338 New England Journal of Medicine 1193–1201.

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compromise, and to provide terminally ill patients with access to critical end-of-life care that, at least in principle, has the potential to align with their autonomy and dignity as human beings.

Some fnal thoughts and observations The evidence of more than two decades of experience in Oregon and 10 years of data from Washington state suggests that legalised MAiD provides an appropriate and ethically acceptable choice to patients who desire it and who qualify under the narrowly drawn statutory guidelines. Even so, caution is warranted in applying these conclusions to other countries which may not have equivalent access to healthcare and other safeguards for the elderly. No physician is required to participate in the practice if it violates his or her religious beliefs or conscience. In US reports, there is, so far, no evidence of abuse, coercion, or expansion of the practice beyond the legally limited class of patients who are terminally ill and retain decisional capacity. Likewise, there is no evidence of disproportionate utilisation by the poor, uneducated, or uninsured. Palliative care is not always effective and, for some patients, the prospect of being forced to endure terminal illness until the very end when they no longer find meaning or enjoyment in life may be unacceptable.68 For all of these reasons, if the principles of patient autonomy and dignity as reflected in the Universal Declaration of Human Rights, the Canadian Charter of Rights and Freedoms, and the US Constitution are to have their fullest meaning from the perspective of individual patients whose preferences and beliefs vary, carefully legalising limited versions of MAiD seems entirely appropriate. Both the United States and Canada have taken steps to legalise medical aid in dying, and both countries demonstrate a serious commitment to care for dying patients. Perhaps the most striking difference between the two countries is that Canadian MAiD legislation includes an option for voluntary euthanasia – something that seems unlikely to be met with acceptance in the United States, whatever the opinion polls might say.The nationwide legalisation of MAiD in Canada, and the inclusion of voluntary euthanasia within the meaning of that term, reflects a political and legal system that is both structurally capable of sweeping change and culturally willing to, first, adopt public positions and debate compromises and, second, accept such change, albeit with appropriate caution. In the United States, although it is structurally possible to implement a nationwide law permitting MAiD, the path that Canada took – recognising the right to MAiD as protected by the federal constitution – is not likely to happen. The US Supreme Court took up the question in 1997 and found that state statutes that broadly criminalise assistance in a suicide do not offend the Constitution. It is unlikely that the Court will revisit this question, especially in these politically polarised times. And while it is structurally possible for the US Congress to enact a federal law legalising the practice of MAiD in all states, this, too, looks politically unfeasible given the vocal and well-represented presence of conservative religious groups in the United States which oppose the practice. One should never say ‘never’ – it was surprising to see, for example, the nationwide legalisation of same-sex marriage via a US Supreme Court decision after years of conflict over the question and in the context of some states having legalised it.69

68 Lamar W Hankins,‘Is Medical Aid in Dying a Human Right? Another View, Hastings Center Bioethics Forum’ (Hastings Center, 19 December 2019) www.thehastingscenter.org/is-medical-aid-in-dying-as-a-human-right -another-view/ accessed 14 October 2020. 69 The US Supreme Court, in Obergefell v Hodges, 135 S Ct 2584 (2015) held that the right of same-sex couples to marry was protected by both the Due Process clause and the Equal Protection clause of the Fourteenth Amendment. The vote of the nine-member Court was 5:4. On 17 May 2004, Massachusetts became the first

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Challenging ethical questions will always remain in matters of life and death. In Canada, where voluntary euthanasia is legal, scholars and policy experts are facing these questions headon. Can patients with early-stage dementia request euthanasia when they reach a specified point of physical and intellectual deterioration?70 Can a patient refuse unwanted medical care in order to propel himself or herself into a ‘terminal’ condition that would qualify for assistance in dying?71 Although the Canadian statute requires patients to be suffering from an illness that causes ‘enduring physical or ongoing psychological suffering that is intolerable to them’ and whose ‘natural death has become reasonably foreseeable,’ should the option of assisted dying be made available to patients whose sole disease is a psychiatric disorder?72 Canadian health law and policy experts, and the Canadian public, continue to wrestle with these questions, as will American experts and the public, should the expansion of MAiD open the door to broader categories of qualified patients or to practices such as voluntary euthanasia. In the end, the United States is and will likely remain a much more divided nation, politically polarised, and so often paralysed and unable to develop consensus. Even reaching a consensus about the obligation of a responsible federal government to provide appropriate healthcare to all residents, in line with universal human rights, seems out of reach at this moment.Within the broader realm of ‘healthcare,’ care for the dying in the United States does not include access to MAiD for all.The United States does not even offer access to healthcare for all.Whatever any individual patient, physician, or legislator may think about the ethical propriety of MAiD, it remains, for some, a desirable and crucial option, particularly when the best palliative care efforts fall short of providing acceptable symptom relief, or when the patient determines that quality of life has become unacceptable.

References Allin, Sara and Rudoler, David, ‘The Canadian Health Care System’ (Commonwealth Fund) https://in ternational.commonwealthfund.org/countries/canada/ accessed 18 October 2020. Brenan, Megan,‘Americans’ Strong Support for Euthanasia Persists’ (Gallup, 31 May 2018) https://news.ga llup.com/poll/235145/americans-strong-support-euthanasia-persists.aspx. Bronskill, Jim, ‘Majority of Canadians Surveyed Support Broader Assisted Dying Law: Leger Poll’ (Global News, Canadian Press, 23 February 2020) https://globalnews.ca/news/6454314/leger-survey-assisted -dying-law/ accessed 14 October 2020. Burt, Robert A,‘The Supreme Court Speaks: Not Assisted Suicide But a Constitutional Right to Palliative Care’ (1997) 337 New England Journal of Medicine 1234. Center to Advance Palliative Care, ‘State-by-State Report Card’ https://reportcard.capc.org/ accessed 14 October 2020. Christakis, Nicholas A and Lamont, Elizabeth B,‘Extent and Determinants of Error in Doctors’ Prognoses in Terminally Ill Patients’ (2000) 320 British Medical Journal 469–473. Compassion and Choices, ‘In Your State’ https://compassionandchoices.org/take-action/in-your-state/ accessed 14 October 2020.

US state to legalise same-sex marriage in response to a ruling by the Massachusetts Supreme Judicial Court in Goodridge v Dept. of Public Health 798 NE2d 941 (Mass 2003). 70 Jocelyn Downie and Georgia Lloyd-Smith, ‘Assisted Dying for Individuals with Dementia: Challenges for Translating Ethical Positions in Law’ in Michael Cholbi and Jukka Varelius (eds), New Directions in the Ethics of Assisted Suicide and Euthanasia (Springer 2015). 71 Jocelyn Downie and Matthew J. Bowes,‘Refusing Care as a Legal Pathway to Medical Assistance in Dying’ (2019) 2 Canadian Journal of Bioethics 73–82. 72 Scott YH Kim and Trudo Lemmens, ‘Should Assisted Dying for Psychiatric Disorders be Legalized in Canada?’ (2016) 188 Canadian Medical Association Journal E337–E339.

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Barbara A Reich Curlin, Farr A, et al., ‘To Die, to Sleep: U.S. Physicians’ Religious and Other Objections to PhysicianAssisted Suicide, Terminal Sedation, and Withdrawal of Life Support’ (2008) 25 American Journal of Hospice & Palliative Care 112–120. D’Oronzio, Joseph C, ‘A Human Right to Healthcare Access: Returning to the Origins of the Patients’ Rights Movement’ (2001) 10 Cambridge Quarterly of Healthcare Ethics 285–298. Department of Justice,‘Proposed Changes to Canada’s Medical Assistance in Dying Legislation’ (Department of Justice, 2020) www.justice.gc.ca/eng/csj-sjc/pl/ad-am/index.html accessed 18 October 2020. Department of Justice,‘Proposed Changes to Canada’s Medical Assistance in Dying Legislation’ www.justic e.gc.ca/eng/csj-sjc/pl/ad-am/index.html accessed 14 October 2020. Downie, Jocelyn,‘After Carter v. Canada’ (National Magazine, 24 February 2015) https://ssrn.com/abstract =2670834 accessed 14 October 2020. Downie, Jocelyn and Bowes, Matthew J,‘Refusing Care as a Legal Pathway to Medical Assistance in Dying’ (2019) 2 Canadian Journal of Bioethics 73–82. Downie, Jocelyn and Lloyd-Smith, Georgia,‘Assisted Dying for Individuals with Dementia: Challenges for Translating Ethical Positions in Law’ in Michael Cholbi and Jukka Varelius (eds), New Directions in the Ethics of Assisted Suicide and Euthanasia (Springer 2015). Emanuel, Ezekiel J, et al., ‘Attitudes and Practices of Euthanasia and Physician-Assisted Suicide in the United States, Canada, and Europe’ (2016) 316(1) Journal of the American Medical Association 79–90. Gaylin, Willard, et al., ‘Doctors Must Not Kill’ (1988) 259 Journal of the American Medical Association 2139–2140. Government of Québec, ‘Medical Aid in Dying’ www.quebec.ca/en/health/health-system-and-services/ end-of-life-care/medical-aid-in-dying/ accessed 14 October 2020. Hankins, Lamar W, ‘Is Medical Aid in Dying a Human Right? Another View, Hastings Center Bioethics Forum’ (Hastings Center, 19 December 2019) www.thehastingscenter.org/is-medical-aid-in-dying-as -a-human-right-another-view/ accessed 14 October 2020. Health Canada, ‘Fourth Interim Report on Medical Assistance in Dying in Canada’ (April 2019) www.c anada.ca/content/dam/hc-sc/documents/services/publications/health-system-services/medical-assis tance-dying-interim-report-april-2019/medical-assistance-dying-interim-report-april-2019-eng.pdf accessed 14 October 2020. Kaiser Family Foundation,Tolbert, Jennifer et al.,‘Key Facts About the Uninsured Population’ (kkf, 2019) www.kff.org. Kamisar,Yale, ‘Some Non-Religious Views Against Proposed “Mercy Killing”’ (1958) 42 Minnesota Law Review 969. Kass, Leon,‘Neither for Love Nor Money:Why Doctors Must Not Kill’ (1989) 94 Public Interest 25–46. Kim, Scott YH and Lemmens, Trudo, ‘Should Assisted Dying for Psychiatric Disorders be Legalized in Canada?’ (2016) 188 CMAJ: Canadian Medical Association Journal E337–E339. Lo, Bernard and Rubenfeld, Gordon, ‘Palliative Sedation in Dying Patients’ (2005) 294 Journal of the American Medical Association 1810–1816. Martin, Keith L,‘Medscape Ethics Report 2018: Life, Death, and Pain’ www.medscape.com/slideshow/201 8-ethics-report-life-death-6011014?faf=1 accessed 14 October 2020. Meier, Diane E, et al., ‘A National Survey of Physician-Assisted Suicide and Euthanasia in the United States’ (1998) 338 New England Journal of Medicine 1193–1201. Meisel,Alan, et al., The Right to Die (3rd edn,Aspen Publishers 2020). Memorandum and Order, Montana First Judicial District Court (5 December 2008) https://compassionan dchoices.org/wp-content/uploads/2018/06/081205-Decision-and-Order-wm.pdf. Noah, Barbara A and Reich-Graefe, René, ‘Rational Patient Apathy’ (2019) 49 Seton Hall Law Review 535. OECD Statistics, National Center for Health Statistics www.oecd.org/els/health-systems/health-data.htm accessed 14 October 2020. Orentlicher, David, ‘The Supreme Court and Physician-Assisted Suicide: Rejecting Assisted Suicide but Embracing Euthanasia’ (1997) 337 New England Journal of Medicine 1236–1239. Orentlicher, David, Matters of Life and Death (Princeton University Press 2001). Orentlicher, David, et al., ‘Clinical Criteria for Physician Aid in Dying’ (2016) 19 Journal of Palliative Medicine 259–262. Pew Research Center for the People and the Press,‘More Americans Discussing and Planning End-of-Life Treatment: Strong Public Support for Right to Die’ (Pew Research Center, 5 January 2006) www.p eople-press.org/2006/01/05/strong-public-support-for-right-to-die/ accessed 18 October 2020.

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Perspectives on medical aid in dying Prokopetz, Julian JZ and Lehmann, Lisa Soleymanai,‘Redefining Physicians’ Role in Assisted Dying’ (2012) 367 New England Journal of Medicine 97. Quill, Timothy E, ‘Dying and Decision Making: Evolution of End-of-Life Options’ (2004) 350 New England Journal of Medicine 2029–2032. Ridic, Goran, et al., ‘Comparisons of Health Care Systems in the United States, Germany, and Canada’ (2012) 24 Materia Socio Medica 112–120. Robinson, John,‘Baxter and the Return of Physician-Assisted Suicide’ (2010) 40 Hastings Center Reports 15–17. United Nations, Universal Declaration of Human Rights, www.un.org/en/universal-declaration-human -rights/ accessed 18 October 2020.

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PART C

The application of a universal right to health in practice

22 A RIGHT TO HEALTH A right granted and agreed, but limited or denied? Clayton Ó Néill and Charles Foster

Introduction This Handbook attempts to define and explore that which some might say is beyond the bounds of definition or exploration. For is there any such thing as a real right to health? And if not, surely one cannot define or explore something that does not exist. Certainly, many aspire to create a world in which there is a right to health; but perhaps (say the cynics) this is dreamy utopianism. Much of this book, we admit, is a catalogue of utopian aspirations. It lays bare the embarrassing dichotomy between the right to health asserted by international treaties and human rights norms and the practical reality. The reality is that the translation of these rights in respect of healthcare, access to treatment, assurance of patient safety, and equitable and proportionate use of resources is patchy. Rarely do we see systematic and disciplined national or international implementation of any aspect of a global health right. This concluding chapter seeks to summarise the main contentions of the individual chapters, to identify any common ground between the approaches adopted by the various jurisdictions, to identify obvious lacunae in the provisions that purport to grant a right to health, to identify the shortcomings in the implementation of those provisions, and to suggest ways in which the substantive, procedural, and political deficiencies relating to the right might be addressed. At the beginning of the book we asked: Does a universal right to health exist in practice? This chapter attempts an answer. No one book could begin to deal comprehensively with global health rights, and we certainly have not tried to do so.There are some glaring geographical omissions, for instance, and in a book primarily concerned with the law, we cannot interrogate satisfactorily, even for one jurisdiction, the policy and governance considerations that play such an important part in making any human right real. All that we can do is to set out a few statements of national and international aspiration and a few national case studies, make some observations about how things might be done rather better than hitherto, and hope that these will provide the seeds for the national and international conversations from which real change will eventually flower. We now revisit briefly and critically the individual chapters.

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Part A In Part A, Charles Foster and Jonathan Herring outline the relationship between the Universal Declaration of Human Rights (UDHR) and the right to health. Charles Foster focuses specifically on Articles 1, 2, 3, 5, and 6 of the UDHR. He links his analysis of Article 1 to the Imago Dei and argues that this article influences other UDHR articles and related instruments. Foster sees Article 1 as informing and informed by the notion that each human life constitutes a story – a story that can be improved by the infusion of qualities such as dignity, freedom, conscience, egalitarianism, and lack of discrimination. Foster argues that legal instruments such as the UDHR should facilitate egalitarianism. He discusses the question of whether a right to life should be subject to any (and if so what?) limitations, and sets out what the General Gomment of the UN Human Rights Committee says about what amounts to arbitrary deprivation of life. He considers what the UDHR says about the liberty and security of the person, and considers the scope of the concomitant duties.A central contention of this book is that rights entail duties, and states are accordingly duty-bound to protect rights or, at the very least (in the case of a right to life), to ensure that they do not arbitrarily engage in actions that result in the deprivation of life.The General Comment frames the relevant duty very broadly. Foster contends that assisted suicide is a ‘classic example’ of the tension that can exist between the right to life and the rights that are classically said to be spawned by autonomy. While acknowledging that autonomy is a crucial principle, Foster observes that it is widely recognised that states should take measures to prevent suicide, particularly within vulnerable constituencies. He links Article 3 of the UDHR to discussions about end-of-life issues that are more usually articulated (at least in Europe) in the language of the European Convention on Human Rights (ECHR). He goes on to deal with abortion, consent to medical treatment, and the provisions of UDHR Article 7. He considers Article 6 of the UDHR and the right to be recognised everywhere as a person before the law. He concludes that some of the potential of Article 1 of the UDHR has been realised, but he considers its influence to be ‘piecemeal.’ He is concerned that a right to health is only conferred by the UDHR through Article 25, and that the scope of Article 1 as a tool for fashioning health rights has been more limited than it need be. Foster concludes that the jurisprudence that has encrusted the UDHR has not asked, let alone answered, the question ‘what is health?’ He is concerned that dignity is not the main motive force of the UDHR, and calls for dignity to be ‘given some hard edged meaning.’ Jonathan Herring continues the audit of the UDHR’s relevance to the right to health, assessing the impact or otherwise of Articles 7, 12, 16, 18, 19, and 25. He focuses on equity and inequity as ethical justifications for a right to health, considering the bulwarks against inequity contained in international human rights treaties/documents, including the International Covenant on Economic, Social, and Cultural Rights (ICESCR) and the Committee on Economic, Social and Cultural Rights (UNCESCR). Herring argues that a right to health is a key component of a number of other rights. He argues that ‘if there is no human right to health, it is not clear there can be a human right to anything.’ He supports this contention by reference to the wording of Article 7 and the potential overlap between Articles 2 and 7. He compares the fight for health rights to the fight against gender inequality, race discrimination, and disability discrimination, and discusses how the notion of equality can be used to develop a broader view of the right to health. He discusses the notion of rights as based on the idea of the individual, and moves on to consider collective understandings of rights. He suggests that the right to equality mandates a positive duty. He concludes that the equality right enshrined in Article 7 can only be honoured if there is a right to health – a right articulated both as an individual and a collective right. Article 12 is formulated in negative terms. It prevents the state from interfering with an 390

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individual’s life. Herring observes that at first sight this negative formulation would appear to debar Article 12 from conferring any positive right to health. But for Herring, that is not the end of the story. He notes that privacy (the prime example of an interest protected by Article 12) means more than merely being left alone, and shows how ill health can impede a person’s ability to experience relationships and flourish accordingly. Privacy, therefore, says Herring, ‘generates a right to health.’ Article 12 also protects honour and reputation, which Herring argues can be regarded more generally as the protection of dignity. For Herring, many aspects of human life are crucially connected with ‘health’ – from which it follows (for instance) that protection of honour and dignity might go at least some of the way towards creating a positive right to health. In his analysis of Article 16, Herring identifies the elements of the right to found a family, suggesting that they include rights of access to assisted conception, contraception, and abortion. Herring considers Articles 18 and 19 together.They relate to freedom of thought, conscience, and religion (Article 18), and freedom of opinion and expression (Article 19). In the health law, the main relevance of these articles is to conscientious objection. Herring views conscientious objection through the lens of moral integrity, and discusses other ways in which it can be viewed. This discussion has parallels with Clayton Ó Néill’s analysis of this area in Part B. Herring’s conclusions bear repeating:‘[w]e should be seeking to produce a healthy society.This is one where society seeks to promote the equality of all; to recognise the value and dignity of every human being; that enables relationships to flourish.That is true health.’ This sets us on the road to this book’s destination.We conclude that a right to health has an inalienable place in the pantheon of universal rights.The right is incontestably present in various august legal instruments, and seems to be valued as an ethical norm in many jurisdictions. But, (as Herring demonstrates) a right to health is allied with, and indeed may be derived from, other rights.Those alliances are crucial.Without them, a robust-looking right to health might be impotent. Many of the chapters in this book make (sometimes tangential) reference to the current (2020) COVID-19 pandemic, and describe the impact that such pandemics have on both access to appropriate healthcare and the application of a right to health in such contexts. Clayton Ó Néill focuses specifically on the correlation between global health emergencies and a right to health. His perspective is global. He considers the effectiveness or otherwise of the responses to health crises, and highlights the disconnect there often is between international action and advice and national action. Ó Néill traces the history of the idea of a right to health. He accepts the World Health Organisation’s constitution’s definition of health (‘a state of complete, physical, mental and social wellbeing and not merely the absence of disease or infirmity’) and endorses Article 12 of the ICESCR which purports to confer a global right to health. He notes that civil and political rights tend to be protected in a more concrete way than economic, social, and cultural rights. He refers to the literature on the relationship between globalisation and economic, social, and cultural rights. He highlights Ssenyonjo’s work on factors such as corruption, failure to comply with national court rulings, poverty, and lack of respect for the rule of law and international bodies1 which, in Africa (and elsewhere), impact adversely on human rights generally. Ó Néill agrees with Ssenyonjo that improvement of the ICESCR’s impact is contingent upon the setting up and application of a large range of economic and educational policies, and discusses the connection between justice and the right to health. Ó Neill alludes to 1 Manisuli Ssenyonjo, ‘The Influence of the International Covenant on Economic, Social and Cultural Rights’ (2017) 64 Netherlands International Law Review 259–289; Manisuli Ssenyonjo, Economic, Social and Cultural Rights in International Law (Hart 2016).

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other international human rights treaties that have an impact upon health rights, and agrees with Gostin that the global response to health inequality is inadequate in many important respects. Ó Néill considers de Campos’ thesis that health needs can be classified as either basic or nonbasic, and sets out some of the lessons from global responses to medical crises – particularly in the context of Ebola. Everyone seems to applaud the idea of a right to health, but there is less national and international enthusiasm for the work and resources necessary to make such a right real.The right is only useful very patchily. Thana de Campos-Rudinsky notes that a right to healthcare gives rise to two types of duty on the part of states: a duty of immediate realisation (sometimes referred to as a minimum core obligation) and a duty of progressive realisation. The nature and scope of these duties have been widely discussed in the literature, particularly in the context of the ICESCR and the UNCESCR. It is crucial, says de Campos-Rudinsky, not to confuse these two types of rights. The distinction matters mainly because, as their name suggests, minimum core obligations should be realised immediately. If they are conflated with duties of progressive realisation, the priority they should have may be diluted. De Campos-Rudinksy illustrates the distinction between the two types of rights by reference to health cases decided by the Inter-American Court of Human Rights (IACHR) of the Organisation of American States. Sometimes, she suggests, the IACHR itself fails to acknowledge the distinction. Throughout this book, we have noted how the practical realisation of global health rights falls short of the aspirations voiced by advocates and embodied in the relevant declarations. De Campos-Rudinsky’s analysis suggests, persuasively, one reason why this might be.

Part B Beginning of life Zahara Nampewo examines alternative reproductive technology (ART) in Uganda.The absence of a public health scheme means that ART is generally only available privately. In vitro fertilisation (IVF) is largely unregulated. Nampewo identifies a lacuna in Ugandan law regulating ART. She connects the right to found a family to the UDHR, Article 16 – a right reflected in the constitution of Uganda. She outlines the new ART techniques and cites case law, particularly from the UK, concerned with their regulation. She discusses the legal status of ART in Africa more broadly. She details some of the religious and cultural objections that often apply to ART, dealing specifically with the issue of clan continuity and the primacy often given to males, and noting that infertility may lead, inter alia, to stigmatisation, isolation, ostracisation, and disinheritance. Nampewo sees the absence from Ugandan law of provisions regulating ART, together with the paucity of resources to pay for ART, as having important negative social implications. But there is perhaps some hope: a recent and encouraging draft policy. Regulation of ART practice, Nampewo argues, will not be enough: community education is crucial too. Nampewo’s discussion of ART in relation to issues such as cost, general trends and patterns, regulation, infrastructure, donors, and surrogates resonates far beyond Africa. She contends that society must recognise that childlessness is not just a social or a personal medical problem, but also a public health issue. Clayton Ó Néill deals with the issue of abortion, not, as is usual, by examining the diverging paradigms of the embryo’s/fetus’ right to life and the mother’s right to choose, but rather by examining healthcare practitioners’ right to object on grounds of conscience to participating in abortion in the context of the recent implementation of the Abortion (Northern Ireland)

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Regulations 2020. He outlines the chronology of the change in the law and explains that for many in Northern Ireland these changes represent a repudiation of fundamental values. He questions the consultation process undertaken before the implementation of the regulations. This process was limited in both scope and time, and contrasts unfavourably with the Citizens’ Assembly which, when the Republic of Ireland was contemplating a comparable change in the law, engaged stakeholders more effectively. Ó Néill notes an English case, Janaway2 and a Scottish case, Doogan,3 which affected the way that conscientious objection to abortion was grafted into the new law in Northern Ireland, but he observes that it was not legally mandatory to implement the principles enshrined in Doogan. He acknowledges that many consider that a right to abortion services is an important right, but argues that ,nonetheless, the right to act as conscience dictates is important too, and must be defended. Ó Néill criticises the narrow definition of ‘participate’ in the new Northern Ireland regulations.

Middle of life Cheluchi Onyemelukwe examines the concept of universal health coverage (UHC) and the right to health in Nigeria. She describes UHC’s legal foundations and sets out her belief that health systems should aim to be preventive, promotive, and rehabilitative and should not depend on an individual’s ability to pay. Onyemelukwe cites different forms of legislation, conventions, and charters, all of which purport to create and regulate, directly or indirectly, a right to health in Nigeria, but she recognises that the practical reality may fall short of the aspiration. The Nigerian Constitution does not clearly identify a right to health as a fundamental right. It provides a right to medical facilities but that, according to Onyemelukwe, is narrower than the right to health.The problem may be primarily the absence of a robust regime for enforcement of UHC. Onyemelukwe outlines recent legal developments which have implications for the right to health and UHC. Adoption of the African Charter as part of domestic law creates an assumption that the right to health is ‘or at least ought to be enforceable in Nigerian courts.’ She discusses whether the right to health is justiciable. Case law indicates that the African Charter is not being used as it might be to make UHC real. Lengthy delays in bringing cases to a conclusion undoubtedly make UHC less accessible than it should be. Social health insurance, which falls short of national free healthcare but is within the financial reach of both the country and individuals, could form part of the solution. More data about the need for and access to are needed. There is already evidence, though, that very few Nigerians are covered by any form of health coverage and for most people, user fees/out-of-pocket payments are the main ways of paying for healthcare. Onyemelukwe observes that the right to health is a precursor to ‘the enjoyment of all other rights.’ This is, of course, applicable to all jurisdictions. Onyemelukwe describes the role of the National Health Act 2014 as the primary statutory enactment dealing with health service delivery, and refers to case law characterising a basic minimum package of healthcare as a right enforceable in the Nigerian courts. Lara Khoury looks at the link between public reporting of safety indicators and the strengthening of patient autonomy and concludes that, counter-intuitively, the link, at least in Quebec, is not strong. She concludes that the main effects of improving the reporting of patient safety indicators are on safety and healthcare provision and delivery (all of which are improved), but

2 Janaway v Salford Area Health Authority [1989] AC 537 (HL). 3 Greater Glasgow Health Board v Doogan and Another [2014] UKSC 68.

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that the effects on patient autonomy are small. Patients in the United States (and increasingly elsewhere) are seen as consumers of healthcare. Quebec does not (yet) have that consumerist ethos, but it is nonetheless apparent from the research analysed by Khoury that patients in Quebec have, at the very least, some voice in the treatment they are given and in the decisions that are made for them.That is not the case in all jurisdictions. Santa Slokenberga discusses – primarily in the Swedish context – the obstacles preventing the provision of optimal medical care, particularly for children and for those who are otherwise vulnerable or lack capacity. Decisions made in respect of gravely ill children are particularly problematic. Slokenberga links the protection and violation of human integrity to the European Court of Human Rights (ECtHR). She notes that Article 12 of the ICESCR (buttressed by articles within the Biomedicine Convention of the Council of Europe) purports to create a right to a high standard of health. But how does one determine, in any particular context or jurisdiction, what a high standard really demands? Health rights cannot intelligibly be disentangled from social rights, rights to housing, water, and so on. Can any international instrument really prescribe justiciable standards in relation to such matters? Slokenberga traces, from 1922 to the present, the evolution of the ethos that governs the doctor–patient relationship.The modern ethos owes a lot to evidence-based medicine – a conception that does not necessarily conduce to optimal patient care. It can become a mantra that inhibits reflective practice and/or makes the clinician focus too narrowly on a clinical problem rather than, holistically, on the patient in the context of society or other vital and perhaps defining relationships.There are also, of course, well-documented difficulties about deciding what the ‘best’ evidence is. Slokenberga concludes that four key components relate to the right to health. Care must be (1) available, (2) accessible, (3) acceptable, and (4) of appropriate quality. Jean McHale and Elizabeth Speakman address the question of whether ‘health tourism’ should be countenanced. They explore the vexed question of the National Health Service (NHS) charging overseas ‘visitors,’ such as workers, tourists, and temporary residents, and the differences in approaches taken to such charging across the devolved countries in the UK.They advocate a policy based on what is equitable and proportionate.They situate healthcare in terms of fundamental human rights to health and healthcare and the question of equitable access to treatment. Equity and proportionality depend on context; therefore, McHale and Speakman examine the regimes for charging for healthcare that apply in the various UK jurisdictions, noting which citizens are exempt from NHS charging, and the provisions that apply to immigrants. They analyse the diverse approaches taken in the devolved countries – something which has, to date, been largely hidden in the literature. While England has been particularly notable in the last half-decade for its tightening of both the charging regulations and their implementation, in Scotland and Wales, in particular, the regulations have been more generous in scope and implementation. McHale and Speakman highlight how the existence and operation of the current charging regulations can act as a deterrent to those seeking treatment as, for example, in the context of accessing maternity care.They demonstrate that, despite the years of distinct approaches, a chiller wind now blows through the devolved countries and pressure to change course in relation to charging policy is now growing.They pose the question: ‘how can compassion and care and concern for an equitable right to healthcare be effectively squared with charging vulnerable visitors for treatment?’This question is juxtaposed with another: ‘How far should the concern with resource allocation extend?’There, of course, lies the rub! In the spirit of wanting to extend a right to health to all, some countries may be more generous than others in terms of permitting access to healthcare. But this broadening of access can have serious economic consequences for a country. So, while a right to health might exist, the question of a right to travel to access healthcare is complex. We suggest, following McHale and Speakman’s 394

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arguments, that policies should be devised and implemented that set out the rights, duties, and obligations applying to those who seek medical treatment and to those who might provide it. Such policies should be equitable and proportionate: adequate medical care should be available to all, but its provision must be financially sustainable and rationally balanced against competing priorities. Harmonising the realisation of such ideals across international borders would, if it is not to perpetuate and deepen divisions between nations, demand sophisticated and nuanced consideration. Naomi N Njuguna sees patient safety in Kenya as related both to a substantive legal right to health, and to effective governance of health systems. She identifies some causes of patient harm (illustrating several by reference to litigated cases) and locates these legally within the framework of the Constitution of Kenya. She suggests that patients will be safer if there is a unified and holistic governance structure, and that the needs of healthcare workers have been sidelined, particularly in the context of the COVID-19 pandemic. Provision of healthcare, she says, must be aligned with the proper resourcing and remuneration of healthcare professionals, and the provision of appropriate working conditions. Patient safety is a holistic idea – holistic in terms of its view of patient needs and its view of the factors that contribute to health: it means more than the mere avoidance of errors. Njuguna essentially joins Peled-Raz in calling for an approach to patient safety grounded in the notion of patient care infused by human rights, and suggests that, in Kenya, the idea of patient safety should be situated within the framework of a right to health which ‘entails holding the state responsible for governance outcomes that influence patient safety.’ John Tingle continues, in the context of English law, the discussion about the relationship between patient safety and a right to health. He concludes that ‘a country cannot maintain that their citizens have a right to healthcare if those services are unsafe and ineffective.A human right to healthcare is meaningless if safe and quality healthcare is not viewed as a core component of it.’ He derives this conclusion from analysis of many sources. He suggests that patient safety is still a challenge to the NHS, but that existing patient safety strategies, informed by the lessons that can be learned from other jurisdictions, are promising. Stephen King examines the system of clinical negligence litigation in England, asking whether the system implies the existence of a right to health.The argument is alluring. If there is a publicly funded healthcare system, surely this itself is evidence of a domestically recognised right to health – for healthcare and health have an obvious connection. If the healthcare system fails an individual, can the system of redress (intended, if the claim is brought in tort, to put the claimant in the position she or he would have been in had the negligence not occurred) not be seen as a further buttressing of the state-sponsored right to health(care)? Helen Hughes completes the series of three complementary chapters dealing with patient safety – the others being by John Tingle (who focuses on the history of the patient safety concept, the procedures that emerged in the course of its evolution, and the flaws in those procedures) and Stephen King (who outlines the English system of clinical negligence, and asks whether it helps to promote patient safety). Hughes asks whether the right to health under Article 12 of the ICESCR connotes a right to safe care, contending compellingly that it does. She sees the ECHR as one of the main European agents of the ICESCR, and notes that the ECHR (particularly in relation to the right to life, the right to liberty, and the right not to be tortured or treated in an inhuman or degrading way) establishes a close relationship between reducing avoidable harm and upholding basic human rights. She embarks on an (often depressing) audit of the way in which the UK falls short of its obligation to provide adequate healthcare. She concludes that the World Health Organisation’s (WHO) Global Patient Safety Action plan could, if properly adopted and enacted by individual states, make real, in the wards, the clinics, 395

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and the operating theatres, the link (clear in the ICESCR) between the right to health and the right to safe care. We often associate a right to health with a right to medical treatment, medicines, and care. But it connotes much more than that. Perhaps it originates with a right to dignity. Sushant Chandra agrees. He sees dignity as Kant saw it. Chandra examines the way that healthcare disputes are adjudicated in India, demonstrating, by reference to judgements of the supreme court, how dignity is seen as a foundational constitutional principle mandating respect for individuals. Chandra cites a number of cases of failure to treat patients appropriately in public hospitals, and where the sanctity of human life and dignity were insufficiently recognised.‘[J]ust because someone is poor,’ he observes,‘the State cannot allow him to die.’ He continues:‘after all, health is not a luxury and should not be the sole possession of a privileged few.’This goes to the heart of healthcare provision in India and elsewhere: a right to health may exist theoretically, but its realisation is often dependent upon money and access to financial resources. Chandra urges the Indian courts to identify more explicitly the relationships between autonomy and dignity and between dignity and equality.That, he contends, would empower the notion of dignity, making it a more useful agent of legal accountability. Edward Lui considers how a right to health operates or does not operate in Hong Kong. He demonstrates that it has an equivocal place amongst constitutional rights, and is insufficiently protected by the common law. He examines two recent government policy documents relating to health and public assemblies, contending that in these policies the government has attempted to balance the right to health with other conflicting rights. Lui examines current restrictions on the freedom of assembly and considers whether or not they have helped to entrench or boost the right to health. He notes that the Hong Kong courts rarely recognise the suite of ICESCR rights which include a right to health. He concludes that the Hong Kong government has shown some signs of wanting to recognise a right to health, but that balancing this right with others is proving difficult. Lui considers that a meaningful right to health in Hong Kong would require coordinated public demand.As it stands,‘a general right to health in Hong Kong remains an aspiration only.’

End of Life Barbara A Reich reviews the ethical and legal foundations of controversial medical practices, including euthanasia and medical aid in dying (MAiD) in the United States and Canada. She explores how cultural differences have affected the availability of MAiD. She relates its availability to the UDHR and to the priority given to the principle of patient autonomy. She notes and assesses the significance of the changing language used to describe various end-of-life practices: ‘physician-assisted suicide’ has morphed into ‘medical assistance in dying.’ She relates end-of-life issues to the varying political landscapes in North America, and surveys the legal mechanisms used to enable assisted dying where it has been permitted, the evidence for the effect of such laws on the doctor–patient relationship, and the North American experience as to whether slippery slopes to involuntary euthanasia are real and unavoidable. Reich is troubled by the inconsistency of the position in relation to assisted dying across the United States. She contends that it is an option that many people may need irrespective of the political realities of the state in which they live. If, then, a right to assisted dying is part of a right to health, its patchy availability is an example of the inconsistent availability (even within one nation) of the right to health. Ian Freckelton considers the way that end-of-life issues have been approached in various Australian jurisdictions and in New Zealand. He notes the relationship between popular and legal debates about the withdrawal and withholding of life-sustaining treatment with the 396

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debates about physician-assisted suicide and euthanasia. He asks whether the legislation has done enough to reduce suffering and to give people autonomy at the end of their lives, whether the ‘beneficence culture’ of medicine has been protected, and whether doctor–patient relationships have been compromised. He relates the history of assisted dying law in the Northern Territory, Victoria,Western Australia, and Queensland. He highlights the role of Lucretia Scales in trying to ensure lawful access to physician-assisted suicide in New Zealand. Her story personalises a debate that is often abstract. Freckelton shows that when assisted dying is legally possible, few avail themselves of it.This may relate to the strict eligibility criteria or to other factors. It may also, however, relate to the fact that many people cling tenaciously to life, even – or perhaps particularly – when it is clear that the end is near. It appears that there is a general movement towards supporting people in their end-of-life choices, but autonomy is not the only player in town. Freckelton’s chapter invites, as did Reich’s, the question of whether a right to assisted dying should be an element of an inalienable global right to health.We return to this issue below. Jesse Wall considers the question of whether global health rights should cover human tissue. He suggests that we may not have any right to own our own body in life or in death. He discusses the legal and ethical nature of human tissue and the legal schemes which govern its posthumous use – particularly in relation to organ donation.Wall observes that the global trend in respect of the use that can be made of human tissue is to give primacy to the wishes of the person to whom the bodily material belongs or belonged. He notes that Article 3 of the UDHR often features in debates about the use of human tissue. He accepts that Article 3 might have a contribution to make, but that the consequences of seeing the use of human tissue as purely a human rights issue are unacceptable. Human rights, for Wall, embody values – which demands analysis of how they should be crystallised in social and legal rules – and also act as standards. These two characteristics of human rights are often insufficiently distinguished, leading to ambiguity about the way that their status is represented in legal discourse. Wall demonstrates how researchers link human rights to moral sensibility, but concludes that this misrepresents the relationship we have with our bodily material. Instead of adopting an approach based on our sensibility, Wall asks whether the approach should instead be that of solidarity. This is akin to Herring and Chau’s idea that our body does not belong only to us.4 Wall suggests that we can only talk intelligibly about our bodies belonging to ourselves when the body is ‘integrated with our subjectivity’ – which it is not when we are dead. It follows, for Wall, that if others can benefit from our dead body, those benefits should weigh (although not necessarily decisively) against our own wishes and those of our families.Wall recognises that the law is a blunt instrument for dealing with human bodies – which possess ‘subtle layers of meaning’ – and argues that the law must facilitate a decision-making process that recognises those subtleties. Those subtleties are not well articulated in the language of human rights: more informal mediation of the issues is desirable.The link to global health rights is plain. Carsten Momsen and Mathis Schwarze examine recent developments in the law relating to assisted suicide in Germany, noting the striking down by the constitutional court of a law prohibiting the ‘business-like’ promotion of assisted suicide, and the creation or articulation by the court of a general right to autonomous decision-making at the end of life.This is a particularly significant development in view of Germany’s haunted past and its explicit legal recognition of dignity as a foundational principle. It entails a conviction that dying is part of living. But does this mean that a right to health entails a right to die at the time and in the circumstances one chooses? It does not

4 Jonathan Herring and Phong Chau,‘My Body,Your Body, Our Bodies’ (2007) 15(1) Medical Law Review, 34–61.

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appear to go so far. Certainly, it does not confer a right to assisted suicide or euthanasia.The court’s decision is constitutional: it is primarily concerned with the legitimate reach of the state – with what the state should not do.The state should, as a general rule (to which there are several important exceptions), not interfere with the decisions made by a capacitous person about the circumstances in which they end their life. Decisions about human rights always have some constitutional colour: they always concern the tension between individual and corporate existence. But this does not mean that constitutional decisions necessarily delineate – let alone create – rights.The lesson from the German experience for this book does not concern the issue of whether or not a right to assisted dying should be part of a global right to health: there will be many different views about that. It is, rather, that a right to health, if it is to be meaningful, must be specifically enacted: we cannot assume that it will spring into existence to fill the vacuum left when a court or a legislature forces the state to retreat from a particular legal domain.

Conclusion This book has examined the main international instruments that purport to confer a right to health. It has surveyed many aspects of health law in many jurisdictions, asking if they are evidence of a national acknowledgement of a right to health, and asking too what they indicate about the practical problems associated with asserting such a right. Several conclusions emerge clearly. Several others, we think, can be cautiously inferred.

The clear conclusions 1. There is an international consensus, embodied in a number of international declarations, that all humans have some basic rights. 2. A right to health is a foundational right. Many other rights cannot be realised unless and until a right to health is recognised. 3. There is no consensus about the precise content of a right to health. For some jurisdictions, for instance, it may include a right to abortion services or to physician-assisted dying. In other jurisdictions to confer such rights would be seen as diminishing the health of the nation, holistically viewed. 4. Health rights cannot be viewed in isolation. Rights generally characterised as social or financial impact on health rights, and vice versa.The boundaries between health and other rights are hard to map, but when one can confidently identify a health right and, e.g. a social right, it will be obvious that they are competitors for resources. 5. While there is near universal acclaim for the idea of a health right, the implementation of health rights is very patchy. Sometimes this is due to inadequate resources; sometimes to doubt about what health rights should entail; sometimes to lack of political will; sometimes to inadequate articulation of the substantive law necessary to enshrine a right; sometimes (and indeed very often) to inadequate implementation of an adequately articulated right (often coupled with inadequate systems, whether regulatory or judicial, for review of the inadequate implementation). 6. Discussion of the right to health often occurs in highly abstract language. It is often forgotten that what is really at stake are the lives and the thriving of real people. This amnesia often drains the discussion of the urgency necessary to effect real change. 7. There are gross discrepancies between the ability of different jurisdictions to implement any of the demands of a right to health. Unless and until those discrepancies are eliminated (which seems to be a messianic rather than a political or legal project), talk about a right 398

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to health is likely to mean very different things to different nations. It might mean a right to unpolluted drinking water in a sub-Saharan African country; it might mean a right to assisted reproductive techniques in Germany. Talk about equity and proportionality is all very well, but can one really expect German voters to give up some of their healthcare rights in order to reduce the disparity between their healthcare provision and that in the sub-Saharan state? We are not advocating despair. Nor are we saying that the global health rights project should be put on hold until there is economic parity between nations.We should do what we can. But agreement (if it can be reached) about the minimally acceptable content of a global health right should not reduce the drive for international parity which, in the end, will be a more potent contributor to global health than any global health rights treaty. 8. Human dignity appears as a constant refrain in appeals for a real right to health, but the substantive meaning of dignity is unclear.While it remains unclear it will be hard to use it as an instrument for meaningful change. Dignity, we suggest, is not constitutionally amorphous. It can be given a sufficiently hard-edged meaning to make a real difference, but more philosophical and legal work is necessary to give it that hard edge. 9. Human rights, as Jesse Wall points out, may not necessarily be the best legal way of achieving all desirable healthcare objectives.We believe that a global right to health is vital, but it should be seen as just one tool in the toolkit.

The cautious conclusions 1. There should be an attempt on an international level to agree what a global health right would entail. 2. This is unlikely, as noted above, to include, for instance, a right to assisted reproduction (there is simply not the money to finance such a right), or to access abortion or assisted dying services (because of the wide difference in views about whether such practices are desirable and contribute to human thriving).This does not mean that aspirations to a right to more than the agreed minimum should be abandoned. Far from it. But the best is often the enemy of the good, and we suspect that it would be here. If assisted dying were on the list of irreducible rights, many nations would simply refuse to sign, so depriving many of the benefit of interventions that should genuinely be on the list. It would be cruelly ironic if millions continued to die of malaria because assisted dying for a few was regarded as a non-negotiable component of a global rights treaty. 3. Health, for these purposes, should be defined holistically, in terms of human thriving, and its relationship with social and other rights expressly acknowledged. 4. There should be an attempt, again on an international level, to agree how a global health right should be implemented and its implementation reviewed and enforced.The systems of review of other human rights violations provide a model, but few would disagree that systems of enforcement in cases of human rights violation are woefully inadequate. We cannot make a realistic case for a special international tribunal to adjudicate global health disputes, and simply join many others in a plea for a regime of international human rights enforcement with real teeth. 5. Human rights, as we noted above, should not be seen as the whole solution. So: Does a universal right to health exist in practice? The answer is currently and clearly no.We have identified several ways in which the international community and its constituent nations might change that answer. 399

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References Ssenyonjo, Manisuli, ‘The Influence of the International Covenant on Economic, Social and Cultural Rights’ (2017) 64 Netherlands International Law Review 259–289. Ssenyonjo, Manisuli, Economic, Social and Cultural Rights in International Law (Hart 2016). Herring, Jonathan and Chau, Phong, ‘My Body, Your Body, Our Bodies’ (2007) 15 (1) Medical Law Review 34–61.

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A G Ondo State v A G Federation 189 AB v Minister of Social Development 84–85 Aboriginal health 31 abortion 7, 392–393; arguments about 102; denial of access 27; and freedom of conscience 39–40; and religion 102–104; rights to 37–38; and violence against women 26, see also Northern Ireland; pregnancy termination Abuya, Timothy 210 accommodations: for healthy adults 31; for people with disabilities 17, 28–29, 31, 36 Additional Protocol to the American Convention on Human Rights,Article 10 51 Adebowlae,Victor 27 adequate standard of living, defining 43–44 Africa: and the ICESCR 58; patriarchal cultures in 86–87; and poverty 58, 85, 91–92, see also specific countries African Charter on Human and Peoples’ Rights 21, 181, 184, 189–194, 201, 393;Article 4 14n7; Article 5 21n65;Article 6 208;Article 16 51, 190–193 Ago, Roberto 72 Akobeng,Anthony K 134 Alma Ata Declaration (1978) 182 Alyne da Silva v Brazil 27, 30 American Convention on Human Rights 62n1 Americans with Disabilities Act 84 Améry, Jean 343 Amnesty International 117–118 An Organisation with a Memory (Donaldson) 234–236, 266 Andel, Charles 260 Anekwe, Lillian 28 aporiai 4, 6–7 arbitrary, defining in international law 15 Aristotle 3–4, 341

asbestos 173 asbestosis 173 Ashcroft, John 372 assisted dying 8, 18–19, 108, 352, 361, 370, 390; ethical debates 377–381, 383, see also Australia; Canada; euthanasia; Germany; medical aid in dying (MAiD); New Zealand; United States; voluntary euthanasia (VE) assisted reproductive technologies (ART) 7, 36–38, 84, 392; concerns about 87–88, 93; costs of 95–97; denial of access 85–86; and the law 88–91; in Uganda 86–99 Attorney General v X 109–110 Australia 363–364, 396–397; Euthanasia Laws Act 1997 (Cth) 350; and palliative care 349–352, 357–358; Queensland 358; Rights of the Terminally Ill Act 1995 (NT) 349–350;VAD legislative overview 348–351;Voluntary and Natural Death Bill 1993 (ACT) 349;Voluntary Assisted Dying Act 2017 (Vic) 348, 351–356, 363;Voluntary Assisted Dying Act 2019 (WA) 348, 356–358 autonomy 341–342, 397; and arguments about reproductive technologies 37–38; and assisted suicide 337–340, 343–345 availability, accessibility, acceptability, and quality (AAAQ) framework 219–223 Azubike v Attorney General of the Federation 193 Baker, Ted 239 Bandhua Mukti Morcha v Union of India 169–170n17 Baxter, Robert 372 Bearman, GML 309 Beijing Platform for Action 26 Biomedicine Convention 282, 394;Article 3 129 ‘Bolam test’ 256–257

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Index Bolitho 256–257 Brazier, M 318 Brazil 75–77 brotherhood 12 Brown, Peter 359 Buganda 86–88 Busingye, Robert 93 Campion, Cam 359 Canada 301; assisted suicide in 349, 355; Canada Health Act (1984) 368; Charter of Rights and Freedoms 374–375; consent in 309–310; Criminal Code 374–376; healthcare-associated infections (HAIs) 303–304; healthcare system 305, 368; heath literacy in 308–309; medical aid in dying (MAiD) 349, 355, 369–370, 374–377, 381–383, see also Quebec Carter v Canada 349, 359, 374 Centre for Reproductive Medicine v Mrs U 89 Chapman,Audrey R 65 Charter of Fundamental Rights of the European Union (CFREU) 125;Article 35 127, 246 Chau, P-L 327–328 children 122; in Africa 87; Child Rights Act (Nigeria) 196–197, 201; and consent 143–144; and the Council of Europe (CoE) 124; incarceration of 273; intersex 124n12, 124n14; lack of medical devices for 131; lack of scientifically appropriate medical care 123–124, 128, 130; safeguarding rights of 142, 145–146, 148; standard of care for 135–138, 141–142, 146; and the UK 272–273, 285; vulnerability of 123, see also Sweden China, and COVID-19 54 citizenship, and rights 3–4 civil and political rights (CPR) 64 Claassen, Rutger 44 Clean Air case 160, 166 clothing, importance of 42 Collins J 359–360 Committee on Economic, Social and Cultural Rights (CESCR) 5, 48, 50, 125n15, 158, 219, 247; General Comment 3 62, 64–67, 70, 169–170; General Comment 4 42; General Comment 7 42; General Comment 14 24, 62, 164; on right to health 32, see also International Covenant on Economic, Social and Cultural Rights (ICESCR) conscientious objection 362, 378, 392–393; and the Abortion Regulations 102, 107, 111–119, 116–119; freedom of 39–40; objections to 113 conflation problems 63–64, 66–69, 73, see also duties of immediate and progressive realisation consent 143–144, 309–310; post-death 318–319, 323 consent procedures 20 Consumer Education and Research Council v Union of India 173

contraception, rights to 37–38 Convention against Torture (CAT) 11, 20, 263, 266 Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) 4–5, 11, 27, 184;Article 11 51;Article 12 51, 117; Article 14 41; and NI Abortion Regulations 102, 108–109; Northern Ireland Report 105, 107–109, 120; Optional Report 107–108 Convention on the Rights of Persons with Disabilities (CRPD) 5, 11, 20–21;Article 5 13; Article 10 14n6;Article 12 21n66;Article 19 29; Article 25 28–29;Article 26 29, see also people with disabilities Convention on the Rights of the Child (CRC) 5, 11, 12n1, 20, 125, 184, 196–197;Article 2 13; Article 3 123n8;Article 5 123n8;Article 6 14n5; Article 12 145;Article 24 51, 122–123, 127; Article 27 40–41; General Comment 15 128 Copp, David 44 Coronavirus Response Investment Initiative 54 corruption, concerns about 58 Council of Europe (CoE) 129; on children’s rights 124 Court of Justice of the European Union (CJEU) 127 COVAX 54 COVID-19 30, 47, 391; and Hong Kong 162–165; and human rights 54–55; and the ICESCR 49; and isolation 54–55; and Kenya 211, 214–216, 220; national responses to 53–55, 59–60; and pharmaceutical companies 56; in Sierra Leone 57; and the UK 257, 265, 271–273, 286, see also global health emergencies; pandemics Crawford, James 72 Crowe, Jonathan 3 culturally appropriate healthcare 222–223 Cuscul Pivaral et al. v Guatemala 62–63, 69–75 D v United Kingdom 20 Daniels, Norman 43–44 de Campos, Thana, The Global Health Crisis 55–56 de Londras, Fiona 103 deaths, justifying 14–15 defensive medicine 218 devolution: and health governance 213–220; in the UK 284, 290–294 Dickson v United Kingdom 84 dignity 12, 22, 169, 396–397; background of 168; and honour 34–35; and India 168–171, 173–174, 176, 178; and personal autonomy 19; and suicide 341–342, 372, 379; in Sweden 141–142 Diringer, Michael N 135 disclosure 144–145 discrimination: and equality 25; and transgender people 25n9; in the United Kingdom 13, see also specific forms of discrimination

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Index DNAR forms 263, 271–272, 380 domestic abuse 26; and privacy 34 Dominican Republic 27 Donaldson, Liam 266 duties: and human rights 323; imposing 323–324 duties of immediate and progressive realisation 64–65, 70–72, 76–77, see also conflation problems; minimum care obligations duty of candour 251 duty of care: in Cuscul Pivaral et al. v Guatemala 70–71, 70–72, 74; and healthcare institutions 63; and incarceration facilities 17, 126n20; and mental illness 75–77; and parents 123; for the vulnerable 63 duty to educate the population 70–74 duty to provide access to HIV testing and medical treatment for the HIV population 74 duty to regulate and supervise local healthcare institutions 63, 70–73 duty to regulate, supervise and investigate 75–76 Dworkin, Ronald 35

evidence, grading 133–134, 139 evidence-based medicine (EBM) 131–133, 135, 139, 146 experience: assessing 139–140; and science 140–141 Fabre, C 319 failed asylum seekers 285, 289, 292–293 Femi Falana v Attorney-General of the Federation 193 fetuses 22, see also embryos food, rights to 41 Foster, Charles 58, 280 France, and COVID-19 53 Francis Carolie Mullin v Administrator of Delhi 169n14 Francis, Robert 237, 251 freedom of conscience, and abortion 39–40 freedom of conscientious objection 39–40 freedoms 5 French revolution 3–4 Friedman, Eric A 57

Ebola epidemic, and the WHO 52–53 economic, social, and cultural rights (ESCR) 62, 64, 66, 70 Edmond, MB 309 Eekelaar, John 34 Egypt 27 embryos 19, 22; and ART 89, see also fetuses emergency medical treatment, in Kenya 210–211 endoxa 4 Enright, Máiréad 103 epidemics, and the WHO 51–53 equality, and UDHR Article 7 24–33 equality rights: changing understanding of 30; requiring action 31 equity, and pandemics 56 eudaimonia 8–9 European Committee of Social Rights 129 European Convention on Human Rights (ECHR) 4, 11, 266, 282, 390;Article 2 18–19, 126, 159, 262–263;Article 3 20–21, 109n16, 125–126, 262–264, 281;Article 5 263–264;Article 7 147–148;Article 8 18n43, 37, 84, 107–108, 109n16, 263;Article 9 112, 114, 117–118; Article 14 262–263; and assisted suicide 18–19 European Social Charter:Article 4 41;Article 11 51, 129 European Union Charter of Fundamental Rights and Freedoms 281 European Union (EU): COVID-19 response 54; Treaty of Lisbon 246; and the UK 246, 281n12, 282, 285–286 euthanasia 8, 18–19, 348, see also assisted dying; voluntary euthanasia (VE) Evans, Natalie 89 Evans v Amicus Healthcare 89 Evans v the United Kingdom 84

Ganda community 86–88 Gaylin, Willard 378n51 gender: and healthcare provision 27, see also transgender people; women gender inequality 25–26 General Comment 20 20 General Comment 36 17–18 Georgina Ahamefule v Imperial Medical Centre 192–193 Germany 332–333, 397–398; § 216 Tötung auf Verlangen 341; § 217 Strafgesetzbuch1 332–335, 337, 342, 344; attitudes towards assisted suicide 342, 344; Bundesverfassungsgericht 332–333, 335–336, 338–339, 344–345;‘business-like’ suicide criminalisation 332, 334–335; doctrine of legal goods 336–337; euthanasia 338–339; legality of assisted suicide 333–334, 336–338, 344–345, 397–398; right-to-die organisations 332, 334–335, 338, 340, 342, 344–345; suicide in 333, 337–338 Gething,Vaughan 288 ‘Getting It Right First Time’ (GIRFT) project 244–245 Gideon Kilundo & Daniel Kilundo Mwenga v Nairobi Women’s Hospital 208 global contexts, importance of 6 The Global Health Crisis (de Campos) 55–56 global health emergencies 47, see also COVID-19 global health law 55–57 Gostin, Lawrence O 49–50, 57–58, 58–59n62, 60, 392 Grading of Recommendations Assessment, Development and Evaluation (GRADE) 133–134, 139 Gray, Paul 289–290 Greater Glasgow Health Board v Doogan and Others (Doogan) 115, 117–119, 393

403

Index Greco, Luís 336 Guararapes Rest House 75 Guatemala 69–75 gynaecologists, in Uganda 92–93 Hale, Lady 107–108 Harding, Seeromani 28 Harris, John 36, 318 Hassemer, Winfried 336 health: defining 48, 279–280, 391; importance of 23 health governance 212–219 health insurance 192, 196, 367; in Germany 340; in Kenya 211, 218; in Nigeria 187, 195–197; and people with disabilities 29; in the UK 248, 250, 270, 290; in the US 337, 368, see also Nigeria; social health insurance health tourism 287–289, 394 healthcare 367; human rights-based approaches 32–33, 224 heath tourism 296; and the UK 287–289 Hepple, Sir Bob 25 herd immunity, and rights to health 30 Herring, Jonathan 58, 122n3, 280, 327–328 Hervey, TK 280 Hickam, DH 214 High Quality Care For All (2008) 232 HIV: in Guatemala 70–75; in Nigeria 180, 193; and violence against women 26 Hong Kong 8, 155, 396; Basic Law 155–156, 158–159; Bill of Rights 159, 166; and COVID-19 162–165; Human Rights Act 1998 156; and the ICESCR 156–157, 160, 165–166; Prevention and Control of Disease (Prohibition on Group Gathering) Regulation 163–165; Prohibition on Face Covering Regulation 161–163; and the right to health 156–158, 160–161, 165–166 honour 34–35, see also dignity housing, right to 41–42 human body 327–328; post-death 317–320, 397 Human Fertilization and Embryology Authority ex parte Blood 89 human identity 30 human rights 279, 320, 322–327, 330, 399; and COVID-19 54–55; malleability of 321–322, 324–326; and patient care 217–219; post-death 317, 329, 397 Human Rights Committee 50 Hunt, Jeremy 283 Hunt, Paul 33, 65–66 Icelandic Human Rights Centre 43 ill health, debates about 24 Imago Dei 12, 22 India 8; and Article 21 169–170n17, 172, 175–176, 178; Constitution 173–174, 176; Delhi High Court 176–177; and dignity 168–171, 173–174, 176, 178, 396; Directive Principles

of State Policies 169–170; and social minimum 169–170, 178; Supreme Court 171–175 inequality, and public health systems 57 infertility 36, 83–86, 91, see also involuntary childlessness Inter-American Court of Human Rights (IACHR) 7, 62, 392; and the conflation problem 68–69; Cuscul Pivaral et al. v Guatemala 69–75; Ximenes Lopes v Brazil 75–77 International Bill of Human Rights 49 International Convention on the Elimination of All Forms of Racial Discrimination (CERD) 184;Article 5 51 International Convention on the Protection of the Rights of All Migrant Workers and Members of Their Families 21n64, 184 International Covenant on Civil and Political Rights (ICCPR) 11, 49–50;Article 3 15; Article 6 13n4, 14–17, 19, 126, 348;Article 7 20–21, 21n63, 348;Article 9 15, 208;Article 11 208;Article 16 21;Article 17 348; and Hong Kong 156 International Covenant on Economic, Social and Cultural Rights (ICESCR) 4, 7, 11, 62, 181, 191, 219;Article 2 49, 64, 158;Article 4 50–51; Article 11 40;Article 12 4–5, 16, 16n23, 22, 24, 48–50, 137, 158–159, 192–193, 247, 348, 391, 394–395; General Comment 12 41, 43; General Comment 14 40, 66–68, 127–128, 155, 185–186, 190; General Comment 19 42–43; and Hong Kong 156–157, 160, 165–166; Optional Protocol 49, 58, 107–108, 247; violations 49–50, see also Committee on Economic, Social and Cultural Rights (CESCR) interventionism, and the courts 177 involuntary childlessness 83, 86, see also infertility Ioannidis, John PA 132–133 Ireland, and COVID-19 54 Irish Republic 102, 286–288, 291n78, 393; Aontú party 104n4; constitution (8th Amendment) 103–104, 110, 120; Life During Pregnancy Act 2013 109–110; Sinn Féin 103–104, see also Northern Ireland isolation, and COVID-19 54–55 Italy, and COVID-19 53 Janaway v Salford Health Authority (Janaway) 115, 118–119, 393 Johnstone, Alex 289 Jonah Gbemre v Shell Petroleum Development Company Nigeria Limited and others 189 Joseph Odafe and Others v Attorney-General of the Federation and Others 193 justice 56–57, 59; importance of 56 Kainz, Howard P 3 Kant, Immanuel 168, 341–342, 396

404

Index Kennedy, Duncan 325, 330 Kenya 8, 85, 90; Constitution (2010) 205, 210, 213, 216, 223–224, 395; and COVID-19 211, 214–216, 220; denial of heathcare 210–212; harmful conduct by medical professionals 209–210; Health Act 2017 210; health costs 208–209, 217, 221; and health governance 213–220; health workers in 211, 214–216; hospital conditions 208, 211–212; and medical errors 205–206; National Patients’ Rights Charter 211; patient detention in 208–209; and patient safety 205–207, 219–223; and universal health coverage 221–222 Kindström-Dahlin, Moa 143 Kizer, Ken 232 Kong, Karen 160 Kusch, Roger 334 Laws, Michael 359 LC v Peru 27 Lecretia’s Choice:A Story of Love, Death and Law (Seales) 360 Legal Defence and Assistance Project (LEDAP) GTE & LTD v Federal Ministry of Education & Anor 190 legal fees, and the NHS (UK) 252–253 letters of claim 252–253 Liao, Matthew 23 Lindemann, Kate 31 Litins’ka,Yana 142n148 local experiences, connected to global contexts 6 Locke, John 3–4 Lopes de Sousa Fernandes v Portugal 126 low-and middle-income countries (LMICs), and patient safety 207, 229 McCoy, David 215 McCrudden, Christopher 164 McGlinchey v UK 21 McGuiness, S 318 McHale, JV 280 Madaga, Alex 210 Mance, Lord 109 MAO & Another v AG & 4 Others 208 Marsh, Luke 159 Matheson, Michael 289 Maung, Hane 36 Mbau, Rahab 222 mediation 254 medical aid in dying (MAiD) 367, 369, see also assisted dying;Australia; Canada; euthanasia; Germany; New Zealand; United States; voluntary euthanasia (VE) medical errors: in Kenya 205–206; in Quebec 300, see also ‘Never Events’ medical ethics 50 medical experimentation 20 Meier, Benjamin Mason 162

Melzer, Nils 273 mental illness: and assisted suicide 333–334, 339, 343–344; state duties towards 75–77 Mid Staffordshire crisis 237–238 minimum care obligations 63, 66–68, see also duties of immediate and progressive realisation minimum wage, in Uganda 91 Mohd Ahmed (minor) v Union of India 175–177 Mohinder Singh Chawla 174 moral duties 56; of pharmaceutical companies 55; of wealthy people 55; of wealthy states 55 Morecambe Bay scandal 238 Mori, Larisa M. 162 Morton, Wendy 273 “mothers” and ART 90–91 National Aboriginal Health Strategy Working Party 30–31 natural law theories 3 Neal, Mary 39 ‘Never Events’ 232–233, see also medical errors The New Bioethics (Neal, Fovargue and Smith) 112 New Zealand 363–364, 396–397; End of Life Choice Act 2019 348, 351, 360–362; New Zealand Bill of Rights Act 1990 (NZBORA) 359–360, 362;VAD legislative overview 359–363 NHS (UK) 228–229, 245–248; Care Quality Commission (CQC) 231, 233–234, 236, 269–272; charging requirements 290–294, 394–395; Clinical Negligence Scheme for Trusts (CNST) 245; costs of 245–247; Cumberlege review 239–241, 268; and devolution 284, 290–294, 395; and discrimination 264–265, 269–270; and ethnic minorities 27, 265; and foreigners 282, 285–286, 292–294, 394–395; Independent Medicines and Medical Devices Safety (IMMDS) Review 268–269; Mansell Report 269; National Institute for Health and Care Excellence (NICE) 245–246; and ‘Never Events’ 232–233; NHS Act 1977 283; NHS Improvement (NHSE&I) 262–263; NHS Resolution (NHSE) 249; patient claims against 248–257; patient claims costs 255–256; patient safety culture 233–234, 236, 239, 241; patient safety issues 234, 237–239, 266–268; and patient safety policy papers 231, 237, 267; Patient Safety Strategy (2019) 240; patient safety timelines/organizations 235–236; private/public relationships in 248–250, 270–271, see also health tourism; United Kingdom Nicklinson case 108–109 Nigeria 8, 85, 180, 393; and the African Charter 190–193, 201; Child Rights Act 196–197, 201; Compulsory Universal Basic Education Act 199; Constitution of the Federal Republic of Nigeria (1999) 181, 188, 190; courts in 189–190, 192–193; Discrimination against Persons with Disabilities (Prohibition) Act,

405

Index 2018 200–201; healthcare costs in 180–181, 183, 188, 194; and HIV 180, 193; National Health Act 197–201, 393; National Health Insurance Commission Bill 196; National Health Insurance Scheme Act 194–196, 199; National Primary Health Care Development Agency (NPHCDA) 199; Patients’ Bill of Rights 200; Presidential Summit on Universal Health Coverage Declaration 186–187, 192; Prisons Act 193; and universal health coverage 181–182, 186–190, 195, 198, 200, 393 NIHRC Supreme Court case 107–109 Northern Ireland 7, 286–288, 292–294;Abortion Regulations (2020) 102, 106–107, 118, 392–393; CEDAW Report 105, 107–109, 111, 120; consultations in 110–111; Criminal Justice Act (NI) 1945 107; midwives in 115; Northern Ireland (Executive Formation etc) Act 2019 105–106, 111, 115, 119–120; Offences Against the Person Act 1861 104–105, 107, 109; residency requirements 291; survey questions 116, see also Irish Republic; United Kingdom Nussbaum, Martha 35, 168, 169n16 obligations, of human rights 323 obligations of conduct 72; of doctors 172 obligations of result 72 Oderberg, David S 113 off-label medications 123, 130–131 Office of the United Nations High Commissioner for Human Rights (OHCHR)/World Health Organization (WHO), Fact Sheet 31 5, 52 O’Neill, Onora 43, 68 Opening the Door to Change 233n29, 237, 239 organ donation 319 Organisation of American States (OAS) 62, 77 Palaszczuk, Annastacia 358 palliative care 291, 355, 380–382; in Australia 349–352, 357–358; in the US 371, 378 Pan-American Health Organization (PAHO), on reproductive/sexual health 37–38 pandemics 391; and equity 56, see also COVID-19 parents: authority of 143–144, 145n176; and duty of care 123 Paschim Banga Mazdoor Khet Samity 174–175 Paterson, Ian 249–250 patient claims, and the NHS (UK) 248–257 patient detention, over unpaid bills 207–209 patient harm 206, 395; denial of treatment 210– 212; from detention 207–209; and foreigners 282; from medical professionals 209–210, 216 patient rights movement 218 patient safety 205–207, 219–223, 244, 259, 275, 299, 393–395; and a culture of prevention 304–305; at a global level 227–228, 230–231, 241, 260–261, 273–275; and consent 309–310; and health financing in Kenya 216–217; and the

WHO 206, 229, 275–276, 395, see also NHS (UK); Quebec Patients’ Rights Directive,Article 4 130 Peled-Raz, Maya 217–218, 395 people with disabilities: accommodations for 17, 28–29, 31, 36; discrimination against 28; and health insurance 29; and incarceration facilities 17; learning disabilities 264, 269–270; mental health issues 265; social model 29; special protections for 17, see also Convention on the Rights of Persons with Disabilities (CRPD) personal autonomy, and dignity 19 Petrova, Dimitrina 27, 29–30 phainomena 4 pharmaceutical companies: and COVID-19 56; moral duties of 55 Platt, H 355 Poots, Edwin 288 poverty: and Africa 58, 85, 91–92; and healthcare needs 26, 42, 55 pregnancy services, inadequate nature of as discrimination 27, 30 pregnancy termination 19, see also abortion Pretty v The United Kingdom 349 Principles and Guidelines on the Implementation of Economic, Social and Cultural Rights in the African Charter on Human and Peoples’ Rights 191, 194 privacy, right to 34, 391 Pt Parmanand Katara 171–172, 175 Pufendorf, Samuel 341 qualified one-way costs shifting (QOCS) 255 quality, and medical care 130–131, 146–147, 230 Quebec 300;Act Respecting Health Services and Social Services (AHSSS) 301–303; assisted dying in 377; data accessibility in 308–310; health data in 306–308, 310; healthcare-associated infections (HAIs) 303–304, 307; healthcare safety in 299; medical errors 300; reporting sytems in 300–304, 393–394, see also Canada R (on the application of Nicklinson and another) v Ministry of Justice 108–109 R v Barnet London Borough Council, Ex parte Shah 284 racial discrimination 27–28 Ram Lubhaya Bagga 174 Ramji Tiwari v State of UP and others 169n15 Ramsden, Michael 159–160 Rao, Mala 27 Raz, J 323 reciprocity principle 44 religion: and abortion 102–104; and ART 87; and conscientious objection 111–112, 116–117; in NI 103 Report of the Committee of Inquiry into Human Fertilisation and Embryology 36

406

Index reproductive rights 35–38 responsibilites, and rights to health 6, 16 right to die 348–349, 396 right-to-die organisations 332, 334–335, 338, 340, 342, 344–345 right to food 41 right to found a family 38 right to health/healthcare 4–5, 51, 227, 279–281, 389, 392, 395–396, 398–399; application mismatch 5; articulation of 57–58; and basic human needs 56; CESCR requirements 32, 49; collective nature of 30, 33; and conscientious objection 120; explicit protections of 24, 60; history of 47–48; and Hong Kong law 156–158, 160–161, 165–166; and human tissue 328, 397; and the ICESCR 49–50, 185–186; jurisprudence on 69; misconceptions about 5; and patient safety 219; and poverty 55; protecting 58; and responsibilites 6, 16, 60; and safe healthcare 261–262; shortcomings 49; wellbeing conception of 56, see also universal right to health right to housing 41–42 right to life 14–15, 169n14 right to medical care 42 right to privacy 34, 391 right to refuse treatment 33–34 right to social security 42–43 right to water 41 rights: and citizenship 3–4; and discrimination 5; and inequality 24; and state obligations 32, 60, 63 Robison, Shona 288 Roma 27 Roosevelt, Franklin D 48 Roxin, Claus 336 Ruger, Jennifer Prah 48, 52, 58 Rynning, Elizabeth 141, 143 Sahlin, Nils-Eric 140–141 Savulescu, Julian 39, 113 Schneider, Elizabeth 34 Schuklenk, Udo 39–40 science: defining in Sweden 139; and experience 140–141, 145 Scotland 283, 287–294, see also NHS (UK); United Kingdom Seales, Lecretia 359–360 Second World War 12, 20 Sen, Amartya 169–170 Serour, Gamal 86 sex discrimination 25–27 sexual assault, against women 26 sexual harassment, against women 26 Seymour, David 360–361 SH v Austria 37 Sheikh, Hakim 174–175 Sherwin, Susan 38

Shrewsbury/Telford scandals 238–239 side-effects, and consent 144 Sierra Leone, and COVID-19 57 Silva Pimentel,Alyne da 27 ‘slippery slope’ arguments 338–341, 378–380, 396 Smalling, Ricardo 39–40 Smiths and Peerbooms case 130 social health insurance 194, 393, see also health insurance social justice 173 social model of disability 29 social security 42–43 Sokas, Rosemary 214 South African Constitutional Court 170, 177 South America 27 Spain, and COVID-19 53 Sreenivasan, Gopal 30 Ssenyonjo, Manisuli 49, 58, 391 statistics: Canada on assisted dying 370, 380; doctors on assisted suicide 358, 378, 381; housing and health 41–42; infertility 85; infertility in Uganda 83–84, 91; United States on assisted dying 370, 379, 381; unsafe patient care 260–261 Steele, Alison 273 stigma, and suicide 339, 344 Stransham-Ford v Minister of Justice and Correctional Services 359 Street, Maryan 359 Sudan 27 suicide 339, 341, 343–344, see also Germany surrogacy 97–98 Sustainable Development Goals (SDGs) 86, 182, 201, 228 Sweden 7, 124, 135–147, 394 Switzerland 342–343 Tasioulas, John 66, 68, 320–321, 323–324, 330 Tesoriero, Paula 362 The Lancet 52 Thierse, Wolfgang 339 Tobin, John 48, 68, 164 Todd, James 128n39 Tracey, David 271 Tracey, Janet 271 transgender people: and the UDHR 25n9, see also gender transparency, importance of 299 treatments, right to refuse 33–34 Treaty of Lisbon 246 Treaty on the Functioning of the European Union (TFEU),Article 168.7 127 Trump, Donald 55 twins, in Banda 88 Uganda 7, 85;ART in 85–99, 92, 392; gynaecologists 92–93; infertility statistics 83–84, 91; Medical and Dental Practitioners Council

407

Index 89; Mulago National Referral Hospital 93; the National Objectives and Directive Principles of State Policy 85 United Kingdom 247, 349;Abortion Act 1967 104–105, 114–115, 117–118;ART in 84, 90, 392; CEDAW Report 105, 107–109; and children 272–273, 285; and COVID-19 54, 164, 257, 265, 271–273, 286; and devolution 284, 290–294; discrimination in 13; Each Other charity 270–271; Equality Act (2010) 263–264, 286; and the EU 246, 281n12, 282, 285–286; and health tourism 287–289, 394; Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 286, 289; hostile environment policy 282–283; Human Rights Act 1998 246, 262, 271, 282, 286, 294–295; Joint Committee on Human Rights (JCHR) 272–273; malpractice costs in 245; NHS Act 1977 283; NHS Act 2006 246; Patient Safety Learning 264n18, 268, 271, 275; residency in 284–285, 289;Windrush scandal 283, see also NHS (UK); Northern Ireland; Scotland United Nations, on universal health coverage 182–185 United States:Americans with Disabilities Act 84; assisted suicide in 337;‘Assisted Suicide Prevention Restriction Act (1997)’ 371; Hawai’i 373–374; health insurance 368; healthcareassociated infections (HAIs) 307; healthcare system of 305, 309, 368–369, 383; medical aid in dying (MAiD) 369–374, 372–373, 375–377, 380–383, 396; Montana 372–374; and ‘Never Events’ 232; Oregon 369n9, 371–374, 378, 382; palliative care in 371, 378; Patient Protection and Affordable Care Act (ACA) 368; poverty and healthcare in 55; racial gaps in health outcomes 28; reporting sytems in 300–301; White House Coronavirus Task Force 55 Universal Declaration of Human Rights (UDHR) 4, 7, 11, 48, 125, 157, 324–325, 330, 390;Article 1 12–13, 22;Article 2 12–13, 21n62, 25, 390; Article 3 13–14, 320–322, 326–328, 367, 390, 397;Article 5 20, 390;Article 6 21–22, 390; Article 7 24–33, 390;Article 12 33–35, 367, 390–391;Article 13 208;Article 16 35–38, 83, 390–391;Article 18 38–40, 390–391;Article 19 39–40, 390–391;Article 22 320–322, 326–328; Article 25 4–5, 22, 40–44, 51, 247, 320–322, 326–328, 390;Article 29 367 universal health coverage 8, 222, 296, 393; and the African Charter 192; and Kenya 221–222; and medical detention 209; and Nigeria 181–182, 186–190, 195, 198, 200–201; and right to health

201; and the UN 182–185; and the WHO 182–184, 227–229 Universal Period Review 65n5 universal right to health 6–8, 60, 389, 399; history of 48, see also right to health unsafe care 260–261, 274, see also Kenya; patient safety vaccination programmes 30 vaccines, and COVID-19 54 Vernon, Helen 255 Vienna Convention on the Law of the Treaties, Article 18 129 Vienna Declaration of the World Conference on Human Rights (1991) 44 Vincent, Charles 207 Vo v France 108 voluntary euthanasia (VE) 349, 369–370, 373, 383, see also assisted dying; euthanasia vulnerable populations, state responsibility for 75–76 Wagner, Anke 207 Wahlberg, Lena 140–141 Wales 287–288, 291–292, see also United Kingdom Walker, Robin 111 Walton, Douglas 338 water, in the ICESCR 41 Weaver, Matthew 238 Weller, Penny 29 Wenham, Clare 52–53 White, B 354–355 Widdows, Heather 58, 58–59n62 William and Anita Powell against the United Kingdom 126 women: violence against 26, see also gender World Health Organization (WHO): 1948 Constitution 181; and epidemics 51–53; health definition 279–280, 391; Health Emergencies Programme 53; on patient safety 206, 229, 275–276, 395; on reproductive/sexual health 37–38; on universal health coverage 182–184, 227–229 World Health Organization (WHO) Constitution 48 Wu, Albert 256 Ximenes Lopes v Brazil 62–63, 75–77 Yamin,Alicia 26, 35 Zuckerman, Adrian 253

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