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MARK ECCLESTON-TURNER AND CLARE WENHAM
DECLARING A PUBLIC HEALTH EMERGENCY OF INTERNATIONAL CONCERN Between International Law and Politics
First published in Great Britain in 2021 by Bristol University Press University of Bristol 1-9 Old Park Hill Bristol BS2 8BB UK t: +44 (0)117 954 5940 e: [email protected] Details of international sales and distribution partners are available at bristoluniversitypress.co.uk © Bristol University Press 2021 British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library ISBN 978-1-5292-1933-3 hardcover ISBN 978-1-5292-1934-0 ePub ISBN 978-1-5292-1935-7 ePdf The right of Mark Eccleston-Turner and Clare Wenham to be identified as authors of this work has been asserted by them in accordance with the Copyright, Designs and Patents Act 1988. All rights reserved: no part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior permission of Bristol University Press. Every reasonable effort has been made to obtain permission to reproduce copyrighted material. If, however, anyone knows of an oversight, please contact the publisher. The statements and opinions contained within this publication are solely those of the authors and not of The University of Bristol or Bristol University Press. The University of Bristol and Bristol University Press disclaim responsibility for any injury to persons or property resulting from any material published in this publication. Bristol University Press works to counter discrimination on grounds of gender, race, disability, age and sexuality. Cover design: blu inc, Bristol Front cover image: martin-sanchez /unsplash Bristol University Press uses environmentally responsible print partners
Contents Table of Instruments List of Figures Notes on the Authors Acknowledgments
iv v vi vii
Introduction one From Westphalian to Post-Westphalian? The Origins of the PHEIC Declaration and the 2005 International Health Regulations two A Public Health Emergency of International Concern: Between Legal Obligations and Political Reality three Case Studies on the PHEIC Declaration four Events That Were Not Declared a PHEIC Conclusion
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73 128 148
Bibliography Index
155 174
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Table of Instruments Constitution of the World Health Organization (1946) 14 UNTS 185 International Sanitary Regulations (1951) 175 UNTS 214 UNSC Res 1308 (17 July 2000) UN Doc/S/Res/1308 International Health Regulations (2005) UNTS 2509 UNSC Res 1983 (7 June 2011) UN/DOC/S/Res/193 UNSC Res 2177 (18 September 2014) UN/DOC/S/Res/ 2177
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List of Figures I.1
2.1
Timeline of notable events, including events declared as a PHEIC (large circle) and events that appear to have constituted a PHEIC, but no declaration was made (small circle) Decision instrument for the assessment and notification of events that may constitute a PHEIC
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Notes on the Authors Mark Eccleston-T urner is a Senior Lecturer in Global Health Law at King’s College London. He is one of the UK’s leading scholars on international law and global health. His published research has addressed legal issues relevant to pandemic diseases, global health governance and international law. His research specialism is in the field of international law and infectious diseases. Within this, his research interests lie in the field of pandemic preparedness, and the law of international organizations in the context of global health. He has published extensively on international law and infectious diseases. He recently co-edited a collection published by Springer entitled Infectious Diseases in the New Millennium: Legal and Ethical Challenges. Clare Wenham is Associate Professor of Global Health Policy at the London School of Economics and Political Science (LSE), trained in International Relations with a PhD from Aberystwyth University. She specializes in global health security and the politics and policy of pandemic preparedness and outbreak response, through analysis of influenza, Ebola, Zika and COVID-19. Her work considers global health governance, the role of the World Health Organization (WHO), national priorities and innovative financing for pandemic control. More recently she has been analyzing the downstream effects of global health security policy on women, and has recently published a monograph with Oxford University Press entitled Feminist Global Health Security. Her work features in The Lancet, BMJ, Security Dialogue, International Affairs, BMJ Global Health and Third World Quarterly.
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Acknowledgments We wish to thank Rebecca Katz and Alexandra Phelan for collaboration on grant bids (unfortunately unsuccessful) seeking to provide an evidence base for the question of “what happens when a PHEIC is declared” (if you are a funder reading this and you wish to finance this project –please reach out). We also wish to thank those with whom we have discussed aspects of this book over the recent years: Sara Davies, Sam Halabi, Adam Kamradt-Scott, Rebecca Katz, Matthew Kavanagh, Alexandra Phelan, Mara Pillinger, Michelle Rourke, Simon Rushton, Maike Voss, and the others at conferences, zoom calls and webinars too numerous to mention. Finally, we thank the Georgetown-Edinburgh research network in global health security and universal health coverage for introducing us.
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Introduction
On 30 January 2020, Dr Tedros Adhanom Ghebreyesus, Director General (DG) of the World Health Organization (WHO) declared the novel coronavirus outbreak (COVID-19) to be a Public Health Emergency of International Concern (PHEIC), using his authority derived from the International Health Regulations (IHR) (2005). The IHR are the singular binding legal treaty governing global health security. In his press conference, he stated: We have witnessed the emergence of a previously unknown pathogen, which has escalated into an unprecedented outbreak and which has been met by an unprecedented response…. We do not know what sort of damage this virus could do if it were to spread in a country with a weaker health system. We must act now to help countries prepare for that possibility.1 He continued: I am declaring a PHEIC over the global outbreak of novel coronavirus. The main reason for this declaration 1
WHO, press conference on the Second Meeting of the IHR Emergency Committee on Novel Coronavirus (2020), https://www.who.int/docs/ default-s ource/c oronaviruse/transcripts/ihr-emergency-c ommittee-f or- pneumonia-due-to-the-novel-coronavirus-2019-ncov-press-briefing- transcript-30012020.pdf?sfvrsn=c9463ac1_2.
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is not because of what is happening in China, but because of what is happening in other countries. Our greatest concern is the potential for the virus to spread to countries with weaker health systems and which are ill prepared to deal with it. Let me be clear, this declaration is not a vote of no confidence in China.2 This statement helpfully highlights the key tensions within the PHEIC mechanism: is the PHEIC a tool of international law to be enacted whenever the objective criteria are met, or a political, normative device within the securitization of health to get governments to pay attention to a health emergency, or does the PHEIC fall ambiguously between the two? COVID- 19 was declared a PHEIC on the recommendation of the IHR Emergency Committee (EC), advice accepted by the DG, which believed: that the outbreak was unusual or unprecedented; that it posed a public health risk to other states through the international spread of disease; and that it might require a coordinated international response. These are the three criteria for a PHEIC, as prescribed at Article 1 of the IHR. Yet, beyond a legal instrument, DG Tedros recognized the extent of the normative power within the PHEIC mechanism. A week prior, DG Tedros had (upon the advice of the EC) delayed declaring COVID-19 a PHEIC, despite it appearing that the criteria to do so were met. Some have argued that DG Tedros needed to manage the delicate political relationship with China, and that declaring a PHEIC could harm such efforts.3 This concern was grounded in the idea that China may have viewed the declaration as a ‘punishment’ for being an ‘infected’ state, or unable to manage its internal health affairs sufficiently, and it may have feared that a PHEIC declaration would lead 2 3
WHO, press conference on the Second Meeting of the IHR Emergency Committee on Novel Coronavirus. Sara E Davies and Clare Wenham, ‘Why the COVID-19 Response Needs International Relations’ (2020) 96 International Affairs 1227.
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to considerable trade and travel restrictions for its people and goods. Managing the relationship with China would become a key feature of the subsequent PHEIC declaration. DG Tedros did this through repeated proclamations that the PHEIC declaration was not actually about China, but rather about the risk COVID- 19 posed to low-and middle-income countries (LMICs). Importantly, DG Tedros also emphasized that China should not be penalized for sharing information with the WHO.4 It is unclear to what extent this extra effort to manage the risks to China were motivated by DG Tedros’ own understanding of the political power of the PHEIC mechanism, or whether it reflected a compromise to assuage the fears of the representatives of the Chinese government who attended the EC meeting. Despite WHO advising against such behaviour, in the days and weeks following the PHEIC declaration, many governments began to alter trade and travel regimes with China, or place restrictions on incoming Chinese nationals. It is not possible to know if this was done in response to the declaration, or in response to the broader threat of the disease, as perceived by many states. Nevertheless, alterations to travel and trade caused not only widespread economic and social disruption for China, but also supply chain interruptions, trade challenges for nations and businesses, and a knock to bilateral and multilateral relations.5 While there was no heterogenous response, several governments focused more on stopping the virus spreading from China, rather than readying national systems.6 The 4 5
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WHO, press conference on the Second Meeting of the IHR Emergency Committee on Novel Coronavirus. Asian Development Bank, ‘The Economic Impact of the COVID- 19 Outbreak of Developing Asia’ ADB Briefs 128 (2020) https:// www.adb.org/sites/default/files/publication/571536/adb-brief-128- economic-impact-covid19-developing-asia.pdf. University of Oxford, ‘COVID-1 9 Gover nment Response Tracker’, https:// w ww.bsg.ox.ac.uk/ research/ research- p rojects/ covid-19-government-response-tracker.
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(flawed) logic was that, by limiting the spread of infection at the source, through the reduction in travel routes, this would mean that health systems elsewhere in the world would remain protected. Few governments perceived novel coronavirus to be an ‘actual’ threat domestically, and so surge capacity and resources (both human and clinical) were not prepared immediately. Thus, for many in Europe and the Americas, governments were caught off guard at the arrival of the pathogen and found themselves on the back foot in fighting the infection.7 In light of this, it appears that the PHEIC declaration inspired states to focus more on limiting international travel and trade than on domestic preparedness. Given that the purpose of the IHR are ‘to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade’8 (emphasis added), this seems somewhat contradictory. A Public Health Emergency of International Concern The PHEIC is key to the global response to health emergencies and is one of the predominant features of the IHR. In these regulations, the PHEIC is defined as an extraordinary event, which is determined, as provided in the IHR, to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response. Any health emergency could be a PHEIC – the mechanism is not limited by origin or source of the ‘event’ in question. This all-hazards approach to disease reporting was intended to overcome the limitations inherent in the 1969
7 8
Davies and Wenham, ‘Why the COVID-1 9 Response Needs International Relations’. Article 2, International Health Regulations (2005) UNTS 2509.
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IHR,9 and allow the WHO to become a real-time epidemic assessor and coordinator of emerging threats.10 As part of this coordination role, Article 12 of the IHR sets out that the DG shall determine whether an event ‘constitutes a public health emergency of international concern in accordance with the criteria and the procedure set out in these Regulations’. In order to do so, the DG shall consider: (a) information provided by the State Party; (b) the decision instrument contained in Annex 2; (c) the advice of the Emergency Committee; (d) scientific principles as well as the available scientific evidence and other relevant information; and (e) an assessment of the risk to human health, of the risk of international spread of disease and of the risk of interference with international traffic.11 Article 12(5) continues that if the DG considers that a PHEIC is occurring, ‘the Director-General shall consult with the state party in whose territory the event arises regarding this preliminary determination. If the Director-General and the state party are in agreement regarding this determination, the DirectorGeneral shall … seek the view of the [Emergency] Committee … on appropriate temporary recommendations.’12 However, it continues that ‘if … the Director-General and the state party in whose territory the event arises do not come to a consensus within 48 hours on whether the event constitutes a public health emergency of international concern, a determination
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David P Fidler and Lawrence O Gostin, ‘The New International Health Regulations: An Historic Development for International Law and Public Health’ (2006) 34 The Journal of Law, Medicine & Ethics 85. Adam Kamradt-Scott, Managing Global Health Security: The World Health Organization and Disease Outbreak Control (Palgrave Macmillan 2015). Article 12(4), International Health Regulations (2005) UNTS 2509. Article 12, International Health Regulations (2005) UNTS 2509.
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shall be made in accordance with the procedure set forth in Article 49’. Such deference to the sovereignty of the state party in question is not unexpected, given the fine balance between sovereignty and public health throughout the IHR, although it does openly allow for the views of impacted states in the PHEIC declaration process, which will likely base their views on factors well beyond the prescribed criteria for a PHEIC found at Article 1 of the IHR. There is a good deal of evidence to suggest that such interference has occurred, and that states are resistant to a PHEIC being declared regarding events in their territory for fear of the unintended consequences;13 for example, West African leaders pushed the WHO to not declare a PHEIC for Ebola, concerned about the negative impact to international trade.14 Importantly, one of our main arguments in this book is that the DG, as the primary agent responsible for declaring a PHEIC, in accepting such political interference, endorses these views of the IHR (that it can be harmful and detrimental to states), and fails to appropriately give effect to the IHR. Figure I.1 outlines the timeline for the PHEICs declared to date, alongside the changes to the IHR, and events which might have been delared a PHEIC but were not (see also Chapter Four). The PHEIC: between international law and politics? Within this book we are concerned with how PHEIC declarations are made, and the legal and political roles of the relevant actors, such as the DG, EC and states. We demonstrate that 13
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It is noteworthy, however, that there is insufficient evidence to say with certainty what the impact of a PHEIC actually is, and therefore whether these fears are well grounded. Maria Cheng, ‘Emails: UN Health Agency Resisted Declaring Ebola Emergency’ Associated Press (Geneva, 20 March 2015) https:// apnews.com/article/2489c78bff86463589b41f3faaea5ab2.
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Figure I.1: Timeline of notable events, including events declared as a PHEIC (large circle) and events that appear to have constituted a PHEIC, but no declaration was made (small circle)
Introduction
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there is a lack of consistency within the PHEIC declaration process, and how the PHEIC is used by relevant actors; it is this very ambiguity between the legal and the political that we seek to explore in this book. As such, our central question is: To what extent is the PHEIC declaration process ambiguous and what is the risk of such ambiguity to achieving global disease control? From this we can reveal insights into the functioning of the IHR, and the relationship between the EC, DG and states. The PHEIC was introduced into the IHR in 2005 as a mechanism for controlling the executive discretion of the DG during a health emergency, through introducing a prescribed process and criteria for the DG to take into consideration when exercising such powers during an emergency. It was intended to limit the manner in which the DG could exercise their executive discretion in respect of the response to a health emergency, and thus the impact on global trade or penalizing particular locations. The IHR control the DG’s executive power in three notable ways: first, the defined, limited criteria for a PHEIC, provided at Article 1 of the IHR; second, the specific process by which a declaration can be made, found at Article 12, which outlines the factors a DG can take into consideration when making such a determination; and finally, the role of the EC, which was intended to reassure member states that the PHEIC would be a technical process, limiting the political executive discretion of the DG, which had been (controversially) utilized during the severe acute respiratory syndrome (SARS) outbreak in 2002/3.15 In spite of this, as we demonstrate, there are a number of stages whereby executive discretion can, and indeed does, disrupt the PHEIC declaration process: • whether the DG convenes an EC (or not); • who is selected to participate in the EC;
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See ‘SARS, China, and the use of discretionary powers at WHO’.
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• what role the affected member state plays dur ing EC meetings; • what evidence is drawn on in coming to a decision as to whether the event constitutes a PHEIC; • whether the DG accepts the recommendation of the EC; and • what Temporary Recommendations (TRs) are put in place. We have sought to interrogate these questions through our analysis of the PHEIC declarations to date. In doing so, we have determined that discretion is utilized in an ad-hoc and inconsistent manner over these differing facets of the PHEIC declaration process, leading to an inconsistent application in how the PHEIC is declared and used during different health emergencies. It is our contention that this inconsistency undermines the normative and legal authority of the PHEIC as a tool in global health. Indeed, as Brunnée and Toope argue, shared understandings of what law is, and to what extent it binds actors, are a key aspect of the criteria of legality.16 Put bluntly, the inconsistency raises the question that if the WHO does not consistently apply its obligations contained within the IHR, why then should states? In the wake of COVID-19, and the failure of governance mechanisms globally, including that of the IHR, it is increasingly likely that such structures and processes will be revised. There are already several review panels that have looked at pandemic preparedness and response, including the Independent Panel for Pandemic Preparedness and Response, the IHR Review Committee and the Independent Advisory Oversight Group of the Health Emergencies Programme, each of which has concluded to some extent that the current IHR provision has not worked as intended, and many governments
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Jutta Brunnee and Stephen J Toope, Legitimacy and Legality in International Law: An Interactional Account (Cambridge University Press 2010).
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have started to consider policy changes or global action to prevent future epidemics and pandemics.17 The IHR Review Committee has called for greater transparency to the EC process, including routine publication of the information EC members are provided with, notification of divergent views among the panel and the rationale of ECs. Thus, it seems clear that we need to better understand the process by which health events are declared PHEICs, to be able to facilitate improvements to the process by which states, the WHO and the epistemic community collectively engage to manage emerging pathogens. Why this matters The arguments we outline in terms of the declaration of the PHEIC are not mere academic folly; the inconsistency and opaque processes we identify have real-world implications.
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WHO, ‘Report of the Third Open Meeting of the Review Committee on the Functioning of the International Health Regulations (2005) During the COVID-1 9 Response’ (3 November 2020) https:// www.who.int/publications/m/item/third-meeting-of-the-review- committee-o n-t he-f unctioning-o f-t he-i nternational-h ealth-regulations- (2005)-d uring-t he-c ovid-19-response; WHO, ‘Interim report on WHO’s response to COVID-19 January-April 2020 Geneva: World Health Organization’ (28 April 2020) https://www.who.int/publications/m/ item/interim-report-on-who-s-response-to-covid---january---april- 2020; United States Government. ‘Reviewing COVID-19 Response and Strengthening the WHO’s Global Emergency Preparedness and Response WHO ROADMAP’ (9 September 2020) https://www.hhs.gov/about/ agencies/oga/about-oga/what-we-do/international-relations-division/ multilateral- relations/ w ho- roadmap- 2 020.html; Governments of France & Germany ‘Non-Paper on Strengthening WHO’s leading and coordinating role in global health’ (2020) http:// g 2h2.org/ wp-content/uploads/2020/08/Non-paper-1.pdf; UK Government ‘Prime Minister’s Speech to United Nations General Assembly’ (26 September 2020) https://www.gov.uk/government/speeches/ prime-ministers-speech-to-un-general-assembly-26-september-2020.
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We suggest there are three major implications of the politicization and lack of consistency in the PHEIC process. First, as a normative tool, without consistency, the power of the instrument may wane, and indeed, given how states and the WHO Secretariat now apparently view the PHEIC as a ‘punishment’, this is already apparent. Second, if there is inconsistency in the approach used by the EC and DG, then this allows for a reproduction of this inconsistent application by states, for which it would be harder to challenge given internal precedent within the international organization alongside perpetuating norms of sovereignty. Finally, the politicization of the process –by both the DG and the EC –challenges the legitimacy and authority of the PHEIC, the IHR and the WHO more broadly in global health security, which in and of itself poses a risk in a time of crisis. Let us elaborate on each of these in turn. The PHEIC is not only a legal tool, it also plays an important political role in global health security: it is a call to arms for the global community to prepare for and support the response to a potential health emergency. The aim of the PHEIC within the WHO at least is to do so a-politically, using technical expertise that could provide a meaningful ‘unbiased’ alarm to encourage greater compliance. That an international organization has such power to sound an alarm is also important, and shows the unique nature of the PHEIC. However, there is an important sequence here. The process by which the PHEIC is declared is legal; it has clearly defined legal criteria, and treaty-based roles and functions are clearly assigned to relevant actors. However, the process has been bastardized by successive DGs, who either refuse to use the mechanism when it is clear the criteria are met, such as with Ebola in West Africa, or allow the EC to take into account political, social and economic factors into their deliberations, which are then accepted and endorsed by the DG. To be clear, where it is apparent an event could constitute a PHEIC, the DG ought to immediately convene an EC and that EC ought to consider only the criteria found
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at Article 1 and the Annex 2 decision-making instrument, and nothing more; that is its treaty role. If the EC takes into account political considerations, then it operates beyond its treaty role, and cannot be held accountable for doing so as an expert advisory committee. The DG then takes this advice, along with the other factors outlined at Article 12, and determines whether a PHEIC ought to be declared. If political, social or economic factors are to be taken into account in the PHEIC declaration process it is at this point, by the DG, as importantly the DG is the one who can be held accountable for such a decision as an elected official. If the DG fails to convene an EC on the basis of these political considerations, then it could be argued that the DG has failed to reasonably exercise their treaty role.18 Compliance with the IHR has always posed a cause for concern. The fundamental tension that occurs is one familiar to international relations: how to incentivize compliance with an international agreement that does not have any built-in enforcement or incentive mechanisms. While there is evidence that many governments do comply with the IHR,19 this is not consistent, and it seems there are acute departures from international law, and broader shared normative goals of global health security, at times of crisis.20 As witnessed in 2020, despite the DG issuing no Temporary Recommendations (TRs) related to travel or trade in the case of COVID-19, many governments decided to pursue these independently, potentially departing
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Mark Eccleston-Turner and Scarlett McArdle, ‘The Law of Responsibility and the World Health Organization: A Case Study on the West African Ebola Outbreak’ in Mark Eccleston-Turner and Iain Brassington (eds) Infectious Diseases in the new Millennium: Legal and Ethical Challenges (Springer 2020). Sara E Davies, ‘The International Politics of Disease Reporting: Towards Post-Westphalianism?’ (2012) 49 International Politics 591. Davies and Wenham, ‘Why the COVID-1 9 Response Needs International Relations’.
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from the IHR.21 Compliance is central to the efficacy of the IHR; and the WHO as the central epidemic coordinator needs to model good behaviour by internally complying with the letter and spirit of the IHR. In this, the political decision- making considerations for the PHEIC declaration lie solely with the DG, and not with the EC. Therefore, the introduction of such considerations as part of EC deliberations, and the inconsistent use of the processes embedded within the IHR by multiple DGs sets an uncomfortable precedent. This leads to a third and final challenge with the departure from the text of the PHEIC process, that of the broader impact it might have on the role of the PHEIC, the power of the IHR and the authority of the WHO in global health security. The procedure laid down in the IHR being followed (and, importantly, being seen to be followed) is of importance not just to the legitimacy of the PHEIC declaration, or the EC, but also to the legitimacy of the WHO itself. An international organization failing to follow the treaty for which it is responsible for also has the potential to do damage to the normative weight of the treaty. First, it signals that the obligations contained within the treaty are obligations that can be ignored or interpreted differently to suit the user. This has the potential to politicize the treaty (the exact opposite of what it was created to do) and weaken the normative weight of it on the basis that ‘legal rules whose content or application depends on the will of the legal subject for whom they are valid are not proper legal rules at all but apologies for the legal subject’s political interests’.22 As Koskenniemi has argued: ‘According to the requirement of normativity, law 21
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Not all trade and travel restrictions during a PHEIC constitute a breach of the IHR. However, it is not possible to determine which amount to a breach, as state justifications for additional health measures under Article 43 of the IHR are not made publicly available. Hersch Lauterpacht, The Function of Law in the International Community (1st paperback edn, Oxford University Press 2011) 189.
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should be applied regardless of the political preferences of legal subjects. In particular, it should be applicable even against a state which opposes its application to itself.’23 While this statement was originally given in respect of states themselves, it does not require a leap of logic to accept that the statement applies equally to international organizations, especially where the international organization is the guardian of the treaty in question. As Loughlin noted: [T]he process of judgment must be independent of the whim of any individual; judgment is concerned with the objective weighing of issues in the balance. Justice demands the evaluation of human behaviour against an objective standard, and it is this objective standard which is reflected through the principles of the law.24 In the context of the IHR, compliance by states is already a delicate, controversial topic: during public health emergencies, states regularly breach the IHR by imposing trade and travel bans on states affected by the outbreak;25 the majority of states have failed to meet the ‘core capacities’ requirements laid out in the IHR for health system strengthening and public health surveillance;26 and there is an ongoing fear that states might breach the IHR in failing to notify the WHO of unusual pathogens
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Martti Koskenniemi, ‘The Politics of International Law’ (1990) 1 European Journal of International Law 4. Martin Loughlin, ‘Sword and Scales: An Examination of the Relationship Between Law and Politics’ (Hart Publishing, 2000) 56. Lawrence O. Gostin and Rebecca Katz, ‘The International Health Regulations: The Governing Framework for Global Health Security’ (2016) 94 The Milbank Quarterly 264. WHO, ‘2018 State Parties Self-Assessment Annual Report on IHR Implementation – Scores per Capacity by WHO Region’ (2018), https://w ww.who.int/g ho/i hr/i hr_0 01_s core_p er_c apacity_by_ region.png?ua=1.
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in their territory.27 Thus, the treaty being undermined by the WHO could have wide-ranging public health consequences for the functioning of the IHR, with significant ramifications for global health security, for state decision making and, more broadly, for international order. Moreover, by their very nature, international organizations are (only) endowed with the powers conferred to them by their member states ceding a degree of their sovereignty to the organization in question, to fulfil an agreed and designated role. If the WHO is seen to be non-compliant with the IHR, this could pose a broader challenge to the WHO’s role as global epidemic coordinator and as the de-facto leader in global health emergencies, something that is evidently becoming increasingly challenged during the COVID-19 pandemic. Much criticism of the IHR has focused on the intrusion on state sovereignty and the scope of the institutional authority afforded to the WHO.28 Political analysts were concerned as to the power the WHO would have to dictate national governance procedures (such as building core capacities) and to declare a PHEIC without explicit governmental consent.29 Legal scholars recognized further concern about the precedent this might set for the potential misuse of the powers contained therein.30 Yet, the IHR are predicated on a broader normative political shift in contextualizing global health security in relation to sovereignty, and that there may be temporary sovereign 27 28
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Rebecca Katz, ‘Pandemic Policy Can Learn from Arms Control’ (2019) 575 Nature. Fidler and Gostin, ‘The New International Health Regulations: An Historic Development for International Law and Public Health’; Kamradt- Scott, Managing Global Health Security: The World Health Organization and Disease Outbreak Control. Christian Kreuder-Sonnen, ‘China vs the WHO: A Behavioural Norm Conflict in the SARS Crisis’ (2019) 95 International Affairs 535. Eric Mack, ‘The World Health Organisation’s New International Health Regulations: Incursion on State Sovereignty and Ill-Fated Response to Global Health Issues’ (2006) 7 Chicago Journal of International Law 365.
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trade-offs to ensure protection from health emergencies.31 Moreover, there are a number of concessions in respect of sovereignty built into the IHR, leading Burci to describe it as an agreement ‘that balances respect for national sovereignty with the new realities of international health cooperation and the increased importance of human security as a political and normative principle’.32 For example, while states must develop core competencies for preventing, detecting and responding to outbreaks, and accept the designation of a PHEIC, there is no enforcement or implementation mechanism to ensure that this happens.33 Even while member states have afforded the WHO the power to declare a PHEIC in respect of their territory, even against those states’ wishes, it can only be done ‘in accordance with the criteria and the procedure set out in [the] Regulations’.34 Furthermore, compliance is predicated on a ‘name and shame’ model whereby governments recognize the benefits to be derived from participating in the global disease control regime. In this approach, governments wish to appear as good actors, complying with the global normative agenda of global health security. This requires them to comply with the IHR, and push to ensure transparency, reporting on and implementing effective disease prevention, detection and response facilities, in order to contribute to the greater good of global health security. For some, such behaviour is 31
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Clare Wenham, ‘Examining Sovereignty in Global Disease Governance: Surveillance Practices in United Kingdom, Thailand and Lao People’s Democratic Republic’ (doctoral dissertation, Aberystwyth University) (2015). Gian Luca Burci, ‘Shifting Norms in International Health Law’ (2004) 16 Proceedings of the American Society of International Law 18. Adam Kamradt-Scott and Simon Rushton, ‘The Revised International Health Regulations: Socialization, Compliance and Changing Norms of Global Health Security’ (2012) 24 Global Change, Peace & Security 57; Davies, ‘The International Politics of Disease Reporting: Towards Post-Westphalianism?’. Article 12(1), International Health Regulations (2005) UNTS 2509.
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considered within their sovereign duty, with ‘sovereignty as responsibility’ being key to multilateral engagement with global issues.35 In this, statehood is not merely a blank cheque, but that to be a responsible sovereign nation, recognized as such by global peers, global norms must be adhered to, such as those of global health security. Norms require good behaviour and the demonstration of ‘oughtness’36 and in this context require compliance with the IHR. If the WHO is unable to model such compliance with the IHR and the norms on which the treaty is based, this might also jeopardize the broader normative agenda of global health security. Methodology To address our central question, we have carried out a blended legal-political analysis of the PHEIC documentation. The sources used to undertake our analysis include: the IHR (2005); preparatory documents related to its negotiation; World Health Assembly (WHA) and WHO Executive Board documentation; EC statements; the transcripts of press conferences hosted after each EC; statements from the DG; and further detail on the PHEIC tool as provided by the WHO Secretariat. As multidisciplinary authors, we each analysed these documents from our own disciplinary standpoint, and using methodologies prescribed accordingly. From an international relations perspective, we undertook in-depth policy content
35
36
Francis M Deng, Sadikiel Kimaro, Terrence Lyons, Donald Rothchild and I William Zartman Sovereignty as Responsibility: Conflict Management in Africa (Brookings Institution Press 2010); SE Davies and J Youde, ‘The IHR (2005), Disease Surveillance, and the Individual in Global Health Politics’ (2013) 17 The International Journal of Human Rights 133. Laura Pantzerhielm, Anna Holzscheiter and Thurid Bahr, ‘Power in Relations of International Organisations: The Productive Effects of “Good” Governance Norms in Global Health’ (2020) 46 Review of International Studies 395.
17
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analysis of the aforementioned documents, considering the political dimensions of the potential loopholes in the PHEIC process. Analysis sought to understand the presence or absence of connection to the legal wording of the PHEIC, alongside consideration of the additional assumptions/nuances included in the text.37 Legally, we rely on legal interpretation and analysis of the IHR, and the manner in which the Regulations have been interpreted and applied by the EC and DG in determining whether a PHEIC should be declared. To do so we employed a case study methodology,38 systematically analyzing each of the PHEICs declared, and those health emergencies that have not been declared a PHEIC. We performed content analysis on the relevant WHO documents relating to the outbreak, and the process of the IHR and PHEIC implementation, including the involvement of the EC and DG where possible. Through such methodology we are better able to understand the PHEIC declaration process by examining its real-world usage. We then contextualized and triangulated these policy findings amid the broader literature on global health governance and global health security within international relations, international law and global public health, to understand the bigger picture in which these decisions were made. This was important in understanding the potential political drivers of the decisions made, and what may have been points of contention. There is one key limitation to this methodology. We only used publicly available documents for our analysis. There are well-explored concerns about the opaque process of the EC
37
38
For similar utilization of such methodology please see: Sara E Davies, Adam Kamradt-Scott and Simon Rushton, Disease Diplomacy: International Norms and Global Health Security (JHU Press 2015); Clare Wenham and Deborah BL Farias, ‘Securitizing Zika: the case of Brazil’ (2019) 50 Security Dialogue 398. Detlef Sprinz and Yael Wolinsky-Nahmias (eds) Models, Numbers, and Cases: Methods for Studying International Relations (University of Michigan Press 2004).
18
Introduction
and PHEIC decision making,39 and thus, we are not able to explore the individual motivations of states, EC members or DGs. There are no transcripts or records of the meetings, and as a result, we can only claim to make reasonable inferences as to what might have motivated their decision making. We do not know what actually occurred ‘in the room where it happened’: what evidence was presented, who spoke, who did not speak, the process by which the outcome of the PHEIC decision was made (that is, whether it was a vote or a consensus), how much of what they covered in the meeting ended up in the EC statement following their deliberations, and what role advisors and state parties played in the process. In some places we were able to unpack this, in consideration of further material published by the EC members in academic journals, or media interviews; however, this is not comprehensive, nor consistent. We see this as a methodological weakness in this text, but more importantly it is a broader normative weakness within the functioning of the IHR. Given the purported power of the PHEIC declaration, the process by which this occurs must be made transparent, within broader norms of good governance.40 Structure of the book The book follows the following format. In Chapter One we outline the history of the IHR and PHEIC process and disentangle the process by which the PHEIC mechanism was created in the IHR (2005) by a range of norm entrepreneurs within the WHO and the broader global health community. In 39
40
Mark Eccleston-Turner and Adam Kamradt-Scott, ‘Transparency in IHR Emergency Committee Decision Making: The Case for Reform’ (2019) 4 BMJ Global Health e001618. Thomas G Weiss, ‘Governance, Good Governance and Global Governance: Conceptual and Actual Challenges’ (2000) 21 Third World Quarterly 795.
19
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Chapter Two we break down the articles of the IHR relevant to the PHEIC process, to understand the legal meaning of the process, and which prerogatives are granted, and to whom. In this, we demonstrate the key roles for the EC and DG and underscore the importance of the PHEIC declaration resting on clearly defined criteria: the event being unusual or unexpected; the potential risk of international spread of the event; and the need for a coordinated international response. We explore these tensions empirically in Chapter Three, in which we dissect the declarations of PHEICs to date. We narrate these chronologically, demonstrating the inconsistent application of the PHEIC criteria, inconsistent exercises of discretionary powers by the DG, and the DG seemingly furnishing the EC with executive political discretion explicitly reserved for the DG in the text of the IHR. In doing so, we argue that the lines between the roles of the DG and EC in declaring a PHEIC have become blurred. We follow this in Chapter Four where we analyse instances where the criteria to declare a PHEIC appear to have been objectively met but no declaration was made. Finally, in the Conclusion we demonstrate why this matters, arguing that where discretionary executive power is afforded by a legal instrument, it is necessary that such power is exercised reasonably and in a proportional manner. For example, that where the option to allow consideration of political or social factors in the PHEIC decision making is permitted, this must be the remit of the elected official (DG) and not the technical committee (EC); giving such power to the EC undermines the broader legal framework in which that power sits. It is our contention that this has occurred with the PHEIC thus far, and this undermines the WHO and IHR’s authority in global disease control, risking global solidarity for health security.
20
ONE
From Westphalian to Post- Westphalian? The Origins of the PHEIC Declaration and the 2005 International Health Regulations
International Sanitary Conferences Modern-day international cooperation for the control of infectious disease began in 1851 with the first International Sanitary Conference (ISC). In these meetings, ten European (city) states and Turkey gathered to map out coordinated guidelines to minimize the effects of disease along trade routes, spurred on by a series of cholera outbreaks in the 18th and 19th centuries, which had devastated port cities.1 Importantly, their mandate was to establish mechanisms to reduce disease spread, and to do so with minimal interference with international trade –a balancing act that remains at the very heart of the current IHR. Conferences continued for almost a century, expanding membership of participating states, and topics covered. While the ISCs were progressive in respect to recognizing the need for international cooperation, they were hampered by the inability to agree to terms, and indeed differences in opinion about understanding disease transmission.2 This limited efforts to 1 2
Hugh S Cumming, ‘The International Sanitary Conference’ (1926) 16 American Journal of Public Health 975. Neville M Goodman, International Health Organizations and Their Work (2nd edn, Churchill Livingstone 1971).
21
DECLARING A PHEIC
create common processes for outbreak response; a tension that continues to blight cooperation for health security 170 years later. Despite these setbacks, ISCs did identify key tools for international infectious disease control: the standardization of quarantine at points of entry; the reporting of outbreaks internationally; and public health capacities to respond to an epidemic.3 By the early 20th century, international health cooperation led to the development of intergovernmental organizations for health: the Office International d’Hygiène Publique (OHIP), the Health Organization of the League of Nations4 and the International Sanitary Bureau, the precursor to the Pan American Health Organization (PAHO).5 Such international cooperation greatly expanded in the wake of the Second World War with the creation of the WHO, a key pillar of the post-war multilateral system.6 As part of this mandate, the World Health Assembly (WHA) (the legislative arm of the WHO) was granted the authority to adopt regulations concerning sanitary and quarantine requirements to prevent the international spread of disease.7 Such activity is structurally aligned to the Constitutional Functions of the Organization, which state that the WHO will ‘establish and maintain administrative and technical services as may be required including
3
4 5 6 7
Valeska Huber, ‘The Unification of the Globe by Disease? The International Sanitary Conferences on Cholera, 1851-1894’ (2006) 49 The Historical Journal 453; Mark Harrison, ‘Disease, Diplomacy and International Commerce: The Origins of International Sanitary Regulation in the Nineteenth Century’ (2006) 1 Journal of Global History 197. The World Health Organization, The First Ten Years of the World Health Organization (1st edn, World Health Organization 1958). Bolivar J Lloyd, ‘The Pan American Sanitary Bureau’ (1930) 20 American Journal of Public Health and the Nations Health 925. Marcos Cueto, Theodore M Brown and Elizabeth Fee, The World Health Organization: A History (Cambridge University Press 2019). Article 21(a), Constitution of the World Health Organization (1946) 14 UNTS 185.
22
From Westphalian to Post-Westphalian?
epidemiological and statistical services … and to stimulate work to eradicate epidemic, endemic and other diseases’.8 Interestingly, the IHR (and the ISC predecessors) are adopted pursuant to Articles 21 and 22 of the WHO Constitution, and are legally binding on member states of the WHO without needing to be independently ratified within the domestic legal system; a unique power within international law making, with the intention to bypass domestic political interference in public health processes, instead of a Treaty approach, such as that of the Framework Convention for Tobacco Control, which requires state ratification. In 1951 the WHA adopted the International Sanitary Regulations (ISR), replacing the existing international health conventions such as ISCs, as well as regional arrangements that had been created through PAHO, and firmly entrenching the WHO at the centre of disease governance arrangements. 9 These Regulations focused on ‘sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease’.10 They identified standard epidemiological procedures;11 a unified consensus on six notifiable diseases (cholera, plague, relapsing fever, smallpox, typhoid and yellow fever);12 and minimum hygiene measures at ports;13 as well as harmonizing the requirements in respect of vaccine certification for certain infectious diseases.14 Importantly for our narrative,
8 9 10 11 12 13 14
Article 2(g), Constitution of the World Health Organization (1946) 14 UNTS 185. Jeremy R Youde, Global Health Governance (Polity Press 2012) 118. Article 22, International Sanitary Regulations (1951) 175 UNTS 214. Article 10, International Sanitary Regulations (1951) 175 UNTS 214. Article 1, International Sanitary Regulations (1951) 175 UNTS 214. Articles 14 and 15, International Sanitary Regulations (1951) 175 UNTS 214. Article 1 and Annexes 2, 3 and 4, International Sanitary Regulations (1951) 175 UNTS 214.
23
DECLARING A PHEIC
while states had to report any predetermined notifiable disease to the WHO, in turn the WHO had to notify other states of any outbreaks emerging. Thus, the WHO played a central role in communicating whatever information was known about the disease. The fact that such powers and duties were developed through international law is also pertinent, as it shows that, even in 1951, the WHO was cognizant of the need to ensure that governments complied with the public health recommendations and recognized that, in order to achieve this, there needed to be some attempt at a binding agreement between states themselves, rather than a mere mandate or policy of the organization. The 1969 International Health Regulations –need for reform The 1951 ISR were updated and renamed the International Health Regulations in 1969, in which the emphasis on quarantine as a method of controlling disease was lessened, and the list of notifiable diseases was reduced to cholera, plague and yellow fever. These measures reflected the belief that the world was winning the battle against infectious disease.15 Accordingly, international cooperation for disease control became less pressing for diplomatic efforts: high-income settings did not consider cholera, plague or yellow fever to be a risk, and LMICs that suffered had little to gain from reporting disease, other than trade restrictions, and thus this area of global disease control began to languish. By the mid-1990s, the WHO and member states began to reconsider the IHR, and the need to bring international 15
Max Hardiman and Annelies Wilder-Smith, ‘The Revised International Health Regulations and Their Relevance to Travel Medicine’ (2007) 14 Journal of Travel Medicine 141; Lawrence O Gostin and Rebecca Katz, ‘The International Health Regulations: The Governing Framework for Global Health Security’ (2016) 94 The Milbank Quarterly 264.
24
From Westphalian to Post-Westphalian?
disease control efforts into the 21st century.16 These efforts were spurred on following outbreaks of: plague in Surat (India) in 1994, which demonstrated the reality of major travel and trade disruption caused by an outbreak; and Ebola in Kikwit (Democratic Republic of the Congo [DRC]) in 1995, where the WHO launched its first coordinated response to an epidemic, which occurred outside the mandate of the IHR. Areas of contention with the IHR consolidated on the narrow definition of diseases and on state compliance with the legal mechanism. As outlined, the 1969 IHR only applied to three notifiable diseases. This meant that there was no duty on states to report any outbreak of disease not on this explicit list, even if the disease posed human pandemic potential. For example, although the DRC did report the Ebola outbreak to the WHO, it did so in order to seek assistance in managing the response when it was unable to do so independently;17 there was no legal obligation to report, despite the risk that it clearly posed to neighbouring countries. Moreover, the reaction to the outbreak in Surat highlighted that the WHO had little control over how states implemented disease control protocol embedded within the IHR, and that after the negative experience that India suffered, states would be even less likely to report.18 The reporting mechanisms within the 1969 IHR were highly deferential to state sovereignty and based on the principle of state reporting of notifiable diseases to the WHO.
16
17
18
Sara E Davies, Adam Kamradt-Scott and Simon Rushton, Disease Diplomacy: International Norms and Global Health Security (Johns Hopkins University Press 2015). JJ Muyembe-Tamfum and others, ‘Ebola Outbreak in Kikwit, Democratic Republic of the Congo: Discovery and Control Measures’ (1999) 179 The Journal of Infectious Diseases S259. Laurie Garrett, Betrayal of Trust: The Collapse of Global Public Health (1st edn, Hyperion 2000); Sara E Davies, Global Politics of Health (Polity 2010) 149.
25
DECLARING A PHEIC
The IHR did not allow for any other method of obtaining disease-pertinent data if a state was not forthcoming with this information. Indeed, there had been increasing evidence of many states failing to report outbreaks to the WHO in a timely manner as they feared that they would suffer from trade or travel reductions from other states.19 Governments reporting cholera, for example, indirectly admit to having their water supply contaminated by faeces and therefore run the risk of severe economic repercussions: export restrictions on food goods and a downturn in tourism. These served to create a strong incentive to not report.20 Indeed, despite the WHO’s expansive constitutional mandate to be the central coordinating authority of international disease control, under the 1969 IHR states retained significant power and influence over the international response to infectious disease outbreaks. Even if the WHO had credible evidence to suggest that there was an outbreak occurring, it could not act until official notification came from the state in question. This quandary was further compounded by the delicate geopolitical aspects of disease control: the WHO would not (publicly) challenge states into declaring outbreaks. The only example of an exception to this rule was the anomaly whereby the WHO shared information about a cholera outbreak in Guinea, without the government having formally reported this.21 19 20
21
Mark W Zacher and Tania J Keefe, The Politics of Global Health Governance: United by Contagion (1st edn, Palgrave Macmillan 2008). B Velimirovic, ‘Do We Still Need International Health Regulations?’ (1976) 133 Journal of Infectious Diseases 478; David Ofori-Adjei and Kwadwo Koram, ‘Of Cholera and Ebola Virus Disease in Ghana’ (2014) 48 Ghana Medical Journal 120; David C Griffith, Louise A Kelly-Hope and Mark A Miller, ‘Review of Reported Cholera Outbreaks Worldwide, 1995–2005’ (2006) 75 The American Journal of Tropical Medicine and Hygiene 973. Lorna Weir and Eric Mykhalovskiy, Global Public Health Vigilance: Creating a World on Alert (Routledge 2012) 74–5.
26
From Westphalian to Post-Westphalian?
Reforming the regulations The move to update the IHR in the 1990s also reflected a broader normative shift towards the securitization of disease within both the WHO and the broader global community.22 This was seen in four ways. First, globalization, migration and rapid urbanization impact the potential speed and spread of infectious disease, and an outbreak in one part of the world could rapidly be elsewhere in a matter of hours.23 Second, the risk of bioterrorism was highlighted, acutely apparent after the Aum Shinrikyo attack on the Tokyo Subway in 1995.24 Third, the connection was made, through HIV/AIDS, that increased prevalence of a disease within a military would directly affect the readiness of an army to be able to respond to a potential attack, and thus would pose a direct security threat as classically understood.25 Finally, there was an increased recognition that a major epidemic would cause economic insecurity across affected societies as public health interventions disrupt routine capital accumulation and trading.26 Social breakdown was
22
23 24 25
26
Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security; Colin McInnes and Kelley Lee, ‘Health, Security and Foreign Policy’ (2006) 32 Review of International Studies 5; AT Price-Smith, The Health Of Nations: Infectious Disease, Environmental Change, and their Effects on National Security and Development (MIT Press 2001); Jeremy Youde, ‘Enter the fourth horseman: health security and international relations theory’ (2005) 6 Whitehead Journal of Diplomacy & International Relations, 193. Simon Rushton, ‘Global Health Security: Security for Whom? Security from What?’ (2011) 59 Political Studies 799. Kyle B Olson, ‘Aum Shinrikyo: Once and Future Threat?’ (1999) 5 Emerging Infectious Diseases 413. UNSC Res 1308 (17 July 2000) UN Doc/S/Res/1308; UNSC Res 1983 (7 June 2011) UN/DOC/S/Res/193; McInnes and Lee, ‘Health, Security and Foreign Policy’. Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security.
27
DECLARING A PHEIC
also highlighted as a concern,27 although this was untested (until COVID-19). As Davies, Kamradt-Scott and Rushton argue, the increased securitization of disease offered enabling conditions for revisions to the 1969 IHR, through norm entrepreneurs in key states and at the WHO, to create an understanding that global disease control required a collective globalist approach to tackling the transnational threat of emerging pathogens. Thus, starting in 1995, the WHO began the process of updating the IHR.28 Reform began with WHO Executive Board Resolution 95/ 12 proposing changes to the IHR, including that member states build capacity for surveillance, laboratory facilities, research and diagnostics activity, and mechanisms for data sharing and collaboration between actors.29 These discussions progressed to the WHA through Resolutions WHA 48.730 and WHA 48.13,31 beginning the process of revisions. While member states agreed that there should be a coordinated governance arrangement for infectious disease control, vast differences remained between states as to what this should look like.32 Throughout the negotiation processes, a key feature of the discussions was the role, power and duties of the WHO. From the early discussions on IHR reform there was a desire to expand the mandate and power of the WHO during a health 27 28 29 30 31
32
Pieter Fourie, ‘The Relationship between the AIDS Pandemic and State Fragility’ (2007) 19 Global Change, Peace & Security 281. Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security 6. WHO, ‘WHO response to global change –Progress report by the Director-General’ (31 October 1994) EB95/12 Ninety-fifth Session. World Health Assembly, ‘Revision and Updating of the International Health Regulations’ (May 12, 1995) WHO Doc. WHA 48.7. World Health Assembly, ‘Communicable Disease Prevention and Control: New, Emerging and Re-emerging Infectious Diseases’ (May 12, 1995) WHO Doc. WHA 18.13. Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security 7.
28
From Westphalian to Post-Westphalian?
emergency; early proposals positioned the WHO as the technical lead for coordinating and disseminating surveillance data from a multitude of national and international sources,33 not limiting this to a state power, and, indeed, the WHO could share information without the consent of the affected state. The intention of the reformed IHR was to further the legitimacy of the WHO as the primary source of information and norms for global health security. Most notably the IHR (2005) sought to formalize the WHO’s role during SARS (broadly seen as successful34) as the lead coordinator of the global response to disease outbreaks. Crucially, the developments proposed the IHR transition from being an inter-state agreement within international law, with the WHO a recipient of information at the behest of the state party concerned (as was the case with the 1969 Regulations), to the WHO being an agent in the process with power in the relationship, or rather a ‘hubs and spokes’ model for the WHO and member states.35 In this way, the WHO would remain at the centre of any governance arrangements, states would be required to report information to the WHO, alongside non-state actors, and the WHO would then have the power to share that information globally after verification, to prevent the international spread of disease.36 This significantly boosted the WHO’s political power in global disease control, but doing so demonstrated the importance that states placed on global health security, that they were willing to cede some sovereignty to the normative goal of global health security.
33 34 35 36
Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security 7. Adam Kamradt-Scott, Managing Global Health Security: The World Health Organization and Disease Outbreak Control (Palgrave Macmillan 2015). Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security. Adam Kamradt-Scott, ‘The Evolving WHO: Implications for Global Health Security’ (2010) 6 Global Public Health 8 801.
29
DECLARING A PHEIC
Importantly, the 1969 Regulations provided no guidance to governments on how to respond to an outbreak, nor did the IHR provide formal scope for the WHO to conduct this vital coordination role, despite the constitutional mandate of the WHO to function as the ‘directing and co-ordinating authority on international health work’.37 While of course the WHO did informally fulfil this role during health emergencies, the fact that such action was not grounded in the IHR themselves meant that the WHO lacked the normative force associated with functions grounded within international law. Therefore, the ability of the WHO to make preparedness and response recommendations was a key development within the legal framework of the IHR (2005). As such, this power was groundbreaking and further consolidated the novel leadership role for the WHO within the IHR and broadly within global health security. A second key feature of the proposed plans was to ensure that any future powers given to states or the WHO for infectious disease control was done with ‘minimal interference with traffic and trade’. To do so, instead of specifying public health interventions that the WHO could recommend during outbreaks (allowing for political interference within the WHO that might favour public health over that of trade), it was preferred that recommendations be context specific and based on the judgement of ‘expert consensus opinion’.38 This formed the starting basis for deliberations around the role of an ‘expert committee’ to meet during a health emergency to decide on what measures are appropriate. In the earliest draft of the revisions to the IHR in 1997, the creation of such a committee was central to the planned reforms. By 2004, the WHO (and by default, states that governed the IHR process) 37 38
Article 2(a), Constitution of the World Health Organization (1946) 14 UNTS 185. David P Fidler, ‘International Law and Global Public Health’ (1999) 48 Kansas Law Review 2.
30
From Westphalian to Post-Westphalian?
had doubled down on this, stating that ‘advisories played a crucial role in coordinating [and] orientating the international response to events and public health threats’.39 This ‘expert committee’ would eventually become the EC in the finalized revisions of the IHR (2005). It was clear that while the WHO would receive expanded powers to recommend interventions that may interfere with travel and trade (albeit minimally), this needed to be done in consultation with an independent expert committee, and this power could not be exercised solely at the discretion of the DG. In this sense, the creation of an EC served two functions: a scientific one, to ensure that the DG was furnished with the highest standard of available evidence on which to make an informed decision; and the EC was also seen as an important check on the executive power to be exercised by a DG during a health emergency –an executive power that would come to be the subject of intense scrutiny and discontent by member states during the SARS outbreak.40 The declaration of a PHEIC also emerges in these early draft papers on IHR reform, albeit slightly later in the process. At the time of the mid-1990s draft papers, the PHEIC was referred to merely as an ‘outbreak alert’. This outbreak alert did not appear in the 1998 provisional IHR draft,41 nor in the 2001 IHR report.42 By 2002, with the publication of Global Crisis, Global Solutions, the need for a ‘transparent process for how to make recommendations’ was being explicitly considered. Indeed, the first time we see the term ‘public health emergency 39
40 41 42
WHO, ‘Review and Approval of Proposed Amendments to the International Health Regulations: Explanatory Notes. Intergovernmental Working Group on the Revision of the International Health Regulations, provisional agenda item 3’ (7 October 2004) A/IHR/IGWG/4. David P Fidler, ‘SARS: Political Pathology of the First Post-Westphalian Pathogen’ (2003) 31 The Journal of Law, Medicine & Ethics 485. WHO, ‘Revision of the International Health Regulations: Progress Report’ (10 March 1998) A51/8. WHO, ‘Revision of the International Health Regulations: Progress Report, February 2001’ (2001) 76 Releve Epidemiologique Hebdomadaire 61.
31
DECLARING A PHEIC
of international concern’ is in the context that states must have the capacity to ‘detect and quickly respond to a public health emergency of international concern’43 even though the declaration of a PHEIC (and the process by which this would occur) was not initially part of the reform agenda. This language is important: it was a clear signal that the proposed IHR revisions were to move away from a restrictive list of notifiable diseases, to encapsulate a broader all-hazards approach to global health security, whereby any disease event of known, or unknown, origin could be included under the IHR remit, including deliberate events, or a chemical or radionuclear event. However, this was not without challenges; some states preferred specific diseases to always be included in the PHEIC mechanism –ultimately, these two approaches were combined in Annex 2 of the IHR.44 The move from the prescribed list to an all-hazards approach warranted a decision instrument to assist states in determining when a potential health emergency was to be reported to the WHO, and when the WHO would act on such notification and make recommendations. This resulted in a ‘Decision instrument for the assessment and notification of events that may constitute a Public Health Emergency of International Concern’ –at Annex 2 of the IHR (2005). Under Annex 2, notification by states to the WHO must occur if the response to two of four criteria45 are affirmative, or if a health emergency is caused 43
44 45
WHO, ‘Global crises, global solutions –managing public health emergencies of international concern through the revised International Health Regulations’ (2002) WHO/CDS/CSR/GAR/2002/4/ENP. P.11. Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security 61. ‘Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international restrictions to travel and trade?’, which is typically used by state parties to determine if a public health event within their territory ought to be notified to the WHO under Article 6 of the International Health Regulations, as a potential PHEIC.
32
From Westphalian to Post-Westphalian?
by poliomyelitis, smallpox, human influenza caused by a new subtype or SARS. SARS, China and the use of discretionary powers at the WHO SARS emerged as an airborne virus in China in 2002/3, infecting people in 26 countries with 8,000 cases and just under 800 deaths, with a short-term economic impact of over $80 billion,46 demonstrating the realities of a globalized pathogen affecting public health, the economy and security simultaneously. For many, SARS was a catalyst for pushing through revisions to the IHR.47 The epidemic personified many of the fears of policy makers and epidemiologists who had justified the previous decade’s conversations about revisions, and indeed demonstrated the need for coordinated efforts to mitigate against international spread. Although it subsequently became clear that China was concealing the severity and scale of the outbreak, from a contemporary IHR perspective, SARS did not constitute a ‘notifiable disease’ and therefore China was not legally bound to disclose this information. Moreover, the Chinese response to SARS further demonstrated the limitations of the state-centric governance system embedded within the 1969 IHR. First, the 1969 IHR were concerned only with disease surveillance and notification at international entry points (ports and airports); internal disease outbreaks within a states’ territory were outside of the remit of the IHR until an infected individual attempted to travel across borders, making detection of SARS all the 46 47
KS Chan and others, ‘SARS: Prognosis, Outcome and Sequelae’ (2003) 8 Respirology S36. Jeremy Youde, ‘Biosurveillance, Human Rights, and the Zombie Plague’ (2012) 24 Global Change, Peace & Security 83; David P Fidler, SARS: Governance and the Globalization of Disease (Palgrave Macmillan 2004).
33
DECLARING A PHEIC
more difficult. Indeed, the IHR (2005) all-hazards approach remedies this by requiring that a state party has capacity to detect and assess health emergencies across the whole national health system.48 In addition, under the IHR (2005), disease notification can come from other states, as well as non-state actors.49 This was a key development in the IHR (2005), providing for an expanded role of all actors within global health security, and for the WHO as the central coordination point in the previously Westphalian-centric model of governance. SARS presented the world with ‘an opportunity to develop new governance structures between multiple actors as infectious diseases continue to interact with humans in the national international and global contexts’.50 As Kamradt-S cott observed, the WHO now found itself acting simultaneously as ‘real time epidemic coordinator, policy advisor, government assessor, and government critic’.51 Through SARS the WHO became central to collating and analyzing data, and providing technical guidance to states, and indeed travel and trade recommendations to minimize the disease’s spread, even when it had no explicit legal mandate to do so.52 Indeed, the WHO’s leadership and coordination during the SARS outbreak ‘represent one of the high marks in the IHR in terms
48
49 50
51 52
Gostin and Katz, ‘The International Health Regulations: The Governing Framework for Global Health Security’; Feng-Jen Tsai and Rebecca Katz, ‘Measuring Global Health Security: Comparison of Self-and External Evaluations for IHR Core Capacity’ (2018) 16 Health Security 304. Article 9, International Health Regulations (2005) UNTS 2509. Obijiofor Aginam, Global Health Governance: International Law and Public Health in a Divided World (University of Toronto Press 2005) https:// www.degruyter.com/view/title/519380. Kamradt-Scott, Managing Global Health Security. David L Heymann and Guenael Roider, ‘SARS: A Global Response to an International Threat’ (2004) 10 The Brown Journal of World Affairs 185; Adam Kamradt-Scott, ‘The WHO Secretariat, Norm Entrepreneurship, and Global Disease Outbreak Control’ (2010) 1 Journal of International Organizations Studies 72.
34
From Westphalian to Post-Westphalian?
of centralization of alert and information functions’53 and, as a result, ‘the alert and response mechanisms of the [revised] IHR are modelled on the tools, processes and assumptions that characterized the global response to SARS’,54 with some concerned that the IHR were being overly shaped by the global response to the 2003 SARS outbreak.55 Reforming the IHR –process, politics and an innovative treaty The following chapter highlights some key aspects of the IHR (2005), in particular those pertaining to the process of the notification and declaration of the PHEIC, yet it is important first to assess the normative changes that took place to the IHR during renegotiation. We can categorize these into five key developments. First, Article 7 of the IHR (2005) jettisoned specific notifiable diseases and instead states are required to report ‘any public health event of international concern (PHEIC)’ –that is, syndromic reporting. The IHR (2005) therefore adopt a significantly broadened scope, and it was hoped in doing so that increased reporting would occur, increasing transparency and the frequency of information sharing to strengthen global health security. Such transparency would, in turn, create an environment for greater dialogue between actors, leading to
53
54
55
Gian Luca Burci and Mark Eccleston-Turner, ‘Preparing for the next Pandemic: The International Health Regulations and World Health Organization during COVID-19’ (2020) 2 Yearbook of International Disaster Law. Burci and Eccleston-Turner, ‘Preparing for the next Pandemic: The International Health Regulations and World Health Organization during COVID-19’. Burci and Eccleston-Turner, ‘Preparing for the next Pandemic: The International Health Regulations and World Health Organization during COVID-19’.
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DECLARING A PHEIC
a more fruitful disease governance mechanism, with increased trust in reporting potential outbreaks.56 The previous IHR had stifled the ability of the WHO to fulfil its constitutional functions of the organization to ‘act as the directing and co- ordinating authority on international health work’57 and to ‘stimulate and advance work to eradicate epidemic, endemic and other diseases’.58 Moreover, formalizing the notification aspects shows an important shift in the relationship between states and the WHO; the new IHR were intended to incentivize states to over-report, thereby essentially giving the WHO influence over how public health data collection systems operate at the domestic level.59 It also gave the WHO the power to decide which of the outbreaks reported are worth investigating and, indeed, which need to be shared internationally. This reaffirms the WHO’s power and position as the central hub of epidemic intelligence. However, this power came with constraints through the IHR, which provide a framework to guide state reporting to the WHO, and crucially for our purposes, provide a framework within which the DG must exercise their powers to declare a PHEIC, as outlined at Article 12. ‘Legalizing’60 the powers of the DG does not just constrain the DG within the limitations set out at Article 12, but the exercise of these powers can also be viewed under 56
57 58 59 60
This obviously relies on states acknowledging outbreaks through the IHR (2005). This has not always been the case and there are still states that choose to ignore these requirements such as Syria and the polio outbreak 2013/4; see: Bachir Tajaldin and others, ‘Defining Polio: Closing the Gap in Global Surveillance’ (2015) 81 Annals of Global Health 386. Article 2(a), Constitution of the World Health Organization (1946) 14 UNTS 185. Article 2(g), Constitution of the World Health Organization (1946) 14 UNTS 185. Jeremy R Youde, Biopolitical Surveillance and Public Health in International Politics (1st edn, Palgrave Macmillan 2010). Legalization refers to a specific set of characteristics that an institution may or may not possess: obligation, precision and delegation; see: Kenneth W
36
From Westphalian to Post-Westphalian?
administrative law principles such as reasonableness, proportionality and necessity,61 albeit not in a justiciable manner. Second, the revised IHR allow for the expansion of sources able to report outbreaks to the WHO, to avoid bottlenecks of states which see no incentive to report any potential emerging threat. Article 9 states that the ‘WHO may take into account reports from sources other than [state] notifications or consultations and shall assess these reports according to established epidemiological principles and then communicate information on the event to the state party in whose territory the event is allegedly occurring’.62 Non-state reports can be received from other states, sub-national agencies, non- governmental organizations, individuals, news reports and internet sources and the WHO is empowered to act on these non-official reports as it sees fit.63 Importantly, in recognition of sovereignty, such a process is moderated by the requirement to verify any emerging reports with the state affected prior to more widespread information sharing with the global community. The WHO has always had the constitutional right to consult with non-governmental and international organizations;64 however, its shift under the IHR to engage with non-state providers of disease-pertinent information was unprecedented. Such revision can be viewed as a game
61
62 63
64
Abbott and others, ‘The Concept of Legalization’ (2000) 54 International Organization 401. Jochen von Bernstorff, ‘Procedures of Decision-Making and the Role of Law in International Organizations’ (2008) 09 German Law Journal 11, 1948; Benedict Kingsbury, Nico Krisch and Richard B Stewart, ‘The Emergence of Global Administrative Law’, 68 Law and Contemporary Problems (2005) 15. Article 9, International Health Regulations (2005) UNTS 2509. Eric Mack, ‘The World Health Organisation’s New International Health Regulations: Incursion on State Sovereignty and Ill-Fated Response to Global Health Issues’ (2006) 7 Chicago Journal of International Law 365. Article 71, Constitution of the World Health Organization (1946) 14 UNTS 185.
37
DECLARING A PHEIC
changer –these newly permissible non-state actors legitimized a host of new eyes and ears to assist in holding governments accountable for their response to public health emergencies by creating a new source of information surveillance, which led the way for the globalization of disease surveillance.65 Third, the IHR (2005) include the explicit obligation on states to assess, strengthen and maintain core capacities for surveillance, risk assessment, reporting and response.66 As previously noted, the pre-IHR (2005) were concerned only with disease surveillance and notification at international entry points; the all-hazards approach of the IHR (2005) required the ability to detect and assess health emergencies across the whole national health system.67 Although the IHR do not specify the exact structure of any national surveillance system, they do tell states what outputs of such processes and systems must be.68 This requires establishing technical leadership during field responses, building local capacity for future epidemics and ensuring respect for legal, human rights and cultural sensitivities.69 There is a further obligation to establish a National Focal Point (NFP), which is required to notify the WHO of any event that may constitute a PHEIC within 24 hours of the discovery of a potential health emergency.
65
66 67
68 69
Sara E Davies and Jeremy Youde, ‘The IHR (2005), Disease Surveillance, and the Individual in Global Health Politics’ (2013) 17 The International Journal of Human Rights 133. Articles 5, 13 and Annex 1, International Health Regulations (2005) UNTS 2509. Gostin and Katz, ‘The International Health Regulations: The Governing Framework for Global Health Security’; Tsai and Katz, ‘Measuring Global Health Security: Comparison of Self-and External Evaluations for IHR Core Capacity’. Youde, ‘Biosurveillance, Human Rights, and the Zombie Plague’. Jessica L Sturtevant, Aranka Anema and John S Brownstein, ‘The New International Health Regulations: Considerations for Global Public Health Surveillance’ (2007) 1 Disaster Medicine and Public Health Preparedness 117.
38
From Westphalian to Post-Westphalian?
Through this move to require core capacities and the non- derogable obligations70 found at Articles 5 and 13, ‘national health systems under the IHR 2005 become an issue of legitimate international concern and must correspondingly generate accountability and responsibility akin to those arising from erga omnes obligations’.71 Such a requirement for domestic structural changes in the updated IHR represented a significant change in the relationship between the WHO and member states. Prior to these revisions the WHO had been loathed to impose standards on the health systems of its member states, thus such an introduction was seen as a potential challenge to the sovereignty of states, which no longer had sole discretion as to when to report an outbreak, nor what public health utilities they needed to have domestically (that is, a potential challenge to their sovereign decision about how to organize their public health system).72 As noted elsewhere, ‘the intrusiveness and implications of the core capacity obligations under the IHR (2005) are one of [their] most striking features and were probably underestimated during the revision process’.73 For 70 71
72
73
Meaning a legal obligation from which no derogation is permitted. Burci and Eccleston-Turner, ‘Preparing for the next Pandemic: The International Health Regulations and World Health Organization during COVID-19’. Mack, ‘The World Health Organisation’s New International Health Regulations: Incursion on State Sovereignty and Ill-Fated Response to Global Health Issues’. It is important to note that there are a number of concessions in respect of sovereignty built into the IHR, leading Burci to describe it as an agreement ‘that balances respect for national sovereignty with the new realities of international health cooperation and the increased importance of human security as a political and normative principle’ –Gian Luca Burci, ‘Shifting Norms in International Health Law’ (2004) 16 Proceedings of the American Society of International Law 18. Burci and Eccleston-Turner, ‘Preparing for the Next Pandemic: The International Health Regulations and World Health Organization during COVID-19’.
39
DECLARING A PHEIC
many, meeting the core competencies required a substantial upgrade to surveillance capabilities, with many states lacking the resources to do this and/or the political will to prioritize the funding over other domestic concerns.74 In 2012, on the fifth anniversary of the IHR (2005) ratification, when states were supposed to have met these prescribed requirements, 107 state parties asked for two further years to implement the requirements.75 In 2014, only 42 states declared that they had met the core requirements.76 This still left 152 state parties in breach of at least one of the core capacity requirements under the IHR. Although there may be several reasons for this lack of compliance, Gostin and Friedman suggest that a key problem is that the IHR do not consider the financial burden put on states to meet the requirements and nor do they offer them a funding mechanism to develop the necessary infrastructure,77 an issue that continues to plague IHR implementation. Fourth, having been absent from previous iterations, human rights are strongly embedded within the IHR (2005). Human rights are referenced at Article 3 in that ‘the implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons’78. They are also expressly mentioned in Article 32, stating that 74
75 76 77
78
Clare Wenham, ‘Examining sovereignty in global disease governance: surveillance practices in United Kingdom, Thailand and Lao People’s Democratic Republic’ (doctoral dissertation, Aberystwyth University) (2015). WHO, ‘Summary of States Parties 2012 report on IHR core capacity implementation’ (2014) WHO/HSE/GCR/2014.5. WHO, ‘Summary of States Parties 2013 report on IHR core capacity implementation’ (2014) WHO/HSE/GCR/2014.10. Lawrence O Gostin and Eric A Friedman, ‘A Retrospective and Prospective Analysis of the West African Ebola Virus Disease Epidemic: Robust National Health Systems at the Foundation and an Empowered WHO at the Apex’ (2015) 385 The Lancet 1902. Article 3, International Health Regulations (2005) UNTS 2509.
40
From Westphalian to Post-Westphalian?
‘[i]n implementing health measures under these Regulations, States Parties shall treat travellers with respect for their dignity, human rights and fundamental freedoms and minimize any discomfort or distress associated with such measures’.79 The Article further provides for a non-exhaustive list of considerations for state parties to consider, including courtesy and respect, and taking into consideration gender, sociocultural, ethnic or religious concerns. It is worth noting that these are limited only to a ‘traveller’, defined as ‘a natural person undertaking an international voyage’;80 therefore, the human rights standards contained within Article 32 only become engaged when an individual crosses an international frontier and do not apply to health measures adopted within a state party’s territory. Fifth, and importantly, the IHR (2005) revisions reflect the global community’s contemporary understanding of health, disease and obligations to one another within a normative understanding of global health security.81 First, the IHR reflect a biomedical interpretation of health and disease, rather than considering social or traditional conceptions of these issues, or a recognition of the downstream effects of epidemics.82 Second, the approach seeks to contain disease at the source, and to alert the global community as soon as possible, through the IHR mechanism.83 Thus, the revisions echo an understanding that disease control is a global phenomenon that requires cooperation, compliance and the good will of all, thereby underlining the goals of global health security that the WHO and other norm entrepreneurs had been highlighting in
79 80 81 82 83
Article 32, International Health Regulations (2005) UNTS 2509. Article 1, International Health Regulations (2005) UNTS 2509. Youde, Biopolitical Surveillance and Public Health in International Politics. Nancy Krieger, Epidemiology and the People’s Health: Theory and Context (Oxford University Press 2011). Guénaël Rodier and others, ‘Global Public Health Security’ (2007) 13 Emerging Infectious Diseases 1447.
41
DECLARING A PHEIC
the previous decade.84 The IHR took this normative approach one step further, codifying norms into international law, and imposing an increasing sense of responsibility for global health security onto individual states. States that are party to the IHR have an explicit responsibility to meet the core capacities for disease control, and to be able to detect an outbreak at the earliest moment within the domestic health system, not just at international points of entry. Not only are states legally required to, but the assumption is that states should prioritise global health security, at the cost of other health priorities the state may have (and with it, the state’s absolute control over its health system and internal affairs). Such transparency, regular reporting and becoming good international citizens was rooted in an understanding of sovereignty as responsibility, even if this places socioeconomic constraints on governments for doing so.85 As has been widely debated in the literature on the IHR, a key concern is the lack of a formal compliance mechanism;86 indeed, there is no enforcement apparatus other than naming and shaming.87 However, this issue is not resolved by creating an enforcement arm for the WHO to implement punitive measures on states with weak health systems which fail to meet their obligations. The issue of sovereignty within the IHR exists in a delicate balance; concern has been raised that some state parties have a degree of distrust around the IHR, as they could, in their view, represent the WHO acting
84
85 86 87
Adam Kamradt-Scott and Simon Rushton, ‘The Revised International Health Regulations: Socialization, Compliance and Changing Norms of Global Health Security’ (2012) 24 Global Change, Peace & Security 57. Davies and Youde, ‘The IHR (2005), Disease Surveillance, and the Individual in Global Health Politics’. Davies, Kamradt-Scott and Rushton, Disease Diplomacy: International Norms and Global Health Security. Sophie Harmann, ‘Norms Won’t Save You: Ebola and the Norm of Global Health Security’ (2017) 11 Global Health Governance.
42
From Westphalian to Post-Westphalian?
as a Trojan horse for external interference in their domestic affairs.88 Moreover, the design of the IHR (2005) ‘imported certain assumptions about the compliance pull and effectiveness of WHO’s alert and guidance that were generated by the response to the 2003 SARS outbreak’,89 the effectiveness of which has not been replicated in subsequent outbreaks.90 Despite this, in agreeing to the IHR (2005), states subscribed to new expectations of each other, and of the WHO, new material requirements and new social norms compounding global health security;91 an achievement not to be dismissed for lack of formal enforcement tools. Indeed, as we come to analyse the PHEIC mechanism, it is important to remember that it (and the IHR) is not merely a legal process providing a framework around the emergency executive powers of the WHO (although such processes are important for their own sake), but it is also a normative call to arms for responding to a potential health emergency, which requires an explicit response from states. We explore the detail of the PHEIC mechanism in detail in the next chapter.
88
89
90
91
Mack, ‘The World Health Organization’s New International Health Regulations: Incursion on State Sovereignty and Ill-Fated Response to Global Health Issues’. Burci and Eccleston-Turner, ‘Preparing for the next Pandemic: The International Health Regulations and World Health Organization during COVID-19’. Ali Tejpar and Steven J Hoffman, ‘Canada’s Violation of International Law during the 2014-2016 Ebola Outbreak Notes and Comments’ (2016) 54 Canadian Yearbook of International Law 366; Nicole J Cohen et al, ‘Travel and Border Health Measures to Prevent the International Spread of Ebola’ (2016) 65 Morbidity and Mortality Weekly Report 57; Nicole J Cohen and others, ‘Travel and Border Health Measures to Prevent the International Spread of Ebola’ (2016) 65 MMWR Supplements 57. Kamradt-Scott and Rushton, ‘The Revised International Health Regulations: Socialization, Compliance and Changing Norms of Global Health Security’.
43
TWO
A Public Health Emergency of International Concern: Between Legal Obligations and Political Reality
The PHEIC mechanism is a tool designed to alert the globe to a new or spreading health emergency that may pose a concern to international travel and trade, and for which an internationally coordinated response may be required. In this chapter, we describe the roles of actors and process for declaring a PHEIC, providing clear and separate roles for state parties, the WHO DG, and the EC. In doing so, we lay out two of the central claims of this book. First, that the criteria to declare a PHEIC have been subject to broad interpretation by the EC beyond the legal text and mandate. Second, and linked to the first claim, that the EC is taking into account political considerations in decision making, a prerogative reserved for the DG, and in turn the DG has allowed this to occur. In the concluding section of this chapter, we outline the implications these two claims have on the good governance and legitimacy of the IHR and WHO. Role of states that are party to the IHR State obligations in respect of the PHEIC declaration are made up of two interlocking components: first, strengthening the national health system to be able to detect and assess
44
Between Legal Obligations and Political Reality
emerging health threats rapidly; and second, making timely notifications to the WHO regarding potential PHEIC events. Under the IHR, state capacity becomes an issue of legitimate international concern, outlined at Articles 51 and 13,2 as well as Annex 1,3 and must correspondingly ‘generate accountability and responsibility akin to those arising from erga omnes obligations’.4 Adherence to these articles has been measured initially by voluntary self-reporting of compliance and subsequently through a Joint External Evaluation (JEE) of states’ capacities, a voluntary peer-review process of states’ current health emergencies infrastructure, although many states have yet to undergo this process. The second duty of states that are party to the IHR is the actual reporting of events that may constitute a PHEIC. Article 6 raises the obligation for states to assess health events using the decision-making instrument5 found at Annex 2 (see
1
2
3
4
5
Which provides that ‘(e)ach State Party shall develop, strengthen and maintain … the capacity to detect, assess, notify and report events in accordance with these Regulations as specified in Annex 1’. ‘The capacity to respond promptly and effectively to public health risks and public health emergencies of international concern as set out in Annex 1’. Annex 1 provides further clarification on the measures states are required to adopt in line with their obligations outlined at Articles 5 and 13, dividing these between Section A and B. Section B –‘Core Capacity Requirements for Designated Airports, Ports and Ground Crossings’ – largely mirrors the obligations which were found in the pre-IHR (2005) with regards to detection and surveillance capacity at international borders. Section A lists a series of public health capacity ‘minimum requirements’ for national health systems, focusing on the capacity of the health system to perform international detection, surveillance and response. Gian Luca Burci and Mark Eccleston-Turner, ‘Preparing for the Next Pandemic: The International Health Regulations and World Health Organization during COVID-19’ (2020) 2 Yearbook of International Disaster Law. Article 6, International Health Regulations (2005) UNTS 2509.
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DECLARING A PHEIC
Figure 2.1) of the IHR6 and to provide relevant notification to the WHO regarding a potential or actual health emergency within their territory,7 furnishing the WHO with accurate and timely information in an ongoing manner, following the initial notification of an event.8 Indeed, this was brought to the fore in 2020 with the concerns that China had not been transparently sharing information with the WHO about the timeline and/or extent of COVID-19, and that there was considerable frustration
6
7
8
‘Decision instrument for the assessment and notification of events that may constitute a Public Health Emergency of International Concern’ Annex 2, International Health Regulations (2005) UNTS 2509. ‘Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international restrictions to travel and trade?’, which is typically used by state parties to determine if a public health event within their territory ought to be notified to the WHO under Article 6 of the International Health Regulations, as a potential PHEIC. Article 5(4) states that the ‘WHO shall collect information regarding events through its surveillance activities and assess their potential to cause international disease spread and possible interference with international traffic. Information received by WHO under this paragraph shall be handled in accordance with Articles 11 and 45 where appropriate’ and Article 7 states: ‘If a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information. In such a case, the provisions of Article 6 shall apply in full.’ Articles 4 and 6, International Health Regulations (2005) UNTS 2509; Article 6(2) states: ‘Following a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern.’
46
Between Legal Obligations and Political Reality
Figure 2.1: Decision instrument for the assessment and notification of events that may constitute a PHEIC Events detected by national surveillance system (see Annex 1) A case of the following diseases is unusual or unexpected and may have serious public health impact, and thus shall be notifieda,b: - Smallpox - Poliomyelitles due to wild-type poliovirus - Human influenza caused by a new subtype - Severe acute respiratory syndrome (SARS).
Any event of potential international public health concern, including those of unknown causes or sources and those involving other events or diseases than those listed in the box on the right shall lead to utilization of the algorithm.
OR
An event involving the following diseases shall always lead to utilization of the algorithm, because they have demonstrated the ability to cause serious public health impact and to spread rapidly internationallyb: - Cholera - Pneumonic plague - Yellow fever - Viral haemorrhagic fevers (Ebola, Lassa Marburg) - West Nile fever - Other diseases that area of special national or regional concern, e.g. dengue fever, Rift Valley fever, and meningococcal disease.
OR
Is the public health impact of the event serious? Yes
No
Is the event unusual or unexpected?
Is the event unusual or unexpected?
No
Yes
No
Yes
Is there a significant risk of international spread? Yes
Is there a significant risk of international spread? Yes
No
No
Is there a significant risk international travel or trade restrictions? Yes
No
Not notified at this stage. Reassess when more information becomes available.
EVENT SHALL BE NOTIFIED TO WHO UNDER THE INTERNATIONAL HEALTH REGULATIONS a As per WHO case definitions. b The disease list shall be used
only for the purposes of these Regulations.
Source: Reproduced from WHO Guidance for the Use of Annex 2 of the International Health Regulations (2005), Annendix, p. 52, https://www.who.int/ihr/ revised_annex2_guidance.pdf
on the part of the WHO that such timely information was not forthcoming.9 9
https://www.theguardian.com/world/2020/jun/02/china-withheld- data-coronavirus-world-health-organization-recordings-reveal
47
DECLARING A PHEIC
Role of the WHO Director-General The DG retains discretion and autonomy as to whether to declare a PHEIC or not; they are free to determine if and when an EC is convened10 and they are free to disregard EC advice11 (although no DG has to date). While the DG is afforded this decision-making power, there are several checks and balances instituted within the IHR to ensure that individual subjectivity is not the determining factor in the decision, despite the significant discretionary power the IHR affords the DG. Indeed, the fact that the criteria to be considered within the process are laid down formally in the IHR is significant, and serves to create a framework within which the DG must reasonably exercise the powers afforded to them under the IHR.12 This procedure serves as a control mechanism over the political subjectivity of an elected individual. Article 12 sets out that the DG shall determine whether an event ‘constitutes a public health emergency of international concern in accordance with the criteria and the procedure set out in these Regulations’.13 To do so, they shall consider:
10 11 12
13
Article 49(1), International Health Regulations (2005) UNTS 2509. Article 12(4), International Health Regulations (2005) UNTS 2509. It has previously been argued that the DG does not have the discretionary power to not make a PHEIC declaration, when the criteria to make such a declaration are clearly fulfilled, see: Mark Eccleston-Turner and Scarlett McArdle, ‘The Law of Responsibility and the World Health Organization: A Case Study on the West African Ebola Outbreak’ in Mark Eccleston-Turner and Iain Brassington (eds) Infectious Diseases in the New Millennium: Legal and Ethical Challenges (Springer 2020). 12(1) International Health Regulations (2005). The decision instrument contained in Annex 2 referenced at (b) is the ‘Decision instrument for the assessment and notification of events that may constitute a Public Health Emergency of International Concern’. ‘Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant
48
Between Legal Obligations and Political Reality
(a) information provided by the State Party; (b) the decision instrument contained in Annex 2; (c) the advice of the Emergency Committee; (d) scientific principles as well as the available scientific evidence and other relevant information; and (e) an assessment of the risk to human health, of the risk of international spread of disease and of the risk of interference with international traffic.14 To further clarify the precise nature of the powers afforded to the DG, and any limits on said powers, we can look to the negotiation history of the IHR. While there is no travaux préparatoire deposited for the IHR, there are WHO Secretariat reports, intergovernmental working group documents, and WHO Regional Office reports regarding the negotiation of the 2005 revisions, from which it is possible to determine the intention of the parties in respect of the PHEIC process and criteria. Most notable is the report of the WHO Intergovernmental Working Group on the Revision of the International Health Regulations from April 2004. Importantly, this working group took place in the post-SARS era, where DG Brundtland had taken unprecedented steps to issue travel recommendations to limit the spread of SARS. Brundtland did so without an express legal mandate, and in doing, for some member states, she was considered to have caused significant economic disruption, and overstepped her prescribed mandate and authority. Thus, it was of paramount importance that states would not be subject to the decisions of their membership organization again, and that efforts were made to mitigate the risks posed by an overly zealous DG. Thus, the process being used by the WHO
14
risk of international spread? Is there a significant risk of international restrictions to travel and trade?’, which is typically used by state parties to determine if a public health event within their territory ought to be notified to the WHO under Article 6 of the International Health Regulations, as a potential PHEIC. Article 12(4), International Health Regulations (2005) UNTS 2509.
49
DECLARING A PHEIC
to declare a PHEIC or issue TRs was of central concern to member states during the negotiations: Concerns were also expressed that the process to be followed by WHO in issuing, modifying or terminating temporary or standing recommendations was not sufficiently transparent and accountable…. The most important change is the introduction of … the principles and criteria to be considered by the Director- General when issuing, modifying or terminating recommendations.15 And: The provision has been revised in response to comments requesting a clear and transparent procedure and appropriate information to, and consultations with, the State affected by the event. Consequently, paragraphs 2 and 3 regarding the procedure to be followed to determine the occurrence of a public health emergency of international concern have been transferred here … [this] … clarifies the factors and considerations which the Director-General has to take into account in determining the occurrence of a public health emergency of international concern.16 It is clear from the preparatory documents, and the text of the IHR itself, that Article 12 on the ‘determination of a
15
16
WHO Intergovernmental Working Group on the Revision of the International Health Regulations, ‘Review and approval of proposed amendments to the International Health Regulations: explanatory notes’ (7 October 2004) A/IHRIGWG/4. WHO Intergovernmental Working Group on the Revision of the International Health Regulations, ‘Review and approval of proposed amendments to the International Health Regulations: explanatory notes’.
50
Between Legal Obligations and Political Reality
public health emergency of international concern’ creates a procedure that the DG must follow in order for the PHEIC declaration to be legitimate. Von Bernstorff, in noting why such procedures are so important for the exercise of power by international organizations to be legitimate, stated that ‘if formalized procedural constraints for the exercise of public authority are important at the national level they are all the more so at the international level since conflicts over substantive legal standards and disagreement over community values are usually more acute’.17 This is particularly important given the WHO has the institutional power to declare a health emergency in a state’s territory, and can do so against the express wishes of that state party. This came to play during Ebola in West Africa and is suspected to have occurred during COVID- 19 where governments pushed back informally to avoid the PHEIC declaration, for fear of the impact this might have on their economies. However, while member states have afforded the DG the power to declare a PHEIC, it can only be done ‘in accordance with the criteria and the procedure set out in [the] Regulations’.18 Member states did not cede such sovereign power in absolute terms to the DG, but on the basis that the process by which a PHEIC is to be declared is followed. If that process is not followed, the decision reached lacks legitimacy,19 and the DG, in accepting and endorsing (improper) recommendations could undermine the authority
17
18 19
Jochen von Bernstorff, ‘Procedures of Decision-Making and the Role of Law in International Organizations’ (2008) 9 German Law Journal 1939, 1948. Article 12(1), International Health Regulations (2005) UNTS 2509. For more on the role of legal procedure in legitimacy, see: Hersch Lauterpacht, Recognition in International Law (1st paperback edn (with new introduction), first published 1947, Cambridge University Press 1947); Thomas M Franck, The Power of Legitimacy among Nations (Oxford University Press 1990).
51
DECLARING A PHEIC
of the PHEIC declaration, and the broader IHR. Indeed, as we go on to discuss, the procedure utilized by the DG has been inconsistently followed across numerous health emergency events, and there appears to have been a number of occasions where the DG has validated the improper criteria set out by the EC in determining whether a PHEIC ought to be declared, or not. Moreover, on declaring a PHEIC, Article 15 empowers the DG to issue TRs. Article 1 frames TRs as ‘non-binding advice’ that applies on a ‘time limited, risk specific basis in response to a PHEIC, so as to prevent or reduce the international spread of disease and minimize interference with international traffic’.20 This may include ‘health measures to be implemented by the state party experiencing the public health emergency of international concern, or by other state parties, regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic’.21 These TRs demonstrate neatly the balance between public health and trade and travel throughout the IHR. Despite their non-binding nature, the IHR should not be overlooked or dismissed; the fact that the WHO is able to issue TRs is, to some extent, extraordinary. The TRs, if adopted by state parties, grant the WHO the power to potentially limit travel and trade between sovereign nations to protect public health. While their non-binding nature clearly detracts from the legal authority of the WHO to interfere with travel and trade, and indeed, governments have frequently diverged from the substantive content of TRs, the political power of TRs should not be so easily dismissed. The fact that the DG was afforded the power to make such TRs demonstrates the normative commitment to global health security, which seemingly
20 21
Article 1, International Health Regulations (2005) UNTS 2509. Article 15, International Health Regulations (2005) UNTS 2509.
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Between Legal Obligations and Political Reality
superseded norms of sovereignty and reflected the shared understanding of global vulnerability to global disease control embedded in the epistemic community and policy makers in the mid-2000s.22 Role of the Emergency Committee While it is the DG who has the ultimate decision as to whether to declare a PHEIC or not,23 in making this determination the DG is required to take into account the advice of a technical expert committee –the IHR Emergency Committee (EC).24 Despite the fact that the advice of the EC is one of a number of factors the DG is to take into account, it appears to be in practice the central factor in determining whether a PHEIC is declared or not. No DG has ever disregarded the advice of an EC, even when the advice given appears illogical or incorrect.25 Indeed, so central is the EC to the PHEIC declaration process that it has become common for the Chair of the EC to co-host the press conference that follows a declaration (or non-declaration, as the case may be), along with the DG. The role of the EC is to review all available data on the event and then advise the DG as to whether the (legal) criteria to declare a PHEIC have been met. Moreover, they are to advise the DG on what (if any) actions the WHO and states should take in responding to the emergency26 –that is, what TRs to
22
23 24 25 26
Sara E Davies, Adam Kamradt-Scott and Simon Rushton, Disease Diplomacy: International Norms and Global Health Security (Johns Hopkins University Press 2015); Jeremy R Youde, Biopolitical Surveillance and Public Health in International Politics (1st edn, Palgrave Macmillan 2010). See ‘Transparency, accountability, and good governance of the PHEIC process’. Article 12(4), International Health Regulations (2005) UNTS 2509. See, for example, ‘Ebola in West Africa’ in ‘Case studies on the PHEIC declaration’. Article 48(1)(c), International Health Regulations (2005) UNTS 2509.
53
DECLARING A PHEIC
issue to minimize the spread and/or impact of the outbreak, although the final decision rests with the DG.27 The requirement of the DG to take advice from a technical expert group in determining a PHEIC was a new addition to the revised IHR,28 intended to diffuse power from one individual into a more participatory and apolitical mechanism. Article 48(1)(a) states that the EC ‘shall provide views on: whether an event constitutes a public health emergency of international concern’. It is clear therefore that the EC is to only be guided by the legal criteria for a PHEIC, as defined at Article 1. The role of the EC is to conduct a technical assessment of a public health crisis using a predetermined algorithm (Annex 2) and legal criteria and, on the basis of that technical assessment, recommend whether a PHEIC should be declared or not. Early negotiating documents were clear that the ‘[t]he Emergency Committee shall be competent to advise the Director-General on whether an event constitutes a public health emergency of international concern and on the issuance of temporary recommendations’.29 There is no scope within Article 48 for the EC to take into consideration anything other than the legal criteria for a PHEIC. The DG convenes the EC and determines its membership,30 which is drawn from a roster of technical experts who have been preapproved and recommended by governments.31 At least one member of the EC ‘should be an expert nominated by a State Party within whose territory the event arises’.32 Recent analysis has shown that although states are able to
27 28 29
30 31 32
Article 49, International Health Regulations (2005) UNTS 2509. See ‘The 1969 International Health Regulations –need for reform’. WHO, ‘Intergovernmental working group on the revision of the Internaitonal Health Regulations’ (12 January 2004) IGWG/IHR/ working paper/12.2003. Article 48(2), International Health Regulations (2005) UNTS 2509. Article 47, International Health Regulations (2005) UNTS 2509. Article 48, International Health Regulations (2005) UNTS 2509.
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nominate individuals to be on the roster, only 82 states have done so, and the majority of the roster is comprised of individuals identified through technical networks and the broader epistemic community of the WHO.33 Yet, whether they are nominated by a state or by the WHO, there is nothing to suggest that individuals may not have a political role within their domestic health systems, as sometimes these can be indistinguishable. EC membership occurs on a case-by-case basis, with each EC’s membership purposively selected according to the source of the health emergency (if known) and/or nature of the event.34 However, the membership of the EC roster is not transparent, it is not known who is on this roster, and how people are selected onto the roster, and in turn how people are selected from the roster onto an EC. Furthermore, as there is no transparency as to the EC meetings,35 we are unable to know how state representatives act differently from WHO-nominated participants, and to what extent their political motivation influences the wider group; but their presence raises questions regarding the independence of the EC, and the legitimacy and impartiality of the decision reached. Moreover, Article 49 permits a state party in whose territory the event arises to present its views to the EC. It can propose the termination of the PHEIC and/ or any TR.36 Therefore, it is possible there are several sources of direct and indirect political interference from state parties in respect of the PHEIC declaration, but given the opaque
33
34 35
36
WHO, ‘WHO’s work in health emergencies: Strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005)’ 74th WHA (5 May 2021). Provisional Agenda Item 17.3, A74/9 Add.1. Article 48(2), International Health Regulations (2005) UNTS 2509. Mark Eccleston-Turner and Adam Kamradt-Scott, ‘Transparency in IHR Emergency Committee Decision Making: The Case for Reform’ (2019) 4 BMJ Global Health e001618. Article 49(7), International Health Regulations (2005) UNTS 2509.
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nature of the PHEIC decision-making process, we have no way of understanding how such political interference is utilized and the extent to which it influences outcomes. However, we must remember that members of the EC are not elected, but are selected as experts by the WHO. Thus, it is improper that they should be allowed to exert political considerations when they are not subject to democratic forms of accountability. The IHR are also silent on how the EC shall make decisions, or the procedures for resolving disputes, Article 48(1)(a) states only that the EC ‘shall provide its views on whether an event constitutes a public health emergency of international concern’. Article 49, which addresses EC procedure, is limited to requiring that ‘the Emergency Committee shall elect its Chairperson and prepare, following each meeting, a brief summary report of its proceedings and deliberations, including any advice on recommendations’.37 The processes by which decisions are made are important to understand: the voting rights, weight or power of particular individuals matter for the legitimacy of those decisions. The WHO is modelled on a one-state, one-vote model, but it is not clear whether this extends to the EC. It is also not clear whether only EC members get any vote, for example, or if all participants, such as country representatives, do. Nor is it clear what the threshold is for acceptance: is it simply a majority, or is unanimity required? These are all political deliberations that must be laid out. Further, it is not apparent how the membership of ECs, including individual backgrounds, gender, nationality and roles, impact the decision making. Recent findings from the IHR Review Committee noted that in EC meetings, given the time allowed for presentations of data from the WHO Secretariat and member states, there was little time for deliberations among committee members as to the declaration.38 A lack of 37 38
Article 49(3), International Health Regulations (2005) UNTS 2509. WHO, ‘WHO’s work in health emergencies: Strengthening preparedness for health emergencies: implementation of the International Health
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formalized structure and procedure means that, in effect, each EC is sui generis and has its own internal legal order, resulting in an inconsistent application of the legal rules found in the IHR, and an inconsistent approach towards decision making within the EC itself. This in itself is problematic. As this book goes on to lay out, there is significant inconsistency in how each of these relevant actors operates during the declaration of a PHEIC. In some instances, the DG unnecessarily frustrates the declaration process by failing to convene an IHR EC when it is clear the PHEIC criteria are met. In others, the decision-making processes and procedures vary from EC to EC, resulting in an inconsistent application of the IHR. Finally, some ECs appear to take into account political considerations reserved for the DG in reaching their recommendation, raising both legal and normative tension for global health security. Such inconsistency of procedures, rules and practices has implications for the wider good governance of the WHO, and with it, the normative authority of the institution, on the basis that ‘fragmentation of institutional practice not only impedes effective legal controls but also makes it more difficult for the public sphere to effectively address and contest political outcomes and redistributive effects of global governance’.39 Each of these problems, which have been present across multiple health emergencies, has occurred because multiple DGs have failed to fully appreciate the PHEIC as a tool in global health security, and failed to appreciate the normative authority and legal processes embedded in the IHR.
39
Regulations (2005)’ 74th WHA (5 May 2021). Provisional Agenda Item 17.3, A74/9 Add.1. von Bernstorff, ‘Procedures of Decision-Making and the Role of Law in International Organizations’.
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Public Health Emergency of International Concern A PHEIC is defined as an ‘extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response’.40 We consider each of these criteria in turn. Extraordinary event
The meaning of ‘extraordinary event’ is not clearly defined within the text of the IHR. Guidance is provided in Annex 2 – ‘Decision instrument for the assessment and notification of events that may constitute a Public Health Emergency of International Concern’ –as to what events may justify reporting an event as ‘extraordinary’.41 This instrument is designed to determine whether a public health event within a state’s territory ought to be notified to the WHO as a potential PHEIC. The instrument is also one of the relevant factors for the DG to take into consideration when determining whether a PHEIC is occurring. It requires states to consider the following questions: ‘Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international restrictions to travel and trade?’ It is reasonable to assume that the question ‘Is there a significant risk of international spread?’ in Annex 2 refers to the second criteria of the PHEIC definition, and ‘Is there a significant risk of international restrictions to travel and trade?’ refers to the third, therefore the first two questions of ‘Is the public health impact of the event serious? Is the event unusual or unexpected?’ could go some way to clarifying what constitutes an ‘extraordinary event’ within the meaning of Article 1 of the IHR.
40 41
Article 1, International Health Regulations (2005) UNTS 2509. Annex 2, International Health Regulations (2005) UNTS 2509.
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Importantly, the language in the IHR for notification of potential PHEICs and the decision instrument is purposefully vague and subjective. The aim is to encourage over-reporting to the WHO, which can then undertake relevant analysis to consider whether an event warrants further investigation. Indeed, this consideration of the extraordinary event demonstrates the ‘all-hazards’ approach taken to IHR (2005). Given the ambiguity in the decision-making instrument within the IHR, it is perhaps unsurprising that there are inconsistencies in how ECs and DGs have interpreted these criteria. When an EC is convened, the meaning of ‘extraordinary event’ is inconsistently interpreted and applied; while this can be easily dismissed based on differing membership or context, it nevertheless poses a problem for the legitimacy and authority of the PHEIC and the normative purpose of the PHEIC tool. When ECs met regarding the 2009-H1N1 outbreak and the 2016 Zika outbreak respectively, they clearly noted that the lack of knowledge around each of these viruses was a factor in these events meeting the ‘extraordinary event’ PHEIC criterion.42 In contrast, in each of the IHR ECs in respect of the Middle East respiratory syndrome coronavirus (MERS-CoV), the experts did not recognize the lack of knowledge about this novel virus as constituting an ‘extraordinary event’, despite it
42
WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Swine Influenza on 25th April 2009’ (25 April 2009) https://www.who.int/mediacentre/ news/statements/2009/h1n1_20090425/en/; WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika Virus and Observed Increase in Neurological Disorders and Neonatal Malformations’ https:// www.who.int/en/news-room/detail/01-02-2016-who-statement-on- the-first-meeting-of-the-international-health-regulations-(2005)-(ihr- 2005)-emergency-committee-on-zika-virus-and-observed-increase- in-neurological-disorders-and-neonatal-malformations.
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being a wholly novel virus, which in part might explain why MERS-CoV was not declared a PHEIC.43 Risk of the international spread of disease
In respect of the second PHEIC criterion, the concern is not ‘international’ but ‘risk … through the international spread of disease’ (emphasis added). Implicit within this is that the concern is on the risk of international spread, and not actual international spread. Indeed, an event can be considered a PHEIC prior to crossing an international border; it must merely have the potential for, or there must be a risk of, cross- border transmission. Indeed, while most events declared a PHEIC had already crossed international frontiers at the point the declaration was made, not all have. As we will go on to discuss later, the resurgence of polio was declared a PHEIC in 2014, despite the fact there was no spread across international borders.44 In providing its reasons, the EC emphasized the ‘public health risk to other states’ (emphasis added) the resurgence of polio posed, along with the risk of ‘international spread across land borders’ and the consequences of international spread to the ‘large number of polio-free but conflict-torn and fragile states which have severely compromised routine immunization services and are at high risk of re-infection’.45 Conversely, cross-border spread is not, in and of itself, a requirement for the declaration of a PHEIC, demonstrated by yellow fever in 2016. The EC met twice in 2016. At each meeting there were confirmed cases of yellow fever in Angola and the DRC –along with further 43 44
45
See ‘MERS-CoV’ in ‘Case studies on the PHEIC declaration’. While there were a very small number of confirmed cases in Pakistan, Afghanistan and Nigeria, these were all unrelated clusters of a virus that is endemic in those states and did not constitute cross-border transmission. See ‘polio’ in ‘Case studies on the PHEIC declaration’. See ‘polio’ in ‘Case studies on the PHEIC declaration’, para 5.
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spread to Kenya and China.46 However, at neither meeting did the EC recommend a PHEIC be declared, on the basis that the risk of onward transmission from those countries was small. Moreover, in justifying its recommendation to not declare a PHEIC, the April 2019 EC for Ebola in the DRC noted there had yet to be ‘international spread’, disregarding the risk element of the criteria entirely.47 This is despite the fact the EC acknowledged the ‘very high risk of regional spread’, the ongoing and complex nature of the current outbreak and the ‘recent increase in transmission in specific areas’ closer to the territorial borders of the DRC.48 Coordinated international response
The IHR do not provide a clear definition of what ‘coordinated international response’ means in the context of the PHEIC. There is no requirement for a coordinated response to be necessary upon PHEIC declaration, merely
46
47
48
WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’ https:// www.who.int/mediacentre/news/statements/2016/ec-yellow-fever/ en/; WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’ https:// www.who.int/en/news-room/detail/31-08-2016-second-meeting-of- the-e mergency-c ommittee-u nder-t he-i nternational-h ealth-r egulations- (2005)-concerning-yellow-fever. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 12th April 2019’ https:// www.who.int/ n ews- room/ d etail/ 1 2- 0 4- 2 019- s tatement- o n- t he- meeting-of-the-international-health-regulations-(2005)-emergency- committee-for-ebola-virus-disease-in-the-democratic-republic-of-the- congo-on-12th-april-2019. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 12th April 2019’.
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that one is potentially required. Despite this straightforward criterion, there remain considerable inconsistencies in how it has been interpreted. Some ECs have interpreted ‘potentially requires a coordinated response’ to mean that the current response is insufficient, and a PHEIC is required to enhance said response. In the 2018 Ebola outbreak in the DRC, the EC considered that the response by the DRC government, the WHO and international partners (that is, a coordinated international response) was sufficient, and that ‘the interventions underway provide[d]strong reason to believe that the outbreak can be brought under control’, and therefore this contributed in part to the decision not to declare a PHEIC.49 It is noteworthy that such a response from the WHO did not necessitate either the declaration of a PHEIC or the use of the powers contained within the IHR, instead those vital activities were ‘performed on the basis of the reserved powers afforded to the WHO and DG by the WHO Constitution as well as separate mandates by the WHA’, leading some to question the utility of the IHR in the active response element of a health emergency.50 This approach is in contrast to the underlying understanding of the EC for polio, which stated that such a response is ‘essential’.51
49
50
51
WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 18 October 2019’ https:// www.who.int/ n ews- room/ d etail/ 1 8- 1 0- 2 019- s tatement- o n- t he- meeting-of-the-international-health-regulations-(2005)-emergency- committee-for-ebola-virus-disease-in-the-democratic-republic-of-the- congo. Burci and Eccleston-Turner, ‘Preparing for the Next Pandemic: The International Health Regulations and World Health Organization during COVID-19’. WHO, ‘Statement on the Meeting of the International Health Regulations Emergency Committee Concerning the International Spread of Wild Poliovirus’ (5 May 2014) https://www.who.int/mediacentre/ news/statements/2014/polio-20140505/en/.
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The EC for Ebola (DRC) took an even more unusual interpretation, at the June 2019 meeting, stating that: ‘While the outbreak is an extraordinary event, with risk of international spread, the ongoing response would not be enhanced by formal TR under the IHR (2005).’52 This is unusual for several reasons. First, the understanding that a coordinated response be actually necessary, rather than potentially, as the IHR require. Second (and more alarmingly) is the idea that coordinated international response is a synonym for TRs. Such an interpretation is wholly inconsistent with how previous ECs approached the question, and indeed is inconsistent with the IHR themselves, which consider TRs as one aspect of a coordinated response to a health emergency. In contrast, at the October 2018 meeting of the EC for Ebola it was stated that ‘[t]he government of the Democratic Republic of Congo, WHO, and partners must intensify the current response’,53 indicating that a coordinated international response was occurring, but that it was inadequate to effectively respond to the outbreak. Despite this, no PHEIC was declared for a further nine months (noting two different outbreak clusters), at which point, in July 2019, the EC actually acknowledged that the criterion of a coordinated international response had been satisfied.54 Bizarrely, during earlier meetings
52
53
54
WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 14 June 2019’https://www.who.int/news-room/ detail/14-06-2019-statement-on-the-meeting-of-the-international- health-regulations-(2005)-emergency-committee-for-ebola-virus- disease-in-the-democratic-republic-of-the-congo. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 18 October 2019’ 201. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 17 July 2019’ (17 July 2019)
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regarding a separate Ebola outbreak in the DRC in 2018, an EC had noted that the current response to the outbreak could be enhanced and had called on the international community to give support to the response, and yet did not declare a PHEIC on the basis that the existing response was ‘rapid and comprehensive’ and there was reason to believe the outbreak could still be brought under control.55 Again, in this scenario the EC appeared to deviate from the criteria laid down in the IHR, and wholly disregarded the ‘potential’ aspect of the criteria. The declaration of a PHEIC and the IHR process A PHEIC declaration empowers the DG to make TRs that, while non-binding, seek to provide public health guidance and counteract unnecessary restrictions states may seek to place on international trade and travel.56 Yet, while TRs may carry normative weight, during past PHEIC declarations, states have not always complied with them consistently. In addition, the PHEIC is typically seen as a clarion call to the international community57 that there is an outbreak on the horizon, but crucially fails to allocate the WHO or states additional financing. A PHEIC declaration, by its very nature, is aligned with states of emergency elsewhere in governance structures, and can bring the outbreak to the attention of governments beyond the health portfolio, including cabinet level, president level and importantly into the treasury and/or department of
55
56 57
https://w ww.who.int/ihr/procedures/statement-emergency-committee- ebola-drc-july-2019.pdf. WHO, ‘Statement on the 1st Meeting of the IHR Emergency Committee Regarding the Ebola Outbreak in 2018’ (18 May 2018) 201 https:// www.who.int/news/item/18-05-2018-statement-on-the-1st-meeting- of-the-ihr-emergency-committee-regarding-the-ebola-outbreak-in- 2018. Article 15, International Health Regulations (2005) UNTS 2509. Lawrence Gostin and others, ‘Ebola in the Democratic Republic of the Congo: Time to Sound a Global Alert?’ (2019) 393 The Lancet 617.
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defence, mobilizing financial and technical assistance.58 Indeed, the purported impact of a PHEIC declaration is one of the compelling reasons for its declaration,59 and the underpinning decision making grounded in the IHR, and wider principles of good governance and administration. As Klabbers noted on this point: ‘When organizations start to … set standards discussions will start about how they do so, and whether they do so well enough to merit further support. They operate, so to speak, on the market of legitimacy, and legitimacy, however precisely conceptualized, is a scarce resource.’60 Transparency, accountability and good governance of the PHEIC process The international legal order has long struggled with the concepts of accountability and transparency,61 particularly since the growth in the power and authority of international organizations has outpaced the mechanisms available to ensure their accountability and transparent decision making. The International Law Association has stated that ‘as a matter of principle, [accountability] is linked to the authority and power of an [organization]. Power entails accountability that is the duty to account for its exercise.’62 A lack of accountability 58 59 60 61
62
Gostin and others, ‘Ebola in the Democratic Republic of the Congo: Time to Sound a Global Alert?’. Gostin and others, ‘Ebola in the Democratic Republic of the Congo: Time to Sound a Global Alert?’. Jan Klabbers, ‘The Paradox of International Institutional Law’ (2008) 5 International Organizations Law Review 151. Nigel D White, ‘Accountability and Democracy Within the United Nations: A Legal Perspective’ (1997) 13 International Relations 1; Jutta Brunnée, ‘International Legal Accountability through the Lens of the Law of State Responsibility’ (2005) 36 Netherlands Yearbook of International Law 21. International Law Association, Final Report of the ILA Committee on the Accountability of International Organizations (Berlin: ILA, 2004), 5, 6.
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and transparency in decision making undermines the decision reached, the decision maker’s legitimacy and the wider organization itself.63 Similarly, in international relations, interactions of international organizations are governed by principles of good governance:64 those of participation, the rule of law, consensus building, equity, inclusiveness, effectiveness, accountability, transparency and responsiveness. For the PHEIC, the lack of good governance and accountability for the decision-making process serves to weaken the normative authority of the PHEIC declaration, and the wider IHR. Blurring the lines between the EC and the DG As the following chapters highlight, there have been several occasions where there has been a blurring of the lines between the role of the DG and that of the EC, through the EC taking into consideration factors beyond its legal remit (as found in Article 48(1)(a) of the IHR), including considerations reserved for the DG. For example, at its October 2018 meeting, the EC for Ebola (DRC) advised ‘that a PHEIC should not be declared at this time’.65 This language is markedly different from the language used during the previous 13 ECs that advised the DG against declaring a PHEIC, in which they stated that either ‘the conditions for a PHEIC 63
64
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Thomas N Hale, ‘Transparency, Accountability, and Global Governance’ (2008) 14 Global Governance: A Review of Multilateralism and International Organizations 73; Alexandru Grigorescu, ‘Transparency of Intergovernmental Organizations: The Roles of Member States, International Bureaucracies and Nongovernmental Organizations’ (2007) 51 International Studies Quarterly 625. Thomas G Weiss, ‘Governance, Good Governance and Global Governance: Conceptual and Actual Challenges’ (2000) 21 Third World Quarterly 795. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 18 October 2019’.
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are not currently met’ or the event ‘does not constitute a PHEIC’. This change in language is indicative of the fact that the advice given by the October 2018 EC was not grounded in the IHR. Further, in April 2019 the EC advised against a PHEIC being declared because ‘there is no added benefit to declaring a PHEIC at this stage’.66 This is not part of the PHEIC criteria. A further example can be seen in the first EC for COVID- 19: the justification to not declare a PHEIC was that ‘now is not the time’ to make a declaration.67 The EC did not expressly state that the criteria to declare were not met at this stage, as was the case with previous instances where an EC advised against a PHEIC, but rather that ‘now is not the time to make such a declaration’. Moreover, at several points in the statement and subsequent press conference, the EC indicated that the criteria to declare a PHEIC were in fact met,68 adding further weight to the notion that the decision to recommend against declaring was motivated by factors beyond the legal criteria. Thus, while being a legal mechanism, the PHEIC process is inherently political in nature, although the political aspects are reserved explicitly for the DG within the IHR. However, as we demonstrate, there are multiple occasions where the EC has stepped beyond its treaty role and explicitly included political, economic and social factors in its deliberations, which 66
67
68
WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-N CoV)’ https:// w ww.who.int/ news-room/detail/30-01-2020-statement-on-the-second-meeting- of-t he-i nternational-health-regulations-(2005)-emergency-c ommittee- regarding-the-outbreak-of-novel-coronavirus-(2019-ncov). https://www.who.int/ n ews/ i tem/ 2 3- 0 1- 2 020- s tatement-on-t he- meeting-of-the-international-health-regulations-(2005)-emergency- committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) https://www.who.int/director-general/speeches/detail/who-director- general-s-statement-on-the-advice-of-the-ihr-emergency-committee- on-novel-coronavirus
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multiple DGs have acquiesced to. The post of DG is a political appointment, and the decision to declare a PHEIC is one that comes with political consequences for the states concerned, as well as the WHO. The WHO has been castigated for declaring, and not declaring, PHEICs, being seen to be adversary to states and/or too lenient in other cases. These positions that the WHO has taken have had long-lasting effects for the political authority of the WHO, with the WHO continually looking to build on previous critiques to regain the central position in global disease control.69 However, the very fact that the process for declaring an event a PHEIC, and the factors on which such a decision ought to be based, are found within the IHR –a treaty –is intended to bring objectivity to the process and mitigate against political interference: it creates a process by which a PHEIC decision ought to be reached.70 Moreover, the IHR are clear on where political considerations can be given weight, and by whom: Article 48(1)(a) is clear that the EC shall provide its views on: ‘whether an event constitutes a public health emergency of international concern’, which signposts to specific criteria for a PHEIC found at Article 1 of the IHR. Thus, it is important to reiterate that the EC’s role is to decide as technical experts whether the public health data meet the PHEIC criteria, whereas it is the DG that makes the decision to declare a PHEIC, considering potential political or economic ramifications. The criteria to be taken into consideration by the DG are significantly broader than those of the EC, containing factors that are clearly political, such as ‘the risk of interference with international traffic’, and based on ‘information provided by the State Party’ or ‘other relevant information’. However, importantly these factors are prescribed to the DG, and not the EC. As already noted, the DG is a political appointment –and thus 69 70
Clare Wenham, ‘The Oversecuritization of Global Health: Changing the Terms of Debate’ (2019) 95 International Affairs 1093. Article 12, International Health Regulations (2005) UNTS 2509.
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there are in-built accountability mechanisms, such as elections every five years, and the ability to be held to account by member states at the WHA, or in the global public commons.71 There are no such accountability mechanisms for the EC, nor should there be; it is a technical expert body. Indeed, until 2011 the names of the members serving were not publicly known,72 when the policy was changed on the basis that: ‘The Organisation … recognized that it requires greater transparency to maintain the trust of the public.’73 Therefore, the distinction between the role of the EC and that of the DG is not merely an arbitrary line in the sand, but rather, it is an important and necessary distinction between the accountability of who makes decisions and on what grounds. The blurring of lines, whereby the EC takes into consideration factors expressly reserved for the DG (that is, the political impact of decisions, the interference with international traffic, information from states and other relevant information), and the DG allows this to occur, has clear implications for the legitimacy of the PHEIC process, the discretionary powers of the DG and the good governance of the WHO. This needs to be considered in the broader landscape of international organizations and their pathologies;74 international
71
72
73
74
Mark Eccleston-Turner and Scarlett McArdle, ‘Accountability, International Law, and the World Health Organization: A Need for Reform?’ (2017) XI Global Health Governance 27. WHO, ‘Implementation of the International Health Regulations (2005) –Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009’ (2011) A64/10. WHO, ‘Implementation of the International Health Regulations (2005) –Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009’ 119. Michael N Barnett and Martha Finnemore, ‘The Politics, Power, and Pathologies of International Organizations’ (1999) 53 International Organization 4.
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organizations wield power beyond that bestowed to them by states, and it is through technocratic workings, such as that of the PHEIC decision making, that the individual agency and power of the WHO and the DG can be seen. Importantly, international organizations can gain power through the processes of bureaucratization, which is seen to depoliticize decision making into technocratic know-how. With the EC absorption of decision making for the PHEIC, in doing so the process can gain authority, and further allow the WHO power to act, but importantly, only if doing so in accordance with the technocratic processes laid out in IHR. However, these technocratic processes shape the way in which the international community might view the particular outbreak, whether to view it as a concern or not, and thus the role of the EC, and the delegation of roles between the EC and the DG, are vital to assess. Transparency and good governance Transparency is widely considered to be central to good governance. As the International Law Association in its Study on the Accountability of International Organizations observed, ‘transparency in … the decision-making process and the implementation of … decisions’ as well as ‘access to information open to all potentially concerned and/or affected by the decisions at stake’ are constitutive of the ‘principle of good governance’.75 There being a process prescribed by law, and
75
The International Law Association has stated that ‘as a matter of principle, [accountability] is linked to the authority and power of an [Organization]. Power entails accountability that is the duty to account for its exercise’; International Law Association, Final Report of the ILA Committee on the Accountability of International Organizations (ILA, 2004), 5, 6; Hale ‘Transparency, Accountability, and Global Governance’; Grigorescu, ‘Transparency of Intergovernmental Organizations: The Roles of Member States, International Bureaucracies and Nongovernmental Organizations’.
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that process being seen to be followed, is demonstrable of a transparent decision-making process, and a transparent process being seen to be followed enhances the legitimacy of the decision made, and the decision maker.76 Even where transparency may not be required by law, encouraging efforts for participatory mechanisms or a clearer social contract between institution and members relies on transparency to ensure that members understand the decisions and process by which they are made. Transparency is key to much of international relations; institutions possess information about ‘aims, goals, intentions, resources and so forth … disclosure allows the public to monitor the conduct of government, holding government accountable for its conduct and acting as a check against corruption or mismanagement’.77 Transparency represents a key tenet of the social contract between governments and populations in liberal democratic societies and has been thus used as a key metric in the conditionalities and state intervention efforts across international organizations and states. Recently, substantive concerns have been raised regarding the opacity of how decisions are made by the EC, along with the factors it takes into consideration when making a determination.78 Given the crucial role the EC plays in determining whether a PHEIC ought to be declared, coupled with the central importance of the PHEIC health emergency governance, any concerns regarding the transparency of processes undermine the decisions reached and, by association, the IHR (2005) and the treaty’s custodian, the WHO. Despite 76
77
78
Devika Hovell, ‘The Deliberative Deficit: Transparency, Access to Information and UN Sanctions’ in Jeremy Matam Farrell and Kim Rubenstein (eds) Sanctions, Accountability and Governance in a Globalised World (Cambridge University Press 1999) 99. Daniel R McCarthy and Matthew Fluck, ‘The Concept of Transparency in International Relations: Towards a Critical Approach’ (2017) 23 European Journal of International Relations 416. Eccleston-Turner and Kamradt-Scott, ‘Transparency in IHR Emergency Committee Decision Making: The Case for Reform’.
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their central role in the declaration of a PHEIC, the minutes or transcripts of ECs are not published, in theory to protect the EC members and permitting them to deliberate freely, and the only indicator of the deliberations is the brief statement published by the EC Chair and/or the DG at the press conference that follows. Such a transparency and accountability deficit becomes even more problematic when coupled with the considerations being taken into account by the EC, and their deviation from the IHR. Such deficits in accountability and irrelevant considerations within the EC would not be as concerning had the prescribed limits of the IHR been properly adhered to and applied by the DG. Indeed, given that the advice of an EC is one of several factors to be taken into consideration by the DG in determining whether a PHEIC should be declared, concerns over the EC process could be dismissed easily as mere technical quibbles. However, the processes of the EC, and the way it reaches conclusions (including taking into account irrelevant considerations), have been validated by the DG across multiple outbreaks. Indeed, the advice of the EC now appears to be the determining factor regarding whether a PHEIC is declared or not. It is clear the DG has fettered away the very right to declare a PHEIC to the EC. Given multiple DGs have accepted and validated the incorrect decisions of multiple ECs, it appears the DG is left with little more than a rubber-stamping role in the PHEIC declaration process.
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THREE
Case Studies on the PHEIC Declaration
To date there have been six PHEIC declarations, as well as several other health emergencies that have been considered as potential PHEICs. These non-PHEIC events fall into two distinct categories: those considered by an EC, but not declared a PHEIC; and those for which an EC was never convened, but which objectively met the criteria for declaration. In this chapter we examine each of the health emergencies declared a PHEIC in turn, followed by the non-PHEIC events. In doing so we explore how the criteria to declare a PHEIC have been understood and applied by the DG and the EC, as well as the wider considerations that each of these actors might have taken into consideration when fulfilling their functions in respect of a PHEIC under the IHR. In doing so, we demonstrate the overarching findings of this book: that the criteria to declare a PHEIC have been subject to broad interpretation by the EC beyond the legal text, which have been subsequently improperly validated by the DG in accepting the advice of EC. We structure each section first with a background to the context of the health emergency, second with detailed analysis of the apparent PHEIC decision making, third with consideration of the TRs recommended, and finally with analysis of the additional lessons learned about the broader PHEIC, IHR process and global health security. In the analysis we centre on the initial declaration of the PHEIC, and only consider later EC
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meetings for each disease outbreak if they are a noteworthy change in advice provided or justification. 2009-H1N1 The United States (US) first reported cases of 2009-H1N1, a novel influenza virus with human pandemic potential, on 18 April 2009.1 By the end of April 2009, more than 1,300 suspect cases and approximately 84 deaths were attributed to the outbreak.2 Under Annex 2 of the IHR, notification by states to the WHO must occur if there is a positive response to two of four criteria,3 or if a health emergency is caused by poliomyelitis, smallpox, human influenza caused by a new subtype or SARS. In response to this notification, on 25 April the DG convened an EC, which recommended 2009-H1N1 to be declared the first PHEIC under the revised IHR.4 PHEIC decision making
The 2009-H 1N1 EC is the only meeting to have met anonymously. While on the one hand this was a novel test
1
2
3
4
WHO, ‘Ad Hoc Scientific Teleconference on the Current Influenza A(H1N1) Situation’ (29 April 2009) http://w ww.who.int/csr/resources/ publications/swineflu/TCReport2009_05_04.pdf. PAHO, ‘Influenza Cases by a New Sub-type: Regional Update’ PAHO, Washington, DC 28 April 2009 http://n ew.paho.org/h q/d mdocuments/ 2009/epi_alerts_2009_04_28_13h_swine_flu.pdf. The criteria being: ‘Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international restrictions to travel and trade?’ WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Swine Influenza on 25th April 2009’ (25 April, 2009) https://www.who.int/mediacentre/news/ statements/2009/h1n1_20090425/en/.
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for the newly introduced mechanism of the IHR, norms of good governance would have cautioned that transparency is integral to confidence and authority building. The WHO later justified anonymity on the basis that ‘in accordance with common WHO practice for expert advisory committees, the identities of the members of the Emergency Committee were not publicly disclosed’.5 The opaque EC gave rise to several concerns regarding its independence and impartiality. Perhaps unsurprisingly, the decision to declare a PHEIC was mired in controversy and accusations of financial impropriety on the part of the (then) anonymous EC members.6 It is interesting to note that the WHO, when changing the policy of EC members serving anonymously in 2011, did so on the basis that ‘the Organization … recognized that it requires greater transparency to maintain the trust of the public’ (emphasis added),7 as opposed to the trust of states. This is strange for a member state organization, given that the IHR is binding on states, not the public, and yet it is important for the process to have public trust. Implicit within this statement is a recognition of the impact of an EC statement, and to whom the WHO considers the EC accountable, well beyond the Westphalian state-based paradigm.8 This, indeed, suggests that part of the 5
6
7
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WHO, ‘Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza (H1N1) 2009’ WA31.2, P.32. A full expose of the controversy is beyond the scope of this text, but the full details of the omnishambles is outlined at: Adam Kamradt-Scott, ‘What Went Wrong? The World Health Organization from Swine Flu to Ebola’ in Andreas Kruck, Kai Oppermann and Alexander Spencer (eds), Political Mistakes and Policy Failures in International Relations (Springer International Publishing 2018). WHO, ‘Implementation of the International Health Regulations (2005) –Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009’ (2011) A64/10 119. Nico Krisch, ‘The Pluralism of Global Administrative Law’ (2006) 17 European Journal of International Law 247.
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PHEIC mechanism and power bestowed on the WHO is to build authority and awareness in the international community, and recognizing the reality of that public sentiment is vital for states’ democratic accountability in supporting WHO efforts. These concerns regarding transparency were not limited to the EC participant list: it is also unclear how members of the EC interpreted the three key criteria for the declaration of the PHEIC, whether unanimity was required to make such a recommendation, and how disagreements within the EC were resolved (for instance, whether a vote was held, and what threshold for votes was required for a motion to carry).9 The ‘brief summary report of its proceedings and deliberations’ is lacking in substance and detail, and indeed, no reference is made within the statement to the PHEIC criteria found at Article 1, which is the only point of reference for the EC. Thus, it is not clear on what basis the decision to declare a PHEIC was based. More alarmingly still, key decisions of the EC in respect of the pandemic phases of alert, moving from Phase 4 to 5 (see the section ‘Additional reflections: 2009-H1N1, a PHEIC and a Pandemic’ later in this chapter) were only taken by ‘a subset of the Emergency Committee rather than inviting input from the full Emergency Committee’.10 Temporary recommendations
Uniquely for the 2009-H1N1 PHEIC, the TRs were linked to the ‘phased’ pandemic system. From the outset of the pandemic, two TRs remained in force in late April 2009 to February 2010, these were: ‘all countries intensify surveillance 9
10
Mark Eccleston-Turner and Adam Kamradt-Scott, ‘Transparency in IHR Emergency Committee Decision Making: The Case for Reform’ (2019) 4 BMJ Global Health e001618. WHO, ‘Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza (H1N1) 2009’ WA31.2 115.
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for unusual outbreaks of influenza-like illness and severe pneumonia’ and ‘countries should not close borders or restrict international traffic and trade’. The DG further stressed on a number of occasions that ‘all measures should conform with the purpose and scope of the International Health Regulations’.11 Regardless, approximately 20% of states implemented measures breaching the TRs during 2009-H1N1.12 For example, countries were advised ‘not to close borders and not to restrict international travel’.13 However, numerous states advised their citizens to avoid travelling to affected states during the early stages of the outbreak, two states reported denying entry to travellers from affected countries, and 61% of states that reported their measures to the WHO reported screening incoming passengers, combined with some form of isolation of confirmed cases.14 While these measures could be compliant with the IHR, provided the measures are in line with the requirements outlined at Article 43,15 the WHO H1N1 Review Committee noted that ‘no country that implemented additional measures (that is, measures that significantly disrupted international travel or trade by more than 24 hours)
11
12
13
14
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WHO, ‘Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza (H1N1) 2009’ 59; The purpose and scope of the Regulations being ‘to prevent, protect against, control and provide a public health response to the international spread of disease’ Article 2, International Health Regulations (2005) UNTS 2509. Sara E Davies, Adam Kamradt-Scott and Simon Rushton, Disease Diplomacy: International Norms and Global Health Security (Johns Hopkins University Press 2015). WHO, ‘Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza (H1N1) 2009.’ WHO, ‘Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza (H1N1) 2009.’ See ‘Role of States that are Party to the IHR’ in Chapter Two.
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complied with their obligations under Article 43 to proactively inform WHO of the rationale for such measures’.16 In respect of trade, despite a joint statement from the WHO, the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE) and the World Trade Organization (WTO) stating that pork products could not transmit the disease,17 several countries placed import restrictions on American, Canadian and Mexican pork products.18 The WHO H1N1 Review Committee held that states should ‘reinforce evidence-based decisions on international travel and trade’19 and concluded that more ‘rigorous implementation of Article 43, by both States Parties and WHO’,20 was required. As the following case studies highlight, one of the predominant themes that bind the practice of PHEICs is the implementation of additional health measures by states, without due rationale. This speaks to a bigger political problem with TRs: member states are bound to follow the IHR under international law, but they are also sovereign states with sovereign 16
17
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WHO, ‘Implementation of the International Health Regulations (2005): Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009 (Report by the Director General)’ (5 May 2011) A64/10. WTO/OIE/WHO/FAO, ‘Joint WTO/OIE/WHO/FAO Statement on A/H1N1 Influenza’ (OIE, 2 May 2009) https://www.oie.int/en/for- the-m edia/p ress-r eleases/detail/article/joint-wtooiewhofao-s tatement- on-ah1n1-influenza/. Rebecca Katz and Julie Fischer, ‘The Revised International Health Regulations: A Framework for Global Pandemic Response’ (2010) III Global Health Governance 1. WHO, ‘Implementation of the International Health Regulations (2005): Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009 (Report by the Director General)’ (5 May 2011) A64/10. WHO, ‘Implementation of the International Health Regulations (2005): Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009 (Report by the Director General)’ (5 May 2011) A64/10.
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decision power over issues that affect their domestic or foreign relations. Therein, many governments choose to prioritize these domestic demands to ‘protect’ their populations and economies, over that of their obligations under the IHR and to global health security. Whether a country focuses on the domestic or international at a time of crisis is on a spectrum, with some countries more likely to focus on protectionist interventions than others.21 Hence, the PHEIC, which aimed at reducing (political) interference with travel and trade through technical guidance from the EC, even in its first trial run, did not work, as governments tended to disregard these TRs. Additional reflections: 2009-H1N1, a PHEIC and a pandemic
During 2009-H1N1 the WHO did not just rely on a PHEIC declaration to sound the global alert, it also adopted a phased approach to declaring a ‘pandemic’ –a tiered system of pandemic alert between one and six –and 2009-H1N1 reached phase six in June 2009.22 Escalating up the phases of alert was based on technical predetermined health indicators of severity, such as the case fatality rate or unusually severe morbidity, and with escalating phases came recommendations to member states regarding surveillance systems, and travel and trade guidance,23 in many ways replicating the PHEIC process.
21
22
23
Clare Wenham, ‘Examining sovereignty in global disease governance: surveillance practices in United Kingdom, Thailand and Lao People’s Democratic Republic’ (doctoral dissertation, Aberystwyth University) (2015). Wenham, ‘Examining sovereignty in global disease governance: surveillance practices in United Kingdom, Thailand and Lao People’s Democratic Republic’. Wenham, ‘Examining sovereignty in global disease governance: surveillance practices in United Kingdom, Thailand and Lao People’s Democratic Republic’ 85.
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These two systems ran in parallel with each other, and even though the IHR make no reference to pandemic or associated tiers, significant weight was attached to the phased system within WHO communication. Indeed, the WHO appeared to place greater emphasis on the pandemic phase declaration, than on the PHEIC declaration, leading to confusion, and detracting from the normative weight of the PHEIC. More alarmingly, the decision to move through the alert levels within the pandemic alert system was taken by the EC, despite this not being their mandate.24 This is important as these technical guidelines were a further attempt to depoliticize the declaration of a pandemic, and an attempt to create less fear or tension within the nomenclature. This mixed messaging was not only confusing for states but is also thought to have jeopardized the authority of the WHO –as it was not clear whether states should be following the TRs within the PHEIC or the pandemic phase recommendations. The reality was that the fear of a major health emergency was enough that many states around the world did both, leading to considerable panic, travel restrictions and stockpiling of antivirals.25 Polio The PHEIC for wild poliovirus (polio) is in many ways an anomaly compared with the other PHEICs: polio has been circulating for centuries, and indeed the WHO has been at the forefront of a Global Polio Eradication Initiative (GPEI), heavily funded by external actors, to ensure global vaccination
24
25
‘At the first Emergency Committee meeting, members would have to decide whether the situation constituted a PHEIC and whether the pandemic alert phase needed to be raised’; Wenham, ‘Examining sovereignty in global disease governance: surveillance practices in United Kingdom, Thailand and Lao People’s Democratic Republic’ 32. Stefan Elbe, Pandemics, Pills, and Politics: Governing Global Health Security (Johns Hopkins University Press 2018).
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against and eradication of the disease.26 This is important: polio disease is well known, not unexpected and there has been a clear public health programme in place with well-utilized vaccination efforts to eliminate the disease. However, 2014 saw an upsurge in transmission rates of polio, with the DG convening an EC in April 2014. It is not known what political motivations might have been behind the desire to call an EC to even allow the possibility of a PHEIC for polio. Other endemic and vaccine-preventable diseases have not resulted in the convening of such a mechanism, let alone the declaration of a PHEIC. One motivation might have been that the considerable efforts of the WHO through the GPEI (and more than US$17 billion provided for the cause27) were at risk of being undone if proactive efforts were not undertaken to try to stem the spread of polio and push for total elimination of the disease. PHEIC decision making
The EC decided that polio met the conditions of a PHEIC, a decision it has continued to support in the subsequent 27 meetings of the EC (at time of writing). As specified, PHEIC declarations must be reviewed on a three-monthly basis. The IHR expressly include polio in the immediately notifiable diseases under the National Focal Point (NFP) process in Annex 2.28 Thus, governments must always report polio emergence and transmission. Accordingly, the decision making for
26
27
28
Aylward and Tangermann, ‘The Global Polio Eradication Initiative: Lessons Learned and Prospects for Success’ (2011) 29 Vaccine; Nicoletta Previsani and others, ‘World Health Organization Guidelines for Containment of Poliovirus Following Type-Specific Polio Eradication —Worldwide, 2015’ (2015) 64 MMWR. Morbidity and Mortality Weekly Report 913. Kimberly M Thompson and Dominika A Kalkowska, ‘An Updated Economic Analysis of the Global Polio Eradication Initiative’ (2021) 41 Risk Analysis 393. Annex 2, International Health Regulations (2005) UNTS 2509.
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reporting is not based on subjective understandings of whether the outbreak is serious, unusual or unexpected or poses a significant risk of international spread –mere detection of cases of the disease is sufficient to warrant notification under Article 6 of the IHR. The first EC meeting ‘advised that the international spread of polio to date in 2014 constitutes an “extraordinary event” and a public health risk to other states for which a coordinated international response is essential’.29 The wording clearly matched the language of the PHEIC and the IHR to ensure compliance. The EC noted that the disease was prevalent in ten states in Central Asia, the Middle East and Central Africa; however, these were all unrelated cases of a virus that is endemic in those states, and did not constitute cross-border transmission.30 In justifying the declaration of a PHEIC, the EC emphasized the public health risk to other states the resurgence of polio posed, along with the risk of ‘international spread across land borders’ and the consequences of international spread to the ‘large number of polio-free but conflict-torn and fragile states which have severely compromised routine immunization services and are at high risk of re-infection’31 –even going so far as to list the states it believed to be at risk from polio resurgence, if it spread unabated.32 This risk-based approach to 29
30
31
32
WHO, ‘WHO statement on the meeting of the International Health Regulations Emergency Committee concerning the international spread of wild poliovirus’ (5 May 2014) https://www.who.int/mediacentre/ news/statements/2014/polio-20140505/en/. WHO, ‘WHO statement on the meeting of the International Health Regulations Emergency Committee concerning the international spread of wild poliovirus’. WHO, ‘WHO statement on the meeting of the International Health Regulations Emergency Committee concerning the international spread of wild poliovirus’ para 5. WHO, ‘WHO statement on the meeting of the International Health Regulations Emergency Committee concerning the international spread of wild poliovirus’ para 9.
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international spread stands in stark contrast to the interpretation and application of the ‘international spread’ criterion during other ECs whereby a lack of cross-border transmission has, on numerous occasions, been used (incorrectly) to justify not declaring a PHEIC.33 Importantly, a further PHEIC justification was the risks to ongoing eradication efforts for a vaccine-preventable disease, which the world was on the cusp of achieving in the early 2000s. While this is an important public health justification, mired in the frustrations of a decades-long global vaccination effort thwarted in the final hurdle by political mishandling, this is not within the criteria to declare a PHEIC. For this reason, its introduction here might reflect the real reason for the convening of the EC, and the motivation for trying to raise awareness of this issue among the highest levels of governments through the normative political power PHEIC mechanism. As transcripts of the EC meetings are not transparent, we are unable to ascertain to what extent concern regarding the immunization campaign against polio was the key driver of the PHEIC notification, compared with the ‘extraordinary’, ‘risking international spread’ and ‘requiring an international response’ needed for a PHEIC declaration. A further justification for declaring a PHEIC was that the risks for disease transmission were particularly acute because of the prevalence of current polio cases in conflict and fragile states, locations that have had compromised immunization services, and given weak or broken health systems may struggle to launch an effective response if infection was (re)introduced.34 Although minimizing transborder spread is a key tenet of the normative and legal goals of the IHR, the
33 34
See section on Ebola in the DRC, for example. Examples of this can be seen throughout the following meetings of the IHR Emergency Committee for polio: meetings 1–18, as well as the 21–26th meetings of the committee.
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quality of the health system and the political context in which disease transmission occurs fall outside the remit of the EC’s decision making, but they can be given consideration by the DG. One could argue that in the event a health emergency spreads to a fragile state with a weak or broken health system, then a coordinated international response could be more likely; however, little recognition of this has appeared in previous ECs. Moreover, in the context of polio, given that there was already a long-established global immunization campaign to eradicate the disease, this line of reasoning appears spurious. Thus, this represents another additional motivation superfluous to PHEIC criteria, but may be indicative of the discussions within the EC. This allows us to hint at the political drivers that contribute to the PHEIC process. Ironically, the aim of the PHEIC was to increase systemization and technical decision making to the outbreak alert process: states had expressed concern regarding the unaccountable exercise of executive authority by the WHO during SARS and the regulatory framework provided by the PHEIC was an effort to depoliticize this. It appears the polio PHEIC counters this entirely. Temporary recommendations
The TRs for polio are interesting, notably given the variability of advice offered, and how targeted this became. All 27 meetings to date have focused on the declaration of a national health emergency and increasing vaccine coverage, particularly in respect of international travel. Yet beyond this, TRs are tiered depending on whether states are actively exporting wild poliovirus, have recently become polio free, or only have historical cases. The creation of this tiered approach to TRs suggests diplomacy on the part of the WHO, in as much as it suggests targeted public health measures. We know that governments exert pressure on the WHO to not declare a PHEIC, or not name and shame them for their explicit failures to manage disease control. It might be that the tiered approach here was to
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assuage different states of their obligations under the PHEIC mechanism. Whereas some states exporting cases would have to make considerable efforts, others with a recent history but that are currently not experiencing cases may not have such a burden. It would be interesting to understand the process by which member states participate in the deliberations of the meetings of the EC, and how these impact on decision making. This politicized and targeted approach became more direct by the third EC meeting, where the TRs explicitly targeted Pakistan, to limit international travel of anyone lacking vaccine documentation, and Pakistan was required to update the DG on the implementation, including how many people’s travel had been restricted consequently, as well as on vaccine delivery programmes.35 This is the first time that one country has been expressly called out within TRs. This is notable as the WHO is usually careful not to ‘name and shame’ individual states for their failure to comply with the IHR, despite this being their only enforcement mechanism.36 Indeed, the EC declarations have been much more general in wording, ‘states with Zika infection’ for example.37 This reveals much about the importance placed on polio eradication. This approach to disease diplomacy by the
35
36
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WHO, ‘Statement on the 3rd Meeting of the International Health Regulations Emergency Committee Regarding the International Spread of Wild Poliovirus’ https://w ww.who.int/m ediacentre/n ews/statements/ 2014/polio-20141114/en/. Sara E Davies and Jeremy Youde, ‘The IHR (2005), Disease Surveillance, and the Individual in Global Health Politics’ (2013) 17 The International Journal of Human Rights 133. WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika Virus and Observed Increase in Neurological Disorders and Neonatal Malformations’ https:// w ww.who.int/ e n/ n ews- room/ d etail/ 0 1- 0 2- 2 016- w ho- statement-o n-t he-fi rst-m eeting-o f-t he-i nternational-h ealth-regulations- (2005)-( ihr-2 005)-e mergency-committee-on-zika-virus-and-observed- increase-in-neurological-disorders-and-neonatal-malformations.
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WHO may also be indicative of the inherent power differential between member states. The WHO may be loathed to call out more ‘powerful states’ in the international community, such as China or Brazil, but a relatively ‘weak’ state such as Pakistan may not be paid the same credence. This can be seen elsewhere in the WHO’s history, such as with the global notification of Guinea spreading cholera in 1979, despite not reporting the disease under the 1969 IHR.38 It is interesting and noteworthy that it was the EC engaging in such disease diplomacy, and not the DG, despite it being beyond the former’s mandate, and its lack of political accountability for such actions. Additional considerations
An interesting change occurred in the remit and terms of the EC from the seventh meeting: the scope was broadened to include circulating vaccine-derived poliovirus (cVDPV) alongside wild poliovirus.39 At this point, cases of vaccine- derived polio had been identified in Ukraine, Madagascar, Lao People’s Democratic Republic (PDR), Nigeria, Guinea and South Sudan. Importantly, in Annex 2 of the IHR, the decision instrument for the PHEIC is based on wild poliovirus and makes no reference to cases that are vaccine derived. Yet, this was added to the justification for the perpetuity of the PHEIC declaration: that vaccine-derived polio could pose a risk for international spread, threaten vulnerable populations and threaten completion of global polio eradication.40 Yet, the
38 39
40
Dhiman Barua, ‘History of Cholera’ in Dhiman Barua and William B Greenough (eds), Cholera (Springer US 1992). WHO, ‘Statement on the 7th IHR Emergency Committee Meeting Regarding the International Spread of Poliovirus’ http://www.who.int/ mediacentre/news/statements/2015/ihr-ec-poliovirus/en/. WHO, ‘Statement on the 7th IHR Emergency Committee Meeting Regarding the International Spread of Poliovirus’.
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paradox remains that wild poliovirus was reducing because of the PHEIC TRs expressly calling for increased vaccination, and yet, increased vaccination is directly leading to more cases of vaccine-derived polio, which in turn is facilitating the extension and continuity of the PHEIC. The PHEIC remained in force, as did the TRs in respect of vaccination campaigns, regardless. By 2018, incidence of wild polio had dropped considerably: the EC noted that it had been four years since it spread beyond the territorial borders of Afghanistan and Pakistan,41 and more than 19 months since the last case of wild polio in Nigeria. Yet, the EC ‘unanimously’ agreed that the PHEIC declaration should remain in place: Although the risk of international spread of wild poliovirus may be diminishing as transmission falls, the impact of any delay in eradicating wild poliovirus caused by international spread, should it occur now, would be even more grave in terms of delaying certification and the need to maintain human and financial resources for a longer period to achieve eradication. The risk of global complacency developing increases as the numbers of wild poliovirus cases remain low and eradication becomes a tangible reality and removing the PHEIC now could contribute to greater complacency.42
41
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WHO, ‘Statement of the 18th IHR Emergency Committee Regarding the International Spread of Poliovirus’ https:// w ww.who.int/ news-room/d etail/1 5-0 8-2 018-s tatement-o f-t he-e ighteenth-i hr- emergency- c ommittee- r egarding- t he- i nternational- s pread- o f- poliovirus. WHO, ‘Statement of the 17th IHR Emergency Committee Regarding the International Spread of Poliovirus’ https://www.who.int/news- room/d etail/1 0-0 5-2018-statement-of-the-seventeenth-ihr-emergency- committee-regarding-the-international-spread-of-poliovirus.
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This development of ‘broader terms than was previously the case to also look at outbreaks of cVDPV’ is important.43 Legally, the scope and mandate of the EC are the responsibility of the DG. Nothing within the IHR explicitly gives the DG the power to expand or modify the terms of an ongoing EC, but it is reasonable to assume that such a power is merely an extension of the power to convene and set the terms of an EC in the first place. However, it is necessary to question whether this is the most appropriate course of action in these circumstances, that is, if vaccine-derived polio ought to be grouped reasonably with wild polio, or whether it warrants a separate EC and PHEIC declaration, and even if it warrants a PHEIC declaration at all. Moreover, the PHEIC is not a tool for eradication: this is not featured anywhere in the IHR, and nor is it the normative function of the mechanism. Using the PHEIC in this manner risks ‘mudding the waters’ of what constitutes a PHEIC, and in turn what constitutes a de-escalation of the PHEIC, in due course.44 The EC further noted that ‘some stakeholders are questioning whether this continued declaration of a PHEIC may weaken its impact as a tool to address global health emergencies, and specifically whether it continues to have utility noting that the risk of international spread appears to have substantially diminished since 2014’. In addressing this, the EC noted that the PHEIC was not originally intended to last as long as it has, or indeed be used as a tool to advance global eradication of polio, but nevertheless, the EC argued that the ‘circumstances of an eradication program such as polio are unique’. We do not dispute this, but it does not necessarily follow that unique 43 44
WHO, ‘Statement on the 7th IHR Emergency Committee Meeting Regarding the International Spread of Poliovirus’. While we have focused on the declaration of a health emergency, on the question of when a health emergency ends, see: Federica Paddeu and Michael Waibel, ‘The Final Act: Exploring the End of Pandemics’ (2020) 114 American Journal of International Law 698.
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circumstances of a global eradication programme necessarily warrant the use of a PHEIC in this manner. The EC further justified such an exceptional use on the basis that it was concerned that the ‘abrupt removal’ of the PHEIC might ‘send out the wrong message to the global community and might reverse the gains made in reducing the risk of international spread in some areas’ and argued that ‘the Temporary Recommendations have been an important factor in reducing the risk of international spread since 2014’,45 although, crucially, it did not reveal what evidence it had used to come to such conclusions. Importantly, this consideration of the continuation of the PHEIC did not appear to come from the DG employing the additional considerations they are permitted to explore prior to PHEIC declaration, but from the EC, a justification that was accepted and later validated by the DG agreeing with the recommendation. The continuation of the PHEIC for polio speaks to a broader assumption with the EC: that of the power of the PHEIC. There is clearly the assumption that the PHEIC for polio is serving a purpose, indeed, the EC argued that the TRs influenced a reduction in wild poliovirus in Pakistan in 2016 and 2017.46 Cynically, the grouping of wild polio with vaccine-derived polio could reflect the need to ensure the end of polio, and the politicization of the process through the PHEIC mechanism. As wild poliovirus was declining, expanding the scope to include vaccine-derived polio was important to keep pressure on states to continue with vaccination efforts. In doing so, this not only demonstrates the perceived power of the PHEIC by the WHO (as discussed 45
46
WHO, ‘Statement of the 19th IHR Emergency Committee Regarding the International Spread of Poliovirus’ https://www.who.int/news- room/d etail/3 0-1 1-2 018-s tatement-o f-t he-n ineteenth-ihr-emergency- committee-regarding-the-international-spread-of-poliovirus. WHO, ‘Statement of the 19th IHR Emergency Committee Regarding the International Spread of Poliovirus’.
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later), but it also risks jeopardizing the normative power of the PHEIC declaration, and the legitimacy of such declarations when they occur. The continued PHEIC might also be linked to fundraising for the GPEI. The EC noted that the PHEIC should support domestic financing for polio control and eradication efforts, as a public health emergency. In 2020, it was noted that funding for polio was declining significantly, with both the end of budget cycles and COVID-19 pandemic expenditure having an impact, ‘the potential for reversal of progress appears high, with many years work undone easily and swiftly if [polio] spreads outside the endemic countries’.47 Thus, the risk of de-escalating the PHEIC could be that donor financing dries up, particularly in a context where other priorities compete for funding and political awareness. Given that a quarter of all WHO staff are funded by the GPEI, regardless of their work programmes, this money ending would have a significant ripple effect across global health. Once again, without transparency over the decision making of the EC, or a robust evidence base regarding the impact and efficacy of a PHEIC declaration, it is hard to understand these tensions. The West African Ebola outbreak The WHO was officially notified of an Ebola outbreak in March 2014 by Guinea.48 The outbreak shortly spread to Sierra Leone and Liberia, and a ‘perfect storm’ of contextual factors and errors by the WHO and members states meant
47
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WHO, ‘Statement on the 26th IHR Emergency Committee Meeting Regarding the International Spread of Poliovirus’ https:// www.who.int/news/item/22-10-2020-statement-of-the-twenty-sixth- polio-ihr-emergency-committee. The WHO Ebola Response Team, ‘Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections’ (2014) 371 New England Journal of Medicine 1481.
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it rapidly morphed from a global health emergency to a humanitarian crisis.49 There were almost 30,000 confirmed cases and more than 11,000 deaths. Importantly, Annex 2 of the IHR expressly mentions that viral haemorrhagic fevers (of which Ebola is the most prominent) ‘shall always lead to utilization of the algorithm, because they have demonstrated the ability to cause serious public health impact and to spread rapidly internationally’. PHEIC decision making
Despite the prominence of Ebola in the PHEIC decision- making instrument, the DG did not immediately convene an EC. Indeed, it was five months after the first notification that the DG first convened a meeting. Meanwhile, the WHO deployed epidemiologists to West Africa, and established initial contact tracing, laboratory support and infection control mechanisms, mirroring that which it had implemented in previous Ebola outbreaks,50 although this was criticized for being insufficient.51 Notably, a similar response was launched for the outbreak of Ebola in 2019 in DRC and the WHO was praised for this activity, demonstrating varing reaction to WHO activities in responding to health emergencies. Prior to the calling of an EC in 2014, Médecins Sans Frontières (MSF), a major responder on the ground in West Africa, had warned that Ebola was ‘out of control’ and had called for a ‘massive
49
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Peter Piot, ‘Ebola’s perfect storm’ (2014) Nature 1221; Sophie Harman and Clare Wenham, ‘Governing Ebola: between global health and medical humanitarianism’ (2018) 15 Globalizations 3, 362. Clare Wenham, ‘What We Have Learnt about the World Health Organization from the Ebola Outbreak’ (2017) 372 Philosophical Transactions of the Royal Society B: Biological Sciences 20160307. Maria Cheng, ‘Emails: UN Health Agency Resisted Declaring Ebola Emergency’ Associated Press (Geneva, 20 March 2015) https:// apnews.com/article/2489c78bff86463589b41f3faaea5ab2.
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deployment of resources’.52 Senior staff at the WHO had also raised the prospect of declaring a PHEIC, which was resisted.53 In contrast, the WHO externally stated that the ‘WHO and partners are providing the necessary technical support to the Ministries of Health to stop community and health facility transmission of the virus’54 and implied that the outbreak was under control, when internally it was quite clear that this was not the case. This suggests that political pressure to avoid a PHEIC declaration was occurring, perhaps by the governments affected, or by some in the international community who feared repercussions. Some in the international community saw a PHEIC declaration as a normative and powerful political tool to inspire and catalyze a global coordinated response (even though there was, and remains, limited evidence to understand the impact of the PHEIC). Thus, MSF, among others, pushed for this political performance to encourage funding, and political and human resources, towards the response. However, it is also clear that politics also drove the slow and/or hesitant approach to the calling of an EC. We know that the affected member states tried to stop the PHEIC declaration.55 However, it is also possible that the WHO, acutely aware of its previous performance of declaring a PHEIC during 2009-H1N1, and the criticism it faced for “crying wolf ”, may had led to a more considered approach to jumping to do so again.56 Thus, while the PHEIC Annex 2 is supposed to control the discretionary 52
53 54
55 56
Médecins Sans Frontières, ‘Ebola in West Africa: Epidemic Requires Massive Deployment of Resources’ (21 June 2015) http://www.msf.org/article/ ebola-west-africa-epidemic-requires-massive-deployment-resources. Cheng, ‘Emails: UN Health Agency Resisted Declaring Ebola Emergency’. WHO, ‘Ebola Virus Disease, West Africa’ (23 June 2014) http:// www.afro.who.int/ e n/ c lusters- a - p rogrammes/ d pc/ e pidemic- a - pandemic-a lert-a nd- response/outbreak-news/4172-ebola-v irus-d isease- west-africa-23-june-2014.html. Cheng, ‘Emails: UN Health Agency Resisted Declaring Ebola Emergency’. Clare Wenham, ‘The Oversecuritization of Global Health: Changing the Terms of Debate’ (2019) 95 International Affairs 1093.
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power of a DG in a health emergency, the decision to call an EC in the first place remains discretionary, and inherently political. In the case of the West African Ebola outbreak, it is clear that there was a delay between the criteria for a PHEIC appearing to have been satisfied57 and the convening of the EC,58 for which the WHO has been heavily criticized.59 Interestingly, it appears that the DG and the WHO learned from such criticism, and moved to quickly call an EC for Zika, but this demonstrates once again the range of ways in which politics can enter the legal process of the PHEIC declaration. An EC was eventually convened in August 2014, by which time there were 1,779 confirmed and suspected cases of Ebola, nearly a thousand of which resulted in death.60 Guinea, Liberia and Sierra Leone were engulfed in crisis and further spread had 57 58
59
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See, for example, Cheng, ‘Emails: UN Health Agency Resisted Declaring Ebola Emergency’. It has been previously argued that the WHO has a legal responsibility to declare a PHEIC when it appears the criteria to do so have been satisfied, included within this would be an obligation upon the Director-General to convene an Emergency Committee in a prompt manner, as without an EC meeting a PHEIC cannot be declared: Mark Eccleston-Turner and Scarlett McArdle, ‘The Law of Responsibility and the World Health Organization: A Case Study on the West African Ebola Outbreak’ in Mark Eccleston-Turner and Iain Brassington (eds) Infectious diseases in the new millennium: legal and ethical challenges (Springer 2020). Lawrence Gostin and Eric Friedman, ‘Ebola: A Crisis in Global Health Leadership’ (2014) 384 The Lancet; Lawrence Gostin, ‘The future of the World Health Organization: lessons learned from Ebola’ (2015) 93 Milbank Quarterly 475; Mark J Siedner, ‘Strengthening the detection of and early response to public health emergencies: lessons from the West African Ebola Epidemic’ (2015)12 PLOS Medicine; Alexander Kekulé, ‘Learning from Ebola virus: how to prevent future epidemics’ (2015) 7 Viruses 3789; World Health Organization, ‘Report of the Ebola Interim Assessment Panel’ (2015) http://www.who.int/csr/resources/ publications/ebola/report-by-panel.pdf. WHO, ‘Ebola Data and Statistics: Situation Summary’ (7 August 2015) http://apps.who.int/gho/data/view.ebola-sitrep.ebola-summary- 20150807?lang=en.World.
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been detected in Nigeria, Senegal and the DRC.61 The EC’s unanimous view was that the conditions for a PHEIC were met. The EC statement directly engaged the criteria found at Article 1 to justify its recommendation, something that stands in stark contrast to others and highlighting the fact that each EC is sui generis in its processes and methods. This speaks to a broader point about ensuring consistency within the EC to ensure continuity and normative power. In making the declaration, the EC expressed the following: (1) ‘the possible consequences of further international spread are particularly serious in view of the virulence of the virus, the intensive community and health facility transmission patterns, and the weak health systems in the currently affected and most at-r isk countries’; and (2) ‘a coordinated international response is deemed essential to stop and reverse the international spread of Ebola’. Again, the EC disregarded the potential requirement for a coordinated response and substituted it for a coordinated response actually being required, or rather, in this case, being ‘deemed essential’. It added to these justifications, including fragile health systems in affected countries, a lack of prior experience with Ebola infection, mobile populations and porous international borders. Leaked internal emails from the WHO revealed that senior leadership considered the declaration of a PHEIC as ‘a last resort’ and that it ‘could be seen as a hostile act’, which goes someway to explaining why the DG delayed the convening of an EC, but it is not clear where such logic originates. It was not the intention of states drafting the IHR that a PHEIC declaration would be a hostile act, or a vote of no confidence in the leadership of the country impacted by the health emergency. This logic appears to be internal to the
61
WHO, ‘Ebola Virus Disease Outbreak –West Africa’ Disease Outbreak News (4 September 2014) http://www.who.int/csr/don/2014_09_04_ ebola/en/.
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WHO: officials stated that ‘a declaration of that nature would only damage relations with the affected countries’ and ‘it may even push the country away and imperils relations with the country office … [t]he problem with declaring a PHEIC is that one has to make recommendations and these risk hurting the country without helping public health’.62 These imply that it was thought the declaration of a PHEIC would cause unaffected countries to close their borders to the impacted region, causing economic harm, against the TRs issued by the DG once a PHEIC declaration had been made. Indeed, these are all political assumptions and demonstrate how individuals may internalize and conceptualize the power of the PHEIC and make value judgements based on this, without a credible evidence base. Temporary recommendations
TRs from the EC were separated for affected states, those bordering affected states and the rest of the world. Leadership was a key focus of these, that the head of state should address the nation directly to declare the emergency and should assume a prominent role in coordinating the national response. This leader should also coordinate the response across stakeholders to ensure management of the pandemic and community trust. Access to personal protective equipment (PPE) remained a key recommendation, and ensuring the protection of healthcare workers amid the epidemic, as well as rigorous contact tracing, diagnostics and airport screening. The focus on leadership amid the EC eight months after the emergence of the virus might indeed reflect the EC/DG’s assessment of disease control management to date, and instead of calling states out might have been a mechanism by which the WHO sought to indirectly
62
See reporting at Cheng, ‘Emails: UN Health Agency Resisted Declaring Ebola Emergency’.
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name and shame governments for their failures to contain the epidemic thus far. Neighbouring states were advised to enable surge surveillance capacities to be able to detect any cases rapidly. Meanwhile, all states were advised that there were no restrictions on travel or trade, but that they should be prepared to facilitate the evacuation of nationals who might have been exposed to the virus. Additional considerations
Importantly, Gostin and Friedman noted that international donations, technical assistance and military assistance began to flow to the region after the PHEIC was declared in early August,63 despite the fact that the WHO had briefed the international community on the seriousness of the outbreak from 8 April.64 It is worth exploring whether this is directly tied to the declaration of a PHEIC. The legal aspect of the PHEIC is also inherently linked to the normative assessment of the risks posed by the global community, for example it might be that international actors planned to provide a response based on their assessment that this was a crisis which they should support, rather than because of their duty to do so under the IHR. Moreover, it is likely in some instances that voting by parliamentarians would have occurred prior to the PHEIC declaration. Greater analysis of the direct effects of the PHEIC is required to make such assessments as to the impact of the PHEIC. Following the PHEIC declaration, the outbreak was subject to proceedings before the 7268th meeting of the United 63 64
Lawrence Gostin and Eric Friedman, ‘Ebola: A Crisis in Global Health Leadership’ (2014) 384 The Lancet. WHO, ‘Key Events in the WHO Response to the Ebola Outbreak’ (19 October 2015) at ‘Chapter 7: Key events in the WHO response to the Ebola outbreak’ http://www.who.int/csr/disease/ebola/one-year- report/who-response/en/.
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Nations Security Council (UNSC), leading to Resolution 2177 recognizing Ebola as an ongoing threat to peace and security.65 Opening briefings were provided by: DG Chan; Dr Nabarro, Senior United Nations Systems Coordinator for Ebola; and Dr Niamah, MSF.66 Each speaker directly appealed to the UNSC for assistance in bringing the outbreak under control, despite the declaration of a PHEIC only a month earlier, and the DG of the WHO appealing for scale-up for several months. The implications of the WHO’s pleas are multiple: Did the WHO not consider itself able to deliver the response required to control the outbreak? Does this indicate admission by the WHO that it had left it too late to respond to Ebola, and that a PHEIC should have been declared earlier, or indeed that the PHEIC did not have the desired effect? Alternatively, it could be an omission that the WHO is no longer the global epidemic coordinator of responses to health emergencies,67 or indeed that the affected locations were post- conflict sites, with other United Nations (UN) agencies ready to support the response, such as the United Nations Mission in Liberia (UNMIL).68 Regardless, it demonstrates a broader power differential between the power of the PHEIC and the WHO as the institution to launch such declarations, and that of the UNSC.
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While Resolution 2177 is the first Resolution to acknowledge a health issue as an ongoing threat to peace and security, Resolution 1308 in 2000 recognized the potential of the AIDS epidemic, if unchecked, to pose a risk to stability and security, and largely focused on the potential of HIV/AIDS to affect the health of UN peacekeeping personnel. Another statement was made by the Secretary General; this is not uncommon but equally not always standard procedure. Kamradt-Scott A ‘The evolving WHO: implications for global health security’ (2011) 6 Global Public Health 8, 801. Sara E Davies and Simon Rushton, ‘Public health emergencies: a new peacekeeping mission? Insights from UNMIL’s role in the Liberia Ebola outbreak’ (2016) 37 Third World Quarterly 3, 419.
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Zika Brazil began to investigate when a cluster of babies were being born in north-east Brazil with microcephaly and severe neurological disabilities, thought to be linked to vector-borne disease. By November 2015, these numbers were high enough for several states in Brazil to declare ‘states of emergency’ to access federal emergency financing to support the outbreak response and vector control. This was swiftly followed through the federal declaration of an Emergência em saúde Pública de Importância Nacional (ESPIN), whereby the government considered the outbreak a health threat nationally, and looked at the impact that this might have on the Sistema Única de Saúde (SUS), the national health system, raising a generation of children with complex health needs.69 A PHEIC was declared for ‘microcephaly and other neurological disorders’,70 which were thought to be associated with Zika virus infection (and which were later causally associated71), on 1 February 2016. As McLoskey and Endericks highlight, Zika would be unlikely to qualify as a PHEIC given that the infection is usually asymptomatic or mild.72 DG Chan stated that the decision for the PHEIC was that the clusters were an ‘ “extraordinary event” and a public health threat to other parts of the world … and a coordinated international 69 70
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Clare Wenham and Deborah BL Farias, ‘Securitizing Zika: the Case of Brazil’ (2019) 50 Security Dialogue 398. WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika Virus and Observed Increase in Neurological Disorders and Neonatal Malformations’. Sonja A Rasmussen and others, ‘Zika virus and birth defects — reviewing the evidence for causality’ (2016) 374 New England Journal of Medicine 1981. B McCloskey and T Endericks, ‘The rise of Zika infection and microcephaly: what can we learn from a public health emergency?’ (2017) 150 Public Health 87.
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response is needed to minimize the threat in affected countries and reduce the risk of further international spread’.73 Importantly, Chan stated to the press that there was no need for travel or trade measures to be introduced, and that efforts should focus on mosquito control and protection from mosquito bites, particularly among pregnant women,74 yet these had not been part of the EC statement after the first meeting, demonstrating the power afforded to the WHO in the process. Indeed, as Mullan et al raise, at the meeting of the EC ‘there was no mention of the public health risk to other States through international spread in the initial meeting where a PHEIC was declared. The Committee also did not note whether a coordinated international response was required. There was no mention in this meeting that the event was considered ‘extraordinary.’75 It appears that the notions of ‘extraordinary’ and ‘risk of international spread’ were retrospectively introduced into this speech to justify the PHEIC as the decision seemed to have been made predominantly due to the unknown and uncertain nature of Zika, which by itself does not meet the IHR criteria for PHEIC declaration but does speak to its extraordinariness, and the additional role of the DG in the process.
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WHO, ‘WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain- Barré syndrome’ (1 February 2016) https://www.who.int/news/item/ 01-02-2016-who-director-general-summarizes-the-outcome-of-the- emergency-c ommittee-r egarding-c lusters-o f-m icrocephaly-and-guillain- barr%c3%a9-syndrome WHO, ‘WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain- Barré syndrome’. Lucia Mullen and others, ‘An analysis of international health regulations emergency committees and public health emergency of international concern designations’ (2020) 5 BMJ Global Health e002502.
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PHEIC decision making
The EC recommendation for the PHEIC was clarified as being: ‘not made on the basis of what is currently known about Zika virus infection.… rather made on the basis of what is not known about the clusters of microcephaly, Guillain-Barre syndrome and possibly other neurological defects’.76 There are a couple of things to note in this regard. First, the absence of knowledge that drove the decision to declare a PHEIC is interesting. PHEIC declarations and the WHO’s decision making can be seen as a dynamic process whereby the WHO learns from public perception (and criticism). The WHO was castigated for delaying a PHEIC declaration during Ebola in West Africa, and it is likely that this in part contributed to the decision to call an EC for Zika, because of the need to demonstrate authority as the lead actor in global health security, and reclaim the trust of the global community through decisive action. Second, the very uncertainty itself may have heightened the sense of fear about the outbreak and contributed to it satisfying at least the ‘extraordinary event’ element of the PHEIC criteria. This clinical manifestation of Zika was new, and thus it was this unfamiliarity that might have resounded with the PHEIC requirement of ‘unexpected’ or ‘unusual’. As McLoskey and Endericks highlight: ‘The link between Zika infection and microcephaly came as a surprise and the appropriate planning had not been considered, either in respect of the response or the research that became necessary.’77 However, this question of uncertainty needs further elaboration. At the first EC there was no conclusive evidence concerning the link between Zika and microcephaly, although 76 77
David L Heymann and others, ‘Zika Virus and microcephaly: why is this situation a PHEIC?’ (2016) 387 The Lancet 719. McCloskey and Endericks, ‘The rise of Zika infection and microcephaly: what can we learn from a public health emergency?’.
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it was highly suspected.78 By the third EC meeting, causal evidence in the Journal of the American Medical Association had demonstrated the link between Zika and microcephaly. As such: ‘The Committee concurred with the international scientific consensus, reached since the Committee last met, that Zika virus is a cause of microcephaly and GBS.’79 Yet, causal connection had been established previously in Brazil, and published in Brazilian medical journals,80 but it appears that this did not constitute sufficient evidence for the EC until it was published in a leading English-speaking journal, raising considerable questions about the representation of evidence, and continued Anglocentrism of the global health arena. This scientific consensus also altered the terms of the PHEIC. At the start, the PHEIC had been for ‘microcephaly cases and other neurological disorders reported in Brazil’, but by June 2016 this wording had changed to ‘Zika virus infection and its associated congenital and other neurological disorders’. Such a change of language insinuates that the ‘unknown’ or ‘uncertain’ challenges at the start of the outbreak were more certain, and this might no longer justify the PHEIC designation. Interestingly, for the Zika outbreak, while there were 14 members of the EC, it appears that there were (at least) ten further advisors to the EC.81 It is not clear what capacity these advisory roles were, and to what extent they were engaged in deliberations about the PHEIC notification. Moreover, 78 79
80 81
WHO, ‘Zika Virus Emergency Committee’. WHO, ‘Statement on the 3rd Meeting of IHR Emergency Committee on Zika Virus and Observed Increase in Neurological Disorders and Neonatal Malformations’ https://www.who.int/en/news-room/detail/ 12-06-2016-who-convenes-3rd-meeting-of-emergency-committee- on-z ika-a nd-o bserved-i ncrease-i n-n eurological-d isorders-and-neonatal- malformations. Clare Wenham, Feminist Global Health Security (Oxford University Press 2021). WHO, ‘Zika Virus Emergency Committee’ (18 November 2016) https:// www.who.int/groups/zika-virus-ihr-emergency-committee.
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from the EC evaluation of the PHEIC declaration, it appears that there were more participants beyond this, including representatives from Brazil, El Salvador and France (which appear in addition to these named advisors, since these do not include anyone from El Salvador).82 We also know that during this first EC meeting, an initial poll was taken as to whether to declare Zika a PHEIC, and the decision was unanimous.83 This is the first time that we see a poll being discussed in relation to EC decision making, although we do not know whether this did not happen in previous meetings but was not made public. Temporary recommendations
TRs for Zika were centred on three areas. First, that there should be routine epidemiological mechanisms of surveillance and response; however, from the first EC, these focused on guidance and measures for pregnant women and those of childbearing age, including methods to reduce exposure, and counselling for those pregnant or with children born with congenital Zika syndrome. Second, longer-term research & development (R&D) efforts into vaccines and treatments were recommended. And third, it was recommended that those travelling to Zika-infected locations should be informed to reduce exposure. Latterly these recommendations also included vector control and public communication about the risk of sexual transmission. Additional reflections
A key driver of the PHEIC discussion for Zika was the forthcoming Olympic Games to be hosted in Rio de Janeiro 82 83
Heymann and others, ‘Zika virus and microcephaly: why is this situation a PHEIC?’. Heymann and others, ‘Zika virus and microcephaly: why is this situation a PHEIC?’.
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in August and September 2016,84 and whether these could lead to greater global disease transmission. Due to the lack of transparency regarding EC processes, we do not have conclusive evidence that the PHEIC declaration was made (partly) because of the Olympics Games, although anecdotal conversations with the WHO Secretariat subsequently have insinuated this to be the case.85 The Olympics featured heavily in the discussions of the third and fourth EC meetings, considering the impact of mass gatherings on international disease transmission.86 Indeed, ‘the Committee was asked to consider the potential risks of Zika transmission for mass gatherings, including the Olympic and Paralympic Games scheduled for August and September 2016, respectively, in Rio de Janeiro, Brazil’.87 The EC concluded that Zika would not pose a significant threat to the Olympics, or to global disease transmission. First, the Olympics were to occur in low season for mosquito activity in Rio de Janeiro; second, enhanced vector control efforts were planned for the games (even prior to Zika’s arrival); and finally, in actual fact the number of people who would travel to and from Rio during the Olympics was not significantly more than at any other time of year (and considerably less than during the Rio Carnival).88 A further important point for the Zika PHEIC was the longer-term considerations that were included during the
84 85 86
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Clare Wenham, Feminist Global Health Security (Oxford University Press, 2021). Wenham, Feminist Global Health Security. Mullen and others, ‘An analysis of international health regulations emergency committees and public health emergency of international concern designations’. WHO, ‘Statement on the 3rd Meeting of IHR Emergency Committee on Zika Virus and Observed Increase in Neurological Disorders and Neonatal Malformations’. Wenham, Feminist Global Health Security.
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EC process of ‘desecuritization’. By November 2016, the EC felt that ‘[b]e cause research has now demonstrated the link between Zika virus infection and microcephaly, the EC felt that a robust longer-term technical mechanism was now required to manage the global response’. The EC recommended an end to the PHEIC, and instead called for sustained research and a dedicated programme of work and resources to address the long-term nature of Zika infection’s sequelae. These longer-term considerations of the PHEIC, and how this would be managed at the WHO, had been less considered within the emergency short-termist approach of the IHR.89 For most PHEICs, the outbreak ended once the epidemic had run its course, but Zika was the first instance whereby an epidemic left long-term sequelae for the children born with microcephaly, something that governance structures for global health security are not equipped to manage. Given this, this might be a further example of the EC acting beyond its mandate to recommend such long-term efforts within states and the WHO. Ebola in the Democratic Republic of the Congo90 Official notification of Ebola in Equateur, DRC to the WHO came in July 2018.91 The WHO had a considerable presence
89 90
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Wenham and Farias, ‘Securitizing Zika: the Case of Brazil’. We recognize that, in some contexts, the outbreak in the DRC is considered as two separate disease events: one in Equateur and one in Kivu. There were two separate EC meetings, although these had almost the same membership, and the two outbreaks were increasingly considered one disease event. Oly Ilunga Kalenga and others, ‘The Ongoing Ebola Epidemic in the Democratic Republic of Congo, 2018–2019’ (2019) 381 New England Journal of Medicine 373. WHO, ‘Ebola Virus Disease –Democratic Republic of the Congo’ Disease Outbreak News (9 August 2018) https://www.who.int/csr/ don/9-august-2018-ebola-drc/en/
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in DRC already,92 thus it is unsurprising that from these very early stages the WHO was heavily involved in the response to this outbreak. The WHO initially deployed 30 technical and logistics specialists to support response activities to the affected area; the WHO’s Global Outbreak Alert and Response Network (GOARN) supported surveillance and notification; and the WHO supported readiness and preparedness activities through risk assessments in non-affected provinces of DRC and in nine bordering countries.93 Despite the DRC rapidly discharging its IHR obligations to notify the WHO of a potential PHEIC within its territory,94 and the WHO’s engagement in the detection of and response to the outbreak, the DG did not convene an EC until October 2018, three months after initial notification. Subsequent meetings followed in April and June 2019, and finally July 2019, at which point a PHEIC was declared. The decision of these earlier meetings to advise against a declaration was met with significant criticism.95
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Jacqueline Weyer, Antoinette Grobbelaar and Lucille Blumberg, ‘Ebola Virus Disease: History, Epidemiology and Outbreaks’ (2015) 17 Current Infectious Disease Reports 21. Lawrence O Gostin, ‘New Ebola Outbreak in Africa Is a Major Test for the WHO’ (2018) 320 JAMA 125. Article 6, International Health Regulations (2005) UNTS 2509. Lawrence Gostin and others, ‘Ebola in the Democratic Republic of the Congo: Time to Sound a Global Alert?’ (2019) 393 The Lancet 617; Lawrence O Gostin and Eric A Friedman, ‘A Retrospective and Prospective Analysis of the West African Ebola Virus Disease Epidemic: Robust National Health Systems at the Foundation and an Empowered WHO at the Apex’ (2015) 385 The Lancet 1902; Eccleston-Turner and Kamradt-Scott, ‘Transparency in IHR Emergency Committee Decision Making: The Case for Reform’; David P Fidler, ‘To Declare Or Not to Declare: The Controversy over Declaring a Public Health Emergency of International Concern for the Ebola Outbreak in the Democratic Republic of the Congo’ (2019) 14 Asian Journal of WTO and International Health Law and Policy 287.
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PHEIC decision making
The fact that the EC did not recommend a PHEIC during three committee meetings is confusing and demonstrates that the discretionary powers were self-afforded, and the EC acted beyond its treaty role in two, interlocking ways. First, the EC considered social, political and economic factors, which it did not have the legal authority to consider, what in administrative law are termed ‘irrelevant considerations’.96 Second, engaging in such analysis is a discretion reserved for the DG, not the EC. As we have argued, the role of the EC in the PHEIC declaration process was intended to be a technical and legal one aligned to the narrowly defined criteria found at Article 1 of the IHR. It was the seemingly a-political and technical nature of Annex 2 that helped to encourage states to agree to this declaratory power afforded to the WHO. Thus, it is important for the normative longevity of the IHR, and continued compliance and adherence to the Regulations, that the strict criteria within the treaty are the sole decision-making points for recommendation by the EC to the DG. Political or economic factors are to be taken into consideration in the PHEIC decision making, but by the DG who is politically accountable through internal and external accountability mechanisms for doing so.97 October 2018
The first EC meeting noted that the criteria to declare a PHEIC were actually met. The EC noted on several occasions that ‘there is a very high risk of regional spread’; that ‘response activities need to be intensified’, which might insinuate requires 96 97
CF Forsyth and William Wade, Administrative Law (11th edn, Oxford University Press 2014) 323. Mark Eccleston-Turner and Scarlett McArdle, ‘Accountability, International Law, and the World Health Organization: A Need for Reform?’ (2017) XI Global Health Governance 27.
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coordinated action; and that there were a number of factors that made the outbreak ‘extraordinary’, such as the very high case fatality rate, that new cases were being identified without epidemiological links and that the outbreak was taking place in an active conflict zone amidst prolonged humanitarian crises. Despite these, the EC advised ‘that a PHEIC should not be declared at this time’.98 This language is markedly different from the language used during the previous 13 ECs, which advised the DG against declaring a PHEIC. These stated that ‘the conditions for a PHEIC are not currently met’ or the event ‘does not constitute a PHEIC’. The October 2018 EC is the only time that members have deviated from stating that the criteria are not met. The implication of this change in language is significant –it implies that the criteria were met at the time of the first EC meeting for Ebola in DRC, but the EC advised against making a PHEIC declaration, regardless, presumably based on additional factors. April 2019
This political decision making beyond the IHR criteria was even more apparent at the second EC, which stated: ‘there is no added benefit to declaring a PHEIC at this stage’. It is not clear how it reached such a clear determination, particularly given it also noted that there is a ‘critical need to strengthen current efforts in both preparedness and response’.99 It is worth 98
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WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 18 October 2019’ https:// www.who.int/ n ews- room/ d etail/ 1 8- 1 0- 2 019- s tatement- o n- t he- meeting-of-the-international-health-regulations-(2005)-emergency- committee-for-ebola-virus-disease-in-the-democratic-republic-of-the- congo. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 18 October 2019’.
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highlighting that the notion of ‘added benefit’ is not part of the PHEIC criteria, and therefore an EC ought not consider it when making a recommendation to the DG. Perhaps most pertinently, given the scarcity of evidence around what occurs during the PHEIC declaration process, there is no basis on which to make informed decisions as to whether the PHEIC would have an added benefit or not. Such justification was based on individual assumptions or, more alarmingly for scientists, anecdotes as to the effect of a declaration. Moreover, the EC noted that the criterion for international spread had yet to be met, because there were yet to be cases beyond the DRC.100 This justification, again, is not grounded within the IHR criteria. The key element of cross-border spread is not ‘international’ but ‘risk … through the international spread of disease’ (emphasis added). It is the risk of cross-border transmission which is central in determining whether a PHEIC ought to be declared. It can be the case that the risk of international spread is high, necessitating a PHEIC, even if cross-border transmission has not yet occurred. This was certainly the case with the resurgence of polio in 2014, despite the fact that there was no ‘international spread’.101 100
101
WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 12th April 2019’ https:// www.who.int/ n ews- room/ d etail/ 1 2- 0 4- 2 019- s tatement- o n- t he- meeting-of-the-international-health-regulations-(2005)-emergency- committee-for-ebola-virus-disease-in-the-democratic-republic-of-the- congo-on-12th-april-2019. While there were a very small number of confirmed cases in Pakistan, Afghanistan and Nigeria, these were all unrelated cases of a virus that is endemic in those states and did not constitute cross-border transmission. The Committee emphasized the ‘public health risk to other states’ the resurgence of Polio posed, along with the risk of ‘international spread across land borders’ and the consequences of international spread to the ‘large number of polio-free but conflict-torn and fragile states which have severely compromised routine immunization services and are at high risk of re-infection’, even going so far as to list the states they believed
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Likewise, even if cross-border transmission has occurred, it does not necessarily follow that there is a high risk of international spread, which would necessitate the declaration of a PHEIC, as was the case with yellow fever in 2016.102 Thus, the October and April ECs showed contradictory positions, acknowledging the ‘very high risk of regional spread’, the ongoing and complex nature of the current outbreak, and the ‘recent increase in transmission in specific areas’ closer to the territorial borders of the DRC.103 June 2019
At the third EC it was stated: ‘While the outbreak is an extraordinary event, with risk of international spread, the ongoing response would not be enhanced by formal Temporary Recommendations under the IHR (2005).’ Remarkably, the EC followed this non-declaration by issuing ‘advice’: ‘the Committee strongly emphasizes its previous advice against the application of any international travel or trade restrictions; the Committee does not consider entry screening at airports or other ports of entry to be necessary’104 –echoing many
102
103
104
to be at risk from the resurgence of polio, if it spread unabated. See the section on polio in this chapter. WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’ https:// www.who.int/mediacentre/news/statements/2016/ec-yellow-fever/ en/; WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’ https:// www.who.int/en/news-room/detail/31-08-2016-second-meeting-of- the-e mergency-c ommittee-u nder-t he-i nternational-h ealth-r egulations- (2005)-concerning-yellow-fever. WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’; WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic
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TRs under the IHR made previously, although lacking the legal and normative force of recommendations issued pursuant to Article 15. From a legal perspective, the EC misunderstood the PHEIC criteria on two key grounds. First, it interpreted the PHEIC criterion of ‘potentially requires a coordinated international response’ to mean ‘issuing of Temporary Recommendations pursuant to Article 15 of the IHR’. Such an interpretation is wholly inconsistent with previous ECs, and indeed, inconsistent with the IHR themselves, which consider TRs as merely one aspect of a coordinated response to a health emergency. As Fidler succinctly noted: ‘In June, the committee effectively deleted the third criterion in the definition and inserted a new one that it made up, something neither the committee nor the Director-General has any right, discretion, or power to do under the IHR.’105 Second, the EC issued advise and recommendations to the WHO, and member states, outside of the framework of the TRs. At first glance, the distinction between general advice issued by the EC and formal TRs may appear somewhat of a legal fiction: they are issued by the same body; they have the same non-binding character; and they are, on occasion, ignored by states. There are, however, significant differences in relation to the normative and legal character. TRs provide an important benchmark in respect of any additional health measures imposed by states during a PHEIC. According to Article 43(3), where a state has implemented an additional health measure that significantly interferes with
105
Republic of the Congo on 14 June 2019’https://www.who.int/news-room/ detail/14-06-2019-statement-on-the-meeting-of-the-international- health-regulations-(2005)-emergency-committee-for-ebola-virus- disease-in-the-democratic-republic-of-the-congo. Fidler, ‘To Declare Or Not to Declare: The Controversy over Declaring a Public Health Emergency of International Concern for the Ebola Outbreak in the Democratic Republic of the Congo’.
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international traffic, it must provide the WHO with its public health rationale, to be shared with other states,106 No such requirements are necessary when the EC provides ‘advice’ outside of the IHR framework, thus there is no normative authority to this advice, and no accountability or evaluation mechanism for its utilization. From a political perspective, however, it appears that there was a determination not to declare a PHEIC. Assessments were made, based on non-existent (or at least classified) evidence, as to what impact a declaration may or may not have on the epidemic situation. Presentations were made during EC meetings, including on the security situation, and the impact this has on an ‘enabling environment to support outbreak response’.107 The assumption was that, given the protracted humanitarian and civil crisis, coupled with a crippled health system, a declaration of a PHEIC may not inspire any meaningful change, and might make things worse. However, despite the reconciliation that this would not be a PHEIC, the EC statement included a comment: ‘UN-wide support is needed to strengthen the public health response and coordinate international assistance’ –that is, the need for an internationally coordinated response, the very point that the EC said was not met for the criteria of the PHEIC (above). Moreover, broader analysis at the time suggested that the declaration of a PHEIC may have unintended consequences: that the potential effect of increased interest, donor funding and intervention by global health actors may throw gas onto the already burning civil fire. This point about funding was made expressly, that it risked the construction of an Ebola economy whereby prices would rise as international actors enter the situation, leading to a black
106 107
Article 43(3), International Health Regulations (2005) UNTS 2509. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 14 June 2019’.
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market and/or unaffordable goods for individuals.108 Again, this was not evidence based, but an assessment made by the EC. As EC meetings are not transparent, we have no way of knowing on what basis such assessments were made. Were there one or two vocal proponents who convinced others in the room through analogic decision theory? Was it at the request of the DRC representative present in the EC meeting, or was it the WHO that did not want to declare a PHEIC, reticent of the criticism it felt following the quick deployment of the PHEIC declaration for Zika? Or, as the third EC notes, is it that while Ebola posed a risk at national or regional levels, the risk posed globally was low. Does this reflect the Western- centrism that the IHR have long since been criticized for?109 More importantly, if political factors were being brought into consideration, not only does this go beyond the criteria of the IHR and the mandate of the EC, but also the EC might have sought the relevant expertise of political analysts of the DRC, for example. In essence, the EC was taking into consideration factors beyond its explicit legal mandate and was doing so from a position lacking any relevant expertise. July 2019
The third EC concluded that ‘a coordinated international response under the International Health Regulations (2005) is required’ and that ‘the conditions for a Public Health Emergency of International Concern (PHEIC) under the IHR (2005) have been met’. A significant difference in the outbreak between the June and July meetings was the identification of a case of Ebola in Goma, a large metropolis in the DRC, close 108
109
Adia Benton and Kim Yi Dionne, ‘International Political Economy and the 2014 West African Ebola Outbreak’ (2015) 58 African Studies Review 223. Simon Rushton, ‘Global Health Security: Security for Whom? Security from What?’ (2011) 59 Political Studies 799.
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to the Rwandan border. This, it appears, was enough to satisfy the EC that the PHEIC criteria were met, because now ‘a coordinated international response’ was required. Its reasoning for this is, frankly, impenetrable. Temporary recommendations
States affected (that is, the DRC, although not expressly named) were told to strengthen community awareness of the infection, ensure point-of-entry controls, work closely with the multi-stakeholder framework of actors in the disease control response, and improve surveillance, tracing and coordination with the health system, particularly with the introduction of vaccines. Interestingly, beyond these epidemiological requests, states were required to minimize security threats to those Ebola treatment units that had come under attack as part of the ongoing insecurity in the region, which in part had raised concerns of the ‘no-added benefit’ of the PHEIC, fearing this might further identify these locations as targets for non-state armed groups in the region.110 Neighbouring states were requested to expand surveillance capacities, as well as increase risk communications and, interestingly enough, ‘map population movements and sociological patterns that can predict risk of disease spread’, something that appears off topic for EC members who are epidemiologists, virologists and clinicians, but may reflect a greater role for the advisors who take part in EC meetings, which included anthropologists. Greater scrutiny should be made as to the role of these advisors, and how they differ from that of EC members, who are also selected for their specialist knowledge. As with the previous Ebola outbreak in West Africa, all states were advised not to place travel or trade restrictions on the
110
Christophe Vogel and others, ‘Clichés can kill in Congo’ (2019) 30 Foreign Policy.
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DRC ‘as they are usually implemented out of fear and have no basis in science’,111 a stark point to mitigate fears that affected regions may have had about a PHEIC declaration, albeit there is no conclusive evidence as to what effect such a TR has on state decision making. Additional reflections
To reiterate, in the first meeting of the EC, the EC believed that a PHEIC was not beneficial, although it did not explain why, politically, socially or economically, nor did it identify where in Article 1 such a criterion was found. The second meeting reiterated the lack of added benefit, but also erroneously argued that the criteria were not satisfied because there was no ‘international spread’ beyond the borders of the DRC,112 despite ‘very high risk of regional spread’. In the third meeting, when international spread was present, the goal posts were shifted so that it was not the potential international coordinated response that was the decision factor, but that TRs were not required despite this not being in the criteria for a PHEIC, and indeed these being issued in all but name and legal standing. Finally, in the fourth meeting, when the EC correctly recommended that a PHEIC be declared, it did so for erroneous and/or unclear reasons. It stated that the criteria were satisfied as ‘a coordinated international response is now required’; but this is not in the criteria. The criterion is that an event ‘potentially require[s] a coordinated international response’.113 Even if we humour
111
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‘Statement on the meeting of the International Health Regulations (2005) Emergency Committee for Ebola virus disease in the Democratice Republic of the Congo on 17 July 2019’ https://www.who.int/ihr/ procedures/statement-emergency-committee-ebola-drc-july-2019.pdf. WHO, ‘Statement on the Meeting of the International Health Regulations (2005) Emergency Committee for Ebola Virus Disease in the Democratic Republic of the Congo on 12th April 2019’. Article 1, International Health Regulations (2005) UNTS 2509.
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such logic, it still fails to make sense. First, there was already a coordinated international response in the DRC –the WHO Health Emergencies Programme had been responding to the outbreak since August 2018. It had been joined by other non- governmental organizations, and states. Second, why did a sole case in Goma mean that the previous arguments put forward by the EC were no longer applicable? Was it more politically acceptable for a PHEIC to be declared at this stage? The farcical deliberations of the EC for Ebola in the DRC are perhaps the starkest example of our underpinning argument, that executive power being improperly exercised or fettered away leads to manifestly absurd results. It is clear that the EC acted outside of its legal authority by taking into account implicit or explicit political considerations when determining whether the legal criteria for a PHEIC were met, which is beyond its role. However, the fault for this farce does not lie solely at the door of the EC; blame must also go to the DG and the WHO Secretariat. In accepting the recommendations laid before him by the EC, DG Tedros endorsed such erroneous reasoning, its (incorrect) decision and the improper role for the EC. By not disregarding the recommendations of the EC in these instances, the DG failed to ensure the IHR were properly implemented, and failed to protect the treaty role of the DG from mission-creep from the EC. To be clear, the role of the EC is to furnish the DG with technical advice, but it is merely advice; the DG is free to disregard it and declare a PHEIC against the recommendations of an EC. By failing to do so, DG Tedros endorsed the EC expanding its role beyond its treaty mandate. Moreover, in accepting the logic that a PHEIC would not enhance or improve the response in the DRC, and that, in actual fact, it would harm outbreak response efforts, the DG agreed that a treaty negotiated under the auspices of the WHO, which at its centre has this exercise in executive power by the DG, was at best ineffective, and at worse actively harmful to states in their response to a health emergency within their territory.
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COVID-19 COVID-19 is the biggest challenge to the IHR and WHO to date, and thus analyzing the PHEIC decision-making process is vital to understand the impact of the PHEIC more broadly. As is widely known by now, SARS-CoV emerged from Wuhan, China in December 2019, and was immediately watched by the global health community as Chinese authorities put the whole city in lockdown in an effort to mitigate disease transmission. By mid-January 2020, cases of the virus had emerged in multiple other countries in the region, and by March 2020, outbreaks of the virus had ravaged almost every country globally. At the time of writing, there have been nearly 200,000,000 confirmed cases globally, and more than 4.1 million deaths. Both these numbers are likely to be under- reported. The DG declared a PHEIC on 30 January 2020. PHEIC decision making
The first EC meeting was held on 22 January 2020. This was a rapid escalation of this governance function comparatively, given that the unknown pneumonia had only been reported at the end of December 2019.114 The EC was briefed by those locations that had reported infection at this time: China, Japan, South Korea and Thailand. According to the EC statement from the first meeting, there were ‘divergent views on whether this event constitutes a PHEIC’, with the EC even holding a vote, which resulted in a tie, with an EC member later clarifying that there was no consensus on whether this event met the criteria for a PHEIC declaration.115 114
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WHO, ‘Timeline: WHO’s COVID-1 9 response’ (2020) https:// www.who.int/ e mergencies/ d iseases/ n ovel- c oronavirus- 2 019/ interactive-timeline#event-0 Youngmee Jee, ‘WHO International Health Regulations Emergency Committee for the COVID-19 Outbreak’ (2020) 42 Epidemiology and Health e2020013.
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This requirement of a consensus (such as by votes) is not a stipulation of the IHR. Indeed, it is at the discretion of each EC as to how it comes to a decision as to what recommendation to make to the DG. However, the lack of transparency in the PHEIC process means that there is no certainty of consistency of approach to decision making in these meetings, leaving room for interpretation. However, for many this was an erroneous decision, with COVID-19 clearly meeting the criteria of a PHEIC, with the sense that political decision making was hindering the legal implementation of the IHR decision instrument.116 The DG instructed participants to meet the following day to continue their deliberations. On 23 January 2020 the EC advised that the event did not constitute a PHEIC, while still noting that the situation was ‘urgent’ and suggesting reconvening in a matter of days to examine the situation further. The conclusion appears to be predicated on the lack of necessary data and the (then) scale of global impact, something that was not a barrier to a declaration during Zika. At that time there were only four cases outside of mainland China, and all with travel history to the affected region. There were again divergent opinions within the EC itself, with several members considering that it was still too early make a declaration, given what they referred to as the ‘restrictive and binary nature’ of the PHEIC declaration. Division within the EC appears to have centred on the meaning of ‘international spread’, within Article 1 of the IHR. If all known cases outside of China were of individuals who were infected in China, but then travelled internationally, an argument could be made that this did not constitute international spread. But again, this is at odds with the text of the IHR, and the way the criteria have previously been interpreted. At this meeting the EC failed to properly conceptualize risk 116
Mullen and others, ‘An analysis of international health regulations emergency committees and public health emergency of international concern designations’.
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in the manner in which the IHR intends. The EC further justified its recommendation on the basis that ‘now is not the time’ to declare a PHEIC.117 The EC did not expressly state that the criteria to declare were not met at this stage, merely that now is not the time to make such a declaration. By a plain reading of the treaty, the criteria did appear to be met, a sentiment subsequently supported by the Independent Panel for Pandemic Preparedness and Response,118 and the wording of the EC –with its emphasis on timing –appears to suggest that it once again took into consideration factors beyond the criteria for a PHEIC when making its determination. Instead, the EC agreed to monitor the situation and reconvene in ‘a matter of days’, being recalled on 30 January 2020. At this point there had been a significant increase in cases and countries reporting cases, and the EC recommended that the outbreak now warranted a PHEIC declaration. The EC believed that a declaration would help to facilitate the interruption of the virus spreading, encouraging countries to put in place strong measures for detection, isolation, treatment, contact tracing and social distancing. In the statement, the EC deemed that ‘a global coordinated effort is needed’ (note that the IHR require a coordinated response to be potentially required, not actually needed) and suggested that there was a risk of international spread through the wording ‘it is expected that further international exportation of cases may appear in any country’.119 The EC made no explicit reference to the ‘extraordinary’ requirement of the PHEIC 117
118
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WHO, ‘Press conference on the meeting of the IHR Emergency Committee Novel Coronavirus (2019-nCoV)’ (22 January 2020) https:// www.pscp.tv/w/1rmxPXvEzWdxN. Independent Panel for Pandemic Preparedness and Response (IPPPR) Main Report (2021) https://theindependentpanel.org/wp-content/ uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_final.pdf. WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak
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criteria in this statement,120 but by implication it considered COVID-19 to be an extraordinary event at this stage. It was not until the fifth meeting of the EC that language began to mirror that explicitly laid down in the IHR as the criteria for a PHEIC: ‘the Committee unanimously agreed that the pandemic still constitutes an extraordinary event, a public health risk to other States through international spread and continues to require a coordinated international response’.121 What was noticeable in this PHEIC declaration was the express concern within the EC and the WHO Secretariat for how China would view the declaration: The Committee emphasized that the declaration of a PHEIC should be seen in the spirit of support and appreciation for China, its people, and the actions China has taken on the frontlines of this outbreak, with transparency, and, it is to be hoped, with success. In line with the need for global solidarity, the Committee felt that a global coordinated effort is needed to enhance preparedness in other regions of the world that may need additional support for that.122
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of Novel Coronavirus (2019-N CoV)’ https:// w ww.who.int/ news-room/detail/30-01-2020-statement-on-the-second-meeting- of-t he-i nternational-health-regulations-(2005)-emergency-c ommittee- regarding-the-outbreak-of-novel-coronavirus-(2019-ncov). Mullen and others, ‘An analysis of international health regulations emergency committees and public health emergency of international concern designations’. WHO, ‘Statement on the 5th Meeting of the IHR Emergency Committee Regarding the Coronavirus Disease (Covid-2019)’ https:// www.who.int/n ews/i tem/3 0-1 0-2 020-s tatement-o n-t he-fi fth-m eeting- of-t he-i nternational-health-regulations-(2005)-emergency-c ommittee- regarding-the-coronavirus-disease-(covid-19)-pandemic. WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’.
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Indeed, in the accompanying press conference, DG Tedros was very clear that the PHEIC declaration was not because of the outbreak in China per se but was to act as a call for support for LMICs to prepare for a potential outbreak (with the assumption that they would be less able to do so than China), a sentiment echoed by subsequent consideration of the EC.123 These statements indicate the extent to which political considerations appear to have influenced both the EC’s recommendations and the DG’s actions. One suggestion might be that there was reticence for the declaration from the Chinese delegation participating in the EC meeting. Due to the lack of transparency regarding the committee’s deliberations, we cannot say whether this occurred. A second suggestion might be that, regardless of Chinese participation in the EC deliberations, the EC and/or DG were concerned as to China’s reaction to the declaration, and thus were drawn into diplomacy efforts to contain any fallout, at a critical time in the outbreak when they required a transparent approach from China. Fearing a PHEIC declaration could be construed as hostile and could result in China simply refusing to engage in sharing further data on the trajectory, epidemiology and clinical presentation of the virus. However, this needs to be understood in the context of Chinese–WHO relations. During SARS, China failed to notify the WHO of the circulating pathogen, and later sought to conceal the extent of the epidemic. Thus, the WHO was notably keen to engage China during the early stages of COVID-19 to ensure continuity of transparency. This led to considerable criticism of the WHO in 2020, with some considering it to be too lenient on China,124 failing to speak out about the 123 124
Jee, ‘WHO International Health Regulations Emergency Committee for the COVID-19 Outbreak’. Theodore M Brown and Susan Ladwig, ‘COVID-19, China, the World Health Organization, and the Limits of International Health Diplomacy’ (2020) 110 American Journal of Public Health 1149.
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mass human rights violations that appear to have occurred in China in response to the outbreak,125 and even the then President Donald Trump listing the WHO’s relationship with China as part of the justification for the US-proposed WHO withdrawal.126 Thus, the delicate language of the PHEIC is important for understanding the contemporary and recent history. We do not have a control country to know how the WHO would have acted had the outbreak emerged in a different location with a less complicated past, but it is hard to understand the convoluted EC statement in the absence of such history. Temporary recommendations
The EC recommended a series of TRs to minimize the spread of COVID-19. Interestingly, the EC made recommendations for distinct groups. The first targeted the WHO, requesting the organization to support the mission to China to investigate the source of the outbreak, human to human transmission, and infection control measures’ success. The WHO was also requested to provide all possible technical, strategic and operational support to those working to reduce disease spread. This is an interesting development as this is the first time that the WHO has been tasked with recommendations by the PHEIC. This development is of note as it marks a change in power relations among the PHEIC stakeholders, as the WHO is considered in parallel to member states and seemingly has
125
126
Alicia Ely Yamin and Roojin Habibi, ‘Human Rights and Coronavirus: What’s at Stake for Truth, Trust, and Democracy?’ (2020) Health and Human Rights Journal, https://www.hhrjournal.org/2020/ 03/human-r ights-and-coronavirus-whats-at-stake-for-truth-trust-and- democracy/. Nitsan Chorev, ‘The World Health Organization between the United States and China’ (2020) 20 Global Social Policy 378.
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actions (and potentially outputs) that require monitoring by the EC. This may in turn question the role of the WHO as the central epidemic coordinator for global infectious disease control. By 2020, the global health governance matrix had become considerably more complicated and convoluted, and this inclusion may be seeking to reclaim some of this role for the institution. Again, it would be interesting to understand whether this was suggested by the EC, or in conjunction with the WHO Secretariat or DG; a lack of transparency in the process makes such contemplation hard. China was requested to provide information on risk management systems, enhance public health measures, enhance surveillance (particularly with the upcoming Chinese New Year, which was only a few weeks after the PHEIC declaration), collaborate with the WHO, share genome data with the WHO, and conduct exit screening at airports. As was noted in the second EC, this action was championed: ‘the measures China has taken are good not only for the country but also for the rest of the world’.127 Even though human rights are strongly embedded within the IHR framework,128 no reference was made by the EC, or the DG, to the potential human rights implications of the Chinese response to COVID-19. Thus, here again, China was lauded for its normative efforts in global health security. TRs were also directed to the wider international community, which was requested to prepare surveillance, detection, isolation and case management, as well as reminding them to report any cases to the WHO under IHR requirements,
127
128
WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’. Gian Luca Burci and Mark Eccleston-Turner, ‘Preparing for the next Pandemic: The International Health Regulations and World Health Organization during COVID-19’ (2020) 2 Yearbook of International Disaster Law.
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following the best technical guidance from the WHO.129 Importantly, states were requested not to impose trade or travel restrictions and were reminded that they had to inform the WHO of any additional public health restrictions put in place beyond WHO guidance, and ensure that these are non- discriminatory under Article 3 of the IHR.130 Even by the end of January 2020 when these TRs were issued, there were already a number of states that had implemented travel and trade restrictions against China.131 Meanwhile, the global community was requested to ‘work in solidarity under article 44 of IHR’, to ‘share information, data and collaborate in disease preparedness and reduction efforts, expanded to facilitating access to all scientific developments globally and equitably’. Moreover, member states were requested to ‘support WHO’ (which seems a strange recommendation, and may further reflect the diminishing sense of loss of control of the organization and/or its failure to display the legitimacy and authority required of leadership during a pandemic), collaborate in global solidarity, build and strengthen preparedness and response efforts, and implement ‘appropriate’ travel measures, balancing the public health benefit with the broader impact within trade and international agreements. States were also further requested to protect healthcare workers with PPE, suitable training and improved testing strategies, ensure the food security supply chain, promote a ‘one health’ approach, engage in community-level activities for the dissemination of
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131
WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’. WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’. Matteo Chinazzi and others, ‘The Effect of Travel Restrictions on the Spread of the 2019 Novel Coronavirus (COVID-19) Outbreak’ (2020) 368 Science 395.
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health protection efforts, address research gaps, share research findings and maintain essential health services.132 Additional reflections
Despite these recommendations, the PHEIC for COVID-19 did not appear to have the effect that the WHO had intended. While the EC and the DG (and broader WHO Secretariat) had sounded the alarm that the outbreak was of global concern, a number of governments failed to follow the TRs issued. Many governments implemented travel and trade restrictions, beyond guidance of the WHO, but at the same time did little to prepare for an epidemic within their borders.133 Given the apathy seen, particularly among some high-income states, on 11 March 2020, DG Tedros moved one step further than the PHEIC and declared COVID-19 to be a pandemic. As he stated, the ‘WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction’.134 This appeared to be with some frustration as he continued: ‘[W]e have called every day for countries to take urgent and aggressive action; We have rung the alarm bell loud and clear.’ The assumption within this is that the PHEIC was not enough of a normative drive on its own to inspire action, but it needed the wording of pandemic to be able to push 132
133 134
WHO, ‘Statement on the 3rd Meeting of the IHR Emergency Committee Regarding the Outbreak of Coronavirus Disease (Covid-19)’. https://w ww.who.int/n ews/i tem/0 1-0 5-2 020-s tatement-o n-t he-t hird- meeting-of-the-international-health-regulations-(2005)-emergency- committee-regarding-the-outbreak-of-coronavirus-disease-(covid-19). Sara E Davies and Clare Wenham, ‘Why the COVID-19 Response Needs International Relations’ (2020) 96 International Affairs 1227. WHO, ‘Press conference on COVID-19’ (11 March 2020) https:// www.who.int/docs/default-source/coronaviruse/transcripts/who- audio- e mergencies- c oronavirus- p ress- c onference- f ull- a nd- f inal- 11mar2020.pdf?sfvrsn=cb432bb3_2.
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governments into action. This might reflect previous PHEICs and their (inconsistent) usage, as well as the fact that not since 2009 had any PHEIC required meaningful action domestically by most of the globe’s states, particularly those in high- income countries, with Ebola, Zika and polio all posing less of a concern for the global north. However, simultaneously it marks a return to previous tiered pandemic phases that the WHO had used in the early 2000s,135 and from which the institution had sought to depart, noting the technocratic decision-making comprizing each element, and the failure for the interim tiers to encourage action. Indeed, these had been abandoned as part of a broader push for an all-hazards approach to global health security. However, the pandemic designation did appear to have some effect. It was after this pandemic declaration in March 2020 onwards that those governments that did not initially follow the TRs and the WHO’s advice began to take the pathogen more seriously, implementing a range of non-pharmaceutical interventions. As yet there is no evidence establishing whether this is linked to the pandemic designation, or indeed, the epidemic curve and soaring case numbers in the spring of 2020. Beyond the empirical case information of the COVID- 19 PHEIC, there have been two further developments for the PHEIC mechanism during COVID-19. The first is the introduction of awareness of the ethical, legal and potential conflicting position of those serving on an EC. Each EC statement mentions efforts for good governance practice, including a reminder of the duty and obligations of the EC, its roles and ethical requirements and the opportunity to declare any conflicts of interest. Moreover, members ‘were additionally reminded of their duty to maintain the confidentiality of the meeting discussions and the work of the committee’ –a key
135
WHO, ‘A checklist for pandemic influenza risk and impact management’ (2018).
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tension in the methodology of researching PHEIC processes and that of the EC in that so much of the content of the meetings and decision making remains opaque. The second key part is the debate surrounding the introduction of an intermediate or tiered PHEIC. In the first meeting of the EC, ‘several members considered that it is still too early to declare a PHEIC, given its restrictive and binary nature’.136 Indeed, it has been subsequently insinuated that the reason the PHEIC was not declared at this time was due to the inability to be able to offer an interim declaration.137 As such, the recommendation of the EC continued: In the face of an evolving epidemiological situation and the restrictive binary nature of declaring a PHEIC or not, WHO should consider a more nuanced system, which would allow an intermediate level of alert. Such a system would better reflect the severity of an outbreak, its impact, and the required measures, and would facilitate improved international coordination, including research efforts for developing medical counter measures.138 The second EC further stated that the ‘WHO should continue to explore the advisability of creating an intermediate 136
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WHO, ‘Statement on the 1st Meeting of the IHR Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’ https:// www.who.int/news/item/23-01-2020-statement-on-the-meeting-of- the-international-health-regulations-(2005)-emergency-committee- regarding-the-outbreak-of-novel-coronavirus-(2019-ncov). Clare Wenham and others, ‘Problems with traffic light approaches to public health emergencies of international concern’ (2021) 397 The Lancet 10287. WHO, ‘Statement on the 1st Meeting of the IHR Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’ https:// www.who.int/news/item/23-01-2020-statement-on-the-meeting-of- the-international-health-regulations-(2005)-emergency-committee- regarding-the-outbreak-of-novel-coronavirus-(2019-ncov).
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level of alert between the binary possibilities of PHEIC or no PHEIC, in a way that does not require reopening negotiations on the text of the IHR (2005)’.139 This continues to circulate within WHO conversations surrounding IHR revisions, but ultimately will not solve the tensions of the PHEIC linked to government compliance, and may simultaneously (re-)introduce new problems for the EC, DG and WHO.140
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WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-NCoV)’. Clare Wenham and others, ‘Problems with traffic light approaches to public health emergencies of international concern’ (2021) 397 The Lancet 10287.
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Events That Were Not Declared a PHEIC
Further to the case studies in the previous chapter, we also sought to understand whether the same inconsistencies were present in outbreaks that were not declared a PHEIC. Within this chapter we consider events for which the DG convened an EC, but which did not result in a PHEIC declaration and second, we also consider events the DG did not convene an EC for, despite the criteria appearing to be met. Considering these events enables us to have a clearer understanding of the use of executive discretion by the DG in regard to the PHEIC, particularly in respect of when an EC is convened, and the relationship between the DG and the EC. We find that multiple DGs failed to convene ECs to consider an event a potential PHEIC, despite the criteria to do so appearing to be met. We further show that the DG is unwilling to go against the advice provided by the EC, even when, as was the case with MERS-CoV, it was apparent that the criteria to declare a PHEIC had been met. This is unusual, given the advice of an EC is one of multiple considerations the DG needs to consider when determining whether a PHEIC declaration is warranted, and goes some way towards demonstrating the extent to which certain aspects of the DG role have been fettered away to the EC.
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MERS-CoV Middle East respiratory syndrome coronavirus (MERS-CoV) is a zoonotic virus, which is transferred to humans from camels. It was first reported to the WHO in 2012, and since then has been detected in 27 countries, and has led to at least 858 deaths and 2,494 reported cases, with an estimated 35% mortality rate.1 The majority of these have occurred in Saudi Arabia, although there was a notable outbreak in South Korea. A considerable issue with the initial global response to MERS was the lack of clear and transparent information. For example, a case was detected in the UK in a passenger recently arriving from Saudi Arabia, after the initial analysis by Public Health England MERS was confirmed, the UK was obligated to report this case to the WHO under Article 6 of the IHR. However, the UK failed to give prompt notification, and instead chose to delay notification by a few days, recognizing that the implicit assumption would be that Saudi Arabia had not complied with its duties under the IHR.2 Information sharing was mired with further delays, including the silencing of those who shared information about the pathogen without approval within Saudi Arabia.3 An EC has met ten times since the pathogen was first detected in 2012. The first two EC meetings were scant on information, with the associated report simply stating that the EC was called for an independent expert view –and it 1
2
3
Mazin Barry, Maha Al Amri and Ziad A Memish, ‘COVID-19 in the Shadows of MERS-CoV in the Kingdom of Saudi Arabia’ (2020) 10 Journal of Epidemiology and Global Health 1. Clare Wenham, ‘Examining sovereignty in global disease governance: surveillance practices in United Kingdom, Thailand and Lao People’s Democratic Republic’ (doctoral dissertation, Aberystwyth University) (2015). Jeremy Youde, ‘MERS and Global Health Governance’ (2014) 70 International Journal 119; Declan Butler, ‘Tensions Linger over Discovery of Coronavirus’ (2013) Nature.
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considered that additional information was required before a decision could be made as to whether to recommend the outbreak be declared a PHEIC.4 Once such data emerged, the EC reconvened to review whether the criteria to declare a PHEIC were now met, concluding at the third and fourth EC meetings that ‘it saw no reason to change its advice to the DG’5 and that it had used a ‘risk assessment approach’6 to make the unanimous decision not to declare a PHEIC.7 It is not clear what this ‘risk assessment approach’ is, what factors this takes into consideration, how they are weighted, or even how they are related to the actual criteria for declaring a PHEIC. As is well established in this book, the decision making for the declaration of a PHEIC is based on the three factors of an unusual or extraordinary outbreak, with a risk to other countries through international spread and potentially requiring a coordinated response. Nevertheless, despite not declaring a PHEIC, and thus the DG not having the legal powers to issue TRs, the EC issued ‘advice’ for countries and the WHO including: targeted surveillance for countries with pilgrims participating in Umrah and Hajj; risk communication; increased diagnostic capacities; and sharing data on the pathogen when available. Interestingly, despite some of these recommendations clearly being targeted 4
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WHO, ‘Middle East Respirator y Syndrome Coronavir us (MERS-C oV)’ (9 July 2013) https:// w ww.who.int/ n ews/ i tem/ 09-0 7-2 013-m iddle-east-respiratory-syndrome-coronavirus-( mers-c ov). WHO, ‘Statement on the 4th Meeting of the IHR Emergency Committee Concerning MERS-CoV’ https://www.who.int/mediacentre/news/ statements/2013/mers_cov_20131204/en/. It is unclear what this actually means; it is a language inconsistent with previous meetings of the MERS EC, and meetings of ECs for other events. It is not language that is found in the terms of reference for the EC in the IHR, nor is it in the criteria that guides the EC found at Article 1. WHO, ‘Statement on the 4th Meeting of the IHR Emergency Committee Concerning MERS-CoV’.
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at Saudi Arabia, the country was never expressly addressed in the recommendations, a notable shift considering how Pakistan was highlighted in the case of polio. This suggests that the decision to include countries in the guidance produced is a nuanced decision affected by geopolitics. By the fourth EC, there were two notable points of analysis. First, this was the first time that ‘expert advisors’ were listed as present in the EC, although there is now one advisor listed for H1N1, but as the membership was not public at the time, this was not disclosed. What is not clear is what the difference is between expert advisors and EC members, given that the members were also selected based on their expertise. It was later clarified that the expert advisors did not participate in the ‘formulation of advice to the Director-General’.8 Second, cases had already emerged beyond Saudi Arabia and there was growing concern about the potential for further international transmission; clearly, the criterion for international spread was met. Indeed, the number of different member state participants contributing to the EC had increased up to 13 by the fifth meeting. Despite this, the EC justified not recommending a PHEIC on the basis of ‘no evidence of human-to-human transmission’, while simultaneously noting that ‘the seriousness of the situation had increased in terms of public health impact’.9 Importantly, human-to-human transmission is not a requirement for a PHEIC to be declared, and this, coupled with the lack of transparency surrounding the EC, means that we are not able to fully understand why this was seen as a quasi-threshold for declaring a PHEIC. Moreover, we have not seen this emphasis placed on human-to-human transmission in other ECs –for example for Zika, which relies on 8
9
WHO, ‘Statement on the 5th Meeting of the IHR Emergency Committee Concerning MERS-CoV’ https://www.who.int/mediacentre/news/ statements/2014/mers-20140514/en/. WHO, ‘Statement on the 5th Meeting of the IHR Emergency Committee Concerning MERS-CoV’.
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a mosquito vector for transmission to occur. A comparison between MERS and Zika also raises the question of why the mass gatherings associated with Umrah and Hajj were not seen as a risk that needed to be mitigated, in the same way that the Olympic Games in Rio de Janeiro were considered a key determinant in the declaration of a PHEIC for Zika. In the seventh, eighth and ninth ECs, additional reasoning was introduced to justify the lack of a declaration. This included: that there was no sustained human-to-human transmission; that the current response activities appeared to be sufficient; and that this might become a seasonal infection. Notably at this time, the ECs included key language for the PHEIC –‘the possibility of international spread … remains a concern’ –despite this not being included in earlier ECs when international spread had already occurred. By the time the outbreak had emerged in South Korea, there was greater concern amid the international community, with the assumption that human-to-human transmission must be occurring, given the lack of camels in Korea. The EC noted that there was a lack of awareness among healthcare workers and suboptimal infection control in hospitals where cases appeared to be spreading.10 It even stated: ‘The recent outbreak in the Republic of Korea demonstrated that when the MERS virus appears in a new setting, there is great potential for widespread transmission and severe disruption to the health system and to society.’11 Such a statement in many ways describes the exact sort of conditions for a PHEIC to be declared, and the wider raison d’être 2005 revisions to the IHR, yet in this case it was
10
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WHO, ‘Statement on the 9th Meeting of the IHR Emergency Committee Regarding MERS-CoV’ https://www.who.int/mediacentre/news/ statements/2015/ihr-ec-mers/en/. WHO, ‘Statement on the 10th Meeting of the IHR Emergency Committee Regarding MERS’ (3 September 2015) https:// www.who.int/mediacentre/news/statements/2015/ihr-emergency- committee-mers/en/.
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seen as a mere warning, rather than a rationale for declaring a PHEIC. The final EC had a clear intention to de-escalate the emergency. While the members (again) agreed that the event did not constitute a PHEIC, they began to use much more long- term language than in previous meetings, recognizing that the outbreak had been unfolding for three years. The EC offered ‘recommendations’ or advice to states, outside of the legal framework of the IHR, taking a long-term perspective on MERS, including: training in healthcare facilities to minimize transmission; addressing the systemic issues that impede the control of MERS in animals and humans; fostering greater data sharing and collaboration; and encouraging national leadership and a whole-of-government response.12 In spite of these recommendations occurring outside of the framework of the IHR, this informal guidance represents some of the most political advice given by an EC across any outbreaks. The EC called on politics and political systems to engage in the response, but also recognized that the fundamentals of outbreak response are based in the structures of societies and health systems and that tackling these are key to reducing the threat of pathogens.13 It is therefore disappointing to see this sort of important engagement with the political dimensions of outbreak response occur in an informal, ad-hoc manner by the EC, rather than through the formalized process created in the IHR and delegated to the DG. This is yet again another example of the mission creep of the EC, which we have identified at multiple points in this text, but once again, this has been endorsed by a DG allowing an EC to step beyond its defined treaty mandate and take into consideration factors reserved explicitly for the DG. This is
12 13
WHO, ‘Statement on the 10th Meeting of the IHR Emergency Committee Regarding MERS’. WHO, ‘Statement on the 10th Meeting of the IHR Emergency Committee Regarding MERS’.
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not an arbitrary distinction between the role of the EC and that of the DG; political considerations, where they are taken into account in the PHEIC declaration process, must be done by the DG in line with Article 12 of the IHR. The DG is a political position, accountable to the WHA and Executive Board for their decision making, and the decision to declare a PHEIC is one that comes with political consequences for the states concerned, as well as the WHO. A situation whereby a technical committee adopts the discretionary power of the DG to consider such political consequences is beyond its legal mandate, leaving the DG with little more than a rubber- stamping role; it is expertocratic decision making and at odds with constitutional legitimacy.14 Yellow fever In 2016, concurrently to the Zika outbreak, an outbreak of yellow fever spread from Angola to the DRC, and subsequently to China and Kenya. This resulted in approximately 8,000 cases, and 400 deaths globally (although the numbers are likely under-reported).15 Urban yellow fever is of particular concern because of the ease of transmission, combined with a high mortality rate, and the risk of spread to other urban areas through transport hubs and networks.16 This, in part, contributed to the decision to call an EC, compounded at this time by the dwindling yellow fever vaccine stockpile, which
14
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Christoph Möllers, ‘Constitutional Foundations of Global Administration’ in Sabino Cassese (ed) Research Handbook on Global Administrative Law (Edward Elgar Publishing 2016) 112. Moritz UG Kraemer and others, ‘Spread of Yellow Fever Virus Outbreak in Angola and the Democratic Republic of the Congo 2015–16: A Modelling Study’ (2017) 17 The Lancet Infectious Diseases 330. WHO, ‘Press Conference for the Meeting of the Yellow Fever IHR Emergency Committee’ (19 May 2016) https:// w ww.who.int/ mediacentre/news/statements/2016/YF-EC-19-May-2016.pdf.
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had been impacted by mass vaccination efforts across affected regions in the past decades. It is important to remember the historical context of yellow fever control:17 it is a pathogen that has afflicted trade routes for centuries, and indeed was one of the three pathogens listed in the 1969 IHR. In recent years, yellow fever has been less of a concern globally, largely due to the scaling up of efforts by the Yellow Fever Initiative (YFI), a global vaccination programme led by the WHO, UNICEF and GAVI, which has sought to vaccinate those deemed high-r isk.18 Yellow fever is referenced in the decision instrument at Annex 2 of the IHR as an event that ‘shall always lead to utilization of the algorithm, because they [such diseases] have demonstrated the ability to cause serious public health impact and to spread rapidly internationally’. To this end, in May 2016, four months after the first notification under the IHR from Angola, DG Chan convened an EC. This was subsequently followed by a second (and final meeting) in August of that year.19 The report of the first EC noted that the impact of the YFI, along with updates on the global stockpile of a vaccine, were part of the briefing the EC received. It appears that these updates, along with the fact that there was a safe and efficacious vaccine as the primary medical countermeasure to mitigate against the outbreak, have gone some way to assuaging fears of the virus.20 Yet the vaccine issue became a point of contention.
17 18
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J Erin Staples, ‘Yellow Fever: 100 Years of Discovery’ (2008) 300 JAMA 960, 100. Amanda Makha Bifani, Eugenia Z Ong and Ruklanthi de Alwis, ‘Vaccination and Therapeutics: Responding to the Changing Epidemiology of Yellow Fever’ (2020) 12 Current Treatment Options in Infectious Diseases 349. WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’ https:// www.who.int/mediacentre/news/statements/2016/ec-yellow-fever/en/. WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’.
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On the one hand, the cheap availability of a well-established vaccine (less than $1 a dose) and a considerable vaccine rollout through the YFI in recent years, coupled with the immediate rollout in areas of elevated risk and among travellers, would do a lot to minimize the potential spread of the disease. Yet, on the other, simultaneous concerns prevailed about the lack of a substantial stockpile for the vaccine and how demand could soon outstrip supply. As part of this, the EC also considered the suitability of a dose-sparing strategy –where individuals are not given as many doses within the regimen as clinically indicated – in response to the outbreak.21 While the EC stopped short of expressly recommending moving to this strategy (perhaps in recognition of its limited, and specific, role under the IHR), it recommended that this should be ‘given due consideration by the relevant experts within the WHO infrastructure to understand if this could be a way to ensure greater coverage of the finite resource’.22 Moreover, the EC gave further consideration as to how manufacturers could increase production to supply the outbreak regions in need of the vaccine. Interestingly, while it was made explicit that vaccine scarcity was not part of the criteria used for the decision making about the PHEIC, the EC nevertheless highlighted a need for international cooperation to consider approaches to fractional dosing (that is, international coordinated response efforts). The language used in the statement from the first meeting of the EC was nuanced in the use of language required for a PHEIC declaration. Urban outbreaks were considered a serious public health event warranting intensified national action and enhanced international support (in contrast to the PHEIC requirement of ‘potentially require coordinated international
21 22
WHO, ‘Press Conference for the Meeting of the Yellow Fever IHR Emergency Committee’. WHO, ‘Press Conference for the Meeting of the Yellow Fever IHR Emergency Committee’.
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response’). At this stage there was clearly a public health risk to other states, as there had already been international spread by the time of the first EC meeting. Indeed, this was part of the justification used as to why the EC was convened in the first place.23 At the second EC meeting, the Republic of Congo also attended the meeting, despite no cases having been identified there at that time. Nevertheless, ‘there was concern that intense population movements between the DRC and the Republic of the Congo pose a risk of expansion of the outbreak’.24 On this basis alone, there was a clearly identified risk of international spread, which satisfied at least one of the PHEIC criteria. To this end, the second EC recognized that yellow fever posed a public health risk to other states, and potentially required a coordinated international response to bring it under control. However, the it was not convinced that this was an ‘extraordinary’ outbreak, within the meaning of the PHEIC criteria; urban outbreaks such as those seen in Kinshasa are not unprecedented within the meaning of Article 1 of the IHR.25 At the accompanying press conference, additional insights into PHEIC discussions were provided, including the EC’s fears of the ‘potentially explosive nature of this disease and the risk internationally’.26 In contrast, it was noted that although yellow fever was a ‘public health threat’, and had crossed international borders, this did not constitute a risk of significant international
23 24
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WHO, ‘Statement on the 1st Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’. WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’ https:// www.who.int/en/news-room/detail/31-08-2016-second-meeting-of- the-e mergency-c ommittee-u nder-t he-i nternational-h ealth-r egulations- (2005)-concerning-yellow-fever. WHO, ‘Press Conference for the Meeting of the Yellow Fever IHR Emergency Committee’. WHO, ‘Press Conference for the Meeting of the Yellow Fever IHR Emergency Committee’.
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spread as ‘it had been associated with migrant workers’.27 It is unclear if spread associated with migrant workers fails to be ‘significant’ in the eyes of this particular EC. At the same time as not declaring the yellow fever epidemic a PHEIC, the EC did issue a series of ‘immediate actions’ for the WHO and member states, similar to TRs, although lacking the legal and normative weight of the IHR. These ‘immediate actions’ included: increased surveillance; vaccination; risk communication; community mobilization; vector control; vaccination certificates for travellers from infected countries; and consideration of rapid management for new importations, given the limited global supply of vaccines. The second EC was equally long-termist in its approach, making it comparable to that of the final EC for MERS –with a focus on how best to manage this endemic disease, with a focus on long-term strategies such as continued surveillance and vaccination strategies at the population level.28 This provides an interesting perspective on what happens at the end of the PHEIC, or end of an EC process. In almost all cases the PHEIC is declared over before the virus has been eradicated or supressed, and thus there needs to be greater consideration as to what happens in the wake of an outbreak, once the fanfare of the PHEIC is over. This can take two different trajectories. In one scenario, such as Ebola, the outbreak is eliminated, and preparedness efforts are increased to mitigate against future development of the spread of the disease. The second scenario is one where the outbreak is not over, such as Zika, whereby the disease becomes endemic, but at low levels, and different policy tools are introduced to ensure longer-term support for the health system and public awareness.
27 28
WHO, ‘Press Conference for the Meeting of the Yellow Fever IHR Emergency Committee’. WHO, ‘Statement on the 2nd Meeting of the International Health Regulations (2005) Emergency Committee for Yellow Fever’.
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What is also interesting in the non-declaration of yellow fever is the discussion about the fragile health systems, which appears several times in the EC’s press conferences, and the impact that impending rainy seasons increasing transmission of vector-borne disease could have on such health systems. The EC states that there are structural challenges in resource- poor settings to deploy vaccines –the key weapon in the fight against the disease –which impedes good population coverage. The emergency on top of routine health concerns means that it is equally hard to get robust data about the effectiveness of the programme. This focus on weak health systems, while undeniably important, was used as part of the justification for the polio PHEIC declaration, but in the case of yellow fever it is seen as supplementary, rather than being part of the issue and justification of the EC. Thus, the inclusion of considerations of health system capacity seems to be non-systematic, suggesting that they are instrumentalized when useful (such as in the case of polio) but not in and of itself a justification amid EC or DG deliberations, noting indeed the lack of formal criteria for assessment within the PHEIC process. Events for which no IHR EC was convened Until now our argument has centred around how the EC and DG have interpreted and applied the IHR once an EC has been convened. In doing so, we have argued that the IHR are poorly designed, and inconsistently applied, due to political factors not embedded within the IHR, and reflect broader geopolitical and multilateral relations. However, in this section we will consider some events that appear to constitute a PHEIC, but for which an EC was never convened (this list is non-exhaustive). Cholera in Zimbabwe
Cholera has long been an established part of the regulation of infectious diseases in international law from the International
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Sanitary Convention (1892) and being a notifiable disease under previous iterations of the IHR.29 Moreover, cholera has due prominence in Annex 2.30 The 2008 cholera outbreak began in Zimbabwe in August 2008, it quickly overwhelmed the country, and spread to South Africa, Malawi, Botswana, Mozambique and Zambia. Nearly 100,000 cases were reported, and more than 4,000 deaths over the course of the outbreak (an unusually high fatality rate for cholera).31 It is clear therefore that cholera in Zimbabwe met the criteria to be declared, or at the very least considered, a PHEIC: it was an unusual or unexpected event, at least in respect of the scale and magnitude of the outbreak, if not the source; there was a clear risk of international spread, as international spread was already occurring, and neighbouring states were proactively planning for further spread; and finally, the event required a coordinated international response. Indeed, that international response had been directly requested by the Zimbabwean government,32 and the WHO was directly involved in said response, along with other UN agencies, and international aid.33 And yet, the DG never convened an EC. Despite this, it did not stop the WHO issuing recommendations in respect of trade and travel
29
30 31
32
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Adam Rainis Houston, ‘Applying Lessons from the Past in Haiti: Cholera, Scientific Knowledge, and the Longest- Standing Principle of International Health Law’ in Mark Eccleston-Turner and Iain Brassington (eds) Infectious Diseases in the New Millennium: Legal and Ethical Challenges (Springer 2020). Annex 2, International Health Regulations (2005) UNTS 2509. Z Mukandavire and others, ‘Estimating the Reproductive Numbers for the 2008-2009 Cholera Outbreaks in Zimbabwe’ (2011) 108 Proceedings of the National Academy of Sciences 8767. Angela Balakrishnan, ‘Zimbabwe Declares State of Emergency over Cholera Epidemic’ The Guardian (London, 4 December 2008) https:// www.theguardian.com/world/2008/dec/04/zimbabwe-health. Balakr ishnan, ‘Zimbabwe Declares State of Emergency over Cholera Epidemic’.
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as regards Zimbabwe –something which typically requires a PHEIC and the issuing of TRs. Nevertheless, the WHO bypassed this system and guidance as part of its DONs system (Disease Outbreak News), in which it stated that the ‘WHO does not recommend any special restrictions to travel or trade to or from affected areas. However, neighbouring countries are encouraged to strengthen their active surveillance and preparedness systems’.34 These recommendations mirror the language of TRs pursuant to Article 15 of the IHR, but as we previously argued, issued outside of the structure and formalism of Article 15, and the IHR, such recommendations lose legal, normative and accountability weight. Cholera in Haiti
Cholera was introduced to Haiti in 2010, when, due to improper sanitation practices, infected faeces from the base occupied by the United Nations Stabilisation Mission in Haiti (MINUSTAH) entered the Artibonite river system, a river system relied on by tens of thousands of Haitians for farming, bathing and drinking.35 This resulted in the most serious cholera epidemic in recent history, infecting nearly 800,000 people and killing more than 9,000 of the cholera-naïve population.36 It has been argued that these official figures undercount both the sick and the dead from this outbreak.37 This
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WHO, ‘Cholera in Zimbabwe’ Disease Outbreak News (2 December 2008) https://www.who.int/csr/don/2008_12_02/en/. Rainis Houston, ‘Applying Lessons from the Past in Haiti: Cholera, Scientific Knowledge, and the Longest-S tanding Principle of International Health Law’. Pan American Health Organization, ‘Epidemiological Update –Cholera’ (24 February 2017) http:// reliefweb.int/ s ites/ reliefweb.int/ f iles/ resources/2017-feb-23-phe-epi-update-cholera.pdf. Francisco J Luquero and others, ‘Mortality Rates during Cholera Epidemic, Haiti, 2010-2011’ (2016) 22 Emerging Infectious Diseases 410.
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was clearly an extraordinary event, both in scale and magnitude of harm. Cholera was introduced to the Haitian population by United Nations peacekeepers who negligently introduced the previously unknown disease into the country.38 Latterly, the UN was insulated from any accountability for this introduction, which remains even more extraordinary given that emergence hunting has proven so pivotal in other outbreaks.39 The outbreak spread rapidly throughout the country, as well as to the Dominican Republic in little over a month.40 It subsequently spread into Cuba and Mexico, demonstrating international spread.41 Moreover, a coordinated international response was desperately required to bring the outbreak under control.42 And yet, no EC was convened. To reiterate, a PHEIC can only be declared after an EC has made an advisory determination, and an EC can only meet if the DG instructs it to do so.43 As previously stated, the process of a PHEIC starts and ends with the discretionary powers of the DG; they convene an EC, and they make the final determination to declare a PHEIC. Moreover, the PHEIC process was designed to limit and control the use of executive discretion by the DG during a health emergency.44 Given this, it is 38
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Rainis Houston, ‘Applying Lessons from the Past in Haiti: Cholera, Scientific Knowledge, and the Longest-S tanding Principle of International Health Law’. Mara Pillinger, Ian Hurd and Michael N Barnett, ‘How to Get Away with Cholera: The UN, Haiti, and International Law’ (2016) 14 Perspectives on Politics 70. ‘Haiti Cholera Reaches Dominican Republic’BBC (London, 17 November 2010) http://www.bbc.com/news/world-latin-america-11771109. WHO, ‘Cholera in Mexico’ (19 October 2013) http://www.who.int/ csr/don/2013_10_19_cholera/en/. Rainis Houston, ‘Applying Lessons from the Past in Haiti: Cholera, Scientific Knowledge, and the Longest-S tanding Principle of International Health Law’. Article 48, International Health Regulations (2005) UNTS 2509. Christian Kreuder-Sonnen, ‘China vs the WHO: A Behavioural Norm Conflict in the SARS Crisis’ (2019) 95 International Affairs 535.
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concerning to us that so much power remains vested in the DG, particularly given the involvement of the WHO within the broader UN system, as well as the lack of clarity on what triggers the DG to call an EC. It is alarming that this outbreak, given the scale if nothing else, was not considered for a fully transparent EC deliberation. Cholera is listed as one of the few diseases whereby its detection ‘shall always lead to utilization of the PHEIC algorithm, because they [these diseases] have demonstrated the ability to cause serious public health impact and to spread rapidly internationally’.45 The implication of this is clear: it is likely that an outbreak of cholera would constitute a PHEIC, and yet, when we are concerned with two of the biggest outbreaks of cholera in the past century, there was silence from the DG. One thing that unites the outbreaks of cholera in Zimbabwe and Haiti is mismanagement of the outbreaks by the UN. In both instances the UN appears to have downplayed the severity of the outbreaks for politically expedient reasons.46 It is unclear if, or to what extent, these highly political considerations within the UN family influenced the DG in their decision to not convene an EC. This also speaks more broadly to the securitized notions of which issues get prioritized in global health security, and by default who/what does not get prioritized.47 Cholera is one of the three notifiable diseases under the 1969 IHR and, indeed, the reason for convening the International Sanitary Conferences in the 19th century. However, as infection control has improved in the global north, and noting the localized
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Annex 2, International Health Regulations (2005) UNTS 2509. C Nicholas Cuneo, Richard Sollom and Chris Beyrer, ‘The Cholera Epidemic in Zimbabwe, 2008-2009: A Review and Critique of the Evidence’ (2017) 19 Health and Human Rights 249; Rainis Houston, ‘Applying Lessons from the Past in Haiti: Cholera, Scientific Knowledge, and the Longest-Standing Principle of International Health Law’. Simon Rushton, ‘Global Health Security: Security for Whom? Security from What?’ (2011) 59 Political Studies 799.
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nature of cholera transmission, this pathogen is no longer perceived as posing a threat to Western economies, and thus it does not get considered for EC discussions, despite almost annual emergence globally. Beyond naturally occurring events While the IHR may have their origins in the control of naturally occurring disease outbreaks, the all-hazards approach embedded within the IHR (2005) is responding to the reality of the 21st century, which can include deliberate events, or a chemical or radionuclear event.48 To this end, both the use of chemical weapons in Syria, and the Fukushima nuclear disaster in Japan, could constitute PHEICs. Use of chemical weapons in Syria began in 2013,49 with almost all the incidents being attributable to the Syrian government50 –a state party to the IHR. The WHO was notified of the events and ran situation reports in response to the conflict and use of chemical weapons.51 The most recent analysis shows that between March 2013 and February 2018, 85 reported uses of chemical weapons in Syria occurred, causing a total of 1,385 deaths and 6,568 injuries in the short term.52 There 48 49
50
51 52
International Health Regulations (2005) UNTS 2509 p 3. The incidents have been investigated by the Organization for the Prohibition of Chemical Weapons − United Nations Joint Investigative Mechanism, the United Nations Commission of Inquiry, the OPCW Fact-F inding Mission in Syria, the United Nations Mission to Investigate Allegations of the Use of Chemical Weapons in Syria and Amnesty International; Ingrid Elliott, ‘ “A Meaningful Step towards Accountability”?’ (2017) 15 Journal of International Criminal Justice 239. Gregory D Koblentz, ‘Chemical-Weapon Use in Syria: Atrocities, Attribution, and Accountability’ (2019) 26 The Nonproliferation Review 575. Debarati Guha-Sapir and others, ‘Civilian Deaths from Weapons Used in the Syrian Conflict’ (2015) BMJ h4736. Guha-Sapir and others, ‘Civilian Deaths from Weapons Used in the Syrian Conflict’.
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was considerable data regarding the public health impact the use of chemical weapons was having on the Syrian population, not just from the direct use of the incendiaries, but also from disruption of the healthcare system and a reduction in both the quality and quantity of food and water supplies,53 as well as from the mass displacement and international refugee crisis caused by people fleeing the violence.54 In 2011, the Fukushima Daiichi power plant in Japan was irreparably damaged by the 2011 Tōhoku earthquake and tsunami causing a reactor core and spent fuel rod meltdown, which led to large-scale radiation dispersion in contaminated water.55 While the earthquake and tsunami killed more than 18,000 people, it is thought that only one person died as a result of the meltdown, although many hospital inpatients died being moved from facilities deemed to be at risk from radiation, and 150,000 people remain unable to return to their homes more than ten years later due to radioactivity concerns. These individuals have faced further health concerns, mainly related to migration –access to health services, quality of housing, access to resources and mental health concerns –and these still remain a factor today.56 There are also still considerable clean-up efforts that remain, as the government must decide what to do with the reactors and site, worrying that moving any material, or allowing it into the sea, would have a significant effect on animal and human health.
53
54 55 56
Jose M Rodriguez-Llanes and others, ‘Epidemiological Findings of Major Chemical Attacks in the Syrian War Are Consistent with Civilian Targeting: A Short Report’ (2018) 12 Conflict and Health 16. Sarah Deardorff Miller, Political and Humanitarian Responses to Syrian Displacement (Routledge, Taylor & Francis Group 2017). Justin McCurry, ‘Japan: The Aftermath’ (2011) 377 The Lancet 1061. A Hasegawa and others, ‘Emergency Responses and Health Consequences after the Fukushima Accident; Evacuation and Relocation’ (2016) 28 Clinical Oncology 4.
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The nature or source in and of itself is not a barrier to these events coming under the remit of a PHEIC declaration.57 Moreover, the fact that both events were geographically contained within their territory is also not a barrier to considering these events as potential PHEICs, as we have been keen to stress throughout this book that we are concerned with potential risk to other states through the international spread of disease, rather than simply actual spread –and both of these events were recognized as having the potential to spread internationally; neither source event recognizes or respects international borders. However, despite the extraordinary nature, and the fact that they did potentially pose a risk to other states through the spread of disease, and required a coordinated international response, no EC was convened for either of the events. It has been hinted that the DG might not have convened EC for some of the events described in this book if the state in question had not given official notification to the WHO of the potential PHEIC under Article 6 of the IHR.58 Yet, Article 12 sets out that the DG shall determine whether an event ‘constitutes a public health emergency of international concern in accordance with the criteria and the procedure set out in these Regulations’.59 In order to do so, the DG shall consider: 57
58
59
David P Fidler and Lawrence O Gostin, ‘The New International Health Regulations: An Historic Development for International Law and Public Health’ (2006) 34 The Journal of Law, Medicine & Ethics 85. Lawrence O Gostin and Rebecca Katz, ‘The International Health Regulations: The Governing Framework for Global Health Security’ (2016) 94 The Milbank Quarterly 264. Article 12(1), International Health Regulations (2005) UNTS 2509; The decision instrument contained in Annex 2 referenced at (b) is the ‘Decision instrument for the assessment and notification of events that may constitute a Public Health Emergency of International Concern’. ‘Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international restrictions to travel and trade?’, which
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(a) information provided by the State Party; (b) the decision instrument contained in Annex 2; (c) the advice of the Emergency Committee; (d) scientific principles as well as the available scientific evidence and other relevant information; and (e) an assessment of the risk to human health, of the risk of international spread of disease and of the risk of interference with international traffic.60 Information provided by the state party (pursuant to Article 6) is one of a range of factors the DG make take into consideration when declaring a PHEIC, or even convening an EC to consider the PHEIC question. However, Articles 9 and 10 allow the WHO to rely on notification and reports from sources other than the state party concerned, so even if official notification had not come from the state party in question, that does not prevent the convening of an EC, or declaring a PHEIC.
60
is typically used by states parties to determine if a public health event within their territory ought to be notified to WHO under Article 6 of the International Health Regulations, as a potential PHEIC. Article 12(4), International Health Regulations (2005) UNTS 2509.
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The PHEIC mechanism has been fraught with tension since it was first introduced in 2005, with the revisions to the IHR. As this book has shown, the declaration process and decision making underpinning a declaration are the source of many of the inconsistencies regarding the PHEIC. In the wake of COVID-19, and the widespread failures of the global health architecture to manage disease transmission, many elements of the system will come under review, and likely reform. While it is too early to know the outcomes of such processes, it is likely that the IHR will be revised in some format in the coming years, or be replaced by, or replicate, a similar mechanism through the proposed ‘pandemic treaty’. We write this book to inform such discussions and demonstrate the need to ensure that any power bestowed upon the DG is exercised in a reasonable and proportional manner. In doing so we highlight the following arguments. First, the PHEIC criteria, as laid out in the IHR, have been inconsistently applied by the DG and the EC throughout the history of PHEIC declarations and non-declarations. To this end, there have been PHEICs declared that do not appear to meet the objective criteria found at Article 1 (and nor did the EC describe these as such). Equally, there have been other events whereby the criteria appear to have been met, but no EC was convened by the DG, or an EC was called, and a PHEIC was not declared. Notably, while the convening of an EC remains the decision of the DG, the decision about declaring a PHEIC or not appears to be in practice at the discretion of
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the EC, rather than the DG simply taking advice from the EC. The role of the EC has thus grown in prominence, and through increased technocratization, the EC has been able to bolster its role within the IHR and governance of health emergencies, affording itself the option to consider social, economic and political interferences in the strict criteria for the PHEIC process. Indeed, as the PHEIC process has developed over successive outbreaks, it appears that there has been greater consideration of factors beyond the treaty criteria and, through continual use of such justifications for the PHEIC declaration the EC has been further empowered to depart from the three criteria for which it is allowed to advise the DG to declare a PHEIC: if the outbreak is extraordinary, if there is a risk of international spread or if the event potentially requires a coordinated international response. Thus, the EC’s role in the PHEIC process has moved beyond a legal mechanism, to be a political-legal process, but for which there are only legal criteria. This may not be an active decision that EC members have taken to create a greater role for themselves in the PHEIC process, and given that membership of the EC rotates, varying based on the expertise required, it is unlikely to be a consistent cognisant decision across groups. Instead, EC deliberations have gradually engaged in mission creep in the PHEIC process and have not been challenged by the DG or the WHO Secretariat for going beyond the scope of their treaty obligations. Through accepting the recommendations of the EC in this way, the DG is complicit in rubber-stamping this role for the EC in the PHEIC declaration process. By default, the recommendations from the EC as to the PHEIC declaration appears to be the only determinant in the DG decision making for PHEIC notification, rather than one of several pieces of information to consider as outlined at Article 12. This may be accidental, or it may be an astute move by a DG to be able to pass the responsibility for decision making (and therefore blame) to an opaque technocratic group rather than individually taking responsibility for
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decisions reached and any potential sequelae. More broadly, this book raises questions as to how the DG exercises their role in the PHEIC declaration process, and to what extent this position needs to be clarified, alongside that of the EC, in future revisions to the IHR. Second, we have demonstrated political intervention emerging at multiple stages of the PHEIC process: • the decision by states whether to report a potential health emergency to the WHO, in line with their Article 6 obligations; • whether the DG convenes an EC, and the factors that influence said decision; • who participates in that EC, and what evidence is considered valuable in the decision making, which is also a political process; • political considerations that occur within the deliberations of the EC meeting. To this end, we do not even know the process by which decisions are made within the EC; we do not know how opinions are weighted and valued, what evidence is presented, and how and what data inform the process of the PHEIC declaration. It is clear, however, that criteria beyond those listed in the IHR are taken into consideration by the EC, as such extensions of the criteria appear in the post-EC press conferences and statements. These have included: the perceived strength of the health system; the ‘added benefit’ that a PHEIC might bring; the harm brought by a PHEIC; and the potential risk of travel and trade disruption. Some of these may be valid concerns, particularly considering the ability (or lack thereof) of some governments to manage an epidemic, and the broader socioeconomic effects a disease response may have. To be clear, these factors are important and, indeed, they are listed at Article 12 as relevant considerations for the DG to consider in declaring a PHEIC. But crucially, these factors are
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to be considered by the DG, not the EC, which is currently not delineated as proscribed. As we have argued, these political considerations should be taken into account by a political actor with political accountability, not a technical advisory group with a clearly defined treaty mandate. Finally, the DG, in accepting the advice of the EC when based on these non- mandated considerations, also makes a political decision to endorse this ultra vires role for the EC, as well as the logic of its decision making. Furthermore, there must be consistency with the criteria detailed in the IHR process, not only to ensure the utility of approach between ECs, but also so that such rigour and consistency will sustain and potentially increase the normative power of the PHEIC tool. This is a vital activity, which can encourage governments to respond to the PHEIC as a call to arms, either preparing domestically for the impact of an incoming health emergency, and/or supporting those countries bearing the brunt of the emergency with resources and capacity so that they are able to handle the crisis, as per Article 44. To ensure consistency in the approach, and the utilization of the criteria designated to the EC in the IHR, legal advisors who appear to be present in EC meetings should be allowed greater scope to weigh in on the process and decision making, with the political support of the DG to do so. Importantly, we do not suggest that politicizing the PHEIC is something to be avoided, or something inherently bad. We recognize that politics cedes in all areas of public and private life, and in many instances, the political reality of a health emergency situation is vital to contextualize the outbreak, and to understand the feasibility of different public health interventions. To that extent, there is a clear argument which would push for greater politicization of the WHO’s role in health emergencies, one that recognizes the power afforded to the international organization, and the ability it has to direct the course of an epidemic, if it is willing to engage in politically challenging decisions. However, in the current format,
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where political considerations are taken into account by an inappropriate entity, the politicization of the legal process of the PHEIC raises challenges. Third, one of the predominant challenges within the PHEIC mechanism is that political decisions are being taken into account by non-political technical experts within the EC, who do not have the due political processes of accountability that are vital for good governance. The EC discussions are not transparent, and so we do not know how decisions are made, and what technical and/or political drivers are taken into consideration. A decision is reached as to whether to recommend a PHEIC or not, by EC members who are nominated by the DG or WHO Secretariat based on their professional expertise, albeit some of the roster of experts is nominated by states. Crucially, they are not selected through a political process, whereby those who they represent elect them to office to be able to make political decisions. If we want to be able to have a political role for the EC, then we need to re-envision the selection process for these individuals, and ensure due process of good governance, notably accountability for decisions, as well as transparency. Having a political process without such mechanisms of good governance is dangerous, and brings into question broader norms of liberal democratic processes, on which the WHO is based. At the very least, if EC members are going to be considering political influences, participation should include expertise from beyond epidemiology to meaningfully weigh in on the socioeconomic and political considerations being made by those without the relevant experience. However, this would have to occur after changes to the IHR to allow for such considerations in the PHEIC deliberations and/ or as an additional consideration for the DG’s decision making. Fourth, there is a clear need for transparency of process, and to ensure that the EC meetings, the EC’s decision making and the data it has been provided with are made publicly available, not just to governments via NFPs, but also to the global public as well. This would not only comply with liberal democratic
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norms of good governance, but in doing so would also lead to the PHEIC process having greater credibility, where the public and governments can understand the process by which decisions have been made, which may in turn affect how they respond to the disease threat and/or PHEIC declaration. Previous changes regarding transparency in the PHEIC mechanism were made on the basis of public confidence in the mechanism and the WHO.1 The IHR Review Committee and the Independent Panel for Pandemic Preparedness and Response have both called for greater transparency over the EC process, including documentation accompanying each EC, which includes the information EC members were provided with (alluded to earlier), noted divergent views among the panel and the rationale for the PHEIC declaration (or not).2 Fifth, there is a dearth of evidence regarding the PHEIC declaration process, as the rationale and processes of the PHEIC declaration are lacking in transparency. It is unclear how the DG determines whether an EC is to be convened, and the membership of the EC, both of which are vital to the declaration process. Moreover, without a more complete dataset in respect of how decisions are made within the EC, and the factors they take into consideration, along with how such factors are weighted, then our understanding of this vital tool within global health security shall remain underdeveloped. Importantly, we do not wish to implicate individual 1
2
Mark Eccleston-Turner and Adam Kamradt-Scott, ‘Transparency in IHR Emergency Committee Decision Making: The Case for Reform’ (2019) 4 BMJ Global Health e001618. WHO, ‘WHO’s work in health emergencies. Strengthening preparedness for health emergencies: implementation of the international health regulations (2005)’ (2020) https://cdn.who.int/media/docs/default- source/documents/emergencies/a74_9add1-en.pdf?sfvrsn=d5d22fdf_ 1&download=true; Independent Panel for Pandemic Preparedness and Response, Main Report (2021) https://theindependentpanel.org/wp- content/uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_ final.pdf.
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EC members of improper practice; as scientists, it is not their role to understand the intricacies of a legal process, or the risk to the normative power of the WHO, IHR and PHEIC of the inconsistencies applied. A final part of this puzzle is that a greater evidence base needs to be created in which it is possible to detail the impact of the PHEIC. At present, the EC and DG make decisions about declaring a PHEIC (or not) based on an assumption as to what effect the PHEIC might have on decision making at national and global levels, yet these data do not exist. We do not systematically have a database of findings as to what happens when a PHEIC is declared. Do governments implement national policies or legislation to ensure the continuity of global health security, such as the Brazilian ESPIN, or do other policy activities occur? Does a PHEIC declaration spur a crisis meeting of the ministry of health in question, or of a cabinet? Does a PHEIC declaration lead to travel and trade restrictions directly, or are these additional health measures implemented by states unrelatedly, with governments making these unilateral decisions based on their own risk assessments of the health emergency? These questions must be addressed by comprehensive research and analysis, to understand the role and influence of the PHEIC, and if in the future the role of the PHEIC were to be increased or reduced, we need a clear evaluation of the tool beforehand. As specified in Article 12 of the IHR, the DG should take into consideration when deciding on a PHEIC the ‘scientific principles as well as the available scientific evidence and other relevant information’. As such, this evidence needs to be made available to the DG and EC so that they can base their decisions on it. It does seem remarkable for an institution that prides itself on evidence-based approaches to public health, that this evidence is not considered a vital piece of the puzzle in deliberations concerning a PHEIC declaration.
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173
Index References to figures appear in italic type. References to footnotes show both the page number and the note number (39n72).
NUMBERS
power 86 severe acute respiratory syndrome (SARS) 33–5 yellow fever 61, 134 cholera Guinea 86 Haiti 141–4 International Health Regulations (IHR) 24, 26 International Sanitary Conferences (ISCs) 21 International Sanitary Regulations (ISR) 23 Zimbabwe 139–41 circulating vaccine-derived poliovirus (cVDPV) 86–90 confidentiality 125–6 consensus 117 coordinated international response 4, 61–4 cholera in Haiti 142 cholera in Zimbabwe 140 COVID-19 2 Ebola in DRC 110, 112–13, 114–15 Ebola in West Africa 94 polio 82, 83, 84 yellow fever 137 Zika 99 COVID-19 China 46–7 impact on polio control 90 PHEIC declaration 1–4, 116–27 Emergency Committee (EC) 67, 125–6
2009-H1N1 59, 74–80
A accountability 70n75 Director General (DG) 12, 68–9, 106, 134 Emergency Committee (EC) 12, 56, 69, 72, 75, 111, 152 governments 38 national health systems 39 PHEIC process 65–6 states 45, 76 United Nations (UN) 142 see also transparency Afghanistan 60n44, 87, 108n101 AIDS 27, 97n65 Anglocentrism 101 Angola 60, 134, 135
B bioterrorism 27 Botswana 140 Brazil 86, 98, 101, 102, 103 Brundtland, G.H. 49 Brunnée, J. 9 Burci, G.L. 16, 39n72
C Chan, M. 97, 98–9, 135 chemical weapons 144–5 China COVID-19 2–3, 46–7, 116, 117, 119–21, 122, 123
174
Index
government responses 51 intermediate and tiered PHEIC 126–7 pandemic declaration 124–5 PHEIC decision making 116–21 Temporary Recommendations (TRs) 121–4 trade and travel restrictions 12–13 Cuba 142
MERS-CoV (Middle East respiratory syndrome coronavirus) 133–4 polio 81, 84, 85, 88, 89 role in PHEIC process 5–6, 36, 48–53, 57, 64, 142–3, 146–7, 148–51 Zika 98–9 see also Chan, M.; Tedros Adhanom Ghebreyesus disease diplomacy 85–6 Dominican Republic 142 DONs (Disease Outbreak News) system 141
D Davies, S.E. 28 Democratic Republic of the Congo (DRC) Ebola 25, 104n90 coordinated international response 62–4 Emergency Committee (EC) 66 PHEIC declarations 104–15 PHEIC decision making 91, 94, 106–13, 114–15 Temporary Recommendations (TRs) 109–10, 113–14 risk of international spread of disease 61 yellow fever 60, 62–4, 134, 137 desecuritization 104 Director General (DG) 2009-H1N1 74, 77 cholera in Haiti 142–3 cholera in Zimbabwe 140 COVID-19 116, 117 Ebola in the Democratic Republic of the Congo (DRC) 105, 106, 107, 108, 115 Ebola in West Africa 91, 94, 97 and Emergency Committee (EC) 11–12, 13, 31, 53–4, 66–70, 72, 88 executive power 8
E Ebola 138 Democratic Republic of the Congo (DRC) 25, 104–15, 104n90 coordinated international response 62–4 Emergency Committee (EC) 66 PHEIC decision making 91, 94, 106–13, 114–15 risk of international spread of disease 61 Temporary Recommendations (TRs) 109–10, 113–14 West Africa 6, 11, 90–7 Director General (DG) 51 international assistance 96–7 PHEIC decision making 91–5 Temporary Recommendations (TRs) 95–6 economic damage 111–12 economic insecurity 27 El Salvador 102 Emergency Committee see IHR Emergency Committee (EC) Endericks, T. 98, 100 expert advisors 131 expert committees 30–1 see also IHR Emergency Committee (EC)
175
DECLARING A PHEIC
I
extraordinary events 58–60 cholera 142 COVID-19 118–19 Ebola 63, 107, 109 polio 82 yellow fever 137 Zika 59, 98, 99, 100
IHR Emergency Committee (EC) 2009-H1N1 59, 74–6 coordinated international response 62–4 COVID-19 2, 67, 116–20, 121–2, 125–7 and Director General (DG) 11–12, 13, 66–70, 72 Ebola 63–4, 66, 91, 92–4, 105, 106–13 events without EC 139–47 extraordinary events 59 IHR reform 31 MERS-CoV (Middle East respiratory syndrome coronavirus) 129–34 PHEIC decision making 18–19 PHEIC process 8–9, 53–7, 148–51 polio 62, 81–4, 85, 86–90 political role 152 risk of international spread of disease 60–1 transparency 10, 55, 71–2, 102, 152–4 yellow fever 60–1, 135–9 Zika 59, 99, 100–2, 103–4 IHR Review Committee 9, 10, 56, 153 Independent Panel for Pandemic Preparedness and Response 118, 153 India 25 intergovernmental health organizations 22 see also Pan American Health Organization (PAHO); World Health Organizations (WHO) international assistance 96–7, 111 International Health Regulations (IHR) 1969 version 24–6, 30, 33–4, 135 1990s reform 27–33 2005 reform 29, 31, 32, 34, 35–43
F Fidler, D.P. 110 France 102 Friedman, E. 96 Fukushima nuclear disaster 145
G Global Crisis, Global Solutions (WHO) 31–2 global health security 41–2 Global Polio Eradication Initiative (GPEI) 80, 81, 90 globalization 27 good governance 66, 70–2, 125 Gostin, L. 96 Guinea 86, 90, 93
H Haiti 141–4 Hajj 130, 132 health systems Brazil 98 Ebola in West Africa 94 Emergency Committee (EC) members 55 IHR requirements 14, 34, 38, 39, 42, 44–5, 45n3 Middle East respiratory syndrome coronavirus (MERS-CoV) 133 polio PHEIC declaration 83–4 yellow fever 138–9 high-income states 124 HIV/AIDS 27, 97n65 human rights 40–1, 122 human-to-human transmission 131, 132
176
Index
K
compliance with 12–13, 14–17, 40, 106 coordinated international response 61–4 COVID-19 1, 12–13 Director General (DG) 8, 48–53 extraordinary events 58–60 legitimacy of 11 PHEIC declaration 4–6 purpose 4 severe acute respiratory syndrome (SARS) 33–5 state obligations 44–7, 74 Temporary Recommendations (TRs) 110 viral haemorrhagic fevers 91 and WHO Constitution 23 see also IHR Emergency Committee (EC); IHR Review Committee International Law Association 64, 70, 70n75 international relations 66, 71 International Sanitary Conferences (ISCs) 21–2, 23, 143 International Sanitary Convention (1892) 139–40 International Sanitary Regulations (ISR) 23–4 international spread of disease, risk of 60–1 cholera 140, 142 COVID-19 117 Ebola 108, 109 MERS-CoV (Middle East respiratory syndrome coronavirus) 131, 132 polio 82–3 yellow fever 137–8 Zika 99 international trade see trade international travel see travel
Kamradt-Scott, A. 28, 34 Kenya 61, 134 Klabbers, J. 64 Koskenniemi, M. 13–14
L leadership 95 Liberia 90, 93 Loughlin, M. 14 low-and middle-income countries (LMICs) 3, 24
M Malawi 140 McLoskey, B. 98, 100 Médecins Sans Frontières (MSF) 91–2 MERS-CoV (Middle East respiratory syndrome coronavirus) 59–60, 129–34 Mexico 142 microcephaly 98, 100–1, 104 migrant workers 138 migration 27, 145 military 27 Mozambique 140 Mullan, L. 99
N National Focal Points (NFPs) 38, 81–2 national health systems see health systems Nigeria 94, 108n101 non-state actors 37–8 notifiable diseases 23–4, 25, 32, 33, 35, 140, 143 nuclear disaster 145
J Japan 116, 145 Journal of the American Medical Association 101
O Olympic Games 102–3, 132
177
DECLARING A PHEIC
P
1990s reform 31–2 2005 reform 35 timeline of notable events 7 see also Temporary Recommendations (TRs) Public Health England 129
Pakistan 85, 86, 89, 108n101, 131 Pan American Health Organization (PAHO) 22, 23 pandemic alert 79–80 pilgrims 130 plague 23, 24, 25 polio 60, 62 PHEIC declaration 80–90 circulating vaccine-derived poliovirus (cVDPV) 86–90 PHEIC decision making 81–4 Temporary Recommendations (TRs) 84–6, 87, 89 political decisions 152 political interferences 6, 23, 30, 55–6, 68, 149 political intervention 150–2 power 65, 70, 70n75, 97 Public Health Emergency of International Concern (PHEIC) 4–6 COVID-19 1–4, 67 declaration process 47, 138 accountability and transparency 65–6 ambiguity of 6–10 implications 10–17 blurring of lines between EC and DG 66–70, 72 inconsistency in 148–50 lack of transparency 153–4 political intervention 150–2 role of Director-General 48–53, 53–4, 57, 64 role of Emergency Committee (EC) 53–7, 152–4 state obligations 44–7 definition 58 coordinated international response 61–4 extraordinary events 58–60 risk of international spread of disease 60–1 and IHR process 64–5 International Health Regulations (IHR)risk
Q quarantine 22, 23, 24
R Republic of Congo 137 research methodology 17–19 risk assessment approach 130, 130n6 risk of international spread of disease 60–1 cholera 140, 142 COVID-19 117 Ebola 108, 109 MERS-CoV (Middle East respiratory syndrome coronavirus) 131, 132 polio 82–3 yellow fever 137–8 Zika 99 Rushton, S. 28
S SARS-CoV 116 Saudi Arabia 129, 131 Senegal 94 severe acute respiratory syndrome (SARS) 8, 29, 33–5, 49, 84, 120 Sierra Leone 90, 93 South Africa 140 South Korea 116, 129, 132 sovereignty see sovereignty state obligations 44–7, 45n3, 74, 122–4 state sovereignty 2009-H1N1 78–9 and Director General (DG) 51, 53
178
Index
International Health Regulations (IHR) 15–16, 17 1969 version 25 2005 reform 37, 39, 42–3 PHEIC declarations 5–6 swine flu see 2009-H1N1 syndrome reporting 35 Syria 144–5
PHEIC process 65–6, 117, 153–4 see also accountability travel 2009-H1N1 77, 79 cholera 141 COVID-19 3, 4, 117, 123, 124 Ebola 109, 113–14 Temporary Recommendations (TRs) 52 Zika 99 travellers 41 Trump, D. 121
T technocratic processes 70 Tedros Adhanom Ghebreyesus 1, 2, 3, 115, 120, 124 Temporary Recommendations (TRs) 9, 12, 50, 52, 53–4, 55, 63, 64 2009-H1N1 76–9, 80 cholera 141 COVID-19 121–4, 122 Ebola in the Democratic Republic of the Congo (DRC) 109–10, 113–14 Ebola in West Africa 95–6 polio 84–6, 87, 89 Zika outbreak 102 Thailand 116 timeline of notable events 7 Toope, S.J. 9 trade 2009-H1N1 78, 79 cholera 21, 141 COVID-19 3, 123, 124 Ebola 6, 109, 113–14 IHR reform 30 severe acute respiratory syndrome (SARS) 34 Temporary Recommendations (TRs) 52 Zika 99 transparency 70–1 China 46 Emergency Committee (EC) 10, 55, 71–2, 76, 83, 120, 131, 152–4 governments 16 International Health Regulations (IHR) 31, 35–6, 41
U Umrah 130, 132 United Kingdom (UK) 129 United Nations (UN) 142, 143 United Nations Security Council (UNSC) 96–7 United Nations Stabilisation Mission in Haiti (MINUSTAH) 141 United States (US) 74, 121 urbanization 27
V vaccinations Ebola 113 polio 80–1, 82, 84, 85, 87 yellow fever 134–6, 138, 139 vaccine-derived poliovirus 86–90 Von Bernstorff, J. 51
W wild polio 86, 87, 88, 89 World Health Assembly (WHA) 22, 23, 134 World Health Organization (WHO) 16, 147 2009-H1N1 75–6, 77–8, 79–80 cholera 140–1 COVID-19 1, 3, 46–7, 120–2
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DECLARING A PHEIC
Director General (DG) see Chan, M.; Director General (DG); Tedros Adhanom Ghebreyesus Ebola 6, 62, 91, 92, 94–6, 97, 104–5, 115 Global Outbreak Alert and Response Network (GOARN) 105 Intergovernmental Working Group 49 International Health Regulations (IHR) 9, 13 1969 version 24–6, 30 1990s reform 28–33 2005 reform 36–9, 41–3 legitimacy of 11, 13–15, 29 origins 22–4 PHEIC declarations 68 polio 81, 84, 85–6 politicization of 151–2 relations with China 120–1 severe acute respiratory syndrome (SARS) 34
staff 90 Syria 144 voting rights 56 Zika outbreak 100 Wuhan 116
Y yellow fever 23, 24, 60–1, 109, 134–9 Yellow Fever Initiative (YFI) 135
Z Zambia 140 Zika 59, 131–2, 138 PHEIC declaration 98–104 long-term considerations 103–4 Olympic Games 102–3 PHEIC decision making 100–2 Temporary Recommendations (TRs) 102 Zimbabwe 139–41
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