Genetic Testing and the Governance of Risk in the Contemporary Economy: Comparative Reflections in the Insurance and Employment Law Contexts [1st ed.] 9783030436988, 9783030436995

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Ius Comparatum – Global Studies in Comparative Law

Lara Khoury Adelle Blackett Lukas Vanhonnaeker  Editors

Genetic Testing and the Governance of Risk in the Contemporary Economy Comparative Reflections in the Insurance and Employment Law Contexts

Ius Comparatum – Global Studies in Comparative Law Volume 34

Series Editors Katharina Boele-Woelki, Bucerius Law School, Hamburg, Germany Diego P. Fernández Arroyo, Institut d’Études Politiques de Paris (Sciences Po), Paris, France Founding Editors Jürgen Basedow, Max Planck Institute for Comparative and International Private Law, Hamburg, Germany George A. Bermann, Columbia University, New York, USA Editorial Board Members Joost Blom, University of British Columbia, Vancouver, Canada Vivian Curran, University of Pittsburgh, USA Giuseppe Franco Ferrari, Università Bocconi, Milan, Italy Makane Moïse Mbengue, Universitè de Genève, Switzerland Marilda Rosado de Sá Ribeiro, Universidade do Estado do Rio de Janeiro, Brazil Ulrich Sieber, Max Planck Institute for Foreign and International Criminal Law, Freiburg, Germany Dan Wei, University of Macau, China

As globalization proceeds, the significance of the comparative approach in legal scholarship increases. The IACL / AIDC with almost 800 members is the major universal organization promoting comparative research in law and organizing congresses with hundreds of participants in all parts of the world. The results of those congresses should be disseminated and be available for legal scholars in a single book series which would make both the Academy and its contribution to comparative law more visible. The series aims to publish the scholarship emerging from the congresses of IACL / AIDC, including: 1. of the General Congresses of Comparative Law, which take place every 4 years (Brisbane 2002; Utrecht 2006, Washington 2010, Vienna 2014, Fukuoka 2018 etc.) and which generate (a) one volume of General Reports edited by the local organizers of the Congress; (b) up to 30 volumes of selected thematic reports dealing with the topics of the single sections of the congress and containing the General Report as well as the National Reports of that section; these volumes would be edited by the General Reporters of the respective sections; 2. the volumes containing selected contributions to the smaller (2-3 days) thematic congresses which take place between the International Congresses (Mexico 2008; Taipei 2012; Montevideo 2016 etc.); these congresses have a general theme such as “Codification” or “The Enforcement of Law” and will be edited by the local organizers of the respective Congress. All publications may contain contributions in English and French, the official languages of the Academy.

More information about this series at http://www.springer.com/series/11943 Académie Internationale de Droit Comparé International Academy of Comparative Law

Lara Khoury • Adelle Blackett • Lukas Vanhonnaeker Editors

Genetic Testing and the Governance of Risk in the Contemporary Economy Comparative Reflections in the Insurance and Employment Law Contexts

Editors Lara Khoury Faculty of Law McGill University Montreal, QC, Canada

Adelle Blackett Faculty of Law McGill University Montreal, QC, Canada

Lukas Vanhonnaeker Faculty of Law McGill University Montreal, QC, Canada

ISSN 2214-6881 ISSN 2214-689X (electronic) Ius Comparatum - Global Studies in Comparative Law ISBN 978-3-030-43698-8 ISBN 978-3-030-43699-5 (eBook) https://doi.org/10.1007/978-3-030-43699-5 © Springer Nature Switzerland AG 2020 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Preface and Acknowledgment

From July 22 to 28, 2018, the 20th General Congress of the International Academy of Comparative Law (IACL) was held in Japan, in the town of Fukuoka on the beautiful southern Island of Kyūshū. For this occasion, Lara Khoury and Adelle Blackett had the privilege of serving as general rapporteurs for a session in Medical Law devoted to a discussion of the legal aspects of genetic testing regarding insurance and employment. Progress in genomic medicine holds the promise of enabling genetic risks to be identified and treatment of diseases to be individually tailored to the needs of the patient. However, the advances may lead to increased, and sometimes underestimated, risks of privacy infringements and of discrimination. The risks are particularly acute in the employment and insurance contexts. To gain insight into these risks and regulatory approaches in different jurisdictions worldwide, we devised a two-part questionnaire. The first part dealt with existing generalist frameworks for regulating genetic testing in the insurance and employment contexts. It sought to enable rapporteurs to consider regulatory approaches in privacy law and antidiscrimination law, at the national and at appropriate regional and international levels. The second part of the questionnaire enabled rapporteurs to consider the efficiency of the specific rights and obligations governing the insurance and employment contexts, and whether they could effectively reconcile different stakeholders’ interests. Colleagues from fifteen (15) jurisdictions answered the questionnaire and seven (7) colleagues, including the two general rapporteurs, participated in a lively panel discussion on the challenges posed by genetic testing in the contexts of insurance and employment in a variety of countries as well as the solutions proposed, if any, in these jurisdictions. We wish to express our appreciation to each of the contributors to this collective project. This book is based primarily on the revised written contributions of several contributors to the IACL session, alongside individually solicited chapters. We thank the International Academy of Comparative Law and its President and Secretary General, Professor Diego P. Fernández Arroyo, for the invitation to v

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undertake this report. We also thank the Association québécoise de droit comparé and its President Nathalie Vézina, for their support. This volume has come to fruition thanks to the support of a sterling team of research assistants who we are pleased to acknowledge: Dr. Kathleen Hammond, Dr. Liam McHugh-Russell, Ms. Lian Francis, Ms. Morgan McGinn, Ms. Emily Painter, Ms. Alexandra Klein, and Ms. Jeanne Mayrand-Thibert. Finally, we express our gratitude to the institutions and funding bodies that made our participation in the IACL Congress and the preparation of this manuscript possible: McGill University’s Faculty of Law and its Dean Robert Leckey, the Canada Research Chair in Transnational Labour Law and Development, the Fonds de recherche du Québec, Société et culture (Research Team Support Programme), and McGill University’s Paper Presentation Programme. This research was undertaken in the institutional contexts of the Labour Law and Development Research Laboratory (directed by Adelle Blackett) and the McGill Research Group on Health and Law (co-convened by Lara Khoury). Montréal, QC, Canada Montréal, QC, Canada Montréal, QC, Canada 10 January 2020

Lara Khoury Adelle Blackett Lukas Vanhonnaeker

Préface et remerciements

Du 22 au 28 juillet 2018, le 20e Congrès général de l’Académie internationale de droit comparé (AICL) s’est tenu au Japon, dans la ville de Fukuoka sur la magnifique île méridionale de Kyūshū. À cette occasion, Lara Khoury et Adelle Blackett ont eu le privilège de siéger en tant que rapporteurs généraux lors de la session portant sur le droit médical consacrée à un débat sur les aspects juridiques des tests génétiques en matière d’assurance et d’emploi. Les progrès de la médecine génomique laissent entrevoir la possibilité d’identifier les risques génétiques et d’adapter individuellement le traitement des maladies aux besoins du patient. Toutefois, les progrès réalisés peuvent entraîner des risques, parfois sous-estimés, d’atteinte à la vie privée et de discrimination. Les risques sont particulièrement graves dans les contextes de l’emploi et de l’assurance. Afin de mieux comprendre ces risques et les approches juridiques de différents ressorts à travers le monde, nous avons conçu un questionnaire en deux parties. La première partie traitait des cadres généralistes existants visant à réglementer les tests génétiques dans les domaines de l’assurance et de l’emploi. Il visait à permettre aux rapporteurs d’envisager des approches réglementaires au sein des normes juridiques portant sur la protection de la vie privée et sur la lutte contre la discrimination, aux niveaux national et régional et international appropriés. La deuxième partie du questionnaire a permis aux rapporteurs de se pencher sur l’efficacité des droits et obligations spécifiques régissant les contextes de l’assurance et de l’emploi et de déterminer s’ils pouvaient concilier efficacement les intérêts des différentes parties prenantes. Des collègues de quinze (15) ressorts ont répondu au questionnaire et sept (7) collègues, dont les deux rapporteurs généraux, ont participé à une table ronde animée sur les défis posés par les tests génétiques dans le contexte de l’assurance et de l’emploi dans divers pays et sur les solutions proposées, le cas échéant, dans ces ressorts. Nous souhaitons exprimer notre reconnaissance à chacun des contributeurs à ce projet collectif. Ce livre est basé principalement sur les contributions écrites révisées de plusieurs des contributeurs à la session de l’IACL, aux côtés de chapitres sollicités individuellement. vii

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Nous remercions l’Académie internationale de droit comparé ainsi que son président et secrétaire général, le professeur Diego P. Fernández Arroyo, de l’invitation à préparer ce rapport. Nous remercions également l’Association québécoise de droit comparé et sa présidente, Nathalie Vézina, de leur soutien. Ce volume a été réalisé grâce au soutien d’une excellente équipe d’assistants de recherche, que nous remercions chaleureusement : Dre Kathleen Hammond, Dr Liam McHugh-Russell, Mme Lian Francis, Mme Morgan McGinn, Mme Emily Painter, Mme Alexandra Klein et Mme Jeanne Mayrand-Thibert. Enfin, nous exprimons notre gratitude aux institutions et aux organismes de financement qui ont rendu possible notre participation au Congrès de l’IACL et la préparation de ce manuscrit : la Faculté de droit de l’Université McGill et son doyen, Robert Leckey ; la Chaire de recherche du Canada en droit transnational du travail et développement, le Fonds de recherche du Québec, Société et culture (Programme de soutien aux équipes) et le programme « Paper presentation grant » de l’Université McGill. Cette recherche a été entreprise dans les contextes institutionnels du Laboratoire de recherche sur le droit du travail et le développement (dirigé par Adelle Blackett) et du Groupe de recherche en santé et droit de McGill (codirigé par Lara Khoury). Montréal, QC, Canada Montréal, QC, Canada Montréal, QC, Canada le 10 janvier 2020

Lara Khoury Adelle Blackett Lukas Vanhonnaeker

Contents

Part I

General Report

Legal Aspects of Genetic Testing Regarding Insurance and Employment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lara Khoury, Adelle Blackett, and Lukas Vanhonnaeker Part II

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Domestic Studies

Legal Aspects of Genetic Testing Regarding Insurance in Belgium . . . . . Cindy Cornelis, Thierry Vansweevelt, and Britt Weyts Analysis of the Use of Genetic Testing in Insurance Policy Contracts and Labour Relations in Brazil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Viola de Azevedo Cunha and Leonardo Heringer Matos

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Genetic Privacy in Employment and Insurance in Canada . . . . . . . . . . . 115 Hilary Young and Colleen Thrasher Legal Aspects of Genetic Testing Regarding Insurance and Employment in Cyprus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Theodoros Trokanas Czech Report on Genetic Testing for Employment and Insurance . . . . . 153 Filip Křepelka The Prohibitions Against Genetic Discrimination in Estonia . . . . . . . . . . 179 Kärt Pormeister L’utilisation des tests génétiques dans le domaine de l’assurance en droit français et européen : une affaire d’assurance et de politique publique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193 Christian Byk

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Regulating Genetic Data in Insurance and Employment: The Italian “Upstream” Way . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221 Marta Tomasi and Carlo Casonato Genetic Testing and the Governance of Risk in the Contemporary Economy of Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237 Yuichiro Sato Legal Aspects of Genetic Testing Regarding Insurance and Employment in Poland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249 Monika Wałachowska Regulating the Use of Genetic Testing by Insurers and Employers in the Province of Quebec: Is the Genetic Non-Discrimination Act Really Necessary? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269 Yann Joly and Gabriel Marrocco Genetic Analyses in the Insurance and Employment Contexts in Switzerland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 Valérie Junod Genetic Testing, Insurance and Employment in the UK: Is the Regulatory Regime Fit for Purpose? . . . . . . . . . . . . . . . . . . . . . . . 317 Gerard Porter Genetic Discrimination in the United States: What State and National Government Are Doing to Protect Personal Information . . . . . . . . . . . . 331 Eric A. Feldman and Erin Quick

Part I

General Report

Legal Aspects of Genetic Testing Regarding Insurance and Employment General Report Lara Khoury, Adelle Blackett, and Lukas Vanhonnaeker

Abstract The legal analysis of genetic testing in insurance and employment reveals layered tensions that are central to the governance of contemporary social risk. The development of genomic medicine promises much, through the ability to identify risk on an individualized basis. However, individualization inevitably raises concerns about privacy protection, all the more pressing when genetic testing is not a fully refined, predictive technology. The individualization of risk yields still more profound tensions to the extent that the Post-War consensus in many societies has been to seek to transfer certain social risks away from the individual, by collectivizing them through a range of state-supported social security mechanisms. On the occasion of the 20th General Congress of the International Academy of Comparative Law held on 24 July 2018 at Kyushu University in Fukuoka, Japan, legal experts worldwide prepared reports on the legal aspects of genetic testing in the contexts of insurance and employment, 14 of which are revised as chapters in this edited volume. This general report highlights commonalities and differences between legal regimes on their approach to genetic testing in these contexts. It chronicles the justifications for and against the collection of genetic information by insurers and employers, legal definitions, as well as the specific rights and obligations and generalist frameworks that apply from a privacy rights and anti-discrimination lens. This comparative endeavor concludes with a reflection on the relevance of transnational standards to address the legal challenges of genetic testing in insurance and employment.

L. Khoury (*) · A. Blackett · L. Vanhonnaeker Faculty of Law, McGill University, Montreal, QC, Canada e-mail: [email protected]; [email protected]; [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_1

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1 Introduction1 Colleagues from 16 jurisdictions have generously reported2 on how the legal systems of their different jurisdictions tackle the challenges brought by legal aspects of genetic testing in insurance and employment.3 Grounded in their work, this General Report offers an overview of the diverse set of norms that surround genetic testing in insurance and employment, accompanied by a window into relevant international, regional and national incursions into the field. This general report does not purport to offer a comprehensive or even free-standing investigation. Similarly, it does not seek fully to describe national orders in respect to the questions raised by the topic.4 Rather, this report offers a basis for comparative reflection, including on whether transnational standard setting might be useful or necessary to address some of the legal challenges of genetic testing in insurance and the employment. The report is structured into two main sections. The first section looks at the range of norms that specifically address the use of genetic testing in employment and insurance. They encompass international sources—including human rights norms— that may be binding or non-binding, as well national statutory, regulatory or soft law mechanisms (Sect. 2). The second section considers general frameworks relevant to genetic testing of each country, including those that flow from general

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Questions 1–2 of the Questionnaire. Our questionnaire in French and English is available as an Annex to this chapter. 3 The national report for Belgium was prepared by Thierry Vansweevelt, Britt Weyts and Cindy Cornelis (Vansweevelt, Weyts and Cornelis, Belgian national report); the national report for Brazil was prepared by Mario Viola (Viola, Brazil national report); the national report for Canada was prepared by Colleen Thrasher and Hilary Young (Thrasher and Young, Canada national report); the national report for Cyrpus was prepared by Theodoros Trokanas (Trokanas, Cyprus national report); the national report for Czechia was prepared by Filip Křepelka (Křepelka, Czechia national report); the national report for Estonia was prepared by Kärt Pormeister (Pormeister, Estonia national report); the national report for France was prepared by Christian Byk (Byk, France national report); the national report for Greece was prepared by Lilian Mitrou (Mitrou, Greece national report); the national report for Italy was prepared by Carlo Casonato and Marta Tomasi (Casonato and Tomasi, Italy national report); the national report for Japan was prepared by Yuichiro Sato (Sato, Japan national report); the national report for Poland was prepared by Monika Wałachowska (Wałachowska, Poland national report); the national report for Quebec was prepared by Yann Joly (Joly, Quebec national report); the national report for Switzerland was prepared by Valérie Junod (Junod, Switzerland national report); the national report for Taiwan was prepared by Wenmay Rei (Rei, Taiwan national report); the national report for the United Kingdom was prepared by Gerard Porter (Porter, United Kingdom national report); insights with respect to challenges brought by legal aspects of genetic testing in insurance and employment in the United States were provided by Eric A. Feldman and Erin Quick after the Congress (Feldman and Quick, United States national report). The national reports are on file with the authors. 4 For a fulsome account of how national orders tackle the questions raised by our theme, the reader is invited to consult the revised contribution of some of the authors of the national reports: Khoury et al. (2020). 2

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anti-discrimination rules and norms protecting rights to autonomy, selfdetermination, confidentiality and privacy (Sect. 3). The legal analysis of genetic testing in insurance and employment reveals layered tensions that are central to the governance of contemporary social risk. The development of genomic medicine promises much, through the ability to identify risk on an individualized basis. However, individualization inevitably raises concerns about privacy protection,5 all the more pressing when genetic testing is not a fully refined, predictive technology.6 The individualization of risk yields still more profound tensions to the extent that the Post-War consensus in many societies has been to seek to transfer certain social risks away from the individual, by collectivizing them through a range of state-supported social security mechanisms.7 The transfer tends to occur through a variety of fiscal measures and social security benefits that are tied to employment and often involve insurance coverage. One rapporteur astutely questions whether genetic testing is part of the same continuum, or rather accelerates a different, contemporary trend of transferring risk back onto the shoulders of the individual.8 It is therefore somewhat surprising that the vast majority of jurisdictions surveyed in this report have little or no data available on the frequency of use of genetic testing in the insurance and employment contexts.9 This apparent lack of data stands in stark contrast with the data available on the prevalence of genetic testing undertaken for medical purposes (e.g. for prenatal diagnostic, filiation, medical diagnosis, predictive testing, and now personalized medicine)10 as well as for the investigation of crimes.11 National reporters pointed to a number of factors that might affect the prevalence of genetic testing in the contexts of insurance and employment. The design of national health or social insurance systems, especially where they provide comprehensive coverage, and even of private insurance schemes, has an impact on the 5

Wałachowska, Poland national report. This tension was raised in different ways by several national rapporteurs. See e.g. Thrasher and Young, Canada national report; Byk, France national report. 7 See Universal Declaration of Human Rights, G.A. Res. 217A (III), U.N. Doc. A/810 at 71 (1948), Arts 22, 23 and 25. 8 Byk, France national report. 9 Viola, Brazil national report; Thrasher and Young, Canada national report; Křepelka, Czechia national report; Casonato and Tomasi, Italy national report; Sato, Japan national report; Rei, Taiwan national report; Wałachowska, Poland national report; Mitrou, Greece national report; Pormeister, Estonia national report; Joly, Quebec national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgian national report; Porter, United Kingdom national report (the Health and Safety Executive noted in 2007 that: “(w)e have not found any evidence that employers are currently carrying out genetic testing in Britain (with the exception of the Ministry of Defence for aircrew training)”). 10 Křepelka, Czechia national report; Wałachowska, Poland national report; Rei, Taiwan national report; Byk, France national report. 11 Křepelka, Czechia national report (because of rapidly decreasing prices, genetic testing proliferates in both domains). 6

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frequency of genetic testing12: one national rapporteur suggests that if the cost of genetic testing13 is covered, physicians may be more likely to prescribe genetic tests.14 Moreover, if the national health insurance provides comprehensive coverage for health services,15 there may be little incentive for private insurers to use genetic testing.16 Finally, the availability of low cost direct-to-consumer genetic testing may have an impact on the prevalence of genetic testing.17 Of course, how countries regulate genetic testing—forbidding it altogether for employment and insurance purposes, or permitting it under strict conditions (Sect. 2 below)—is likely to influence the frequency of the testing.18 For instance, the Quebec rapporteur observes that a conjunction of three factors could affect the reliance upon genetic testing in the Canadian context: (1) the adoption of a specific genetic anti-discrimination statute in 2017; (2) a commitment by Canadian insurers, starting on 1 January 2018 to restrict the use of genetic test results for life coverage equal to or above $250,000; and (3) the inclusion of genetic testing within the services covered by the public health care system.19 Diving into the heart of our topic, we find another factor influencing prevalence: insurer-induced fear of higher premiums or exclusion of coverage not only affects the willingness of individuals to undergo useful predictive genetic tests, but also affects the protection of their rights as patients by restricting de facto their access to preventive health care20 and equitable access to health care.21

12 Sato, Japan national report; Porter, United Kingdom national report; Joly, Quebec national report; Rei, Taiwan national report; Křepelka, Czechia national report. 13 E.g. Porter, United Kingdom national report (access to genetic testing is free within the NHS based upon clinical need—usually when there is relevant family history). 14 Suggested by Junod, Switzerland national report. 15 Rei, Taiwan national report. 16 Rei, Taiwan national report. The existence of a publicly funded healthcare system in Canada also explains the limited amount of discriminatory treatment on the ground of genetic status and why it took so long to adopt legislation on genetic discrimination: Joly, Quebec national report. 17 E.g. Porter, United Kingdom national report. 18 Thrasher and Young, Canada national report; Joly, Quebec national report; Junod, Switzerland national report. 19 Joly, Quebec national report, citing to CLHIA, “Industry Code: Genetic Testing Information for Insurance Underwriting” (11 January 2017) and Genetic Non-Discrimination Act, Canada, SC 2017, c 3. 20 Protected under article 35 of the Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012 (Trokanas, Cyprus national report). 21 Protected under article 3 of the Oviedo Convention (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164): Trokanas, Cyprus national report. This could include their right to access healthcare, where applicable: Pormeister, Estonia national report.

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2 Specific Rights and Obligations Regarding Genetic Testing in the Insurance and Employment Context 2.1

Justifications For and Against the Collection of Genetic Information by Employers and Insurers22

As suggested in the introduction, perspectives vary on whether employers and insurers should be permitted to collect genetic information in the employment and insurance contexts, even though some jurisdictions report an absence of political and bioethical debates about genetic testing altogether.23 We therefore asked national rapporteurs to share their appraisal of the justifications and objections raised in their jurisdictions for and against such collection. The justifications for collection by the insurance industry are grounded in a number of arguments. In some countries, the insurance industry invokes its business model of setting premiums based on risk to justify collecting genetic information.24 In a nutshell, genetic information enables industry actors to classify individuals in the appropriate risk category.25 The argument is that by avoiding inaccurate risk classification, genetic data collection fends off against unfair practices26 and solidifies the foundations of insurance, namely the collectivization of risk and solidarity.27 The collection of genetic information can also be seen as remedying the asymmetry of information between the insurer and the individual seeking insurance, which may lead to self-selection or anti-selection.28 Moreover, as scientific developments allow the identification of genetic origins for an increasing number of diseases, protection against the disclosure of genetic health risks may undermine an insurer’s ability to decide what risks to underwrite when applicants simply remain silent on frequently occurring illnesses with a genetic origin and potentially on a broader range of medical data.29

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Question 19 of the Questionnaire. Křepelka, Czechia national report. 24 Thrasher and Young, Canada national report. See also Feldman and Quick, United States national report. 25 Vansweevelt, Weyts and Cornelis, Belgium national report. See also Byk, France national report and Pormeister, Estonia national report (insurers, contrary to employers, may have a legitimate interest in accessing an individual’s genetic information, especially in the context of life insurance or long-term medical insurance). 26 Joly, Quebec national report; Porter, United Kingdom national report; Junod, Switzerland national report. 27 Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgium national report. See also Sato, Japan national report (insurers frame genetic information collection as part and parcel of a distributive justice scheme). 28 Raised by Vansweevelt, Weyts and Cornelis, Belgium national report. The concepts of selfselection and anti-selection are explained by the rapporteurs on Belgium. 29 Raised by Vansweevelt, Weyts and Cornelis, Belgium national report. 23

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In the employment context, justifications for the collection of genetic data30 are generally formulated through the lens of the employers’ right to manage, which includes ascertaining an employee’s ability to carry out the duties of the employment relationship31 and helping to match employees with suitable jobs.32 A further articulated justification is linked to employers’ responsibility to provide a safe workplace: some argue that employers may need an employee’s disclosure in order to protect the worker with a genetic disorder against specific risk factors (e.g. if a particular task requires exposure to a particular substance).33 Others situate the responsibility at the level of avoiding compromising the safety of others in the workplace,34 or of arriving at an equitable organization and distribution of work.35 In some case, the broader organization of work has an impact on genetic testing. In Japan, it is argued that the collection of genetic information as part of the recruitment process is justified by the “lifelong employment system” whereby employees are expected to remain in the same employment until their retirement age (usually 60 years old).36 Yet in other contexts, the debate might be mute for distinct structural reasons. In Czechia for instance, there is little incentive for employers to have recourse to genetic testing for two seemingly contradictory reasons: the skilled workforce available is limited and employment contracts can easily be terminated.37 Context matters. Objections to the collection of genetic information are also varied, some being general and others pertaining to each of the contexts under study. The main objection common to both the employment and insurance sectors focuses on the danger of genetic discrimination, which we discuss below.38 Another shared objection centres

30 Some jurisdictions report that no data is available on that topic (Casonato and Tomasi, Italy national report) or that employers and insurers do not collect genetic information (Rei, Taiwan national report). 31 Thrasher and Young, Canada national report; Joly, Quebec national report; Křepelka, Czechia national report. 32 Feldman and Quick, United States national report. 33 Křepelka, Czechia national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgian national report. 34 Křepelka, Czechia national report; Porter, United Kingdom national report; Junod, Switzerland national report (safety of third parties). The Czechia report observes that causal links between genetic disorders and workplace safety are largely speculative but notes that geneticists indicate that early symptoms of Huntington’s disease could compromise work performance and safety (Křepelka, Czechia national report). 35 Junod, Switzerland national report. 36 Sato, Japan national report. 37 Křepelka, Czechia national report. 38 Thrasher and Young, Canada national report; Casonato and Tomasi, Italy national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgium national report. See also Sato, Japan national report. Interestingly, the rapporteurs for the United States explain with respect to the prohibition of genetic discrimination in both sectors, that the enactment of the Genetic Information Nondiscrimination Act (PL 110–233, 21 May 2008, 122 Stat 881) was not a response to actual discriminatory practices but instead was aimed at mitigating the public’s fear of future

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on the state of the science: genetic testing often cannot conclusively predict a person’s future health, as one may have a predisposition to a disease, but not ever actually acquire it.39 Moreover, requiring disclosure and allowing the use of genetic data in insurance and employment has broader health consequences: it may serve as a disincentive for individuals who could receive life-saving information from pursuing genetic testing, out of the fear that they will be compelled to disclose the results.40 In the insurance sector, opponents to genetic testing emphasize the dangers of creating an uninsured “genetic underclass.”41 They also point to objections grounded in the protection of privacy and personality rights42 and contractual freedom.43 They worry about the consequence of disclosure for relatives whose health history may be required for—or whose health risks might be revealed through—the testing.44 They additionally raise the dangers of self-selection by the insurance seeker who is often not in a position to obtain an accurate market assessment.45 Finally, in the employment context, it is argued that there are less intrusive means by which to assess the reasonable ability of potential employees to perform the work required for their employment, such as by asking about suitability and ability to perform certain tasks.46 Next, we explore normative approaches that address specifically whether genetic tests can be requested by employers and insurers or whether employers and insurers can request existing genetic results. Given these rules are often influenced by concerns about potential discrimination, we start by exploring anti-discrimination and other human rights provisions dealing specifically with genetics (Sect. 2.3) before moving on to other types of legislation, subordinate regulations, and soft law instruments governing the use of genetic information and testing in the employment and insurance sectors (Sect. 2.4). But we look first at the treatment of the various concepts associated with genetic testing under the international and national laws surveyed (Sect. 2.2).

genetic discrimination and preventing such practices (Feldman and Quick, United States national report). 39 Thrasher and Young, Canada national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgium national report. 40 Vansweevelt, Weyts and Cornelis, Belgium national report (raised by the rapporteurs for the insurance sector, but applicable to employment as well). 41 Porter, United Kingdom national report. 42 Vansweevelt, Weyts and Cornelis, Belgium national report; Sato, Japan national report. 43 Vansweevelt, Weyts and Cornelis, Belgium national report (the Belgium national report provides an explanation of the impact on the contractual freedom of the policyholder). They also raise possible suspicion on the part of the insurer if genetic information is not voluntarily disclosed. 44 Vansweevelt, Weyts and Cornelis, Belgium national report. 45 Vansweevelt, Weyts and Cornelis, Belgium national report. 46 Pormeister, Estonia national report.

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Legal Conceptualizations of Genetic Testing and Information47

The field of genetics is gaining in importance at the international and regional levels. Relevant concepts—mainly genetic tests and genetic data/information48—have been defined internationally, and those definitions have influenced definitions adopted nationally. International law recognizes a “special status” for human genetic data. Indeed, the non-binding49 United Nations Economic, Social and Cultural Organization (UNESCO) 2003 International Declaration on Human Genetic Data (2003 UNESCO Declaration) invokes four reasons for this status, namely that it may: (1) be predictive of genetic predispositions concerning individuals; (2) have a significant impact on the family, including offspring, extending over generations, and in some instances on the whole group to which the person concerned belongs; (3) contain information the significance of which is not necessarily known at the time of the collection of the biological samples; and, finally (4) have cultural significance

47

Questions 3 and 4 of the Questionnaire. For ILO documents referring to genetic data and testing, see: ILO—Report of the DirectorGeneral, Equality at Work: Tackling the Challenges (Global Report under the follow-up to the ILO Declaration on Fundamental Principles and Rights at Work, ILO Conference, 96th Session 2007, Report I(B)) at 48–49; ILO—Report of the Director-General, Equality at Work: The Continuing Challenge (Global Report under the follow-up to the ILO Declaration on Fundamental Principles and Rights at Work, ILO Conference, 100th Session 2011, Report I(B)) at 52 (the report briefly identifies some regulatory developments in Serbia, Armenia, the United States and Canada with respect to genetic status and testing); ILO—Protection of Workers’ Personal Data (ILO 1997) at 1, 4 et seq and 17; ILO, Technical and Ethical Guidelines for Workers’ Health Surveillance, Occupation Safety and Health Series No. 72 (ILO 1998) at 7. It should be noted that the International Labor Organization (ILO) increasingly distinguishes between genetic screening and monitoring (ILO— Protection of Workers’ Personal Data (ILO 1997) at 17). UNESCO International Declaration on Human Genetic Data, 16 October 2003; European Convention on Human Rights (1950); Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 21; 12th Additional Protocol to the Convention (signed in 2000, not yet into force); Council directive 2000/78/EC establishing a general framework for equal treatment in employment and occupation, OJ L 303, 2 December 2000; Council directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin, OJ L 180/22, 19 July 2000; Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164; Treaty on the Functioning of the European Union, OJ C 326/47, 26 October 2012, Art 10; Thrasher and Young, Canada national report (Canadian Human Rights Act, RSC, 1985, c H-6); Trokanas, Cyprus national report (referring to EU norms and the Oviedo Convention); Křepelka, Czechia national report (Constitution of the Czech Republic); Mitrou, Greece national report (Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes, adopted 27 November 2008, CETS no 203); Byk, France national report (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016). 49 UNESCO refers to declarations as “purely moral or political commitment[s], binding States on the basis of good faith.” 48

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for persons or groups.50 Accordingly, “(d)ue consideration should be given to the sensitivity of human genetic data and an appropriate level of protection for these data and biological samples should be established.”51 Some jurisdictions52 recognize implicitly53 this “special status” although not necessarily through explicit reference to the 2003 UNESCO Declaration. Implicit recognition flows from the inclusion of “genetic characteristics” as a ground of discrimination in human rights legislation for instance,54 or because of its special treatment in national legislation.55 This special status is sometimes contested, however.56 Finally, the Greek Constitution generally states that everyone has a right to the protection of his or her health and his or her genetic identity, which is interpreted as entailing the protection of genetic information.57 In the surveyed jurisdictions, distinct normative texts define genetic data or information. Internationally, the 2003 UNESCO Declaration defines human genetic data as: “(i)nformation about heritable characteristics of individuals obtained by analysis of nucleic acids or by other scientific analysis.”58 Regionally, the EU General Data Protection Regulation 2016/679,59—which entered into force and is applied only since 25 May 2018,60—considers genetic data to be “personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural

50

UNESCO International Declaration on Human Genetic Data, 16 October 2003, Art 4(a). UNESCO International Declaration on Human Genetic Data, 16 October 2003, Art 4(b). 52 Others do not: Viola, Brazil national report; Porter, United Kingdom national report. 53 Thrasher and Young, Canada national report (but the cultural significance of genetic information is neither explicitly nor implicitly recognized in Canada); Joly, Quebec national report; Trokanas, Cyprus national report (“sensitive”); Křepelka, Czechia national report; Casonato and Tomasi, Italy national report (through the prohibition); Sato, Japan national report; Rei, Taiwan national report (“sensitive”); Wałachowska, Poland national report (“sensitive data”); Pormeister, Estonia national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgium national report; Byk, France national report; Mitrou, Greece national report (soft law). 54 As observed by: Joly, Quebec national report (Canadian Human Rights Act, RSC, 1985, c H-6); Křepelka, Czechia national report; Pormeister, Estonia national report (Personal Data Protection Act, RT I, 6 January 2016, 10, and Human Genes Research Act, RT I, 14 March 2014, 30, ss 25–27). 55 E.g. Rei, Taiwan national report (Personal Data Protection Act, Art 6: “sensitive personal data”). 56 As noted by Porter, United Kingdom national report and Wałachowska, Poland national report. 57 Mitrou, Greece national report (Arts 2, 5(5), 9(a), 21 and 25). 58 UNESCO International Declaration on Human Genetic Data, 16 October 2003, Art 2(i). 59 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016. 60 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 99(2). 51

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person in question.”61 At the national level,62 examples include Estonia’s definition of genetic data as “data concerning the genes, gene products or hereditary characteristics of a human being, including a description of DNA or a part thereof, which is obtained as a result of genetic research.”63 In the United States,64 the Genetic Information Nondiscrimination Act defines genetic information as “(i) such individual’s genetic tests, (ii) the genetic tests of family members of such individuals, and (iii) the manifestation of a disease or disorder in family members of such individual”,65 excluding information about an individual’s sex and age.66 As for genetic test, testing or screening, a number of definitions exist. The 2003 UNESCO Declaration defines genetic testing as “a procedure to detect the presence or absence of, or change in, a particular gene or chromosome, including an indirect test for a gene product or other specific metabolite that is primarily indicative of a specific genetic change.”67 Several of the national regulatory regimes surveyed have adopted definitions that are consistent with this terminology,68 while others have

61 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 4(13). A second definition is found in the preamble (Rec 34):

Genetic data should be defined as personal data relating to the inherited or acquired genetic characteristics of a natural person which result from the analysis of a biological sample from the natural person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained. 62

Some jurisdictions do not provide definitions of genetic information: Viola, Brazil national report; Trokanas, Cyprus national report; Křepelka, Czechia national report; Sato, Japan national report; Rei, Taiwan national report; Wałachowska, Poland national report; Mitrou, Greece national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgian national report. 63 Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, s 2 (9)). This definition applies in the contexts of insurance and employment in particular (see Human Genes Research Act, RT I, 14 March 2014, 30, ss 26–27)). See also for genetic information: Casonato and Tomasi, Italy national report (Authorization No. 8/2016 for the Processing of Genetic Data—15 December 2016, point 1 (i)); Thrasher and Young, Canada national report (one can infer from the definition of genetic test exposed below that “genetic information” includes DNA, RNA or chromosomes and the predictions of disease or vertical transmission risk that they suggest); Joly, Quebec national report. For other definitions of genetic data, see: Italy, Casonato and Tomasi, Italy national report (Authorization No. 8/2016, point 1a). 64 Feldman and Quick, United States national report. 65 Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881, s 201(4). 66 Feldman and Quick, United States national report. 67 UNESCO International Declaration on Human Genetic Data, 16 October 2003, Art 2(xii). 68 Thrasher and Young, Canada national report (the terminology is similar to article 2(i) and (xii) of the UNESCO Declaration with a few differences); Joly, Quebec national report (the Genetic Non-Discrimination Act does not use or define the terms “human genetic data” or “human proteomic data”: Genetic Non-Discrimination Act, Canada, SC 2017, c 3, ss 2 and 8); Casonato and Tomasi, Italy national report (similar but not exactly the same wording. There is no mention of

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adopted narrower definitions than that contained in the 2003 UNESCO Declaration.69 In Canada, the recent Genetic Non-Discrimination Act defines “genetic test” as “a test that analyses DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis.”70 Finally, the United States’ Genetic Information Nondiscrimination Act defines “genetic test” as “analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes”.71 Soft law instruments also provide definitions of “genetic information” and “genetic testing,”72 such as in the United Kingdom where the 2014 Concordat and Moratorium on Genetics and Insurance states that “predictive genetic tests” examine the structure of chromosomes (cytogenetic tests) or detect abnormal patterns in the DNA of specific genes (molecular tests).73 Proteomic or epigenetic data are generally not included in the definition of genetic information, data or test(ing)74—although the UNESCO Declaration does provide a

proteomic data); Pormeister, Estonia national report (similar but not identical language. Estonian law does not define “genetic testing” but has a definition for “genetic research” which is broader (Human Genes Research Act, RT I, 14 March 2014, 30, s 2(7)). Contra: The Swiss Federal Act on Human Genetic Testing of 8 October 2004 (in force since 1 April 2007, RS 810.12) adopts definitions different from those of the Declaration; it focuses on the notion of genetic analysis (analyse génétique): Junod, Switzerland national report. 69 E.g. Porter, United Kingdom national report (the definition provided in the Concordat and Moratorium does not extend to “an indirect test for a gene product or other specific metabolite that is primarily indicative of a specific genetic change”). 70 An Act to prohibit and prevent genetic discrimination, 1st sess, 42nd Parl, 2015, (assented to 4 May 2017), SC 2017, c 3, s 3), s 2. 71 Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881, s 201(7). 72 Mitrou, Greece national report (see the definition of genetic data for insurance purposes of the Greek National Bioethics Commission); Porter, United Kingdom national report (“genetic testing” is used repeatedly throughout the ICO Employment Practices Code, but no clear definition is given). 73 Porter, United Kingdom national report (UK Government and the Association of British Insurers (ABI), “Concordat and Moratorium on Genetics and Insurance’ (2014), available at: https://www. abi.org.uk/globalassets/sitecore/files/documents/publications/public/2014/genetics/concordat-andmoratorium-on-genetics-and-insurance.pdf. In the United Kingdom, the government has deliberately avoided resorting to the general non-discrimination framework, rather relying on two soft law instruments applying respectively in the employment and insurance sectors: Porter, United Kingdom national report. For other definitions of genetic screening, see: Casonato and Tomasi, Italy national report (Authorization No. 8/2016, point 1 (g)). For other definitions of genetic test, see: Casonato and Tomasi, Italy national report (Authorization No. 8/2016, point 1 (c)); Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Art 3). 74 Thrasher and Young, Canada national report; Joly, Quebec national report (see Genetic Non-Discrimination Act, Canada, SC 2017, c 3, ss 2 and 8); Casonato and Tomasi, Italy national report; Porter, United Kingdom national report; Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, s 2(9) includes gene and hereditary characteristics, however); Junod, Switzerland national report (no explicit reference in the Federal Act on Human

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definition of human proteomic data.75 The rapporteurs for Canada and Quebec observe that relevant definitions tend implicitly to include proteomic or epigenetic data.76 In the United States, the Genetic Information Nondiscrimination Act explicitly refers to “an analysis of human (. . .) proteins” in its definition of “genetic test”.77 Do the definitions of the relevant terminology refer explicitly to the broader concept of family history? Many do not.78 However, in Estonia for instance, family history is covered by the definition of genetic data under the Personal Data Protection Act if the family history reveals genetic information regarding a specific, directly or indirectly identifiable, individual.79 National orders distinguish between genetic tests in two distinct ways. A first distinction pertains to whether tests are diagnostic (used to identify existing health problems) or predictive (used to predict disease susceptibility). In general, definitions in national laws do not make this distinction.80 However, the Oviedo Convention—which Cyprus, Czechia, Estonia, France, Greece, and Switzerland have ratified81—does so by limiting the use of predictive tests82 to health purposes or

Genetic Testing of 8 October 2004 (in force since 1 April 2007, RS 810.12) but it applies to any results arising from genetic testing). 75 The Declaration defines it as: “[i]nformation pertaining to an individual’s proteins including their expression, modification and interaction” (Art 2 (ii)). 76 Thrasher and Young, Canada national report; Joly, Quebec national report (some but not all proteomic and epigenetic data). 77 Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881, s 201(7). 78 Thrasher and Young, Canada national report; Joly, Quebec national report; Casonato and Tomasi, Italy national report; Porter, United Kingdom national report (the ABI Concordat and Moratorium does not include family history, but section 21(f) explicitly allows insurers to seek, with the person’s consent, access to appropriate family medical history, inter alia, to accurately price the risk from any health information an applicant discloses). 79 Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, ss 2 (9) and 4(2)–(4) of the Personal Data Protection Act (RT I, 6 January 2016, 10)). In Cyprus, “genetic information” and “genetic test” are not defined in legislation but soft law instruments include family history implicitly or explicitly: Trokanas, Cyprus national report. In Greece, family history is regarded as data pertaining to the health of a person if it allows explaining, assessing or predicting the health status of this person: Mitrou, Greece national report. 80 Thrasher and Young, Canada national report; Joly, Quebec national report (s 2 of the Genetic Non-Discrimination Act (SC 2017, c 3) refers to both diagnostic and predictive tests); Casonato and Tomasi, Italy national report. 81 See https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/164/signatures?p_ auth¼lczs9fbu 82 Defined as: “(t)ests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease” (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 12).

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research linked to health purposes.83 Switzerland provides an example in which the distinction is made in the legislation and determines whether genetic testing is allowed, as we will see below.84 In the United Kingdom, the “Concordat and Moratorium” applies only to predictive genetic tests.85 Cyprus seeks to prohibit insurers from conducting preventive medical screening for diagnosis of existing pathologies and tests for the detection of risks of future disorders and diseases.86 Finally, the rapporteurs for the United States note that the Genetic Information Nondiscrimination Act’s definition of “genetic information” subtracts from the Act’s protections individuals whose diseases have manifested themselves.87 A second reported distinction concerns the “venue” in which the genetic tests are conducted: within a clinical or research setting or sold directly to consumers (DTC).88 For instance, in Canada, the Genetic Non-Discrimination Act does not apply to researchers or health care practitioners89; in Switzerland, despite efforts to regulate DTC, they currently fall outside the scope of application of existing regulatory regimes.90

83 Subject to appropriate genetic counselling: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 12 (mentioned in Mitrou, Greece national report and Křepelka, Czechia national report). 84 It refers to predictive tests as pre-symptomatic genetic analysis (“analyses génétiques présymptomatiques”): Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Art 3(d)). 85 Porter, United Kingdom national report (an exception is found in section 21(c)(iii) of the ABI Concordat and Moratorium). 86 Trokanas, Cyprus national report (“National Bioethics Committee’s Opinion with respect to predictive health-related medical information before the conclusion of private (life or health) insurance” of 22 January 2008: by classifying medical history under medical methods and practices to predict diseases. This Opinion is classified as a “soft law” instrument. Trokanas, Cyprus national report. 87 Feldman and Quick, United States national report (Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881). 88 Pormeister, Estonia national report (the Human Genes Research Act (RT I, 14 March 2014, 30) implicitly distinguishes through the way it is structured); Porter, United Kingdom national report (the ICO Employment Practices Code does not, but the ABI Concordat and Moratorium establishes that customers are not required to disclose predictive or genetic test results acquired as part of clinical research). Other countries do not make such distinction: Trokanas, Cyprus national report; Casonato and Tomasi, Italy national report; Mitrou, Greece national report (but the Greek national report provides a caveat). 89 Thrasher and Young, Canada national report and Joly, Quebec national report. See also Wałachowska, Poland national report (a distinction was made in a 2012 Bill between tests occurring within a clinical setting, for research purposes, and tests sold to consumers; a working group recommended testing for medical purposes only). 90 Junod, Switzerland national report. See also Pormeister, Estonia national report (parts of the Human Genes Research Act apply only to research (i.e. to the EGB), and others apply more generally to genetic testing).

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National laws may regulate genetic testing, implicitly or explicitly, directly or indirectly, via constitutional law,91 consumer law,92 laws pertaining to biobanks,93 employment law,94 and even criminal law.95 Regulatory regimes have tended to regulate genetic testing through non-discrimination provisions or other legislation specifically targeting genetic testing and information. In addition, data protection laws play a crucial role, which is described in Sect. 3.2. Some jurisdictions surveyed do not have laws specifically regulating the use of genetic data for employment or insurance purposes96 (see Summary Table in Annex 1) or, even, data protection laws.97 The countries that have regulated on the matter through specific regulatory texts include Canada,98 Italy,99 Estonia,100

91

Thrasher and Young, Canada national report (Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982 being Schedule B to the Canada Act 1982 (UK), 1982, c 11, esp ss 7-8, 15); Trokanas, Cyprus national report (Constitution of the Republic of Cyprus of 1960); Mitrou, Greece national report (Greek Constitution, Art 5). 92 Mitrou, Greece national report (Act 2251/1994 on the protection of consumers). 93 Rei, Taiwan national report (Biobank Management Act of 2010); Mitrou, Greece national report (Recommendation on Biobanks in biomedical Research the Greek National Bioethics Committee). 94 Casonato and Tomasi, Italy national report (articles 5 and 8 of the Statute of the Workers’ Rights (Law no. 300 of May 20, 1970, “Rules on the protection of the freedom and dignity of workers and of trade union freedom and union activity in the workplace, and rules on the public employment service”). 95 Křepelka, Czechia national report (the report explores this possibility); Junod, Switzerland national report (Penal Code, Art 321, protecting medical secrecy); Byk, France national report (Penal Code, Art 225-3(1), protecting against discrimination). 96 Viola, Brazil national report; Trokanas, Cyprus national report; Křepelka, Czechia national report; Sato, Japan national report; Rei, Taiwan national report; and the UK, Porter, United Kingdom national report (except in the insurance sector through soft law). 97 Viola, Brazil national report. 98 Genetic Non-Discrimination Act, Canada, SC 2017, c 3: Thrasher and Young, Canada national report; Joly, Quebec national report (the Genetic Non-discrimination Act amends the Canadian Labour Code and the Canadian Human Rights Act, RSC, 1985, c H-6). This Genetic Non-Discrimination Act was found to be an invalid exercise of federal powers by the Quebec Court of Appeal in December 2019, after the Canadian and Quebec reports were drafted: Dans l'affaire du: Renvoi relatif à la Loi sur la non-discrimination génétique, 2018 QCCA 2193. The Supreme Court of Canada heard the arguments on appeal of this decision in October 2019 but has not yet rendered its decision: https://www.scc-csc.ca/case-dossier/info/sum-som-eng.aspx? cas¼38478. 99 General Authorisation No. 8/2016 for the Processing of Genetic Data: Casonato and Tomasi, Italy national report (General Authorisation No. 8/2016 for the Processing of Genetic Data— 15 December 2016 (issued by the Garante per la protezione dei dati personali)). 100 Human Genes Research Act, RT I, 14 March 2014, 30 (ss 25–27 for insurance and employment: Pormeister, Estonia national report).

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Switzerland,101 France,102 Belgium103 and the United States104 (see Summary Table in Annex 1).

2.3

Anti-discrimination Norms Dealing Specifically with Genetic Status105

Human rights based anti-discrimination norms that apply to genetic discrimination exist internationally, regionally and nationally. Some are of general application and have been interpreted to include genetic discrimination. Others have been adopted specifically to tackle the issues arising in genetic testing. While different rapporteurs underscore important developments in non-discrimination law, none consider the measures in place to offer a panacea. Some even query whether the increasingly affordable and widespread nature of genetic testing blurs the line between discriminatory use of genetic information and attention to how an individual’s genetic constitution may make him or her more or less suitable for a particular job or more or less of an insurance risk.106 Internationally, the Universal Declaration of Human Rights, the two UN covenants107 and the anti-discrimination conventions108 provide a generalist framework of human rights that is reflected in the specific, more contemporary, texts that have since been elaborated by other UN agencies. The generalist norms are discussed in greater detail in Sect. 3 below. Discrimination based on genetic status is specifically addressed in a number of international instruments of varying normativity (see Summary Table in Annex 1). These include the non-binding UNESCO Universal Declaration on Human Genome

101

Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Arts 26 to 28). 102 Byk, France national report. 103 Vansweevelt, Weyts and Cornelis, Belgium national report (Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014, Arts 58 and 64 and Act of 28 January 2003 concerning medical examinations that are carried out within the framework of industrial relations, Belgian State Gazette, 9 April 2003). 104 Feldman and Quick, United States national report. 105 Questions 8, 9 and 11 of the Questionnaire. 106 Feldman and Quick, United States national report. 107 International Covenant on Civil and Political Rights of 16 December 1966; International Covenant on Economic, Social and Cultural Rights of 16 December 1966 (the United States have not ratified this International Covenant); Convention on the Elimination of All Forms of Discrimination against Women, 18 December 1979 (the United States have not ratified the Convention); International Convention on the Elimination of All Forms of Racial Discrimination, adopted on 21 December 1965. 108 See in particular the UN Convention on the Rights of Persons with Disabilities of 13 December 2006.

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and Human Rights of 11 November 1997 (1997 UNESCO Human Genome Declaration), which states that “[e]veryone has a right to respect for their dignity and for their rights regardless of their genetic characteristics” and that no one shall be “subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity.”109 In addition, the 2003 UNESCO Declaration provides that “[e]very effort should be made to ensure that human genetic data and human proteomic data are not used for purposes that discriminate in a way that is intended to infringe, or has the effect of infringing human rights, fundamental freedoms or human dignity of an individual or for purposes that lead to the stigmatization of an individual, a family, a group or communities.”110 The United Nations specialized agency, the International Labour Organization (ILO), has similarly issued a non-binding Code of practice on the protection of workers’ personal data. The Code of practice stresses “the need to develop data protection provisions which specifically address the use of workers’ personal data in order to safeguard the dignity of workers, protect their privacy and guarantee their fundamental right to determine who may use which data for what purposes and under what conditions.”111 At the regional level in Europe, the Charter of Fundamental Rights of the European Union112 prohibits any discrimination based on “genetic features” by EU institutions when applying EU law.113 The EU General Data Protection Regulation 2016/679 emphasizes the importance of preventing discriminatory effects on natural persons on the basis of genetic or health status, or measures having such an effect.114 The regional human rights body, the Council of Europe, has issued the Oviedo Convention on Human Rights and Biomedicine, which also prohibits any form of discrimination against a person “on grounds of his or her genetic heritage.”115 The American Convention on Human Rights provides generalist protection, and is discussed under Sect. 3 below. 109

UNESCO Universal Declaration on Human Genome and Human Rights of 11 November 1997, Arts 2(a) and 6. 110 UNESCO International Declaration on Human Genetic Data of 16 October 2003, Art 7. 111 ILO—Code of practice on the Protection of Workers’ Personal Data (ILO 1997), preamble at 1. Although, the ILO does not address the specific issue of genetic discrimination, one could argue that it includes genetic information in the notion of data. 112 The Charter of Fundamental Rights of the European Union (OJ C 326/391, 26 October 2012) covers all of the rights and freedoms enshrined in the ECHR as well as others flowing from the ECJ case law, constitutional traditions of EU countries and other instruments. 113 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 21 (1). See also Arts 3 (integrity of the person), 7 (respect for private and family life) and 8 (protection of personal data). 114 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, para 71 of the Preamble. 115 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 11.

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Legislative texts in several surveyed jurisdictions explicitly mention genetic grounds for prohibited discrimination (see Summary Table in Annex 1).116 This is the case of Canada, where the Genetic Non-Discrimination Act of May 2017 amended the Canadian Human Rights Act—which only applies to federal regulated activities—to include “genetic characteristics” as a prohibited ground of discrimination.117 The Belgian Anti-Discrimination Act, applying to public and private sectors, and to labour relations, forbids the use of genetic characteristics to discriminate.118 It should be noted that some jurisdictions specifically refer in their national legislation to international texts that address genetic discrimination (Italy119) or that prohibit any form of discrimination (Poland120). Finally, the French Penal Code also prohibits discrimination based on genetic characteristics, but makes an exception for health-related discrimination for life, health and invalidity insurance. This exception was later modified to forbid, even in such cases, reliance on predictive genetic tests for a disease that is not yet declared or for a genetic predisposition to a disease.121 Other jurisdictions also explicitly recognize genetic status as a ground of discrimination in soft law instruments.122 However, virtually all of the national rapporteurs indicated a lack of judicial decisions dealing specifically with genetic discrimination in the insurance and/or

116

Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 9); Trokanas, Cyprus national report (in application of Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 11); Křepelka, Czechia national report (in application of the Charter of Fundamental Rights and Freedoms of the European Union, Art 11 of the Oviedo Convention, Art 11 and the Law on Specific Medical Services); Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Art 4; Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette 30 may 2007, Art 3). 117 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 9. Provincial human rights legislations do not address genetic discrimination specifically. But before the Act was adopted, the case law in the Canadian province of Quebec started to recognize genetic information as a possible ground for discrimination: Joly, Quebec national report and cases cited). 118 Vansweevelt, Weyts and Cornelis, Belgium national report (Art 3) (discrimination can be justified, however). 119 Casonato and Tomasi, Italy national report. 120 Wałachowska, Poland national report (“undoubtedly” encompasses discrimination based on genetic history). 121 Byk, France national report (Penal Code, Arts 225-1 and 225-3). There are also provisions applying to employment (the report only covers insurance). See also Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, but provides no sanction; the latter has to be found within other norms); Pormeister, Estonia national report. 122 Trokanas, Cyprus national report (Cyprus National Bioethics Committee’s Opinion of 22 January 2008); Mitrou, Greece national report (Greek National Bioethics Commission, Explanatory Report of the Recommendation on the collection and use of genetic data).

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employment contexts.123 There were two limited exceptions in Quebec124 and in the United States where, according to the Employment Opportunity Commission (EEOC), 206 genetic discrimination claims were filed with the Commission in 2017.125 In some contexts, for example in Italy, this dearth of information could have resulted from strict observance of the prohibition against the use of genetic data or from the fact that genetic data discrimination did not lead to legal action when it occasionally occurred.126 The rapporteurs for Belgium underscored the extent to which “genetic discrimination, as with a lot of other forms of discrimination, stays under the radar.”127 For the countries in which human rights or anti-discrimination rules do not address genetic status specifically, we will consider below whether the general anti-discrimination framework can be extended to cover situations of genetic discrimination, in particular through expansive definitions of the notion of “disability.” Initially, though, we look at other types of normativity regulating the insurance and employment contexts and specifically addressing the rights and obligations of insurers and employers with regard to genetic testing.

2.4 2.4.1

Specific Rights and Obligations of Insurers and Employers in Other Types of Norms128 The General Prohibition Model

The general prohibition model is found in jurisdictions that either specifically forbid requiring genetic testing or transmission of genetic information for employment and 123

Vansweevelt, Weyts and Cornelis, Belgium national report; Viola, Brazil national report; Thrasher and Young, Canada national report; Křepelka, Czechia national report; Trokanas, Cyprus national report; Pormeister, Estonia national report; Mitrou, Greece national report; Wałachowska, Poland national report; Casonato and Tomasi, Italy national report; Sato, Japan national report; Junod, Switzerland national report; Rei, Taiwan national report; Porter, United Kingdom national report. Sato, Japan national report discusses a case dealing with the refusal to provide disability insurance based on the diagnosis of Krabbe disease. Partially granting the plaintiff’s claim, the court, in an obiter dictum, identified a link between this case and the problem of genetic information (the Japanese report provides details on the reasoning of the court on this issue). 124 Joly, Quebec national report (The Quebec Superior Court annulled a life insurance contract because of the omission to disclose the results of a genetic test, but in a context where the insured had symptoms of the disease, as did his father and brother. This 1990 decision precedes the adoption of the Genetic Non-Discrimination Act). 125 Feldman and Quick, United States national report. This number must be put in perspective as it corresponds to only 0.2% of total discrimination claims filed with the EEOC in 2017. 126 Casonato and Tomasi, Italy national report, nothing the absence of data to support this claim, however. 127 Vansweevelt, Weyts and Cornelis, Belgium national report. 128 Questions 5–6, 8 and 19–23 of the Questionnaire. Kindly note that we have not included Regulation (EU) 2017/746 on in vitro diagnostic medical devices due to enter into force 26 May 2022. On this Regulation: Pormeister, Estonia national report.

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insurance purposes, or that reserve the testing for healthcare (“therapeutic model”129) and/or research purposes. Several of our surveyed jurisdictions have adopted general laws prohibiting both insurers and employers from requiring genetic testing or from disclosing genetic test results (see Summary Table in Annex 1).130 For instance, Italy forbids employers to ask questions regarding the genetic status of job applicants and to require genetic testing prior to employment.131 In Belgium, using genetic information and testing is absolutely banned in the context of insurance.132 In Canada, since 2017, it is a crime under the Genetic Non-Discrimination Act to require individuals to undergo testing or to disclose results of genetic tests whether they are diagnostic or predictive.133 Finally, some jurisdictions prohibit the use of genetic data in employment and/or insurance contexts through soft law.134 Another prohibition model is found in the United States, where it applies to the employment context but is restricted to only certain types of insurance contracts. More specifically, Congress passed the Genetic Information Nondiscrimination Act in 2008, which limits the ability of employers and insurers in the health insurance sector to obtain, and use, genetic information when making decisions.135 This prohibition does not apply to other types of insurance such as life, disability and long-term insurance.136 At the state level, many states have adopted

129

Byk, France national report. The French rapporteur describes six different models: therapeutic, prohibition and quality control models, moratory, proportional approach and status quo. 130 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3); Joly, Quebec national report; Trokanas, Cyprus national report; Casonato and Tomasi, Italy national report; Wałachowska, Poland national report; Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, s 26 (employers) and s 27 (insurers)); Vansweevelt, Weyts and Cornelis, Belgium national report (exceptions to the prohibition are not regulated); Byk, France national report (Code civil, Art 16-10; Code de la santé publique, Art L-1141-1). 131 Casonato and Tomasi, Italy national report (Arts 5 and 8 of the Statute of the Workers’ Rights (Law no. 300 of 20 May 1970)). 132 Vansweevelt, Weyts and Cornelis, Belgium national report (Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014). In the employment context, information gathering would be allowed only to determine current (not future) health status to assess suitability for a particular job. 133 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3). The constitutionality of the Genetic Non-Discrimination Act has been upheld by the Supreme Court of Canada in Reference re Genetic Non-DiscriminationAct, 2020 SCC 17. 134 Mitrou, Greece national report (in employment, consent is not an exception); Trokanas, Cyprus national report (insurance, if the person is unaware). 135 Feldman and Quick, United States national report (Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881). 136 The rapporteurs for the United States note though that the Patient Protection and Affordable Care Act and the Americans with Disabilities Act provide an additional layer of protection by prohibiting discrimination based on pre-existing conditions. The Patient Protection and Affordable Care Act of 2010 explicitly lists “genetic information” as a prohibited ground for discrimination (s 2705): Patient Protection and Affordable Care Act of 2010, PL 111–148, 23 March 2010, 124 Stat. 119; Americans with Disabilities Act of 1990, PL 101–336, 26 July 1990, 104 Stat. 327. See Feldman and Quick, United States national report.

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non-discrimination statutes which apply to health insurance but are, however, of limited practical use because they generally echo the federal law on that topic.137 The most important state laws are those that extend the prohibition of genetic discrimination to the forms of insurance not covered by the federal law (e.g. life, disability or long-term insurance), although some states include exceptions to the extended prohibitions in their legislation.138 The Oviedo Convention regulates the employment and insurance sectors by reserving predictive genetic tests for health purposes or for scientific research linked to health purposes.139 France has incorporated this rule in its Civil Code,140 without specifying if data collected for medical and scientific purposes could then be used in insurance; however, since 2002, the French Public Health Code (Code de la santé publique) explicitly forbids such use.141 The Recommendation CM/Rec(2016)8 of the Committee of Ministers to the member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic tests, applies the Oviedo Convention rule above by more specifically prohibiting predictive genetic testing in the insurance sector, while making an exception for existing test results under strict conditions.142 Caveats exist, which vary depending on whether one looks at the insurance or the employment contexts. One caveat surrounds consent. An exception to the Oviedo Convention’s prohibition of genetic testing outside of the health care and health research context applies if the person concerned consents to genetic testing.143 This consent-based exception also exists in Canada.144 However, from a human rights

137

Feldman and Quick, United States national report. E.g., in Arizona: Feldman and Quick, United States national report. 139 Subject to appropriate genetic counselling. Predictive tests are those which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 12 (this article opposes explicitly medical and insurance purposes, however. See Byk, France national report). 140 Byk, France national report (article 5 of law 94-653 of 29 july 1994, JO 30 july 1994 which introduced new article 16-10 of the Civil Code). 141 Byk, France national report (Code de la santé publique, Art L-1141-1). 142 As noted by Byk, France national report and Casonato and Tomasi, Italy national report. 143 As noted by Trokanas, Cyprus national report (Explanatory Report of the Oviedo Convention, nrs. 84–85). 144 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, ss 3- 5); Joly, Quebec national report (e.g., “an employer with the consent of the employee can ask health-related questions/examinations (. . .)—when these are relevant for a quality or an aptitude required by the employment”). See also Mitrou, Greece national report (insurance context) and Feldman and Quick, United States national report. In addition to non-discrimination laws, many states have adopted laws on the privacy of genetic information (not necessarily stand-alone laws, sometimes included in non-discrimination laws). Under these laws, genetic information can generally be disclosed with the consent of the individual at issue. Interestingly, some question whether consent can truly be valid at the conclusion of a contract if the 138

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law perspective, consent would not necessarily shield the insurer or employer against allegations of discrimination where genetic status is a recognized ground of discrimination or where it is covered by other grounds of discrimination.145 Moreover, Belgium, Italy, Switzerland and Estonia prohibit even voluntary disclosure of genetic information in the insurance and employment contexts; France does so for insurance and Greece for employment purposes.146 Another possible caveat concerns legal obligations that may indirectly pressure candidates to disclose information that may have a genetic component, such as where laws require the disclosure of “relevant information” to obtain life insurance. The rapporteurs on Canada point out that information about family history could presumably be disclosed under this obligation. As family history is not included in the restrictions under the 2017 Genetic Non-Discrimination Act, questions concerning family history would thus be exempt from the anti-discrimination provisions of provincial human rights legislation.147 Finally, some jurisdictions make an exception where disclosure is necessary to protect the life or physical integrity of the person concerned or a third party, which could arguably apply in the employment context.148 Finally, it is not necessarily the case that in some jurisdictions where the law is silent, as in Japan, Taiwan and Czechia,149 insurers and employers simply assume that they can ask questions about genetic information or require genetic testing prior to offering employment or insurance. In fact, the rapporteurs on Japan and Taiwan note that they generally do not do so in practice.150 Failing to respect the different prohibitions amounts to a criminal offence in Canada,151 Cyprus,152 Belgium,153 and under article 25 of the Oviedo

consequence of withholding it is that no employment or insurance will be provided: e.g., Wałachowska, Poland national report. 145 Thrasher and Young, Canada national report. 146 Vansweevelt, Weyts and Cornelis, Belgium national report; Casonato and Tomasi, Italy national report (General Authorization 8/2016); Junod, Switzerland national report; Pormeister, Estonia national report; Byk, France national report (Code de la santé publique, Art L-1141-1); Mitrou, Greece national report (soft law). 147 Thrasher and Young, Canada national report. See also Junod, Switzerland national report. 148 Casonato and Tomasi, Italy national report; Vansweevelt, Weyts and Cornelis, Belgium national report (possible by Royal Decree); Mitrou, Greece national report. 149 Sato, Japan national report. See also Rei, Taiwan national report and Křepelka, Czechia national report (public health insurance is compulsory so genetic status plays no role in this context. The Czechia report notes that the situation is different with respect to private insurance). 150 Sato, Japan national report (assumed by the rapporteur for Japan). The Taiwanese rapporteur also notes that employers and insurers there do not collect genetic information: Rei, Taiwan national report. 151 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 7). 152 Trokanas, Cyprus national report (Law 69 (I)/2015 on the Application of Medically Assisted Reproduction, Art 18(1)(d) and 18(7)). 153 Vansweevelt, Weyts and Cornelis, Belgium national report (employment).

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Convention.154 It exposes the offender to fines,155 imprisonment,156 or other sanctions.157 Aside from these prohibitions that are broad and apply to both the employment and insurance sectors, national laws may regulate with specific rules applicable to one or the other sector only. This approach is generally found where, instead of generally forbidding genetic testing, national laws allow it under certain conditions.

2.4.2

Conditional Allowance to Request Information or Testing158

Switzerland offers an interesting model of conditional allowance of requesting genetic information (not testing) in the insurance sector. Rights of insurers vary according to the type of insurance at stake, compulsory or optional.159 All candidates to compulsory insurance (health insurance, invalidity insurance, accident insurance, unemployment insurance, old age insurance) must be accepted; insurers are forbidden from asking questions on medical status, including, presumably, genetic status.160 However, at the conclusion of a contract for optional insurance, the insurer can ask questions regarding the applicant’s state of health, under strict conditions. The questions must be relevant and cannot concern a future risk that has not yet materialized, except if the person has already taken a pre-symptomatic test. This exception is itself subject to numerous conditions; in addition to the relevance of the information, the insurer must also demonstrate the scientific validity of the test.

154

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164 (noted by Trokanas, Cyprus national report). 155 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 7): up to CAD 1 million); Trokanas, Cyprus national report (not exceeding EUR 100,000; in case of a second breach, not exceeding EUR 150,000); Casonato and Tomasi, Italy national report; Pormeister, Estonia national report; Junod, Switzerland national report. 156 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 7): up to 5 years; Trokanas, Cyprus national report: not exceeding 7 years; Junod, Switzerland national report: up to 3 years; must be intentional. 157 Trokanas, Cyprus national report. For instance, damages: Pormeister, Estonia national report. 158 Our questionnaire (question 22) also asked what power insurers and employers have over the samples used to conduct genetic testing. Some rapporteurs explained that genetic testing would be done either within the clinical context of the health care system (e.g. the National Health System in the UK) and/or would be subject to obligations imposed on health care institutions or laboratories where the test would be conducted (e.g. in Taiwan): Porter, United Kingdom national report (it is doubtful that such a retention would be permissible under the Human Tissue Act 2004, the Data Protection Act 1998 or the Human Rights Act 1998); Rei, Taiwan national report. 159 A similar distinction is relevant in France: Byk, France national report. 160 Junod, Switzerland national report.

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Moreover, there are restrictions as to the type of insurance this exception applies to and the sum insured.161 Another national practice is to allow insurers to use genetic information only for certain types of insurance (e.g. life insurance) and above a fixed insured amount.162 For instance, in the United Kingdom, requiring genetic testing is prohibited but insurers can request existing test results under narrowly defined conditions163 referred to as a “ceiling approach.” This approach means that customers are not asked or pressured to take a predictive genetic test to obtain insurance cover, and do not have to disclose predictive test results under a certain ceiling of insurance coverage.164 For policies that exceed this ceiling, insurers may seek information about, and customers must disclose, tests approved by the Government for use with a particular insurance product.165 Insured persons do not have to disclose the results of a genetic test taken after the insurance coverage has started for as long as that coverage is in force.166 Finally, national orders may regulate genetic testing indirectly by discouraging, for instance, insurance companies from resorting to genetic testing.167 For example, Brazil forbids insurance companies from excluding applicants from coverage for more than 1 year, rendering tests largely useless.168 Industry normativity can also establish parameters within which requests for information of testing will have to remain. For instance, the Canadian Life and Health Insurance Association (CLHIA) adopted in 2014 an Industry Code on Genetic Testing Information for Insurance through which their members commit to (1) not require applicants to undertake genetic testing, (2) seek genetic test results conducted in the context of research only when test results have been made available

161

Junod, Switzerland national report (the rapporteur explains how one determines the relevance of the medical information sought and observes that for life insurance, for instance, almost any healthrelated information is likely to be relevant). 162 Thrasher and Young, Canada national report: The practice in the Canadian insurance sector shows that insurers tend to use genetic information only for life insurance policies with a value of at least CAD 250,000. These industry standards are not enforceable, however. 163 Porter, United Kingdom national report. 164 Policies up to GBP 500,000 of life insurance, or GBP 300,000 for critical illness insurance, or paying annual benefits of GBP 30,000 for income protection insurance: Porter, United Kingdom national report. 165 To date, the only test approved under the agreement is for Huntington’s Disease: Porter, United Kingdom national report. 166 Porter, United Kingdom national report. 167 Junod, Switzerland national report. Soft law instruments also address the rights and obligations of insurers. E.g. Cyprus National Bioethics Committee’s Opinion of 22 January 2008 (the insurer is not entitled to request tests in order to calculate a risk of future disorders or diseases unknown by the insured at the time of the conclusion of the contract): Trokanas, Cyprus national report. 168 Viola, Brazil national report; Trokanas, Cyprus national report.

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to the applicant or his physician, and (3) not require genetic test results for life insurance policies for coverage equal to or below $250,000, as of January 2018.169 Similarly, in France, the Fédération française des Sociétés d’assurances announced in 1994 that its members would not use genetic information to assess the insurability of its applicants.170 Finally, in a joint initiative between government and industry, the United Kingdom government and the Association of British Insurers (ABI) have agreed to abide by a policy framework (“Concordat”) and voluntary Moratorium on insurers’ use of predictive genetic tests until 1 November 2019.171 In the employment sector, different models172 also exist that allow for exceptions to a general prohibition, such as for safety concerns. In the United Kingdom, the Information Commissioner’s Office (ICO) Employment Practices Code permits genetic tests to be required, but only once a job offer is made. This enables a potential employer to obtain information where a worker with a particular, detectable genetic condition is likely to pose a safety risk to others or where it is known that a specific working environment or practice might pose risks to workers with particular genetic variations.173 The Swiss employer also benefits from narrow latitude: if the position requires it and symptoms justify it, a genetic analysis can be undertaken by the work physician with the candidate’s consent, but the employer would only be informed of the evaluation of fitness to work, not of the test results. As for “presymptomatic” testing, it is permissible only under very strict conditions that turn on the need to diagnose a condition that could threaten the safety of the worker, or third parties or the environment, which remains rare.174

169

Joly, Quebec national report (Industry Code on Genetic Testing of the Canadian Life and Health Insurance Association, s 4.1-4.3). 170 Byk, France national report: for a 5-year period—corresponding to the period of time after which the Loi sur la bioéthique (Loi n  94-653 du 29 juillet 1994) had to be reviewed—later renewed for another 5 years. 171 Porter, United Kingdom national report. 172 This area is also influenced by soft law instruments in several jurisdictions (e.g. Trokanas, Cyprus national report; Mitrou, Greece national report; Junod, Switzerland national report; Byk, France national report) as well as at the ICO level: The ICO Employment Practices Code puts forwards some key principles and restricts the freedom of employers to make use of genetic testing. 173 Porter, United Kingdom national report. Statute, case law or the ICO Employment Practices Code do not require disclosure in the employment context: the General Data Protection Regulation will apply in the United Kingdom until 31 december 2020 and governs the processing of genetic information by organizations operating within the European Union. 174 Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Arts 22–23). It is reportedly rare for employers to ask questions about the genetic status of a candidate, or health-related questions in general. Some jurisdictions also have relevant legal rules regulating the conduct of medical examinations in the context of employment: Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 28 January 2003 concerning medical examinations that are carried out within the framework of industrial relations, Belgian State Gazette, 9 April 2003); Křepelka, Czechia national report (unclear whether genetic testing falls within their ambit).

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27

Extraterritorial Jurisdiction

We have asked the national rapporteurs whether their jurisdictions exercise any extraterritorial jurisdiction over human genetic data collection. Some rapporteurs noted that where national laws criminalize the practice of insurance companies requiring genetic testing or the disclosure of genetic results, criminal law would apply on the basis of the location where the crime occurs rather than the place of incorporation.175 Some national laws also address the transfer of confidential genetic information across borders.176 In Taiwan, multinational companies must abide by Taiwanese law when collecting genetic data in Taiwan and individuals must be informed of any export of their human tissue,177 which is only permitted with government approval.178 Finally, an agreement between Canadian and United States insurers allows the confidential sharing of information provided by insurance applicants between insurers of these two countries.179 Italy, Estonia, the United Kingdom and Switzerland do not report any exercise of extraterritorial jurisdiction over human genetic data collection.180 Although the United Kingdom does not exercise extraterritorial jurisdiction over human genetic data collection, its “Biobank Access Procedures” provide that “Information will not be transferred to people or organisations situated abroad without adequate protection.”181 Finally, the EU Data Protection Directive 95/46/EC restricts the transfer of “personal data” outside of the European Economic Area to countries or territories that ensure an adequate level of protection for the rights and freedoms of data subjects in relation to the processing of the data.182

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Thrasher and Young, Canada national report (The same applies in the context of employment contracts); Vansweevelt, Weyts and Cornelis, Belgium national report. 176 E.g. the Japanese Data Protection Act: Sato, Japan national report (the Act does not apply, however, to transfers within a company). Moreover, Japanese ethical guidelines require that a research institution guarantees that human dignity and human rights in the context of research are respected in the foreign country: Sato, Japan national report. 177 Human Subjects Research Act (Rei, Taiwan national report). 178 Human Biobank Management Act (Rei, Taiwan national report). 179 Joly, Quebec national report (in addition, some large-scale biobanks and databases—for example that of the International Cancer Genome Consortium in Toronto—host genetic data, which include data collected outside of Canada. Similarly, some genetic data of Canadians is held in research centres abroad, on the Internet and in the cloud compute. Biobanks and research centres have to comply with legal and ethical requirements that are applicable, and which may include Canadian requirements). 180 Casonato and Tomasi, Italy national report; Pormeister, Estonia national report; Porter, United Kingdom national report: Junod, Switzerland national report. 181 Porter, United Kingdom national report and UK Biobank, “UK Biobank Access Procedures” (2011), available at: http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Access-Procedures2011.pdf. 182 Noted by Porter, United Kingdom national report (incorporated in the UK by the Data Protection Act 1998).

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Rights and Obligations of the Insurance or Job Applicant, the Insured or Employee, and Close Family Members183

The rights and obligations of the person whose genetic information is sought are also relevant, and necessarily take on a different shape depending on whether genetic testing or required disclosure of results of genetic tests is prohibited or allowed. In jurisdictions that prohibit mandatory genetic testing and the disclosure of genetic information, domestic law sometimes explicitly provides that employees must not face disciplinary measures or reprisals for insisting on their rights.184 Requesting medical screening to diagnose existing pathologies the insured is not aware of may infringe a person’s right not to know in Cyprus.185 In jurisdictions where genetic disclosure or testing can be required, the question is rather what sanctions a person may face in the event of a refusal to comply. Non-compliance may affect contractual relationships, rendering insurance contracts void186 or allowing disciplinary measures or the termination of an employment contract.187 It can also affect the insurance coverage.188 Section 2 provided a portrait of the legal normativity that explicitly and specifically surrounds the use of genetic testing in employment and insurance, uncovering the fact that several jurisdictions have not yet regulated the field. Does this mean that genetic testing by employers and insurers can take place freely in these jurisdictions? Not necessarily as there exist generalist frameworks that create a legal environment in which the use of genetic testing is circumscribed and even, in some cases, forbidden. In this respect, we have invited national rapporteurs to explore the substance and efficacy of their general human rights frameworks, focusing on general protections against discrimination, and the protection of confidentiality and privacy of health-related information.

183

Questions 24–25 of the Questionnaire. Thrasher and Young, Canada national report (Canada Labour Code, which only applies to federally-regulated entities. For other instances, the legal regime is unclear); Joly, Quebec national report (retaliation is also prohibited in the context of insurance); Wałachowska, Poland national report. 185 Trokanas, Cyprus national report (National Bioethics Committee’s Opinion of 22 January 2008). 186 E.g. under the doctrine of uberrima fides in the UK (requiring parties to the contract to act in the “utmost good faith”): Porter, United Kingdom national report. See also Junod, Switzerland national report (Swiss Federal Law on Insurance Contracts, 2 April 1908, RS 221.229.1, Art 6). 187 Junod, Switzerland national report; Porter, United Kingdom national report (on grounds of breach of the duty of mutual trust and confidence or even misrepresentation, subject to antidiscrimination rules). 188 Junod, Switzerland national report. This can also be the case in jurisdictions where the law is silent but where insurance applicants must disclose their family history and any pre-existing diseases: Rei, Taiwan national report (note that by contrast, in the employment context, there exists no duty to inform of pre-existing symptoms and employers cannot terminate contracts simply because an employee failed to disclose his or her genetic status). 184

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3 Generalist Frameworks Relevant to the Regulation of Genetic Testing189 This section focuses on how general protections against discrimination, as well as protections of the rights to privacy and confidentiality, inform permissible and prohibited uses of genetic information by employers and insurers.

3.1

General Non-discrimination Protection

International and regional instruments prohibiting discrimination may be relevant to preventing the discriminatory use of genetic information or testing by employers and insurers, even where they do not mention genetic status in the list of grounds for prohibited discrimination. At the international level,190 the United Nations Convention on the Rights of Persons with Disabilities generally provides for the principles of equality and non-discrimination and applies them explicitly to the work and employment contexts.191 The UNESCO Universal Declaration on Bioethics and Human Rights of 19 October 2005 (2005 UNESCO Bioethics Declaration) also prohibits discrimination and stigmatization on “any grounds, in violation of human dignity, human rights and fundamental freedoms.”192 In employment matters, the International Labour Organization’s widely ratified Equality of Treatment and Opportunity Convention, 1958 (No. 111)193 prohibits: (a) any distinction, exclusion or preference made on the basis of race, colour, sex, religion, political opinion, national extraction or social origin, which has the effect of nullifying or impairing equality of opportunity or treatment in employment or occupation; (b) such other distinction, exclusion or preference which has the effect of nullifying or impairing equality of opportunity or treatment in employment or occupation as may be determined by the Member concerned after consultation with representative employers’ and workers’ organisations, where such exist, and with other appropriate bodies. 189

Questions 8–18 of the Questionnaire. Most surveyed jurisdictions are original signatories to this Convention; Switzerland acceded to the Convention in 2014. 191 UN Convention on the Rights of Persons with Disabilities of 13 December 2006, Arts 5 and 27 (the United States have not ratified the Convention). 192 UNESCO Universal Declaration on Bioethics and Human Rights of 19 October 2005, Art 11. In addition to the UNESCO Universal Declaration, other conventions apply as general non-discrimination protections: International Covenant on Civil and Political Rights of 16 December 1966; International Covenant on Economic, Social and Cultural Rights of 16 December 1966; Convention on the Elimination of All Forms of Discrimination against Women, 18 December 1979; International Convention on the Elimination of All Forms of Racial Discrimination, adopted on 21 December 1965. 193 Convention concerning Discrimination in Respect of Employment and Occupation, No. 111, adopted 25 June 1958. 190

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Similarly, regional instruments afford general protection against discrimination. They include the American Convention on Human Rights—signed and ratified by Brazil194—which protects against discrimination for reasons of “race, color, sex, language, religion, political or other opinion, national or social origin, economic status, birth, or any other social condition.”195 The Council of Europe’s European Convention on Human Rights (ECHR), which applies to all of the EU member states surveyed, similarly protects against discrimination “on any ground such as sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status.”196 The rapporteur on Estonia notes that the ECHR considers that “differential treatment based on a genetic disease” could fall within this provision.197 In the European Union, discrimination is prohibited by Council Directive 2000/43/EC of 29 June 2000, implementing the principle of equal treatment between persons irrespective of racial or ethnic origin and, in the specific context of employment and by Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation. Binding regional instruments, to which some national laws specifically refer,198 may be directly applicable in certain national orders, as specifically referenced by certain rapporteurs.199

194

Viola, Brazil national report. The Convention has not been signed by Canada and the United States. 195 American Convention on Human Rights of 22 November 1969, Art 1.1. 196 European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted 4 November 1950, entered into force 3 September 1953, CETS no 005, Art 14 (noted in Trokanas, Cyprus national report and Porter, United Kingdom national report). See also article 8 (respect for private and family life) of the 12th Additional Protocol to the Convention (signed in 2000, not yet into force), and Art 10 of the Treaty on the Functioning of the European Union (OJ C 326/47, 26 October 2012) applying to policies and activities of the EU. Note that Art 21 of the Charter of Fundamental Rights of the European Union (OJ C 326/391, 26 October 2012) mentions “genetic features” (see above Sect. 2). 197 Pormeister, Estonia national report (GN and others v Italy, no. 43134/05). 198 E.g. Casonato and Tomasi, Italy national report (the Italian Authorization 8/2016 refers in its preamble to Art 11 of the Oviedo Convention (The ratification process of the Oviedo Convention has not been completed in Italy, but a decision by the Corte di Cassazione allows judges to use the Oviedo Convention as an interpretative tool when specific legislation is missing or it is unclear); Rei, Taiwan national report (recognizes the UN Convention on the Rights of Persons with Disabilities of 13 December 2006); Porter, United Kingdom national report (European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted 4 November 1950, entered into force 3 September 1953, CETS no 005: incorporated in UK law in the Human Rights Act 1998); Junod, Switzerland national report (Constitution, Art 8 (linked to Art 14 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted 4 November 1950, entered into force 3 September 1953, CETS no 005; Arts 2, 3 and 26 of the International Covenant on Civil and Political Rights of 16 December 1966; Art 11 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 6 of the UNESCO International Declaration on Human Genetic Data, 16 October 2003). 199 Viola, Brazil national report; Trokanas, Cyprus national report; Křepelka, Czechia national report; Casonato and Tomasi, Italy national report; Rei, Taiwan national report; Wałachowska,

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At the national level, most of the jurisdictions under consideration prohibit discriminatory treatment on the basis of origin, race, sex, colour, or age without explicitly mentioning genetic status. Several jurisdictions enshrine general antidiscrimination protection in their constitutional frameworks.200 In addition, most provide generalist human rights legislation,201 which tends to apply to the private sector as well as the public sector. Some rapporteurs mention that constitutional or human rights anti-discrimination rules that do not mention genetic characteristics can sometimes be interpreted as encompassing them.202 Notably, the reports identify

Poland national report; Mitrou, Greece national report; Pormeister, Estonia national report; Porter, United Kingdom national report; Vansweevelt, Weyts and Cornelis, Belgium national report; Byk, France national report. 200 Viola, Brazil national report (Article 3, IV of the Constitution provides that one of the fundamental objectives of the Republic is “to promote the well-being of all, without prejudice as to origin, race, sex, colour, age and any other forms of discrimination”; Article 7 prohibits “any discrimination with respect to wages and hiring criteria of handicapped workers”); Thrasher and Young, Canada national report (Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982 being Schedule B to the Canada Act 1982 (UK), 1982, c 11: mental and physical disability. Also protects against unreasonable search and seizure and interference with life, liberty and security); Trokanas, Cyprus national report (community, race, religion, language, sex, political or other convictions, national or social dissent, birth, colour, wealth, social class or any ground whatsoever); Křepelka, Czechia national report (Constitution of the Czech Republic: equality); Casonato and Tomasi, Italy national report (Italian Constitution: equality and race); Sato, Japan national report (Article 14 of the Japanese Constitution: equal protection. It is not clear whether the equal protection clause covers discrimination on the ground of a genetic condition); Rei, Taiwan national report (Article 7 of the Constitution (equal right for all citizen)); Wałachowska, Poland national report (Article 32 of the Polish Constitution of 1997); Pormeister, Estonia national report (s 12 of the Constitution, only applies to relationships with the state; Estonian Equal Treatment Act, RT I, 26 April 2017, 9, applying to private parties); Junod, Switzerland national report (Constitution, Art 8). 201 Casonato and Tomasi, Italy national report (Authorization 8/2016: does not explicitly mention genetic status as an included ground of discrimination but preamble refers to international sources doing so); Sato, Japan national report (Act on Prohibition of Discrimination by Disability); Rei, Taiwan national report (Article 16 of the People with Disabilities Right Protection Act (disabilities)); Wałachowska, Poland national report (Art 11(3) of the Labour Code of 1974); Pormeister, Estonia national report (Estonian Equal Treatment Act, RT I, 26 April 2017, 9, ss 1, 2 and 5); Porter, United Kingdom national report (Equality Act 2010, but the UK rapporteur notes that the approach in the United Kingdom is to deliberately avoid using human rights framework, rather relying on specialized soft law instruments). See also: the Czech Law on Insurance (industry timidly supports anti-discrimination measures, while explicitly allowing differentiation of premiums or exclusion on gender, age and health status if justified by methods of insurance mathematics. The individual genome as a specific criterion for differentiation is not explicitly mentioned): Křepelka, Czechia national report. 202 E.g., Casonato and Tomasi, Italy national report (the Italian Constitution does not explicitly include genetic status as a ground for discrimination, but Art 2 (inviolable rights) and Art 3 (discrimination, including racial) can be interpreted as including genetic status as a ground of discrimination. No case law exists on that question. Moreover, even though Italian Authorization 8/2016 (human rights legislation) does not explicitly list genetic status as a ground of discrimination, its preamble refers to international sources doing so). See also Pormeister, Estonia national report (para 12 of the Constitution. Genetic discrimination is without a doubt understood to be

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intersections between discrimination on the ground of genetic status and other forms of discrimination,203 such as those based on actual or perceived disability,204 or race205 and with the principles of non-discrimination and non-stigmatization of the UNESCO International Declaration on Human Genetic Data.206 One rapporteur also argues that a case could be made for the inclusion of “genetic discrimination” in relation to insurance and employment within the prohibition of discrimination on the grounds of “birth or other status” provided in the ECHR.207 However, others report no intersection of discrimination on the ground of genetic status with other forms of discrimination.208 How do anti-discrimination norms fare —whether they mention genetic status or not—in the employment and insurance contexts? The answers may be deceptively simple. The rapporteur from Taiwan even suggests that genetic discrimination in the contexts of employment and insurance is not a challenge given the comprehensiveness of the national health insurance scheme.209 Other rapporteurs argue that the same analytical framework that applies to discrimination generally should apply to

covered by the Constitution’s general prohibition against discrimination and genetic discrimination intersects with forms of discrimination based on traits or factors that can be revealed by genetic data (race, ethnic origin, and disability in some cases) which is forbidden by the Estonian Equal Treatment Act (RT I, 26 April 2017, 9)). 203 Trokanas, Cyprus national report; Křepelka, Czechia national report; Pormeister, Estonia national report. 204 Pormeister, Estonia national report (Estonian Equal Treatment Act, RT I, 26 April 2017, 9, ss 1, 2 and 5); Thrasher and Young, Canada national report (Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982 being Schedule B to the Canada Act 1982 (UK), 1982, c 11, s 15, presented as a potential argument); Joly, Quebec national report and Thrasher and Young, Canada national report (in Québec (CDPPDJ) v Montreal (City of), [2000] 1 SCR 665, par. 76, L’Heureux-Dubé J. of the Supreme Court of Canada notes that the concept of handicap under the Quebec Charter of Human Rights and Freedoms must be interpreted in light of advances in biomedical technology, including genetics). Note that in some jurisdictions, disability inclusion may be unlikely if the person is asymptomatic. See Porter, United Kingdom national report and Pormeister, Estonia national report. 205 Porter, United Kingdom national report; Junod, Switzerland national report; Sato, Japan national report (in Japan, as a consequence of the relatively homogeneous population, discrimination on the basis of race or national origin is not common. Discrimination on the basis of genetic status might be relevant with respect to some tribes/large families that suffer from physical disabilities such as congenital deaf). 206 UNESCO International Declaration on Human Genetic Data, 16 October 2003, Art 7(a), noted by Trokanas, Cyprus national report. 207 Porter, United Kingdom national report. 208 Viola, Brazil national report; Thrasher and Young, Canada national report (no case or secondary sources discussing the issue); Casonato and Tomasi, Italy national report; Sato, Japan national report; Rei, Taiwan national report; Mitrou, Greece national report; Vansweevelt, Weyts and Cornelis, Belgium national report. 209 Rei, Taiwan national report (moreover, specific laws prohibit discrimination in the employment context).

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genetic discrimination in the contexts of employment and insurance210 (Canada,211 Italy,212 Poland,213 Belgium214). Certainly anti-discrimination legislation215 typically applies in the employment and insurance contexts, such as the Belgian AntiDiscrimination Act216 and the Estonian Human Genes Research Act.217 Jurisdictions that adopt soft law approaches also tend explicitly to encompass the employment218 and the insurance219 contexts. Yet some national reports take pains to illustrate the potential complexity of applying non-discrimination principles particularly in the insurance context, where the individual assessment of risk based on statistical probabilities may come into conflict with human rights frameworks that seek precisely to avoid stereotyping individuals on the basis of assumed group characteristics.220 Finally, rapporteurs note other rights that may appear in human rights legislation and that are relevant to the protection of citizens’ genetic information, such as the right to equality,221 to privacy,222 to respect for private and family life,223 to

210

Junod, Switzerland national report (except for discrimination based on gender). Thrasher and Young, Canada national report (in Canada, the only difference consists of the scope of application of the different laws—federal or provincial level); Joly, Quebec national report. 212 Casonato and Tomasi, Italy national report (General Authorization 8/2016). 213 Wałachowska, Poland national report. 214 Vansweevelt, Weyts and Cornelis, Belgium national report (the Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette 30 May 2007 applies both to insurers and employers). 215 Pormeister, Estonia national report. 216 Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette 30 May 2007, Art 5, para 1 and Art 4, 1 ). 217 Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, ss 25 and 27. This Act partially applies only to the Estonian Gene Bank (EGB) but parts of it have a more general application). 218 Mitrou, Greece national report (Greek National Bioethics Commission, Recommendation on the collection and use of genetic data); Porter, United Kingdom national report (ICO, “The Employment Practices Code” (2011)). 219 Mitrou, Greece national report (Greek National Bioethics Commission, Recommendation on the collection and use of genetic data (2002) and Greek National Bioethics Commission, Opinion on the use of genetic data on private insurance (2008)); Porter, United Kingdom national report (UK Government and the Association of British Insurers, “Concordat and Moratorium on Genetics and Insurance” (2014)). 220 See e.g. Joly, Quebec national report, discussing Zurich Insurance Co. v Ontario (Human Rights Commission) [1992] 2 SCR 321. 221 Joly, Quebec national report; Sato, Japan national report (Japanese Constitution, s 14. Not clear it includes discrimination based on a genetic condition); Křepelka, Czechia national report. 222 Joly, Quebec national report; Trokanas, Cyprus national report. 223 European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted 4 November 1950, entered into force 3 September 1953, CETS no 005, Art 8, noted by Porter, United Kingdom national report; Vansweevelt, Weyts and Cornelis, Belgium national report. 211

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autonomy and self-determination224 and to social solidarity.225 The protection against unreasonable search and seizure is also invoked.226

3.2

Privacy, Confidentiality and Disclosure227

Protections afforded to the rights to privacy and confidentiality, as well as rules to follow when disclosing personal information, are also all relevant, even if indirectly, to our topic. We review here briefly the positions of our surveyed jurisdictions.

3.2.1

Confidentiality of Clinical and Research Data

Genetic testing regularly occurs, some would argue without controversy,228 in the clinical medical context (e.g. prenatal genetic testing, use of genetic testing for diagnostic purposes) and in biomedical research settings. These are not the focus of our reports. However, a brief look at safeguards existing in the clinical and research spheres is important because of the risk that information revealed in these contexts—communicated to patients and appearing in their medical records or, in an anonymized manner, in the researcher’s files—will be requested by the insurer or employer.229 Particular safeguards exist in most countries to protect the confidentiality of this information. In the background of debates with respect to genetic testing and the use of resulting information are, as the United Kingdom rapporteur aptly observes, concerns about patients’ autonomy and self-determination.230 Relevant codes of ethics,231 other soft

224

Joly, Quebec national report; Vansweevelt, Weyts and Cornelis, Belgium national report; Mitrou, Greece national report (personal freedom and integrity). 225 Joly, Quebec national report. 226 Thrasher and Young, Canada national report (Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982 being Schedule B to the Canada Act 1982 (UK), 1982, c 11, s 8). 227 Questions 7 and 13–17 of the questionnaire. 228 See Byk, France national report. 229 Although we will not explore these, it is noteworthy that several rapporteurs cite medical laws relevant to our topic: Křepelka, Czechia national report; Casonato and Tomasi, Italy national report; Byk, France national report. On patients’ rights: Trokanas, Cyprus national report. 230 Porter, United Kingdom national report; Vansweevelt, Weyts and Cornelis, Belgium national report. 231 Viola, Brazil national report (Code of Ethics of the medical profession, Arts 73–79); Casonato and Tomasi, Italy national report (Code of medical ethics (2014), Art 46); Mitrou, Greece national report (Hippocratic Oath; 2005 Code of Medical Ethics, Art 13 (also Arts 8 and 20); Penal Code, Art 371).

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law instruments,232 formal legislation233 or private law norms234 hold physicians to an obligation of confidentiality.235 The physicians’ Code of Ethics of Brazil is particularly on point in this respect as it specifically forbids physicians to disclose a worker’s medical examination results to employers.236 Moreover, Brazilian physicians can only share information with an insurance company in the case of their patient’s death and only if the information is included in the death certificate.237 The physician’s obligation of confidentiality is also enforced through criminal laws (e.g. in Greece,238 Japan239 and Switzerland240) or other laws governing the medical sector.241 In several of the jurisdictions surveyed, physicians may be allowed to share results of genetic tests with employers and insurance companies if the patient provides written consent242 or has otherwise given explicit and informed consent.243

232

See Porter, United Kingdom national report. E.g. the Code of Ethics of Physicians of the Canadian province of Quebec is a formal legal text: Code of Ethics of Physicians, c M-9, r17, s 20; Rei, Taiwan national report (Physician Act, s 23 and Medical Care Act, s 74. Consent is an exception); Sato, Japan national report (Criminal Code); Wałachowska, Poland national report; Křepelka, Czechia national report; Pormeister, Estonia national report (unless the patient consents, an exception that applies in most jurisdictions). 234 Porter, United Kingdom national report. Also in Canada (Thrasher and Young, Canada national report). 235 See also Vansweevelt, Weyts and Cornelis, Belgium national report (not even released by consent because of its public order character). 236 Viola, Brazil national report (Code of Ethics of the medical profession, Art 76). 237 Viola, Brazil national report (Code of Ethics of the medical profession, Art 77). Patient’s written consent constitutes an exception, however. 238 Mitrou, Greece national report (Penal Code, Art 371; exceptions are provided in the Code of Penal Procedure). 239 Sato, Japan national report (Criminal Code, Art 134 governs doctors and medical staff’s duty of confidentiality and imposes up to 6 months of imprisonment and a fine of up to 100,000 yen in case of a breach). 240 Junod, Switzerland national report (Penal Code, Art 321). 241 See legislation cited in: Rei, Taiwan national report; Wałachowska, Poland national report; Porter, United Kingdom national report. See also more generally: Pormeister, Estonia national report (Law of Obligations, s 768(1) and Personal Data Protection Act, RT I, 6 January 2016, 10, para 14(2); genetic data, as sensitive information can only be disclosed in very limited circumstances), Human Genes Research Act, RT I, 14 March 2014, 30, ss 26–27: employers and insurers cannot collect data); Junod, Switzerland national report (cantonal laws might apply; Penal Code, Art 321 and Loi fédérale sur la protection des données, 19 june 1992, Art 35); Vansweevelt, Weyts and Cornelis, Belgium national report. 242 Viola, Brazil national report; Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 5); Joly, Quebec national report (Law on Specific Medical Services); Křepelka, Czechia national report (informed consent must be given in writing for genetic testing and the communication of results to third parties); Rei, Taiwan national report. The fact that the patient consents to the disclosure of his or her genetic information to the employer or insurer does not mean the employer and insurer are permitted to use it, see e.g. Junod, Switzerland national report and discussed above in Sect. 2. 243 Trokanas, Cyprus national report (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of 233

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Limited exceptions exist, however.244 Belgium,245 Estonia246 and Italy247 go further by forbidding consensual and non-consensual communication of genetic information to the employer and the insurer; France does the same for the insurance sector.248 Similar safeguards exist for biomedical research. At the regional level, the Oviedo Convention includes provisions seeking to protect research participants’ privacy.249 Several jurisdictions surveyed also regulate the use of genetic test results, or more broadly any information, obtained in the context of biomedical research.250 For

personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 9(1)–(2)); Wałachowska, Poland national report (Statute on Doctor’s Activities (1996), Art 40; Statute on Patient’s Rights of 2008, Arts 13–14); Mitrou, Greece national report (Penal Code, Art 212(2) and Data Protection Act (Act 2472/97), Art 7); Porter, United Kingdom national report (Access to Medical Reports Act 1988, s 3); Junod, Switzerland national report; Sato, Japan national report (refers to consent generally); Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 5. Personal Health Information Protection Act, 2004, SO 2004, c 3, s 44. Personal Information Protection and Electronic Documents Act, SC 2000, c 5, ss 4.3.4. and 4.3.6, clause 4.3 of schedule 1); Joly, Quebec national report; Trokanas, Cyprus national report (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/ EC, OJ L 119/1, 4 May 2016, Rec 32); Pormeister, Estonia national report. In Italy, this appears prohibited as concerns disclosure to employers or insurers: Casonato and Tomasi, Italy national report (2014 Code of medical ethics, s 46). 244 Thrasher and Young, Canada national report (Personal Health Information Protection Act, 2004, SO 2004, c 3, ss 29 and 44; Personal Information Protection and Electronic Documents Act, SC 2000, c 5, s 7(3); Health Protection and Promotion Act, RSO 1990, c H.7. [Ontario]); Joly, Quebec national report (ss 6 and 8 Genetic Non-Discrimination Act, Canada, SC 2017, c 3 (exception for health practitioners and researchers)); Trokanas, Cyprus national report (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 9(2)); Pormeister, Estonia national report (para 14 (2) of the Personal Data Protection Act, RT I, 6 January 2016, 10). 245 Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9). 246 Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, ss 26–27). 247 Casonato and Tomasi, Italy national report (in Italy, genetic data is considered more-thansensitive data and is therefore entitled to the highest degree of protection. See General Authorization 8/2016, Recital). Although the General Authorization 8/2016 only explicitly addresses the case of employers, art 46 of the Code of medical ethics (2014) seems to extend this regime to the insurance context. 248 Byk, France national report (Code de la santé publique, Art L-1141-1). 249 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Arts 10 and 16 and Chapter V in general (general protections that do not concern genetic research data in particular however (Pormeister, Estonia national report)). 250 Křepelka, Czechia national report (regulating who is allowed to provide genetic testing and how); Rei, Taiwan national report (Personal Data Protection Act, Art 6: prohibits the collection,

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instance, in Italy, employers and insurers are explicitly forbidden from accessing genetic information obtained in the context of biomedical research.251 In Poland, genetic data obtained in the context of medical research can be disclosed for scientific purposes (so presumably not to the insurer or employer) but the anonymity of the person tested must be ensured.252 Confidentiality of research-related genetic data may in some countries be protected through internal university ethics codes or guidelines (e.g. in Brazil)253 or funding agencies’ policies (e.g. in Canada, the Tri-Council Policy Statement254). Finally, in Canada, the Canadian Life and Health Insurance Association (CLHIA)255 has committed not to seek the results of genetic tests conducted in the context of research if the results have not been communicated to the applicant or her/his physician.256 Genetic data257 or, more generally, medical information, are often treated as sensitive information requiring stringent legal protections. As our discussion on

processing and usage of sensitive personal data unless it is stipulated by law, within public duty, part of public record already opened to the public or necessary for the statistics or research of health or criminal prevention); Wałachowska, Poland national report (Civil Code of 1964, Art 23); Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, s 22 (4): applies to the Estonian Gene Bank, and Personal Data Protection Act, RT I, 6 January 2016, 10); Porter, United Kingdom national report (biomedical researchers in the UK are bound by the common law duty of confidentiality and the Data Protection Act 1998. In addition, individual biomedical research projects (e.g. UK Biobank) usually provide information on their policy for data management and the sharing of anonymised data at the time of obtaining informed consent from participants); Junod, Switzerland national report (Penal Code, Art 321bis); Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 8 December 1992 on the protection of privacy with regard to the processing of personal data, Belgian State Gazette, 18 March 1993, Art 2. See also the directives of the National Council of the Order of Physicians. In Japan, ethical guidelines on the transfer of information govern this topic. If the researcher is not a doctor or medical staff, there is no legal duty of confidentiality, but contractual confidentiality clauses provided in the employment contracts may apply: Sato, Japan national report (Data Protection Act, Art 76: does not apply to research institutions and/or researchers). 251 Casonato and Tomasi, Italy national report. 252 Wałachowska, Poland national report (Statute on Doctor’s Activities, 1996, Art 28). 253 Viola, Brazil national report. 254 Thrasher and Young, Canada national report (Canadian Institute of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada, Ethical Conduct for Research Involving Humans (Government of Canada, 2014) [Tri-Council Policy], Art 13, available at: http://www.pre.ethics.gc.ca/pdf/eng/ tcps2-2014/TCPS_2_FINAL_Web.pdf. The Canadian Tri-Council consists of the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada. Its policy regarding the ethical conduct of research specifies that core principles of ethical research involving consent, privacy and confidentiality apply to genetic information and genetic research. Although the Tri-Council cannot enact legally binding instruments, research ethics approval and adherence to the Tri-Council’s policy are conditions for receiving Tri-Council research funding. 255 Industry Code on Genetic Testing of the Canadian Life and Health Insurance Association, s 4.2. 256 Thrasher and Young, Canada national report and Joly, Quebec national report. 257 Casonato and Tomasi, Italy national report.

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consent above reveals, privacy and data protection legislation258 play a central role in securing the confidentiality of personal files containing genetic information.259 For instance, in Canada, different federal and provincial laws govern medical records, as well as employers’ and insurers’ records.260 Subject to some exceptions, genetic test results contained in a patient’s medical or hospital file cannot be disclosed to third parties, including employers and insurers, without the patient’s consent.261 Provincial and federal legislation also addresses the question of privacy in the context of biomedical research, and the Canadian rapporteurs report that this web of legislation makes non-consensual disclosure rarely permissible.262 Notably, 258

Trokanas, Cyprus national report (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 9(3)). Křepelka, Czechia national report (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016; Law on Protection of Personal Data); Pormeister, Estonia national report; Rei, Taiwan national report (Personal Data Protection Act reinforces the Physician Act and the Medical Care Act, tightening the regulation for sensitive personal data which includes genetic data); Mitrou, Greece national report (Data Protection Act (Act 2472/97, Art 10)); Wałachowska, Poland national report; Sato, Japan national report (Data Protection Act); Porter, United Kingdom national report (Data Protection Act 1998: “personal data”; Access to Medical Reports Act 1988, s 3); Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 8 December 1992 on the protection of privacy with regard to the processing of personal data, Belgian State Gazette, 18 March 1993; Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002 for medical records); Junod, Switzerland national report (Loi fédérale sur la protection des données, 19 june 1992); Pormeister, Estonia national report (exceptions apply, such as to protect one’s life, health or freedom); Trokanas, Cyprus national report. The EU General Data Protection Regulation, which entered into force 25 May 2018 (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016), also imposes a confidentiality obligation. In some jurisdictions, while a physician may be asked to deliver a medical certificate or report confirming ability to work, this does not mean that the employer will have access to the medical record or even to the detailed reasons as to why a person may or may not be able to exercise certain types of employments: e.g., Wałachowska, Poland national report and Junod, Switzerland national report. 259 Some rapporteurs also note the confidentiality of information contained in medical or research records, but without referring to data protection laws: Casonato and Tomasi, Italy national report. 260 Thrasher and Young, Canada national report (Privacy: Privacy Act (RSC 1985, c P-21) and statutory privacy torts in British Columbia, Saskatchewan, Manitoba and Newfoundland & Labrador); Joly, Quebec national report (Data protection: Personal Information Protection and Electronic Documents Act (SC 2000, c 5) applies to the private sector and the Personal Health Information Protection Act, 2004, SO 2004, c 3, which provides an example of provincial personal health privacy legislation (esp s 4(1), 29)). 261 Thrasher and Young, Canada national report (Personal Health Information Protection Act, 2004, SO 2004, c 3, s 29). 262 Thrasher and Young, Canada national report: Personal Information Protection and Electronic Documents Act, SC 2000, c 5, s 7(3) and Personal Health Information Protection Act, 2004, SO 2004, c 3, s 44.

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federal law permits non-consensual disclosure for statistical or scholarly study or research, purposes that cannot be achieved without disclosing the information and where it is impracticable to obtain consent.263 Thus, it is only rarely that disclosing the results of genetic tests obtained in biomedical research is permissible without the patient’s consent. Beyond privacy and confidentiality, the disclosure of socio-legal risks is also a concern where genetic testing is undertaken for clinical or biomedical research purposes. While some rapporteurs inform us that the issue is unclear264 or has not been addressed265 in their jurisdiction, others point to national266 and international267 laws and ethical guidelines promoting the disclosure to biomedical research participants of the risks of discrimination in employment or insurance associated with both the fact of having undergone genetic testing and the possible test results. The physician’s268 and researcher’s269 duty to inform is also invoked as the source for this disclosure. Canada even requires researchers to develop plans to manage information in order to address these risks.270

263

Personal Information Protection and Electronic Documents Act, SC 2000, c 5. The organization disclosing must also inform the Commissioner of the disclosure before the information is disclosed: Personal Information Protection and Electronic Documents Act, SC 2000, c 5, Art 7(3)(f). See also Personal Health Information Protection Act, 2004, SO 2004, c 3, s 44; Thrasher and Young, Canada national report. 264 Křepelka, Czechia national report (according to unofficial sources, several geneticists providing genetic counseling recommend that their clients purchase life insurance prior to genetic testing). 265 Viola, Brazil national report; Pormeister, Estonia national report. 266 Thrasher and Young, Canada national report (Tri-Council Policy, at 195–196); Joly, Quebec national report (a study demonstrates that this is also often done in clinical and research consent forms in Canada); Rei, Taiwan national report; Junod, Switzerland national report (for pre-symptomatic genetic tests); Sato, Japan national report (“7 Informed Consent” (3)) and explanatory note: In Japan, government-issued Ethical Guidelines require a head researcher to inform the donor of “any disadvantage that the donor might incur”, including social stigma). In the clinical setting, guidelines issued by the Japanese Association of Medical Sciences warn that genetic information may cause a social disadvantage to the examinees and their relatives should such information be inappropriately handled or disclosed (2011 “Guidelines for Genetic Tests and Diagnoses in Medical Practice”, available at http://jams.med.or.jp/guideline/genetics-diagnosis_e. pdf. The guidelines do not provide more information regarding such risks). Some note that given the prohibition existing in their jurisdiction, the need for such disclosure may be mute: Casonato and Tomasi, Italy national report (although the socio-legal risks have to be communicated in the context of research carried out on “isolated populations”, as per point 5 of the General Authorization 8/2016); Joly, Quebec national report; Pormeister, Estonia national report. 267 World Medical Association, Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects (2013), s 26: Joly, Quebec national report. 268 E.g., Vansweevelt, Weyts and Cornelis, Belgium national report; Wałachowska, Poland national report; Joly, Quebec national report. Porter, United Kingdom national report (but a court would need to be persuaded to extend the scope of the duty to warn—usually concerned with risks of physical injuries resulting from treatment—to include socio-legal and economic risks of genetic testing). 269 Joly, Quebec national report; Rei, Taiwan national report (Human Subject Research Act 2011, s 14). 270 Thrasher and Young, Canada national report (Tri-Council Policy, at 194 and Art 13.2).

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In addition, private companies offering Direct-to-Consumer (DTC) services in the United Kingdom do sometimes include details about possible consequences for insurance and employment in their information and/or informed consent forms.271 Interestingly, the UK Biobank information leaflet uses potential socio-legal risks as a justification for not disclosing individualized genetic research results to participants, explaining that: “(t)his is because such feedback outside of the normal clinical setting is of questionable value, and might even be harmful (for example, causing undue alarm and having potentially adverse effects on insurance status), especially when given without prior counselling or support.”272 Finally, the Swiss case law has developed a general rule forcing physicians to inform their patients of a manifest risk of prejudice in insurance or employment. Whether a physician assesses a risk as manifest or not may depend on whether that physician exercises in a field where this risk arises frequently.273 It is unclear whether this could include socio-legal risks linked to genetic testing. Beyond the confidentiality of medical and research information, an additional consideration concerns the confidentiality of the genetic data collected by the employer or insurer, when they are permitted to do so.274

271

Porter, United Kingdom national report (for instance, the company 23andMe includes such information within its “Consent and Legal Agreement”: 23andMe, “Consent and Legal Agreement” (2017), available at: https://www.23andme.com/en-gb/about/consent/?version¼1.3). See also in the UK (Porter, United Kingdom national report): Joint Committee on Medical Genetics, “Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information” which addresses ways in which healthcare professional should respond to patient concerns about the possible implication with respect to insurance of genetic testing for Huntington’s disease and other conditions. There is no similar overarching professional guidance document for the biomedical research setting. 272 Porter, United Kingdom national report, UK Biobank, “Information Leaflet” (2010), available at: https://www.ukbiobank.ac.uk/wp-content/uploads/2011/06/Participant_information_leaflet.pdf? phpMyAdmin¼trmKQlYdjjnQIgJ%2CfAzikMhEnx6. 273 Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Arts 5 and 14). For instance, the Swiss rapporteur notes that the risk of increased difficulties in getting life insurance of more than CHF 400,000 may not be “manifest” to all physicians. 274 Of course, where genetic testing is forbidden in an employment or insurance context—such as in Italy—insurers and employers are prohibited from detaining genetic information: Casonato and Tomasi, Italy national report. The only exception to this general rule provided in articles 3.1 and 3.2 (b) of the General Authorization 8/2016 arises where it is indispensable in order to protect the life or the physical integrity of the job applicant or of a third person.

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Confidentiality of Insurer or Employer’s Data

Data protection laws,275 privacy laws and privacy torts276 are all relevant to address this issue. They may require the holder of the information to keep it confidential.277 For instance, the European Union is regulating the use of genetic information mostly through its data protection laws278 which require that genetic data be “processed by or under the responsibility of a professional subject to the obligation of professional secrecy.”279 Canada is also a good example of a non-EU country that mostly regulates the use of genetic information through its data protection regime.280 Finally, the legislation of 41 US states protects specifically the privacy of genetic information through varying models such as including provisions in broader non-discrimination laws or in stand-alone statutes.281

3.2.3

Right to Access Information and the Right Not to Know

We invited national rapporteurs also to address whether, where genetic testing is allowed in the employment or insurance context, the person tested may require access

275

E.g. Canadian Personal Information Protection and Electronic Documents Act, SC 2000, c 5 and Japanese Data Protection Act (Sato, Japan national report). 276 Thrasher and Young, Canada national report; Joly, Quebec national report; Porter, United Kingdom national report (insurers or employers in the UK are bound by the common law duty of confidentiality and the Data Protection Act 1998. In addition, insurers are required to protect personal medical information in accordance with the ABI Confidentiality Policy (para 21(h)). The ICO Employment Practices Code also emphasizes that information about a workers’ health must be kept securely and handled in accordance with the Data Protection Act (Porter, United Kingdom national report)); Junod, Switzerland national report. 277 It goes beyond the scope of this general report to explore in detail the complex web of data protection legislation and privacy rules applying in our 15 national jurisdictions. This topic was addressed by the rapporteurs: Thrasher and Young, Canada national report; Joly, Quebec national report; Trokanas, Cyprus national report; Křepelka, Czechia national report; Casonato and Tomasi, Italy national report; Rei, Taiwan national report; Wałachowska, Poland national report; Mitrou, Greece national report; Pormeister, Estonia national report; Porter, United Kingdom national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgium national report. 278 Such as through the regime of its General Data Protection Regulation which replaced on 28 May 2018 the Data Protection Directive 95/46/EC: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Article 9(2) to (4), esp 9(2)(h) and (3), therefore applying in the EU member states that have already implemented the Data Protection Directive in their domestic legislation. 279 Referred to by Trokanas, Cyprus national report. 280 Moreover, CLHIA members have committed to maintain strict confidentiality in handling and storing genetic test results they may detain: Joly, Quebec national report. 281 Feldman and Quick, United States national report (See the Genome Statute and Legislation Database Search: Privacy (2018)).

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to the test results or, conversely, can ask not to be told by invoking a “right not to know.” The Oviedo Convention recognizes that “(e)veryone is entitled to know any information collected about his or her health” but notes that a wish not to be so informed shall be observed.282 Several jurisdictions also provide for the right of the patient to gain access to information about his or her health in national laws and regulatory texts (e.g. dealing with data protection, patients’ rights, physicians’ practice, hospitals, medical ethics, privacy, freedom of information, and consumer law)283 or in soft law instruments,284 although some report it may be difficult to exercise in practice.285 Can a person invoke his or her right not to know to prevent the employer and insurer from disclosing genetic information in their possession? This also calls into question whether national orders surveyed pay attention more generally to the right not to know one’s genetic information, particularly where the information in question is non-actionable. While Brazil has not addressed the issue,286 Canada (includ-

282

Noted by Trokanas, Cyprus national report. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 15; Trokanas, Cyprus national report; Casonato and Tomasi, Italy national report; Rei, Taiwan national report; Wałachowska, Poland national report; Mitrou, Greece national report; Pormeister, Estonia national report; Joly, Quebec national report; Porter, United Kingdom national report; Junod, Switzerland national report; Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002); Viola, Brazil national report (e.g. the right to access information protected by the Consumer Protection Code applies to any kind of processing of data in a consumer-provider relationship, including that between an insurer and its clients. The Code grants consumers the right to access his/her personal data; Brazilian courts extend these rights to the data subject’s legal representatives (parents/tutors) or his/her heirs). 284 Vansweevelt, Weyts and Cornelis, Belgium national report (Privacy Commission, “Informatienota over de bescherming van persoonsgegevens in België”, available at https://www. ou.nl/documents/40554/187634/Belgische_regelgeving_bescherming_van_persoonsgegevens.pdf/ b1e5f2f1-eeb4-4a8b-a44c-500da473015c). 285 Sato, Japan national report (although the Data Protection Act provides in theory for the right of access to information, in order to exercise this right, one must be able to identify the data controller and the data that the data controller possesses). 286 Viola, Brazil national report. 283

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ing Quebec),287 Cyprus,288 Czechia,289 Greece,290 Switzerland,291 Italy,292 and Belgium293 explicitly preserve the right of individuals to refuse knowing about their genetic information once they undergo a genetic test.294 In Canada, such a refusal cannot justify denying the individual access to services or contracts.295 The right not to know is also addressed in soft law instruments in Cyprus,296 Japan,297 Taiwan,298 and the United Kingdom.299 Finally, all parties to the Oviedo Convention would be held to its injunction to respect the wishes of individuals not to be informed of information concerning their health.300

287

Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 2. See also Canada Labour Code, RSC 1985, c L-2, s 8); Joly, Quebec national report. 288 Trokanas, Cyprus national report (Cyprus National Bioethics Committee’s Opinion of 22 January 2008, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 10(2) and Law 1 (I)/2005, Art 10(4)). 289 Křepelka, Czechia national report (Law on Specific Medical Services, Chapter on “Genetic examinations”). 290 Mitrou, Greece national report (Code of Medical Ethics of 2005, Art 11(2)). 291 Junod, Switzerland national report (Federal Act on Human Genetic Testing of 8 October 2004, in force since 1 April 2007, RS 810.12, Art 6 (exception in Art 18(2) in case of imminent physical danger. Abolishing this exception is planned as part of the current reform of the Federal Act on Human Genetic Testing). 292 Casonato and Tomasi, Italy national report (General Authorization 8/2016, point 6, para 2). 293 Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 7, para 3 and Art 8, para 3; Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 10, paras 2–3). 294 Casonato and Tomasi, Italy national report (General Authorization 8/2016, point 6, para 2); Wałachowska, Poland national report; Pormeister, Estonia national report (Human Genes Research Act, RT I, 14 March 2014, 30, s 11(1) with respect to donors of the EGB). 295 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 2); Joly, Quebec national report (in the few instances where genetic information may be required in order for the employee to be fit for the employment, the right not to know could be restricted since the test results could provide indications on unwanted health information). 296 Trokanas, Cyprus national report (Cyprus National Bioethics Committee’s Opinion of 22 January 2008). 297 Sato, Japan national report (through ethical guidelines issued by the Government, divulging genetic information to the patient without the latter’s consent would constitute a tort). 298 Rei, Taiwan national report (the legal system is silent but IRBs (research ethics boards) normally requires principal investigators to respect the right not to know when the research involves genetic testing). 299 Porter, United Kingdom national report (Joint Committee on Medical Genetics, “Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information” (2011). In the UK, there are discussions on the topic, but the right not to know is not formally recognized within statute or at common law). 300 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 10(2) (does not mention genetic information specifically).

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We end this section by considering the position of family members who may have an interest in having the familial genetic information kept private considering the risks they may run as well when seeking employment or insurance.

3.2.4

Family Members’ Interests

Traditional medicolegal approaches focused on the individual patient come under pressure in the context of genetic testing in which the interests of family members could be relevant.301 Nevertheless, many domestic regulatory regimes surveyed do not address the interests of family members in keeping a patient’s or research subject’s genetic information private,302 although some, like the regime in the United States, do.303 In other contexts, those interests may be protected under human rights laws (e.g. in Canada304) or other laws (e.g. Belgium305). General principles of human rights and privacy law may also apply to protect the right not to know of their genetic information belonging to family members of the person tested.306 Interestingly, while the UK Concordat and Moratorium allow insurers to

301

As emphasized in the UK context by Porter (Porter, United Kingdom national report). Viola, Brazil national report; Thrasher and Young, Canada national report; Rei, Taiwan national report (in Taiwan, insurers and employers can only access genetic information with the person’s consent. This access is limited to the information that is necessary for the purpose of the collection. In case consent is granted, family members might be vulnerable); Pormeister, Estonia national report (in Estonia, the Human Genes Research Act recognizes the interests of family members as far as it expressly states that the gene donor does not have the right to access information regarding his genealogy: Human Genes Research Act, RT I, 14 March 2014, 30, s 11(2). The strict prohibition of collecting the genetic information of an employee / insurance seeker arguably indirectly protects family members); Junod, Switzerland national report. 303 The Genetic Information Nondiscrimination Act includes “the genetic tests of family members” under its definition of “genetic information”: Feldman and Quick, United States national report (Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881). 304 Thrasher and Young, Canada national report (Canadian Human Rights Act (RSC, 1985, c H-6) and other provincial human rights codes); Joly, Quebec national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3, s 85 individuals cannot authorize the disclosure of genetic test results of a relative). 305 Vansweevelt, Weyts and Cornelis, Belgium national report (Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9: prevents access by third parties to medical records, which may contain familial information; Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014, Arts 58 and 61: prohibition to request and communicate genetic information in connection with the conclusion or performance of an insurance contract also introduced to protect the privacy of relatives); Act of 28 January 2003 concerning medical examinations that are carried out within the framework of industrial relations, Belgian State Gazette, 9 April 2003: in the employment context, examinations and questions to receive genealogical information are forbidden. 306 Thrasher and Young, Canada national report; Vansweevelt, Weyts and Cornelis, Belgium national report. 302

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access appropriate information on family history with a person’s consent,307 they acknowledge—and try to address—the fact that requesting information about family history from an applicant’s doctor presents ethical and practical difficulties with regards, particularly, to the confidentiality owed to family members.308 The Belgian rapporteurs suggest that where regulations impose several layers of safeguards to protect an insured person’s health data,309 the interests of family members may not be completely absent from the minds of domestic regulators. What if a family member is not in possession of genetic information, but would like to gain access to genetic information? In Canada and the United Kingdom, family members do not have a right to access a relative’s medical information even where that information may have implications for them.310 Conversely, in Italy, disclosure of genetic tests/screening results and/or research findings to individuals belonging to the same genetic line as the data subject is possible if they entail factual, direct benefits in terms of treatment, prevention and/or awareness of reproductive choices. However, disclosure is only allowed if a request has been made and the data subject has expressly consented to it. If the data subject’s consent is not or cannot be given because he or she cannot be found, disclosure is also permitted if the results/ findings are indispensable to protect family members’ health—including reproductive.311 Other countries also recognize the right for the family members of a tested individual to gain access to the individual’s information where their health might be jeopardized if they are not given the relevant information.312 Finally, in Italy, the ban on the disclosure of genetic information to employers and insurers applies in a similar manner to the tested individual and to its family members. Accordingly, if an individual possesses genetic data about one or more of his or her relatives, employers and insurers are banned from having access to this information as well.313

307

Porter, United Kingdom national report (ABI Concordat and Moratorium on Genetics and Insurance, para 21(f). Furthermore, in the UK it is not clear that family members could successfully invoke the Data Protection Act 1998 to prevent disclosure in this context). 308 Porter, United Kingdom national report. 309 Vansweevelt, Weyts and Cornelis, Belgium national report. See also for Canada, Joly, Quebec national report (insurers have committed not to require genetic test results from family members). 310 Thrasher and Young, Canada national report; Joly, Quebec national report (Loi sur les services de santé et les services sociaux, Québec, 2015, RLRQ C-42, Art 19); UK, Porter, p. 12 (Access to Medical Reports Act 1998 does not extend the right of access to personal information to family members; Data Protection Act 1998, s 7: it is unclear whether family members’ rights to access personal information are included and it is unlikely that the Freedom of Information Act 2000 could be used by family members as a legal route to gain access to another family member’s medical information or medical report). 311 Casonato and Tomasi, Italy national report (General Authorization 8/2016, point 9, para 7). 312 Casonato and Tomasi, Italy national report (General Authorization 8/2016, point 9, para 7); Junod, Switzerland national report (assumption of the author). Also, in Japan, family members have access to genetic information if the tested individual is a minor and the family member is a parent or a legal guardian: Sato, Japan national report. 313 Casonato and Tomasi, Italy national report.

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Under some conditions, a physician in Greece, Poland, Estonia and Quebec may be relieved from confidentiality obligations after the patient’s death.314 This is also the case in Japan where surviving family members may have a right to obtain the data if it relates to them. Interestingly, upon the death of an individual, his or her information appears to become familial: “if the information on the dead is also information on surviving individuals such as bereaved families, it is the information of the surviving individuals.”315

4 Conclusion316 Jurisdictions that have not yet elected specific legal regimes to address genetic testing may be considered in this uncertain moment to have an advantage as they can now choose how to address genetic testing in the contexts of insurance and employment on the basis of the experience of others. But they must choose. The lack of guidance may otherwise leave existing insurance or employment applicants, as well as industry actors themselves, with a range of uncertainties, and heightened inequality.317 Not acting may leave the space open for abusive practices on genetic testing to proliferate. In these jurisdictions, resort to non-discrimination laws in the context of health risks may be a way to fill gaps. Broader and explicit regulatory regime may also be called upon to address the practice of insurers or employers making decisions based on genetic testing.318 For some of the national rapporteurs, the avenue of general data protection laws tended to be favoured.319 But, even where data protection laws exist and are considered helpful to protect a person’s privacy, rapporteurs insist on the need to regulate more specifically genetic testing in the contexts of employment and insurance, should the practice become more widespread. Rapporteurs from jurisdictions with a specific regulatory regime expressed satisfaction: some jurisdictions reported that regulations imposing the highest level of protection for employees, job seekers and insurance applicants were particularly appropriate.320 The United Kingdom rapporteur felt that the regime provided in soft 314

Wałachowska, Poland national report; Mitrou, Greece national report; Pormeister, Estonia national report (Personal Data Protection Act, RT I, 6 January 2016, 10, Chapter 3); Joly, Quebec national report (Loi sur les services de santé et les services sociaux, Québec, 2015, RLRQ C-42, Art 23). See also in Belgium, regarding access to medical files: Vansweevelt, Weyts and Cornelis, Belgium national report. 315 Sato, Japan national report (commentary to the Japanese Data Protection Act). 316 Questions 26–29 of the Questionnaire. 317 Sato, Japan national report. 318 Rei, Taiwan national report; Wałachowska, Poland national report. 319 Viola, Brazil national report (Brazil appears to be taking this route, with three bills on general data law pending in the National Parliament). 320 Casonato and Tomasi, Italy national report.

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law instruments adopts a reasonable and proportionate approach, which pragmatically balances the conflicting interests involved.321 But even where this matter is specifically regulated, legal uncertainties remain, including on aspects of genetic privacy322 and discrimination on the ground of genetic status in the insurance and employment contexts.323 In Belgium, although the current regulation offers particularly comprehensive protection of genetic information,324 the rapporteurs call for a global evaluation of the existing legislation on the basis of what is done elsewhere (such as in the Netherlands) and for national regulation of the use of genetic research and testing.325 They also note the lack of efficient enforcement mechanisms as an issue in the field of genetic testing in the insurance context, leading to incomplete protection and abuse.326 In Canada, the specific legal regime of the Genetic Non-Discrimination Act327 allows individuals to undergo genetic testing and to benefit from its advantages without being exposed to risks of insurance-based or employment-based discrimination on the basis of genetic status.328 However, the rights and obligations of insurers and employers to family members or relatives that voluntarily disclosed genetic information need to be clarified;329 in particular precision is needed on the exact use that can be made of genetic information that is voluntarily disclosed.330 Rapporteurs also call for the situation to be more closely monitored; for more information about how existing regulations are being applied by

321

Porter, United Kingdom national report (with respect to insurance, the approach taken in the ABI Concordat and Moratorium seems on its face to be a pragmatic attempt to balance the conflicting interests involved. However, an irony of this framework is that while insurers will not reject individuals because of an adverse genetic test result, they remain free to reject them on the basis of family history). 322 Thrasher and Young, Canada national report. Křepelka, Czechia national report; Joly, Quebec national report (raising the necessity to avoid needlessly distinguishing genetic testing information from other types of predictive medical data in laws as such a distinction is untenable from both a scientific and social justice standpoint). 323 Trokanas, Cyprus national report (raising the need to add to the existing regimes specific legislation addressing the question of genetic status in the insurance and employment contexts and suggests adopting a regime modelled on other European countries. Cyprus also expressed the view that ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes (adopted 27 November 2008, entered into force 1 July 2018, CETS no 203) would constitute a first step in providing a comprehensive legal framework in the field of genetic testing); Křepelka, Czechia national report; Mitrou, Greece national report. 324 Vansweevelt, Weyts and Cornelis, Belgium national report. 325 Vansweevelt, Weyts and Cornelis, Belgium national report. 326 Vansweevelt, Weyts and Cornelis, Belgium national report. 327 Thrasher and Young, Canada national report (Genetic Non-Discrimination Act, Canada, SC 2017, c 3). 328 Thrasher and Young, Canada national report. 329 Thrasher and Young, Canada national report. 330 Thrasher and Young, Canada national report; Joly, Quebec national report; Křepelka, Czechia national report.

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insurers and employers to be acquired;331 for more statistics on genetic testing to be collected;332 for more empirical research on the topic to be carried out; and for education campaigns to be developed.333 Finally, the regulation of private DNA testing companies and their relationship with the fields of insurance and employment could become increasingly important in the coming years.334 Looking forward, one question of central interest is whether the anti-discrimination frameworks of the different jurisdictions surveyed—whether they include or not genetic status—are sufficiently effective to tackle the challenges of genetic testing in employment and insurance. Some rapporteurs described their country’s general antidiscrimination framework as insufficient in this respect.335 Most notably, the rapporteur affirms this to be the case of Czechia because of the impact its history has had on the public perception of the need for anti-discrimination safeguards. As the rapporteur notes, the transition from communist ideology to liberal democracy and market economy brought with it a general reluctance to embrace anti-discrimination laws in the population, as they were associated with new leftism or neo-Marxism.336 This reluctance is said to explain the delay in the implementation of EU anti-discrimination directives in Czechia337 and the weakness in the enforcement of national, international and supranational laws. The effectiveness of the anti-discrimination framework with respect to genetic status can be questioned in Czechia if principles of non-discrimination are not respected by employers and if selection in that context on the basis of gender, age, race or handicap is practiced.338 The rapporteurs for Canada also offer a mixed assessment of the ability to address genetic discrimination in the context of insurance or employment.339 While some commentators in Canada argue that explicitly addressing the issue of genetic discrimination is a step forward for human rights, others contend that the Genetic Non-Discrimination Act does not go far enough (for example by only addressing 331

Porter, United Kingdom national report. Junod, Switzerland national report. 333 Raised by Joly, Quebec national report. 334 Emphasized by Porter, United Kingdom national report. Interestingly, the French rapporteur also asks whether the fact that the concept of insurance relies on uncertainty whereas genetic testing aims to foresee the future raises the question of whether the use of genetic testing could mean the end to the idea of insurance as such: Byk, France national report. 335 Viola, Brazil national report; Trokanas, Cyprus national report; Křepelka, Czechia national report. See also Ajunwa (2016), p. 75. 336 Křepelka, Czechia national report. 337 Křepelka, Czechia national report: the Law on Equal Treatment was temporarily blocked by the president. 338 Křepelka, Czechia national report. 339 Thrasher and Young, Canada national report (as observed above, the Quebec Court of Appeal has found the Act unconstitutional because it exceeds Parliament’s constitutional authority by legislating on matters of provincial jurisdiction, seeDans l'affaire du: Renvoi relatif à la Loi sur la non-discrimination génétique, 2018 QCCA 2193). See also Mitrou, Greece national report (there are discussions as to whether processing genetic data in the specific sectors of employment and insurance should be prohibited). 332

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genetic testing340). There is a lingering concern in Canada about the effect on insurance premiums of genetic testing and genetic information in general, as well as about genetic exceptionalism. The genetic exceptionalism point calls into question why family medical history or other medical information should be treated differently under law than genetic information, recognizing that to single out prohibitions on genetic testing may offer insufficient protection.341 The rapporteurs for the United States also raise the broad issue of genetic exceptionalism, noting that people generally subscribe to this idea which is strengthened by genetic information privacy laws.342 Likewise, the Swiss rapporteur notes that the precise meaning of discrimination on the basis of genetic information will require clarification, in light of the fact that both employers and insurers are allowed to take decisions on the basis of the insured or the employee’s health.343 As for the rapporteur for Japan, he notes that the absence of legal texts tackling the question of discrimination on the ground of genetic status and information is problematic. In particular, a survey by the Japanese Ministry of Health revealed that 70% of the participants surveyed thought that there should be a statute to regulate and protect genetic information. 3.2% of the participants reported experiencing some sort of discrimination in the insurance context on the basis of family members’ genetic disease.344 Similarly, the rapporteur for Taiwan observed that people worry about genetic discrimination in general in the absence of a specific regime addressing the issue, since Taiwan only regulates discrimination on the grounds of disability and gender. The rapporteur for Taiwan insists on the necessity to enact legislation protecting against discrimination based on all health risks, regardless of whether they are revealed by genetic tests or not.345 Meanwhile, some national rapporteurs are confident that the non-discrimination framework of their jurisdiction provides a sufficient basis to address the challenges posed by genetic testing in the context of insurance or employment.346 In Estonia, where there is a genetic non-discrimination framework in place for the employment and insurance contexts, a remaining drawback is that the regime is not subject to the same procedural rules and remedies as other forms of discrimination.347 In

340

Thrasher and Young, Canada national report. Thrasher and Young, Canada national report; Joly, Quebec national report (more discrete and new types of genetic discrimination such as by law enforcement or immigration agencies can still be an issue. Another problem lies in the fact that the law still provides for consensual use of genetic results by employers and/or insurers). 342 Feldman and Quick, United States national report. The rapporteurs for the United States further argue that once predictive genetic testing becomes demonstrably accurate and reliable, the time will have come to reconsider the idea of genetic exceptionalism. 343 Junod, Switzerland national report. 344 Sato, Japan national report. 345 Rei, Taiwan national report. 346 Casonato and Tomasi, Italy national report; Wałachowska, Poland national report (observing thought that there are some uncertainties, especially if the practice becomes more common); Vansweevelt, Weyts and Cornelis, Belgium national report. 347 Pormeister, Estonia national report. 341

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Switzerland, there are difficulties in assessing the efficiency of the existing framework because of the absence of data, but it would seem that it provides little protection against genetic discrimination.348 Finally, in the United States, as more information is obtained about the extent of genetic discrimination in the areas of insurance and employment, and as genetic testing becomes more reliable, the US rapporteurs suggest a policy-based approach that challenges insidious discrimination instead of an approach that carves out genetic information for special treatment.349 Another aspect that will need to be explored further as research advances on this topic is the need for more solid transnational action. The rapporteurs for Brazil and Belgium raise the critical need for transnational and European action in this context,350 given the transnational nature of some stakeholders such as insurance companies. The rapporteur for Brazil suggests that ILO, UNCITRAL and UNIDROIT could play a role in fostering transnational action.351 The rapporteurs for Canada acknowledge the potentially fruitful role of transnational action in terms of harmonization in the context of privacy laws and international data sharing.352 They nevertheless find it more likely that progress will result from domestic effort in Canada.353 For the Japanese and United Kingdom rapporteurs, transnational action could be beneficial in contributing to the creation of “minimum standards,” “best practices” and workable models. They recognize, however, that differing circumstances and legal situations (in particular in terms of the structure of healthcare systems and general regulation of insurance and employment) might limit the role of transnational action in the governance of genetic testing in the insurance and employment sectors.354 The rapporteur for Poland echoed this concern and suggested the creation of a supranational body to monitor genetic data processing.355 This general report offers a modest contribution to future reflections on the potential usefulness of transnational action on genetic testing in insurance and employment. It has canvassed the range of regulatory initiatives on genetic testing in insurance and employment that exist, and has noted the spaces created both through a range of legislative mechanisms of a general or specific nature, and through industry action. It has clarified the interplay between international and regional instruments and the various emerging, local initiatives. In this sense, it

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Junod, Switzerland national report. Feldman and Quick, United States national report. 350 Viola, Brazil national report; Vansweevelt, Weyts and Cornelis, Belgium national report (the Council of Europe’s Committee on Bioethics is actively working on the subject). See also Rei, Taiwan national report. However, Pormeister, Estonia national report (transnational action is only relevant in the employment context especially with respect to the enforcement of the prohibition of genetic discrimination by contrast with the insurance field where the systems might differ from one country to the other and, consequently, render the task of harmonized transnational action difficult). 351 Viola, Brazil national report. 352 Thrasher and Young, Canada national report; Joly, Quebec national report. 353 Thrasher and Young, Canada national report (as a consequence of the country’s dualist tradition, issues pertaining to the division of powers, and in light of the complexity of existing laws). 354 Sato, Japan national report; Porter, United Kingdom national report. 355 Wałachowska, Poland national report. 349

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has also been able to capture both the specificity of certain national experiences and the high degree of convergence that has emerged, often in keeping with the relevant regional and international texts. To the extent that leading stakeholders are selforganized transnationally, and that whether or not it should, data travels beyond borders, minimum standards or more robust governance frameworks established internationally or regionally may well provide needed guidance for future coordinated action. International organizations like the tripartite ILO where governments are represented alongside workers and employers might be well placed to reflect in particular on the employment dimensions. But this general report makes no recommendation beyond the following: the canvassed national experiences confirm that it is both timely and useful to pursue further comparative and international analysis of law and practice, with a view to standard-setting into the future.

Annex 1 Summary Table Table 1 Summary table

Jurisdiction International

EU

Anti-discrimination norms (national) specifically mentioning genetic status • UNESCO (1997, 2003) ILO Code (1997)

• EU Charter (2000), art. 21 • Oviedo Convention, art. 11 (1997) • Additional protocol 2008 (In force on 1 July 2018) (non-stigmatization) • Treaty on the functioning of the EU, art. 21 (1) (equality of people with different genetic features) • General Data Protection Regulation 2016/679

Other types of legislation/regulation specifically addressing genetic testing in employment and insurance (Y/N)

• Oviedo Convention, art. 12 (1997) • Recommendation CM/Rec (2016) 8

Genetic testing in employment and insurance forbidden, allowed, allowed under some conditionsa 1. Genetic discrimination forbidden (1997; 2003) 2. Need for safeguards stressed (ILO) 1. Predictive genetic tests forbidden for purposes other than healthrelated (Oviedo). Forbidden to request predictive genetic tests for insurance (Rec 2016) 2. Consent is an exception (Oviedo) 3. National laws may request results of existing tests depending on the particular risk to insure (insurance) (Rec 2016) 4. Genetic discrimination forbidden (Oviedo; Reg 2016/679; Charter: by EU institutions when applying EU law) (continued)

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Table 1 (continued)

Jurisdiction Belgium

Anti-discrimination norms (national) specifically mentioning genetic status • Anti-discrimination Act 2007 (Note that Belgium did not sign Oviedo Convention)

Other types of legislation/regulation specifically addressing genetic testing in employment and insurance (Y/N) • Patient Rights Act Insurance Act 2014 Medical Examination Act 2003

Brazil

No

No

Canada

• Genetic Non-Discrimination Act (2017)—amending Canada Human Rights Act

• Genetic Non-Discrimination Act (2017)

Cyprus

• Soft law instruments Oviedo Convention

• Soft law Oviedo Convention

Czechia

• Law on Specific Medical Services • Oviedo Convention and Additional protocol 2008

• Law on Specific Medical Services (genetic testing for medical purposes) • Oviedo Convention

Genetic testing in employment and insurance forbidden, allowed, allowed under some conditionsa 1. Forbidden test and data; absolute ban (insurance) 2. Predictive tests forbidden. Information about current health allowed only to determine suitability (employment) (MEA) 3. Consent not an exception (insurance; PRA) 4. Exceptions allowed by Royal Decree (employment, e.g., safety to worker or others. None as of now) 5. Use of genetic characteristic to discriminate forbidden (ADA) Mute for insurance as insurers cannot exclude coverage for more than 1 year 1. Forbidden (diagnostic and predictive) 2. Exception if consent 3. Anti-discrimination provision only for federally regulated activities 1. Forbidden (by reference to EU legislation?) 2. Predictive and diagnostic tests forbidden for conditions person unaware of (insurance) (soft law) 1. Communication of results to third parties only with consent (LSMS) 2. Forbids discrimination based on results of (continued)

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Table 1 (continued)

Jurisdiction

Anti-discrimination norms (national) specifically mentioning genetic status

Other types of legislation/regulation specifically addressing genetic testing in employment and insurance (Y/N)

Estonia

• Human Genes Research Act (part of Act only applies to EGB) • Oviedo Convention

• Human Genes Research Act (part of Act only applies to EGB) • Oviedo Convention

France

• Oviedo Convention • Code pénal, art. 225-3 (1) (1994) (insurance, discrimination based on predictive genetic tests or genetic predispositions)

• Code de la santé publique, L-1141-1 (insurance) • Code civil, art. 16-10 (1994) • Soft law (Fédération française des Sociétés d’assurance) • Oviedo Convention

Genetic testing in employment and insurance forbidden, allowed, allowed under some conditionsa genetic tests done medical purposes (LSMS). Discrimination impossible under public health (universal) insurance 1. Forbidden to collect data 2. Consent not an exception under HGRA 3. Genetic discrimination prohibited generally and with respect to employment and insurance 1. Genetic tests can only be carried out for medical or scientific purposes. Does not say whether results thereby obtained can be used in insurance (C.civ.), but CSP forbids (insurance) 2. Absolute ban for tests and communication of results (insurance) 3. Consent not an exception (CSP) 4. Voluntary moratorium between 1994 and 2004 (insurance) 5. Forbids discrimination based on genetic characteristics (except for life, health and disability insurance to reveal actual disease (not predictive) (CP) (No information provided for employment sector) (continued)

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Table 1 (continued)

Anti-discrimination norms (national) specifically mentioning genetic status • No legislation • Soft law • Oviedo Convention

Other types of legislation/regulation specifically addressing genetic testing in employment and insurance (Y/N) • No legislation • Soft law • Constitution (protection of genetic identity) • Oviedo Convention

Italy

(Not mentioned. Note that Italy did not ratify the Oviedo Convention)

• General Authorization 8/2016 (by reference in the preamble)

Japan

No

No

Poland

No (Polish constitution and Labour Code refer to “any form” of discrimination however) (Poland signed but did not ratify the Oviedo Convention) • Genetic Non-Discrimination Act (2017), amending Canadian Human Rights Act

• No • Draft Bill in 2012 (not yet adopted)

Jurisdiction Greece

Quebec

• Genetic Non-Discrimination Act (2017) (also amends Canadian Labour Code)—diagnostic and predictive

Genetic testing in employment and insurance forbidden, allowed, allowed under some conditionsa 1. Forbidden. Consent not an exception, but other exceptions apply (protection and safety) (employment) (soft law) 2. Forbidden (insurance). Consent is an exception for private insurance (soft law) 3. Protection of genetic identity/information (Greek Constitution) 4. Soft law prohibits discrimination based on genetic characteristics 1. Forbidden (insurance), without any exception 2. Forbidden (info and tests) (employment), except for the aim of protecting the life or physical integrity of the job applicant or a third party 3. Consent not an exception n/a. Does not occur in practice 1. Forbidden (through EU rules?) 2. Any form of discrimination encompasses genetic history

1. Forbidden (both diagnostic and predictive), consent is an exception 2. Discrimination grounded on genetic characteristics forbidden (federal activities) (continued)

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Table 1 (continued)

Jurisdiction Switzerland

Anti-discrimination norms (national) specifically mentioning genetic status • Loi fédérale sur l’analyse génétique humaine 2004 • Oviedo Convention

Other types of legislation/regulation specifically addressing genetic testing in employment and insurance (Y/N) • Loi fédérale sur l’analyse génétique humaine 2004 • Oviedo Convention

Taiwan

No

No

United Kingdom

(UK did not sign Oviedo Convention)

• Concordat and Moratorium (soft law) (insurance) • ICO Employment Practice Code 2011 (employment)

Genetic testing in employment and insurance forbidden, allowed, allowed under some conditionsa 1. Forbidden for compulsory insurance. Allowed (information) under strict conditions for optional insurance 2. Allowed if necessary to assess aptitude (employment) 3. Consent not an exception under LAGH 4. Discrimination based on “genetic patrimony” forbidden (LAGH) Mute for insurance and employment (comprehensive coverage from NHI) 1. Forbidden to request tests (insurance) 2. Forbidden to request results of predictive and diagnostic genetic tests acquired as part of clinical research (insurance) (C&M) 3. Forbidden to request results of predictive genetic tests acquired otherwise (diagnostic tests not protected) (insurance) (C&M) 4. Allowed to ask results of existing tests (info) according to “ceiling” approach (insurance). (C&M). Not required to disclose results after cover has started 5. Voluntary moratorium on use of predictive genetic tests until 1 Nov 2019 (insurance) (C&M) 6. Freedom restricted for employers (safety risk or risk to worker) (ICO). Medical tests prohibited until a job offer is made (continued)

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Table 1 (continued)

Jurisdiction United States

a

Anti-discrimination norms (national) specifically mentioning genetic status • Genetic Information Nondiscrimination Act of 2008 (GINA) • Patient Protection and Affordable Care Act of 2010

Other types of legislation/regulation specifically addressing genetic testing in employment and insurance (Y/N) • American with Disabilities Act of 1990 (ADA) • State laws (both non-discrimination laws and privacy laws)

Genetic testing in employment and insurance forbidden, allowed, allowed under some conditionsa 1. Forbidden (employment and health insurance) 2. Genetic discrimination with respect to other types of insurance (e.g. life, disability or long-term insurance) is regulated by state laws

For jurisdictions subject to the Oviedo Convention, see the EU section

Annex II Questionnaire: Legal Aspects of Genetic Testing Regarding Insurance and Employment Useful Details for Reading the Questionnaire The questions have been formulated to enhance their relevance across a wide variety of jurisdictions and legal traditions. It is understood, however, that in certain cases, the questions might need to be slightly adapted by the national rapporteurs to enable a fulsome response. The rapporteurs are asked to: • refer to the most important sources. These sources may be constitutional, legislative, jurisprudential, doctrinal, or derived from the agreements between concerned parties or public policies. • underscore at opportune moments, the context (juridical, social, economic) within which the responses are inscribed, and refer to statistical data if pertinent and available. The questionnaire does not distinguish between the different types of insurance (e.g. life insurance, health and accident insurance) but the national rapporteurs may make these distinctions where necessary. Also, the term “insurance” is used to refer to insurance obtained through a private company. Moreover, the use in the questionnaire of the terms “insurer” and “employer” is meant to include, where applicable, agencies or medical intermediaries undertaking tests on their behalf. Your response may require you to distinguish between the responsibilities of each. If there are particular considerations that apply to public health insurance, do not hesitate to take these into account in your responses. Similarly, in respect to

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questions on employment, national rapporteurs are kindly asked to provide any nuances necessary to account for differences in the law—including available recourse and remedies—that might apply to workplaces or workforces that are unionized, and those that are not unionized.

Introduction 1. Are data available about the frequency of use of “genetic testing” in insurance and employment processes? Have you observed a change over time? 2. Please briefly identify any public policies that may influence both the prevalence of genetic testing and the assumption of risk.

Part I: Are Existing Generalist Frameworks for Regulating Genetic Testing Adequately Adapted to the Insurance and Employment Contexts? A. General 3. Does your jurisdiction define “genetic” information for the purpose of employment or insurance? More particularly: (a) Does the definition include family history? (b) Does it include proteomic or epigenetic data? (c) Is a distinction made between genetic tests occurring within a clinical setting, for research purposes, and tests sold to consumers? (d) Is a distinction made between genetic tests that reveal existing health problems (diagnostic tests) and genetic testing that only predicts disease susceptibility (predictive tests)? (e) Is the use of terminology consistent with Article 2 (i)(ii) and (xii) of the UNESCO International Declaration on Human Genetic Data? 4. Does your jurisdiction recognize the “special status” of genetic data in keeping with Article 4 of the UNESCO International Declaration on Human Genetic Data? 5. Briefly, does information derived from genetic testing receive particular or distinctive legal consideration (e.g. through specific regulatory texts, stateinitiated policies or voluntary codes) in your jurisdiction? 6. Does your jurisdiction exercise extraterritorial jurisdiction over human genetic data collection, notably by multinational insurance companies headquartered there? 7. Where genetic testing is undertaken in a clinical medical setting or in a biomedical research setting, does the physician or researcher have a duty of disclosure to

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the patient or participant of the socio-legal risks associated with the testing, in particular in relation to the possible impact for insurance or employment applications?

B. Human Rights (Please, note any applicable international, supranational and/or regional (including the following regional human rights instruments: African (Banjul) Charter on Human and Peoples’ Rights, the American Convention on Human Rights and the European Convention on Human Rights and Fundamental Freedoms,) norms, in addition to domestic norms).

B.1 Non-discrimination Protection 8. Is protection against genetic discrimination covered under general human rights protections in your jurisdiction? If so, is genetic status expressly referenced as an included ground of discrimination, or are other categories, such as disability, interpreted to include genetic status? 9. Has discrimination on the basis of genetic status been seen to intersect with other forms of discrimination, for example on the basis of gender, family status, race, ethnic origin or national origin, for individuals belonging to groups that may be considered pre-disposed to particular illnesses (e.g. persons of African descent and Sickle-cell anemia; Tay-Sachs disease in persons of Ashkenazi Jewish heritage, etc.)? 10. Is discrimination in employment and discrimination in respect to insurance addressed according to the same analytical framework? 11. Please discuss any pivotal human rights decisions from your jurisdiction regarding genetic discrimination in the insurance and/or employment contexts. In the process, please explain: (a) Your jurisdiction’s dominant approach to identifying discrimination (e.g. adverse impact or intent-focused analysis) (b) How the burden of proof and evidentiary burden are distributed between the parties (c) The adequacy of the remedial awards 12. Overall, does the general non-discrimination framework provide a sufficient basis to address the challenges posed by genetic testing in the context of insurance or employment?

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B.2 Privacy, Confidentiality and Disclosure 13. How does your jurisdiction protect the confidentiality of information derived from genetic testing and the privacy of the person who was subject to it? More precisely, what protection is afforded to: (a) Genetic test results contained in a patient’s medical or hospital file from disclosure to or access by third parties, including employers and insurers? (b) Genetic test results obtained in the context of biomedical research? (c) Genetic information detained by, or for, an insurer or employer in case genetic testing is permitted in these contexts? 14. What role does consent play in allowing genetic information contained in a medical or hospital file to be disclosed to third parties such as insurers and employers? 15. How does your legal system protect the interests of family members, including those not yet born, in the protection of their genetic information? What if any role does your jurisdiction provide to family members in decision-making about disclosure to third parties—notably employers and insurers—of genetic information contained in an individual’s medical or hospital file? 16. Does your jurisdiction recognize individuals’ right of access to information regarding their health or medical status that might be available to insurers or potential employers? Does it recognize the same right to family members? 17. Does your legal system recognize that individuals and their family members have a right not to know about their genetic information? If so, how does this right play out in the context of insurance and employment?

B.3 Other 18. Please discuss and evaluate any other rights or principles, recognized in your legal system, that are relevant to the use of genetic testing in the context of insurance or employment (e.g. autonomy, self-determination).

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Part II: Do the Specific Rights and Obligations in the Insurance and Employment Contexts Effectively Reconcile Stakeholders’ Interests? A. Rights and Obligations of Insurers and Employers Insurance 19. How does the insurance industry justify collecting genetic information? What are the main objections?

Employment 19. How do employers in your jurisdiction justify collecting genetic information as part of the recruitment process? What are the main objections? 20. Are insurers specifically allowed to ask 20. During the recruitment process, are questions about an applicant’s genetic status, or employers specifically permitted to ask questo require genetic testing prior to granting tions of job applicants regarding their genetic insurance coverage? Please, specify the condi- status, or to require genetic testing prior to tions and clarify the moment at which this employment? Please specify the conditions information may be requested. What are the (e.g. specific safety-sensitive jobs) and clarify sanctions for contravening these rules? If you the moment during the hiring process at which have relevant data, please indicate whether the this information may be requested (e.g. only regulatory framework yields high compliance after an offer of employment has been made conditional on successfully passing a medical examination?) 21. Where genetic testing is permitted for insurance purposes, including employer-provided insurance, does your regulatory framework distinguish between: (a) The nature of insurance to be underwritten (b) The monetary value to be insured (c) The kind of testing/result (e.g. predictive versus diagnostic) (d) The type of uses considered appropriate for information derived from the genetic testing (e.g., in insurance: assessing rates/caps; excluding some conditions/rejecting coverage) 22. Where an insurer is allowed by law to use 22. Where an employer is permitted by law to genetic testing, is retention of the samples after undertake genetic testing as part of the the insurance-related decision has been made recruitment process, can the samples be permitted? If so, for how long can the samples retained by the testing agency (e.g. medical be kept? Is the insurer permitted to undertake intermediary) after the hiring decision has been further, future testing (in case tests for new made? If so, for how long can the samples be conditions are developed for instance)? kept? Is the employer permitted to undertake further, future testing (in case tests for new conditions are developed for instance)? 23. Where the law permits an insurer or employer to require genetic testing, does the insurer or employer have any obligations to manage the psychosocial risks to the person associated with the testing, or learning the results of the testing (e.g. psychological harm; disclosure of facts about close family relationships, such as non-paternity; stigmatization; intra-family conflict. . .)?

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B. Rights and Obligations of the Insurance or Job Applicant, the Insured or Employee, and Close Family Members Insurance 24. Does your jurisdiction require voluntary disclosure on the part of an insurance applicant where results of DNA testing are contained within their existing medical records? If such an obligation exists, is it imposed only at the application stage? 25. What are the consequences of failing to disclose the results of prior genetic testing or other genetic information?

Employment 24. Does your jurisdiction require disclosure of genetic information or any prior genetic testing by the job applicant to a potential employer?

25. If a job applicant refuses or fails to disclose past genetic testing to an employer, is the employee liable to disciplinary measures including potentially the termination of employment (e.g. for “dishonesty”)?

Conclusion 26. Do you consider that the risks and benefits associated with genetic testing in the insurance and employment context are currently appropriately distributed through your jurisdiction’s regulatory framework? 27. What, if any, recommendations would you formulate to address genetic testing in the insurance and employment contexts in an equitable and efficient manner? 28. Is there a fruitful role for transnational, including international, action in the governance of genetic testing in insurance and employment? 29. Are there other themes or issues of central importance to your jurisdiction that were not covered by this questionnaire?

Annex III Questionnaire: Les Aspects Jurisdiques des Tests Génétiques en Relation à l’Assurance et l’Emploi Précisions utiles à la lecture du questionnaire Les rapporteurs sont priés de : • Citer les sources les plus importantes. Ces sources peuvent être constitutionnelles, législatives, jurisprudentielles, doctrinales, ou relever d’accords entre les acteurs concernés ou de politiques publiques. • Souligner aux moments opportuns le contexte (juridique, social, économique) dans lequel leurs réponses s’inscrivent, et faire référence aux données statistiques si elles sont pertinentes et disponibles.

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Les questions sont formulées pour être pertinentes à une variété de ressorts et de traditions juridiques. Il est toutefois possible que, dans certains cas, les rapporteurs nationaux doivent reformuler légèrement les questions afin de favoriser leur plus grande pertinence. Le questionnaire ne fait pas de distinction entre les différents types d’assurance (assurance vie, assurance maladie-accident, etc.), mais les rapporteurs nationaux peuvent faire les distinctions nécessaires. De plus, le terme “assurance” tend à référer à l’assurance provenant de l’industrie privée. Enfin, lorsque le questionnaire utilise les termes “assureurs” et “employeurs”, il inclut les agences ou intermédiaires médicaux effectuant des tests en leur nom, si pertinent. Il pourrait être nécessaire de différencier les responsabilités de chacun lorsque pertinent. Si des considérations particulières s’appliquent à l’assurance maladie « publique », n’hésitez pas à en tenir compte dans vos réponses. Similairement, en ce qui a trait aux questions concernant l’emploi, les rapporteurs nationaux sont priés d’apporter les nuances nécessaires afin de tenir compte des distinctions s’imposant entre les recours et remèdes pertinents aux milieux de travail ou employés qui sont syndiqués, et à ceux qui ne le sont pas.

Introduction 1. Est-ce que des données sont disponibles concernant la fréquence de l’utilisation des « tests génétiques » en matière d’assurance ou d’emploi ? Avez-vous observé des changements au fil du temps ? 2. Identifiez brièvement les politiques publiques influençant la prévalence des tests génétiques, ainsi que la répartition des risques.

Partie 1: Est-ce que les cadres généralistes qui réglementent les tests génétiques sont adaptés aux contextes de l’assurance et de l’emploi? A. Général 3. Est-ce que votre ressort définit l’information génétique à des fins d’emploi ou d’assurance ? Plus particulièrement : (a) Est-ce que la définition inclut l’historique familial ? (b) Est-ce qu’elle inclut les données protéomiques ou épigénétiques ? (c) Fait-on une distinction entre les tests génétiques effectués dans un contexte clinique, dans un contexte de recherche, et ceux vendus directement aux consommateurs ?

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(d) Fait-on une distinction entre les tests génétiques qui révèlent des problèmes de santé existants (tests diagnostiques) et ceux qui ne font que prédire la susceptibilité de développer une maladie (test prédictif) ? (e) Est-ce que l’usage de la terminologie concorde avec celle utilisée par l’article 2 (i)(ii) et (xii) de la Déclaration internationale sur les données génétiques humaines de l’UNESCO ? 4. Votre ressort reconnait-il le « statut spécial » des données génétiques en accord avec l’article 4 de la Déclaration internationale sur les données génétiques humaines de l’UNESCO ? 5. Brièvement, est-ce que l’information dérivée des tests génétiques fait l’objet d’un traitement juridique particulier (par exemple, par le biais de textes règlementaires, de politiques publiques ou de codes volontaires) ? 6. Est-ce que votre ressort exerce une compétence extraterritoriale à l’égard de la collecte des données génétiques humaines, notamment par des compagnies d’assurance multinationales dont le siège social y est situé ? 7. Lorsque des tests génétiques sont entrepris dans un contexte médical clinique ou de recherche, est-ce que le médecin ou le chercheur a une obligation de renseignement préalable en ce qui concerne les risques sociaux-juridiques associés à ces tests, particulièrement en ce qui a trait à leurs effets sur la possibilité d’obtenir une assurance ou un emploi ?

B. Droits de la personne Vous êtes priés de noter les normes internationales, supranationales et/ou régionales (incluant par exemple la Charte africaine des droits de l’homme et des peuples (Banjul), la Convention américaine relative aux droits de l’homme, et la Convention européenne de sauvegarde des droits de l’homme et libertés fondamentales) applicables, en plus des normes nationales pertinentes.

B.1 Protection contre la discrimination 8. Est-ce que la protection contre la discrimination génétique est assujettie à la protection générale des droits de la personne dans votre ressort ? Si oui, est-ce que le statut génétique est expressément reconnu comme un motif de discrimination, ou est-ce que d’autres catégories, telles que le handicap, sont plutôt interprétées de façon à inclure le statut génétique ? 9. Dans votre ressort, est-ce que la discrimination basée sur le statut génétique recoupe d’autres formes de discrimination fondée, par exemple, sur le sexe, le statut familial, la race, l’ethnicité ou l’origine nationale, pour des individus appartenant à des groupes prédisposés à certaines maladies (par ex., l’anémie drépanocytaire chez les personnes de descendance africaine ; la maladie de Tay-Sachs chez les personnes d’origine juive ashkénaze, etc.) ?

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10. Est-ce que la discrimination en matière d’emploi et la discrimination en matière d’assurance sont abordées selon le même cadre analytique ? 11. Discutez des décisions charnières en matière de droits de la personne provenant de votre resort concernant la discrimination génétique dans le contexte de l’assurance et/ou de l’emploi. Ce faisant, expliquez : (a) L’approche dominante utilisée afin d’identifier les instances de discrimination (par exemple, une analyse fondée sur les effets préjudiciables de la discrimination ou centrée sur l’intention) ; (b) Comment le fardeau de la preuve est réparti entre les parties ; (c) Si les mesures correctives sont satisfaisantes. 12. Dans son ensemble, la protection juridique générale offerte contre la discrimination est-elle suffisante afin de faire face aux défis soulevés dans le contexte de l’assurance et de l’emploi à l’égard des tests génétiques ?

B.2 Vie privée, confidentialité et divulgation 13. Comment votre ressort protège-t-il la confidentialité de l’information obtenue à la suite de tests génétiques et la vie privée de la personne concernée par ces tests ? Plus précisément, quelle protection est offerte à/aux : (a) Résultats des tests génétiques contenus dans le dossier médical ou hospitalier d’un patient afin d’éviter la divulgation aux, ou l’accès par les, tiers, incluant les employeurs et assureurs ? (b) Résultats des tests génétiques obtenus dans le contexte de la recherche biomédicale ? (c) L’information génétique détenue par, ou pour, un assureur ou un employeur dans les cas où les tests génétiques sont permis dans ces contextes ? 14. Quel rôle joue le consentement dans la divulgation de l’information génétique contenue dans un dossier médical ou hospitalier à des tiers tels que les assureurs et employeurs ? 15. Comment votre système juridique protège-t-il les intérêts des membres de la famille, incluant ceux des individus à naître, dans la protection de leur information génétique ? Quel rôle jouent les membres de la famille dans le processus décisionnel menant à la divulgation à des tiers — notamment à des employeurs ou assureurs — de l’information génétique contenue dans le dossier médical ou hospitalier d’un individu ? 16. Est-ce que votre ressort reconnait aux individus un droit d’accès à l’information concernant leur santé ou leur statut médical qui pourrait être à la disposition des assureurs ou des employeurs potentiels ? Est-ce qu’elle reconnait le même droit aux membres de sa famille ? 17. Est-ce que votre système juridique reconnait aux individus ainsi qu’à leur famille un droit de ne pas connaitre leur information génétique ? Si oui, quel rôle se droit joue-t-il dans le contexte de l’assurance et de l’emploi ?

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B.3 Autre 18. Veuillez discuter et évaluer tout autre droit ou principe, reconnu dans votre système juridique, pertinent à l’utilisation des tests génétiques dans le contexte de l’assurance et de l’emploi (par exemple, autonomie, autodétermination) ?

Partie 2: Est-ce que les droits et obligations spécifiques dans les contextes de l’assurance et de l’emploi concilient efficacement les intérêts des acteurs? A. Droits et obligations des assureurs et des employeurs Assurance 19. De quelle façon l’industrie de l’assurance justifie-t-elle l’obtention d’informations génétiques ? Quelles sont les objections principales ? 20. Est-ce que les assureurs sont spécifiquement autorisés à poser des questions concernant le statut génétique d’un candidat, ou à requérir un test génétique avant de lui fournir une couverture d’assurance ? Spécifiez les conditions et identifier à quel moment un assureur peut exiger ces informations. De plus, indiquez quelles sont les sanctions en cas de contravention. Si vous possédez des données pertinentes, indiquez si le cadre réglementaire génère un haut taux de conformité

Emploi 19. Comment les employeurs justifient-ils l’obtention d’informations génétiques dans le cadre du processus de recrutement ? Quelles sont les objections principales ? 20. Durant le processus de recrutement, est-ce que les employeurs sont autorisés à poser des questions spécifiques aux candidats concernant leur statut génétique, ou à requérir des tests génétiques avant l’embauche ? Spécifiez les conditions (par exemple, des emplois sujets à des enjeux de sécurité) et clarifiez le moment durant le processus de recrutement lors duquel ces informations peuvent être requises ? (Par exemple, seulement après qu’une offre d’emploi soit émise à la condition qu’un examen medical soit effectué ?) Si vous possédez des données pertinentes, indiquez si le cadre réglementaire génère un haut taux de conformité. 21. Lorsque des tests génétiques sont permis à des fins d’assurance, incluant l’assurance offerte par l’employeur, est-ce que votre cadre réglementaire fait des distinctions quant à : (a) La nature de l’assurance à être souscrite (b) La valeur monétaire assurée (c) Le type de test/résultat (par exemple, prédictif versus diagnostique) (d) Le type d’utilisation considérée comme appropriée de l’information obtenue à la suite de tests génétiques (par exemple, établir les taux/plafonds ; exclure certaines conditions/rejet de la protection). 22. Lorsque le droit autorise un employeur à 22. Lorsque le droit autorise un assureur à requérir des tests génétiques dans le cadre du requérir des tests génétiques, celui-ci peut-il processus de recrutement, les échantillons conserver les échantillons après la prise de décision ? Si oui, pendant combien de temps ? peuvent-ils être conservés par l’agence ayant Est-ce que l’assureur a la permission d’effectuer effectué le test (par exemple un intermédiaire d’autres tests dans le futur (dans le cas où, par médical) après la prise de decision concernant l’embauche ? Si oui, pendant combien de (continued)

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exemple, des tests pour détecter de nouvelles conditions sont développés) ?

temps ? Est-ce que l’employeur a la permission d’entreprendre d’autres tests dans le futur (dans le cas où, par exemple, des tests pour détecter de nouvelles conditions sont développés ?) 23. Lorsque le droit permet à un assureur ou un employeur de requérir des tests génétiques, est-ce que ces derniers ont l’obligation de gérer les risques psychosociaux associés à ces tests (par exemple, préjudice psychologique ; divulgation des faits concernant des relations familiales, tels que la nonpaternité ; stigmatisation ; conflit intrafamilial...) ?

B. Droits et obligations du preneur d’assurance ou du candidat à l’emploi, de l’assuré ou de l’employé, et des proches Assurance 24. Quelles sont les obligations de divulgation à l’assureur dans l’hypothèse où des résultats de tests d’ADN se trouvent au dossier médical ? Si une obligation de divulgation existe, est-elle imposée uniquement au moment de la souscription ? 25. Quelles sont les conséquences d’une absence de divulgation d’un résultat de test génétique ou d’une information de nature génétique ?

Emploi 24. Est-ce que votre ressort requiert une divulgation de l’information génétique ou de tests génétiques préalables par le candidat à l’emploi à un employeur potentiel ?

25. Si un candidat à l’emploi refuse ou omet de divulguer des tests génétiques antérieurs, l’employé est-il sujet à des mesures disciplinaires incluant potentiellement son congédiement (par exemple, pour « malhonnêteté ») ?

Conclusion 26. Est-ce que vous considérez que les risques et bénéfices associés aux tests génétiques en matière d’assurance et d’emploi sont actuellement convenablement distribués au travers du cadre réglementaire de votre ressort ? 27. Quelles recommandations formuleriez-vous afin d’aborder les enjeux reliés aux tests génétiques dans le contexte de l’assurance ou de l’emploi de manière équitable et efficace dans votre ressort ? 28. L’action transnationale, incluant l’action internationale, peut-elle jouer un rôle fécond dans la gouvernance des tests génétiques en matière d’assurance et d’emploi ? 29. Y a-t-il d’autres thèmes centraux propres à votre ressort que le présent questionnaire n’aborde pas ?

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References Ajunwa I (2016) Genetics data and civil rights. Harv Civ Rights Civ Liberties Law Rev 51:75 Khoury L, Blackett A, Vanhonnaeker L (eds) (2020) Genetic testing and the governance of risk in the contemporary economy – comparative reflections in the insurance and employment law contexts. Springer, Berlin

Part II

Domestic Studies

Legal Aspects of Genetic Testing Regarding Insurance in Belgium Cindy Cornelis, Thierry Vansweevelt, and Britt Weyts

Abstract This chapter outlines the use of genetic testing for insurance purposes in Belgium. The content focuses on the legal framework by which genetic testing and, more broadly, genetic information is protected in Belgian law. One of the problems concerning the legal framework is the lack of conceptualization of the concepts “genetic testing” and “genetic information.” Besides the definition of concepts, the possibilities of disclosure and access to medical information are studied. Finally, the possible arguments for and against the collection of genetic information are examined.

1 Legal Framework The Belgian Insurance Act 20141 specifically regulates the use of genetic information and genetic testing. The use of genetic data in insurance has been prohibited by law since 1992. Article 58, paragraph 1 of the Insurance Act 2014 stipulates that “[g]enetic data may not be communicated.” Article 61, paragraph 3 states “[t]he medical examination, necessary for the conclusion and execution of the agreement, can only be based on the history of the current state of health of the prospective insured person and not on techniques of genetic research to predict the future state of health.” Article 61 always applies when a person’s health status is relevant to the conclusion or execution of an insurance agreement, regardless of whether it concerns life or non-life insurance.2

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Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014. Bill concerning insurance, Parlementaire Stukken Kamer 2013–14, nr 3361/1, 39.

C. Cornelis · T. Vansweevelt (*) · B. Weyts University of Antwerp, Faculty of Law, Antwerp, Belgium e-mail: [email protected]; [email protected]; [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_2

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The use of genetic tests and genetic information is prohibited to avoid any systematic prejudice against “the genetically weak” and prevent improper risk selection by the insurer. The prohibition aims to ensure social solidarity between the “genetically strong” and the “genetically weak.”3 The legislature also seeks to protect the private life and the right to privacy of the insured person and his/her family, in ascending, descending and lateral lines of relation, as genetic information about a person also reveals information about his/her family members. Their right to privacy could also be threatened by the communication of genetic data.4 Relatives’ genetic data are therefore also covered by the ban.5 The Belgian rule is clear: every use or communication of genetic data is prohibited.6 The absolute prohibition means that the insurer is de facto obliged to accept any genetic risk.7 The prohibition applies to any form of information about the policyholder’s genetic condition, regardless of how the insurer has obtained the information.8 The prohibition has a wide personal scope: it applies to the policyholder, the insured, the physician and the insurer.9 By determining that genetic data cannot be communicated, the legislature allows insurance applicants to conceal the fact that they are a carrier of a defective gene.10 Insurance applicants cannot be sanctioned for this concealment.11 The ban is absolute and affects the communication of both favorable and unfavorable data.12 The prohibition will always apply, even when policyholders give their consent to use the data.13

3 Amendments to the bill on the land insurance contract, Parlementaire Stukken Kamer 1990–91, 1586/4, p. 6; Report Verheyden to the bill on the land insurance contract, Parlementaire Stukken Kamer 1990–91, nr 1586/5, pp. 34 and 75–76; Report Monset to the bill on the land insurance contract, Parlementaire Stukken Senaat 1991–92, nr 306/2, p. 10; Wuyts (2013), p. 175; Vansweevelt (2015), pp. 28–29; PARIS and Callewaert (2015), p. 22; Schuermans and Schoubroeck (2015), p. 215; Fontaine (2016), p. 211. 4 Report Verheyden to the bill on the land insurance contract, Parlementaire Stukken Kamer 1990–91, nr 1586/5, p. 34; Report Monset to the bill on the land insurance contract, Parlementaire Stukken Senaat 1991–92, nr 306/2, pp. 8 and 31. 5 Paris and Callewaert (2015), pp. 22–23. 6 Rouvroy (2000), p. 589. 7 Troch (2003), pp. 53–54. 8 Paris and Callewaert (2015), p. 22. 9 Ponet et al. (1993), p. 430; Freriks (1994), p. 32; Claassens (1994), p. 43; Jeger and Cauwenbergh (1996–1997), p. 243; Troch (2003), p. 53; Wuyts (2014), p. 318; Schuermans and Schoubroeck (2015), p. 216; Vansweevelt and Weyts (2016b), p. 425. 10 Jacobs (1997), p. 31; Vansweevelt (2015), pp. 28–29. 11 Wuyts (2014), p. 318; Vansweevelt (2015), pp. 28–29. 12 Colle (2010), p. 309; Vansweevelt and Weyts (2016b), p. 425. 13 Freriks (1994), p. 32; Vansweevelt and Weyts (2016b), p. 427.

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The Belgian legislature is aware of the sensitive and specific nature of genetic data.14 This is evident from parliamentary records.15 Abuse of genetic information, for example, could lead to the stigmatization of minority groups, such as ethnic groups with common genetic defects.16 There is also recognition of the family, racial or ethnic character of genetic data.17 In a limited way, the legislature can be seen as having recognized the special status of genetic data. There is no consensus, however, on the degree of specificity of genetic data, and numerous authors dispute the separate treatment and the special status of genetic data.18 The problem, moreover, is the lack of enforcement. In the context of insurance, there are no sanctions when the prohibition is violated.19 It is only at a corporate level that the insurance company can be sanctioned by the inspection body, the Financial Services and Markets Authority (FSMA).20 Otherwise, the legislation does not set out sanctions of any kind. We might ask ourselves how the insurer can be prevented from using genetic data. For example, when a policyholder discloses a favorable result, how can the insurance company be prevented from granting a premium reduction?21 Despite the lack of enforcement in the Insurance Act 2014, the Anti-Discrimination Act indirectly provides a means to address and prevent violations of the prohibition, as discussed below. The Belgian legislature has adopted the same approach in the context of employment. Using predictive genetic research to obtain information about the health of a job applicant or employee is explicitly prohibited for any reason other than to check whether he/she is suitable for a particular job.22 However, in this context, exceptions are possible by Royal Decree. Special dispensation can be granted by the legislature via Royal Decree in specific situations to conduct genetic testing. It is possible that

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Guldix et al. (1994), p. 74. Report Verheyden to the bill on the land insurance contract, Parlementaire Stukken Kamer 1990–91, nr 1586/5, p. 34; Report Monset to the bill on the land insurance contract, Parlementaire Stukken Senaat 1991–92, nr 306/2, pp. 8 and 31. 16 Tack and Dierickx (2008–2009), pp. 387–388. 17 Guldix et al. (1994), p. 74; Tack and Dierickx (2008–2009), p. 388. 18 Guldix et al. (1994), p. 74; Jacobs (1997), pp. 28–29; Rouvroy (2000), p. 600. 19 Deberdt (1994), p. 82. 20 Wuyts (2014), pp. 319–320. 21 Fagnart (2011), pp. 145–146. 22 The same prohibition applies to AIDS–tests. Act of 28 January 2003 concerning medical examinations that are carried out within the framework of industrial relations, Belgian State Gazette, 9 April 2003, Art 3, para 1: 15

The biological tests, medical examinations or oral questions to obtain medical information about the health status or genealogical information of an employee or job applicant may not be performed for reasons other than those related to the current suitability of the employee for and the specific characteristics of the vacancy. Pursuant to this principle and without prejudice to the provisions of chapter IV, predictive genetic testing and AIDS tests are prohibited. Plets (2003), p. 618; Essers (2005), p. 14; Van Eeckhoutte (2017), p. 494.

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certain genetic diseases can affect an employee’s work duties and pose a danger to the employee and others, for example pilots, nurses or employees transporting people or goods.23 Up until now there is no Royal Decree that determines under which exceptional conditions examinations can take place. Without a Royal Decree, predictive genetic research is prohibited.24 In the employment context, violating the law results in criminal sanctions.25 Protection against the use of genetic testing in the contexts of insurance and employment is also provided by the Anti-Discrimination Act.26 The AntiDiscrimination Act creates a general framework to combat discrimination based on certain protected criteria by punishing discriminatory behaviour.27 The law explicitly forbids the use of genetic information to discriminate.28 Genetic discrimination, like discrimination on the basis of race or gender, is prohibited since, in both cases, the discrimination is based on unchanging, inherent characteristics and not on the basis of skills or qualifications. There is, however, no published case law in Belgium on genetic discrimination. As far as the regulation of genetic data in the Insurance Act 2014, the Medical Examination Act and the Anti-Discrimination Act goes, there is no specific legislation on (the use of) genetic testing or the information derived from the tests. There is no general legal framework specifically aimed at collecting and using genetic data.29

2 Legal Conceptualization of Genetic Information and Testing 2.1

Legal Definition

Articles 58 and 61 of the Insurance Act 2014 prohibit the use of genetic information. The concepts of genetic information and genetic testing, however, are not defined in

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Report to the bill concerning medical examinations that are carried out within the framework of industrial relations, Parlementaire Stukken Kamer 2002–03, 2133/002, p. 3; Handelingen Senaat 2002–03, 14 November 2002, nr 2–241, p. 27; Plets (2003), p. 619. 24 Van Eeckhoutte (2017), p. 494. 25 Act of 28 January 2003 concerning medical examinations that are carried out within the framework of industrial relations, Belgian State Gazette, 9 April 2003, Art 9; Social Criminal Code of 6 June 2010, Belgian State Gazette, 1 July 2010, Art 117. 26 Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette 30 may 2007. 27 Van Eeckhoutte (2017), p. 1267. 28 Art 3 Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette 30 may 2007 refers to “a physical or genetic characteristic.” 29 Schuermans and Schoubroeck (2015), p. 628; Defloor and Nys (2011), p. 496.

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the Insurance Act 2014.30 It is problematic that the legislature did not define these concepts. It is not clear what is meant by the terms “genetic data,” “techniques of genetic research” or “predictive genetic research” used in these articles.31 However, the accurate interpretation of these concepts is important because they determine the scope of the legal regime.32 The lack of definition begs a variety of questions. Does the term genetic data include genetic predisposition?33 Do “genetic research techniques” include genetic data that are discovered accidentally during medical examinations?34 Are genetic data different from medical data and, if so, what is the difference, for example, between genetic data and an individual’s medical history?35 In addition, advances in genetics make the distinction between what is genetic and what is not more difficult. Certain disorders, such as Huntington’s disease and cystic fibrosis, are clearly genetic in nature. Other common conditions are not so easily defined. For example, distinctions are blurred when a faulty gene is the cause of a classical disorder.36 The distinction between genetic data and other health data, therefore, seems arbitrary when all diseases are, in part, caused by genetic factors.37 The only legal definition that applies in Belgium is the one in the General Data Protection Regulation (GDPR).38 The GDPR regulates the collection and processing of data. According to the GDPR, genetic data are “personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question.”39 It remains to be seen whether this definition will suffice in insurance matters.

30

Schuermans and Schoubroeck (2015), p. 215. The Medical Examination Act 2003 also does not define the concept of genetic information and testing. 31 Freriks (1994), p. 32; Hautenne (2003–2004), p. 222; Schamps (2003–2004), p. 141; Wostyn et al. (2009), p. 145; Wuyts (2013), p. 176; Vansweevelt and Weyts (2016b), p. 426. 32 Rouvroy (2000), p. 589. 33 Jeger and Cauwenbergh (1996–1997), p. 248. 34 Troch (1993–1994), p. 1299. 35 Troch (2003), p. 54; Wuyts (2014), p. 318; Vansweevelt (2015), p. 29. 36 Jeger and Cauwenbergh (1996–1997), pp. 249–250; Vansweevelt and Weyts (2016b), p. 426. 37 Rouvroy (2000), p. 600. 38 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, pp. 1–88. 39 Art 4, 13 of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016.

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Contractual Definition

In the absence of a legal definition, the contracting parties can agree to a contractual definition. The principle of contractual freedom applies. This means that individuals are free to sign contracts, to choose their contracting parties and to determine the contents of the agreements.40 Contracting parties can, therefore, define the meaning of relevant concepts in their agreement.41 Contractual freedom, however, is limited by public order, good morals or provisions of imperative law.42 Imperative laws, such as section 4 of the Insurance Act 2014,43 can contain prohibitions and injunctions, and they can limit how a contract’s content can be determined.44 Although the Insurance Act 2014 does not specifically define genetic information, the imperative character of article 61 aims to protect the policyholder against the use of genetic data. When a contractual definition is so strict that the protection of the consumer is non-existent, this is contrary to the ratio legis. Such a definition might then be considered a violation of a rule of imperative law.

3 Disclosure of and Access to Medical Information What are the rules for disclosing and accessing medical information, more specifically genetic information? In the absence of a general legal framework, lex specialis provides for the protection of genetic information in certain branches of the law.

3.1

Criminal Code

Based on article 458 of the Criminal Code, a physician is bound by professional confidentiality. Some believe that with the patient’s consent, information can be disclosed to third parties.45 They apply a functional interpretation of the duty of confidentiality: since article 458 protects the interests of the patient, he/she can

40

Cass 23 December 1977, Arresten van het Hof van Cassatie 1978, 509; Pasicrisie belge 1978, I, 480; Vanackere et al. (2016), p. II.4-18. 41 Vanackere et al. (2016), p. II.4-20. 42 Van Ommeslaghe (2013), p. 173; Feltkamp (2013), pp. 9–10; Vanackere et al. (2016), pp. II.420b–II.4-21. 43 Section 4, art 56 of the Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014. 44 Wery (2014), p. 306; Vanackere et al. (2016), pp. II.4-20b–II.4-21. 45 Van Neste (1989), p. 191; Ponet et al. (1993), p. 428; Nys (2005), p. 564; Goffin (2007–2008), p. 1316; Blockx (2011–2012), p. 115; Callens et al. (2015), p. 378.

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renounce his/her right and give the physician permission to make the data known to third parties.46 Others disagree and apply a more absolute interpretation. The duty of confidentiality indeed exists to protect the individual interest. Primarily, however, it exists in the public interest and only as an ancillary in the individual interest.47 Criminal law, and the duty of professional confidentiality, has a public order character and private individuals cannot deviate from this by private agreement.48 The patient’s consent cannot exempt the physician from his/her duty of professional confidentiality and cannot cancel the unlawfulness of the violation.49 Clearly, under Belgian law, discussion endures about whether or not consent can be used as a justification.50 In the context of insurance, however, it is clear: the insurance applicant’s consent to use genetic information is not accepted.51

3.2

Patient Rights Act

Prior to any medical intervention, the patient has the right to health information and the right to informed consent.52 Before the patient can give his/her consent, the health care professional has an obligation to provide all the information required to be able to consent in full knowledge.53 Given the potential major impact of the test results, all types of associated information in genetic research is of great importance, for example: the destination of DNA samples, confidentiality, access to the medical file, methods of managing genetic data relating to family members and third parties,

46 Ponet et al. (1993), p. 427; Dijkhoffz (2002–2003), pp. 88–89; Nys (2005), p. 564; Colle (2015), p. 240; Blockx (2011–2012), p. 114; Blockx (2013), pp. 173–174. 47 Van Der Straete and Put (2005), p. 37; Dierickx et al. (2014), pp. 588–589. 48 Cass 30 October 1978, Arresten van het Hof van Cassatie 1978–79, 235, Revue générale des assurances et des responsabilités 1980, nr 10.272; Stevens (2002–2003), p. 2; Van Den Wyngaert and Vandromme (2009), p. 270; Dierickx et al. (2014), pp. 677–678 and 680. 49 Labor Court Bergen 5 September 1980, Informatieblad RIZIV 1981, p. 151, noot R Grosemans, Journal des Tribunaux 1980, p. 742, noot R Grosemans, Journal des Tribunaux du Travail 1981, p. 107, Rev dr pén 1981, p. 99, noot, Tijdschrift voor Sociaal Recht 1981, p. 71; Verhaegen and Herveg (2002), pp. 116 and 120; Vanheeswijck (2011), p. 345; Dierickx (2014), p. 186. 50 Code of Medical Duties of 1975, Belgian National Council Of Physicians, old Art 64; Nys (1989), p. 239; Van Der Straete and Put (2005), p. 188; Dierickx et al. (2014), p. 678; Fontaine (2016), pp. 235–236. 51 Freriks (1994), p. 32; Vansweevelt and Weyts (2016b), p. 427. 52 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Arts 7 and 8. 53 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 8, para 2: “The purpose, nature, degree of urgency, duration, frequency, relevant contraindications, side effects and risks associated with the intervention, aftercare, possible alternatives and financial consequences.”

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and information about social and societal consequences, such as employment and insurance.54 Every patient has a right to access his/her medical file. This right to access applies to all the data and documents that make up the file.55 The patient also has a right to receive a copy of the file.56 There are two exceptions: the patient does not have access to the physician’s personal notes and to data concerning third parties.57 With the consent of the patient or his/her confidant or representative, staff members of care institutions and the general practitioner also have access to a patient’s file.58 The patient has the right to know who accessed or consulted his/her medical file.59 The Patient Rights Act provides protection by excluding third parties from access to medical records.60 Insurers or employers cannot obtain knowledge about the genetic information of the prospective policyholder or employee, which could reveal sensitive information not only about the subject of the record, but also his/her relatives. However, after the patient has died, an indirect right of access is granted to the spouse, legally cohabiting partner or partner, as well as relatives up to and including the second degree. The right of access is exercised by a physician provided that the person wishing to access the medical file submits an adequately justified and specific request for access and that the patient has not explicitly opposed this access.61 After the patient’s death, there is no right to copy the file.62 So, in principle, the insurer has no right of access. The next of kin could, however, exercise their right to access with a consulting physician of the insurance company. This is not a problem when all parties have the same interests. However, it can become problematic when the insurance company has a conflict of interest and wants

54 VLD (1996), p. 25; Cassiman (2004), p. 199. This is also emphasized in art 12 of the Convention on Human rights and Biomedicine, which requires an appropriate genetic counseling in addition to informed consent. 55 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9, para 2; Vansweevelt (2014), p. 494. 56 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9, para 3. 57 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9, para 2. 58 Vansweevelt (2014), pp. 500–502. 59 European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted 4 November 1950, entered into force 3 September 1953, CETS no 005, Art 8; Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 15; Vansweevelt (2014), pp. 495–496. 60 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9; Vijverman (2013), p. 58; Vansweevelt (2014), p. 546. 61 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9, para 4; Vansweevelt (2014), pp. 522–529. 62 Vansweevelt (2014), p. 541.

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to circumvent article 61 of the Insurance Act 2014.63 An example would be that the insurance company refuses to pay out because it believes the insured person lied about his/her medical history and wants to collect evidence by accessing the patient’s file. The Belgian National Council of Physicians has stated that it is ethically unacceptable for a consulting physician of an insurer to assist the next of kin in inspecting the deceased’s file with the aim of circumventing article 61.64 Nonetheless, the insurer can try to access the patient’s file via other techniques. When the patient is alive, the insurer can simply ask for a copy of his/her medical records. The patient is entitled to a copy of the file, and can decide if he/she wants to hand it over to the insurer.65 However, the physician may refuse to issue a copy if he/she has clear indications that the patient has been pressured by an insurer to obtain a copy.66 In the context of legal proceedings, the insurer can request an expert’s report in which the court expert will have to request the patient’s file. In this way, the insurer is given indirect access to the file.67 The insurer may also ask the court to add a relevant document to the case file if there are “serious, certain and consistent suspicions that a party or a third party has a document in its possession that contains evidence of a relevant fact,” for instance the patient’s medical file.68 Finally, after the patient has died, certain relatives can get information about the health of the insured based on their right to access the patient’s medical files with the help of a physician.69 They are not entitled to a copy, but the physician can take notes from the patient file.70 The relatives can give these notes to the insurer. In all circumstances, the application of article 61 of the Insurance Act 2014 should be kept in mind. The insurer may not ask for genetic information and the physician or policyholder may not disclose it.71

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Vijverman (2013), p. 58. Belgian National Council Of Physicians (2006). 65 Vansweevelt (2014), p. 550. 66 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9, para 3, s 2; Colle (2015), p. 240. 67 Vansweevelt (2014), p. 548. 68 Judicial Code of 10 October 1967, Belgian State Gazette, 31 October 1967, Art 877. 69 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 9, para 4. 70 Vansweevelt (2015), p. 38. 71 Report Verheyden to the bill on the land insurance contract, Parlementaire Stukken Kamer 1990–91, nr 1586/5, p. 76; Report Monset to the bill on the land insurance contract, Parlementaire Stukken Senaat 1991–92, nr. 306/2, pp. 8 and 10; Vansweevelt and Weyts (2016b), p. 425. 64

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Insurance Act 2014

As explained above, the Insurance Act 2014 provides protection by introducing a complete and absolute prohibition on requesting and communicating genetic information in connection with the conclusion or execution of an insurance contract.72 When closing an insurance contract, the insurer needs information to evaluate the risk. If the insurance applicant is alive, the following safeguards apply to protect his/her health data: (1) the physician can only issue a statement at the insured person’s request, (2) the physician is chosen by the insured person, (3) the medical certificate must be required for concluding or executing the contract, (4) the physician may only issue the medical certificate to the insured person, (5) the declaration must be limited to a description of the current state of health and (6) the insured person can only deliver the statement to the consulting physician of the insurer.73 The insured must personally request the medical certificate; the insurer or family members cannot request this.74 After the insured person’s death, the insurer can also have an interest in information about the cause of death. Article 61, paragraph 4 of the Insurance Act 2014 regulates the post mortem certificate. The legislature also provides legal guarantees here: (1) the insurer must obtain the insured person’s prior consent, (2) the physician of the insured person delivers the medical certificate on the cause of death and (3) it is delivered to the consulting physician of the insurer.75 This only applies to a post mortem certificate and not a copy of the patient file. A copy of the complete file would constitute a violation of professional confidentiality.76 The question arises whether heirs and other beneficiaries can give the physician permission to disclose information. In Belgium, there is controversy about the possibility of substitute permission. On the one hand, some argue that the right of the insured to relieve the physician from his/her professional confidentiality could be regarded as a personal and extra-patrimonial right. The consent of third parties cannot relieve the physician from his/her professional confidentiality. So, the physician may not submit a death certificate at the request of a family member.77 On the other hand, some contend that family members could give substitute permission if the interests of the insured person and those of the surviving relatives coincide, or at least if the interests of the deceased would not be harmed.78

72

Art 58 jo 61 of the Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014. Art 61, paragraphs 1 and 2 of the Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014; Defloor (2014), p. 147. 74 Defloor (2014), p. 147. 75 Art 61, para 4 of the Insurance Act of 4 April 2014, Belgian State Gazette 30 April 2014; Vijverman (2013), pp. 58–59; Vansweevelt (2014), p. 547. 76 Vansweevelt (2014), p. 547. 77 Antwerp 16 February 2005, Rechtskundig Weekblad 2007–08, p. 33; Antwerp 22 October 2014, Tijdschrift voor Gezondheidsrecht 2014–15, noot T Vansweevelt; Defloor (2014), p. 37. 78 Weyts (1997–1998), p. 331; Vansweevelt (2015), p. 37. 73

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Nevertheless, under article 61 of the Insurance Act 2014, the insurer may never request or use genetic information. If it asks the relatives of the insured to disclose genetic information, it violates the law.

4 Arguments for and Against the Collection of Genetic Information The prohibition of the use of genetic information in insurance has been criticized in Belgian literature. There are both proponents and opponents to the prohibition. Proponents of the use of genetic information are often insurers. The opponents are mostly geneticists. Both sides present valid arguments.

4.1 4.1.1

Justifications for the Collection of Genetic Information Technical Aspects of Insurance

Insurers argue that they should have the option to differentiate premiums. Insurers must be able to implement a segmentation policy. This implies that they need to be able to balance the premium and the risk on the basis of the actuarial principles. If insurers do not have all the relevant information, the premium for a certain risk cannot be estimated well and be adapted to the situation. This is based on the principle that equal situations must be treated the same, and unequal situations must be treated differently.79 This is actuarial fairness. The prohibition disregards this principle.80 The fact that insurers cannot take genetic information into account may have important consequences. When a person has a hereditary condition, he/she would, in principle, pay a higher premium for whole-life insurance (“overlijdensverzekering”) and a lower premium for life insurance (“overlevensverzekering”).81 Since the insurer cannot use this information, it will take into account the possibility that a

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Guldix et al. (1994), pp. 133–134; Desmet (2005–2006), pp. 509–510; Fontaine (2016), p. 206. Goessens (2018), p. 161; Fontaine (2016), p. 211. 81 Life insurance in Belgium covers death or non-death. Life insurance can be an “overlijdensverzekering”, an “overlevensverzekering” or a combination of both. Death insurance, “overlijdensverzekering”, covers the risk of death. When the insured dies, the insurer will pay out the insurance performance. With life insurance, “overlevensverzekering”, it is not the risk of death that is covered but the risk of longevity. The life insurance policy can pay out a capital on reaching a certain age, often 65 years, or may provide for the payment of an annuity from a certain moment until the end of life. Barbaix (2016), pp. 839–840. The combination of both insurance types (“gemengde levensverzekering”) is also possible but does not change the foregoing. 80

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policyholder has a genetic disorder.82 Instead of a standard rate with additional premiums for those who pose a higher risk, a general rate is used that takes into account the greatest risks, with the possibility of negotiating a lower premium.83 All policyholders pay the same higher premium, based on the average risk. Policyholders with a “good” risk will then switch to an insurer that differentiates on the basis of genetic information to receive a lower premium. Insurers then claim that policyholders with a “bad” risk go to an insurer that does not differentiate on the basis of genetic information. The premium will still be lower than when it is differentiated. This insurer will attract “bad risks”. As a result, it will receive more claims with more or higher reimbursements. To compensate for this, the premiums will be raised, which causes even more “good risks” to leave the pool. This creates a vicious cycle. This is something various authors fear will happen.84 In the same line but on a larger scale, from a wider territorial point of view, the ban may also result in “good risks” taking out insurance in countries where the premium is determined considering genetic profiles. “Bad risks” that do not receive insurance in their countries may come to Belgium to get insurance, resulting in increasingly expensive insurance policies.85 Insurers, therefore, argue that if they are no longer able to differentiate premiums, their competitive position on the free market will be jeopardized.86 Private insurance is a service that, in contrast to social security, can only be used by paying a fee that is proportionate to the risk.87 In addition, in the context of insurance, the possibility that a risk will materialize must be uncertain. When it is certain that a genetic disease will occur, the risk is, in principle, not insurable. This is sometimes expressed as: a burning house cannot be insured.88 To that end, it can also be argued that the prohibition ignores the fact that developments in genetics have no influence on the element of chance.89 The element of chance is the same as with other medical data, as there is uncertainty about the development of most genetic disorders. The risk assessment based on genetic and classical medical data must, therefore, be the same. Since the influence on the element of chance is limited, the same actuarial and legal principles can be applied.90

82

Guldix et al. (1994), p. 134; Desmet (2005–2006), pp. 509–510. Fagnart (2011), p. 146. 84 Freriks (1994), p. 33; Guldix et al. (1994), pp. 133–134; Troch (2003), p. 55, footnote 5; Desmet (2005–2006), pp. 509–510; Goessens (2018), p. 119. 85 Fagnart (2011), p. 146. 86 Guldix et al. (1994), p. 133; Desmet (2005–2006), p. 509. 87 Fagnart (2011), p. 145. 88 Emeritiforum (2012), p. 3. 89 Jeger and Cauwenbergh (1996–1997), p. 248. 90 Jeger and Cauwenbergh (1996–1997), pp. 252–253. 83

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Asymmetric Information and Adverse-Selection

The most important argument upon which insurers rely is that of adverse-selection, or anti-selection. When concluding an insurance contract, the insurer does not have the same information as the policyholder. It is important that both parties have equal information.91 To solve this problem, the spontaneous obligation to provide information applies to policyholders. However, due to the fact that genetic data does not have to be communicated, an information asymmetry arises again, and the insured has an advantage over the insurer.92 Policyholders know, consciously or unconsciously, more about their genetic risks than the insurer.93 Due to the fact that the insurer does not receive information about genetic risks, there is a risk of adverse-selection, or anti-selection.94 Adverseselection means that prospective policyholders who realize that they have a high risk and expect this risk to materialize in the future will be more likely to purchase insurance whereas those with a low risk are less likely to do so.95 This is especially problematic when policyholders decide for what amount they want to be insured.96 Policyholders who know that they are genetically disadvantaged can obtain an unjustified advantage based on their prior knowledge by taking out insurance policies at very high amounts at the community’s expense. The premium is based on the average risk, whereby a low premium is determined by, and the losses for the insurer distributed among, all policyholders.97 This can lead to an increase in the amounts of reimbursements, which increases the premiums and causes the policyholders with “good risks” to leave the pool. Adverse-selection allows the policyholder to purchase insurance with a higher level of insurance benefits while being protected by the right to remain silent or even lie.98 Solidarity should not go so far that policyholders can abuse their knowledge and allow the community to pay for it.99 The solidarity obligation applies to the community and the social security system, and should not be borne by private insurers alone.100

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Jacobs (1997), p. 21. Jacobs (1997), pp. 21 and 33; Rouvroy (2000), p. 597; Desmet (2005–2006), pp. 511–512. 93 Jacobs (1997), p. 21; Troch (2003), p. 55; Fontaine (2016), pp. 206–207. 94 Nys (1992), p. 212; Guldix et al. (1994), p. 141; Rouvroy (2000), p. 588; Troch (2003), p. 55; Vansweevelt and Weyts (2016b), p. 425. 95 Jacobs (1997), p. 22; Rouvroy (2000), p. 588; Raeymaekers (2001), p. 137; Vansweevelt and Weyts (2016b), p. 425. 96 Jacobs (1997), p. 22. 97 Nys (1992), p. 212; Freriks (1994), p. 33; Jacobs (1997), pp. 22 and 33; Raeymaekers (2001), p. 137. 98 Rouvroy (2000), p. 597. 99 Jacobs (1997), p. 22. 100 Cassiers and Vermeersch (2000), p. 31. 92

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Insurers cannot protect themselves in any way against this risk of adverseselection unless they are allowed to ask questions about, and segment premiums on the basis of, genetic data.101 The ban is, by this argument, unbalanced and unacceptable, and must be changed.102

4.1.3

Discrimination

The legislature wanted to avoid genetic discrimination and ensure that people with genetic disorders would not face difficulties when concluding an insurance contract because of this abnormality. Belgian law defines direct and indirect discrimination. Direct discrimination is a direct distinction based on a protected criterion that cannot be justified. A direct distinction is the situation that occurs when one is treated less favorably than someone else or has been treated in a comparable situation based on one of the protected criteria.103 Indirect discrimination is an indirect distinction based on a protected criterion that cannot be justified. An indirect distinction arises when a seemingly neutral provision, measure or practice may particularly disadvantage persons characterized by a certain protected criterion compared to other persons.104 However, prohibiting discrimination does not only mean that equal cases are treated the same; unequal cases must also be treated differently.105 Discrimination occurs when people in the same factual circumstances are treated differently. Individuals in different situations who are treated differently are, therefore, not discriminated against if the difference in treatment is not based on an opinion about the person’s superiority or inferiority because of a certain characteristic. Individuals with the same genetic abnormality who pay a higher premium than people without this abnormality are, therefore, not discriminated against. The difference in premium is justified by an objectively observable difference.106 Systemic discrimination however, is not allowed. For example, insurers used to systematically refuse to provide health insurance to individuals, mostly women, who had breast cancer in the past. This is a type of prohibited indirect discrimination on a systemic basis.

101

Nys (1992), p. 216; Troch (1993–1994), p. 1299; Freriks (1994), pp. 33–34; Vansweevelt and Weyts (2016a), p. 47. 102 Freriks (1994), p. 34. 103 Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette, 30 May 2007, Art 4, 6 –7 . 104 Act of 10 May 2007 to combat certain forms of discrimination, Belgian State Gazette, 30 May 2007, Art 4, 8 –9 . 105 European Court of Human Rights, Case relating to certain aspects of the laws on the use of languages in education in Belgium, 23 July 1968, application no 1474/62; 1677/62; 1691/62; 1769/ 63; 1994/63; 2126/64; Arbitragehof, decision no 4/92 of 23 January 1992; Velaers (2007), pp. 86, 88 and 93; Vansweevelt and Weyts (2016a), p. 47. 106 Guldix et al. (1994), p. 143.

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In purely technical-actuarial terms, discrimination is, therefore, not an argument to prohibit the use of genetic information.107 By applying segmentation, unequal treatment and discrimination are prevented.108 Actuarial equality is perfectly compatible with differential treatment based on genetics when the criteria used are not arbitrary, but objective. If the increased premium corresponds to increased risk attributable to genetic characteristics, there is no problem from an actuarial point of view.109

4.1.4

Scientific Progress

Finally, genetics is still evolving.110 In the context of insurance law, this can cause problems regarding the prohibition. With an increasing number of diseases determined to have a genetic origin, what aspects of the policyholder’s state of health will be permitted in communications to the insurer?111 In principle, frequently occurring illnesses will be excluded from the duty to disclose if they have a genetic origin. There is a risk that the protection will then shift from genetic risks to medical data in general. This will undermine the underwriting freedom of insurers.112

4.2 4.2.1

Objections to the Collection of Genetic Information Consequences for Research and Health Care

The use of genetic data for insurance purposes could have a negative impact on the willingness of individuals to undergo genetic testing, due to fear that the results will be communicated to the insurer, even if such testing could provide life-saving information.113 Responsible individuals would be punished. If they were required to reveal their negative results, they would risk being disadvantaged in contrast to persons who did not undergo testing. This may ultimately entail no one wanting to undertake his/her medical responsibility: “ignorance is bliss.”114 It may even result in family members of a policyholder who know that he/she has a certain condition no longer wanting to be tested out of fear of the insurance consequences.115 This might

107

Guldix et al. (1994), p. 143; Salomons (1998), p. 167. Vansweevelt and Weyts (2016a), p. 47. 109 Rouvroy (2000), p. 594. 110 Freriks (1994), p. 29. 111 Schuermans and Schoubroeck (2015), p. 216, footnote 51. 112 Van Hoyweghen (2010), p. 444. 113 Nys (1992), pp. 212–213; Freriks (1994), p. 29; Troch (2003), p. 52; Jorde et al. (2015), p. 318. 114 Jacobs (1997), p. 24; Desmet (2005–2006), pp. 517–518. 115 Evers-Kiebooms and Welkenhuysen (2005), p. 27. 108

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even have implications for scientific research. When individuals fear that their genetic information might be used by insurers and refrain from genetic testing, they will probably no longer participate in scientific research either. Nevertheless, scientific research is important for the improvement of genetics. It is argued that when no one wants to be examined anymore, the genetic truth fades into the background.116 In this way, the right to require genetic testing not only obstructs access to insurance, but also to health care.117 The unwillingness to undergo testing can also have consequences for the health of the general population. Hereditary diagnoses can be used to make early diagnoses, which allow the patient to adjust his/her behavior so that the illness is inhibited or even prevented. Though in certain cases total prevention is not possible, based on this knowledge, the patient can make important decisions, for example about reproduction.118 The long-term consequences to society can also be detrimental. When someone has knowledge of the fact that he/she is a carrier, he/she can act on this and, after a while, this can ensure that a disease occurs less frequently or even disappears.119

4.2.2

Value of Genetic Information

Scientific progress has significantly increased the predictive value of genetic data. This knowledge will only increase, and many genes will be discovered that are the cause of certain disorders.120 In the future, it is likely that every individual will be fully screened for the most common genetic disorders. The desire to use this information will, therefore, increase.121 However, genetic information does not always offer complete certainty. The predictive value of the information is only (almost) certain in a limited number of cases. Usually it provides merely the chance—a probability—of a certain disease developing.122 Many genetic disorders are multifactorial or multi-genetic. It may not be clear what the seriousness of the disease will be or when it will manifest, if ever. With autosomal dominant disorders, for example Huntington’s disease, there is certainty or high probability that the condition will manifest later in life. But even in those cases, there remains uncertainty about when precisely and to what extent the

116

Desmet (2005–2006), p. 518. Nys (1992), pp. 212–213; Troch (2003), p. 52. 118 Jacobs (1997), p. 23. 119 Jacobs (1997), p. 24. 120 Nys (1992), p. 209. 121 Nys (1992), p. 209; Cassiman et al. (2000), p. 68. 122 Rouvroy (2000), p. 595; Fagnart (2011), pp. 143–144; Vansweevelt (2015), pp. 28–29. 117

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disease will manifest.123 Genetic predispositions should, therefore, not affect the assessment.124 As such, the importance and value of genetic information is overestimated.125 For example, if the presence of BRCA1/2 is confirmed, the risk for the insurer hardly increases. The patient follow-up is better, and prevention is improving.126 For example, the patient is monitored better with intermediate check-ups. When a carcinoma is discovered, immediate intervention is possible, preventing metastases. When a patient decides she does not want to take the risk, she can take preventive measures by having a mastectomy. All these measures ensure that advanced cancer is avoided and the insurer does not have to reimburse the high costs of cancer treatment.

4.2.3

Genetic Discrimination

One of the Belgian legislature’s reasons for introducing the ban was to avoid genetic discrimination. If genetic data is used as a selection criterion, it is feared that this would lead to an ever-increasing differentiation between policyholders based on individual predispositions. This would result in increasing individualization in insurability and insurance conditions, which allows for the danger of genetic discrimination.127 This could eventually lead to a dichotomy in society between the “genetically strong” and the “genetically weak.”128

4.2.4

Personality Rights

Genetic data are highly personal. They are immutable, do not age and are an integral part of a person’s life from birth. When they are made public, this is a serious violation of personal privacy.129 Thus, insurers who use genetic tests as a negative recruitment tool violate the privacy of the individual.130 Additionally, the obligation to undergo a genetic test that uncovers an untreatable genetic condition can be a psychologically heavy burden that violates psychological

123 Jeger and Cauwenbergh (1996–1997), p. 252; Rouvroy (2000), pp. 586 and 595; EversKiebooms and Welkenhuysen (2005), p. 24; Fagnart (2011), p. 144. 124 Jeger and Cauwenbergh (1996–1997), p. 254. 125 Remans (2005), pp. 156–157. 126 Emeritiforum (2012), p. 4. 127 Nys (1992), p. 212; Jacobs (1997), p. 24; Colle (2010), p. 309; Defloor and Nys (2011), p. 498. 128 Guldix et al. (1994), p. 139; Evers-Kiebooms and Welkenhuysen (2005), p. 27. 129 Guldix et al. (1994), p. 137; Desmet (2005–2006), pp. 513–514; Calcoen (2012). 130 Troch (2003), p. 52; Evers-Kiebooms and Welkenhuysen (2005), p. 27.

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integrity.131 This is also a violation of privacy.132 It is unfair to confront a person with such new information that is unchangeable for the rest of his/her life.133 To that end, it would be irresponsible to allow insurers to impose such inquiries for their own economic purposes, and thereby expose policyholders to psychological risks.134 In addition to the right to privacy, other personality rights are affected when people are required to share genetic information. A person’s right to selfdetermination is threatened when he/she cannot freely choose whether he/she wants to receive certain information or not.135 Everyone has the right to acquire information about his/her state of health. Genetic information is included in this right to information, even where no curative therapy exists.136 But, a patient always has the right to decide that he/she does not want to receive certain information. Accordingly, the right to self-determination can also be formulated in a negative way as the right not to know one’s genetic profile.137 No one can oblige the patient to receive certain information. The duty to inform becomes a duty to not inform.138 Genetic information about a patient also provides information about his/her family members. These family members also have the right to choose not to want to know this information. Based on the right not to know, no one can be forced to undergo genetic research. The decision to undergo a genetic examination must be taken freely, without external pressure, such as from an insurer.139 When this testing becomes a precondition for an applicant to contract for necessary insurance, this free consent comes under attack. Exerting pressure to undergo a genetic examination to qualify for insurance may constitute a disproportionate infringement of the right to self-determination. In the context of hereditary research, this also means that having to undergo non-voluntary research can infringe one’s private life, particularly because a person can be confronted with serious health risks for which there is no prospect of prevention or treatment.140 However, nuance is required insofar as the right to self-determination

131

Guldix et al. (1994), pp. 140–141; Desmet (2005–2006), p. 517; Calcoen (2012). Nys (1992), p. 213. 133 Guldix et al. (1994), p. 141; Desmet (2005–2006), p. 517. 134 Guldix et al. (1994), p. 141. 135 Guldix et al. (1994), p. 137. 136 Bill concerning the rights of the patient, Parlementaire Stukken Kamer 2001–02, nr 1642/001, p. 20; Vanderhulst (2015–2016), p. 329; Vansweevelt and Tack (2014), p. 335. 137 Act of 22 August 2002 concerning the rights of the patient, Belgian State Gazette, 26 September 2002, Art 7, para 3 and Art 8, para 3; Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164, Art 10, paras 2–3; Vansweevelt and Tack (2014), p. 342. 138 Bill concerning the rights of the patient, Parlementaire Stukken Kamer 2001–02, nr 1642/001, p. 22; Craeynest and Cokelaere (2007), p. 295. 139 Hillen (1991), p. 971; Nys (1992), p. 213; Troch (1993–1994), p. 1298, footnote 212. 140 Bill concerning the rights of the patient, Parlementaire Stukken Kamer 2001–02, nr 1642/001, p. 22; Nys (1992), p. 213; Dijkhoffz (2003–2004), p. 105; Nys (2010), p. 50; Panis (2015), p. 401. 132

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is also limited by the law itself. Because of the absolute prohibition, policyholders are also prevented from communicating positive results to the insurer when they want to.141 In the context of insurance and employment, the fact that everyone has the right not to know his/her genetic passport is an argument to prohibit the use of genetic information.142

4.2.5

Contractual Freedom

In the context of non-compulsory insurance contracts, everyone is free to choose whether or not to purchase the insurance.143 When the conclusion of the insurance contract is linked to the condition that the policyholder shares genetic information, he/she has the free choice whether or not to conclude the contract. Policyholders must decide for themselves whether or not they want to give up their privacy.144 Based on the right to self-determination, individuals have the right not to be subjected to testing to which they did not consent.145 They can always refuse to undergo this examination.146 The question, however, is whether there truly is freedom and free choice.147 Policyholders are not always in a position to refuse, as a result of which the free consent comes under question.148 For example, obtaining a mortgage is often linked to obtaining life insurance. Since most people are unable to buy or build a home without a loan, the borrower’s free choice is thereby limited.149 In such cases, policyholders will probably provide the information required to purchase the insurance despite a preference to keep this information private.150 It is, therefore, often morally or financially mandatory to purchase insurance and to give up part of one’s privacy.151 Were pressure exerted on policyholders to undergo a genetic test in order to qualify for insurance, this would constitute a disproportionate infringement of the

141

Goessens (2018), pp. 150–151. Bill concerning the medical examinations that are carried out within the framework of labor relations, Parlementaire Stukken Senaat 2002–03, 2–20/4, 3; Handelingen Senaat 14 November 2002, 2–241, p. 29; Hillen (1991), p. 971; Nys (1992), p. 213; Troch (1993–1994), p. 1298, footnote 212; Vansweevelt and Tack (2014), p. 342. 143 Jacobs (1997), pp. 22–23; Desmet (2005–2006), pp. 513–514. 144 Desmet (2005–2006), pp. 513–514; Fagnart (2011), p. 144. 145 Nys (1992), p. 213. 146 Guldix et al. (1994), p. 137. 147 Jacobs (1997), pp. 22–23; Desmet (2005–2006), pp. 513–514. 148 Nys (1992), p. 213; Rouvroy (2000), p. 600. 149 Desmet (2005–2006), pp. 513–514. 150 Jacobs (1997), pp. 22–23. 151 Desmet (2005–2006), pp. 513–514. 142

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right to self-determination.152 A certain legislative paternalism is, therefore, justified to protect policyholders, even against themselves.153

4.2.6

Suspicions

If policyholders are allowed to communicate genetic data voluntarily, some will do so and others will not. The fact that no information is shared may arouse suspicion with the insurer that there is a genetic disorder. As a result, the policyholder would then be placed in a higher risk category. This creates a domino effect: when certain policyholders decide to share their data, others are forced to follow. The protection in the legislation for the policyholder by means of the right to private life and free consent is not sufficient to provide effective protection against discriminatory practices.154

4.2.7

Consequences for Relatives

Another reason people cannot be nonchalant about the use of genetic data is that this information has an impact on people other than the policyholder. The privacy and physical integrity of third parties are also involved.155 Genes are the basis of the human body. We inherit them from our parents and transfer them to our offspring.156 Much of the genetic information is therefore the same within a family. People’s genetic codes indirectly provide information about their family members. There is a real possibility that a relative is a carrier of the same abnormal gene.157 Genetic analysis of an individual therefore has consequences for his/her relatives. Test results also provide information about the patient’s family members in the ascending, descending and lateral lines, whose right to privacy can be threatened.158 Giving an insurer access to such knowledge can also make it more difficult for these relatives to access insurance.159

152

Nys (1992), p. 213. Rouvroy (2000), p. 600. 154 Rouvroy (2000), p. 601. 155 Nys (1992), p. 214; Guldix et al. (1994), p. 138; Tack and Dierickx (2008–2009), p. 388. 156 Guldix et al. (1994), p. 95; Desmet (2005–2006), p. 514; Calcoen (2012). 157 Guldix et al. (1994), p. 95. 158 Report Monset to the bill on the land insurance contract, Parlementaire Stukken Senaat 1991–92, nr 306/2, p. 31. 159 Nys (1992), p. 214; Desmet (2005–2006), p. 514. 153

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Actuarial Aspects

Opponents of the use of genetic information contend that the actuarial arguments upon which proponents of genetic testing rely—for example, the risk of adverseselection as a justification for its use—are debatable. Genetic analysis indicates a certainty or high probability of disease or defect only in exceptional case; usually it offers evidence only of a predisposition.160 When a large number of people with predispositions purchase high coverage insurance but only a few develop the disease, this is to the insurer’s benefit. This is because the policyholders that did not develop the disease have paid a high premium, yet the insurer does not have to pay any reimbursements.161 The actual danger of adverse-selection is limited and needs to be qualified. Adverse-selection depends on the capacity of policyholders to assess their position on the market and use this information in an economically rational way. However, policyholders rarely know the market and can hardly assess their position in that market. The notion that they could calculate their actuarially correct premium is unrealistic. Psychological factors also influence people’s behavior, such that people do not behave rationally and leave the pool when they think they are paying too much.162 Moreover, the majority of the population has no knowledge about their genetic risk profile. The danger of adverse-selection, therefore, is not borne out.163 In addition, there is propitious, or auspicious, selection. This counters the idea that “good risks” tend to leave the pool when premiums rise. Those at high risk often do not purchase insurance and those at low risk are often risk-averse and willing to pay a high premium. Thus, there is a negative correlation between the extent to which policyholders are risk-averse and their expectation of loss.164 Is the release of genetic information, then, socially desirable? Persons with “bad genes” would be disadvantaged and left no longer able to purchase insurance or able to do so only at a high premium. They would be deprived of the opportunity to provide financial security for their family in the event of premature death. Is this not the purpose of an insurance policy, to enable people to financially support their families if they die prematurely? People may also die prematurely as a result of another illness or accident, unrelated to their genetic disorder.165 Insurers often argue that they will still offer insurance but with higher premiums. The question is whether they will actually offer insurance when it concerns, for example, Huntington’s disease. Insurers are not charities, and exist to make a profit. They will, therefore, not cover very bad risks.166

160

Rouvroy (2000), p. 595; Fagnart (2011), pp. 143–144; Vansweevelt (2015), pp. 28–29. Rouvroy (2000), p. 598. 162 Goessens (2018), p. 165. 163 Goessens (2018), p. 166. 164 Goessens (2018), p. 165. 165 Jacobs (1997), p. 24; Desmet (2005–2006), p. 515. 166 Desmet (2005–2006), p. 515. 161

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Insurers argue their competitive position on the market is threatened if they cannot differentiate premiums on the basis of underlying risk. This creates a vicious cycle, as discussed above.167 This outcome is easily avoided by prohibiting all insurers from differentiating on the basis of genetic information.168 When no insurer can use genetic information, no one has an advantage and all must bear the costs of claims related to genetic disorders equally.169 Moreover, we may wonder whether genetic information can be used as a criterion to assess risks. For the evaluation of risks, no criteria can be used that are not pertinent actuarially.170 A “normal genome” is not an objective reality. It does not exist.171

5 Conclusion The current regulatory framework in Belgium offers the most comprehensive protection for the consumer. The legislature wants to offer maximum protection. Employers and insurers are not allowed to ask about genetic data or to require genetic testing prior to granting employment or insurance coverage. However, there are some fundamental pros and cons. The current regulations should be analyzed and evaluated to assess if the existing regime remains the most appropriate solution, and to see if the risks and benefits associated with genetic testing could be more appropriately addressed. For instance, definitions are important to define the scope of the regulation, and current ones are insufficient. To make appropriate recommendations, a complete evaluation is needed. A general regulation on the use of genetic research and testing would also be useful, especially to ensure that the protection of genetic data is addressed in an equitable and efficient manner. This would also enable adequate protection in the context of insurance and employment.

References Barbaix R (2016) Levensverzekeringen. In: Vansweevelt T, Weyts B (eds) Handboek Verzekeringsrecht. Intersentia, Antwerp, pp 839–845

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Freriks (1994), p. 33; Guldix et al. (1994), pp. 133–134; Troch (2003), p. 55, footnote 5; Desmet (2005–2006), pp. 509–510; Goessens (2018), p. 119. See above, Sect. 4.1.1 (Technical Aspects of Insurance). 168 Jacobs (1997), p. 21; Desmet (2005–2006), p. 510. 169 Guldix et al. (1994), p. 134. 170 Rouvroy (2000), p. 595. 171 Rouvroy (2000), p. 600.

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Belgian National Council Of Physicians (2006) Inzage van het medisch dossier van een overledene door de raadgevende arts van een verzekeringsmaatschappij. www.ordomedic.be. Accessed 15 Nov 2018 Blockx F (2011–2012) Les données que les patients “confient” à leur médecin. Tijdschrift voor Gezondheidsrecht 2:114–115 Blockx F (2013) Beroepsgeheim. Intersentia, Antwerp Calcoen P (2012) Genetic information, private insurance and human rights, Emeritiforum KU Leuven. https://www.kuleuven.be/emeritiforum/em/Forumgesprekken/2012-2013/291112. Accessed 15 Nov 2018 Callens S, Caenen S, Van Leuven L (2015) E-Health en het omgaan met gegevens in de gezondheidszorg. In: Callens S, Peers J (eds) Organisatie van de gezondheidszorg. Intersentia, Antwerp, pp 371–426 Cassiers L, Vermeersch E (eds) (2000) Erfelijkheid: genetische tests en maatschappij. Garant, Leuven Cassiman J (2004) Wat zit er in mijn genen? Davidsfonds, Leuven Cassiman D, Cassiman J, Degryse P (eds) (2000) Adam en Eva en andere verhalen over genetica. Stichting Kunstboek, Oostkamp Claassens H (1994) De nieuwe verzekeringswet en de medische expertise. Het standpunt van een verzekeringsjurist. In: Van Steenberge J (ed) Medisch beroepsgeheim en verzekeringen. Die keure, Bruges, pp 35–50 Colle P (2010) Handboek bijzonder gereglementeerde verzekeringscontracten. Intersentia, Antwerpen Colle P (2015) De nieuwe wet van 4 april 2014 betreffende de verzekeringen: algemene beginselen van het Belgische verzekeringsrecht. Intersentia, Antwerpen Craeynest P, Cokelaere M (2007) Onze genen. Handboek menselijke erfelijkheid. Acco, Leuven Deberdt R (1994) Het medisch beroepsgeheim en de orde van de geneesheren. In: Van Steenberge J (ed) Medisch Beroepsgeheim en verzekeringen. Die keure, Bruges, pp 65–95 Defloor S (2014) Het gebruik van medische informatie in private verzekeringen. Intersentia, Antwerp Defloor S, Nys H (2011) Patiëntengegevens en verzekeringen. Een onmogelijke relatie. In: Van Schoubroeck C, Devroe W, Geens K, Stuyck J (eds) Over grenzen. Liber Amicorum Herman Cousy. Intersentia, Antwerp, pp 495–503 Desmet B (2005–2006) Genetisch onderzoek en verzekeringen. De wet van de (genetisch) sterkste. Jura Falconis 4:505–548 Dierickx A (2014) Het beroepsgeheim en de toestemming van de geheimgerechtigde. In: Rozie J, Deruyck F, Huybrechts L, Van Volsem F (eds) Liber amicorum Michel Rozie. Intersentia, Antwerp, pp 183–192 Dierickx A, Buelens J, Vijverman A (2014) Het recht op de bescherming van de persoonlijke levenssfeer, het medisch beroepsgeheim en de verwerking van persoonsgegevens. In: Vansweevelt T, Dewallens F (eds) Handboek Gezondheidsrecht, II. Intersentia, Antwerp, pp 583–702 Dijkhoffz W (2002–2003) Rol van medische getuigschriften in de functionele opvatting van het beroepsgeheim. Tijdschrift voor Gezondheidsrecht 2:87–98 Dijkhoffz W (2003–2004) Het recht op informatie en geïnformeerde toestemming. Tijdschrift voor Gezondheidsrecht 2:104–124 Emeritiforum (2012) Genetische informatie, private verzekeringen en rechten van de mens – een stand van zaken in recht en praktijk. KU Leuven, Leuven Essers E (2005) Juridische aspecten bij de werving en selectie van werknemers. Sociale Wegwijzer 5:11–14 Evers-Kiebooms G, Welkenhuysen M (eds) (2005) Die ziekte in mijn familie, krijg ik die later ook? Predictieve genetische tests. Lannoo, Tielt Fagnart J (2011) Droit privé des assurances terrestres: principes généraux. Kluwer, Waterloo

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Feltkamp R (2013) Contract, contractsluiting, voorbesprekingen en onderhandelingen – enkele basisnoties. In: Feltkamp R, Janssens E (eds) Ondernemingscontracten stap voor stap. Larcier, Ghent, pp 5–40 Fontaine M (2016) Droit des assurances. Larcier, Brussels Freriks D (1994) De verzekeringswet van 25 juni 1992 en het medisch beroepsgeheim. In: Van Steenberge J (ed) Medisch beroepsgeheim en verzekeringen. Die keure, Bruges, pp 11–34 Goessens E (2018) Private verzekering en solidariteit. Intersentia, Antwerpen Goffin T (2007–2008) Toestemming in het medisch recht. Een nieuwe lezing van een oud probleem. Rechtskundig Weekblad 32:1306–1317 Guldix E, Stuy J, Jacobs K (1994) Het gebruik van genetische informatie: het ethisch en juridisch kader voor het maatschappelijk gebruik van geïndividualiseerde genetische informatie. Federale Diensten voor Wetenschappelijke, Technische en Culturele Aangelegenheden, Brussels Hautenne N (2003–2004) Les examens médicaux liés à la relation de travail: bref commentaire de la loi du 28 janvier 2003. Tijdschrift voor Gezondheidsrecht 4:220–224 Hillen M (1991) Verzwijging van erfelijkheidsgegevens bij het aangaan van verzekeringsovereenkomsten. Ars Aequi November:967–973 Jacobs K (1997) Genetische informatie en verzekeringen. Recht en Kritiek 23:16–38 Jeger N, Cauwenbergh P (1996–1997) Individuele levensverzekeringen “overlijden” en erfelijkheidsonderzoek: een kritische analyse van de artikelen 5 en 95 van de wet van 25 juni 1992 op de landverzekeringsovereenkomst. Tijdschrift voor Gezondheidsrecht 4:239–256 Jorde L, Carey L, Bamshad M (2015) Medical genetics. Elsevier, Philadelphia Nys H (1989) Predictief genetisch onderzoek: enkele juridische aspekten. Vlaams Tijdschrift voor Gezondheidsrecht May–June:235–241 Nys H (1992) Van afkomst naar toekomst? Juridische grenzen van erfelijkheidsonderzoek bij verzekeringen. Tijdschrift voor verzekeringen 299:209–219 Nys H (2005) Geneeskunde – Recht en Medisch Handelen. APR. Kluwer, Mechelen Nys H (2010) Recht en bio-ethiek. Wegwijs voor mensen in de gezondheidszorg. Lannoo, Leuven Panis S (2015) Stamcellen en recht: een juridische analyse van wegneming tot gebruik. Intersentia, Antwerp Paris C, Callewaert V (2015) Actualités en droit des assurances. Larcier, Brussels Plets I (2003) Medische onderzoeken op het werk. Nieuw Juridisch Weekblad 3:618–621 Ponet F, Rubens R, Verhees W (1993) De Landverzekeringsovereenkomst: praktische commentaar bij de wet van 25 juni 1992. Kluwer, Antwerp Raeymaekers P (2001) Genen en gezondheid. Natuur en techniek, Amsterdam Remans J (2005) De boom van goed en kwaad. Acco, Leuven Rouvroy A (2000) Informations génétiques et assurance. Discussion critique autour de la position “prohibitionniste” du législateur belge. Journal des Tribunaux 5978:585–603 Salomons R (1998) Erfelijke gegevens en verzekering. In: Cousy H, Van Schoubroeck C (eds) Liber Amicorum Hubert Claassens. Maklu, Antwerp, pp 165–177 Schamps G (2003–2004) Le secret médical et l’assureur: commentaire du nouvel article 95 de la loi du 25 juin 2002 sur le contrat d’assurance terrestre. Tijdschrift voor Gezondheidsrecht 2:131–150 Schuermans L, Schoubroeck C (2015) Grondslagen van het Belgische verzekeringsrecht. Intersentia, Antwerp Stevens J (2002–2003) Het beroepsgeheim van de advocaat en dat van de geneesheer. Tijdschrift voor Gezondheidsrecht 1:2–11 Tack S, Dierickx A (2008–2009) Nader gebruik van lichaamsmateriaal voor wetenschappelijk onderzoek: Toelaatbaarheid getoetst vanuit het recht op respect voor het privéleven (art. 8 EVRM). Tijdschrift voor Gezondheidsrecht 2:372–396 Troch K (1993–1994) Het medisch beroepsgeheim en zijn impact op de levensverzekering. Rechtskundig Weekblad 35:1294–1301 Troch K (2003) Art. 95 Wet Landverzekeringsovereenkomst. In: Cousy H, Schuermans L, Bernauw K, Van Schoubroeck C (eds) Verzekeringen: artikelsgewijze commentaar met overzicht van rechtspraak en rechtsleer, vol 8. Kluwer, Antwerp, pp 1–64

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Analysis of the Use of Genetic Testing in Insurance Policy Contracts and Labour Relations in Brazil Mario Viola de Azevedo Cunha and Leonardo Heringer Matos

Abstract In view of the conceivable effects of genetic testing on insurance policy and labour contracts, and the consequential bioethical issues involved, the present article analyses the possibility of using these resources for risk selection in insurance policy contracts and as criteria for employability, in light of the current legal framework in Brazil. In that sense, we will address the question of whether genetic testing and profiling, which intrude much more on an individual’s intimacy and privacy than conventional medical examinations, may be considered as legal means of establishing selection criteria for a job position or used to assess risks in an insurance policy contract.

1 Introduction The development of new technologies in genetic engineering has fuelled discussions on the protection of genetic (personal) data, given that new forms of discrimination may arise from this category of data. Genetic testing can provide information on whether an individual will develop, or has a strong predisposition to, certain diseases based on his/her genetic markers. Notwithstanding criticisms of genetic determinism, genetic testing may reveal information that leads to the assumption that an individual’s genetic markers are associated with the development of human

The authors would like to thank Beatriz Laus for her great work on the English version of the text as well as on translating into English the citations that were originally in Portuguese. They would also like to thank Prof. Laura Khoury and Dr. Lukas Vanhonnaeker for the review of this paper. M. Viola de Azevedo Cunha (*) Centre for Media Pluralism and Media Freedom of the European University Institute (CMPF), Florence, Italy e-mail: [email protected] L. Heringer Matos Borges and Schumacher Law Firm, Rio de Janeiro, Brazil e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_3

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behaviours, such as drug addiction and aggressiveness.1 This potential predictability could result in significant disruptions to society, especially when it comes to labour relations and insurance policy contracts.2 Risk is the essential element of insurance. In this context, risk is a possible yet uncertain future event, in relation to its actual occurrence or the moment (time and place) of its realization. It does not depend on the insured’s or the insurer’s will.3 Therefore, insurance companies analyse this potential risk according to information available on the asset or person being insured. They assess whether the risk involved is insurable or not, and, in so doing, attribute value to it, establishing insurance premiums to be paid accordingly. Thus, insurance policy and genetic data are strictly related. To accurately assess what it will be covering, the insurance company needs to intimately acquaint itself with the insured person. Even in the case of insurance payment for damages, the insurer must effectively access the insured’s personal sphere, drawing upon information concerning his/her health, economic status, personal habits, and family health history. These are all intimately related to a person’s genetic identity. The ongoing development of technological resources in genetics has also increased potential impact of the use of genetic predictive testing on labour relations, insofar as it may become a possible and, eventually, useful tool for refining criteria when selecting candidates for a position. Hypothetically, this type of testing could be applied to exclude candidates from certain laborious activities that must be performed in environments capable of triggering diseases for which such candidates have a genetic predisposition. Although constitutional and ethical limits restrain the employer, some degree of autonomy exists when it comes to establishing requirements to fulfill in order to attain certain job positions. Therefore, it is acceptable and legal to require from employees, to protect their own health and safety, that they undergo medical exams to assess their suitability and whether their job performance will be satisfactory, pursuant to article 168 of the Brazilian Labour Laws Consolidation (CLT).4 The question is whether genetic testing and profiling, which intrude much more on an individual’s intimacy and privacy than conventional medical examinations, may be considered as legal means of establishing selection criteria for a job position. Due to the severity of the consequences that can result from genetic testing in this scenario (i.e. exclusion from the labour market), the concerns expressed by those who fear the emergence of a “genetically inferior” category of individuals must be addressed.5

1

Moffitt (2005), pp. 533–554. Moraes (2003), p. 128. 3 Guerreiro (2004), p. 80. 4 Consolidação das Leis do Trabalho (Decreto-Lei n
5.452, de 1
de maio de 1943). Available in Portuguese at http://www.planalto.gov.br/ccivil_03/decreto-lei/Del5452.htm. 5 Lima Neto (2004), p. 85. 2

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Thus, the present paper analyses the possibility of using these resources for risk selection in insurance policy contracts and as criteria for employability. It does so in view of the conceivable effects of genetic testing on these specific types of contracts (i.e. insurance policy and labour contracts), the consequential bioethical issues involved, and the current legal framework in Brazil.

2 Privacy and Data Protection Under Brazilian Law Article 5(X) of the Brazilian Federal Constitution6 defines privacy as a fundamental human right. Therefore, it establishes that the private life and privacy of an individual is inviolable. Similarly, the Brazilian legislator included a right to privacy in article 21 of the Brazilian Civil Code (CC).7 By doing so, the law confers upon judges the power to take the necessary measures to prevent or terminate privacy violations.8 However, the legislator failed to define what such powers would be or what would constitute a violation of privacy. Until recently, the only legislation in Brazil that dealt with personal data was the Brazilian Consumer Protection Code (Law no. 8.078/90).9 Articles 43 and 44 of this Code provide for rules regarding data subjects’ rights (access, rectification and erasure), storage limits for default information as well as notification obligations for data controllers in the context of consumer and credit bureaus but only in the context of consumer relations. These provisions were inspired by the US Fair Credit Reporting Act.10 Despite the great advance they represented, this model “was already born with certain intrinsic limits, which is verified not only in relation to its incidence—situations characterized as consumer relations—but by the character of its provisions.”11 In recent years, the legal landscape has undergone a significant change with the enactment of the Brazilian Internet Bill of Rights (Law no. 12.975/14).12 The Internet Bill of Rights—also referred to as the Marco Civil da Internet—established fundamental rights and principles that regulate Internet use in Brazil, as well as 6 Constituição da República Federativa do Brasil de 1988 (available in English at http://www.stf.jus.br/ repositorio/cms/portalStfInternacional/portalStfSobreCorte_pt_br/anexo/BrazilFederalConstitution_ atualizadaataemenda99de2017Eletrni.._.pdf). 7 Código Civil (Lei n
10.406 de 10 de janeiro de 2002, available in Portuguese at http://www. planalto.gov.br/ccivil_03/LEIS/2002/L10406.htm). 8 Doneda (2006), p. 53. 9 Código de Defesa do Consumidor (Lei n
8.078 de 11 de setembro de 1990, available in English at http://www.procon.rj.gov.br/procon/assets/arquivos/arquivos/CDC_Novembro_2014_Ingles.pdf). 10 Grinover et al. (2001), p. 352. 11 Doneda (2006), p. 340 (authors’ translation). 12 Marco Civil da Internet (Lei n
12.965 de 23 abril 2014, available in English at https://www.cgi. br/pagina/marco-civil-law-of-the-internet-in-brazil/180).

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privacy and data protection for Internet users (articles 3(I) and (II)). Prior to the Internet Bill of Rights, the Information Access Law (Law no. 12.527/11)13 and the Positive Database Registry Law (Law no. 12.414/11)14 both addressed the issue of personal data protection. Recently, Law no. 13.709/18,15 and its subsequent amendment by Provisional Measure no. 869 on December 28, 2018—converted into Law no. 13.853/19,16 was also approved. Although this law will only enter into force on 16 August 2020,17 it establishes a General Data Protection Law (LGPD) in Brazil, adding to the Brazilian legal system standards and guarantees that aim at protecting privacy and personal data.18 The LGPD, in its preliminary provisions, explicitly references genetic data, classifying them as sensitive data,19 a specific category that can only be processed and accessed20 in specific circumstances. Although the LGPD addresses an important regulatory gap concerning personal data protection in Brazil by including provisions on genetic data, it does not exhaustively cover all possible developments on the subject. These will therefore continuously demand improvements and updates. As is evident from experience, important technological developments have occurred over a very short time span in the field of genetics. These advances have brought forth moral and ethical conflicts hitherto unimaginable in our society.

Lei de Acesso à Informação (Lei n
12.527 de 18 novembro 2011, available in English at http:// www.mpf.mp.br/atuacao-tematica/sci/normas-e-legislacao/legislacao/legislacao-em-ingles/law-12. 527). 14 Lei do Cadastro Positivo (Lei n
12.414 de 9 de junho de 2011, available in Portuguese at http:// www.planalto.gov.br/ccivil_03/_Ato2011-2014/2011/Lei/L12414.htm). 15 Lei Geral de Proteção de Dados Pessoais (Lei n
13.709 de 14 de agosto de 2018, available in Portuguese at http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2018/Lei/L13709.htm). 16 Medida Provisória n
869 de 28 Dezembro 2018 (available in Portuguese at http://www.planalto. gov.br/ccivil_03/_Ato2015-2018/2018/Mpv/mpv869.htm). 17 See, for instance, Alves (2018). It is important to highlight that Provisional Measure no. 959 was published on April 29, 2020, postponing the entry into force of the LGPD to May 3rd, 2021, but it has still to be confirmed by the National Parliament (available in Portuguese at http://www.planalto. gov.br/ccivil_03/_Ato2019-2022/2020/Mpv/mpv959.htm#art4) 18 The only provisions of the General Data Protection Law that are already in force are the ones establishing a Data Protection Authority and a National Data Protection and Privacy Council. 19 Article 5: 13

For the purposes of this law, the following definitions should be considered: (...) II – sensitive personal data: personal data on racial or ethnic origin, religious conviction, political opinion, trade union membership, religious affiliation, philosophical or political beliefs, data concerning health or sex life, genetic data or biometric data, when associated with a natural person; (emphasis added). Authors’ translation. The official version of the Law is available in Portuguese at http://www. planalto.gov.br/ccivil_03/_Ato2015-2018/2018/Lei/L13709.htm. 20 See Section 4 of this paper.

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It would be too disturbing to imagine a society like that of Aldous Huxley’s dystopia, “Brave New World.”21 Unfortunately, current fears regarding genetic data use are not arising from an imaginary world. On the contrary, they are real and originate from past historical atrocities, committed many times without a clear perception of their gravity at the relevant time. For example, BBC Brazil published an article in April 2017 entitled “Eugenia: how a movement in the EUA to create ‘better’ human beings influenced Hitler,”22 that alluded to the strong influence of eugenic ideals in Northern American society in the early twentieth century. The article reproduced a passage from Justice Oliver Wendel Holmes Jr’s majority reasons in the 1927 Buck v Bell case. In an eight-toone majority decision, the US Supreme Court not only recognized the constitutionality of the forced sterilization of women with mental disorders, but also declared it would be “irresponsible” not to do so.23 In recent years, legislation has emerged in Brazil that specifically regulates the use of genetic data, in addition to the aforementioned legislative acts related to the issue of personal data protection. In this regard, it is worth mentioning Law no. 12.654/12,24 which established the possibility of using genetic data for criminal purposes. Moreover, Law no. 11.105/05 (National Biosecurity Law)25 establishes the National Biosafety Council and implements the provisions contained in articles 225(II) and (IV) and paragraph 1 of the Brazilian Federal Constitution,26

21

Huxley (1996). Lang-Stanton and Jackson (2017). The original title in Portuguese is “Eugenia: como movimento para criar seres humanos ‘melhores’ nos EUA influenciou Hitler”. 23 US Supreme Court, Buck v Bell, 274 US 200 (1927). 24 Lei n
12.654 de 28 de maio de 2012 (available in Portuguese at http://www.planalto.gov.br/ ccivil_03/_Ato2011-2014/2012/Lei/L12654.htm). The Federal Supreme Court, in Special Appeal No. 973.837/MG, is deliberating on the unconstitutionality of this legislation. This case is still pending judgment. Reporting judge: Gilmar Mendes. 25 Lei Nacional de Biossegurança (Lei n
11.105 de 24 de março de 2005, available in Portuguese at http://www.planalto.gov.br/ccivil_03/_ato2004-2006/2005/lei/l11105.htm). 26 Constituição da República Federativa do Brasil de 1988 (available in English at http://www.stf. jus.br/repositorio/cms/portalStfInternacional/portalStfSobreCorte_pt_br/anexo/ BrazilFederalConstitution_atualizadaataemenda99de2017Eletrni.._.pdf). Article 225: 22

Everyone has the right to an ecologically balanced environment, a common good used by the people and essential to a healthy quality of life, imposing upon the Government and the community the duty to defend and preserve it for present and future generations. 1
To ensure the effectiveness of this right, it is incumbent upon the Government to: (. . .) II – preserve the diversity and integrity of the country’s genetic heritage and supervise entities dedicated to the research and manipulation of genetic material; (. . .) IV – require, in accordance to legislation, a previous public environmental impact study for any construction or activity that may cause significant degradation of the environment; V – to control the production, marketing and use of techniques, methods and substances that pose a risk to life, quality of life and the environment;

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establishing safety standards and surveillance mechanisms for activities involving genetically modified organisms and their derivatives. Even though genetic data and their use in the context of insurance policy and labour relation contracts raise diverse ethical and moral concerns, Brazil still lacks detailed and specific legislation on the matter. However, draft bills exist concerning the use of genetic data. Moreover, at the international level, the Universal Declaration on the Human Genome and Human Rights27 was used to determine important guidelines for the reflections and findings raised in this paper.

3 Privacy Versus Free Enterprise Article 170 of the Brazilian Federal Constitution mentions the principle of free enterprise, thereby including business or entrepreneurial activity as a constitutional right. As for the human person, it is protected by the principles of equality, psychophysical integrity, freedom, and solidarity. All of these principles derive from the general clause on human dignity (Article 1(III) of the Brazilian Federal Constitution) and will need to be balanced against each other on a case-by-case basis. The need to establish basic social rights for urban and rural workers in order to protect them from different types of discriminatory actions also led to the adoption of articles 7(XXX), (XXXI), and (XXXII) of the Brazilian Federal Constitution. These provisions unequivocally guarantee protection against discrimination. Ordinary legislation further corroborate them. This is the case, for instance, of Law no. 9.029/95,28 article 1, which prohibits: any discriminatory and restrictive actions concerning the application to or maintenance of employment relationships for reasons pertaining to sex, origin, race, color, civil status, family status, disability, professional rehabilitation, age, among others, except for in the case of child and adolescent protection, provided for in article 7, subsection XXXIII of the Brazilian Federal Constitution.

Moreover, the Federal Constitution promotes, as a fundamental objective of the Republic, “the well-being of all, without prejudice at to origin, race, sex, colour, age and any other forms of discrimination” (article 3(IV)). It also provides for punishment in case of “any discrimination against fundamental rights” (article 5(XLI)). Hence, there is a need to establish limits when using information about people, both in relation to private and public entities.29

27 UNESCO Universal Declaration on the Human Genome and Human Rights, adopted on 11 November 1997. 28 Lei n
9.029 de 13 de abril de 1997 (available in Portuguese at http://www.planalto.gov.br/ccivil_ 03/LEIS/L9029.HTM. The provision cited in the text was translated from Portuguese to English by the authors). 29 Dallari (2003).

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Could an insurance company require the provision of genetic data for insurance purposes?30 While insurers may reject a risk resulting from a gene that causes degenerative disease, they may be interested in insuring certain diseases that have a genetic component, as a 1997 report from a reinsurer suggests.31 Furthermore, could insurers refuse to enter into contracts with people who test positive for certain genes? Would we be faced with a case of discrimination? Or, where a test provides a high degree of certainty about a future disease, would denying insurance be acceptable, since the insurance policy is based on a future and uncertain event—that is, on risk? Would it be up to the State to define limits on the collection and use of personal data for the purposes of entering into contracts? These questions become even more intriguing for labour relations, given the relationship between labour performance and compliance with the basic principle of human dignity. Could an employer use predictive genetic testing when choosing a prospective employee in order to select a candidate better suited for the job? Could the employer exclude from consideration candidates who test positive for predispositions to diseases or behaviours? Given that the Brazilian Federal Constitution did not anticipate the need for protection against genetic discrimination as a social right, would it be correct to assume the legality of such discrimination in Brazil? Or would the prohibition against discrimination in employment relations be afforded a broader scope of protection? In other words, relying on a systemic interpretation of the constitutional text, could we contemplate that it covers any form of degrading of the human person based on his/her genetic information? These are a few of the questions that this analysis strives to answer, relying on available legal parameters currently in force in Brazil. Although they might prove insufficient in providing a univocal response, some of their elements will certainly offer a plausible solution that respects the guarantees set forth in the Brazilian Federal Constitution.

4 Informed Consent for Legal Use of Genetic Data Effectively using personal data, especially genetic related data, requires the data subject’s informed consent—a cornerstone of ethical research involving humans. This dates back to the Nuremberg Code,32 published in 1947 as a way of alerting

30

Moraes (2003), p. 128. Chuffart (1997). In this report, the author argues that certain insurance companies specialize in the coverage of diseases such as cancer. In fact, there are examples of Insurance companies, especially in the US, that offer cancer treatment coverage policies. See, for instance, https://www.thebalance. com/best-cancer-insurance-4169725. 32 The Nuremberg Code, 1947, https://history.nih.gov/research/downloads/nuremberg.pdf. 31

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mankind to the atrocities committed during the Second World War, which refers to “a voluntary consent of the person subjected to research.”33 Consent, and all that it entails, has not gone unnoticed by national doctrine. Various authors have acknowledged the need for preserving the genetic information and protecting the principles of self-determination and privacy of the person tested. They have determined that genetic testing “should be voluntary, after prior and informed advice on potential benefits and risk percentage involved,” and that “in order to safeguard the privacy of the person tested, the complete genome analysis can only occur after explicit and prior informed consent of a person who is of age and in complete access to his or her mental and physical capabilities.”34 Thus, consent in itself is not enough. The person who decides to go through with genetic testing must be fully capable of providing consent that is both informed and resulting from his/her own free will, something that can be difficult to achieve, as the person will be hardly able to envision all the potential risks and consequences of undergoing genetic test and of eventually disclosing its results.35 In insurance, which typically involves mass contracts (i.e. life, personal accident, and health insurance), it is virtually impossible for the contractor to refuse to disclose information and if he or she does not provide the required information, the coverage will be probably denied. If a person does not consent to an insurer’s request for information, he/she will be unable to take out the insurance and will have to find another insurer. In this scenario, the consumer finds him/herself in a vulnerable position, as established by the Consumer Protection Code (Law no. 8.078/90, article 4(I)).36 Accordingly, article 766 of the Civil Code requires the insured person to provide all information that may influence the acceptance of an insurance proposal or premium rate, under the penalty of forfeiting the guarantee due to bad faith. This contractual asymmetry is also present in employment relationships, and may prove even more pernicious and significant. It is not credible that a job applicant will have the peace of mind and freedom to refuse the exams required by the employer under regular circumstances. It is unreasonable to assume that an individual preferring to refuse consent to genetic testing will simply give up that opportunity and seek work elsewhere. The individual who seeks a place in the labour market in order to survive, maintain his/her dignity, and provide his/her family with the basic necessities is vulnerable to the “demands” of those in power. It is unlikely, especially in a

33

Dallari (2003), p. 73. Diniz (2005), pp. 73–64. 35 Dallari (2003), p. 73. 36 Lei n
8.078 de 11 de setembro de 1990 (available in English at http://www.procon.rj.gov.br/ procon/assets/arquivos/arquivos/CDC_Novembro_2014_Ingles.pdf), Art 4: 34

The objective of the National Policy for Consumer Relations is to tend to consumers’ needs, impose respect for the consumer’s dignity, health, and safety, protect his interests and ensure transparency and harmony in consumer relations, based on the following principles: (amended by Law no. 9008 of March 21, 1995) I -Recognition of the consumer’s vulnerability in the consumer market;

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country like Brazil which faces an economic and social chasm, that a worker would be able to exercise effective freedom of choice and refuse to sacrifice his/her privacy. Since we are dealing with genetic data and, thus, with the collection and processing of genetic material to obtain such data, the discussion is especially delicate. This is because “the genome can reconstruct the link between generations, and data relating to a single person can provide information on all those belonging to their biological group. Past, present, and future can, therefore, be examined through genetic data.”37 Be that as it may, and regardless of the relevance and forcefulness of the arguments that question the role of consent in allowing for a legal and legitimate use of genetic data in insurance policies and labour contracts, the LGPD, in article 11, enables the processing of sensitive data, including genetic data, as long as the data subject provides consent. Therefore, the first impediment when striving to use genetic data is obtaining the data subject’s consent. Given that the LGPD requires that the consent of the data subject be free and informed for its use in genetic data in insurance policies and labour contracts to be legal, the existence of true consent may be questioned in these contexts. Moreover, the possibility that genetic data will be processed regardless of the data subject’s consent remains. Brazilian data protection legislation, when in force, will allow this type of processing in exceptional cases, as determined by article 11 II (a) to (g) of the LGPD: Article 11. The processing of sensitive personal data which is otherwise prohibited, may only occur in the following circumstances: (. . .) II – without providing consent of the data subject, in cases in which it is indispensable for: a) compliance with a legal or regulatory obligation by the controller; b) shared processing of data necessary for the implementation, by the public administration, of public policies foreseen in laws or regulations; c) conducting studies by research institutions, guaranteeing the anonymization of sensitive personal data when possible; d) the exercise of rights, including in contract and in judicial, administrative and arbitral proceedings, the latter in accordance with Law no. 9.307/96 (Arbitration Act); e) for the protection of the data subjects’ or third party’s life or physical safety; f) for purposes of healthcare, in a procedure performed by health professionals or health entities; or g) in guaranteeing fraud prevention and security of the data subject during processes of identification and authentication of registration in electronic systems, safeguarding the rights mentioned in article 9 of this Law except in cases in which rights and fundamental rights of the data subject prevail and require personal data protection.

However, no concrete cases or circumstances would actually allow for the legitimate and legal use of genetic data without the data subject’s consent in the context of insurance policies and labour relation contracts. In such cases, our 37

Rodotà (2008), p. 222.

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understanding is that the processing of sensitive data will only be legally recognized and allowed if the data subject provides unambiguous informed consent. Any type of processing should, in addition, comply with the principles established in the LGPD. Notably, these include data minimization, which limits processing to the minimum necessary to achieve the purposes of the envisioned data processing, with the inclusion of relevant and proportional data regarding the purpose for which the data was processed. They also encompass the principle of non-discrimination, which prohibits the processing of personal data for unlawful, abusive, or discriminatory purposes (article 6(III) and (IX) LGPD).

5 Discrimination and Adverse Selection The second, and certainly the most relevant, impediment when requiring genetic data in insurance policies and labour relation contracts concerns discrimination of the potential insured person or worker. Professor Stefano Rodotà, as the chairman of the Italian data protection authority, referred to this potential consequence: “[a]lthough genetics offer extensive possibilities, just as extensive are the risks of using genetic data that may lead to discrimination in access to work or credit, life insurance or disease contracts.”38 For example, doctrinal authors mention a case of discrimination by an insurance company resulting from the obtaining and processing of a consumer’s genetic data. A DNA test allows the identification of the presence of a recessive gene. Based on these results, the insurance company excluded from this person’s health coverage all illnesses related directly or indirectly to the indicated genetic propensity.39 However, insurers have a strong argument to validate the use of genetic data and dispel the idea of discrimination: adverse selection.40 They argue that people generally have better knowledge of their health status than health insurance companies. Older people, who are at greater risk of getting sick, and those who have more medical problems, are primarily the ones who seek insurance. As a result of this informational asymmetry, companies increase the price of insurance. This leads to an adverse selection whereby healthy people are inhibited from entering into health plans. The inclusion of the elderly and patients in insurance plans is increasing, reducing the profitability of the sector.41 This argument leads to the following question: would becoming aware of their high chances of developing certain diseases in the future lead people to take out life or health insurance, or enhance the coverage they already have? Conversely, if people were aware that they had a remote risk of presenting a particular disease in

38

Rodotà (2008), p. 223. Diniz (2005), p. 74. 40 See Pindyck and Rubinfeld (2002), p. 681. 41 Irons (2001). 39

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the future, would that be cause for them to refrain from taking out life or health insurance?42 These dilemmas are also present in labour relations and have dramatic consequences when considering different perspectives and the parties involved. From the perspective of employee protection, would it be reasonable, or even expected, that an employee with a genetic predisposition to a particular disease be prevented from working in environments that could subject him/her to agents that trigger the predisposed disease? Incidentally, it should be said that the “reduction of risks inherent to work, by means of health, hygiene and safety standards” is a constitutional guarantee for employees, pursuant to article 7(XXII) of the Brazilian Federal Constitution. The reasoning, however, that views the use of genetic testing as an admirable and beneficial end for employee health may be premised on a naïve view of labour markets. One may wonder whether large corporations will be more likely to use genetic testing, rather, for abusive and discriminatory purposes, to avoid financial losses arising from removing their employees due to health problems or even just to improve productivity? Due to the fact that genetic testing necessarily involves seriously exposing an individual’s privacy, precaution is called for to ensure the use of this resource is not trivialized. There is concern that this may result in the creation of a genetically inferior subcategory of humans. Although Brazil still lacks specific legislation on the subject, these concerns have led to the proposal and proceedings of draft bills in the National Congress, all of which aim at prohibiting the use of genetic tests for purposes other than medically related ones. Accordingly, draft bills no. 4.610/9843 and no. 4.900/99,44 for example, contemplate a total ban on the use of genetic data for discriminatory purposes, especially for insurance policy contracts and labour relations: PL no. 4.610/98: Article 2. The performance of predictive tests for genetic diseases or tests that allow people to identify if they are a carrier of a gene responsible for a disease or for the genetic predisposition to a disease is only allowed for medical purposes or medical research, and after genetic counselling by a qualified professional. Article 3. Denying, limiting or suspending insurance coverage of any nature based on genetic information of the contracted or insured person, as well as establishing differentiated premiums, based on such information: Penalty: detention, from three months to one year, and fine. Article 4. Denying, limiting or suspending coverage by health plan based on genetic information of the contractor or beneficiary, as well as establishing differentiated monthly payments, based on such information: Penalty: detention, from three months to one year, and fine.

42

Rothstein and Horung (2004), p. 1. Projeto de Lei n
4.610/98 (available in Portuguese at https://www.camara.leg.br/ proposicoesWeb/fichadetramitacao?idProposicao¼20995). 44 Projeto de Lei n
4.900/99 (available in Portuguese at http://imagem.camara.gov.br/Imagem/d/ pdf/DCD23JAN1999.pdf#page¼269). 43

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(. . .) Article 6. Refusing, denying or preventing registration in a public tender or in any other forms of recruitment and selection of personnel based on the genetic information of the applicant, as well as, based on information of this nature, hindering, preventing access to and maintenance of a job, employment, position or function in the Public Administration or in the private sector: Penalty: detention, from one month to a year, and fine. PL no. 4.900/99: Article 1. This law provides for genetic data pertaining to the human person in order to ensure their right against discrimination due to their genetic characteristics in labour relations, health insurance contracts, life and disability insurance contracts, and health plans. (. . .) Article 6. Genetic information and data may not be used for the purposes of: I – Discrimination in employment relationships and labour contracts, including: a) dismissing or failing to hire an employee or apprentice, or discriminate with respect to wages, benefits or working conditions; b) limiting, segregating or classifying an employee or apprentice so as to restrict his/her opportunities to advancing professionally; II – qualifying a health, life or disability insurance policy purchaser; III – in contracting medical plans; IV – to reject, limit, cancel, deny, approve, establish differentiated standards, or otherwise affect the benefits of a medical plan or health, life or disability insurance. 1
It is forbidden for the employment agency to not recommend a potential employee or to discriminate against him/her based on genetic information. 2
It is forbidden for a union or union center to exclude from its staff, discriminate, classify or encourage discrimination of a member of the professional category on the basis of genetic information.

Likewise, the proposition contained in draft bill no. 111/201545 attempts to add article 799—A to the Brazilian Civil Code: Article 799 – A. It is lawful to require that the individual interested in contracting life insurance be previously examined for health issues, thus undergoing medical procedures. 1
If excused from the medical examination procedures referred to above, the insurer cannot be exempted from the obligation to indemnify, alleging that the insured failed to provide information. 2
In the medical examination procedures mentioned in the head of article 799—A, the use of tests or genetic information to determine or estimate the risk of death or development of diseases is forbidden. 3
A contractual clause which excludes payment of the insured capital is void only if based on inaccurate statements or due to the omission of relevant information on the questionnaire on the insureds’ health condition, unless there is unequivocal evidence of bad faith.

According to Senator José Medeiros, the author of the bill, this legislative proposal is justified for the following reasons:

Projeto de Lei n
111/2015 (available in Portuguese at https://www25.senado.leg.br/web/ atividade/materias/-/materia/120073).

45

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Thus, before concluding the life insurance contract, the insurer should require the insured to perform a medical exam in order to determine their state of health. Otherwise, and in the event of an accident, it shall be obliged to indemnify, unless the insured’s bad faith is proven. In determining the health status of the person interested in taking out life insurance, “genetic discrimination” must be avoided, i.e. decisions should be made based on the genetic risk of death or of developing a disease. Inappropriate or unauthorized use of genetic information can result in significant social and psychological harm to individuals, including stigmatization and discrimination, especially concerning insurance policy contracts and health plans for health and life insurance, and in labour relations. Therefore, although it is not yet a well-developed topic in the population’s consciousness, the issue of genetic discrimination raises increasingly intense ethical debates and must be tackled by all legal means.

These legislative proposals appear to be in line with the guidelines set out in the UNESCO Universal Declaration on the Human Genome and Human Rights.46 This is especially the case with regard to concerns that the use of genetic testing may lead to discrimination against an individual on account of their genetic markers.47 Therefore, there is an inherent risk that genetic tests be used as a source of discrimination, which may lead Brazil to restrict their use exclusively for medical purposes.

6 The “Right Not to Know” in the Genomic Era Another important debated issue regarding the performance of genetic tests in Brazil is the argument that individuals may have a legitimate interest, and thus the right, in not knowing their genetic markers in order to avoid psychological consequences. Therefore, the data subject has the right not to know, regardless of the purpose for which the genetic test was conducted. This is especially important since, in many cases, genetic tests only detect predispositions, meaning the results—that is, the disease—may or may not be confirmed in the future.48 Despite this lack of certainty, the consequences of a “positive” result in a genetic test could seriously affect the person’s life simply because he/she would then be aware of the presence of a gene that could cause the future development of a serious disease.49 Aware of the seriousness this problem poses, Bruno Lewicki stressed the importance of extending the term “privacy” to encompass “a right not to know” that would 46

UNESCO Universal Declaration on the Human Genome and Human Rights, adopted on 11 November 1997. 47 Article 6: No one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity. 48 49

Lewicki (2003), p. 123. Lewicki (2003), p. 123.

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allow the data subject to “decide on the degree of information about his own person that he wishes to have access to.”50 In this context, requiring genetic tests and processing the data for the purpose of risk assessment in insurance policy contracts or for the selection of candidates for jobs leads to complex discussions. The issues extend beyond what is normally debated when considering the use of traditional sensitive data51 (i.e. less specific health-related data) and sexual orientation.52 However, even recognizing that the choice not to know is inextricably linked to the exercise of an individual’s freedom of self-determination, and although this guarantee was elevated to the category of rights of the individual by the Universal Declaration on the Human Genome and Human Rights,53 an important precedent of the Superior Court of Justice mitigates this right. Judge Massami Uyeda writing for the majority of the Third Chamber of the Superior Court of Justice in Brazil54 regarding Special Appeal No. 1.195.995,55 recognized that: “[u]nder the individual prism, the right of the individual to have no knowledge that he/she is an HIV virus carrier (if it is understood that this right results from a right to privacy) succumbs, and is supplanted by a greater right, namely, the right to life, the right to a healthier life, and longevity.” The ruling further states that: Even if the individual has no interest or chooses to remain unaware of the illness that affects him/her (for whatever reason), the confidential information about his/her state of health as informed by the Hospital or Laboratory, even if involuntarily, as was the case, does not constitute violation of privacy because it results in a greater protection to the individual himself.

Although we might disagree with the position adopted by the Superior Court of Justice in the aforementioned ruling, we cannot fail to observe the tendency of the case law to impose limits on the so-called “right not to know,” especially when there is an apparent conflict between this individual right and the public interest.

50

Lewicki (2003), p. 124. Doneda (2006), pp. 160–161. 52 It should be noted that in relation to health data, the LGPD—with the wording given by Law no. 13.853/19—forbade its sharing for the purposes of gaining economic advantage, except for “the provision of health services, pharmaceutical assistance and health insurance assistance, provided that paragraph 5 of this article is observed, including auxiliary diagnosis and therapy services, in the interests of data subjects, and to allow: I—data portability when requested by the data subject; or II—the financial and administrative transactions resulting from the use and provision of the services referred to in this paragraph” (Paragraph 4 of article 11—authors’ translation). 53 UNESCO Universal Declaration on the Human Genome and Human Rights, adopted on 11 November 1997, Art 5(c): 51

The right of each individual to decide whether or not to be informed of the results of a genetic examination and the resulting consequences should be respected. 54

The Superior Court of Justice works as the third (and last) instance for cases regarding the infringement of federal laws (not including infringements of labour, electoral or military laws, which are analyzed by the respective courts). 55 Special Appeal No 1.195.995 (authors’ translation, available in Portuguese at https://ww2.stj.jus. br/processo/pesquisa/?tipoPesquisa¼tipoPesquisaNumeroRegistro&termo¼201000981867& totalRegistrosPorPagina¼40&aplicacao¼processos.ea).

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7 Considerations on Genetic Data Protection in Insurance Policy Contracts and Labour Relations Legislation in Brazil that specifically addresses the collection and use of genetic data for the carrying out of insurance and labour contracts is scarce or even non-existent. Nevertheless, national scholars, such as Professor Maria Helena Diniz, argue that “insurance companies have no right in requiring a genetic analysis before or after the contract with the insured has been effected, nor can they demand the results of said tests as they have no right to obtain information on the insured’s genetic data.”56 Invoking the Universal Declaration of the Human Genome, Diniz also states: Consequently, one can easily conclude that no one can be discriminated against in schools or public tenders, for example, because of information on their genetic code. Most importantly, insurers will not be able to deny or interrupt coverage or charge higher premiums from those who are discovered to have a genetic disease after precociously manipulating their genetic material.57

It seems that despite several international documents on the subject, “in view of the current and potential multiplication of dilemmas present in the daily practice of biomedicine, there is a need to establish certain external limits, which are necessarily ethical and legal in nature.”58 It is our understanding that these limits are linked to the preservation of human dignity—the guiding principle of Brazil’s legal system— and, therefore, individual interest should prevail over collective interests. However, allowing access to insurance in a private insurance scenario without adapting the risk could result in adverse selection. Individuals that know they are at a higher risk of developing certain genetic diseases would probably seek insurance coverage more than people who know they are less exposed to the same risks. For example, older and sicker people are more likely to purchase life and health insurance, respectively, than healthy and young people. This risks unbalancing the mutual assurance system, due to a higher volume of indemnities in relation to the premiums received. This problem is far from being solved. As for the labour market, we have previously mentioned the possibility of using genetic tests in order to protect the worker’s own health, hence validating them as lawful instruments. On the other hand, arguments that justify banning their use in labour relations based on the desire to avoid the creation of a discriminatory environment and the emergence of a category of non-employable individuals have been sufficiently discussed. Considering the need for providing employee guarantees and safeguards, we conclude that the correct reading of legal and constitutional provisions suggests that it is forbidden to use genetic tests for labour relations in Brazil. Alternatively, at a minimum, their use and processing should be restricted to

56

Diniz (2005), p. 77. Diniz (2005), pp. 79–80 (authors’ translation). 58 Moraes (2003), p. 128 (authors’ translation). 57

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very specific types of activities, with rules that still need to be established so as to avoid the misuse of data.

8 Conclusion Human rights, including the rights to privacy and non-discrimination, are involved59 where genetic data is required for the purposes of contracting insurance policy contracts or applying for job opportunities, i.e. the labour market. The legislator, as society’s appointed representative, is responsible for making laws limiting the use of such data in the aforementioned contractual relations. Taking into account the uniqueness of these contracts and the vulnerable positions of the employee and the insured, the legislator should determine whether the use of genetic tests in these contexts is legal or whether it should be prohibited. If the legislator chooses to approve the use of genetic tests, rigid parameters and limits for the processing of this sensitive personal data should then be imposed. Given Brazil’s peculiarities—notably the enormous educational gap60 and economic inequalities61 among the population—, genetic testing is a topic that still requires thorough debate, as it involves issues that go beyond the scientific aspects, covering not only the protection of privacy but also the risks of discrimination, which becomes highly sensitive in a country with a high level of inequalities which it could exacerbate. These, among many other issues, should be decided by Brazilian society. For the moment, it is our belief that genetic testing cannot be used either for insurance underwriting purposes or for the assessment of employees in labour relations in Brazil. Genetic testing is a contemporary issue and will increasingly require a multisector reflection, free from biases, to develop legislation that concurrently safeguards individuals’ interests and rights, protects them from discrimination, and encourages rather than prevents ongoing technological advancement.

References Alves FM (2018) Quando entrará em vigor a LGPD?. https://www.linkedin.com/pulse/quandoentrar%C3%A1-em-vigor-lgpd-fabricio-da-mota-alves/. Accessed 27 Mar 2019 Borges R (2017) Brasil tem maior concentração de renda do mundo entre o 1% mais rico. El Pais, São Paulo. https://brasil.elpais.com/brasil/2017/12/13/internacional/1513193348_895757.html. Accessed 27 Mar 2019 Chuffart A (1997) Genetics and life insurance: a few thoughts. Swiss Re, Zürich

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Fernandez (1991), p. 101. Instituto Nacional de Estudos e Pesquisas Educacionais Anísio Teixeira (INEP) (2017). 61 Borges (2017). 60

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Dallari DB (2003) Ética Sanitária. In: Araha MI (ed) Direito Sanitário e Saúde Pública: Coletânea de Textos. Vol 1 Série E – Legislação de Saúde. Ministério da Saúde, Brasília. http://bvsms. saude.gov.br/bvs/publicacoes/direito_san_v1.pdf. Accessed 17 Jan 2019 Diniz MH (2005) O impacto da biotecnologia no direito à privacidade. In: Martin IGS, Pereira AJ (eds) Direito à Privacidade. Idéias & Letras e Centro de Extensão Universitária, São Paulo, pp 71–83 Doneda D (2006) Da privacidade à proteção de dados pessoais. Renovar, Rio de Janeiro Fernandez E (1991) Teoria de La Justicia y Derechos Humanos. Editorial Debate, Madrid Grinover AP et al (2001) Código Brasileiro de Defesa do Consumidor comentado pelos autores do anteprojeto, 7th edn. Forense Universitária, São Paulo Guerreiro MF (2004) Seguros Privados: Doutrina, Legislação e Jurisprudência, 2nd edn. Forense Universitária, Rio de Janeiro Huxley A (1996) Brave new world. Black Cat Cideb, Ferrara Instituto Nacional de Estudos e Pesquisas Educacionais Anísio Teixeira (INEP) (2017) SAEB 2017. https://medium.com/@inep/resultados-do-saeb-2017-f471ec72168d. Accessed 27 Mar 2019 Irons J (2001) Nobel prize for “Asymmetric Information”. https://jsirons.wordpress.com/2001/10/ 23/nobel_prize_for/. Accessed 17 Jan 2019 Lang-Stanton P, Jackson S (2017) Eugenia: como movimento para criar seres humanos ‘melhores’ nos EUA influenciou Hitler. https://www.bbc.com/portuguese/internacional-39625619. Accessed 23 Sept 2018 Lewicki B (2003) A privacidade da pessoa humana no ambiente de trabalho. Renovar, Rio de Janeiro Lima Neto FV (2004) Ética, mapeamento de DNA e discriminação genética: novos desafios da pósmodernidade. In: Leite EO (ed) Grandes temas da atualidade: bioética e biodireitos. Forense, Rio de Janeiro, pp 71–89 Moffitt TE (2005) The new look of behavioral genetics in developmental psychopathology: geneenvironment interplay in antisocial behaviors. Psychol Bull 131:533–554 Moraes MCB (2003) O conceito de dignidade humana: substrato axiológico e conteúdo normativo. In: Sarlet I (ed) Constituição, Direitos Fundamentais e Direito Privado. Livraria do Advogado, Porto Alegre, pp 105–147 Pindyck R, Rubinfeld DL (2002) Microeconomia, 5th edn. Prentice Hall, São Paulo Rodotà S (2008) A vida na sociedade da vigilância: a privacidade hoje, 1st edn. Renovar, Rio de Janeiro Rothstein MA, Horung CA (2004) Public attitudes. In: Rothestein MA (ed) Genetics and life insurance: medical underwriting and social policy. MIT Press, London, pp 1–25

Genetic Privacy in Employment and Insurance in Canada Hilary Young and Colleen Thrasher

Abstract In 2017, Canada enacted the federal Genetic Non-Discrimination Act. While there are many other statutes and common law provisions relevant to genetic discrimination in Canada, the new Act is the only law that specifically addresses genetic discrimination in the employment and insurance contexts. It makes it unlawful to require genetic testing or the disclosure of results of genetic tests as a condition of employment or insurance. This chapter discusses the Act in detail, and also considers other laws relevant to genetic privacy in the insurance and employments contexts, such as human rights, privacy, and insurance laws. The discussion reveals that while Canada has a strong genetic non-discrimination law, there is some uncertainty given the lack of case law interpreting the Act and other laws in the context of genetic privacy. For example, its application to genetic information about family members remains unclear. Commentators also remain divided as to whether it is appropriate to deny insurers access to genetic information while allowing family history to be used in determining insurability and premiums.

1 Introduction In 2017, Canada enacted new federal law prohibiting genetic discrimination in the insurance and employment contexts: the Genetic Non-Discrimination Act (the Act). In addition, Canada has a variety of provincial and federal laws that affect genetic privacy in the insurance and employment contexts, including human rights, privacy, and insurance laws. Together, these laws make it unlawful to require genetic testing or the disclosure of results of genetic tests as a condition of employment or

H. Young (*) Faculty of Law University of New Brunswick, Fredericton, NB, Canada e-mail: [email protected] C. Thrasher University of New Brunswick, Fredericton, NB, Canada e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_4

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insurance. They also prohibit non-consensual use of health information, including genetic test results. Other health information, however, including information about genetic status gleaned from family history, may be used to determine insurability and set premiums. These laws are set out below, along with commentary about their strengths and weaknesses as tools for protecting genetic privacy. The task is made more difficult by a lack of case law testing these laws in the context of genetic information. In the final section of the chapter, we discuss whether such laws strike the right balance between incentivizing the use of genetic tests where they could be helpful, and allowing businesses, especially the insurance industry, to rely on relevant health information.

2 The Genetic Non-discrimination Act In May 2017, the Act came into force.1 Other countries had genetic antidiscrimination laws for some time,2 and some activists, health care professionals and politicians considered that it was time for Canada3 to act to ensure that individuals did not forego important genetic testing out of a concern that a positive test would affect their insurability and employability.4 The Act prohibits requiring individuals to undergo genetic testing and requiring them to disclose the results of genetic tests under certain conditions, including as a condition of insurance and employment contracts. The Act does not mention employment and insurance explicitly, but rather refers to the provision of goods and services and entering into contracts. The most relevant provisions are sections 3–5: 3 (1) It is prohibited for any person to require an individual to undergo a genetic test as a condition of (a) providing goods or services to that individual; (b) entering into or continuing a contract or agreement with that individual; or (c) offering or continuing specific terms or conditions in a contract or agreement with that individual. (2) It is prohibited for any person to refuse to engage in an activity described in any of paragraphs (1)(a) to (c) in respect of an individual on the grounds that the individual has refused to undergo a genetic test. 4 (1) It is prohibited for any person to require an individual to disclose the results of a genetic test as a condition of engaging in an activity described in any of paragraphs 3(1) (a) to (c).

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Genetic Non-Discrimination Act, SC 2017, c 3. The United States, for example, has had such legislation since 2008: Genetic Information Nondiscrimination Act of 2008, Pub L No 110-233, 122 Stat 881. 3 The legislation actually originated in the Senate and did not have the support of the Federal Cabinet, which had concerns about its constitutionality. Nevertheless, Parliament passed the bill. 4 See e.g. Gold (2016). 2

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(2) It is prohibited for any person to refuse to engage in an activity described in any of paragraphs 3(1)(a) to (c) in respect of an individual on the grounds that the individual has refused to disclose the results of a genetic test. 5 It is prohibited for any person who is engaged in an activity described in any of paragraphs 3(1)(a) to (c) in respect of an individual to collect, use or disclose the results of a genetic test of the individual without the individual’s written consent.

These provisions prohibit not only requiring that tests be done or that results be disclosed, but also seem to prohibit offering incentives to those who voluntarily disclose genetic test results. That would amount to requiring disclosure of genetic test results in order to offer specific terms of an insurance contract, contrary to section 3(1)(c) or 4(1). As a result, insurance companies cannot effectively penalize those who do not disclose genetic test results by offering lower prices only to those who do take such tests and disclose the results. Further, section 5 prohibits the use of genetic test results without consent. The bill’s sponsor, Senator James Cowan, explained the purpose of section 5 as being to prevent companies from searching social media, for example, for evidence of genetic test results which they could then use.5 Section 5 refers to genetic tests “of the individual,” however, so it might not function to prevent the use of one person’s genetic test results in relation to a different, related person. A recent article in Science demonstrated that based on direct-to-consumer genetic test databases, “about 60% of the searches for [American] individuals of European-descent will result in a third cousin or closer match.”6 Further, this methodology could soon permit close to 100% of such searches to be successful.7 In other words, technology now permits us to find genetic information about many individuals on the basis of the genetic information of others. Given this, there may be a gap in the legislation, unless courts interpret “genetic test of the individual” to include genetic tests of a related individual. Before the legislative enactment, the Canadian insurance industry had proposed a voluntary policy of not requiring disclosure of genetic test results for those applying for life insurance policies with a value of $250,000 or less. An earlier version of the bill contained a similar exclusion.8 However, the legislation as passed is much broader, as it is not limited to life insurance or to policies of a certain value. Breaches of the Act can lead to fines of up to $1 million and to prison terms of up to 5 years.9

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Canada, Senate, 42nd Parl, 1st Sess, Vol 150, Issue 8 (27 January 2016) at 1450 (Hon James S Cowan). 6 Erlich et al. (2018), p. 690. 7 Erlich et al. (2018), p. 690. 8 Canada, Senate, 42nd Parl, 1st Sess, Vol 150, Issue 8 (27 January 2016) at 1450 (Hon James S Cowan). 9 Genetic Non-Discrimination Act, SC 2017, c 3, s. 7.

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In addition to creating a new criminal offence,10 the Act amends the Canada Labour Code11 so as to prohibit mandatory testing or disclosure of genetic test results in the employment context and to permit investigations and adjudications where the relevant provisions are alleged to have been violated. However, the Canada Labour Code only applies to employees in sectors within the legislative authority of the Federal government, such as banking, shipping, and aviation. The Act also amends the Canadian Human Rights Act12 to make “genetic characteristics” a new ground of discrimination. Like the Canada Labour Code, the Canadian Human Rights Act applies only to employees of the Federal government and federally-regulated industries. It is discussed further in the section on human rights law. Researchers and health care practitioners are exempted from the Act. This was arguably unnecessary given that voluntary disclosure is still permissible under the Act and consent generally governs disclosure of personal information to health care professionals and others. The constitutionality of the Act was challenged, but in 2020 the Supreme Court upheld the federal government’s right to enact it under its criminal law power.13

3 Insurance Law Provincial insurance laws require applicants to disclose relevant health information to their insurers when obtaining life and health insurance policies.14 Further, provincial human rights legislation permits insurance companies to discriminate on the basis of “age, sex, marital status, family status or disability.”15 The Act alters this approach in that the results of genetic tests need not be disclosed. The importance of insurance laws (and the relevant human rights code exemptions) to questions of genetic testing is therefore significantly diminished with the coming into force of the Act.

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Criminal Code, RSC 1985, c C-46. Canada Labour Code, RSC 1985, c L-2. 12 Canadian Human Rights Act, RSC, 1985, c H-6. 13 Genetic Non-Discrimination Act, 2020 SCC 17. 14 See e.g. British Columbia’s Insurance Act (Insurance Act, RSBC 2012, c 1, ss 51(1), 111), which states at section 51(1): 11

An applicant for insurance and a person whose life is to be insured must each disclose to the insurer in the application, on a medical examination, if any, and in any written statements or answers furnished as evidence of insurability, every fact within the applicant's or person’s knowledge that is material to the insurance and is not so disclosed by the other. 15

See e.g. Ontario Human Rights Code, RSO 1990, c H.19, s 22.

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Despite the Act, insurance companies are permitted to discriminate on the basis of genetic information voluntarily disclosed, since the Act simply prohibits requiring testing and disclosure. It does not prevent the use of voluntarily disclosed information. Thus, applicants for insurance may believe they are required to disclose under the heading of family history and this information may then be used in assessing premiums and other terms of the insurance contract. In addition, since the Act only prohibits mandatory testing and disclosure of the results of genetic tests, insurance companies may still rely on genetic characteristics learned from family history in its decision whether or how to insure someone. It is unclear whether one would be permitted not to disclose a genetic condition confirmed by a genetic test if it were already suspected based on family history. The plain language of the Act suggests that the family history would have to be disclosed but not the fact that it was confirmed by a genetic test. It is also unclear whether one would have to disclose the fact of a family member’s genetic predisposition under the guise of family history. But again, this would presumably not have to be disclosed if the predisposition were discovered only through genetic testing.

4 Human Rights Laws 4.1

The Canadian Charter of Rights and Freedoms

Section 15 of the Canadian Charter of Rights and Freedoms16 (the Charter) prohibits discrimination on the basis of enumerated grounds, including mental and physical disability. It also prohibits unreasonable search and seizure in section 8, which includes seizure of DNA samples,17 for example, and interferences with life, liberty, and security of the person in section 7. These prohibitions, as well as the section 15 non-discrimination provision, are subject to reasonable limits on these rights, as provided for in section 1 of the Charter. The Charter, however, is unlikely to protect against discrimination in the employment and insurance contexts. This is primarily because the Charter only protects against discrimination perpetrated by the government, whether in the form of government action or legislation.18 While there is a common law test to determine whether discriminatory behaviour can be attributed to the government, as per

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Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982 being Schedule B to the Canada Act 1982 (UK), 1982, c 11. 17 See R v SAB, 2003 SCC 60, [2003] 2 SCR 678. 18 RWDSU v Dolphin Delivery Ltd, [1986] 2 SCR 573 at paras 34–35, 9 BCLR (2d) 273.

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RWDSU v Dolphin Delivery Ltd,19 private employers and insurance companies would likely never satisfy the criteria, and they are therefore likely immune to Charter challenges. In addition, although the Charter protects against discrimination on the basis of mental and physical disability, it is unclear whether genetic status would be included in the meaning of a disability. There is no case law on the issue of whether genetic discrimination is covered by section 15—either by virtue of genetic predisposition constituting a disability or by virtue of genetic characteristics constituting a protected analogous ground of discrimination.20 Indeed, no court cases have directly examined the scope of any legal protection Canadians might have from genetic discrimination. That said, the case of Québec (Commission des droits de la personne et des droits de la jeunesse) v Montréal (City); Québec (Commission des droits de la personne et des droits de la jeunesse) v Boisbriand (City) is instructive. The case was decided on the basis of the Quebec Charter, which is discussed in Yann Joly’s Chapter 12 but, in obiter, the Supreme Court of Canada referred to section 15 of the Canadian Charter and cited with approval secondary sources stating that the enumerated ground of “disability” in section 15 includes perceived disabilities.21 Genetic information may indeed yield evidence of perceived disabilities or of the perceived propensity to become disabled. Unfortunately, genetic information’s potential inclusion under section 15 still does very little to prevent discrimination in insurance or employment contexts. Interpretive questions are, therefore, better suited to human rights legislation.

4.2

Human Rights Statutes

Canada also has federal and provincial human rights statutes. It was noted above that the Act amended the Canadian Human Rights Act so as to include “genetic characteristics” as a prohibited ground of discrimination under Section 3(1).22 Notably, however, the Canadian Human Rights Act only applies to federally regulated activities, such as banking and air travel, so its ability to prevent genetic discrimination in the employment context is thereby limited to such activities. The Act, a federal statute, does not amend provincial human rights statutes. Provincial human rights legislation applies generally to the public and private sector in each province and territory, other than to activities under federal jurisdiction, but does not explicitly protect against genetic discrimination. Granted, statutes may

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RWDSU v Dolphin Delivery Ltd, [1986] 2 SCR 573 at paras 34–35, 39, 9 BCLR (2d) 273. Walker (2014), s 3.1. 21 Québec (Commission des droits de la personne et des droits de la jeunesse) v Montréal (City); Québec (Commission des droits de la personne et des droits de la jeunesse) v Boisbriand (City), 2000 SCC 27 at para 49, [2000] 1 SCR 665. 22 Genetic Non-Discrimination Act, s 10. 20

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implicitly do so in that they protect against discrimination on the basis of disability. Further, commentators including academics and journalists counsel against legislative amendments specifically enumerating genetic characteristics as a prohibited ground of discrimination; rather, in their view, existing legislation can be interpreted so as to create effective barriers to genetic discrimination in the workplace.23 In particular, the prohibited ground of disability can be understood to include genetic characteristics since it includes the possibility of becoming disabled.24 In J v London Life Insurance Company, the British Columbia Human Rights Tribunal interpreted the enumerated ground of ‘physical disability’ as including the “perceived propensity to become disabled in the future.”25 Note, however, that J v London Life Insurance Company was not a case about genetic characteristics; it was about discrimination on the basis of perceived risk of acquiring HIV. Nonetheless, discrimination due to a perceived propensity to become disabled is the essence of genetic discrimination. The prohibition of discrimination on the basis of race and sex may also be relevant to genetic discrimination. Karen Eltis has argued that genetic information can result in group stigmatization; Ashkenazi Jewish women, for example, are perceived as having higher rates of the BRCA gene, but they do not show a higher incidence of breast cancer than “women of other ethnic origins”.26 Related to workplace discrimination, in the 1970s, the chemical company commonly known as DuPont tested “African-American applicants (. . .) to identify the sickle-cell gene” and was subsequently accused of “scientific racism.”27 The acts of singling out members of a marginalized group because of their genetic information and because of their racial or ethnic characteristics may occur simultaneously. Genetic discrimination, consequently, may be addressed by the prohibited grounds of race, sex, ethnicity, or creed. Uniquely, a Private Member’s Bill (Bill 164) that received its second reading in Ontario, would amend the Ontario Human Rights Code to specifically enumerate genetic characteristics as a prohibited ground of discrimination.28 Further, the proposed amendment would prohibit workplace harassment on the ground of genetic characteristics and would codify the “right to equal treatment with respect to employment without discrimination because of (. . .) genetic characteristics.”29 Of 23

Labman (2004), p. 228; Picard (2017). Labman (2004), p. 239. 25 J v London Life Insurance Company, 1999 BCHRT 36 at para 46. 26 Eltis (2007), p. 283. 27 Labman (2004), p. 232: Dupont became concerned with the possibility that “carriers of the sicklecell trait [were] more vulnerable to certain hemolytic agents” and only tested African-American employees for whether they were carriers. This was an example of scientific racism -- the use of selective or pseudo-scientific arguments to make claims of racial superiority or inferiority. The African-American employees were marginalized on the basis of a belief about their genetic makeup. 28 Ontario, Bill 164, An Act to Amend the Human Rights Code with respect to immigration status, genetic characteristics, police records, and social conditions, 2nd sess, 41st leg, 2017, s 1. 29 Human Rights Code Amendment Act, s 4. 24

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significance is the fact that Bill 164 does not include a proposed amendment to section 22 of the Ontario Human Rights Code, “meaning that the current exemption given to insurance companies to discriminate on the basis of age, sex and marital status would not apply to genetic characteristics.”30 Many lawyers have supported Bill 164, but they have additionally noted that it does not go far enough with respect to other kinds of discrimination.31 The Bill did not pass before there was a change of government in Ontario, so there is still no provincial legislation that enumerates genetic characteristics as a prohibited ground of discrimination. Turning to the procedural world of human rights law, under human rights statutes, complaints must generally be brought before an administrative tribunal rather than a court. The onus, burden, and nature of unlawful discrimination are similar to those in the Charter context. There are, however, differences. The enumerated grounds of discrimination in human rights legislation are exhaustive, whereas the Charter also protects against discrimination on analogous grounds. Discrimination in the Charter context can be justified, according to section 1, on the basis that it is a limit on rights that is justifiable in a free and democratic society. In the human rights legislation context, workplace discrimination is permitted when it is a bona fide occupational requirement. Employers otherwise have “a duty to accommodate disability, short of undue hardship.”32 Such a duty provides insight into why employers may want to genetically test their employees since “potential disabilities (. . .) may later create medically related absences (. . .) or demands for accommodation.”33 That said, as of the coming-into-force of the Act, it is a criminal offence to require anyone to undergo genetic testing or to require them to disclose the results of genetic tests as a condition of entering or continuing a contract; employers, consequently, would be criminally prohibited from requiring genetic testing or test results from employees.34 Perhaps the greatest difference between the Charter and human rights legislation relates to remedies. Under the Charter, discriminatory laws may be struck down. A court may also, or alternatively, grant any other appropriate remedy. Human rights tribunals, on the other hand, may have broad remedial powers, but they are restricted to those provided for in their governing legislation. Thus, the adequacy of remedial measures depends a great deal on which human rights laws apply and on the discretion of courts or administrative decision-makers. In sum, no provincial human rights laws explicitly prohibit discrimination on the ground of genetic characteristics, though Ontario may amend its Human Rights Code to do so. That said, genetic discrimination could be prevented by way of other enumerated grounds, disability being the most relevant; but, race, sex, ethnicity, and creed may additionally intersect with genetic characteristics.

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Simes (2017). Davidson (2017). 32 Labman (2004), p. 231. 33 Labman (2004), p. 231. 34 Genetic Non-Discrimination Act, SC 2017, c 3, ss 3, 4, 7. 31

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5 Privacy Law The landscape of Canadian privacy laws is complex. Depending on who invades one’s privacy, the environment in which the invasion occurs, and whether health information is involved, different laws apply. In addition to the Act, one or more of the following may apply to protect against genetic discrimination in the employment and insurance contexts: • federal private-sector privacy legislation (Personal Information and Protection of Electronic Documents Act (PIPEDA));35 • provincial private-sector privacy legislation (e.g. Alberta Personal Information Protection Act);36 • federal public sector privacy legislation (Privacy Act);37 • in some provinces and territories, legislation dealing specifically with health information privacy (e.g. Manitoba’s The Personal Health Information Act);38 and • provincial statutory and common law privacy torts. While human rights laws specifically target discrimination, “[privacy] laws can affect the amount and type of information insurance companies, employers, or others may obtain, including doctors, employers in the private or public sectors, and public bodies involved in health care delivery.”39 Examining each of these privacy statutes in detail is beyond the scope of this chapter, but they generally require consent for the collection, use, and disclosure of personal information. Personal information is defined broadly and includes genetic information.40 Medical information is considered especially sensitive, and the degree of sensitivity must be considered in determining the form of consent required

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Personal Information Protection and Electronic Documents Act, SC 2000, c 5, s 2(1). Personal Information Protection Act, SA 2003, c P-6.5. 37 Privacy Act, RSC 1985, c P-21. 38 The Personal Health Information Act, CCSM, c P33.5. 39 Walker (2014), p. 7. 40 For this reason, the federal Privacy Commissioner recommended against a provision in the draft genetic non-discrimination bill that would have amended the Federal Privacy Act and the Personal Information Protection and Electronic Documents Act. He understood the definition of personal information in these laws already to include genetic information. In his testimony before the Standing Senate Committee on Human Rights, he stated: 36

In both the Privacy Act and PIPEDA, personal information is broadly defined as information about an identifiable individual. Information derived from all types of genetic testing is already covered by existing definitions. Adding genetic information as an example could have the unintended consequence of narrowing the definition of personal information. Standing Senate Committee on Human Rights, Evidence, 42nd Parl, 1st Sess, Issue No 2 (24 February 2016).

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for collection, use, and disclosure.41 Thus, disclosure of genetic information is not generally permitted without the consent of the person whose personal information it implicates. There are, however, exceptions. For example, one may disclose personal information when a court order requires it. While laws such as PIPEDA and the federal Privacy Act refer to “personal information,” personal health information privacy statutes, such as Ontario’s Personal Health Information Protection Act (PHIPA),42 refer to personal health information. PHIPA requires consent for the collection, use, and disclosure of personal health information, including genetic information, in the care of “custodians.”43 Subject to exceptions, test results contained in a patient’s medical or hospital file cannot be disclosed to third parties, including employers and insurers, without the patient’s consent. Nor can a patient herself be required to disclose such information. Exceptions include when disclosure to another health information custodian is reasonably necessary for medical purposes and it is not practical to obtain consent; to ascertain eligibility to receive health care; to a public health authority or Chief Medical Officer of Health if permitted by law; for the purpose of eliminating or reducing a significant risk of serious bodily harm to a person or group of persons; and for the purpose of legal proceedings.44 Such exceptions are unlikely to be relevant in the employment and insurance contexts. Although these statutes are likely to proscribe most non-consensual disclosures of genetic information, note that it can be especially difficult to achieve a remedy where there has been a breach. Complaints must first be adjudicated by the Privacy Commissioner, who can only make non-binding recommendations.45 Then, should the matter proceed to court, damages awards for breach of these statutes tend to be small.46 In addition to statutes prohibiting non-consensual disclosure of personal information, there are statutory and common law privacy torts which could be engaged where there has been a breach of genetic privacy.47 Those torts are generally grounded in the concept of reasonable expectations of privacy.48 Inappropriately 41

Personal Information Protection and Electronic Documents Act, ss 4.3.4 and 4.3.6. Personal Health Information Protection Act, 2004, SO 2004, c 3, Sch A. 43 See e.g. Personal Health Information Protection Act, s 29. Some provinces refer to these as “trustees.” See e.g. the Manitoba Personal Health Information Act, CCSM c P33.5. 44 See Personal Health Information Protection Act for a complete list of exceptions. See especially ss 38–49. 45 See e.g. Privacy Act, ss 29, 35, 48–49; Personal Information Protection and Electronic Documents Act, ss 11, 13, 14, 16. See also Scassa (2013). 46 See e.g. Scassa (2013). 47 British Columbia, Saskatchewan, Manitoba and Newfoundland & Labrador have statutory privacy torts. See e.g. Privacy Act, RSBC 1996, c 373. Ontario and some other provinces have common law privacy torts. See Jones v Tsige, 2012 ONCA 32, 108 OR (3d) 241. 48 BC’s Privacy Act, RSBC 1996, c 373, ss 1(1)–(2) state: 42

(1) It is a tort, actionable without proof of damage, for a person, wilfully and without a claim of right, to violate the privacy of another.

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acquiring or using genetic information about an employee or insured person could contravene these laws. In summary, non-consensual disclosure to an employer or insurer will rarely be permitted under PIPEDA, related provincial privacy statutes, or provincial personal health privacy legislation. Invasions of privacy involving genetic information may also be tortious.

6 Obligations in the Medical and Research Contexts Physicians owe tort duties to patients to disclose material risks of all health care interventions. This might include socio-legal risks of undergoing testing, although there is no case law addressing this question. With regard to research, the Tri-Council Policy Statement for Ethical Conduct for Research Involving Humans is an important guide, though not legally binding. In article 13.3, it states that researchers must disclose to participants “the (. . .) implications of [the genetic] findings.”49 In addition, researchers must disclose “datasharing requirements.”50 Given that these are broad requirements, they suggest that research participants should be informed of socio-legal risks associated with genetic tests. The implications of genetic testing for access to insurance and employment are specifically mentioned in article 13.2 of the Tri-Council Policy Statement, which includes a requirement that researchers develop information management plans in order to address risks.51 With the coming into force of the Act, the implications for insurance or employment applications have changed, but the nature of doctors’ and researchers’ duties has not.

(2) The nature and degree of privacy to which a person is entitled in a situation or in relation to a matter is that which is reasonable in the circumstances, giving due regard to the lawful interests of others (emphasis added). Ontario’s common law privacy tort requires intrusions to be “highly offensive to a reasonable person.” See Jones v Tsige at para 70. 49 Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010), p. 195. 50 Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010), p. 196. 51 Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010), p. 194.

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7 Discussion Commentary on the state of Canadian law protecting genetic privacy has largely focused on the Act. While many have hailed it as a step forward for human rights,52 some have dismissed it as mere virtue-signaling53—a solution to a non-problem. Others think it is inappropriate to permit discrimination on the basis of health status and family history, but not to permit the use of genetic test results. This is the genetic exceptionalism54 argument: if health information is relevant to insurability and premiums, why treat genetic data differently? The insurance industry objects to the Act on this basis and warns that it will cause higher premiums for everyone.55 The most compelling response to the genetic exceptionalism argument is that the potential use of non-genetic health information does not prevent people from being treated or diagnosed, whereas there is anecdotal evidence that people are avoiding genetic testing because they fear the implications of results for insurability and employment.56 Some think that the Act does not go far enough. Yvonne Bombard, a prominent researcher on genetic discrimination in Canada, argues that prohibitions on genetic testing may not be sufficient because discrimination due to family history occurs just as frequently as discrimination due to genetic information for diseases with genetic characteristics like Huntington’s.57 Both family history and genetic characteristics allow the possibility of discrimination on the basis of potential or future illness, as opposed to present illness. Further, prohibiting genetic discrimination while allowing discrimination based on family history is, to some extent, illogical. Genetic information may yield good information of future illnesses, depending on the illness in question,58 whereas family history can be misleading. The question persists: why prohibit differential treatment on the basis of more reliable, but not less reliable, information? In a self-reported study by Yvonne Bombard, discrimination on the basis of family history was more prevalent than genetic discrimination for those at risk of Huntington’s disease.59 Although the Act does not prohibit discrimination on the basis of family history, the Huntington’s Society of Canada has shown support for such a prohibition. Further, the Canadian Coalition for Genetic Fairness, supported by the Huntington’s Society, intervened in support of the law in the recent

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See e.g. Office of the Privacy Commissioner of Canada (2017). See e.g. Picard (2017). 54 Lemmens (2000), p. 369. 55 See e.g. Goldberg (2017). 56 See Canada, Senate, 42nd Parl, 1st Sess, Vol 150, Issue 8 (27 January 2016) at 1440 (Hon James S Cowan). 57 Hall (2009). 58 Lemmens (2000), p. 371. 59 Bombard (2009), p. 1431. 53

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constitutional challenge of the Act.60 Even with gaps or ambiguities in the Act, therefore, it has received support from some stakeholders. Perhaps the criticisms of the Act from a range of stakeholders, arguing it goes too far and not far enough, suggest that it achieves a reasonable balance. Yet in our view, there are gaps in the law. As noted above, the Act does not appear to prevent the use of one person’s genetic tests against a relative. Relatedly, it is unclear whether a relative’s genetic test results count as part of one’s family history, which may still form the basis of insurability and premiums decisions.

8 Conclusion In the words of Trudo Lemmens, “[g]enetic information traverses the bounds of personal autonomy,”61 which makes genetic discrimination particularly difficult to regulate. It is even more difficult in a federal state like Canada, in which the federal government has jurisdiction over criminal law but the provinces have jurisdiction over contracts and provision of services, such as insurance. The Act provides protection against certain uses of genetic information and Canadians should now be more willing to undergo genetic tests, resulting in earlier and better treatment or preventative care. Human rights and privacy laws also have a role to play in preventing discrimination and unauthorized disclosures of genetic information. Yet questions remain about the underlying policy issue: how best to promote access to genetic tests while not denying insurance companies (in particular) relevant health information. Canada’s approach is likely to change over time as genetic technologies improve and become more predictive and more commonplace.

References Bombard Y, Veenstra G, Friedman JM et al (2009) Perceptions of genetic discrimination among people at risk for Huntington’s disease: a cross sectional survey. BMJ 338(7708):1431 Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010) Tri-council policy statement: ethical conduct for research involving humans. Interagency Secretariat on Research, Ottawa Davidson T (2017) Lawyers laud proposed additions to Ontario Human Rights Code, but say more change needed. Lawyer’s Daily. https://www.thelawyersdaily.ca/articles/4864. Accessed 9 Nov 2018

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Stauffer (2018). Lemmens (2000), p. 371.

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Eltis K (2007) Genetic determinism and discrimination: a call to re-orient prevailing human rights discourse to better comport with the public implications of individual genetic testing. J Law Med Ethics 35(2):282–294 Erlich Y, Shor T, Pe’er I et al (2018) Identity inference of genomic data using long-range familial searches. Science. http://science.sciencemag.org/content/early/2018/10/10/science.aau4832. Accessed 9 Nov 2018 Gold K (2016) How genetic testing could be used against you – and how Bill S-201 could change that. The Globe and Mail. https://www.theglobeandmail.com/life/health-and-fitness/health/bills-201-aims-to-end-genetic-discrimination-in-canada/article29494782/. Accessed 9 Nov 2018 Goldberg S (2017) Insurers lose genetic testing fight. Advisor’s edge. https://www.advisor.ca/ insurance/life/insurers-lose-genetic-testing-fight/. Accessed 9 Nov 2018 Hall J (2009) Study finds genetic discrimination by insurance firms. The Star. https://www.thestar. com/life/health_wellness/2009/06/09/study_finds_genetic_discrimination_by_insurance_firms. html. Accessed 9 Nov 2018 Labman S (2004) Genetic prophecies: the future of the Canadian workplace. Man Law J 30 (2):227–248 Lemmens T (2000) Selective justice, genetic discrimination, and insurance: should we single out genes in our laws? McGill Law J 45:347–412 Office of the Privacy Commissioner of Canada (2017) New genetic non-discrimination law will promote privacy and human rights in Canada. Office of the Privacy Commissioner of Canada. https://www.priv.gc.ca/en/opc-news/news-and-announcements/2017/nr-c_170505/. Accessed 9 Nov 2018 Picard A (2017) Anti-genetic-discrimination bill is little more than virtue signaling. The Globe and Mail. https://www.theglobeandmail.com/news/national/anti-genetic-discrimination-bill-is-lit tle-more-than-virtue-signalling/article34261843/. Accessed 9 Nov 2018 Scassa T (2013) The failure of privacy law. http://www.teresascassa.ca/index.php?option¼com_ k2&view¼item&id¼123:the-failure-of-privacy-law&Itemid¼80. Accessed 9 Nov 2018 Schmitz C (2019) SCC to look at constitutionality of genetic ban nixed by ex-AG Canada but supported by new AG. Lawyer’s Daily. https://www.thelawyersdaily.ca/articles/9895/scc-tolook-at-constitutionality-of-genetic-discrimination-ban-nixed-by-ex-ag-canada-but-supportedby-new-ag. Accessed 8 Apr 2019 Simes N (2017) Ontario adding social condition, other protected grounds to Human Rights Code. Lawyer’s Daily. https://www.thelawyersdaily.ca/articles/5335/ontario-adding-social-conditionother-protected-grounds-to-human-rights-code. Accessed 9 Nov 2018 Stauffer J (2018) January 2018 update: going to court to protect genetic fairness. Huntington Society of Canada. https://www.huntingtonsociety.ca/gna/. Accessed 9 Nov 2018 Walker J (2014) Genetic discrimination and Canadian law. Library of Parliament Background Paper #2014-90-E. https://lop.parl.ca/sites/PublicWebsite/default/en_CA/ResearchPublications/ 201490E. Accessed 9 Nov 2018

Legal Aspects of Genetic Testing Regarding Insurance and Employment in Cyprus Theodoros Trokanas

Abstract This text aims to explore the uncharted waters of using genetic testing in the context of insurance and employment in Cyprus. Cyprus’ existing legislative vacuum is filled by recourse to international, European, and national texts, of both a hard and soft law nature. The text begins by presenting different definitions of the terms “genetic testing” and “genetic data.” Then, it examines the need for special status recognition for genetic data and raises the key question of whether genetic testing poses a threat to legal principles and human rights. Next, it explores which legally binding instruments of European and Cypriot origin apply to genetic testing performance in general (e.g. the Council of Europe’s Oviedo Convention), as well as to the processing of the resulting genetic data (e.g. the EU General Data Protection Regulation). Finally, the knotty problem of unregulated genetic testing for insurance and employment purposes is addressed through Opinions of national authorities (e.g. the Cyprus National Bioethics Committee) or advisory bodies (e.g. the European Group of Ethics), as well as Recommendations from international organisations (e.g. the Council of Europe).

1 Genetic Testing and Genetic Data Definitions The Cypriot legal order lacked precise definitions of the terms “genetic testing,” “genetic data,” and “genetic information” until the EU General Data Protection Regulation 2016/679 (GDPR) entered into force on 25 May 2018, protecting natural persons with regard to the processing and free movement of personal data, and

T. Trokanas (*) Hellenic Open University, School of Social Sciences, Patras, Greece University of Macedonia, School of Business Administration, Department of Accounting and Finance, Thessaloniki, Greece e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_5

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repealing Directive 95/46/EC.1 In the absence of definitions, Cypriots were obliged to resort to non-binding international and European texts.

1.1

Definitions at an International Level

Article 2 of UNESCO International Declaration on Human Genetic Data2 defines “genetic testing” as a procedure to detect the presence, absence, or change in a particular gene or chromosome, including an indirect test for a gene product or other specific metabolite that is primarily indicative of a specific genetic change.3 The same article of the Declaration refers to the results of genetic testing as “genetic information” or “genetic data.” They include any information about heritable characteristics of individuals obtained by analysis of nucleic acids or by other scientific analysis.4

1.2 1.2.1

Definitions at a European Level Non-binding Instruments

At a very early stage, the Council of Europe appreciated the need to guide its members’ legislation and policy in the field of genetic testing. Recommendation No R(92)3 on Genetic Testing and Screening for Health Care Purposes makes the first serious attempt to address the issue.5 It systematises the main purposes of genetic tests as follows: (1) diagnosis and classification of a genetic disease; (2) identification of unaffected carriers of a defective gene in order to counsel them about the risk of having affected children; (3) detection of a serious genetic disease before the clinical onset of symptoms in order to improve the quality of life using secondary preventive measures and/or to avoid giving birth to affected offspring; and 1 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016 (Regulation (EU) 2016/ 679 of the European Parliament and of the Council of 27 April 2016). 2 UNESCO International Declaration on Human Genetic Data, adopted unanimously and by acclamation on 16 October 2003 by the 32nd session of the General Conference of UNESCO (UNESCO International Declaration on Human Genetic Data). 3 UNESCO International Declaration on Human Genetic Data, Art 2(xii). 4 UNESCO International Declaration on Human Genetic Data, Art 2(i). 5 Council of Europe, Recommendation No R(92)3 of the Committee of Ministers to Member States on Genetic Testing and Screening for Health Care Purposes, adopted by the Committee of Ministers on 10 February 1992 at the 470th meeting of the Ministers’ Deputies. Recommendation No R(92)3 had been preceded by Recommendation No R(90)13 on the specific issue of prenatal genetic screening, prenatal genetic diagnosis and associated genetic counseling.

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(4) identification of persons at risk of contracting a disease where both a defective gene and a certain lifestyle are important causes of the disease.6 The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes adopted a more laconic definition of “genetic tests” on 27 November 2008.7 According to Article 2(1), the Protocol applies to tests, carried out for health purposes, involving the analysis of human biological samples and aiming specifically to identify the genetic characteristics that are inherited or acquired during early prenatal development. The same wording inspired the drafters of Recommendation CM/Rec(2016)8 on the processing of personal health-related data for insurance purposes, including data resulting from genetic tests.8 The Opinion of the European Group of Ethics in Science and New Technology (EGE), “Ethical aspects of genetic testing in the workplace,” of 28 July 2003 provides a comprehensive definition of genetic tests in the specific context of employment.9 According to the Opinion, genetic testing includes both genetic screening and genetic monitoring.10 Genetic screening can function as an indicator of future health or susceptibility to occupational hazards for current or prospective employees.11 Genetic monitoring involves regular examinations for chromosomal abnormalities in cell samples of persons who, in their working environment, risk exposure to agents causing genetic damage.12 On the other hand, the first attempt to define “genetic data” dates back to the Council of Europe’s Recommendation No R(97)5 on the protection of medical data.13 Its drafters set out with the purpose of differentiating between “medical

6 See Council of Europe, Recommendation No R(92)3 of the Committee of Ministers to Member States on Genetic Testing and Screening for Health Care Purposes, adopted by the Committee of Ministers on 10 February 1992 at the 470th meeting of the Ministers’ Deputies, Principles and Recommendations, para a. 7 Unfortunately, Cyprus has not yet signed this Protocol, as is also the case with the overwhelming majority of the Council of Europe Member States. 8 See Recommendation CM/Rec(2016)8 of the Committee of Ministers to the Member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic test, adopted on 26 October 2016, para 4. 9 European Group on Ethics in Science and New Technologies (EGE), “Ethical Aspects of Generic Testing in the Workplace”, Opinion of the European Group on Ethics in Science and New Technologies to the European Commission no 18, 28 July 2003 (EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”). 10 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 1(e). 11 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 1.2. 12 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, paras 1(g) and 1.2.3. 13 Council of Europe, Committee of Ministers, Recommendation No R(97)5 on the Protection of Medical Data, adopted by the Committee of Ministers on 13 February 1997 at the 584th meeting of the Ministers’ Deputies.

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data”14 and “genetic data.”15 The Declaration’s very definition of “medical data” shows that it is a generic term, which encompasses “genetic data.” Nonetheless, as further clarified in the Explanatory Memorandum of the Recommendation,16 not all “genetic data” are “medical data.” Genetic data are medical data only if they are relevant to the health or disease of an individual or his or her relatives. The EGE Opinion, “Ethical aspects of genetic testing in the workplace,” of 28 July 2003 classifies family medical histories as genetic tests, insofar as they can be indicative of a person’s genetic status.17 The Cyprus National Bioethics Committee also adopts this approach in its Opinion with regard to predictive health-related medical information before the conclusion of private (life or health) insurance contracts of 22 January 2008.18

1.2.2

Legally Binding Instruments

Paradoxically, the first Cypriot legal text to define the term “genetic data” was the EU GDPR, which entered into force on 25 May 2018. Article 4(13) defines this term as personal data relating to the inherited or acquired genetic characteristics of a natural person, which give unique information about the physiology or the health of that natural person. It further specifies that such data result from an analysis of a biological sample from the natural person in question,19 in particular chromosomal,

14 Council of Europe, Committee of Ministers, Recommendation No R(97)5 on the Protection of Medical Data, adopted by the Committee of Ministers on 13 February 1997 at the 584th meeting of the Ministers’ Deputies, Art 1: “the expression ‘medical data’ refers to all personal data concerning the health of an individual. It refers also to data which have a clear and close link with health as well as to genetic data”. 15 Council of Europe, Committee of Ministers, Recommendation No R(97)5 on the Protection of Medical Data, adopted by the Committee of Ministers on 13 February 1997 at the 584th meeting of the Ministers’ Deputies, Art 1:

the expression ‘genetic data’ refers to all data, of whatever type, concerning the hereditary characteristics of an individual or concerning the pattern of inheritance of such characteristics within a related group of individuals. It also refers to all data on the carrying of any genetic information (genes) in an individual or genetic line relating to any aspect of health or disease, whether present as identifiable characteristics or not. 16 Council of Europe, Committee of Ministers, Explanatory Memorandum to Recommendation No R(97)5 on the Protection of Medical Data, adopted by the Committee of Ministers on 13 February 1997 at the 584th meeting of the Ministers’ Deputies, Appendix to the draft recommendation, para 43. 17 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 1.1.3. 18 Opinion of the Cyprus National Bioethics Committee with regard to predictive health-related medical information before the conclusion of private (life or health) insurance contracts of 22 January 2008, para 2, http://www.bioethics.gov.cy/Moh/cnbc/cnbc.nsf/All/ 16C6A7E6891495BCC2257CB30042BD04?OpenDocument. 19 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 4 (13). See also Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April

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deoxyribonucleic acid (DNA), or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained.20

2 Genetic Data Status Recognition 2.1

Theoretical Standpoints

Genetic information has been accorded the status of “Holy Grail,” an impression fuelled by public fascination for the inherent power of genes, coupled with a historical fear of eugenics.21 Despite this, genetic data’s special status has been a highly divisive issue. Some theorists have coined the term “genetic exceptionalism” to convey the idea that genetic data are qualitatively different from other personal data, including medical data.22 In fact, these theorists advocate that genetic data are not individual data, but are intrinsically familial, insofar as they reveal information not only about one’s own genetic make-up, but that of one’s relatives as well.23 On the contrary, a more cautious approach24 regards as distinctive not the genetic data themselves, but rather certain uses of them. Such opinion bases genetic data’s distinctive nature not on the fact that they are relevant to individuals, but instead on the eagerness of third parties to access and process them.25

2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA, OJ L 119/89, 4 May 2016, Art 3 (12) and Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC, OJ L 295/39, 21 November 2018, Art 3(17). 20 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 34. See also Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA, OJ L 119/89, 4 May 2016, Recital no 23. 21 Burge (2013), p. 523. 22 For relative discussion see O’Neill (2004), pp. 101 ff; Burge (2013), p. 522 ff; McGuire et al. (2008), p. 495; Evans and Burke (2008), pp. 500–501. 23 O’Neill (2004), p. 101. 24 O’Neill (2004), p. 105. 25 O’Neill (2004), p. 105.

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Special Status Recognition by the UNESCO International Declaration on Human Genetic Data

The drafters of the UNESCO International Declaration on Human Genetic Data also engaged in the heated debate about the status of genetic data. In Article 4(a), they recognised its special status, justifying their stance on multiple grounds. Firstly, genetic data can be predictive of genetic predispositions in individuals.26 In fact, their significance may not necessarily be known at the time of their collection, and their predictive power may turn out to be stronger than what was believed at the time of testing.27 Secondly, genetic data may have a significant impact on the family, including offspring, extending across generations, or even on a whole group–e.g. ethnic, racial–to which the person concerned belongs.28 Lastly, genetic data may have cultural significance for persons or groups.29 For these reasons, Article 4(b) of the Declaration commands due consideration of the sensitivity of genetic data together with the establishment of an appropriate level of protection for them.30

2.3

Sensitive Data Status Recognition in Cypriot Personal Data Protection Legislation

The Cypriot legislation has not explicitly granted a special status to genetic data, such as that in Article 4(a) of the UNESCO International Declaration on Human Genetic Data. Nevertheless, since the enactment of Law 138 (I)/2001 on the processing of personal data (protection of the individual),31 it has been a widelyheld scholarly view that genetic data resulting from genetic testing falls under the definition of “sensitive data,” and, in particular, data concerning “health”32 under Article 2 of Law 138 (I)/2001.33 In this respect, it could be argued that the Cypriot 26

UNESCO International Declaration on Human Genetic Data, Art 4(a)(i). UNESCO International Declaration on Human Genetic Data, Art 4(a)(iii). 28 UNESCO International Declaration on Human Genetic Data, Art 4(a)(ii). 29 UNESCO International Declaration on Human Genetic Data, Art 4(a)(iv). 30 UNESCO International Declaration on Human Genetic Data, Art 4(b). 31 Cyprus enacted Law 138 (I)/2001 in conformity with its obligation to transpose Directive 95/46/ EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The Law was published in the Official Journal of The Republic of Cyprus Annex I (I), no 3549, 23 November 2001. 32 See The Working Party, “ARTICLE 29 Date Protection Working Party”, Working Document on Genetic Data, 12178/03/EN WP 91, adopted on 17 March 2004, part III. Cf Section 1180(a)(1) of the United States Genetic Information Non-Discrimination Act (GINA) (enacted by the 110th United States Congress, 21 May 2008, 122 Stat 881): “Genetic information shall be treated as health information”. 33 Law 138 (I)/2001, Official Journal of The Republic of Cyprus Annex I (I), no 3549, 23 November 2001, Art 2: 27

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legislation has given some consideration to the sensitivity of human genetic data within the spirit of Article 4(b) of the UNESCO International Declaration on Human Genetic Data. This conception was reinforced by a series of personal data protection texts which made explicit references to “genetic data” under the generic term “special categories of personal data:” (a) Article 9(1) of the EU GDPR, especially in conjunction with the affirmation of its drafters that, terminology-wise, “special categories of personal data” equals “sensitive data;”34 (b) Article 10(1) of EU Directive 2016/680; (c) Articles 10(1) and 76(1) of EU Regulation 2018/1725; and (d) Article 6(1) of Protocol 22335 amending Convention 108 of the Council of Europe for the Protection of Individuals with regard to Automatic Processing of Personal Data.36

3 A Human Rights Approach to Genetic Testing 3.1

The Principle of Equality/Non-discrimination

The widespread use of genetic tests and the subsequent processing of the genetic findings engender fears that genetic data may reach third parties, who would be tempted to exploit them. The selection against, and stigmatisation and discrimination of, data subjects might seriously compromise or violate the equality principle. In Cyprus, the principle of non-discrimination can be found within general and specific human rights protection provisions. At the general level, Article 28(2) of the Constitution of the Republic of Cyprus of 196037 and Article 14 of the European (. . .) “sensitive data” mean data concerning racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, health, sexual life or sexual orientation, criminal prosecution and convictions. 34

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recitals nos 10 and 51. 35 Protocol amending the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data opened for signature on 10 October 2018, CETS no 223. The Amending Protocol has not been signed by Cyprus yet. 36 Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data opened for signature on 28 January 1981, entered into force on 1 October 1985, ETS no 108. This Convention was the first binding international instrument to protect individuals against abuses related to the collection and processing of personal data. It was opened for signature on 28 January 1981 and entered into force on 1 October 1985. The Treaty was signed by Cyprus on 25 June 1986 and was ratified on 22 February 2002 with Law 28 (III)/2001 published in the Official Journal of The Republic of Cyprus Annex I (III), No 3549, 23 November 2001. Law 28 (III)/2001 entered into force on 1 June 2002. 37 Constitution of the Republic of Cyprus of 1960, Article 28(2): Every person shall enjoy all the rights and liberties provided for in this Constitution without any direct or indirect discrimination against any person on the ground of his community,

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Convention of Human Rights (ECHR)38 embrace the fundamental principle of non-discrimination. At the specific level, Article 11 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention)39 explicitly prohibits any form of discrimination against an individual on the grounds of his or her genetic heritage. Its drafters state that Article 11 is deemed to expand the list of prohibited discriminatory grounds set out in Article 14 of the European Convention on Human Rights.40 However, they exclude from the ambit of Article 11 positive measures aimed at redressing a certain balance in favour of the disadvantaged because of their genetic inheritance.41 Undoubtedly, the Charter of Fundamental Rights of the European Union delivers the broadest conception of the principle of non-discrimination.42 Article 21(2) of the Charter entrenches the principle of non-discrimination including, inter alia, on the basis of genetic features.43

race, religion, language, sex, political or other convictions, national or social dissent, birth, colour, wealth, social class or any ground whatsoever, unless there is express provision to the contrary in this Constitution. 38

European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, was adopted on 4 November 1950 and entered into force on 3 September 1953, CETS no 005, Art 14: The enjoyment of the rights and freedoms set forth in this Convention shall be secured without discrimination on any ground such as sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status. 39

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine was adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164. The Oviedo Convention and its Additional Protocol on the Prohibition of Cloning Human Beings was signed by Cyprus on 30 September 1998, was ratified on 20 March 2002 with Law 31 (III)/2001 and entered into force on 1 July 2002. The Convention was implemented via Cypriot Law 31 (III)/2001. 40 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, in force since 1 December 1999, CETS no 164, para 76. 41 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, in force since 1 December 1999, CETS no 164, para 77. 42 By virtue of article 6 of the Treaty of Lisbon, the Charter of Fundamental Rights of the European Union has become legally binding. 43 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 21 (2): Any discrimination based on any ground such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited.

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The most recent associations of the principle of non-discrimination with genetic data were made in the Recital of EU Directive 2016/68044 and in Article 76(1)(b) of Regulation 2018/1725,45 which concern the processing of genetic data for the purpose of uniquely identifying a natural person. To the best of my knowledge, Cypriot Courts have not rendered judgments regarding genetic discrimination in the insurance or employment contexts. At a soft law level, all the above-mentioned provisions overlap with the principles of non-discrimination and non-stigmatization of Article 6 of the UNESCO Universal Declaration on the Human Genome and Human Rights (1997)46 and Article 7(a) of the UNESCO International Declaration on Human Genetic Data (2003).47 Examining the same issue from a particular angle, the EGE’s Opinion, “Ethical aspects of genetic testing in the workplace,” of 28 July 2003 encourages employers to guarantee fair treatment for all applicants and to avoid any discrimination.48 The Cyprus National Bioethics Committee, in its Opinion with regard to predictive health-related medical information before the conclusion of private (life or health) insurance contracts of 22 January 2008, voices particular concerns over the collection and use of genetic information as a source of discrimination, stigmatization (e.g. of individuals, family members, geographical, or ethnic groups), and injustice in the form of higher premiums, or even refusal to insure.49 44

Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA, OJ L 119/89, 4 May 2016, Recital no 23: “Any discrimination based on genetic features should in principle be prohibited”. 45 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC, OJ L 295/39, 21 November 2018, Art 76(1)(b): “Discrimination against natural persons on the basis of such personal data shall be prohibited”. 46 UNESCO, Universal Declaration on the Human Genome and Human Rights, adopted on 11 November 1997, Art 6: “No one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity”. 47 UNESCO International Declaration on Human Genetic Data, Art 7: Non-discrimination and non-stigmatization. (a) Every effort should be made to ensure that human genetic data and human proteomic data are not used for purposes that discriminate in a way that is intended to infringe, or has the effect of infringing human rights, fundamental freedoms or human dignity of an individual or for purposes that lead to the stigmatization of an individual, a family, a group or communities. (b) In this regard, appropriate attention should be paid to the findings of population-based genetic studies and behavioural genetic studies and their interpretations. 48 49

EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.3. EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.

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To conclude, the principle of non-discrimination is acknowledged as a pinnacle of modern legal systems. Naturally, the newly-asserted protection against discrimination on the basis of genetic status blends with the traditional protection against discrimination on other grounds.

3.2

Other Principles or Rights Involved

Subjecting a person to genetic tests and processing his or her genetic data contravenes the right to privacy,50 which is safeguarded in Article 15(1) of the Constitution of the Republic of Cyprus of 1960,51 Article 8 of the ECHR,52 and Articles 753 and 854 of the Charter of Fundamental Rights of the European Union. According to the drafters of the Cyprus National Bioethics Committee Opinion with regard to predictive health-related medical information before the conclusion of private (life or health) insurance contracts of 22 January 2008, being subjected to genetic tests prior to the conclusion of an insurance contract may infringe one’s right to informational self-determination, in particular one’s right to ignorance.55

50

Cf S and Marper v United Kingdom (2009) 48 EHRR 50, paras 70 ff. The Court held that the retention of cellular samples and DNA profiles by the authorities after the end of criminal proceedings constitutes an interference with the right to respect the private lives of the individuals concerned (European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted on 4 November 1950, entered into force on 3 September 1953, CETS no 005, Art 8(1)). See also Taylor (2012), p. 74. 51 Constitution of the Republic of Cyprus of 1960, Article 15(1): “Everyone has the right to respect for his private and family life”. 52 European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted on 4 November 1950, entered into force on 3 September 1953, CETS no 005, Art 8(1): Right to respect for private and family life. 1. Everyone has the right to respect for his private and family life, his home and his correspondence (. . .). 53

Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 7: “Respect for private and family life. Everyone has the right to respect for his or her private and family life, home and communications”. 54 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 8: “1. Everyone has the right to the protection of personal data concerning him or her”. The right to data protection is rooted in the right to privacy. The Charter breaks new ground in recognizing the right to data protection as a right separate from the right to privacy (See Kranenborg 2014, para 08.21). 55 Opinion of the Cyprus National Bioethics Committee with regard to predictive health-related medical information before the conclusion of private (life or health) insurance contracts of 22 January 2008, para 2, http://www.bioethics.gov.cy/Moh/cnbc/cnbc.nsf/All/ 16C6A7E6891495BCC2257CB30042BD04?OpenDocument. As explained elsewhere in the same Opinion, it is irrelevant whether the infringement of the right to ignorance results from regular medical tests (e.g. X-rays, ultrasounds, blood tests etc.) or from genetic tests (para 4.2.).

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Revealing and forcing genetic knowledge on the insured is deemed to be a burdensome experience and an irreparable upset of his or her normal life.56 The right not to know is enshrined in both Article 10(2) of the Oviedo Convention57 and Article 10 (4) of Cypriot Law 1 (I)/2005 on the safeguard and protection of the Rights of Patients and related matters.58 It is also proclaimed in Article 5(c) of the Universal Declaration on Human Genome and Human Rights.59 The drafters of the Cyprus National Bioethics Committee Opinion also stress that the fear of a higher premium or exclusion of coverage due to a genetic proclivity may lead an individual to avoid undergoing useful predictive tests, which may encroach upon his or her right to health.60

4 Genetic Testing Regulation in Cyprus 4.1 4.1.1

Genetic Testing Regulation in General National Bioethics Committee Opinion of 9 July 2015

On 9 July 2015, the Cyprus National Bioethics Committee published an Opinion on incidental or unexpected findings from genetic testing using Next Generation Sequencing (NGS) Technologies. Its drafters agreed, in principle, that the methods 56 Opinion of the Cyprus National Bioethics Committee with regard to predictive health-related medical information before the conclusion of private (life or health) insurance contracts of 22 January 2008, para 2, http://www.bioethics.gov.cy/Moh/cnbc/cnbc.nsf/All/ 16C6A7E6891495BCC2257CB30042BD04?OpenDocument. 57 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, into force since 1 December 1999, CETS no 164, Art 10(2): “Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed”. 58 Law 1 (I)/2005, OJ Annex 1 No 3943, 7 January 2005, pp 1–26, Article 10(4): “Τhe patient shall not deemed to have waived his right to know, unless he has asked it in writing”. 59 UNESCO, Universal Declaration on the Human Genome and Human Rights, adopted on 11 November 1997, Art 5(c): “The right of each individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected”. 60 See, for example, article 35 of the Charter of Fundamental Rights of the European Union (OJ C 326/391, 26 October 2012):

Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all the Union's policies and activities. See also Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, Art 3: “Equitable access to health care. Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality”.

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of Targeted Exome Sequencing or Targeted Genome Sequencing do not differ from the conventional genetic tests currently used. They stated that the Whole Genome Sequencing (WGS) and Whole Exome Sequencing (WES) methods should be conducted in qualified labs, by knowledgeable and experienced geneticists, in close cooperation with the ordering doctor as well as genetic counselors. Whether clinical screening is conducted for diagnostic or research purposes, every person undergoing it should be informed about the possible implications of NGS testing on him- or herself and his or her close relatives. Only the person concerned should sign consent forms. These forms should include, among others, the choice of disclosing only clinically significant or clinically actionable findings. The Opinion mentions reporting incidental findings to minors, for whom parental information and consent are required.

4.1.2

The Ratification of the Oviedo Convention

Law 31 (III)/2001, which ratified the Oviedo Convention,61 constitutes the only Cypriot legislative text concerning genetic testing. Its Article 1262 sets forth the general conditions for lawfully conducting predictive genetic tests.63 Firstly, predictive genetic tests are allowed strictly for health purposes or for scientific research related to health purposes. By argumentum a contrario this denotes that the drafters of the Convention excluded purposes unrelated to health, such as medical examination prior to the conclusion of an employment or insurance contract,64 even with the assent of the person concerned.65

61

See above footnote 39. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, Art 12: 62

Predictive Genetic Tests. Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling. 63 The Drafters urge that Member States develop appropriate professional standards in the field of genetic tests, in the spirit of Recommendations of the Council of Europe, No. R (90) 13 on the specific issue of prenatal genetic screening, prenatal genetic diagnosis and associated genetic counselling and No. R(92)3 on genetic testing and screening for health care purposes (Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 80). 64 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 84. 65 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS

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However, the drafters acknowledge that exceptional circumstances merit proper consideration. A predictive genetic test as part of a pre-employment medical examination is not necessarily inconsistent with health purposes. For instance, an employer could offer a predictive genetic test in order to improve a working environment which would otherwise jeopardize an employee’s health because of his or her genetic predisposition.66 Moreover, national legislation may allow genetic testing for purposes other than health, under the conditions provided for in Article 26 (1)67 of the Oviedo Convention.68 They could be permitted, for example, to establish the parentage of a child (protection of rights and freedoms of others)69 or for the DNA identification of a person as part of a criminal investigation (protection of crime).70

no 164, para 85. It should be reminded that the Drafters of Recommendation No R(92)3 on genetic testing and screening for health care purposes had already cautioned against insurers using genetic tests for the conclusion or modification of contracts: “Principle 7 – Insurance. Insurers should not have the right to require genetic testing or to enquire about results of previously performed tests, as a pre-condition for the conclusion or modification of an insurance contract”. 66 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 85. 67 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, Art 26: Restrictions on the exercise of the rights. 1. No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others. This provision echoes partially the provisions of Article 8(2) of the European Convention for the Protection of Human Rights and Fundamental Freedoms (as amended by Protocols nos 11 and 14, adopted on 4 November 1950, entered into force on 3 September 1953, CETS no 005). See Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 149. 68 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 87. 69 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 152. 70 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 153.

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Secondly, the drafters of Article 5 of the Oviedo Convention’s general requirement of a prior free and informed consent71 understand it to be applicable to predictive genetic tests as well.72 Thirdly, appropriate genetic counseling is a supplementary prerequisite for every person undergoing a predictive genetic test. Genetic counseling should be received both before and after the procedure, and it should be non-directive.73 The information provided should focus on the pertinent medical facts, explain the purpose and nature of the tests, point out possible risks, evaluate the results and consequences of tests, and give choices.74 In addition to the three previously mentioned conditions, whenever a genetic test is performed in reproductive contexts, such as non-invasive prenatal testing—using only maternal blood—for gender identification of the fetus, Article 1475 on the prohibition of the future child’s sex-selection will apply. According to Article 25 of the Oviedo Convention, it is up to Member States to determine sanctions for a breach of any of its provisions.76 In Cyprus, Article 18 (1) element (d) of Law 69 (I)/2015 on the Application of Medically Assisted

71

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, Art 5: General rule. An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time. 72 Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, para 88. 73 On the nature of genetic counseling, see Council of Europe, Recommendation No R(92)3 of the Committee of Ministers to Member States on Genetic Testing and Screening for Health Care Purposes, adopted by the Committee of Ministers on 10 February 1992 at the 470th meeting of the Ministers’ Deputies, Principle 3. 74 Council of Europe, Recommendation No R(92)3 of the Committee of Ministers to Member States on Genetic Testing and Screening for Health Care Purposes, adopted by the Committee of Ministers on 10 February 1992 at the 470th meeting of the Ministers’ Deputies, Principle 3. 75 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, Art 14: “Non-selection of sex. The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided”. 76 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted on 4 April 1997, entered into force on 1 December 1999, CETS no 164, Art 25: “Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Convention”.

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Reproduction77 lays down a blanket prohibition on the infringement of any provision of Oviedo Convention. According to Article 18(6) of Law 69 (I)/2015, if the Cypriot Council of Medically Assisted Reproduction finds a breach of any of the prohibitions under Article 18, it suspends the license of the Medically Assisted Reproduction Unit for 2 years and imposes an administrative fine not exceeding EUR 100,000. In case of a second breach, it permanently suspends the license and imposes an administrative fine not exceeding EUR 150,000. Lastly, according to Article 18(7), any person infringing any prohibition of Article 18 commits a criminal offence, and may be sentenced to imprisonment not exceeding 7 years.

4.2

Genetic Testing Regulation with Regard to Insurance

In Cyprus, there are no specific laws on the subject of genetic testing in the context of insurance. In addition, no soft law self-regulation has been elaborated (e.g. a voluntary Code of Practice by the Cypriot Association of Insurers or Guidelines by the Cyprus Medical Association78 or the Cyprus Society for Human Genetics79), with the exception of an Opinion of the Cyprus National Bioethics Committee. Furthermore, no statistical data have been compiled and publicized in Cyprus. The Cyprus National Bioethics Committee, in its Opinion with regard to predictive health-related medical information before the conclusion of private (life or health) insurance of 22 January 2008, delimits the use by insurers of genetic testing. The drafters take the stance that the insurer is not entitled to request tests to calculate the risk of future disorders and diseases of which the insured is unaware at the time the contract is concluded. Likewise, their standpoint is that the insurer is not entitled to request medical screening for diagnosing existing pathologies unknown to the insured. By contrast, they accept that the insurer may request medical screening if information provided by the candidate to insurance raises reasonable suspicion that he or she might be high-risk due to the presence of a disease. However, this does not allow the insurer to demand genetic or blood tests, which can determine genetic predisposition. Finally, the Opinion defends the right of an insurance applicant not to disclose the results of genetic tests, which he or she voluntarily underwent before the conclusion of a health insurance contract.

77

Law 69 (I)/2015 on the Application of Medically Assisted Reproduction, OJ Annex 1 No 4510, 15 May 2015, pp. 849–878. 78 See the official website of the Cyprus Medical Association at https://www.cyma.org.cy. 79 See the official website of the Cyprus Society for Human Genetics at https://www.cshg.org.cy.

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Genetic Testing Regulation with Regard to Employment

In Cyprus, there are no specific laws on the subject of genetic testing in the employment context either. Similarly, no statistical data have been compiled and publicized. The EGE Opinion, “Ethical aspects of genetic testing in the workplace,” of 28 July 2003 shapes a comprehensive relevant ethical framework and sets a benchmark for Cyprus on the issue. The EGE basically addresses the problem as a conflict between, on the one hand, employers’ duty to protect the health of their employees and third parties, including by means of adapting the workplace80 and, on the other hand, employees and candidates’ rights to privacy and to the protection of personal data.81 In an attempt to reconcile conflicting interests of the stakeholders, the EGE accepts in principle that a medical examination may be a part of an employee or a potential employee’s aptitude assessment.82 Nonetheless, the EGE rejects the medical examination as a sole criterion of selection, suggesting that the medical examination take place only after the phase of selection.83 The EGE questions the predictive value of existing84 genetic tests and especially their relevance and reliability in the employment context.85 Therefore, the EGE views both general genetic screening in the context of a pre-employment medical examination and the disclosure of results of previously-run genetic tests as unethical and it is firmly convinced that the employer’s legitimate duties and rights (e.g. employee health protection and ability assessment) can be fulfilled through a regular medical examination, without recourse to genetic screening.86 In this framework, the EGE deems justifiable for employers to consider only the present health status of employees.87 In exceptional circumstances, which the EGE believes should be explicitly regulated by law,88 the use of genetic screening may be tolerated if it is necessary to guarantee the protection of workers or third parties’ health.89 In this case, the following conditions should be fulfilled: (a) there is scientifically proven evidence that the genetic test is valid and is the only method to obtain this information, (b) its performance does not prejudice the aim of improving conditions in the workplace,90 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, paras 2.2 and 2.7. EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.1. 82 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.5. 83 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.6. 84 Obviously, at the time of elaboration of the said EGE Opinion and certainly before the year 2003. 85 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.9. 86 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.10. 87 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.8. 88 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.13. 89 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.11. 90 In other words, the performance of a genetic test shall not be misused as a means of excusing the employer from his statutory duty to improve conditions in the working environment. 80 81

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(c) the principle of proportionality is respected regarding the motivations involved to perform the test, and (d) the principle of non-discrimination is not violated.91 Additionally, the prior assent of the appropriate labour organisation, as well as that of a specific ad hoc independent committee, should be required.92 The applicant or employee should consent to the genetic test,93 after having received full information on the reasons for performing it, its potential outcomes, its implications/consequences, and the conditions of storing and access to the data.94 The applicant or employee should also be provided with access to independent legal counseling upon request.95 As with other medical data, genetic data resulting from testing remain confidential; only the applicant or employee and the health professional should have access to it, and they should not be transferred to third parties without consent.96 Confidentiality should be preserved, especially in cases of an employee’s cross-border movement.97 Lastly, the EGE warns about the danger that genetic screening or monitoring conducted in the workplace be disclosed for insurance purposes.98

5 Genetic Data Processing in Cyprus 5.1

Genetic Data Processing in General

The Council of Europe’s Recommendation No. R (97) 5 on the protection of medical data was the first soft law text to tackle the collection and processing of genetic data. In Principle 4.9, the drafters assert that such actions should, in principle, only be permitted for health reasons and, in particular, to avoid serious risks to the health of the data subject or third parties. They add that the collection and processing of genetic data in order to predict illness may be allowed in cases of overriding interest and subject to appropriate safeguards defined by law.

5.1.1

Law 138 (I)/2001

Until the entry into force of the GDPR on 25 May 2018, Article 6(1) of the Cypriot Law 138 (I)/2001 on the processing of personal data (protection of the individual)

EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.12. EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.14. 93 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, paras 2.16 and 2.7. 94 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.15. 95 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.15. 96 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.18. 97 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.20. 98 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 2.19. 91 92

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had prohibited the collection and processing of sensitive personal data, obviously including genetic data.99 Article 6(1) element (στ) creates an exception for health data required for preventive medicine, medical diagnosis, provision of care or treatment, or the management of health care services. Additionally, a professional health care provider subject to professional secrecy obligations or equivalent codes of conduct must be the one processing this health data.

5.1.2

General Data Protection Regulation 2016/679

The legal landscape for the processing of personal data has undergone a radical transformation due to an EU secondary legislation trio: (a) GDPR 2016/679, (b) Directive 2016/680 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA, and (c) Regulation 2018/1725 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC. These three legal texts do not regulate special categories of personal data (i.e. sensitive data) uniformly. GDPR 2016/679 and Regulation 2018/1725 operate on a presumption against the processing of special categories of personal data that is rebuttable under certain legal circumstances. Conversely,100 Directive 2016/680 adopts a presumption in favour of processing special categories of personal data, albeit under strict conditions.101 This divergence might lead us to conclude that it is

99

See above footnote 31. This idea was inspired by Commission Nationale Informatique et Libertés (2017), p. 59. 101 Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA, OJ L 119/89, 4 May 2016, Art 10: 100

Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual orientation shall be allowed only where strictly necessary, subject to appropriate safeguards for the rights and freedoms of the data subject, and only: (a) where authorised by Union or Member State law; (b) to protect the vital interests of the data subject or of another natural person; or (c) where such processing relates to data which are manifestly made public by the data subject.

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not the categorization, per se, of some personal data as “special” that makes them worthy of extra protection, but rather the purpose of their processing. That is, more rigidity is maintained for general purpose processing, while more flexibility is allowed for specific purpose processing (e.g. activities of the police or other law-enforcement authorities, focusing mainly on the prevention, investigation, detection, or prosecution of criminal offences). Applied to genetic data, the same assumption may support the views of those102 who believe that genetic data’s distinctiveness derives not from the data themselves, but from their uses. More specifically, Article 9(1) of the GDPR reiterates103 the guiding principle to the effect that the processing of genetic data is prohibited as it constitutes a special subcategory of personal data. Exceptionally, Article 9(2) of the GDPR lifts the prohibition pursuant to an exhaustive list of derogations, among which consent dominates. According to Article 9(2)(a) of the GDPR, in order to process genetic data, one must obtain the explicit consent of the data subject for one or more specified purposes.104 Article 4(1) of the GDPR defines consent as any freely given, specific, informed, and unambiguous indication of the data subject’s wishes by which he or she, by a statement105 or clear affirmative action,106 signifies agreement to the processing of his or her personal data. A preliminary observation107 could be that consent for the processing of genetic data is subject to a stricter requirement of explicitness,108 which is not the case under Article 6(1)(a) of the GDPR.109 At the same time, of course, the general conditions for consent to be valid, under Articles 7 and 8 of the GDPR, must be met.110

102

See above footnote 24. See Article 6(1) Directive 95/46/EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, which the GDPR repeals. 104 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 32: “Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them”. 105 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 32: “By a written statement, including by electronic means, or an oral statement”. 106 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 32: “Silence, pre-ticked boxes or inactivity should not therefore constitute consent”. An opt-out model is generally not permissible (Voigt and Von dem Bussche 2017, p. 95). 107 Voigt and Von dem Bussche (2017), p. 93. 108 This means that the data subject should explicitly consent to genetic data being processed (Voigt and Von dem Bussche 2017, p. 112). 109 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 6 (1): “Processing shall be lawful only if and to the extent that at least one of the following applies: (a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes;”. 110 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 51: “In addition to the specific requirements for such processing, the general principles 103

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As it has been rightly pointed out,111 consent under Article 9(2)(a) of the GDPR cannot effectively lift the prohibition of genetic data processing in an employment context, where employees or prospective employees are either subordinate or dependent. In these cases, a clear imbalance exists between the data subject (employee) and the data controller (employer),112 such that consent cannot be regarded as freely given. The data subject has no genuine, free choice and may be unable to refuse or withdraw consent without detriment113 (e.g. fear of loss of job offer or promotion). Moreover, one might claim that the processing of genetic data falls within the scope of Article 9(2)(h) of the GDPR.114 This derogation allows the processing of genetic data for health-related purposes for the benefit of natural persons and society as a whole115 (e.g. preventive or occupational medicine, assessment of the working capacity of the employee, contract with a health professional, etc.). Nevertheless, such processing shall be subject to the additional legal requirement of Article 9(3) of the GDPR,116 that genetic data be processed by, or under the responsibility of, a professional bound by a professional secrecy obligation. The processing of genetic data by third parties within the employment or insurance contexts is addressed in the GDPR Recital no 54. The drafters of the Regulation alert Member States to the fact that the exception that allows for the processing of special categories of data without the data subject’s consent (see Article 9(2)(a) of

and other rules of this Regulation should apply, in particular as regards the conditions for lawful processing”. See also Voigt and Von dem Bussche (2017), p. 112. 111 EGE Opinion “Ethical Aspects of Genetic Testing in the Workplace”, para 1.9. 112 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 43. 113 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 42. 114 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 9 (2): Paragraph 1 shall not apply if one of the following applies: (. . .) (h) processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3;”. 115

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 53. 116 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 9 (3): Personal data referred to in paragraph 1 may be processed for the purposes referred to in point (h) of paragraph 2 when those data are processed by or under the responsibility of a professional subject to the obligation of professional secrecy under Union or Member State law or rules established by national competent bodies or by another person also subject to an obligation of secrecy under Union or Member State law or rules established by national competent bodies.

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the GDPR) for public interest reasons in the area of public health (Article 9(2)(i) of the GDPR117) should not result in personal data being processed for other purposes by third parties, such as employers or insurance and banking companies. Needless to say, according to Article 83(5) of the GDPR, infringements of the provisions of Article 9 may carry administrative fines of up to EUR 20,000,000 or, in the case of an undertaking, up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher.

5.1.3

Law 125 (I)/2018

Article 9(4) of the GDPR gives individual Member States substantial leeway to maintain or introduce further conditions or limitations on the processing of genetic data. Exercising its discretionary power, Cyprus enacted Law 125 (I) of 2018 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. Article 9 of the law tightens up on the regulation of the processing of two special categories of personal data: genetic and biometric data. In fact, it introduces stricter provisions for further processing of genetic and biometric data as well as a ban on processing genetic and biometric data in the context of health or life insurance. Article 9(1) of the Cypriot Law 125 (I) of 2018 absolutely prohibits processing genetic and biometric data in the context of health or life insurance. This blanket rule is a striking example of a Member State legislation that declines to adopt the derogation of Article 9(2)(a) of the GDPR, with the result that the data subject’s consent may not lift the general prohibition for the processing of these special categories of personal data.118 Article 9(2) of the Cypriot Law 125 (I) of 2018 requires separate consent for any further processing of genetic and biometric data, even in cases where the data subject had given his or her initial consent. This deviates from the general rule in Article 6 (4) of the GDPR,119 which implies that where the data subject had initially given consent, a controller is allowed to further process the personal data, without consent

117

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 9 (2): Paragraph 1 shall not apply if one of the following applies: (. . .) (i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;

118

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 9 (2)(a): “(. . .) except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject;”. 119 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Art 6 (4):

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for the new purpose, provided that the initial collection purpose is compatible with the new one.120

5.2

Genetic Data Processing with Regard to Insurance: Recommendation (2016) 8 of the Council of Europe

The Council of Europe’s Recommendation CM/Rec(2016)8 on the processing of personal health-related data for insurance purposes, including data resulting from genetic tests, is the most recent piece of the genetic data processing jigsaw governing the insurance industry.121 The Recommendation is divided into seven basic principles, each one of them being composed of multiple consecutively-numbered points. Principle 4, which comprises points 15, 16 and 17, addresses the use of genetic tests for insurance purposes. Invoking Article 12 of the Oviedo Convention,122 the Recommendation’s Point 15 absolutely prohibits carrying out predictive genetic tests for insurance purposes. This means that an insurer cannot subject an applicant to a predictive genetic test in order to contract or modify an insurance policy. The insurer also cannot refuse its conclusion or modification on the ground that the applicant has not submitted himor herself to a predictive genetic test.123 Point 16 extends the processing prohibition to existing predictive data resulting from genetic tests. Nonetheless, processing is exceptionally permitted if it is Where the processing for a purpose other than that for which the personal data have been collected is not based on the data subject’s consent or on a Union or Member State law which constitutes a necessary and proportionate measure in a democratic society to safeguard the objectives referred to in Article 23(1), the controller shall, in order to ascertain whether processing for another purpose is compatible with the purpose for which the personal data are initially collected, take into account, inter alia: (a) any link between the purposes for which the personal data have been collected and the purposes of the intended further processing; (b) the context in which the personal data have been collected, in particular regarding the relationship between data subjects and the controller; (c) the nature of the personal data, in particular whether special categories of personal data are processed, pursuant to Article 9, or whether personal data related to criminal convictions and offences are processed, pursuant to Article 10; (d) the possible consequences of the intended further processing for data subjects; (e) the existence of appropriate safeguards, which may include encryption or pseudonymisation. 120

In this spirit, see Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, Recital no 50. 121 Recommendation CM/Rec(2016)8 of the Committee of Ministers to the Member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic test, adopted on 26 October 2016. 122 See above footnote 61. 123 See Explanatory Memorandum to Recommendation CM/Rec(2016)8 of the Committee of Ministers to the Member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic test, adopted on 26 October 2016, para 15, point 39.

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authorised by law124 and follows an independent conformity assessment, per the criteria laid down in Principle 1, point 5 for the justification of health-related personal data. More specifically, the exceptional processing of genetic data for insurance purposes is permitted only if it satisfies the following conditions: (a) the purpose of the processing has been specified and the relevance of the data duly justified; (b) the quality and validity of the data are in accordance with generally accepted scientific and clinical standards; (c) data resulting from a predictive examination have a high positive predictive value; and (d) the processing is duly justified in accordance with the principle of proportionality in relation to the nature and importance of the risk in question. As the drafters of the Recommendation point out, conformity assessment is not to be made on an individual basis, i.e. for each insured person, but by type of test from which the data would result and with regard to a particular risk to be insured (e.g. processing of data resulting from a Huntington’s disease genetic test in relation to specified high-value policies).125 Point 17 of the Recommendation stipulates that existing data from genetic tests undergone by the insured’s family members should not be processed for insurance purposes. This blanket ban acts as an exception to the exception rule of Point 16, which conditionally permits the processing of existing data from genetic tests. Thus, it reestablishes the general prohibition of processing existing genetic data resulting from genetic tests in Point 16.

6 Conclusion In conclusion, the legal framework in Cyprus does not suffice to meet the challenges posed by genetic testing in the context of insurance and employment. Given that, it is expedient for Cyprus to adopt tailored legislation modeled on the paradigm of other European countries.126 Obviously, the ratification of the Council of Europe’s Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes, as well as the creative assimilation of the Council of Europe’s Recommendation CM/Rec(2016)8 on the processing of 124

Explanatory Memorandum to Recommendation CM/Rec(2016)8 of the Committee of Ministers to the Member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic test, adopted on 26 October 2016, para 16, point 40: “law” includes codes, legislation, regulations, guidelines and statutory rules, as well as codes of practice and agreements that are publicly available and have been agreed between the Member State and insurers. It also includes legal rulings, contract law and common law that relates to the principles of insurance contracts.

125

Explanatory Memorandum to Recommendation CM/Rec(2016)8 of the Committee of Ministers to the Member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic test, adopted on 26 October 2016, para 16, point 40. 126 For a presentation of selected European national legislations and USA federal legislation see Trokanas (2011), pp. 557–574.

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personal health-related data for insurance purposes, including data resulting from genetic tests and of the EGE Opinion “Ethical aspects of genetic testing in the workplace” could be good starting points for future legislative initiatives in Cyprus.

References Burge K (2013) Personalized medicine, genetic exceptionalism and the rule of law. Wash J f Law Technol Arts 8(4):501–541 Commission Nationale Informatique et Libertés (2017) Les données génétiques. La documentation Française, Paris Evans J, Burke W (2008) Genetic exceptionalism. Too much of a good thing? Genet Med 10 (7):500–501 Kranenborg H (2014) Part I commentary on the articles of the EU charter, Article 8. In: Peers S, Hervey T, Kenner J, Ward A (eds) The EU charter of fundamental rights, a commentary. Hart Publishing, Oxford, pp 223–265 McGuire A et al (2008) Confidentiality, privacy, and security of genetic and genomic test information in electronic health records: points to consider. Genet Med 10(7):495–499 O’Neill O (2004) Autonomy and trust in bioethics. Cambridge University Press, Cambridge Taylor M (2012) Genetic data and the law, a critical perspective on privacy protection. Cambridge University Press, New York Trokanas T (2011) The use of genetic data in private insurance. Problems and global perspectives. In: Bottis M (ed) An information law for the 21st century. Third international seminar on information law 2010, Ionian University, Corfu, Greece, Department of Archive and Library Science, International Society for Ethics and Technology, Institute for Legal Informatics. Nomiki Bibliothiki, Athens, pp 557–574 Voigt P, Von dem Bussche A (2017) The EU General Data Protection Regulation (GDPR), a practical guide. Springer International Publishing, Cham

Czech Report on Genetic Testing for Employment and Insurance Filip Křepelka

Abstract Genetic testing for both medical and forensic purposes has become routine in Czechia, as in other developed countries. However, its use is sporadic in the fields of employment and insurance, likely due in part to the state of Czech political and socio-economic development as well as the shortcomings of postsocialist law. Although the Council of Europe and the European Union stipulate general principles, domestic legal discourse about the particularities of the regulation of genetic testing is in its infancy. Discrimination based on individual genetic makeup is generally illicit in the employment context. Despite the fact that covert testing without informed consent is certainly punishable, one might expect it would occur in countries with perfunctory implementation of laws. Therefore, the absence of genetic testing in the workplace in Czechia is better explained by its impracticality, although rare exceptions exist that seek to protect healthcare practitioners handling dangerous substances. Genetic testing and consideration of its results do play a role in life insurance. For instance, one insurer’s contract terms exclude women with a genetically identified risk of breast cancer. However, another phenomenon is important in a country with an underdeveloped insurance market: instead of conducting controversial and likely illicit genetic testing, insurers simply exclude rare monogenetic diseases. Finally, Czechia has universal public health insurance, but we can expect that genetic makeup could be considered in the allocation of treatment and its public financing in the future.

1 Introduction This paper is a Czech report for the section “Genetic Testing for Insurance and Employment,” initiated and organized by Professors Lara Khoury and Adelle Blackett (McGill University, Montreal, Canada) at the 20th General Congress of

F. Křepelka (*) Masarykova univerzita, Brno, Czechia e-mail: fi[email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_6

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the International Academy of Comparative Law held on 24 July 2018 at Kyushu University in Fukuoka, Japan. The paper first describes the legal framework surrounding genetic testing for purposes other than employment and insurance. Genetic tests have been crafted primarily for these other purposes, and their application in the fields of employment and insurance remains marginal in Czechia, leaving the legal regulation of genetic tests in employment and insurance terra incognita in this country.1 It is thus important to first explore the general framework related to genetic tests. There is no systematic translation and publication of Czech laws into English, and translations differ. Therefore, this report refers to laws, legal instruments, institutions, and other phenomena related to Czechia in the Czech language to facilitate their identification.2 The paper will consider the standards of the Council of Europe and the European Union, which together establish the relevant international legal framework. Because rapporteurs from other European countries also discuss this framework, this text will focus on its implementation in Czechia. Czechia qualifies as a developed country. However, it is consistently behind the top 15–20 countries in various rankings.3 Namely, perfunctory governance must be considered; post-socialist states are frequently inefficient and corrupt, and their laws suffer from lability, formalism, oversimplification, and unpredictability. Unsurprisingly, cynicism and nihilism is a frequent attitude towards any governance.4 While genetic testing is a modern diagnostic technology, it is not so complex and expensive to be unavailable in Czechia. Indeed, Czech laboratories serve a domestic clientele and also offer their services to foreigners. Their prices are competitive, thanks to lower wages. Nevertheless, the situation sketched above could explain societal and political attitudes to genetic tests in Czechia, which differ from attitudes in the richest and most stabilized countries.

1

In accordance with official policy, this text uses the short country name Czechia (Česko). Readers shall bear in mind that the official long name, the Czech Republic (Česká republika), is used in many other texts. See the Ministry of Foreign Affairs’ updated document, “How to Use the Short Country name ‘Czechia’” at https://www.mzv.cz/jnp/en/foreign_relations/public_diplomacy/digi tal_diplomacy/how_to_use_the_short_country_name.html. 2 The Collection of Laws (Sbírka zákonů, abbreviated Sb.) is an official publication, available also on the Internet (www.sbirka.cz). Consolidated versions of statutes can be found, inter alia, at www. zakonyprolidi.cz. Nevertheless, legal practitioners and scholars have access to subscription-based databases (ASPI, Codexis, EPIS, LexGalaxy etc.) with additional information. 3 As GDP per Capita, GDP per Capita—Parity Purchasing Power, Human Development Index, Corruption Perception Index, Global Competitiveness Index, Democracy Index, Worldwide Governance Indicators etc. Certainly, cautiousness is necessary. Any indicator has its strengths and shortcomings. Nevertheless, considered together, these indicators indicate the situation of a country in comparative perspective. 4 International readers will find a good overview of law in post-socialist countries in Kischel (2015), pp. 571–594. The author, however, highlights significant differences among post-socialist countries.

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2 Equality 2.1

Several Legal Instruments Stipulating Equality

Addressing genetic discrimination in the field of employment and insurance requires consideration of several provisions protecting equality. On a national level, both the Constitution of the Czech Republic5 and the Charter of Fundamental Rights and Freedoms, as the national catalogue of fundamental rights,6 guarantee equality. The European Convention for the Protection of Human Rights and Fundamental Freedoms prohibits discrimination that would infringe the fundamental rights and freedoms enshrined within it. The 12th Additional Protocol to the Convention, adopted in 2000, prohibits discrimination based on listed criteria in other fields than those covered by fundamental rights established by the Convention. Czechia signed the Additional Protocol in 2000 but has not yet ratified it. The Convention on Human Rights and Biomedicine, adopted under the auspices of the Council of Europe in 1997 in Oviedo (the Oviedo Convention),7 specifies fundamental rights in the field of medicine. This Convention is not a pan-European standard, since many large countries are not signatories.8 Czechia has ratified it, though there has since been debate about whether this was unduly enthusiastic. Czech laws were not assessed or adjusted for compliance before ratification. The implementation of the Oviedo Convention depended on the principle of direct effect and the primacy of duly-ratified international conventions in accordance with the Czech Constitution.9 The Oviedo Convention prohibits discrimination against a person on the ground of his/her genetic heritage,10 and reserves predictive genetic tests for health and

Ústava České republiky, published as 1/1993 Sb, Article 1. Listina základních práv a svobod, adopted as Czechoslovak federal constitutional law 23/1991 Sb and republished in 2/1993 Sb. for the Czech Republic, Art 1. An English translation is available at https://www.usoud.cz/fileadmin/user_upload/ustavni_soud_www/Pravni_uprava/AJ/Listina_ English_version.pdf. 7 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164. 8 See Chart of signatures and ratifications at https://www.coe.int/en/web/conventions/full-list/-/ conventions/treaty/164/signatures. 9 Article 10 of the Constitution of the Czech Republic (cited supra). 10 Article 11 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164. 5 6

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research uses alone.11 Drafters of the Convention realized the importance and potential of this emerging technology and feared its misuse. The European member states and the European Union have developed their antidiscrimination policies through several directives. Directive 2000/78/EC12 requires suppression of discrimination based on disability, while recognizing the challenges faced by employers of disabled employees. Reasonable accommodation is required in the employment context. Directive 2000/43/EC prohibits racial discrimination in the context of access to goods and services.13 The extent to which these directives and their implementation in national law could be applied to regulate genetic discrimination in employment and insurance is open to debate. Czechia reluctantly implemented these directives with the Law on Equal Treatment in 2009.14 The principle of equality is also enshrined in the Treaty on the Functioning of the European Union and in the Charter of Fundamental Rights of the European Union.15 The Charter explicitly mentions equality vis-à-vis genetics.16 Global human rights conventions such as the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights provide for equality in their respective fields of application.17 In addition, the Convention on the Rights of Persons with Disabilities addresses specifically equality for disabled people.18

2.2

Effectiveness of Constitutional, International and Supranational Laws

Combatting genetic discrimination in the fields of employment and insurance might take the form of an intervention by the high courts of the Czech Republic, the 11 Article 12 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164. 12 Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation, OJ L 303/16, 2 December 2000. 13 Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin, OJ L 180/22, 19 July 2000. 14 Zákon č 198/2009 Sb, o rovném zacházení. 15 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012. 16 Article 21(1) of the Charter provides that “[a]ny discrimination based on any ground such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited” (emphasis added). 17 Both covenants adopted by the General Assembly of the United Nations Organisation 16 December 1966, Article 26 of the International Covenant of Civil and Political Rights and, among others, Art 2 para 2 and Article 12 of the International Covenant of Economic, Social and Cultural Rights. 18 Adopted by the General Assembly of the United Nations Organisation 13 December 2016, Art 8 specifies the principle of equality.

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Council of Europe and the European Union. Therefore, it is pertinent to summarize their roles. The Constitutional Court enforces the Constitution and the Charter of Fundamental Rights and Freedoms. International conventions stipulating fundamental rights and freedoms also have constitutional rank.19 Czechia has a strong constitutional judiciary: both individual complaints and applications made by qualified entities (e.g., specified numbers of deputies, senators, regions, or ombudsmen) can result in the striking down of unconstitutional statutes or their provisions. The European Court for Human Rights accepts individual complaints once all national remedies have been exhausted and awards compensation if a breach is identified. Its case law enjoys significant authority within the Council of Europe’s member states. Unlike the European Human Rights Convention, the Oviedo Convention lacks effective enforcement mechanisms. Nevertheless, there is no doubt that it belongs to the class of international conventions enjoying direct effect and primacy in Czechia. Czech authorities are expected to apply it directly and set aside or reinterpret Czech laws in accordance with the Convention. Once ratified, the Protocol mentioned above will enjoy the same status. Physicians, bioethicists, human rights activists, and politicians tend to regard the Oviedo Convention and its protocols as the realisation of key principles of biomedical ethics even beyond legality. Founding treaties of the European Union and its regulations enjoy direct effect and primacy as well. Directives are to be incorporated by member states in a timely manner into their national laws.20 To streamline the interpretation of the law of the European Union applied by its member states, the Court of Justice of the European Union delivers preliminary rulings, answering questions referred to it by a national court.21 Czechia’s Public Defender of Rights (Ombudsman), with the assistance of his or her Office,22 contributes to the improvement of administration and to the implementation of anti-discrimination policies by providing opinions on complaints and general control.

19 Based on interpretation of Art 10 of the Constitution of the Czech Republic by the Constitutional Court. 20 Article 289 of the Consolidated version of the Treaty on the Functioning of the European Union, OJ C 326/47, 26 October 2012. 21 Article 267 of the Consolidated version of the Treaty on the Functioning of the European Union, OJ C 326/47, 26 October 2012. 22 Veřejný ochránce práv, and Kancelář veřejného ochránce práv, see www.ochrance.cz.

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Reluctance Regarding Anti-discrimination Policies in Post-socialist Countries

The prior legacy of inequality fuelled the socialist and communist ideologies of the nineteenth and twentieth centuries. Accordingly, socialist regimes in Central and Eastern Europe placed high value on equality. Egalitarianism was omnipresent. Unsurprisingly, the socialist regimes’ transition to liberal democracy and a market economy was marked by a preference for liberties. Even today, many Czechs have doubts or reject anti-discrimination policies as new leftism or neo-Marxism. The perfunctory implementation of international and supranational laws, and the frequent shortcomings in the application of national laws in Czechia, reflect low societal support for their underlying principles. Czechia delayed the implementation of EU anti-discrimination directives with the Law on Equal Treatment.23 The prominent hostility of the then right-wing majority to non-discrimination principles resulted in an absence of debate on details, including genetic discrimination. We could subsume defective genetic makeup under disability.24 Genetic defects result in debilitating illnesses or premature death. At least, there is risk of it. Certainly, the commentaries of the Law on Equal Treatment are silent on the issue.25 Nevertheless, this silence reveals absent cases and weak debate on this issue in Czechia. The movie Gattaca (1997)26 provides a picture of a dystopian future where ubiquitous genetic tests divide individuals in “valid” and “invalid” groups. Genetic defects thus establish individualised and permanent stigma comparable to the collective stigma associated by persons deemed to be members of an “inferior” race. Racial discrimination is not only prohibited by international, European and national laws, but is also generally regarded as heinous attitude. Therefore, eventual subsuming of genetic makeup under race or likening them would render discrimination based on genetic defect more unacceptable.

Zákon č 198/2009 Sb, o rovném zacházení. See definition of (health) disability (zdravotní postižení) in paragraph 5(6) of the Law on Equal Treatment (Zákon č 198/2009 Sb, o rovném zacházení). 25 Kvasnicová et al. (2015) and Boučková et al. (2010). 26 Directed by Andrew Nicol, for the synopsis and the cast see https://www.imdb.com/title/ tt0119177/. 23 24

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3 Genetic Testing in Czechia 3.1

The Reality of Genetic Testing

Genetic testing for medical purposes—aimed primarily at the confirmation of an existing disease rather than prediction—is routine. Health insurance funds finance many tests so long as they are deemed necessary both by a physician and by their insurance adjusters, who are charged with containing and managing the funds’ expenditures. Czechia’s population does not have an elevated prevalence of any single-gene disease, nor has any mass research project emerged in Czechia, similar to Iceland’s deCODE genetics, Inc. research project.27 Unsurprisingly, therefore, genetics and its ethical and legal aspects have attracted little attention. Most Czechs have not undergone any genetic testing; there are no known surveys on Czech attitudes toward the practice. Therefore, I can only speculate as to whether Czechs would perceive genetic testing as extraordinary. One notable exception to the rarity of testing in Czechia exists, however. Pregnant women routinely undergo prenatal screening, which is financed by health insurance funds. Abortion is legal on request until the 12th week of gestation28 and is permitted until the 24th week if the foetus is malformed or at risk of a genetic disease. The prospect of caring for such babies justifies abortion even for the women longing for a child. Pregnant women face societal pressure to undergo prenatal screenings and, thereafter, abortions if the results indicate any risk. Paternity disputes became frequent during the socialist period. Contrary to methods used in the past, genetic testing enables the confirmation or refutation of paternity. Preliminary tests have proliferated as a result of lower prices and the ease of collection of samples. Genetic testing can also settle other kinship disputes, such as the swapping of babies after delivery, as was the case at the Třebíč hospital.29 The Czech Republic Police (Policie České Republiky) collects samples and has established a bank of genetic profiles for the investigation of serious crimes. Authorities resort to genetic testing to an extent comparable to other countries. Genetic analysis of samples collected at crime scenes has become an important method of obtaining evidence, but as in other countries, initial optimism has faded following several tricky cases such as the Phantom of Heilbronn.30

27

For an overview, see Winickoff (2006). See the Law on Abortion (zákon č 80/1986 Sb, o umělém přerušení těhotenství), paras 4–5. 29 See Lazarová (2007). Many newspapers abroad reported on this case. 30 See Ferraci-Porri (2009). There is also rich coverage of this case in newspapers and on the Internet. Investigating various crimes, police authorities in Germany and adjacent countries have collected at crime scenes identical genetic samples. There were considerable doubts that one particular female could commit all these crimes. Extensive investigation revealed that sticks for collection of samples were contaminated when manufactured. Phantom criminal was a worker of manufacturer. Sterility requirements were found insufficient. 28

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Specific Legal Framework for Genetic Testing

Since 2012, the “Genetic examinations” chapter of the Law on Specific Medical Services and Conditions of their Provision has set out a particular legal framework for genetic testing in Czechia.31 Compared to laws in other countries, such as Germany,32 the relevant provisions are succinct. However, the more general rules set out in the Law on Medical Services33 are also applicable. For example, provisions addressing children, minors, and incompetent adults as well as emergency situations apply mutatis mutandis. There were no specific rules regulating genetic testing before the recodification of medical law in the two above-cited laws in 2012. Nevertheless, providers of genetic testing developed appropriate standards without specific legal framework. It shall be noted here that Czech health care needed decades to recognize patients’ autonomy and competence. The Oviedo Convention, agreed under the auspices of the Council of Europe, specified the fundamental rights for medicine and contributed significantly to the reinterpretation of the Law on Care for Health of the Nation34 which, despite frequent amendments, mirrored collectivism and paternalism of the period of socialism (1948–1989). The provisions on “Genetic examinations” cited above focus on the licencing of providers of genetic testing. Certified genetic medical service providers must engage specialized physicians and other experts to guarantee, among other things, the correct interpretation of genetic testing results. The “Genetic examinations” chapter expressly applies only to genetic testing for medical purposes. Testing conducted to determine paternity and to identify suspects in criminal investigations therefore fall outside its scope. “Medical purposes” are defined as the determination of a predisposition to hereditary diseases, among other things.35 Whether the law applies to employers’ and insurers’ use of genetic testing remains unclear. The provisions cited above require the patient’s written consent for genetic testing to be carried out. Consent must be based on detailed information about the substance and consequences of this testing. However, geneticists are ill-equipped to adequately discuss with patients the social consequences of testing, which can vary widely according to the patient’s situation. Similarly, they can hardly explain the legal consequences of genetic testing if the framework remains unclear in many aspects. The “Genetic examinations” chapter contains the following terse antidiscrimination provision: “[r]esults of genetic tests shall not be used for any Zákon č 373/2011 Sb, o specifických zdravotních službách, paras 28–30. Gesetz über genetische Untersuchungen bei Menschen (Gendiagnostikgesetz) 31 July 2009, published in (2009) BGBl I S 2529. For the German text, see https://www.gesetze-im-internet.de/ gendg/index.html. 33 Zákon č 372/2011 Sb, o zdravotních službách a podmínkách jejich poskytování. 34 Zákon č 20/1966 Sb., o péči o zdraví lidu. 35 Zákon č 373/2011 Sb, o specifických zdravotních službách, para 28(9) a.3. 31 32

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discrimination of [the] patient or genetically relative persons.” It is clear that this provision does not apply to unborn children. The abortion of foetuses whose genetic makeup points to genetic disease is legal, and Czech society accepts it. Nevertheless, the following pages will reveal several borderline situations, in which the application of this provision is debatable.

3.3

Emerging Europeanisation of Rules for Genetic Testing

The Oviedo Convention envisages the creation of protocols for particular issues. The Council of Europe adopted the Additional Protocol concerning Genetic Testing for Health Purposes36 in 2008. It sets principal rules for the use of genetic testing, recovery of samples, quality of genetic services, clinical utility, individualised supervision, information and genetic counselling, persons incompetent to consent, informed consent with testing, gene tests on uncontactable persons and the deceased, respect for privacy, genetic screening, and public information. Unsurprisingly, the Protocol reiterates the principle of non-discrimination and non-stigmatisation in genetics.37 According to unofficial information, the Czech government signed the Protocol with considerable delay in 2017, during its presidency of the Council of Europe, as a gesture of a country frequently reluctant to accept international obligations. Generally, the Protocol took a decade to enter into force, as many countries were reluctant to expand their international obligations. Ultimately, the Protocol’s entry into force was triggered by Portugal’s ratification.38 Czechia’s ratification process was completed several months later.39 One side effect of multi-track European integration has been the prevalence of overlapping law-making in particular areas. The European Union has entered the field of genetic testing, with a regulation on in vitro diagnostic devices that contains a

36

Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes, adopted 27 November 2008, entered into force 1 July 2018, CETS no 203. For early commentary, see Lwoff (2009). 37 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes, adopted 27 November 2008, entered into force 1 July 2018, CETS no 203, art 4. 38 See https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/203/signatures?p_ auth¼mLcQSKgn. 39 After the approval by the Chamber of Deputies and the Senate, the ratification by the president and notification to the CoE, the Additional Protocol entered into force for Czechia on 1 September 2019. Official translation of the Additional Protocol into Czech language is available in Sdělení ministerstva zahraničních věcí č 41/2019 Sb m s o sjednání Dodatkového protokolu o genetickém testování pro zdravotní účely (Notification of the Ministry of Foreign Affairs on Conclusion of the Additional Protocol).

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specific provision on genetic testing.40 This regulation is scheduled to enter into force in 2022. The provision has an interesting legislative history. The European Parliament inserted it on the authority of the so-called Passau University Opinion,41 which claimed that the European Union is entitled to legislate on medical practice related to medical devices. Providers of direct-to-consumer genetic tests questioned the European Union’s competency to make laws governing the relations between physician, provider, and patient.42 In the end, the provision has stipulated that persons tested shall be “provided with relevant information on the nature, the significance and the implications of the genetic test.” However, the member states can adopt adequate measures to enhance patients’ protection.43

3.4

Gene Theft

Gene theft is the collection of genetic samples without an individual’s knowledge or consent for the purpose—aside from human cloning—of investigating his/her genetic profile. The new Penal Code44 introduced, among other specific crimes, the illicit collection of organs and tissues from human body,45 the illicit manipulation with personal data about other individuals collected within the exercise of government function46 and breach of confidentiality.47 We need to consider their applicability for gene testing. The principle nulla poena sine lege is an obstacle for an extensive interpretation of these provisions, that would make them hardly applicable to gene theft. Doctrinal writings on this recently adopted Penal Code have not addressed its application to gene theft. Nevertheless, administrative sanctions are applicable. According to the specific provisions on genetic testing mentioned above, healthcare providers or laboratories communicating results to third parties without the patient’s consent can be fined up to CZK 500,00048 (approximately EUR 20,000). Serious incompliance with

40

Regulation (EU) 2017/746 of the European Parliament and the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/ EU, OJ L 117/176, 5 May 2017. 41 See Schweitzer and Hans-Georg (2013). 42 See Hitchcock and Vollebregt (2014). 43 Regulation (EU) 2017/746 of the European Parliament and the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/ EU, OJ L 117/176, 5 May 2017, Art 4 para 1, 2 and 4. 44 Zákon č 40/2009 Sb, trestní zákoník. 45 Ibid, para 164. 46 Ibid, para 180. 47 Ibid, para 180 with relation to definition of confidentiality in para 124. 48 Zákon č 373/2011 Sb, o specifických zdravotních službách, paras 90(1)(f) and (7)(b).

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requirements of administrative law can result also in the withdrawal of authorisations by supervisory authorities. Moreover, courts would likely qualify genetic testing conducted without an individual’s consent as an infringement of his/her privacy and bodily integrity and award compensation according to provisions of the new Civil Code.49 However, the ease with which genetic samples can be collected renders the above restrictions difficult to enforce. Laboratories offer to analyse anonymous samples on their web pages. In paternity cases, samples may be obtained without the consent of the mother or child, whose interests are frequently at odds with those of the suspected father. One provider advertises that its administration of genetic testing of a sample in one case enabled identification of the writer of anonymous letters harassing a business. In practice, the state does not penalize these uses of genetic testing. I expect that many would criticize any attempts at enforcement as creating an incentive for “offshore testing,” thereby undermining business for domestic laboratories. There is an understanding that Czech laboratories test samples from countries with restrictive laws. It is easy to send samples across uncontrolled borders within the European Union. Unsurprisingly, therefore, we do not know the incidence of genetic testing conducted without the person or proxy’s consent. No surveys have been conducted or estimates constructed concerning the scale of this phenomenon. Nevertheless, coercion used to obtain samples for genetic testing would surely be regarded as an illicit interference into an individual’s intimate sphere, opening the door to a claim for pecuniary damages. Criminal prosecution can follow if subsumed under the crime of restriction of individual freedom.50 Genetic testing aimed at the investigation of a serious crime was questioned as an interference to bodily integrity lacking clear statutory framework establishing competence for the Police. Doubts about the legality of the practice vanished with the introduction of non-invasive methods of sample collection using, for instance, saliva, skin, or hair fragments, instead of blood. Nevertheless, the legal framework that governs the operation of the police biobank containing samples and genetic profiles remains perfunctory, which may potentially undermine the resort to genetic testing in criminal prosecutions.51

Zákon č. 89/2012 Sb., občanský zákoník, paras 84–90, 91–103, 111–112 and 2956–2957. Para 174 of the Penal Code. 51 See Kožina (2018), pp. 59–101. 49 50

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Genetic Privacy and Data

Medical practitioners and healthcare providers must respect patient confidentiality. Czechia has detailed rules on keeping and protecting medical records.52 In addition, the Law on Protection of Personal Data53 implementing the EU Data Protection Directive54 has been in force in Czechia since 2001, i.e., since before its accession to the European Union in 2004. Since 2018, the General Data Protection Regulation (the “Regulation”) has strengthened and homogenised data protection in the European Union.55 Information about an individual’s genetic makeup resulting from genetic testing56 undoubtedly falls within the category of sensitive information addressed explicitly by the Regulation.57 As mentioned below, specific rules for genetic testing confirm that genetic information reveals individuals’ perpetual and unchangeable features. The Regulation’s impact on genetic testing is the subject of considerable debate in Europe.58

3.6

Genetic Exceptionalism in the Law

Specific provisions, chapters—entire laws in other European countries—and conventions indicate lawmakers’ recognition of an individual’s genetic makeup as a specific, permanent, and unalterable individual characteristic. There is sufficient evidence for “genetic exceptionalism”59 both in the laws of Czechia and elsewhere, cemented with supranational law of the European Union and pan-European international law of the Council of Europe.

Zákon č 372/2011 Sb, o zdravotních službách a podmínkách jejich poskytování, paras 53–69b. Zákon č 101/2000 Sb, o ochraně osobních údajů. 54 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281/31, 23 November 1995. 55 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016. Nevertheless, the member states are entitled to adopt detailed rules specifying the extent and limits of personal data protection. 56 For a detailed analysis of global and European frameworks in the field of human genetics and debate about it, see Taylor (2012). For an analysis of—among others—the emerging Czech framework, see Antoš (2014). 57 Recital 34 and Article 4 (13) of the Regulation provides a definition. 58 For a brief overview, see Pormeister (2017). 59 Evans and Burke (2008). 52 53

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Little Attention to Genetic Discrimination in Czechia and in Europe

Despite the specific framework outlined above, there is no jurisprudence or administrative practice relating to alleged discrimination resulting from genetic testing in Czechia. Even the Ombudsman and her office, which combat discrimination with an activist style that largely lacks broad societal support, address the issue only sporadically.60 A consultation with an official in the office’s anti-discrimination department revealed that the office had received no complaints alleging genetic discrimination until 2018.61 Notable Czech geneticists, among which Renata Gaillyová,62 recognize the psychosocial aspects of genetic testing and promote training of general practitioners and experts in the field of genetic counselling. Few Czech physicians, biologists, bioethicists, psychologists, or sociologists focus on the ethical aspects of genetics, though the expertise of Věra Franková are a notable exception deserving attention.63 Nonetheless, no real public debate about genetic testing has emerged. The absence of disputes keeps genetic testing outside the awareness of both legal practitioners and scholars. Unsurprisingly under such conditions, the “Genetic testing” chapter of the Law on Specific Medical Services emulates the standards developed in other countries. The Protocol provides for a more elaborate framework than the existing chapter. Simultaneous application of both frameworks allows for the clarification of peculiarities. Genetic discrimination is not a particularly salient issue in Europe either.64 There are no landmark judgments from either the European Court of Justice or the European Court for Human Rights. Nevertheless, there are elaborate national frameworks in other European countries, such as the Gendiagnostikgesetz in Germany, which could provide inspiration for Czechia.65 60

One document only briefly mentions genetic discrimination as a threat. Interview conducted on 20 June 2017 (on file with the author). 62 Chief of the department for genetic medicine in the Faculty Hospital in Brno, the biggest of four hospitals attached to the Masaryk University. 63 Lecturer at the Institute of Medical Humanities, 1st Faculty of Medicine, the Charles University, Prague, among others, see Franková (2009). 64 Three hundred-page Handbook on European non-discrimination law—2018 edition prepared by the European Union Agency for Fundamental Rights and Council of Europe and the European Court for Human Rights (http://fra.europa.eu/en/publication/2018/handbook-european-law-non-dis crimination) mentions only provisions of the Charter of fundamental Rights of the European Union and the Oviedo Convention addressing genetics, without discussing their application in various situations. 65 Introductory commentary can be found in Fenger (2014). Schillhorn and Heidemann (2017) is 457 pages commentary explaining in detail provisions of this German federal statute with resort to extensive literature and official interpretation by expert bodies. 61

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4 Genetic Testing in Employment 4.1

Outline of Labour Laws in Czechia

Labour law in Czechia is an expression of two countervailing tendencies: protectionism ultimately rooted in the alleged worker protections of the socialist period on the one hand, and, on the other, a laissez-faire attitude tied to the crude neoliberalism of the immediate post-socialist years. The new Labour Code,66 recodified a decade earlier than the new Civil Code67 and retained as a separate piece of legislation, embodies the former tendency. However, the latter cannot be ignored. As regards wages, labour time, and safety, the laissez-faire approach prevails due to shortcomings in the enforcement of labour laws by slow courts and weak trade unions. This results in an absence of assertive collective bargaining and a dearth of solidarity among various groups of employees. Medical examinations of applicants and employees are addressed in the chapter “Labour-medical services and examination of health feasibility of candidates for employment,” of the Law on Specific Medical Services.68 The Decree Regarding Occupational Health Services69 implementing this Law specifies examinations of workers in general and in particular professions, as well as job candidates, students, apprentices, and pupils. This Law and its schedules do not specifically address the use of genetic testing. However, the tendency to interpret Czech labour law as a plethora of cogent rules in conjunction with the European Union’s new anti-discrimination rules addressing labour relations raises serious doubts as to whether Czech employers could ever genetically test their employees.

4.2

Realities of Genetic Testing in the Field of Employment

According to a leading geneticist in Brno,70 genetic testing for occupational purposes is largely non-existent in Czechia. The only exception is the screening of the few healthcare practitioners who handle cytostatic pharmaceuticals, which are suspected to cause genetic mutations. However, the mere illegality of genetic testing in the context of employment cannot explain its factual absence in Czechia. Many legal rules are breached frequently. Instead, Czech employers seem to lack any incentive to rely on genetic tests in the selection of employees. Zákon č 226/2006 Sb, zákoník práce. Zákon č 89/2012 Sb, občanský zákoník. 68 Zákon č 373/2011 Sb, o specifických zdravotních službách, paras 52–60. 69 Vyhláška č 79/2013 Sb, o pracovnělékařských službách. 70 According to a conversation with Renata Gaillyová in June 2017. 66 67

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Despite perennial complaints, employers in Czechia can dismiss their employees rather easily, compared to other countries. Seeking compensation for unlawful dismissal through judicial action is a lengthy, difficult, and unpredictable process. Moreover, a significant part of an employee’s wage results from his/her boss’s positive assessment, whereas a low wage could signal dissatisfaction. Czechia enjoys a low unemployment rate, except in rust belts and remote regions. There is a serious shortage of native skilled workers, which has been alleviated by immigration from the East. Under such conditions, employers do not dare select employees on the basis of as infeasible and potentially sensitive a criterion as genetics. It is debatable whether Czech managers are prudent and prescient enough to even consider genetic testing in their human resources management. Other tasks, problems, and risks are more acute. Additionally, managers from the West could come with presupposition that genetic tests are controversial. Few employers select workers transparently. They do not trust diplomas, school grades, certificates, or recommendations. Applicants who are rejected rarely complain; legal action is sporadic, and proceedings are lengthy and their outcomes unpredictable. Employers know that they must avoid overt discrimination in job advertisements to escape criticism and complaints. Nevertheless, selection based on sex (e.g., expected maternity), age (e.g., lack of perspective), race (e.g., the stereotype that Roma are quick tempered, uneducated and criminal), or handicap (e.g., necessary accommodation and reduced performance) is an all-too-common reality. Rejection based on appearance, religious beliefs, political activism and ideology, or apparent disease not directly compromising performance would spark suspicion. It is possible that managers could perceive an applicant or employee’s genetic disorder negatively (e.g., “he/she is weird”) or simply fear the premature termination of his/her career. Nevertheless, we should not generalize. People can show unexpected sympathy to those suffering from gene defects. Applicants and workers provide blood samples as part of their general medical examinations. It is possible that they could inadvertently “consent” to genetic testing when filling out complex forms. Some employers may possess biological samples without having obtained their employee’s consent. An employer determined to carry genetic testing would be capable to realize it. Genetic laboratories compete for clients. As mentioned, law in reality differs frequently from law in books in a post-socialist country.

4.3

Unfeasibility of Genetic Testing in the Field of Employment

There is awareness of genetic discrimination in employment in the global expert community. This project confirms it. High-profile cases in the United States of

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America71 show the intent of some employers to collect and analyse their employees’ genetic information. However, such activities are not widespread. I hypothesise that the few cases attracting attention reveal overeager managers. I suggest comparing this phenomenon with psychological testing. Psychological testing has developed as an auxiliary method of selection or promotion of workers. Nevertheless, psychologists and other consultants would likely extend their contribution if demanded. The question of whether there exist any workable models for the genetic testing of applicants and employees that are feasible for human resources managers remains unanswered. The optimism surrounding human genetics, which led to overinvestment in recent decades, has proven misplaced. Although there are many mutations that lead to debilitating and fatal diseases, these diseases are rare. Common diseases typically result from lifestyle and environmental factors, while the role of individual genes remains unclear. Nevertheless, the decrease in price for genetic tests makes them more affordable for employers, and the progress in their interpretation may make genetic testing of applicants or employees feasible in the near future. We shall remember that there is no significant employers’ engagement in the fields of healthcare and social security in Czechia. There seems to be no workable selection of employees based on genetic testing.

4.4

Sensitivity of Genetic Testing in the Field of Employment

Genetic testing is controversial in the West in general and in employment in particular. Restrictions imposed on it enjoy broad support. People appear to recognize the importance of everyone having the opportunity for and access to employment. As evidence, the Genetic Information Non-discrimination Act (2008) is a rare example of a federal law that received almost unanimous bipartisan support in the United States of America.72 Attempts to dilute this standard have been unsuccessful.73 It is easy to conclude that provisions of the Oviedo Convention and the Protocol (once ratified) render genetic testing in the field of employment impermissible. Moreover, the European Union would likely support this position and apply its

71

Burlington Northern Santa Fe Rail Road tested its engineers for genetic predisposition for carpal tunnel syndrome. After public outrage, the Equal Employment Opportunity Commission successfully pushed for settlement, see https://www.eeoc.gov/eeoc/newsroom/release/4-18-01.cfm. 72 Enacted by thy 110th United States Congress, effective since 21 May 2008, public law 110-233, 122 Stat 881. For early and advanced discussion see e.g. Nemeth P and Bonette TW (2009) and Ajunwa (2016). 73 See e.g. an amendment of the 2008 Genetic Information Non-Discrimination Act with the proposed H.R.1313—Preserving Employee Wellness Programs Act enabling employee’s consent for genetic testing related to optional health programmes.

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Charter of Fundamental Rights and anti-discrimination laws as an obstacle to genetic testing in the field of employment. Without any case law, we can only hypothesise that the emergence of genetic testing of workers for various reasons will shake this stance in the future.

4.5

Discussing Various Rationales for Genetic Testing of Applicants and Workers

There are many reasons why an employer may wish to genetically test job applicants and employees. First, an employer may be trying to detect genetic defects resulting in a disease with adverse implications for workplace or general public safety. There are many situations in which health conditions impact job eligibility.74 For example, epileptics cannot be drivers or operators of machinery, and specific restrictions are determined by the past frequency and severity of seizures. An example with a particular genetic aspect is Huntington’s disease, whose early symptoms could compromise safety in certain fields of work. The protection of the public would justify genetic testing if it could be shown to diminish risk in the early stages of disease. Psychologists offer private businesses testing to avoid uncooperative, unreliable or otherwise unfitted applicants. Unequivocal condemnation of genetic testing for such purposes is difficult to justify if other diagnostic methods resulting into similar a selection of applicants and the exclusion of workers are accepted. Pathological psychological traits justify workers’ exclusion from certain professions, including drivers, police officers, soldiers, and pilots. The second reason for genetic testing could be that a particular genotype combined with aspects of a specific job—for example, exposure to a certain substance— causes, worsens, or increases the risk of a disease for that worker. The protection of workers’ life and health is paramount.75 Many workplace restrictions serve primarily to protect the health of workers—for example, prohibition on smoking in the workplace. Nevertheless, many risks cannot be entirely eliminated. For example, coal miners generally stop working after a fixed number of years exposed to pollutants, while some stop earlier if the work has an increased adverse effect on their health. Employers are liable for occupational diseases and injuries.76 Czech law in general and labour law in particular77 typically do not allow a worker to renounce

74

There are numerous ministerial decrees adopted by ministries in accordance with provisions of laws, specifying requirements for various professions (drivers, miners, soldiers, policemen, healthcare practitioners, etc.) in Czechia. 75 Paras 101–108 of the 2006 Labour Code. 76 Paras 269–270 of the 2006 Labour Code. 77 Para 2898 of the 2012 Civil Code, para 4a of the 2006 Labour Code.

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future claims for compensation. Furthermore, it is difficult to justify a prohibition on genetic testing if other diagnostic measures are routine. The third reason could be employers’ desire to select the best applicant for a job or the ideal worker for a promotion. Employers already test performance, knowledge, experience, creativity, reliability, and resilience. These methods reveal unchangeable psychological and somatic traits. We can speculate that some of these traits have a genetic background. Genetic testing cannot currently be used for such purposes, but this could change with further improvement of testing technologies. We must consider why genetic testing should be unacceptable if psychological or somatic tests, which are allowed, could be rather invasive and their results just as controversial as the former. The fourth reason is that employers may wish to reject a candidate for a job, or to fire, demote, or simply refuse to promote an employee whose genetic profile predicts a future disease that would terminate prematurely his/her career. People would likely perceive this as unacceptable discrimination. Nevertheless, even this reason does not deserve total condemnation. The exorbitant investment in training78 or the dependence on particular individuals79 could rationally support such practices.

5 Genetic Testing in Insurance 5.1

Universal Public Health Insurance

Public healthcare insurance80 covers the entire population of Czechia and is compulsory. Employers, employees, and self-employed persons pay contributions. The State subsidises health insurance for children, students, parents on leave, and seniors. The economically inactive must still pay a lump sum. Health insurance funds (pl. zdravotní pojišťovny)—of which there were seven in 2018—contract public and private medical providers, who in turn provide health care to their clients. Standard care is generally free and co-payments are negligible. All funds follow national policy, which includes complex annual ministerial decrees on reimbursement. Money is redistributed among the health insurance funds according to the age of their clients.

78 It is worth to note that the 2008 Genetic Information Non-Discrimination Act (USA) is not applicable on US military personnel, while specific internal rules limiting genetic testing are applicable. We can discuss whether genetic profile could play role in the selection of an astronaut for a particular space mission by the National Aeronautics and Space Administration, if extensive health checks serve routinely this purpose. 79 For example, lead actors are totally irreplaceable in advanced phases of filming. I suggest that film producers escape restrictions with absolute discretion of producers including health checks. 80 Established with the Law on Public Health Insurance (Zákon č 48/1997 Sb, o veřejném zdravotním pojištění), laws on public health insurance funds and numerous ministerial decrees, annual decrees on reimbursement being crucial. For detailed overview, see Křepelka (2017).

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These funds must not refuse any client with a pre-existing disease, injury, or disability. Even reckless behaviour (e.g., alcoholism, smoking, drug addiction, overeating, serious and chronic incompliance of patients, etc.) does not result in increased premiums or co-payments, reduction of coverage, or exclusion. Clients will continue to be covered even if they fail to pay their contributions and even when their debt will skyrocket. Discussing patient responsibility is a sensitive issue. Under such conditions, genetic testing for the purpose of excluding potentially expensive clients is beyond consideration.

5.2

Eventual Genetic Discrimination in Provision of Medical Treatment and Its Public Financing

The clients (pojištěnci) of health insurance funds enjoy equal access to medical services. Persistent egalitarianism seems to be a deeply rooted legacy of socialism.81 However, significant differences result from the uneven allocation of money to branches of medicine. Elderly patients with chronic diseases frequently wait for treatment, and palliative care is underfinanced. Similarly, expensive innovative treatments are rationed through a concerted policy of the health insurance funds. Experts have highlighted and criticized regional disparities in coverage, especially because specialised care is available only in the biggest cities. Courts have begun to review health insurance funds’ decisions denying coverage for necessary but expensive treatments that are regarded as extraordinary and innovative, and thus not financed. However, their first judgments reveal an absence of any convincing methodology for the allocation of scarce resources. Therefore, one single judgment demanding administrative reconsideration of discrimination based on health status in cessation of treatment of a deceased infant suffering from genetically implied epidermolysis bullosa by parents82 could be regarded as the first recognition of de facto genetic differentiation in the field of universal public health insurance at the best. Organ transplantation is regulated by a specific regime based on elaborate inclusion and exclusion criteria due to a chronic organ shortage.83 A defective genetic makeup that would result in the risk of organ rejection would be a justifiable ground for refusing eligibility under such conditions.

81

The Constitutional Court curtailed differentiation specified with a ministerial decree, reserving the issue to the Parliament, which is politically incapable to adopt laws on this differentiation. 82 Judgment of the Supreme Court (Nejvyšší soud) 30 Cdo 2260/2017, JB a ZK v Fakultní nemocnice v Motole, 13 December 2017, ECLI:CZ:NS:2017:30.CDO.2260.2017.1. 83 Zákon č. 285/2002 Sb, o darování, odběrech a transplantacích tkání a orgánů a o změně některých zákonů (Law on Donations, Removals and Tranplantations of Tissues and Organs), para 17.

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Mandatory Private Insurance of Resident Foreigners

Most residents—nationals of non-European Union countries84—are required to purchase private insurance.85 Insurers refuse coverage to those with pre-existing conditions and to other risky clients. Several foreigners are thus uninsurable and fail to obtain or retain their residence permits. This regime is the subject of criticism. Non-governmental organizations campaign for the inclusion of these residents in the public health insurance system. Insurance companies lobbied successfully for their exclusion, because most immigrants are young, healthy men. Instead, the government tries to fill these lacunae with increasingly detailed rules. No insurance company explicitly mentions genetic testing as a ground for exclusion. Single-gene diseases are thus not expressly excluded. However, policy terms contain many limitations and exclusions. We must also consider that these private insurance companies provide coverage limited to clients with restricted residence rights. Given that many single-gene diseases require permanent care and are debilitating, it appears unlikely that such diseases would be covered.

5.4

Insurance of Medical Treatment of Superior Quality

The Czech public healthcare system provides good healthcare when compared with other European countries.86 Under such conditions, there is limited private health care in Czechia. Czech insurance companies have not developed any supplementary medical insurance. Nevertheless, insurance provided by foreign insurance companies is available as a result of extensive cooperation among insurance companies and brokers. Unsurprisingly, this insurance excludes pre-existing conditions. Thorough analysis would be needed to identify whether clients with unfavourable gene profiles would enjoy coverage.

5.5

Life Insurance

As in other countries, private life insurance is a sector in which genetic testing seems to be a feasible basis by which to distinguish clients according to their risk profile. Certainly, the thoroughness of the required medical examination differs depending 84

Nationals of the other member states European Union are assigned to Czech public health insurance according to its rules on coordination of social security (Regulation 883/2004). 85 Zákon č. 326/1999 Sb., o pobytu cizinců na území České republiky (Law on Residence of Foreigners on the Territory of the Czech Republic), para 180j. 86 Björnberg (2018).

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on the premiums to be charged. Nonetheless, insurers routinely demand that prospective clients present their medical records. The contract terms of several insurers include exclusions based on unfavourable genetic makeup. The Czech subsidiary of Generali explicitly excludes women with diagnosed BRCA1 or BRCA2 mutations, and terminates pro futuro coverage for breast cancer if subsequent testing reveals these mutations.87 According to unofficial information, several geneticists recommend that their clients purchase life insurance prior to undergoing genetic testing. Insurers tend to put genetically determined diseases on the list of exclusions or expect reduced compensation for their onset. An analysis of contract terms realized by a leading insurance broker reveals significant differences resulting from different specifications of diseases and their stages. Many serious diseases are excluded altogether or covered only in the final stages, and age could nevertheless terminate the coverage. Many insurers resort to positive lists on which insurable diseases are identified, and rare single-gene diseases are seldom listed.88 Genetic discrimination can thus emerge without demands for genetic testing or the consideration of results of existing tests

5.6

Squaring the Circle: Anti-discrimination in Insurance

The European Union shapes rules for the insurance sector, just as it does for employment. Nevertheless, these rules are primarily aimed at the resilience of insurers necessary to enable their cross-border operations in the internal market.89 With regard to genetic discrimination, Germany cautiously curtails the use of genetic tests for determining risk in insurance, with an exception for policies above a specific sum.90 In Great Britain, insurers have adopted a voluntary moratorium on the use of genetic testing.91

See Zvláštní pojistné podmínky pro rizikové životní pojištění (Special contract terms for risk life insurance), ZPP RŽP, 2013/04 of Generali Pojišťovna, as, Art 6 (1.5), http://www.generali.cz. 88 BrokerTrust, Pojištění vážných chorob pro finanční poradce (Insurance of serious diseases for financial advisers), https://docplayer.cz/3742982-Pojisteni-vaznych-chorob-pro-financni-poradce. html. 89 Currently including Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II), OJ L 335/1, 17 December 2009. 90 Para 18 of the Gendiagnostikesetz. 91 See Concordat and Moratorium on Genetics and Insurance (between Her Majesty Government and the Association of British insurers—ABI), 2014, https://www.abi.org.uk/globalassets/sitecore/ files/documents/publications/public/2014/genetics/concordat-and-moratorium-on-genetics-andinsurance.pdf. See also Jackson (2006), p. 359. 87

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Czechia’s Law on Insurance92 offers lukewarm support for equality, while allowing for the differentiation of premiums or exclusion on the basis of gender, age, and health status if justified by actuarial mathematics.93 Though individual genetic makeup is not an explicitly mentioned criterion, it can be subsumed under health status. The Court of Justice of the European Union in Test Achats embraced gender equality in insurance by striking down the exemption for sex-specific premiums.94 This judgment sparked considerable debate.95 Differentiating clients according to their characteristics and future risk is a cornerstone of insurance, and various proxy criteria are used. Discrimination is not only the legal term for undesirable selection, but also a key concept of insurance mathematics. Lawmakers can brand certain controversial criteria as inacceptable. Besides sex, race could be mentioned. Probably, the insurance industry can absorb it. However, differentiation on the basis of age and health status is hardly surmountable. Contrary to the employment context, there is unlikely to be consensus in Europe that differentiation based on unfavourable genetic makeup should be eradicated in the field of insurance. However, genetic makeup could be equated with race, thereby rendering genetic testing unacceptable as a basis of insurance decisions. Nevertheless, genetic makeup is also a proxy for an individual’s future health status. As previously mentioned, adjudication is lengthy and unpredictable. There have not been many cases of consumers bringing suits against insurance providers who have offered illicit terms. Certainly, anti-discrimination laws can be a means of achieving compensation of damages for infringement of dignity (so-called satisfaction in central European legal traditions) in cases of illicit refusal of coverage. However, such compensation is hardly equivalent to the hypothetical coverage in case of illness, injury, or death. It shall be noted here that courts are generally reluctant to award considerable sums in these cases. The concept of punitive damages is alien in Czech law. The official from the Ombudsman’s Office I consulted informed me about the recent efforts of her department in the field of insurance. In light of complaints made by several rejected insurance applicants, the office scrutinized the applicable contractual terms. They questioned the listed exclusions in a closed roundtable with the insurers’ representatives (Brno, 22nd June 2017). They criticised exclusions of psychiatric diseases, former drug addiction, and HIV/AIDS. I tried unsuccessfully to attract attention to the exclusion of women with genes for breast cancer mentioned above. There is a continuing risk that ongoing resistance to genetic discriminatory practices in the field of insurance could fail to produce any change. People at risk

Zákon č 277/2009 Sb, o pojišťovnictví. Zákon č 277/2009 Sb, o pojišťovnictví, para 59. 94 Judgment of the Court (Grand Chamber) of 1 March 2011, Association Belge des Consommateurs Test-Achats ASBL and Others v Conseil des ministres, C-236/09, 2011 I-00773. 95 For an in-depth analysis, see Armbrüster (2012). 92 93

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of genetically determined diseases are a minority, and insurers can marginalize them by excluding their diseases from insurable risks.

5.7

Testing and Discounts

If we cannot exclude the possibility that genetic information will be concealed or misstated in the field of employment, we must also expect the same in the field of insurance. Thorough medical examinations of clients considering expensive insurance policies may include, in addition to routine examinations, the collection of samples tested with the agreement of the parties to the policy or secretly. Moreover, insurance companies may offer discounts to prospective clients whose genetic tests reveal an absence of genetic disorders.96 I expect that most people would accept these terms, feeling no solidarity with those suffering from such disorders.

5.8

Insurance Fraud and Human Genetics

Insurance fraud has become frequent due to the ineffective prosecution of property crimes in post-socialist Czechia. This phenomenon contributed to increasing premiums. Therefore, the new Penal Code defines insurance fraud as a specified crime. Several people have since faced prosecution, with insurers drawing media attention to their cases. Unsurprisingly, fraud allows insurers to refuse compensation. Insurance fraud is frequently connected with medical examinations. Unscrupulous physicians confirm non-existent illnesses and injuries, or declare conditions to be more serious than they actually are. Therefore, insurers resort to their own physicians to verify claims. Clients are required to keep their insurers informed about their status and any changes in their condition. There is no doubt that intentionally concealing unfavourable genetic mutations would be qualified as insurance fraud if the insurer had previously requested information about genetic risks. It is less clear whether fraud could be presumed if an insurer had not specifically asked for such information, but where all relevant health status information is otherwise required. Equally unclear is the likely legal treatment of familial information indicating susceptibility to hereditary diseases. The degree of knowledge clients have of their familial susceptibility may vary widely. We can only speculate that people who know, or who suspect due to familial incidence, that they have unfavourable genetic makeup fear purchasing life

96 Jackson highlights that UK moratorium does not exclude consideration of negative test results for, as exemplified, early onset Alzheimer’s Disease Jackson (2006), p. 361.

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insurance because they could be accused of insurance fraud and their compensation denied.

5.9

The Underdevelopment of Life Insurance in Czechia

Life insurance is underdeveloped in Czechia. Elderly people remember the confiscation in 1953 of their already frozen savings, including life insurance policies. Despite the relative stability of Czechia’s currency, people fear inflation. The wealthy have developed their own investment strategies, while the middle class relies on property ownership. The real estate bubble became a serious concern, but was also an opportunity for investors. Poor Czechs simply lack the money to purchase life insurance. Moreover, numerous insurance brokers compete fiercely for clients, and many resort to the manipulation of inexperienced clients, which renders life insurance untrustworthy.

6 Conclusion Genetic testing for both medical and forensic purposes has become routine in Czechia, as in other developed countries. Nevertheless, its use remains sporadic in the fields of employment and insurance, likely due in part to the state of Czech political and socio-economic development as well as the shortcomings of postsocialist law. Although the Council of Europe and the European Union stipulate general principles, domestic legal discourse about the particularities of the regulation of genetic testing is in its infancy. Discrimination based on individual genetic makeup is generally illicit in the employment context. Despite the fact that covert testing without informed consent is certainly punishable, one might expect it would occur in countries with perfunctory implementation of laws. Therefore, the absence of genetic testing in the workplace in Czechia is better explained by its impracticality, although rare exceptions exist that seek to protect healthcare practitioners handling dangerous substances. Genetic testing and consideration of its results do play a role in life insurance. For instance, one insurer’s contract terms exclude women with a genetically identified risk of breast cancer. Moreover, instead of controversial and likely illicit genetic testing, insurers exclude rare monogenetic diseases. Czechia has universal public health insurance, but we expect that genetic makeup could be considered in the allocation of treatment and its public financing.

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References Ajunwa I (2016) Genetic data and civil rights. Harvard civil rights. Civil Liberties Law Rev 51:75–114 Antoš O (2014) Právní režim informací v genetických databázích a biobankách. Dissertation. Masaryk University, Brno Armbrüster C (2012) Das Unisex Urteil des EuGH (Test Achats) und seine Auswirkungen, Zentrum für Europäisches Wirtschaftsrecht. Bonner Rechtsjournal 1:105–106 Björnberg A (2018) European health consumer index report. Health Consumer Powerhouse, https:// healthpowerhouse.com/media/EHCI-2017/EHCI-2017-report.pdf. Accessed 16 Nov 2018 Boučková P et al (2010) Antidiskriminační zákon – Komentář, 2nd edn. CH Beck ČR, Praha Evans JP, Burke W (2008) Genetic exceptionalism. Too much of a good thing? Genet Med 10:500–501 Fenger H (2014) Gesetz über genetische Untersuchungen beim Menschen. In: Spickhoff A et al (eds) Medizinrecht. Beck’sche Kurzkommentare. CH Beck, München Ferraci-Porri M (2009) L’affaire du fantôme de Heilbronn. Plongée dans une enquête criminelle hors norme. Editions Normant, Nantes Franková V (2009) Pojem genu a některé jeho etické konsekvence. Dissertation. Charles University, Staré Město Hitchcock J, Vollebregt E (2014) Opinion – the competence of the European Union to legislate in relation to certain amendments endorsed by the European Parliament in connection with a Commission Proposal for an in vitro diagnostic device regulation. https://www.eshg.org/ fileadmin/eshg/documents/IVD/ESHG_Opinion_19_February_2014_final.pdf. Accessed 16 Nov 2018 Jackson E (2006) Medical law. Text, cases and materials. Oxford University Press, Oxford Kischel U (2015) Rechtsvergleichung. CH Beck, München Kožina J (2018) Identifikační genetika v právní praxi. Wolters Kluwer, Alphen aan de Rijn Křepelka F (2017) Regulation of health care and medicine in the Czech Republic. In: Powalowski A, Vrabko M, Mrkývka P (eds) Selected issues of public economic law in theory, judicature and practice in the Czech Republic, Poland and Slovakia. Wydawnictwo – CH Beck, München, pp 149–167 Kvasnicová J et al (2015) Antidiskriminační zákon, komentář. Wolters Kluwer ČR, s. r. o, Praha Lazarová D (2007) Baby swap at hospital uncovered nine month later. https://www.radio.cz/en/ section/curraffrs/baby-swap-at-hospital-uncovered-nine-months-later. Accessed 16 Nov 2018 Lwoff L (2009) Council of Europe adopts protocol on genetic testing for health purposes. Eur J Human Genet 17:1374–1377 Nemeth P, Bonette TW (2009) Genetic discrimination in employment. Labor and Employment Law. Michigan Bar Journal. https://www.michbar.org/file/barjournal/article/documents/ pdf4article1461.pdf, Accessed 17 June 2019 Pormeister K (2017) Genetic data and the research exemption: is the GDPR going too far? Int Data Privacy Law 7(2):137–146 Schillhorn K, Heidemann S (2017) Gendiagnostikgesetz. Kommentar für die Praxis. Medhochzwei, Heidelberg Schweitzer M, Hans-Georg K (2013) Options for action of the European Union in the area of human genetics and reproductive medicine in the light of the proposal for a regulation on in vitro diagnostic medical devices. http://www.cep.uni-passau.de/fileadmin/dateien/fakultaeten/jura/ institute/cep/HumanGenetics-Opinion_English_7-3-13.pdf. Accessed 16 Nov 2018 Taylor M (2012) Genetic data and the law – a critical perspective on privacy protection. Cambridge University Press, Cambridge Winickoff DE (2006) Genome and Nation: Iceland’s health sector database and its legacy. Innov Technol Gov Glob 1(2):80–105

The Prohibitions Against Genetic Discrimination in Estonia Kärt Pormeister

Abstract Genetic discrimination is explicitly prohibited under Estonian law. Furthermore, the law establishes specific prohibitions concerning genetic discrimination in employment and insurance contexts. Employers and insurance providers are not allowed to ask for or obtain genetic data or tissue samples of, respectively, employees or job applicants, and insured persons or persons applying for insurance. Employers are prohibited from imposing discriminatory working conditions and wages based on genetic factors, and insurers are not permitted to establish insurance conditions or preferential insurance rates, or to limit insurance coverage, based on genetic risks. However, these prohibitions are established under the Human Genes Research Act, and genetic discrimination is not proscribed by the general Equal Treatment Act. The scope of the latter is limited to discrimination on the grounds of nationality (ethnic origin), race, skin colour, religion or other beliefs, age, disability or sexual orientation. As a result––unless genetic discrimination coincides with one of the grounds of discrimination listed––claimants in genetic discrimination cases are left without some of the procedural benefits provided by the Equal Treatment Act.

1 Introduction Estonian law explicitly establishes both a general prohibition on genetic discrimination and two specific bans on genetic discrimination in employment and insurance. These bans are absolute. In addition to prohibiting discriminatory practices, they prohibit employers and insurers from collecting or obtaining tissue samples or genetic data in the first place. The absolute nature of the bans has been challenged in certain aspects, and can most notably be called into question in regard to life insurance. Though the non-discrimination rules regarding genetics are clearly established in Estonian law, the approach to non-discrimination is fragmented, K. Pormeister (*) University of Tartu, School of Law, Tartu, Estonia © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_7

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depriving claimants in genetic discrimination cases of the benefit of a shared burden of proof rule afforded to claimants in certain other cases of discrimination. In order to explore the prohibitions on genetic discrimination in Estonia, this chapter will first analyse the law applicable to genetic discrimination, both at the international and EU level, and at the national level. This will be followed by an introduction to the Estonian Human Genes Research Act, the national law that establishes non-discrimination rules regarding genetics. Thereafter, the prohibitions themselves will be analysed. This will be followed by an exploration of some of the critiques expressed against the absolute nature of the bans on the collection of genetic data in the employment and insurance contexts. Finally, the fragmented nature of the Estonian legal framework regarding discrimination will be analysed and its shortcomings in regard to genetic discrimination will be discussed.

2 Law Applicable to Genetic Discrimination in Estonia 2.1

International and EU Law

In terms of international law, Estonia has signed and ratified1 the Oviedo Convention on Human Rights and Biomedicine,2 which, in Article 1, establishes a general prohibition against discrimination with regard to the application of biology and medicine and, in Article 11, prohibits discrimination on grounds of genetic heritage specifically. Although, under Article 1, the scope of the Oviedo Convention concerns specifically “the application of biology and medicine,” the prohibition on genetic discrimination in Article 11 quite clearly prohibits “[a]ny form of discrimination against a person on grounds of his or her genetic heritage.” Given the general scope of the Oviedo Convention, however, it remains open to doubt whether the prohibition in Article 11 would apply to the employment and insurance contexts, or only to more narrowly-defined medical or scientific contexts. Genetic discrimination has also been found by the European Court of Human Rights (ECtHR) to fall under the prohibition of discrimination in Article 14 of the European Convention on Human Rights (ECHR).3 Although the latter does not

1 Chart of Signatures and Ratifications of Treaty 164. Status as of 21 August 2018. https://www.coe. int/en/web/conventions/full-list/-/conventions/treaty/164/signatures. 2 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force 1 December 1999, CETS no 164. 3 European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols nos 11 and 14, adopted 4 November 1950, entered into force 3 September 1953, CETS no 005.

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explicitly list genetics as a ground for discrimination, it contains a non-exhaustive list ending with “or other status.”4 At the EU level, the Charter of Fundamental Rights of the European Union,5 in Article 21, prohibits discrimination based on, inter alia, genetic features. However, as established in Article 51, the Charter only applies to Member States when they are implementing EU law. Furthermore, the EU directive concerning equal treatment in employment and occupation does not include under its scope of application discrimination on the grounds of genetics.6 Thus, though there are a few rules stemming from international and EU law (applicable in Estonia) that address and prohibit genetic discrimination, none of these establish bans on genetic discrimination that would be clearly applicable in matters of employment and insurance. Though Article 14 of the ECHR might establish a general prohibition on genetic discrimination, it is highly unlikely that the ECtHR would recognize the existence of an absolute ban on the use of genetic data in employment or insurance.

2.2

Estonian National Law

Under Estonian national law, the Constitution7 establishes, in paragraph 12, both a principle of equality before the law and a general non-discrimination rule. Although paragraph 12 does not explicitly mention discrimination based on genetics, the Constitution establishes, much like Article 14 of the ECHR, a non-exhaustive list of possible grounds of prohibited discrimination, which ends with “or due to other circumstances.” Furthermore, the Supreme Court has, in its case law, considered genetics to constitute a potential ground of discrimination. Moreover, as it is independent of an individual’s will, genetics as a ground of discrimination is subject to a higher threshold for justification when differential treatment is established compared to grounds of discrimination like language, which is learnable, and those that are somewhat changeable like religion and other views.8 However, the non-discrimination rule in the Constitution only addresses the relationship between the state and individuals (i.e. equality before the law). As regards the private sector, a non-discrimination rule is established in the Equal

4

European Court of Human Rights, GN and others v Italy, 1 December 2009, application no 43134/ 05. 5 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012. 6 Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation, OJ L 303/16, 2 December 2000, Art 1. 7 Constitution of the Republic of Estonia.—RT 1992, 26, 349. 8 Supreme Court of Estonia (en banc), case no 3-4-1-12-10, 7 June 2011.

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Treatment Act (ETA).9 Unfortunately, as is apparent from its first paragraph, the ETA only concerns the protection of persons against discrimination on grounds of nationality (ethnic origin), race, colour, religion or other beliefs, age, disability, or sexual orientation. There is no “open clause” in the list of grounds of discrimination in the ETA, as is the case with the ECHR (“or other status”) and the Estonian Constitution (“or due to other circumstances”). Thus, genetic discrimination can be deemed to fall under the scope of the ETA only to the extent that genetic factors intersect with the grounds listed in paragraph 1 (1) of the ETA. For example, discrimination based on physical or mental symptoms stemming from a genetically predisposed or predetermined disease, and amounting to a “disability,” might be covered by the ETA. It could fall under discrimination based on disability, though it might technically be discrimination based on genetics as well. The same argument could be made for discrimination based on ethnic origin, as this can be detectable based on genetic data, but may also be based on other sources (i.e. physical features or documented information). It follows that the ETA would not cover discrimination based on asymptomatic genetic mutations, as these would not intersect with any of the categories set out in the ETA’s exhaustive list of protected grounds. In terms of genetic discrimination specifically, Estonian law also establishes, in the Human Genes Research Act (HGRA),10 a general prohibition on genetic discrimination, accompanied by two specific prohibitions regarding insurance and employment. Furthermore, under paragraph 153 of the Estonian Penal Code,11 unlawful restriction of the rights of a person, or the granting of unlawful preferences to a person on the basis of his or her genetic risks, is punishable by a fine or by detention. Before turning to the specifics of these prohibitions, some background information and clarification about the HGRA should be offered, to better explain the fragmented nature of the provisions regarding non-discrimination in Estonia.

9 Estonian Equal Treatment Act—RT I, 26 April 2017, 9. Available in English at https://www. riigiteataja.ee/en/eli/503052017002/consolide. 10 Estonian Human Genes Research Act—RT I, 14 March 2014, 30. Available in English at https:// www.riigiteataja.ee/en/eli/518062014005/consolide. 11 Estonian Penal Code—RT I, 29 June 2018, 66. Available in English at https://www.riigiteataja. ee/en/eli/509072018004/consolide#para1.

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3 The Estonian Human Genes Research Act The HGRA was adopted in 2000 and came into force in 2001. It has since been subject to little change. The HGRA was primarily adopted to govern the activities of the Estonian Biobank (EBB). The EBB was initially a state-run non-profit, but is now part of the University of Tartu.12 The fact that the HGRA was specifically designed to govern the EBB is evident from the text of the act. Namely, paragraph 6(2) sets out that Chaps. 2–4 of the HGRA do not apply to genetic testing other than that carried out by the EBB. These chapters concern the rights of the EBB’s gene donors (Chap. 2), the processing activities of the EBB (Chap. 3), and data protection rules specific to the EBB (Chap. 4). Thus, a large part of the HGRA only addresses matters that concern the EBB. Although paragraph 6(2) of the HGRA refers to genetic tests carried out in other contexts, this clause merely sets out that such testing can be carried out in cases and for purposes provided by law. However, there is no such (national) law. As of 2018, the only legal rule specifically governing genetic tests is Article 12 of the Oviedo Convention. In 2022, Article 4 of the 2017 EU regulation concerning in vitro diagnostic medical devices13 will complement this single rule, and specifically address genetic testing in the healthcare context. Though the HGRA mostly deals with the regulation of the EBB, there are a few notable clauses in the HGRA of a universal nature. Most important is Chap. 5, which addresses prohibitions on genetic discrimination.

4 The Prohibitions Against Genetic Discrimination Under the HGRA The HGRA establishes a universal prohibition against genetic discrimination. Paragraph 25(1) of the HGRA prohibits restricting the rights and opportunities of a person, or conferring advantages on a person, on the basis of the structure of their DNA and the genetic risks resulting therefrom. Paragraph 25(2) addresses the EBB specifically, by setting out a distinct prohibition against discrimination on the basis of the status of being a gene donor (to the EBB). The HGRA goes further than establishing a general prohibition. It specifically addresses the employment and insurance contexts. Under paragraph 26(1), employers are prohibited from collecting genetic data about employees or job applicants and from requiring employees or job applicants to provide tissue samples Official website for the Institute of Genomics of the University of Tartu, “Estonian Genome Center, University of Tartu (The Estonian Biobank)”, https://www.geenivaramu.ee/en/about-us. 13 Regulation (EU) of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/ EU, OJ L 117/176, 5 May 2017. 12

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or descriptions of DNA. In terms of discriminatory treatment in employment, paragraph 26(2) of the HGRA prohibits employers from imposing discriminatory work and wage conditions for people with different genetic risks. Thus, the protection against genetic discrimination in employment is twofold. In addition to being prohibited from establishing discriminatory practices based on genetics, employers are not allowed to ask for or collect tissue samples and genetic data of employees or job applicants. Analogously to the employment context, paragraph 27(1) of the HGRA prohibits insurers from collecting genetic data on insured persons or persons applying for insurance and from requiring clients to provide tissue samples or descriptions of DNA. Under paragraph 27(2) of the HGRA, insurers are not allowed to establish different insurance conditions for people with different genetic risks, to establish preferential tariff rates, or to determine insured events restrictively. Thus, as was the case with employers, the protection afforded to individuals is twofold. Not only are insurers prohibited from discriminating based on genetics, they are not allowed to collect tissue or genetic data from the insured or insurance applicants in the first place.

5 Critiques of the Prohibition Against Genetic Discrimination in Estonia The absolute prohibitions regarding genetic discrimination under the HGRA, specifically in employment and insurance, came under some criticism in 2001 when they first came into force. Nõmper has criticized the absolute ban on genetic testing in both employment and insurance.14 Regrettably, Nõmper’s work appears to be the only academic publication in Estonia addressing this issue. The absolute bans established by the HGRA and criticized by Nõmper have, however, stood the test of time and remain unaltered. Regardless, Nõmper raises some valid points criticizing the bans on genetic discrimination in employment and insurance, which shall be addressed below.

5.1

Critiques Regarding the Absolute Ban on Genetic Testing in Employment

Nõmper argues that an absolute ban on genetic testing in employment is an unfair approach for employers, and that genetic testing should be permissible in employment relationships under strict and limited conditions. According to Nõmper, an employer should have a right to require genetic testing both prior to entering into and 14

Nõmper (2001), pp. 117 and 119–120.

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during the course of an employment relationship, to the extent that such testing is necessary to determine the existence of a genetic disease that might render the fulfilment of job obligations a health risk for the (potential) employee or impose a risk on co-workers, the employer’s assets, or clients. Nõmper takes this even further by stating that it should not matter whether there is a causal link between the working conditions and the manifestation of the risks stemming from the genetic disease. In Nõmper’s opinion, the employer should be able to avoid hiring or retaining an employee who poses a potential risk, regardless of whether the manifestation of the risk is caused by factors related to the job.15 One could use the example of pilots and Huntington’s disease to illustrate Nõmper’s point. The manifestation of Huntington’s disease will not depend on the working conditions of a pilot (e.g. exposure to high altitude or any other workplace related factors), however, the manifestation of symptoms like involuntary movements might potentially create a risk for the pilot, the employer, and others. However, Nõmper concedes that knowledge regarding a possible future loss in an employee’s ability to work should never outweigh the privacy interests, since the employer has to factor in the eventual loss of personnel as a normal business risk. Nõmper’s arguments in favour of allowing limited genetic testing in the employment context are debatable. Namely, symptomatic conditions can be detected based on the symptoms themselves. Genetic testing might be used to confirm a suspected diagnosis, but ultimately it is the physical or mental symptoms of a genetic condition that will warrant the employer’s interests in terms of risks, rather than the mere possibility of a genetic condition or genetic predisposition to disease. As far as asymptomatic conditions are concerned, there appear to be few arguments to justify the employer’s alleged interests in genetic testing. Nõmper seems to argue that if an occupational health doctor needs to make a decision about the state of health of a (potential) employee, the doctor should have all possible diagnostic methods made available.16 However, there are two major flaws in this line of argument. First, as stated by the World Health Organization in 1948, “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”17 Although this definition has been criticized by some as being unrealistic in the sense of being unattainable,18 it can be used to demonstrate the following point. As long as a genetic mutation does not affect an individual’s physical, mental or social well-being, it does not affect his or her state of health. Second, and closely connected to the previous point, a health care professional does not begin the assessment of an individual’s health with a genetic test. Referrals to genetic specialists are usually (at least in the Estonian healthcare context) based on

15

Nõmper (2001), p. 117. Nõmper (2001), p. 117. 17 Preamble to the Constitution of WHO as adopted by the International Health Conference, New York, 19 June–22 July 1946. 18 Scully (2004), p. 650. 16

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the suspicion that a patient might have a genetic condition19—a suspicion for which there would be no basis if there were no symptoms. If there are symptoms, the argument goes back to the previous point: that the manifested symptoms should influence the determination of health status and potential risks in the work environment. The grey area in this discussion might be late-onset or adult-onset genetic diseases. For example, returning to the example of Huntington’s disease, genetic testing will give a definite answer as to whether or not a person is a carrier of the mutation. Testing can also determine whether or not the individual carrying the mutation will develop the disease (depending on the specifics of the mutation).20 However, the exact time the disease will manifest itself cannot be predicted.21 Given that early symptoms include involuntary movement like jerking or twitching, the disease’s manifestation can pose a significant risk in certain occupational categories, for example in the case of surgeons, pilots, or people operating heavy machinery, who, if they were to suffer unpredictable, involuntary movements, might put the health and safety of others at risk. Given that the window for the manifestation of Huntington’s can differ significantly, ranging from 3–4 to up to 85 years of age,22 the question is what the approach to genetic diseases like Huntington’s should be in the employment sector. On the one hand, the disease’s eventual manifestation might create a significant risk for certain employers and employees in specific circumstances. On the other hand, the disease might not even manifest itself before retirement age. If it manifests during the course of employment, depending on specific circumstances, the symptoms might not be such as to create a risk in a given work environment.

5.2

Critiques to the Absolute Ban on Genetic Testing in Insurance

Nõmper also criticizes the absolute ban on genetic testing in insurance. He argues that there is no need for an absolute ban in the Estonian context, where the universal healthcare system provides health insurance for most of the population (by the end of 2017, the number of insured persons was 1,240,927,23 amounting to approximately 94% of the population). Nõmper deems the absolute ban overly conservative, given that basic health insurance is provided to most of the population. Thus, there is no

19

Genetic Alliance (2009), p. 29. US National Library of Medicine. Huntington disease, https://ghr.nlm.nih.gov/condition/hunting ton-disease#inheritance. 21 Orth and Schwenke (2011). 22 Myers (2004). 23 Official website of the Estonian Health Insurance Fund, https://statistika.haigekassa.ee/ yldnaitajad.html. 20

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need to limit the contractual freedom of insurance providers to such an extent that they are barred from inquiring about genetic conditions that might considerably affect insurance risks. Nõmper’s proposition to allow insurance providers to ask for genetic information is balanced by his suggestion that people applying for insurance should only be obliged to provide genetic information to the extent that insurance providers specifically ask (i.e. not by vague stipulations such as “and all other relevant information”).24 Indeed, in the context of state-provided universal health insurance coverage, allowing private insurance providers to ask for certain genetic information on a limited set of conditions would, in the author’s opinion, clearly not deprive individuals of the fundamental right of access to healthcare (enshrined in, e.g. Article 35 of the Charter of Fundamental Rights of the European Union). Furthermore, the Estonian ban on genetic testing in insurance does not just cover health insurance. Paragraph 27 of the HGRA prohibits all insurance providers from requiring genetic data and making insurance terms conditional upon genetic factors. In certain cases in insurance, the rationale for an absolute ban on genetic testing is debatable. One such case is life insurance. Life insurance, unlike medical insurance and access to health care, does not serve the protection of health and life, but only offers a monetary payout in the event of the insured individual’s death. The insurance provider might have a legitimate interest in knowing whether a person applying for life insurance carries a gene mutation that is likely to affect life expectancy. In cases in which the person applying for life insurance coverage is aware of having such a genetic mutation, the absolute ban on genetic testing (including the prohibition on requesting any sort of genetic information) can facilitate fraudulent behaviour. Hence, in the insurance context, in certain circumstances, arguments can be made in favor of granting insurance providers a limited right to ask for specific and relevant genetic information (e.g. the right to ask for information or confirmation from the applicant regarding dominant gene mutations with high penetration that cause disease with a high mortality risk).

6 The Fragmented Approach to Genetic Versus Other Types of Discrimination in Estonian Law The HGRA and its prohibitions on genetic discrimination predate Estonia joining the EU. The HGRA (entered into force in 2001) also predates the ETA (entered into force in 2009), which was adopted to implement a number of EU directives.25 As

24

Nõmper (2001), pp. 118–120. Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin, OJ L 180/22, 19 July 2000; Council Directive 2000/78/EC establishing a general framework for equal treatment in employment and 25

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such, the limited scope of the ETA set out in paragraph 1(1)—via its exhaustive list of grounds of discrimination—is a result of it being an instrument adopted for the purpose of implementing specific EU law, rather than being designed to systematically tackle discrimination in Estonia. As noted above, the exhaustive list of grounds for discrimination in the ETA does not include genetic discrimination and the ETA would thus cover genetic discrimination only insofar as it intersects with the types of discrimination that are explicitly covered (e.g. in the case of a genetic condition that has physical manifestations that amount to a disability within the meaning of the ETA). The problem with genetic discrimination not being expressly listed in paragraph 1 (1) of the ETA is that the ETA provides for a number of procedural benefits that should mutatis mutandis also be applied in the case of genetic discrimination.

6.1

Genetic Discrimination Versus Other Types of Discrimination

As noted, the ETA covers discrimination based on nationality (ethnic origin), race, skin colour, religion or other beliefs, age, disability or sexual orientation. Of these categories, genetic discrimination might intersect with discrimination on the grounds of ethnic origin, race, skin colour and disability. Whilst discrimination based on ethnic origin, skin colour and race will always coincide with genetic discrimination (since skin colour and the manifestation of visible physical traits associated with ethnic origin and race is due to genetic features), this is not the case with disability. According to paragraph 5 of the ETA, disability is the loss of, or an abnormality in, an anatomical, physiological or mental structure or function of a person, which has a significant and long-term unfavorable effect on the performance of everyday activities. By this definition, a genetically-related disability would depend on the physical manifestation of a genetic mutation, and require the latter to have a “significant and long-term unfavorable effect on the performance of everyday activities.” This means that asymptomatic genetic conditions would not intersect with any of the grounds of discrimination listed in the ETA. Neither would those that do not

occupation. 02.12.2000. O.J. L 303; Directive 2004/113/EC implementing the principle of equal treatment between men and women in the access to and supply of goods and services. 21 December 2004. OJ L 373; Directive 2006/54/EC of the European Parliament and of the Council on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (recast). 26 July 2006. OJ L 204; Directive 2010/41/EU of the European Parliament and of the Council on the application of the principle of equal treatment between men and women engaged in an activity in a self-employed capacity and repealing Council Directive 86/613/EEC. 15 July 2010. OJ L 180; Directive 2014/54/EU of the European Parliament and of the Council of 16 April 2014 on measures facilitating the exercise of rights conferred on workers in the context of freedom of movement for workers. 30 April 2014. OJ L 128.

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amount to a “significant and long-term unfavourable effect” on the individual’s life intersect with ETA grounds. Thus, unless a genetic condition has manifested in a way that falls under the definition of “disability” within the meaning of the ETA, discrimination based on such a condition would not fall under the scope of the ETA.

6.2

Procedural Benefits Provided Under the ETA

One of the notable procedural benefits of the ETA concerns the burden of proof. Under the general burden of proof rule in civil court, established in paragraph 230 of the Code of Civil Procedure (CCP),26 each party has to prove the facts they claim. Hence, the discriminated party would have to prove the fact of discrimination. However, the ETA establishes, in paragraph 8(1), a shared burden of proof, stipulating that an application of a person addressing a court, a labour dispute committee, or the Gender Equality and Equal Treatment Commissioner shall set out the facts on the basis of which it can be presumed that discrimination has occurred. Then, the burden of proof shifts to the respondent, who, under paragraph 8(2) of the ETA, has to prove in the course of proceedings that there has been no breach of the principle of equal treatment. If the person fails to provide proof, such failure is deemed to be equal to an acknowledgement of discrimination. This only applies in civil proceedings, and not in administrative or criminal proceedings (paragraph 8(3) of the ETA). Although this procedural benefit does not apply to genetic discrimination, the fact that insurers and employers are specifically prohibited under paragraphs 26–27 of the HGRA from requesting, accessing, obtaining, or collecting tissue samples or genetic data should shift the burden of proof onto them where it is established that they had access to, or were in possession of, relevant tissue or genetic data. Of course, the latter would have to be proven by the claimant. However, in a sense, this sort of prohibition could be said to establish a somewhat similar presumption as the ETA’s burden of proof rule described above. This would shift the burden of proof onto the employer or insurer to show that despite having access to genetic data, they did not base any decisions on it. This, of course, would assume that the claimant is in fact able to prove that the (potential) employer or insurer had access to tissue or genetic data—a fact that might not be easy to prove. Hence, the approach to the burden of proof in discrimination cases under the ETA still provides a significant benefit for claimants. In addition to the burden of proof exception, the ETA also provides specific rules for damages in discrimination cases. In addition to patrimonial damages, the ETA affords the right to claim non-patrimonial damages (paragraph 24(1) and (2) of the ETA). In regard to the amount of compensation, a court or a labor dispute committee

26 Estonian Code of Civil Procedure—RT I, 04 July 2017, 31, available in English at https://www. riigiteataja.ee/en/eli/506022018001/consolide.

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will take into account, inter alia, the scope, duration, and nature of discrimination (paragraph 24(3) of the ETA). Since no minimum or maximum amounts have been established, it is hard to evaluate the adequacy of the remedial awards. The HGRA, which specifically covers genetic discrimination in employment and insurance relationships, does not govern damages. Hence, in cases where the ETA cannot be invoked (i.e. where genetic discrimination does not intersect with the grounds governed by the ETA), the Law of Obligations Act (LOA)27 governs the determination of damages. The LOA establishes, under paragraph 134(2), a right to a reasonable amount for non-patrimonial damages. Furthermore, under paragraph 134 (6) of the LOA, in cases of a breach of personality rights (which can include antidiscrimination rights), a court determining the amount of non-patrimonial damages can take into consideration the need to exert influence upon the person who caused the damage to avoid causing further damage, taking into account their financial situation. Thus, though the ETA might not apply to genetic discrimination, non-patrimonial damages can still be claimed based on the general rule under the LOA. Another, though arguably minor, procedural benefit is established in paragraph 7 of the ETA. The person suspected of discriminatory practices has to, upon the written request of the person allegedly discriminated against, give written explanations within 15 days. Though this is not a considerable procedural benefit, it still allows the person who suspects they have been discriminated against to evaluate the written explanation to better estimate the need for, and prospects of, official proceedings.

6.3

Concluding Remarks on Genetic Discrimination and the ETA

From the above, it can be concluded that the most crucial procedural benefit under the ETA—one that unfortunately does not apply to cases of genetic discrimination— is the shared burden of proof rule. Proof is perhaps the most difficult aspect of any discrimination dispute, even more so in cases of genetic discrimination. There is no logical reason for this procedural benefit not to apply to genetic discrimination. The author of this chapter has written to the Ministry of Social Affairs and proposed that genetic discrimination be included in the scope of the ETA. However, this proposal was met with a negative reply.28 Namely, the official in charge of revisions to the ETA stated that the ETA is not meant to cover all possible forms of discrimination, but only to protect minorities. Including genetic discrimination in the scope of the ETA would, according to the official, deviate from the focus of the ETA.

27 Estonian Law of Obligations Act—RT I, 22 March 2018, 4, available in English at https://www. riigiteataja.ee/en/eli/508082018001/consolide. 28 The e-mail exchange took place in June 2017 and is on file with the author.

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This reply is baffling: it reflects an erroneous understanding of the essence of genetic discrimination, and intimates that prohibitions against genetic discrimination are irrelevant to the protection of minorities.

7 Conclusion Estonian law sets out both a general prohibition on genetic discrimination, and specific prohibitions for the employment and insurance contexts. Not only are employers and insurers prohibited from establishing practices or basing decisions on genetic features of (prospective) employees or clients; they are also not allowed to ask for or obtain tissue samples or genetic data. These bans on genetic discrimination are of an absolute nature, with no exceptions. It is arguable that certain exceptions could be justified, for example, in the case of life insurance for applicants with genetic conditions that affect their lifespan. Though the prohibitions on genetic discrimination are explicitly established under Estonian law, the regulatory approach to non-discrimination is fragmented. Namely, the general law for equal treatment (ETA) includes in its scope an exhaustive list of grounds of discrimination that does not include genetic discrimination. As a result, cases of genetic discrimination are not subject to the procedural benefits established under the ETA, most notably the shared burden of proof rule.

References Genetic Alliance (2009) The New York-Mid-Atlantic Consortium for genetic and newborn screening services. Washington (DC). https://www.ncbi.nlm.nih.gov/books/NBK115554/. Accessed 12 Nov 2018 Myers RH (2004) Huntington’s disease genetics. NeuroRx 1(2):255–262 Nõmper A (2001) Geenitestide õiguslikust regulatsioonist. Juridica II/2001:113–123 Orth M, Schwenke C (2011) Age-at-onset in Huntington disease. PLOS Currents. http://currents. plos.org/hd/article/age-at-onset-in-huntington-disease/. Accessed 12 Nov 2018 Scully JL (2004) What is a disease? Disease, disability and their definitions. EMBO Rep 5 (7):650–653

L’utilisation des tests génétiques dans le domaine de l’assurance en droit français et européen : une affaire d’assurance et de politique publique Christian Byk

Résumé L’information susceptible d’être révélée par l’usage des tests génétiques va-t-elle transformer la pratique de l’assurance ? Si les risques que nous portons dans nos gènes viennent à la connaissance de l’assureur, celui-ci estimera-t-il encore que nous sommes assurables et à quel coût ? À l’inverse, protéger de façon excessive l’accès à une information connue ou susceptible de l’être ne créerait-il pas une asymétrie aux dépens des assureurs ? Si la question est si difficile à résoudre, c’est qu’elle dépasse de fait la sphère technique du droit de l’assurance. Elle suppose de définir le rôle social du contrat d’assurance, notamment au regard de la protection de la santé, et d’en déduire une politique législative correspondant aux choix politiques, éthiques et économiques d’une société. C’est à cette réflexion que ce rapport, qui analyse le cadre juridique du droit français dans l’espace européen, invite en mettant en avant, à côté de modèles plus libéraux, une politique interventionniste étatique.

Abstract Will the information likely to be revealed by the use of genetic tests transform the practice of insurance? If the risks we carry in our genes come to the insurer’s knowledge, will the insurer still estimate that we are insurable and at what cost? Conversely, would excessive protection of access to information that is known or likely to be known create asymmetry at the expense of insurers? If the question is so difficult to solve, it is because it goes beyond the technical sphere of insurance law. It involves defining the social role of the insurance contract, particularly with regard to the protection of health, and from this analysis deducing a legislative policy corresponding to the political, ethical and economic choices of a society. It is to this reflection that this report, which analyzes the legal framework of French law in the European area, invites by putting forward, alongside more liberal models, a state interventionist policy.

C. Byk (*) Cour d’appel de Paris (droit des assurances), Paris, France Comité intergouvernemental de bioéthique de l’UNESCO, Paris, France © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_8

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1 Introduction Poser la question des tests génétiques au regard des assurances, c’est à coup sûr évoquer le mariage de l’eau et du feu et susciter dans l’opinion publique un surcroît de crainte face à l’usage de techniques dont les applications séparées n’ont déjà pas toujours bonne presse. Si la rencontre entre les deux techniques parait si sulfureuse, c’est que la première a la vertu de prévoir l’avenir quand la seconde vit de l’incertitude. Dès lors, on peut se demander si la connaissance issue de l’emploi des tests génétiques ne va pas radicalement mettre fin à l’idée même d’assurance. L’effroi qui nous saisit est d’autant plus grand que les risques soumis à ce balancement entre incertitude et prévision concernent la maladie, l’invalidité, la dépendance et le décès, autrement dit des risques inhérents à notre condition humaine et sociale, notamment ceux que le droit des assurances appelle « les accidents de la vie ».1 Ces risques, nous les partageons individuellement, en tant qu’ils nous atteignent différemment selon notre condition physique ou sociale, mais aussi collectivement parce que leur ampleur et la protection, dont nous bénéficions à leur égard, dépendent d’un système politique, économique et social complexe, dont la fragilité nous est apparue avec la « crise » des modèles sociaux et la mondialisation de l’économie.2 Pour savoir jusqu’à quel point les fondements éthiques et juridiques de notre organisation sociale peuvent, le cas échéant, se trouver affectés par cette synergie diabolique des contraires à laquelle participerait l’utilisation des données issues de tests génétiques, il convient, au préalable, de nous interroger sur ce que nous attendons de l’assurance par rapport aux risques évoqués et de quelles politiques nous disposons pour orienter nos choix (Sect. 2). À cet égard, le droit français ne constitue qu’une référence parmi d’autres dans un cadre européen qui, bien que progressant sur le chemin d’une réglementation commune, offre une certaine liberté aux États pour établir celle qui leur paraît la plus appropriée à la protection des données sensibles que sont les informations issues des tests génétiques (Sect. 3).

1

Commercialisés en France depuis le début des années 2000, les contrats « garantie des accidents de la vie » visent à indemniser, selon les règles de droit commun, l’assuré et éventuellement sa famille des dommages corporels résultant des « accidents de la vie » (accidents domestiques, accidents survenus dans le cadre des loisirs, catastrophes naturelles ou technologiques, accidents médicaux, agressions ou attentats). Cette indemnisation vient en complément de ce qui est pris en charge par les régimes de prévoyance (sécurité sociale et complémentaire santé). En 2015, il y avait en France environ 5 millions de contrats couvrant près de 10 millions de personnes. 2 Rosanvallon (1995).

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2 Des politiques publiques en rapport avec des choix de société Les interrogations sur l’utilisation des tests génétiques dans le domaine de l’assurance sont apparues, comme le montre la littérature sur la question, dès les années 1990.3 Cependant, il semble qu’avec la découverte de nouvelles technologies génétiques, qui ont ouvert la voie au développement de la médecine personnalisée,4 nos traits prédictifs génétiques pourraient jouer un grand rôle dans la connaissance du risque en santé et, par conséquent, intéresser les compagnies d’assurances dans leur travail d’évaluation. Ce constat devrait ainsi conduire nos sociétés à mieux comprendre la manière dont évoluent les besoins en matière de protection de la santé et la capacité des systèmes existants à y faire face (Sect. 2.1). Ce n’est qu’à ce prix que des modèles de politique pourront être adaptés ou élaborés afin d’orienter la dynamique des facteurs sociaux, économiques et réglementaires vers de nouveaux équilibres. Et, la question des tests génétiques est une bonne illustration de ce cheminement (Sect. 2.2).

2.1

La sociologie des risques concernés

Elle dépend de la spécificité des données de santé, y inclus les données génétiques, et d’un examen de celles-ci lorsqu’elles sont mises au service d’une plus grande individualisation de la protection en matière de santé.

2.1.1

Les risques liés à la santé : une spécificité multiple

La maladie, l’invalidité, la dépendance et le décès ne sont pas des risques anodins. Ils constituent le cœur même de la protection sociale sanitaire,5 promue par le modèle de l’État providence6 et fondée sur les principes d’égalité d’accès aux soins, de qualité et de solidarité.

3

Argus de l’assurance (2003). Burg (1994), p. 43; Ewald (1999), p. 541; Ewald and Moreau (1994); Fotheringham (1999), pp. 1–6; Hermitte et al. (2000); Lemmens and Austin (2001), pp. 26–37; Lemmens et al. (2004), pp. 1–14; Murray (1997); Otlowski (2000), pp. 193–196; Simon (2003). 4 OPECST (2014). 5 Thuillier (2003). 6 Ewald (1986).

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C’est dire combien leur perception sociale a une valeur hautement symbolique au point où, lorsqu’il est interrogé sur cette question, le citoyen fait de la santé sa première préoccupation.7 Pour autant, les risques liés à la santé subissent également le poids des évolutions. Le vieillissement de la population donne une place plus grande aux maladies chroniques et affecte particulièrement le financement du système de santé.8 Par ailleurs, la démographie médicale9 a un effet direct sur l’égalité d’accès et la qualité des soins, certaines spécialités ou territoires manquant de professionnels en nombre suffisant. La transformation des pratiques,10 le rôle de plus en plus important de la technologie médicale et de la place de l’hôpital ont contribué, par ailleurs, à modifier les attentes des patients, dont la participation au système de santé, comme à l’acte de soins, est désormais prise en compte tant par l’éthique que le droit.11 Pour tout dire, le rôle de la médecine ne se limite plus à traiter un patient, victime d’une maladie ou d’un accident ; il permet aujourd’hui de déplacer les frontières de la vie, offrant à l’individu une maîtrise possible de la procréation, de la sexualité, une vie plus longue et de meilleure qualité et, demain peut-être, via les tests génétiques, une individualisation de son suivi médical. Peut-on alors considérer que cette évolution n’affecte pas la raison d’être de la couverture des risques santé ?

2.1.2

La nouvelle pesée des risques au regard de leur individualisation

Si une évaluation individuelle des risques ne soulève guère d’opposition de principe lorsqu’elle s’inscrit dans le souci d’une recherche d’efficacité des soins pour la personne concernée, il n’en est pas de même lorsqu’il s’agit de la prendre en compte pour aborder le financement de la protection sociale, même limitée à la part de marché dévolue à l’assurance privée. Elle conduit alors à s’interroger pour savoir si une maîtrise financière du risque santé bâtie sur une meilleure connaissance et gestion des risques individuels est susceptible de faire voler en éclats la prise en charge socialisée du risque médical.

Boisselot (2006) and Ministère des finances et des comptes publics, Ministère des affaires sociales et de la santé, Ministère du travail, de l’emploi, de la formation professionnelle et du dialogue social, Direction de la Recherche, des Études, de l’Évaluation et des Statistiques (2016). 8 Direction générale de la santé (2004). 9 Berland (2005). 10 Herzlich and Adam (2007). 11 Revue française des affaires sociales (2017) and Bureau and Hermann-Mesfen (2015). 7

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L’interrogation On peut, en effet, imaginer que le développement de l’usage des tests génétiques permette de prévoir l’occurrence de certaines maladies ou d’établir avec plus de précision le risque encouru pour d’autres. Un suivi personnalisé, combinant actions de prévention et traitement précoce, pourrait ainsi s’avérer doublement bénéfique pour la santé de l’individu et la gestion du système de santé. Ces nouvelles pratiques, qui révéleraient les individus les plus coûteux pour le système, seraient-elles susceptibles d’en affecter les principes de fonctionnement, fondés, comme c’est le cas pour la plupart des pays européens, sur la solidarité ? Autrement dit, une perception individualisée du risque dans un contexte de recherche d’individualisation de la protection sociale, impliquant une meilleure place pour l’assurance privée, ne va-t-elle pas modifier l’équilibre et la philosophie du système de transfert des risques qui a prévalu jusqu’ici ?12 Dans ces conditions, on peut redouter que l’introduction des tests génétiques au profit des assureurs joue le rôle d’un facteur accélérateur de ce changement.

Les hypothèses Qui, des assurances sociales ou de l’assurance privée, va subir le plus fortement cette emprise de l’individualisation ? 1
En théorie, la réponse à cette question ne sera pas la même suivant que les risques en cause sont soumis à un régime de couverture obligatoire ou non. En effet, alors que le premier est exclusivement construit sur la solidarité et le refus de connaître les risques individuels ou collectifs de ses bénéficiaires, le second suppose précisément une évaluation et une sélection des risques. 2
En réalité, les régimes de protection sociale pourraient bien subir de plein fouet les conséquences de cette individualisation, dont les tests génétiques ne sont sans doute qu’un révélateur. Deux raisons mettent en lumière la possible déstabilisation, voire la désintégration pour certains, des régimes de protection sociale. La première est purement comptable et tient à l’augmentation des dépenses de santé susceptible d’être induite par l’essor des tests génétiques.13 Cette misère des moyens est d’ailleurs déjà une réalité dans certains pays. Ainsi, en France, face au constat de précarité du financement des tests génétiques, non remboursés par la caisse d’assurance maladie et qui doivent, en conséquence, être pris en charge par les hôpitaux, les centres de recherche ou les malades, la loi du 9 août 2004 relative à la

12 13

Hériard Dubreuil (2006). Miller et al. (2002), p. l.

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politique de santé publique14 a fait des maladies rares, à 80% d’origine génétique, une priorité. L’un des objectifs fixés par la loi est précisément d’assurer l’équité dans l’accès au diagnostic. Mais cet objectif restera inévitablement ciblé, laissant de côté des diagnostics jugés non encore fiables, voire économiquement peu justifiés. La seconde raison tient à l’évolution des esprits et des politiques qui, tendant à laisser plus d’autonomie aux assurés dans les stratégies de santé, en viendraient à admettre que la totalité du coût de la dépendance liée, par exemple, à la survenance d’une maladie dégénérative ne saurait reposer uniquement sur la solidarité nationale dès lors qu’une grande partie de ce coût est lié à l’aménagement des conditions nécessaires au maintien d’une qualité de vie.15 Dans cette (r)évolution, l’utilisation des tests génétiques a-t-elle déjà la capacité de mettre à bas le système tel qu’il fonctionne encore aujourd’hui ou sa force n’estelle pas largement amplifiée par la perception sociologique que nous avons de la « révolution génétique » appliquée à l’homme, facteur d’attentes comme de peurs sans limite ?16

2.2

Les tests et données génétiques dans le contexte du rôle social de l’assurance

Plus prosaïquement, les tests génétiques constituent-ils de « simples éléments nouveaux » d’une évaluation « classique » du risque assurantiel ou, au contraire, doit-on les considérer comme un facteur favorisant l’exclusion de l’accès au marché de l’assurance et, au regard du rôle social de l’assurance, quelle politique publique adopter à leur égard ? Répondre à cette interrogation et entrevoir les éléments d’une politique publique rendent nécessaire une analyse de la relation complexe entre tests génétiques et assurance.

2.2.1

La relation entre tests génétiques et assurance

L’assurance est un contrat en vertu duquel, en contrepartie d’une prime, une partie s’engage à compenser l’autre d’une perte liée à un préjudice particulier par suite de la survenance de risques désignés. Comme elle vise à minimiser les pertes financières résultant d’événements inattendus, elle implique que la compagnie d’assurance soit en mesure de garantir le risque que de tels événements se produisent et, par

Loi n
2004-806 du 9 août 2004 relative à la politique de santé publique JO n
185 du 11 août 2004, p. 14277. 15 Loones (2005). 16 Mahieu and Assous (2006) and Bagur (2003). 14

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conséquent, crée une obligation pour l’assuré de divulguer les risques connus (conditions préexistantes) ou toute information pertinente potentiellement liée à ces risques.

Le processus de souscription Dans le processus de souscription, les attentes des individus en matière de longévité et de santé sont quantifiées et exprimées sous forme de probabilités statistiques. Habituellement, les assureurs classent les demandeurs en quatre catégories de risque: « standard », « non standard » (la demande est acceptée, mais assortie d’une ou de plusieurs des conditions suivantes: augmentation de la prime, exclusion, période de couverture restreinte et indemnité réduite), « différée » (l’assureur a refusé la proposition d’assurance au moment de la souscription, mais offre au demandeur la possibilité de faire réévaluer sa demande à une date où le facteur de risque devrait avoir diminué avec le temps) ou « refusé ». C’est dans le cadre de cette logique technique que les données génétiques et les tests nécessaires pour y avoir accès entrent en relation avec la pratique de l’assurance, mais seulement certains types de contrats sont concernés.

Les contrats concernés Compte tenu du rôle des systèmes de santé financés par des fonds publics dans la plupart des pays européens et notamment la France, l’influence potentielle de l’utilisation de données génétiques dans la souscription individuelle est limitée dans la pratique à un ensemble de contrats spécifiques : – L’assurance-vie qui prévoit le paiement d’une somme forfaitaire convenue en cas de décès de l’assuré ; – L’assurance invalidité ou protection du revenu qui prévoit que des sommes régulières doivent être versées lorsqu’une personne assurée est incapable de travailler en raison d’une maladie ou d’une blessure ; – L’assurance contre les traumatismes qui prévoit le paiement d’une somme forfaitaire convenue si la personne assurée est diagnostiquée avec une des conditions spécifiées. Ces trois types de contrats sont « garantis renouvelables » : une fois en vigueur, l’assuré n’est pas obligé d’informer la compagnie d’assurance de tout changement de circonstances. – L’assurance maladie et accident : elle est similaire à l’assurance invalidité, mais est offerte par les compagnies d’assurances générales et est renouvelable. Cela signifie que tout changement de circonstances doit être déclaré lors du renouvellement ;

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– L’assurance voyage qui est conçue pour couvrir les coûts et réduire les risques associés à des événements inattendus lors de voyages nationaux ou internationaux. Elle couvre habituellement les assurés dans deux catégories principales : les coûts associés aux frais médicaux et les annulations de voyage. Une fois compris l’apport potentiel des tests génétiques aux besoins de l’assurance et fort des principes de politique qui orientent la protection sociale, nous pouvons alors essayer de voir de quels types de politique nous disposons pour répondre aux objectifs et interrogations essentielles mis en avant dans nos sociétés.

2.2.2

Quelle politique publique pour les tests génétiques en assurance ?

Les exemples de refus d’assurer certains risques aggravés dans le domaine de la santé ne manquent pas.17 L’information sur le risque est donc une donnée clé et particulièrement sensible des enjeux sociaux et humains posés par l’extension souhaitée de la couverture des risques et par leur grande diversité. Dans quelle mesure les tests génétiques, qui apportent une information sur les risques, mais aussi les prédispositions, et qui concernent le futur autant que le présent, contribuentils à fournir cette information, dont on sait qu’en matière d’assurance elle doit être loyale ?18 Faut-il, cependant, dans certaines circonstances, dépasser, voire délaisser, le rôle central de l’information dans la relation assureur-assuré pour y faire prévaloir, au nom d’une égalité absolue, un droit à l’assurance ?19 Mais alors, sur quel mécanisme le fonder pour en garantir tout à la fois la respectabilité éthique, la viabilité économique et la liberté de choix de l’assuré ? Est-il loyal d’utiliser des tests génétiques à des fins d’assurances en santé ? L’assurance, c’est-à-dire la convention par laquelle une partie, l’assuré, sollicite, moyennant paiement d’une prime, la couverture d’un risque par son cocontractant, l’assureur, suppose que ce dernier, pour fixer le montant de la prime, dispose d’informations lui permettant d’évaluer le risque. La loyauté, qui est l’un des fondements de la liberté contractuelle, implique alors que l’assuré lui fournisse ces informations sans rien n’omettre ni retrancher qui puisse fausser l’opinion que l’assureur pourra se faire du risque.20

17

Pour le diabète, cf Hermitte (2000a), p. 20. Hoy and Polborn (2000). 19 Coelho (2007). 20 Cour de cassation 1re civ 22 mai 2002 ; Dalloz (2002), pp. 1956 et s : 18

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Mais, l’outil particulier que constituent les tests génétiques ne risque-t-il pas de porter atteinte à des valeurs sociales prééminentes — la protection de la vie privée, la prohibition de la discrimination dans l’accès aux soins — si son usage se banalise ?21 Réglementé et contraint par des dispositions d’ordre public protectrices de l’assuré, le contrat d’assurance ne justifie-t-il pas un encadrement encore plus rigoureux dans un domaine aussi sensible que la santé ?22 À regarder le droit des pays européens,23 la réponse est certainement positive, mais où se situe alors l’équilibre entre l’obligation de loyauté de l’assuré et la nécessaire protection de ses droits ?

Jusqu’où la sélection du risque est-elle nécessaire ? Au regard du mécanisme de catégorisation des risques, qui semble désormais prévaloir dans le domaine de l’assurance, les tests génétiques sont bien plus puissants que tous les outils de diagnostic du risque existant puisqu’ils permettent, en théorie, d’affiner l’analyse du risque en l’individualisant. Détachée de l’analyse de comportements collectifs, la sélection va pouvoir se fonder sur des données génétiques individuelles ciblant des risques particuliers en matière de santé, ceux les plus coûteux. Dès lors, l’assureur pourra plus aisément déterminer les individus à exclure de l’assurance ou à n’assurer qu’avec une surprime. Cette exclusion, que le droit ne considère pas comme une discrimination parce que la certitude de l’occurrence d’un risque mettrait à néant la logique assurantielle, peut-elle, doit-elle être compensée par des mesures protectrices de l’assuré et lesquelles ? Une première mesure, qui respecte pleinement l’économie du contrat d’assurance, est de n’autoriser la transmission d’informations d’ordre génétique (de façon directe ou indirecte) que si celles-ci ont une incidence réelle et mesurable sur la gestion du risque.24 Autrement dit, si la part de l’influence des gènes reste faible ou indéterminée dans l’occurrence d’une maladie, fût-elle grave, le recours aux tests génétiques perd sa finalité et est éventuellement coûteux. On peut ainsi imaginer déterminer une liste de risques pour lesquels les assureurs s’engageraient

L’assureur n’est pas tenu de cantonner ses interrogations aux seuls éléments caractérisant le risque qu’il est invité à garantir et l’assuré doit répondre sincèrement à toutes les questions posées par l’assureur pour apprécier ce risque, à défaut de quoi il s’expose aux sanctions de l’art. L 113-8 du Code des assurances si, du moins, le manquement à cette obligation a exercé une influence sur l’opinion de l’assureur. 21

Benoit-Browayes and Kaplan (2000), pp. 1 et 24. Boussuge et al. (2002). 23 Bouillong (2000) and Commission européenne (2004). 24 Tel est le sens de la jurisprudence précitée (Cour de cassation 1re civ 22 mai 2002) de la Cour de cassation française qui, s’agissant de l’obligation d’information de l’assuré, ne sanctionne le manquement à cette obligation que pour autant qu’il a pu influer sur l’opinion que l’assureur s’est fait du risque. 22

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ou seraient obligés par la loi à ne pas solliciter d’informations obtenues par le moyen de tests génétiques. Une seconde mesure, sans doute plus contraignante pour l’assureur et qui a déjà été mise en œuvre dans certains pays, consiste à lui interdire de solliciter la réalisation de tests génétiques sans pour autant l’empêcher de demander à l’assuré les informations en sa possession, mais établies à d’autres fins.25 Ainsi seraient pris en compte le caractère particulier des tests génétiques, limitant leur recours à des fins médicales, scientifiques ou judiciaires, et le respect de la prohibition de l’asymétrie de l’information, propre au contrat d’assurance parce que nécessaire pour lutter contre l’anti-sélection. Peut-on aller au-delà et laisser à l’assuré le soin de ne pas livrer des informations qu’il connaît, voire de mentir sur celles-ci parce qu’il s’agit de données d’ordre génétique ? En tout état de cause, et pour diverses raisons que nous allons développer, il existe en Europe une politique législative interventionniste dans laquelle la France, par sa législation fortement prohibitive, constitue un modèle juridiquement assez radical.

3 Des politiques interventionnistes : La position du droit français et le « modèle européen » La prise de conscience de la dimension éthique et politique de l’utilisation des tests génétiques en assurance a très tôt conduit à une émergence du droit international en ce domaine en même temps que certains États, comme la France, affirmaient une volonté forte de donner à leur politique une position interventionniste.

3.1

Les raisons de l’émergence du droit dans une dualité de sources européennes et nationales

Nous avons rappelé les raisons de l’attachement que l’Europe et la France en particulier portent au maintien d’un système de santé fondé sur le principe de solidarité, dernier grand symbole concret de l’État-providence en « crise. » D’autres raisons, non moins cruciales, tiennent à l’image « apaisée » que la communauté scientifique et les pouvoirs publics veulent donner aux citoyens de la génétique et de ses nouveaux et puissants outils. L’ensemble de ces raisons aident à comprendre la double nature du défi posé: il relève à la fois d’une politique industrielle et d’une politique de santé fondée sur des valeurs sociales auxquelles les Français comme les Européens ont marqué leur attachement.

25

Dupuy and Dupuy (2005).

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Préserver l’image de la science et de ses potentialités industrielles

Si les années 1980 ont marqué en Europe le développement d’une politique harmonisée de la recherche biomédicale chez l’homme, dont on peut juger qu’elle a eu globalement un certain succès pour avoir été bien accueillie tant par les chercheurs que par l’opinion,26 le même type de politique menée à partir des années 1990 dans le domaine des biotechnologies a suivi une route chaotique qui n’a pas clos les débats de fond entre des partisans et des opposants aux fortes convictions.27 C’est pour éviter cet écueil que, dès l’origine, la communauté scientifique française, fortement engagée dans le développement de la génomique humaine,28 a tenu à montrer qu’elle partageait avec les citoyens les mêmes valeurs sociales et que la génétique ne devait pas avoir de finalité commerciale, mais se devait de respecter la vie privée de chacun. Dès lors, les assureurs privés, qui jouissent dans l’opinion du même taux de sympathie que les industriels du médicament, constituaient un point de fixation opportun pour mobiliser la réglementation à l’encontre de leurs activités, principalement dans le domaine de la santé, dès lors qu’elles impliqueraient l’utilisation de tests génétiques. Toutefois, il n’est pas certain que l’attitude attentiste et pragmatique qui fut celle des assureurs au début des années 1990 persiste avec les nouvelles techniques de séquençage du génome humain et la plus grande fiabilité et le moindre coût des tests génétiques.

La première période : le projet de décryptage du génome humain Cette période — les années 1990 — est caractérisée par deux attitudes distinctes. Celle des scientifiques et des régulateurs (organisations professionnelles, juristes pouvoirs publics) qui ont rapidement mis l’accent sur la nécessité de réguler les tests génétiques à d’autres fins que scientifiques et médicales sur la base des droits de l’homme. L’autre, celle des assureurs, pragmatiques, a été fondée sur une approche attentiste. Prôner une stricte politique réglementaire s’explique clairement par le fait que les généticiens s’inquiétaient de l’image négative qui serait celle du « Programme Génome Humain » si les données issues de tests génétiques pouvaient être utilisées en dehors du domaine médical alors que les assureurs, en adoptant une attitude attentiste, considéraient principalement que l’incertitude des résultats de ces tests, au demeurant coûteux, ne conduisait pas, en l’état, à changer leurs outils d’évaluation du risque.29

26

Amiel (2003) and Assemblée nationale, Commission des affaires sociales (2017). Néanmoins le décès en 2015 à Rennes d’une personne, d’autres ayant subi des effets indésirables graves, a conduit à analyser de façon approfondie le processus de vigilance des essais cliniques. Autume and Duhamel (2016). 27 Byk (2002), pp. 339–370; Joly and Marris (2003), pp. 195–206; Oury (2006). 28 Picard and Gay (2017). 29 Comme l’a souligné Marie-Angèle Hermitte dans son étude (Hermitte 2000b, p. 1233) :

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C’est pourquoi en 1994, la Fédération Française des Sociétés d’Assurances a annoncé que, pour une période de cinq ans coïncidant avec la période de cinq ans à l’expiration de laquelle la loi sur la bioéthique (loi n
94-653 du 29 juillet 1994) devait être révisée, ses membres n’utiliseraient pas l’information génétique pour déterminer l’assurabilité des demandeurs. Ce moratoire a ensuite été prolongé pour une nouvelle période de cinq ans. En tout état de cause, le point commun entre ces deux attitudes a été un manque (provisoire ?) d’intérêt pour l’utilisation des tests génétiques dans le domaine de l’assurance.

La seconde période : le temps de la médecine personnalisée C’est l’entrée, à compter de la décennie 2000, dans l’époque de la médecine personnalisée,30 parfois appelée médecine génétique.31 Il s’agit de classer, comprendre, traiter et prévenir les maladies en fonction des profils biologiques et environnementaux uniques des individus. Cela se fait par un dépistage génétique pour la détection précoce des maladies, qui peuvent ensuite être traitées efficacement sur la base de la constitution génétique unique du patient, les antécédents familiaux et la prédisposition génétique. Bien que le concept de médecine personnalisée ne soit pas nouveau et puisse être critiquable,32 le séquençage (cartographie de la localisation des gènes et recherche de l’ordre des bases dans l’ADN) du génome humain ouvre la voie à de nouvelles pratiques de dépistage et de traitement.33 Or, les tests génétiques, qui fournissent des informations sur le risque de développer une condition particulière, peuvent être une épée à double tranchant quand il s’agit de demander une assurance individuelle. Par exemple, les tests génétiques prédictifs posent des questions fondamentales pour l’assurance invalidité, une ressource cruciale pour répondre aux besoins de base quand l’incapacité interdit tout revenu du travail.34 Toutefois, l’espoir de mieux servir les patients, mais aussi le système de santé en améliorant la qualité des tests et des traitements et en réduisant le nombre d’actes

de nombreux tests qui pourraient intéresser les scientifiques n’intéresseront pas les assureurs. Ils doivent être totalement techniquement fiables et pertinents en ce qui concerne le calcul du risque (...) En d’autres termes, pour avoir un impact économique, le résultat du test doit établir une distinction suffisante entre l’individu et le reste de la population. 30

Boyer-Bévière and Belrhomari (2015). Selon David Levine, expert canadien en gestion de la santé, l’expression « médecine de précision » serait plus conforme à la pratique clinique. Cf Desjardins Assurances (2015). 32 Billaud and Guchet (2015), pp. 797–803. 33 André and Dogan (2015), pp. 27–32. 34 Wolf and Kahn (2007), pp. 6–32. 31

L’utilisation des tests génétiques dans le domaine de l’assurance en droit. . .

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médicaux inutiles35 transforme les tests génétiques d’un outil de recherche en un puissant outil du traitement médical.

3.1.2

Un défi industriel, éthique et juridique

Le défi industriel et économique En France, comme dans les autres pays européens, le défi est grand pour l’industrie pharmaceutique.36 La révolution potentielle apportée par la médecine personnalisée est souvent perçue comme un moyen de développer de nouvelles stratégies et alliances afin d’améliorer la rentabilité. Dans cette nouvelle compétition, en 2016, dans le cadre du « projet génomique », le gouvernement français a annoncé la création de 12 plateformes de séquençage du génome à grande vitesse37 et plusieurs hôpitaux soumettent déjà des données de leurs patients à des algorithmes qui caractérisent les altérations génomiques.

Le défi éthique et juridique Concernant les enjeux éthiques et juridiques, les chercheurs scientifiques, craignant les conséquences de cette concurrence au niveau international, ont estimé qu’« il [était] essentiel que la protection de ces données génétiques sensibles reste une affaire nationale. »38 Dans cette logique, ils ont tenté d’alerter l’opinion publique contre une mauvaise utilisation commerciale des tests génétiques et ont dénoncé la « publicité mensongère » que représente cette « offre. »39 La voie était ainsi ouverte à la mise en place d’un corpus juridique conjuguant les apports et influences réciproques du droit européen et des droits nationaux et tout particulièrement du droit français.

35

de Kervasdoué (2015), pp. 40–42. Bonnefoi (2017), p. 136. 37 France Génomique rassemble et mutualise les ressources des principales plateformes françaises de génomique et de bio-informatique. Voir https://www.france-genomique.org/spip/. 38 Genopole–Amgen (2015). 39 Déclaration adoptée par dix sociétés médicales le 18 mars 2010. Le texte se termine par un avertissement : 36

Si les études à l’échelle du génome apportent une contribution essentielle à la connaissance scientifique, l’utilisation exclusive de l’information qui en résulte n’a pas de sens pour la santé : elle conduit à une perception erronée du risque pour les individus. Alibi pour la prédiction du risque individuel pour les maladies multifactorielles à partir de la seule information génomique Il est important d’informer avec rigueur et clarté sur l’évolution des connaissances en génomique et débattre des limites de leurs applications.

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La construction d’un corpus juridique européen et la proximité du droit français avec celui-ci

Il ressort des études de droit comparé40 que diverses approches existent concernant les politiques de réglementation publique. Si la plupart d’entre elles sont fondées sur le respect des droits de l’homme, en particulier du principe de non-discrimination, une certaine diversité existe néanmoins en termes d’application. On peut citer « le modèle thérapeutique, » qui limite les tests génétiques à des fins médicales, « le modèle fondé sur l’interdiction, » qui empêche les assureurs d’utiliser des tests et des données génétiques en toutes circonstances, « le modèle de contrôle de qualité, » qui incite les assureurs à tester et développer des outils actuariels adéquats, le moratoire volontairement adopté par les assureurs en temps de réflexion, l’approche proportionnelle, qui n’oblige pas le futur assuré à divulguer ses données génétiques lorsque le montant assuré est inférieur à une certaine somme et, enfin, le « statu quo ». En outre, même lorsqu’elles favorisent une orientation spécifique, chaque politique peut inclure des caractéristiques empruntées à d’autres modèles. Dans le domaine normatif, les choix politiques européens et français sont assez proches et, d’une certaine manière, imbriqués. L’Europe et la France s’inscrivent dans une approche protectrice des droits de l’homme et donc relativement restrictive aux dépens des assureurs, le droit français étant marqué par une position nettement radicale, l’État imposant un principe absolu de non-utilisation des tests génétiques à des fins d’assurance.

3.2.1

Le droit européen

Le droit européen offre dans la sphère régionale une approche concrète et effective de principes proclamés par le droit international.

La référence au droit international Au regard du rôle moteur joué par l’UNESCO dans l’élaboration des premières normes en ce domaine,41 on peut dire que le droit applicable aux tests génétiques est un droit nettement inspiré par le droit international. Ainsi, la Déclaration internationale sur la protection des données génétiques énonce-t-elle que : Les données génétiques humaines, les données protéomiques humaines et les échantillons biologiques associés à une personne identifiable ne devraient pas être communiqués ni rendus accessibles à des tiers, en particulier des employeurs, des compagnies d’assurance, des établissements d’enseignement ou la famille, si ce n’est pour un motif d’intérêt public 40 41

Godard et al. (2003), pp. 123–142; Lemmens et al. (2004), pp. 1–14; Lanctôt (2007), pp. 13–54. Byk (1998), pp. 675–695; Yusuf (2007).

L’utilisation des tests génétiques dans le domaine de l’assurance en droit. . .

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important dans des cas restrictivement prévus par le droit interne en conformité avec le droit international des droits de l’homme, ou encore sous réserve du consentement préalable, libre, éclairé et exprès de la personne concernée, à condition que ce consentement soit conforme au droit interne et au droit international des droits de l’homme.42

Mais, ce texte n’ayant pas valeur juridique contraignante, il convient de rechercher celle-ci dans le droit européen.

Le droit européen Il se partage entre le biodroit élaboré par le Conseil de l’Europe43 et l’application par le droit communautaire des assurances des règles de principe protectrices de l’individu telles que reconnues et mises en œuvre dans le cadre de l’Union européenne (UE).44 1
Le droit issu du Conseil de l’Europe C’est en 1992 que le Conseil de l’Europe45 a abordé pour la première fois la question des tests génétiques en adoptant la Recommandation (92) 3, dont le principe 4 (Égalité d’accès-non-discrimination) énonce que : i. Il doit y avoir égalité d’accès aux tests génétiques, sans considération d’ordre financier et sans condition préalable concernant d’éventuels choix personnels. ii. Aucune condition ne peut être liée à l’acceptation ou à la soumission à des tests génétiques. iii. La vente au public de tests visant à diagnostiquer des maladies génétiques ou une prédisposition à de telles maladies, ainsi que de tests visant à identifier des porteurs de telles maladies, ne devrait être autorisée que dans des conditions strictes, déterminées par les législations nationales.46

42

UNESCO, Déclaration internationale sur les données génétiques humaines, http://www.unesco. org/new/fr/social-and-human-sciences/themes/bioethics/human-genetic-data/, art 14 b. 43 Bélanger (2004), pp. 73–87. 44 L’arrêt de principe portant sur la non-discrimination – en l’espèce limitée aux femmes – en matière d’assurance est: Arrêt de la Cour (Grande Chambre) du 1er mars 2011, Association belge des consommateurs Test-Achats ASBL et autres c Conseil des ministres, C-236/09, 2011 I-00773. 45 Pour mémoire, le Conseil de l’Europe est une organisation intergouvernementale regroupant, en 2018, 47 États membres, dont les 28 États membres de l’Union européenne. Créé par le traité de Londres du 5 mai 1949, il apparaît comme l’organisation des États attachés à la démocratie libérale et au pluralisme politique. Ses objectifs principaux sont de défendre les droits de l’homme et la prééminence du droit, rechercher des solutions aux problèmes de société, développer la stabilité démocratique en Europe et favoriser la prise de conscience et la mise en valeur de l’identité culturelle de l’Europe et de sa diversité. Il est distinct du Conseil européen qui est une institution de l’Union européenne réunissant les chefs d’États et de gouvernements des États membres. 46 Recommandation R (92)3 sur les tests et le dépistage génétique à des fins médicales (10 février 1992), https://wcd.coe.int/com.instranet.InstraServlet?command¼com.instranet.CmdBlobGet& InstranetImage¼573835&SecMode¼1&DocId¼601432&Usage¼2.

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Premier instrument contraignant en droit international dans le domaine de la bioéthique, la Convention d’Oviedo47 reprend cette prohibition de la discrimination,48 mais se fait également plus précise à l’égard des assurances puisque son article 1249 interdit de réaliser des tests génétiques à des fins autres que médicales « dans la mesure où les tests prédictifs, dans le cas des contrats d’assurance privés ou d’emploi, ne tendant pas à un objectif sanitaire, ils comportent une atteinte disproportionnée aux droits de l’individu ou au respect de la vie privée. »50 La mise en œuvre de ces deux articles trouve quelques indications dans le droit dérivé. En premier lieu et bien que limité aux objectifs de santé, le Protocole additionnel de 2008 à la Convention — ce protocole est entré en vigueur le 1er juillet 2018 — relatif aux tests génétiques à des fins médicales,51 a renforcé le principe de non-discrimination en y ajoutant celui de la non-stigmatisation.52 Mais, quoique venant en second lieu, c’est surtout la « Recommandation CM/Rec (2016)8 du Comité des Ministres aux États membres sur le traitement des données à caractère personnel relatives à la santé à des fins d’assurance, y compris les données résultant de tests génétiques (26 octobre 2016) »53 qui constitue un véritable texte d’application de l’interdiction énoncée à l’article 12 de la Convention. Elle confirme, en effet, qu’un assureur n’est pas en droit de demander la réalisation d’un test génétique prédictif comme une condition préalable à la conclusion ou à la

47 48

Byk (2001), pp. 47–70. Article 11 (non-discrimination) : Toute forme de discrimination à l’encontre d’une personne en raison de son patrimoine génétique est interdite.

49

Article 12 (tests génétiques prédictifs) : Il ne pourra être procédé à des tests prédictifs de maladies génétiques ou permettant soit d’identifier le sujet comme porteur d’un gène responsable d’une maladie soit de détecter une prédisposition ou une susceptibilité génétique à une maladie qu’à des fins médicales ou de recherche médicale, et sous réserve d’un conseil génétique approprié.

50

Convention pour la protection des droits de l’Homme et de la dignité humaine à l’égard des applications de la biologie et de la médecine, adoptée le 4 avril 1997, entrée en vigueur le 1er décembre 1999, STCE n
164, rapport explicatif, para 88. 51 Protocole additionnel à la Convention sur les Droits de l’Homme et la biomédecine relatif aux tests génétiques à des fins médicales, adopté le 27 novembre 2008, entré en vigueur le 1er juillet 2018, STCE n
203. 52 Article 4 (non-discrimination et non-stigmatisation): 1
Toute forme de discrimination à l’encontre d’une personne, en tant qu’individu ou en tant que membre d’un groupe, en raison de son patrimoine génétique, est interdite. 2
Des mesures appropriées sont prises en vue de prévenir la stigmatisation de personnes ou de groupes en relation avec des caractéristiques génétiques. 53

Voir https://wcd.coe.int/ViewDoc.jsp?p¼&Ref¼CM/Rec(2016)3&Language¼lanFrench&Ver¼ original&Site¼CM&BackColorInternet¼C3C3C3&BackColorIntranet¼EDB021&BackColorLogg ed¼F5D383&direct¼true.

L’utilisation des tests génétiques dans le domaine de l’assurance en droit. . .

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modification d’un contrat d’assurance et qu’il ne peut non plus refuser la conclusion ou la modification d’un contrat au motif que le candidat à l’assurance ne s’est pas prêté au test. Toutefois, elle établit une exception à ce principe pour les données préexistantes, permettant, lorsque la loi nationale le prévoit spécifiquement, l’autorisation de leur traitement après une évaluation indépendante du respect des critères de finalité, qualité, validité, prédictibilité et proportionnalité, par type de test utilisé et par rapport à un risque particulier à couvrir. Cette exception est elle-même l’objet d’une exception s’agissant des données existantes résultant de tests génétiques effectués sur des membres de la famille de l’assuré(e), dont le traitement reste ainsi interdit.54 Enfin, abordant les questions de bioéthique par ricochet via le contrôle qu’elle exerce sur l’application de la Convention européenne des droits de l’homme, la Cour européenne des droits de l’homme a eu l’occasion de se prononcer dans une affaire55 où les requérants alléguaient avoir fait l’objet d’une discrimination. La Cour a cependant estimé qu’il n’existait en l’espèce aucune discrimination.56 2
Le droit de l’Union européenne La Charte des droits fondamentaux de l’UE,57 proclamée en 2000 et qui est devenue juridiquement contraignante pour l’UE avec l’entrée en vigueur du Traité de Lisbonne, en décembre 2009, inclut un article 21 relatif à la non-discrimination, dont le paragraphe 1 stipule que: « [e]st interdite, toute discrimination fondée notamment sur le sexe, la race, la couleur, les origines ethniques ou sociales, les caractéristiques génétiques, la langue, la religion ou les convictions, les opinions politiques ou toute autre opinion, l’appartenance à une minorité nationale, la fortune, la naissance, un handicap, l’âge ou l’orientation sexuelle. » Par ailleurs, le Règlement (UE) 2016/679 du 27 avril 2016 relatif à la protection des personnes physiques à l’égard du traitement des données à caractère personnel et à la libre circulation de ces données58 dispose qu’en principe, le « traitement (...) de

Rapport explicatif, paras 15 – 17, https://search.coe.int/cm/Pages/result_details.aspx? ObjectId¼090000168069c49e. 55 CEDH, Costa et Pavan c Italie, 28 août 2012, requête n
54270/100. 56 CEDH, Costa et Pavan c Italie, 28 août 2012, requête n
54270/100, para 76 : 54

Dans le cas d’espèce, la Cour constate qu’en matière d’accès au D.P.I., les couples dont l’homme est affecté par des maladies virales transmissibles sexuellement ne sont pas traités de manière différente par rapport aux requérants, l’interdiction d’accéder au diagnostic en question touchant toute catégorie de personnes. Cette partie de la requête est donc manifestement mal fondée et doit être rejetée au sens de l’article 35 §§3 et 4 de la Convention. 57 Charte des droits fondamentaux de l’Union européenne, version consolidée 2012, JOUE C 326/02, 26 octobre 2016. 58 Règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016 relatif à la protection des personnes physiques à l’égard du traitement des données à caractère personnel et à la libre circulation de ces données, et abrogeant la directive 95/46/CE, JOUE 119/1, 4 mai 2016.

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données génétiques59 dans le but d’identifier de manière unique une personne physique est interdit. »60 Bien qu’une série d’exceptions soit énumérée au paragraphe 2 de l’article 9, y compris en matière de santé (point h), les paragraphes 3 et 4 indiquent clairement que: 3. Les données à caractère personnel visées au paragraphe 1 peuvent faire l’objet d’un traitement aux fins prévues au paragraphe 2, point h), si ces données sont traitées par un professionnel de la santé soumis à une obligation de secret professionnel conformément au droit de l’Union, au droit d’un État membre ou aux règles arrêtées par les organismes nationaux compétents, ou sous sa responsabilité, ou par une autre personne également soumise à une obligation de secret conformément au droit de l’Union ou au droit d’un État membre ou aux règles arrêtées par les organismes nationaux compétents. 4. Les États membres peuvent maintenir ou introduire des conditions supplémentaires, y compris des limitations, en ce qui concerne le traitement des données génétiques, des données biométriques ou des données concernant la santé.

Quant à la jurisprudence de la Cour de justice de l’Union, on relève un cas en lien avec l’assurance et la discrimination, mais il concerne l’égalité de traitement entre hommes et femmes et non la génétique et la discrimination. Dans cette affaire,61 la Grande Chambre de la Cour a décidé que « l’article 5, paragraphe 2, de la directive 2004/113, qui permet aux États membres concernés de maintenir sans limitation temporelle une dérogation à la règle des primes et avantages unisexes, va à l’encontre de la réalisation de l’objectif de l’égalité de traitement entre hommes et femmes, qui est l’objectif de la directive et est incompatible avec les articles 21 et 23 de la Charte des droits fondamentaux de l’Union européenne. Cette disposition doit donc être considérée comme invalide à l’expiration d’une période transitoire appropriée. »

Conformément à son article 99(1), la date d’entrée en vigueur du règlement a été fixée au 25 mai 2018. Voir http://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri¼CELEX:32016R0679& from¼FRdd. 59 L’article 4(13) définit les « données génétiques » comme : les données à caractère personnel relatives aux caractéristiques génétiques héréditaires ou acquises d’une personne physique qui donnent des informations uniques sur la physiologie ou l’état de santé de cette personne physique et qui résultent, notamment, d’une analyse d’un échantillon biologique de la personne physique en question. 60

Règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016 relatif à la protection des personnes physiques à l’égard du traitement des données à caractère personnel et à la libre circulation de ces données, et abrogeant la directive 95/46/CE, JOUE 119/1, 4 mai 2016, Article 9.1. 61 Arrêt de la Cour (Grande Chambre) du 1er mars 2011, Association belge des consommateurs Test-Achats ASBL et autres c Conseil des ministres, C-236/09, 2011 I-00773.

L’utilisation des tests génétiques dans le domaine de l’assurance en droit. . .

3.2.2

211

L’approche interventionniste française

La France est sans doute l’un des pays qui, avec la Suisse,62 possèdent les mécanismes les plus développés où la défense de l’intérêt général est imposée au secteur privé. Les contraintes législatives à l’utilisation des tests génétiques y sont conformes à la tradition politique interventionniste de l’État, bien que cela aille à l’encontre de la libéralisation progressive du secteur des assurances et des efforts des assureurs pour diversifier leurs produits. Cette tradition explique principalement l’approche réglementaire forte choisie en France, mais cependant pas l’interdiction absolue d’utiliser des tests génétiques à des fins d’assurance, qui est beaucoup plus liée à l’influence de la communauté scientifique sur le législateur. Comme nous l’avons rappelé, c’est la recherche d’une légitimité éthique qui doit être considérée comme l’aspect substantiel de la politique française d’interdiction. Elle est liée à la considération que les données de santé et les données génétiques en particulier, ne devraient pas être utilisées à des fins commerciales. L’interdiction absolue d’utiliser des tests génétiques à des fins d’assurance Cette interdiction repose sur l’idée que les données génétiques ont une spécificité qui les différencie des autres données de santé. 1
La spécificité des données génétiques Cette spécificité découle des textes internationaux précités63 et notamment de la Déclaration internationale sur les données génétiques humaines.64 Ainsi, le 6e considérant de la Déclaration est rédigé comme suit : Reconnaissant également que les données génétiques humaines ont un statut particulier en raison de leur caractère sensible, car elles peuvent être prédictives de prédispositions génétiques concernant des individus et que la prédictibilité peut être plus forte que évaluée au moment de la dérivation des données ; ils peuvent avoir un impact significatif sur la famille, y compris la descendance, s’étendre sur des générations et, dans certains cas, sur l’ensemble du groupe ; ils peuvent contenir des informations dont la signification n’est pas nécessairement connue au moment de la collecte des échantillons biologiques ; et ils peuvent avoir une signification culturelle pour des personnes ou des groupes.

Plus spécifiquement, l’article 4 de la Déclaration définit la spécificité des données génétiques comme suit : Article 4: Spécificité

62

Loi fédérale sur l’analyse génétique du 8 octobre 2004, https://www.admin.ch/opc/fr/classified-compilation/20011087/index.html. 63 de Lamberterie (2004). 64 UNESCO, Déclaration internationale sur les données génétiques humaines, http://www.unesco. org/new/fr/social-and-human-sciences/themes/bioethics/human-genetic-data/.

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(a) La spécificité des données génétiques humaines tient au fait: (i) qu’elles peuvent indiquer des prédispositions génétiques concernant des individus ; (ii) qu’elles peuvent avoir une incidence significative sur la famille, y compris la descendance, sur plusieurs générations, et dans certains cas sur l’ensemble du groupe auquel appartient la personne concernée ; (iii) qu’elles peuvent contenir des informations dont l’importance n’est pas nécessairement connue au moment où les échantillons biologiques sont collectés ; (iv) qu’elles peuvent revêtir une importance culturelle pour des personnes ou des groupes. (b) Il faut accorder l’attention qui convient au caractère sensible des données génétiques humaines et assurer un niveau de protection approprié à ces données ainsi qu’aux échantillons biologiques.

En outre, la notion de spécificité est soutenue par la doctrine juridique et repose sur l’idée que les données génétiques sont la source de risques importants pour la protection de la vie privée, car elles ont une capacité prédictive et révèlent des informations non seulement sur l’individu testé, mais aussi sur sa famille : les données génétiques se distinguent sur plusieurs points des données de santé traditionnelles : elles ne sont pas uniquement personnelles, elles ont un pouvoir prédictif. Elles ne concernent pas que l’individu déterminé sur qui on a fait le prélèvement biologique mais aussi les proches, la descendance, le groupe ethnique auquel il peut appartenir. (. . .) Leur spécificité peut aussi justifier un régime particulier qui prend en compte la nature des risques consécutifs aux différentes finalités poursuivies : identification d’une personne à travers ses empreintes génétiques ou bien étude des caractéristiques génétiques d’une personne à des fins médicales ou de recherche scientifique. Ce seront donc ces différentes finalités qui nous serviront de fil conducteur pour analyser à travers les règles du droit positif quelques-uns des enjeux éthiques et juridiques qui encadrent l’accès à l’information véhiculée par les données génétiques.65

2
Le champ de l’interdiction Le paradoxe français réside dans le choix d’une interdiction absolue d’utiliser des tests génétiques à des fins d’assurance, mais dans l’admission d’alternatives « classiques » pour y échapper. – De l’assurance comme exception à la sanction de la discrimination... Le nouveau Code pénal de 1994 comportait deux articles: l’article 225-1 stipulant que toute distinction fondée sur la santé ou le handicap serait considérée comme une discrimination alors que l’article 225-3 1
exonérait les activités d’assurance pour les « discriminations fondées sur l’état de santé, lorsqu’elles consistent en des opérations ayant pour objet la prévention et la couverture du risque de décès, des risques portant atteinte à l’intégrité physique de la personne ou des risques d’incapacité de travail ou d’invalidité ».

65

de Lamberterie (2004).

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Dans le même temps, la première loi sur la bioéthique66 a introduit le nouvel article 16-10 du Code civil stipulant que « l’examen des caractéristiques génétiques d’une personne ne peut être entrepris que pour la recherche médicale ou scientifique. » Mais, ce texte était muet ou ambigu quant à la possibilité d’utiliser à des fins d’assurance les données obtenues pour la recherche médicale ou scientifique. – . . . à l’exception de l’exception au profit des tests génétiques prédictifs Souhaitant se conformer à l’avis adopté en 1995 par le Comité consultatif national d’éthique,67 soutenu par les organisations médicales et le public, selon lequel la génétique avait des caractéristiques spécifiques, le législateur a finalement incorporé dans la Loi de 2002 sur les droits des patients68 une disposition interdisant également l’utilisation à des fins d’assurance de données génétiques initialement collectées à des fins médicales et scientifiques. C’est le nouvel article L. 1141-1 du Code de la santé publique ainsi rédigé : Les entreprises et organismes qui proposent une garantie des risques d’invalidité ou de décès ne doivent pas tenir compte des résultats de l’examen des caractéristiques génétiques d’une personne demandant à bénéficier de cette garantie, même si ceux-ci leur sont transmis par la personne concernée ou avec son accord. En outre, ils ne peuvent poser aucune question relative aux tests génétiques et à leurs résultats ni demander à une personne de se soumettre à des tests génétiques avant que ne soit conclu le contrat et pendant toute la durée de celui-ci.

En conséquence, la disposition du Code pénal réprimant la discrimination a également été modifiée pour inclure dans l’article 225-3 1
une exception à l’exception « lorsque [les discriminations] se fondent sur la prise en compte de tests génétiques prédictifs ayant pour objet une maladie qui n’est pas encore déclarée ou une prédisposition génétique à une maladie. » 3
Quels sont les contrats et les informations concernés ? Il s’agit des contrats d’assurance décès, des contrats complémentaires au système de protection sociale obligatoire et couvrant la maladie, l’invalidité, la dépendance et la perte de revenus du travail, des contrats couvrant l’invalidité et le décès et constituant la condition ou l’accessoire d’un contrat de crédit. – L’information concernée L’interdiction s’applique à toute information résultant d’un test génétique, que le test ait été réalisé avant la formation du contrat, au moment de sa souscription ou pendant la durée de son exécution. Le test peut avoir été effectué soit à l’initiative de l’assuré, soit à la suite d’une demande implicite ou explicite de l’assureur. Mais, l’exception à l’exemption ne s’applique pas aux données relatives aux paramètres biologiques, aux symptômes cliniquement reconnus, ou aux résultats de tests laboratoires non génétiques ainsi qu’aux antécédents personnels ou familiaux.

66

Article 5 de la loi 94-653 du 29 juillet 1994, JO du 30 juillet 1994. CCNE (1995). 68 Article 98 de la loi 2002-303 du 4 mars 2002, JO du 5 mars 2002. 67

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Cela signifie que l’interdiction est limitée à l’analyse des caractéristiques génétiques de la personne telles que définies aux articles 16-10 du Code civil et R 1131-2 du Code de la santé publique.69 La jurisprudence, qui révèle cependant un nombre très limité d’affaires pour lesquelles le juge a dû prendre en compte l’aspect génétique d’une maladie, est, soit peu significative, soit conforme à cette interprétation. Ainsi, dans une première affaire, la relation avec la discrimination génétique n’était qu’indirecte. Le juge a noté dans son raisonnement que « le financement [du projet] n’a pu être achevé en raison des dernières informations fournies par Gérard A. concernant une maladie génétique l’affectant, qui a fait obstacle à l’établissement d’une police d’assurance-vie sur sa tête. »70 Dans un deuxième cas, le titulaire d’une police d’assurance-vie avait été affecté par une maladie génétique et la question soulevée devant les tribunaux était de savoir si une telle maladie pouvait remettre en question la validité de la désignation du bénéficiaire du contrat. Cependant, la cour n’a pas tenu compte de ce point en jugeant que « peu importe que la maladie soit chronique ou accidentelle et que son origine soit purement psychique ou physiologique, ou génétiquement apparentée. L’important est que la déficience mentale soit suffisamment sévère pour écarter le discernement. »71 Dans un autre cas, le plus pertinent, le juge a annulé le contrat d’assurance au motif que la personne n’avait pas révélé une maladie connue, qui était en fait une maladie génétique. Observant que « l’alcoolisme est défini comme une maladie chronique primaire avec des facteurs génétiques, psychosociaux et environnementaux influençant son développement et ses manifestations, » la cour a estimé que M. X. ne pouvait pas répondre négativement à la question ‘Avez-vous eu des maladies ? Avez-vous été hospitalisé ?’, parce qu’il avait souffert d’alcoolisme avant 1994 [et] qu’il avait une connaissance personnelle de cette maladie (...) du fait des antécédents familiaux, cette information lui étant fournie durant son séjour (à la clinique).72

Comme l’illustre ce dernier cas, la loi interdit l’utilisation de tests génétiques et des données ou conclusions dérivant de ces tests à des fins d’assurance, car

69

Articles 16-10 du Code Civil et R.1131-2 du Code de la Santé Publique : Constituent des analyses aux fins de détermination des caractéristiques génétiques d’une personne ou de son identification par empreintes génétiques à des fins médicales : 1
Les analyses de cytogénétique, y compris les analyses de cytogénétique moléculaire ; 2
Les analyses de génétique moléculaire ; 3
Toute autre analyse de biologie médicale prescrite dans l’intention d’obtenir des informations pour la détermination des caractéristiques génétiques d’une personne équivalentes à celles obtenues par les analyses mentionnées aux 1
et 2
ci-dessus. Ces analyses sont récapitulées dans un arrêté du ministre chargé de la santé pris après avis de l’Agence de la biomédecine.

Cour d’appel de Montpellier, sect 2, 20 mai 2008, n
07/04456. Cour d’appel de Riom, 1ère section, 26 mai 2011, n
10/00873. 72 Cour d’appel de Paris, sect 2–5,14 octobre 2014, n
12/00849. 70 71

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l’information génétique est considérée comme très sensible. Mais la loi ne renonce pas à l’obligation faite au souscripteur de divulguer une maladie qui peut se révéler avoir une dimension génétique si l’assureur utilise d’autres types de tests que génétiques et impose au souscripteur de répondre à un questionnaire qui n’implique pas de dévoiler des informations découlant de tests génétiques. 4
Que signifie cette approche ? Premièrement, elle nous fait prendre conscience du rôle social des contrats d’assurance dans le système de protection sociale français, un rôle beaucoup plus important que celui officiellement reconnu. En second lieu, elle pose la question de la nature de l’information génétique et des raisons pour lesquelles on estime en France qu’il y a un risque accru à permettre aux assureurs d’y avoir accès et qu’en conséquence, il est nécessaire de la réglementer avec un régime spécifique et rigoureux. Dans son étude, Marie-Angèle Hermitte s’interroge : Un outil technique peut-il être isolé en tant que tel dans la sphère médicale (...) [et] quelles seraient les conséquences d’une telle décision pour l’économie du contrat d’assurance ? (...) Si les contrats d’assurance-vie sont considérés comme des outils sociaux légitimes à côté de la sécurité sociale, dont ils sont bien distincts, quelle est leur fonction dans la société ? Le contrat d’assurance est-il un simple confort ou fait-il partie des biens premiers auxquels chacun doit avoir accès ? (. . .) Il faudra surtout se poser la question de savoir pourquoi le contrat d’assurance a été qualifié de contrat de bonne foi, impliquant par nature que les deux parties disposent du même niveau d’information sur le risque. Entre les mains de l’assureur, le test génétique n’est-il qu’un outil de plus venant s’insérer entre le questionnaire de santé, les tests biologiques classiques et les radios, est-il d’une nature plus dangereuse, ce qui impliquerait un régime juridique distinct ?73

La réponse à cette question repose clairement sur l’autre aspect de la politique législative française qui utilise un cadre d’assurance pour couvrir les risques aggravés.

Les efforts contractuels pour assurer les risques aggravés de santé Nous devons être clairs. La décision d’établir une politique visant à faciliter l’accès à l’assurance pour les personnes présentant des risques aggravés n’est pas directement liée aux tests génétiques. Elle est principalement le résultat d’une lutte contre la discrimination à laquelle ont été confrontées les personnes infectées par le VIH alors qu’elles n’avaient pas encore développé les symptômes de la maladie. Néanmoins, par ricochet, elle concerne aussi les personnes présentant des risques génétiques ainsi que les personnes atteintes, par exemple, d’un cancer en rémission. 1
Un premier accord (1991) entre le gouvernement et les professionnels de l’assurance a permis d’améliorer le traitement des données médicales et l’assurance décès pour les prêts immobiliers, mais il s’est limité aux personnes

73

Hermitte (2000b), p. 1233.

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vivant avec le VIH. Un deuxième accord, la Convention Belorgey,74 a été signé en 2001 entre le gouvernement, les professionnels, les associations de consommateurs et les associations représentant les personnes malades ou handicapées. Il a étendu le système à d’autres pathologies, établi le principe d’une analyse à trois niveaux et mis en place un code de conduite. 2
La loi de 2002 sur les droits des patients a imposé une nouvelle convention : la convention AERAS (« s’Assurer et Emprunter avec un Risque Aggravé de Santé, » « contracter une assurance avec risque aggravé pour la santé ») signée en 2006.75 Elle couvre les risques d’invalidité et de décès, crée un dispositif de plafonnement des primes d’assurance, renforce les facilités offertes dans le cadre des procédures de demande de prêt et met en place un comité de médiation. En cas de refus, les demandes sont soumises à un examen à plusieurs niveaux : par la compagnie d’assurance sélectionnée par la banque, par le service médical d’un assureur non lié à la banque, par des experts médicaux d’un groupe d’assurance collective. La loi de 2007 sur l’accès au crédit pour les personnes présentant des risques aggravés pour la santé a donné une reconnaissance légale à ce mécanisme conventionnel.76 Une convention AERAS rénovée (2011) a créé une couverture d’assurance invalidité spécifique et des améliorations ont également été adoptées dans le domaine de l’information des emprunteurs. Enfin, un avenant à la convention a été signé en 2015.77 Il introduit le « droit à l’oubli. » Les anciens patients atteints de cancer ont la possibilité, après une certaine période de rémission, de ne pas déclarer la maladie lors de la conclusion d’un contrat d’assurance-prêt et, par conséquent, aucune prime supplémentaire ne s’appliquera en raison de leur cancer. Une grille de référence a été élaborée pour répertorier les maladies (cancers et autres pathologies, notamment chroniques) pour lesquelles une assurance sera accordée sans surprime ou dans des conditions proches des conditions standards après un certain temps adapté à chacune de ces pathologies. En 2013, près de 97% des demandes avaient été acceptées.

74

Convention Belorgey visant à améliorer l’accès à l’emprunt et à l’assurance des personnes présentant un risque de santé aggravé, 19 septembre 2001, http://www.cnsd77.fr/dossiers/legisla tion/belorgey02.HTM. 75 Convention AERAS (S'Assurer et Emprunter avec un Risque Aggravé de Santé), 6 juillet 2006, http://www.aeras-infos.fr/cms/sites/aeras/accueil.html. 76 Loi 2007-131 du 31 janvier 2007 relative à l’accès au crédit des personnes présentant un risque aggravé de santé, JO du 1er février 2007. 77 Avenant à la Convention AERAS, signé le 2 septembre 2015.

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4 Conclusion Comparée à des systèmes plus libéraux, la politique législative française peut paraître trop étatiste, sa vision d’une protection fondée sur les droits de l’homme aboutissant à une interdiction absolue alors que des systèmes plus libéraux préfèrent avoir recours à des techniques d’assurance pour négocier un dispositif pragmatique pour les risques aggravés. La philosophie pratique de l’approche française repose de fait sur deux piliers, l’un plus visible et conforme à l’image que le législateur et les acteurs sociaux souhaitent donner et l’autre plus effective et utilisant, sans trop les modifier, les techniques classiques de l’assurance. Les principes sont là pour affirmer le rôle social du contrat d’assurance dans la société tandis que la technique du droit des assurances est choisie pour résoudre concrètement les questions sensibles, considérant les assureurs comme des partenaires clés dans la mise en œuvre de cette fonction sociale. Il est intéressant de constater que si l’approche du droit antidiscriminatoire n’est pas concrètement visible, cette dernière approche, qui repose essentiellement sur la négociation entre acteurs et utilise la technique traditionnelle du droit des assurances, a permis des avancées significatives dans l’accès aux assurances avec des risques aggravés pour la santé. Devons-nous alors considérer que la première approche est inutile ou plutôt, comme je le pense, qu’elle est la condition même du processus de négociation entre les acteurs concernés ?

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Simon J (2003) Genetic testing and insurance: an international comparison. Int J Bioethics 14 (3–4):59–78 Thuillier G (2003) Principes de l’histoire de la protection sociale. Comité d’histoire de la sécurité sociale, la Documentation française, Paris Wolf SM, Kahn JP (2007) Genetic testing and the future of disability insurance: ethics, law & policy. J Law Med Ethics 35(2):6–32 Yusuf AA (ed) (2007) L’action normative à l’UNESCO, Élaboration de règles internationale sur l’éducation, la science et la culture, vol I. Brill/Martinus Nijhoff, Leiden

Regulating Genetic Data in Insurance and Employment: The Italian “Upstream” Way Marta Tomasi and Carlo Casonato

Abstract The regulatory approach to the collection, use, and disclosure of genetic data is paradigmatic of the difficult choices lawmakers face when confronting multifaceted issues. Within that broad frame, the processing of genetic data by insurance companies and employers creates specific issues and concerns. Lawmakers have to find the right balance among the interests of various stakeholders, avoiding both discrimination and over-protection. The Italian law on data processing for employment and insurance purposes takes a rather different approach from those chosen by other legal orders. This paper analyses the peculiarities of the Italian system, related in particular to the source of law adopted to regulate the issue, the “comprehensive” consideration of different kinds of genetic information, and the narrow exceptions to the general prohibition. The consideration of Italy’s privacybased, precautionary, and exceptionalistic approach permits a reflection, more broadly, on other rights connected to the treatment and flow of genetic information.

The article, updated as of November 2018, has already been published in the Annuario di diritto comparato e di studi legislativi (2018) and represents the fruit of joint reflections by the two authors. Nevertheless, Sects. 1–3 were written by Carlo Casonato, Sects. 4–8 by Marta Tomasi. The final section is coauthored. M. Tomasi (*) Free University of Bozen-Bolzano, Faculty of Economics, Bolzano, Italy e-mail: [email protected] C. Casonato University of Trento, Faculty of Law, Trento, Italy e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_9

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1 Introduction It is not easy for law or policymakers—to regulate matters with such a potential for controversy as genetics.1 In this field, as in a number of other innovative areas linked to the life sciences, the law has to take into account many conflicting interests, trying to balance the pros and cons that progress can generate.2 In regulating these kind of issues, moreover, the law must handle other threats. In particular, it has to keep up with continuously changing objects without sacrificing certainty and predictability. The law also has to take into account very different, and often countervailing, moral, social, and political opinions, without losing its consistency and reliability. It must finally pay particular attention to the very specific features of the singular matters to be ruled on and cases to be decided, while preserving equality and a certain degree of uniformity.3 The collection, use, and disclosure of genetic data are paradigmatic of the difficult choices lawmakers have to make when facing multifaceted issues. This kind of data contains sensitive information, which is not just health-related in general but may in some cases have predictive value concerning the likely expression of certain diseases. Information obtained from genetic data, moreover, relates both to the individual, who may have given his/her consent, and to family members, who may not even be aware that the data are being collected. Within this framework, the processing of genetic data by insurance companies and employers raises critical issues and concerns. In deciding the price of a life insurance policy, or even whether to offer it, insurers may lawfully consider applicants’ risk factors, such as smoking and obesity. Are genetic data different from these factors and in some way exceptional?4 The answer is usually affirmative.5 Furthermore, can an individual purchase insurance while hiding his/her genetic data, when that data is indicative of a substantial risk of death or disability? Does the behaviour not, in some way, betray the principle according to which the insurance contract must be based on a necessarily unknown occurrence of the insured risk? Moving to the labour context, the situation is very similar. The processing of genetic data for employment purposes is “both full of promise and fraught with ethical peril.”6 Of course, an employer cannot discriminate against a person because 1

Brownsword et al. (1998), pp. 593–597 and, on biobanks, Mauron (2008), p. 1. Dierickx and Borry (2009). 3 Casonato (2017). 4 Clayton (2015), p. 2225. 5 Klitzman et al. (2014), p. 1855: 2

Treating genetic information differently from other data with predictive value utilized by life insurers is warranted by a combination of factors: the desire to avoid disincentives for potentially valuable genetic testing in medical contexts; the extent to which genetic predispositions are out of a person’s control (in contrast, e.g., to smoking or obesity); and the concern about the implications of genetic information for family members. 6

MacDonald and Williams-Jones (2002), p. 235.

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of his/her genetic “imperfections,” and in any event, there is no such a thing as “perfect DNA.” But one can ask if there are genetic characteristics that may be particularly relevant to the selection of a job candidate. Specific genetic tests, for instance, may be designed to identify people at risk of a work-related disease or who might be susceptible to particular workplace substances or chemicals.7 Against the nominal fairness of this possibility, however, must be considered the scarcity of scientific data supporting this risk, and the bulk of evidence, on the contrary, leading to a substantial risk of discrimination.8 Here again, in short, lawmakers have to find the right balance between different stakeholders’ interests, avoiding both discrimination and excessive protection.9 Different countries choose different regulatory approaches in which the interests at stake are accommodated in various ways.10 At the extreme ends of the spectrum, we may see an open, permissive model contrasted with a closed, restrictive one. Italian law on data processing for employment and insurance purposes can be singled out as a very distinctive approach.

2 The Processing of Genetic Information in Italy: An Exceptionalistic Privacy-Centered Approach When it comes to the processing of genetic information, the Italian legal order follows an approach based on substantive exceptionalism: information derived from genetic testing in Italy is subject to distinctive legal consideration and a specific regime. The legal framework, in fact, reflects the belief that genetic information is special and deserving of greater consideration than any other form of data. This is true in two ways. First, genetic testing falls not under antidiscrimination law, but is instead placed under the overarching theme of privacy, thus implying that it is subject to the principle that “everything which is not allowed is forbidden.” Second, genetic information is addressed by privacy rules that are specific to, and different from, those concerning any other personal data, even health-related data. According to article 90 of the Italian Code of Privacy (Legislative Decree no 196 of 30 June 2003), the processing of genetic data shall be allowed exclusively in the cases provided for in ad hoc or general authorizations granted by the Italian data protection authority (the Garante).11

7

Mayor (2003), p. 702. Vos (2008), p. 155. 9 Benschop and de Vries (2008), p. 138. 10 Nill et al. (2019). The article deals with five public policy options on genetic testing information: Full information ban; No restrictions; Limited voluntary disclosure; Codes of Conduct; and, Duty to Disclose. 11 The previous regime was based on Law 675 of 31 December 1996. See Gerards et al. (2005). 8

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The Code of Privacy confers upon the Garante the challenging task of enacting a regulatory instrument that addresses numerous conflicting regulatory needs, depending on the context in which the test is being performed and the purpose pursued (e.g. medical v non-medical). This enactment has to be exercised in a plural procedure: the link with other institutions is ensured by the need for the Garante to consult with the Minister of Health and to obtain the opinion of the Higher Health Care Council. Following this procedure, the Garante adopted in 2007 the first version of the General Authorization for the processing of genetic data (hereinafter General Authorization or Authorization).12 The Authorization underwent a significant change in 2011 and has since been renewed annually without substantial revision.13 An overview of the content of the General Authorization confirms the exceptionalistic and precautionary attitude of the Italian legal order: in short, the contexts in which the processing of genetic information is allowed are quite restricted, with strong emphasis placed on the risks engendered by such procedures. For example, Italian researchers have experienced great difficulties in meeting the requirements of the provision dealing with the dissemination of data. According to point 9 of the General Authorization, “Research findings may only be disseminated as aggregated information, or in accordance with such arrangements that can prevent data subjects from being identified also by way of indirect identification data; this shall also apply to publications.”14 The provision provides no exemption for cases where consent is granted. This provision, aimed at protecting research participants against possible discrimination, thus not only threatens to hamper research but also ironically restrict the autonomy of those willing to take part in research projects who may want the opportunity to be re-contacted if relevant information emerges.15 Aware of the complexity of the task it faces and the variety of cases to be regulated, the Garante closes the General Authorization with a provision concerning the possibility, in specific and exceptional circumstances, of obtaining a one-time authorization for a protocol to handle genetic data not otherwise covered by the Authorization.16

12

General Authorization for the processing of genetic data, 22 February 2007, Official Journal of the Italian Republic no 65, 19 March 2007. 13 See the English version of the website of the Garante: http://www.garanteprivacy.it/home_en/ italian-legislation. The translated version is that of 2014, which is basically identical to that of 2016, currently in force. 14 See point 9 of the General Authorization. 15 On the relevance of re-contacting and other critical issues of the restrictive model see Gibbons (2009) and Otlowsky (2012). 16 See point 10 of the General Authorization.

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3 Setting the Context: Definitions in the Garante’s General Authorization Generally speaking, the Authorization defines genetic data (point 1, a) as “the result of genetic tests and/or any other information that, regardless of its type, identifies an individual’s genotypic characteristics that can be inherited within a related group of individuals.” In addition, the Authorization (point 1, i) provides for a definition of genetic information: “‘genetic information’ shall mean the activities aimed at providing information on the specific features of genetic screening.” Regarding the definition of genetic screening, the General Authorization (point 1, g) states that “genetic screening” shall mean any genetic test that is carried out on a given population or group – including family tests aimed at detecting (via “cascade screening”) individuals that are potentially at risk of developing a given genetic disorder – in order to assess their common genetic characteristics or else to detect at an early stage individuals that are affected by and/or carriers of genetic diseases and/or other hereditary characteristics.

Genetic test is defined (point 1, c) as the analysis, for clinical purposes, of a specific gene, or of a product and/or function thereof or of other DNA constituents and/or a chromosome, in order to carry out a diagnosis or confirm a clinical suspicion in an individual already affected by disease (diagnostic test), or else in order to detect or rule out a mutation associated with a genetic disease that might develop in a healthy individual (pre-symptomatic test), or in order to assess an individual’s liability to develop multi-factor diseases (predictive or susceptibility test).

While the Recitals of the Authorization explicitly recall the UNESCO International Declaration on Human Genetic Data, some of its definitions are quite different.17 For instance, genetic information refers not, as in the UNESCO Declaration, to a kind of medical data,18 but to the processes by which a patient is informed about aspects of a given genetic screening.19 Consequently, proteomic data are not expressly mentioned in its definitions and cannot be considered part of “genetic information,” as they are in the UNESCO Declaration. The critical issue with the definitions provided by the Garante in the General Authorization is that, as mentioned above, the act aims at regulating fields that are profoundly different from one another. This “comprehensive” approach is reflected by the section concerning definitions, which does not make any distinction, for example, between genetic tests occurring within a clinical setting (for research

17

On differences in terminology, see Knoppers and Saginur (2005). On the UNESCO Declaration, see among others Langlois (2013) and Bagheri et al. (2016). 18 UNESCO International Declaration on Human Genetic Data, adopted unanimously and by acclamation on 16 October 2003 by the 32nd session of the General Conference of UNESCO, Recital: “Recognizing that genetic information is part of the overall spectrum of medical data and that the information content of any medical data, including genetic data and proteomic data, is highly contextual and dependent on the particular circumstances.” 19 In Italian, in the current common language, genetic information is often used as a synonym for genetic data.

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purposes) and tests sold to consumers, nor between diagnostic and merely predictive tests.

4 The Exclusion of Employment and Insurance Purposes The latest version of the General Authorization for the Processing of Genetic Data20 identifies a rather/particularly restrictive list of legitimate purposes for the processing of genetic data. Among these, the Authorization refers to health care (with specific regard to genetic diseases and the protection of the genetic identity of the data subject or of third parties belonging to the same genetic line), scientific and statistical research, defense needs in trials, and the fulfilment of specific obligations. Insurance and employment purposes, by contrast, are not on the list21; their absence can hardly be unintentional. The topics were directly addressed by the Italian Authority, as evidenced in one of the Recitals: Whereas any other processing operations concerning genetic data that are not referred to herein shall be regarded as unlawful, except for those mentioned above, including employers’ activities aimed at establishing employees’ and/or job candidates’ professional eligibility, irrespective of whether such activities are grounded in the data subjects’ consent, and the activities carried out by insurance companies.

Two arguments can be used to limit the extent of this statement. First, the literal formulation only addresses decisions about “professional eligibility” and does not in particular refer to other possible negative consequences, for example, promotions or relocations. Second, the statement is not part of the core text but is rather located in the Recitals, which usually play a more “scene-setting” or interpretative role than a fully “normative” one. Nonetheless, the provision is relevant in showing that the two scenarios—employment and insurance—were deliberately left out of the list of legitimate purposes. Beyond this clear indication, the exclusion of the possibility of processing genetic data for the employment and insurance purposes is supported and confirmed by several further hints located in and beyond the text of the Authorization. First, with specific regard to pre-symptomatic and susceptibility tests, which represent the most useful kind of tests for insurance and employment purposes, the Authorization clearly states that “[p]rocessing of genetic data and use of biological samples to perform pre-symptomatic and susceptibility tests are only permitted in order to achieve health care purposes, including informed reproductive choices and health care-related research purposes.”22

20 General Authorization No 8/2016 for the Processing of Genetic Data, 15 December 2016, Official Journal of the Italian Republic no 303, 29 December 2016. 21 See point 3 of the General Authorization. 22 See point 3.1 of the General Authorization.

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Second, with regard to the same kind of tests, the Italian Code of medical ethics (Codice di deontologia medica, 2014)23 explicitly states that “[t]he physician shall not prescribe or perform predictive genetic tests requested or conducted merely for insurance or employment purposes.”24 A third element is offered by the interpretation of the restriction, in the context of scientific research, regarding the re-use of samples or data collected for a previous or different research program (i.e. secondary uses). In particular, according to the provisions set out in the General Authorization, the communication of genetic data to bodies pursuing research purposes is allowed exclusively within the framework of joint projects. Outside joint projects, genetic data can be communicated for the purposes of directly related research aims, so long as that data does not include any identifying information, but no communication or transfer to third parties is allowed. The limitations on performing tests and on the opportunities for third parties to access information generated for different purposes clearly testify to the intention of lawmakers to restrain, as much as possible, the handling of genetic information. Finally, looking to general norms not specifically related to genetic data, a prohibition on the use of genetic information in the employment context seems to be borne out by articles 5 and 8 of the Statute of Workers’ Rights.25 These two articles, in particular, prohibit employers from performing tests to evaluate the ability of their employees or, more generally, from investigating facts that are irrelevant to evaluating a workers’ professional aptitude. The use of genetic testing in insurance and employment seems, therefore, to be indisputably prohibited under Italian jurisdiction.26 This ban produces several consequences: (a) Employers and insurers are not allowed to access genetic test results contained in medical or hospital files of employees, or of job or insurance applicants. (b) Employers and insurers are not allowed to access genetic test results obtained in the context of biomedical research. (c) Insurers and employers are not permitted to retain genetic information. Interestingly, this clear-cut prohibition is not—though the other rules set forth by the Authorization are—of a legislative nature. The Parliament and the Government, in fact, in entrusting the Garante with the regulation of the processing of genetic data, limited their instructions to the need to provide for specific informative duties

23

For some considerations about the relationships between rules of medical ethics and the Italian legal system, see Petrini and Ricciardi (2016). 24 Code of Medical Conduct, approved by the National Federation for the Orders of Doctors and Dentists on 18 May 2014. The original Italian text of article 46.3 provides that “Il medico non prescrive né esegue test predittivi richiesti e prodotti a fini meramente assicurativi od occupazionali.” 25 Law no 300 of May 20, 1970, Rules on the protection of the freedom and dignity of workers and of trade union freedom and union activity in the workplace, and rules on the public employment service, Official Journal of the Italian Republic no 131, 27 Mayo 1970. 26 For one possible exception in the employment context, see below Sect. 6.

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and to protect the right not to know (article 30 of legislative decree no 196/2003). No specific direction was given concerning the purposes for which processing of genetic data would be allowed. Nonetheless, as mentioned above, indications can be found in other legal norms to confirm and support the regulatory choices made by the Garante.

5 What Is the Role of Individual Consent? As already mentioned, the Recital of the General Authorization that excludes from authorizations to process genetic data both employers’ activities aimed at establishing employees’ and job applicants’ professional eligibility and activities carried out by insurance companies rejects any role for individual consent in the former context, but is silent on the relevance of consent in the latter. Thus, consent to disclosure by job applicants and employees is explicitly excluded. Employers are not allowed to obtain genetic information even with the consent of an employee or applicant. As for insurance, the Authorization does not explicitly rule out the possibility of allowing access to genetic data with an insurance applicant’s consent. Are there other facets of Italy’s legal order that may be useful in understanding whether this difference in wording produces different consequences in the practical reality of the two contexts? As mentioned above, indications contained in the Code of medical ethics (Codice di deontologia medica) offers a solid basis for an broad interpretation, according to which consent could play no role as a waiver in insurance, either. According to article 46 of the Code of medical ethics (2014), “[t]he physician does not prescribe or perform predictive genetic tests requested or conducted merely for insurance or employment purposes.”27 The importance of the tacit content of this rule emerges when compared with its previous version. Article 46 of the Code of medical ethics of 2006 allowed the physician to perform genetic tests for insurance or employment purposes with the express and informed consent of the insurance or job applicant/employee.28 Even if not explicit, this shift acknowledges the difficulties inherent in the principle of consent in these contexts, where the imbalance of power in the roles affects the ability of consent to act as an instrument to empower individual positions, and risks reducing it to a “waiver of rights.”

The original Italian text (2014) provides that “Il medico non prescrive né esegue test predittivi richiesti e prodotti a fini meramente assicurativi od occupazionali.” 28 The original Italian text (2006) provides that “Il medico non deve eseguire test genetici o predittivi a fini assicurativi od occupazionali se non a seguito di espressa e consapevole manifestazione di volontà da parte del cittadino interessato che è l’unico destinatario dell’informazione.” 27

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6 A “Rule-Plus-Abstract-Exception” Model: An Interpretative Way to Allow Genetic Testing in Specific Cases? While the use of genetic testing in insurance is generally prohibited, the General Authorization provides, indirectly, for one exception to the standard prohibition in the labour context.29 That is, genetic testing can be used for the aim of protecting the life or physical integrity of the job applicant, employees, or third parties. Its use has to be fundamental to this end, and, consequently, a link between a genetic profile and the specific job to be performed must be proven. The described aim, in particular, is set out under point 3.2, b of the Authorization. That is to say, the General Authorization is applicable, even without the data subject’s consent, so long as the processing of genetic data is indispensable to the fulfillment of specific obligations or tasks as set forth in national or supranational instruments concerning occupational safety, and complies with the limitations laid down in the Garante’s General Authorization for the processing of sensitive data in the employment context.30 Should testing under these auspices be conducted, the entire set of guarantees provided by the Authorization is obviously to be respected. Thus, the normative scheme can be interpreted as a “rule-plus-exception” model. The exception is extremely narrow: the employer will have to prove not only the aim of protecting the life or physical integrity of the job applicant or a third person, but also the genetic information’s fundamental role in pursuing that aim. It must be noted that the relevant literature shows no evidence of the application of this kind of genetic test. Nor has any relevant case law been reported. This lack of data can be interpreted in three different ways: (i) the non-explicit nature of the exception means it is relatively unknown, with the result that the general prohibition prevails; (ii) the narrow nature of the exception makes it hard to apply in practice since situations in which an employer would have a real and concrete interest in taking advantage of the possibility offered by the law are rare.

29 30

See point 3.2, b) of the General Authorization. General Authorization no 1/2016, point 3.2, letter b) (translation provided by the Garante): This authorisation shall also be granted if the processing of genetic data is indispensable: (. . .) To fulfil specific obligations or ensure that specific obligations are fulfilled, or to discharge specific tasks as set forth expressly in Community instruments, laws and/or regulations applying to social security and welfare, occupational and/or population safety and hygiene, also without the data subject’s consent, in compliance with the limitations laid down in the Garante’s general authorisation for the processing of sensitive data in the employment context.

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7 Consequences on the Rights Connected to the Flow of Genetic Information The restrictive and precautionary attitude of the Italian regulator has consequences for some of the rights connected to the handling and flow of genetic information, making them, at least in part, less problematic. For instance, given the general ban on genetic testing in insurance and employment contexts, the disclosure duties in the Authorization does not, contrary to the rule in many other countries, explicitly cover the possible impact of testing for insurance or employment applications. The risks of discrimination and stigmatization are mentioned and have to be communicated only in cases of scientific research carried out on isolated populations.31 This easily comports with the idea that insurance and employment being the contexts in which discrimination on genetic grounds is most likely to happen, the general prohibition applicable in Italy could be expected to absorb any risk of discrimination. While this makes information obligations easier to meet, it can be argued that other risks of discrimination, not necessarily related to the field of insurance and employment, tend to be overlooked. In this case at least, the impossibility of handling genetic data in insurance and employment contexts involves a change in the content, and quality, of the right to information. Other rights are affected not in their content but in their scope. This is true, for example, with regard to the interest in having access to one’s relative’s genetic information recognized by some legislation. The “hybrid legal protection”32 to which members of an individual’s biological family are entitled is addressed by the General Authorization, which qualifies their position compared to that of third parties. In this respect, point 9, paragraph 7 of the General Authorization states that Genetic test/screening results and/or research findings that entail factual, direct benefits in terms of treatment, prevention and/or awareness of reproductive choices also to the individuals belonging to the same genetic line as the data subject may be communicated to such individuals if they so request and the data subject has expressly consented thereto, or if the results/findings in question are indispensable to prevent those individuals’ health from being jeopardized – including reproductive risks – and the data subject’s consent is not given or cannot be given because the data subject is nowhere to be found.

Thus, upon request, information of indispensable relevance for health purposes can be communicated to family members. Obviously, the prohibition against the handling of genetic data in the insurance and employment contexts implies limited protection of access by relatives to relevant information in the clinical or research

31

See point 5 of the General Authorization No 8/2016 for the Processing of Genetic Data, 15 December 2016, Official Journal of the Italian Republic no 303, 29 December 2016. 32 Council of Europe, Committee of Ministers, Explanatory Memorandum to Recommendation No R(97)5 on the Protection of Medical Data, adopted by the Committee of Ministers on 13 February 1997 at the 584th meeting of the Ministers’ Deputies, Appendix to the draft recommendation, para 58.

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setting (or in other restricted possible situations considered by the Authorization), but will not derive from tests carried out in the insurance or employment contexts. Similar considerations may apply to the right not to know about genetic information, which represents one of the most debated points in the discussion about the legal implications of advances in genetics.33 According to point 6, paragraph 2 of the General Authorization, individuals have a right not to know about their genetic information: As regards processing that is carried out by means of genetic tests, including screening, also for purposes of research and/or family reunion, the informed consent of the individuals that undergo the collection of the biological material required for performing such analysis shall have to be obtained. In said cases, the data subject shall have to state whether he/she wishes to be informed of the findings of the test/research, including unexpected findings concerning him/her where such findings are factually and directly beneficial to the data subject in terms of treatment, prevention, and/or awareness of reproductive choices.

The prohibition on the processing of genetic data for some purposes restricts the overall flow of genetic information, making these rights more manageable, at least from a “quantitative” viewpoint, and easing the coordination between different contexts. One’s right not to know will have to be balanced with some competing interests (e.g. his/her right to health, or the right to know of his/her biological relatives) but not with others (e.g. the interests of the employers or of insurance companies).

8 An Alternative Approach to Privacy: Non-Discrimination? Despite the clear favour shown by the Italian regulators towards privacy as the basis of the regulatory approach to genetic information, an alternative approach can be considered. It is often argued that legislation meant to protect genetic privacy by restricting the disclosure of genetic information may not suffice, insofar as an individual’s refusal to undergo a test or give up their genetic information would result in a negative outcome for them (e.g. the impossibility of purchasing an insurance contract, or of being appointed to a position).34 The issue, then, is not only whether access to genetic information is gained, but also how it is used. In this sense, in particular, a prohibition on the use of genetic data may also be based on the principle of non-discrimination. The General Authorization does not explicitly include genetic status as a ground for discrimination. Nonetheless, it mentions, in its preamble, several international

33 34

See Andorno (2004) and, more recently, Chadwick et al. (2014). Gerards et al. (2005).

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sources that do. In particular, the Authorization refers to the 1997 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention),35 to the 2003 UNESCO International Declaration on Human Genetic Data,36 and to the Charter of Fundamental Rights of the European Union.37 The Oviedo Convention, article 11 (Non-discrimination) states that “[a]ny form of discrimination against a person on grounds of his or her genetic heritage is prohibited.” It is relevant to note that the ratification process of the Oviedo Convention has not been completed in Italy; therefore, Italy is not a member of the Convention. Despite an ad hoc statute having been enacted,38 it was never filed with the Council of Europe. Nevertheless, following a decision by the Corte di Cassazione (decision October 16 2007, no 21748), judges may use the Oviedo Convention as an interpretative tool, when specific legislation is missing or unclear. Very similarly, article 7 of the UNESCO Declaration of 2003, Every effort should be made to ensure that human genetic data and human proteomic data are not used for purposes that discriminate in a way that is intended to infringe, or has the effect of infringing human rights, fundamental freedoms or human dignity of an individual or for purposes that lead to the stigmatization of an individual, a family, a group or communities.

As for provisions prevailing in the EU, article 21 of the Charter of Fundamental Rights includes genetic features among the grounds on which discrimination is prohibited and unlawful.39 In Italy, the EU Charter, as an EU treaty, has a morethan-constitutional status, meaning that it prevails not only over statutes, but over constitutional principles as well, with the sole exception of supreme principles. With regard to national sources, genetic status is not expressly mentioned in the Italian Constitution. In Europe, constitutional provisions concerning genetic identity have only been introduced more recently than 1948, when the Italian Constitution entered into force. Nonetheless, it is inspiring to think that, back in 1947, the discussion surrounding the introduction of article 32.2 of the Constitution, which provides that no one may be obliged to undergo any health treatment except under the provisions of the law and that the law may not, under any circumstances, violate

35 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164. 36 UNESCO International Declaration on Human Genetic Data, adopted unanimously and by acclamation on 16 October 2003 by the 32nd session of the General Conference of UNESCO. 37 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012. 38 Law no 145/2001, Official Journal of the Italian Republic no 95, 24 April 2001. 39 Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 21 (1):

Any discrimination based on any ground such as sex, race, color, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited.

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the limits imposed by the respect for the human person, briefly addressed the potential and risks associated with genetic progress.40 Despite the lack of a specific and explicit reference to genetic issues, the non-discrimination approach is rooted in general constitutional provisions. In particular, article 3 of the Italian Constitution, concerning the principle of equality, includes “race” as a ground for discrimination which might be interpreted to include genetic status. More appropriately, given the well-established non-biological nature of the category of race, the protection against discrimination on the basis of genetic status can be grounded in the provision of article 3, listing just some examples of grounds for unlawful discrimination, read together with article 2, concerning inviolable rights.41 As of yet however, the Italian Constitutional Court has not had a chance to establish the interpretation of the constitutional equality framework in relation to genetic status. This general consideration is also relevant to the employment and insurance contexts: there are no pivotal human rights decisions in Italy regarding genetic discrimination. Two alternative explanations for this might be that: (i) the prohibition on the use of genetic data is strictly observed, or (ii) genetic data discrimination has occasionally occurred, but no legal cases have been filed. No data is available regarding the latter possibility. The downside of this approach is that the principle of non-discrimination usually requires a comparison to other individuals or groups lacking the genetic defect and who have been treated more favorably. On the upside, as mentioned above, the non-discriminatory approach could be applicable even in situations where an individual has consented to the disclosure of his/her genetic information.

40

See the reports (in Italian) of the discussion of the Assemblea costituente at www. nascitacostituzione.it (17–18 April 1947). 41 See articles 2 and 3 of the Constitution of The Italian Republic (Official Journal of the Italian Republic, no 298, 27 December 1947). Article 2: The Republic recognizes and guarantees inviolable rights of man, for the individual, and for social groups where personality is expressed, and demands the fulfilment of the fundamental duties of political, economic, and social solidarity. Article 3: All citizens have equal social dignity and are equal before the law, without distinction as to sex, race, language, religion, political opinions, or personal or social condition. It is the duty of the Republic to remove those obstacles of an economic and social nature that, by in fact limiting the freedom and equality of citizens, impede the full development of the human person and the effective participation of all workers in the political, economic and social organization of the country.

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9 Concluding Remarks: Genetic Privacy and the Role of the “Veil of Ignorance” The Italian regime for the use of genetic data in insurance and the workplace is exceptional in a number of ways. First, Italy is atypical with regard to the source of law providing the rule for the use of genetic data in insurance and the workplace. The legal regime is not provided for directly by a statutory instrument, but by a general authorization authored by the Garante through a pluralistic decision-making procedure. While this choice may be criticized from a democratic point of view, it serves an instrumental purpose, putting technical expertise in the hands of policy makers and increasing adaptability to an ever-changing field. Second, Italy is distinctive in its reliance on privacy rather than antidiscrimination as the basis of its approach. The general rule, with few very, strict exceptions, is that genetic data are simply not accessible to insurance companies and employers, even with the consent of the individual—a third distinctive element of Italy’s approach. In this way, Italy has established “upstream protection” based on privacy as opposed to the “downstream protection” achievable by antidiscrimination.42 A fourth distinctive feature of the Italian legal system deals with the aforementioned “comprehensive” approach in defining genetic data: unlike other legal systems, the Authorization, on the one hand, regulates fields that are profoundly different from one another and, on the other hand, considers genetic information as a unique and homogeneous category. How this regulatory scheme will practically come to be adapted to the new provisions set out in the European General Data Protection Regulation,43 which fully came into force in May 2018, is still an open question.44 Thus far, it is not easy to say whether the distinctive elements of the Italian regime produce more pros or cons. Confronting legal provisions with the data from practical reality, yet, it is worth mentioning that there is no litigation on the subject, nor, consequently, any waste of resources in this respect.

For this distinction see the Privacy Commissioner of Canada’s speech “Privacy Upstream, Discrimination Downstream: The (Un)Intended Consequences of Data Analytics”, given at the Reboot 18th Annual Privacy and Security Conference, 10 February 2017, https://www.priv.gc.ca/ en/opc-news/speeches/2017/sp-d_20170210_pk/. 43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016. 44 The latest version of the General Authorization (2016) states that the GDPR is applicable as of 25 May 2018 “except for modifications the Garante intends to adopt as a consequence of relevant modifications of the law and measures necessary to apply the Regulation.” Correspondingly, point 9.4 of the GDPR allows Member States to “maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health.” 42

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From a broader perspective, it is possible to claim that the “privacy/upstream” model is a good example of the virtues John Rawls attached to his idea of a “veil of ignorance.” This well-known theory assumes that a fair and impartial decision depends on the decision-maker’s lack of all knowledge of personal characteristics and social and historical circumstances. Among the essential features of this “original situation” is that “no one knows his place in society, his class position or social status, nor does anyone know his fortune in the distribution of natural assets and abilities, his intelligence, strength and the like.”45 Applying this notion to our field, we can say that the less information the insurance company or employer knows about the candidate, the fairer and more impartial the decision will be.46 From this point of view, Italy appears to have a very good system, able to balance the different stakeholders’ positions—a system that, through ignorance of the genetic profile of the individual, ensures predictability and fairness, legal certainty, and equal satisfaction of the main interests involved.

References Andorno R (2004) The right not to know: an autonomy based approach. J Med Ethics 30:435–439 Bagheri A, Moreno JD, Semplici S (eds) (2016) Global bioethics: the impact of the UNESCO international bioethics committee. Routledge, Cham Benschop R, de Vries G (2008) Work, health and genetics: problems of regulation in a changing society. In: de Vries G, Horstman K (eds) Genetics from laboratory to society: societal learning as an alternative to regulation (health, technology and society). Palgrave Macmillan, New York, pp 138–154 Brownsword R, Cornish WR, Llewelyn M (1998) Human genetics and the law: regulating a revolution. Mod Law Rev 61:593–597 Casonato C (2017) 21st Century biolaw: a proposal. BioLaw J 1:81–95 Chadwick R, Levitt M, Shickle D (2014) The right to know and the right not to know. Genetic privacy and responsibility. Cambridge University Press, Cambridge Clayton EW (2015) Why the Americans with disabilities act matters for genetics. JAMA 313:2225–2226 Dierickx K, Borry P (eds) (2009) Challenges for biobanks: ethics, law and governance. Intersentia, Antwerpen Gerards JH, Heringa AW, Janssen HL (2005) Genetic discrimination and genetic privacy in a comparative perspective. Intersentia, Antwerpen Gibbons SMC (2009) Regulating biobanks: a twelve-point typological tool. Med Law Rev 17:313–346 Klitzman R, Appelbaum PS, Chung W (2014) Should life insurers have access to genetic test results? JAMA 312:1855–1856 Knoppers BM, Saginur M (2005) The Babel of genetic data terminology. Nat Biotechnol 23:925–927 Langlois A (2013) Negotiating bioethics: the governance of UNESCO’s bioethics programme. Routledge, London

45 46

Rawls (1999), p. 11. In this sense, see Rao (2006).

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MacDonald C, Williams-Jones B (2002) Ethics and genetics: susceptibility testing in the workplace. J Bus Ethics 35:235–241 Mauron A (2008) Introduction: biobanks, genomics, and research – a nightmare for public policy makers. In: Elger B, Biller-Andorno N, Mauron A, Capron AM (eds) Ethical issues in governing biobanks. Global perspectives. Routledge, Oxon, pp 1–12 Mayor S (2003) Report warns of danger of genetic discrimination in the workplace. BMJ 327:702 Nill A, Laczniak G, Thistle P (2019) The use of genetic testing information in the insurance industry: an ethical and societal analysis of public policy options. J Bus Ethics 156(1):105–121 Otlowsky MFA (2012) Tackling legal challenges posed by population biobanks: reconceptualising consent requirements. Med Law Rev 20:191–226 Petrini C, Ricciardi W (2016) The relationship between medical ethics and the legal system in Italy: food for thought. Annali dell’Istituto Superiore di Sanità 52:582–586 Rao R (2006) A veil of genetic ignorance? Protecting genetic privacy to ensure equality. Villanova Law Rev 51:827–840 Rawls J (1999) A theory of justice. Harvard University Press, Cambridge Vos R (2008) Genetic risks and justice in the workplace: the end of the protection paradigm? In: de Vries G, Horstman K (eds) Genetics from laboratory to society: societal learning as an alternative to regulation (health, technology and society). Palgrave Macmillan, New York, pp 155–170

Genetic Testing and the Governance of Risk in the Contemporary Economy of Japan Yuichiro Sato

Abstract Genetic testing is conducted in Japan, but the results are not used in insurance and employment because of the national public health insurance system and the administrative pressure on private insurance companies and employers. This may persist for several years, but increasing pressure from foreign countries and insurance companies will likely change the situation in the near future. There is no clear legal guidance on the status of genetic information, nor a general statute prohibiting genetic discrimination. To my knowledge, this has caused no major problems thus far because Japan is generally homogeneous (both ethnically and politically) and administrative requests (“gyosei shido” in Japanese) are well complied with, but it may do so in the future. Furthermore, some commentators express concern about the treatment of genetic information in Japan. To address these issues, clear legal guidance and a comprehensive anti-discrimination statute are needed. So-called direct-to-consumer (DTC) genetic testing kits are available in Japan online, falling outside the Ministry of Health’s medical device regulation. This seldom causes legal problems for insurance and employment but may potentially result in difficulties where customers do not seek genetic counselling from medical professionals. Clarification of the nature of DTC genetic testing kits is also needed.

1 Introduction Japan has a civil law system; therefore, acts of Parliament are the main source of law.1 With regard to genetic testing in the insurance and employment contexts, discrimination acts, labour acts, the Act on the Protection of Personal Information (Data Protection Act, DPA) and the insurance policies on national health insurance

1

For the general state of affairs of medical law in Japan, please see Kai et al. (2019).

Y. Sato (*) Department of Education, Tokyo Gakugei University, Tokyo, Japan e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_10

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and private life insurance constitute the relevant legal framework. Furthermore, because genetic information is derived from human bodily materials, regulations of both data and human bodily substances should also be consulted. Japan does have the DPA, but the legal situation concerning bodily materials is not clear. Whole cadavers and parts of cadavers are subject to a statute which provides surviving relatives with the right to have the samples returned to them in some situations (and not in others).2

2 Legal Context for Genetic Testing 2.1

Definition of Genetic Testing and Related Terms

Japanese statutes do not include a definition of genetic testing or genetic information. Related definitions are found in the DPA—“sensitive personal information” includes medical history—and in the Act for Eliminating Discrimination against Persons with Disabilities (see Sect. 2.3 below), which includes the term “a person with a disability.” In both statutes, however, the genetic condition must be expressed in a person’s phenotype to benefit from legal protection.

2.2

Discrimination: General Observations

Article 14 of the Constitution provides that “[a]ll of the people are equal under the law and there shall be no discrimination in political, economic or social relations because of race, creed, sex, social status or family origin.” It is not clear if discrimination based on genetic condition is covered by this provision; it was debated in a committee of the Diet on the subject.3 Japan does not have a comprehensive antidiscrimination act, and special statutes are not enough.4 Protection from discrimination in employment is provided for in labour acts, but there are no provisions concerning employees’ genetic status. We will discuss this in the following section.

2

See Kai et al. (2019), paras 110–114. Report of the commission on the constitution of House of Councilors, http://www.kenpoushinsa. sangiin.go.jp/kenpou/houkokusyo/houkoku/03_20_01.html (in Japanese). 4 See UN Committee on the Elimination of Racial Discrimination, Concluding observations on the combined tenth and eleventh periodic reports of Japan, https://tbinternet.ohchr.org/Treaties/CERD/ Shared%20Documents/JPN/CERD_C_JPN_CO_10-11_32238_E.pdf and UN Committee on the Elimination of Discrimination against Women, Concluding observations on the combined seventh and eighth periodic reports of Japan, http://docstore.ohchr.org/SelfServices/FilesHandler.ashx? enc¼6QkG1d%2fPPRiCAqhKb7yhsryr9E9fM8JLxSfpAS5QTBCjaoYUCJTappT6L0KnewZnW VtHe85eNjSs33vAagefQMojwEB%2f0mSHGEkj2WYIs2mdx4Hd72kL2QxB4gWM%2fKDB. 3

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Anti-Discrimination in Labour Acts

As described above, anti-discrimination provisions are scattered across several acts. The Act for Eliminating Discrimination against Persons with Disabilities5 prohibits administrative agencies and private entities from violating the rights or interests of persons with disabilities (articles 7(1) and 8(1)). The Act also requires such entities to provide reasonable accommodation to eliminate social barriers faced by persons with disabilities. For administrative agencies, this is a legal duty (article 7(2)); private entities, by contrast, are only expected to make reasonable endeavors (article 8(2)). The Act on Employment Promotion of Persons with Disabilities provides that employers must give an equal opportunity to persons with a disability at the recruitment stage and during their employment (article 34). It also prohibits wage discrimination and other discriminatory treatment based on a person’s disability (article 35). In both circumstances, however, the genetic condition must be expressed in the person’s phenotype. Despite these protections, the freedom to hire or not hire is broadly accepted. The Supreme Court has stated that companies have the right to choose who to hire and under what conditions, in accordance with the law (December 12, 1973).6

2.4

The Data Protection Act

The DPA was enacted in 2003 and amended in 2015 to add provisions concerning sensitive personal information and personal identifiers. Sensitive personal information (“special care-required personal information”) is defined as “personal information comprising a principal’s race, creed, social status, medical history, criminal record, fact of having suffered damage by a crime, or other descriptions prescribed by cabinet order as those the handling of which requires special care so as not to cause unfair discrimination, prejudice or other disadvantages to the principal”7 (article 2(3)). Data-handling entities must obtain this information only from the data subject, except in cases expressly permitted by law (article 17(2)), whereas general personal information may be obtained from a third party (article 17 (1)). Personal identifiers include nucleotide sequences, constituting DNA, which the Personal Information Protection Commission recognizes as sufficient to identify a

5 Act for Eliminating Discrimination against Persons with Disabilities, Act no 65 of 26 June 2013, http://www.japaneselawtranslation.go.jp/law/detail/?id¼3052&vm¼04&re¼01 (official translation). 6 Minshu 27(11)1536, http://www.courts.go.jp/app/files/hanrei_jp/931/051931_hanrei.pdf. 7 Act on the Protection of Personal Information, Act no 57 of 30 May 2003, http://www. japaneselawtranslation.go.jp/law/detail/?id¼2781&vm¼04&re¼01&new¼1 (official translation).

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specific individual (article 2(2) of the DPA8). These identifiers should always be deemed as identifiable information and, therefore, may not be anonymised. This means that certain genetic data is protected as identifiable information. However, the DPA does not have provisions concerning discrimination. The DPA imposes some constraints on the disclosure of personal information to third parties, whether they are located within (article 23) or outside Japan (article 24). The transferring of general personal data within Japan may be done without the consent of the data subject, although data subjects must be notified that data may be transferred (meaning they must know whether their genetic status information is available to insurers or potential employers). Transferring sensitive personal data to third parties within Japan requires specific consent. The same is true for transferring general data to foreign countries, unless the country’s protection system provides the same level of protection as Japan (as determined by the Personal Information Protection Commission), or the foreign recipient has established a sufficient data protection system. In cases of direct-to-consumer (DTC) genetic testing and non-invasive prenatal testing or diagnosis (NIPT/D), it is common practice for data subjects to give their consent to DTC companies and NIPT/D laboratories to enable data transfer between a research institution headquartered in a foreign country and its branch office in Japan.

2.5

Duty of Confidentiality and Privacy Rights

Doctors and other licensed medical staff have a duty of confidentiality. For example, article 134 of the Criminal Code establishes this duty for doctors and midwives (as well as the penalty for its violation: imprisonment for not more than six months or a fine of not more than 100,000 JPY). Furthermore, the DPA prohibits the for-profit transfer of databases by data-handling entities to third parties. It imposes penalties of imprisonment for not more than one year or a fine of not more than 500,000 yen. Finally, article 13 of the Constitution of Japan provides for comprehensive, fundamental human rights. The Supreme Court confirmed the right to withhold private information pursuant to article 13 in a judgement issued on 12 September 2003.9

8 Cabinet Order no 507 of 10 December 2003 to enforce the Act on the Protection of Personal Information, http://www.japaneselawtranslation.go.jp/law/detail/?id¼2885&vm¼04&re¼01& new¼1 (official translation). The order defines one of the personal identifiers as “base sequence constituting Deoxyribonucleic Acid (alias DNA) taken from a cell” (article 1). The guidelines issued by the Personal Information Protection Commission (November 2016) explain that whole nuclear genome sequence data, whole exome sequence data, whole genome, some kind of SNP data, or four bases repeat of nine loci or more shall be personal identifier. See https://www.ppc.go. jp/files/pdf/guidelines01.pdf. 9 Minshu57(8)973, http://www.courts.go.jp/app/files/hanrei_jp/357/052357_hanrei.pdf.

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International Documents

International treaties are not self-executing in Japan, meaning that treaties and other international documents must be enacted by the Diet to be legally effective. UNESCO’s International Declaration on Human Genetic Data is mentioned in Japan’s governmental guidance for the proper handling of personal data in medical and nursing care.10 The “Fundamental Principles of Research on the Human Genome,” issued by a governmental committee in June 2000,11 emulates the UNESCO Declaration. The principles provide the following: Principle 1. The Significance of the Human Genome 1. The human genome is the heritage of humanity. 2. The human genome is the blueprint of human life. It provides all members of humanity with a biological basis as a human being and it also underlies the uniqueness and diversity of each human being. 3. The existence of a human being is not determined only by his/her genome. 4. Conveying the fundamental information of human life from parents to children, from children to grandchildren, and so on, the human genome builds the fundamental structures and functions of an individual as a human being. At the same time, however, the human genome is influenced by various factors in the natural and social environment. Principle 2. Diversity of the Human Genome and the Dignity and Human Rights of Individuals The human genome differs from one individual to another. The diversity of genetic characteristics signifies the originality and uniqueness of each individual and the plurality of humanity as a whole. Thus, it is imperative that, regardless of their genetic characteristics, all individuals or groups of individuals are respected for their dignity and human rights, and that they are equal to one another and are not subjected to any form of discrimination. Although this document affirms that it is “quasi-constitutional,” it has no binding legal effect, so its influence on statutes and judgments is quite limited.

2.7

Ethical Guidelines

Although the DPA contains an exemption from the data handlers’ duty in the context of research as per article 78 (data subjects do not have a legal right to access their personal information in a research setting), the Act only applies to the private sector. 10 See https://www.mhlw.go.jp/file/06-Seisakujouhou-12600000-Seisakutoukatsukan/0000194232. pdf (in Japanese). 11 See http://www.mext.go.jp/b_menu/shingi/kagaku/rinri/pri00614.htm.

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Institutions in the public sector are regulated by another statute that lacks such an exemption. Therefore, the Ethical Guidelines for Human Genome/Gene Analysis Research follow the general principles of the DPA, allowing for the right of the data subject to access his or her personal information. The Guidelines further oblige research institutions to guarantee that human dignity and human rights be respected by research institutions in foreign countries (“6 Collaborative Research with Overseas Institutions”).12

3 Genetic Testing Practices 3.1

General Context for Genetic Testing

Japan has a comprehensive national health insurance system, so the results of genetic testing are not used as criteria for enrollment in health insurance. Private insurance companies offer supplementary health insurance and other forms of insurance. However, since they do not request genetic testing, their results have yet to be used in Japan. Nevertheless, some insurance companies have indicated their desire to use genetic testing results to guide decisions on whether or not to insure potential customers.

3.2

Genetic Testing in Medical Settings

Several types of genetic testing are used in medical settings in both the national health insurance and private insurance contexts. Testing for genes linked to congenital diseases—usually rare genetic diseases—is often conducted as a clinical research at research labs in medical schools, rather than as a normal medical test under the national health insurance scheme.13 In such cases, the doctor treats the patient (and potentially his/her family members as well) for a long time in a clinical setting. It is especially true where the patient suffers from a rare disease and there are few specialists. As hospitals’ departments of genetic diagnosis are usually separate from other departments, genetic data are often distinguished from other types of data in internal

12

The old version of the Guidelines is available at http://www.lifescience.mext.go.jp/files/pdf/ n796_00.pdf and you would find it in 4 with the same title (in English). The new version of the Guidelines is available at https://www.mhlw.go.jp/general/seido/kousei/i-kenkyu/genome/ 0504sisin.html (in Japanese). 13 As of January 2018, 150 diseases (271 genes) may be tested as clinical research. On the availability of genetic testing and counselling, see http://www.idenshiiryoubumon.org/search/ (in Japanese).

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policies, and kept more securely, with access more strictly regulated. The Japanese Association of Medical Sciences issues guidelines on genetic testing.14 It notes that genetic information may lead to social disadvantage for examinees and their relatives should such information be inappropriately handled or disclosed. However, the guidelines do not require doctors and researchers to explain such risks or disadvantages to their patients.

3.3

Genetic Research

With regard to research in particular, the Ethical Guidelines require a head researcher to inform the donor of “any disadvantage that the donor might incur” (“7 Informed Consent” (3)). The guidelines’ explanatory note makes clear that this should include information about social disadvantages, such as social stigma. Although the guidelines are not legally binding, universities and large research institutions adhere to them because of the Ministry of Education’s authority. There is debate as to whether researchers should release research findings (regarding both the target gene and incidental findings) to subjects,15 but the guidelines provide for the right of a research subject to access his or her genetic information following the DPA’s model, as described above in Sect. 2.7. A major problem is that research results are often of a quality suitable only for research—that is, not medically certified—and unreliable. If the researcher is not a medical doctor, he/she is unlikely to have detailed medical knowledge or experience in genetic counselling, and mere “disclosure” may cause harm to the data subject. Furthermore, in such situations, the researcher is under no legal duty of confidentiality except those set out in the labour contract between the researcher and the research institution (a researcher often owes a duty of confidentiality to the research institution, but whether it expand beyond the labour contract to benefit third party such as research participant is unclear). And, as described above, the DPA provides a research exemption, so the institution and/or researcher are not legally subject to the conditions of the Act. The DPA also permits data transfer if there is no opposition on the part of the data subject, except in the case of sensitive personal information (article 23 (2)).

3.4

Direct-to-Consumer Genetic Testing

Despite the Medicinal and Medical Device Act, selling DTC genetic testing kits is not prohibited in Japan, and consumers can obtain such kits on Amazon or other online services. Some companies have relationships with universities, but

14 Guidelines for Genetic Tests and Diagnoses in Medical Practice, approved on 8 February 2011, http://jams.med.or.jp/guideline/genetics-diagnosis_e.pdf. 15 As an example, see https://www.megabank.tohoku.ac.jp/english/ethics/.

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others do not, and the companies often return the results alone, without explaining their significance and with little or no additional guidance. The Japan Medical Association questions the accuracy of DTC genetic testing and has proposed that the Ministry of Health regulate the industry.16

3.5 3.5.1

Other Areas Police/Forensic Investigation

In forensic examinations, DNA testing may be undertaken to identify the offender or victim pursuant to a court-issued warrant where samples are removed from body (whether living or dead). The warrant is not required to collect samples such as saliva and hair in a crime scene. So-called “DNA fingerprint” data are also stored in prefectural police stations, subject to internal bylaws.17

3.5.2

Medical Checkup on Employment

In Japan, it is standard for an employer to request that a prospective employee undergo a medical checkup before beginning his/her employment, pursuant to the Labour Safety and Hygiene Act and regulations. A general practitioner performs the checkup; therefore, it does not include genetic testing (the items needed for the medical checkup are prescribed in article 43 of the regulations). The employer has a duty to offer medical checkups to employees once a year, but, once again, this does not include genetic testing (article 44 of the regulations).

3.5.3

Genetic Testing for the Determination of Father-Child Relationship

In Japan, the child of a married couple (referred to as a “legitimate child” in the Civil Code) is presumed to be the child of the husband. This presumption is so strong that only the husband may challenge the child’s legitimacy, within one year after he learns of the child’s existence, pursuant to articles 774–777 of the Civil Code. This presumption does not apply in cases such as those involving the couple’s long-term separation, but it is widely accepted that mere medical/genetic inconsistency of parenthood does not negate the presumption. Therefore, genetic testing must be 16 New development of genetic diagnosis and gene therapy, http://dl.med.or.jp/dl-med/teireikaiken/ 20160608_3.pdf (in Japanese). 17 A lawsuit was filed recently (13 June 2019) claiming that the storage lacks legal authority and is therefore unconstitutional. See https://www.chunichi.co.jp/s/article/2019061390213606.html (in Japanese).

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conducted within 1 year after the child is born to rebut the presumption, and such testing is quite rare. Conversely, the paternity of a child of an unmarried couple is not presumed (in this case, proof of the filiation of the father or a filiation judgment is needed). Although the birth rate of children out of wedlock is very low (about 2%), sometimes the father-child relationship is contested and the court may order genetic testing. A party to the proceedings may undergo genetic testing before the trial and present the results as evidence in court. The genetic testing may be done by university laboratories (often in the legal medicine department) or private companies.

4 Legal and Social Issues Surrounding Genetic Testing 4.1

General

It is widely recognized that the Japanese public schools do not adequately teach human genetics. Moreover the word for “gene” is the same as for “heredity” in Japanese. These lead to misunderstandings about genetic testing. Many people hold the misconception that genetic diseases are necessarily hereditary, caused by the “bad blood” of the family. Some parents (especially mothers) blame themselves for their children’s diseases. Social welfare services are insufficient, and parents (again, often mothers) who are told that their fetus may have a congenital disease often choose abortion due to financial fears, among others. Some hospitals offer counselling and provide information about social welfare resources.

4.2

Discrimination

As described above, discrimination is insufficiently regulated, and there have been very few legal cases (one is described in Sect. 4.4.2) or disputes. Thus, the situation is unclear, with scant legal regulation and limited guidelines. Japan’s population is relatively homogeneous, so discrimination based on race and national origin is not so common; a few examples involve discrimination against Ainus (the native inhabitants of Hokkaido) and Koreans (many of whom were forced to move to Japan before World War II and during Korean War). Nevertheless, there are some tribes/large families with physical disabilities such as congenital hearing loss, and this may result in discrimination on the basis of genetic status and membership within that tribe.

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Recently, the results of a survey funded by the Ministry of Health18 indicated that 70% of people supported enacting legislation to regulate and protect genetic information. Furthermore, the survey found that 3.2% of respondents reported having experienced discrimination in insurance based on family members’ genetic disease (as described below in Sect. 4.4.1, insurance companies do not use genetic information in enrollment, so it seems that the discrimination is not based on the analyzed genetic result itself, but, for example, the diagnosis of genetic disease).

4.3

The Interests of Family Members

Under the DPA, family members do not have a legal right to a data subject’s genetic information. However, when the data subject dies, his or her data is no longer within the scope of the DPA, and family members to whom the deceased’s data relate have a right to access it, because the data is related to them and is, therefore, their data; guidance on the DPA states that “if the information on the dead is also information on surviving individuals such as bereaved families, it is the information on the surviving individuals.”19 The Ethical Guidelines issued by the government provide for the right not to know, but it is unclear whether this is enforceable under the law and whether it includes the right of family members. It is generally accepted that disclosing a patient’s diagnosis to family members against his/her will would constitute a tort. It therefore follows that family members do not have a right to know the patient’s genetic information if the patient exercises his/her own right not to know.

4.4 4.4.1

Private Insurance General Matters

As described above, private insurance companies offer health and other types of insurance in Japan. Although the use of genetic information is not prohibited, insurance companies rarely ask applicants about their genetic status. However, some insurance companies appear to want to use genetic testing results in their decision-making processes for applicants. It may be safely said that insurance companies generally comply with the de facto requests (which means requests that are not based on legal authority) by the Financial Services Agency.

18

Report on the use of genetic information and genome-literacy, http://mhlw-grants.niph.go.jp/ niph/search/NIDD00.do?resrchNum¼201605018A (ZIP-compressed files, in Japanese). 19 Guidance for the proper handling of personal data in medicine and care, p. 6, https://www.mhlw. go.jp/file/06-Seisakujouhou-12600000-Seisakutoukatsukan/0000194232.pdf (in Japanese).

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A Legal Case

Although it is not strictly speaking a genetic discrimination case, a court judgment regarding life insurance may be of interest. The plaintiff had received treatment for a problem with his legs. He signed a contract with the defendant, the insurance company, in 1989. The contract provided that the company would pay “if the insured injury or disease occurs after the term.” In 1992, the plaintiff was officially classified as “highly disabled,” and in 1995 had a galactosylceramidase activation test and was diagnosed with Krabbe disease. Before and after this diagnosis, the defendant had paid for his hospitalization. The plaintiff claimed disability insurance but was refused on the ground that his disability predated the insurance contract. The plaintiff argued in court that the defendant’s refusal was against public order (section 90 of the Civil Code) because he had a right to undergo this advanced medical test and to know the diagnosis; he argued that the defendant’s denial of coverage was not consistent with that right. The plaintiff also insisted that the refusal would lead to the unjust result that all genetic diseases would be denied coverage because the insured has the gene at birth, which is before the contract came into effect. The district court20 denied the plaintiff’s claim based on the term in the contract, whereby the insurer only had to pay for diseases occurring after the contract came into effect. The court rejected the plaintiff’s argument on the nature of and need for the protection of genetic information, holding that no genetic information was provided to the insurer. The appellate court21 partially granted the plaintiff’s claim and demanded that the defendant pay 10 million JPY on the ground of estoppel. The insured had made several claims to the regional branch, but the branch head had explained that it would be better not to claim at that time but rather to wait until the situation became worse. The court also stated as an obiter dictum that the court may use genetic information as evidence because there was no special statutory regulation.

4.5

Employment

Japan has a “lifelong employment” custom whereby employees are hired and retained until retirement age—usually 60 or 65 years old. The employer must have reasonable grounds to dismiss an employee (Labour Contract Act22 article 16), and if an employee becomes ill, he/she may take a leave of absence (usually not more than 3 years). The employer also has a duty of care toward its employees throughout their employment (Labour Contract Act article 5 and Labour Safety and Hygiene Act),

20

1198 KINYUUSHOUJIHANREI 55 (Kobe Dist Ct, 18 June 2003). 1198 KINYUUSHOUJIHANREI 48 (Osaka App Ct, 27 May 2004). 22 Labor Contracts Act, Act no 128 of 5 December 2007, available at http://www. japaneselawtranslation.go.jp/law/detail/?id¼2578&vm¼04&re¼02 (official translation). 21

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which includes ensuring that employees can cope with the job given their health status. So, while the health status of an employee is a major concern for the employer, it remains unusual for employers to collect genetic information in medical check-ups at the beginning of a contract or during an annual medical check-up (described above in Sect. 3.5.2). It is not clear whether an employee has a duty to disclose genetic information to the employer, but if an employer happens to obtain information about an employee’s genetic condition, the employer would have a duty of care toward him/her in terms of his/her safety in the workplace, as described above. If a job applicant refuses or fails to disclose past genetic testing to an employer and is subsequently hired, dismissal is possible but would not be based on disciplinary measures. If the termination occurs during the probation period (usually from three to six months), the employer can base its decision on its legal freedom not to employ. If the termination occurs after the probation period, it is subject to the Labour Contract Act.

5 Conclusion As described above, although there are no definitions and provisions in statutes or clear guidelines and regulations concerning the use of genetic testing results, it has not caused problems thus far. However, Japanese society might change drastically in this fast-moving world. If Japan evolves into a freer and less administrative society, the lack of clear guidelines may lead to uncertainties and inequality. I would like to stress the importance of precautious measures to address problems concerning genetic discrimination.

Reference Kai K, Sato Y, Nagamizu Y (2019) Medical Law in Japan, 3rd edn. Kluwer Law International, Alphen aan den Rijn

Legal Aspects of Genetic Testing Regarding Insurance and Employment in Poland Monika Wałachowska

Abstract In this article, the author analyses the framework for genetic testing in insurance and employment in the Polish legal system. The task is made difficult, however by the lack in Poland of any specific regulations in this area. For this reason, the general rules of insurance law, civil law, human rights law, medical law, and labour law are considered, along with data protection law. This paper highlights how the idea of a “special status” for genetic information is today no longer dominant, having been replaced with an understanding of genetic data simply as one type of medical data. As a consequence, the general rules applicable to the broader field apply to genetic data as well. Since there is no specific legal framework, the general rules on the duty to inform the patient are also used, along with the obligation to protect the privacy and other personality rights of both employees and patients undergoing genetic testing. The author also emphasizes that the genetic testing permitted cannot be conducted or applied in a way which infringes any antidiscrimination standards or the rules of confidentiality of sensitive personal data. The chapter concludes by stressing the desirability of introducing complex legislation on genetic testing both in insurance and employment.

1 Introduction The issue of genetic testing has raised many questions regarding the legal boundaries of such testing as well as its use and purpose. When it comes to employment contracts, for example, employers might have an interest in performing genetic testing to determine whether a specific position should be given to a certain employee. Some professions are prone to higher risks, and employees in some professions should perhaps not be employed in such risky workplaces. However, it is not necessarily in the employee’s best interest that genetic testing be performed.

M. Wałachowska (*) Nicolaus Copernicus University, Faculty of Law and Administration, Toruń, Poland e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_11

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The risk of discrimination leads to the conclusion that, in general, this kind of data gathering should not be allowed. The risk of discrimination is also significant in the context of insurance.1 To avoid such discrimination, an insurer assessing risk should not determine an individual’s premium or the availability of a certain kind of insurance protection based on the applicant’s predisposition to a genetically-based disease. In both employment and insurance, one should look not only to the rights to privacy and autonomy, but also to the right not to be informed. However, when an insurance company is gathering information, it is to some extent inevitable that its inquiries will touch upon health-related data—indicating, for example, the risk of some disease. For life insurance, the normal practice is to gather data on the insured party’s medical history (or the party to the insurance contract, when concluding an insurance contract for a third party; latin, pactum in favorem tertii), having in mind that the insurance contract is based on the good faith of both parties (latin, uberrima fides). While this is an acceptable practice, it should not be obligatory to undergo genetic testing,2 primarily because such testing would surely lead to discrimination.3 Even if we accept the use of genetic testing, the protection of the resulting genetic data must also be considered when drafting laws. Moreover, as Poland has no specific regulation concerning genetic testing in the contexts of insurance and employment,4 it is difficult to assess how frequent such testing is in practice. However, information available online5 and in the literature indicates this is an emerging problem. We observe the expanding use and availability of genetic testing in general, particularly DNA testing to establish family ties, but also in medical diagnostics that assess the risk of future disease.

1

Pawlikowski (2015), pp. 17–19. Grzymkowska (2009), p. 132. 3 Michalska and Twardowski (2001), pp. 233–235; Pawlikowski (2013), pp. 8 and 83; KrekoraZając (2014), pp. 25, 6–70. 4 With the exception of the Law of Insurance Activities and Reinsurance (ustawa o działalności ubezpieczeniowej i reasekuracyjnej) of 11 September 2015, OJ 2015, no 1844 which, similarly as the previous Act of 2003, plainly prohibits the gathering of genetic data by the insurer, when accessing the medical records of a patient being i.e. the insured party in an insurance contract. 5 See http://forumfarmaceutyczne.blog.pl/?p¼5520 and http://wyborcza.pl/1,76842,14155468, Testy_genetyczne_poza_kontrola__A_ustawa__ktora_moze.html. 2

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2 Legal Framework of Genetic Testing in Poland Since there is no specific legal framework for genetic testing in Poland, there is no official definition of “genetic” information. However, the Data Protection Act of 29 August 19976 provided,7 in article 27, that it was forbidden to process data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, religious affiliation, or party or union affiliation, “as well as health, genetic code (. . .), unless otherwise provided by law or by consent of the person in question.” Consequently, such information is an element of the general personal data protected by law, but is also regulated as “sensitive” data. This definition of sensitive data does not encompass family history. However, the Act of Insurance Activities of 2015 allows an insurer, especially in the case of life insurance, to gather and process the information and data needed for the evaluation of risk. This includes medical history however, insurers are not permitted to gather or process the genetic data. Moreover, the binding definition of “sensitive” data does not encompass or define either proteomic or epigenetic data. Therefore, the gap in the regulation leaves open questions as to whether genetic testing should be allowed only within a clinical setting for research purposes, or also through tests sold directly to consumers. It is worth mentioning that, in a draft statute dating from 2012, the distinction was addressed and considered as important.8 The Working Group9 rightly recommended testing only for medical (health) purposes.10 The lack of specific regulation poses many practical questions. For example, should a distinction be made between genetic tests that reveal existing health problems (diagnostic tests) and genetic testing that only predicts susceptibility to a certain disease (predictive tests)? To answer this, we must turn to more general legal rules, especially those found in medical law statutes.11 In both instances, the duty to inform plays a prominent role. One could argue that, especially in the case of Unified text – OJ 2016, no 922. The new Data Protection Act of 24 May 2018, OJ 2018 no 1000 implements the application of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016. Consequently the proper provisions of the Regulation apply accordingly (the rule is the same). 8 See Raport Zespołu do Spraw Molekularnych Badań Genetycznych i Biobankowania – Testy genetyczne dla celów zdrowotnych, Warsaw 2012, available at http://igcz.poznan.pl/wp-content/ uploads/2016/08/Ustawa-o-testach-genetycznych.pdf. 9 Regulation of Ministry of Health of 15th September created a Working Group for the purpose of preparing rules on genetic testing and bio-banking. 10 See section 10 of the report (Raport Zespołu do Spraw Molekularnych Badań Genetycznych i Biobankowania – Testy genetyczne dla celów zdrowotnych, Warsaw 2012, available at http://igcz. poznan.pl/wp-content/uploads/2016/08/Ustawa-o-testach-genetycznych.pdf). 11 See Ustawa o zawodach lekarza i lekarza dentysty [Statute on Doctor’s Activities] of 5 December 1996 (unified text – OJ 2017, no 125); ustawa o prawach pacjenta i Rzeczniku Praw Pacjenta [Act on Patients’ Rights and Patients’ Ombudsman] of 6 November 2008 (unified text – OJ 2016, no 186). 6 7

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predictive testing, counselling is of huge importance. Patients should be informed not only of the medical risks of a procedure (i.e. blood testing) but, more importantly, of the possible personal and social implications of the results (which might entail, for example, information concerning family members). Diagnostic tests are especially important prior to conception and in prenatal care. In light of the Infertility Treatment Statute of 25 June 2015,12 the use of pre-implantation genetic testing is allowed only for medical purposes, and must be preceded by genetic counselling (article 26). Testing for the purposes of phenotype selection (e.g. choosing the baby’s sex) is forbidden unless it is relied on to avert a severe, incurable hereditary disease. Counselling plays a very important role for predictive testing. One can argue that a patient has the right to know if he/she may be prone to illness in the future or has a chance of passing a disease onto his/her descendants. However, sometimes a lack of knowledge is more desirable. All the above mentioned factors should be considered when drafting special legal rules in Poland, hopefully in the near future. No specific regulation in Poland suggests that genetic data cannot, de lege lata, have a special status. To find such status, we must turn to the EU Regulation of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/ EC, which came into force on 25 May 2018 (GDPR).13 The Regulation provides some definitions, which have formed part of the Polish legal system since its coming into force. Article 4 states that for the purposes of the Regulation: “genetic data” means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, form an analysis of a biological sample from the natural person in question.

This wording bears notable similarities with article 4 of the UNESCO International Declaration of Human Genetic Data (the GDPR provides for special rules for the protection and processing of genetic data). The GDPR applies, according to article 3, “to the processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union, regardless of whether the processing takes place in the Union or not.” Article 9 of the GDPR adds that the processing of genetic data is generally prohibited, with exceptions outlined in paragraph 2. Such processing may be allowed, per subparagraph h, if “necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional.” In this context,

Unified text – OJ 2017, no 865. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, pp. 1–88. 12 13

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processing will be legal “when those data are processed by or under the responsibility of a professional subject to the obligation of professional secrecy under Union or Member State law or rules established by national competent bodies” (paragraph 3). However, “Member States may maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health” (paragraph 4). It is worth mentioning that before the GDPR came into force, genetic data was provided “special status” under article 8 of EU Directive 95/46 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Furthermore, article 1 of the Charter of Fundamental Rights in the EU (2012) protects dignity, and articles 7–8 protect privacy and personal data. Notably, the Convention for the protection on Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine, 1997 (the Oviedo Convention) does not address genetic data specifically; therefore, the general rule of article 10 (protection of privacy) applies accordingly. Apart from that, the Polish legal framework encompasses article 8 of the European Convention on Human Rights of 1950 (protection of privacy) and article 14 (prohibition of discrimination) under which genetic heritage can be understood as “other grounds” of discrimination.14 Moreover, article 21 of the Charter of Fundamental Rights of the European Union (2012) directly prohibits genetic discrimination.

3 Special Status of Genetic Data? There has long been discussion in Poland over whether to subject genetic data to special treatment in data protection law, or to treat it as an ordinary case of medical record. De lege lata, genetic information derived from testing is not covered under any specific regulation. The only distinction of note is that all medical data, like other intimate information (including health-related information), is distinguished as “sensitive” under both the Data Protection Act of 1997 (and of 2018) and GDPR. The gathering and processing of such sensitive data (as well as its accessibility to third parties) are regulated more strictly than are other personal data, and the legal protections are widened and strengthened. The discussion as to whether we should treat genetic data specifically stems from the concept of genetic information as being “exceptional” (in that it informs people’s risk of and propensity to contract some illnesses and, in so doing, the unsuitability of

14

Grzymkowska (2009), p. 171.

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certain people to certain professions).15 Furthermore, genetic data includes not only predictive information, but also implicates the interests of third parties (e.g. family members). It can also provide information about a person’s ethnic roots, their biological history, etc.16 Moreover, it might not yet be possible to properly interpret some of the information gathered at the time of testing. Nowadays, the idea of a “special status” for genetic information no longer dominates.17 On the contrary, the prevailing approach is to treat such data as a part of general, personal medical data—no matter that it might concern not only the person undergoing the testing but also implicate third parties. As it stands, general rules of the duty to inform, confidentiality, and informed consent are to be applied, though some specific rules should perhaps be introduced when it comes to bio-banking.18 It is worth mentioning that the duty to inform should be interpreted in a broader sense: the doctor’s duty should encompass not only information about the testing method, but should also extend to tan advisory role and to explanations concerning the possible importance of the results to third parties (i.e. family members).

4 Issues of Jurisdiction Over Human Genetic Data Collection, if Gathered by Multinational Insurance Companies Headquartered in One Country Under Directive 95/46, if a company was performing activities in a country, it must follow that country’s data protection laws.19 According to the wording in case C-230/14 of the Court of Justice of the EU (the Weltimmo case of 1 October 201520), the processing of data is carried out in the context of the activities of an 15

See also Art 4 of the UNESCO Universal Declaration on the Human Genome and Human Rights, adopted on 11 November 1997. The Declaration states that there should be a special protections granted for genetic data and that this data is to be treated differently/specially. 16 Grzymkowska (2009), p. 134. 17 Grzymkowska (2009), p. 134. See also Łakomiec (2016), p. 83; Kapelańska-Pręgowska (2011), p. 144; Krajewska (2008), p. 64. 18 Wytyczne dotyczące biobankowania ludzkiego materiału biologicznego dla celów badań naukowych [Guidelines for biobanking of human biological material for research pursposes] prepared by the Group on Research in Biomedicine acting at the Ministry of Science and Higher Education in 2013–2014, Łakomiec (2016), p. 87. 19 See also Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 27. 20 Judgment of the Court (Third Chamber) of 1 October 2015, Weltimmo sro v Nemzeti Adatvédelmi és Információszabadság Hatóság, C-245/14. See also Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Art 18.

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establishment of the controller on the territory of the Member State. When the same controller is established on the territory of several Member States, he/she must take the necessary measures to ensure that each complies with the obligations laid down by the applicable national law. Therefore, if the results of genetic testing (or any medical data) are shared electronically (e.g. via email) to a third country, that country’s protection rules should also be followed. However, the public authority of a Member State has jurisdiction only within its own territory. Moreover, an authority of another Member State may request a national authority to exercise its powers.21 The Court also ruled that where the supervisory authority of a Member State, to which complaints have been submitted in accordance with Article 28(4) of Directive 95/46, reaches the conclusion that the law applicable to the processing of the personal data concerned is not the law of that Member State, but the law of another Member State, Article 28(1), (3) and (6) of that directive must be interpreted as meaning that that supervisory authority will be able to exercise the effective powers of intervention conferred on it in accordance with Article 28(3) of that directive only within the territory of its own Member State. Accordingly, it cannot impose penalties on the basis of the law of that Member State on the controller with respect to the processing of those data who is not established in that territory, but should, in accordance with Article 28(6) of that directive, request the supervisory authority within the Member State whose law is applicable to act.

De lege lata, according to its article 3, the GDPR applies to the processing of personal data “in the context of the activities of an establishment of a controller or a processor in the European Union, regardless of whether the processing takes place in the Union or not.” The Regulation “applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: [. . .] such data subjects in the Union; or (b) the monitoring of their behaviour as far as their behaviour takes place within the Union.” Moreover, it “applies to the processing of personal data by a controller not established in the Union, but in a place where Member State law applies by virtue of public international law.”

21

See also Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016, Preamble, para 5, stating that “National authorities in the Member States are being called upon by Union law to cooperate and exchange personal data so as to be able to perform their duties or carry out tasks on behalf on an authority in another Member State.” This could be the case when, for example, a natural person no longer wants its data to be processed in another Member State.

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5 The Duty to Inform as Applicable to Genetic Testing Undertaken in a Clinical Medical Setting or in a Biomedical Research Setting: The Problem of the Socio-Legal Risks Associated with the Testing As already observed, since there is no specific applicable legal framework in Poland, rules regarding the general duty to inform must apply to the conduct of genetic testing. Doctors are obliged to inform their patients or participants in medical research studies of the general risks associated with a test (especially when it comes to the possible disclosure of results to third parties). However, one could argue that the duty to inform is not relevant in the insurance or employment contexts, in as much as gathering genetic data is prohibited in insurance and predictive testing as a prerequisite for (continued) employment could be considered as a form of proscribed discrimination. Moreover, since the results of genetic testing are undoubtedly subject to medical secrecy duties, if the patient would be apt to disclose them to third parties, article 40 of the Statute on Doctors’ Activities (1996), further obliges the doctor to inform the patient about (any) risks involved with disclosure to (any) third party. Given that the information may reveal medical information about third parties (e.g. children), doctors should warn patients not to disclose their own information (i.e. revealing information about genetically based disease may infringe third persons’ privacy). It is worth mentioning that in 2012, the draft of a statute on the standards of genetic testing for health purposes was prepared.22 The draft was intended to conform with the Oviedo Convention (and its additional protocols) for the protection on Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine.23 The authors aimed to prohibit discrimination based on genetic characteristics or heritage, as well as to provide for neutral legal solutions.24 The draft contained regulations protecting the patient and informed consent. The general idea was to prohibit genetic testing (or revealing its results) as a prerequisite to concluding an insurance contract, in accordance with article 12 of the Oviedo Convention.25 The same rule was proposed for the field of employment.

22

Draft bill of the Law on Genetis Tests Performed for Health Purposes, available at http://igcz. poznan.pl/wp-content/uploads/2016/08/Ustawa-o-testach-genetycznych.pdf. 23 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, CETS no 164 (signed but not yet ratified by Poland). 24 Witt and Witt (2016), p. 76. 25 Draft bill of the Law on Genetis Tests Performed for Health Purposes, available at http://igcz. poznan.pl/wp-content/uploads/2016/08/Ustawa-o-testach-genetycznych.pdf.

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6 Genetic Testing and Human Rights In the absence of specific Polish regulation on genetic testing and genetic status, general international and national human rights norms may be particularly relevant to the regulation in practice. The European Convention on Human Rights (1950) plays an important role in the regard, especially articles 8 (protection of privacy) and 14 (prohibition of discrimination). Moreover, article 32 of the Polish Constitution of 1997 states directly that any form of discrimination on any grounds, shall be forbidden by law. Undoubtedly, discrimination based on genetic history is encompassed by this rule, although no law in force directly puts this constitutional norm into effect.26 Likewise, article 11(3) of the Labour Code of 197427 forbids discrimination in employment on any grounds. It follows that differential treatment based on genetic testing results or genetic heritage could also be deemed discriminatory. The interactions an individual’s genetic status and other status characteristics raise additional issues. In particular, the common genetic heritage of certain populations may make them more (or less) susceptible to certain geneticallyindicated diseases. To the degree that medical professionals may identify an individual’s health risks on the basis of population characteristics, he/she should inform the patient of the option to undergo genetic testing and the possible risks stemming from the knowledge of the results. Undoubtedly this issue should be taken into account when drafting future regulations in Poland. The knowledge obtained on the basis of genetic testing should remain confidential because it could otherwise lead to discrimination. There is no case law reported on these matters. However, it should be noted that, according to article 18(3d) of the Labour Code, a successful plaintiff is entitled to minimum damages set by reference to the monthly minimum wage—since 1 January 2020, this amounts to 2600 PLN (approximately 570 EUR),28 quantum of damages does not depend on the size of the loss. That is, this sum is awarded even if the plaintiff does not prove the injury; it thus has a penal function and may bring satisfaction to the plaintiff.29 According to article 18(3b) paragraph 1 of the Labour Code, the employee does not have to prove the discrimination. This reversal of the burden of proof is contrary to the general rule in article 6 of the Civil Code of 1964. The employee must only present the facts upon which the discrimination is founded. It is for the employer to prove they committed no discriminatory practices.30 26

Kasnowska (2014), p. 117. Unified text: OJ 2016, no 1666. 28 Rozporządzenie Rady Ministrów [Regulation of the Board of Ministry] of 10 September 2019 on the minimum salary in 2020 (OJ 2019, no 1778). 29 Judgment of the Supreme Court of 10 July 2014, II PK 256/13, Lex No1515454. 30 Judgment of the Supreme Court of 9 June 2006, III PK 30/06, OSNP 2007, No 11–12, item 160; Maniewska (2016), comment of Art 18(3a)–18(3b). 27

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Having presented the general non-discrimination framework, we can now consider whether it is sufficient to address the challenges posed by genetic testing in the insurance and employment contexts. The answer is not simple: since Poland has yet to introduce a special legal framework for genetic testing, we must draw a conclusion based on the existing law. While the general non-discrimination rules may seem to be sufficient, genetic testing in employment might be allowable in certain situations. One such example is where disease susceptibility would be an obstacle to performing specific tasks of the position. Therefore, genetic testing is only allowed where it is conducted for health purposes (compare article 12 of the Oviedo Convention31). When it comes to insurance, the general rules of data protection apply and, de lege lata, the proper understanding and application of these rules provide protection to the insured. In spite of the aforementioned doubts, some authors believe that genetics-based discrimination is not yet a real threat in labour law (nor in other fields), but that it may become so in the future.32 Keeping in mind the risks posed by genetic testing, however, regular monitoring of insurance companies and employers is advisable,33 especially when we consider that a person may not wish to know if she/he is prone to a genetically-based disease. In this field, as in insurance, the basic principle to be invoked is that provided in article 51 of the Polish Constitution (1997): no one shall be obliged to disclose personal information unless otherwise stated by the law. In labour law, article 22 (1) of the Labour Code (1974) states that employers have the right to obtain certain information about employees. As this provision does not include genetic data among the information an employer can demand, neither can it be understood to fall under the purview of the exception in article 51 of the Constitution—“unless otherwise stated by the law.” The aim of article 22(1) is to protect the privacy of employees and job candidates, as well as to prevent discrimination.34 However, article 22(1) is not engaged if an employer obtains genetic information from other sources, since it applies solely to exchanges between employer and employee or candidate. Genetic data falls within the personal sphere of the employee or candidate and is, therefore, not accessible unless otherwise provided by law (see article 22(1) paragraph 4 of the Labour Code). Ultimately, it is important to emphasize that a request for disclosure of genetic data when concluding an employment contract constitutes discrimination.35 31

Kapelańska-Pręgowska (2011), pp. 327–329; Kulesza (2006), p. 8; Pawlikowski (2013), p. 84. Zoń (2013), p. 329. 33 Kapelańska-Pręgowska (2011), p. 317. 34 Zoń (2013), p. 330. See also Świątkowski (2012). 35 Zimny (2000), p. 5, cited in Zoń (2013), p. 331. Moreover the Resolution of the European Parliament of 16 March 1989 on ethical and legal problems of the genetic engineering did not allow the genetic testing demanded from the candidate. The Resolution of the Committee of Ministry of the Council of Europe R(92)3 of 10 February 1992 also stated that conclusion of an employment contract should not depend on the candidate undergoing genetic testing. 32

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Moreover, article 27 of the Data Protection Act (1997) could have been recalled (as its relation to article 22(1) of the Labour Code was not clear), providing for the grounds of legal processing of sensitive data. However, in general, no sensitive data, including genetic information, can be processed unless otherwise provided by law or agreed to by the person. This greater protection is based on the need to prevent discrimination.36 Similarly, article 9 of GDPR prohibits processing “special” data (e.g. genetic data), unless certain exceptions apply. The exceptions should not be interpreted broadly and should take into account the purpose and adequacy of processing and time limits.37 The person whose genetic data is to be processed must consent in writing However the doctrine rightly claims that consent obtained before concluding (or during) an employment contract is void because it was not freely negotiated.38 The doctrine concludes that article 22(1) of the Labour Code should be treated as lex specialis in relation to the former article 27 of the Data Protection Act,39 especially upon the acknowledgment that genetic data is included under the right to the protection of privacy. We should also consider whether genetic testing (or otherwise obtaining genetic data) could be legally acceptable during employment. Here too, the risk of discrimination is prominent (especially when, for example, the employer wishes to perform a prognostic genetic test to determine an employee’s predisposition to certain diseases). Broadly speaking, employers may only obtain an employee’s health data when directly permitted by law.40 As a matter of law, however, the employer has an obligation to protect the health of employees and to fulfil this obligation, he/she might be allowed to require an employee to undergo a medical examination (see article 229 of the Labour Code). Based on the examination, the doctor will issue a medical certificate evaluating the employee’s ability to work (in general or at a specific post). The employer, however, does not have access to the actual medical records, thereby protecting the employee’s privacy. In short, genetic testing cannot be required except where it is intended to protect the employee’s health and, even if the employee’s medical history includes information about genetic heritage, the employer cannot legally seek access to this information; doing so would be discriminatory.41 Since the employer has an obligation to provide a safe environment that protects the employee’s health, we must further distinguish between genetic testing and genetic monitoring (which could also be discriminatory).42

36

Barta, Fajgielski and Markiewicz (2011), pp. 548–549. Drozd (2005), p. 11. 38 Gersdorf, Rączka and Skoczyński (2005), pp. 119–120; Zoń (2013), p. 332; Barta, Fajgielski and Markiewicz (2011), p. 458. 39 Zoń (2013), p. 332. 40 Wujczyk (2012), p. 294, cited in Zoń (2013), p. 333. 41 Zoń (2013), p. 334. 42 Kapelańska-Pręgowska (2011), p. 321. 37

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Additionally, article 32 of the Constitution prohibits discrimination on any ground; therefore, genetic heritage cannot be invoked by the employer during the recruitment of future employees. The equal treatment rule set forth in article 18 (3a) paragraph 1 of the Labour Code develops this rule further, adding that it applies at any stage of (or even before) employment. Direct discrimination, in the context of article 18(3a), means that an employee is treated less favourably, on any grounds, than are others in the same situation. Indirect discrimination is understood as treating a group differently based on one of the grounds mentioned in the open catalogue set out in article 18(3a). Genetic heritage should be seen as a prohibited criterion under either form of discrimination. Moreover, the employer’s duty is not only to refrain from discrimination, but also to actively counteract it (see article 18(3a) in connection with article 94 point 2b).43 All these arguments apply equally for the purposes of insurance (e.g. genetic heritage cannot serve as a negative factor when concluding an insurance contract).

7 Privacy, Confidentiality, and Disclosure The protection of the privacy of the person undergoing genetic testing is another of the legal issues raised by such testing in the employment and insurance contexts. Such protections extend to the handling of medical records and encompass regulations over third-party access to them (including access by insurers and employers). The general rules of non-disclosure and professional (medical) secrecy should be particularly stressed here. Article 40 of the Statute on Doctor’s Activities (1996) states that doctors have an obligation to keep confidential all patient information gathered in the course of performing their professional activities. The same obligation appears in article 13 of the Patients’ Rights Act of 2008, but applied to all medical professionals, including nurses, medical rescuers, and so forth. Health care providers (including doctors, hospitals, etc.) may only provide access to medical records to the patient, his/her legal representative, or an authorised person, including after the patient’s death (article 26 of the Patients’ Rights Act). The authorised person can be any third person named by the patient (or his/her legal representative). According to the 2015 Act on Insurance Activities, insurers are also granted access rights to certain medical information, but genetic data is excluded. Clearly, unless provided for by law or mediated by the patient’s consent, genetic data remains confidential, even after the patient’s death (however, since February 2019, article 26 section 2a of the Patient’s Rights Act states that after patient’s death, in case of a dispute between relatives, the permit to disclose medical data is issued by court). There is thus no general legal basis for the employer to access employees’ medical records, especially those containing genetic testing results.

43

Zoń (2013), p. 336.

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Under article 26 of the Patients’ Rights Act, the social security office is also extended limited access to medical records, where it is necessary for the purposes of ongoing proceedings (e.g. in case of pensions). Having in mind its “sensitive” status, I would, however, argue this access right does not extend to genetic data. General rules also apply in cases where genetic test results are obtained in the context of biomedical research. However, where such data is obtained in the course of medical experiments, the results can be disclosed for scientific purposes without the person’s consent, as long as his/her anonymity is ensured (article 28 of the Statute on Doctor’s Activities). When such data is gathered during clinical research, special rules regarding non-disclosure should be adopted. So far, the Pharmaceutical Law of 6 September 201144 contains only general rules for the processing of gathered data (see articles 37ca and 37ia). We must also consider what role consent plays in allowing genetic information contained in a medical or hospital file to be disclosed to third parties, such as insurers and employees. I would argue that genetic testing falls within the general legal framework of consent to medical treatment. This means that not only is consent a prerequisite to perform the testing, but consent must be properly informed, in line with medical law (see below). Of important note in this context is the Oviedo Convention, which allows national laws to introduce genetic testing outside medical purposes (article 26) only on limited grounds.45 The fourth Protocol on genetic testing for health purposes (27 November 2008) stresses that testing can be performed only for health purposes, unless otherwise regulated in national law. In any case, the national legislator should carefully circumscribe these exceptions, drawing rational boundaries, keeping in mind privacy and non-discrimination principles, as well as proportionality and the need to protect the employee and third parties (e.g. for pilots). As yet, the protocol on genetic testing in insurance and employment has not been drafted.46 The fifth protocol concerns only genetic testing for health purposes.47 In any case, the consent of the person in question would be needed not only for genetic testing, but also for the disclosure of the results. As there is no specific regulation concerning genetic testing and the disclosure of its results in Poland, the general rules of medical law apply. Article 40 of the Statute on Doctor’s Activities (1996) applies here (similarly—articles 13–14 of the Statute on Patient’s Rights of 2008). In general, the genetic information contained in medical or hospital files is protected under professional (medical) secrecy. Therefore, it is the patient or his/her legal representative who decides to disclose the information and to whom. That secrecy remains binding after the patient’s death (with some exceptions; see below). Article 40, however, provides for some

Unified text – OJ 2017, no 1015. Grzymkowska (2009), p. 131. 46 Kapelańska-Pręgowska (2011), p. 60. 47 Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, adopted 27 December 2008, CETS no 203. 44 45

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exemptions, which are to be interpreted narrowly: They include the patient’s informed consent, which means that the patient must be informed of the consequences of disclosure. To sum up, third persons have no general right to the disclosure of any medical data (the same rule applies to medical files). Only the patient (or his/her legal representative) can decide to disclose, and only after having been properly informed about the risks of disclosure. However, it is debatable whether such a disclosure is ever valid, especially when the genetic data is disclosed upon conclusion of a contract (of employment or insurance). Since the parties are not equal, one could conclude that the consent is void.

8 Protection of the Interests of Family Members Versus the Protection of Genetic Information When considering the rights of family members in genetic testing, we must again refer to general legal rules concerning the protection of privacy, non-disclosure duties, and professional secrecy. As previously noted, genetic information is understood to form part of a person’s health information Therefore, it falls under civil and medical law protections, as well as the Data Protection Act. Since this data is recognized as “sensitive,” gathering and processing it requires the patient’s consent (or that of his/her legal representative), unless otherwise provided by law. This data can be part of the medical or hospital file (if such information is essential for treatment, prognosis, etc.) Thus, it is generally the patient (or his/her legal representative) who will decide to whom the files will be disclosed. There is no legal framework for nasciturus either. Therefore, it is for the parents to decide to undergo prenatal testing (including genetic tests). The Act on Planning of the Family and the Grounds of Termination of Pregnancy of 199348 provides that a pregnant woman has the right to prenatal care and information about possible testing—including genetic testing—especially when there is a risk of a hereditary disease (article 2 paragraph 2a).49 Where a severe hereditary disease is discovered, an abortion might be performed subject to the pregnant woman’s decision to exercise her rights in this respect. However, when it comes to the disclosure of genetic data gathered in the prenatal stage, general rules again apply. Parents (i.e. legal representatives) of a prenatallydiagnosed child have the right to decide to disclose such information and to whom. However, they are not obliged to do so. Nor does an insurance company have a right to obtain this data (as a part of medical records). Furthermore, I can see no reason for, or interest of, an employer to obtain this data.

48 49

OJ 1993 no 17, item 78. Nesterowicz (2016), pp. 280–285.

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9 Access to Information Regarding Health or Medical Status (Enclosed Also in Medical Records). A Right Not to Know the Results of Testing When an employee or candidate is undergoing medical testing, he/she has the right to access the records on general grounds (i.e. it is a patient’s right to access his/her medical records—see article 26 of the Patients’ Rights Act of 2008). As previously noted, the doctor issues a medical certificate evaluating the employee’s ability to work (in general or at a specific job). However, the employer does not have access to these medical records, thereby ensuring the protection of the employee’s privacy. In the 2012 draft statute,50 article 20 prohibits the employer from requiring genetic testing or demanding the disclosure of genetic data before concluding an employment (or similar) contract. Insurance companies, on the other hand, do have access (as does the patient him-/herself) to medical records, with the exception of genetic testing results and genetic data. Family members have full access, if authorised by the patient (or his/her legal representative). After the patient’s death, close persons (defined by article 3 of the Patients’ Rights Act51) may release the doctor from his/her professional secrecy obligations. This leads to the question of whether this release encompasses genetic data or information about genetic heritage. At first glance, the answer seems to be affirmative. However, one must consider the privacy interests of family members, and their right not to know about their genetic heritage. We must, therefore, assess each case individually. For example, if the doctor is released from his/her secrecy obligations, should he/she inform the close persons about their chance or higher probability of developing a genetic disease? Though the answer should perhaps be affirmative, this matter needs attention when drafting laws in Poland. We should also bear in mind that even after introducing paragraphs 2a–2b to the article 26 of Patients’ Rights Act in 201952 it is unclear whether genetic data should be disclosed after the patient’s death. According to the new law the patient may object to disclosure of its medical records to third persons after its death. However a close person may submit an application to the court for permission to access the medical records (only for the purposes of claiming damages upon the patient’s wrongful death or for the protection of its own life or health). This means in general that with the permission of the court, the child of the diseased patient, for example, may obtain the latter’s medical records. The question remains whether it includes genetic tests results. In general, the answer should be affirmative (if, for example, such data is necessary to decide whether to undergo specific medical tests).

50

See Draft bill of the Law on Genetis Tests Performed for Health Purposes, available at http://igcz. poznan.pl/wp-content/uploads/2016/08/Ustawa-o-testach-genetycznych.pdf. 51 Spouse, relatives to the 2nd degree, next of kin to the 2nd degree in a straight line, person authorised by the patient and a living-partner. 52 Statute of 6 December 2018, entered into force 9 February 2019, OJ 2018, item 150.

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We should also stress that, in addition to the patient’s right to obtain information about his/her health, diagnosis, prognosis, etc., he/she has the right not to be informed (or to be partially informed). At any time, however, the patient has a right to obtain full information (see article 31 of the Act of Doctor’s Activities of 1996 and article 9 of the Patients’ Rights Act of 2008). This provision is general, and it thereby applies to genetic information. Ultimately, it is the individual who decides in this matter. In the insurance and employment contexts, the exercise of this right is of no importance: since neither the insurer nor the employer has the right to obtain the genetic information, the patient’s knowledge (or lack thereof) is irrelevant.

10

Other Rights and Principles Relevant to the Use of Genetic Testing in the Context of Insurance or Employment (e.g. Autonomy, Self-Determination)

As mentioned, the draft bill of the Law on the Genetic Testing for Health Purposes was prepared in 2012.53 The authors aimed to prohibit discrimination based on genetic characteristics or heritage, as well as provide for neutral legal solutions.54 The draft contained regulations protecting the patient and informed consent. It outlined exactly who could prescribe genetic testing, provided detailed rules for the supervision of the testing and biological material, clarified who has access to the information, and laid out procedures for counselling concerning the testing itself and its results. The goal lay in protecting the confidentiality of the data “but also providing in some exceptional cases access to the data to third parties” (article 11). Unfortunately, Parliament has yet to introduce these laws concerning genetic testing, or any specific regulations concerning such tests in the fields of labour or insurance. In September 2016, the Ministry of Health created a Working Group on regulating genetic testing and bio-banking. As of yet, no official proposals have been produced—although the group was supposed to present the general aims of the future regulations.55 For many years, even the Ombudsman has tried to persuade the Ministry of Health to proceed further on the discussed topics, but without success.56 All of these efforts to further the law were undoubtedly aimed at the protection of human dignity, autonomy, and self-determination.

53 The text in Polish is available at http://igcz.poznan.pl/wp-content/uploads/2016/08/Ustawa-otestach-genetycznych.pdf. 54 Witt and Witt (2016), p. 76. 55 See Zarządzenie Ministra Zdrowia [Regulation of Ministry of Health] of 15 September 2016 w sprawie powołania Zespołu do spraw uregulowania wykonywania testów genetycznych i biobankowania [act creating a Working Group on preparing rules of genetic testing and bio-banking]. 56 See for example a letter of 24 March 2016, available in Polish at: https://www.rpo.gov.pl/pl/ content/wystapienie-do-ministra-zdrowia-ws-badan-genetycznych.

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At present, genetic testing must be prescribed by a doctor after obtaining the informed consent of the patient (or his/her legal representative). Since 2009, the activities of laboratories carrying out genetic tests have been regulated, providing for special quality standards.57 However, access to testing and the types of tests available are not regulated. Therefore, there is no obligation to provide information with do-it-yourself-kit that consumers may purchase, even though these tests’ results may be difficult for an individual user to interpret.58 Moreover, no statute gives a patient the right to a genetic consultation or examination. Only article 51h of the Code of doctors’ ethics mentions this possibility. On the other hand, one could argue that the right to information encompasses that of being informed about the availability of genetic testing.59 All of these values are also encompassed in the EU Regulation No. 2017/746 from 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (coming into force on 26 May 2022). Article 4 states: 1. Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as defined in point (a) of article 3 of Directive 2011/24/EU of the European Parliament and of the Council and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate. 2. In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that there is appropriate access to counseling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science and technology. 3. Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used. 4. Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent. These provisions could serve as a good example for legislators for the drafting of the national laws that are currently-lacking in these matters.

57

See Rozporządzenie Ministra Zdrowia [Regulation of Ministry of Health] of 23 March 2006, changed in 2009 and 2015 (unified text: OJ 2017, no 1665). 58 Kapelańska-Pręgowska (2016), p. 94. 59 Krekora-Zając (2014), pp. 240–241.

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Conclusion

Even though Poland has a general framework on non-discrimination, protection of privacy, confidentiality, and consent, these are insufficient to protect the interests at stake in the conduct and regulation of genetic tests. It is desirable to introduce comprehensive legislation on genetic testing both in insurance and employment. The law should state directly that it is forbidden to compel genetic testing when concluding an employment or insurance contract. Moreover, as a rule, genetic testing should be limited solely to health/medical purposes. De lege lata, without a doubt, the Oviedo Convention with its protocols, the UNESCO documents, EU law, and human rights conventions and recommendations play an important role and can serve as guidance for national legislators. However, in an era of the internet and transnational business activities, perhaps a supranational body would be best placed to monitor the processing of genetic data in order to enable agreed-upon common standards.

References Barta J, Fajgielski P, Markiewicz R (2011) Ochrona danych osobowych. Komentarz. Wydawnictwo C.H. Beck, Warsaw Drozd A (2005) Zasady przetwarzania danych w aktach osobowych pracowników. PiZS 3:11–19 Gersdorf M, Rączka K, Skoczyński J (2005) In: Salwa Z (ed) Kodeks pracy. Komentarz. LexisNexis Polska, Warsaw, pp 119–120 Grzymkowska M (2009) Standardy bioetyczne w prawie europejskim. Wolters Kluwer Polska, Warsaw Kapelańska-Pręgowska J (2011) Prawne i bioetyczne aspekty testów genetycznych. Wolters Kluwer Polska, Warsaw Kapelańska-Pręgowska J (2016) Wybrane problemy prawnej regulacji testów genetycznych. In: Białek A, Wróblewski M (eds) Wybrane aspekty praw człowieka a bioetyka. Biuro Rzecznika Praw Obywatelskich, Warsaw, pp 89–101 Kasnowska A (2014) Dopuszczalność zastosowania testów genetycznych w ocenie ryzyka ubezpieczeniowego w Polsce i innych państwach Unii Europejskiej. Rozprawy Ubezpieczeniowe 2(17):105–119 Krajewska A (2008) Informacja genetyczna a zakres autonomii jednostki w europejskiej przestrzeni prawnej. Wroclaw University Press, Wroclaw Krekora-Zając D (2014) Prawo do materiału genetycznego człowieka. LexisNexis Polska, Warsaw Kulesza E (2006) Kilka uwag o przetwarzaniu danych osobowych pracowników przez pracodawcę – regulacje obowiązujące i uwagi de lege ferenda. In: Biuro Generalnego Inspektora Ochrony Danych Osobowych (ed) Ochrona danych osobowych wczoraj, dziś, jutro. Biuro Generalnego Inspektora Ochrony Danych Osobowych, Warsaw, pp 7–15 Łakomiec K (2016) Regulacja badań genetycznych a konstytucyjny standard ochrony praw jednostki. In: Białek A, Wróblewski M (eds) Wybrane aspekty praw człowieka a bioetyka. Biuro Rzecznika Praw Obywatelskich, Warsaw, pp 79–87 Maniewska E (2016) Commentary of Art 18(3a)–18(3b). In: Maniewska E, Jaśkowski K (eds) Kodeks pracy Komentarz, vol 1. Wolters Kluwer Polska, Warsaw

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Michalska M, Twardowski T (2001) Człowiek wobec osiągnięć współczesnej biotechnologii. In: Twardowski T, Michalska A (eds) Korzyści, oczekiwania, dylematy biotechnologii. Agencja Edytor, Poznań, pp 231–239 Nesterowicz M (2016) Prawo medyczne. TNOiK, Toruń Pawlikowski J (2013) Biobankowanie ludzkiego materiału biologicznego dla celów badań naukowych – aspekty organizacyjne, etyczne, prawne i społeczne. Wydawnictwo Uniwersytetu Medycznego w Lublinie, Lublin Pawlikowski J (2015) Ochrona prywatności dawców w kontekście biobankowania ludzkiego materiału biologicznego dla celów badań naukowych. In: Nawrot O, Wnukiewicz-Kozłowska A (eds) Temida w dobie rewolucji biotechonologicznej. Wydawnictwo Uniwersytetu Gdańskiego, Gdańsk Świątkowski A (2012) Kodeks pracy. Komentarz. Wydawnictwo C.H. Beck, Warsaw Witt MP, Witt MM (2016) Czy genetyka kliniczna to dziedzina bezpieczna? In: Białek A, Wróblewski M (eds) Wybrane aspekty praw człowieka a bioetyka. Biuro Rzecznika Praw Obywatelskich, Warsaw, pp 71–78 Wujczyk M (2012) Prawo pracownika do ochrony prywatności. Wolters Kluwer Polska, Warsaw Zimny W (2000) Przesłanki legalizujące przetwarzanie. Biuletyn Ochrony Danych Osobowych 2000(4):5–7 Zoń KM (2013) Różnicowanie pracowników ze względu na dziedzictwo genetyczne w prawie polskim. Acta Universitatis Wratislaviensis 315(1):329–342

Regulating the Use of Genetic Testing by Insurers and Employers in the Province of Quebec: Is the Genetic Non-Discrimination Act Really Necessary? Yann Joly and Gabriel Marrocco

Abstract Insurers and employers have become increasingly interested in the capacity of genetic information to predict future health outcomes. This trend has sparked fears that they may use this information to discriminate between individuals based on their genetic characteristics. Despite limited empirical evidence, concerns among some interest groups have prompted many G8 countries to adopt legislation to protect against genetic discrimination (GD), including Canada in 2017. Quebec was quick to challenge the constitutionality of the Genetic Non-Discrimination Act (GNDA) on the basis that the Canadian government exceeded its legislative power over criminal law, impinging on the provinces’ jurisdiction over local matters and property and civil rights. It argued that the provinces and territories are the competent legislators to enact such regulation, and that existing laws in Quebec make specific legislative action unnecessary. This chapter explores Quebec law pertaining to privacy, insurance, employment, and human rights and critically evaluates Quebecers’ current protections against GD, including that afforded by the GNDA. It also reviews Quebec’s constitutional challenge to this new Canadian legislation.

1 Introduction The province of Quebec has taken a growing interest in genetic research as researchers in the province have launched multiple genomic research initiatives, including large-scale infrastructure projects like the CARTaGENE biobank, which hosts data from over 40,000 Quebecers.1 These innovative projects often require that 1 Genome Quebec (2018), “Our History”, http://www.genomequebec.com/en/history.html; https:// cartagene.qc.ca/en/aggregated-data/number-individuals-cartagene-metropolitain-region.

Y. Joly (*) · G. Marrocco McGill University, Faculty of Medicine, Department of Human Genetics, Montreal, QC, Canada e-mail: [email protected]; [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_12

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Quebecers be ready to share their genetic and health data for medical research purposes. As this research progresses towards clinical applications, more patients will receive genetic testing to improve preventive care and medical treatment. Quebec has also been targeted by a growing number of direct-to-consumer genetic testing (DTC-GT) companies, like 23andMe and AncestryDNA, which offer information about users’ ethnic background or predict their disease risks. The ubiquity of genetic data in public and private databases has raised ethical issues relating to data protection and potential discrimination by third parties such as insurers and employers. The debate on genetic discrimination (GD) hinges on the question of whether genetic information is different from the other types of health data which insurers, and to a lesser extent employers, rely on to make certain decisions. One position, commonly referred to as genetic exceptionalism, stipulates that the law should explicitly afford special status and more protection to genetic information because of its sensitive nature. Genetic exceptionalism emerged from its predecessor, “HIV exceptionalism”2, that suggests that such health information raises distinct issues, thus demanding special protections. Developments in genetic technologies, such as progress in detecting rare monogenic disorders in the 1980s and the commencement of the Human Genome Project in 1990 raised various novel issues associated with this new dearth of information.3 Legislators and policymakers generally considered three key options to address this, as highlighted by Rothstein (2007): (1) maintain the status quo; (2) establish a comprehensive law concerning the collection, use, and disclosure of health information generally; and (3) enact specific provisions dealing with genetic information.4 Each of these courses of action is rooted in either the view that genetic information should be treated no different from other health information (such as option 1 and 2), or that genetic information is unique and should be treated as such (as illustrated in option 3). The table provided below (Table 1) succinctly summarizes this ongoing debate. Of the three legislative and policy options laid out above, it appears that the third is the preferred course of action in the US.5 In Canada, the fear of GD and its negative effect on patients’ or research participants’ decisions to undergo genetic testing is well documented,6 and to a lesser extent, such apprehensions have been documented in Quebec.7 Wide-ranging concern among the population has prompted many European and North American governments to implement various policy solutions, many of which are discussed in this book. So far, Quebec has generally resisted international pressure to adopt a governance framework based on genetic

2

See Murray (2019), p. 14. Rothstein (2007), p. 59. 4 Rothstein (2007), p. 59. 5 Rothstein (2007), p. 59. 6 See e.g. Phoenix Strategic Perspectives Inc (2016); Bombard et al. (2012); Stavropoulos et al. (2016), p. 6. 7 See Dalpe et al. (2017). 3

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Table 1 The genetic exceptionalism debate Justifications Genetic information is complex. It often offers only probabilistic results and is hard to validate, making it susceptible to interpretation errors.

Genetic information has predictive value and can give us information on an individual’s future health risks. Information on genetic predispositions is not unique to an individual. These predispositions are shared with family members, ancestors, descendants, and sometimes with larger population groups. Genetic information is particularly useful for the identification of individuals. Even if collected for healthcare or research purposes, it can be used in biometric surveillance systems or to discriminate between individuals. Genetic data are rich in informational content. A small number of markers can identify an individual, establish filiation, and uncover various predispositions to diseases. It is also possible that analysis by a medical professional or researcher could reveal unanticipated or incidental information about the patient or research participant. Genetic information is easy to collect, analyze, and store in computerized form.

Counter-arguments Non-genetic medical information can also be hard to interpret. For example, medical diagnosis of certain diseases can be complicated by symptoms that are variable or common to other diseases. Medical, environmental and occupational data relating to an individual can also inform interested parties about their future health risks. The collective nature of genetic information is a point in favour of democratizing access amongst affected individuals and populations, rather than affording it additional protection. An individual can also be uniquely identified using clinical data such as blood type, pathologies, medical imaging test results, or specific dates and places contained in their medical file. In practice, the amount of relevant information that can be extracted from an individual’s genetic data is limited by technological barriers, as well as our limited knowledge of genetics in general.

Developments in computing, artificial intelligence, and big data make this statement true for most types of health data.

exceptionalism. This may be due to the lack of empirical evidence and limited discussion about the existence and impact of GD in the province.8 The only robust published studies on the incidence of GD in Canada (excluding the province of Quebec) are based on data from families with a history of Huntington’s disease.9 Their conclusion that GD is widespread therefore only applies to the particular context of rare dominant genetic disorders transmitted by mutations on a single gene.10 The Canadian government recently responded to public fear of GD via the Genetic Non-Discrimination Act (GNDA),11 adopted in 2017. The GNDA, amongst other interdictions, prohibits any person from requiring an individual to undergo a

8

See Joly et al. (2017), pp. 9–10. Bombard et al. (2007, 2009, 2012). 10 Joly et al. (2017), p. 10. 11 Genetic Non-Discrimination Act, SC 2017, c 3. 9

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genetic test or disclose the results of a genetic test as a condition of providing goods or services, entering into or continuing a contract or agreement, or offering specific conditions in a contract or agreement with an individual.12 The act is further discussed below, in Sect. 8 of this chapter. The present chapter will focus on the existing legal framework relevant to potential discriminatory uses of genetic information by insurers and employers, often referred to as GD, in Quebec. First, it provides an outlook of the Canadian constitutional landscape in the context of privacy, insurance, employment, and human rights. Second, it analyzes legislation in those domains pertaining to the processing of personal information, and more specifically, genetic information, by insurers and employers in Quebec. It concludes with Quebec’s constitutional challenge to the GNDA and a critical evaluation of the effectiveness of the protection afforded to Quebecers when it comes to regulating the processing of their genetic information by third parties.

2 The Separation of Power Between Provincial and Federal Governments In Canada, legislative powers are divided between the provinces and the federal government according to the Constitution Act, 1867 (the Constitution).13 However, the boundaries of some constitutional powers are not clearly defined, or were not foreseen in 1867, and therefore were not explicitly included in the Constitution. The contemporary Canadian constitutional landscape involves a complex interplay between shared competences (e.g. immigration),14 cooperative legal regimes (e.g. the now repealed firearms registry),15 and the need to uphold the text of the Constitution when it provides a clear delineation of powers to preserve a sense of predictability.16

2.1

Protection of Personal Information

The federal government legislates in the economic domain through its jurisdiction over trade and commerce. Quebec does the same through its extensive jurisdiction over property, civil rights, and matters of a merely local or private nature.17 In the

12

Genetic Non-Discrimination Act, SC 2017, c 3, ss 3–4. Constitution Act, 1867 (UK), 30 & 31 Vict, c 3, reprinted in RSC 1985, Appendix II, No 5, ss 91–95. 14 Constitution Act, 1867 (UK), 30 & 31 Vict, c 3, reprinted in RSC 1985, Appendix II, No 5, s 95. 15 Quebec (Attorney General) v Canada (Attorney General), 2015 SCC 14, at para 60–63 and 76. 16 2015 SCC 14, at paras 17–18; Wright (2010), pp. 635–642. 17 See generally Bastarache (2012). See also Nisker (2006), pp. 326 ff. 13

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public sector, both levels of government have adopted their own legislation applicable to public bodies.18 In the private sector, the federal government adopted the Personal Information Protection and Electronic Documents Act (PIPEDA)19 in 2000, which encompasses every aspect of the collection, use, and transfer of personal information in the private sector in Canada. Despite initial controversy over its constitutional validity, this regulatory scheme is now largely accepted.20 PIPEDA applies to information management within each province, unless provinces adopt legislation that is deemed substantially similar to it by an order of the Governor General in Council.21 It also applies to information that crosses interprovincial or international borders. Quebec’s Act respecting the protection of personal information in the private sector (PPIPS) has been deemed substantially similar to PIPEDA, thus replacing its provisions for intraprovincial information management.22

2.2

Insurance

Insurance is not explicitly mentioned in the Constitution. In practice, insurance contracts are mostly regulated by provincial governments through their jurisdiction over property and civil rights. The federal government only has the power to regulate the incorporation of national insurance companies.23 Federally incorporated companies must comply with provincial legislation unless it effectively prevents them from establishing themselves as viable commercial entities in the province.24

2.3

Employment

The division of powers over employment is clearly delineated: any employer that undertakes activities under the scope of federal jurisdiction (e.g. banking and interprovincial trade) must comply with federal labour standards,25 while entities 18

Privacy Act, RSC 1985, c P-21; Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1. 19 Personal Information Protection and Electronic Documents Act, Canada, SC 2000, c 5; OPC (2018). 20 Nisker (2006), pp. 342–343; Bastarache (2012), p. 4. 21 Personal Information Protection and Electronic Documents Act, Canada, SC 2000, c 5, s 26(2) (b). 22 Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 2; Organizations in the Province of Quebec Exemption Order, SOR/2003-374. 23 See Canadian Indemnity Co. v British Columbia (Attorney-General), [1977] 2 SCR 504, p. 512. 24 [1977] 2 SCR 504, pp. 513 and 519. 25 See generally Canada Labour Code, RSC 1985, c L-2; Employment Equity Act, SC 1995, c 44.

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under provincial jurisdiction (e.g. hospitals and schools) are subject to provincial labour standards.26 Although issues may arise for businesses that engage in both interprovincial and local activities,27 this will not be discussed here.

2.4

Human Rights

Entrenched in the Constitution in 1982, the Canadian Charter of Rights and Freedoms (Charter) protects individuals’ rights against state interference (e.g. the rights to life, liberty, and security).28 These rights may not be infringed upon by federal or provincial governments,29 unless the infringement can be demonstrably justified in a free and democratic society.30 At the federal level, the Canadian Human Rights Act (CHRA)31 protects every individual against discrimination based on prohibited grounds in areas of federal jurisdiction. In Quebec, the Charter of Human Rights and Freedoms (CHRF), a quasi-constitutional statute,32 offers individuals comprehensive protection against discrimination, including discrimination by private-sector insurers and employers, based on prohibited grounds in areas of provincial jurisdiction.33 It also protects other individual rights such as dignity, inviolability of the person, and privacy.34

26

See generally Labour Code, CQLR c C-27; Act respecting occupational health and safety, CQLR c S-2.1; Act respecting labour standards, CQLR c N-1.1. 27 See Actton Transport Ltd. v British Columbia (Director of Employment Standards), 2010 BCCA 272; Arthurs (2007), pp. 52 ff. 28 Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11, s 7. 29 Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11, s 32; Eldridge v British Columbia (Attorney General), [1997] 3 SCR 624, para 44 (for an exhaustive definition of “Government”). 30 Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11, s 1; R v Oakes, [1986] 1 SCR 103 (for the analytic framework developed by the Supreme Court). 31 Canadian Human Rights Act, RSC 1985, c H-6, ss 3(1) and 3(3). 32 See Bosset and Coutu (2015); St-Hilaire (2012), pp. 550–551 (for an in-depth analysis of the Charter of Human Rights and Freedom’s status). 33 Bosset and Coutu (2015); Charter of Human Rights and Freedoms, CQLR c C-16, ss 10–20.1. See also Samson (2008). 34 Charter of Human Rights and Freedoms, CQLR c C-16, ss 1, 4, 5 and 9.

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Discussion

Quebec represents an interesting case study for this book because its legal system is distinct from that of other Canadian provinces: its fundamental principles of private law are not found in the common law, but rather, in the Civil Code of Quebec (CCQ).35 Quebec is the competent legislator for most aspects of insurance and employment contracts, and it has adopted personal information protection laws that are distinct from federal legislation. Hence, the collection, use, and disclosure of genetic information, including for discriminatory purposes, is mostly a question of provincial legislation. The main exceptions to this are the GNDA (although it has recently been deemed ultra vires by the Quebec Court of Appeal), which will be discussed below, and federal employers, such as banks and the military. For a discussion of the federal legal framework pertaining to genetic information in those contexts, see Chapter 4 on “Genetic Privacy in Employment and Insurance in Canada”.

3 Personal Information Protection Legislation and Confidentiality Underlying all legislation pertaining to the protection of personal information in Quebec is the idea that every individual has a right to privacy.36 This fundamental right is protected by the CHRF37 and the CCQ.38 In this section, we examine how personal information protection laws implement the right to privacy. We will also briefly examine another closely related fundamental legal principle: the obligation of professional secrecy.39

3.1

The Civil Code of Quebec

The basic requirements for the protection of personal information are set out in the CCQ. It asserts that “[e]very person who establishes a file on another person shall have a serious and legitimate reason for doing so” and that “[h]e may gather only information which is relevant to the stated objective of the file.”40 Once this information is collected, it may not be used nor communicated to third parties “for 35

See generally Civil Code of Québec, CQLR c CCQ-1991 [CCQ]. See also Devinat (2011), Gervais and Seguin (2001) and Allard (2001) (for an analysis of Quebec’s legal system). 36 Trudel (2014) and Allard (2006). 37 Charter of Human Rights and Freedoms, CQLR c C-16, s 5. 38 Civil Code of Québec, CQLR c CCQ-1991, ss 3 and 35. 39 Charter of Human Rights and Freedoms, CQLR c C-16, s 9. 40 Civil Code of Québec, CQLR c CCQ-1991, s 37.

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purposes that are inconsistent with the purposes for which the file was established”41 without individual consent, except as authorized by law.

3.2

The PPIPS, ADHPBPPI, and Genetic Information

The PPIPS was explicitly designed to clarify the requirements of the CCQ relating to the processing of personal information in the private sector.42 It applies to any person other than a public body, as defined in the Act respecting Access to documents held by public bodies and the Protection of personal information (ADHPBPPI),43 who establishes a file on another person.44 Personal information is defined as “any information which relates to a natural person and allows that person to be identified.”45 The PPIPS adds three conditions to the processing of personal information: (1) information in the file should not only be relevant, but “necessary for the object of the file”46; (2) the individual whose information is collected must be notified of the object of the collection, its purported use, the person who will have access to it, the place where information will be kept, and his/her rights to request access, rectification, or deletion of the information47; and (3) information must be collected directly from the individual concerned unless he/she consents to collection from a third party, except as authorized by the act.48 The ADHPBPPI applies to public bodies, an umbrella term further clarified in the first sections of the act.49 It defines personal information as “information concerning a natural person which allows the person to be identified.”50 Among other things, the ADHPBPPI, like the PPIPS, requires information collected on a person to be necessary “for the exercise of the rights and powers of the body or the implementation of a program under its management.”51 It demands that the public body inform the person to whom the information relates of its name and address, the purpose of 41

Civil Code of Québec, CQLR c CCQ-1991, s 37. Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 1. 43 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, ss 1–7. 44 Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 3. 45 Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 2. 46 Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 5. 47 Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 8. 48 Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 6. 49 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, ss 1–7. 50 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 54. 51 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 64. 42

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the collection, who will have access to the information, the consequences in case of refusal to reply, and the rights to access and correction.52 Finally, the ADHPBPPI demands that, once the stated purpose for the retention of information is accomplished, it must be destroyed, except as provided otherwise by law.53 The PPIPS contains no such provision. Pursuant to case law from the Commission d’accès à l’information (CAI), it is illegal for public and private entities to collect personal information that is not necessary for the furtherance of a legitimate objective even with individual consent.54 Moreover, the two acts prevail over any subsequent Quebec legislation that may contradict their prescriptions, unless it is explicitly stated that it applies notwithstanding these statutes.55 No specific mention of genetic data can be found in either act, nor has any court explored whether the PPIPS or ADHPBPPI apply to it. We can only infer, through documents published by the CAI and certain academic publications, that the broad definition of “personal information” encompasses at least some types of genetic information.56 However, it is far from clear when such information will be deemed necessary for employment or insurance purposes. The Court of Quebec affirmed that both the PPIPS and ADHPBPPI must be interpreted to fit the requirements of the CHRF.57 Hence, a similar analytical framework to that developed by the Supreme Court of Canada (SCC) in R. v Oakes58 to justify violations of fundamental rights, in our case the right to privacy, should apply to the criteria of necessity found in the PPIPS and ADHPBPPI.59 This means that the collection of personal information will be necessary when it has an important and legitimate objective that proportionally outweighs the individual’s right to privacy.60

52

Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 65. 53 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 73. 54 Société de transport de la ville de Laval v ML, [2003] CAI 667 (CQ), paras 44 and 67; Granosik (2014) and CAI (2016). 55 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 168; Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 94; CAI (2016) (the CAI found that more than 150 derogations to this rule were found in Quebec legislation in 2015). 56 CAI (2016), pp. 94 ff; Walker (2014), pp. 7–8; Orr (2004), pp. 136–137. 57 [2003] CAI 667 (CQ), para 38. 58 [1986] 1 SCR 103; The Supreme Court later confirmed that this framework was also applicable to section 9.1 of the Charter of Human Rights and Freedoms in Ford v Quebec (Attorney General), [1988] 2 SCR 712, para 63. 59 [2003] CAI 667 (C.Q.), para 40; Granosik (2014), pp. 99–100. 60 [2003] CAI 667 (C.Q.), para 44.

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Considering the significant limitations to our knowledge of the relevance of genetic testing outside of monogenic disorders61 and the deeply personal, and at the same time familial, nature of genetic information,62 it is not clear whether a proportionality test would favor the collection of genetic information in this context. A final concern, given our rapidly evolving knowledge of genetics, is that someone in possession of genetic information or a biological sample could later retest or reinterpret it to reveal more information about an individual. The Court of Quebec noted that when it comes to health information, only a medical professional can make a diagnosis,63 and, according to the ADHPBPPI, only a qualified person can have access to personal information.64 Hence, any interpretation of genetic test results for diagnostic purposes would need to be done by a medical professional, who is in turn bound by professional secrecy.65 Notably, when acting as experts for third parties such as employers or insurers, a medical professional must restrict disclosures of information to those necessary to answer the questions asked to them.66

3.3

The Act Respecting Health Services and Social Services (ARHSSS)67

Except for specific provisions,68 Quebec legislation, unlike federal legislation and legislation from certain other provinces,69 does not differentiate between “personal information” and “personal health information.” However, it has some specific provisions for information contained in medical files.70

61

OPC (2012); CAI (2016), pp. 98–99; OPC (2017); Boucratie (2003), pp. 22–26. See generally Rothstein (2005). See also Joly et al. (2017), p. 7. 63 [2003] CAI 667 (CQ), paras 51–53; Medical Act, CQLR c M-9, s 31(1). 64 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 62. 65 See Sect. 3.4. 66 Code of ethics of physicians, CQLR c M-9, r 17, s 67. 67 Act Respecting Health Services and Social Services, CQLR c S-4.2. 68 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, ss 83, 84.1 and 87.1 (“Medical information”); Act respecting the protection of personal information in the private sector, CQLR c P-39.1, ss 18.2, 31 and 38 (“Health information”, “Medical information”, and “Medical file”). See also Act respecting the sharing of certain health information, CQLR c P-9.0001 (defines certain types of health information in establishing the “Quebec Health Record”, but this falls outside the scope of regular privacy statutes studied in this chapter). 69 See e.g. Personal Information Protection and Electronic Documents Act, Canada, SC 2000, c 5, s 2(1); Personal Health Information Act, SNL 2008, c. P-701, s 31; Health Information Act, RSA 2000, c H-5, s 22. 70 Act Respecting Health Services and Social Services, CQLR c S-4.2, ss 18–28. 62

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Pursuant to the Act respecting Health Services and Social Services (ARHSSS), information recorded in the medical file of a user71 is confidential, and may only be accessed with the user’s consent72 except as allowed in the act (e.g. in application of the Public Health Act or the Youth Protection Act).73 The ARHSSS also contains special rules pertaining to access by minors and adults lacking capacity to consent,74 blood relatives of an individual,75 and researchers.76 These provisions apply notwithstanding the ADHPBPPI.77

3.4

Professional Secrecy

In Quebec, all professionals are bound by a duty to preserve the confidentiality of any confidential information that becomes known to them in the course of their professional activities,78 including genetic information.79 The only exceptions to this duty are express authorization by law and consent by the professional’s client.80 Note that the Quebec Court of Appeal found that medical professionals in Quebec do not have a legal duty to warn relatives of an individual affected by a genetic disease about their own genetic risks.81 However, they can disclose such information if they have a “reasonable cause to believe that there is a serious risk of death or serious bodily injury threatening a person or an identifiable group of persons.”82

In Quebec, the term “user” refers to any person who uses public services. As there is no competition in the health sector in Quebec, the word “user” is used instead of “client” to emphasize usage rather than economic value. Office québécois de la langue française (2013). 72 Act Respecting Health Services and Social Services, CQLR c S-4.2, s 19. 73 Act Respecting Health Services and Social Services, CQLR c S-4.2, ss 19–19.2. 74 Act Respecting Health Services and Social Services, CQLR c S-4.2, ss 17, 20–22. 75 Act Respecting Health Services and Social Services, CQLR c S-4.2, ss 21 and 23 (notably blood relatives of an individual can access his medical file after his death to “verify the existence of a genetic or hereditary disease”). 76 Act Respecting Health Services and Social Services, CQLR c S-4.2, ss 19(7), 19.1 and 19.2. 77 Act Respecting Health Services and Social Services, CQLR c S-4.2, s 28; Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, ss 3 and 7. 78 Professional Code, CQLR c C-26, s 60.4. 79 Laurie (2002), p. 230. 80 Professional Code, CQLR c C-26, s 60.4, para 2. 81 Watters v White, 2012 QCCA 257, paras 86 and 124. 82 Professional Code, CQLR c C-26, s 60.4; Code of ethics of physicians, CQLR c M-9, r 17, s 20 (5); Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 59.1; Act respecting the protection of personal information in the private sector, CQLR c P-39.1, s 18.1. 71

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4 Personal Information in Insurance and Employment Now that we have laid out the basic requirements that all public and private entities must abide by in processing personal information, we shall examine how they interact with specific legal regimes in insurance and employment. Life insurance will be the focus of our discussion in insurance law rather than health insurance because, unlike the US, for example, the Canadian health system is publicly funded.

4.1

Insurance

Insurance contracts depend on the utmost good faith of all parties involved, because the client and/or the insured holds information that the insurer must obtain to correctly pool risks in the interest of mutuality83 (i.e. the principle of symmetry of information).84 Section 2408 of the CCQ states the following: The client, and the insured if the insurer requires it, is bound to represent all the facts known to him which are likely to materially influence an insurer in the setting of the premium, the appraisal of the risk or the decision to cover it, but he is not bound to represent facts that the insurer knows or is presumed to know because of their notoriety, except in answer to inquiries.85

A fact will be “likely to materially influence an insurer” if it would have influenced a reasonably competent insurer of similar risks.86 Pursuant to section 2409 of the CCQ, the insured has a duty to disclose all such facts that a “normally provident insured” would have disclosed.87 Failure to meet this standard of disclosure nullifies the contract at the insurer’s demand.88 Moreover, if a questionnaire is submitted by the insurer, clients have an obligation to answer to the best of their knowledge.89 Their answers are measured against an objective standard based on a reasonable interpretation of the questions.90 One 83 The principle of mutuality, not to be confused with mutual insurance companies, is a way of distributing losses incurred by the occurrence of risks covered by insurance companies: the more occurrences, the higher the premiums will be. It is based on solidarity between insured who share a common interest in everyone paying a fair premium based on an accurate pooling of risks by the insurer (i.e. based on good faith sharing of information by all insured). Belanger and Tawali (2009), p. 309; Dubreuil (1992), pp. 1089–1090. 84 Bombard and Lemmens (2010), p. 1; Salman et al. (2015), pp. 514 and 516; Intact, compagnie d’assurances (Compagnie d’assurances ING du Canada) v Harvey, 2011 QCCA 712, paras 31–32. 85 Civil Code of Québec, CQLR c CCQ-1991, s 2408. 86 Deslauriers (1994), p. 53. 87 Civil Code of Québec, CQLR c CCQ-1991, s 2409. 88 Civil Code of Québec, CQLR c CCQ-1991, s 1410. 89 Civil Code of Québec, CQLR c CCQ-1991, s 2408. 90 Lluelles (2009), p. 271; Industrielle Alliance, cie d’assurance sur la vie v Blais, 2008 QCCA 258, para 41.

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study showed that Canadian insurers generally use open-ended questions to solicit as much information as possible from clients91; specific questions can often backfire against the insurer, as insurance contracts are interpreted in favor of the insured.92 Another important aspect of the insurer’s inquiry generally includes requesting consent to access the insured’s medical file,93 who thereby waives his/her right to confidentiality.94 However, it must be noted that from an equality and human rights perspective, denying insurance based on genetic factors could be problematic, as will be explained below.95

4.2

Employment

A general obligation to act in good faith is imposed upon each party when an employment contract is formed.96 Hence, any information that is determinative to each party’s consent must be exchanged.97 Failure to meet the duty to inform nullifies an employment contract ab initio if it induces an error relating to an essential element of the contract.98 However, unlike insureds, job candidates have little to no duty to inform except for honestly answering the employer’s questions,99 the onus being on the employer to inquire.100 Some employers may mandate medical examinations to ensure that a candidate has the required aptitudes and qualifications for employment, and to fulfill their duty to protect their employees’ health, security, and dignity.101 Because they may violate the candidates’ rights to integrity and privacy,102 such examinations require free and informed consent. They must also be limited to necessary information to comply

91

Ngueng Feze and Joly (2014), pp. 60–61. Civil Code of Québec, CQLR c CCQ-1991, s 1432. 93 Ngueng Feze and Joly (2014), pp. 59–61. 94 See generally Frenette v Metropolitan Life Insurance Co, [1992] 1 SCR 647 (where the Supreme Court recognizes the legality of this practice). 95 See Sect. 5.; Québec (Commission des droits de la personne et des droits de la jeunesse) v Montréal (City); Québec (Commission des droits de la personne et des droits de la jeunesse) v Boisbriand (City), 2000 SCC 27, para 76. 96 Civil Code of Québec, CQLR c CCQ-1991, s 1375. 97 Lluelles and Moore (2012), pp. 1090–1091. 98 Civil Code of Québec, CQLR c CCQ-1991, ss 1400–1401. 99 Brière et al. (2010), pp. 218–219. 100 Bank of Montreal v Bail Ltée, [1992] 2 SCR 554, para 48. See also Québec (Procureure générale) v Consortium ad hoc Katz Gendron Jodoin Perron Rousseau Babin & Associés, Roussy, Michaud & Associés, Cadoret, Savard, Tremblay & Associés, Jean Roy, a.g., 2015 QCCA 159, para 65. 101 Civil Code of Québec, CQLR c CCQ-1991, s 2087. 102 Civil Code of Québec, CQLR c CCQ-1991, ss 3 and 35; Charter of Human Rights and Freedoms, CQLR c C-16, ss 1, 5 and 9. 92

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with the personal information protection legislation discussed in Sect. 3.2.103 Note that medical professionals who conduct these examinations also have a duty to limit their investigation, and the information they share with employers, to what is necessary for the evaluation of a candidate’s aptitudes.104 We will see below that asking or using such information can also violate anti-discrimination provisions in the CHRF.

5 The Right to Equality One of the main worries related to the use of genetic information by insurers and employers is the potential for GD.105 In Quebec, section 10 of the CHRF provides an exhaustive list of prohibited grounds of discrimination106 that requires a broad and liberal interpretation.107 In discrimination cases based on the CHRF, the plaintiff must first establish prima facie evidence of discrimination. This means that the plaintiff must show “(1) a ‘distinction, exclusion or preference’, (2) based on one of the grounds listed in the first paragraph, and (3) which ‘has the effect of nullifying or impairing’ the right to full and equal recognition and exercise of a human right or freedom.”108 If this is shown by the plaintiff and the defendant cannot justify the conduct, a broad range of remedies can be ordered by courts.109 Specific provisions in the CHRF allow certain discriminatory practices by employers and insurers, which we will examine later.

5.1

Are Genetic Characteristics a Prohibited Ground of Discrimination?

No definitive answer to this question can be given, since no explicit mention of such a ground can be found in the CHRF. However, some guidance can be found in the case law on discrimination based on the enumerated ground of “handicap”. The SCC confirmed in a key ruling on the CHRF that a distinction based on certain medical ailments, even if an individual is asymptomatic, constitutes discrimination

103

Brière et al. (2010), pp. 218–219; St-Pierre Plamondon (2017). Brière et al. (2010). 105 See generally Joly et al. (2013); Salman et al. (2015); Faulkner (2017) (for insurance); Boucratie (2003) (for employment). 106 Charter of Human Rights and Freedoms, CQLR c C-16, s 10; 2000 SCC 27, para 69. 107 2000 SCC 27, para 28. 108 Quebec (Commission des droits de la personne et des droits de la jeunesse) v Bombardier Inc (Bombardier Aerospace Training Center), 2015 SCC 39, para 35. 109 Charter of Human Rights and Freedoms, CQLR c C-16, s 49. 104

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based on handicap.110 The Court maintains that “the Charter also prohibits discrimination based on the actual or perceived possibility that an individual may develop handicap in the future.”111 If the defendant based the decision in whole or in part on the fact or subjective perception that the complainant suffered from a handicap, then there is discrimination.112 However, some ailments might not be included in this concept of handicap: As the emphasis is on obstacles to full participation in society rather than on the condition or state of the individual, ailments (a cold, for example) or personal characteristics (such as eye colour) will necessarily be excluded from the scope of “handicap”, although they may be discriminatory for other reasons.113

Justice L’Heureux-Dubé, in an obiter dictum, affirmed that the term handicap is bound to expand, especially “given both the rapid advances in biomedical technology, and more specifically in genetics.”114 This liberal construct of the concept of handicap will likely include discrimination based on some genetic characteristics, unless the concept is restricted by courts in the future. This interpretation is further supported by cases in which the ‘Commission des lésions professionnelles’ and the ‘Tribunal administratif du travail’ considered some individuals with genetic predispositions to certain ailments to be “already handicapped”115 for the purpose of employer cost relief claims.116

5.2

Insurance

For the purpose of insurance contracts, information related to age, sex, civil status, or health is deemed non-discriminatory where its use is warranted and based on actuarial data.117 This exception has been criticized by some,118 but is strictly applied by courts and tribunals.119 110

2000 SCC 27, paras 48 and 69. 2000 SCC 27, para 81. 112 2000 SCC 27, paras 41 and 67. 113 2000 SCC 27, para 82. 114 2000 SCC 27, para 76. 115 Act respecting industrial accidents and occupational diseases, CQLR c A-3.001, s 329 (“in the case of a worker already handicapped when his employment injury appears, the Commission may, on its own initiative or on the application of an employer, impute all or part of the cost of the benefits to the employers of all of the units”). 116 Pioro et al. (2013), pp. 31–34; See e.g. Reboitech inc. (15 March 2004), QCLP , para 34; Radiateur d’auto Drummond inc., 2009 QCCLP 6325. 117 Charter of Human Rights and Freedoms, CQLR c C-16, s 20.1. 118 Smith Lacroix and Belanger (2012), pp. 110 ff; Lanctôt (2008). 119 I I et Régie des rentes du Québec, 2001 CanLII 56003 (QC TAQ); Commission scolaire de Kamouraska-Rivière-du-Loup v Gauvin, 2013 QCCS 4782; Kowalewski et Commission de la construction du Québec, DTE 2012T-544 (CRT). 111

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Employment

It is a priori contrary to the CHRF for an employer to ask for information relating to prohibited grounds of discrimination on a form or in an interview unless it “is useful for the application of section 20.”120 Section 20 stipulates that a “distinction, exclusion or preference based on the aptitudes or qualifications required for an employment” is deemed non-discriminatory.121 According to the SCC, “aptitudes or qualifications required for an employment” will be deemed non-discriminatory when “imposed honestly, in good faith (a subjective test); and (. . .) related in an objective sense to the performance of employment (. . .) in that it is reasonably necessary to assure the efficient and economic performance of the work (an objective test).”122 Since the employer also has a duty to accommodate employees,123 it is necessary for them to show that they “cannot accommodate persons with the characteristics of the claimant without incurring undue hardship.”124 As shown in a 2012 ruling by the Court of Appeal,125 applying section 18.1 of the CHRF is far from straightforward. This case involved the dismissal of an employee who made multiple false declarations in a medical questionnaire relating to his psychiatric history. In short, the court found that if employers could justify their questionnaires under section 20 of the CHRF, the dismissal would be valid.126 On the other hand, if it cannot be justified, the questionnaire and the dismissal, if based on the questionnaire, will be deemed discriminatory.127 Note that some authors have questioned the standard of proof applied by the court, arguing it is either too lenient,128 or too burdensome.129 Moreover, the Court’s decision does not address cases in which a candidate might simply refuse to answer a questionnaire considered discriminatory under section 18.1, resulting in their exclusion from the selection process.130

120

Charter of Human Rights and Freedoms, CQLR c C-16, s 18.1. Charter of Human Rights and Freedoms, CQLR c C-16, s 20. 122 Brossard (Town) v Quebec (Commission des droits de la personne), [1988] 2 S.C.R. 279, para 67. See also more recently Syndicat des infirmières, inhalothérapeutes, infirmières auxiliaires du Coeur du Québec (SIIIACQ) v Centre hospitalier régional de Trois-Rivières, 2012 QCCA 1867, para 69. 123 Drapeau and Aubry (2015), pp. 432–436. 124 British Columbia (Superintendent of Motor Vehicles) v British Columbia (Council of Human Rights), [1999] 3 SCR 868, para 20. 125 2012 QCCA 1867. 126 2012 QCCA 1867, para 79. 127 2012 QCCA 1867, paras 56, 78–84. 128 Fournier (2013). 129 St-Pierre Plamondon (2017). 130 Fournier (2013). 121

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6 Can Insurers Collect Genetic Information? Setting aside the protection provided by the federal GNDA, the short answer to this question is yes. There is no a priori prohibition on the collection of genetic information by insurers in the CCQ or other insurance-specific provisions in Quebec. Moreover, there are two precedents from the Quebec Superior Court that would support this position. These two early court cases stated that clients and the insured had an obligation to disclose (1) the result of a genetic test that shows they carry a serious genetic condition (in this case Steinert’s disease),131 and (2) their family history of diseases.132 However, in both cases, the insured had suffered symptoms of their condition and had clear knowledge of either its genetic underpinning (in the first case) or its familial history (in the second case). Some authors have challenged this conclusion when it comes to predictive genetic testing or tests of questionable scientific value, such as some of those administered by DTC-GT companies.133 They question the idea that a normally provident insured would have sufficient knowledge of all the nuances and clinical implications associated with genetic risk prediction. There are also conflicting views on the actuarial value of those genetic tests. One group, mainly comprised of actuaries, argue that a complete ban would result in a spike in premiums.134 On the other hand, independent academics mostly argue that the effect would be marginal.135 Hence, it is not clear that such information is “likely to materially influence an insurer in the setting of the premium.”136 Note that members of the Canadian Life and Health Insurance Association (CLHIA) have adopted a voluntary policy on genetic testing.137 Amongst other guarantees, they pledge to (1) not require a genetic test to be undergone as part of the application process; (2) restrict their use of genetic test results to life insurance contracts valued over CAD 250,000; (3) refrain from requesting genetic test results undergone for research purposes if they were not disclosed to the applicant or his/her physician; and (4) refrain from requesting genetic test results of an applicant’s family members.

131 Audet v Industrielle-Alliance, compagnie d’assurance sur la vie, [1990] JQ no 2532 (CS), paras 12–14. 132 Bélanger v Great-West, Cie d’assurance vie, [1999] JQ no 6467 (CS), paras 46–50. 133 Salman et al. (2015), pp. 517–519. 134 Canadian Institute of Actuaries (2014) and Society of Actuaries (2018). 135 MacDonald (2011) and Hoy and Durnin (2012). 136 Civil Code of Québec, CQLR c CCQ-1991, s 2408. 137 CLHIA (2017).

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7 Can Employers Collect Genetic Information? If section 18.1 of the CHRF is interpreted strictly, employers are prohibited from requesting any genetic information that will be deemed to fall under the concept of handicap as construed by the SCC, unless they can show the information to be necessary for the application of section 20.138 The same applies to pre-hiring medical examinations that could eventually include genetic testing. Given the current limitations of genetic tests, it would be hard for employers to establish their necessity in the selection process, at present. However, some of those limitations may fade as science progresses, meaning that the employer’s duty to protect employees’ health and security could eventually legitimize if not require the use of genetic tests to identify predispositions to certain occupational diseases.139 If employers do begin to select employees based at least in part on their genetic profiles, those decisions would also be subject to the analytic framework applicable to section 20. In order to justify a refusal to hire or a dismissal on this basis, they would have to show that accommodating individuals with certain genetic characteristics would impose an undue hardship (excessive constraint) on their enterprise.140 While symptomatic individuals suffering from serious genetic conditions could potentially impose a significant burden on an employer, the same can hardly be said of asymptomatic individuals. As it is hard to know when symptoms might manifest themselves, employing a carrier of a genetic mutation known to cause serious ailments may entail some level of risk. For example, in the case of a carrier of the Huntington’s gene, what if symptoms first begin to affect someone while this individual is driving a school bus? However, it is undesirable that individuals predicted to develop a genetic disease in an uncertain future, should be refused employment in the present while they do not suffer from a disability impacting their current ability to work.141 In summary, the protection of employees’ genetic information hinges on the breadth of the definition of “handicap.”

8 The GNDA and Its Constitutional Challenge by the Quebec Government 8.1

Summary of the GNDA’s Provisions

The GNDA prohibits any person from requiring an individual to undergo a genetic test or disclose the results of a genetic test as a condition of providing goods or 138

See Sect. 5.3. Civil Code of Québec, CQLR c CCQ-1991, s 2087; See also generally MacDonald and Williams-Jones (2002); Schill (2000). 140 See Drapeau and Aubry (2015), pp. 432–436. 141 Rothstein (1993), p. 223. 139

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services, entering into or continuing a contract or agreement with, or offering specific conditions in a contract or agreement with an individual.142 Any contravention to this first part of the act without explicit written consent by the individual constitutes a criminal offense.143 It makes an exception only for medical professionals and researchers.144 The law also amends the Canadian Labour Code to protect employees from being required to undergo a genetic test or to disclose its results, and the CHRA by adding “genetic characteristics” as an illicit ground of discrimination.145 The GNDA defines the term “genetic test” in the main part of the act146 and in the context of employment.147

8.2

Constitutional Challenge

As explained above in Sect. 2, the Constitution divides powers between the two levels of government—federal and provincial. Thus, legislation from one level must have a subject matter that can be assigned to one of its legislative powers. If it does not, the legislation is prima facie ultra vires.148 However, it can be saved if it impinges only incidentally on the other level of government’s areas of jurisdiction.149 It can also be saved if the subject matter is found to have a double aspect, allowing both levels of government to legislate.150 Shortly after the law was passed, Quebec’s government referred the question of the constitutionality of sections 1–7 of the GNDA to Quebec’s Court of Appeal (QCCA). In an historic turn of events, the Attorneys General representing both governments agreed that the law was unconstitutional. Thus, an amicus curiae had to be nominated to argue in favor of the law.

142

Genetic Non-Discrimination Act, SC 2017, c 3, ss 3–4. Genetic Non-Discrimination Act, SC 2017, c 3, s 7. 144 Genetic Non-Discrimination Act, SC 2017, c 3, s 6. 145 Canada Labour Code, 1985 c L-2, s 247.98; Canadian Human Rights Act, RSC 1985, c H-6, s 3 (1) and (3). 146 Genetic Non-Discrimination Act, SC 2017, c 3, s 2: “[G]enetic test means a test that analyzes DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis.” 147 Canada Labour Code, 1985 c L-2, s 247.98(1): “[G]enetic test, in relation to an employee, means a test that analyzes the employee’s DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis.” 148 Bastarache (2012), p. 5; Quebec (Attorney General) v Lacombe, 2010 SCC 38, paras 19–20. 149 2010 SCC 38, paras 36 and 38. 150 2010 SCC 38, para 37. 143

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Four concerns expressed by both Attorneys General echo the criticisms that have been levelled at the act by scholars and other public voices since its adoption151: (1) the marginal evidence for genetic discrimination defeats the argument that it is necessary to protect Canadians through a criminal prohibition152; (2) the legislation does not prohibit discrimination per se, but completely outlaws the use of genetic tests and their results whether their use is in reality discriminatory or not153; (3) because of the law’s restrictive definition of genetic tests, third parties could obtain information on the genetic characteristics of individuals through indirect inquiries on family history and other personal health information, or a variety of other biochemical tests154; (4) by allowing voluntary submission of test results, the law fails to prevent situations in which some individuals could receive preferential treatment for their results, thus adversely affecting those who refuse to do so and significantly reducing their level of protection.155

In December 2018, the QCCA sided with the Attorneys General in finding that the GNDA was ultra vires. The Canadian Coalition for Genetic Fairness, intervener in the QCCA, appealed the decision to the Supreme Court of Canada (SCC). In a 5 to 4 decision, the SCC overturned the QCCA’s ruling and upheld the GNDA.156

9 Conclusion Despite providing sanctions for the illegal collection of genetic test results and restricting the exceptions to human rights and privacy legislation that could be found in the PPIPS and ADHPBPPI, the protection offered by the GNDA ends when genetic information is provided voluntarily by the individual157 or when a procedure does not fit the act’s static definition of genetic testing. It is also questionable whether consent is actually possible in many situations, given the repercussions of being refused employment or life insurance. In cases where consent is obtained, Quebec’s general framework could limit abuses, especially in employment. First, an employer or insurer must satisfy the criteria of necessity in order to collect genetic information (see Sect. 3.2). Failure to abide by this standard exposes the contravening party to fines and other remedies.158

151

See e.g. Joly et al. (2017), pp. 7–9; Buzzetti (2017). Mémoire du Procureur Général du Québec (26 June 2018), p. 8. 153 Mémoire du Procureur Général du Québec (26 June 2018), pp. 8–14. 154 Mémoire du Procureur Général du Québec (25 May 2018), paras 87 and 95. 155 Mémoire du Procureur Général du Canada (25 May 2018), para 43. 156 Genetic Non-Discrimination Act, 2020 SCC 17. 157 Civil Code of Québec, CQLR c CCQ-1991, ss 10 and 1399. 158 Act respecting Access to documents held by public bodies and the Protection of personal information, CQLR c A-2.1, s 91; Act respecting the protection of personal information in the private sector, CQLR c P-39.1, 158. 152

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In employment, the candidate has to answer the employer’s questions honestly (see Sect. 4.2), but the employer cannot ask any questions relating to prohibited grounds of discrimination, nor mandate medical examinations that would reveal such information unless necessary to evaluate legitimate requirements for employment (see Sect. 5.3). Any contravention can result in remedies being ordered against the employer.159 In the case of insurance, a client will only need to disclose information if it is material and if a reasonably provident insured would have disclosed it (see Sect. 4.1). Thus, although insurers continue to enjoy an exemption from prohibited discrimination grounds (see Sect. 5.2), the Quebec legal framework applicable to GD in employment and insurance does address some of the limitations of the GNDA. The CLHIA’s recent policy on genetic testing, while not legally binding, is another reassuring element. If seriously followed by members of this association,160 it will greatly limit the use of genetic information by Canadian insurers. By challenging the constitutionality of GNDA, Quebec had given itself the opportunity to better gauge how the use of genetic technologies will develop before deciding what kind of statutory or administrative models would work best to prevent abuses. The province should follow up this strategy with a proper enquiry and public consultation on the incidence and effect of GD within a reasonable period to better assess the efficacy of such an approach on the grounds. Otherwise, this stance could be perceived as a sign of Quebec’s disinterest in what could turn out to become an important challenge to human rights and social values in developed economies.161

References Allard F (2001) The Supreme Court of Canada and its impact on the expression of Bijuralism. www.justice.gc.ca/eng/rp-pr/csj-sjc/harmonization/hfl-hlf/b3-f3/bf3a.pdf. Accessed 15 Oct 2018 Allard F (2006) La Charte des droits et libertés de la personne et le Code civil du Québec: deux textes fondamentaux du droit civil québécois dans une relation d’“harmonie ambiguë”. R du B 66(5):33–80 Arthurs HW (2007) Labour and the “real” constitution. Les Cahiers de Droit 48:43–64 Bastarache M (2012) The constitutionality of PIPEDA: a re-consideration in the wake of the Supreme Court of Canada’s Reference re Securities Act. http://accessprivacy.s3.amazonaws. com/M-Bastarache-June-2012-Constitiutionality-PIPEDA-Paper-2.pdf. Accessed 17 Oct 2018

159

Charter of Human Rights and Freedoms, CQLR c C-16, s 49. The Canadian Life and Health Insurance Association is a voluntary association whose member companies account for 99% of Canada’s life and health insurance business. 161 This chapter was written before the Supreme Court of Canada rendered its judgement in the Reference re Genetic Non-Discrimination Act , 2020 SCC 17. In this five against four majority decision the Supreme Court overturned the judgement of the Quebec Court of Appeal and confirmed the constitutionality of the GNDA. This decision does not affect the content of this chapter that focuses on Quebec’s policy framework applicable to genetic discrimination nor our conclusion that public consultation and evidence-based research on the real incidence of genetic discrimination is the best way forward for the province of Quebec. 160

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Belanger A, Tawali J (2009) Le spectre de la mutualité dans le contrat d’assurance. Revue générale de droit 39:297–328 Bombard Y, Lemmens T (2010) Insurance and genetic information. In: Encyclopedia of life sciences. Wiley, Chichester. https://doi.org/10.1002/9780470015902.a0005203.pub2 Bombard Y et al (2007) Engagement with genetic discrimination: concerns and experiences in the context of Huntington disease. Eur J Hum Genet 16:279–289 Bombard Y et al (2009) Perceptions of genetic discrimination among people at risk for Huntington’s disease: a cross sectional survey. BMJ 338(b2175):1–8 Bombard Y et al (2012) Beyond the patient: the broader impact of genetic discrimination among individuals at risk of Huntington disease. Am J Med Genet B Neuropsychiatr Genet 159B:217–226 Bosset P, Coutu M (2015) Acte fondateur ou loi ordinaire? Le statut de la Charte des droits et libertés de la personne dans l’ordre juridique québécois. RQDI Hors-serie:37–60 Boucratie N (2003) Discrimination génétique lors de la pré-embauche: Élaboration d’une politique d’encadrement. Dissertation, University of Montreal Brière J-Y et al (2010) Le droit de l’emploi au Québec, 4th edn. Wilson & Lafleur, Montréal Buzzetti H (2017) Le projet de loi sur la discrimination génétique est inconstitutionnel, selon les assureurs. Le Devoir, 10 March 2017 Buzzetti H (2018) Discrimination génétique: Québec conteste une loi fédérale. . . et Ottawa opine. Le Devoir, 7 August 2018 Canadian Institute of Actuaries (2014) Genetic testing model: if underwriters had no access to known results. https://www.cia-ica.ca/docs/default-source/2014/214082e.pdf. Accessed 15 Oct 2018 Canadian Life and Health Insurance Association (2017) Industry code: genetic testing information for insurance underwriting. https://www.clhia.ca/domino/html/clhia/CLHIA_LP4W_LND_ Webstation.nsf/resources/Genetic+Testing/$file/Backgrounder+genetic+testing.pdf. Accessed 16 Nov 2018 Commission d’accès à l’information (CAI) (2016) Rétablir l’équilibre. www.cai.gouv.qc.ca/docu ments/CAI_RQ_2016.pdf. Accessed 15 Oct 2018 Dalpe G et al (2017) Breast cancer risk estimation and personal insurance: a qualitative study presenting perspectives from Canadian patients and decision makers. Front Genet. https://doi. org/10.3389/fgene.2017.00128 Deslauriers P (1994) La déclaration précontractuelle de risque en droit québécois. Les Éditions Yvon Blais, Cowansville Devinat M (2011) Le bijuridisme et le bilinguisme canadiens: des idéaux sous tension. Revue française de linguistique appliquée XVI:33–50 Drapeau M, Aubry A (2015) La discrimination fondée sur le handicap ou le moyen pour y pallier: concepts fondamentaux et évolution nécessaire. Revue du Barreau 74:415–464 Dubreuil (1992) L’assurance: un contrat de bonne foi à l’étape de la formation et de l’exécution. McGill Law J 37:1087–1109 Faulkner C (2017) Genetic discrimination: information privacy in public and private sectors. DJIM. https://doi.org/10.5931/djim.v13i1.6927 Fournier S (2013) De Charybde en Scylla: le dilemme des candidats face à une question discriminatoire en embauche. In: Développements récents en droit du travail, vol 364. Les Éditions Yvon Blais, Cowansville, pp 129–170 Genome Quebec (2018) Our history. http://www.genomequebec.com/en/history.html. Accessed 15 Oct 2018 Gervais M-C, Seguin M-F (2001) Some thoughts on bijuralism in Canada and the world. www. justice.gc.ca/eng/rp-pr/csj-sjc/harmonization/hfl-hlf/b2-f2/bf2.pdf. Accessed 15 Oct 2018 Granosik L (2014) Le critère de nécessité: son évolution, son importance, son impact et son application. In: Développements récents en droit du travail, vol 392. Les Éditions Yvon Blais, Cowansville, pp 85–110

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Hoy M, Durnin M (2012) The potential economic impact of a ban on the use of genetic information for life and health insurance. https://www.priv.gc.ca/en/opc-actions-and-decisions/research/ explore-privacy-research/2012/gi_hoy_201203/. Accessed 15 Oct 2018 Joly Y, Dalpé G (2019) Vers une discrimination génétique au Canada? http://www.droit-inc.com/ article24362-Vers-une-discrimination-genetique-au-Canada. Accessed 8 Apr 2019 Joly Y, Ngueng Feze I, Simard J (2013) Genetic discrimination and life insurance: a systematic review of the evidence. BMC Med 11:25–40 Joly Y et al (2017) Policy brief: genetic discrimination in Quebec: a flexible and proactive approach to address a complex social issue. http://www.genomequebec.com/DATA/PUBLICATION/32_ en~v~Genetic_Discrimination_in_Quebec_-_Policy_Brief.pdf. Accessed 15 Oct 2018 Lanctôt S (2008) L’utile et le juste de la discrimination dans la sélection, la classification et la tarification des risques assuranciels. Dissertation, University of Montreal Laurie G (2002) Genetic privacy, a challenge to medico-legal norms. Cambridge University Press, Cambridge Lee IB (2011) The assisted human reproduction act reference and the federal criminal law power. Can Bar Rev 90:471–493 Lluelles D (2009) Précis des assurances terrestres. Thémis, Montréal Lluelles D, Moore B (2012) Droit des obligations, 2nd edn. Éditions Thémis, Montréal MacDonald A (2011) The actuarial relevance of genetic information in the life and health insurance context. https://www.priv.gc.ca/media/1737/gi_macdonald_201107_e.pdf. Accessed 15 Oct 2018 MacDonald C, Williams-Jones B (2002) Ethics and genetics: susceptibility testing in the workplace. J Bus Ethics 35:235–241 Murray TH (2019) Is genetic exceptionalism past its sell-by date? On genomic diaries, context, and content. Am J Bioethics 19(1):13–15 Ngueng Feze I, Joly Y (2014) Can’t always get what you want? Try an indirect route you just might get what you need: a study on access to genetic data by Canadian life insurers. Curr Pharmacogenomics Pers Med 12:56–64 Nisker J (2006) PIPEDA: a constitutional analysis. Can Bar Rev 85:317–343 Office of the Privacy Commissioner of Canada (2012) Genetic information, the life and health insurance industry and the protection of personal information: framing the debate. https://www. priv.gc.ca/en/opc-actions-and-decisions/research/explore-privacy-research/2012/gi_intro/. Accessed 15 Oct 2018 Office québécois de la langue française (2013) Usager. https://www.oqlf.gouv.qc.ca/ressources/ bibliotheque/dictionnaires/terminologie_relations_professionnelles/usager.html. Accessed 30 Oct 2018 OPC (2017) Direct-to-consumer genetic testing and privacy. https://www.priv.gc.ca/en/privacytopics/health-genetic-and-other-body-information/02_05_d_69_gen/. Accessed 15 Oct 2018 OPC (2018) PIPEDA in brief. https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/ the-personal-information-protection-and-electronic-documents-act-pipeda/pipeda_brief/. Accessed 15 Oct 2018 Orr S (2004) Privacy of genetic information in Canada: a brief examination of the legal and ethical tools that should frame Canada’s regulatory response. CJLT 3:127–140 Phoenix Strategic Perspectives Inc (2016) Survey of Canadians on privacy-related issues. https:// www.priv.gc.ca/en/opc-actions-and-decisions/research/explore-privacy-research/2016/por_ 2016_12/#fig24. Accessed 15 Oct 2018 Pioro M, Mykitiuk R, Finkler L, Nisker J (2013) Understanding the use of “genetic predisposition” in Canadian legal decisions. MJLH 7:1–65 Rothstein MA (1993) Medical screening and the employee health cost crisis. The Bureau of National Affairs, Washington DC Rothstein MA (2005) Genetic exceptionalism and legislative pragmatism. Hastings Cent Rep 35:27–33

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Rothstein MA (2007) Genetic exceptionalism and legislative pragmatism. J Law Med Ethics 35 (2 Suppl):59–65 Salman S, Ngueng Feze I, Joly Y (2015) Divulgation de L’information Génétique en Assurances. Can Bar Rev 93:501–536 Samson M (2008) Le droit à l’égalité dans l’accès aux biens et aux services: L’originalité des garanties offertes par la charte québécoise. RDUS 38:413–481 Schill AL (2000) Genetic information in the workplace. Workplace Health Saf 48:80–91 Smith Lacroix J-H, Belanger A (2012) Le droit, la statistique et l’assurance. RJT 46:99–129 Society of Actuaries (2018) The impact of genetic testing on life insurance mortality. https://www. soa.org/Files/resources/research-report/2018/2018-impact-genetic-testing-report.pdf. Accessed 30 Oct 2018 Stavropoulos DJ et al (2016) Whole-genome sequencing expands diagnostic utility and improves clinical management in paediatric medicine. Genomic Med. https://doi.org/10.1038/npjgenmed. 2015.12 St-Hilaire M (2012) The codification of human rights in Canada. RDUS 42:507–569 St-Pierre Plamondon M (2017) Les examens médicaux préembauche: faisons le point. In: Développements récents en droit du travail, vol 429. Les Éditions Yvon Blais, Cowansville, pp 137–181 Trudel P (2014) Le droit à la vie privée en droit civil québécois. Paper presented at the Annual CIAJ Conference, St-John, 16–17 October 2014 Walker J (2014) Genetic discrimination and Canadian law. In: Library of parliament. Publication No. 2014-90-E, pp 1–16 Wright WK (2010) Facilitating intergovernmental dialogue: judicial review of the division of powers in the Supreme Court of Canada. SCLR 51:625–693

Genetic Analyses in the Insurance and Employment Contexts in Switzerland Valérie Junod

Abstract Genetic analyses in the fields of employment and insurance are rare in Switzerland, although we lack accurate statistics. Generally speaking, insurers and employers choose not to resort to genetic testing because they have many other, simpler alternatives to obtain similar information. Workers and patients are protected in theory against genetic discrimination. But, in practice this protection has a limited scope because private insurers can refuse to enter into an insurance contract on any grounds and employers can fire, after due notice, an employee who is frequently ill. After a general introduction (Sect. 1), this article presents the Swiss legal framework (Sect. 2) for genetic analyses in employment and insurance relationships, highlights certain of its weaknesses (Sect. 3) and sets forth a number of recommendations.

1 Introduction and Context Genetic analyses in the fields of employment and insurance are rare in Switzerland, although we lack accurate statistics. Generally speaking, insurers and employers choose not to resort to genetic testing because they have many other, simpler alternatives to obtain similar information. Workers and patients are protected in theory against genetic discrimination. But, in practice this protection has a limited scope because private insurers can refuse to enter into an insurance contract on any grounds and employers can fire, after due notice, an employee who is frequently ill. Genetic analyses (GA) in the fields of employment and insurance have not received much attention in Switzerland. Rather, of late, it is the issue of prenatal genetic analysis of embryos in vitro or fetuses in utero that has attracted media attention. GA

V. Junod (*) University of Lausanne, Lausanne, Switzerland University of Geneva, Geneva, Switzerland e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_13

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for employment or insurance purposes have been regulated since 2004.1 In 2015–2018, the Swiss Federal Law on genetic analysis (FLGA)2 was revised completely. However, the legislature ultimately decided to retain, with only few changes,3 the provisions applicable to GA in the context of employment or insurance.4 Both at the time of the parliamentary vote and before, the media had devoted little attention to the subject, and there are no available statistics regarding the extent to which such analyses are currently being used.5 Even anecdotal reports on genetic discrimination in employment or insurance relationships have been scarce. In all likelihood, GA in these two sectors are infrequently sought and exploited.6 This can be explained, at least in part, by the strict legal framework governing GA together with the availability of easier alternatives to obtain similar information. Referring to the 2018 revised FLGA, even though it is not yet in force, this article presents the Swiss legal framework (Sect. 2) and highlights some of its weaknesses (Sect. 3). However, to understand the overall legal environment, it will be helpful to outline briefly how insurance companies and employers assess and process the general, non-genetic medical risks of their clients and employees. This is the subject of Sect. 1. Section 3 lays down several recommendations for improving Swiss regulations. To understand what employers and insurance may do in connection with genetic testing, it is important to first know what they are permitted to do with respect to other health information; this is the topic of this section.

1.1

Insurance

Most social (public) insurances are mandatory in Switzerland, at least for employees (as opposed to self-employed individuals); these include medical insurance, accident

1

See also the legal basis in section 119 of the Swiss Federal Constitution (Federal Constitution of the Swiss Confederation of 18 April 1999, RS 101, in force since 1st January 2000, available in an unofficial English translation at https://www.admin.ch/opc/en/classified-compilation/19995395/ index.html). 2 Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/opc/en/classified-com pilation/20011087/index.html. 3 For an overview of the changes, see the Federal Council’s “message” (i.e. explanatory report) of 5 July 2017, object 17.048, FF 2017, p. 5253. 4 A proposal to extend private insurers’ right to ask for genetic information was defeated before Parliament. See the parliamentary debates of 26 February 2018 and of 30 May 2018 (https://www. parlament.ch/fr/ratsbetrieb/suche-curia-vista/geschaeft?AffairId¼20170048). Another proposal was made to entirely ban predictive GA; it was also rejected. Parliament chose to follow the recommendations of the government to maintain the status quo (i.e. the solution of the former law). 5 All in all, the Swiss government (Federal Council) reported that 140,000 GA had been performed in 2016, up from 50,000 in 2006. See Parliamentary debates of 26 February 2018, speech of Alain Berset (object 17.048). 6 Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5359.

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insurance, old-age insurance, maternity insurance, unemployment insurance (for employees), disability insurance, military insurance, child allocation and complementary benefits to old-age insurance.7 In other words, each individual must secure her own insurance, sometimes with the possibility of choosing the insurance company (e.g. choosing an insurance company, also called sickness fund for “caissemaladie,” among some 50 companies offering such policies) and some other options (e.g. the amount of the deductible for sickness insurance). The corresponding political choice was to force insurers to accept all clients under roughly equal conditions. For example, with respect to basic health insurance (covering medical benefits, not wage losses), all sickness funds must accept all patients and charge a premium independent of age (in the 0–18, 19–25 or over 26 age bracket), sex and health status.8 Sickness funds are forbidden from asking medical questions to assess the health status of their potential new clients.9 The same is true for other public mandatory insurance (e.g. accident, old age, disability and unemployment), since insurance firms cannot differentiate based on the good or poor health of individuals. Thus, there can be no anti-selection or moral hazard; the insurance operates to pool risks based on the solidarity principle. Beyond mandatory public insurance, individuals can decide whether to purchase additional insurance coverage (e.g. life insurance) or complementary insurance coverage (e.g. sickness and accident insurance10). Some insurance policies are offered through employers (see Sect. 1.3 below). Where the individual is selfemployed, these policies may be a financial necessity or even crucial (e.g. unemployment coverage and complementary retirement insurance) as independently employed individuals cannot join many public (social) insurance pools.11 When the insurance is optional, each party is free to enter into the relationship or refuse to contract (i.e. contractual freedom and economic freedom). Insurance companies, including sickness funds, can then ask questions to assess the prospective client’s risks, including her medical risks.12 This is viewed as an accepted practice, designed to decrease the asymmetry of information between the client and the insurer and to avoid moral hazard and anti-selection.13

7

Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5363. On the other hand, differences in premiums based on the individual’s Canton of domicile are, for example, admissible. 9 The same applies once the client has been accepted; her poor health cannot lead to higher premiums nor to exclusion by the social sickness insurance fund. Another issue is whether the social sickness insurance is entitled to receive information on insured patients’ diagnoses. See Rohmer (2006), chapters F.2.b) and fc). 10 A common complementary sickness and accident insurance is one that pays for a private or semiprivate room in a public or in a private hospital. 11 Pärli and Studer (2014), p. 128. 12 See section 4 of the Swiss Federal Law on Insurance Contracts, 2 April 1908, RS 221.229.1. 13 On this issue see Lanz (2014), pp. 14–35. 8

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Companies typically send a detailed questionnaire14 to learn whether the person is currently under medical treatment or has been in the past (e.g. in the past five or ten years).15 The questions are sometimes quite intrusive.16 They often ask for the names of the attending physician and require that the patient release the former from their professional secrecy obligations, so as to allow the insurance company to contact the doctor directly to obtain more detailed information.17 If patients refuse, the insurance companies will, in all likelihood, refuse to issue a policy. Even though the consent of the individual is not truly “free,” it is still considered valid. Authors in the Swiss legal literature criticize this.18 Based on anecdotal information (no study exists of all commonly used insurance questionnaires), questions directly related to genetic analyses (GA) are uncommon, with the primary focus being on current and former diseases. For example, the prospective client will be asked whether she has suffered from any cancer—and not whether she took a test for BRCA1/2. In some cases, when the prospective client declares symptoms or diseases with a possible genetic origin, the insurance company may follow up and ask questions about the genetic traits of the client. However, due to lack of publicly available information on the subject, it is impossible to know for sure. Based on the answers they receive on questionnaires and using their own statistical analysis tools, insurance companies will calculate the proposed premiums 14

Section 4 of the Swiss Federal Law on Insurance Contracts, 2 April 1908, RS 221.229.1. Based on two questionnaires collected from Swiss sickness funds, the questions asked are very extensive. They include: Have you consulted a doctor over the last five years? Have you been hospitalized in the last ten years? Are you currently being medically treated, medical treatment including classic medicine, dental medicine, complementary medicine? Is there any ongoing medical investigation? Are you planning any medical treatment or investigation? Have you undergone any treatment during the last previous year, including interventions for esthetic purposes? Are you currently unable to work or have you been unable to work for over three weeks in the last five years? Have you ever had a tumor? Do you suffer from sequelae from a disease, an accident or a congenital infirmity? Have you been treated for obesity? Have you been tested for HIV or hepatitis B or C? Have you taken any medicine regularly over the last five years? Have you consumed any drugs? Do you regularly drink alcohol? Do you smoke? Are you pregnant? Have you received any benefits from sickness, accident or disability insurance in the last five years? Have you ever been refused an insurance (life, disease, accident, disability) policy? 16 See Hugentobler (2013), p. 1142. 17 The prospective client must sign a statement whereby she frees her doctors from their duty to maintain medical secrecy. This further extends to hospitals and other sickness funds and insurance companies. Moreover, the insurance company asks the prospective client’s permission to consult other databases held by the insurance company or by the group. This can be relevant when the prospective client is already insured by the same sickness fund for the basic sickness insurance. The validity of such signed waivers is debatable. See e.g. Rohmer (2006), Chapter G.2.c)ca)i. It may be argued that the insurance company is requesting its prospective client to excessively limit her personal liberty (section 27 of the Swiss Civil Code (Swiss Civil Code of 10 December 1907, RS 210, in force since 1st January 1912, unofficial English translation available at https://www.admin. ch/opc/en/classified-compilation/19070042/index.html)). However, once more, there is no case law on the issue and it remains unclear what exactly is permitted. 18 See e.g. Dupont (2017), p. 199. 15

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or refuse to extend an offer for insurance coverage. The prospective client has no right to appeal should she consider the premium too high or should she be refused coverage altogether. In that sense, the principle prohibiting discrimination based on health status19 or genetic traits does not operate to guarantee that sick (or potentially sick) persons will be insured (see further Sect. 2 below). Private insurers can adapt insurance contracts at given time intervals and sometimes also following a claim made by the client. However, in practice, insurance companies do not terminate the initial contract after the occurrence of a disease. For example, the complementary sickness insurance will usually be maintained even if the insured client has aged, and thus requires much more regular medical treatment. The situation is different if the insurance company finds out that its client lied in the questionnaire and that this lie has had a (negative) impact on the contract (e.g. she hid the existence of past medical treatment for depression). In that case, the company can immediately terminate the contract and refuse to cover past expenses for this hidden disease or disease group.20 For example, a sickness insurance company providing complementary health insurance will refuse to reimburse the costs of past medical expenses incurred by the patient, once it finds out that she had known about her disease but did not mention it in the questionnaire. The company can even ask that the patient reimburse the benefits already received before the company became aware of the “réticence” (the commonly used technical term to refer to the client’s lie or omission).

1.2

Employment Law

This subsection focuses on the rules applicable to employees and employers of the private sector. Employees of the public sector are hired under a variety of laws (i.e. legislation of the hiring Canton, federal public employment law or even private employment law in some cases); due to the wide variety of possible situations, they will not be analyzed here. Suffice to say that public-sector employees typically enjoy broader protection when they fall sick; they will receive their salary for a longer period of time and their risk of being fired because of their disease is lower. Prospective private-sector employers in Switzerland do not systematically ask questions about the health status of their potential future employees. Such questions

19 Section 8(2) of the Swiss Federal Constitution states a (theoretically) broad prohibition against discrimination: “No person may be discriminated against, in particular on grounds of origin, race, gender, age, language, social position, way of life, religious, ideological, or political convictions, or because of a physical, mental or psychological disability” (emphasis added). However, the provision (paragraph 2, more specifically) binds the State and State actors but not private employers or insurance companies proposing private insurance contracts. On the other hand, section 4 of the FLGA, regarding the prohibition of genetic discrimination, binds everyone. 20 Section 6 of the Swiss Federal Law on Insurance Contracts, 2 April 1908, RS 221.229.1. For more on this issue see Lehmann (2017), pp. 149–161.

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are not banned entirely, but are often frowned upon. Because they intrude into the private sphere, they are only admissible when directly relevant to the prospective job.21 Section 328b of the Swiss Code of Obligations (CO) lays down binding limits for such questions.22 The intrusion (i.e. the questions asked) must be necessary to assess the employee’s suitability for the job. Once the employment contract has been entered into, additional questions are allowed only to the extent that they are necessary to properly execute the contract.23 The employer may also ask questions to verify whether the employee’s claimed work incapacity is correct (i.e. she is truly incapable of working due to an accident or a disease). In that case, the employer may compel the worker to undergo a medical control with an appointed doctor.24 To some extent, the case law and the legal literature suggest that prospective workers must spontaneously mention circumstances that make them unable to perform their duties when this incapacity is to occur immediately after hiring or shortly afterwards.25 Sensitive medical questions should be asked through a doctor appointed by the employer (“Médecin mandaté par l’employeur”26), so that the employer is only told whether or not the candidate is able to perform her work duties.27 It goes without saying that the employer must keep the information obtained confidential, and only make it accessible to the staff members who truly need to use it for valid employment purposes.28

21 Individuals can claim protection of their personal data under section 13 of the Swiss Constitution, sections 27 and 28 of the Swiss Civil Code and more broadly under the Federal Act on Data Protection (FADP) of 19 June 1992, RS 235.1, in force since 1 July 1993, unofficial English translation at https://www.admin.ch/opc/en/classified-compilation/19920153/index.html (currently under revision). 22 See also section 362 of the Swiss Code of Obligations (Code of Obligations of 30 March 1911, RS 220, in force since 1 January 1912, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/19110009/index.html), which makes it possible for the employer to extend a contractual regime more favourable—not less—than 328b to the employee. 23 The provision remains applicable once the employment contract has ended, if the employer must still perform certain contractual duties (e.g. issue a work recommendation). For more on this provision see Pärli (2016), pp. 52–77; Pärli (2015), pp. 409–423; von Kaenel (2007), pp. 93–117. 24 Dunand (2013), p. 337. Once more, the diagnostic will not be communicated to the employer; the latter will only know if the worker is indeed unable to work for a medical reason. 25 See e.g. Dunand (2013), pp. 332–333. The employer may even be allowed to invalidate ex tunc (retroactively) the employment contract if it entered into the contract without the knowledge of such circumstances. 26 According to the Federal Council in its Message of July 2017 (Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5361), the “médecin mandaté par l’employeur” could even be the attending physician of the individual. 27 Dunand (2013), p. 336. 28 In some situations, the employer may be forced to cooperate with insurers and to transfer them information concerning the employee. See Dupont (2017).

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Deciding which suitability questions are admissible calls for an appraisal of proportionality in each specific case.29 The consent of the worker or candidate is not relevant (i.e. it does not justify asking questions that go beyond these legal limits).30 The individual remains free to refuse to answer, but if the employer’s questions satisfy the requirement set by section 328b of the CO, her refusal may lead to adverse consequences (i.e. she may not be hired or be dismissed).31 For example, a company planning to hire a bus driver would be allowed to ask questions about the prospective driver’s vision, whereas a company planning to hire an accountant would not. The diagnosis must never be disclosed to the employer, only the (in)ability to carry out the planned or actual job functions; for this reason, the process is usually delegated to a specialized advisory doctor (“médecin mandaté”).32 Moreover, the questions must address the current health of the worker, and not her long-term prospects. Based on anecdotal evidence, it appears that pointed medical questions are most often raised when the work carries the potential for physical harm, either to the employee (e.g. construction work) or third parties (e.g. transportation).33 Questions that aim only to determine whether, in the future, the person is more likely than average to miss days of work due illness are inadmissible.34 With respect to the matter of inadmissible questions, most authors in the Swiss legal literature accept that the prospective worker can either refuse to answer (obviously a hazardous route) or lie in order to safeguard her job prospects.35 If already employed, the worker who is asked illicit questions may be entitled to

29 See section 4(2) of the Federal Act on Data Protection (FADP) of 19 June 1992, RS 235.1, in force since 1 July 1993, unofficial English translation at https://www.admin.ch/opc/en/classifiedcompilation/19920153/index.html (currently under revision). Moreover, it must be made clear (transparent) to the employee that questions are being asked and for what purpose. The answers must then be handled securely (i.e. not passed on to other parties). The data controller (here, the employer) must act in good faith. 30 Pärli (2015), p. 416; von Kaenel (2007), pp. 101–102 and 111; Dunand (2013), p. 327. 31 Dunand (2013), p. 328. 32 See the Judgment of the Federal Tribunal of 4 May 2017 in ATF 143 IV 209, JdT 2017 IV 367. 33 See the examples given by von Kaenel (2007), p. 102. Indeed, employers have a duty to protect all their workers from the risk that an(other) employee may represent for them (for example in the case of highly contagious disease). 34 For example, a patient group specialized in HIV advises:

If your HIV infection reduces your ability to work, you must mention this to the employer (. . .). This means that as long as you feel healthy and your doctor did not decide to put you on medical leave, you have no obligation to inform your employer. (Author’s translation). Online at Aide Suisse contre le sida, Droit du travail, https://www.aids.ch/fr/vivre-avec-vih/ droit/droit-du-travail.php. 35 Pärli (2015), p. 422; Lempen (2017), p. 282; Dunand (2013), p. 332. On this issue and the range of questions that can be asked, see also Ducor (2013).

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terminate the work contract immediately for cause, but that is usually not very helpful, as the person does not automatically receive an indemnity.36 To my knowledge, no cases of inadmissible questions or of refusal to hire based on health status have ever been litigated.37 This is unsurprising, considering neither is sanctioned directly in Swiss employment. Only refusal to hire based on sex (e.g. because of a pregnancy) is explicitly prohibited in a federal law on gender equality38; even these cases are rare.39 A person who suspects that she was not extended a job offer because of her poor health has few options for proving discrimination against her and for obtaining compensation. Sections 328 and 28 of the CO may apply, but the burden of proof they impose is likely to prove insurmountable. Once the employee is hired, she benefits from limited legal protection against dismissal or sanctions due to her health status. If she cannot work due to a disease or an accident, she is entitled to receive her salary for a certain period of time (calculated based on the duration of her employment). For example, after two years of employment with one employer, the worker will receive her salary for a maximum of one to two months.40 Moreover, depending on how long she has been holding her position with the employer, the worker will be protected against firing for a certain period of time. For example, in her second employment year, her employer cannot fire her while medically ill for a period of 90 days.41 Once these protection periods lapse, the employer can cease to pay the salary and/or terminate the worker. The above rules apply regardless of whether the disease is due to a genetic trait. In summary, the protection of persons suffering from diseases is limited in the employment context. At some point in time, the person will lose her right to receive her salary and her contract may be terminated.

36 Pärli (2015), pp. 422–423. A lawsuit for damages remains possible, but this is usually viewed as cumbersome (costly and complicated) by workers. 37 In July 1996, the Federal Tribunal issued its judgment 122 V 267, where it found, incidentally, that the personal questions that a firm had asked a potential employee were indeed inadmissible, but the focus of the case was whether the employee who was not offered the position was entitled to unemployment insurance. In a later case (4C.189/2002 of 27 September 2002), involving an employer and an employee, the Federal Tribunal ruled that the worker had not unduly hid his poor health at the hiring stage, as he could still consider himself able to perform the tasks; that the employer had asked no specific questions was among the decisive factors. See also judgment 8C_417/2011 of 3 September 2012. 38 Lempen (2017), pp. 269–286. Sections 3, 5 and 8 of the Federal Act on Gender Equality (Gender Equality Act, GEA) of 24 March 1996, in force since 1 July 1996 (RS 151.1), available at https:// www.admin.ch/opc/en/classified-compilation/19950082/index.html. 39 See the database of judicial cases at http://www.leg.ch/jurisprudence/search&article-LEg¼3/ and Pärli and Studer (2014), p. 129. 40 Section 324a(2) of the Swiss Code of Obligations. Often the employer and the employee agree that coverage of wages during a period of incapacity will be paid instead by an insurance company, offering longer coverage at a slightly lower rate. See section 324a(4) of the Swiss Code of Obligations. 41 Section 336c(1)(b) of the Swiss Code of Obligations.

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If an employee was dismissed because of work incapacity imputable to a disease, the employment certificate she receives may mention the reason for the dismissal. However, the specific disease cannot be mentioned, only the fact that the inability to work due to a disease was the cause of termination. Obviously, such an employment certificate can make it harder for the individual to find a new position.

1.3

“Crossover” Situations: Insurance Offered Through the Employer

In some situations, insurance for the individual is organized through the employer. For example, the employer may offer supplementary old-age insurance (“prévoyance professionnelle surobligatoire”), complementary sickness coverage or loss-of-wage insurance in case of maternity, accident or disease. The employer contracts with a given insurance company to offer one broad policy covering all (or a subset of) its workers—a group policy. Despite the existence of such a global policy, the insurance company may still want to assess each employee’s risk when calculating premiums. Therefore, the insurance company may ask the future employee to fill out a detailed health questionnaire.42 To some extent, the insurance company may refuse to extend coverage for some medical risks (for the risk of invalidity or death for a maximum of five years and risk of sickness and accident, but not for retirement schemes). Temporary refusal (called “réserves”) may have an impact on the employer, because the employee can then claim wages during a period of sickness or accident directly from the employer, as opposed to the insurance company.43 In principle, the employee should return the questionnaire directly to the insurance company, making sure that the document is not transmitted via the employer and that it does not receive a copy.44 This is because the questions that the insurance company is allowed to ask are typically much broader than those the employer can raise (see section 328b of the CO, mentioned above). The employer cannot take advantage of the insurance questionnaire to receive information that is—by law— not considered to be relevant to its own hiring decisions. In practice, whether the rules are always complied with is not entirely clear.

42

Dunand (2013), p. 337. This raises the issue of whether the employer can then ask the insurance company for information the latter holds about the health status of the worker. On this question, see Dupont (2017), p. 220. 44 Pärli (2016), p. 71; Pärli (2015), pp. 419–420; Dunand (2013), p. 337; Dupont (2017), p. 219. 43

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2 Swiss Legal Framework for (Medical) Genetic Analyses Having just described the general protections benefitting clients of insurance companies and private sector workers, this Section focuses on the specific rules applicable to genetic testing in these two contexts. We base our analysis on the Swiss Federal Law on genetic analysis (FLGA) and its new (yet unknown) ordinances even though both are not yet in force.45 The FLGA is only applicable to GA achieved through medical tests as well as their resulting information; genetic information acquired through other means, for example, from family medical history, is usually not under the purview of this Law.46 As a preliminary observation, it is important to note that Swiss law does not mean to have an extraterritorial reach. Unfortunately, the Swiss FLGA does not specify its geographic application. The relevant criterion is most likely the location of the insurance company and the employer. Thus, if a Swiss-based company wants to hire a foreign worker to work in Switzerland, the Swiss protections, including the FLGA, would apply. However, if a Swiss company plans to hire a Swiss individual to work at its French office, with the work relationship being subject to French law, the FLGA would likely not apply. The question is even harder to answer when a Swiss company wants to offer life insurance to an individual domiciled in France. If the insurance policy is subject to Swiss law, the FLGA should apply; conversely, if the Swiss company makes it clear that French law governs the insurance relationship, then the FLGA would probably not apply. The legal doctrine has not discussed these issues, nor have the Swiss courts decided them.

2.1

In the Context of Insurance

The FLGA sets forth various rules which mostly target the contracting stage. It is not clear whether these rules, particularly the limits regarding diagnostic tests, are also applicable once the insurance contract has been entered into and the issue turns to whether, for example, the client is entitled to a given benefit. Generally speaking, the client who claims a given benefit (e.g. payment or reimbursement) must provide all useful information establishing her right to the benefit. Courts in Switzerland usually take the stance that insurance companies are at liberty to ask and obtain all kinds of information that may be related to the claim at issue.47

45 Entry in force is expected in 2021. See the information available on the website of the Federal office for Public Health, under the title “Révision de la loi fédérale sur l’analyse génétique humaine,” at https://www.bag.admin.ch/bag/fr/home/medizin-und-forschung/genetischeuntersuchungen/aktuelle-rechtsetzungsprojekte1.html. 46 See Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5363. 47 See more broadly on the issue Dupont (2017), pp. 195–228.

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Diagnostic Tests

As explained above, the insurer cannot take into account genetic traits at any stage for most mandatory public insurance (e.g. basic sickness insurance for health benefits, unemployment insurance, old-age insurance, disability insurance and retirement insurance). On the other hand, the results of medical GA can be relevant for private complementary sickness/accident insurance, (private facultative) life insurance, (facultative) unemployment insurance for independent workers, and (complementary) retirement insurance.48 The insurer can never request nor use GA that relate to non-medical traits of the individual (e.g. ancestry and personality).49 As previously explained, these insurance companies can send written questionnaires to investigate the precise (current and past) health status of the prospective client. No clear limits as to the scope of questions apply, including in the genetic field (except for predictive tests, as explained in the next paragraph). As long as the insurance company can convincingly argue that the answer to the question could be relevant to calculating premiums or to denying coverage, then the question is allowed. Thus, a company can ask whether the prospective client—or any member of her family—has suffered from any genetic disease. That questions may impinge on the privacy of third parties (i.e. the family members) has so far—to my knowledge—not been ruled unlawful.50 In any case, no litigation exists on the admissibility of genetic questions in insurance questionnaires. As a result, the assumption is that any health question is permitted. The practical limit has probably more to do with the length of the questionnaire. A company that asks clients to fill out a 20-page questionnaire would risk losing clients, including good clients, especially if its competitors are only using a two-page questionnaire. Hence, companies prefer to ask broad, general questions and wait to receive the answers before asking—if need be—more targeted questions. Companies may also require that an independent doctor (i.e. not the person’s usual doctor) examine prospective clients, but this is not common, except possibly for high-value life insurance policies.

48

In Switzerland, coverage for loss of wages due to disease can be complex because there are two options: public facultative insurance or private facultative insurance. In most cases, employers prefer to contract a private policy with a private insurance. In these cases, the principle of freedom of contract applies and the insurance company can refuse coverage of a given employee or impose high premium because of a high-risk assessment. 49 Section 37 of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html; Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5358 (“leur origine n’a pas d’importance, qu’il s’agisse d’informations excédentaires acquises dans le cadre d’analyses dans le domaine médical ou de résultats d’analyses en dehors du domaine medical”). 50 See however the recommendation of Lehmann (2017, p. 153), whereby the questions should be asked in such a manner as to make the family member unidentifiable. How this can be achieved is, however, difficult, especially if the prospective client has few family members (e.g. no brothers or sisters, no aunts or uncles).

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The FLGA only limits so-called “presymptomatic” GA for insurance purposes. Presymptomatic GA are analyses that take place before the patient has noticed any symptoms (referred to below as “predictive GA”). The classic example is Huntington’s disease: if someone wishes to be tested because her parent is suffering from this genetic disease, but she herself has no symptoms, this genetic analysis will be labelled “predictive.” The boundary between symptomatic testing and predictive testing may not always be clear, since the criterion used to determine the cut-off is whether the patient has noticed any symptoms.51 Of course, if the patient is experiencing some light symptoms, but has not mentioned them to anyone, she can easily affirm that the analysis is not predictive. Conversely, if the patient is complaining of some general ills and a genetic analysis is ordered to reach a diagnostic, the analysis may be deemed diagnostic (and not predictive). This is so even though the concrete symptoms may have been imputable to something else (e.g. a concomitant flu).

2.1.2

Predictive Tests

The legislature has chosen to offer broader protections to prospective insurance clients with respect to predictive GA.52 In most circumstances, use of such analyses is banned. More precisely, the insurance company cannot request that the prospective client submit herself to such tests. It also must not ask for the results of such a test if it was already undertaken at the initiative of the prospective client. Finally, the company is forbidden to use the results of this analysis, should it “accidentally” receive the results.53 In other words, any use of predictive GA is generally banned.54 According to the Federal Council, this ban encompasses data from GA performed on family members of the prospective client.55 Consent of the individual does not void the prohibition. Breach of this ban is punishable by criminal sanctions; individuals working for the insurance company who requested or used diagnostic GA in violation of the FLGA (sections 42 and 43) can face up to three years in jail.56

51

See Kieser (2005); Gallegos López (2011), pp. 220–223. This satisfies the mandate at section 12 of the Oviedo Convention (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164). 53 This should also imply that if the client spontaneously sends the insurance company the test results establishing that she is not suffering from a given genetic disease, the company cannot use the results to offer more attractive premiums. 54 The Federal Council adds in its Message of July 2017 (Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5363): “ni les personnes à assurer ni leurs proches ou des tiers ne peuvent être interrogés quant à l’existence de telles données”. 55 Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5363 (“ou sur ses proches”). 56 Section 56(1)(h)-(i) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin. ch/opc/en/classified-compilation/20011087/index.html. 52

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The FLGA has, however, introduced one exception to this broad ban. An insurance company may ask a prospective client for the results of an existing predictive test57 and use them if the following conditions are (cumulatively) met: 1) The insurance contract is for complementary health benefits (not including loss of revenue), facultative unemployment insurance, life insurance for a capital amount exceeding CHF 400,000, or complementary disability insurance covering a yearly benefit exceeding CHF 40,000.58 A contrario, this is never possible for mandatory social insurance, insurance covering loss of wages due to sickness or maternity, and when insurance does not reach the above-mentioned threshold. 2) The results of the predictive test are scientifically reliable.59 How to establish scientific reliability is not specified, although the Federal Council suggests asking the specialized Federal Expert Commission on genetic analysis in case of doubt.60 3) These results are statistically relevant to calculating the future premiums.61 4) The prospective client has been apprised of the results of the (already performed) predictive analysis.62 This safeguards the right not to know that section 8 of the FLGA lays down. If all the requirements are met, the insurance company can ask to forward the results to an independent physician appointed by the company (“médecin-mandaté”).63 The client must agree; if she refuses, the contract negotiation will end.

57 The context in which the test took place does not matter. Tests undertaken in the context of a clinical trial, performed in the course of clinical care or “self-tests” realized at home are all subject to the same rule—as long as the patient has been told the result. 58 Sections 44(1) and 43(1) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https:// www.admin.ch/opc/en/classified-compilation/20011087/index.html. How to calculate the cut-off may be difficult if the actual amount insured varies according to different criteria that are not selfevident at the time of contracting. According to the Federal Council in its Message of July 2017 (Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5364), only about 2% of currently subscribed life insurance policies reach this threshold. 59 Section 44(1)(a) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin. ch/opc/en/classified-compilation/20011087/index.html. 60 Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5365. 61 Section 44(1)(b) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin. ch/opc/en/classified-compilation/20011087/index.html. 62 Section 44(1)(c) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin. ch/opc/en/classified-compilation/20011087/index.html. This was not explicitly stated in the former Swiss Law. 63 Section 44(3) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html.

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If the client agrees, the above-mentioned independent physician will receive and process the results and inform the insurance company only of the risk group to which the prospective client belongs (e.g. whether she belongs to the high-risk category). In other words, the diagnostic will not be directly communicated to the insurance company. Of course, depending on the situation, the fact that the prospective client belongs to the high-risk category may indirectly divulge the test results. Insurance companies can only use the information they received to decide whether or not to offer the specific insurance policy discussed and, if so, to calculate the premiums. They cannot use it to decide premiums for a different insurance contract nor to renegotiate a distinct policy.64 They also cannot rely on it to enter into or to renegotiate other insurance contracts for family members.65 A contrario, an insurance company cannot ask for, nor use the results of, a predictive analysis if the contract has already been entered into. Put differently, it cannot use the results to renegotiate premiums. An insurer can never ask a prospective client to undergo a predictive genetic analysis. If the client has undergone a predictive test, but ultimately declined to know its results, the insurance company cannot ask for them. The insurance company cannot ask for the results of a predictive test if they are too uncertain to be properly interpreted (i.e. to infer whether the feared disease will indeed materialize and thereby impact on the level of insurance benefits). For example, if a test discloses that the prospective client has a 20% chance of developing Alzheimer’s disease in her 80s, that information would—probably—not be relevant. A prospective client who, knowing the result of a predictive test, realizes that she definitely will incur, later in life, a serious or perhaps even life-threatening genetic disease can contract a life insurance policy for up to CHF 400,000. She does not have to disclose her reason for wanting this insurance. Similarly, she can contract a facultative disability insurance policy for up to CHF 40,000 yearly payments, without having to reveal her future disease. She should be allowed to lie if the insurance questionnaire asks a specific question regarding this predictive test. The asymmetry of information is accepted in such situations. The cut-off is the amount at issue—below or above CHF 400,000 for a single capital payment and CHF 40,000 for yearly payments. Of course, she cannot cumulate policies for an amount below the cut-off, although in practice, such circumventing behaviour may not be immediately apparent.66

64 Section 44(3) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html. 65 Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5365. 66 Section 44(3) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html. 43(3) FLGA states that the sums covered by the same type of insurance (e.g. life insurance) must be aggregated to decide whether the cut-off is reached. It is logical that the addition include policies from different insurers, but that can lead to complications in practice since insurance companies are usually left to rely on their clients’

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Interestingly, for complementary health insurance covering the costs of health care services (e.g. a private bed in the hospital), no cut-off amount exists.67 Any known and relevant results of an existing predictive analysis must be communicated upon request (as well as results of diagnostic tests, of course). This is probably because setting a cut-off amount would be very difficult; indeed, costs (to be reimbursed) tend to accrue over time, with no one-time or yearly payments. All in all, the rules in Switzerland should discourage individuals from undergoing predictive genetic testing—at least as long as the results cannot lead to short-term health measures to cure or minimize the upcoming disease. Indeed, a person who learns that she will suffer from Huntington’s disease in 30 years may find it much more difficult to secure insurance coverage, whereas had she chosen to ignore her status, the risk would have been slight or null. Of course, one major loophole of the system is that it relies on the parties’ good faith. For example, a patient may seek a test abroad and then deny having been tested when questioned by the Swiss insurance company. Given that the test was done abroad, the odds of the insurer learning of its existence are low.

2.2

In the Context of Employment

Employers are limited in their possible use of GA. In most cases, they cannot request or use such tests. In particular, they must never request or use GA that relate to nonmedical traits of the individual (e.g. ancestry or personality).68 The limits set forth by the FLGA are explained below. Breaches of its rules are punishable by criminal sanctions. Individuals who request or use a genetic test when the FLGA does not allow it face up to three years in jail.69

2.2.1

Diagnostic Tests

In the context of an existing employment relationship, an employer can request that a worker submit herself to a genetic analysis if the results would be relevant for the position occupied. The analysis must target the suspicion of a given existing disease, as opposed to a non-medical trait (e.g. creativity, if that proved to be gene-related).70

declarations. See Federal Council’s message of 5 July 2017, object 17.048, FF 2017, Message of July 2017, p. 5364. 67 This is criticized by Mund (2005), pp. 118–121. 68 Section 37 of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html. 69 Section 56(1)(f) and (g) of the FLGA for violations of sections 39 and 40. 70 See Pärli (2016), p. 64.

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One could imagine the case of a bus driver who starts having seizures; the employer could ask that she undergoes a genetic analysis to ascertain whether the cause of these seizures is genetic, provided that this answer is relevant to reach a proper course of action (e.g. adapt the work environment71). The legislation does not define what relevance for the position (“caractéristiques ayant un rapport avec le poste concerné”) consists in, but it is assumed that the disease must present a risk for the employer, for the employee, for other employees or for the environment. A result disclosing only that the worker is more likely to fall sick should not be relevant. That an employer may want to know whether the new accountant is more prone to falling sick is certainly in its interest (to organize work and limit costs), but the balance of interests at issue still favours the protection of the employee. Very little litigation exists on this topic, and none pertaining to genetic questions. Legal insecurity will, therefore, remain until the courts have the opportunity to rule on the matter. In the situation considered above, the employee risks being fired if she refuses to undergo the analysis. The employer will have to prove that having this genetic information is truly necessary to determine whether the employee can safely perform her job functions. If that is the case, termination with notice will not be held to be abusive (section 336 of the CO). If other measures can minimize the risks, for example, moving the employee to a different position, then the employer should be compelled to try these alternatives before resorting to termination.72 The issue then becomes whether the costs of these measures are reasonable. If the diagnostic analysis takes place, its results will be communicated to the patient and to the independent physician designated by the employer. The patient may opt not to be informed of the results. The employer will not be apprised of the results directly. By analogy with what was explained above, the physician will only tell the employer whether the employee can safely perform her job functions. Of course, once again, if the employer receives a negative answer, it can probably infer that she suffers from the disease genetically tested. In practice, this situation arises only very rarely. Employers almost never request diagnostic (post symptomatic) GA. The reason is simply that very few genetic tests are relevant to employment relationships. The FLGA contains no provision regarding the admissible use of existing results of past diagnostic GA. Logically, section 38 of the FLGA should apply by analogy when an employer wants to ask for the results of existing GA and then use them to make a decision. In other words, asking and using the known results should only be allowed when this is proven to be relevant. Once again, relevance should be admitted only strictly—minimizing the costs for the employer or facilitating the organization of work is not sufficient. The wording of the FLGA (“en lien avec des rapports de travail”) suggests that its rules apply to existing employment relationships, and not prospective ones.

71 The duty to organize a secure workplace is laid down at section 6 of the Swiss Federal Law on Work (RS 822.11). 72 See e.g. Pärli and Studer (2014) p. 142.

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However, this leads to a potentially absurd result. The employer would first have to hire the person, then ask for the relevant information, then terminate the contract if the results are “bad.” It makes much more sense also to apply sections 39 and 40 of the FLGA in the context of negotiations for future employment contracts. This would maintain coherence with section 328b of the CO, the general provision described above. The Federal Council’s Message states that the provisions of the FLGA are already applicable during hiring discussions.73

2.2.2

Predictive Tests

The Federal Law contains two provisions on predictive GA in the context of employment. The basic principle is that employers can never require that their employees submit themselves to such an analysis.74 If the employee, of her own volition, has already undergone a predictive genetic analysis, then she cannot be compelled to communicate the results to her employer (or to the independent, appointed physician).75 Should the employer learn the results by chance, it is prohibited from using them, for example, to terminate the employment relationship.76 Consent of the employee does not lift these bans. Section 40 of the FLGA introduces an exception to these three prohibitions (i.e. to ask for the analysis, to ask for its results [when already available] and to use the results). It is not entirely clear why this exception was introduced in the 2004 legislation and retained in 2018. Since the entry into force of the initial FLGA, the exception has never been used. The requirements are so strict that no employer has ever tried to invoke them. Because of its lack of practical relevance, the exception will only be briefly summarized. Basically, an employer may compel an employee to undergo a predictive genetic analysis if knowing the results has been duly recognized as the only way to avoid an otherwise unavoidable high risk to the employee, to third parties or to the environment. Moreover, the Federal Expert Commission on genetic analysis must have confirmed that this predictive analysis is indeed scientifically and medically relevant.77

73

Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5361 (“Dans la perspective de la conclusion d’un contrat de travail ou durant les rapports de travail”). 74 Section 39(a) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html. 75 Section 39(b) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin.ch/ opc/en/classified-compilation/20011087/index.html. 76 Section 39(b) of the Swiss Federal Law on genetic analysis. 77 In addition, the Swiss Institute for Accident Insurance (Suva) may need to give its authorization (see section 40(2) of the Federal Act on Human Genetic Testing (HGTA) of 8 October 2004, in force since 1 April 2007, RS 810.12, unofficial English translation available at https://www.admin. ch/opc/en/classified-compilation/20011087/index.html).

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To summarize, in practice, employers can almost never require employees to undergo GA. They could ask for the results of an existing diagnostic genetic analysis or require that one such analysis take place, but they would have to satisfy the— rather high—relevance requirement. Even though doubts as to how to interpret this requirement subsist, it seems that employers do not want to test the limits of this concept.

3 Critical Analysis From the legislature’s perspective, the FLGA reaches a reasonable compromise between the opposing interests of the various parties. Insurers and employers may—within certain limits—learn information that is truly relevant to reach their decision to enter into a contract. Beyond a certain risk, the possible asymmetry of information between the insurance company and the client is “corrected,” in the sense that the insurance company may ask for pertinent genetic results. In the context of employment, the employer must be allowed to acquire the information necessary to curtail material risks incurred by the worker or third parties. The current situation is not perfect, however. Our description of the current regulatory landscape leads us to argue that the following issues ought to be clarified or improved: – The applicability of the FLGA to international relationships should be spelled out. Is the decisive criterion the applicable law to the employment contract or the insurance contract? Is it the domicile of the individual? The headquarters of the company? A combination of the above? – It should be confirmed that sections 38 to 40 of the FLGA apply not only in the context of an existing employment relationship, but also when one is being contemplated and negotiated—the Federal Council has stated so, but the FLGA is not sufficiently clear. – It should be clarified to what extent insurance companies can ask questions about the health status of family members, including questions about results of predictive and diagnostic genetic tests undergone by family members. Presently, the FLGA’s prohibition applies only to the test results obtained directly by the prospective client. Nothing in the FLGA explicitly prevents insurance companies from asking for test results of family members, even though the Federal Council states that the ban on predictive GA encompasses such results.78 – The FLGA should limit how far back in time insurance companies can go in asking health-related questions. Some companies have questionnaires that span the previous five years, while others use a ten-year cut-off. This is already quite long. The legislature should ensure the setting of a reasonable limit (e.g. the last

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Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5363.

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five years if no sequelae are present). Some authors have suggested a “right to be forgotten” for diseases cured or otherwise successfully treated several years prior. After a period of time, the person should no longer have to fear that her past disease will influence her social and legal life.79 Section 38 of the FLGA should be amended to explicitly apply also when the employer wants to use the results of an existing diagnostic test. Indeed, the current wording (“analyses génétiques prescrites en lien avec des rapports de travail”) suggests that the provision comes into play only when the employer is asking for a GA to be undertaken, even though such a strict interpretation would lead to illogical results. How to establish the reliability and relevance of genetic tests ought to be clarified. The FLGA only states that reliability and relevance are requirements, but no one knows how to establish them. One could develop a list of genetic tests that meet this requirement, depending on the insurance contract and on the type of employment relationship at issue. In my view, the Federal Expert Commission on genetic analysis should be consulted, not only when employers intend to use predictive GA, but also when insurance companies plan on doing so. It should be mentioned in the FLGA that GA can only be asked for and used when there exists no other way to reasonably minimize the anticipated risk (subsidiarity principle). For example, a question about an allergy asked by a prospective employer should not be admissible if the employer is able to organize the work so that the (future) employee is never in contact with the substances to which she is allergic. Similarly, a genetic disease that can be cured should not be viewed as relevant for life insurance purposes. The identity of the independent doctor and what her permitted relationship with the insurance company or with the employer is should be spelled out in the law or in guidelines. It should be established which party must ultimately bear the costs when the employer or insurer is entitled to request that the individual undergo a genetic analysis or asks to receive existing results. Since no contractual relationship may exist at the time the information is requested (but only a negotiation toward a possible future contract), it is not obvious that the costs can be charged to the prospective employer or insurer. It would also be worth rethinking whether the exceptions of sections 40 and 44 of the FLGA are worth maintaining, as they are probably rarely if ever used.

In addition, the legislation should ban attending physicians from directly disclosing health information to (existing or prospective) employers and insurers, even with the written consent of the patient. Indeed, the patient is rarely in a position of power allowing her to refuse her consent when solicited by the employer or insurer. For this reason, if an insurance or employer wants to ask questions of the treating doctor, it

79

Fanti (2016), pp. 107–108.

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should be through a written questionnaire that the patient can examine before and after the physician completes it. A further recommendation pertains to the situation of independent workers. Because these individuals do not benefit from public (mandatory) insurance for risks related to unemployment and loss of wages (due notably to disease or sickness), they have to “hunt” for insurance coverage on the private market. Past a certain age or with any kind of previous health conditions, it can be very difficult to find an insurance company willing to insure these risks. Often, these individuals remain uninsured.80 This is a strong deterrent against creating or managing one’s own enterprise. The rules described above raise a more general question related to discrimination. According to section 4 of the FLGA, no one should be discriminated against based on her genetic profile.81 This provision bans discrimination both by State actors and by private parties, including employers and insurance companies.82 It protects the persons who undergo GA and their family members who might be indirectly concerned.83 Section 4 does not specify that it covers only discrimination in the enjoyment of existing rights or fundamental liberties, but it implicitly accepts it. Moreover, discrimination is only illicit when not objectively justified.84 To our knowledge, Swiss courts have never applied this general principle; therefore, they have never had to decide the breadth of the rule. Given the various provisions that allow employers and insurance companies to ask for and use the results of genetic tests, section 4 clearly does not impose a total ban on all discrimination. For example, a complementary sickness fund can refuse to extend an insurance offer to a patient based on her genetic risks, including where they are only prospective, as in the case of predictive analysis.85 Similarly, an employer can terminate a worker because her genetic disease causes her to miss work too often. The burden of proof is

80

Pärli and Studer (2014), p. 128; Kieser (2005). See also the UNESCO International Declaration on Human Genetic Data of 16 October 2003, available at http://portal.unesco.org/en/ev.php-URL_ID¼17720&URL_DO¼DO_TOPIC&URL_ SECTION¼201.html, Art 7 and the Oviedo Convention (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164), Arts 1 and 11. 82 Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5311. 83 Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5311. 84 See Federal Council’s message of 5 July 2017, object 17.048, FF 2017, p. 5311: 81

En vertu de la jurisprudence du Tribunal fédéral, l’interdiction de discriminer ne requiert ‘pas une égalité de traitement absolue, mais elle laisse de la place aux inégalités de traitement dans la mesure où elles sont fondées’. 85

In a different context, it has often been noted that private insurance companies systematically refuse to extend life insurance or complementary sickness health insurance to HIV-positive individuals. This form of discrimination, all the more unfair given the good life expectancy of such patients, has never been challenged. Cf Aide Suisse contre le sida, Assurance-vie, available online at https://www.aids.ch/fr/vivre-avec-vih/droit/assurance-vie.php.

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not even reversed in favour of the employee.86 Moreover, the FLGA imposes no criminal penalties for a violation of section 4.87 These examples raise the question of the residual scope of the principle in section 4 of the FLGA. The principle of freedom of contract is at the basis of Swiss employment and Swiss insurance law. Each party can freely decide whether to enter into a contract and can freely negotiate its terms—as long as they follow the (few) mandatory provisions of Swiss law. To that extent, freedom of contract seems to prevail over the principle of non-discrimination. Thus, an individual suffering from a genetic disease cannot complain if no one wants to hire her, extend her life insurance, or insure her for complementary health risks. The State will not fill in the gaps either. That person will have to get by with the minimum public-social insurances (e.g. basic sickness insurance, basic disability insurance, and basic old-age insurance). A more general question is whether it is wise to isolate genetic health risks. The FLGA focuses solely on risks resulting from genetic tests, yet similar risks may arise from other sources. For example, a family member may have been diagnosed with a genetic disease, based either on a genetic test or on other diagnostic tools. In that case, the genetic test results are not those of the employee or the prospective insurance client. The FLGA would not directly apply—and applying it by analogy would stretch its boundaries. A similar issue is the risk caused by other, non-genetic diseases. Some diseases may be diagnosed early, before the patient experiences symptoms. If a patient is told that she has a high risk of experiencing a stroke (due to, say, high cholesterol) or breaking bones (due to osteoporosis), this information is a type of presymptomatic diagnostic. Yet, the rules of the FLGA would not apply. The insurance company would be entitled to ask any question regarding this presymptomatic risk, and even possibly to request a diagnostic test. In theory, the employer could also ask questions, at least if the risk could be held relevant to the employment (e.g. the worker should be tested because her work requires carrying heavy loads and people with osteoporosis are more prone to injuries and should, therefore, be “avoided”). Hence, it would appropriate to focus on health risks in the context of employment law and insurance law, rather than on the genetic nature of the test.

86

Pärli and Studer (2014), p. 142. It is also worth noting that the termination of employment contracts that breach Swiss laws is not devoid of effect (i.e. the contract remains terminated), but rather leads to the payment of an indemnity capped at six months’ of wages: sections 336a(2) and 337c(3) of the Swiss Code of Obligations. 87 On the possible remedies, see Federal Council’s message of 5 July 2017, object 17.048, FF 2017, pp. 5311 and 5312.

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4 Conclusion Perhaps as important as the recommendations above, what is lacking in Switzerland is transparency. No one knows how many workers are fired in Switzerland on account of their health. Maybe many, maybe very few. Similarly, no one knows how many people are denied insurance or offered unattractive policies because of their poor health. Without this information, it is difficult to decide whether legal changes should be implemented. The absence of litigation may suggest that stakeholders are satisfied with the current situation. However, it may also mean that people believe they have little chance of successfully challenging the decisions of insurers and employers, or that it would be too costly to do so, given the high costs of litigation in Switzerland.88 A final comment concerns the complexity of the topic and the lack of understanding of the general population. Very few people understand clearly what kind of medical questions can be asked, by which parties, for which legal relationships, and with what consequences. Employers propose some insurance contracts that cover risks (i.e. loss of wages due to disease or sickness) that may also fall under public social insurance or private insurance schemes. Some questions are viewed as illegal, yet are commonly asked. All this serves to create a climate of confusion where workers and patients are mostly submissive and stoic. No one dares to challenge the status quo.

References Ducor P (2013) Travail et assurances: gare aux questions illicites. https://www.planetesante.ch/ Magazine/Ethique-politique-et-droit/Caisse-et-assurance-maladie/Travail-et-assurances-gareaux-questions-illicites. Accessed 15 Jan 2019 Dunand J-P (2013) Commentaire de l’article 328b Code of Obligations. In: Dunand J-P, Mahon P (eds) Commentaire du contrat de travail. Stämpfli, Bern, pp 317–355 Dupont A-S (2017) La protection des données confiées aux assureurs. In: Dunand J-P, Mahon P (eds) La protection des données dans les relations de travail. Collection CERT, Schulthess, Genève/Zürich, pp 195–228 Fanti S (2016) Big Data & protection des données dans le domaine de la santé. https://lexing.ch/wpcontent/uploads/2017/10/31.pdf. Accessed 15 Jan 2019 Gallegos López LL (2011) L’information génétique, une nouvelle source de discrimination. Dissertation, Université de Lausanne Hugentobler M (2013) Arbeitgeberschreck Gesundheitscheck. PJA 2013:1142–1152 Kieser U (2005) Gentechnische Untersuchungen beim Menschen – eine Blick auf ein neues Gesetz. Swisslex/Schulthess, Zürich Lanz FW (2014) Adverse Selection und Moral Hazard in der Privat- und Sozialversicherung. LBR Schulthess, Zürich

88 In Switzerland, there are no class action, no contingency fees, no punitive damages and the “loser” has to bear all the costs of the procedure, including part of the legal costs of the “winner”.

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Lehmann A (2017) Les réserves pour raisons de santé et les conséquences d’une fausse déclaration de santé en droit des assurances. REAS 2017(2):149–161 Lempen K (2017) Protection des données et discrimination lors de la procédure de recrutement. In: Dunand JP, Mahon P (eds) La protection des données dans les relations de travail. Schulthess, Geneva, pp 269–286 Mund C (2005) Genetische Information und Grundrechtsschutz: Zu den persönlichkeitsrechtlichen Grenzen postnataler genetischer Untersuchungen beim Menschen. Digma 5:118–121 Pärli K (2015) Comment of Article 328b Code of Obligations. In: Baeriswyl B, Pärli K (eds) Datenschutzgesetz (DSG). Stämpfli, Bern, pp 409–423 Pärli K (2016) Die Bearbeitung von Arbeitnehmerpersonendaten durch den Arbeitgeber im Interesse von Sozial- und Privatversicherungen. In: Reimer-Kafka G (ed) Sozialversicherung: Von der Wiege bis zur Bahre. Schulthess, Zürich, pp 52–77 Pärli K, Studer M (2014) Arbeit und Existenzsicherung. In: Naguib T, Pärli K, Copur E, Studer M (eds) Diskriminierungsrecht – Handbuch für Juris-Innen, Berater_innen und DiversityExpert_innen. Stämpfli, Bern, pp 121–161 Rohmer S (2006) Spécificités des données génétiques et protection de la sphère privée. Schutlhess, Zürich von Kaenel A (2007) Das neue Bundesgesetz über genetische Untersuchungen beim Menschen (GUMG), Eine Übersicht aus arbeitsrechtlicher Warte. DTA Revue de droit du travail et d’assurance-chômage (DTA) 2007(3):145–148

Genetic Testing, Insurance and Employment in the UK: Is the Regulatory Regime Fit for Purpose? Gerard Porter

Abstract This chapter provides an overview of the current legal and policy landscape governing genetic testing in the context of insurance and employment in the UK. It focuses on the characteristic features of the UK regulatory regime, namely the decision to avoid including “genetic characteristics” within the general antidiscrimination legislation, and instead to regulate the use of genetic test results by insurers and employers through soft law guidance documents. Other relevant guidance documents and statutes are also considered. The overall adequacy of the UK regime, and the degree to which it satisfactorily reconciles the divergent interests of the various stakeholders, are examined critically.

1 Introduction A helpful starting point for assessing the current landscape in the UK would be to get a sense of the frequency of genetic testing in the context of clinical care, insurance, and employment in the UK. Data is available on the frequency of use of genetic testing for clinical purposes within the UK National Health Service (NHS).1 Access to genetic testing within the NHS is based upon clinical need and is free at the point of delivery. Genetic testing may be carried out for a number of reasons, including to: diagnose a person with a genetic condition; help work out the chances of a person developing a particular condition; or determine whether a person is a carrier of a certain genetic mutation that could be inherited by their children. Patients will usually need a referral from a GP or a specialist doctor for genetic testing to be carried out. If undergoing testing, patients are also usually referred for 1 The NHS is the public national healthcare system for the United Kingdom. Funded through the general taxation system and overseen by the Department of Health, the system provides healthcare to every legal resident in the UK.

G. Porter (*) University of Edinburgh, Edinburgh Law School, Edinburgh, UK e-mail: [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_14

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genetic counselling at one of the NHS regional genetics centres. In the UK, it is rare for genetic testing to take place other than where there is a relevant family history. Nevertheless, it is possible that genetic testing could become more commonplace in the coming years. In July 2017, the UK’s Chief Medical Officer proposed making genomic testing “routine” within the NHS so as to improve patient care through precision medicine and to allow genomic data to be pooled for research purposes. Such a scenario is plausible, but various issues would need to be considered before implementation. By contrast, little information is available about the frequency of use of genetic testing in the context of insurance. The Association of British Insurers (ABI) has not published annual reports on the topic. It is not clear if the ABI is currently gathering this information from its members. In 2007, the Human Genetics Commission (an advisory body in operation from 1999 to 2010) published a response to the Discrimination Law Review consultation in which it submitted some evidence of what it viewed as “genetic discrimination” in relation to insurance, but conceded that this information was “anecdotal” and that the evidence base was weak.2 With regard to employment, data is also limited, but the use of genetic testing by employers does not appear to be widespread. In 2007, the Health and Safety Executive published a briefing note stating that: “We have not found any evidence that employers are currently carrying out genetic testing in Britain (with the exception of the Ministry of Defence for aircrew training).”3 There do not appear to have been any systematic attempts to study the situation since 2007. More recently however, in 2016, BBC News reported that the CEO of a UK travel company, Momondo Group, had encouraged the top management team to take DNA tests through a private company as an experiment in “improving the company’s workplace culture.”4 The tests appear to have been genetic ancestry tests, rather than tests to determine genetic predisposition to health conditions. This initiative appears to have been an idiosyncratic “one-off,” and cannot be said to indicate significant uptake of genetic testing by UK employers at the current time.

2 The Legal Framework: “Soft Law” Guidance Documents In the UK, there is no formal recognition of the “special status” of genetic data expressed in terms that reflect Article 4 of the UNESCO International Declaration on Human Genetic Data. Ideas and claims similar to those within Article 4 have been discussed within high-level government policy documents that seek to respond to the social issues raised by genetic testing. At the same time, the UK government has also paid attention to the opposing view that cautions against entrenching protection

2

Human Genetics Commission (2007). Health and Safety Executive (2007). 4 BBC News (2016). 3

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based on notions of “genetic exceptionalism” within regulatory frameworks. As in other countries, some commentators question whether genetic data is truly “special,” if the arguments made to support the claim are analysed critically. The normative status of genetic data thus still appears to be contested and subject to competing arguments and perspectives in the UK. The approach of the UK government to date has been to deliberately avoid using the general non-discrimination framework—as established under the Equality Act 2010—to address the challenges posed. Instead, two more specialised “soft law” guidance documents have been produced to restrict the use of genetic testing by insurers and employers. In the context of insurance, the UK government and the ABI have agreed to abide by a Code on genetic testing and insurance (The ABI Code), which sets out limited circumstances in which predictive genetic tests can be used by insurance companies.5 The ABI Code is open-ended, and builds on and replaces an earlier Concordat and Moratorium on Genetics and Insurance (ABI Concordat and Moratorium). In the context of employment, the Information Commissioner’s Office (ICO) published the Employment Practices Code in 2011.6 The ICO Employment Practices Code is designed to supplement and aid interpretation of employers’ duties under the Data Protection Act 19987 and to encourage best practices. The Information Commissioner issued the Code under its powers conferred by section 51 of the Data Protection Act 1998. The ICO Employment Practices Code puts forwards some key principles and restricts the freedom of employers to make use of genetic testing. The underlying philosophies of these documents are not fleshed out entirely, but some similarities and overlaps in the analytical frameworks can be observed. For example, both the ABI Code and the ICO Employment Practices Code stress that measures relating to the use of genetic tests in insurance and employment should be proportionate and based on sound scientific evidence. Furthermore, both documents emphasise the need to strike a fair and workable balance between the needs of insurers and employers, on the one hand, and of insurance applicants and employees on the other. Finally, they acknowledge that people have a legitimate interest in taking predictive genetic tests that may be beneficial for their healthcare, and should not be deterred because of anxieties about adverse treatment by insurers or employers.

5

HM Government and the Association of British Insurers (2018). The Information Commissioner’s Office (2011). 7 Data Protection Act 1998 (c 29). At the time of writing, the ICO is working on updating the Employment Practices Code, as necessitated by the repeal and replacement of the Data Protection Act 1998 by the Data Protection Act 2018. 6

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Scope and Definitions

“Genetic information” is not defined clearly within the UK for the purposes of employment or insurance. The ABI Code applies to genetic tests which look for a particular gene variant. This is regardless of whether the test was carried out as part of a single-gene test, a panel, or up to the level of whole genome sequencing. It does not apply to non-genetic medical tests, for example: urine, blood or cholesterol tests, MRI or CT scans or ECGs. The term “genetic testing” is used repeatedly throughout the ICO Employment Practices Code, but no clear definition is given. Importantly, the definition of “genetic testing” in the ABI Code does not include family history. Indeed, it explicitly provides that insurers are “lawfully permitted to seek access to appropriate family medical history and to reports from general practitioners where relevant to applications for health-related policies.” The ICO Employment Practices Code definition of “genetic testing” does not explicitly include family history. Neither the ABI Code nor the ICO Employment Practices Code explicitly includes proteomic or epigenetic data. The ICO Employment Practices Code does not draw a distinction between genetic tests occurring within a clinical setting, for research purposes, and tests sold to consumers by private companies. The ABI Code covers the disclosure of predictive genetic tests regardless of the purpose for which they were obtained. This includes, but is not limited to, a voluntarily purchased, direct-to-consumer test, one taken on the recommendation of a clinician or one taken as part of any scientific research. Commitment 3c of the ABI Code, however, carves out an exception for predictive genetic test results obtained exclusively in the context of scientific research, which do not need to be disclosed to an insurer, regardless of the test or the level of cover. The terms of the ABI Code apply only to predictive genetic tests. Diagnostic genetic tests fall outside the scope of special protections set out in the ABI Code and can therefore be used by insurers to assess and price risk in the same way as other sources of potentially relevant medical information. Whilst the ICO Employment Practices Code seems to refer mostly to predictive genetic tests, one section could be construed as relating to both predictive and diagnostic tests.8

Part 4.5.3 of the ICO Code states: “Only use genetic testing to obtain information where it is clear that a worker with a particular, detectable genetic condition is likely to pose a serious safety risk to others or where it is known that a specific working environment or practice might pose specific risks to workers with particular genetic variations.”

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Rights and Obligations

The following sections set out in more detail the ways in which the aforementioned two key soft law documents attempt to balance the divergent interests of the stakeholders in the domains of insurance and employment.

2.2.1

Insurance

Insurers argue they should have access to all relevant information to enable them to assess and price risk fairly in the interests of all their customers. Objections include those grounded in ideas of “genetic discrimination” and consequentialist arguments about the dangers of creating an uninsured “genetic underclass.” The ABI Code establishes that insurers cannot request applicants to undergo genetic tests, but can request existing test results under narrowly defined conditions. Sanctions for insurance companies that contravene these rules are not clearly set out, but disputes would be resolved according to a defined complaints procedure, with the possibility of referring the complaint to the Financial Ombudsman Service. The ABI Code adopts a “ceiling approach” in relation to genetic testing and insurance. Customers may not be asked, nor pressured, to take a predictive genetic test to obtain insurance cover. Customers are not required to disclose the results of predictive genetic tests for policies up to GBP 500,000 of life insurance.9 For policies that exceed these financial limits, however, insurers may seek information about, and customers must disclose, tests approved by the Government for use with a particular insurance product. Applications for government approval of specific predictive genetic tests by insurers may only be for conditions that are monogenic, late onset, and high penetrance. To date, the only test approved under the agreement is for Huntington’s disease. Disclosure on the part of applicants is only required if the insurance policy is above the threshold value and the applicant has already undergone testing for Huntington’s disease. Customers are not required to disclose a genetic test result from a test taken after the insurance cover has started, for as long as that cover is in force. As mentioned above, insurance companies cannot request that customers take genetic tests. If customers do undergo testing, this would most likely be within the clinical context of the NHS. Whilst something of a grey area, it is doubtful that indefinite retention of biological samples for the benefit of an insurer who may wish to undertake further testing in the future would be permissible under the Human Tissue Act 2004, the Data Protection Act 2018, or the Human Rights Act 1998. In England and Wales, insurance contracts are governed by the doctrine of uberrima fides, which requires parties to the contract to act in the “utmost good faith.” In practice, this means that insurance applicants must make full and complete

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HM Government and the Association of British Insurers (2018), p. 5.

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disclosure of all material facts in the insurance application. Failure to do so makes the contract voidable.

2.2.2

Employment

The ICO Employment Practices Code permits genetic testing only in narrowly defined circumstances; i.e. as a way to obtain information where it is clear that a worker with a particular, detectable genetic condition is likely to pose a safety risk to others or where it is known that a specific working environment or practice might pose risks to workers with particular genetic variations. In general, employers are prohibited from requesting medical tests until the stage at which a job offer is made. An employer would likely arrange for genetic testing through the employee’s general practitioner, who would send the sample to an NHS laboratory for analysis. As discussed above in the context of insurance, it seems unlikely that indefinite retention of biological samples for the benefit of an employer who may wish to undertake further testing in the future would be permissible under the Human Tissue Act 2004, the Data Protection Act 2018 or the Human Rights Act 1998. Neither statute, nor case law, nor the ICO Employment Practices Code requires disclosure of genetic information or any prior genetic testing by the job applicant to a potential employer. However, if an employer has legitimate grounds to use genetic information in accordance with the limited health and safety criteria in the ICO Employment Practices Code, and the employee fails to disclose material information, it is possible that the employee’s contract could be fairly and lawfully terminated. The employer could argue there has been a breach of the duty of mutual trust and confidence. Alternatively, the employer could claim there has been a breach of the contract or a misrepresentation. The employer would need to consider if the misrepresentation justifies termination and ensure its actions are not discriminatory. Other guidance documents and statutes may also be implicated in the overall regulatory framework for the use of genetic test results by insurers and employers in the UK.

3 Clinical Guidelines and the Biomedical Research Context In the clinical medical setting, a professional guidance document has been produced, entitled “Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information.”10 The socio-legal risks associated with genetic testing are not listed within the core issues that should usually be discussed during the consent process, but are mentioned elsewhere within the

10

Joint Committee on Medical Genetics (2011).

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guidance document. Several “scenarios” address how healthcare professionals should respond to patient concerns about the possible insurance implications of genetic testing for Huntington’s disease and other conditions. Furthermore, the suggested consent form template has an input field for recording a “Note of other specific issues discussed [e.g. research, insurance].” In the biomedical research setting, there is no comparable overarching professional guidance document. Individual genetic research projects and private companies offering direct-to-consumer (DTC) services may include details about possible consequences for insurance and employment in their information and/or informed consent forms. For example, the well-known DTC genetic testing company 23andMe includes information about possible socio-legal risks within its “Consent and Legal Agreement”: Genetic data you share with others could be used against your interests. You should be careful about sharing your genetic information with others. Currently, very few businesses or insurance companies request genetic information, but this could change in the future.11

Interestingly, the UK Biobank information leaflet uses the issue of insurance as a justification for not disclosing individualised genetic research results to participants: This is because such feedback outside of the normal clinical setting is of questionable value, and might even be harmful (for example, causing undue alarm and having potentially adverse effects on insurance status), especially when given without prior counselling or support.12

Biomedical researchers in the UK are bound by the common law duty of confidentiality and the Data Protection Act 2018. In addition, individual biomedical research projects (e.g. UK Biobank) usually provide information on their policies for data management and the sharing of anonymised data at the time of obtaining informed consent from participants.

4 Human Rights The Human Rights Act 1998 incorporates the rights set out in the European Convention of Human Rights and Fundamental Freedoms 1950 (ECHR) into UK law. The UK is not a signatory to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine 1997 (the Oviedo Convention) or to any of its Additional Protocols. Article 14 (“Prohibition of discrimination”) of the ECHR provides that: The enjoyment of the rights and freedoms set forth in this Convention shall be secured without discrimination on any ground such as sex, race, colour, language, religion, political

11 12

23andMe (2017). UK Biobank (2010).

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or other opinion, national or social origin, association with a national minority, property, birth or other status.

An argument can be formulated that “genetic discrimination” in relation to insurance and employment constitutes discrimination on the grounds of “birth or other status,” and therefore violates Article 14 of the ECHR. This argument has yet to be tested before a UK court or the European Court of Human Rights, so its likelihood of success remains an open question. To date, there have not been any human rights cases in the UK dealing with genetic discrimination in the insurance or employment contexts. A human rights case of tangential interest is S and Marper v UK.13 This case concerned two individuals whose fingerprints, cellular samples, and DNA profiles had been retained by the police despite the fact that criminal proceedings against them had been dropped or had resulted in acquittal. The applicants complained that this violated their right to respect for private life under Article 8 of the ECHR. The Grand Chamber of the European Court of Human Rights held unanimously that there had indeed been a violation of the right to respect for private life. Given the nature of personal information contained in cellular samples, their retention per se was regarded as engaging Article 8(1). Furthermore, the UK government’s retention policy could not be justified adequately under the criteria set out in Article 8(2). Whilst the retention policy did have a clear basis in domestic law and pursued a legitimate aim, it failed to strike a fair balance between the respective public and private interests. The blanket and indiscriminate nature of the powers of retention of the fingerprint and DNA material of any person suspected but not convicted of a criminal offence was held to be a disproportionate interference with the person’s right to respect for private life that could not be regarded as necessary in a democratic society. The outcome and reasoning in S and Marper v UK illustrate that the retention of genetic samples and profiles by public authorities can engage Article 8(1) of the ECHR. State interference with the right to private life will therefore need to be justifiable under the balancing test used to assess compliance with Article 8(2). Nevertheless, it is also important to note that this case concerned retention of DNA samples and profiles for the purpose of preventing disorder or crime. It is not clear if the ratio in this case would be seen as relevant and applicable in the quite different contexts of insurance and employment. Questions would also arise about the extent of the “horizontal effect” of the Human Rights Act in disputes between private parties (e.g. private sector employers and employees) rather than between citizens and the state.

13

S and Marper v United Kingdom (2009) 48 EHRR 50.

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5 General Anti-discrimination Framework Genetic features were not included as one of the nine protected characteristics within the Equality Act 2010. The Equality Act is the main piece of anti-discrimination legislation in the UK. It brought together and replaced numerous disparate pieces of legislation. In 2007, prior to the passing of the Act, a consultation paper was published that set out the Government’s proposals for a single Equality Bill and sought comments from individuals and organisations. In its response to the consultation, the Human Genetics Commission (HGC) argued in 2007 that unfair discriminatory treatment of groups or individuals on grounds of genetic difference should be prohibited in the same way that ill-treating people because of their sex or race is restricted.14 The HGC’s arguments were not accepted by the UK government, which concluded that there was little, if any, evidence of a real-world problem of “genetic discrimination.” The government also questioned whether discrimination law is the most appropriate route to deal with problems that may arise in the future. Nevertheless, it was agreed that the situation should be monitored and the need for legislation kept under review, taking into account scientific advances and the effectiveness of non-legislative options.15 “Disability” was included as one of the protected characteristics under the Equality Act 2010.16 For the purposes of the Act, a disability is defined as a physical or mental impairment that has a substantial and long-term adverse effect on a person’s ability to carry out normal day-to-day activities. A person who is currently “disabled” because of a genetic condition that has already begun to manifest itself would receive some legal protections in relation to employment. However, it seems unlikely that an asymptomatic person who simply had a predisposition to developing a genetic illness in the future could seek protection on the grounds of “perceived disability discrimination.” It is worthy of note that insurers are exempt from many of the rules that apply to other service providers, and can treat the disabled less favourably as long as the treatment is evidence-based and “reasonable.”17 Race is a protected characteristic under the Equality Act 2010.18 Discrimination on the basis of genetic status could arguably constitute “indirect discrimination” on the grounds of race. Awareness of this potential problem appears thin amongst insurers and employers and within government policy circles. Taking a historical perspective, however, Leigh reports that up until the mid-1960s, insurers asked applicants about their ethnic origins and even charged so-called “racial extras.” After the passing of the Race Relations Act 1968, insurers removed the additional premiums from existing contracts and resolved not to charge them for new

14

See Department for Communities and Local Government (2007), pp. 132–134. UK Government (2008), pp. 180–184. 16 Equality Act 2010 (c 15), s 6. 17 Schedule 3, Part 5, s 21 of the Equality Act. 18 Equality Act 2010 (c 15), s 9. 15

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proposals.19 This is an interesting precedent for considering the relationship between genetics and indirect racial discrimination in the context of insurance.

6 Privacy, Confidentiality and Disclosure The confidentiality of information derived from genetic testing and the privacy of the person who was subject to it are protected by several legal sources. First, a duty of confidentiality exists by virtue of the common law. A series of court decisions have established the principle that information given or obtained in confidence should not be used or disclosed further, except in limited circumstances (i.e. where the patient has given consent; where disclosure is required by law; or where disclosure is in the “public interest”).20 A doctor who discloses confidential information without proper justification could be sued under the common law tort of breach of confidence. Second, the Data Protection Act 2018 regulates the processing of “personal data” about living individuals in the UK.21 It sets out the responsibilities of “data controllers” when processing personal data as well as a number of rights for individuals, including rights of access to their information. The Data Protection Act 2018 sits alongside General Data Protection Regulation (GDPR),22 and tailors the way that the GDPR (which also forms part of UK law) applies in the UK. Article 5 of the GDPR establishes six key principles for the processing of personal data, namely: personal data shall be processed lawfully, fairly and in a transparent manner; collected for specified, explicit and legitimate purposes; adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed; accurate and, where necessary, kept up to date; kept for no longer than is necessary; and processed in a secure manner. Third, Article 8 of the ECHR establishes a right to respect for private and family life.23 This right is not absolute, but any state interference must be in “accordance with the law” and “necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.”24 Two professional guidance documents also are of relevance. Guidance produced by the General Medical Council (GMC) entitled “Confidentiality: Good Practice in

19

Leigh (1996). See generally Campbell v Mirror Group Newspapers [2004] 2 All ER 995. 21 Data Protection Act 2018 (c 12), Schedule I, Part I. 22 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016. 23 Transposed into UK law by the Human Rights Act 1998 (c 42), Schedule I, Part I, Art 8. 24 Human Rights Act 1998 (c 42), Schedule I, Part I, Art 8(2). 20

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Handling Patient Information” (2017) explains, reflects upon, and supplements the legal rules in the UK regarding confidentiality.25 UK doctors who fail to follow GMC guidance may face disciplinary action under the GMC’s internal “fitness to practice” procedures. In addition, more specialised guidance entitled “Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information” (2011) has been produced by the Joint Committee on Medical Genetics.26 The legal sources and professional guidance documents listed above would all apply in relation to access by third parties (including employers and insurers) to genetic test results contained in a patient’s medical or hospital file. In addition, the provision of genetic test results to employers and insurers must follow the specific procedures laid out in the Access to Medical Reports Act 1988. Under section 3 of the Act, the insurer or employer is required to notify the patient before applying to a medical practitioner for a medical report. The patient must consent to the application. The patient must also be informed in advance of their legal rights under the Act, namely: the right to access the medical report before or after it is supplied; the right to withhold consent; and the right to request an amendment of the report (under given conditions). This legal framework is also explained and discussed in three professional guidance documents: the GMC’s “Confidentiality: Disclosing Information for Employment, Insurance and Similar Purposes” (2017)27; the British Medical Association (BMA)’s “Access to Medical Reports: Guidance from the BMA Medical Ethics Department” (2009)28; and “Medical Information and Insurance: Joint Guidelines from the British Medical Association and the Association of British Insurers” (2010).29 Insurers or employers in the UK are bound by the common law duty of confidentiality and the Data Protection Act 2018. In addition, the ICO Employment Practices Code also emphasises that information about a worker’s health must be kept securely and handled in accordance with the principles set out in the Data Protection Act 1998.30

25

General Medical Council (2017a). Joint Committee on Medical Genetics (2011). 27 General Medical Council (2017b). 28 British Medical Association (2009). 29 British Medical Association and the Association of British Insurers (2010). 30 The Information Commissioner’s Office (2011), p. 83. 26

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7 Protection of Family Members The ABI Code allows insurers to seek, with the person’s consent, access to appropriate information on family history.31 However, a guidance document issued jointly by the BMA and the ABI acknowledges that requesting information about family history from an applicant’s doctor presents ethical and practical difficulties. The guidance document attempts to resolve the conflicting duties in the following way: In order to ensure that there is no breach of family members’ confidentiality, doctors may choose not to provide certain details regarding family history. Doctors should, however, report the results of any test or investigations they have undertaken on applicants because of their family history, whilst bearing in mind the limited moratorium on the use of genetic information in insurance. This information may be useful in confirming or counteracting information about family history provided by the patient. For example, if the applicant had mentioned a family history of breast cancer, it may be helpful for the doctor to report that the applicant had undergone tests, such as BRCA testing, which revealed a reduced risk of developing cancer (subject to the restrictions under 6.4 regarding disclosure of genetic test results). Under no circumstances should doctors reveal information about an insurance applicant’s family if the information did not come from the applicant him or herself.32

It is not clear that family members could successfully invoke the Data Protection Act 2018 to prevent disclosure in this context. Under section 3 of the Access to Medical Reports Act 1998, the patient is granted the right to access a medical report before or after it is supplied to third parties such as insurers or employers. The Act does not extend this right to family members. Section 45 of the Data Protection Act 2018 sets out a right of access to personal data, but it is not clear that family members could use this provision to obtain access to information pertaining to themselves (i.e. on the grounds that they are a “data subject”) within another family member’s medical records or medical report. In addition, the Freedom of Information Act 2000 gives anyone the right to ask for recorded information held by public authorities. However, as numerous exemptions apply in relation to “personal information,” it is unlikely that the Freedom of Information Act 2000 could be used by family members as a legal route to gain access to another family member’s medical information or medical report.

8 The “Right Not to Know” The putative “right not to know” has been discussed within the academic literature in the UK. It is not formally recognised within statute or common law as yet, but is acknowledged within a professional guidance document entitled “Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and

31 32

HM Government and the Association of British Insurers (2018), p. 10. British Medical Association and the Association of British Insurers (2010), p. 12.

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Sharing Genetic Information” (2011) produced by the Joint Committee on Medical Genetics. Although the emphasis of this guidance is upon the appropriate sharing of samples and information disclosure between family members, the document highlights that sometimes individuals may wish not to know their risks of developing a genetic condition or the details of any genetic changes. It affirms the principle that as long as individuals understand the consequences of the decision not to receive information, such wishes should be afforded appropriate respect. There is a strong focus on respecting patient autonomy within UK medical law. Patient self-determination constitutes one important aspect in the debates and emerging regulation around genetic testing and any subsequent use of information by insurers and employers. However, the issues are notoriously complex and multifaceted. Patient autonomy is important, but is not the only animating principle in this context. The traditional medicolegal approach in the UK tends to focus on the individual patient to the exclusion of others. It may be difficult—and sometimes perhaps even undesirable—to apply this model in the context of genetic information, which can also be relevant to family members.

9 Conclusion It is difficult to ascertain how well the risks and benefits associated with genetic testing in the insurance and employment contexts are currently being distributed by the UK’s regulatory framework, due to the general lack of information on how the relevant rules are being applied. Nevertheless, if assessing the two main soft law instruments at face value, it can be argued that the approach taken in the ICO Employment Practices Code—which restricts employers from using genetic information unless there is a clear and pressing health and safety-related reason for doing so—is a reasonable and proportionate approach. It is hoped that future, updated versions of the ICO Employment Practices Code will also enshrine the same policy stance. With regard to insurance, the approach taken in the ABI Code appears to be a pragmatic attempt to balance the conflicting interests involved. However, an irony of this latter framework is that while insurers will not reject individuals because of an adverse genetic test result, they remain free to reject them on the basis of family history (which can be viewed as a crude form of genetic test). In order to address genetic testing in insurance and employment contexts in an equitable and efficient manner, the situation in the UK should be monitored more closely. There needs to be more concrete empirical data about how the current UK regulations are being applied by insurers and employers. The regulation of private DNA testing companies and their relationship with the fields of insurance and employment could become increasingly important in the coming years. Furthermore, although there may be significant differences between countries in terms of the structure of healthcare systems and the general regulation of insurance and employment, national-level case studies may be helpful for building international consensus around best practices and workable regulatory models.

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References 23andMe (2017) Consent and Legal Agreement. https://www.23andme.com/en-gb/about/consent/? version¼1.3. Accessed 26 Nov 2018 BBC News (2016) DNA testing at work: one company’s unusual policy. 3 December 2016. http:// www.bbc.co.uk/news/av/business-38183937/dna-testing-at-work-one-company-s-unusual-pol icy. Accessed 26 Nov 2018 British Medical Association (2009) Access to Medical Reports: Guidance from the BMA Medical Ethics Department. https://www.bma.org.uk/advice/employment/ethics/confidentiality-andhealth-records/access-to-medical-reports. Accessed 26 Nov 2018 British Medical Association and the Association of British Insurers (2010) Medical Information and Insurance: Joint Guidelines from the British Medical Association and the Association of British Insurers. http://www.financial-ombudsman.org.uk/news/pdf/medical-information-and-insur ance.pdf. Accessed 26 Nov 2018 Department for Communities and Local Government (2007) A framework for fairness: proposals for a single Equality Bill for Great Britain. https://webarchive.nationalarchives.gov.uk/ 20120919212654/http://www.communities.gov.uk/documents/corporate/pdf/325332.pdf. Accessed 26 Nov 2018 General Medical Council (2017a) Confidentiality: Good Practice in Handling Patient Information. https://www.gmc-uk.org/-/media/documents/Confidentiality_good_practice_in_handling_ patient_information___English_0417.pdf_70080105.pdf. Accessed 26 Nov 2018 General Medical Council (2017b) Confidentiality: Disclosing Information for Employment, Insurance and Similar Purposes. http://www.gmc-uk.org/guidance/ethical_guidance/30665.asp. Accessed 26 Nov 2018 Health and Safety Executive (2007) Genetic testing in the workplace. http://www.hse.gov.uk/ horizons/assets/documents/genetictesting.pdf. Accessed 26 Nov 2018 HM Government and the Association of British Insurers (2018) Code on genetic testing and insurance: a voluntary code of practice between HM Government and the Association of British Insurers on the role of genetic tests in insurance. https://www.abi.org.uk/globalassets/files/ publications/public/genetics/code-on-genetic-testing-and-insurance-final.pdf. Accessed 10 Mar 2019 Human Genetics Commission (2007) Human Genetics Commission response to the Discrimination Law Review consultation, a framework for fairness: proposals for a single Equality Bill for Great Britain. https://webarchive.nationalarchives.gov.uk/20120504102334/http://www.hgc. gov.uk/Client/document.asp?DocId¼134&CAtegoryId¼4. Accessed 10 Mar 2019 Joint Committee on Medical Genetics (2011) Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information. http://www.bsgm. org.uk/media/678746/consent_and_confidentiality_2011.pdf. Accessed 26 Nov 2018 Leigh S (1996) The freedom to underwrite. https://www.actuaries.org.uk/documents/freedomunderwrite. Accessed 26 Nov 2018 The Information Commissioner’s Office (2011) The Employment Practices Code. https://ico.org. uk/media/for-organisations/documents/1064/the_employment_practices_code.pdf. Accessed 26 Nov 2018 UK Biobank (2010) Information leaflet. https://www.ukbiobank.ac.uk/wp-content/uploads/2011/ 06/Participant_information_leaflet.pdf?phpMyAdmin¼trmKQlYdjjnQIgJ%2CfAzikMhEnx6. Accessed 26 Nov 2018 UK Government (2008) The Equality Bill: government response to the consultation. https://assets. publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/238707/ 7454.pdf. Accessed 26 Nov 2018

Genetic Discrimination in the United States: What State and National Government Are Doing to Protect Personal Information Eric A. Feldman and Erin Quick

Abstract This chapter explores the debate in the US over the use of genetic information by employers and insurers. It describes the passage and content of the Genetic Information Nondiscrimination Act (GINA), discusses the Act’s definition of genetic discrimination, and provides an overview of state laws aimed at preventing genetic discrimination. The chapter then turns to the use of genetic information in the workplace and examines how GINA limits the ability of employers to obtain, and use, genetic information when making hiring and other employment decisions. The discussion of employment is followed by an analysis of GINA’s impact on the use of genetic information in the health insurance context, which is contrasted to life, long-term care, and disability insurance, all unaffected by GINA. The final section of the chapter highlights a few of GINA’s accomplishments and speculates about how current policy is likely to be affected by changes in the science of genetic testing.

1 Introduction A prominent American lawsuit alleging genetic discrimination, Lowe v Atlas Logistics (Atlas),1 reads like a satirical detective story; let’s call it “the case of the devious defecator.” At the heart of the case is a mystery that Atlas Logistics Group Retail Services, a storage company, was desperate to solve. An employee apparently had an aversion to using the restroom, and instead had taken to defecating on Atlas’s warehouse floor. The challenge for Atlas was straightforward—it had to find the

1

Lowe v Atlas Logistics Grp. Retail Servs. (Atlanta), LLC, 102 F. Supp. 3d 1360 (N.D. Ga. 2015).

E. A. Feldman (*) · E. Quick University of Pennsylvania Carey Law School, Philadelphia, PA, USA e-mail: [email protected]; [email protected] © Springer Nature Switzerland AG 2020 L. Khoury et al. (eds.), Genetic Testing and the Governance of Risk in the Contemporary Economy, Ius Comparatum - Global Studies in Comparative Law 34, https://doi.org/10.1007/978-3-030-43699-5_15

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person who was soiling the workplace.2 Somehow—was it a poop scoop?—the company identified two potential culprits. It then asked them to provide DNA samples to see if they matched the offensive fecal deposits found in the warehouse.3 The two employees voluntarily submitted to cheek swabs, which confirmed that neither was responsible for surreptitiously squatting on company property. Cleared of the charge of “devious defecator,” the employees sued Atlas for discrimination under a federal law called the Genetic Information Nondiscrimination Act of 2008 (GINA).4 The DNA test administered to the employees is commonly used in criminal investigations seeking to match a suspect’s DNA to samples found at a crime scene. It is highly accurate at DNA matching, but that’s about all it can do. It provides no information about an individual’s specific genetic characteristics, such as their propensity for disease or their particular physical traits. Despite the limited information revealed by the test, and the fact that Atlas used it solely to establish whether either of the employees was responsible for unauthorized warehouse defecation, the jury awarded one plaintiff USD 250,000 and the other USD 225,000. The jury tacked on an additional USD 1.75 million in punitive damages because Atlas acted “with malice or with reckless indifference to the plaintiffs’ federally protected rights.”5 It is easy to mock both the facts and the outcome of Atlas, but the case raises a number of serious and difficult issues. Most fundamentally, Atlas highlights the difficulty of distinguishing lawful and appropriate genetic testing from genetic testing that is impermissible under federal law. If the police want to determine whether there is a genetic match between a suspect’s DNA and genetic material found at the scene of a crime, the police can legally require (not simply request) that the suspect provide a DNA sample. Similarly, courts can order genetic testing to determine paternity, and individuals must comply. What makes Atlas different? Why were the employees able to successfully sue the company? The short answer is that GINA explicitly prohibits employers from asking employees to undergo genetic testing. The court in Atlas found that the company’s request for a cheek swab directly violated the statute, which states that “[i]t shall be an unlawful employment practice for an employer to request, require, or purchase genetic information with respect to an employee.”6 The defendant argued that testing for identification, as opposed to propensity for disease, was outside the intended 2 Lowe v Atlas Logistics Grp. Retail Servs. (Atlanta), LLC, 102 F. Supp. 3d 1360 (N.D. Ga. 2015), p. 1361. 3 Lowe v Atlas Logistics Grp. Retail Servs. (Atlanta), LLC, 102 F. Supp. 3d 1360 (N.D. Ga. 2015), pp. 1362–1363. 4 Jack LOWE and Dennis Reynolds, Plaintiffs, v. ATLAS LOGISTICS GROUP RETAIL SERVICES (ATLANTA), LLC, Defendant, 2013 WL 11007237 (N.D.Ga.). 5 Verdict Form, Lowe, 2015 WL 2058906 (No. 1: 13-CV-2425-AT). The court ultimately awarded each plaintiff USD 300,000. Order Denying in Part and Granting in Part Plaintiffs’ Motion for Injunctive Relief at 6, Lowe, 2015 WL 2058906 (No. 1:13-CV-2425-AT). 6 42 U.S.C. § 2000ff–1.

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scope of the statute—an interpretation seemingly shared by the Equal Employment Opportunity Commission (EEOC)—but the court chose to interpret GINA’s language broadly.7 The questions Atlas raises in the employment context invite a broader set of concerns about genetic information. As genetic testing becomes increasingly affordable and widespread, where should we draw the line between an individual’s right to control his or her genetic information and the use of that information by employers or insurers to appropriately distinguish between differently situated individuals? What constitutes the discriminatory use of genetic information, as opposed to being appropriately attentive to how an individual’s unique genetic constitution may make them more or less suitable for a particular job or more or less of an insurance risk? This chapter explores the debate in the US over the use of genetic information by employers and insurers, detailing how the approach toward genetic discrimination has been both under- and over-inclusive. It describes the passage and content of GINA, discusses the Act’s definition of genetic discrimination, and provides an overview of state laws aimed at preventing genetic discrimination. The chapter then turns to the use of genetic information in the workplace and examines how GINA limits the ability of employers to obtain, and use, genetic information when making hiring and other employment decisions. The discussion of employment is followed by an analysis of GINA’s impact on the use of genetic information in the health insurance context, which is contrasted to life, long-term care, and disability insurance, all unaffected by GINA. The final section of the chapter highlights several of GINA’s accomplishments, speculates about how current policy is likely to be affected by changes in the science of genetic testing, and discusses how best to treat genetic information so as to effectively protect personal information.

2 Genetic Discrimination in the United States 2.1

Genetic Discrimination: The Federal Response

The United States Congress passed GINA in 2008, shortly after the Human Genome Project completed its effort to map the entire sequence of human DNA.8 Although GINA eventually gained overwhelming support in Congress, it likely would not exist were it not for the efforts of Representative Louise Slaughter. Slaughter first introduced legislation to prevent genetic discrimination in 1995 because she was In accordance with administrative procedures required for discrimination claims, the plaintiffs first brought their complaint to the EEOC, which issued a Dismissal and Notice of Rights Letter that stated, “the EEOC is unable to conclude that the information obtained establishes violations of the statutes.” Lowe v Atlas Logistics Grp. Retail Servs. (Atlanta), LLC, 102 F. Supp. 3d 1360 (N.D. Ga. 2015), p. 1364. 8 National Human Genome Project (2012). 7

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worried that research developed by the Human Genome Project could lead insurers to deny health insurance coverage based on individual genetic characteristics.9 After her first legislative efforts failed, Representative Slaughter focused her efforts on educating members of Congress about genetic testing, because most of them did not understand the underlying science.10 As Congressional support for GINA strengthened in the late 1990s and early 2000s, outside stakeholders also began to advocate for Representative Slaughter’s bill. As a result, the bill was expanded to include a prohibition on genetic discrimination by employers, not only health insurers. Although broadening the bill alienated a coalition of trade associations, support from Presidents Clinton and Bush kept the bill alive. New leadership in Congress after the 2006 election gave GINA a final push; more than a decade after Slaughter first introduced GINA, the bill passed the House 420 to 3, and a year later passed the Senate 95 to 0. The passage of a law specifically aimed at preventing genetic discrimination is best explained by the nature of genetic information itself. Thanks to scientific breakthroughs since the 1940s, we now know that everyone’s DNA contains a unique blueprint that can predict (at least in theory) the manifestations of future medical conditions.11 One’s genetic profile may also reveal information about his or her relatives, including their current and future health profile and previously unknown family relationships. Moreover, the history of stigmatization involving genetics, such as the forced sterilization of thousands of vulnerable individuals early in the twentieth century and targeted genetic testing of African Americans for sickle cell disease in the 1970s, counsels caution in the use of genetic information.12 Representative Slaughter, who had degrees in both microbiology and public health, understood how genetic information could help in the treatment of some diseases, but she was also attentive to the history of discrimination and argued persuasively that a new law was needed to ensure that such information would not be misused. In some ways, genetic information may be less unique than it appears.13 Many medical tests reveal information about an individual’s risk of falling victim to a particular disease. Those same tests often provide information about one’s relatives. Nonetheless, both political leaders and the public generally view genetic information differently than other types of individual information, and therefore deserving of particular legal protection. Public opinion surveys consistently show that people subscribe to the idea of “genetic exceptionalism,”14 which leads them to think about genetic information differently than other medical information. Even though most members of the public are unaware of GINA, they express support for the principles

9

Slaughter (2013), pp. 41 and 46. Slaughter (2013), p. 50. 11 Murray (1997), p. 62. 12 Murray (1997), p. 62; Prince (2017), p. 636. 13 Murray (1997), pp. 64–66. 14 Slaughter (2013), pp. 46–47. 10

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that underlie the law.15 GINA itself directly references public opinion, including in the justification for a genetic nondiscrimination law the need to “allay [public] concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.”16 Although some instances of genetic discrimination had been reported prior to GINA’s passage,17 lawmakers made clear that the bill was not a response to current discriminatory practices but was instead aimed at mitigating the public’s fear of discrimination and preventing future discrimination.18 This preemptive approach makes GINA a unique civil rights statute that focuses not on widespread existing discrimination but rather on the possibility of it occurring in the future. GINA has two explicit goals—preventing genetic discrimination by health insurers and preventing genetic discrimination in the workplace. Title I specifically prohibits group and individual health insurance providers from requiring those seeking insurance to undergo genetic testing and forbids health insurers from making underwriting, eligibility, or coverage decisions based on genetic information.19 Title II similarly prohibits employers from requesting that applicants or employees undergo genetic testing and makes it unlawful for employers to base decisions about hiring, firing, work requirements, or compensation on genetic information.20 Both Title I and Title II rely on the Act’s definition of an individual’s “genetic information” as “(i) such individual’s genetic tests, (ii) the genetic tests of family members of such individual, and (iii) the manifestation of a disease or disorder in family members of such individual” excluding information about an individual’s sex and age.21 A “genetic test” is defined as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.”22 These definitions are broad and so far remain untested in court. But one can imagine that as technologies like testing for epigenetic changes or biomarkers for specific disease further develop, legal questions will arise as to what constitutes a genetic test within GINA’s jurisdiction.23 Critics of GINA generally applaud the goal of preventing genetic discrimination but find fault with the scope of GINA’s provisions. Most notably, GINA applies only to health insurance but not to other forms of insurance. As a result, federal law in the United States permits companies that provide life, disability, and long-term care insurance to genetically test existing or prospective customers and use the results of

15

Almeling and Gadarian (2014), p. 493; Slaughter (2013), p. 62. Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881. 17 National Partnership for Women & Families (2004). 18 Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881; Slaughter (2013), p. 46. 19 Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881. 20 Genetic Information Nondiscrimination Act of 2008, PL 110–233, 21 May 2008, 122 Stat 881. 21 42 U.S.C. § 2000ff. 22 42 U.S.C. § 2000ff. 23 Dupras et al. (2018). 16

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those tests when making underwriting, eligibility, coverage, and rating decisions. The absence of federal legislation that decries the use of genetic information by many types of insurers leaves some consumers vulnerable to coverage decisions based on their perceived genetic risk. The specter of life insurance companies charging women with a BRCA mutation higher rates than women without the mutation, or of long-term care insurance companies refusing to cover people with a genetic predisposition for Alzheimer’s disease, fuels the debate over whether such treatment constitutes inappropriate discrimination or reasonable actuarial calculations.24 A second perceived shortcoming of GINA is that it does not apply to the military.25 The Department of Defense can and does collect DNA from service members, both for identification and predictive purposes.26 There are currently certain safeguards that protect service members from discrimination based solely on perceived genetic risk and ensure that benefits after service are not denied based upon a hereditary but unmanifested risk.27 However, due to the structure and operation of the military, it will likely have more latitude than other employers to make work-related decisions based on genetic information obtained from service members, particularly as genetic testing progresses and is able to more accurately predict physical and behavioral traits.28 A third criticism of GINA focuses on its definition of genetic information. GINA is aimed at preventing the inappropriate use of genetic information obtained through genetic testing, but its definition of genetic information excludes manifested diseases. As a result, GINA prevents an insurer from using information about someone’s genetic proclivity to a certain type of cancer when setting health insurance rates, but it does not prevent that insurer from basing an underwriting decision on the fact that someone already has a certain type of cancer. Other laws, notably the Patient Protection and Affordable Care Act (ACA) and Americans with Disabilities Act (ADA), have provisions that protect patients from discrimination based on preexisting conditions in health insurance and on disability when symptoms substantially limit life activities in employment. Ambiguity remains, however, about the line between a genetic risk and a manifested disease, as well as the gap between when GINA protection ends and ACA or ADA protection begins.29 For genetic conditions like Huntington’s disease, for example, a positive genetic test signals the existence of disease, but for other conditions that involve degrees of risk it can be difficult to determine when the disease has manifested. For progressive degenerative conditions like Alzheimer’s disease or multiple sclerosis, for example, early stages

24 The limited scope of GINA in the insurance setting is in part mitigated by state genetic nondiscrimination laws with more stringent standards than GINA, discussed in Sect. 2.2. 25 Slaughter (2013), pp. 59–60. 26 De Castro et al. (2016). 27 Slaughter (2013), pp. 59–60; De Castro et al. (2016), pp. 2–3. 28 Slaughter (2013), pp. 59–60. 29 Prince and Berkman (2012), p. 657.

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of the disease involve mild vision problems. Such symptoms could constitute a manifested disease not covered by GINA, but may be so mild that they would not be considered a disability covered by the ADA. Does the genetic risk become a manifested condition as soon as these early symptoms appear? Must the individual who has early symptoms be aware that the symptoms are indicative of a more serious disease? While cases of this type may be less ubiquitous than those involving insurance and the military, they present a challenge for courts faced with developing a consistent test for determining the border between genetic risk and disease. Finally, because GINA treats genetic information differently than other types of medical information that are routinely collected and shared, it can be difficult for medical providers to decide whether (or when) to include genetic information in a patient’s medical records, particularly when those records are likely to be shared with employers and insurers.30 Insurers and employers who inadvertently receive genetic information are not sanctioned under GINA (although they are prohibited from requesting such information), but possession of such information clearly increases the possibility that it will be used in a discriminatory manner, contrary to GINA. Although GINA is the most significant law in the US aimed at preventing genetic discrimination, it is not the only legal resource available to those who believe they have been victims of genetic discrimination. Indeed, the text of GINA makes clear that the federal protections it mandates are not exclusive. They do not preempt state positive law, nor do they preclude causes of action brought under other federal statutes. As a result, legal claims involving genetic discrimination often reference not only GINA but also other federal and state laws.31 For example, the Health Insurance Portability and Accountability Act protects the privacy of identifiable patient data, such as genetic information that might be included in one’s medical records.32 Likewise, the ADA protects the confidentiality of employee medical conditions, bars medical examinations of job applicants, and prohibits employment decisions based on health considerations that do not directly relate to a person’s ability to perform a job.33 In addition, some states have passed their own laws prohibiting genetic discrimination, a number of which predate GINA. The following section provides an overview of state laws intended to prevent genetic discrimination.

30

Klitzman (2010). 42 U.S.C. § 2000ff–8: “[n]othing in this chapter shall be construed to (. . .) limit the rights or protections of an individual under any other Federal or State statute that provides equal or greater protection to an individual than the rights or protections provided for under this chapter.” 32 Pub. L. No. 104–191, 110 Stat. 1936 (1996). 33 Pub. L. 101–336, 104 Stat. 328; Pub. L. 110–325, 122 Stat. 3554. See also Rothstein et al. (2015), p. 526. 31

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Genetic Discrimination: State Laws

As a formal legal enactment of the United States Congress, GINA’s legal protections extend to all Americans. Many citizens are afforded an additional layer of legal protection by state legislation that prohibits genetic discrimination in insurance and employment, some of which are more expansive than GINA. Of the 50 states, 48 have health insurance nondiscrimination statutes.34 Most of the statutes prohibit health insurance companies from denying coverage on the basis of genetic information, and many assert that genetic information cannot be considered a preexisting condition in the absence of a disease diagnosis.35 Sixteen statutes also bar health insurers from requesting or requiring genetic testing as a condition of insurance eligibility.36 California’s robust genetic discrimination statute prevents insurers from considering genetic information when setting premiums, whereas Mississippi and Washington have yet to pass any type of health insurance nondiscrimination law. In comparison to the 48 states with laws aimed at preventing genetic discrimination by health insurers, only 35 have nondiscrimination statutes specific to employment. Most of the statutes, like GINA, treat genetic discrimination as the violation of a civil right, with some making it unlawful for employers to collect genetic information and others only prohibiting discrimination itself.37 State laws prohibiting genetic discrimination in health insurance and employment largely echo the prohibitions in GINA, so their impact is relatively modest. Of greater significance are state statutes that prohibit or restrict the use of genetic information in contexts not addressed by GINA, particularly those involving insurance other than health insurance. With the exception of federal laws like the ACA and GINA, the federal government has historically left the regulation of insurance to the states.38 This has enabled states to regulate the use of genetic information in life, long-term care, and disability insurance.

34

Table of State Statutes Related to Genomics (2018). Genome Statute and Legislation Database Search: Health Insurance Nondiscrimination (2018). See e.g. ARS § 20-2301 ff (“A genetic condition is not a preexisting condition in the absence of a diagnosis of the condition related to the genetic information and shall not result in a preexisting condition limitation or preexisting condition exclusion.”); 215 ILCS 97/20 (“Genetic information shall not be treated as a [preexisting condition] in the absence of a diagnosis of the condition related to such information.”); ORS § 746.135 (“A person may not use genetic information to reject, deny, limit, cancel, refuse to renew, increase the rates of, affect the terms and conditions of or otherwise affect any policy for hospital or medical expenses (. . .). A person may not use genetic information about a blood relative to reject, deny, limit, cancel, refuse to renew, increase the rates of, affect the terms and conditions of or otherwise affect any policy of insurance.”). 36 Genome Statute and Legislation Database Search: Health Insurance Nondiscrimination (2018). 37 Genome Statute and Legislation Database Search: Health Insurance Nondiscrimination (2018). 38 This division was codified in the McCarran-Ferguson Act in 1945 and has not been significantly altered since. See National Association of Insurance Commissioners (2019). 35

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Almost half of the states have laws that prohibit discrimination in non-health insurance. Arizona, for example, stops providers of life and disability insurance from refusing to issue insurance because of an applicant’s “genetic condition.”39 In the absence of a diagnosable medical condition, it also prohibits insurers from using the results of genetic testing in underwriting unless there is a legitimate basis for an underwriting decision based on actuarial projections or claims experience.40 With limited exceptions, California law imposes civil penalties on insurers who require genetic testing as a condition for purchasing life and disability insurance.41 California also prohibits discrimination against healthy carriers of a genetic marker for a disease when determining insurance eligibility and setting rates.42 Five states— Maine, Maryland, Massachusetts, Montana, and New Jersey—have statutes similar to California’s that prohibit life insurance providers from “unfairly” discriminating on the basis of genetic information, by which they mean underwriting without a basis in actuarial projections or claims experience.43 Colorado prohibits the collection and use of genetic information by providers of group disability or long-term care insurance.44 Idaho allows the “fair use” of genetic information in life insurance underwriting and ratemaking, but bars disability insurance companies from using genetic tests or private genetic information when underwriting such policies.45 The Oregon legislature passed a bill that stops insurers from using genetic information to deny or affect the terms and conditions of insurance policies, but permits genetic testing with the informed consent of the insured.46 Finally, Vermont’s statute includes criminal and civil penalties for insurers who require genetic testing or underwrite policies based on genetic testing results, going further than other states with a blanket ban on genetic testing for any insurance policy.47 In addition to genetic information nondiscrimination laws, 41 states have legislation that protects the privacy of genetic information. The specific protections afforded by these statutes vary from state to state, but they typically require that genetically tested individuals provide informed consent before their DNA is collected and/or disclosed.48 Some genetic information privacy protections are included

ARS § 20-448. ARS § 20-448. 41 Cal. Insurance Code § 10146 ff. 42 Cal. Insurance Code § 10140 ff. 43 Genome Statute and Legislation Database Search: Other Lines of Insurance Nondiscrimination (2018). 44 CRS § 10-3-1104.7. 45 IC § 41-1313. 46 ORS § 746.135. 47 VSA 8 § 4724; 18 V.S.A. § 9334. 48 Genome Statute and Legislation Database Search: Privacy (2018). See e.g. FS § 760.40 (“DNA analysis may be performed only with the informed consent of the person to be tested, and the results of such DNA analysis, whether held by a public or private entity, are the exclusive property of the person tested, are confidential, and may not be disclosed without the consent of the person tested.”); NYCL (CVR) 79-l (“No person shall perform a genetic test on a biological sample taken from an individual without the prior written informed consent of such individual (. . .). Any further 39 40

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as provisions within broader nondiscrimination laws, while others are stand-alone statutes.49 Although genetic information privacy laws do not explicitly protect people from discrimination, they reinforce the idea of “genetic exceptionalism” by specifying that genetic information, unlike many other types of information, is particularly deserving of confidentiality, and that consent is necessary if such information will be collected and/or disclosed. In some cases, however, the consent requirement of genetic information privacy statutes provides little protection to consumers; if insurers or employers can require that individuals submit to genetic testing in order to obtain insurance or employment, then individuals’ right to protect the privacy of their genetic information is effectively eliminated. In short, both federal law (especially GINA) and a patchwork of state laws prohibit the collection of, and reliance on, genetic information in the contexts of employment and health insurance. Twenty-one states have passed laws that limit the ability of companies to collect or rely on genetic information in non-health insurance, like life and long-term care. And most states have legislation that underscores the right to keep one’s genetic information private. At least superficially, it might appear that the US has a relatively robust set of laws addressing genetic discrimination. The next sections of this chapter explore the impact of those laws. How common is genetic discrimination in the US, and how effective is the current legal framework at addressing instances of such discrimination?

3 Genetic Discrimination in the Employment Sector in the United States 3.1

Employment

Employers in the US may wish to seek medical information about potential or current employees for a variety of reasons. Such information—past, current, and predictive—may indicate whether an employee is suited to particular work. Someone with a high genetic propensity for sudden onset seizures, for example, may be a poor candidate for a job as a bus driver, just as a person with a high risk of developing environmental cancers may not be the right choice to work in a nuclear energy plant. Information about an employee’s health condition may also have an impact on an employer’s health care expenses, pension payments, and retirement benefits. In some cases, the information sought by an employer may be found in a current or potential employee’s standard medical records. In others, the information can come from someone’s family medical history, or from a genetic test.

disclosure of genetic test results to persons or organizations not named on the informed consent shall require the further informed consent of the subject of the test.”). 49 Genome Statute and Legislation Database Search: Privacy (2018).

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Although GINA addresses the collection and use of genetic information, there are other laws that offer employees legal protection from the inappropriate use of their medical information. The ADA is the most important federal law to address employee medical conditions; its legal protections vary depending on whether an individual is a job applicant, has received an offer but not begun work, or is in an employment relationship. When someone is applying for a job, the ADA prevents employers from conducting medical examinations or asking questions about the existence or nature of a disability.50 Once a job offer is tendered, employers can make it contingent on a successful medical examination, but can only withdraw the offer if individuals are unable to perform their jobs with reasonable accommodations for their disability.51 Medical examination of current employees is permitted as long as it is job-related and consistent with business necessity.52 The ADA framework enables employers to screen employees for medical conditions that could affect their ability to perform a particular job, but does not allow employers to base employment decisions on the cost of the employer’s health insurance benefit payments. For instance, federal law bars individuals with a history of a seizure disorder from obtaining a pilot’s license. If a pilot developed a seizure disorder and reported it to the airline as part of a routine medical examination, the airline could legally fire that individual. However, the airline could not fire or refuse to hire a pilot with hepatitis C if the disease did not detract from the pilot’s ability to fly airplanes. Not hiring someone with hepatitis C because of a belief that those with hepatitis C are morally deficient, or because paying for the treatment of hepatitis C may increase the employer’s health insurance costs, constitutes discrimination and violates the ADA. Genetic information is, by its very nature, more speculative than information about a patient’s past or current medical condition, but it has the potential to be (mis)used in a similar manner. On the one hand, there is the upside potential that, at some point in the future, genetic tests might be able to accurately predict the manifestation of serious medical conditions, and that could in turn enable employers to evaluate whether particular employees can safely perform the functions of a given job. The downside, and arguably more likely scenario, is that employers who obtain genetic information about an employee’s future health risk could make employment decisions based on that information, even when it is highly speculative and weakly predictive. The result will be employment decisions rooted in prejudice, stereotype, and fear—exactly the types of decisions GINA is meant to prevent. Indeed, the early cases that fueled the passage of GINA were primarily about employers whose use of genetic tests did not relate to the employees’ ability to perform their jobs, which the architects of GINA were intent on making legally sanctionable.53 In one case cited by Congress as proof that employers were engaging

50

Rothstein (1997a), p. 288. Rothstein (1997a), p. 288. 52 Rothstein (1997a), p. 288. 53 Slaughter (2008). 51

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in pre-employment genetic screening, a court found that an employer violated the constitutional privacy rights of employees by performing pre-employment medical evaluations that included unauthorized blood tests.54 One of the tests was a genetic test for the sickle cell trait, which the employer selectively applied to samples from African American employees.55 In its judgement for the plaintiffs, the court stated that “the most basic violation [of privacy rights] possible involves the performance of unauthorized tests—that is, the non-consensual retrieval of previously unrevealed medical information that may be unknown even to plaintiffs.”56 A few years later, the EEOC settled with Burlington Northern and Santa Fe Railroad Company (BNSF) for USD 2.2 million to resolve claims stemming from the company’s practice of requiring medical testing, including genetic testing, of employees who had reported injuries from work-related carpal tunnel syndrome.57 Carpal tunnel likely has some connection to a person’s genome, but no known link to a specific genetic profile existed at the time that BNSF tested its employees.58 Employer ignorance about the predictive value of genetic testing in that case put employees in the position of either having to submit to genetic testing without any clear value or risk losing their jobs for refusing.59 Although the case was brought under the ADA, the EEOC’s position that the collection of the DNA itself violated the ADA previewed the protections that were later embedded in GINA. As is sometimes the case with disability discrimination, genetic information cannot be discerned by simple observation. Therefore, the creators of GINA not only prohibited discriminatory actions based on genetic information, which could be difficult to prove in court, they prohibited the collection of employee genetic information, which may be easier to police, and, by extension, prevents misuse of genetic risk data based on insidious motivations or fear. The case of the devious defecator was a direct result of the bright line drawn—the employer was liable for violating GINA by virtue of having requested its employees undergo genetic testing, regardless of the intent behind the request. One might imagine that such a broad prohibition on obtaining and using genetic information would trigger a wide range of lawsuits. The following review of genetic discrimination cases brought against employers in the US instead reveals that, at least so far, there has been relatively little litigation involving genetic discrimination in the workplace.

54

See Norman–Bloodsaw v Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998). Norman–Bloodsaw v Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), p. 1265. 56 Norman–Bloodsaw v Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), p. 1269. 57 U.S. Equal Employment Opportunity Commission (2002). 58 Schulte and Lomax (2003). 59 U.S. Equal Employment Opportunity Commission (2001). 55

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Employment Related Genetic Discrimination Claims in the United States

Given the power imbalance between employees and employers that can discourage reports of discrimination, getting an accurate measure of the prevalence of genetic discrimination can be difficult. Moreover, the lack of public knowledge about genetic discrimination laws may limit the likelihood that employees will bring such claims. Nonetheless, some employees have filed legal claims under GINA.60 Their first step is to contact the EEOC, where the great majority of claims are resolved. Those that are not settled as a result of an EEOC investigation can be filed in federal court. According to the EEOC’s annual claims database, there were only 206 genetic discrimination claims filed with the Commission in 2017, compared to 84,254 total workplace discrimination charges.61 At only 0.2% of total claims, genetic discrimination claims were the least common type of claim handled by the EEOC in 2017, and in no year since the passage of GINA have genetic discrimination claims constituted more than 0.5% of complaints reported to the EEOC.62 Not only are genetic discrimination claims relatively rare, but the majority of them—70% in 2017—are determined by the Commission to have “no reasonable cause.”63 Of the remaining claims, 21% reach so-called “merit resolutions,” which include settlement, withdrawal of the complaint with benefits, or a finding that the allegations were meritorious.64 In cases where the EEOC investigates and finds evidence of discrimination, the parties can resolve their dispute through informal conciliation. If that is unsuccessful, the EEOC itself can file a lawsuit in federal court or can instead leave it to the employee to bring the case to court.65 If the EEOC does not find any evidence of discrimination, the employee can commence a suit in federal court. According to a study by Mark Rothstein et al, many plaintiffs in such cases do not in fact allege that the employer collected samples for genetic testing, but instead claim that medical examinations included questions prohibited by GINA.66 When plaintiffs do assert that employers sought their genetic information, it is generally because the employer

60

Because state statutes vary in the protections they offer and there are no high-profile cases that have been brought under state law, this analysis focuses on federal genetic discrimination claims. Given how few claims make it to court, the jury verdict in the case of the devious defecator is particularly notable. 61 EEOC conventions refer to employee reports of discrimination as “charges,” but we will refer to them as complaints in order to use consistent language throughout different sections. 62 U.S. Equal Employment Opportunity Commission (2018a). 63 U.S. Equal Employment Opportunity Commission (2018b). 64 U.S. Equal Employment Opportunity Commission (2018b). 65 U.S. Equal Employment Opportunity Commission (2018c). 66 Rothstein et al. (2015), pp. 552–554.

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wanted information about the plaintiff’s family medical history, and was not asking plaintiffs to undergo genetic testing.67 Although questions about family medical history may have been a permissible part of a pre-employment medical screening prior to GINA’s passage, the EEOC has brought numerous actions against companies that have asked employees about family medical history in contravention of GINA. The Commission has entered six-figure settlements with at least four companies that inquired about the family medical history of employees or job applicants.68 While many of the cases against companies that collected family medical history also violated one or more provisions of the ADA, the EEOC has filed stand-alone GINA claims against multiple companies. The message sent by these cases is clear: it is unacceptable for employers to seek information about family medical history. After one six-figure settlement, an EEOC attorney said that “employers should take heed of this settlement, because there are tangible consequences to unlawfully asking employees and applicants about their family medical history.”69 Similarly, the Commission’s general counsel has stated, “[e]mployers need to be aware that GINA prohibits requesting family medical history. When illegal questions are required as part of the hiring process, the EEOC will be vigilant in ensuring that no one is denied employment opportunities on a prohibited basis.”70 Plaintiffs bringing genetic discrimination claims under GINA typically pair them with additional claims, such as discrimination based on disability, age, or race. In Lee v City of Moraine Fire Department (Lee), for example, the plaintiff firefighter brought a claim against the local government alleging that it was discriminatory to require a more comprehensive physical for firefighters over the age of 40 than for younger firefighters.71 Because the plaintiff was asked about his family medical history during the required physical examination, the court found that the city had violated GINA.72 Likewise, in a case brought by the EEOC against Dollar General, the EEOC alleged that the company improperly required post-offer employee medical examinations that discriminated against people with disabilities (one person’s offer was rescinded because he had monocular vision).73 As in Lee, because the employer also requested information about the employee’s family medical history, the employer was found to have violated GINA.74

67

Rothstein et al. (2015), pp. 552–554. Recent searches performed by the authors returned results consistent with these findings. In many instances the plaintiff alleged discrimination based on disability or race but included GINA as a basis for their suit. 68 U.S. Equal Employment Opportunity Commission (2013, 2014a, b, 2016a, b, c, d, e, 2017). 69 U.S. Equal Employment Opportunity Commission (2016a). 70 U.S. Equal Employment Opportunity Commission (2014a). 71 No. 3:13-CV-222, 2015 WL 914440 (S.D. Ohio 3 March 2015) p
1. 72 No. 3:13-CV-222, 2015 WL 914440 (S.D. Ohio 3 March 2015) p
11. 73 U.S. Equal Employment Opportunity Commission (2017). 74 U.S. Equal Employment Opportunity Commission (2017).

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One recent regulatory action by the EEOC offers a sharp contrast to its more general approach to genetic discrimination. In May 2016, the EEOC issued a regulation allowing employers to request genetic information, including that of an employee’s spouse, as part of a voluntary wellness program. Wellness programs offered by employers attempt to promote employee health by making participants more aware of how their lifestyle relates to their health and rewarding those who participate in healthy activities, such as joining a gym or taking nutrition classes. These programs typically require participants to fill out health questionnaires and may mandate physical examinations and blood tests. EEOC regulations permit employers to offer employees a monetary incentive for participating in wellness programs, typically in the form of a discount on the employee’s contribution to his or her health insurance premium.75 The Commission’s 2016 rule states that as long as the incentive is no more than 30% of the total cost of the individual health insurance plan, the request for genetic information will be considered voluntary and thus permissible under GINA.76 In response to this wellness initiative, the American Association of Retired Persons (AARP) sued the EEOC, arguing that the incentives included in the new rule were coercive and thus out of step with GINA’s requirement that the provision of genetic information by employees be “voluntary.”77 The US District Court for the District of Columbia granted the AARP’s motion for summary judgment, holding that the EEOC’s decision to consider a 30% inducement “voluntary” was arbitrary and capricious.78 The court reasoned that the EEOC did not provide any evidence in the administrative record to demonstrate that a 30% reduction in the cost of an individual’s health care insurance would not be coercive for employees who were financially strapped.79 The Commission’s new rule is, as least for now, suspended pending further action by the EEOC.80 The EEOC’s wellness rule may foretell an increase in employers interested in collecting genetic information from employees, and the AARP’s litigation may be an indication of the controversy that will ensue. So far, both lawmakers and rule-makers in the US have been broadly supportive of genetic antidiscrimination laws, finding little objectionable about statutes that promote privacy and equal treatment. It is possible, however, that their support for laws that prohibit the procurement and use of genetic information will weaken as genetic testing technology improves and provides more accurate predictions of future disease. Genetic Information Nondiscrimination Act, 29 CFR § 1635 (2016). Genetic Information Nondiscrimination Act, 29 CFR § 1635 (2016). 77 See AARP v United States Equal Employment Opportunity Comm’n, 14 (D.D.C. 2017). 78 AARP v United States Equal Employment Opportunity Comm’n, 14 (D.D.C. 2017), p. 34. 79 AARP v United States Equal Employment Opportunity Comm’n, 14 (D.D.C. 2017), p. 29. 80 AARP v United States Equal Employment Opportunity Comm’n, 238 (D.D.C. 2017). 75 76

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Consider a situation in which a genetic test can accurately predict that someone has a 75% chance of developing a sudden onset seizure disorder in the next 5 years. An individual who tests positive would surely want to explore the possibility of controlling the condition with medication or monitoring it with additional testing. If there were no available treatment, the individual may decide to limit or avoid certain activities that could endanger his or her life or health in the event of a seizure. The individual’s health insurer and employer are also likely to find such information useful in setting premiums and assigning specific work tasks. If the individual worked as a pilot, for example, the airline would have to be sure that in the event of a sudden seizure its passengers would not be endangered. Indeed, if such a test were available, one might think it reasonable for the airline to ask (or require) its potential (or current) employees to be tested. While such testing may raise difficult questions about the interpretation of genetic tests, their accuracy, and the inherent power imbalance between employers and employees, an increased predictive accuracy also points to the possibility that genetic testing may provide certain safety benefits that sometimes outweigh worker privacy concerns. This leads to an important question: as understanding of the human genome continues to improve, is GINA’s blanket prohibition on the collection and use of genetic information by employers a tenable policy? Or would a more permissive approach to genetic testing, coupled with job-based reasonable accommodation per the ADA, be a better solution?

4 Genetic Discrimination in the Insurance Sector in the United States 4.1

Insurance

Because insurance underwriting depends upon accurate assessments of risk, understanding the prohibition on health insurers using predictive genetic information poses a particular challenge to the distinction between arbitrary discrimination and data-driving categorization. An even greater challenge is presented by state laws that also prevent life, disability, and long-term care insurers from using such information. To adequately justify restrictions on the use of genetic information by insurers, it is necessary to carefully distinguish between prohibited genetic information and permissible medical information that insurers routinely use when underwriting and setting rates for health insurance. Scholars who have explored this distinction note that, in the insurance context, “discrimination” is a neutral term that describes the process of risk classification followed by insurers when setting higher rates for so-called higher risk individuals and lower rates for so-called lower risk

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individuals.81 That process, of course, is not value neutral; insurers have discretion in determining what constitutes high and low risk, and government regulators can intervene if they believe insurers’ risk assessments do not appropriately reflect sound actuarial principles or are based on suspect social or ethical judgments.82 Still, the puzzle remains—what constitutes “fair” discrimination? Theories of “efficient discrimination” or “actuarial fairness” are based on the view that insurance classifications are fair when people with like characteristics are charged the same premium.83 In contrast, John Rawls’ theory of “social fairness” articulates a view of fairness that depends upon people not being singled out for inherent traits that are subject to negative social stereotypes.84 Rawls’ theory arrives at this conception of justice by applying a “veil of ignorance” where those deciding the governing principles know nothing about their own characteristics that could serve as advantages or disadvantages.85 Policies decided from behind a veil of ignorance seek to level the playing field to avoid disadvantaging individuals based on morally arbitrary features, which may result in subsidization of groups which have historically faced invidious discrimination.86 Insurers are prohibited from setting rates based on race, for example, even though statistical evidence indicates that, on average, African Americans have a shorter life expectancy than Caucasians in the US, because systemic racism and oppression are a key cause of the discrepancy in life expectancy.87 As noted in Sect. 2 above, GINA and a number of state genetic nondiscrimination laws sharply distinguish between the use of genetic information by health insurers and by those writing policies for life, long-term care, and disability insurance. To the extent that one believes genetic information occupies a special moral sphere and thus warrants distinctive legal treatment, the stark distinction between health insurance and other types of insurance is difficult to justify. Why, then, have GINA and 36 states codified a distinction between health insurers, which are legally prohibited from referencing genetic information, and other insurers, which are not? When GINA was passed, genetic testing had become an effective tool for both research and clinical use. But many Americans feared that if they underwent genetic testing to inform their health care decisions, health insurers would deny coverage based on a pre-existing condition or use the test results in some other way so as to deny or limit their coverage.88 Because for most people in the US the absence of

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Rothstein and Anderlik (2001), p. 354; Gaulding (1995), p. 1654; Rothstein (1997b), p. 468; Prince (2017), p. 630. 82 Prince (2017), pp. 630–633. 83 Prince (2017), pp. 630–633; Gaulding (1995), pp. 1654–1658; Rothstein and Anderlik (2001), pp. 654–656. 84 Prince (2017), pp. 630–633; Gaulding (1995), pp. 1654–1658; Rawls (1971). 85 Rawls (1971). 86 Rothstein and Anderlik (2001), p. 356. 87 Gaulding (1995), pp. 1658–1660. 88 Slaughter (2013), pp. 41–42; Areheart and Roberts (2019), pp. 12–14.

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health insurance is equivalent to the absence of health care, protecting their access to health insurance by prohibiting genetic discrimination was an easy political win, whereas opposing a genetic nondiscrimination law was an untenable political position.89 In contrast, life, disability, and long-term care insurance do not have the same personal, social, or political salience as health insurance. In 2017, over 90% of Americans had some form of health insurance, while only 54% had life insurance, 34% had employer provided disability insurance, and 25% had long-term care insurance.90 The prevalence of health insurance underscores its relative importance compared to other types of insurance and helps to explain why legislators have been particularly concerned about legal protections from genetic discrimination in health as opposed to non-health insurance. Given the central role risk assessment plays in the business of insurance, as the science of genetic testing continues to improve, insurers of all kinds will have a stronger incentive to use genetic information in underwriting and rate-setting. Statutes that prohibit the use of genetic information could become costly if consumers who learn that they have a high risk of developing a genetic disease selectively choose to purchase insurance, and insurers cannot inquire about their genetic risk.91 The following section examines whether, at present, insurers are currently engaging in genetic discrimination, legal or illegal.

4.2

Insurer Use of Genetic Information in the United States

GINA explicitly prohibits health insurers from requesting genetic tests and using genetic information when pricing insurance, and some state laws extend that prohibition to life, long-term care, and disability insurance. How effective are those prohibitions? Did insurers use such information before the law made the practice illegal? Now that the laws are in place, are insurers ignoring them and relying on genetic information? Are insurers acting differently across states—using genetic information in states that do not prohibit it but steering clear of such information when it is legally sanctioned? Unfortunately, it is difficult to provide confident answers to these questions. Although one might imagine that insurance companies would be anxious to use any information that enables them to more accurately predict risk and would therefore be collecting genetic information when they can legally do so, little is known about insurer behavior in this area. Anecdotes about healthy women being denied life insurance because they carry a gene that increases the risk for breast cancer have been widely reported in news publications, but the

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Slaughter (2013), pp. 41–42; Areheart and Roberts (2019), pp. 12–14; Gruber (2009), p. 14. Berchick et al. (2018), LIMRA (2017), One America (2017) and PR Newswire (2017). 91 One study found that patients who learn that they have a high risk of developing Alzheimer’s disease are more likely to purchase long-term care insurance. See Taylor et al. (2010). 90

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reports provide little insight into whether the practices are widespread.92 No significant legal cases about genetic discrimination in insurance have been reported. Much of the scholarship about the role of genetic information in insurance is theoretical and speculative, and lacks an empirical assessment of actual instances of genetic discrimination by insurers.93 A small number of empirical studies have examined genetic discrimination in this arena, but their scope is limited. A 2013 literature review, for example, analyzed 33 studies and found that a plurality reported rare instances of genetic discrimination in life insurance.94 A few studies analyzed in the review identified genetic discrimination as a serious concern and suggested that, in at least some cases, genetic discrimination had led insurers to deny life insurance coverage.95 Of the studies included in the review, 16 collected data from the US, but only three found evidence that insurance decisions were influenced by genetic information.96 It is difficult to know how much one can extrapolate from those studies to other types of insurance. The authors of the review are critical of the methodology of the studies; they point out that the studies relied on different definitions of genetic discrimination, with those relying on a broader definition most likely to find evidence of genetic discrimination.97 Moreover, many of the studies used Huntington’s disease as the genetic condition upon which insurers discriminated. The unique nature of that disease makes those studies particularly difficult to generalize.98 One study conducted prior to the enactment of GINA surveyed health insurance underwriters to see if their underwriting decisions changed when they obtained genetic information.99 The survey found that genetic information did not have a significant impact on the policies they offered.100 Obtaining the results of genetic tests, as opposed to examining an individual’s medical history without genetic test results, changed the underwriter’s coverage decisions in only seven out of 92 scenarios.101 However, because the study surveyed health insurance underwriters prior to GINA and the ACA, it has limited relevance. Perhaps the strongest evidence that insurers are underwriting, or plan to underwrite, based on genetic risk is a recent story about a life insurance company acquiring the right to use a genetic testing technique that can supposedly determine people’s biological (as opposed to chronological) age. The insurance company,

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Farr (2016). Rothstein and Anderlik (2001), Gaulding (1995), Tenenbaum and Goodman (2017), Rothstein (1997b) and Prince (2017). 94 Joly et al. (2013). 95 Joly et al. (2013). 96 Joly et al. (2013), pp. 5–8. 97 Joly et al. (2013), pp. 10–11. 98 Joly et al. (2013), pp. 10–11. 99 Pollitz et al. (2007), p. 350. 100 Pollitz et al. (2007), p. 350. 101 Pollitz et al. (2007), p. 350. 93

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GWG Life, licenses an epigenetic testing technology that analyzes marks on human DNA rather than examining the genetic sequence itself.102 These chemical marks occur naturally as one matures and result from the normal functioning of human cells.103 The fact that GWG Life has started testing DNA samples from its customers raises questions about whether the company is hoping it will be able to use the test as a basis for setting life insurance rates. If GWG Life’s technology can accurately predict how long people are likely to live, it could greatly improve the company’s ability to underwrite life insurance policies. Would their use of such a test constitute genetic discrimination? Or would a test that can predict biological age with a high degree of accuracy be an appropriate tool for life insurance companies, and a desirable, perhaps even fair, way to allocate the cost of insurance? If a test accurately revealed that a 50 year-old man has a biological age consistent with a person 10 years younger, actuarial fairness would dictate that he should pay less in premiums than a 50 year-old man with the same medical history whose biological age matches someone 10 years older. Under GINA and most state laws, life insurers could use this genetic information to price their policies, whereas the same information is off-limits to health insurers. Still, it is worth questioning whether this differential treatment for different types of insurance is sound policy. For instance, if someone undergoes genetic testing and learns that he or she has a high risk of Alzheimer’s disease, should he or she be allowed to purchase long-term care insurance without disclosing that information? The same question could apply to people with manifested diseases. Indeed, in the case of Alzheimer’s disease the line between predictive testing and manifested disease is particularly fuzzy. Recent studies have established that elevated levels of certain proteins can predict the development of Alzheimer’s disease up to a decade before clinical symptoms begin.104 GINA includes analysis of proteins in its definition of a genetic test but specifically excludes “an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes” from that definition.105 The protein tests for Alzheimer’s disease focus on the proteins themselves, not any genetic change they indicate, so they likely do not qualify as a genetic test under GINA’s definition. Yet the role that these proteins play as biomarkers is much closer to an indication of genetic risk than the traditional legal tests for manifested disease, which typically require some clinical measure of symptoms.106 Instead of focusing the policy debate about insurance underwriting on genetic information, a more robust approach would consider genetic risk as part of a continuum of a person’s medical status. If the rationale for protecting genetic information is that people should be able to take advantage of its predictive power to safeguard their health without being burdened by higher health insurance premiums

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Dupras (2018). See also GWG Holdings, Inc. (2017). Dupras (2018). 104 Dubois et al. (2016) and Fiandaca et al. (2015). 105 42 U.S.C. §2000ff (7). 106 Prince and Berkman (2012), pp. 657–661. 103

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for genetic risks beyond their control, then the same rationale applies equally to nongenetic early indicators of disease.

5 Conclusion Both federal and state laws in the US contain legal protections from genetic discrimination in employment and health insurance, and some state legislation extend those protections to life, disability, and long-term care insurance. At present, limited evidence of widespread genetic discrimination exists, especially in the insurance context, but as the sophistication of genetic testing develops it may well become more prevalent. The EEOC’s wellness rule and GWG’s use of epigenetic testing in life insurance both indicate that advances in science may provide employers and insurers with an incentive to obtain and use genetic information. In some instances, their reliance on genetic information may be desirable; it could help them to more accurately price insurance for differently situated individuals and could play a role in helping to match employees with suitable jobs. From that perspective, when predictive genetic testing reaches the point where it is demonstrably accurate and reliable, the time will come to reconsider the idea of genetic exceptionalism that underlies GINA and state genetic information laws. After all, predictive genetic information is just one part of a person’s overall medical profile, and concerns about genetic discrimination are simply a subset of a more general need to prohibit employment and insurance-related discrimination. A policy approach based on targeting invidious discrimination rather than carving out genetic information for special treatment could be beneficial to the public, as well as employers and insurers. For example, Anya Prince, a legal scholar whose research focuses on genetic discrimination, has argued for an approach that balances insurer need for information to accurately price plans with concerns that genetic testing will be used in an exploitative way.107 In her framework, regulators would approve certain genetic tests for known genetic risk that have been established as accurate, and insurers providing different kinds of insurance could use those test results.108 A similar approach could be set up for employers so they would have access to genetic tests that could accurately predict job-related risks. For now, however, although the science of genetic testing continues to improve, the information it provides cannot support confident conclusions about individual risk that justify denying people certain jobs, charging them more for insurance, or refusing to hire or insure them. When it does, we will then be faced with the difficult choice of refusing to make use of the predictive power of genetic information, or overtly discriminating against people on the basis of qualities over which they have no control.

107 108

Prince (2017). Prince (2017).

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