The Ethics and Governance of Human Genetic Databases European Perspectives Part 1 ppsx

The Ethics and Governance of HumanGenetic Databases European Perspectives The Medical Biobank of Umea˚ in Sweden, deCODE’s Health SectorDatabase in Iceland, the Estonian Genome Project a

The Ethics and Governance of Human

Genetic Databases

European Perspectives

The Medical Biobank of Umea˚ in Sweden, deCODE’s Health SectorDatabase in Iceland, the Estonian Genome Project and the UK Biobankwere planned to contain health data and genetic data from large popula-tions Some include genealogical or lifestyle information They are resour-ces for research in human genetics and medicine, exploring interactionbetween genes, lifestyle, environmental factors and health and diseases.The collection, storage and use of this data raise ethical, legal andsocial issues In this book, bioethics scholars examine whether existingethical frameworks and social policies reflect people’s concerns, andhow they may need to change in light of new scientific and technologicaldevelopments The ethical issues of social justice, genetic discrimina-tion, informational privacy, trust in science and consent to participation

in database research are analysed, whilst an empirical survey, conducted

in the four countries, demonstrates public views of privacy and relatedmoral values in the context of human genetic databases

The research presented in this book was conducted within the project

‘Ethical, Legal and Social Aspects of Human Genetic Databases:

A European Comparison’, funded by the European Commission’s 5thFramework Programme (QLG6-CT-2001-00062)

M A T T I H A ¨ Y R Y is Professor of Bioethics and Philosophy of Law at theUniversity of Manchester

R U T H C H A D W I C K is Distinguished Research Professor at CardiffUniversity

V I L H J A ´ L M U R A´R N A S O N is a Professor of Philosophy and Chair of theCentre for Ethics at the University of Iceland

G A R D A R A ´ R N A S O Nis a Research Fellow at the University of Manchester

Cambridge Law, Medicine and Ethics

This series of books was founded by Cambridge University Press withAlexander McCall Smith as its first editor in 2003 It focuses on the law’scomplex and troubled relationship with medicine across both the devel-oped and the developing world In the past twenty years, we have seen

in many countries increasing resort to the courts by dissatisfied patientsand a growing use of the courts to attempt to resolve intractable ethicaldilemmas At the same time, legislatures across the world have struggled

to address the questions posed by both the successes and the failures ofmodern medicine, while international organizations such as the WHOand UNESCO now regularly address issues of medical law

It follows that we would expect ethical and policy questions to beintegral to the analysis of the legal issues discussed in this series Theseries responds to the high profile of medical law in universities, in legaland medical practice, as well as in public and political affairs We seek toreflect the evidence that many major health-related policy debates in the

UK, Europe and the international community over the past two decadeshave involved a strong medical law dimension Organ retention, embry-onic stem cell research, physician assisted suicide and the allocation ofresources to fund healthcare are but a few examples among many Theemphasis of this series is thus on matters of public concern and/orpractical significance We look for books that could make a difference

to the development of medical law and enhance the role of medico-legaldebate in policy circles That is not to say that we lack interest in theimportant theoretical dimensions of the subject, but we aim to ensurethat theoretical debate is grounded in the realities of how the law doesand should interact with medicine and healthcare

General Editors

Professor Margaret Brazier, University of Manchester

Professor Graeme Laurie, University of Edinburgh

Editorial Advisory Board

Professor Richard Ashcroft, Queen Mary, University of London

Professor Martin Bobrow, University of Cambridge

Dr Alexander Morgan Capron, Director, Ethics and Health, World Health Organization, Geneva

Professor Jim Childress, University of Virginia

Professor Ruth Chadwick, Cardiff Law School

Dame Ruth Deech, University of Oxford

Professor John Keown, Georgetown University, Washington, DC

Dr Kathy Liddell, University of Cambridge

Professor Alexander McCall Smith, University of Edinburgh

Professor Dr Mo´nica Navarro-Michel, University of Barcelona

Books in the series

Marcus Radetzki, Marian Radetzki, Niklas Juth Genes and Insurance: Ethical, Legal and Economic Issues

The Ethics and Governance of Human Genetic Databases

Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore, São Paulo

Cambridge University Press

The Edinburgh Building, Cambridge CB2 8RU, UK

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© Matti Hayry, Ruth Chadwick, Vilhjalmur Arnason, Gardar Arnason 2007

2007

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1 Introduction: some lessons of ELSAGEN

V I L H J A ´ L M U R A´ R N A S O N 1

2 On human genetic databases

3 American principles, European values and the

mezzanine rules of ethical genetic databanking

M A T T I H A ¨ Y R Y A N D T U I J A T A K A L A 14

4 The languages of privacy

5 A sociological perspective: public perceptions of

privacy and their trust in institutions managing

and regulating genetic databases

11 Regulating human genetic databases in Europe

12 Consent and population genetic databases: a

comparative analysis of the law in Iceland,

Sweden, Estonia and the UK

H O ¨ R D U R H E L G I H E L G A S O N 97

13 Third parties’ interests in population genetic

databases: some comparative notes regarding the

law in Estonia, Iceland, Sweden and the UK

14 Transforming principles of biolaw into national

legislation: comparison of four national laws

in three aspects

15 Governance of population genetic databases: a

comparative analysis of legal regulation in Estonia,

Iceland, Sweden and the UK

S U S A N M.C G I B B O N S 132

16 The legal jigsaw governing population genetic

databases: concluding remarks on the ELSAGEN legal

findings

viii Contents

Part IV Ethical questions 147

17 Introduction: ethical questions

24 The impact of biobanks on ethical frameworks

27 Bioethical analysis of the results: how well do laws and

regulations address people’s concerns?

M A T T I H A ¨ Y R Y A N D T U I J A T A K A L A 249

G A R D A R A ´ R N A S O Nis Research Fellow, University of Manchester

V I L H J A ´ L M U R A´ R N A S O N is Professor of Philosophy and Chair of theCentre for Ethics, University of Iceland

R U T H C H A D W I C K is Distinguished Research Professor and Director ofthe ESRC Centre for Economic and Social Aspects of Genomics atCardiff University

M A R K C U T T E R is Senior Lecturer and Director LLM Medical Law andBioethics at the Lancashire Law School, University of Central

M A R G R E ´ T L I L J A G U D M U N D S D O ´ T T I R is a researcher at the Department

of Sociology, University of Iceland

L E N A H A L L D E N I U S is Associate Professor of Ethics and Human Rights,Malmo¨ University, Sweden

M A T T I H A ¨ Y R Y is Professor of Bioethics and Philosophy of Law,University of Manchester

H O ¨ R D U R H E L G I H E L G A S O Nis Lecturer, University of Iceland, in PrivacyLaw at the Faculty of Law, and in Computer Security and

Cryptography at the Department of Computer Science; Consultant,the Legal Farm, Hartford, VT, USA; Executive Director, Do´mbær,Reykjavı´k, Iceland; partner LM Attorneys, Reykjavı´k, Iceland

R A I N E R K A T T E L is Professor of Public Administration and EuropeanStudies, Tallinn University of Technology, Estonia

x

J A N E K A Y Eis Research Fellow at the Oxford Genetics Knowledge Park,the Ethox Centre, University of Oxford

K U ¨ L L I K I K O R T S is a PhD student in Sociology, University of Tartu,Estonia

S I G U R D U R K R I S T I N S S O N is Associate Professor of Philosophy,University of Akureyri, Iceland

A N T S N O ˜ M P E Ris Attorney at Law, Raidla & Partners

S A L V O ¨ R N O R D A L is Director of the Centre for Ethics, University ofIceland

K A D R I S I M M is researcher, lecturer and project manager at theDepartment of Philosophy, Centre for Ethics, University of Tartu,Estonia

M A R G I T S U T R O P is Professor of Practical Philosophy, Head of theCentre for Ethics, University of Tartu, Estonia

T U I J A T A K A L Ais Lecturer in Bioethics and Moral Philosophy, University

of Manchester, UK; and Adjunct Professor in Practical Philosophy,University of Helsinki, Finland

P I I A T A M M P U U is post-graduate fellow in media and communication,Department of Journalism and Communication, University of Tartu,Estonia

S U E W E L D O Nis an independent researcher in sociology

L O T T A W E N D E Lis Senior Lecturer and researcher, Department of Law,Umea˚ University, Sweden

S A R A H W I L S O Nis a post-doctoral researcher at the ESRC-funded Centrefor the Economic and Social Aspects of Genomics (Cesagen) atLancaster University

1 Introduction: some lessons of ELSAGEN

Vilhja´lmur A´rnason

The investigation of ELSAGEN (Ethical, Legal and Social Aspects ofHuman Genetic Databases: A European Comparison), which was funded bythe European Com-mission from 2002 to 2004, was occasioned by plans toconstruct population-wide databases in the four participating countries:deCODE’s database in Iceland, the Estonian Genome Project, UKBiobank and Medical Biobank of Umea˚ in Sweden Interdisciplinaryresearch teams – with scholars and students from philosophy, law andsociology – were formed at ethics centres of six universities in these fourcountries: the University of Iceland, which coordinated the project, TartuUniversity in Estonia, Lund University in Sweden and the Universities ofCentral Lancashire, Lancaster and Oxford in the United Kingdom Thisresearch also benefited from the network ‘The Ethics of Genetic andMedical Information’, financed by the Nordic Academy of AdvancedStudy (NorFA, now NordForsk) from 2002 to 2006

This research, therefore, concerns databases which are new or underconstruction and which will collect information specifically for theintended multi-disease and population health research A human popu-lation genetic database is a collection of genetic, medical and, in somecases, genealogical data from a large number of people, arranged in asystematic way so as to be searchable.1 As a rule, such databases areintended to provide data for research in human genetics and medicine,exploring interaction between genes, lifestyle, environmental factors andhealth and diseases They are mainly non-clinical databanks in the sensethat the aim is not to gain information about individuals for clinicalintervention but to obtain general knowledge about diseases and toimprove health and health services More specifically, the aim of theresearch is to identify genes linked to common diseases and to the regu-lation of drug response as a basis for drug development Some of thedatabanks are also intended for clinical use where the aim is to gain data

1

See HUGO Ethics Committee, ‘Statement on Human Genomic Databases’, 2002

1

about individual participants and inform them about their health risksand possible ways to deal with them (for example, the ‘gene card’ inEstonia) There are different sets of ethical questions at issue in thecases of clinical vs non-clinical databanks: ELSAGEN concentrated onthe latter, i.e on issues concerning the collection, storage and use of datamainly intended for genetic epidemiology and pharmaceutical research.2The ELSAGEN research project had two major objectives: (I) toanticipate and address questions raised by recent developments in gene-tics research by providing knowledge of ethical, legal and social aspects ofpopulation-based human genetic databases; and (II) to consult citizens inorder to gain knowledge of public views of privacy and related moralvalues in the context of human genetic databases.

The main theoretical tasks of the project can be divided into fivecategories: (1) empirical mapping, i.e finding out what are the actualpolicies and people’s concerns regarding human genetic databases in thefour countries; (2) interpretive, comparative analysis of existing laws,policies and views; (3) conceptual analysis of the basic categories in themoral discourse about databases, such as privacy, consent, discrimina-tion and social benefits; (4) critical analysis of arguments, laws, policiesand views that have been put forth or voiced concerning these issues; and(5) finally, establishing how existing ethical frameworks and social poli-cies reflect people’s concerns and how they need to change in the light ofnew scientific and technological developments

In order to deal with these theoretical tasks and to reach the objectives

of ELSAGEN, five workpackages were formed The following is a briefdescription of these workpackages and a summary of the main lessons to

be learned from them The main results of the research work aredescribed in the individual sections of this book

1 A Workpackage on National and European Values was divided into(i) an empirical survey which was to provide knowledge about publicviews on privacy concerning human genetic databases, people’s trust

in public and commercial organizations with regard to the collectionand storage of personal data, and to what extent these views andattitudes vary between the four countries; and (ii) bioethical analysis

of the results

Some of the most significant results from the empirical survey cern people’s perception of the trustworthiness of professionals andinstitutions Not surprisingly, previous experience of gene technology

con-2

For a general discussion of ethical and legal aspects of databanks, see e.g B M Knoppers

(ed.), Populations and Genetics Legal and Socio-Ethical Perspectives (Leiden: Martinus

Nijhoff, 2003 ).

2 Vilhja´lmur A´rnason

seems to shape citizens’ views and concerns in this respect Thus there

is generally more trust in genetic science and scientists amongEstonians and Icelanders than there is in England If people feel thatthey can trust scientists and institutions, they seem to be willing tofurther genetic science and believe that it will improve their healthand welfare even though in many cases they do not claim to understandthe issues The bioethical implications of the survey are discussedspecifically in the concluding chapter of this book

2 A Workpackage on Social Issues was divided into (i) governance –analysis of the exercise of political, economic and administrativeauthority in the management of databases; (ii) discourse on databases –analysis of the public discourse on the databases, studying the types ofarguments used in the debates; and (iii) social justice – analysis ofconceptions and applications of social justice in relation to the data-bases

It is striking that none of the four databanks that were the focus of theresearch are in operation, at least not according to the plans that werethe focus of the ELSAGEN research Although genetic databankresearch in Iceland is thriving, the Icelandic HSD project has stalled.The Swedish company UmanGenomics has ceased operating, and theplans in the UK and Estonia are still in (slow) progress.3 There aredifferent reasons for the slowness or lack of progress in each case, whichcannot be discussed here, but the general lesson is that public consulta-tion is an important factor that should be undertaken early in theprocess It is time-consuming but crucial for building trust amongprospective participants This requires an extensive informed publicdebate in time to feed into the policy- or law-making processes.Another important lesson for governance is that political authority andregulation should be kept independent of the commercial intereststhat most often need to be harnessed in order to finance the projects.This separation is an important precondition for trust, and it requirescareful thought about the relationship between community ownershipand commercial interests Finally, on the issue of social justice, there is

a tension between global and local relevance As Chadwick andWilson have pointed out, while global arguments are used for theirimplementation, the benefits of databases may reside in their localrelevance.4Other research has shown that people are motivated by the

3

The Medical Biobank of Umea˚ is still functioning, however.

4 R Chadwick and S Wilson, ‘Genomic Databases as Global Public Goods?’, Res Publica

10 ( 2004 ), pp 123–134.