THE ETHICS AND GOVERNANCE OF HUMAN GENETIC DATABASES: EUROPEAN PERSPECTIVES
Matti Häyry, Ruth Chadwick, Vilhjálmur Árnason and Gardar Árnason, eds,
Cambridge:
Cambridge University Press, 2007, Series: Cambridge Law, Medicine and Ethics (No. 4),
ISBN-13: 9780521856621, 283 pp, £50.
This book marks the conclusion of the ELSAGEN project, a
three-year collaboration between the University of Iceland, the
University of Tartu, Estonia, the HETA Law Offices, Tallinn, Estonia,
Lund University, Sweden, Lancaster University, UK, the University
of Central Lancashire, UK and the University of Oxford, UK. The
project started at the beginning of 2002 and had two general objectives.
First, the intention was to conduct ethical, legal and social studies of
genetic databases with the aim to “anticipate and address questions
raised by recent developments in genetics research by providing
knowledge of ethical, legal and social aspects of population-based
human genetic databases”.
(1) Second, empirical work was scheduled to
“consult citizens by providing knowledge of public views of privacy
and related moral values in the context of human genetic databases.”
(2)
The project focused on four countries, the UK, Iceland, Sweden and
Estonia. Due to the contributors coming from a wide and varied
background, the book constitutes a multidisciplinary consideration of
the issues surrounding human genetic databases.
The book is divided into five main parts as well as an introduction
and conclusion. The five main parts encompass a background, social
concerns, legal issues, ethical questions and political considerations,
emphasising the multidisciplinary nature of the book.
The introduction summarises the ELSAGEN project, listing the
objectives of the study and describing, in detail, the workpackages
and the teams undertaking the work.
The background chapter of the book is divided into three chapters,
the first one providing an overview of human genetic databases. In
this chapter, Árnason describes the four genetic databases the project
considered in their context, namely the Medical Biobank of Umeå in
Sweden, deCODE’s Health Sector Database in Iceland, the Estonian
Genome Project and UK Biobank. Unfortunately, a typographical error
occurred in the description of the Icelandic Supreme Court decision
of 2003 declaring the Health Sector Database unconstitutional, which
distorts the legal reasoning. On page 12, it reads ‘close relatives of
a diseased person’ instead of ‘close relatives of a deceased person’,
(3)
leading to a different legal concept. The second of the three background
chapters, by Häyry and Takala, is the most detailed one, focusing on
ethical deliberations. The final part of the background part is provided
by Nordal’s very interesting contribution on language, which readers
may have liked to see expanded to form a more detailed contribution.
In fact, the difference in the length of the chapters is particularly
noticeable in the background part.
Part II has social concerns as its topic and is the result of the
empirical studies of the ELSAGEN project. This part starts with
an introduction of the issues which are examined, namely public
attitudes to genetic information. Special emphasis is placed on
public perception of privacy regarding personal medical and genetic
data. Also, people’s attitudes towards the trustworthiness of public
and private organisations are examined. The sociological part of the
project was aimed towards providing an understanding of the wider
social concerns that genetic research databases create. The intention
was to take account of the existing, different social contexts in each
country.
A first overview over the following chapters examining each
country in turn shows some discrepancies in structure. Most noticeably,
Korts’ chapter on Estonia lacks a description of the methodology
applied to gain knowledge from the people asked. Besides this
omission, the chapters are well-structured and provide an excellent
basis for a comparative study of attitudes to human genetic research
databases and their context in the four countries. Surprisingly, part
II does not end with the drawing together of the individual country
results and a comparative conclusion, rather, a chapter on public
discourses on human genetic databases, which focuses on only one
of the four databases, concludes this part. While undoubtedly very
interesting and well-written, Tammpuu’s chapter does not sit well in
this context, in particular as the introduction to part II is obviously
written for the four empirical chapters applying similar methodology
to determine public attitudes. Also, with Tammpuu’s chapter focusing
on Estonia, similar chapters for the other three countries seem to be
missing.
Part III deals with the legal issues surrounding human genetic
databases. Rather than devoting a chapter or two to each country, the
individual contributions in this part of the book consider a topic each
and apply this to each of the four countries in comparative studies.
The legal part of the book starts with an introductory chapter
from Kaye, which emphasises the need for harmonisation in both
definition and law. Kaye’s chapter is intended to raise the questions
surrounding the regulation of human genetic databases, ranging
from consent over benefit-sharing and feedback to ownership and
intellectual property rights. Kaye also touches briefly upon the
question of genetic exceptionalism in posing the question whether
genetic databases should be regulated differently. The second chapter
in part III considers the well-known and much discussed problem of
consent for population genetic databases. Helgason takes a comparative
approach to the problem, taking legislation in the four countries into
account and discussing the main questions surrounding the consent
issue, such as whether consent is needed at all, how explicit it needs to
be and whether informed consent is possible in this context. The next
chapter focuses on third parties’ rights and interests in human genetic
databases. Wendel divides these third parties into three categories,
family, societal concerns and financial concerns such as employers
and insurers and discusses each in turn, comparing the approaches
the law takes in the four countries. Nõmper’s chapter on transforming
principles of biolaw into national legislation compares three separate
aspects in the four legislations, feedback, genetic counselling and
benefit sharing. Each of the three aspects is examined fairly briefly.
This chapter would have benefited from a more detailed analysis,
since it feels slightly rushed, particularly as it deals with three separate
topics, each of which is deserving of its own chapter. Gibbons’
chapter focuses on the governance of human genetic databases
and compares legislative approaches. She considers forms of legal
regulation, supervisory bodies and notification requirements, ethical
review as well as enforcement powers and sanctions. Similarly to
Nõmper’s chapter, Gibbons’ contribution, while also excellent, could
have benefited from being slightly longer and more detailed. As it
is, the two chapters can only summarise the problems and solutions.
Having written the introduction to the legal part, Kaye also provides
the concluding chapter, drawing some of the findings together.
Part IV considers the ethical aspects of human genetic databases.
After a very brief one-page introduction by Árnason, Wilson
and Chadwick examine social justice in the context of population
genomics. They discuss genomics as a global public good in detail
before moving on to touch upon ethnic identity and genetics and
the implications of different ethnic genetic responses to drugs. The
chapter concludes with a brief consideration of benefit-sharing in
a broader social context. The next chapter then follows on with a
more detailed discussion of benefit-sharing, considering the concept
in various contexts. In this chapter, Simm starts by looking at the
origins and then continues to transfer the concept to the medical and
social context. She then briefly considers what exactly can or should
be shared, before applying the benefit-sharing model to population
biobanks. In her chapter on genetic discrimination, Halldenius considers,
from an ethical and philosophical point of view, when distinctions
between people will need to be seen as unfair discrimination. From
a standard account of discrimination, Halldenius then applies this to
genetics to determine whether the standard view can explain genetic
discrimination. Having touched upon privacy in a different context in
part I of the book, in the next chapter Nordal considers the ethical
aspects of privacy, focusing on informational privacy and information
technology and arguing that if privacy is taken seriously, then new
directions for securing privacy interests have to be found. Several of
the topics which have already been considered in other chapters such
as the familial context of genetic information are considered in this
chapter from a privacy point of view. Sutrop discusses the concept of
trust in her chapter. Starting with an examination of the concept of
trust, she then proceeds to discuss what kind of trust is needed for
large-scale human genetic databases and how to build and maintain
that trust. In the last chapter of part IV, Kristinsson and Árnason
return to the topic of informed consent in connection with human
genetic database research. The chapter is divided into two parts,
first, the philosophical questions of what informed consent is are
examined, and second, the challenge set by human genetic databases
for informed consent and its applicability are discussed.
In part V, political considerations are undertaken. In the first
chapter, Chadwick and Cutter examine the impact of biobanks on
ethical frameworks. For this, the authors take a step back and reflect
on the debate surrounding human genetic databases and their impact
on ethics, suggesting four different possibilities of what is meant by
‘impact’ in this connection. Chadwick and Cutter identify these as
ethics and governance, new models for specific issues, harmonisation
and theoretical issues, discussing each in turn. The second chapter
considers rhetorics and policy in connection with human genetic
databases. Árnason sets the scene by quoting a journalist’s
paraphrasing of Francis S. Collins’ prediction regarding the Human
Genome Project. He then provides a summary of the history of
genetics, focusing on the terminology for genes, chromosomes etc.
and how this changed with new discoveries. He then considers
how the concept and a deterministic view of genes are defined to
demonstrate the powerful rethorics surrounding genetics. In the final
chapter, Kattel considers genetic databases and governance, looking at
the concerns surrounding this type of research. According to Kattel,
these uncertainties surrounding genetic databases endanger the basic
freedom of the modern democratic state. Kattel proceeds to discuss
aspects of commercialisation, from analysing the presumption that
new technologies will create new markets to the commercial aspects
of the four databases considered in the ELSAGEN project. This
chapter introduces several very interesting concepts regarding the
governance of human genetic databases, however, readers may have
benefited from a longer and more detailed analysis.
In the conclusion, Häyry and Takala sum up the answers to
the issues raised by the various teams during the duration of the
ELSAGEN project, drawing on the contributions in the four main
parts of the book.
The book provides an excellent summary of the prevalent issues
surrounding human genetic databases. For newcomers to the area, the
book constitutes a good introduction to the prevalent topics. However,
due to its nature, it does not provide many new research results. Still,
the book is a valuable resource for interdisciplinary research into
genetic databases.
Dr Renate Gertz
School of Law
University of Edinburgh
1 http://www.elsagen.net
2 Ibid.
3 Emphasis placed by the author
©2007 A B Academic Publishers