The Ethics and Governance of Human Genetic Databases European Perspectives Part 7 pps

the issue of benefit-sharing further. A differentiation is useful between the

universal list above (describing the entire positive potential of the genetic

enterprise) and a specific benefit-sharing framework directed towards

those who directly participate in research.26 These two issues should

not be joined if we still want to make use of the sharing framework,

and by differentiation much confusion is avoided because a number of

benefit-sharing arguments function only in a specific context, whereas

others have relevance universally. For example, compensation for risks

taken is an important aspect where smaller research projects are con￾cerned and desert might be considered a relevant distributive principle.

Alternatively, compensation for fairness and the principles of need and

equality gain significance in cases of successful drug development for

diseases rampant in the poorer areas of the world.

Benefit-sharing and population biobanks

The practice of benefit-sharing, especially as first applied in agriculture,

introduced a perspective that recognizes the contributions of commun￾ities and populations. Human genetics complicated the issue further as

genetic information is by nature shared, thus involving individuals and

communities who might not have participated in research in the tradi￾tional sense. As research is increasingly associated with for-profit com￾panies and practices, this has given credence to additional concerns of

political, social and economic origin. Of course, in principle ‘genetic

research on a global scale’ is still made up of specific research projects,

but many calls for benefit-sharing ask us to look beyond these specific

projects and assess the impact of the entire phenomenon, inclusive of

factors outside the regulated medical sphere. It is like taking stock of the

ocean instead of focusing on the drops of water making it up.

Population biobanks provide an intersection for benefit-sharing con￾cerns – whilst mostly focused on medical research, they ill-fit the tradi￾tional medical frameworks (for example, besides benefit-sharing the

appropriate redefinition(s) of informed consent have been a significant

challenge). The very scale and scope of population biobanks have intro￾duced new concerns for fairness and justice that call for a different

justification for benefit-sharing. But, of course, fairness and various

justice-related concepts are notoriously difficult to agree upon. For instance,

whose concerns are to be taken as relevant? In small-scale research

26 Kadri Simm, ‘Benefit-Sharing: An Inquiry Regarding the Meaning and Limits of

the Concept in Human Genetic Research’, Genomics, Society and Policy 1, 2 (2005),

pp. 29–40.

168 Kadri Simm

projects this is easier to assess than in biobanks, where significant social

concerns might arise.

It is also important to draw attention to the way justifying arguments

for benefit-sharing determine the recipients of those benefits. In other

words, certain justifications necessarily exclude or include specific groups

or communities. For example, when we consider the genome to be a

common property of humanity, the sharing should be done among all

human beings. On the other hand, when benefit-sharing is conceptual￾ized as a compensation for voluntarily taken risks, it would seem unfair

to share benefits with those who have not taken any risks. Furthermore,

different justifications can be contradictory and the employment of those

competing concerns can complicate the issue further.

In biobanks the question will inevitably be raised as regards who

in particular will benefit. Can and should a relevant community be

delineated when not everyone will be involved? The case of individual

benefits (as in the Estonian promise of giving individual feedback based

on DNA samples) could be a strictly desert-based undertaking. The

Icelandic project has promised cheaper drugs based on research results,

but it is unclear whether that would include non-participants. By con￾trast, the UK Biobank explicitly does not promise personal gains and

insists on the altruistic motivation of the participants: they expect the

participation of the elderly but the expressly stated objective is to benefit

all (also outside the UK), thus making solidarity central in sharing scien￾tific benefits.

It is an open question whether population biobanks would rather

follow the traditional reciprocal form of benefit-sharing or whether

more inclusive arrangements based on solidarity are taken up. The con￾cept of benefit-sharing has been transformed as ethical, social, political,

economic and scientific developments have had their impact on research.

The rationale for benefit-sharing within biobanks can rely on competing

discourses, and it is largely up to the organizers as well as the participants

to decide upon the content of this notion.

Benefit-sharing and biobanks 169

20 Genetic discrimination

Lena Halldenius

The argument in this chapter proceeds from an empirical fact and a

conceptual dissatisfaction. ‘Genetic discrimination’ is now an ethical

and legal issue. In countries like France, Denmark and Norway insurance

companies and employers are banned from asking individuals to undergo

or disclose results from genetic tests. There is backing in the Council of

Europe’s Convention on Human Rights and Biomedicine1

and the

Universal Declaration on the Human Genome and Human Rights.2

The term ‘discrimination’ is explicitly used in these documents. In

Sweden, legislation was recently proposed by a parliamentary committee.

The proposals affect both the insurance sector (previously regulated in a

trade agreement) and the employment sector (previously unregulated).3

The genetic discrimination scare is exacerbated by plans to build

population genetic biobanks and databases in several countries, like

Estonia and the UK. In Sweden there is no such comprehensive genetic

project underway, but the PKU register holds blood samples from every

individual born in Sweden since 1975. These large-scale biobanks raise

ethical issues not only about consent procedures, data protection, and

whether people should have a right to know (or not to know) what their

genetic make-up looks like. They also raise issues about the ethical

viability of third-party use. Genetic information is ever becoming more

and more accessible. With the advent of large-scale biobanks and genetic

1

‘Any form of discrimination against a person on grounds of his or her genetic heritage is

prohibited’, Convention on 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, Oviedo, 4 April 1997, ETS 164, art. 11.

2

‘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’, UNESCO, The Universal Declaration on the Human Genome and

Human Rights, adopted by the General Conference of UNESCO at its 29th Session on

11 November 1997, art. 6.

3

SOU 2004:20 Genetics, Integrity and Ethics, Final Report from the Committee on

Genetic Integrity (SOU 2004:20 Genetik, integritet och etik. Slutbeta¨nkande av

Kommitte´n om genetisk integritet).

170