Education and debate

The Icelandic databasedo modern times need modern sagas?

Ruth Chadwick, professor of moral philosophy. 

Centre for Professional Ethics, University of Central Lancashire, Preston PR1 2HE

r.chadwick{at}lancaster.ac.uk

On 17 December 1998, as a result of legislation instigated by deCODE genetics, a Delaware biotechnology company working in Reykjavik, the Icelandic parliament adopted a law making it legal for a private company to construct an electronic database of the country's health records.¹ deCODE has received an exclusive licence to build a database of Iceland's medical records (including diagnoses and test results, treatments and side effects) and will be able to combine and analyse these with genetic and genealogical data. The act also grants deCODE exclusive rights to commercial exploitation of the database for 12 years. Accordingly, deCODE has entered into a (non-exclusive) arrangement with Hoffmann-La Roche which gives the latter company access to the database for the purpose of researching the genetic origins of 12 common diseases.

	Are the rules out of date?

The debate before and after the bill on Iceland's proposed database has been vigorous. Sigurdur Gudmundsson, Iceland's surgeon general, was quoted in the New Yorker as saying, "I don't think this country can just sit here and say, `Nope, sorry, we are going to stand on rules that existed in a different era for a different world.' "² But are the rules being applied to the database able to address adequately the issues that have been raised? It is striking that both proponents and opponents have classified the ethical and human rights issues similarly, into five main areas: informed consent, privacy, scientific freedom, benefit to Iceland, and commercial monopoly (sometimes included under scientific freedom or benefit). ^{3 4} These concerns can be grouped under two broad headingsmatters of medical ethics and the question of scientific freedom versus commercial interests. The ethical issues are clearly important and relevant to international conventions and policies concerned with human rights. However, the way we categorise issues in a debate can sometimes obscure other aspects that need to be considered and prevent us from questioning whether traditional distinctions need to be revised.

	Better, cheaper health care?

The database will not help directly any individual patient with the management of his or her condition, say those who are in favour of the database. Rather, it will be a tool in the development of new or improved methods of achieving better health, prediction, diagnosis, and treatment of disease and in establishing more cost efficient ways of operating health services.⁵ The database can help to achieve the first aim by providing informationfor example, on genetic and environmental risk factors in common diseases and statistical data on disease and treatment. The health economics aim is a secondary one, but it is still important. Although the average health status and the life expectancy of the population are high, Iceland's health insurance system is sixth in the Organisation for Economic Cooperation and Development's league table of expenditure on health care in relation to gross national product.⁵

Making use of a valuable asset
Iceland's population of approximately 270 000 has a genetic history that makes it particularly valuable for genetic research into common diseases (box).² Furthermore, the extent to which the new genetics will affect the delivery of health care remains unclear, and Iceland, say the proponents of the database, provides a unique opportunity for testing this. It has also been argued that since the data in the records have been paid for out of public funds they are not owned by individuals or institutions and should be used for the public benefit. ^{5 6}

	Sources of possible harm

Privacy and confidentiality
The main concern is the threat to privacy and confidentiality. Although privacy and confidentiality are different concepts, the issues have not been clearly distinguished in the debate. The central issue is the security of the information in the database. There is concern that information identifying individuals could fall into the hands of groups who might use it for their own purposes: insurers or employers, for example, might use the information to discriminate against some people. Two aspects of this issue need to be addressedthe extent (if any) to which a trade-off between privacy and other benefits is reasonable, and whether the security measures adopted by the Icelandic database afford adequate protection to individuals.

Informed consent
According to the European Directive 95/46, informed consent is necessary if personal data are to be used for purposes other than those for which they were originally gathered, but consent is not required if the data are not personal.⁸ Iceland chose to establish a database of information that was not personally identifiable. Icelanders have been offered the opportunity to opt out of the database and will be informed continuously about their right to withdraw from the database at any time.¹

(Credit: CAROLINE THOMSON)

Scientific freedom
Scientific freedom is a more complex issue. The value of the free flow of information and the importance of free scientific inquiry is widely recognised. ^{11 13} The scientific community in Iceland has been angered by the database proposals, arguing that scientists who want to undertake genetic research will find it harder to raise research funds for their work. However, deCODE's answer is that the database will increase the research opportunities for scientists in Iceland in relation to funding, access to patients, and access to patients' records. The supporters of the database have also argued that this initiative will attract funding and scientists back to Iceland and that the amount of funding provided by deCODE is greater than the medical research funding offered by the Icelandic agency that grants research funding.

	Defining benefit

Proponents of the database consider that it will lead to a reverse brain drain as well as the better management of Icelandic health care.³ Sceptics argue that this benefit will accrue to only a few Icelanders, and that it will take the form of highly paid jobs. The government's annual licence fee will not prove to be a net benefit to the country as a whole.

We need to determine what is understood by the word "benefit," and this will become increasingly important in the context of population based genetic research. Does it mean financial and health gains (for example, free medicines from Hoffmann-La Roche) or does it also include more intangible benefits such as prestige to the country? Those who believe that the Icelandic population is being turned into a commodity criticise the definition of benefit in financial terms. Lewontin says that Iceland is carrying the "commodification" of people "to its final conclusion by making its entire population into a captive biomedical commodity."¹⁵ He points to the irony of this in the light of the individualism of the Icelandic sagas. Perhaps this is an example of the value impact of new technology: the environmental impact of technologies is frequently discussed, but a value impact assessment is also required, which would include a consideration of the ways in which we are forced to reconsider, reinterpret, or enrich our understanding of cherished values and principles.

	Identifying real issues?

What is interesting about this classification of the ethical issues discussed above is the way in which it centres on very traditional issues in medical ethics (informed consent and privacy) and in scientific research (scientific freedom versus commercial interests). What has not been highlighted so much in the ethical discussion is the relevance of genetics and the phenomenon of "geneticisation," although this is a constant background presence in the debate. deCODE says that "it may be argued that the database will save lives, improve health, and cure disease."³ This is analogous to the rhetoric of progress associated with the human genome project. As in that case, it is challenged by arguments concerning another shadowy presencethe history of abuse of genetic information. Both sides of the database debate, however, seem to agree about the value of the science; they disagree about commercialisation and access. The prevailing model of health here is one that makes genetics central.

In the debates about informed consent and privacy there is also widespread agreement on the value of these traditional ways of looking at things. There is little scope for considering the challenges to traditional principles that result from advances in medical technology. Are these data really individual or national resources? If they are a national resource then the logic of the case might suggest that even opting out should not be offered. The disagreements over whether and to what extent informed consent and privacy will be adequately protected have not been resolved. Whether these approaches need reconsideration or supplementation in the present context should be addressed in the context of clear criteria of what would count as a public health success.

The case for the database has so far failed to convinceand this is because there has been an insufficient attempt to provide an articulation of benefit, or of what "benefit" might mean. A sharper critique of the "why?" as well as the "why not?" is required. Who will benefit, and in what way? If these questions are not answered, commercialisation will understandably be met with absolutist support for traditional principles and frameworks in forms that may no longer be entirely appropriate.

	Acknowledgments

In preparing this manuscript I have been provided with information by representatives of deCODE and Mannvernd (Icelanders for Ethics in Science and Medicine). I also thank my research assistant Nicholas Joll and my colleagues on the Human Genome Organisation Ethics Committee, especially Kåre Berg, the Honourable Justice Michael Kirby, and Bartha Knoppers.

	Footnotes

Competing interests: None declared.

	References

1.	Ministry of Health. Act on a health sector database. Reykjavik: Ministry of Health , 1998(No 139/1998.)
2.	Mannvernd (Icelanders for Ethics in Science and Medicine). www.mannvernd.is (Accessed 14 May 1999.)
3.	deCODE genetics. www.database.is (Accessed 14 May 1999.)
4.	Specter M. Decoding Iceland. New Yorker 1999 Jan 18: 40-51.
5.	Council of Europe Steering Committee on Bioethics. The Icelandic act on a health sector database and Council of Europe conventions. Strasbourg: Ministry of Health and Social Security , 1999(CDBI-CO-GT2(99)7 1999.)
6.	Ministry of Health. Bill on a health sector database. Reykjavik: Ministry of Health , 1998.
7.	Council of Europe. Convention for the protection of individuals with regard to automatic processing of personal data. Strasbourg, Council of Europe, , 1981.
8.	European Parliament. Directive on the protection of individuals with regard to the processing of personal data. Brussels: European Parliament , 1995(Directive 95/46/EC.)
9.	Council of Europe. Recommendation on the protection of medical data. Strasbourg: Council of Europe , 1997(No R(97)5.)
10.	Council of Europe. Recommendation concerning the protection of personal data collected and processed for statistical purposes. Strasbourg: Council of Europe , 1997(No R(97)18.)
11.	Unesco. Universal declaration on the human genome and human rights. Geneva: Unesco , 1997.
12.	McInnis MG. The assent of a nation: genethics and Iceland. Clin Genet 1999 55:234-9.
13.	Human Genome Organisation Ethics Committee. Statement on the principled conduct of genetic research. Genome Digest 1996 May:2-3.
14.	Greely H, King MC. Letter to the government of Iceland. www.mannvernd.is (Accessed 14 May 1999.)
15.	Lewontin RC. A human population for sale. New York Times 1999 Jan 23.

(Accepted 28 May 1999)