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BMJ 1999;319:441-444
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The Icelandic database
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On 17 December 1998, as Collections under which this article appears:
a result of legislation CLINICAL:
instigated by deCODE
genetics, a Delaware Genetics
biotechnology company Ethics:
working in Reykjavik,
the Icelandic parliament Other Ethics
adopted a law making it Informed Consent
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.
Summary points
-----------------------------------------------------------------
The government of Iceland has granted an exclusive licence to
deCODE genetics to construct a database of the country's health
records
-----------------------------------------------------------------
Debate about issues of informed consent, privacy, scientific
freedom, benefit, and commercial monopoly is vigorous
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The question at issue is whether the rules being applied to the
database can deal with the issues raised
-----------------------------------------------------------------
A debate that focuses on traditional principles risks ignoring
new challenges brought about by advances in medical technology
-----------------------------------------------------------------
If the role of commercialism is to be assessed and defined
appropriately, benefits to the individual and to public health
need to be articulated clearly
Are the rules out of date?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 headings[---]matters 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
information[---]for 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
Importance of the Icelandic database
* Meticulous medical records on every Icelander have been kept
since the second world war
* Since the second world war, tissue samples have been taken from a
large proportion of the population and have been stored
* Family trees have been drawn up for most of the population
* There has been no immigration for a thousand years
* The population's standard of living is uniformly good
There will of course also be "spin offs" in terms of advantages for
particular people or organisations. The pharmaceutical companies who deal
with deCODE will be able to develop and test new products. It is the
position of the licensee and the licensee's arrangement with Hoffmann-La
Roche that have given rise to some of the major criticisms. The fear is that
these companies will benefit while Icelanders as whole, and scientists in
particular, may be subject to "harm."
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 addressed[---]the 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.
>From an ethical point of view, the balancing of privacy and confidentiality
against other considerations is not new. The security of data on
identifiable parties has long been one consideration, and public health
interests form another, though more controversial, issue. These days
individual privacy is under attack on many fronts[---]not only in health
care[---]and widespread surveillance of people's lives is as common in
Iceland as elsewhere.2 However, the dangers inherent in modern technology
and science are judged to be considerable,5 and this has led to attempts to
ensure protection through various international policy documents and
legislation.7-10
One view is that the aims of genetic research, in particular, should not
prevail over respect for the rights of individuals.11 Whether the database
is compatible with such rights as are protected by Council of Europe
Conventions has been examined by the council's steering committee on
bioethics.5 In considering what is reasonable, this body concluded that
identification of the Iceland data "cannot be regarded as reasonably
possible without substantial effort" and that the data are therefore
anonymous according to the criteria of international law. This is so despite
the inclusion of genetic information in the database and the controversy
over whether genetic information should be regarded in the same way as other
medical data. The act includes measures "to ensure protection of
confidentiality in connecting information from the health sector database
with the databases of genealogical and genetic information" (article 10).
Though the original bill allowed for a decoding key, this was removed in the
final version. Article 11 further provides that employees of the licensee
must sign an oath of confidentiality.
Although the Council of Europe Steering Committee on Bioethics considers
that the database is acceptable from the perspective of international law,
the critics are not reassured about the protection afforded. With regard to
the dangers to privacy, at least, they are concerned to have an absolute
guarantee rather than one based on a criterion of reasonableness such as is
used by the Committee.12
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
[Image]
(Credit: CAROLINE THOMSON)
Do these provisions protect sufficiently the interests of individual
Icelanders? Once again there are different areas of disagreement. There are
concerns about the adequacy of an opting out system for rights protection,
as compared with fully informed consent, which is considered to be at the
heart of ethical medical practice and research. Against this, the
requirement for informed consent is generally viewed to be less for
epidemiological research on medical records[---]especially where these are
anonymous.13 Autonomy is upheld to some degree at least by the opting out
provisions included in the Icelandic act. On the other hand the claim that
some people might be in favour of research in general, while objecting to
particular kinds of research that they might be unable to foresee, has some
force.14
The debate about the rival merits of opting out and informed consent,
however, is undermined by a deeper problem about understanding of what is
involved. At one level it is suggested that individual Icelanders mistakenly
think they will not have information about them entered on the database
until they next visit the doctor (J Eyfjord, personal communication); at
another there is concern that informed consent would not even be possible in
principle, because doctors are not in a position to explain the risks.
Although invasion of privacy is one possible source of harm, the possible
future uses of the database are potentially too broad to be foreseen and
explained.12 So even if a system of informed consent was seen to be
implemented, it could not provide genuine protection. In fact a requirement
for informed consent has not been chosen on the grounds that it would be
likely to reduce participation and thus the usefulness of the database.12
In genome research, different levels of consent have been recognised.13 The
Council of Europe Steering Committee on Bioethics has concluded that
relevant Council of Europe recommendations allow research for legitimate
purposes to use personal data without obtaining informed consent, provided
that the scientific research is provided for by law and constitutes a
necessary measure for reasons of public health.5 This is one of the main
points at issue. The Icelandic database is considered to constitute a
measure in the interest of public health[---]but is it "necessary" for
public health? This question needs to be answered, but if one of the
justifications of the database is to test the extent to which the new
genetics can deliver, it is not clear how it can be answered in the
affirmative beforehand and thus provide a clear public health justification
for overriding considerations of informed consent.
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.
However, for scientists wishing to use the database there are necessary
conditions such as not using or divulging information in a way that will
adversely affect deCODE's business interests. Applications from scientists
working outside the licensee's business have to be addressed to the access
committee.1 However, any research carried out in the public domain (for
example, by universities) is likely to have an adverse effect on the
licensee's commercial interests.14
Once again different aspects of the debate need to be considered. One
concern is the extent to which scientists will be enabled or hampered by
this development. Another, more difficult, question is whether the database
poses a new kind of threat to scientific freedom or whether it simply
presents, under the guise of commercialisation, a new twist to an old
problem. Inquiry itself is not to be prevented, but commercial interests
will affect who does what. However, this is becoming a widespread feature of
contemporary scientific work[---]for example, work on the genome. What is
unclear is the specification of the principles to be defended on both sides
[---]what counts as scientific freedom in this context, and what are the
purported benefits that justify the level of control that will exist?
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 presence[---]the 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 convince[---]and 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)
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