ICELAND鈥檚 270 000 citizens are a dream come true for genetics researchers.
One thousand years of near-isolation has meant that their ancestry can be traced
right back to the original Viking and Irish settlers. With their medical
records, which stretch back a century, the genes of Icelanders offer scientists
unparalleled opportunities to map the evolution of human diseases.
Iceland鈥檚 parliament realises this and is about to cash in its people鈥檚
legacy. It is on the verge of passing a bill that would authorise the creation
of a single database containing genetic, genealogical and medical details about
all Icelanders. The bill would also license deCode Genetics, a private company
in Reykjav铆k funded mainly by American investors, to manage the database.
deCode has already signed a $200-million deal with Hoffman-La Roche, the
Swiss-based pharmaceuticals company, for exclusive access to the database to
probe the genetic origins of 12 common diseases
(This Week, 21 February, p 19).
A large majority of MPs support the bill, which is still being revised and
will be voted on later this month. They claim the deal will bring prestige to
the country and create hundreds of new jobs in research. In addition, Hoffman-La
Roche has agreed to supply Icelanders free of charge with any medicines that
result from their research.
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But many Icelanders were fiercely critical of the proposed law when a first
draft was published in March. They have since been joined by voices from abroad,
including the European Union鈥檚 powerful Data Protection Commissioners, who
police member countries鈥� compliance with the EU directive on data security.
These critics claim that the new law fails to respect internationally recognised
safeguards designed to protect the privacy, dignity and rights of people whose
records are entered into databases for genetics research.
杏吧原创s are as concerned as privacy campaigners. If the new legislation
fails to respect these safeguards, they argue, it could tarnish the image of
genetics research across the world. 鈥淚f people think they鈥檝e been cheated,
deceived or let down, the backlash will be bad for research,鈥� says Henry Greely,
a professor of law at Stanford University, who wrote a letter of protest to the
Icelandic government. 鈥淧eople will be unwilling to participate if it鈥檚
unethical, so it鈥檚 an important first test and it may influence how [genetic
research] is done in other places.鈥�
Richard Lewontin, a professor of zoology and biology at Harvard University,
agrees that if Icelanders are seen to have been 鈥渟old down the river鈥�, the law
will only add to rising levels of cynicism about genetics. 鈥淭here鈥檚 this general
feeling that genes are being exploited for private profit. The population of
Iceland has been turned into a tool for this one company, and that seems
completely objectionable,鈥� he says.
However, most criticism has been focused not on deCode, but on apparent
weaknesses in the law that could compromise people鈥檚 rights. For example,
Icelanders will not be asked for consent before their records are entered onto
the database. A third draft, drawn up after consultation with critics, allows
objectors to opt out, but Icelanders will otherwise be presumed to have
consented.
鈥淭he parliament is really making a decision [about consent] on behalf of
Icelanders, and we think that鈥檚 wrong,鈥� says P茅ter Hauksson, chairman of
Iceland鈥檚 Mental Health Alliance and founder of Mannvernd, a consumer group set
up to oppose the plan. His misgivings are echoed in a letter he received a month
ago from the EU鈥檚 Data Protection Commissioners, who voiced their concern after
seeing an earlier draft of the law. 鈥淭he principle of free and informed consent
of the person concerned to the storage and further processing of his or her data
must be fully respected,鈥� they stated.
K谩ri Stef谩nsson, the Harvard-trained Icelandic geneticist who
founded deCode, says that consent will be sought from individuals when they
provide tissue samples. But he says it would be unnecessary and impractical to
obtain consent for entering medical records onto the database for
epidemiological studies. 鈥淲hat we are doing is exactly the same as what people
are doing all round the world.鈥�
But the commissioners point out in their letter to Hauksson that the earlier
versions of the proposed law fall short of international obligations by failing
to allow subjects who initially give their consent to withdraw it later. They
urge the Icelandic government to reconsider the project 鈥渋n the light of
fundamental principles laid down in a number of international declarations and
treaties鈥�, including the European Convention on Human Rights, the Council of
Europe Convention on Data Protection and the European directive on the
protection of personal data.
Another sticking point is deCode鈥檚 intention to encrypt the medical records
rather than make them anonymous, a provision that critics say would break all
conventions on the use of personal data by enabling information to be traced
back to individuals. 鈥淚n a country with a relatively small population,
information on genetics is likely to indicate biological lineage and to reveal
identities of persons concerned,鈥� say the EU data commissioners. 鈥淭he use of a
code to replace [names] is in any case not sufficient to secure anonymity.鈥�
The bill also denies Icelanders the right to choose whether to receive data
from geneticists about their future health, such as a previously unknown
predisposition to cancer. This right is enshrined in UNESCO鈥檚 Universal
Declaration on the Human Genome and Human Rights, to be adopted by the UN itself
next week. Jon Johanes Jonsson, director of clinical biochemistry at the
National University Hospital of Iceland, echoes this concern: 鈥淚f it鈥檚 coded
[rather than anonymous], you have obligations towards the patient.鈥�
Stef谩nsson says these are issues not for deCode, but for the Icelandic
Health Ministry, which must decide whether to act on new information. 鈥淲hat we
are doing in the database is to discover basic knowledge. It will be the
duty of the healthcare system [to decide] how to deal with it.鈥�
But all these criticisms have hardened opposition to the plan abroad. 鈥淭he
scientific community of the world will not sit idly by without making a
considerable protest,鈥� says Lewontin, who is drafting a letter of complaint to
the Icelandic government on behalf of the US Council for Responsible Genetics, a
coalition of geneticists. He warns of a possible boycott of scientific
cooperation with Iceland if the bill is passed.
The EU鈥檚 data commissioners appear to be slightly happier with later versions
of the bill, although they are reserving their final judgement until it is
passed. Iceland is incorporating the EU directive on data protection into
domestic law next year, so in theory the commissioners could prosecute
Reykjav铆k for any breaches.
In Iceland, doctors, geneticists and academics are leading the opposition.
Doctors wield considerable power as it is they who will feed information about
patients into the database. 鈥淲e鈥檝e said this bill won鈥檛 work unless there鈥檚 an
agreement with the doctors,鈥� says Gudmundur Bjornsson, chairman of the Icelandic
Medical Association. 鈥淚t will be stillborn.鈥�
Yet with a huge majority of MPs in favour, the bill is almost certain to be
passed. And Stef谩nsson says he has evidence from opinion polls that only
1 in 10 Icelanders opposes it. But others are unconvinced. 鈥淚鈥檓 sure we will see
an international backlash against genetics, the scientific community will
respond aggressively and there will be a great many protests,鈥� warns Hauksson.