Biology Reference
In-Depth Information
net profits (after taxes) to the health care infrastructure or for vaccines, tests, drugs and
treatments, or to local, national and international humanitarian efforts (HUGO Ethics
Committee
2000b
).
However, to date the Health Sector Database has not materialized, because the
Icelandic Supreme Court stopped its development. In 2003, the court came to the
conclusion that the Act on a Health Sector Database violated the Icelandic constitu-
tion by not sufficiently protecting the right to privacy.
5
By ruling that the Act was in
conflict with the constitution, the judgment declared invalid the legal framework for
deCODE's plans to collect data from medical records in a centralized database. There
had already been signs that deCODE had lost interest in constructing its database: in
November 2002 deCODE had indefinitely postponed relevant negotiations with
Iceland's largest hospital, the National University Hospital (Sigurdsson
2003
). With
the Supreme Court's decision it became clear that the database would most likely
never be established. No attempt was made by deCODE or the government to revise
the legal framework to remove the conflict with the constitution. If there had been any
interest in reviving the project, such a revision would certainly have been feasible.
Nevertheless, deCODE continued to conduct genetic studies within the
Icelandic population, and it did meet some research milestones set in its first
agreement with Roche, though at a considerable financial loss.
6
The failure to
make a profit caused financial difficulties for deCODE, aggravated by the fact that
their operating funds had been handled by Lehman Brothers, a bank that lost sub-
stantial funds in failed investments. By November 2008 deCODE was practically
bankrupt. The Icelandic government was unable to provide support, as it was also
struggling financially, following the collapse of Iceland's main banks. A year later,
in November 2009, deCODE filed for bankruptcy protection and started liquidat-
ing its assets. deCODE's key operating subsidiary, Íslensk erfðagreining, was sold
to a group of investors, but it is still operating under the name of deCODE genet-
ics, and, although the company has a new CEO, Kári Stefánsson remains on board
as executive chairman and president of research (Carmichael
2010
).
There are few international laws or regulations, if any, that apply to the
Icelandic database. The CBD and the Bonn Guidelines exclude human genetic
resources, as noted at the outset (Bonn Guidelines
2002
). UNESCO's Universal
Declaration on the Human Genome and Human Rights, adopted by the General
Conference of UNESCO at its 29th session on 11 November 1997, does apply, in
particular via a range of clear statements regarding informed consent,
7
but includes
5
It decided in the case of
Gudmundsdóttir v. the State of Iceland
(No. 151/2003), that the daugh-
ter of a deceased man could prevent his health information from being entered into the Health
Sector Database. For a good analysis of the judgment, see Gertz (
2004
).
6
Apparently deCODE only received US$74.3 million out of the expected US$200 million (see
Sigurdsson
2003
).
7
For example: 'In all cases, the prior, free and informed consent of the person concerned shall
be obtained. If the latter is not in a position to consent, consent or authorization shall be obtained
in the manner prescribed by law, guided by the person's best interest' (UNESCO
1997
: article
5(b)).
