Biology Reference
In-Depth Information
biosamples from patients (with some sort of informed consent given) and the sec-
ond by collating public genealogical records. The Health Sector Database, how-
ever, was more difficult, because the company would need access to confidential
medical records. Therefore deCODE proposed new legislation which would allow
the construction of the database with an exclusive operating licence granted to an
unnamed company (which would naturally be deCODE).
The Act on a Health Sector Database (No. 139/1998) was passed by the
Icelandic parliament on 17 December 1998, after extensive debate in parliament
and society at large, and in the face of immense opposition from doctors, scientists
and the organized opposition group Mannvernd (although the majority of the pub-
lic supported deCODE and the Act).
3
The most controversial aspect of the Act was
the implied 'presumed consent'. Data relating to individuals would be included in
the database on the assumption that they did not object. Those who did not want to
take part would have to make this wish explicit and opt out. Many physicians were
reluctant to cooperate with deCODE and give the company access to the medical
records of their patients. The Icelandic Medical Association was also opposed to
the Health Sector Database, and received support from the World Medical
Association regarding its concern about the ethical issues, in particular those relat-
ing to consent, and the standard requirement that research participants should be
able to withdraw their participation.
In January 2000, despite the protests, deCODE genetics was granted an exclusive
operating licence for the Health Sector Database for 12 years, and a separate agreement
was concluded between deCODE and the Minister of Health that the company would
pay the state an annual fee of 70 million kr. (close to
€
1 million at the time) for its
licence, as well as 6% of profits, up to a maximum amount equivalent to the annual
fee.
4
In addition, deCODE was to pay all costs incurred by the database, such as those
of the monitoring institutions. The annual fee and share of profits was to be used for the
health care system and for research, and can be considered benefit sharing. Interestingly,
this falls within the (non-binding) benefit-sharing recommendations of the Human
Genome Organisation (HUGO) Ethics Committee Statement on Benefit Sharing, which
suggests that in the case of profit-making endeavours, the general distribution of bene-
fits should be the donation of a percentage (recommendation 6 suggests 1%-3%) of the
3
Mannvernd
means literally 'human protection'. Although Mannvernd calls itself, in its full
name, the 'Association of Icelanders for Ethics in Science and Medicine', it is specifically the
'organized opposition to the Icelandic government's Act on a Health Sector Database', according
to its website (
http://www.mannvernd.is
). Its members are primarily medical doctors, scientists
and academics. Mannvernd and its individual members were highly active and visible during the
parliamentary debates on the Health Sector Database Act in 1998 and, to a lesser extent, during
the following three or four years, as the association encouraged people to opt out of the database.
4
'Samkomulag á milli heilbrigðis- og tryggingamálaráðherra og Íslenskrar erfðagreiningar
ehf. í tengslum við útgáfu rekstrarleyfis til gerðar og starfrækslu gagnagrunns á heilbrgiðissviði'
[Agreement between the Minister of Health and Insurance and Íslensk erfðagreining (deCODE)
in relation to a licence to operate a health sector database], signed 21 January 2000 by the
Minister of Health, Ingibjörg Pálmadóttir, and Kári Stefánsson, CEO of deCODE genetics Inc.
Available (in Icelandic only) at
http://www.mbl.is/serefni/decode/
(see articles 4 and 6).
