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only vague general references to sharing the benefits of genetic research so that
they are available to all. 8 UNESCO's Universal Declaration on Bioethics and
Human Rights, adopted by the General Conference of UNESCO at its 33rd session
on 19 October 2005, also applies to this case, but again it is vague on the sharing
of benefits 'with society as a whole and within the international community'
through any of a number of generalized forms, the most relevant of which in this
case are the 'provision of new diagnostic and therapeutic modalities or products
stemming from research' and 'access to scientific and technological knowledge'. 9
Although the database itself never materialized, the case of the Icelandic data-
base is significant from the perspective of benefit sharing. Benefit sharing was
barely an issue at all in the debates and discussions in Iceland, but two specific
benefit-sharing agreements were negotiated: one between deCODE and Roche for
free pharmaceutical and diagnostic products for the Icelandic population, and the
other between deCODE and the Ministry of Health as part of the operating licence.
There is no requirement for benefit sharing of any kind in the Act on a Health
Sector Database, but article 4 implicitly leaves benefit sharing to negotiations with
the licensee: 'The minister [of health] and licensee may agree on further payments
to the Treasury, which shall be devoted to promoting the health service, research
and development' (Icelandic Parliament 1998 : article 4). The Icelandic popula-
tion was expected to enjoy various other indirect benefits as a result of deCODE's
operations in Iceland and the database in particular. These included economic ben-
efits, jobs created in the biotechnology sector, an improved research environment
for genetics and medicine in Iceland, and attracting talented Icelandic scientists
back home from abroad. And, of course, Icelanders expected to have access to the
medications resulting from the research through the national health service.
Given that Iceland is, notwithstanding its recent economic crisis, a wealthy
Western nation, with universal health care coverage providing heavily subsidized
or free medication to citizens, it is perhaps surprising that deCODE negotiated
benefit sharing at all for the Icelandic population. One possible explanation for
Roche's generosity is the fact that deCODE's database would allow it to track the
use of Roche's free products in Iceland, and closely monitor their effectiveness
and reported side effects in a population that, in most cases, would be consider-
ably larger and easier to manage and monitor than those available for post-market-
ing (Phase IV) trials. deCODE wanted to create 'a totally informative population
with which … to model both disease and host - drug interactions ' (emphasis added)
(Gulcher and Stefánsson 1998 : 526). In this context, the promise of free drugs was
criticized, although it aligns with the requirements of the Declaration of Helsinki
8 'Benefits from advances in biology, genetics and medicine, concerning the human genome,
shall be made available to all, with due regard for the dignity and human rights of each individ-
ual' (UNESCO 1997 : article 12(a)). '[D]eveloping countries [should] benefit from the achieve-
ments of scientific and technological research so that their use in favour of economic and social
progress can be to the benefit of all' (UNESCO 1997 : article 19(a)(iii)).
9 UNESCO ( 2005 ), article 15, specifies examples of sharing benefits of scientific research in
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