Læknablaðið - 15.06.1999, Page 58

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LÆKNABLAÐIÐ 1999; 85
ment available for genetic re-
search early on, the research
community has had a long and
successful history of collabo-
rations with international re-
search teams.
Databases, such as the Can-
cer Registry and the Icelandic
Heart Association’s databases,
have been constructed by
various Icelandic institutions.
Regulatory agencies such
as the National Bioethics Com-
mittee and the Data Protection
Committee, were established
in order to assure that ethical
research standards were fol-
lowed.
deCODE Genetics
Founded in Delaware in
1996 by US venture capitalists
and several Icelandic scien-
tists, deCODE Genetics is the
corporation that initiated the
HSD. deCODE Genetics is
also the corporation that most
likely will be granted the
exclusive license to the HSD.
With the goal to use population
genetics to map and clone
genes responsible for several
common polygenic diseases,
deCODE has published an ex-
tensive list of diseases current-
ly being researched.
Several weeks before the
fírst HSD bill was introduced
deCODE Genetics signed a
200 million USD contract with
Hoffman-La Roche, a Swiss
pharmaceutical corporation.
The details of this contract
have not been made public.
Recently, deCODE Genetics
announced plans to go public
upon receiving the exclusive
license to the HSD. The price
of a limited number of de-
CODE shares, already traded
in Iceland, has correlated with
the passing of the Act on a
Health Sector Database.
Health Sector Database
Act Announced
In March 1998, the Minis-
try of Health introduced a bill
in Parliament for the creation
of a Health Sector Database
(HSD). The database was
meant to be a comprehensive
retrospective and prospective
collection of medical records
of the entire population of Ice-
land. Everyone would be in-
cluded. There would be no in-
formed consent and no provi-
sions for opting-out. A mono-
poly was to be granted to a
single corporation.
With no provisions to opt-
out and the lack of informed
consent, the bill was seen as a
violation to human rights.
Granting a monopoly of gene-
tic research was seen as a
serious threat to the research
community. The Bill met with
heavy opposition and was
withdrawn.
In June 1998, a new version
of a bill was circulated for re-
view. In October 1998 after
amendments that included an
opting-out clause, the Minis-
try of Health reintroduced a
third version of the bill. Again
the bill met with heavy oppo-
sition.
Despite this, the HSD was,
in December 1998, voted into
law. The vote was along poli-
tical party lines with only one
member of the coalition
government voting against it.
The Act still contains a provi-
sion granting a monopoly to a
privately funded company for
the creation and the commer-
cial use of the database; lack
of informed consent presides;
and the all-inclusive database
is legally permitted to link
medical records with genea-
logical and genetic data.
The Icelandic Medical As-
sociation recognizes the
scientific value of databases
containing health information
and biological samples. While
the IMA supports the use of
databases in research, the Act
on a Health Sector Database
violates basic principles es-
tablished to allow the use of
these resources and at the
same time uphold patient’s
autonomy and dignity.
Specifically the IMA
objects to:
1) Invasion of privacy
The sheer amount of data
gathered in one place with
flawed control mechanisms is
a great threat to personal pri-
vacy.
The HSD Law seriously
conflicts with medical data
protection principals. The data
in the database is encrypted
but not anonymous, with a key
available to connect names to
the coded information. This
key will be used routinely to
add information about indivi-
duals to the database.
According to the Act,
health data can be connected
to genealogical and genetic
data and this changes the
nature of an already extremely
extensive database. The Act
specifies that the licensee
shall make methods of work
and procedures for the inter-
connecting of these three
databases. Each connection
will, however, not be indepen-
dently reviewed. Given the
definition of what constitutes
genetic data (Act. 3, item 7),
the extensive interconnection
of data from the three data-
bases means that individuals
will be personally identi-
fiable. When invasion of pri-
vacy becomes an issue,