Læknablaðið - 15.05.1999, Blaðsíða 58

440
LÆKNABLAÐIÐ 1999; 85
Mr. President
We have been informed that
the Icelandic Act on a Health
Sector Database might be taken
up for discussion in the Medical
Ethics Committee at the 153rd
WMA Council Session in San-
tiago, Chile 15-18 April 1999.
We welcome this as we have
called for an extensive discussion
of the relevant issues both during
the preparation of the bill and
also after its adoption by the Par-
liament. However, we are con-
cerned about the quality of the
information that your members
might receive on the Act as we
are aware that a number of mis-
conceptions regarding the legis-
lation has already formed the
opinion of many in the intema-
tional medical community. Un-
fortunately, these misconceptions
at times are based on misinfor-
mation.
In order to make sure that this
will not be the case at your dis-
tinguished meeting, this Ministry
offers you any assistance within
its capacity to ensure that your
deliberations, should they occur,
would be based on correct infor-
mation. We therefore invite you
to submit questions to us and to
visit our homepage, or to inform
us if you would like to receive an
information packet on this legis-
lation. Furthermore, we are wil-
ling to send a representative from
this Ministry to be available to
you during your meeting for fur-
ther clarification of those matters
that you might consider impor-
tant.
Clearly, a response to that
offer at your earliest convenience
would be appreciated, as travel
arrangements need to be made.
We would like to use this op-
portunity to review the most im-
portant facts about the Icelandic
Act on a Health Sector Database:
The Act was passed in the Ice-
landic Parliament in December
1998 following a thorough dis-
cussion both among the public
and in Parliament. It passed with
great majority in Parliament and
in polls among the public 75% of
those taking position were in
favour of the Act.
The proposed database is not
unique. There are centralized
databases with health care data in
various countries, and with very
different levels of security of
data. We believe that our data-
base will be of a very high quality
containing important information
for research and also regarding
protection of personal data. In
fact, a number of our precautions
regarding protection are unique
and will hopefully pave the way
for future databases. Granting a
license to operate a health data-
base to a third party is not unique
to Iceland as there exists of
course thousands of databases
worldwide run by private com-
panies. The Cancer Registry of
this country and a database of the
Icelandic Heart Preventive As-
sociation have been run by third
party organizations for decades.
The difference might be that
those are non-profit organiza-
tions but the amount of funding
and financial risk involved in the
proposed database is so large that
it is unlikely that a non-profit
organization would be willing to
undertake the venture. Such
organizations will not be exclu-
ded from consideration as pos-
sible licensees and the operating
license will be granted following
a public advertisement and dis-
cussions with organizations wil-
ling and capable of undertaking
the organization and the running
of a centralized health care data-
base.
No health care data will be
copied and transferred to the
database without prior consul-
tation with the physicians in-
volved. Physicians in public
health care institutions will not
be able to veto the transfer but
physicians in private practice can
do so.
Each person can veto the trans-
fer of his/her own health care
information to the database. This
method of respecting personal
autonomy was chosen after care-
ful consideration and consulta-
tion with clinicians and ethicists
as more appropriate than infor-
med consent under those circum-
stances, i.e. large scale epidemio-
logical research with non-identi-
fiable personal data. The broad
purpose of the database makes in-
formed consent very difficult to
administer and its adoption
would have far-reaching effects
on epidemiological research.
Mr. President.
We sincerely hope that the dis-
cussion on the proposed Icelandic
database will be balanced and
based on the correct information
from Iceland, should you decide
to put it on your agenda.
The contact persons in the
Ministry regarding this are:
Mr. Thorir Haraldsson
Special Advisor to the Minister
of Health and Social Security
Mr. Sveinn Magnusson M.D.
Chief of Office for Health Care
Institutions
Mrs. Ragnheiður Haraldsdottir,
M.Sc. R.N.
Deputy Secretary General
All are at the
Ministry of Health and Social
Security
Laugavegur116
150 Reykjavik
Iceland
We would like to take this
opportunity to wish you all the
best for your conference in Chile
as we reiterate our offer of any
assistance of ours that you deem
appropriate and necessary.
O.b.m.
Ragnheiður Haraldsdottir
Thorir Haraldsson