Alert from Iceland

From Petur Hauksson, Gedhjalp Mental Health Alliance, 2 December 1998

The Icelandic government is with great haste rushing a bill through parliament that proposes a whole-population database of health information. We need your help to stop this violation of users' rights.

The bill, introduced at the initiative of the genomics company deCode Genetics Inc., would allow the Ministry of Health to license a company to compile a database containing medical records of all Icelanders, together with genetic and genealogical information. The bill allows the licensee exclusive rights to the commercial exploitation of the data for 12 years.

The exact purpose of the database has never been made very clear. According to the company's recent non-confidential corporate summary, the applications would include research into hereditary diseases and thus enable deCode's clients, who will be mainly drug companies, to develop and test new products. Insurance companies are also mentioned as possible clients. A number of secondary uses are envisaged, such as providing management information to the health service.

The main concerns can be summarized as follows:

a) Consent and ethical review. The bill allows only for people to opt out of the database but not to give any other form of consent. At the same time there is to be little ethical or scientific review of the applications, commercial or scientific, that the licensee may make of the data. This is in violation of accepted norms for the use of personal data.

b) Confidentiality and privacy. The bill designates the database as anonymous but legal experts have pointed out that the database as described in the bill consists of personal information, which, though de-identified by encryption of names, will not be anonymous. This would mean that physicians who pass information about their patients to the database would be in violation of medical ethics.

c) Monopoly and scientific openness. The bill allows a single company monopoly control over an essential scientific resource. As such it endangers freedom of scientific research as well as freedom to engage in commerce. deCode will control virtually all the information which is needed for human genetics research in Iceland. The monopoly control of data is thought to be the main objective of deCode in sponsoring the database bill and their policy was referred to in an editorial in the October issue of Nature Genetics as collaborate or die. The Science Faculty of the University of Iceland has adopted a strongly worded resolution condemning these provisions of the bill.

The Icelandic Mental Health Alliance (Gedhjalp), an advocacy group, opposes the bill because consent will not be sought from each individual and the rights of children and others who cannot opt out (i.e. the severely mentally ill) are not protected. The strange concept of presumed consent is used in the bill; those who do not opt out are considered as having consented to the firm's genetic research on personal health information. There will be no rules about how information about the dead may be used.

We have demanded that free and informed consent be obtained from every individual before he or she is registrered in the database. We have also requested legislation protecting personal information and a law prohibiting discrimination on the grounds of a genetic probability of disease.

The Icelandic Association for Ethical Science (Mannvernd), was started in order to focus opposition to the data-base bill. For more information on the bill, other organizations' standpoints and science magazines' writings about the bill, please refer to the English-language website at:

http://www.simnet.is/mannvernd/english/index.html

HOW YOU CAN HELP NOW—E-MAIL OR FAX OR WRITE:

You can help us by writing a polite letter of concern to the Icelandic prime minister and health minister (and a copy to us if possible, please).

Below is a suggested letter. Please write a letter, postcard, fax or E-mail that reflects your own views.

Mr. David Oddsson, Prime Minister
Stjornarradshusinu,
Laekjartorgi,
Reykjavik,
Iceland

E-mail: postur@for.stjr.is
FAX: +354 562 4014

Dear sir

We are seriously concerned about the proposed bill on a health-sector database in Iceland. Specifically we feel that informed consent should be sought from each participant before he or she is registered in the database and the information is used for research.

Also the proposed licensing of the database to a private company is worrisome, as it implies a scientific and commercial monopoly on health information.

We understand that Iceland does not have a law that protects individuals from discrimination and misuse of genetic information. It is advisible to prepare such a legislation before the database is formed.

Please reconsider your plans for a health-sector database legislsation.

Yours respectfully,

The same letter should be sent to:

Ms. Ingibjorg Palmadottir, Minister of Health
Heilbrigdismalaraduneyti,
Laugavegi 116,
Reykjavik,
Iceland

E-mail: postur@htr.stjr.is
Fax: +354 551 9165

We are extremely grateful for any help and participation in preventing this infringement of users' rights.

Yours sincerely,
Petur Hauksson,
Gedhjalp, Mental Health Alliance
Tryggvagotu 9
101 Reykjavik
Iceland

E-mail: gedhalp@isholf.is
Tel: +354 552 5990
Fax: +354 552 5029