Munich

The Icelandic Medical Association (IMA) has failed to reach agreement with the genomics company deCODE Genetics over Iceland's new national health sector database, which is to be run by the company. The dispute centres over the plan for automatic inclusion of patients' health records in the anonymized database.

Opponents are concerned that deCODE, which launched itself on the Nasdaq stock exchange last month, is painting an excessively optimistic picture of the conflict to shareholders.

It's the law: Iceland's parliament (above) has approved ‘presumed consent’. Credit: WOLFGANG KAEHLER/CORBIS

The new system will collect and store information from the Icelandic health service. Under the present rules, patients would be presumed to have given their consent to inclusion even if they had not been consulted.

The Icelandic government approved plans for the database in 1998. In January this year it granted deCODE a 12-year licence to operate the database and market — in encrypted form — the information it contains together with the company's own genomics data of the Icelandic population.

A law passed in 1998 requires health records to go into the database unless an individual actively opts out. But the IMA insists that transfer should be based on informed, rather than presumed, consent — the issue should be discussed with each patient.

Six months ago, the two sides embarked on discussions to resolve the issue. But compromise has proved impossible, and a joint press release was issued last week reporting that talks “had been concluded”.

The IMA is upset that deCODE has issued an English translation of the press release — now posted on the Nasdaq website — giving a more positive slant to the discussions than the Icelandic original had. The Icelandic release, for example, says that the talks “covered the content and have been to the point”, whereas deCODE's English version says the discussions “have been both positive and productive”.

Sigurbjörn Sveinsson, chairman of the IMA, says that deCODE “did not seek our approval of their English version, and there is obvious inconsistency in the two versions”.

But Kári Stefánsson, deCODE's chief executive officer, says the company does not need the IMA's approval to proceed with the database on the basis of presumed consent. “The law is quite clear,” he says, adding that he is still keen to make peace with the IMA.

Most Icelandic doctors oppose presumed consent, and many say they will not hand over records that are not already in hospital databases. “I don't feel comfortable with handing over data when we don't know how it will be used in the future,” says Sigurdur Björnsson, an oncologist on the IMA board.

Stefánsson says that only a few records remain outside public institutions, and the project does not require support from all the doctors, as the database does not need to represent 100% of the population to be useful.

http://www.decode.com

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