Centre for Research Ethics & Bioethics (CRB)

LifeGene: Case closed?

2014-09-15

The LifeGene project has been heavily discussed among biobank researchers in the last couple of years.  The project gave rise to a number of both scientific and legal matters.

The Swedish Data Inspection Board decided that the project was unlawful in December 2011, and that LifeGene didn’t comply with Swedish or European law. I have already commented on the new Swedish law and how it applies to cases like LifeGene in a previous newsletter. Since then, the Administrative Court of Stockholm ruled against the Data Inspection Board. The Court found that LifeGene, with the new law in place, now is a lawful research project.

The appeal was filed in january 2012 by Karolinska institutet, formally responsible for the project. The Court gave its ruling more than two years later on May 19, 2014. The Data Inspection Board had argued that LifeGene was in violation of the Personal Data Act (Sections 9, 10 and 15) and did not respect that personal information only can be collected for specific and lawful purposes and if the registered person has consented.

Since Swedish administrative law states that the act in force at the time of the ruling should be applied, the Court decided to apply the new act to the LifeGene appeal. According to the Court it is clear from the act and its ordinance that Karolinska Institutet has mandate to process personal information in the LifeGene register according to the purpose stated in the law.
Not surprisingly, the Court considers that the purpose is specific enough. Since the participants have been informed and then consented to processing personal information, in accordance with the criteria in the law, the Court is of the opinion that the decision taken by the Data Inspection Board no longer is valid. We can conclude that the LifeGene case is closed, at least for now. From a legal point of view, there are questions that remain unanswered. The Court did not analyze if and how the Swedish national legislation respects European law, especially fundamental rights in EU law.

One could also question how informed consent can be considered valid in a situation where the legislation that applies to the consent is enacted more than one year after the decision is taken. Another matter worthy of a discussion is how principles of national administrative law can be united with other demands of rule of law, such as legitimate expectations and foreseeability. These are important for the nation state and the public sphere to function, but also for the realization of individual’s rights.

By Anna-Sara Lind

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