Legal aspects of direct-to-consumer genetic testing


Regulating health services is challenging because of the multitude of legal questions it raises.  Not only do they relate to the quality of the service and protection of its users, but also to the competence and authority of actors involved. Here Santa Slokenberga, LLD, offers insights from her research on regulating direct-to-consumer genetic testing at the European level.

We live in a globalized world where several beyond-the-state actors have both the competence and authority to regulate direct-to-consumer genetic testing. This raises questions about the coexistence and interaction of these actors, and the effects this has on the national legal orders. I spent almost 5 years researching the regulatory challenges at the European level. My thesis examines how the Council of Europe and the EU interact through rules on direct-to-consumer genetic testing. I also studied the effect on the EU Member States’ competence and authority to protect individuals within their jurisdictions.

Santa Slokenberga, LLD

In my research, I trace how each of the legal orders regulate direct-to-consumer genetic testing. I also show how the Council of Europe and the EU use their law-making, interpretative and enforcement tools in order to accommodate the other legal order’s laws in their system. As a result, it is becoming increasingly difficult to draw clear lines between the ‘Council of Europe law’ and the ‘EU law’ in these areas, and to ascertain the Member States’ obligations in each of the legal orders. By aligning its laws with the EU, the Council of Europe also creates far-reaching implications on regulation in those Council of Europe member states that are not part of the EU.

The analysis demonstrates the challenging position held by national legal orders. They are required to navigate through a complex web of rules to ascertain if they have discretion to regulate direct-to-consumer genetic testing, and the extent to which they have this discretion. I argue that, in a way, direct-to-consumer testing can be seen as a form of ‘test’ to European legal orders. This test shows a need for formal cooperation and convergence also in matters that might seem small, but bring considerable consequences.

About the thesis: European Legal Perspectives on Health-Related Direct-to-Consumer Genetic Testing

By Santa Slokenberga

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