European Legal Perspectives on Health-Related Direct-to-Consumer Genetic Testing

Sammanfattning: This doctoral thesis examines how the coexistence of the Council of Europe and the EUinfluences rules on direct-to-consumer genetic testing, as well as how these influencesreflect on individual states that are simultaneously bound to both of the legal orders ofinterest.Through the lens of legal pluralism and state sovereignty this research examines thecompetence and authority of the Council of Europe and the EU to handle the market aspects(technical performance and utility) as well as privacy (consent to a medical serviceand data protection requirements), and examines the obligations these two legal ordersplace on the Member States of the EU. This research traces the avenues for coexistencebetween the legal orders in relation to direct-to-consumer genetic testing, and examineshow the coexistence of the Council of Europe and the EU is reflected in the legal frameworkthat is relevant to the regulation of direct-to-consumer genetic testing.It can be observed that the EU is soaking in the Council of Europe norms in some areas,as with valid consent to a medical intervention, but also exporting its own norms tothe Council of Europe in other areas, as with the area of data protection. Consequently,one can question whether it is increasingly becoming more difficult to draw clear limitsbetween the ‘Council of Europe law’ and the ‘EU law’ in these areas. The Council of Europeby aligning its laws with the EU creates far-reaching implications to the states thatare members of the Council of Europe but are not the Member States of the EU.This thesis claims that the resulting fragmented regulatory space and the interactionbetween the Council of Europe and the EU make the legal sources challenging to interpretand foresee as a result the principle of legal certainty could be undermined. In theabsence of formalized interaction between the two legal orders, interpretation difficultiescould create further challenges.

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