This doctoral thesis examines how the coexistence of the Council of Europe and the EU
influences rules on direct-to-consumer genetic testing, as well as how these influences
reflect on individual states that are simultaneously bound to both of the legal orders of
interest.
Through the lens of legal pluralism and state sovereignty this research examines the
competence 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 service
and data protection requirements), and examines the obligations these two legal orders
place on the Member States of the EU. This research traces the avenues for coexistence
between the legal orders in relation to direct-to-consumer genetic testing, and examines
how the coexistence of the Council of Europe and the EU is reflected in the legal framework
that 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 to
the 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 limits
between the ‘Council of Europe law’ and the ‘EU law’ in these areas. The Council of Europe
by aligning its laws with the EU creates far-reaching implications to the states that
are 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 interaction
between the Council of Europe and the EU make the legal sources challenging to interpret
and foresee as a result the principle of legal certainty could be undermined. In the
absence of formalized interaction between the two legal orders, interpretation difficulties
could create further challenges.
Stockholm: Jure, 2016. , s. 374
direct-to-consumer genetic testing, legal pluralism, state sovereignty, coexistence, privacy, consent, technical performance, utility