Enhancing EU legal frameworks for genetics & genomics research SIENNA project Policy Brief #2

The existing EU legal frameworks (e.g., clinical trials and advanced therapy medicinal products, data protection, in vitro diagnostic medical devices, medical devices, and fundamental rights) are relevant for regulating human genomic technologies and should be able to cope with many of the challenges that they pose. However, SIENNA research has identified various gaps and challenges that must be addressed in order to ensure ethical and human rights respectful design, development, deployment, and use of genomic technologies and to further the right to enjoy the benefits of scientific progress and its applications. This brief presents some of the urgent actions required and recommendations for the European Union institutions, and the Member States.

Who is this for?

European Parliament, European Council and Council of the European Union, the European Commission, Medical Device Coordination Group, European Data Protection Board and European Data Protection Supervisor, EU Member States.