SIENNA D2.2 Analysis of the legal and human rights requirements for genomics in and outside the EU

This report examines how the law currently responds to challenges in the area of genetics and genomics, and identifies the challenges, limitations and gaps that emerge.It also identifies key human rights norms and regulatory approaches that could be examined further for shaping legal responses to the new and emerging technology in the area with due regard to competences and authority of various actors regulating/contributing to the shaping the regulatory environment in the area. It analyses the ethical concerns, scrutinizes the legal and human rights responses in the area of genomics at the international and regional human rights legal orders, and the EU; carries out comparative analysis in selected EU Member States and non-EU countries, and surveys the legal responses, academic legal discussions and legal developments in the areas of concern; examines national comparative perspectives against the international and regional norms and human rights standards; identifies key human rights and legal challenges that emerge regarding genetics and genomics and shows the convergences and distinctions in the regulation of genomics and the challenges this presents for future innovation.