Fundamental Disjunctions in the EU Legal Order on Human Tissue, Cells & Advanced Regenerative Therapies.

Abstract

The unprecedented expansion of EU controls on biological materials under the aegis of the EU’s expanding remit on public health has caused a major reshaping of the regulatory landscape of the life-sciences in Member States. This article analyzes the challenges to national and supranational legal orders posed by the integration of ethical norms within the EU Human Tissue and Cells Directive 2004/23/EC and the Advanced Therapies Regulation (EC) 1394/2007. We show how the infiltration of substantive moral norms in morally contested fields of biotechnology is facilitated by the incorporation into the EU legislative texts of fundamental norms such as respect for human dignity contained in the EU Charter of Fundamental Rights and the Council of Europe’s Convention on Human Rights and Biomedicine. The first part of the article sets out the constitutional and normative challenges posed by the EU legislative intervention on ethical matters in the field of health and new biotechnologies. The second part examines the substantive content of the integrated fundamental norms highlighting their open-ended and indeterminate character and the areas of overlap and disjunction. The third part introduces an analytical matrix which is deployed to analyze the reach of fundamental norms in shaping the more specific ethical controls in the legislative texts and reveals how the mix of technical and evaluative norms resolves the ethical and constitutional tensions in the EU texts.