La donazione dei materiali biologici umani ai fini della ricerca biomedica nell'ambito del diritto internazionale e del diritto dell'Unione Europea

The purpose of the thesis is to explore the international legal framework addressing human biological materials and biomedical research. Chapter I aims at contextualizing the reflection, by primarily focusing on a biological and a medical premise concerning the scientific issues related to human biological materials. In this sense, it is stressed that the DNA contained in human biological materials represents their main feature, which characterizes them both biologically and legally. In this regard, the main scientific implications for biomedical research are taken into consideration, in order to explain the peculiar importance of human biological materials for science and for biomedical research. After delving into the issues related to self-ownership and the dichotomy between the physical and the spiritual dimensions that affect the human body as a whole and its separated parts, the thesis explores the tripartite conception of the status of human biological materials, which distinguishes between the material, the informational and the human dimension. This tripartite conception of the status of human biological materials constitutes the background against which the main approaches developed in the common law and civil law systems are assessed, with specific reference to such landmark decisions as: Moore v. Regents of University of California; Greenberg v. Miami Children's Hospital; Washington University v. Catalona. Italy, Spain, France and Germany have represented the reference legal orders for analysing emblematic civil law systems, especially in relation to the juxtaposition of the legal paradigms respectively embraced. Chapter II delves into the responses that the international legal order and European Union law (EU law) have offered in relation to human biological materials and biomedical research. The focus is set, at the global level, on the experience of the UNESCO and, at the regional level, on the Council of Europe and on the European Union. In this respect, special emphasis is put on the most significant instruments that have been adopted so far, in particular: the Universal Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data and the Universal Declaration on Bioethics and Human Rights, adopted by the UNESCO; the European Convention on Biomedicine and Human Rights and its Additional Protocol, as well as Recommendation Rec (2016) 6, in relation to the Council of Europe. Finally; finally, with regard to the legal order of the European Union, in light of the architecture of the Treaties, special attention is given to the Charter of Fundamental Right of the European Union, Directive 98/44/EC, Directive 2004/23/EC and the General Regulation on Personal Data. Again, the relevant jurisprudence of the European Court of Human Rights and of the European Court of Justice is taken into account, despite the issues related to human biological materials and their donation to biomedical research have never been addressed as such. Chapter III analyses the international framework related to biobanks and biomedical research for the purpose of advancing some proposals, in order to clarify how the international legal order has tried to tackle the need to ensure an appropriate approach to human biological materials from a perspective of equal and fair access. The reflection is framed in terms of human rights. In this regard, in particular, the right to science or to enjoy the benefits of scientific progress is used as a helpful paradigm for the reflection, and the issues related to access are taken into consideration from the viewpoint of the noyau dur of the right to health. Finally, several proposals are advanced, in particular the adoption of a “strong” soft law instrument, consistent with the new gradual normativity that is gaining ground in international law as a response to the current treaty fatigue.