Legal issues surrounding French research-focused biobanks.

Abstract

The French law does not name them expressly under this word; nevertheless the legislator provided them recently with a relatively interconnected legal framework. On one hand, the technical specific rules related to the activities of biobanks (on which conditions a biobank can be established, on which conditions samples can be given thereto). On the other hand, there is an application to biobanks of the big principles of "French-style" bioethics: 'non property' principle, informed consent and data confidentiality principles. We shall show that in so doing, the French legislator grasped and answered the main part of the questions raised and so paved the way for a sustained acitivity of biobanks in France. In spite of this dense legal framework, the law has not anticipated at present all the questions arising from the practice of biobanks, notably the rights of the donors such as an on-going control on the use of biological material and associated data they gave for research purposes, as well as researchers' right to access biobanks and current issues related to ownership. We shall thus discover the French legal framework for biobanks used for research purposes. Then we shall try to clear issues remaining unresolved.