“Genetic research on human biological samples (HBS). Old and new challenges for public and private law”

Human biological samples constitute a precious source of genetic information for researchers looking to develop new treatments, diagnosis methods, or products to be sold on the market. The use of HBS in genetic research raises an innumerable amount of (bio)ethical and legal issues, including the requirements for the validity of the consent of the donor of the sample; the adequate level of protection of the personal data associated to it; and how to balance the different interests on the sample (personal, familiar and societal) and the protection of the fundamental rights of the sample donor. Furthermore, several different actors play a role in in the use of HBS (e.g. donors, hospitals, pharmaceutical companies, and universities, research ethics committees). Which law should govern these dissimilar issues and actors? This paper investigates to what extent the traditional public and private law instruments are enough to provide an answer to the issues raised by genetic research on HBS.