In the light of current European Regulations, both on emerging technologies and on new medicines, a whole life cycle regulatory approach towards products is suitable. Following this perspective, it is increasingly necessary to investigate in advance both the applicable ex ante regulations, in order to manage risks for humans and ex post protection approaches for those injured by innovative medical products. This essay describes the main liability issues connected to the new personalised therapies. The liability issues emerge on a two-fold profile. The first issue deals with the allocation of liability for potential damage consequent to a hybrid sale-service transaction. The complex nature of this transaction is, in fact, typical of drug lifecycle management (prescription, preparation, use, etc). The second issue pertains to the examination of the essential elements of the facti specie of damage within the condition of intrinsic techno-scientific uncertainty. Unavoidably, this condition characterises personalised medicine, because of a lack of clinical expertise.
