Legal Aspects of Biobanking as Key Issues for Personalized Medicine & Translational Exploitation

Abstract

This perspective-article provides an overview on selected legal aspects of biobanking. It discusses these issues with a focus on public biobanks in a university setting and the specific challenges posed by personalized medicine (PM). We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs). .

Keywords: biobanks, law & ethics, intellectual property, informed consent, personalized medicine, open innovation, translational medicine