Paper on “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”

By Timo Minssen

I am pleased to announce that my co-author Professor Jens Schovsbo from the University of Copenhagen and I completed a paper addressing “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”.

This perspective article, which has been written upon request by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry.

To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by 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).

We will publish the paper on SSRN as soon as we receive the approval by “Personalized Medicine”. I’ll keep you posted.

UPDATE: The full paper is now available here.

Introducing Guest Blogger Timo Minssen

Timo Minssen is Associate Professor of IP & Innovation Law at the University of Copenhagen (UCPH), Centre for Information & Innovation Law (CIIR), Denmark. Before joining UCPH, Timo graduated from law school in Göttingen (Germany) in 2001 and was trained in the German court system from 2002-2003. He also passed the Swedish “juris licentiate” (LL.Lic.) and “juris doctor” exams (LL.D.) and holds two IP- and Biotech- related masters degrees from the Universities of Uppsala and Lund (Sweden). In addition he worked for a Life Science company and for various law firms in Sweden and Germany.

From 2007-2009 Timo was a stipendiary at the Max Planck Institute for Intellectual Property and Competition Law in Munich. He was also responsible for a course in comparative patent law at the Chicago-Kent College of Law (USA) and worked for the European Patent Office. At Lund University he was engaged as a teacher at the Faculty of Law and in interdisciplinary epigenetics research at the Pufendorf Institute for Advanced Studies. At UCPH he is co-leading CIIR’s Copenhagen Biotech & Pharma Forum and teaches international classes for both students and pharma professionals in EU-, Competition-, and Pharmaceutical Law and IPR. Timo is a frequent speaker on a variety of topics and has published extensively in comparative US and European patent law, EU- and Competition Law. In 2013-14, he will be a Visiting Scholar at the Petrie-Flom Center, and later at the University of Oxford.

See a full listing of Minssen’s research here.