Legal Aspects of Biobanking for Personalized Medicine

Abstract and Introduction

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. 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 setup. 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.

Introduction

Biopharmaceutical innovation gaps, the gradual shift from closed to open innovation approaches, as well as rapid technological developments in, for example, synthetic biology, epigenetics and personalized medicine (PM), have highlighted the increasing importance of large-scale longitudinal biobanks. As biobanks are becoming an ever more important tool for translational and other research, an effective organization, transparent regulation and international cooperation between biobanks in different countries has become a crucial factor for enhancing innovation, competitiveness and public trust.

For these reasons it is hardly surprising that the importance of biobanks has been generally recognized: already in 2009 Time Magazine listed biobanking as one of the top ten ideas that are changing the world right now.^[1] Also, the European Commission recognized the sound governance of biobanks as one of the most important challenges for the European innovation system^[2] and the European Strategy Forum on Research Infrastructures has identified biobanks as one of the main priority research infrastructures for the European Research Area for the next 10–20 years.^[3,4]

The increasing significance of biobanks in an era of rapid advances in translational medicine requires substantial investments in the creation, organization and maintenance of biobanks and their collection of human biological material and associated data. This raises not only important organizational and ethical questions, but also legal questions of how to deal with intellectual property rights (IPRs) that might arise out of the creation or later use of such biobanks.^[5] It is therefore important to develop proper legal policies to achieve a reasonable balance between the different parties involved, such as biobanks, donors, researchers, universities and companies.

For these reasons new legal challenges related to biobanking have emerged where everyone who is involved in biobanking, including lawyers, needs to take account of not only different legislations but also different cultural and ethical traditions. At the same time the technological development is proceeding rapidly and brings new possible uses of the bio samples or data stored in biobanks. This poses additional difficulties as seen from a legal perspective.

This perspective article deals with the legal aspects of biobanking and points toward 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 and commercialization issues.

To this end, we start out by briefly defining the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. While this should motivate lawyers and others to carefully reflect over the appropriateness of the applicable legal and ethical framework, it would still need to be clarified in which atmosphere legal issues would have to be evaluated. The next part therefore describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. First, it makes sense to briefly sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and IPRs. After this, we use an ongoing 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 all those involved in biobanking and result in a transparent and 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.