Legal Framework - Work package 4

The commercialization part of WP 4 analyzes which organisational and legislative choices biobanking may involve and whether publicly funded biobanks should engage in tech-transfer and the protection of research results through i.a. IPRs. Besides providing insights that will re-emerge in WP6, special emphasis will be laid on interconnecting WP4 with WP2 and WP3.In particular the WP will discuss the potential consequences of direct involvement in downstream IPRs for publicly funded biobanks and consider alternate policy choices to strike a balance between the interests of the different stakeholders. Thus the legal part will also discuss alternative strategies in response to IPR concerns, such as mechanism to prevent exclusive licensing (as required by most IPR holders), contract-obligations to return research results to the biobank and making optimal use of the research exemption. This will provide the basis for further investigations directed to e.g. new collaborative models of innovation such as public-private partnerships, open-source sharing or other new models for the commercialization and translational exploitation of biobanks. Thus, the analysis will discuss de lege ferenda possibilities based on the legal status quo, apart from traditional legal analysis to determine various choices under the present state of the law. To achieve a critical evaluation and analysis of the existing norms and institutions, this will also entail the use of comparative analysis to identify and discuss international variations in terms of the legal positions and justifications and the exploitation of a law & technology approach, in order to describe scientific developments and evaluate their impact on IPR protection and regulation of biobanking. This will i.a. involve discussions of how legal and scientific developments have contributed to the current “paradigm shift” in pharmaceutical R&D and how this in turn affects biobank-related debates and choices. This might also result in more specific discussions of topical issues, including the role that biobanks play in personalized medicine, developing treatments for orphan diseases or in other specific areas of translational exploitation.