A Case Study: The Interdisciplinary UCPH 2016 Project on 'Global Genes – Local Concerns'
In order to illustrate some of the rights issues in more detail and the need for legal issues to be seen in context and through the eyes of all the stakeholders involved in a biobank project, we will in the following briefly describe a concrete and ongoing research project which we are currently involved in at UCPH. The project is currently in its startup phase but we think that it because of its design and the questions it asks may provide some inspiration on current challenges and how these could be addressed from a legal perspective.
The project combines legal, bioethical and social science perspectives with human genetic studies that involve patient material from different countries. Biological samples collected internationally, for example, in Pakistan and through an international patient organization will be genetically screened to identify candidate disease genes and study their function. Simultaneously, these models will serve as cases for studies of donor motivation, stakeholder attitudes/concerns and legal/commercialization issues to identify concrete barriers for cross-national biobank-based research and utilization of research results. We further address the schism between the international character of the cooperation and the territorial nature of the legislation. By the inclusion of Pakistan, where a high degree of illiteracy contradicts the general rule of written informed consent, we seek to address the specific challenges regarding the involvement of vulnerable populations. The involvement of patient support group(s) points toward a future paradigm shift where patients will increasingly interact directly with researchers across national boundaries.
The general aim of the project is to identify the interests, hopes and concerns of those involved in a concrete biobanking setup and to use the experiences from this to promulgate recommendations that will enable future biobanks to overcome regulatory and other barriers. The project will more specifically investigate the legal issues related to data protection associated with the transnational collection and collaboration raised by the project. Key questions to be addressed include legal dogmatic questions such as 'what laws apply when samples that are collected in one country are being used in another?' Is it for instance the Danish rules on 'informed consent' that apply or the Pakistani ones? And, can a consent obtained under the Pakistani rules be relied upon when the samples are being used in Denmark? One cannot expect to find the answer to such questions only in statues. Instead, one needs to look in a broader normative space consisting of values, basic legal principles and positive law. It is necessary to examine all of these to determine the legal question at hand, and as such this part must go beyond a mere analysis of statutory law and case law. The methodological challenge is to account for the differences in the local legal norms and values and the resulting plurality of both law and (legal) culture.
As far as the legal aspects of commercialization are concerned, the relevant questions are which organizational and legislative choices biobanking may involve and whether publicly funded biobanks should engage in tech-transfer and the protection of research results through IPRs or consider alternate policy choices to strike a balance between the interests of the different stakeholders. Such alternative strategies may be needed in part in response to the widespread concern that IPRs may be used to limit access to protected technology in overly restrictive ways and in part to take into account the specific interests associated with publicly funded universities. Responses to this could include mechanisms 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. Another and related aspect involves the use of new collaborative models of innovation such as public–private partnerships, 'crowd-sourcing' and open-source sharing or other new models for the commercialization and translational exploitation of biobanks. This will involve discussions of how legal and scientific developments contribute to the current 'paradigm shift' in pharmaceutical R&D and how this in turn affects biobank-related debates and choices and other relevant issues. This might also result in more specific discussions of topical issues, including the role that biobanks could play in developing orphan drugs and treatments against rare or neglected diseases.
The project in this way exemplifies a number of the general challenges modern biobanks face: it is international, involves different groups of stakeholders with various and sometimes competing interests and concerns, is research-oriented but with commercial possibilities and originates in a university setting. We hope to use the project to promulgate concrete recommendations that can be used in future, similar projects and which provide concrete, ethically and legally sound guidance in biobanking projects generally. The precise character of the recommendations will vary. They may take the form of questions that should be considered or how to develop local best practices (e.g., for compiling a questionnaire to be used by illiterate donors), and sometimes they may take the form of a 'standard contract' (e.g., a material transfer agreement) or provide general background information to be used in future rule- or decision making (e.g., on the different routes for applying for patents).
Personalized Medicine. 2014;11(5):497-508. © 2014 Future Medicine Ltd.