As pointed out by Brownsword, lawyers need to be particularly careful when working out the regulatory environment for biobanks to avoid what he calls the 'mistake of legal exclusivity' (i.e., to assume that the only signals in the regulatory environment are formal legal signals) and the 'mistake of normative exclusivity' (i.e., to assume that the only signals in the environment are normative). As far as the more concrete legal choices are concerned, we also encourage lawyers to be mindful that the legal framework should not just concern 'rights' issues but also deal with the two other bottom lines identified by Brownsword, that is, the obligations to act as stewards for the agency commons to provide a supportive infrastructure for transactions and interactions between stakeholders, and to respect the participants' freedom to exercise their moral choice or moral responsibilities.
On the general level, we take these insights to indicate first that any decisions as to the design of the regulatory environment should take the form of a process that takes account of the values, hopes and concerns of all stakeholders involved. Second, we take from them that the legal environment should consist of a number of different elements, some of which are aimed at providing for legally binding rights and obligations while others take on a different form and are, for example, aimed at facilitating discussions or professional training.
More concretely, we stress the importance of defining a clear and adequate system for obtaining consent that provides flexibility but at the same time puts up roadblocks. From a legal perspective, one should expect to deal with issues ex post and for these reasons one should avoid relying on legal models that are static and inflexible, such as detailed consent obligations. Instead, legal solutions should be vested in institutions that are designed to adapt the relationships established, for example, through consent. Guiding principles for such endeavors should be the notion of 'dynamic consent' and the description of the shift in legal regulatory models from 'consent to institutions.' Moreover, any guidelines on informed consent in, for example, a PPP setting would also have to be practically realistic and feasible. If the industry is involved, such guidelines would also have to acknowledge and respect the competitive business environment in which the industry operates and that risky investments might require a certain degree of certainty. Only then the industry will be willing to agree to any elaborated consent regime with many far-reaching obligations. This indicates that any decisions on the applicable regime for informed consent will require intensive consultations between the involved parties and might have to be made on a case-by-case basis.
The same applies to the consideration of IPRs. We think it is important to provide for a discussion of strategies and policy choices for publicly funded biobanks and their various users with regard to the question of how to address and manage IPRs directed to HBMs, the associated data stored in the biobank and the results of the research using the HBM and associated data. This would also entail the consideration of alternative strategies, such as encouraging nonexclusive licensing practices; encouraging biobanks to develop IPR policies; clarifying the patent eligibility for different types of HBM and/or diagnostic methods using HBM; clarifying the patent law's research exemption; curtailing the scope and length of protection to the inventor's actual contribution to the state of the art; clarifying the obligation of researchers to return research results to the biobank and/or to share it with other researchers/patients; and optimizing specific forms of protection such as trade secrets and data/market exclusivities.
Regarding PM in particular the balancing of stakeholder's interests and drawing a reasonable line between openness and closeness is very challenging for publicly funded biobanks. Due to its novelty and its very dynamic nature, PM requires a well-functioning interdisciplinary collaboration between the different actors on various levels, that is, from patients and medical practitioners to internationally operating organizations, industries and policy makers. This in turn necessitates an extraordinary flexibility and curtailed case-by-case solutions. But the organizational setting should also be sufficiently robust and predictable in order to create a reasonable legal certainty for the various stakeholders and to promote the necessary investments in still unpredictable scientific endeavors. Within this complex environment, biobanks and policy makers will have to address the above-mentioned options and strategies for informed consent, IPRs and licensing. Operators of publicly funded biobanks will have to take the necessary decisions proactively and rather sooner than later in order to enhance translational medicine and to fully exploit the great possibilities that the emerging field of PM entails. In order to improve the important public trust in biobanks, such decisions should be made within a controllable and transparent institutional setting and by well-trained professionals.
The authors thank K Høyer, Faculty of Health Sciences, Department of Public Health, University of Copenhagen, and M Verlinden, visiting researcher at the Centre for Information and Innovation Law (CIIR), University of Copenhagen, Faculty of Law and PhD Candidate in Biomedical Sciences at KU Leuven for their valuable comments.
At the time of writing, T Minssen was a Visiting Scholar at Harvard Law School. He would like to thank the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for their valuable support.
Financial & competing interests disclosure
Our studies are supported by the "GlobalGenes-Local Concerns" project (see: https://globalgenes.ku.dk/) under the umbrella of the University of Copenhagen's "Excellence Program for Interdisciplinary Research" (see: https://research.ku.dk/strengths/excellence-programmes/). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Personalized Medicine. 2014;11(5):497-508. © 2014 Future Medicine Ltd.