A review of the key issues associated with the commercialization of biobanks

Abstract

Biobanks1 have emerged as a significant research tool, gaining support from both the scientific community and regional, national and international research funding agencies. However, developing and maintaining these platforms is expensive. Indeed, in a recent survey of operational personnel representing 456 biobanks, funding shortages concerned 71% of those surveyed and 37% identified ‘funding’ as ‘the biobank's greatest challenge.’2 Thus, unsurprisingly, biobanks may seek support from the private sector or philanthropic organizations, which have an interest in sustaining them as research resources. The scientific community is also increasingly facing pressure to commercialize and translate their work, thus increasing expectations of industry partnerships.3 Funding agencies, in part, create and reinforce this commercialization pressure, by earmarking grants for projects that aim to bring products and therapies to the market within a short amount of time.4 This commercialization process creates a range of policy challenges for scientists, research participants, and funders. The goal of this document is to outline the policy issues associated with the commercialization of biobanks and, where possible, to review the relevant evidence and/or ethical and legal norms.5 We do not attempt to provide suggestions for policy reform. Nevertheless, given that securing funding for biobanks remains a challenge and that researchers are increasingly pressured to work with industry and to rapidly translate their work, a scoping document of this nature—one that draws together international expertise and relevant research—seems timely and, we hope, can stand as a resource for future research and policy work. ‘Commercialization’ can refer to a number of different activities. It can refer to the commercialization of biobank resources (data or samples of human biological material) or of research results derived or products developed from those resources. It can also refer to publicly funded biobanks partnering with or receiving funding from private, for-profit entities like biotech companies, pharmaceutical corporations, or the medical device industry. For the purposes of this scoping document, we will largely focus on the introduction of private funding and partnerships to an existing, publicly funded biobank. This focus is justified because many biobanks are not-for-profit entities associated with larger (often publicly-funded) bodies, such as universities and hospitals, and funded, often through short-term grants, by these bodies, by the government, or by a mixture of public and private funds.6 Survey evidence indicates that these biobanks are greatly concerned with securing adequate long-term funding.7 As Meijer and colleagues note, with the expansion and change in the size, goals and structure of biobanks, ‘stable sources of core funding will be necessary in most cases, from the public sector, patient organizations and private foundations.’8 Given this reality, we believe that commercialization will particularly and uniquely impact publicly supported biobanks, as they consider various means, including private partnerships, to ensure financial security.9 Of course, biobanks vary greatly in organization, priorities, and funding,10 and thus commercialization will affect different biobanks in different ways. Not every biobank will seek commercial partnerships in response to financial pressures, and, indeed, delineating which factors (eg type of biobank; organizational structure; research goals and focus) influence the development of private partnerships may be an important question for future research. Indeed, we hope this overview of issues will inform these future funding decisions. In addition to our primary focus on the introduction of private financing and partnerships, some of the emerging research and commentaries on the issues associated with commercialization are relevant to a range of other activities and are worth considering here. For example, issues of public trust can be triggered by a variety of commercialization practices, as we will see. Thus, where appropriate, we will discuss commercialization activities beyond just the introduction of private funding. Before turning to the issues at hand, it may be useful to set out some of the scenarios in which commercialization may occur. In this paper, as noted, we largely concentrate on the introduction of private funding to a pre-existing publicly funded biobank. In such a case, a chief concern for the biobank will be retaining participants who were, presumably, originally recruited with an understanding that the biobank would be a ‘public good.’ In this case, issues related to consent, participant retention, and withdrawal of biological material and associated data are particularly important. We can contrast this with a scenario in which the biobank is a public-private partnership from its inception. In such as case, enrollment of participants and obtaining consent to