Biobanks

'A review of the key issues associated with the commercialization of biobanks' by Timothy Caulfield, Sarah Burningham, Yann Joly, Zubin Master, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, Amy McGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, Helen Wallace and Ma'n H. Zawati in (2014) 1(1) Journal of Law and the Biosciences 94-110 comments that

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.’ 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. 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. 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. 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. 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.’ 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.

Of course, biobanks vary greatly in organization, priorities, and funding, 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 commercial imperatives, if any, are likely to be the prime focuses of the biobank. The different situations of these biobanks may inform and nuance the discussion that follows.

The authors note

Biobanks are expensive to maintain. A lack of sufficient funding may have a dramatic impact on sustainability and raise challenging policy issues. Two recent bankruptcies of private population biobanks, Genizon in Québec, Canada and deCODE Genetics in Iceland, illustrate the ethical and policy dimensions of the issues raised in this context. Both biobanks were privately owned and recruited their participants from homogeneous population groups originating in geographically determined locations.

Given these similarities, it is interesting to note the different outcomes of bankruptcy in the two cases. deCODE (with 140,000 samples from the Icelandic population) first declared bankruptcy in 2009, selling its assets (including its biobank) to Saga Investments LCC. Saga is a group comprising some of the original investors in deCODE who kept running the company with a similar management structure. Following an unsuccessful attempt to pierce the direct-to-consumer (DTC) market, the company was acquired by the biotechnology giant Amgen for US$415 million. So far, the sale has not affected the management and objectives of the biobank, which remains located in Iceland. As part of the deCODE licence, the government required that the biobank stay in Iceland, even if third parties became involved. However, Amgen has not offered any written guarantee that this arrangement will prevail over time and no court decision has been rendered to that effect. Genizon (with 50,000 samples from the French Québec founder population) was a Québec-based private biotechnology company in the business of mapping and identifying genes for complex disorders. It filed for bankruptcy and liquidated its tangible assets, excluding the biobank, in 2011. Later that year, the Superior Court of Québec mandated Génome Québec (GQ), a provincial public funding agency, to act as the trustee of the biobank. In late 2012, Genome Québec launched a call for tenders with the hope of transferring Genizon's biobank to a Québec research centre. Following the closure of the call for tenders, Genome Quebec turned down two valid bids by public groups deciding instead that it would continue managing the Genizon biobank by itself.

In cases like this, what should happen to the samples and data of the participants? Can they be sold like other types of material assets? Transferred to another country? Or should they be destroyed instead? Responses to these questions could have far reaching implications for participants’ privacy, autonomy and dignity. In the case of bankruptcy, the biobank's policies, especially those regarding data privacy and data sharing, are relevant for courts to determine the extent of what can be done with the participants’ data and samples. The informed consent form signed by the participants will also play an important role in that respect, by creating conditions that should be respected post-bankruptcy. In this type of bankruptcy cases, US experts have alluded to the possibility of legally appointing a Consumer Privacy Ombudsman (CPO) to assist the court on privacy aspects of the process. However, to require this special procedure, the proposed liquidation should meet strict criteria that likely would not apply to most cases involving genomic biobanks. Given the sensitive nature of medical data, including genetic data and tissue samples, and the importance of preserving public trust in science, it appears that clear policies are required. Those policies should give weight to the promises made to research participants at the inception of a biobank and ensure more predictable outcomes in case of bankruptcy. However, developing such policies may be challenging, as issues relating to bankruptcy or biobank closure are rarely priorities at the inception of a biobank project and tend to be considered only in times of hardship.