Legal architecture in relation to governance of and access to biobanks.

The European Strategy Forum on Research Infrastructures (ESFRI) identified biobanks as one of the main priority research infrastructures for the European Research Area (ERA) for the next 10 to 20 years. Millions of human biological material (HBM) and associated data are collected each year for a variety of purposes. These purposes may include basic research studies, clinical trials and epidemiological studies.

The legal framework that determines access to biobanks remains unclear. The absence of a defined set of applicable rules creates legal uncertainty for biobanks and applicants. The PhD project studied the legal framework that determines the relationship between a biobank and a researcher that applies for access to HBM and data stored in a biobank. In an interdisciplinary context, the PhD project aims to contribute to the creation of a clear and smooth legal framework – i.e. legislation, non-binding normative instruments and access arrangements – applicable to biobanks.

The general introduction provides a deeper insight into the use of HBM and associated data for research purposes. First, it highlighted the importance of biobanks for biomedical research. Second, it looked at different types of HBM and data collected for research purposes. Third, it described the different research purposes to collect and use HBM and data. Finally, it dug deeper into the definition of the terms ‘biobanks’ and ‘biobank networks’.

The first chapter of the PhD reports on a comparative analysis of access arrangements of organizations, biobank networks and biobanks. The comparative analysis revealed a lack of harmonization on how access conditions are defined and implemented. A considerable number of access arrangements did not contain clear information on how the biobank initiatives (should) implement several of the studied access conditions. The lack of clear information on access conditions could hinder access to biobanks and biobank networks. The analysis did reveal a trend to grant custodianship to biobanks or biobank networks and no longer to individual collectors or principal investigators. This can be explained by the fact that biomedical research requires access to large amounts of HBM and data of high quality. Finally the comparative analysis confirmed that the majority of the biobank initiatives establishes an access committee to evaluate requests for access to HBM and data. The mandate of such access committees is not always clearly defined.

The second chapter of the PhD reports on an empirical study of access practices in the context of biobanking. Interviews were conducted with stakeholders and experts to gather qualitative data on the different perspectives held by stakeholders in relation to the rights and obligations of custodians and applicants with respect to access to HBM and data stored in biobanks. The first part of the semi-structured interviews focused on the evaluation of access requests by access committees. The interviews raised the importance of clarifying the interaction between research ethics committees and access committees of biobanks.

There was no consensus among the interviewees on whether and to which extent access committees of biobanks should evaluate the quality, the scientific and medical usefulness and the ethical value of research projects. The interviewees did agree that access committees should only evaluate access requests on the condition that they dispose of sufficient expertise, experience and independence. The interviewees felt that similar evaluation criteria should apply to academic and non-academic applicants. Following the interviews, there is no doubt that applicants need to obtain the approval from the access committee of a biobank – and a research ethics committee – to use leftover HBM in a new project.

The access fees charged by biobanks are often insufficient to compensate all costs in relation to the collection, storage and distribution of HBM and data for research purposes. Two interviewees raised the need to develop new mechanism to feed some of the benefits of biomedical research back into the biobank infrastructure and the health care system. Public biobanks could charge a higher access fee to industrial or external applicants – compared to internal applicants – for the access to a publicly funded collection of HBM and data.

There was consensus among the interviewees that an applicant could be required to share his research results with the biobank and/or other researchers. One should however protect the legitimate interests of the researcher that generated the research results.

Today, quite some collections of HBM and data are established at the initiative of the principal investigators of specific research projects. Furthermore biobanks still rely on individual clinicians or researchers for the collection of specific HBM and data. Biobank initiatives could recognize such contribution by granting a temporary priority right to conduct research with the collected HBM and data.

The third chapter of the PhD reports on a comparative study of the legal framework applicable to access to biobanks. The comparative study started with description and analysis of the legal framework applicable to access to biobanks in Belgium and Denmark, at the international level and at the level of the Council of Europe. Subsequently it compared the different legal frameworks applicable to access to biobanks. The conclusion summarized to which extent the rights and obligations of the custodian and the applicant are regulated via the existing legal framework.

The legal study in Chapter 3 shows that the Belgian legislation applicable to biobanks mainly focuses on the rights and obligations of the donor and the custodian. Fewer provisions relate to the rights and obligations of the applicants. The Belgian and Danish legislation applicable to biobanks do not contain any provisions on the mandate of an access committee. Some international normative instruments provide additional guidance on the role of an access committee and the development of access policies, procedures and mechanisms. The OECD Guidelines for Human Biobanks and Genetic Research Databases formulate the general principle that biobanks should develop policies on the commercialization of HBM and data, intellectual property rights (IPRs), the sharing in scientific advancements and its benefits and the sharing of research results.

The fourth chapter of the PhD reports on a legal study on IPRs in biobanking and on the return and sharing of research results. This study discusses the risks and opportunities associated with the identified IPRs for an effective protection and use of biobanks in translational research and innovation. The study concluded that an IPR policy may be used as a tool to enhance the acknowledgement and protection of the interests of the biobank. Such policy may also be used to stimulate the development of biobanks as essential research tools or infrastructures. However, one should avoid that IPRs would become an obstacle to the use of HBM and data in research projects. Chapter 4 tackled the question of how to address and manage IPRs directed to HBM and data stored in the biobank and the results of research using the HBM and associated data. We looked amongst others into the question whether biobanks should be involved in upstream and downstream IPRs. Finally the chapter highlights how biobanks could be involved in the development of policies on the sharing of research results.

The fifth chapter of the PhD formulates concluding findings and recommendations on the legal framework applicable to biobanks. First, we conclude that an optimal legal framework combines legislation, soft law and access arrangements. Second, we recommend that biobanks should develop clear policies on the evaluation of access requests. Third, we suggest that biobanks clearly define the conditions under which industrial companies can access publicly funded collections of HBM and data. Fourth, we draw the attention to the importance of recognizing the contributions of individual collectors to the collections of HBM and associated data. Fifth, we recommend that biobank initiatives would develop a policy on the sharing of research results. Sixth, biobanks are invited to develop a policy on IPRs. Finally, we highlight the importance of involving donors and patients in the access policies of biobanks.