Legal Challenges and Strategies in the Regulation of Research Biobanking

Abstract

In this chapter, some of the legal challenges of research biobanking are discussed and illustrated by examples of possible analogies as well some comparative notes on the regulatory strategies adopted in the Nordic countries. Human biological material is compared with biologicalwaste, raw materials, human beings, personal or nonidentifiable health data, and different kinds of public resources. It is concluded that the complex nature of human biobanks would seem to defy any attempt at a simplified regulatory analogy. Even so, it is clear that the application of more sophisticated analogical reasoning will still be valuable in the regulatory process and that policy makers must try to identify an appropriate combination of diverse approaches. While the international nature of biomedical research provides a strong incentive for more harmonised rules, the regulatory process is here further complicated by the plurality of religious, cultural, social and legal traditions, as well as issues of regulatory competence. Nevertheless, some degree of regional or even international consensus could certainly be reached with regard to less controversial areas and issues, and this potential must be further explored. The regulation of research biobanking should be perceived as an ongoing step-by-step process, rather than a problem that will soon be solved once and for all. In the short-term perspective especially, it must be expected that legal restrictions and administrative inconveniences may cause additional costs and delay or even prevent promising research. The long-term aim must be to serve the best interests of the public, by a careful balancing of the freedom of research against other fundamental rights and values.