Jane Reichel


Bioethics in global biobanking touches upon several internationally accepted fundamental rights and values, namely the sample donor’s right of privacy, the patient’s right to health, and – at least implicitly – scientific freedom. From the perspective of fundamental rights, however, there are very few internationally applicable rules as to the enforcement of these rights at the administrative level. Instead, the combination of the practical need for common rules and the lack of political will and/or legislative competence within the international community or the European Union (EU) seems to have paved the way for soft law. Further, the role of courts in the area of bioethics and biobanking, nationally as well as internationally, is limited. The implementation of administrative rules at the national or regional levels is carried out by research committees and research funding institutions, usually with limited or no right to appeal to the general court system. Consequently, the traditional mechanisms of political and judicial control to a large extent are unavailable. The question raised here is whether the theories connected to global administrative law can be of any guidance in developing a legitimate regulatory regime for international biobanking. Can principles of participation, transparency, and reasoned decisions be of relevance in this area of law?

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