Banks, Repositories and Registries of Stem Cell Lines: The Challenges to Legal Regulation

Abstract

Stem cell biobanks can be understood as repositories of stem cells and stem cell lines including the data associated with the biological material. Such biobanks have widely differing extents, characters and purposes. Some are very large and serve broad-spectrum purposes. Others are smaller and have more distinct aims. Some are public, others are commercial. Altogether the area of stem cell banks is highly complex, which implies a regulatory challenge for legislators. This paper aims at clarifying how stem cell banks are regulated in international law with a special focus on the balancing of interests of different stakeholders. Tissue donors may have various interests in regards to stored stem cell samples, especially an interest in self-determination and privacy protection. These interests must be balanced against the interests of other actors, not least those patients who can benefit from the development of new treatment but also the interest of society at large in development of new knowledge. New issue arises in situations where stem cell research is moved from the laboratory to the clinic. The change of purposes associated with the translation of research into clinical practise gives rise to special regulatory concerns and challenges, especially in regards to tissue donor’s right to self-determination. The paper concludes that the international regulation only to a limited extent refer explicitly to how the transition from laboratory research to stem cell treatment should be dealt with, and that there is a need for clarification in international law of how to tackle this challenge.