Europe and tissue research: a regulatory patchwork

Many tissue research projects are under way in Europe. All major projects are part of the Biobanking and Biomolecular Resources Research Infrastructure, in short BBMRI-EU. The regulatory landscape is complex. The European Union can only act within the authority attributed to it by the European Union Treaties. Ethics as such is not part of its competences. It can regulate the free flow of services and regulated the processing of personal data in 1994. A major overhaul is under way which could seriously hamper research. Research with tissue as such is regulated at the national level and through international non-binding instruments. Different approaches can be seen, in combination with new approaches to governance. Data protection is a key component in biobanking projects. It is proposed to focus less on the vain quest for anonymity of data before they reach the research domain, but instead on the safety of personal data once there.