Do we need a biobank law?

Abstract

This paper deals with the question of whether it is necessary to pass a special law for the establishment and operation of biobanks. For this purpose, some legal aspects are presented by way of example that are involved in operating a biobank (data protection, personal rights, consent, protection against seizure, etc.). The authors then discuss a draft law from 2010 which, however, was rejected by parliamentary committees on the grounds that there was no need for legislating this issue. This is then followed by the description of a second attempt to create a biobank law, which was undertaken by a group of professors from Augsburg and Munich in 2015. Again, the authors conclude that there is no acute need for such a law. Biobanking science and practice have already given rise to regulations (guidelines, model texts, procedural rules, etc.) that create a sufficiently secure basis for bio-banking.