The advances in computer technology and high-throughput DNA sequencing have led to a substantial increase in the amount of genetic research being conducted throughout Europe. This, in turn, has led to the establishment of many different kinds of genetic databases. Population genetic databases, which have been the focus of the ELSAGEN project, represent one kind of human genetic database that is currently being developed in Europe. There are many more genetic databases that are not as well known and have not been subjected to the same intense international scrutiny and debate. Examples include web-based digital collections such as Ensembl, collections made as ‘add-ons’ for clinical trials or genetic databases established for one-off, specific research projects. Scientists have expressed concern that the current regulatory framework for human genetic databases within Europe is inadequate. In May 2004 the EC Expert Group on Genetic Testing recommended that ‘action be taken at the EU level … to follow and address regulatory issues related to collections of human biological material and associated data and their uses’. The concern is that the lack of standardized guidelines inhibits co-operation amongst researchers and the sharing of samples from genetic databases across national borders. The research of the ELSAGEN legal team has shown that there are significant obstacles to achieving a uniform European regulatory system for human genetic databases. The purpose of this chapter is to discuss some of the preliminary issues that would need to be addressed before such a regulatory system could be developed within Europe.