• stem cell research
• stem cell regulation
• European regulation
• public participation

The European Union (EU) has, at present, no jurisdiction over research carried out in the member states, or concerning the “ethics” of member states. This does not, however, mean that decisions made by the European institutions cannot influence such matters greatly.

There has recently been a lot of focus on the decision not to fund embryonic stem cell research during the first year of the 6th framework programme (mainly due to opposition to funding from the German government), but behind the scenes a much more important and wide ranging set of regulations are being prepared.

The European Commission has prepared a draft directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells.¹ The purpose of this directive was originally to “ensure the quality and safety of human tissues and cells for clinical use” in the EU. This is clearly a laudable objective, fully in line with the EU’s jurisdiction in consumer protection and public health.

During the intricate processes of political …