EU leaves decision on stem-cell ethics to member states[fr][de] 

The European Parliament adopted by a clear majority, on 25 April 2007, the amended report by Miroslav Mikolášik on the proposal for an EU regulation for advanced therapies. With this vote, the Parliament rejected all ethical amendments proposed to the report and, therefore, backed EU-wide regulation on products or cures derived from human embryonic stem cells. The decision to allow the use of these treatments in respective territories is left to member states. 

The bio-industry quickly welcomed the vote, as the future regulation will create one European regulatory framework and a single European marketing authorisation for gene therapy, cell therapy and tissue engineered products. The regulation is expected to foster innovation, as it will remove industry hurdles of addressing 27 differing regulatory systems across Europe. 

Patient organisations also welcome the report, as an EU regulatory framework will harmonise patient access to innovative treatments and a centralised procedure for the marketing authorisation of the new products will ensure a high level of health protection. 

"Today's Parliament vote paves the way for an early adoption of this eagerly awaited regulation, for which patients and industry have been waiting too long. With this regulation, we unleash the EU potential for innovation, often driven by SMEs, while respecting member states' decisions on ethical concerns," said Commission Vice- President Günter Verheugen. 

The regulation still needs an official endorsement by the Council before its publication in the official journal.