On November 16, the European Commission proposed closing a market authorization hole in Europe by regulating tissue-engineering products as ‘advanced therapies’ rather than medical devices.
In the proposal, the London-based European Medicines Agency (EMEA) would evaluate commercial tissue-engineering products, such as skin and cartilage replacements, alongside gene therapy and cell therapy products, which it already handles. Scientific opinions on these three categories would be prepared by a new ‘Committee for Advanced Therapies’ (CAT), manned by multidisciplinary European experts.
The new, centralized procedure at the EMEA would replace the current patchwork of individual market authorization procedures carried out in each European country. According to the European Commission, that will put an end to a procedure that has, until now, stifled investments and prevented new tissue products from reaching all patients in the European Union. The rules would contain strong requirements for risk management and long-term traceability, but leave ethical questions, such as those arising from the use of germ cells or embryonic stem cells, to individual member states. Hospitals and tissue-banks developing treatments for in-house patients would get exemptions.
Johan Vanhemelrijck, secretary general of EuropaBio, a Brussels-based European bioindustry association, welcomed the proposal, saying “these new rules will…provide a level playing field for hospitals and companies.”
The plan will now be taken up by the European Parliament and the European Council, who will have to agree on a final decision.
doi:10.1038/nbt0106-11