The Commission answers to industry’s urgent need for a single, farmework for gene, cell and tissue-based therapies by proposing an integrated legal framework for all advanced therapies.
The Commission published its official proposal for a regulation for a community regulatory framework on advanced therapies on 16 November 2005. The new rules will bring all advanced – gene, cell and tissue-based – therapies within a single, integrated and tailored European regulatory framework to ensure consistency across member states.
The main elements of the proposed framework for advanced therapies are:
- a centralised marketing authorisation procedure, to harmonise and facilitate access to the EU market;
- a new expert Committee for Advanced Therapies (CAT) within the European Medicines Agency (EMEA) to assess advanced therapy products;
- new, tailore-made technical requirements for advanced therapy products;
- strengthened risk management and traceability requirements;
- special incentives for small and medium-sized enterprises (SMEs).
The Commission thinks that human tissue- and cell- based products should be founded on the philosophy of voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient.
As to the ethical aspects, the proposal respects national competence as regards the use of for example embryonic stem cells. In accordance with the subsidiarity principle decisions on such use or non-use remain a national responsibility.