Advanced Therapies : Vote Postponed against Backdrop of Debate on Ethics

Article excerpt

Negotiations are continuing between the Council, the European Parliament and the European Commission on the proposal for a regulation on advanced therapy medicinal products. The EP's vote at first reading, scheduled for the mid-March plenary session, has been postponed until April at the earliest. The Commission's proposal aims to create a single regulatory framework that entails a centralised authorisation procedure, via the European Agency for Evaluation of Medicinal Products (EMEA) in London, for the development of gene therapy, cell therapy and tissue engineering, which are promising for the treatment of genetic diseases, rare cancers and serious burn cases. The three institutions are still working on the scope of the new regulation.

Although the report by Miroslav Mikola ik (EPP, Slovakia) was adopted on 30 January by the Health and Environment Committee, two amendments relating to ethical issues were not put to the vote. They have been included in the Mikola ik report and will be put directly to the plenary vote. German MEP Hiltrud Breyer (Greens) demanded the exclusion of "human embryonic and foetal cells, primordial germ cells and cells derived from those cells". "Delaying approval of the regulation or excluding certain products will prevent some patients from obtaining access. What is even worse though, is that those who do get access to these therapies will have no guarantee on their safety," warned Alastair Kent, President of EGAN (European Genetic Alliance Network), which has teamed up with patient associations to demand "a regulation now". …