Brussels, 21/02/2007 (Agence Europe) - There is indeed the possibility of a first reading agreement being reached on the draft regulation on advanced therapies. That is what is suggested by the first trilogue between the Parliament, the European Commission and the Council of Ministers represented by the German presidency to be held on Wednesday 28 February. Though it is impossible at this point to prejudge the outcome of these negotiations, the adoption of this regulatory framework, to ensure a high level of safety in the new therapies derived from tissue and cell engineering in the framework of a centralised approval procedure, would appear to be coming closer. This is good news for the medical sector and for patients, after the delay incurred by this matter in the European Parliament in the second half of 2006.
Commission departments are still stressing that the Parliamentary environment committee, during the vote on the report by Slovakian Christian Democrat Miroslav Mikolasik (see EUROPE 9355), adopted a number of amendments which brought useful clarification to the European Commission's original proposal. Negotiations should now focus on the scope of the regulation and the exemptions granted to hospitals and SMEs. To ensure the negotiations are brought to a successful conclusion, it would seem essential that the rapporteur should concentrate on the amendments actually voted by the committee. Two ethical amendments by the legal committee, which were not voted on in committee have been included in the report. These amendments, which would see removed from the scope of the regulation any medicines which contain or which are derived from human embryonic and foetal cells, stem cells or cells derived from these cells, are unacceptable to the European Commission, which deems them “radical” and “dangerous for public health” insofar as they would allow some products to avoid quality, safety and pharmacovigilance rules put in place at European level. In the proposal, there is no intention of legislation on the ethical issues, which are principally a matter for member states, which regulate research and industrial production conditions on their territory and, after a medicine has been approved, are able to regulate distribution on its territory. In the Parliament, there is a feeling that the Council does not want to discuss ethical amendments. For the Council's health group, what is at stake principally is identifying the nature of combined products, in which a medical device produces a pharmacological, metabolic or immunological action. A large group of member states, which includes France, Poland, Spain and the United Kingdom, are arguing for a solution based on the main effect, which would mean that all products whose main therapeutic effect came from the device itself would be excluded from the centralised approval procedure. Member states are still split on exemptions. Some, like Germany, would like a maximum exemption for hospitals (where therapies are often implemented in response to the specific needs of the patient or a small group of patients) and SMEs. Spain would like hospital networks to be considered. France, on the other hand, would like derogations to be limited. (oj)