Brussels, 30/01/2007 (Agence Europe) - The draft regulation on advanced therapy medicines, which got bogged down at the Parliamentary committee stage in September 2006 (see EUROPE 9272 and 9266) has finally got out of the woods. On Tuesday 30 January, the report by Slovakian Christian Democrat Miroslav Mikolasik was finally adopted in committee by 55 votes to 6, with 3 abstentions, following a long vote on some 150 amendments. Curiously, the most sensitive point - the limitation of the scope of the future regulation - was not put to the vote. Two amendments from the legal committee excluding the use of cells which are, even distantly, embryonic in origin will go directly to the mid-March plenary.
Tuesday's vote supports the actions of the Commission seeking to extend Community pharmaceutical regulation to these new medicines from tissue and cellular engineering, submitting them to a centralised marketing authorisation procedure through the European Agency for the Evaluation of Medicinal Products (EMEA) in London. A number of amendments are useful, notably stressing the pharmacological, immunological or metabolic nature of the action of the medicine. They seek to avoid confusion between actual medicines and medical devices, which are already dealt with in another directive. The Parliamentary committee also wants unwanted effects to be covered by pharmacovigilance. It stresses the traceability of medicines and their raw materials, and compliance with transparency rules. MEPs approved a number of measures to help companies, especially SMEs, take part in the development of innovative therapy medicines. Finally they wanted the Parliament to be consulted over the appointment by the Commission of four (not two) doctors' representatives and the four (not two) representatives of patients' associations within the future committee responsible for advanced therapy medicines in the EMEA. Referring to the “enhanced cooperation” between Parliamentary committee provided for in Article 47of the regulation, the out-going chairman of the environment committee, German Christian Democrat Karl-Heinz Florenz did not put the two amendments from the legal committee to the vote. These amendments, contained in the opinion drafted by German Green Hiltrud Breyer condemn a whole section of innovative medicine, because they exclude from the scope of the regulation “advanced therapy medicinal products that contain or are derived from human embryonic and foetal cells, primordial germ cells and cells derived from those cells”. To the despair of patients' associations, they were directly included in the Mikolasik report and will be put to the plenary. (oj)