Brussels, 28/02/2003 (Agence Europe) - The Council's working group has finished assessing the draft regulation on the European Medicines Agency, but the European Commission is finding it hard to finalised its amended draft directive on the authorisation of medicines for human use. First announced for the end of January, then for February, it is unlikely to be completed before the end of March. When it voted on the regulation and the two directives (the other one concerning veterinary medicine) in October 2002, the position adopted by the European Parliament seemed to give rise to disagreements between Commissioner Liikanen (Enterprise) and Commissioner Byrne (Health) over information for patients and the length of time that clinical data is protected, which can favour either innovative companies or the generics industry.
The text of the draft regulation still has to be examined by Coreper, on 12 March, with a view to reaching political agreement at the Council meeting of 2 June.
Various important issues, such as how to define generic medicine and extending the centralised procedure to all new active substances (as desired by the Commission and the Parliament) have still not been answered. In terms of extending the centralised procedure, a very small number of Member States (France, Belgium, Portugal and Greece) support the Commission and Parliament's position.
Germany is very reticent in this connection and has called for a change in the legal basis. It suggests using Article 308 (foreseeing simple consultation of the EP and unanimous voting at Council) rather than Article 95 (codecision). This is favoured by the Council's legal service and might be supported by the UK.
The Commission and its legal service, however, are planning to keep the current legal basis, which can only be changed if unanimously decided upon by the Council. Germany's argument is based on the fact that the regulation only partly harmonises pharmaceutical legislation.