Brussels, 16/12/2003 (Agence Europe) - This Wednesday may see the final stage of Parliament's involvement in the long process of revision the Community pharmaceutical legislation. The European Parliament, which must pronounce itself at second reading before lunch, must approve the compromise amendments negotiated with the Council by both rapporteurs, German Social Democrat Rosemarie Müller and French Christian Democrat Françoise Grosstête. The "Medicines" package may thus help to bypass a conciliation procedure, and a third reading.
As we previously indicated, the MEPs had already taken a step towards the Council during the committee vote. Negotiations allowed positions to be brought closer together on the scope of the obligatory centralised procedure. Parliament and Council may agree on a text which provides that requests for marketing authorisation are obligatorily submitted to the European Agency in London for medicines containing a new active ingredient for the four indications retained by the Council (Aids, cancer, diabetes, progressive dementing diseases) and "medicines reputed to treat rare conditions" as per regulation 141/2000. Four years after the regulation entered into force, medicines will be added in the field of viral and auto-immune diseases, and other immune response malfunctions. The Commission will then be able to present a proposal at any time modifying the scope of the obligatory centralised procedure, with the Council deciding by qualified majority. Among amendments which were the object of a compromise with the Council are also improvements to the prescriptions on pharmacovigilance and transparency, and setting up a system for the collection of expired or unused medicines in the Member States. Lastly, the Council agreed on the introduction of an environmental criterion, but this will have no effect upon marketing authorisations.