Euro Ministers Agree EMEA Fee Structure

The Council of Ministers of the European Commission has reached an agreement on the fee structure for the European Medicines Evaluation Agency, which started work at its London offices this week without having received authority from the European Commission to charge fees (Marketletter January 2). The Council agreement, which was reached on December 21, will now go forward for discussion at the European Parliament's plenary session, scheduled for January 14-21.

Meantime, the European Federation of Pharmaceutical Industries' Associations has expressed its frustration that the EMEA is not able to accept marketing authorization applications until the fee regulation is adopted. It notes that Article 58 of Regulation 2309/93, which lays down the centralized registration procedure rules and establishes the EMEA, stipulates that innovative medicinal products may be registered only by means of this procedure. Moreover, it says, the regulation lacks any transition provision and the existing concertation procedure was repealed on January 1, whether or not the new structure was in place.

The EFPIA says further delay will therefore penalize precisely those medicinal products which are innovative, and warns that the consequences for the research-based industry, but above all for the patients, "may be grave."