EU Mutual Recognition "Disaster" Warning

While the European Union mutual recognition procedure for drug approvals is currently voluntary and does not become compulsory until January 1998, the signs coming through now are not favorable for a successful transition, Marie Donnelly of the European Commission told a members' meeting of the European Proprietary Medicine Manufacturers' Association in London last month.

Initial enthusiasm and political commitment to the procedure have waned, and must be reinjected if we are not to face disaster in 1998, she warned. Companies do not use the procedure, some misuse it and some are withdrawing from it. This is very serious, she said; companies are losing a valuable opportunity to gain the experience which they will need post-transition. She said that the practice adopted by some companies of having copy authorizations to introduce variations in various markets without touching the marketing authorization is not useful, and also condemned the application by some companies for market authorization in six or eight EU member states, and then withdrawing them.

The immediate past chairman of the Committee on Proprietary Medicinal Products' Mutual Recognition Facilitation Group, Vittorio Silano, said that only about one-third of EU member states could be described as very active Reference Member States for the procedure. Two-thirds of the member states have been active RMS, and one-third not active at all, he said.