Committee publishes Opinion on orphan medicinal products
The Economic and Social Committee of the Council of Ministers has published its Opinion on the European Commission Proposal for a European Parliament and Council Regulation on orphan medicinal products in the Official Journal. The Committee adopted this Opinion at its meeting on 27 January 1999. Since then, the European Parliament has adopted a number of amendments taking up specific points. The Commission's proposal would establish a Community procedure for designating orphan medicinal products and would introduce incentives for research, development and marketing, in particular by granting exclusive marketing rights for a ten-year period. The proposal is that an orphan medicinal product must be designated as such if it is intended for: - The diagnosis, prevention or treatment of a condition affecting fewer than 5 per 10,000 persons in the Community; - Treating a serious and communicable disease and is unlikely to be marketed without incentives. Orphan medicinal products may be eligible for further incentives made available by the Commission and the Member States to support research, development and availability. However, Member States would have to inform the Commission of measures taken to this end, and the Commission would have to publish a regular inventory detailing the incentives introduced by the Community and the Member States.