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Parliament to give opinion on orphan medicinal products

The European Parliament in Strasbourg is due to give an opinion next week on a European Commission proposal to introduce incentives to develop and market medicinal products for the prevention, diagnosis and cure of rare conditions ("orphan medicinal products").

The proposal w...

8 March 1999 - 8 March 1999
France

The European Parliament in Strasbourg is due to give an opinion next week on a European Commission proposal to introduce incentives to develop and market medicinal products for the prevention, diagnosis and cure of rare conditions ("orphan medicinal products").

The 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.

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