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Parliament amends proposal on orphan medicinal products

While supporting 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 European Parliament has adopted a number of amendments taking up specif...
While supporting 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 European Parliament has adopted a number of amendments taking up specific points.

Reporting for the Environment Committee, Christian Cabrol (F, UFE) was in favour of support specifically going towards dealing with tropical diseases and other illnesses, which have a serious debilitating effect. Otherwise, he supported the Commission's intention to help pharmaceutical companies with registration fees and also the idea of providing tax incentives.

Renate Heinisch (D, EPP) also supported the proposal. She was particularly anxious to ensure that EU research funds helped in this regard, while Elena Marinucci (I, PES) pointed out that the EU was now coming into line with a similar approach adopted in the USA. It was only right, she said, for the EU to be supportive, by accepting its responsibility to help a small number of human beings affected by such illnesses. She emphasised that the intention was not for EU funding to replace the private sector, but rather to provide incentives and support, concentrating on the scientific and humanitarian aspects, rather than the commercial side.

José Valverde López (E, EPP) also supported the proposal, adding that he was tabling a number of amendments, one of which was designed to ensure that the London-based European Medicines Evaluation Agency would be fully involved in the process.

Marie-Paule Kestelijn-Sierens (B, ELDR) pointed out that the costs for developing new drugs to treat these diseases, were just as high as those with more widespread potential and that it was vital to help industry in this area.

Other speakers in the debate also supported the proposal with Clive Needle (Norfolk, PES) emphasising that it could be seen as a new innovation in promoting a partnership between the public and the private sector. He supported the clause, which would ensure that unreasonable "profits" would be avoided, although he recognised that it was difficult to see how these could come about.

Replying to the debate, Commissioner Bangemann explained that the proposal was needed to develop the research in this area, as a purely market place approach was not sufficient, especially as research was expensive. He did point out that EU funding had been going towards projects in this area for some time. The intention was to continue with this. While he could accept many of the amendments tabled, he could not agree to those designed to impose an additional economic criteria, or a special fund, and amendments aimed at encouraging research in the third world.

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.

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