The cost of developing and marketing orphan medicinal products would not be recovered by their expected sales.

The great majority of these orphan medicinal products contain new innovative ingredients.

Since 2000, 123 products have been designated as orphan medicinal products and placed on the Community register.

Mrs Grossetête talked of the Regulation on orphan medicinal products, which is very important.

By the same token, in the draft regulation on orphan medicinal products, the Commission also proposes to involve general practitioners.

The regulation is certainly a step in the right direction, but I think the Commission needs to rethink its definition of 'orphan medicinal products'.

Secondly, the development of medicines for rare diseases, the so-called orphan medicinal products, is of crucial importance.

This is granted if a designated orphan medicinal product obtains a marketing authorisation in all Member States.

Mr President, Commissioner, ladies and gentlemen, the proposal for a regulation that is before us concerns orphan medicinal products.

Mr President, orphan medicinal products are so called because they are used in the treatment or diagnosis of conditions that occur so rarely.

Orphan Medicinal Product designation and positive Scientific Advice granted by the EMA .

You will, without doubt, remember that at the beginning of our mandate, we voted in favour of a regulation on orphan medicinal products, which allow us to treat rare conditions.

I am also in favour of a retroactive measure for orphan medicinal products presented before this regulation comes into force, in order to benefit the sick people concerned as early as possible.

Mr President, the Grossetête report on orphan medicinal products responds to an important requirement. It is to be congratulated for providing an immediate although imperfect solution to this problem.

Orphan drug and Orphan medicinal product designations granted by the FDA and EMA respectively, for the treatment of ovarian cancer.

The policy on orphan medicinal products, which is a genuine success at European level, stipulates that all market authorisation applications for these medicinal products shall be issued through the centralised procedure.

The European Union (EU) has enacted similar legislation, Regulation(EC) No 141/2000, in which pharmaceuticals developed to treat rare diseases are referred to as "orphan medicinal products."

The EU's legislation is administered by the Committee on Orphan Medicinal Products of the European Medicines Agency (EMA).

The regulation on orphan medicinal products which entered into force in January 2000 provides a system of incentives for sponsors to develop and market designated orphan medicinal products.

As far as the second amendment is concerned, it is calling for an additional EUR 1 million for orphan medicinal products, which the European Agency for the Evaluation of Medicinal Products requires.

Only if there is a clear benefit for Europe as a whole can we make budget funds available, for example to fund the exchange of knowledge of new medicines and therapies and the development of orphan medicinal products.

This is consistent with ongoing activities in biomedical research, and with the recent proposal for a regulation on orphan medicinal products used for the treatment, prevention or diagnosis of these rare diseases where the commercial return is insufficient.

As the United States is now at the forefront of clinical and pharmacological research, it has become a model of contemporary society in several respects. That country has had extremely successful legislation on orphan medicinal products since 1983.

Apart from the fact that it has taken nearly two years to present this proposal for a regulation, we have to recognise that an incentive system for developing orphan medicinal products has existed in the United States since 1983.

In my view, it is important to accept the amendment that allows the committee on orphan medicinal products envisaged in the Commission's proposal to operate under the aegis of the European Agency for the Assessment of Medicines.