Nurture orphan drugs, says Committee
There needs to be a Community procedure for designating orphan medicinal products and incentives for research, development and marketing of them, according to the Committee on the Environment, Public Health and Consumer Protection, which has adopted a report on a Commission proposal for a regulation. Rare, exotic diseases are often made even more distressing for sufferers when they are told a cure is unavailable because it costs too much. The pharmaceutical industry currently knows of about 5000 of these rare diseases but is wary of investing in the development and marketing of products which will rarely be bought. These cures - which no one wants to develop - are known as "orphan drugs". The Commission's initiative follows the successful US Orphan Drug Act in 1983 and the European Community's existing research on orphan drugs under the Fourth Framework Programme for research and development. The aim of the proposal is to give incentives to the pharmaceutical industry. This will be done by accelerating the procedures for obtaining Community marketing authorisation and exemption for the applicant from paying all or part of the fees due on lodging a file. There will also be market exclusivity for ten years and allowance of national incentives. The amendments adopted by the Committee included: - A proposal for setting up an Orphan Medicinal Product Innovation Promotion Fund (to be financed with revenue from sales of the orphan drugs after a ten-year period of exclusivity); - An addition to the definition of "orphan medicinal products" saying that it is unlikely that, without incentives, the marketing of the medicinal product in the Community would generate sufficient returns to justify the necessary investment.