Brussels, 07/06/2012 (Agence Europe) - On 7 June, the European Commission designated the 1,000th orphan medicinal product. This record number demonstrates that the legal framework for designating orphan medicinal products is working as it should, the Commission is pleased to state. John Dalli, Health and Consumer Policy Commissioner, has said: “The EU's legislation on orphan medicinal products has been a great success in providing strong incentives for the development of medicinal products for the diagnosis, prevention and treatment of rare diseases. These incentives are key to developing medicines that can make a difference: the difference between a life of suffering with no adequate medication, or a better life with appropriate treatment.”
Orphan medicines are for the treatment of diseases that affect not more than five persons in every 10,000 in the EU. At present, over 30 million European citizens suffer from a rare disease. Due to the limited number of patients affected and the fragmentary nature of knowledge on rare diseases, it is difficult for those concerned to obtain an exact diagnosis of their ailment, appropriate medical advice or appropriate treatment. More often than not, the medicines needed by the patients have not yet been developed as, given their low economic potential, they have not been adopted by the pharmaceutical industry. In order to encourage research in this field, the European Union adopted, in 1999, specific legislation which grants very interesting incentives for medicinal products designated as orphan medicines. The manufacturers of such medicines, when these are authorised, may obtain commercial exclusivity in well-defined conditions for a duration of up to ten years. To date, the 1,000 designations have already led to the authorisation of around 70 orphan medicinal products for the treatment of 62 orphan diseases. (IL/transl.jl)