Over 30 million European citizens suffer from a rare disease. The small numbers of patients affected by a single disease and the fragmentation of knowledge about rare diseases translates into difficulties for people to get the right diagnosis, the right medical advise and the right medicine. In many cases, the medicine they need has not yet been developed. Today's 1000th designation of an orphan medicinal product marks a tremendous success in improving this situation.
Orphan medicines relate to diseases which affect not more than 5 persons in 10.000 in the EU. As a consequence, the economic potential of such medicines is very limited which hampers the development of new medicines.
In response, the EU adopted dedicated legislation in 1999 which provides strong incentives for medicines which have been designated as orphan medicines. They can obtain, under clearly defined conditions, market exclusivity of up to 10 years once they are authorised.
The record number reached today of 1000 designations demonstrates that the legal framework for orphan product designations lives up to its potential: not only does it support research, it also helps identify promising products and bolster their development with the goal of market authorisation. Indeed, these 1000 designations have already led to the authorisation of around 70 orphan medicinal products for the treatment of 62 orphan diseases.
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