New European rules on the licensing of medicines for rare diseases give companies that develop new treatments exclusive rights to market products for those conditions.
European Regulation EC 141/2000 says that once a marketing authorisation for an "orphan" medicine has been granted by the European Medicines Evaluation Agency, or once all European Community member states have issued mutual recognition marketing authorisations, no further applications for authorisation of similar products for the same indications will be accepted for 10 years. If the product becomes sufficiently profitable within five years, the 10 year period can be cut to six years. Licensing charges can also be waived by the EMEA in full or in part.
The aim is to encourage the development of medicines to treat life-threatening or debilitating diseases which occur in no more than five in 10,000 persons in the European Community.
The regulation came into effect on January 22 and is immediately binding on all EC member states.