HEALTH : MEDICINAL PRODUCTS FOR PAEDIATRIC USE: PROGRESS NEEDED.

PositionReport

The system for the marketing authorisation for medicinal products for paediatric use, laid down by Regulation 1901/2006, is a real disappointment: only one marketing authorisation has been issued for a medicine for children and only a few other projects are underway. Yet such an authorisation provides eight years of data exclusivity and ten years of commercial exclusivity for any new medicine that has been designed exclusively for treating children and that is not protected by a patent. This is what emerged from a progress report(1), released on 24 June by the European Commission, on the implementation of the regulation.

Regulation 1901/2006 entered into force on 26 July 2007 to stimulate the production of medicines for children, by stepping up research, development and authorisations. Before that, more than half of medicines prescribed for children had been neither developed nor authorised for use on children. According to the report, "the incentive of data and market exclusivity does not work for these products...

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