The report of Françoise Grossetête (F), Vice-Chairwoman of the EPP-ED Group in the European Parliament, on medicinal products for paediatric use was adopted by the plenary.

"This is about saving children's lives, not about cost and profitability. 100,000,000 Europeans are under the age of 18. Thanks to the European Union, our children will soon be able to benefit from safe medicines designed for children", Françoise Grossetête said.

The proposed regulation intends to increase the development and authorisation of medicines for use on children while ensuring that children’s medicines are subject to high quality research and children are not subjected to unnecessary clinical trials. The proposal also aims to improve the information available on medicines for children.

At present, our children do not have access to medicinal treatment tailored to their needs. Lots of medicines are not developed specifically for paediatric use. The products given to children are very often identical to those prescribed for adults, only in smaller doses. "Children, however, are not mini-adults". They need special pharmaceuticals, not only to ensure that they are better tolerated, but also to increase efficiency and safety.

One of the central points in the debate was the incentive for laboratories to further develop research in the area of paediatric medicine. Since research activities are random per definition, it is important to establish a clear system in this area.

Following long negotiations, Françoise Grossetête has won support for an extension of the six-month supplementary protection certificate. This extension will be granted only if paediatric research is validated by the Paediatric Committee of the European Agency in London.

By Eva Mitsopoulou