ECPC Members Brief
Medicines for Children – EU implements Pediatric Legislation

Dear ECPC Members,

The new Pediatric Regulation entered into force in the European Union (EU) on 26 January 2007. The Regulation ensures that in future Europe’s children (0 - 17 years) will benefit from medicines that have been specifically tested and authorised for their use. The Regulation will close a serious gap in the area of public health.

Cancer is the leading cause of death in children outside of accidents. It is estimated that each year in Europe about 13 000 children will develop cancer and 3 000 will die of the disease. Yet until now these children’s access to innovative therapy was extremely limited.

ECPC welcomes this long overdue Regulation that would guarantee the maximum possible safety in child medication and end the anomaly that at least 50% of the medicines given to babies, toddlers and adolescents - according to Commission figures - have never been tested in children. Children’s metabolism may respond differently from that of adults to medicines.

ECPC very much hopes that this Regulation will fulfill its objectives to:

• facilitate the development and availability of medicines for children aged 0 to 17 years,
• ensure that medicines for use in children are of high quality, ethically researched, and authorised appropriately,
• improve transparency and the availability of information on the use of medicines for children,

without:

• subjecting children to unnecessary trials,
• or delaying the authorisation of medicines for use in adults.

The Pediatric Regulation dramatically changes the EU regulatory environment for pediatric medicines. It brings new tasks and responsibilities for the European

Last update 20 August 2007 HS