Commission proposes comprehensive regulation of children's medicines

The European Commission has bitten the bullet and proposed a comprehensive regulation controlling the production, sale and use of children's medicines in the EU following many months of consultations.

Brussels wants to guarantee special care is taken to ensure the safety and effectiveness of paediatric medicines. Acting enterprise Commissioner Olli Rehn said the proposal 'achieves the right balance' between protecting children 'and the need to strengthen the competitiveness of the pharmaceutical industry.'

If the proposal is agreed by EU ministers and MEPs, a new expert committee would be created within the European Medicines Agency (EMEA) to assess and agree testing plans regarding market authorisations, ensuring children are taken into account. Such applications would have to include data on children, although there would be waivers for medicines unlikely to benefit them.

Also there would be deferrals ensuring medicines are tested on children only when safe and that such tests do not delay adult medicine authorisations.

Furthermore, the regulation would encourage the development of child medicines, giving a six months extension to supplementary protection certificates. Also, for off-patent medicines, 10 years of data protection would be created for new studies under a paediatric use marketing authorisation (PUMA).

There would be increased safety monitoring for children's medicines and the pharmaceutical industry would be forced to unveil any existing studies on children and medicines.

An EU inventory of the therapeutic needs of children would be created by a new European network of research and trial centres. Finally, a system of free scientific advice would be provided to the sector by EMEA.