European Parliament votes in favour of paediatric medicines regulation

The European Parliament has voted in favour of a regulation to promote paediatric medicines, an unsurprising decision which is likely to result in the legislation coming into effect at the beginning of 2007.

The draft regulation covers medicines which are currently being developed, patented drugs and also older, off-patent products. Its flagship measure, which aims to put an end to the lack of medicines for paediatric use, provides for an extra six months' intellectual property rights for products that undergo complementary studies for use in children.

To benefit from this extension, companies must provide a "paediatric investigation plan" to the European Medicines Agency (EMEA)'s future paediatric committee.

A system of derogations from the obligation to present results for adults' and children's trials at the same time will ensure that the approval of a product's use in adults is not held up. The criteria for these derogations will be decided by the future paediatric committee, which will be created within six months of the entry into force of the regulation.

Two to three years after the regulation comes into effect, the paediatric committee will draw up an in-ventory of therapeutic needs, especially with a view to determining research priorities.

The Parliament also voted in favour of a transitional clause for pharmaceutical companies submitting paediatric investigation plans.

Under this clause, for five years after the regulation comes into effect, companies will be able to submit their investigation plan up to six months before the expiry of the product's supplementary protection certificate (SPC). After five years, plans will have to be submitted no later than two years before SPC expiry.

This clause should allow several products that will soon fall into the public domain to benefit from the measure. For medicines which are already in the public domain, the regulation provides for a 10-year extension in data protection for a new paediatric indica-tion.

Off-patent drugs should also benefit from an EU programme for the public financing of research, under the Commission's 7th framework programme for research and development, a parliamentary source told APM.

As for orphan medicines, for which there is already a specific regulation granting 10 years' market exclusivity, the paediatric regulation provides for this exclu-sivity to be prolonged by a further two years if an orphan medicine is studied for paediatric use.

A special logo will be put on the packaging of medicines approved in paediatric indications.