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European Parliament approves paediatric legislation

Pharma firms that carry out R&D will enjoy six-month extension on patents for children's medicines

Pharma firms in Europe that carry out research on their medicines to ensure they are safe and effective for use in children will be rewarded with a six-month extension on patents, after the European Parliament approved new legislation.

The parliament overwhelmingly voted to accept the long-awaited law on medicinal products for paediatric use, saying it would improve the lives of Europe's children by increasing the availability of fully researched, developed and authorised medicines specifically for them.

The subject of paediatric medicines has long been a thorny issue; companies have been reluctant to develop them, partly out of concerns over the safety of testing and partly due to the limited market size. Pharma has made no secret of the fact that it has viewed paediatrics as an area where it is difficult to recoup R&D expenses.

European legislators hope the new system will be an incentive for pharma firms to conduct research; the six-month extension to the Supplementary Protection Certificate, which currently lasts for up to five years, will in effect constitute a useful six-month patent extension.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the vote, which effectively clears the last obstacle before the new framework for paediatric R&D is launched on January 1, 2007.

ìThis new paediatrics regulation will allow Europe to reclaim a central role in innovative drug development worldwide, and catch up with other world regions where the necessary framework for paediatric research has been implemented to meet the needs of the patient population,î said EFPIA director general, Brian Ager.

The law will cover drugs currently in development and not yet authorised, as well as authorised drugs both on- and off-patent. Firms will have to present a `paediatric investigation plan', essentially a research and development programme aiming at guaranteeing the necessary data for those who require paediatric treatment.

A paediatric scientific committee at the European Medicines Agency will oversee the process, which has been inspired to some extent by what has happened in the US. There was a notable uptake by companies to do paediatric projects after similar US legislation was adopted.

There are currently very few drugs on the market specifically licensed for the treatment of children. Most drugs prescribed for children are off-label, or unlicensed, adult medicines, which can carry the risk of inappropriate dosing or insufficient efficacy.

In 2002, the European Commission published a consultation paper, Better Medicines for Children, which explored the idea of legally obliging pharma companies to carry out paediatric research.

A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA) said the new regulation ìrecognises the need for a regulatory approach which includes both incentives and requirements to ensure that new medicines for children are developed, and medicines already on the market meet the specific needs of childrenî.

30th September 2008

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