Children’s research encouraged by new rules
New European rules intended to increase the supply of medicines licensed
for paediatric use by providing research incentives come into effect
on 26 January 2007 (PDF 210K).
Companies that test their medicines for suitability to treat children
will get an extra six months’ market exclusivity for medicines
under patent, regardless of whether the results are positive, provided
information is included in the summary of product characteristics. From
26 July 2008, such research will be compulsory. Orphan medicines will
get an extra two years’ market exclusivity.
A greater incentive is on offer for medicines that are out of patent.
In these cases, companies that license them specifically for use by children
will get 10-year paediatric use marketing authorisations.
The changes are being introduced by a European Regulation, which does
not have to be transposed into national legislation. Other changes brought
in by the new Regulation include:
• A European database of paediatric clinical trials
• A requirement to submit paediatric clinical trial data to regulatory
authorities
• A European Paediatric Clinical Trials Network
• Central funding for the study of off-patent medicines
• An identifying symbol on the package of all products authorised for
paediatric use
The new rules and the incentives they offer have been welcomed by Tony
Nunn, clinical director of pharmacy at the Royal Liverpool Children’s
NHS Trust and associate director of the Medicines for Children Research
Network.
“This is the most significant piece of legislation related to children’s
medicines that we’ve seen,” Mr Nunn said. “It will
set the scene for the next 10 to 20 years and put right some of the wrongs
that children have suffered under the Medicines Act 1968.” Mr Nunn
said that the Medicines Act had made it too difficult for manufacturers
to research and develop medicines for children.
“This will improve the availability of medicines for children that
have been appropriately researched and developed and made available in
age-appropriate
formulations and reduce the use of unlicensed and off-label medicines,” he
said.
He added that more clinical trials would be carried out in babies and
children and that the data would have to be made available even if the
results did not support use of the medicine under investigation. The
Medicines for Children Research Network meant that the UK would be well
placed to carry out these trials. |
The
Pharmaceutical Journal
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