EU improves drugs for children
Paediatric drugs must be rigorously researched, the report argues.
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Friday, 14, Dec 2007 12:57
New legislation passed by the European parliament will encourage more thorough research on drugs used to treat children, it has been claimed.
After concerns that European children were being treated with unlicensed or off-label pharmaceuticals, the European parliament implemented legislation in December 2006 to ensure high-quality transparent research was produced.
And according to Professor Imti Choonara of the University of Nottingham, the regulatory laws will reduce the risk of drug toxicity amongst child patients.
"It will also provide better data on the benefits and harms of drugs used in infants and children," he added in a report published in this week's British Medical Journal.
"This will hopefully be achieved without subjecting children to unnecessary clinical trials and - as authorisation for medicines in children can take longer than in adults - will not slow down the introduction of new drugs for adults."
While it is more expensive to develop drugs for children than for adults, the new legislation provides financial incentives for drug companies to study paediatric pharmaceuticals.
He adds that the European Medical Agency will face a challenge to ensure that the drugs studied are those likely to benefit children rather than generate the most profit.
And he explained that a European register of clinical trials will be established and the results submitted to the regulatory agency made public, with the aim of benefiting as many European children as possible.
"Hopefully, the new legislation will stimulate scientific interest in the study of drugs in children and increase the number of paediatric clinical pharmacologists in Europe," Prof Choonara added.