New legislation by the European parliament will improve the regulation of drug treatment for children, says a child health expert in this week's BMJ.
Over the past ten years, studies have shown widespread use of unlicensed and off-label drugs to treat children, writes Professor Imti Choonara from the University of Nottingham.
AdvertisementIn 1999, concerns were raised about children in Europe receiving unlicensed or off-label drugs instead of ones that have been scientifically evaluated and licensed. So in December 2006, the European parliament passed legislation to ensure that drugs used for children are subject to high quality research.
It will also provide better data on the benefits and harms of drugs used in infants and children, without subjecting children to unnecessary clinical trials and without slowing down the introduction of new drugs for adults.
The legislation provides considerable financial incentives for the drug industry to study drugs in children. However, the author points out that experience in the United States has shown that the drug industry is more likely to study drugs that are prescribed extensively in adults and generate the most profit than those that infants and children require clinically.
A European register of clinical trials of drugs for children will also be established and the results submitted to the regulatory agency will be made public. This transparency is essential, says the author, if it is to benefit children in Europe.
To ensure that clinical trials in children of all ages are designed and performed with safety as a priority, the industry will need to work closely with paediatric health professionals, he adds.
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, he concludes.