European Parliament legislation will improve the regulation of pediatric drug treatment, according to an Editorial in the British Medical Journal (BMJ), this week’s issue.
Author, Professor Imti Choonara, University of Nottingham, UK, explains that over the past decade studies have indicated that the use of unlicensed and off-label drugs to treat children is widespread. Eight years ago the European Union had expressed concern about the popularity of off-label drugs usage for children, rather than treatments which had been scientifically evaluated and licensed. In December last year the European parliament introduced legislation to make sure that drugs used for pediatric treatment are subject to high quality research.
It will also provide improved data on the advantages and disadvantages of medications used for babies and children, without subjecting children to needless clinical trials and without undermining the introduction of new drugs for adults.
The legislation encourages companies to study drugs for children, with some financial incentives. However, the author notes that in America drug companies tend to study drugs that have done well with adults – the ones that have made the most money – possibly at the expense of the clinical needs of infants and children.
A register of European clinical trials of pediatric drugs will be established, and the results which are sent to the regulatory agency will be available to the public. The writer stresses that transparency is crucial if it is to benefit European children. It will be necessary that the pharmaceutical industry work closely with pediatric health professionals to make sure that all clinical trials in children are designed and performed safely.
The new legislation will hopefully stimulate scientific interest in the study of pediatric drugs and raise the total number of pediatric clinical pharmacologists in the European Union, the writer concludes.
Editorial
“Regulation of drugs for children in Europe”
Imti Choonara
BMJ 2007;335:1221-1222 (15 December), doi:10.1136/bmj.39400.376424.BE
Written by – Christian Nordqvist