Half of the drugs used in the European Union to treat children and 90% of drugs given to newborn babies have never been tested or authorised for use in these age groups, warns a new UK report. The report supports new European proposals to test drugs in children.
The report, published last week, supports the European Commission’s proposal to introduce a common EU–wide procedure for testing and approving drugs for use in children and incentives to encourage manufacturers to develop drugs specifically for paediatric use.
The subcommittee of the House of Lords European Union Committee that developed the report said: “It is high time this was done, and the framework proposed seems right.”
However, it cautioned: “Ethical considerations on the implementation of the rules need to be carefully considered, and the incentive mechanisms proposed are a leap of faith which will have to be examined rigorously after they have been tried out.”
The report found that many prescription and over the counter drugs are currently not properly tested on children before they are launched.
After hearing evidence from relevant bodies—including the British Medical Association, Cyril Chantler, the chairman of Great Ormond Street Children’s Hospital, and the Royal College of Paediatrics and Child Health—the committee advised the UK government to support the European Commission’s proposals.
It said: “There is an overwhelming and urgent need to take effective action at European level to govern clinical trials in children and the authorisation of medicinal products for paediatric use with the minimum of delay.”
The committee considered that new guidelines covering clinical trials involving children must take children’s vulnerability into account, paying particular attention to their rights and capacity to give informed consent. Trials must also allow for the possibility of conflict between parents and children in giving consent to participate in trials.
In addition, trial guidelines should clarify the distinction between consent and acquiescence in trials involving children, as well as the extent to which any trial might benefit an individual child taking part.
The committee was also concerned about proposals for incentives designed to stimulate the development of drugs for children. These include extending the period of market exclusivity for drugs tested in children and giving 10 years of data protection for new paediatric studies with off–patent medicinal products developed specifically for use in children.
Baroness Thomas of Walliswood, who chairs the subcommittee, said: “The arrangements proposed are based on a system that seems to work well in the US and is accepted by most professionals here.
“We’ve recommended that they should be rigorously examined in a few years’ time to make sure they are working properly, giving drug companies fair rewards for their research and development, but ensuring that the cost to the NHS and the health services of other member states is reasonable.”
The report says that the UK government should ask the European Commission to carry out a full economic review of the incentive arrangements after a few years of operation.
In addition, the report recommends that clinical trials should assess the effects of drugs on children of different ages and that the European Clinical Trials Database should contain full details of all trials involving children.
Finally, it advises that all medical products should be properly labelled to indicate their suitability for children. If passed, the new European law is likely to come into force in 2007.
Paediatric Medicines: Proposed EU Regulation is accessible at www.publications.parliament.uk/pa&/ld/ldeucom.htm.