EU law may require drug trials on children

Clinical trials: Drug companies will have to carry out clinical trials on children before bringing new drugs onto the market if an EU regulation endorsed by the EU Council of Health Ministers earlier this month is passed by the European Parliament next year.

The regulation, which is expected to become law in all member states by early 2007, also includes a requirement for research evidence before a pharmaceutical company can apply for a licence to use a drug in children which is already on the market.

Currently more than 50 per cent of medicines used to treat children across Europe have not been tested for use on children and are not authorised for use on children.

Most doctors use drugs "off-label" relying on clinical experience to adapt dosage and frequency of drugs when using them with children.

However, inaccuracies do occur especially with dosage calculations and when risks of side effects aren't fully known.

Welcoming the proposed legislation, the Irish Medicines Board (IMB) said, "The fact that this legislation will stimulate paediatric clinical trials will result in the provision of medicines that are geared specifically towards children and so will be of benefit to them.

"Drugs act differently in children compared to adults, and children also respond differently which has consequences in terms of effectiveness and side effects."

The proposed measures also include the establishment of an EU paediatric study programme, Medicines Investigation for the Children of Europe (Mice), to encourage research into the use of off-patent medicines in children.

The legislation will also herald the way for improved safety monitoring of drugs used on children and patient leaflets with specific child dosage instructions and details on side effects in children.

The Irish Pharmaceutical Healthcare Association (IPHA) urged early completion of work on the legislation, which is due for its second reading in the European Parliament next year.

"For the sake of our children and potential improvements in their health outcomes which could come from further research, we cannot afford to delay," said a IPHA spokesman.

"Our children must be able to benefit from medicines tailored to their special needs and this must be achieved by restoring a strong pharmaceutical research and development presence for Europe without delay," he said.

A series of waivers proposed within the regulation allow drug companies to omit clinical trials on children for drugs used in adult-only diseases or if there is good evidence that the drugs are dangerous for children.