Children are being denied the same rights as adults in the provision of properly-tested drugs

Consumers' Association

About 40% of the drugs used in paediatric medicine have either no explicit licence for use on child patients, or are used "off-label" by doctors.

This means they are licenced for children, but are being prescribed for conditions not covered by the licence.

In the treatment of newborn babies, as many as 65% of commonly-used drugs fall into these categories.

Drug manufacturers usually conduct adult trials on new medicines.

This is because is it ethically simpler to obtain consent from adults than from children or their parents - and there are usually far more adult patients with a particular condition, making it easier to draw together the large groups needed for a well-constructed trial.

Parents are normally unwilling to allow their children to participate in a clinical trial.

Dr Trevor Jones, the director general of the Association of the British Pharmaceutical Industry (ABPI), said: "There are practical and ethical issues involved in testing medicines particularly where infants or babies may be involved. It is simply unethical to carry out experimental studies on babies unless we are convinced it is safe to do so."

'Rights denied'

Clara Mackay, from the Consumers' Association, said: "Children are being denied the same rights as adults in the provision of properly-tested drugs.

"Parental consent for testing new treatments or procedures with children is understandably an issue of concern. But we are equally concerned that children are being prescribed medicines every day which have not been tested or licensed for such use."

The association sent out letters to 80 pharmaceutical companies asking them to outline their policies on trials involving children, but only a handful replied.

The ABPI complained that the letters had only been sent out at the end of April, and that two weeks was not long enough to formulate a "reasoned response to a serious issue."

The Royal College of Paediatrics and Child Health recently published the first ever guide to the safe use of adult drugs in children, giving guidance on safe dosages and side-effects.

The ABPI said that it hoped to have an international system for licensing medicines for five different age groups agreed in November.

The Consumers' Association campaign has been backed by the medical charity Action Research.

Action Research paediatrician Dr Mike Shields, of the Queen's University of Belfast, said: "The way that the body gets rid of drugs is very different in children compared with adults.

"We need data that tells us which drugs are safe to use with children and what dose to give them."

A spokesman for the Royal College of Nursing also called for the licensing of medicines prescribed for children to be tightened.

Paediatric nursing adviser Sue Barr said: "Parents are bound to be worried by this report - children can't be treated as `small adults' when drugs are being prescribed."