New EU rules mean medicines will be developed just for children

Jun 4 2006

In a rather worrying revelation it appears that fifty percent of the medicines currently used to treat children have only been tested on adults.

As they do not have the authorisation for use specifically on infants, it means it is often difficult for doctors to gauge the right dosage or predict likely side-effects.

This practice is fraught with danger as children sometimes absorb drugs differently to adults, and can suffer different side effects.

But fortunately that is about to change in Europe and by next year medicines which are made especially for children will hopefully be available.

The European Parliament has issued new rules regarding drugs for children and have drawn up draft legislation that will require that drugs are tested on children; in exchange drug companies will be given six months extra patent protection from generic drugs.

Cancer specialists say that many cancer drugs are widely used to treat children on an "off-label" or unlicensed basis, and the new rules would improve safety.

The regulation will help to ensure that only safe and effective medicines specifically formulated for children are used and remove the guesswork currently used as to what level of dose would be safe for a child to take.

The new rules will cover drugs still in the development stage and which are not as yet authorized as well as those already in use.

Drug firms will be required to submit a "pediatric investigation plan" to show how the treatment should be used for children.

The EU is emulating the United States, which introduced pediatric legislation in 1997 that led to new prescribing information and label changes on 44 drugs.

The EU's drug approval body, the European Medicines Agency, will set up a pediatric committee and the new rules are expected to encourage drug firms to carry out research into drugs for children.