The European parliament will vote on a new regulation on medicaments for children today. The new legislative text is beneficial for medics specializing on children patients, and of course especially for the children.

The problem that the regulation wants to change lies in fact, that not all of medicaments and drugs on the market, that are given to both adults and minors, are tested for use by children. And the children are not "little adults" - in many cases the young organism reacts on medicaments differently than organism of an adult person.

The paediatrists rightly complain, that they have to turn on answers of empirical experience, when prescribing medicaments for their little patients - as they have no studies on safety and utility of medicaments for children. It is surprising, that in general there was not made any testing on effects on children on circa 50% of the drugs. It seems that in case of newborn children or children with malign tumours around 90% of medicaments given by doctors were not tested on their effects on minors.

It is clear, that the medics do not give to children dangerous or harmful medicaments, but it is also clear, that if there were made adequate studies, the doctors would have more information and should be thus able to decide which medicament and what amount is for the given patient the best.

Some least educated critics are afraid, that there are going to be „tests on kids.“ This fear is absolutely wrong. In the first place – major part of the tests might be and is conducted in the laboratories and not on humans. Secondly, if are the medicaments tested on humans, there are very severe rules and such studies are checked balanced and controlled, that there is no danger. And thirdly, in my opinion, it is much less ethical and more risky to give to the children medicaments, whose exact effects we do not know and we cannot control them else than in a closely-observed and safe study and then heal the patients better.

The regulation, on which we are going to decide, brings an entirely new approach towards medicaments for children. It creates an obligation for all medicaments-manufacturers to establish an adequate study of effects of newly created medicaments on children. To be more precise, the regulation creates for the manufacturers a new duty to propose the undertaking of the study by a special paediatric commission. If the commission agrees on the necessity of the study, the manufacturer has to conduct it and publish its outcomes. A reward for such study should take form of prolongation of patent protection of the medicament for six months.

In consequence of the new regulation the paediatricians will have more information on what medicaments and how might be prescribed for children. The quality of healthcare will be higher. Also the parents of small patients will have more information about medicaments given to their offspring. The regulation on medicaments for children is one of the meaningful legislative acts of the EU that bring a benefit for citizens of all Member States.

Further information from:
Office of Milan Cabrnoch MEP: +32 2 2845378 (Brussels), +33 3 88175378 (Strasbourg)