The European Parliament voted on 7 September in favour of a European Commission Directive to guarantee that medicines administered to children are actually suitable for them. An overwhelming majority of MEPs supported this way the stimulation of research into development of paediatric medicines in Europe.
The Parliament’s decision will now go to the Council, where the governments of the EU member states will have to decide if they approve the Directive as it is or if they send it back to the Parliament for further debate.
According to the European Medicines Agency (EMEA), the body in charge of authorizing medicines in Europe, 50% or more of medicines used in children in the EU have never been actually studied in children. They have been tested in adults and not necessarily in the same indication (or the same disease). This is mainly due to difficulties in conducting clinical trials and to the low profitability of the market.
The law was passed a day after UK scientists unveiled a study suggesting that two-thirds of children treated in hospital are given drugs that have not undergone appropriate tests.
The Directive as voted by the Parliament provides a six month extension for patent products to allow industry to develop children’s medicines - hoping it will provide the necessary incentives for pharmaceutical companies to invest in research in drugs for children. A revision clause sets out that this rather controversial point should be re-evaluated six years after entering force.
MEPs adopted amendments aiming to shorten procedures and administrative delays, to improve transparency and the exchange of information to prevent the duplication of clinical trials. They also asked for a new research programme - to be called MICE "Medicines investigation for the children of Europe" - to be launched to adapt for children existing substances which are no longer covered by patents.
The creation of a new Pediatric Committee was also another of the amendments proposed by the Parliament. This Committee should be set up within the European Medicines Agency, within six months of the entry into force of the Directive. It would have the task of independently evaluating scientific investigation plans put forward by companies wishing to benefit from the incentives created by the regulation.
Position of the European Council
The Employment, Social Policy, Health and Consumer Affairs Council has adopted its position on the directive for medicinal products for paediatric use. It should be noted that the Polish delegation voted against it.
The European Parliament must now consider this position in second reading. This should begins in April 2006.
Procedure file on the European Parliament’s Legislative Observatory
