EU Parliament vote should mean more pediatric medicine developments

Following a proposal from the European Commission in September 2004, the European Union Parliament and Council have reached a final agreement on a regulation for pediatric medicines. Currently, more than 50% of the medicines used to treat children in Europe have not been tested and authorized for pediatric use.

Parliament voted on the issue this month, and it will now be easier for pharmaceutical companies to develop infant medicines, aimed at ending the current situation, under which most children take small doses of drugs developed for adults, which may not correspond to their metabolism and can even be harmful. Drugmakers which develop effective and safe tests for pediatric medicines will receive a six-month patent extension. Only those firms meeting strict standards will be allowed to market infant medicines.

"This regulation, which is in favor of pediatric medication, is a concrete response to various expectations. This text shows how much Europe influences day-to-day life. A single member state alone does not have the means to promote such a policy in favor of all children," commented the rapporteur for the legislation, Francoise Grossetete (EPP-ED, France).