European health ministers are giving strong backing to moves to encourage pharmaceutical companies to research and develop medicines specifically for children. The initiative has the strong support of the British government, which has made securing an agreement on the necessary legislation one of the priorities of its six month presidency of the European Union, which begins on 1 July.
About a quarter of the EU's 450 million inhabitants are younger than 19, but more than half of all medicines used to treat children have not been specifically tested or authorised for use by this age group. This raises potential problems over correct dosages and possible side effects for young people when they are prescribed drugs authorised on the basis of clinical trials of adults.
The draft pan-European legislation, which was examined by health ministers in Luxembourg on 3 June and will be voted on by the European parliament in July, aims to establish incentives and procedures for developing paediatric medicines. It seeks to ensure high quality research without subjecting children to unnecessary clinical trials.
A strong incentive to encourage pharmaceutical companies to become more active in this area is the suggestion that they should enjoy a six month extension to the supplementary protective certificate—the equivalent of prolonging their patent for this period—for medicines they develop.
Although accepting the need to give manufacturers a financial carrot, several health ministers believe that the incentives may be too generous. The European Generic Medicines Association, which represents over 500 companies and their subsidiaries throughout Europe, agrees.
It estimates that the additional six months' protection would produce €50m (£34m; $61m) for a mid-range product with annual sales of €100m. Blockbuster items stand to gain up to a €500m windfall. It believes that a three month extension would be sufficient.
Commenting on the proposal, Greg Perry, the association's director general, said, "Granting an automatic six month blanket extension will unduly delay the introduction of generics. This will have serious effects on companies working to supply low cost generic medicines to Europe's healthcare systems and will generate undue additional cost burdens to Europe's healthcare systems and patients."
Another unresolved feature of the proposal is the extent to which data on clinical trials should be disseminated. Most governments believe that this should be as wide as possible, if only to prevent unnecessary or duplicative tests, but they have yet to agree the final arrangements.
Measures would be put in place to prevent any authorisation delays for drugs which are developed to treat illnesses found only in adults, such as senile dementia or breast cancer. In addition, the draft legislation foresees the creation of a new expert committee within the London based European Medicines Agency to assess and agree pharmaceutical companies' paediatric testing plans.