Brussels, 28/09/2004 (Agence Europe) - Initiated two years ago, the proposal for a regulation on medicines for use by children will finally see the light of day on Wednesday. The proposal has long been called for by the European Parliament and paediatricians and aims to promote clinical trials in order to determine a posology adapted to the paediatric use of all medicines. This therefore provides a remedy to a situation in which the large majority of medicines are never clinically tested in children, with laboratories simply suggesting that the amount taken should be reduced depending on the child's weight.
The proposal, to be revealed on Wednesday by Commissioner Olli Rehn, is largely based on a regulation that has been in place in the United States since 1997 and which allows several hundred clinical tests to have taken place since then. Key elements in the proposal are: - the obligation to provide data on paediatric use during the request for marketing authorisation (AMM) of new medicines; - a system of exemptions to this obligation for medicine that is not used for children or when testing may be dangerous for children, as well as a clause aimed at preventing delays in making products for adults available; - the creation, within the European Medicines Agency, of an experts committee responsible for validating paediatric testing; - six-month extension of the supplementary protection certificate for medicines that have been tested in children; - the introduction of authorisation for paediatric use for existing medicines which accompanies ten years of data protection for new studies awarded via a Paediatric Use Marketing Authorisation (PUMA); - increased safety monitoring for children's medicines and compulsory submission by industry of existing studies in children; - and an EU inventory of the therapeutic needs of children and an EU network of investigators and trial centres to conduct the studies required.
The Commission also foresees support for paediatric research. At the outset, the proposal included funds for this. Known as "MICE", for Medicine Investigation for Children of Europe, one third of funds should have come from profits made by the industry from extension of protection periods. It should have allowed financing of research and clinical testing on projects already begun. Given the opposition of DG Research, the fund disappeared after interservice consultation. The reason given was simple: research financing must come within the framework-programme and there is no need for provisions on this in the text. The subject should therefore go back to the discussion table in the context of development of the 7th framework programme, the Commission reassures. It remains to be seen whether the original financing formula, which involved a compulsory contribution from industry, will be kept in place or whether a more traditional formula for financing will be used.