Parliament endorses regulation to improve R&D in paediatric medicines
The European Parliament has reached a final agreement on a regulation on children's medicines aimed at increasing research and development and authorisation of medicines for paediatric use. Before any medicine is authorised for use in adults, the product must undergo extensive testing, including pre-clinical tests and clinical trials to ensure that it is safe, of high quality and effective. In contrast, more than 50 per cent of the medicines used to treat children in Europe remain untested and unauthorised for use in children. In practical terms, the Commission says, this leaves doctors with a very limited choice of medicines to prescribe to children. The agreement looks set to change this with the introduction of a package of requirements obliging pharmaceutical companies to present the results of clinical trials involving children at the time of the authorisation of drugs. The same would apply to companies that already have patent-protected drugs on the market and wish to extend the use of the drug. Similarly, the regulation aims to better regulate research in the field, proposing the following support measures: - a commitment to EU funding into studies on off-patent medicines for children; - the establishment of an expert committee, the Paediatric Committee within the European Medicines Agency (EMEA); - measures to increase the robustness of pharmacovigilance for medicines for children; - an EU inventory of the therapeutic needs of children to focus research, development and authorisation of medicines; - an EU network of investigators and trial centres to conduct the research and development required; - a system of free scientific advice for the industry, provided by the EMEA; - a publicly available database of paediatric studies. Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Brian Ager, welcomed the agreement, saying: 'Research-based pharmaceutical companies are already engaged in researching better medicines for children, but this new Paediatrics Regulation will allow Europe to re-claim a central role in innovative drug development worldwide, and catch up with other world regions where the necessary framework for paediatric research has been implemented to meet the needs of the patient population.' The Council is expected to formally endorse the agreement in the coming days.