Commission adopts proposal for children's medicines
On 29 September the European Commission adopted a proposal for new European regulations on medicinal products for paediatric use. The aim of the proposal is to improve the health of European children by increasing the research and development of children-specific medication and ensuring the authorisation of medicines developed to meet their therapeutic needs. The package of measures includes: the creation of an expert committee within the European Medicines Agency (EMEA); a requirement to provide data on the use of a product in children at the time of marketing authorisation applications; a six-month patent extension for studying children medicines; a new type of authorisation, the Paediatric Use Marketing Authorisation (PUMA), which allows ten-years of data protection for innovation on off-patents products; a requirement for industry to submit existing studies in children; a system of free scientific advice for industry; a database of paediatric studies; an EU inventory of the therapeutic needs of children and an EU network of investigators and trial centres to conduct the studies required. The overall package aims to stimulate innovation to ensure that the European pharmaceutical industry increases the amount of research and development it carries out to adapt products to the need of the paediatric population. 'Today's proposal is a good example of the Commission actively working to improve life for European citizens. In this case, by promoting the availability of new and better medicines specifically designed for our children' said Enterprise and Information Society Commissioner Olli Rehn. 'I believe that our proposal achieves the right balance between these objectives and the need to strengthen the competitiveness of the pharmaceutical industry', he added. Reacting to the proposal, the Association of the British Pharmaceutical Industry (ABPI), congratulated the European Commission but regretted that clinical trial work to be carried out on European children had not been encouraged. 'The incentive of a six-month extension to a medicines patent for companies undertaking clinical trial work in children is a step in the right direction, but it needs to go further to attract such work into the UK and Europe,' said Dr Richard Tiner, director of medicine at the ABPI. The ABPI also expressed its disappointment that the proposal does not offer immediate granting of incentives for paediatric clinical trial work, which means that instead of starting immediately, work on clinical trials for children will probably have to wait until the proposal is accepted by both the European Parliament and the Council. 'While the UK-based pharmaceutical industry fully supports the proposal's aim to foster paediatric research in Europe and to produce medicines adapted to the needs of children, they do not go as far as they could. The UK and Europe could and should be a centre for excellence in conducting paediatric research, but the proposed incentives are not great enough to attract such work here,' added Dr Tiner. The proposal will now be delivered to the Council and European Parliament where it will be subject to the co-decision procedure. The proposal is not likely to become law until the end of 2006.