Political agreement on paediatric medicines
EU health ministers reached political agreement on the European Commission's proposal for a Regulation on Medicines for Children on 9 December. The proposal can now proceed to the second reading in the European Parliament, and should become law by 2007. Currently over half of all medicines administered to children have not been tested and authorised specifically for children. Whilst medicines for adults must have undergone extensive testing, including pre-clinical tests and clinical trials to ensure that they are safe, of high quality and effective, doctors have a limited choice of medicaments for children who are ill. The Council reached political agreement, by qualified majority, on a draft European Parliament and Council regulation on medicinal products for paediatric use, the main objective of which is to improve child health by increasing the research, development and authorisation of medicines for use by children. At the same time, the regulation will help remove obstacles to intra-Community trade in paediatric medicinal products. Commission Vice President Günter Verheugen expressed his satisfaction on the political agreement: 'I very much welcome this landmark agreement. This regulation will improve the health of children by ensuring innovation in the development of medicines for their use.' Mr Verheugen thanked the UK Presidency for reaching this milestone so quickly and called on the Austrian Presidency and the European Parliament to ensure that this important regulation becomes law as soon as possible. The regulation will increase high quality research and therefore development and authorisation of medicines for children through a combination of obligations, incentives and support measures. The regulation requires specific data on paediatric use at the time of an authorisation application, which should result from an agreed paediatric investigation plan. This requirement will apply to all new medicines, as well as new indications, pharmaceutical forms and routes of administration for existing patent-protected medicines. The obligation will be complemented by a system of waivers for medicines unlikely to benefit children ,and a system of deferrals to ensure that medicines are tested in children only when it is safe to do so, and to prevent the requirements delaying the authorisation of medicines for adults. As compensation for these extra costs, and as an incentive for more research and development in the field of paediatric medicinal products, the regulation foresees a reward for compliance with the requirements in the form of a six-month patent extension, raised to an additional two extra years of market exclusivity for orphan medicines, on top of the existing 10 years awarded under the EU orphan regulation. The regulation also establishes a new type of marketing authorisation, the Paediatric Use Marketing Authorisation (PUMA), which allows 10 years of data protection for innovation (new studies) on off-patent products. Support measures for the implementation of the regulation include a commitment to EU funding for research on off-patent medicines for children --the so-called 'M.I.C.E. Programme', the establishment of an expert committee within the European Medicines Agency (EMEA), to perform independent evaluations of the scientific investigation plans put forward by companies wishing to benefit from the incentives, and specific measures to increase the robustness of pharmacovigilance for medicines for children. The proposal equally provides for a European network of researchers and trial centres to be set up to avoid duplicating research, and an EU inventory of the therapeutic needs of children aimed at focusing research, development and authorisation of medicines. Finally, the proposal also includes a system of free scientific advice for the industry, provided by the EMEA, and a publicly available database of paediatric studies.