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Paediatric drugs: Europe can and must do better

The European Commission's draft Regulation on paediatric drugs needs amending.

In 2004, the European Commission proposed a Regulation to encourage the development of new paediatric drugs. The draft Regulation provides for additional incentives (paid out of public funds) to pharmaceutical companies to persuade them to develop more medicines for children and therefore to finance more research involving children. The Medicines in Europe Forum, of which Prescrire is a member, welcomes the Commission's initiative, but holds the view that the draft Regulation must be brought back to its initial aim of promoting public health. A thorough review of children's real needs must be carried out by independent bodies, so as to direct research along the right lines. Incentives should be offered to public institutions as well as to private firms. The parameters should be made clear, to avoid any bending of the rules or inappropriate use of incentives and funds. The rewards should be proportional to the research and development efforts made to develop drugs that are genuinely needed. There should be increased pharmacovigilance during trials on children. The Forum intends to support amendments aiming to make the draft Regulation even more effective in fulfilling its public health aims.

©Prescrire March 2005

Source: "La proposition de Règlement européen relative aux médicaments "pédiatriques" est trop loin des besoins des enfants" Rev Prescrire 2005 ; 25 (259) : 226-227.

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