english.prescrire.org > Spotlight > Archives : 2005 > Medicines for paediatric use: a move towards better European regulation

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2005 : 1 | 30 | 60

Medicines for paediatric use:
a move towards better European regulation

MEPs improved the proposed European Regulation on Medicinal Products for Paediatric Use on its first reading. But the European Commission and national governments can still challenge these measures.

The draft European Regulation on Medicinal Products for paediatric use proposed by the European Commission (Enterprise Directorate-General) seeks more to emulate US policy in this field than genuinely to improve the evaluation of medicines for children. It allows drug manufacturers to extend their monopoly on marketing a drug for adults by 6 months if they fund a trial on children, whatever the outcome. Despite heavy lobbying by pharmaceutical companies and their allies to adopt the proposed Regulation hastily and without amendment, the bill was significantly improved by the MEPs on its first reading, thanks in particular to campaigning by the Medicines in Europe Forum. MEPs favoured a better definition of children's needs and of research priorities, increased transparency at various important stages of the process of evaluating drugs for paediatric use, and improved paediatric pharmacovigilance. Unfortunately, the rewards provided for by the Regulation remain unrelated to the therapeutic benefits a drug offers children, or to the real cost of the research undertaken. But hopefully the gains will not be challenged by the European Commission or the Ministers, or during its second reading in Parliament.

©Prescrire November 2005

Source: "Médicaments pédiatriques : règlement européen en partie amélioré, mais des manques importants " Rev Prescrire 2005 ; 25 (266) : 781-782.

- More articles in Prescrire's "Spotlight"...