Draft EU regulation on paediatric medicines: some improvements but still far from perfect

(1) In 2004, the European Commission proposed a draft European Regulation on paediatric medicines. This draft was more closely oriented towards defending drug companies' interests than with meeting children's medical needs. (2) Despite pressure from drug companies and their allies, several major improvements were made to the draft at its first reading in the European Parliament, thanks especially to the efforts of the Medicines in Europe Forum. (3) In particular, European deputies pushed for a better definition of children's needs and paediatric research priorities, greater transparency at various important stages of the market authorization procedure, and strengthened pharmacovigilance. (4) Yet the incentives and rewards offered to companies fail to take into account the notion of true therapeutic advantages and R&D expenditure. (5) Unfortunately the Commission refused some important amendments and published a new draft proposal, which was accepted by the Council of Health Ministers at the end of 2005. The new draft will come before the Parliament for a second reading in 2006.