The Pharmaceutical Journal
Vol 274 No 7337 p205
19 February 2005

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· Labelling
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Letters to the Editor

Medicines for children

Support draft European legislation

From Mr A. J. Nunn, FRPharmS

Your short news report (PJ, 12 February, p168) suggests that the Medicines in Europe Forum has misinterpreted the draft European legislation on the development of paediatric medicines. This legislation will provide incentives and requirements to develop and authorise new medicines for children at the same time as for adults. There will be additional incentives to authorise paediatric indications and formulations of existing patented medicines. There will also be new requirements for pharmacovigilance, including requests for long-term studies in children, for example, to monitor effects on growth and development. The legislation proposes a new Paediatric Committee within the European Medicines Agency which will scrutinise applications for paediatric drug development plans and only approve those that are in the interests of children. What is not available in the current draft, which was present in the earlier consultation, is a funded study programme to encourage research on older medicines, many of which are adapted “adult” medicines or extemporaneous formulations already used for children.

European expert groups are currently identifying the needs and priorities for medicines for children. The Department of Health and the Medicines and Healthcare products Regulatory Agency paediatric strategy (PJ, 21 August 2004, p246) will assist in delivering on these needs by encouraging pharmaceutical companies to present existing paediatric data for scrutiny, by encouraging marketing in the UK of suitable paediatric medicines authorised in other countries and by establishing a clinical research network specifically for the study of medicines for children. I fail to see how any of this “will encourage paediatric use of risky and useless medicines”. It is to be hoped that the Medicines in Europe Forum and others with an interest in removing the “therapeutic orphan” status from children, will support the draft European legislation and, if necessary, seek appropriate additions during its forthcoming passage through the European Parliament.

Anthony J. Nunn
Clinical Director of Pharmacy
Royal Liverpool Children’s NHS Trust

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