The Pharmaceutical Journal
Vol 274 No 7343 p392
2 April 2005

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· Anticoagulation services
· RFID tagging
· Repeat dispensing (2)
· Council election (5)
· PI insurance (2)
· Generics
· Prescription charges
· Medicines for children
· The Society
· CPD
· The register (2)
· The Journal (2)

Letters to the Editor

Medicines for children

Let us have more proactive scepticism

From Dr C. L. C. Tuleu, MRPharmS

I was puzzled by the news item “Child medicine licensing plans inadequate” (PJ, 12 February, p168) which let the reader doubt on the true aspirations of the proposed EU regulations on medicinal products for paediatric use. But then I was horrified by the original position statement (PDF 110K) written by Medicines in Europe Forum, which is composed of family and consumer organisations, patients groups, health insurance companies and few para-pharmacy bodies. This may explain the rather politically and financially oriented discourse in the position statement but it certainly does not justify statements such as “most European children are in good health and do not need new drugs”, “there is no paediatric therapeutic desert”, and “those regulations would increase paediatric consumption of useless and risky drugs, authorised by a paediatric committee affiliated to the [European Medicines Agency] financed mainly by pharmaceutical industry”.

It has been internationally recognised that children are at risk because they are administered the only available inappropriate medicines that have not been clinically tested for safety, efficacy and quality in their age group. The proposed regulation to be finalised, it is hoped, by late 2006 aims to establish a legislative framework that will fulfil the following main objectives:

· Increased availability of medicines specifically adapted and licensed for use in the paediatric population
· Increased information available to the patient/carer and prescriber about the use of medicines in children, including clinical trial data
· Increased high quality research into medicines for children

European regulators are in a great position, being able to benefit from the similar positive American experience, to achieve the best outcome for children, carers and health professionals. More energy should be spent to make the draft regulation even more valuable to facilitate ethical paediatric therapeutic advances rather than to feed the emotive and newsworthy debate “Healthcare of our kids versus profit-making pharmaceutical companies”. If we all agree that the draft regulation seeks to “answer an important true need”, let us have a more proactive scepticism.

Catherine Tuleu
London

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