• Press Office

    Posted in category News Release by Press Office on 29/09/2004

    European proposals on children's medicines do not go far enough, says ABPI

The proposal for new European regulations on children's medicines is welcome - but the European Commission is missing an opportunity to encourage clinical trial work in children to be carried out in Europe, the Association of the British Pharmaceutical Industry (ABPI) said today.


‚ÄčThe full text of the proposal - which has come under criticism for taking nearly four years to produce - has to be studied in depth by the industry.

"The incentive of a six-month extension to a medicines patent for companies undertaking clinical trial work in children is a step in the right direction, but it needs to go further to attract such work into the UK and Europe," said Dr Richard Tiner, Director of Medicine at the ABPI.

The ABPI also expressed its disappointment that the proposed arrangements did not allow for immediate granting of incentives for paediatric clinical trial work. This means that work on clinical trials for children is likely to wait until the proposals have completed their journey through the European system - probably about 18 months - rather than being able to start immediately.

"While the UK-based pharmaceutical industry fully supports the proposal's aim to foster paediatric research in Europe and to produce medicines adapted to the needs of children, they do not go as far as they could. The UK and Europe could and should be a centre for excellence in conducting paediatric research, but the proposed incentives are not great enough to attract such work here," said Dr Tiner.

"However, the number of medicines licensed for use in children in Europe will continue to rise because of continuing research in the US."

For further information, please contact: ABPI Press Office 020 7747 1410

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