The Pharmaceutical Journal
Vol 272 No 7297 p532
1 May 2004

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Legislation will delay child medicines claim

European legislation (PDF 100K) on children's medicines will delay their availability, according to the Association of the British Pharmaceutical Industry (PJ, 20 March, p341).

Richard Tiner (the association’s director of medicine) regretted that EU proposals on the matter were unlikely to be finalised for at least another 18 months.

The Journal understands that the industry’s concerns over the issue may include proposed links between submission of paediatric data with incentives such as extensions to patent protection and marketing exclusivity outlined in draft legislation. These rewards will not be available retrospectively.

An ABPI spokesman confirmed that the industry considers incentives an important, although not principal, issue related to licensing of medicines for children.

The spokesman also confirmed that there were no reasons why pharmaceutical companies were currently unable to pursue paediatric licensing for medicine, despite the lack of EU regulation.