HC Deb 13 February 2004 vol 418 cc301-2W
Paul Flynn

To ask the Secretary of State for Health what plans he has to restrict the prescription of unlicensed drugs to children. [155331]

Ms Rosie Winterton

There are no plans to impose a general restriction on the prescription of unlicensed medicines to children.

Most medicines have only been tested for safe and effective use in the adult population and there are comparatively few medicines on the market that are specifically licensed for the treatment of children. This leads to prescribers having no option but to prescribe unlicensed and off-label medications in this patient population.

Normally, if a product has not been licensed for use in children because of a lack of clinical trial data and/or clinical experience, the summary of product characteristics contains statements to this effect and use in children is not recommended. However, further restrictions (contraindications) have been introduced with respect to the off-label or unlicensed use of specific medicinal products where there is evidence that the benefit/risk may be unfavourable.

The real solution to this problem lies not in restricting paediatric prescribing but in stimulating the development and testing of appropriately formulated medicines for use in the paediatric population. It is expected that the European Commission will adopt a proposal for a Regulation on medicines for paediatric use by the end of April 2004. It will contain a number of incentives and obligations to stimulate the development of medicines for children. In the mean time officials have been asked to develop a UK strategy to deliver, in the short and medium term, improved availability of medicines that are appropriately labelled and appropriately formulated for use in children.

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