HC Deb 06 November 2003 vol 412 cc787-8W
Mr. Boswell

To ask the Secretary of State for Health what action he is taking to ensure that drug treatments currently licensed for adults are evaluated and made available for paediatric use. [134495]

Miss Melanie Johnson

The current legislative framework governing the authorisation of medicinal products contains neither obligations nor incentives to either evaluate medicinal products for use in the paediatric population or to make the products available for paediatric use. The United Kingdom is taking an active part in developing European legislation, which will establish a system of obligations and incentives for the development and evaluation of medicines for paediatrics use. This is, however, unlikely to be finalised before 2006.

In the meantime, the UK will continue to use the existing regulatory framework to encourage the pharmaceutical industry to evaluate medicines for use in the paediatric population. The Committee on Safety of Medicines, an independent expert committee that advises the Licensing Authority has established a paediatric sub-group to provide expert advice on the regulatory strategy to improve the availability of medicines licensed for use in children.

The Medicines and Healthcare products Regulatory Agency (MHRA) routinely asks companies for paediatric development plans where appropriate, both pre- and post-licensing. In addition, when a marketing authorisation for a medicinal product is granted or amended the pharmaceutical companies are required by the Licensing Authority to provide evidence-based statements on paediatric use in the summary of product characteristics. The MHRA monitors authorisations granted for the paediatric use of medicines in the United States and contacts the marketing authorisation holder with a request for the data to be submitted to the MHRA for assessment. Several companies have submitted data in response to such requests and UK authorisations for paediatric use have been granted as a result. In other cases, the MHRA has asked companies to consider developing formulations of medicinal products that are specifically adapted for paediatric use. Following positive responses, the MHRA is actively discussing formulation development plans with several companies.

The MHRA is keeping the UK pharmaceutical industry informed of legislative developments at the European level and has offered to give regulatory and scientific advice on the development of medicines for paediatric use.

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