HC Deb 30 July 1998 vol 317 cc507-8W
Mr. Love

To ask the Secretary of State for Health what plans he has to implement the recommendations of the Licensing Medicines for Children report of May 1996, produced by the joint working party of the British Paediatric Association and the Association of the British Pharmaceutical Industry, on the development of medicines for children; and if he will make a statement. [43822]

Ms Jowell

[holding answer 1 June 1998]: The report of the British Paediatric Association and the Association of British Pharmaceutical Industries joint working party on the development of medicines for children made five recommendations. Of these five, three were felt by the working party to require action by the Department, and more particularly the Medicines Control Agency (MCA).

The three recommendations and action taken on them are:

Medicines are licensed for specific age ranges.

It is the MCA practice to license products for use in the recommended specific age ranges when appropriate data are presented. Use of the age ranges has been confirmed in the revised European guideline on the investigation of medicinal products in children.

The Committee on Proprietary Medicinal Products reviews its guidelines in the light of these concerns.

This has been done. The revised guideline came into operation in September 1997.

That surveillance at various levels is introduced on the use of unlicensed medicines and the prescribing of medicines "off label".

The MCA has well-established systems for monitoring the safety of marketed medicines in normal clinical practice. This covers all patient groups using medicines, including children, and "off label" usage. Nevertheless, a more targeted approach to surveillance of medicines used by children may be warranted, and the MCA reviewed the matter in conjunction with the Royal College of Paediatrics and Child Health. As a first step the MCA has agreed to fund, jointly with the Trent Health Region, the first year of a study which will assess the advantages of a regional monitoring centre for drug safety in children. It is hoped that this will be up and running in September 1998.