§ Ms DrownTo ask the Secretary of State for Health what action he will take to ensure that the existing licensing framework for medicines minimises the risks posed to children's health. [67187]
§ Ms Jowell[holding answer 2 February 1999]: The safety of medicines is monitored via the "Yellow Card" adverse reaction notification scheme by medical staff at the Medicines Control Agency (MCA). This has recently been extended on pilot basis in Trent Region to cover adverse reactions specific to use of medicines in children.
There is currently no obligation on companies to apply for a licence for use of their product in children, although it is desirable wherever possible that medicines should be used under the terms of the licence. There can be practical difficulties in conducting such clinical trials—as well as significant ethical concerns. However, because of the concern about extensive "off-label" use of medicines in children, in 1997 European guidelines were developed to encourage the conduct of clinical trials in children. This is a major step forward and requires an applicant for a marketing authorisation (licence) in the United Kingdom or elsewhere in Europe, to justify reasons for not supplying data on use of the product in children. If the industry's response to the guidelines fails to result in 165W the timely availability of licensed medicines for children, the UK will consider what further steps can be taken to minimise the risks posed to children's health from use of such medicines.