§ Mr. LoveTo ask the Secretary of State for Health (1) what steps he is taking to monitor the use of unlicensed and off-label treatments on children; and if he will make a statement; [159605]
(2) what research his Department has carried out into the extent of the use of unlicensed and off-label treatments on children; and if he will make a statement. [159606]
§ Ms Stuart[holding answer 30 April 2001]: The vast majority of medicines on the United Kingdom market have been granted a marketing authorisation. Use of medicines in children where this is not specified in the 148W marketing authorisation ('off-label' use) is permitted under UK law where the clinician believes it is justified. This is a matter for clinical judgment, informed by specialist guidance produced by and available to the profession. The Medicines Control Agency and Committee on Safety of Medicines continue to monitor the safety of all medicines, whether used within their product licence or used unlicensed or 'off-label'.
It is our view that children should have access to medicines that have been fully evaluated for use in childhood. As medicines regulation in the UK derives largely from European legislation, an international approach is needed. We have therefore raised the profile of the issue at European level to encourage companies to undertake appropriate trials on the use of medicines in the treatment of children. This formed the basis for an international guideline, operational in the European Union from January, and applicable in the United States of America and Japan. In addition the European Commission has been asked to develop measures for children's medicines. We await their proposals.