§ Mr. Love
To ask the Secretary of State for Health (1) what assessment the Government have made under the licensing process of the side-effects of medicines used on children; 
(2) if he will assess the applicability for the United Kingdom of the system for licensing medicines for children in the United States, which will compel pharmaceutical companies to provide information about the effects of their drugs on children; 
(3) what is the incidence of adverse reaction of children to (a) unlicensed and (b) off-label treatments. 
§ Ms Jowell
There is no centrally held record of suspected adverse reactions to medicines and the incidence is not therefore known. However, the Yellow Card Scheme exists for health professionals to report suspected adverse reactions to the Medicines Control Agency and Committee on Safety of Medicines on a voluntary basis. This scheme has been successful in identifying new hazards to medicines so that prescribers may be informed about the safe use of medicines. In addition, a pilot scheme has been set up in the Trent Region, with funding from the Medicines Control Agency, to monitor the safety of medicines in children. This includes suspected adverse reaction reports associated with unlicensed and off-label usage of medicines in children.
When an application is made for a licence for a medicine for use in children, the evidence submitted in 88W support of the quality, safety and efficacy of the medicine is evaluated. The side-effects occurring during the paediatric clinical trials are assessed as part of this evaluation. A final decision regarding the grant of a licence for use in children is made after weighing the potential benefits of the proposed treatment against the potential risks.
Currently in the United Kingdom the decision to undertake appropriate trials to support an application for a licence for use of a medicine in the treatment of children rests with pharmaceutical companies. A recently adopted European guideline encourages the pharmaceutical industry to undertake appropriate clinical trials on products with anticipated therapeutic benefits in children. However, if the guidance does not have the effect of increasing the availability of appropriate medicinal products for children, there is scope for the UK and other Member States to raise with the European Commission the question of whether legislation similar to that in operation in the United States should be introduced to strengthen the European regulatory framework.