§ Mr. LoveTo ask the Secretary of State for Health (1) what steps he is taking to ensure that the issue of establishing a proper licensing system for medicines used in the treatment of children is given the highest priority at a European level; [83788]
(2) what steps he plans to take to examine the experience of the United States in the licensing and regulation of medicines used on children; and if he will make a statement; [83790]
(3) what steps he is taking to press the European Commission to monitor the implementation of EU guidance on the licensing of medicines used in the treatment of children. [83787]
§ Mr. HuttonThe United Kingdom took the lead in revising the European guideline and is committed to working closely with the European Commission and other Member States to monitor the effectiveness of its operation. The Government are committed to ensuring that the regulatory system within Europe effectively addresses the licensing of medicines for use in children. We will work with other Member States to press the Commission to take further action should this prove necessary.
We intend to monitor closely the combination of financial incentives and legislation which has now been introduced in the United States. We will keep the 201W Commission informed of the effectiveness of the US initiative, and its suitability or otherwise for replication within the European Union.