§ Mr. LoveTo ask the Secretary of State for Health (1) what steps he is taking to make EU guidance on medicines for children legally binding on pharmaceutical companies; [69684]
(2) what steps he is taking to assess the cost to the NHS of making guidance on medicines for children legally binding on pharmaceutical companies; [69685]
(3) what steps are being taken by EU member states to monitor the way pharmaceutical companies comply with EU guidance on the licensing of medicines for children; which companies have complied with this guidance; which products are being developed in accordance with this guidance; and when the application of the guidance will be extended to products already on the market, in other EU member states. [69683]
§ Ms JowellThe European Union guidance came into operation in September 1997. As the development times for medicinal products are relatively long, there will be a delay before trials in children are submitted with all relevant applications for authorisation of medicinal products.
Where a medicinal product has an anticipated therapeutic benefit in children, the applicant is asked to provide details of a paediatric development plan if this is not already included in the dossier supporting the application for marketing authorisation. Information relevant to paediatric use, based on the availability or not of paediatric data, is included in the product particulars. The EU guidance on the investigation of medicinal products in children applies to products already on the market as well as to new products. Information on those companies which have so far complied with this guidance in other member states is not available, neither is information on those products which are being developed in accordance with this guidance in other member states.
221WEuropean guidance is not legally binding on pharmaceutical companies and no steps have been taken to assess the costs to the National Health Service of making guidance on medicines for children legally binding on pharmaceutical companies. If the guidance does not have the effect of increasing the availability of appropriate medicinal products to children, there is scope for the United Kingdom and other Member States to raise with the European Commission the question of whether legislative steps should be taken to strengthen the regulatory framework.