Drugs (Children) (Hansard, 16 October 2001)

§ Ms Blears

[holding answer 19 July 2001]We recognise the critical importance of this issue and agree that children should have access to medicines that have been fully evaluated to the same high standards of safety, quality and efficacy as those available for the adult population. The issue is not confined to the United Kingdom, but affects the whole of Europe and the United States. Medicines regulation in the UK derives largely from European legislation and an international approach to the issue is therefore needed.

We have consequently raised the profile of this issue at a European level, including taking the lead in developing a European guideline, adopted in 1997, to encourage companies to undertake appropriate clinical trials on the use of medicines in the treatment of children. This formed the basis for an international guideline, which came into operation in January in the EU, and also applies in the USA and Japan. In addition, the Council of the European Union has asked the European Commission to bring forward measures to make sure that medicines for children are fully adapted to their specific needs. We are presently waiting for their proposals. However, the Commission has stated its intention to comply with this request. The UK will play an active role in the development of this initiative to ensure that effective solutions are found.

In addition, the Committee on Proprietary Medicinal Products (CPMP), the scientific advisory committee of the European Medicines Evaluation Agency (EMEA), recognising the importance of this topic has announced its intention to set up a Paediatric Expert Group to advise the EMEA and its scientific committees on all questions relating to the development and use of medicinal products in children. The UK has nominated representatives to this Paediatric Expert Group.

In the meantime, the UK Government have taken important steps to address the issue at a national level within the existing regulatory framework. The Committee on Safety of Medicines (CSM), an independent expert committee that advises the Licensing Authority has established a Paediatric Sub-Group to provide expert advice on the regulatory strategy to improve the availability of medicines licensed for use in children. MCA now routinely asks companies for paediatric development plans where appropriate. Pharmaceutical companies are required by the Licensing Authority to provide dosage information in the Summary of Product Characteristics when a Marketing Authorisation for their 1135W medicinal product is granted or amended in the UK. This dosage information must be supported by the findings from clinical trials undertaken in the relevant adult or paediatric patient population.

The safety of all medicines whether licensed, used outside the terms of their licence, or unlicensed, is monitored by the Medicines Control Agency and CSM. Various data sources are used for monitoring safety including: the UK Yellow Card Scheme for reporting suspected adverse drug reactions, suspected adverse drug reaction reports from abroad, the world-wide medical and scientific literature, clinical trial reports and periodic safety updates from manufacturers. The UK Yellow Card Scheme acts as an early warning system for drug safety hazards but is not a scheme for recording all suspected adverse reactions that occur in the UK. Data from the Yellow Card Scheme cannot, therefore, provide estimates of the incidence of adverse reactions, including fatal adverse reactions occurring in children. The CSM Working Group on Paediatric Medicines also advises on the collection of information on adverse reactions in relation to unlicensed use of medicines in children.