Book Description

Over 50 per cent of all medicines given to children (and about 90 per cent of those given to the newly-born) have never been tested or authorised for use on them. The Committee's report examines the European Commission's proposal to introduce a Regulation (the Clinical Trials Directive) on medicinal products for paediatric use which aims to stimulate the development of medicines for children and lay down rules for testing and approval. Issues discussed include: the need for better regulation of paediatric medicines; the ethical considerations involved in clinical trials on children, including the issue of consent; mechanisms for implementing the Regulation; access to the database of information on clinical trials; the rewards and incentives proposed to stimulate the research and development of medicines; and the legal basis for the regulation under the EC Treaty. The Committee's report recognises the urgent need for effective action at the European level to authorise medicines for paediatric use and gives broad support to the proposed Directive. However, a number of key issues are highlighted, including: the need for improved labelling of medicines; that the guidelines underpinning the Directive should take account of ethical considerations involved to ensure the rights and capacity of children to give informed consent to trials; and concerns are raised about the adequacy of proposed incentive mechanisms.