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Clinical Trials

Volume 409: debated on Friday 18 July 2003

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To ask the Secretary of State for Health what impact the introduction of the Medicines for Human Use (Clinical Trials) Regulations in May 2004 will have on trials of new treatment regimes carried out by researchers in hospitals and universities; and if he will make a statement on how the directive will be implemented in the UK. [126828]

The draft regulations are to transpose into United Kingdom law, Directive 2001/20/EC on approximation of the laws, regulations and administrative provisions of the member states relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Consultation on the draft regulations closed on 16 May 2003. The Medical Research Council's (MRC) response is available in full on its website. Its assessment reflected the main concerns expressed by the charitable and public sector.The Department of Health and the MRC have agreed jointly to lead a project to clarify the arrangements for publicly funded clinical trials involving medicines in the UK. It will draw up practical advice to enable publicly funded clinical trials involving medicines to comply with the law while making best use of existing good practice, minimising additional bureaucracy and making maximum use of public resources to avoid unnecessary expense.The project is about to start, under the chairmanship of Professor Kent Woods, Director of the national health service health technology assessment programme. It will draw extensively on expert advice from trialists and from the charitable and public sector.Member states are required to implement the Directive fully by 1 May 2004. I announced that the process of developing the regulations should be completed some time after Parliament reconvenes in October, with the aim of an update around that time.