Mr. CunninghamTo ask the Secretary of State for Health what evaluation his Department has made of the long term effects of the EU Clinical Trial Directive on clinical research in the UK. [132585]
§ Miss Melanie Johnson [holding answer 20 October 2003]The European Directive on the conduct of clinical trials was adopted in February 2001. The main aim of the Directive is to simplify and harmonise procedures across the Community whilst ensuring the protection of trial subjects and providing a safe environment for the development of new medicines. Member states are required to implement the Directive fully by 1 May 2004.
The scope of the Directive is wide and the UK Regulations will apply to all clinical trials on medicinal products for human use conducted in the UK, including academic and healthy volunteer studies, with the exception of non-interventional trials.
The former Parliamentary Under-Secretary of State for Health, my noble Friend Lord Hunt of Kings Heath, invited the Medical Research Council (MRC) and the Academy of Medical Sciences to co-ordinate a report on the impact of the Directive on academic studies. The impact assessment, prepared by the MRC with the active support of others including Cancer Research UK, the National Co-ordinating Centre for Health Technology Assessment and a number of academic experts formed the basis for a response to the Medicines and Health products Regulatory Agency (MHRA) consultation on the draft regulations to implement the Directive into UK law earlier this year.
In responding to concerns, and to provide an environment in which patients are protected but high quality research is not inhibited, the Government have taken steps to attempt to influence the Commission in its consideration of a Commission Directive on Good Clinical Practice (GCP) and also in reviewing guidance that the Commission published earlier this year.
In another initiative, the Department and the MRC have announced a joint project to work with experts to find practical solutions to the issues identified in the impact assessment. Details of the project can be found on www.ncchta.org/eudirective/index.asp.
With our careful exploration of the impact on publicly-funded research and organisations that support it and delays in the Commission finalising the GCP Directive and other guidance, the United Kingdom's implementing regulations are not expected to be made until early in 2004.
Further information on the scope of the Directive and the proposed UK implementing regulations is available on the MHRA's website www.mhra.gov.uk on the Clinical Trials Directive pages.