EU Directives (Hansard, 12 February 2004)

§ Mr. Best
To ask the Secretary of State for Health what assessment he has made of the impact of(a) EU 1688W Directive 2001/20/EC and (b) the Medicines for Human Use (Clinical Trials) Regulations 2003 on cancer research in the UK. [152325]

§ Miss Melanie Johnson
Member States were required to transpose the provisions of the Clinical Trials Directive (2001/20/EC) into national legislation by 1 May 2003, and to implement the Directive by 1 May 2004. The Government have consulted widely on these important new Regulations and undertaken to take account of all points of view, including the views of those involved in cancer research before finalising the implementing Regulations. One of the main aims of Directive 2001/20/EC is to provide a safe environment for participants in clinical trials while not inhibiting the development of essential new medicines for human use. Implementation of an efficient regulatory system will help new effective medicines for diseases such as cancer to reach the market more quickly whilst protecting subjects enrolling into clinical trials.

§ Mr. Best
To ask the Secretary of State for Health if he will make a statement on(a) EU Directive 2001/20/EC and (b) the Medicines for Human Use (Clinical Trials) Regulations 2003. [152327]

§ Miss Melanie Johnson
The Clinical Trials Directive (2001/20/EC) was agreed by Member States in 2001. Member States were required to transpose the Directive into national legislation by 1 May 2003 and to implement the provisions of the Directive by 1 May 2004. Transposition of the Directive was delayed in the United Kingdom because of concerns expressed by the academic research community about the possible impact on academic research and because of the European Commission's delay in finalising two Commission Directives, one on Good Manufacturing Practice (GMP) and one on Good Clinical Practice (GCP). The GMP Directive was agreed by Member States in 2003. We are committed to implementing the Clinical Trials Directive by 1 May 2004. We are currently finalising our implementing Regulations.