§ Baroness Knight of Collingtreeasked Her Majesty's Government:
What were the circumstances that led to the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) being laid before the House on 1 April; who was consulted about their contents prior to laying them; and what provision will be made for parliamentary scrutiny and debate prior to their implementation. [HL2487]
82WA
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)The Medicines for Human Use (Clinical Trials) Regulations 2004 implement into UK law Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The regulations were laid before the House on 1 April to enable the UK to fulfil its obligation under European Community law to implement the directive by 1 May 2004.
The Government have consulted extensively with stakeholders on the UK regulations. Consultation has been ongoing through workshops and meetings with key stakeholders including the pharmaceutical industry, ethics committees, those responsible for medical research and development in the National Health Service, the academic community and medical research charities. The Medicines and Healthcare products Regulatory Agency conducted a formal consultation exercise between February and May 2003 and received over 160 responses from a wide range of stakeholders including the pharmaceutical industry and those involved in non-commercial trials. Following this, the Government established a Medical Research Council/Department of Health joint project to help to develop practical solutions to some of the potential problems identified by non-commercial trialists. Throughout the process of drawing up the regulations I have had numerous meetings with, and written to, various groups and individuals with interests in non-commercial trials to keep them informed of progress and to seek feedback. Where possible, the Government have taken account of the concerns of stakeholders in the regulations laid before Parliament.
Scrutiny of these regulations will be the same as for any other statutory instrument under the negative procedure. The regulations have been brought to the attention of Parliament and it is always open to Members to lay a prayer against such regulations. I wrote to a wide range of stakeholders including Front-Bench spokesmen on 1 April to inform them of the laying of the regulations. I understand that a Starred Question has been tabled for response in the House of Lords on 5 May and a Prayer against the regulations will be debated in the House of Commons on 25 May.