§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)We are today laying before Parliament the Medicines for Human Use (Clinical Trials) Regulations 2004, which will implement into United Kingdom law Directive 2001/20 of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The regulations will come into force on 1 May 2004, the date by which member states are required to implement the directive.
These regulations will ensure that the rights, safety and well-being of clinical trial subjects are protected by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to principles of good clinical practice derived from the principles set out in the amended 1964 Declaration of Helsinki. In addition, the regulations will further protect public health by ensuring that the results of clinical trials are collected, recorded and analysed in accordance with internationally recognised principles so that they can be audited and verified before being used to impact on public health, for example through a publication that changes medical prescribing practice or as evidence to support applications to place medicines on the market.
The regulations will provide a statutory basis for:
- standardisation of procedures for ethical and competent authority consideration and authorisation;
- good clinical practice (GCP) standards for commencing and conducting clinical trials;
- good manufacturing practice (GMP) standards for medicines used in clinical trials; and
- inspections against internationally accepted principles and standards of GCP and GMP, supported by enforcement powers.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health will be publishing guidance on the new procedures which the regulations will implement from 1 May 2004. This will cover applications for clinical trial authorisations, inspections, ethics committee applications, informed consent for incapacitated adults and sponsorship of clinical trials.
The Government have undertaken extensive consultation with stakeholders in both the pharmaceutical industry and the non-commercial clinical trials sector on how to implement the directive. 72WS Where possible, concerns expressed by the non-commercial sector, in particular, about the possible regulatory burden, have been taken into account in the UK regulations. Furthermore, the MHRA and Department of Health have been working with stakeholders to help them to comply with the practical requirements of the regulations. The Government believe that the regulations achieve a proper balance by safeguarding the rights of patients involved in clinical trials while avoiding a disproportionate impact on those who carry out clinical trials.