MCA
This article was originally published in SRA
Executive Summary
National Audit Office report on regulating medicines in the UK
National Audit Office report on regulating medicines in the UK
The UK National Audit Office has published a report on the Medicines Control Agency (MCA) entitled Safety, Quality, Efficacy: Regulating Medicines in the UK1,2. The report states that the MCA has a good national and international record in protecting public health and ensuring that medicines are safe, of good quality and effective if used properly. However, the report highlights the need for the MCA to:
- improve the quality of public information and advice, including patient information leaflets;
- improve communication to clinicians of suspected adverse reactions;
- improve communication to the public of risks from unregulated medicines, including those bought over the Internet, and unlicensed herbal medicines; and
- after merging with the Medical Devices Agency (MDA) in April 2003, maintain an influential position in the European regulatory environment.
The report has been welcomed by the Association of the British Pharmaceutical Industry (ABPI) which states that it believes `companies ought to have greater freedom to provide additional information to patients about medicines'3. In addition ABPI suggests that 100% funding of the MCA from industry may not be appropriate and that it is important that the process of assessing a new medicine is conducted in an independent way.
References
1. National Audit Office press notice, 16 January 2003, www.nao.gov.uk
2. Safety, Quality, Efficacy: Regulating Medicines in the UK, report by the Comptroller and Auditor General, HC 255, Session 2002-2003, 16 January 2003
3. The Association of the British Pharmaceutical Industry (ABPI) press release, 16 January 2003