Volume 15: Government and Public Administration
5. Risk analysis: an analytical approach to policy-making
Risk assessment of medicines

5.39 Veterinary and human medicines were regulated by licensing their manufacture and sale. The statutory position is described in vol. 14: Responsibilities for Human and Animal Health and the licensing system is described in vol. 7: Medicines and Cosmetics.

5.40 A manufacturer's licence was granted if the relevant premises were deemed to be suitable, the staff involved were considered competent, and the process was of an appropriate quality. Applications for product licences were assessed in terms of the safety, quality and efficacy of the product. Applicants had to submit supporting information about the ingredients, the process of manufacture and control, and how the product would be administered, and also the results of tests and clinical trials, together with pre-clinical and clinical data. ¹

5.41 Veterinary medicines were licensed on behalf of the Minister of Agriculture, Fisheries and Food by the Veterinary Medicines Directorate (VMD), which became an Agency of MAFF in April 1990 (the development of such Agencies is described in Chapter 6). The required supporting information had to cover potential risks to human health from exposure to the medicines and potential risks to the environment. Applications were assessed by VMD officials advised by the Veterinary Products Committee (VPC), a committee of independent experts. Products had to be re-authorised every five years, by means of a Periodic Safety Update Report, which included details of all suspected adverse reactions.

5.42 Human medicines were licensed on behalf of the Secretary of State for Health by the Medicines Control Agency (MCA), ² advised by the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and the Committee on Review of Medicines (CRM). The assessment process involved risk-to-benefit considerations, identifying potential hazards and taking account in particular of the nature of all constituents; the product's therapeutic and side effects, dosage, pharmaceutical form, method and route of administration, and expected shelf life; and the data and results of all tests and clinical trials. The MCA was also responsible for monitoring and responding to adverse reactions.

5.43 The Medical Devices Agency (MDA) ³ was involved in the development of European standards for risk analysis of medical devices and animal tissues used in them. One of its functions was to consider reports of incidents, involving medical devices, which had the potential to affect the safety of patients or users, and to investigate serious ones. On receiving such a report, risks to patients and users were assessed 'with the aim of formalising these' so that investigations would start only if they were 'likely to improve device safety'. ⁴ One of the Agency's 'Key Activities' was to 'scrutinise applications from manufacturers for clinical investigations to establish whether the risks to patients outweigh the possible benefits', while among its 'Operating Principles' was that of ensuring 'that levels of regulation are not excessive'. ⁵