Volume 1: Findings and Conclusions
7. Medicines and cosmetics
The medicines licensing system

858 Under the Medicines Act 1968, medicinal products could not be sold in the UK without a 'product licence' from the 'licensing authority'. The Secretary of State for Health carried out this role for the UK as a whole in respect of human medicines and the Minister of Agriculture, Fisheries and Food carried out the equivalent role in respect of veterinary medicines. In order to be granted a licence, a product had to satisfy criteria of safety, quality and efficacy. The licensing authority also had power to revoke, vary and suspend product licences.

859 Licensing decisions on human products were handled on Ministers' behalf by officials in the Medicines Division (MD) of DH, and from 1989 by the Medicines Control Agency (MCA). Those on veterinary medicines were handled in MAFF's Animal Medicines Division (part of the Animal Health Group) advised by the Medicines Unit and the Biological Products and Standards Department of the Central Veterinary Laboratory (CVL), amalgamated in 1989 as the Veterinary Medicines Directorate (VMD). These officials were a mixture of administrators, doctors, pharmacists and toxicologists. Ministers were consulted over controversial decisions.

860 Individual licensing decisions could be appealed against and legal challenges mounted. The burden of proof lay with the licensing authority to justify its decisions. Decision-making thus had to be based on proper evidence and be demonstrably untainted by departmental and political interests. Officials and Ministers relied heavily on advice from several committees of outside experts set up under section 4 of the Medicines Act and known as 'section 4 committees'. Many of the members were of great eminence in their field and their advice was almost invariably followed. This was certainly the case in dealing with BSE.

861 The main section 4 committees that advised on human medicinal products at risk from BSE were the Committee on Safety of Medicines (CSM), chaired by Professor (later Sir) William Asscher; the Committee on Dental and Surgical Materials (CDSM), chaired by Professor (later Sir) Colin Berry; and the Committee on Review of Medicines (CRM), chaired by Professor David Lawson. Two subcommittees of the CSM played a key role: the Biologicals Sub-Committee (BSC) and the specially constituted BSE Working Group (BSEWG), both chaired by Professor Gerald Collee. The Veterinary Products Committee (VPC), chaired by Professor Sir James Armour, advised on all types of veterinary products.

862 One source of relevant evidence was information on adverse reactions to licensed medicinal products, reported by the medical profession and the pharmaceutical industry on yellow cards, which gave their name to the system of reporting - the yellow card system.

863 Informal methods were often preferred to formal licensing action under the Medicines Act. 'Guidelines' and 'recommendations' were issued, with which manufacturers were expected to conform. They had the merit of offering some flexibility in the light of particular circumstances and avoiding contentious litigation. We were told that in practice they were a powerful tool.

864 By 1987 the licensing arrangements in both DH and MAFF had developed a number of weaknesses. Faced with EU deadlines for reviewing 'Product Licences of Right' (those granted as an interim measure to products already on the market at the time that the UK licensing system was first set up), Ministers commissioned management reports from Dr N J B Evans and Mr P W Cunliffe about how arrangements might be improved. They found that the basic system was sound, but a two-year backlog in handling applications was mainly associated with understaffing, antediluvian data-holding systems and blurred management lines. The subsequent restructuring into Executive Agencies was intended to rectify some of the defects but itself caused some transitional turmoil.