Volume 7: Medicines and Cosmetics
2. The operation of medicines licensing
Responsibilities for medicines licensing in 1988/89
Responsibilities within DH for human medicines licensing
Responsibilities within MAFF for Veterinary medicines licensing

Responsibilities within DH for human medicines licensing

2.62 We turn now to consider the Departments and officials who operated the licensing system. At the time when BSE first emerged, the licensing regime for human medicinal products was operated by officials in Medicines Division in DH. This Division was organised in three parallel structures: medical staff, pharmaceutical staff and administrative staff. ¹ Responsibility for staff in these structures was essentially divided along professional/administrative lines. The professional staff reported to the Senior Principal Medical Officer (SPMO) or the Chief Pharmaceutical Officer and the administrative staff reported to the Under Secretary. ²

2.63 Over the period 1984-89 Medicines Division employed some 300 people, 200 of whom were administrative staff and 100 professionals (20 doctors and 80 pharmacists). ³ The three parallel structures in the Division together with some of their key personnel are described below.

(a) Administrative staff

2.64 Mr Clive Wilson, a Grade 3 Under Secretary, was joint head of Medicines Division and head of its administrative branches. He had joint responsibility for supporting and advising Ministers in their statutory responsibilities as the medicines Licensing Authority. ⁴

2.65 Mr David Hagger, the Grade 5 Assistant Secretary reporting to Mr Wilson, headed MB1, the branch with administrative and policy responsibilities for medicines licensing. The most relevant section in MB1 in relation to BSE was MB1C. Its responsibilities included providing the administrative lead on policy for medicines licensing issues for which the CSM was the appropriate advisory body; providing the administrative secretariat of the CSM; and managing the product licence database. ⁵

(b) Medical staff

2.66 Dr Gerald Jones, a Grade 3 SPMO, was joint head of Medicines Division and headed the medical branches. He was responsible for all professional work concerning drug regulation, new drug applications, adverse reactions, review of existing products, advertising, legal status and the servicing of all the advisory committees. In addition he had responsibility for policy formulation and advice to Ministers. ⁶

2.67 The medical staff were organised into three branches, each headed by a Principal Medical Officer (PMO) who reported to Dr Jones. These branches and their corresponding PMOs were:

1. MB3A: New drugs and biologicals - Dr Jefferys from September 1986 to 1990;
2. MB3B: Review of medicines and dental and surgical materials - Dr Wood to September 1988 and Dr Adams from September 1988 to May 1990; and
3. MB4: Adverse reactions and post-marketing surveillance - Dr Jenkins to September 1988 and Dr Wood from September 1988. ⁷

(c) Pharmaceutical staff

2.68 Dr Wills was the Chief Pharmacist at DH (Grade 4 level) until December 1989. ⁸ He headed the Pharmacy Division, which was entirely separate from Medicines Division, but he was also professional head of all the pharmacists within DH, including those within Medicines Division. After June 1990 the Chief Pharmacist became part of Medicines Division, reporting to the Under Secretary there. ⁹

2.69 The pharmacists were in Branch MB5 (MB5A, MB5B and MB5C from 1989), headed by a Deputy Chief Pharmacist (Grade 5 level) who reported to Dr Wills. Mr Stewart was the head of MB5A, and Dr Purves (Grade 6 level), who had the lead responsibility for biologicals and was the pharmaceutical assessor to the CSM's Biologicals Sub-Committee (CSM/BSC), reported to him. ¹⁰

2.70 Members of each of these three structures - administrators, doctors and pharmacists - were involved in assessing any licence application, or in other licensing action with respect to a medicinal product. As between the two sets of professional staff, the role of pharmacists was to assess the safety of the manufacturing of the product, from the selection of the ingredients, to the end product. The role of doctors was to analyse the data from clinical trials of the product on human patients. ¹¹

Responsibilities within MAFF for Veterinary medicines licensing

2.71 In 1987 three parts of MAFF shared responsibility for veterinary medicinal products. Animal Medicines Division, part of Animal Health Directorate, at Tolworth, took the lead on policy and regulatory action, including issue of licences, under Mr Wilkes until October 1988, and subsequently Mr Scollen. ¹² Professional and scientific advice was provided by two divisions located at the CVL at Weybridge. Their responsibilities were as follows:

1. The Medicines Unit, headed by Mr Alastair Kidd, assessed the safety, quality and efficacy of veterinary medicines and of animal feed additives. It also provided the Secretariat for the VPC, the relevant section 4 advisory committee of independent experts. ¹³
2. The Biological Products and Standards Department (BP&S), headed by Dr Denise Thornton, examined and advised on applications for licences for veterinary immunological products; tested samples of such products; provided British standards for use in quality control; and provided for the inspection of manufacturers of veterinary immunological products. ¹⁴

2.72 Two non-statutory committees of senior officials - the Scientific Secretariat and the Biologicals Committee (BC) - dealt with licence applications and decided, in cases where they had a discretion, which applications should be referred to the VPC. General policy matters were all presented to the VPC for review and advice. ¹⁵ Mr Kidd told us:

At monthly meetings the Biologicals Committee and Scientific Secretariat considered licence applications for veterinary biological and pharmaceutical products respectively and the assessment reports of BP&S and Medicines Unit staff. The Scientific Secretariat of the VPC drew its members from a variety of sources including the Medicines Division of the Department of Health and toxicologists from the Department of Health and from the Chemical Division of Porton Down. As far as the Biologicals Committee was concerned, the Department of Health was not represented and any contact with the Department of Health was on an informal basis. However, as technical documents were invariably submitted to the VPC, Department of Health officials were fully informed through their presence at VPC meetings and were able to comment or pass papers on to appropriate colleagues. The Biologicals Committee/Scientific Secretariat subsequently made recommendations as to whether a product authorisation should be granted or not. The comments of the appropriate committee were incorporated into the reports prior to assessment of licence applications by the VPC. ¹⁶

2.73 Dr Little was Deputy Director of the CVL. His command included the Medicines Unit and BP&S. ¹⁷ He told us that he had 'specific responsibility' for veterinary medicines and that he was responsible for reacting appropriately to any information including on BSE, which might impinge upon their safety. ¹⁸ Dr Little also chaired a liaison group between MAFF and the National Office of Animal Health (NOAH) which met every few months. ¹⁹ NOAH was the trade association to which most manufacturers of animal medicinal products belonged. ²⁰

2.74 In April 1989 the three divisions merged to become a new Veterinary Medicines Directorate (VMD) on the CVL site at Weybridge. This was headed by Dr Rutter, who reported to Mr Cruickshank. ²¹