Volume 7: Medicines and Cosmetics
6. Ensuring medicinal products complied with the guidelines
Responsibility for managing the process
Human medicines: Medicines Division, MCA
Medical devices: PD/STD, MDD
The BSE Working Group
Veterinary medicines: the VMD and the VPC

Human medicines: Medicines Division, MCA

6.18 Officials in Medicines Division were responsible for the follow-up to the questionnaire and guidelines. Administrators working under Mr Hagger handled the collation of replies and chasing up non-responders. They were also responsible for logging material into the database. Those on the professional side provided papers and assessments to the expert committees considering BSE. These people included Dr Jefferys, Dr Adams, Dr Rotblat, Dr Raine, Dr Purves, Mr Sloggem, Dr Boyd, and Dr Winship.

6.19 In April 1989 Medicines Division was renamed the Medicines Control Agency (MCA) and Dr Keith Jones took up the new position of Director. ¹ It acquired full agency status in July 1991.

6.20 Later developments were at a European level and European guidelines on human medicines were issued in 1992. Dr Purves, Mr Sloggem and Dr Jefferys of the MCA were involved in this process as well as Dr Schild and Dr Minor of the National Institute of Biological Standards and Control (NIBSC).

Medical devices: PD/STD, MDD

6.21 The Supplies Technology Division of the NHS Procurement Directorate (PD/STD) was involved in the follow-up to the guidelines and questionnaire on two fronts. First, it was responsible for following up the guidelines and questionnaire sent to the medical device industry regarding unlicensed products. Secondly, it had to respond to the CSM/VPC questionnaire, as it held certain medicinal product licences on behalf of the Secretary of State.

6.22 Restructuring meant that the STD was renamed the Medical Devices Directorate (MDD) from August 1991 and then became the Medical Devices Agency (MDA) in September 1994. Miss Duncan, head of the implants and sterilisation areas of STD, and Mr Burton, a Principal Pharmaceutical Officer who attended the BSE Working Group meetings, had the central roles in relation to medical devices follow-up.

The BSE Working Group

6.23 As recommended by the Human and Veterinary Medicines Briefing Group (HVMBG) in February and agreed by the CSM on 23 February 1989, a new working group was set up to advise on BSE, the BSE Working Group (BSEWG). It was a group of expert advisers who reported through the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and the Committee on the Review of Medicines (CRM). Its terms of reference were:

To advise the Section 4 Committees on the implications of BSE to human medicinal products. ²

6.24 The BSEWG considered the follow-up to the questionnaire and guidelines on human medicines, although it also received updates on veterinary medicines. The Working Group was important in overseeing compliance with the guidelines and we look at its meetings in some detail in this chapter.

6.25 The Working Group met altogether five times between September 1989 and July 1992. Professor Collee, chairman of the Biologicals Sub-Committee (BSC), was its chairman. Through its high powered membership, which included Professor Asscher, chairman of the CSM, and also the chairmen of other section 4 committees and of the Spongiform Encephalopathy Advisory Committee (SEAC), it had an immediate channel of communication with each of those committees. Other outside experts were from NIBSC, as well as Dr Taylor of the Neuropathogenesis Unit (NPU) and Dr Kimberlin. Medicines Division fielded medical and pharmaceutical staff and Dr Aileen Lee, head of Veterinary Medicines Directorate's Biological and Recombinant Products team, represented MAFF. Annex 1 contains a table of those attending each of the five BSEWG meetings and their positions.

Veterinary medicines: the VMD and the VPC

6.26 MAFF's follow-up to the questionnaire and guidelines on veterinary medicines fell to the Veterinary Medicines Directorate (VMD) with assistance from the VPC as expert advisors. ³ The VPC received two reports on follow-up to the questionnaire, in September 1989 and December 1990. These two reports were also seen by the BSEWG. Administrators under Mr Alan Taylor (Head of Administration, Biological and Recombinant Products) processed the responses to the questionnaire, with technical questions being referred to Mr Alastair Gray on the professional side. From late August 1989, Dr Aileen Lee had the central role in VMD for advising on the follow-up to the questionnaire. ⁴

6.27 The VMD had been newly created in April 1989 to bring together existing divisions within a single unit, with Dr Rutter as its Director. In April 1990 the VMD became an Executive Agency of MAFF. ⁵