Volume 1: Findings and Conclusions
Executive Summary of the Report of the Inquiry
8. Medicines

• Despite the highly regulated licensing regime for medicines, systematic records of the action taken in response to BSE in respect of individual medical products are lacking.
• Past experience of the transmission of animal disease through vaccines, and of transmission of CJD through medication and through the contamination of surgical instruments, showed that minute particles of infected tissue from an apparently healthy donor could transmit a TSE.
• MAFF officials recognised in 1987 that there was a risk that BSE might be transmitted through veterinary products and began to take steps to address this risk which were commendable. They failed, however, to share their concerns with those in DH who were responsible for handling human medicinal products. This was inadequate interdepartmental liaison.
• On learning of BSE in March 1988 the CMO, Sir Donald Acheson, sought to ensure that the potential risks that the disease posed in relation to human medicinal products were addressed. However, Medicines Division (MD) did not bring the matter before their advisory committees until November 1988. Of this period, two months' delay was attributable to a failure to accord the matter appropriate priority.
• MD did not appreciate the extent of the concern felt by the Southwood Working Party about medicines administered by injection and about the existing stocks of these. This was compounded by the wording of the Southwood Report, which described the risk posed by medicines as remote without making it plain that this risk assessment was predicated on the assumption that remedial measures were being taken to address the risk.
• Having regard to the legislative constraints, it was reasonable to issue guidelines in relation to both human and veterinary medicinal products rather than resort to direct regulatory action.
• Production of the relevant human and veterinary medicines involved similar raw materials and processes. The approach in respect of each needed to be consistent. Yet DH and MAFF did not discuss joint guidelines until January 1989. Once again this reflected inadequate interdepartmental liaison.
• The decision to continue to use existing vaccine stocks until these could be replaced was reasonable. Vaccines cannot be produced overnight. An embargo on existing stocks would have led to interruptions, potentially lengthy, in vaccination programmes. The overwhelming professional opinion at the time was that there was bound to be death and disablement in the event of breaks in the vaccination programmes, on a scale which far outweighed the potential risks from BSE. Some comfort can be derived from the 1993 results of tests carried out on bovine serum by the Neuropathogenesis Unit (NPU), which failed to lead to infection in mice.
• The task of identifying medicinal products to which the guidelines applied was made more difficult and protracted by:

- the inadequate database of licensed products;
- the need to make case-by-case enquiries in relation to thousands of products;
- inadequate staffing;
- unclear management responsibilities; and
- the administrative dislocation involved in reorganisation at the time of the relevant DH and MAFF divisions as Executive Agencies.
Staff from the two new Agencies - the Medicines Control Agency (MCA) and the Veterinary Medicines Directorate (VMD) - worked diligently to overcome these difficulties.

• The establishment of the BSE Working Group with a high-powered membership to advise all of the section 4 committees on human medicinal products thought to pose a potential risk was a sound decision.
• The small number of products that included high-risk tissues as an ingredient was identified and dealt with reasonably promptly.
• The role of the BSE Working Group, like that of the Committee on Safety of Medicines (CSM) and Veterinary Products Committee (VPC), was purely advisory. The task of identifying individual products for consideration by the Group and following up recommendations made by the Group was for officials.
• Decisions taken in relation to individual medicinal products were reasonable, but the speed with which decisions were taken and followed up suffered from lack of clear and purposeful leadership in the MCA.
• More effective handling arrangements were adopted within DH's Procurement Division (serving the National Health Service) to review medical devices.
• Existing stocks of a small number of human vaccines prepared using bovine tissues may have been used up to 1992 and of animal vaccines for even longer.
• The decision to continue using existing stocks of vaccines was not considered to be one that needed to be taken or approved by Ministers. Had it been, we consider that Ministers would have accepted the overwhelming professional advice, but would have been concerned to see that the process of phasing out these stocks was more vigorously pursued.
• Officials in the MCA and VMD do not appear to have been systematically accountable to anyone for the manner in which the phasing out exercise was handled. Nor, given the low-profile handling, was there any parliamentary or public scrutiny of their actions.