Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Phase 1: the initial response on veterinary medicines

866 MAFF was quick to recognise in 1987 that veterinary medicines using bovine material might carry a risk, in particular where, as in cattle medication, there was no species barrier. Mr Wilesmith's initial investigations of BSE cases had included medications as a potential transmission agent, but by the end of 1987 he had ruled this out as not fitting the pattern of cases.

867 However, Dr Little, the CVL Deputy Director responsible for veterinary medicines, had meanwhile been giving the implications for these medicines some thought. He went out of his way to attend a meeting on 9 September 1987 of the BSC (the section 4 subcommittee of the CSM referred to above) in order to see how it handled a licence application in which possible transmission of CJD was a concern. We have already noted in Chapter 3 that differing perceptions about what happened at that meeting were to create an unfortunate misunderstanding between MAFF and DH about how much thought the latter was giving to BSE. We return to this below when we look at initial action taken by DH.

868 Within MAFF, Dr Little carried matters forward by commissioning a paper in November 1987 from a member of his staff, Mr Peter Luff. The paper was impressive as an initial overview of what was known about BSE in relation to safety of veterinary medicines. It reviewed options for action. Unfortunately, those responsible for human medicines were not sent Mr Luff's paper.

869 The paper was discussed twice in early 1988 by the Biologicals Committee, a working group of MAFF officials who handled routine biological product applications. They decided to leave the matter in abeyance for the time being.

870 It was resurrected in June, soon after a special discussion on BSE organised by Dr Philip Minor of the National Institute for Biological Standards and Control (NIBSC), and after Ministers' decision to introduce a ruminant feed ban. Dr Little and his staff acted swiftly. By 6 July Mr G W Wood of the CVL had prepared a set of draft guidelines for producers of veterinary medicines using bovine material.

871 These draft guidelines were given in July to NOAH, the trade association representing veterinary medicines producers, and were discussed with them on several further occasions.

872 Meanwhile MAFF provided letters of warning both to the Veterinary Record and to individual practitioners about the dangers of pituitary hormone material prepared outside the ambit of Medicines Act licensing. The concerns about BSE coincided with a review of hormone-based products that had Product Licences of Right. A warning about BSE was issued in general guidance produced in November and approved by the VPC on completion of the review. By the end of 1988 MAFF officials were also ready to seek the endorsement of the VPC for the proposed general guidelines on BSE.

873 All these were admirable initiatives so far as veterinary medicines were concerned. The problem was that the parallel interest of those dealing with human medicines had been neglected. Apart from a copy of the MAFF draft guidelines sent to Dr Harris, the Deputy Chief Medical Officer at DH, in July 1988, at the suggestion of Dr Minor of the NIBSC, we could find no trace of any significant contact between the two licensing authorities about BSE and medicines throughout this period.

874 In December, Dr Paul Adams of DH, who was following up recommendations by the CSM on human medicines, had some discussion with Mr Bradley at the CVL, and the penny began to drop that MAFF and DH should work together on advice about the same biological material forming the basis of both animal and human medicines.