Volume 7: Medicines and Cosmetics
6. Ensuring medicinal products complied with the guidelines
Introduction
The agreed policy framework for action in March 1989
The period covered in this chapter
Chronicling the events
Structure of the chapter

6.1 Officials in DH and MAFF now had the task of dealing with the concerns already identified, and securing replies to all the questionnaires in order to establish whether other products needed urgent action. The advice of expert committees had to be obtained on questionable products, compliance with the guidelines had to be achieved, and decisions taken on potentially contaminated stocks. We look in this chapter at the way these tasks were carried out and whether the response was adequate.

6.2 We also examine the interaction between decisions to exclude Specified Bovine Offal (SBO) from the human food chain and about the application of the guidelines to similar products for medicinal use. The operation of the different regulatory provisions led to differing outcomes.

The agreed policy framework for action in March 1989

6.3 As at March 1989, licensing officials now had the following policy framework within which to work where bovine and ovine ingredients had been used:

1. For oral and topical products the guidelines did not apply. These would continue to be licensed in the usual way.
2. For products to be injected, or applied to the eye or open wounds:
   • Informal contacts and negotiations with companies already in touch about applying the guidelines to identified risk products should continue.
   • The guidelines should operate on all new applications for licences, and on products with Licences of Right when they were reviewed by the Committee on the Review of Medicines (CRM) and the Veterinary Products Committee (VPC).
   • As information was collected from the questionnaires, existing licensed products (whatever the class of licence) that appeared to hold a risk would be considered on a case-by-case basis.
   • No decision had been taken about existing stocks of risk products or how much latitude should be given if firms holding licences argued that finding other source material was difficult.

6.4 To assist decision-taking on human products, it had been agreed that the new BSE Working Group would advise all the relevant section 4 committees on risk. In the case of veterinary medicines that role would continue to rest with the VPC.

The period covered in this chapter

6.5 This chapter spans the seven years 1989-96, a period when two major changes affected the way matters were handled.

6.6 The first was the reorganisation of the administrative arrangements within the UK for licensing veterinary medicines and human medicines. Preparatory changes were made in 1989, and formal Executive Agencies set up in 1990 and 1991. The Medical Devices Agency followed in 1994. This reorganisation did not affect the basic Medicines Act licensing system and officials' use of section 4 committees as advisers. It did, however, affect the way the officials were organised, their accounting lines and the performance standards they were expected to meet.

6.7 The second major change was increasing EU involvement. In 1990 the EC Committee on Proprietary Medicinal Products decided to set up a working party to monitor BSE in medicinal products and this was given impetus as the first cases of BSE were detected in France and Switzerland. Not only were ingredients and products internationally traded, but, as explained in Chapter 2, EC Directives meant that a product licensed in one country was deemed to meet the licensing requirements in certain others. The EU licensing arrangements were carried a stage further in 1995, with the introduction of a single 'EU licence' for some products.

6.8 European guidelines on human medicines came into effect in May 1992 and closely similar guidelines on veterinary products a year later. In addition the World Health Organisation (WHO) offered a formal view in November 1991 that the careful sourcing of material was the best way of securing safety from the remote risk in medicinal products. While the guidelines and the WHO opinion provided a working framework, they did not remove all difficulties from the international scene, in particular in respect of the use of gelatine and tallow. This international dimension dominates the latter part of the chronology in this chapter.

Chronicling the events

6.9 In chronicling events we had great difficulty in pinning down the actual dates when the use of UK-sourced bovine material in manufacture ceased and when stocks manufactured using UK-sourced bovine material ceased to be used. In relation to human medicines Dr Jefferys told us:

One reason for the lack of documentation may be that in 1993/4 it appeared that Medicines Division's involvement in BSE had finished . . . In the circumstances, files may well have been weeded and documentation lost as a result. ¹

6.10 Dr K Jones, Chief Executive of the Medicines Control Agency (MCA), also told us:

I am also handicapped by the loss of my BSE files . . . I have no idea who removed them, why or when . . . I am very concerned that my copies are not available . . . ²

6.11 This lack of precise information applied to both human and veterinary products, though there was a rather clearer information trail on medical devices. It was neither appropriate nor feasible for the Inquiry to attempt to trace data on individual products, but we wanted to know how the process of coping with identified risk material was managed and monitored. We found that neither MAFF nor the MCA had the data we needed to perform this exercise.

6.12 We did not see any comprehensive submissions to Ministers about the exercise of following up the guidelines and questionnaire, either seeking decisions or giving details of progress. It appears that no reports of this sort were drawn up.

6.13 An audit of compliance with the European Guidelines by manufacturers of human medicines carried out by the MCA in April 1996 ³ focused on the current situation and dealt only sketchily with the history of events. It lacked the details we sought and appeared in some respects inconsistent with the material we had already studied. The parallel audit of veterinary medicines was also unable to provide a complete picture. ⁴

6.14 We therefore turned to the individual reports presented by officials to the relevant advisory committees as the only readily available source of contemporary information and apparent form of accountability. These briefed the committees about progress in their allotted field, and sought or suggested recommendations on individual products where officials considered there were special problems. These reports and the associated brief minutes of the committees provided only parts of the story we needed. We were, however, helped by records of meetings by individual officials, in particular those held by Procurement Directorate (PD) on medical devices and other items, and by the observations and papers offered by various witnesses.

6.15 Thus, despite the gaps in the material as officially recorded and available today, we were able to trace events and actions sufficiently to enable us to form a number of conclusions about the adequacy of the response. These are set out at the end of this chapter.

Structure of the chapter

6.16 As in earlier chapters, we set out the main features of the chronology of events, then discuss the adequacy of the response. That response was influenced by much that had already happened and the discussion sets it in that context.

6.17 The chapter covers a long span of years, during which significant changes in responsibilities occurred. To assist understanding of how events were handled, we start with a brief résumé of who was responsible for following up the guidelines on human medicines, medical devices and veterinary products and the changes that took place.