Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Overview of the way the guidelines were implemented
Veterinary medicines
Human medicines

977 We discuss at some length in Chapter 6 of Volume 7 some features of the way in which phasing out existing products was handled and the reasons for this. We note in particular three factors that directly influenced the response:

1. Uncertainty about the risk. Officials and expert committees had to operate mainly on the basis of value judgements, unable as they were to assess and cite proven adverse reactions.
2. The management situation. The heavy task of conducting a case-by-case approach was superimposed on a creaking system that was overloaded and understaffed. Meanwhile the licensing divisions were undergoing restructuring and had new management preoccupied with other pressing tasks.
3. Mixed messages about the urgency. The general perception after February 1989 was that although the measures were in themselves quite drastic, they did not have to be treated as an emergency given that Southwood assessed the risk as remote. The low-key presentation of risk, carefully crafted to avert public alarm about the vaccination programme while remedial action was being taken, had the unfortunate result of being taken as the message itself. This must also have influenced manufacturers' attitudes.

Veterinary medicines

978 In the case of veterinary products, a decision was taken that the VMD should pace and match its action to that of the MCA. Although we thought this was a reasonable approach, it seemed, unfortunately, that playing second fiddle was one of the factors that led to a less urgent and decisive approach than was originally envisaged. We are in no doubt that a further factor was that, like the MCA, the VMD read the Southwood message as basically reassuring. Whether the decisions on veterinary medicines had an impact on the numbers of BSE cases may never be known. It is impossible to say today whether continued use of bovine-based medication may have added to the total number of BABs.

Human medicines

979 In the case of human products, the problems in tackling the exercise were greater and the organisational arrangements more complex. The lack of an obvious lead branch in MD continued in the MCA. While there was a team effort, this lacked leadership to prescribe what it was expected to achieve overall and who was to do what by when. Matters were not helped along by changing responsibilities during the process of integrating the administrative and professional branches.

980 The BSEWG was a useful means of achieving speedy advice from the key experts. But the Working Group relied on the MCA to refer matters to it and to act appropriately after receiving its advice. It did not itself lay down any imperatives, such as deadlines for action to be completed, other than to urge that things be done 'as soon as possible' in some cases. Officials were not accountable to it. However, once the BSEWG ceased to meet, the impetus for officials to prepare progress reports appeared to disappear.

981 The three most sensitive groups of products used for humans were (i) those containing brain and other high-risk tissues as an ingredient, (ii) sutures and (iii) vaccines. We concluded on these as follows:

• Products directly containing high-risk tissues, eg brain and glands: the small number of products concerned were identified and dealt with reasonably promptly.
• Sutures: discussions were promptly and effectively conducted with the major UK producer, safeguards introduced and use of UK materials phased out as speedily as practicable. The experts' recommendations on sutures for general use were reasonable. On the specific question of continuing use in neurosurgery, we think with hindsight that it would have been preferable if the minority view among the experts that this should not continue had prevailed. We note, however, that as yet no cases of vCJD appear to be associated with their use.
• Vaccines: bovine material was not an ingredient in the finished product. What was unclear was whether its use as a growth medium for cells allowed infection to transmit. Results of studies on serum carried out by the NPU in which no infectivity was detected were not available until 1993. The general view before then was that this was a very low-risk material and that there was in any event only a remote risk of the BSE agent passing to humans via medicines. Given this, and the dangers of interruption to the vaccination programme, we think it was not unreasonable to conclude that the balance of risk to benefit favoured using the existing vaccines until alternative supplies became available.

982 The corollary, it seemed to us, was that the replacement process needed to be as speedy as possible. While the individual decisions taken by DH about each of the products concerned were reasonable, it can be seen with the benefit of hindsight that they contributed overall to a protracted process of achieving compliance with the guidelines. Parallel delays were incurred in the treatment of veterinary products. It seems highly unlikely that so long a period of grace was envisaged by those taking decisions on vaccines in February 1989. Knowing what is now known, a harder line might have been taken to reduce the length of time that both people and animals continued to be exposed to suspect products. Although this is in part attributable to the false impression on risk, there was undoubted room for improvement in the way the guidelines were followed up. In particular we think it would have been better if:

1. there had been a handling plan with well-defined leadership that 'managed' the whole process to specific deadlines; and
2. there had been clear expectations about reporting to top management and Ministers. We believe Ministers should take a lively interest in what is being done in their name, and that there should be clear presentation to them of important policy decisions.

983 We have noted that, once medical devices were identified as a concern, action to ensure their safety was handled purposefully. The PD style of administrative approach (see paragraph 865 above) might with advantage have been mirrored elsewhere and have led to a brisker momentum in phasing out suspect products.

984 Taking animal and human medicines as a whole, matters that were handled well included the heroic venture of a questionnaire to all licence holders to make good the faults in the database. Despite believing that action was purely precautionary, officials worked diligently to carry the follow-up action to its conclusion. The most urgent items were identified and dealt with promptly. A voluntary total switch of sourcing was secured, despite there being no firm evidence to offer of human risk. All this was achieved while struggling with the legacy of serious past failings in the running of the licensing system that were still being addressed.