Volume 7: Medicines and Cosmetics
6. Ensuring medicinal products complied with the guidelines
1989
First meeting of the BSEWG
VMD report to the VPC
CDSM and CSM consider the BSEWG advice
Further consideration of tissues to be covered by the SBO ban
Medical devices
Inconsistency between the SBO ban and BSEWG advice
Human SBO ban: consideration of the implications for medical devices
MCA: issues arising from the BSEWG meeting
CRM: considering products of concern
The Bovine Offal (Prohibition) Regulations 1989 (the SBO ban)
Presentation on veterinary medicines to the Royal Society of Medicine
Medical devices
Update on veterinary medicines

First meeting of the BSEWG

6.77 The BSEWG met for the first time on 6 September 1989. As will be seen from Annex 1, this was a large meeting with 26 people present. In his opening remarks Professor Collee, the chairman, observed that their task was to advise the section 4 committees on the implications of BSE with special regard to human medicinal products but not veterinary medicines, which were the responsibility of MAFF. The minutes continue:

Since the publication of the Southwood Report, no further evidence had come to light to change the original view that the risk of BSE being transferred to humans is considered to be remote and theoretical. Hence the likelihood of the BSE agent affecting humans via medicinal products . . . is also thought to be remote. Nevertheless the Working Group would need to consider this risk and balance it against the obvious and known advantages to health afforded by the current availability of medicines and vaccines incorporating bovine material. To date available evidence has suggested that cattle are likely to be a dead-end host for the BSE agent, but the Chairman sounded a note of caution and stressed the need for further investigative research into the disease, of which little is really known and quoted from the Southwood Report: -

'From present evidence, it is . . . most unlikely that BSE will have any implications for human health. Nevertheless, if the assessments of this likelihood are incorrect, the implications would be extremely serious.' ¹

Responses to the questionnaire

6.78 Around 75 per cent of holders of human medicinal product licences had responded to the March questionnaire by this time. The importance of achieving a total response was emphasised and licence holders who had not replied were to be followed up before the next Working Group meeting. ²

Ranking the risks: the paper by Dr Rotblat and Dr Purves

6.79 Dr Rotblat and Dr Purves had prepared a paper summarising the questionnaire responses received so far. ³ As had been agreed on 12 June, the 574 products that used animal ingredients were divided into the following categories, in decreasing order of concern: ⁴

Products with bovine brain/lymphoid tissue as ingredients and administered by injection.	111
Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection.	135
Tissue implants, open wound dressings, surgical materials, dental and ophthalmic products with bovine ingredients.	27
Products with bovine ingredients and administered topically.	5
Products with bovine ingredients and administered orally.	9
Products with other animal/insect/bird ingredients.	131
Products with materials produced from animal material by chemical processes eg. stearic acid, gelatin and lanolin.	156

6.80 The paper identified a number of general and theoretical considerations. It noted that these considerations must take into account a number of other factors including:

2.1 the findings of the Southwood Report in which it was stated that 'the risk to man of infection via medicinal products was remote.' It is important not to undermine this considered advice by demanding unnecessary assurances and information from manufacturers. ⁵

The BSEWG considers the risks

6.81 The Working Group concluded that, on the evidence available, products with bovine ingredients in the last four categories gave no cause for immediate concern (ie, no action was required with regard to these products). ⁶ The Working Group made four general recommendations in relation to products falling within the first three categories: ⁷

1. That no licensing action is required at present in regard to products produced from bovine material or using prepared bovine brain in nutrient media and sourced from outside the United Kingdom, the Channel Isles and the Republic of Ireland provided that the country of origin is known to be free of BSE, has competent veterinary advisers and is known to practise good animal husbandry.

2. The Joint CSM/VPC guidelines should apply to all bovine material sourced from UK, Channel Islands and the Republic of Ireland and any other area known to have BSE. Companies which at present cannot comply should be encouraged to do so as soon as possible. The timescale should be agreed with the Licensing Authority for each individual product as appropriate.

3. No licensing action is required at present with respect to products containing material from animals other than cattle.

5. The Licensing Authority should continue to review scientific progress in the field of BSE, so as to be in a position to take licensing action in the future should this be necessary. ⁸

6.82 The first two of these recommendations varied the CSM/VPC guidelines by allowing bovine material from foreign BSE-free sources. The CSM/VPC guidelines had specified that certain high-risk tissues should not be used in manufacture, whatever the source (refer to Chapter 5 for a list of the guidelines).

Identification of high-risk products

6.83 Dr Rotblat's and Dr Purves's paper indicated that of the 574 products identified as using animal ingredients, 17 contained bovine ingredients of UK origin only and 40 contained bovine ingredients of mixed origin, including the UK. ⁹ The paper noted that, with two exceptions, the replies to date did not give immediate cause for concern, although 176 products did not conform to the CSM/VPC guidelines. ¹⁰

6.84 The paper contained an analysis of these 176 products. ¹¹ Most of them contained bovine material sourced from outside the UK and, we assume, were not thought to be of immediate concern for this reason. Others fell into the lower four risk categories identified in paragraph 6.78 above.

6.85 The first of the two exceptions that gave cause for concern was a range of homoeopathic medicines (including 53 injectable ones) that contained material obtained from cattle, including 20 that used material derived from brain. More information was needed on the source of the bovine material used, and the BSEWG noted that further follow-up action would be needed, with the possible involvement of the CRM. ¹²

6.86 The second exception was surgical catgut, made from bovine intestines, which was discussed at length in a separate paper presented to the BSEWG by Dr Raine, Medical Assessor to the CDSM. ¹³ We review this below. ¹⁴

Surgical catgut

6.87 Of 27 positive responses in the third category (tissue implants, etc) surgical catgut was the only product that was found to use material from cattle within the UK.

6.88 The reasons for concern over catgut, set out in Dr Raine's paper, were: the source material's proximity to lymphoid tissue; and the large scale of production and use of surgical catgut. Discussions had already been taking place with the major UK manufacturer of surgical catgut, Ethicon, since it approached MCA officials in June 1989 (Ethicon had applied for a renewed licence in April 1989).

90% of Ethicon catgut is manufactured from bovine serosal tissue, the balance being ovine sub-mucosal material. The requirement for raw material is 25 million metres per annum, originating from 550,000 cattle (13% of the UK cattle kill from 18 abattoirs distributed throughout the UK). One animal yields about 45 metres of intestine and the catgut manufacturing plant requires the input from 2,500 animals per day. ¹⁵

6.89 Dr Raine's paper explained to the Working Group that Ethicon's plans to change to Australasian raw material were well advanced, but noted that this would entail procuring the equivalent of 10 per cent of the annual cattle kill in Australia and 24 per cent of the New Zealand kill. Ethicon had proposed the following course of action and timetable. ¹⁶

Short Term	[to be] Completed By
a. Source material - Feasibility studies
- operation of abattoir selection procedures	End Aug 1989
- change over to Australasian raw material	End Oct 1989
b. Manufacture - reintroduction of heat setting	End Dec 1989
c. Clinical - contraindicate in neurosurgery and paediatric surgery	?
Long Term
a. Commence production from Australasian sourced raw material	? 1991
b. Conversion of surgical profession to use of synthetic absorbable sutures rather than catgut.	? date

6.90 In the meantime, Ethicon had proposed some short-term safety measures, on which the Working Group's views were sought:

1. use of 'clean beef cattle' ie, 18 months to 2 years;
2. procedures specified by Company in current manufacturing process (enzyme, alkali, tanning, alcohol packing, terminal sterilisation 25KGys);
3. reintroduction of heat-setting step (149ºC for 1 hour);
4. contraindications in neurosurgery and paediatric surgery. ¹⁷

6.91 The BSEWG was divided. A minority (three members) considered that bovine-derived catgut should be excluded from neurosurgery until or unless it came from a BSE-free country. This was because:

i. of the experience of the agent of Creutzfeldt Jacob Disease;

ii. of an anxiety that the BSE agent may differ in some subtle ways from the classical scrapie agent;

iii. infectivity in various microbial models could be related to the site of inoculation or implantation. ¹⁸

6.92 However, a majority of those present concluded that the risks did not justify a ban on its use in neurosurgery because:

iv. catgut sutures have been made for many years from sheep intestine which may have been infected with scrapie with no epidemiological evidence of an association with CJD,

v. catgut is seldom used in neurosurgery because of the risk of inflammatory response associated with its dissolution,

vi. to raise this concern amongst doctors at this time, based upon a purely theoretical risk, might hazard the public perception of the safety of other products of bovine origin. ¹⁹

6.93 The BSEWG advised that Ethicon's product licence should be renewed and did not require the company to warn against using catgut in paediatric surgery or neurosurgery. In addition, a general recommendation was made that any UK bovine material used for catgut should come from 'clean beef cattle' of 18 months to 2 years of age and be subject to certain sterilisation and heat treatment processes. ²⁰ However, a changeover to Australasian sourced raw material was the preferred option for Ethicon in the medium to long term. The Working Group specified no timetable for this changeover: Ethicon's proposal had indicated that this could perhaps be achieved by 1991. ²¹

6.94 Professor Collee later added a Chairman's note to the minutes:

Members of the Working Group will appreciate that they have an advisory role and that the Section 4 Committees will take account of situations in which opinion may be divided.

Accordingly, it is reasonable to record a minority view that bovine-derived catgut sutures should forthwith be excluded from neurosurgery until or unless the materials are sourced from BSE-free countries. There seems to be an implied, albeit remote, risk if present practice is permitted. This worry may be linked with (1) our experience of the agent of Creutzfeldt Jakob disease, (2) our anxiety that the BSE agent may differ in some subtle ways from the 'classical' scrapie agent, and (3) our knowledge that infectivity in various microbial models can be related to the site of inoculation or implantation. If this is logical, it is not unreasonable to avoid even a remote outside chance that cerebral implantation of UK-sourced bovine-derived catgut may be harmful.

Three members of the Working Group have registered this anxiety. They understand that the debated point would draw attention to a hazard that the majority feel is non-existent, but it is difficult to escape the logic and scientific consistency of the minority view. ²²

6.95 Professor Collee told us:

The question of bovine-derived catgut sutures was also carefully discussed at the meeting. On receiving the draft minutes of this meeting, I amended them and added a Chairman's note (paragraph 9) to reflect our discussion. In light of the Working Party's advisory function, I was anxious that the comments on the use of catgut sutures in neurosurgery should be recorded. I was personally concerned by this issue. Since the relevant sutures were manufactured from bovine intestine, this bovine intestine might be contaminated with bovine lymphoid tissue. Although at this time it was not proven that lymphoid tissue harboured the BSE agent, lymphoid tissue was regarded, on the basis of the scrapie analogy, as being potentially infective. ²³

Medical devices

6.96 The Working Group also considered a report from PD/STD regarding unlicensed products containing bovine material. They agreed that there was no particular cause for concern, provided the guidelines were followed. PD/STD intended to follow the lead of the MCA in deciding on future action. ²⁴

Veterinary medicines

6.97 The BSEWG had before them a paper prepared by Dr Lee of VMD. ²⁵ This summarised the replies received so far to the veterinary medicines questionnaire. About 45 different ingredients of bovine or ovine origin had been identified in products, the most common being bovine serum (86 products). However, different companies had interpreted the questionnaires differently and some apparently complete returns were, in fact, incomplete. In particular, on closer investigation, the stated country of origin of the animal material was often the country where the material was purchased, not necessarily the country the animal had lived in. Dr Lee reported that more work was needed to get as complete a picture as possible, but that in the meantime effort would be concentrated on products that 'can be identified as having a possible risk of BSE contamination. Follow-up letters with specific questions will be required for the licence holders of these products.' ²⁶

6.98 Handwritten notes on a copy of this report from Dr Lee's files indicate that some of the products contained bovine ingredients sourced from the UK. ²⁷ The handwritten notes continue:

When we have as full information on these products as possible, we can then judge the degree of risk, in consultation with experts, as required, and in the light of this a course of action for each can be worked out - such as setting a timetable for compliance with the guidelines, as you have suggested, or if necessary, suspension of the licence. VPC will of course need to be consulted & we will of course keep you informed of progress.

6.99 The BSEWG noted that 75 per cent of recipients had responded to MAFF's questionnaire, and that the Working Group would be kept informed of progress with the remaining licence holders who had not responded. ²⁸ The minutes record: 'considerations relating to veterinary medicines are not the same as those relating to human medicines.' ²⁹ It is not clear whether this reflected the collective view of the Working Group or was part of the MAFF presentation.

VMD report to the VPC

6.100 Dr Lee's report on veterinary medicines, although presented to the BSEWG, had been prepared as the first VMD progress report for the VPC meeting on 20 and 21 September. ³⁰ The report had earlier been discussed by the Biologicals Committee at its meeting on 4 September 1989. ³¹

CDSM and CSM consider the BSEWG advice

6.101 At the CDSM meeting on 20 September 1989, the Committee received a report of the BSEWG meeting earlier in the month. It also considered the licence renewal application for surgical catgut. The Committee advised that the catgut product should be granted a renewed licence on two conditions:

(i.) when bovine material from the UK, Channel Islands or Eire was used, it should come from 'clean beef cattle' (18 months to 2 years of age);

(ii.) current manufacturing procedures (as specified by the manufacturer) should continue to be used.

The Committee remarked that a change to Australasian material was the preferred option in the mid to long term. ³² Professor Berry, Chairman of the CDSM, reported this to the BSEWG when it next met in January. ³³ At that time, he commented on the reservations expressed by the minority of the BSEWG in September, and wished to make it clear that the selection of materials other than those established in use by clinical experience exposed patients to potential hazards that might be greater than those posed by catgut.

6.102 When the CSM met on 28 September 1989, it noted Professor Collee's report of the BSEWG meeting and endorsed the recommendations made by the BSEWG earlier in the month. ³⁴ (See paragraph 6.80 above.)

Further consideration of tissues to be covered by the SBO ban

6.103 Meanwhile MAFF officials were reviewing the scope of the proposed SBO ban in the light of responses to their consultation document received by the deadline of 13 September 1989 (refer to paragraphs 6.56-6.58).

6.104 A meeting called by Mr Meldrum took place on 18 September between DH and MAFF to discuss details of the ban on bovine offal, including possible exceptions to it. ³⁵Attendees were Mr Bradley, Mr Lowson and Mr Lawrence from MAFF; Dr Metters and Dr Pickles from DH; as well as Sir Richard Southwood, Dr Tyrrell, and Dr Kimberlin. Of relevance to medicines were the potential risks from catgut and from foetal calf serum. During discussion it was indicated that the CSM was looking at the issue of sutures and that DH would decide on action following that advice. Those at the meeting regarded foetal calf serum as low risk provided that care was taken when it was collected. ³⁶

6.105 After the meeting, Dr Metters contacted Mr Hagger, and asked whether, if bovine offal was to be excluded from human consumption, it was consistent to continue to allow the use of catgut derived from bovine intestines. ³⁷ He also raised the issue of foetal calf serum. He asked for confirmation that these were to be discussed at an MCA meeting that was to be held soon.

6.106 On 25 September Mr Maslin circulated to MAFF officials and to Dr Pickles a summary of the comments on the SBO ban that had been received through the consultation process. ³⁸ Although few of the comments were relevant to medicines, one respondent, the Royal Environmental Health Institute of Scotland, had suggested:

If it is intended that these regulations are to prevent the risk of material infecting the human population then it would be appropriate to remove pharmaceutical manufacturers from this section. ³⁹

6.107 This was considered at a meeting on 27 September 1989 called by MAFF to reach decisions in the light of responses to the consultation. ⁴⁰ Nobody from DH attended. However, Dr Lee from VMD attended, as did representatives from Northern Ireland, Scotland and Wales. It was concluded that: '[t]he current exemption for pharmaceuticals should be maintained. The Regulations were not the correct vehicle to control these products and we should rely on the Medicines Act. A possible amendment to apply the exemption specifically to those covered by the Medicines Act should be considered.' The minutes of the meeting also noted that a further provision should be made to allow offals that were used in pharmaceuticals to be stored frozen at abattoirs (or removed unfrozen). ⁴¹ The minutes of the meeting were copied to Mr Taylor of VMD and Dr Pickles of DH.

Medical devices

6.108 The BSEWG's views were discussed at the PD/STD meeting on 21 September 1989 and it was agreed to follow the BSEWG's lead by taking no steps in relation to bovine material sourced outside the British Isles. ⁴²

6.109 The meeting was told that a 'definitive list of companies which had not responded to the PD questionnaire had been produced and a second reminder letter [had been] sent to all UK and other European companies'. ⁴³ It was thought important to get replies from the few UK companies that were still to respond by a deadline of 30 October 1989.

6.110 Of the 10 companies sent follow-up letters after indicating compliance with the guidelines, eight had now replied. Four of these companies had changed their response and the others stated that their animal materials were not susceptible to BSE. It was noted that:

No company which claimed to fully comply with the draft guide-lines could therefore be identified. ⁴⁴

6.111 It was decided to consult Miss Duncan about the paper on 'Inactivation of scrapie-like agents', 'as such an action would raise the profile of BSE contamination and may not accord with the action of the MCA.' ⁴⁵

Inconsistency between the SBO ban and BSEWG advice

6.112 Dr Metters continued to question the possible inconsistency between the terms of the SBO ban and advice from the BSEWG (refer to paragraph 6.104). He asked Dr Pickles on 4 October whether MAFF's proposed 6-month age limit, above which SBOs would be banned for human consumption (see vol. 6: Human Health, 1989-96) was inconsistent with the BSEWG's 18-month-to-2-year limit on bovine material used to manufacture sutures. ⁴⁶ Dr Pickles replied on 9 October, explaining that the 18 month to 2 year limit was interim action to reduce the risk, while Ethicon made arrangements to source from overseas.

[Ethicon] volunteered to reduce the 'risk' by using beef not milk cows (sensible, since BSE is less common in the former) and animals under two years (their rationale being that such animals are unlikely to be just about to go down with BSE, which usually appears later but also I suspect recognises the usual life span of beef cattle.) The expert working party accepted this interim compromise, knowing neither being beef cattle nor being under 2 years was any real guarantee, but realising there was no alternative. ⁴⁷

6.113 On 12 October, Dr Metters responded. ⁴⁸ He asked whether the difference could be defended and justified on scientific grounds. Dr Pickles advised 'the ready defence is that those decisions were taken on expert advice'. ⁴⁹

Human SBO ban: consideration of the implications for medical devices

6.114 On 3 October 1989, Dr Pickles sent a minute to Miss Duncan of PD to bring her up to date with what was happening with the proposed SBO ban. ⁵⁰ Dr Pickles was aware that several unlicensed devices were made from cattle tissues and said that she hoped that the way things were going at the moment, no great supply problems would be caused. She explained that she had 'argued not to ban collection of offal intended for pharmaceutical and related use, since more rigorous control would be applied later'. However, Dr Pickles thought the MAFF rules might be relevant only to products licensed under the Medicines Act. She therefore asked whether Miss Duncan had any comments that needed to be passed on to MAFF without delay.

6.115 On 6 October 1989 Mr Burton replied to Dr Pickles on Miss Duncan's behalf:

3. We are pleased to note that, as a result of your intervention, the removal of specified bovine offal from the place of slaughter to a pharmaceutical manufacturer would remain permissible . . .

4. On the medical device front we are only currently aware of two British manufacturers using UK derived bovine material. Both make heart valves using pericardium and this tissue is not included in the definition of 'specified bovine offal'. Consequently the proposed regulations should not affect these products. However if 8.1 of the proposals ⁵¹ could be amended to read '. . . pharmaceutical and other medical product manufacturers . . .' it would not then act as a barrier to any further developments. Products made from such offal would still come under the scope of the PD/STD Guidelines. We would be grateful if you would pass this view on to MAFF.

5. There may be some unlicensed medicinal products, used on a named patient basis, which would be assisted by proposal 8.1. This causes us some concern since rigorous licensing controls would be bypassed in these cases. I have been passing details of any such products to Mr Love as we become aware of them.

6. We also find it strange that research is not included alongside 'instructional or diagnostic purposes' in 8.1 of the proposals. ⁵²

6.116 Dr Pickles passed this on to Mr Maslin on 10 October. She said:

. . . I thought you might be interested in the attached minute from the procurement directorate who have responsibility for devices etc not covered by the Medicines Act.

Note in particular:

(1) they are keen to retain the right to remove unstained offal to a pharmaceutical manufacturer

(2) it would help if this could be amended to 'pharmaceutical and other medical product manufacturers'

(3) they suggest 'research' could be added to 'instructional or diagnostic purposes'. ⁵³

6.117 We asked Dr Pickles, when she gave oral evidence, whether she was able to remember the circumstances in which the exemption for pharmaceuticals was made. She explained that it was because more rigorous controls would be applied later. If a product could only be made from bovine material, but by a sterilisation process that would make the BSE agent completely safe, for example, it would seem inappropriate for the SBO ban to prevent the product from getting the right source material. Dr Pickles added that she was confident there would be no loopholes in the way regulatory controls were applied to medicines. ⁵⁴ In a later statement to the Inquiry Dr Pickles clarified this evidence. She said that she found it difficult even on reflection to remember exactly how the request for the exemption for pharmaceuticals originated. However, she thought it unlikely that the suggestion originated with her and unlikely that it was in response to a specific request from a company. ⁵⁵

MCA: issues arising from the BSEWG meeting

6.118 On 10 October 1989, Mr Love, an administrator in MCA working for Mr Hagger, sent a minute to Dr Jefferys about putting the recommendations of the BSEWG into practice. Among the matters raised by Mr Love were the highly relevant questions of setting timescales for the three high-risk categories, stockpiled products and the need for a coordinated Licensing Authority approach with clear allocation of responsibility. We set this important minute out in full: ⁵⁶

1. Following the meeting of the CSM at the end of September and its acceptance of the recommendations of the BSE Working Party, it would now seem appropriate for the LA [Licensing Authority] to consider what action is required to take the exercise forward in line with the recommendations.

2. I have set out below some possible points which may or not be completely relevant and are certainly not exhaustive and I would be grateful for your opinion and those of the copy recipients of this minute [Drs Adams, Purves, Raine and Rotblat, Mr Hagger and Mrs Shersby] on the following

a. do the guidelines need updating as a result of the Working Party meeting?

b. what further action, if any, should be taken re notifying industry of the recommendations of the Working Party? (by means of a possible article in MAIL?)

c. should active encouragement now be given to those companies which do not meet the guidelines and source material from areas where BSE is known, to change within appropriate timescales to BSE free sources? This would be for all applicable products in the first three categories as set out in the Working Party minutes and not merely catgut.

d. a need to consider further products which may be stock-piled and not meet the guidelines.

e. a need to alert the CRM about the Weleda [homoeopathic] products and determine if any special action should be instigated.

3. Some or all of the above points may be unnecessary or are already being taken forward but I believe that the necessity for a coordinated LA role in the BSE exercise should now be considered along with 'what needs to be done and by whom' being developed.

6.119 Mr Love also wrote to Mr Burton of PD saying that he had raised these issues with Dr Jefferys and that '[a]s soon as the MCA stance on these and other points is finalised I shall let you know'. ⁵⁷

6.120 On 13 October 1989, Dr Jefferys replied. He stated that he had discussed the matter with Dr Adams, Dr Purves and Mr Hagger and that they agreed that the Working Party needed to meet in January. He did not think that the CSM/VPC guidelines needed updating and thought there was no need to notify the industry further. An in-house procedure would need to be considered for approaching non-complying companies and for establishing an acceptable timetable for them to comply with the guidelines. ⁵⁸ Dr Jefferys said in a written statement to us that Mr Hagger's division was responsible for contacting manufacturers who did not respond to the questionnaire. He added that approaching those companies that did not comply with the guidelines and establishing an acceptable timetable for them to do so was the responsibility of the MCA and the Inspectorate rather than the CSM. ⁵⁹

CRM: considering products of concern

6.121 We noted above that a range of homeopathic products, made by Weleda, was one of two sets of products that gave immediate cause for concern to the BSEWG in September. On 7 November, the CRM considered a paper on these homoeopathic products, prepared by Dr Winship, who had ascertained that the bovine material used was all sourced in Germany. ⁶⁰ The CRM therefore considered that no further action was required. ⁶¹

The Bovine Offal (Prohibition) Regulations 1989 (the SBO ban)

6.122 The Bovine Offal (Prohibition) Regulations 1989 came into effect on 13 November 1989 implementing the SBO ban in England and Wales. The pharmaceutical manufacturers' exemption remained in the final version. ⁶² Equivalent regulations came into force in Scotland and Northern Ireland on 30 January 1990. ⁶³

Presentation on veterinary medicines to the Royal Society of Medicine

6.123 Dr Lee of VMD presented a paper entitled 'BSE: Implications on Production of Veterinary Medicines' to a meeting of the Royal Society of Medicine on 15 November 1989. ⁶⁴ Originally the paper was to include a discussion of human medicinal products but the MCA objected to this lest the MCA/CSM or DH stance on BSE be compromised and asked that she restrict her paper to veterinary medicines. ⁶⁵ The MCA decided not to send a representative to the conference and a briefing minute warning Ministers and officials of possible media interest noted:

The subject is too problematical scientifically and too sensitive politically for officials to speak out at what seems to be a conference with the object of stimulating scientific hypotheses. We have examined the proposed VMD talk, and are satisfied that is should not repercuss on MCA interests. ⁶⁶

6.124 The introduction to Dr Lee's paper to the Royal Society of Medicine gave a reassuring message:

BSE has few implications for production of veterinary medicines. Indeed, there would be no implications at all if the Veterinary Medicines Directorate and manufacturers did not take what is really a belt, braces and pieces of string approach to all aspects of safety and quality of veterinary medicines. ⁶⁷

Medical devices

6.125 By 24 November 1989, all the manufacturers of medical devices had responded to the questionnaires sent out by PD/STD in March 1989 (see Chapter 5). Of 76 products that used animal materials, 34 contained products of bovine origin and 13 of those were sourced either from the UK or from Europe. Of those 13, 6 were a minor component (ie, a coating or impregnation of gelatine or collagen), 4 were an aid in the production process (ie, tallow), and only 3 contained bovine material as a major component. ⁶⁸ Only two of these three products were thought to be of concern; the third was made by a continental manufacturer using bovine pericardium from a closed herd on the continent. ⁶⁹

6.126 On 8 December 1989, PD/STD met with these two manufacturers, who were both producers of heart valves. ⁷⁰ The main purpose of the meeting was to discuss the companies' current manufacturing procedures, their future plans and their compliance with the BSE guidelines. Their views were also sought as to the practical feasibility of the guidelines with respect to the manufacturing process, and any improvements that could be suggested.

6.127 Mr Burton told us:

. . . I believe the companies were left in no doubt, from our discussion, that their compliance with the guidelines was required, even in the absence of our having any specific statutory power, because we could, if we had felt it appropriate, influence the market for their products due to the fact that the NHS effectively represented a monopoly purchaser. ⁷¹

Update on veterinary medicines

6.128 On 28 December 1989, Dr Lee circulated a further update on replies to the veterinary medicines questionnaire. ⁷² Since August four more replies had been received, bringing the total number of companies replying to 190; 302 products had materials of bovine, ovine or caprine origin as ingredients, ie, one less than recorded in August. Dr Lee's note stated:

Follow-up letters will be sent out soon to those companies who have not yet sent in a return for one or more of their products. Follow-up letters are also being sent out to companies where further information is required due to an inadequate return or to allow better assessment of any possible risk.

The note went on to say that MAFF were aware from the returns, direct contacts and licence variation requests that many manufacturers were making efforts to comply.