Minutes of Meetings - June 2000

Animal Procedures Committee  APC (2000) 3rd Meeting
Minutes of the meeting held on 28 April 2000

1. Apologies for absence

1.1 Apologies from Mr Baker, Professor D Clark, Professor S Clark, Mr McCracken and Professor Purchase.

2.1 The Secretariat distributed revised draft minutes of the meeting of 12 April, incorporating amendments to paragraphs 6.1, 6.6, 8.1, 8.3 and 9.1. The minutes were then agreed. [Secretary's note: the meeting of the Committee scheduled for 10 May was cancelled.]

3.2 Visits (para 7) The Chairman noted that members of the Committee had visited Glaxo-Wellcome on 17 May. A planned visit to Porton Down in July had had to be postponed, but it was hoped that this could take place in the Autumn.

Action: Secretariat

3.3 Annual funding of research (para 3.5) Professor Anderson said that he had corresponded with Mr Evans about a change in the Treasury rules which might allow finance to be allocated for a longer period that one year only. However, he reported that he had been told that the Research and Alternatives sub-committee's research budget would continue to be allocated on a year by year basis, but that the sub-committee could operate on the assumption that similar funding in following years would be forthcoming. Professor Anderson also referred to another unsatisfactory effect of annual budgetting, which was that in order to make payments by the end of the financial year grants had to be paid for research projects before a satisfactory report at the conclusion of the project had been received. The Committee regretted that both matters were a common feature of government accounting. It was noted that the commissioning of interim reports and staged payments were a partial solution to the second problem identified.

3.4 Research and Alternatives sub-committee - progress report. Professor Anderson reported that the sub-committee had short-listed seven applications for funding in the current financial year. Five applicants had been interviewed on 7 June, and the other two would be interviewed on 18 July. Decisions on the applications would be made on or shortly after 18 July.

3.5 Biotechnology working group - progress report Professor Richardson reported that the working group had made progress, but had not yet been able to finalise its report for the current meeting, as had originally been intended. She hoped to present the working group's report to an APC meeting in September or October.

Action: Secretariat

3.7 Openness working group - progress report Professor Atterwill reported that the working group had had two meetings, at which the issues had been discussed, and statistical analyses of the details of the responses carried out. The next meeting of the working group was scheduled for 26 July, when several witnesses would be interviewed. The working group hoped to present a report to the APC in the Autumn.

4.2 Fees and resources It was suggested that the issues raised in this section, such as the enhancement of the Inspectorate through an increase in fees, could be included in a wider discussion about regulation, monitoring and enforcement which might be included in the forthcoming APC weekend conference.

4.3 Level of regulation and export of animal use It was accepted that these issues too could be included in a wider discussion by the APC. There were indications that the 1986 Act was being used by other countries as a basis for new legislation. On the other hand there was evidence that in a flexible market, such as the EC, animal experimentation was being commissioned outside the UK.

4.4 The scope of the 1986 Act An amendment was accepted to the fourth sentence of paragraph 12, which should read "For instance chicken embryos with a 24-day incubation period do not exhibit any sensory mediated response to stimuli until 5 days before hatching." The Committee accepted the working group's suggestion that there should be no change to section 1 (2) (a) of the Act, which provides that a mammal, bird or reptile is protected only from the stage of its development when half the gestation or incubation period has elapsed. Professor Broom said that there had been research carried out since the addition of Octopus vulgaris to the list of protected species which indicated that other cephalopods should be added to the list. The Committee agreed that the important factor in deciding which cephalopods might be added to the list was the welfare issue of the extent to which a species was capable of suffering. The Chairman suggested that the Committee might wish to advise the Minister that work should be carried out to investigate this. It was noted, however, that any investigative process should not involve invasive procedures being carried out on cephalopods.

4.5 The retrospective assessment of severity It was noted that it was already a requirement of the Ethical Review Process that a retrospective review of the severity of each completed project should be carried out.

4.6 Schedule 1 - humane methods of killing It was agreed that guidance on the definition of an anaesthetic, and guidance on the effects on welfare of gases which are not conventional anaesthetics could be improved. No further research was indicated, as there was much information already available. These suggestions might also be put to the Minister.

4.7 Re-use of animals It was accepted that there could be good welfare reasons for allowing a certain amount of animal re-use. The Chairman invited the working group to assess the current guidance on re-use against that background, perhaps with the use of co-opted members. Professor Broom agreed that the working group would undertake this task.

4.8 Acquisition of animals Professor Broom said that visits by ASPI to overseas primate sources had resulted in improvements in welfare. He agreed that more work needed to be done in order to assess whether the guidance on the acquisition of animals was adequate.

4.9 The Chairman asked the working group to look again at some sections of the report in the light of the points made during the discussion which had taken place, and to bring a revised paper to the Committee which he could send to the Minister inviting him to consider the recommendations.

Action: Professor Broom

5.2 Professor Dunbar said that current use of primates was not as high as had been feared. However, as far as future use was concerned, increasing human longevity was making the development of solutions to diseases of old age more pressing than current diseases causing concern, such as heart disease and cancer. That could lead to an increase in the use of primates for research into neuro-degenerative diseases.

5.3 Professor Dunbar said that most of the conclusions in the part of the report which discussed primate use in regulatory toxicology related to contract research organisations. First, there was much uncertainty about regulatory requirements, which might lead to an overuse of primates. Secondly, there was a need to improve licence applications so that the justification for primate use was more transparent. This could be assisted by a central exchange data base. Thirdly, a "fast track" mechanism for licensing individual projects within the framework of a blanket licence could reduce public fears and speed up the licensing process. Fourthly, the sub-committee had concerns that in some projects primates might be being used prematurely in a sequence of experiments in order to save time. The sub-committee was clear that there had to be firm evidence for the use of primates.

5.4 In discussion Professor Bulfield said that the solution to the uncertainty about regulatory requirements lay not so much with the contract research organisations as with government and the regulatory authorities, in the UK and worldwide. Dr Langley suggested that advice could be fed through the Minister to the International Conference on Harmonisation. The Chief Inspector noted that there was a Home Office forum working with the regulatory authorities to improve clarity.

5.5 The Committee noted that although many applications for the use of primates contained well-argued justifications for the use of primates, others were lacking in this area. Although the Ethical Review Procedure process was improving standards, some members of the Committee expressed continuing concern.

5.6 The Chairman thanked the sub-committee for its work, and suggested that the paper could form the basis for a consultation symposium, to which interested parties could be invited. Such a symposium could take place in the Autumn, and the Committee could then present advice to the Minister, based on a revised document, by Christmas. Mr Cobley said that the Home Office supported the idea of a symposium. It was agreed to adapt the paper into a consultation document, and to consider who should be invited to a symposium. [Secretary's note: the Chairman subsequently decided to consider adaptations to the paper.]

5.7 The Committee then discussed the letter from UKXIRA (APC(00)14). This suggested that a member of UKXIRA might join the Primates sub-committee as a co-opted member on occasions when xenotransplantation issues were discussed. The letter also asked whether UKXIRA could have access to information held by the Inspectorate on past and present xenotransplanation research. Dr Jennings (a member of UKXIRA) said that at UKXIRA meetings she had been asked about xenotransplantation-related primate applications, but had felt prevented from commenting because of the confidentiality requirement in the 1986 Act. A UKXIRA presence on the Primates sub-committee would also be helpful. The Committee expressed interest in the suggestion, and noted that liaison between the APC and UKXIRA had been a recommendation of the Kennedy report. The Secretariat was asked to liaise with the Home Office, the Inspectorate and UKXIRA and prepare a paper on both issues raised by UKXIRA for consideration at the next meeting.

Action: Secretariat

5.8 The Committee then considered the vacancy left in the Primates sub-committee by Mr Ward's resignation. It was agreed that Dr Jennings should join the sub-committee.

6.1 The Chairman said that he had written to the Minister on 11 May passing on the Committee's conclusions about the Home Office report into the allegations made by the BUAV about conditions at Harlan-Hillcrest. The substance of that letter had been incorporated into the minutes of the APC's meeting of 12 April (paragraphs 5.4 to 5.8). The Chairman and the Secretary had then attended a meeting with the Minister, and the Chairman had later spoken with the Minister on the telephone. The Chairman said that in his discussions with the Minister he had emphasised that the views expressed in his letter of 11 May represented the majority feeling of the Committee, but it had not been unanimous. His discussions with the Minister had been frank and useful. The Chairman said that the letter of 16 June (APC(00)12) expressed his interest in the tentative suggestions which the Minister had made about how the APC might be involved in some future enquiries. He emphasised that he had not committed the Committee to any course of action. Mr Walsh said that the Minister was still considering his response to the Chairman's letter of 16 June. Against that background the meeting agreed that the issue should be considered further once details of the Minister's proposals were available.

7. Cost/Benefit working group

7.1 The Chairman said that progress on the Cost/Benefit consultation paper had been delayed because it had been suggested in his discussions with the Minister that the working group might be asked to expand its remit to cover wider issues. The Chairman said that he had referred to those suggestions also in his letter of 16 June (APC(00)12). He explained that the wider issues referred to might include aspects of the 1986 Act and moral questions posed by it, but that he had not been given details. The meeting considered whether such work might be taken forward by research which the Research and Alternatives sub-committee could sponsor. However, it was probable that firm details of the Home Office's proposals would not be available before the next meeting of the sub-committee, at which all the year's research budget might be allocated.

7.2 It was recognised that any significant widening of the Cost/Benefit working group's remit would need additional resources. The Chairman said that he had made that point in his discussions with the Minister. The Chairman said that any proposals from the Minister would first need to be considered by the Cost/Benefit working group, but wider issues would need to be considered by the full Committee. As there was no meeting of the Committee until September, the Chairman said that on receipt of the Home Office's proposals he would consult by E mail with the working group and, if necessary, the full Committee.

8.1 Mr Cobley referred to the letter from scientists to Lord Sainsbury about a perceived deleterious effect of the bureaucracy associated with licensing on the competitiveness of UK science. He said that the letter had led to considerable discussion at official and Ministerial level, and a response would eventually be given. In the meantime, a meeting to discuss the concerns had been arranged between Lord Sainsbury and a representative group of scientists.

9.2 Murine LNNA Dr Langley also referred to the information on the LLNA mouse test which had been circulated in the current set of papers (INF(00)19). She asked whether the Inspectorate intended to restrict the licensing of the more severe guinea pig tests now that all the US agencies had set a lead in doing so. The Chief Inspector said that European Commission advice was that Murine LNNA had been scientifically validated. However, in the absence of a definitive regulatory protocol (a definitive protocol appended to Annex V of Directive 67/548) it was not yet considered to 'reasonably and practically available', but the issue was being kept under review. He said that on the other hand the Commission considered that the 3T3 Neutral Red Assay for the determination of phototoxic potential and the TER/Episkin tests for skin corrosion had been scientifically validated and, now that they were detailed on Annex V, were considered to be reasonably and practically available. He said that the Home Office would not therefore issue authorities for animal use where these in vitro methods would suffice.

9.3 Experiments using tobacco smoke Dr Langley then referred to the Committee's recommendation in 1999 to the Minister that the COPD applications (using tobacco smoke) should be approved but that the Inspectorate should receive a report after four months to compare actual welfare effects on animals with those which had been predicted. She asked what the outcome of that had been. The Chief Inspector said that quarterly reports had been received on both projects covering both the scientific progress and the effects on the animals. The work was still at the pre-validation/validation stage with technical problems being identified and resolved and the most refined protocols developed in order to minimise exposure times. He would make a report to the Committee in due course.

9.4 Dr Southee Dr Southee announced with regret that she intended to offer the Minister her resignation from the Committee, as she was moving to the USA. The Chairman thanked Dr Southee for her contribution to the Committee.

9.5 Weekend conference The dates suggested for the weekend conference in York - 22-23 September - were not convenient. The Secretariat was asked to rearrange the conference for later in the year, and to circulate a draft agenda.

Action: Secretariat

9.6 Professor Anderson said that for each meeting the Committee was provided with information from press cuttings about animal experimentation. He suggested that while the press cuttings were useful, in addition the Home Office might give a brief report at each meeting about any significant developments. It would be particularly helpful to have progress reports on projects whose applications the Committee had been asked to discuss. The Home Office representatives agreed to consider this.

Action: Home Office

10.1 The next meeting will be held on 13 September, at the Home Office, Queen Anne's Gate.

APC Secretariat
28 July 2000

• Minutes of Meetings
• Reports and Publications
• Consultation Letters
• Press Releases

• Animals (Scientific Procedures) Act 1986 (available on the Home Office website)

[Copyright Statement] [Complaints Procedure]