Minutes of Meetings April 2002

At the Home Office

Present:

Professor Banner (Chairman)
Professor Anderson
Professor Atterwill
Professor Broom
Professor D Clark
Professor Dunbar
Dr Festing
Professor Flecknell
Mr Gregory
Professor Holland
Dr Hubrecht
Dr Jennings
Dr Langley
Mr McCracken
Dr Morris
Professor Purchase
Professor Richardson (until 12.20 pm)

Mr Cobley
Mr Walsh
Mr Wood
Ms Cotton
Mr Newnham

Home Office (Inspectorate)
Dr Richmond

Department of Health, Social Services and Public Safety for Northern Ireland (Inspectorate)
Mr D Collins

1.2 Other observers at the meeting included the inspector responsible for animal procedures in Northern Ireland and a new member of the Animal Procedures and Coroner's Unit licensing section.

1.3 The Committee congratulated Dr D Clark, Dr Jennings, Dr Langley and Professor Martin on their reappointment as members of the APC for a further four-year term from 1 April 2002.

1.4 Professor Banner recommended that the meeting agenda be altered slightly and the committee was asked to consider the two applications on primates and microsurgery and the paper on infringements as the first main agenda items. The members agreed to consider these after matters arising from the previous meeting's minutes.

Item 2: Minutes of the meeting held on 13 February 2002 and Points of Order (APC (02) 19

1. The minutes from the last meeting were approved subject to the following amendments:

• Paragraph 3.2 of the minutes was amended to read 'The Committee noted that the receipt of the application [relating to a new project licence for use of non-human primates] from the applicant had been delayed.
  
• Paragraph 3.4 was amended to read 'On a related matter, Mr McCracken repeated a request, made at a previous meeting, for clarification as to whether the APC paper on GATT and animal welfare could be disclosed to the current House of Lords Select Committee on Animal Experimentation.'

• Paragraph 3.5 of the minutes mentioned the name and place of work of a non-APC member of the Schedule 1 working group. It was agreed that these should not be made public for reasons of personal security.

• Paragraph 4.2 of the minutes was amended to read 'The Chief Inspector also explained that the personal licensing system and a data base held by the Animal Scientific Procedures Licensing Unit would identify any potential trainee who had previously been shown to be unable to master the surgical techniques involved'.
• Annex B of the draft minutes incorrectly referred to the Farm Animals Advisory Committee and this was amended to read Farm Animal Advisory Committee

2.3 The Secretary confirmed that the minutes from the December and February APC meetings had not yet been placed on the APC website. It was agreed that when minutes were placed on the website it was important to label them clearly to distinguish between draft and final minutes.

Action: Secretariat

3.4 Paragraph 3.3 Home Office policy on publication of research findings (February 2002 minutes): [Secretary's note: At the February meeting the Home Office agreed to provide a comment on section 10 of the 1986 Act. The head of the Home Office Animal Procedures Policy section had written to the Secretary on 28 March, and the letter had been circulated to members as an Information paper (INF(02)13). The letter stated that Section 10(1) of the 1986 Act appeared to allow the Secretary of State very wide scope to impose conditions on project licence holders, including an insistence on the publication of research findings arising from projects licensed under the Act.. However, considerations of reasonableness, relevance and practicability had a bearing on any decision to impose conditions on licensees. Failure to take account of these factors might render any such decision liable to successful challenge by means of representations under s.12(4) of the Act or judicial review. A further consideration would be the remedial action which might be available in the event on non-compliance.

3.5 No blanket publication requirement was placed on project licence holders. However, standard project licence condition 11 required project licence holders to maintain a list of publications resulting from the licensed programme of work and to make a copy of any such publication available to the Secretary of State on request. In addition, the project licence holder was required to submit the publication list on expiry or revocation of the licence. Standard project licence condition 12 further required project licence holders to submit such other reports as the Secretary of State might from time to time require.

3.6 In practice, the majority of research findings were published. However, a number of factors would influence the precise timing of publication and in some cases this might be some time after the project has been completed. Publication of negative or inconclusive results, for which it might be difficult to find a publisher, might also be problematic.

3.7 The Home Office went on to say that considerations of reasonableness and practicability and the difficulty of ensuring compliance all argued against a mandatory publication requirement. It would be unreasonable to require publication of results either at intervals or at a specific time if this conflicted with the intellectual or commercial interests of the project licence holder. Furthermore, the Home Office was not in a position to take on the role of publishing house for failed or flawed research. And it would have no realistic means by which to enforce publication once a project licence had expired.]

3.9 Item 4 Two Microsurgery applications (Feb 2002 minutes): The APC Secretariat had passed the recommendations of the Committee to allow these two applications to the Home Office on 22 February, with the suggestion that the protocol sheet be amended as suggested by Dr Morris.

3.10 Item 6 Enforcement and Compliance (Feb 2002 minutes): This was a later agenda item. It was noted that the Secretariat has not yet been able to trace an earlier APC paper on prosecution practice (paragraph 6.4) but that it should be available for the next meeting.

3.11 Item 7 Accommodation and Care and Item 8 Infringements (Feb 2002 minutes): These would be discussed as later agenda items.

3.12 Item 9 Members' Appraisals (Feb 2002 minutes): Work on this paper was continuing.

3.13 Item 10 Miscellaneous Issues (Feb 2002 minutes): Professor Broom had provided some additional information on pain in cephalopods (paragraph 10). Professor Banner undertook to consider this matter further and report back to the next meeting.

3.14 The Secretariat would provide information by the next meeting on clarification of expenses (paragraph 10.1).

3.15 Wild-caught and endangered species (paragraph 10.2 and 10.3): Further liaison between Mr Gregory and Professor Broom would take place and a revised proposal would be brought to a future meeting.

3.16 Item 11: Design and Statistical analysis of experiments (Feb 2002 minutes): Dr Festing was taking forward the preparation of this paper and hoped to present it at the APC meeting on 26 June 2002.

4.2. Professor Purchase declared a conflict of interest as he was involved with the institution making the application. Another member declared an interest as he had a personal connection with a Parkinson's disease sufferer.

4.6 Layperson Understanding of the Application: Some members expressed frustration that the application seemed to raise more questions than it answered. The Ethics Review Process summary was felt to be deficient. One member suggested that information tables similar to those provided within a recent COPD application (APC (99) 31 A) would have been beneficial.

4.7 Severity Ratings: Questions were asked about the level of severity involved. The Chief Inspector was able to provide some information and explained that for a time the well-being of the animals would be severely compromised such that they would need constant care and attention. Professor Broom noted that he was not completely familiar with the model involved, but suggested that quantitative assessments of welfare should be developed and used. Dr Hubrecht raised questions about the psychological, as opposed to the physical welfare of the animals and how this could be measured and monitored.

4.8 The Committee noted that it had identified areas where more information would have been helpful. However, it was also noted that that might be due to assumptions being made and to the format of the application form. It did not necessarily mean that the project was deficient in those areas. It was agreed by a vote of 11 to 4 that Professor Banner would prepare a letter recommending approval of the application but also explaining in detail the concerns of the Committee The draft letter would be circulated to the full Committee for comment prior to finalisation.

5.3 Professor Banner then opened up the scope of the discussion and sought direction on the Committee's proposed strategy for dealing with applications in the future. He reminded the Committee of the types of applications that the APC were expected, by convention, to see and provide advice to the Secretary of State upon. Those were those applications involving:

• wild-caught non-human primates
• non-human primates in procedures of substantial severity;
• microsurgery
• tobacco and tobacco products.

5.4 The Committee was asked to consider whether all of these should still be seen and how. The convention within the APC was for applications to be sent to a subcommittee for preliminary discussion and then referred back to the full APC for wider discussion.

5.5 There were a variety of views of this subject. Several members felt that the current practice was flawed and could be improved. There was some confusion as to what kind of advice the APC was expected to provide and some felt that a more strategic approach could be taken to specific kinds of project applications rather than looking in isolation at each application referred to the Committee.

5.6 Questions were raised about the level of expertise within the APC to properly consider the ethical, scientific and technical merits of some applications and whether work was being duplicated by the ERP, the Home Office and the APC. Some members suggested that the APC should have greater access to a wider range of applications and that more information on the Secretary of State's response to APC recommendations would be useful.

5.7 Professor Banner felt that it was important for the committee to decide both what types of applications it might wish to see and how it would consider them. He invited Professor Purchase to chair a working group to consider this issue further in the light of the points made and to provide a paper for discussion at a future meeting. The membership of the working group would be Professor Purchase, Professor Richardson, Professor Banner, Dr Langley and Dr Hubrecht.

6.1 At the 2001 APC weekend conference there had been a useful session on enforcement and compliance. At the February meeting three key issues had been identified and discussed. Those were:

6.2 The APC had previously concluded that it did not have a role to play in progressing the first topic but that more information would be sought on the latter two topics.

6.4 Professor Banner reminded the committee of discussions at the 2001 weekend conference that had identified animal technician training and motivation as a key issue. He commented that the issue of compliance and enforcement was important but that there was nothing concrete that the Committee had identified which it could progress in the short term. It was agreed that the matter would be considered further when the information from CPS, discussed above, had been received.

7.2 Dr Jennings suggested that there was still room for the APC to add value in this area and that proactive measures could be undertaken by a working group. Professor Broom said that accommodation; husbandry and care were areas vital for animal welfare and endorsed the setting up of a working group.

7.3 Dr Morris agreed that excellent work was taking place in Europe which would lead to a radical change in the standards. The emphasis would need to be on implementation and would require change in emphasis from minimum standards to best practice. Any APC advice to the Minister might address the best way to implement better practice.

7.4 Professor Holland suggested that the APC could be more proactive in promoting research in this area. There were wider intellectual issues to consider and these could be formulated into specific research proposals. Dr Hubrecht noted that a strategic view needed to be taken, as skilled researchers regular long-term funding to gain fluency in an area of science. He felt that collaboration with the MRC and BBSRC could be useful. It was agreed that Dr Hubrecht would add this issue to the agenda for the Friday 12 April Biotechnology meeting with the Wellcome Trust, BBSRC and MRC and report back to the full Committee.

Action: Dr Hubrecht [Secretary's note - this issue was raised at the 12 April meeting]

8.1 This paper described the 20 "Class three" (i.e. more serious) infringements on which action had been completed in the thirteen months between November 2000 to December 2001.

8.2 A general discussion took place. It included clarification of what the revocation of a licence might imply. The Chief Inspector explained that this included those whose licences had expired before the disciplinary action; those who had surrendered their licence voluntarily; and those who had had their licence withdrawn. Professor Anderson felt that more information should be included, for example about the species of animals involved. The Home Office undertook to consider including this information.

8.3 It was noted that in several cases module 5 animal ethics training had been recommended by AP&CU as a remedial measure. The education and training subcommittee was invited to take note of this trend.

8.4 Another member noted the ratio of self-reporting versus inspector findings and commented that fuller information would be helpful. Questions were raised about the different levels of admonition, problems with cage labelling and a particular incident involving revocation of a personal licence. Both the Head of the Animal Procedures Licensing Section of AP&CU and the Chief Inspector were able to provide detailed information on both issues to the satisfaction of the Committee.

10.1 Mr McCracken advised that he wished to write to the Minister regarding the Home Office's statement that it could not require the publication of research results, and he requested copies of relevant Hansard extracts. Professor Banner reminded members of the convention that such requests should be made through the Chairman and that he was responsible for representing the views of the Committee to Ministers.

10.2 Dr Langley discussed statements made by the Minister in her evidence to the House of Lords Select Committee on Animal Experimentation (INF(02)9) regarding the difficulty of spending the APC research budget. It was agreed that comment on the issue would be sought from the Research and Alternatives sub-committee and the issue would be further discussed at the next meeting.

10.3 Professor Banner drew the Committee's attention to INF(02)15 which contained a draft statement on scientific validity prepared by the cost/benefit working group provided to members for their general information. He asked for any general comments to be forwarded to the APC Secretariat.

10.4 There was some discussion about the cost/benefit working group's proposal to send a copy of the draft report to the House of Lords Select Committee on Animal Experimentation before the APC members had had time to consider it carefully. In the light of this discussion, Professor Banner agreed that the draft report would not be sent to the Select Committee, but that he would comment to the Select Committee in a personal capacity on the general lines of thinking of the working group.

Action: Professor Banner

10.5 Mr Gregory provided the Committee with a progress report on the schedule 1 working group. He advised that the interactive discussion at the recent IAT Conference had gone well and the working group would review the information at its next meeting on 22 April 2002. Once the working group's terms of reference had been finalised they would be communicated to the full Committee.

Action: Mr Gregory

11.1 Professor Banner reminded committee members that the next meeting would take place on 26 June 2002.

APC Secretariat

April 2002

POINTS OF ORDER DISCUSSED AT THE APC MEETINGS ON 12 DECEMBER 2001 AND 13 FEBRUARY 2002 (AND AS AMENDED AT THE MEETING ON 10 APRIL 2002)

The Chairman referred to the attendance by a member of the Committee at the House of Lords Select Committee on Animal Experimentation on 11 December. The member had sent the minority report of the working group on openness to that committee. The Committee noted its disappointment that the member had disclosed an internal working paper outside the Committee, and expressed its concern that such a disclosure might prejudice the Committee's future internal and external discussions. All members were reminded that the well-established principle of confidentiality of working papers should be respected by all.

Professor D Clark asked to discuss the need for confidential information provided to the Committee to be kept as such. He said that an individual from the pharmaceutical industry had raised this with him recently. Professor Clark said that the individual had expressed concern that a member of the APC had disclosed information which it had been understood had been given in confidence in the course of a visit by the APC to an establishment.

The Chairman said that it was a matter of principle with the APC that visits were made for the purposes of informing members about the work of establishments; that these visits were not inspections; and that the Committee made no public comments of any kind about them. There was no disagreement.

Most Committee members felt that any information gleaned during a visit should not be used in other contexts as a matter of principle. The Chairman expressed his concern that, even though the member involved had not identified the site about which he commented, future site visits by the APC might be jeopardised by an establishment's concerns that any such information might be used to identify it or come to be used against it.

The discussion then turned to the evidence given by a member of the Committee to the House of Lords Select Committee, where he had put on record a comment that he said had been made to him during a visit. The Chairman had written to the Chairman of the House of Lords Select Committee stating that the APC would regret that action very much. The Committee endorsed the Chairman's letter. [Secretary's note: a copy of the Chairman's letter is attached.]

ANIMAL PROCEDURES COMMITTEE

ROOM 978, 50 QUEEN ANNE'S GATE

LONDON SW1H 9AT

020 7273 2915 or 2770

From the Chairman

Reverend Professor Michael Banner MA DPhil

Lord Smith of Clifton

Chairman

Select Committee on Animal Experimentation

House of Lords

London SW1

15 January 2002

Dear Lord Smith

I have had sight of the transcript of the examination by the Select Committee of Mr Robert McCracken on 11 December. As you know, Robert McCracken is a member of the Animal Procedures Committee (APC) and I hope it will be helpful to offer my comments on certain parts of his evidence which relate to the APC.

Paragraph 809 to 811 of the transcript

I am sure that Mr McCracken would want me to clarify a matter where he may not have been entirely clear. He refers to APC's examination of licence applications, and suggests that the APC is hindered in its function of advising the Secretary of State because it does not see the analysis by the Animals (Scientific Procedures) Inspectorate of the application. Your colleagues may have gained the impression that the APC has been refused sight of these analyses. However, it is not the case that the Committee has asked for the Inspectorate's reports and been refused them. (Indeed, in my four years as Chairman I have no recollection of the Committee ever asking the Home Office for documents or information of any kind and being refused.) The APC has always understood its role, in considering and advising on licence applications, to be that of an independent source of advice to the Home Secretary alongside the advice from the Inspectorate and the Animal Procedures and Coroners Unit (AP&CU). For that reason it does not ask for information concerning the advice the Inspectorate proposes to give, though during its consideration of a licence application it can naturally turn to the Inspectorate (and to applicants) for information on technical detailed matters.

Paragraph 808 of the transcript

The APC will regret very much that Mr McCracken has put on record a comment which he alleges was made to him during a visit. It is a matter of principle with the APC that visits we make are for the purposes of informing us about the work of establishments, but that these visits are not inspections and that we make no public comments of any kind about them. Any breach of this principle plainly puts in jeopardy the openness which many establishments have shown in hosting such visits, and hence threatens the ability of the APC to carry out its work on the basis of an informed knowledge of the system.

I hope these comments are helpful.

Yours sincerely

MICHAEL BANNER