Minutes of Meetings - October 2002

Professor Banner (Chairman)
Professor Anderson
Professor Broom
Professor Bulfield
Professor D Clark
Professor S Clark
Professor Flecknell
Professor Holland
Dr Langley
Professor Martin arrived at 12.35 (during item 10)
Mr McCracken arrived at 12.05 (during item 7)
Professor McNeilly
Dr Morris
Professor Richardson

Home Office (AP&CU)
Mr Cobley
Mr Walsh

Home Office (Inspectorate)
Mrs Houlton

Secretariat
Mr West
Mr Earle
Mr Brenner

1.1 The Chairman opened the meeting at 10.32 and welcomed members. Apologies for absence from the meeting were received from the following APC members: Professor Atterwill, Professor Dunbar, Dr Festing, Mr Gregory, Dr Hubrecht, Dr Jennings and Professor Purchase. Dr Richmond and Dr Anderson from the Inspectorate and Mr Wood from the Home Office had also offered their apologies for absence.

1.2 The Chairman welcomed Mrs Houlton from the Inspectorate. He also welcomed Mr Earle to the APC Secretariat as the replacement for Ms Bacon. He added that Ms Bacon had left the Secretariat on promotion and the Committee agreed that he should write to thank her for her service to the Committee.

1.3 The Chairman noted that this was the last APC meeting that Professor Anderson, Professor Flecknell and Professor Purchase were eligible to attend, as their second and final terms of membership would end on 30 November. On the Committee's behalf he thanked them for their considerable efforts for the Committee, and wished them well in the future.

2.1 The Committee confirmed that the revised minutes of the meeting of 10 April were agreed and could be posted on the website.

2.2 The minutes from the meeting of 26 June were subject to the following amendments:

• Professor Dunbar and Professor Holland were absent from the meeting, not present as was incorrectly stated in the original minutes.
  
• Paragraph 8.1 Dr Morris's declaration of interest was amended.
  
• Paragraph 12.7 was amended to read that the Primates sub-committee would consider this at a future meeting.
  
• Paragraph 12.11 was amended to read "Dr Langley asked if the work referred to in the article had indeed been stopped and if it was the work conducted under the licence application which the APC had examined some time ago. The Chief Inspector said he was not aware of any ongoing licensed work on non-human primates being halted in the way described in the article, and he had not identified the researcher to whom the article referred."

The committee agreed that subject to these amendments, the minutes would be ratified and posted on APC's website.

3.1 The Chairman advised that a revised annual report had been circulated to the membership and no substantive comments had been received. It was anticipated that the report would be laid before Parliament in late October.

Item 5: Freedom of Information and the Code of Practice for Scientific Advisory Committees

3.2 The Secretary explained that the paper had not yet been written, but it was anticipated that it would be prepared in time for the next meeting in December.

Item 6: Cost/Benefit Working Group Report

3.3 This was a later agenda item.

3.4 The Chairman had responded to Genewatch in a letter dated 19 September. This was listed in the supplementary paper, INF(02)24. The reply had been copied to the Bodyshop, who had also expressed interest in this matter.

Item 8: BUAV allegations about non-human primate research at Cambridge University

3.5 A working group had been set up to review the BUAV's allegations. The Committee agreed the membership, which was Professor Holland (chair), Dr Jennings and Professor Atterwill. The terms of reference for the review were also agreed by the committee;

• "To assess the BUAV's allegations about the use of marmosets at Cambridge University in the light of the Chief Inspector's report and the Home Office's response to that report, in order to identify further areas of discussion by the APC."

The Chairman noted that the Chief Inspector was due to complete his findings shortly and the working group would then consider his report and the Home Office response. The Chairman noted that Professor Anderson had e-mailed him expressing his concern about the BUAV video. The Chairman asked the Secretariat to forward that e-mail to Professor Holland.

3.6 Professor Flecknell explained that there were a total of three reports which all confirmed that there was a need to improve the statistical design of experiments. He suggested that Dr Festing should become a member of the Education Sub-Committee in order to assist taking forward this important work. Professor Flecknell noted that a CD-ROM on this subject had been produced which had been funded by an APC research grant. He suggested that access to this could be helped by a website link.

3.7 This was a later agenda item.

3.8 The membership of this sub-committee was agreed: Dr Hubrecht (chair), Dr Jennings, Professor Broom, Mr Gregory and Dr Morris. The Secretary read out the proposed terms of reference suggested by Dr Hubrecht.

• "The Sub Committee will deal with housing and husbandry issues on a case by case basis as requested by the APC Committee or where issues are determined as being important by the sub-committee.
  
• "Where housing and husbandry issues overlap with those of other committees, the housing and husbandry sub-committee will seek advice from those sub-committees."

The Committee agreed these terms of reference.

Item 12.3: Any other business: difficulty of spending APC research budget

3.9 The Secretary had written to Dr Langley on behalf of RASC on 19 September. A copy was included in Information paper INF(02)24.

3.10 The working group had taken delivery of the literature search which it had commissioned. An update would be provided at the next meeting

3.11 An interim letter was being sent to Mr Dan Lyons at Uncaged. The Chairman added that he hoped to send a substantive reply shortly. Dr Langley asked if the APC had completed its examination of issues stemming from the Imutran report. The Chairman replied that some of the issues would be covered in the Cost/Benefit report and a future Primate report, but he asked the Secretary to prepare a note summarising progress on the four issues which, after discussion at the meeting on 13 February, the Committee had agreed to consider further.

4.1 Professor Banner introduced paper APC(02)33, which was the Home Office's response to the APC's Biotechnology Report, and invited comments from the Committee. There was general concern, particularly from the members of the Biotechnology working group, that the response did not appear adequately to respond to all of the recommendations put forward in the report. The Chairman said that he would liaise with the members of the working group to work up a draft letter expressing the Committee's concerns. The draft would be circulated to the full membership before being sent to the Minister.

4.2 It was noted that the Minister had not yet met the Committee. The Secretary explained that the Minister had accepted an invitation to attend the Committee's meeting in September, but that meeting had been cancelled by the Committee. The Minister would be invited to attend the meeting in February 2003.

5.1 Professor McNeilly introduced the report. He reminded the Committee that an earlier draft of the Primates sub-committee report had been discussed at the meeting on 26 June. Comments made by members of the Committee at the meeting and subsequently had informed this final version of the report. Dr Langley referred to the potential for earlier micro-dosing which could be introduced before phase 1 clinical trials and offered to provide an appropriate amendment that could be included in the report.

5.2 Professor Broom said that although the report was written about primates and the use of primates, it should be made clear that its recommendations could apply to other animals. Professor McNeilly said that he would add an appropriate sentence to the report. [Secretary's note: Professor Broom subsequently suggested the following amendment should be inserted on page 2 at the end of paragraph 2, and on page 6 at the end of paragraph 2: "It is recognised that many of the issues discussed and recommendations made refer also to some animals which are not primates."] Some minor drafting points were identified, and the Secretariat was asked to resolve these by correspondence with members of the sub-committee.

5.3 The Chairman thanked the sub-committee for their work on the report: Professor Dunbar, Professor Atterwill, Dr Jennings, Dr Langley and Professor McNeilly. It was agreed that once finalised, the report would be submitted to the Minister with an appropriate covering letter from the Chairman.

6.1 Professor Banner said that by convention, the Secretary of State referred to the Committee applications involving:

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

At the APC meeting on 10 April 2002 there had been a general discussion of the Committee's policy on reviewing applications. A working group, comprising Professor Purchase (chair) Professor Banner, Dr Hubrecht, Dr Langley and Professor Richardson had been set up to consider both what types of applications the Committee might wish to see in future and how it would consider them. The working group had now completed the position paper APC(02)35, which the Committee was invited to consider. Its conclusions were:

• The Home Office should cease the automatic referral to the APC of the types of applications currently referred to it by convention.
  
• The Home Office, separately or in conjunction with the APC, should seek to identify applications which raised novel and problematic trends and issues and should refer them to the APC.
  
• The Home Office should publicise this change of approach, and invite the public to participate in identifying such trends and issues.

6.2 Professor Banner asked the Committee to consider whether paper APC(02)35 could form the basis of a letter to the Minister suggesting a change to current Home Office practice. He noted that APC(02)40 was an expression of Dr Jennings' concern that as a matter of policy the Committee should continue to consider applications for moderate and substantial severity experiments involving non-human primates. In discussion the following points were made:

• The current system of referrals should continue, but the Committee should decide on a case by case basis whether it could usefully comment.
  
• Alternatively, the current system of referrals should not be altered, as the current system reassured the public that the APC took an interest in controversial applications.
  
• The APC might wish to see a random sample of applications involving any species in procedures of substantial severity, rather than restricting its consideration to applications involving primates in procedures of substantial severity.
  
• Conversely, the Committee should concentrate on applications for procedures involving primates, seeing applications involving both moderate and substantial severity.
  
• Severity levels were not the best means of identifying applications to be seen by the Committee. The emphasis should be that any application raising novel or controversial issues might be seen by the Committee.
  
• The Committee might wish to delay its consideration until the Government's responses to the House of Lords report and to the BUAV allegations about Cambridge University had been received.
  
• The APC's role was not to reproduce the cost/benefit assessment, but to consider more strategic issues.

6.3 The Chairman noted that there appeared to be broad consensus that

• Microsurgery applications did not merit referral to the APC.
  
• The Home Office should refer to the APC applications involving non-human primates in procedures of both moderate and substantial severity.
  
• The Home Office should refer to the APC a random sample of applications involving procedures of substantial severity for species other than non-human primates.
  
• The Home Office should continue to refer to the APC any application raising novel policy issues or other concerns.

The Chairman said that in the light of the discussion and the consensus which had emerged, the working group would re-draft the paper for future consideration by the Committee.

7.1 The Chairman explained that there would be an opportunity for a general discussion of the House of Lords report at the Annual Conference, but that at this stage he wished to invite the Committee to comment on two particular recommendations. He suggested that the Committee should put on record

• that as currently constituted the Committee was not equipped to carry out the detailed role of monitoring the Inspectorate that the report appeared to envisage; and
  
• that the Committee welcomed the recommendation that the Secretariat be strengthened in order to cope with the demands of the Committee's work, but considered that further separation of the Secretariat from the Home Office was not necessary.

7.2 Mr Cobley explained that the convention was that the Government response to a Select Committee report should be given within six months of the report's publication, ie by January 2003. However, it was hoped that the response would be ready earlier, in November. It was noted that the Committee was not obliged to comment on the report, but that any comment would need to be made before November in order to have any chance of influencing the Government's response.

7.3 The Committee agreed that it might wish to comment further after the Government had announced its response to the Select Committee's report. In the meantime, the Committee agreed that the Chairman should comment as suggested on the two recommendations identified in the paper, but there was general agreement that further comment should be made on several other points, as follows:

• The Committee believed that its research budget was well spent, as the Committee was well placed to identify worthwhile projects. That budget should therefore be retained by the APC, unless the Government also accepted the parallel recommendation that a Centre for the three Rs be introduced. The Committee also welcomed recommendations 10 to 13, relating to initiatives by Government to increase research into alternatives to the use of animals.
  
• The Committee would welcome the opportunity to consider the efficacy of the Act and regulations as applied to experimental farm animals.
  
• The Home Office should be reminded that the Committee's "miscellaneous" recommendations had included a recommendation that Members should be paid.

The Chairman said that he would amend the proposed letter as discussed and circulate a revised draft to the membership, with the aim of writing to the Minister by the end of October.

8.1 The Chairman invited views from the committee on the proposed agenda for the weekend conference. The Secretary explained that the Chief Inspector would not be available to speak on regulatory issues. The Chairman added that the agenda should include the paper by Professor Purchase on the public's perception of the APC, which had been briefly discussed at the meeting on 10 April (APC(02)18). The Committee also intended to view a video (funded by the Home Office on the recommendation of the APC) on the natural history of the laboratory rat. It was agreed that the author of the video should be invited to present it. The Secretariat would consult after the meeting with Professor Flecknell about a suitable speaker on laboratory animal welfare.

The Chief Inspector would shortly complete his report on the BUAV's allegations about non-human primate work at Cambridge University, after which it would be submitted to Ministers. Mr Cobley explained that it would then be for the Minister to decide on any further action, and on whether the Home Office's response to the allegations would be published.

An infringement which the Home Office had brought to the Committee's attention was discussed. The Committee identified certain questions to be addressed, and the Secretariat was asked to pursue these with the Home Office.

• Professor Banner said that the draft report in APC(02)39 had already been partially amended at a recent meeting of the working group. He invited comments on the draft report. The following points were raised at the meeting.
  
• Professor Flecknell suggested that caution was needed when quantifying the harms of procedures on animals. He suggested that page 37 should be revised to make that clearer. After discussion, he and Professor Broom agreed to supply material for an annex discussing the quantification of harms at greater length.
  
• Dr Langley expressed concern about paragraph 2.8 on page 5, suggesting that it should explain that the mere fact of being confined was a harm to an animal. Professor Holland agreed to re-work that paragraph.
  
• Mr McCracken said that paragraph 4.4.1 on page 70 did not accurately reflect Section 24 of the 1986 Act. He also suggested that the working group should ensure that any references to openness in the Cost/Benefit report should reflect the conclusions of the Committee's report on openness.
  
• Dr Langley referred to paragraph 4.3.4 on page 70 of the draft report. She reminded the Committee that the practice of the Food Standards Agency (FSA) was to invite public input on dossiers from companies seeking approval, before the FSA made its decision. That public input was prospective, as NAVS and the BUAV had argued for in their representations to the Committee about public input into licence applications. FSA carried out this prospective consultation electronically via their website and had been running this public consultation scheme for a year, despite the fact that there were very tight deadlines for the assessment of applications. Dr Langley suggested that if the APC were not to support prospective public consultation it would have to give detailed reasons why such a practice was appropriate for applications to the FSA but inappropriate for the application for project licences under the Act. The Chairman agreed to review the paragraph.

• Professor Stephen Clark agreed that a cost could be deemed acceptable provided there was no better way of achieving a desired aim. But he suggested that there was a need to be as imaginative as possible when considering how an aim could be achieved. For example, a case could be made for using animals to develop a medicine to eradicate bilharzia in Africa. However, it could be argued that investment to improve the quality of water supply in Africa could achieve the same desired result. Professor Holland agreed to address Professor Clark's concern.
  
• The Chairman confirmed that the term Local Review Process used on pages 76 and 77 would be changed to Local Ethical Review Process.
  
• Dr Morris said that he found the section on page 76 dealing with the various roles of those involved in cost/benefit assessment confusing, and said that he would forward a proposed amendment.
  
• The Committee agreed that the report merited being presented in a high quality format, and should perhaps be published officially.

10.2 The Chairman asked members to forward any further written comments, and said that the working group would make further amendments to the report, with the intention of circulating a final draft to members before the next meeting in December.

Item 11: Any other business

Allegation made by "Animal Aid" (INF(02)24)

11.1 Mrs Houlton explained that the Inspectorate was examining the complaint made by Animal Aid about a named project licence holder. The Chairman noted that if an infringement which had compromised animal welfare was identified a report would be given to the Committee on completion of action.

Plans to promote research alternatives

11.2 Dr Langley referred to PCD Circular 2/2002, and asked about progress on the Home Office's plans to review the scope for improving the application of the three Rs with Government departments and other agencies. Mr Walsh explained that the Home Office could provide the Committee with details of the review of data sharing and the three Rs after Ministers had been advised of the outcome.

12.1 Professor Banner advised that the next meeting of the APC would take place on 11 December at University College, London. Professor Martin explained that following the meeting a visit to the Animal House and the clinical pharmacology block of UCL had been arranged.