Minutes of Meetings - December 2001

Apologies were received from Mr Baker, Professor Broom, Professor Bulfield, Professor D Clark, Professor S Clark, Professor Holland and Professor Martin of the APC, and Mr Wood of AP&CU.

2. One correction was suggested. The second sentence of paragraph 4.2 of the minutes should state "Dr Morris said that he was a Council member of the Research Defence Society, and his company (GlaxoSmithKline) was supportive of HLS". That amendment was accepted and the minutes were then agreed.

3.1 Paragraph 3.4 Code of Practice on Ferrets and Gerbils INF(01)33 contained the Chairman's letter to Angela Eagle of 1 October and her reply of 6 November, which was noted.

3.2 Paragraph 3.5 Schedule 1 working group Mr Gregory was in the process of fixing a preliminary meeting of the Schedule 1 working group.

3.3 Paragraph 3.6 Sucralose A paper about the Sucralose experiments has been prepared - INF(01)36A. Dr Langley said that she still had some questions, which she agreed to send to the Secretariat.

3.4 Paragraph 4: "Uncaged" allegations about Imutran/HLS The Chairman had written to Angela Eagle on 23 November asking for clarification about why the Home Office had not asked the APC to provide scrutiny of the investigation (INF(01)32). No reply had been received. [Secretary's note: a reply has now been received, and a transcript of Angela Eagle's letter of 14 December is attached to these minutes.]

3.5 Paragraph 5.2. COPD licences It had been agreed that Dr Langley was to attend a meeting of the Cost/Benefit working group in order to discuss issues arising from the APC's involvement in these licence applications. Action: Secretariat

3.6 Paragraphs 6.1 and 6.2 taking forward APC's openness and biotechnology recommendations Due to pressure of other work, the Secretariat had not been able to progress these matters.

3.7 Paragraph 7 AOB Dr Judson has been invited to attend the meeting.

4. Opening the discussion the Chairman said that there had been some useful discussions at the weekend conference, including those on accommodation and care and on enforcement and compliance. He referred to the various fora where work on both topics was being taken forward in UK and in the rest of Europe. Referring to the Committee's full work programme, he expressed concern that extra work should not be taken on unless that resulted in significant added value. He said that the Committee now needed to decide whether there was work that the Committee itself could usefully take forward.

4.1 There was a short discussion of the three themes which had emerged from the presentations given at the weekend conference: implementing best practice; how increased funding of research into animal welfare might be stimulated; and the training and motivation of technical staff. It was agreed that Dr Jennings, who had co-ordinated the discussion at the weekend conference on this topic, would work up the presentations into a paper. Besides presenting the information given at the weekend conference, the paper would need to include a discussion of the value of the Committee taking forward any topics. The paper could be discussed at a future meeting, and be placed on the APC website and form the basis of an annex to the annual report. Action: Dr Jennings

4.2 It was noted that the discussion at the weekend conference had identified the need to attempt to correct public misconceptions both about the current system of regulation and about recent improvements, such as the ERP process. The Chairman said that he had asked Professor Broom, who had made proposals about enforcement and compliance, to work up a short paper on this topic. Any paper, which resulted from discussions, could be discussed at a future meeting, and be placed on the APC website and form the basis of an annex to the annual report. Action: Professor Broom

4.3 There was a short discussion about the Committee's practice of examining reports by the Home Office of infringements against the Act. Such reports could be examined on a regular basis through the year, or could be examined on a yearly basis. The latter practice resulted in some delay in the Committee's consideration, but had the merit of enabling emerging themes and concerns to be identified. The Chairman asked the Secretariat to prepare a paper explaining the current practice. Information was also requested on the system of record keeping in establishments, and the Chairman asked the Secretariat to prepare a paper on that. Action: Secretariat

4.4 Professor Purchase drew parallels between enforcement and compliance relating to animal scientific procedures with the enforcement of Health and Safety legislation. He said that as with the Home Office's approach to ensuring compliance with animal experimentation legislation, the Health and Safety Executive sought to improve safety performance through engendering a positive attitude of self-interested compliance. He suggested that there could be useful transferable lessons to be learnt from HSE's practices. It was agreed that the Secretariat would consult HSE and prepare an information paper. Action: Secretariat

4.5 Members had been asked to complete feedback forms after the weekend conference, and their views had been summarised in INF(01)31. The Chairman said that the feedback was generally very positive, and some useful suggestions for future conferences had been made. He expressed the Committee's gratitude to Ms Bacon for organising the conference so efficiently.

5. 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.

6 The Committee was generally content with the work programme set out in APC(01)28, but the following comments were made. The Chairman suggested two items for the main committee: a review of future work (perhaps at the weekend conference in November 2002); and the consideration of the two papers on enforcement and compliance and on accommodation and care (see Item 4 above). He hoped that those two papers could be considered at the April meeting, with the intention of agreeing any further action on the two topics by June. It was suggested that the Committee should also carry out further work on openness - in particular consideration of the possibility of publication of "blind alley" research - but it was noted that that topic was being taken forward by the Home Office.

6.1 It was agreed that one of the aims for the Primates sub-committee - to update the report on primate use and report to the Home Secretary by January 2002 - was unachievable. Dr Jennings agreed to liaise with the Secretariat about a revised timescale. Action: Dr Jennings

6.2 Several members suggested that the Committee might do more to assist the needs of science and industry. Following the Committee's various recent consultation exercises considerable feedback had been received about the perceived over-bureaucratisation of the licensing process. The Committee should address these concerns more fully. After a short discussion it was agreed that there should be an item in the annual programme for 2002 "to review whether the APC should carry out further work to consider the regulatory burden on science and industry, taking into account

• the conclusions of the APC's biotechnology report;
• the report of the Expert Group on Efficient Regulation;
• the report of the House of Lords Select Committee on Animal Experimentation;
• the Home Office's review of the Ethical Review Process;
• the stakeholder meeting of the Better Regulation Task Force; and
• the work programme of the Nuffield Council on Bioethics."

Members agreed that the Committee's consideration of this item should not take place until all the listed reports were available. Action: Secretariat

7 Dr Anderson introduced the Inspectorate's review of the ERP. There were three recommendations:

• certificate holders should continue to establish and maintain local ethical review processes acceptable to the Secretary of State;
• the process statement describing the ERP, set out in Appendix J to the Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986, should remain unchanged; and
• the ERP should be seen as an evolving process, and the Secretary of State should draw the attention of those involved in ERPs to the insights into "best practice" set out in the review.

The review had been submitted to Ministers and been accepted, as noted in a Parliamentary Question on 6 November.

7.1 It was suggested that the process by which a cost/benefit assessment was carried out first by the ERP and then by the Home Office was sequential and potentially repetitive, and therefore ran the risk of unnecessarily increasing the time involved in acquiring a licence. However, it was the view of the Home Office that the role of the ethical analysis undertaken within the ERP was to ensure that the establishment's values were properly reflected in applications, and not to duplicate the regulatory cost/benefit assessment subsequently undertaken by the Home Office. It was agreed that this should be considered further by the Cost/Benefit working group. Action: Secretariat

7.2 The role of the "lay members" of ERPs was discussed. It was noted that there were two levels of independence among organisations' lay members. Some were from within the organisation itself, but from a different part of the organisation from animal experimentation. Others were from outside the organisation. The Chief Inspector said that both types of lay member were effective. He said that Inspectors were actively promoting best practice on this and other issues by using the review to inform the regular advice they gave to establishments. It was noted that the RSPCA was investigating how training for lay members of ERPs might be taken forward. The RSPCA was also considering holding a series of meetings to develop and share best practice. This had also been discussed at the recent Certificate holders' Conference.

8 Professor Purchase, having declared an interest as the author of the report, introduced this item. He said that interviews with scientists from France, Germany, the United States and the UK had confirmed that

• those working in the UK under the Animals (Scientific Procedures) Act 1986 felt they experienced delays in carrying out their work because of the times taken to prepare and process applications for project licences and amendments; and
• there was some anecdotal evidence that the length of time taken to comply with animal experimentation legislation was longer in the UK than in Germany, the United States or France.

8.1 Professor Purchase said that there were several reasons for the length of time taken to comply with the legislation in the UK. They included

• the nature of the legislation;
• the Home Office's administrative arrangements;
• inadequate knowledge by licence applicants of those administrative arrangements; and
• complexity of administrative arrangements within establishments.

The report, which contained several recommendations, had been sent to Angela Eagle. Professor Purchase suggested that the recommendations of perhaps most interest to the Committee were that AP&CU should become an agency, and that the Certificate Holders' Forum should accept the role of identifying and sharing best practice. Professor Purchase also suggested that the APC itself needed to consider whether the time taken by its consideration of licence applications which were referred to it could be reduced.

8.2 In a brief discussion Dr Jennings expressed regret that the report's references to the ERP had not drawn attention to the ERP's contribution to a real improvement in science and welfare. Mr Cobley said that the Home Office was currently considering the report, and Angela Eagle would send a substantive reply in due course. He acknowledged that the AP&CU website needed improvement, and said that that was being addressed.

8.3 The Chairman thanked Professor Purchase for his contribution and said that the APC would seek to monitor the responses to the report. It would be one of the bases for the Committee's consideration of the regulatory burden (see item 5 above). Action: Secretariat

9 The Chairman said that Cabinet Office guidance required appraisals of all members of NDPBs to be carried out. He said that paper APC(01)31 set out the proposals for the appraisal of APC members, and he asked for comments. It was clarified that besides providing evidence for the process of re-appointments, the appraisal process was a means of identifying areas for possible improvement, and that appraisals would not be disclosed to Cabinet Office. It was noted that care needed to be taken when assessing a member's attendance on official APC visits (for example to establishments carrying out animal experimentation}. That was because some members frequently visited such establishments as part of their everyday work, and so did not need to attend such organisations with the APC.

9.1 Professor Purchase suggested that the appraisal system should include targets and objectives. Another suggestion was that the Chairman's assessment should include an element of upward appraisal of his performance by members. Clarification of what was the "person specification" was also requested. Professor Purchase agreed to send details of his thoughts about targets and objectives to the Secretariat. A revised form would then be circulated by the Secretariat for members' comments. Action: Professor Purchase and Secretariat

10 Introducing this item, Dr Jennings said that the sub-committee had submitted a report to the main Committee at the meeting in June 1999. That report had sought to address two issues: the minimisation and eventual elimination of primate use and suffering; and the use of primates in regulatory toxicology. Since then the sub-committee had decided to update and revise the report in the light of other papers. One of those - a paper by the Boyd Group on the use on non-human primates (NHPs) - was attached to APC(01)32. The paper was a draft, and as yet contained no recommendations. The sub-committee was meeting immediately after the main committee. The Chairman asked for comments on the paper, and asked the sub-committee to consider them and produce a revised paper which could be discussed at the APC meeting in February 2002.

10.1 Comments were as follows:

• The debate about whether a case-by-case cost/benefit assessment should be carried out was debated in paragraph 5.1 of the Boyd Group report.
• The report appeared to concentrate on the use of NHPs in regulatory toxicology. That was because regulatory toxicology accounted for 75% of all NHP procedures.
• Other issues - acquisition; housing and care; and the use of wild caught primates - would be the subject of future work by the sub-committee.
• The balance between use of NHPs in toxicological and non-toxicological studies could be clarified by a change of title.
• The report needed to explore the ethics of using human volunteers as a second species instead of NHPs.
• The recommendations would need to identify which bodies could take work forward.
• The sub-committee should assess whether a stakeholders' forum would be helpful.

10.2 The Chairman thanked the sub-committee, and asked members to send the sub-committee any further substantive points. Lastly, it was agreed that Dr Hubrecht should join the sub-committee.

11.1 The Secretary said that he had been informed that the Home Office had received a project licence application which, if granted, would involve non-human primates in procedures of substantial severity. The aim of the project was to find ways of relieving Parkinson's disease and some of the side-effects of current therapies, such as spontaneous involuntary movements. The application was one which would be referred for advice to the APC. The Chairman said that the previous procedure for assessing such applications had been for the application to be discussed initially in the full committee; then a working group would formulate questions to be answered by the applicant, either in writing or by interview; followed by a final decision being taken by the full committee. He was mindful of the need to consider the application fully, but at the same time was conscious of the need for a decision to be made expeditiously. He suggested that the application could be copied to all the membership. Members could send their comments to the Primates sub-committee, which could then carry out an initial assessment and formulate questions which might be asked of the applicant, who had been put on standby to attend the APC meeting on 13 February 2002. In that way the Chairman hoped a decision could be made at the February meeting. [Secretary's note: AP&CU have informed me that the primates application will now not be coming forward in time for the 13 February meeting. AP&CU expect the application by no later than the end of February. There will therefore be time for it to be assessed first by the Sub-Committee and then discussed substantively at the 10 April meeting.]

11.1.2 In discussion it was suggested:

• that the Primates sub-committee could decide whether to ask for sight of the applicant's ERP review;
• that the Primates sub-committee could decide whether the applicant should be asked to make a presentation;
• that the papers referred to the Committee should include sections 17 and 18 of the application form; and
• that at the conclusion of the process the Committee should carry out a retrospective assessment of the procedures.

11.1.3 It was suggested that the assessment of the application carried out by the Inspectorate should be available to the Committee. The Chairman said that the APC has always understood its role, in considering and advising on applications, to be that of an independent source of advice to the Home Secretary alongside the advice from the Inspectorate and AP&CU. For that reason it did not ask for information concerning the advice that the Inspectorate proposed offering, though it naturally turned to the Inspectorate (and to applicants) for information on detailed technical matters. That practice could be looked at again during the retrospective assessment of procedures.

11.2.1 Angela Eagle had given evidence to the House of Lords Select Committee at a public session on 13 November. The transcript of the proceedings would appear on the Select Committee's website shortly.

11.2.2 Publication of the ERP review report had been announced in answer to a written Parliamentary Question on 6 November. The report and its appendices were available on the Home Office website.

11.2.3 Angela Eagle was currently considering the review of section 24 of the 1986 Act.

11.2.4 AP&CU would be convening a meeting of signatories to the Data Sharing Concordat in the New Year to review progress with implementation.

11.2.5 The European Commission had recently tabled a proposal to amend Directive 86/609/EEC. The Commission believed that the Directive required a full revision - over and above the changes required to align it with the Council of Europe Convention (ETS 123) - since its scientific basis dated back some 15 years and some provisions were out of date.

11.2.6 On 7 December, the RSPCA had published a report on the welfare implications of the acquisition and transport of non-human primates for use in research and testing. The RSPCA was sending its report to the Home Office and to the Department for the Environment, Food and Rural Affairs. Ministers had not yet considered the report. [Secretary's note: Dr Jennings distributed copies of the report to the membership.]

11.2.7 Miss Sinclair, the Director of the Community Policy Directorate of the Home Office had recently retired. Her replacement was Ms Hilary Jackson, currently the Home Secretary's Principal Private Secretary.

Home Office policy on publication of research findings

11.3 Mr McCracken referred to the Home Office's response to the APC's report on openness, reproduced as a written answer in Hansard for 19 October 2001, which stated "It is already Home Office policy to encourage publication of research findings, but we cannot require it." He suggested that section 10 of the 1986 Act did in fact empower the Secretary of State to insist on such a requirement.

12 Wednesday 13 February 2002, at the Home Office.

APC Secretariat

January 2002

TRANSCRIPT OF ANGELA EAGLE'S LETTER OF 14 DECEMBER TO MICHAEL BANNER

Dear Rev Banner

Thank you for your letter of 23 November reporting the conclusions of the Animal Procedures Committee arising from its recent discussion of the allegations made against Imutran Limited and Huntingdon Life Sciences in the Uncaged Campaigns report "Diaries of Despair".

As to the scope of the Chief Inspector's compliance review, I can confirm that the Chief Inspector did consider and provide me with advice on the wider lessons to be learned from his findings. He made four recommendations, all of which I have accepted. These were that no change was needed either to the nature or mechanics of the cost/benefit assessment, or to the formula used to make best use of inspection resources; that arrangements should be made to ensure that Ministers receive regular progress reports on the projects they personally authorise; and that when the Secretary of State requires special reports on the outcomes of specific research programmes, the Inspectorate should be empowered to check the content of the reports against the original research records.

With regard to the decision not to invite the Animal Procedures Committee to provide a quality assurance panel in this case, this stemmed from the nature of the review the Chief inspector was asked to carry out. Although it was not stated explicitly when the APC agreed to the arrangements for such panels, I am told that it was always intended that the need for them would be considered on a case by case basis. It was also assumed that they would not be needed in every case. In particular, it was not envisaged that such panels would be used in connection with the routine work of the Inspectorate. Jack Straw's announcement of the Imutran review made clear that he had asked the Chief Inspector to carry out a compliance review "as part of the Inspectorate's normal statutory inspection and reporting function". The appointment of a quality assurance panel was, therefore, not appropriate. I am sorry if this was not made clear before now.

Kind regards

ANGELA EAGLE

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