Minutes of Meetings - February 2001 (final)

[Secretary's note: The Chairman was delayed due to travel difficulties, arriving during the discussion on Home Office recent developments (item 4.5 below). Professor Richardson took the chair until his arrival. Mr Baker, Mr Gregory and Professor Martin had to leave the meeting after item 5. 

1.1 Apologies were received from Professor Anderson, Professor D Clark, Professor S Clark, Professor Flecknell, Professor Holland, Professor McNeilly and Ms Bacon (Secretariat). The Chairman welcomed Mr Wood, who had recently joined the Home Office's Animal Procedures section.

2. Minutes of the meeting of 13 December

2.1 Draft minutes had been circulated to the membership for comment on 22 January. It was noted that Professor Purchase's name had been omitted from the apologies section. Dr Langley suggested that a note was needed to explain why some of the agenda items had not been discussed. The Secretariat agreed to incorporate an explanatory note into the final version of the minutes. Concern was also expressed that the draft minutes did not reflect sufficiently the discussion of the minority report of the Openness working group. [Secretary's note: an amended version of the minutes of the meeting of 13 December has now been placed on the APC website. Paragraphs 8.3 and 8.13 contain additional references to the differences which were expressed about openness.]

3. Matters arising from minutes of 13 December

3.1 Primates sub-committee The Chairman was holding a short meeting with Professor Dunbar and Dr Jennings of the Primates sub-committee after the main meeting in order to discuss how to take forward the report of the sub-committee which had been presented at the June 2000 meeting. A full meeting of the Primates sub-committee would be held in April. Action: Secretariat

3.3 APC membership Letters requesting nominations for new members of the APC had been sent out during the week beginning 29 January. The deadline for nominations was 30 March.

3.4 Drug labelling The Secretariat had obtained some further information from the Department of Health, and would present a paper about drug labelling at the Committee's next meeting. Action: Secretariat

3.5 Report by the Home Office on Infringements At the meeting on 13 December members had expressed the wish for more information to be contained in the infringement report. The Secretariat had written to the Home Office about this on 11 January, and the Home Office were presenting a revised infringements paper later in the meeting.

3.6 APC/UKXIRA relations The Secretariat had written to UKXIRA on 9 January asking for a nomination for a member of UKXIRA who might be co-opted onto the Primates sub-committee. No nomination had yet been received. The Secretariat had written to the Home Office on 1 February about approaching xenotransplantation licence holders in order to seek their agreement to pass information to UKXIRA. Mr Cobley said that this was being taken forward. Action: Home Office

3.7 Training for NACWOs As agreed at the last meeting the Chairman had written to Mike O'Brien on 11 January commending the mandatory training of NACWOs.

4. Oral report by Home Office on recent developments

4.1 Mr Walsh presented this item.

4.2 House of Lords ad hoc committee on animal experimentation This committee, originally announced in July 2000, was now being set up.

4.3 Ethical Review Procedure (ERP) As part of the Home Office's review of the ERP consultation letters were sent to certificate holders in December and a separate letter to other stakeholders in January. The consultation document was displayed at the Home Office website.

4.4 Application for Judicial Review The BUAV had recently applied for judicial review of the Home Office policy on the implementation of A(SP)A sections 5(5) and 11(b) with particular reference to the production of monoclonal antibodies by the ascitic method and to the LLNA test. There was a short discussion about the APC's role, which it was agreed should be discussed further under any other business.

4.5 Measures against animal extremists The Home Office was in the process of considering amendments to the Criminal Justice and Police Bill to counter more effectively the illegal activities of some animal extremists. There would be a consultation exercise, and members expressed interest in APC involvement in that. Mr Cobley said that he would ensure that the APC was involved in the consultation exercise, which was the responsibility of the Home Office's Policing and Crime Reduction Group. Action: Home Office

4.6 Freedom of Information A series of individual consultations by Michael O'Brien and officials with interest groups had recently concluded. In the light of those consultations officials were currently preparing further advice for Ministers.

4.7 Prime Minister's Pharmaceutical Industries Task Force The sub-group of the task force which had examined animal experimentation was shortly to report to the main committee. A number of measures to improve turnaround times of project licence applications had been agreed.

4.8 Home Office guidance and Codes of Practice Guidance on regulatory toxicology studies was due to be published in early March. Copies would be sent to the APC membership. The Code of Practice for ferrets and gerbils had been referred to Mike O'Brien for approval. Once a decision had been made the Committee would be informed. Action: Home Office

5. Report by the Biotechnology working group

5.1 Professor Richardson, chair of the Biotechnology working group introduced the working group's report. She thanked the members of the working group and the Secretariat for their work. There had been a diversity of views expressed both in the responses to the consultation exercise and by the membership of the working group, and it had taken time to achieve a consensual report

5.2 The Chairman thanked Professor Richardson and the working group, and congratulated them for their major achievement in producing what he considered to be a serious and practical document. He noted that both the Royal Society and the AEBC were currently examining biotechnology issues, and that in addition to the Committee's task of advising the Secretary of State, both those bodies would find sight of the Committee's agreed report helpful.

5.3 The Committee then discussed the report and various amendments were suggested. In addition it was noted that:

• The Committee needed to consider whether there should be a permanent Biotechnology sub-committee.

• The recommendations should make it clearer where current practice was being endorsed.

• The issue of whether the prohibition of experimentation on any of the Great Apes should be extended to other primate species needed careful examination by the Primates sub-committee.

• It should be made clear that the quality of some welfare score sheets needed improvement, and that the use of score sheets was not the only method of welfare assessment.

• The report should make clear that it was recording the benefits sought through the use of biotechnology, not endorsing them.

• The Chief Inspector agreed to provide factual clarification of certain licensing issues.

5.4 The Chairman said that he and Professor Richardson would redraft the report to reflect the discussion which had taken place and the Chief Inspector's clarifications. He asked members to send any other comments about style etc to the Secretariat. A draft with the amendments marked up would then be circulated to the membership for comment. The Chairman would consider any comments received, and then send the report to the Minister. Action: Chairman, Professor Richardson and Secretariat.

6. Allegations by "Uncaged" about Imutran/HLS

6.1 The Chairman noted that he had written to the Minister on 11 January asking for more background on the Home Office's decision to institute a routine review of compliance with the relevant project licence authorities, rather than a special investigation by the Inspectorate, as had occurred with the earlier allegations about Harlan-Hillcrest. A reply from the Minister, Mike O'Brien dated 12 February had just been received and the Secretariat distributed copies. [Secretary's note: copies of the Chairman's letter of 11 January and Mike O'Brien's reply of 12 February are attached to these minutes as an annex.]

6.2 It was noted that one of the issues raised by the "Uncaged" report that the Committee would need to address was the Cost/Benefit assessment. Because the original licence applications had been referred to the Committee, the Committee itself had been involved in some of the processes criticised by "Uncaged". The Chief Inspector confirmed that his examination did not include a retrospective re-assessment of the Cost/Benefit assessment. After a short discussion it was agreed that the Chairman should write again to Mike O'Brien asking him to explain in more detail the distinction between the allegations against Harlan-Hillcrest (which had resulted in an investigation by the Inspectorate) and the allegations by "Uncaged" against Imutran/HLS (which had resulted in a review by the Chief Inspector of Imutran's standards of compliance with the authorities given them). The letter would also need to explain the Committee's concerns about the Cost/Benefit assessment with which it had been involved, and to ask why that aspect had not been included in the Chief Inspector's examination. The letter would also need to ask for the Minister's confirmation that the Chief Inspector's report would be disclosed to the Committee. [Secretary's note: The Chairman wrote to Mr O'Brien on 20 March. A copy of his letter is also in the annex attached to these minutes.]

6.3 Dr Langley said that she would prepare a paper for the next meeting of the Committee, setting out her concerns about the Cost/Benefit assessment and the Committee's involvement in it. The Chairman confirmed that the allegations by "Uncaged" would be an agenda item at the next meeting, and asked the Secretariat to identify the earlier papers relating to the Committee's discussion of the applications by Imutran. Action: Dr Langley and Secretariat.

7. Committee's report on Openness

7.1 The Chairman summarised the situation. Two Openness reports had been discussed at the last meeting, a majority report and a minority report. Discussion had identified two areas of disagreement - the amount of information which should be made available on the licence application form, and the means by which negative results could be made public in order to reduce nugatory experiments. After the last meeting a letter had been sent to the Minister on behalf of the whole Committee. This had summarised the recommendations agreed by the Committee, and reflected some of the varied views expressed. The Chairman said that he hoped that it would now be possible to agree the substance of a report from the whole Committee, which could be sent to the Minister and placed on the Committee's website. The Chairman welcomed Mr Limpkin of the Home Office's Freedom of Information Unit, who was attending for the discussion on this item.

7.2 The Committee then discussed draft B. The Chairman said that this was a version of the report the Chairman had prepared in consultation with the Chair of the Openness working group, taking account of the Committee's views expressed at the meeting on 13 December. The Chairman said that draft B also contained amendments suggested by the Home Office's Freedom of Information Unit. These had been prepared with the intention of aiding clarity and to take account of present provisions relating to freedom of information.

7.3 Points made in the discussion included the following:

• Paragraph 15 should include reference to the various stages at which disclosure might take place, and the concerns expressed that delays might be caused by the Home Office having to reply to requests for information.

• There should be a reference to Part I and the exemptions in Part II of the Freedom of Information Act.

• The report should make clear that it proposed that section 24 of A(SP)A should be amended, so that there would no longer be a blanket prohibition on disclosure.

• Paragraph 19 should include reference to the publication scheme which the Home Office would be required to develop, and should state that such a scheme would need to be informed by the need for openness, and not incorporate unnecessary exemptions.

• The footnote in paragraph 21 should refer to "life sciences" rather than "life science industries".

7.5 After the discussion the Committee agreed that the Chairman and Professor Atterwill would revise the report in the light of the comments made. Their draft would be shown to Mr Limpkin and Mr McCracken, and then sent to the Minister and placed on the website. Mr McCracken also raised the issue of whether the Openness working group's minority report should be placed on the website. It was also agreed that the Chairman's letter presenting the Committee's report to the Minister should make fuller reference to the differences of opinion which had led to the minority report.  Action: Chairman, Professor Atterwill and Secretariat.

8. Report by the Home Office on Infringements

8.1 Mr Walsh presented APC(01)2, the Home Office's paper on infringements. This expanded on the paper presented at the meeting of 13 December, incorporating the additional information requested by the Committee.

8.2 In discussion, Mr Walsh confirmed that the identification numbers for individual establishments would be used in future reports in such a way as to ensure that readers would be able to identify repeated infringements. He would supply to the Committee the criteria used by the Director of Public Prosecutions in determining whether prosecution was in the public interest. Mr Walsh also agreed to supply further details about the infringement at establishment 16, where severity levels had been breached. Action: Home Office. Lastly, it was noted that prosecution action had been considered in response to the infringement at establishment 2, but had not been pursued because the licensee had been under medical treatment which might have influenced actions. It was suggested that the Committee might wish to have a future discussion about whether applicants for personal licences should be required to declare any medical condition that might affect their ability to carry out licensed procedures.

8.3 The Chairman thanked the Home Office for the revised report.

9. Statistics of Scientific Procedures on Living Animals Great Britain 1999

9.1 Dr Langley referred to figure 5 on page 22, which showed a historical overview of procedures by type of establishment from 1987 to 1999. This showed an overall reduction in numbers of procedures. Dr Langley noted that most of the reduction had been in the commercial sector, and asked why there had not been similar reductions in other sectors. The Chief Inspector suggested that the main factor leading to an increase in animal use was the increasing use of genetically modified animals, and these were used less in industry than in some other sectors.

9.2 The Committee noted the statistics.

10. APC working methods

10.1 The Secretariat had prepared paper APC(01)3 for this item. In addition the Committee considered INF(01)3, which gave proposed dates for Committee meetings in 2001, 2002 and 2003. It was agreed that

• Where possible, reports and papers should be written rather than given orally. This would aid clarity, save time and be helpful for absent members. (Mr Cobley said that reports by the Home Office which were currently given orally could be provided in writing in future.) Action: Home Office.

• The Secretariat should maintain a library of documents, so that members did not have to keep bulky papers. There should also be an index.

• The Secretariat might attend meetings with other bodies such as UKXIRA, and report back to the Committee.

10.2 The Chairman thanked members for their suggestions. He said that there would be an agenda item at the next meeting to discuss how to take forward the Committee's work programme. He and the Secretariat would prepare a paper. Action: Secretariat.

11. Any other business

11.1 APC website It was noted that there were some inaccuracies on the Committee's website. For example, membership details of the Openness working group were inaccurate.

11.2 Government response to Philips report on BSE (INF(01)6 The Committee had been included in a consultation by MAFF about the Government's response to the Philips BSE Inquiry report. Replies were requested by 11 May. The Chairman asked the Secretariat to distribute to the membership copies of Chapter 14 of the Philips report and the Governments interim response. The Committee's response should be discussed at the next meeting, for which the Secretariat should prepare a paper. Action: Secretariat.

11.3 Home Office consultation about ERP The Home Office had invited the APC to contribute to its review of the ERP (INF(01)10). A reply was requested by 23 March. The Chairman asked members to reflect on whether, and if so in what terms the Committee should reply, and to pass any comments to the Secretariat. The Chairman would then reply to the Home Office. Action: Chairman.

11.4 Mutagenesis screening Dr Langley referred to a large project concerned with work on understanding the function of genes. She was concerned that the project appeared to be speculative, might involve large numbers of animals, some of which might suffer from poor welfare. If that were the case, she suggested that the Cost/Benefit assessment which would have been carried out might be of interest to the Committee. The Chairman said that the Cost/Benefit working group should consider Dr Langley's concerns, and asked her to write to him as Chair of that working group. Action: Dr Langley.

11.5 Experiments involving the use of tobacco In answer to a request from Dr Langley, the Chairman asked the Secretariat to identify previous Committee papers on two applications which involved the use of tobacco in connection with the development of drugs to treat chronic obstructive pulmonary disease. This was in order that the Committee could discuss at the next meeting a concern which Dr Langley had raised. He also asked Dr Langley to write to the Secretariat setting out her concern. Action: Dr Langley and Secretariat.

11.6 Application for Judicial Review The Committee briefly discussed the application by the BUAV for judicial review (see item 4.4 above). It was agreed that the Committee would await the result of that process and consider the outcome at a later date.

11.7 Weekend Conference It was agreed to move the date for the weekend conference from October to November. Action: Secretariat.

12. Date of next meeting

12.1 This will be at 10.30 on Wednesday 11 April at the Home Office.

APC Secretariat
20 March 2001

ANNEX

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

Mike O'Brien MP
Parliamentary Under-Secretary of State
Home Office
50 Queen Anne's Gate
London SW1H 9AT

11 January 2001

Dear Mr O'Brien

ALLEGATIONS BY "UNCAGED" ABOUT IMMUTRAN/HLS

These allegations were briefly discussed at the meeting of the Animal Procedures Committee on 13 December. The Committee noted the Home Secretary's reply of 29 November to a Parliamentary Question by Derek Wyatt MP, and learnt that the Chief Inspector had started the examination of the issues which was announced in the Home Secretary's reply. Against that background, the Committee felt that discussion of the serious issues raised by the allegations by "Uncaged" should be postponed until its next meeting, which will be held on 14 February.

The Committee agreed that I should write to ask if you could provide some background on the decision to institute a routine review of compliance with the relevant project licence authorities, rather than a special investigation, as occurred with the allegations about Harlan-Hillcrest. I have to say that the Committee was somewhat surprised that you did not seek to commission a special investigation by the Inspectorate, making use of the procedures we had so recently discussed whereby the APC would act as an independent monitor of the quality and thoroughness of the investigation of serious allegations regarding the regulation of establishments.

It would be very helpful if you could reply before 14 February.

Yours sincerely

MICHAEL BANNER

All of the allegations relevant to the Animals (Scientific Procedures) Act 1986 relate to administrative or regulatory issues that it is entirely proper for the Home Office to consider. We decide, therefore, to ask the Chief Inspector of the Animals (Scientific Procedures) Inspectorate, as part of hi routine duties, to review the available evidence and advise Ministers on Imutran's standards of compliance with authorities under the 1986 Act. The question of APC involvement under the procedures recently agreed did not therefore arise.

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