Minutes of Meetings - October 2001 (final)

1.1 The Chairman announced that representatives from the Home Office would not be present for the first part of the meeting. They normally attended meetings of the Committee as observers, but he had asked them not to attend this meeting until the discussion about the Home Office's response to the "Uncaged" allegations had been concluded. That was because some members of the Committee might have found it difficult to discuss the adequacy of the Home Office's response to the allegations by "Uncaged" in the presence of those Home Office officials who had been closely involved in formulating the Home Office response.

2. Two corrections were suggested. The last sentence of paragraph 7.1 of the minutes should refer to the Research and Alternatives sub-committee, not the Research and Training sub-committee. An ambiguity was also identified in the letter of 25 September which the Chairman had sent to the Minister about the "Miscellaneous" recommendations. The penultimate sentence of paragraph 2 should read "Different species of mammal exhibit varying degrees of development at birth, but there does not seem to be any species in which the embryo is known to have a sensory-mediated response to stimuli half-way through its gestation." Subject to those two corrections, the minutes were agreed. The Secretariat undertook to notify the Home Office of the change to the letter of 25 September. [Secretary's note: the Home Office was notified of the amendment on 17 October.]

3.1 The Chairman noted that information which the Committee had requested about the number of unannounced visits to Huntingdon Life Sciences (HLS) was contained in paragraph 4.6.

3.2 Paragraph 6.2 referred to the paper APC(01)20, which had been prepared by the scientists involved in the Oxford macaques experiments which had been the subject of a NAVS campaign. The Chairman noted that the scientists had been asked to give their permission for the paper to be appended to the minutes. Unfortunately, they had been unwilling to do so.

3.3 The Chairman noted that one of the recommendations of the Miscellaneous working group had not been incorporated into his letter of 25 September to the Minister - that relating to wild-caught and endangered species, discussed at paragraph 7.9. He said that Professor Broom and Mr Gregory were discussing this recommendation, and he asked them to prepare a short paper to be discussed at the December meeting of the Committee. Action: Professor Broom and Mr Gregory.

3.4 The Chairman said that he had written to Angela Eagle on 1 October expressing the Committee's hope that the higher standards for ferret cages would eventually be adopted. Referring to the reference in the letter to the lack of research into ferrets' welfare and behavioural needs, Professor Anderson confirmed that at its next meeting the Research and Alternatives sub-committee would be discussing the possibility of commissioning research into ferret welfare. It was however noted that there were several species of animals used in experimental procedures in greater numbers than ferrets about which little welfare information was available.

3.5 The Chairman said that Mr Gregory had been unable to recruit enough members for this working group from members of the Committee. He asked Mr Gregory to consider whether he might identify members from outside the Committee who could be co-opted onto the working group under section 20(3) of the 1986 Act. Action: Mr Gregory

3.6 The Chairman said that the Home Office had not had time to prepare a paper about Sucralose experiments in time for the current meeting. Action: Secretariat.

3.7 The Secretariat announced that the representative from Pfizer was unable to attend the weekend conference. However, he would give his presentation on the animal experimentation work of Pfizer when the Committee visited there in the new year. The Chairman said that the resulting available timeslot at the weekend conference could be partially filled by a short round up of the work programmes of all existing sub-committees and working groups. Action: chairs of existing sub-committees and working groups

4. Before discussion began the Chairman referred to the Committee's Code of Conduct and asked for any declarations of interest.

4.1 Dr Langley confirmed that she had not written the report by "Uncaged". However, she had received payment (more than a year previously) for giving assistance to its author. She offered to withdraw from the meeting. Professor Atterwill said that he was a Director of HLS, although not of the division about which allegations had been made. He was also a shareholder. He offered to withdraw from the meeting. Professor Flecknell also declared an interest in HLS, and offered to withdraw from the meeting. The offers made by Dr Langley, Professor Atterwill and Professor Flecknell were accepted, and those three members withdrew from the meeting.

4.2 Other members declared the following interests. Dr Morris said that he was a member of the Research Defence Association, and his company (GlaxoSmithKline) was supportive of HLS. Professor Broom said that he had formerly been a member of HLS's ERP committee. Professor Bulfield said that his company (Roslin) had previously carried out xenotransplantation work. Professor Martin said that he was a Director of Eurogene, which had used HLS services in the past. Dr Jennings said that she had written a report for the RSPCA on the allegations by "Uncaged", and she had a particular interest in highlighting welfare issues.

4.3 The Chairman said that there were a very large numbers of papers available to the Committee on this item. That was why at the last meeting he had asked Professor Richardson to chair a small working group (the other members were Mr Baker, Professor D Clark and Dr Jennings) to carry out an analysis of the issues which the Committee might address. He thanked all the members of the working group for their efforts.

4.4 Professor Richardson said that the working group had tried to identify the main issues and suggest a framework for discussion with the intention of fostering a better understanding of the Committee's role within the general regulatory framework of the Animals (Scientific Procedures) Act 1986. The working group had identified four substantive issues which the Committee might take forward: implementation and compliance; the Home Office response to the allegations; primates; and xenotransplantation.

4.5 The Committee agreed that the Home Office's response to the allegations was the immediate issue for attention. The other three more general issues could be taken forward after that.

4.6 In the first place Members noted that shortly before the allegations by "Uncaged" were publicised, the Committee had been concerned with allegations made by the BUAV about conditions at Harlan-Hillcrest. Following the APC's discussions of the Home Office response to those allegations, the Home Office had itself suggested that in future investigations the APC might be asked to supply a panel in order to quality assure the Inspectorate's report. The Chairman had twice asked for an explanation for the reasons in the case of the "Uncaged" allegations for deciding against commissioning an investigation by the Inspectorate, with a quality assurance panel provided by the Committee. There was general agreement that no satisfactory explanation had been given, and the Committee agreed that the Chairman should write to the Minister again.

4.7 It was noted that the remit of the Chief Inspector's examination had been tightly drawn, and that it had been reasonable, in the first instance, to start any examination with the project licences and the licence holders' compliance with them. That might have been because the "Uncaged" report had itself emphasised instances of non-compliance. Most, but not all the members agreed that the examination had satisfactorily addressed its remit - the compliance issue. Most members were concerned that the remit had not been wide enough. Members considered that once the technical issues of compliance with authorities had been addressed, it would have been appropriate to consider the issues stemming from the instances of non-compliance. For example, were the errors identified symptomatic of wider problems of poor practice; did the errors suggest that Imutran/HLS were performing less well than expected; and what lessons could be learnt which could facilitate better handling of similar projects in the future? It was agreed that the Chairman's letter to the Minister should also address those issues.

4.8 The Chairman said that a draft letter would be circulated to Members for comments. His letter would be appended to the minutes after he had written to the Minister. Action: Secretariat.

4.9 The Home Office Minister of State responsible for animal experimentation, Angela Eagle MP then visited the Committee. [Secretary's note: At the same time the Home Office representatives joined the meeting, and Dr Langley, Professor Atterwill and Professor Flecknell rejoined the meeting.] After the Chairman had introduced the members to Ms Eagle she made a few general remarks. She said that as a newcomer to the interesting and controversial area of animal experimentation she was currently on a steep learning curve. That included meeting several stake holder organisations such as ABPI, NAVS and RDS; visiting various establishments using animals; and listening to the range of interested parties. She thanked the Committee for its recent advice on Openness, Biotechnology and Miscellaneous issues which she had read with interest, and paid tribute to the Committee's breadth of expertise. The meeting then broke for lunch during which Ms Eagle spoke informally with Members.

4.10 After lunch the Committee began discussion of how to take forward the wider issues which had been identified by the working group: implementation and compliance; primates; and xenotransplantation. The Chairman welcomed back the three members who had left the meeting earlier. The Committee agreed that it was acceptable for them to join in the discussion of the wider issues stemming from the particular allegations.

4.11 It was agreed that the issues relating to primates should be addressed by the Primates sub-committee. The Chairman asked that the Primates sub-committee prepare a paper for discussion at the December meeting of the Committee on the issues relating to primates identified in paper APC(01)25. Those were

• Acquisition and transport. Conditions in and transport from overseas centres. What role could the Inspectorate play overseas?
• What are the responsibilities of other individuals and bodies involved in either primate use or the regulatory process (eg licence holders, ERPs, funders).
• Training of primates and the staff working with them.
• The role of the Primates and other sub-committees and working groups of the APC.

Action: Secretariat/Primates sub-committee

The Chairman asked the Secretariat to prepare a paper of background material for the discussion at the weekend conference. Action: Secretariat.

4.13 The Committee then addressed the xenotransplantation issues identified in APC(01)25. Those were

• Did the APC have a role in addressing issues proactively? How should the APC cover the welfare and ethical issues emerging from new technologies.
• Was the APC satisfied with the extent of its liaison with other bodies that had a bearing on its work (e.g. UKXIRA, DEFRA, FAWC)?
• Was there a mechanism for monitoring recommendations pertaining to the Committee's work (e.g. Kennedy Committee Report and the APC's own reports)?

After a brief discussion the Committee agrees that it needed more information before it could come to a view on those issues. The Secretariat was asked to establish

• what progress had been made on the recommendation of the Kennedy report, which had been accepted by the Government, that xenotransplantation should be treated in a coordinated manner;
• What AEBC envisaged as an "overarching body" to monitor all animal welfare; and
• Whether UKXIRA had completed its report on the practicality of xenotransplantation.

Action: Secretariat

4.14 The Chairman concluded the discussion about the allegations by "Uncaged" about Imutran HLS by thanking the working group for having facilitated the Committee's deliberations. It was agreed that in the event of any similar allegations in future, it would be useful to carry out at a much earlier stage the work to analyse the issues of relevance to the Committee.

5.1 Dr Langley referred to the two COPD licence applications which the Committee had considered in 1999. She said that she had later become concerned that there were similarities between the two projects which indicated that there was duplication of research involving animals. Some members were against re-investigating the Committee's consideration of these applications, as they suggested that at this stage it would not be of great value. Members also recalled that the Committee's lengthy discussions of the two applications it had been recognised that the two projects differed significantly ("There was a big difference between the two applications.." (minutes of APC meeting of October 1999, paragraph 5.9)). Members also said that repetition of experiments was a basic principle of biological science: a finding that had not been reproduced elsewhere could be classed only as anecdotal.

5.2 However, it was accepted that Dr Langley's paper identified an important matter of principle, namely, the extent to which possible duplication of projects might affect the Cost/Benefit assessment; and to what degree duplication was acceptable. The Chairman therefore invited Dr Langley and the Chief Inspector to attend an early meeting of the Cost/Benefit working group. The issue could then be discussed and a short report drawn up for the main Committee. Action: Secretariat [Secretary's note: at this point the Chairman left the meeting to attend another engagement. Professor Richardson took the Chair for the remaining items.]

6.1 It was noted that recommendation 11 was the responsibility of AEBC, which should take the recommendation forward with DEFRA, and that recommendations 23 and 24 were already being taken forward by the AEBC. It was further noted that the first part of recommendation 19 ("Data relating to any adverse welfare effects should be made available to any potential user of a new GM strain..") was already a de facto requirement of a project licence. However, there was strong support for a proposal that the Committee should liaise with the three main funding bodies (MRC, BBSRC and the Wellcome Trust), and propose that, with the APC, they should agree to set up a joint multi-disciplinary working group to look at all the identified biotechnology recommendations. Such a working group could take forward a project to evaluate currently available research on GM animals and commission further research, guided by the recommendations of the Committee's report into Biotechnology. It was agreed that the Chairman should be invited to write to the Chairs of the three bodies putting forward this proposal. Action: Secretariat/Chairman

6.2 After a short discussion it was agreed that recommendation 6 ("To assist public debate the Life Science institutions should be encouraged to open their facilities to the responsible public") could be progressed by the Chairman writing to ABPI. It might also be possible for this to be drawn to the attention of Certificate Holders at their forthcoming conference. Action: Secretariat/Chairman

6.3 It was noted that Recommendation 7 (Where the APC discusses a report by an APC working group which has "quality assured" an investigation by the Inspectorate, that discussion, the report of the quality assurance working group and the Inspectorate report should all be made available on the web, suitably anonymised.) had been accepted by the Home Office. This would be taken forward in the context of the Chairman's letter to the Minister about the "Uncaged" allegations.

6.4 Recommendation 8 stated that the Committee should have a programme of regular interaction with other committees, representative bodies and pressure groups in the UK and overseas. It was agreed that this issue was subsumed into the wider question of the Committee's liaison with other bodies discussed at paragraph 4.13 above.

7 Professor Anderson raised three items.

7.1 Professor Anderson said that Dr Judson was the recipient of a grant from the Home office for developing an international toxicology information centre. The Committee welcomed Professor Anderson's suggestion that Dr Judson should be invited to give a presentation of his work at the next meeting of the Committee. Action: Secretariat

7.2 Professor Anderson referred to the committee's report for 1995, which had suggested that the Committee should commission research into ethical and philosophical studies. The Research and Alternatives sub-committee wished to draw this recommendation to the attention of the main Committee, to establish whether it remained the Committee's wish. The Acting Chair invited Members to pass any suggestions for such research to the Research and Alternatives sub-committee. Action: Members

8 The next meeting would be on 12 December 2001, at the Home Office.

APC Secretariat

October 2001