ANIMAL PROCEDURES COMMITTEE
APC (2003) 2nd Meeting
MINUTES OF THE MEETING HELD ON 9 APRIL 2003
At the Home Office, Queen Anne’s Gate, London
Present:
Professor Banner (Chairman)
Professor Bulfield
Professor D Clark
Professor S Clark
Professor Dunbar
Dr Festing
Professor Holland
Dr Hubrecht
Dr Jennings
Dr Langley
Professor Martin
Mr McCracken
Professor McNeilly
Mr Moore
Dr Morris
Professor Oliver
Professor Richardson
Home Office (AP&CU)
Mr Cobley
Ms Shaw (observer)
Mr Walsh
Mr Wood
Home Office (Inspectorate)
Mr D Anderson
Dr Fry
Secretariat
Mr West (Secretary)
Mr Earle
Ms Littin
Mr Brenner
Item 1: Welcome / Apologies for Absence
1.1 The Chairman opened the meeting at 10:38. He welcomed Dr Fry and Mr
D Anderson from the Animals (Scientific Procedures) Inspectorate and Ms
Shaw from the Home Office who was attending as an observer. Professor
Oliver who had been appointed to the Committee from 1 March was welcomed
to her first meeting. Apologies for absence had been received from Dr
Atterwill, Professor Broom, Mr Gregory and Dr Richmond, and for his anticipated
late arrival from Professor Holland. Professor Dunbar, Dr Hubrecht, Dr
Jennings, Dr Langley, Professor McNeilly and Mr Earle had been delayed
by their attendance at an earlier meeting of the Primates sub-committee,
and they joined the meeting during Item 3 (11:02am). Professor Holland
and Professor Bulfield joined the meeting during Item 4 (11:22am).
Item 2: Minutes of the meetings held on 12 February 2003
2.1 These had been circulated to members on 7 March. There were no comments,
so the minutes were ratified.
Action: Secretariat to post February minutes on the APC website.
Item 3: Matters arising from the February minutes
Item 3: Matters arising from minutes of December 2002
3.1 Publication of Primates Report (paragraph 3.4) The APC report ‘The
use of primates under the Animals (Scientific Procedures) Act (1986):
analysis of current trends with particular reference to regulatory toxicology’
had been sent to the Minister in December and had been published. The
Chairman congratulated Mr Earle on his work in producing the final report,
and suggested that the same format and style would be used for future
reports. [Secretary’s note: see Item 11 for discussion on the public
release of this document].
3.2 Publication of Cost/Benefit report (paragraph 3.4) The Chairman noted
that Ms Littin was collating all comments that had been received from
members of the Cost/Benefit working group on the draft. She would then
circulate it to members of the main Committee before it was finalised
and published.
Action: Secretariat (Ms Littin).
3.3 “Uncaged” issues (paragraph 3.11) Dr Langley had had
concerns about the paper APC(02)47 ‘APC's continuing work stemming
from allegations by Uncaged Campaigns about Imutran/HLS xenotransplantation
work’ that had been circulated at the last meeting. The paper had
been amended to correct the inaccuracy identified.
3.4 BUAV allegations about Cambridge (paragraph 3.15) The Chairman noted
that serious personal circumstances for one member had prevented the meeting
of the British Union for the Abolition of Vivisection (BUAV)/ Cambridge
Working Group scheduled for 5 March from taking place. [Secretary’s
note: this Working Group will be meeting on 29 April].
3.5 The Chairman reported that he had corresponded with Michelle Thew,
Chief Executive of the BUAV about what he considered to be a misleading
statement in a recent BUAV press release. The Chairman noted that Ms Thew
had replied defending the statement, basing her argument on minor differences
between the wording of the Committee's annual reports for 2000 and 2001
and the original minutes of meetings. The Committee agreed with the Chairman's
proposal that he should write back stating that he was still of the opinion
that the BUAV statement seriously misrepresented the Committee’s
view on the Inspectorate. [Secretary’s note: copies of the Secretary's
letter of 14 February; Ms Thew's reply of 27 March; the Chairman's letter
of 8 May and a letter from Ms Thew dated 15 May are attached at Annex
A].
Item 4: Government’s response to the House of Lords’
Select Committee report
3.6 It was noted that later agenda items deal with fora, applications
and the proposed Centre for the 3R's.
Item 5: Schedule 1 working group
3.7 It was noted that the next Schedule 1 Working Group meeting would
be held on 23 April.
Item 6: Urgent primates application
3.8 This was a later agenda item (Item 6).
Item 7: Appraisal system for members
3.9 The Chairman reported that he had carried out an appraisal of the
performance in 2002 of all members (except those who had retired from
the Committee in 2002). He reminded members that the appraisal system
would be reviewed at a later meeting.
Action: Secretariat to include this item in the agenda for the meeting
on 8 October 2003.
Item 8: APC Publication scheme
3.10 There had been no progress on this by the Secretariat owing to other
commitments, but it was intended to be completed by the June meeting.
Action: Secretariat to finalise Publication Scheme document.
Item 9: Uncaged Campaigns update (INF(03)7 and INF(03)11)
3.11 The Chairman explained that he had written to Dan Lyons of Uncaged
Campaigns in terms agreed at the last meeting of the main Committee. The
letter included account of completed and continuing work by the Committee
stemming from issues raised by Uncaged Campaigns. Mr Lyons had replied
expressing his dissatisfaction with the APC’s response to the allegations
and making additional allegations. The Chairman proposed that the matter
not be reopened, on the grounds that the issues had already been considered
by the Committee and now needed to be taken up by the Home Office, and
that he reply in such terms.
3.12 There was some agreement that the Committee had devoted a considerable
amount of its time to the issues raised by Uncaged Campaigns, and that
it was important to move on. The point was also made that the Committee
needed to determine how far it could commit itself in the future to issues
highlighted by external sources such as Uncaged Campaigns or the BUAV,
as opposed to work that it had itself identified, or that had been given
to it by Ministers. The Chairman noted that he had passed to the Home
Office the allegations made in the letter from Uncaged Campaigns of 29
October 2002.
3.13 It was noted that the Committee's decision not to take these matters
further did not prevent Mr Lyons from pursuing these matters elsewhere.
The Committee's reply could make suggestions as to how he could take forward
his concerns.
3.14 Two members suggested that the Committee should ask Uncaged Campaigns
for any further information that might support the allegations. They were
concerned that the Committee might be criticised for not following up
these allegations. The Committee felt, however, that any further investigation
of these allegations was a matter for the Home Office, not the APC.
Action: Secretariat to draft letter to Uncaged Campaigns.
3.15 Two members noted that both the BUAV and "Uncaged" Campaigns
had asked or offered to meet the Committee. The Committee did not think
it necessary to meet with either organisation at this stage. [Secretary's
note: copies of the Chairman's letter of 7 March, Mr Lyons reply of 4
April and the Chairman's letter of 28 April are attached at Annex B.]
Item 10: Publicising the APC
3.16 This is a later agenda item (Item 9).
Item 11: Miscellaneous issues
3.17 This is a later agenda item (Item 7).
Item 4: The APC’s policy on applications (APC(03)11)
4.1 The Chairman introduced the report from the last Applications Working
Group meeting, which set out the type of applications that the proposed
Applications Sub-Committee would wish to see. The Working Group had suggested
to the Committee that it should reconsider its strategy about which types
of application it would wish referred to it by the Home Office.
4.2 The Committee discussed the recommendations and concluded that the
paper should be re-drafted to better explain the reasons for requesting
the changes and to more clearly define what type of applications the new
Sub-Committee would wish to have referred to it from the Home Office.
4.3 The Committee asked that the Applications Working Group and Secretariat
consult with the Home Office on a mechanism for identifying applications
before re-drafting the strategy paper for discussion at the June meeting.
Action: Secretariat and Applications Working Group.
Item 5: The APC’s annual report for 2002
5.1 The Chairman asked that detailed comments be sent to the Secretariat.
The report would then be circulated in its final form for further comment
before being sent to Ministers and laid before Parliament.
5.2 It was agreed that the report on primate use should not be included
as an annex to the annual report since it had already been published separately
for public information.
Action: Secretariat.
Item 6: Special primates application (APC(03)13)
6.1 The Home Office had asked the Committee to give urgent consideration
to a project licence application involving the use of marmosets in procedures
of substantial severity. The aim of the project was to develop an improved
vaccine and therapy regime against an infectious disease. The members
had previously received a copy of the licence application and had been
invited to submit questions that would be passed to the applicants at
a meeting with Primates Sub-Committee. That meeting had been held immediately
before the main Committee’s meeting. One member declared an interest,
as he was a member of the Ethical Review Process of the organisation concerned.
The Chairman invited Professor Dunbar, the Chairman of the Primates Sub-Committee
to report back on the meeting.
6.2 Professor Dunbar summarised the outcome of the Primates Sub-Committee’s
meeting with the project licence applicants and reported that questions
had been raised under three broad headings. He gave a summary of the applicants’
answers;
• What was the scientific justification for the experiment? The
applicants acknowledged that there was an existing vaccine for this disease,
but it was known to have a number of deficiencies. Earlier efficacy trials
on another species had given positive results, which the applicants believed
could lead to an improved vaccine and better post-exposure therapies.
The applicants had explained that as non-human primates represented the
closest animal species to humans it had been necessary to conduct experiments
in marmosets in order to predict the efficacy of a vaccine.
• What need did this programme of work address? The applicants explained
that there was judged to be a risk of exposure to the disease virus and
that the programme of work would advance the development of a better vaccine
and therapy than was currently available.
• Why were marmosets being used when there had been existing studies
conducted on macaques? It was understood that because marmosets are considerably
smaller than macaques, marmosets would receive better husbandry when being
kept in disease barriered conditions. The applicants had also explained
that a further study involving macaques would not have led to any reduction
in the numbers of animals used. This helped inform the members that the
cost/benefit assessment supported the future use of marmosets over macaques.
6.3 The Committee discussed several other aspects of the application,
including:-
• Monitoring
• Clinical symptoms
• Minimising suffering through analgesia and sedation
• Severity
• Humane endpoints
• Habituation
• Scaling.
6.4 In the light of these clarifications the Committee agreed (by 12
votes to 2 with one member stating that he was unable to decide) to recommend
to the Minister that the licence be granted, while advising him, however,
that reassurances and clarifications be sought on a number of specific
points. The Primates sub-committee was asked to formulate the points of
particular concern to be included in the letter from the Chairman.
6.5 Secretary’s note: the letter was sent to the Minister on 30
April and is attached at Annex C].
Item 7: Miscellaneous issues (APC(03)14)
7.1 The Chairman reminded the Committee that at the last meeting it had
decided to forward to the Minister the paper proposing the expansion of
the Act to include all cephalopods. The Chairman reported that in the
light of later comments he had received, it had become clear that the
Committee needed to better marshal the paper before submitting it to the
Home Secretary. An external expert in cephalopods had been contacted to
give his opinion on the ability of all cephalopods to experience pain,
distress or lasting harm and his thoughts would advise the Miscellaneous
Working Group on how to improve the paper. The Chairman confirmed that
a summary of the expert’s opinions would be presented to the main
Committee.
7.2 With regard to the use of wild-caught or endangered animals in scientific
procedures, Mr Moore suggested that a solution to the concerns expressed
in the papers might be that applications for the use of wild-caught or
endangered animals in scientific procedures be considered by the Applications
Sub-Committee in the future. The Chairman noted the absence of Professor
Broom and Mr Gregory, and suggested that further discussion be delayed
until the next meeting when they would be present.
Item 8: Home Office response to the APC’s Biotechnology
report
8.1 Professor Richardson, chair of the former Biotechnology working group
reminded the Committee that the Committee's report on Biotechnology had
been sent to the Home Office in July 2001. A response had been received
in July 2002, but the Committee had considered this was not as full or
comprehensive as it should have been. The Chairman had written expressing
the Committee's concerns in December 2002, and the Home Office had provided
a second more substantive reply. Professor Richardson had been asked to
collect comments from members on the Home Office’s second response.
8.2 Professor Richardson reported that a few members had expressed continuing
concerns with the second response of the Home Office. For example, they
considered that the response had missed the point of several of the report's
recommendations, and that it had failed to address some main concerns
of the report. Professor Richardson suggested that rather than continuing
a dialogue which risked becoming sterile, the Committee should try to
understand how this problem had arisen and how it might be avoided in
future. Possible reasons for the unsatisfactory reception of the report
were that the recommendations might have been ill-conceived, or expressed
poorly, or not launched with enough publicity, or that the Committee's
views were not taken seriously. Professor Richardson proposed that before
publishing any future reports the Committee should work more closely with
the Home Office Inspectorate and the Home Office in order to identify
proposals needing further support or development, so that the Committee
would be in a better position to determine its own views in the full knowledge
of any perceived problems. The Committee might also consider how the reports
could be published and publicised in order to achieve maximum impact.
Further comments were that the Committee should ensure that reports had
clear recommendations; that practical concerns were taken into account;
that the Committee should specifically ask questions of people that would
be affected by recommendations when drafting reports (although it was
recognised that this was already normal practice); and that reports should
suggest ways of implementing recommendations.
8.3 The Chairman reported that he had spoken to the Director of the Home
Office Community Policy Directorate and to the Minister about the need
to enter into constructive dialogue with the Home Office as to how to
take forward constructively the Committee's recommendations and proposals.
He noted that the Home Office was kept informed of the Committee’s
thinking on pertinent issues, but that this was not always reciprocated.
He had suggested that the Committee’s reports deserved a more constructive
response that recognised the thought put into the reports. The Chairman
suggested that a public launch involving stakeholders as well as more
communication with the Home Office might be the way forward. He said that
the reports on cost-benefit assessment and primate use would test this
method.
8.4 The Chairman asked Professor Richardson to prepare a two-page report
setting out the Committee's conclusions about the response by Home Office
to the Committee's report on biotechnology in particular, and any general
lessons to be learnt from this episode. This report would be attached
to the minutes of the next meeting.
8.5 It was further suggested that a reduced version of the report on Biotechnology
could be released publicly, and that the recommendations in the report
be placed on the APC website. The Chairman asked Professor Richardson
to consider these suggestions in her report as well.
Action: Professor Richardson and Biotechnology Working Group.
Item 9: Publicising the APC (APC(03)15)
9.1 The Chairman suggested that members forward their comments on this
document to the Secretariat, and that a further draft be brought to the
next meeting.
Action: Members and Secretariat.
Item 10: APC response to Home Office letter inviting views on
research into alternatives (APC(03)16)
10.1 Professor D Clark explained that the Research and Alternatives Sub-Committee
(RASC) had drafted preliminary answers to this letter. He said that it
was difficult to come to a conclusion because there were several other
initiatives on alternatives - such as industry moves to change standards
for toxicity testing, and the existence of other organisations such as
the Medical Research Council's Centre for Best Practice in Animal Research
(CBPAR) - that would influence how research into Alternatives might be
improved. While members of RASC were supportive that something needed
to be done in this area, they were concerned that future advances would
affect a UK Centre for the 3R's, and that RASC's research funding would
be removed meaning that it would no longer be able to sponsor particular
research initiatives that the Committee felt were important.
10.2 It was agreed that the letter (without Annex C) would be sent to
the Home Office. Members were asked to send detailed comments on it to
the Secretary.
[Secretary's note: The letter was sent to the Home Office on 28
April. A copy is at Annex D]
Item 11: APC seminars and fora in 2003/ 2004 (APC(03)17)
11.1 It was agreed that the two priorities for fora were the public release
of the reports on primate use and on the cost-benefit assessment. Members
suggested that one full-day event would be desirable, and that the flyer
to publicise the APC (Item 8 above) could be launched at the same time.
Action: Secretariat to arrange a one day event.
Item 12: November meeting
12.1 The Secretary reported that the Committee's November Weekend conference
would take place on 14 and 15 November. Members were asked to send any
suggestions for topics and speakers to the Secretary.
Action: Secretariat to book conference venue; members to send
suggestions to Secretariat.
Item 13: Improving statistical design (APC(03)19)
13.1 Dr Festing reported that forty people had attended a meeting on improving
statistical design in order to refine and reduce animal use in scientific
procedures. The meeting had been organised CBPAR. At that meeting it had
been considered that this was a long-term issue that would best be addressed
by several initiatives, including changes to PhD training. It was noted
that the Research and Alternatives Sub-Committee of the APC could not
fund any of these initiatives as all of its funding was currently accounted
for.
Item 14: Any other business
14.1 AP&CU/ ASPI Current Issues APC (03)20 Mr Walsh introduced this
paper. He explained that the Government had established two working groups
to look at issues raised by the House of Lords Select Committee on the
Use of Animals in Scientific Procedures. One working group was considering
issues around openness and section 24 of the Act; the other was exploring
the establishment of a UK Centre for research into the 3R's. Both working
groups were chaired by Mr Cobley, and would report back to Ministers in
due course.
14.2 Some members expressed concern that the openness working group had
been set up with scientific stakeholders, without animal welfare group
representatives. Mr Walsh explained that animal welfare groups would be
consulted separately. Dr Morris said that industry was eager to move toward
more openness. Professor Banner noted that the scientific stakeholders
would be best placed to raise matters of practicality and security matters,
as was required by the Minister.
14.3 In response to a query by Dr Langley, Mr Walsh stated that the initial
terms of reference for the Inter-Departmental Group on the 3R's covered
toxicology issues only, but that the remit could be expanded as issues
arose.
14.4 RSPCA Lay Member’s Forum 16 May 2003 Dr Jennings reminded the
Committee about the RSPCA forum for lay members of Ethical Review Processes
and the publication ‘A Resource Book for Lay Members of Local Ethical
Review Processes’.
Item 15: Date of the next meeting: 25 June 2003
15.1 The Chairman closed the meeting at 1:20 PM.
APC Secretariat
28 April 2003
Annex A
1. Letter from Revd Prof Banner to Michelle Thew, British Union for the
Abolition of Vivisection, 14 February 2003
2. Extract From APC Annual Report For 2000, From The Section "Home
Office Investigation Of Harlan-Hillcrest"
3. Extract From APC Annual Report For 2001, From The Section "Allegations
By "Uncaged" About Xenotransplantation Work At Imutran And Huntingdon
Life Sciences"
4. Letter from Michelle Thew, British Union for the Abolition of Vivisection,
to APC, 27 March 2003 - Non-human primate research at Cambridge University
5. Letter from Revd Prof Banner to Michelle Thew, British Union for the
Abolition of Vivisection, 8 May 2003
6 Letter from Michelle Thew, British Union for the Abolition of Vivisection,
to APC, 15 May 2003 - Non-human primate research at Cambridge University
Annex B
1. Letter from Revd Professor Michael Banner to Dan
Lyons, Uncaged Campaigns March 2003- The Animal Procedures Committee's
response to the allegations made by "uncaged" about xenotransplantation
work carried out by Imutran and Huntingdon Life Sciences and the Home
Office's Response to the allegations
2. Completed and continuing work stemming from allegations by "Uncaged"
about xenotransplantation work at Imutran/HLS produced by APC March 2003
3. Letter to Revd Prof Banner from Dan Lyons, Uncaged Campaigns April
2003
4 PQ from Mrs Eileen Gordeon (Romford) addressed to Mike O'Brien 1 November
2000
5 Letter from Dan Lyons, Uncaged Campaigns, 28 April 2003 to Revd Prof
Banner. APC and diaries of despair.
6 Text of written ministerial statement made to the House of Commons
on 10 April 2003.
Annex C
Letter to Bob Ainsworth from Revd Professor Michael Banner -
Primates Application 30/2033 Advice of the Animal Procedures Committee
(APC)
Annex D
- Letter from APC to Dr Jon Richmond, Chief Inspector ASPI, 28
April 2003 - Report of the House of Lords Select Committee on Animals
in Scientific Procedures: A centre for the Three Rs: Response by the Animal
Procedures Committee.
Annex 1 Research projects supported by Home Office Funding
1987-2003 on the recommendations of the APC.
Annex 2 Projects which were still in progress at the
beginning of 2002
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