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ANIMAL PROCEDURES COMMITTEE
APC (1999) 5th Meeting
MINUTES OF THE MEETING HELD ON 8 SEPTEMBER 1999
Present:
Professor Banner (Chairman)
Professor Anderson
Professor Atterwill
Mr Baker
Professor Broom
Professor Bulfield
Professor D Clark
Professor S Clark
Professor Dunbar
Professor Flecknell
Mr Gregory
Professor Holland
Dr Jennings
Dr Langley
Professor Martin
Mr McCracken
Professor McNeilly
Professor Purchase
Professor Richardson
Dr Southee
Dr Suckling
Professor Turner
Mr Ward
1.1 Apologies for Absence
1.1 Apologies were received from Professor Johnston.
1.2 The Chairman welcomed Mr Robert McCracken as a new member of the Committee.
1.3 Ms Sara Bacon was to join the Secretariat at the end of September
and attended the meeting as an observer.
2 Minutes of the previous meeting (30 June)
2.1 The minutes were agreed subject to minor changes.
3 Matters arising
3.1 Minister's forum (para 3.1) Several APC members had been present at
the forum on 9 July. The event was reported in the press.
3.2 An event on these lines - but chaired from within the APC, rather
than by a Minister - could be a useful part of some of the APC's consultation
exercises. The possibility of such an event might come up at the meeting
the Chairman would have in October with Mr Mike O'Brien, who had replaced
Mr Howarth over the summer as the Minister with responsibility for animal
procedures.
3.3 Primate applications (para 6) The primate sub-committee had seen further
information about the application described in paper APC(99)23 (para 6.1).
It had advised the Home Office that it saw no reason within the terms
of the legislation why the application should not be approved.
3.4 The Chairman had written to Mr Howarth (paper INF(99)24) conveying
the APC's view that the Home Office should turn down the other application
(APC(99)22) examined at the June meeting. The Home Office had since refused
this application, but the Secretary reported that the applicant was preparing
a revised version. The Home Office might ask the Committee to examine
this at its meeting on October 13. If so, the Secretariat would make arrangements
to allow the primate sub-committee to see it in advance. That would allow
them to form a view as to whether the applicants might be asked to attend
a further main Committee meeting and to formulate any key questions that
should be put to them there.
Action: Secretariat
3.5 Housing and care of ferrets and gerbils (para 7) The Chairman had
sent the Committee's advice to the Minister (paper INF(99)22. No reply
had yet been received.
3.6 Freedom of Information (para 9). The Chairman had responded to the
Home Office consultation document on behalf of the Committee (paper INF(99)23).
Chapter 4 of the Committee's published review of the Act (see pages 82-84
of the 1997 annual report) had promised that the APC would consider 'what
additional information (about animal procedures & individual licences)
could or should be made public'.
3.7 The Chairman proposed a working group to consider this and make recommendations
to the Committee about what it should propose to the Home Secretary. Professor
Atterwill would chair the group - its other members would be Mr Baker
and Mr McCracken. The Secretariat would set about organising its first
meeting as soon as possible.
Action: Secretariat
3.8 BUAV judicial review (para 13.1) The British Union for the Abolition
of Vivisection (BUAV) had sent the Home Office a copy of the legal advice
on which they would base their application for judicial review of the
Department's continuing authorisation of LD50 work. Home Office ABCU were
consulting about this material and would reply to BUAV as soon as they
could. Action: Home Office ABCU
3.9 Harlan-Hillcrest (para 13.2) The Chief Inspector said that the Inspectorate
was continuing to investigate the BUAV's allegations about Hillcrest and
expected to be able to make a full report to the Minister by mid-October.
It would then be for the Minister to decide what action to take, but it
was clear from the reply to a Parliamentary Question that he would share
the report with the Committee.
Action: Home Office Inspectorate
4 LASA overbreeding report - APC(99)28
4.1 Members welcomed LASA's report. They wondered where its data came
from. Together with the anonymity of the authors this made it difficult
to make a judgement as to whether the estimates it made of the overbreeding
of laboratory animals were reasonable. The Committee also noted that it
only covered rodent species. The proposition in the report's conclusion
that 'the production of a living organism that has no assigned use is
undesirable' seemed an odd and debatable premise from which to work.
4.2 The ethical review processes in establishments ought to take in questions
of overbreeding. The report cited the need at times to provide specimens
at short notice as one reason for the existence of the 'managed' surplus.
One way of reducing this might be to require users to specify in advance
what these lead times were to be as part of their project licence applications.
The Chief Inspector thought that LASA's most important recommendation
was no. 13 ('introduce a system of full cost recovery from the user .
to instil a responsible attitude towards the generation of surplus').
4.3 The APC had included material on overbreeding, with recommendations,
in its published review of the legislation (chapter 5). The Secretariat
would arrange for a small group of members to meet the LASA task force
to discuss the overbreeding issue and consider further recommendations
to put to the APC. These members would be Professor McNeilly (chair),
Mr Baker and Mr Gregory. A Home Office Inspector would also form part
of the group.
Action: Secretariat
5 Home Office standards of service - APC(99)29
5.1 The paper set out the Home Office's revised code of practice for dealing
with its animal procedures licensing work. This was an expansion of the
previous Home Office document. Mr Wilkes asked for APC comments on it,
explaining that the Home Office would also consult licence holders before
introducing it.
5.2 Members thought that the code was an improvement on its predecessor.
But delays were a major problem with the current system and the code did
not say anything about how long the Home Office would take to process
applications. There was a distinction between the relatively straightforward
administrative processing done by Home Office ABCU and the work done by
the Inspectorate, which involved detailed consideration of applications
and discussing them with their originators. It would help if the code
of practice set out this distinction more clearly.
5.3 Applicants themselves could be responsible for delay if they did not
properly spell out everything the Inspectorate needed to know, and applications
for novel types of work would inevitably take longer to deal with. The
Committee accepted that the time the Inspectorate spent in dealing with
individual applications should not be subject to set limits.
5.4 On the other hand members believed that there was scope for giving
some indication in the code of how long the Home Office could be expected
to take when processing the more straightforward, properly constructed,
applications. The Home Office might set out targets for processing times
or say how long the majority of applications took in practice.
5.5 The reference in the code to the 'confidentiality' requirements of
section 24 of the 1986 Act could be sharpened up. Section 24 does not
prohibit disclosured 'for the purpose of discharging . functions under
(the) Act'.
5.6 Home Office ABCU would consider these points.
Action: Home Office ABCU
6 Revised application form & notes - APC(99)30
6.1 The revised form and notes circulated as APC(99)30 were a draft
and the Home Office would trial them before their introduction. They existed
in an electronic as well as a paper version, and members stressed the
importance of making sure that the electronic version of the form was
user-friendly.
6.2 The introduction of section 18b requiring applicants to spell out
what steps they had taken to implement the 3R's (reduction, replacement,
refinement) was a major change.
6.3 Members expressed concern about the place of the ethical review process
(e.r.p.) in applications and how the outcome of the process appeared on
the form. The applicant had to indicate that the e.r.p. had been completed,
but the form did not ask what conclusion it had reached. It might be thought
inefficient and a waste of resources that a detailed review of the ethics
of a particular experiment which had been conducted by the establishment
which wanted to carry it out was not communicated to the Home Office Inspectorate.
6.4 As against that, the e.r.p. was there to advise the applicant, not
the Home Office. The quality of the reviews would inevitably vary and
the Inspectorate was required to make its own independent assessment of
the ethics of each application. They would be regularly in touch with
applicants as they developed their applications, and could ask to see
the full report of any particular e.r.p. if they wished. The Inspectorate
would introduce a system for sampling e.r.p.'s once the system had bedded
down.
6.5 The Home Office did not expect applicants to say anything about husbandry
considerations on the application form, but the Inspectorate would ask
about them if they were an issue in any particular case. There was also
no specific reference - as there had been in a previous version of the
form - to welfare questions. The Home Office would consider putting something
in the notes.
6.6 The form did not contain anything requiring the applicant to certify
that the research in question had not been done before. Applicants might
for instance be asked to certify that they had made a 'diligent search'
of the literature for similar work and to describe the nearest parallel
they had found. Nor was there anything obliging applicants to publish
the results of their research or to discuss the effects of the animals
of the conditions in which they were held.
6.7 Other members pointed out that repetition of work is an important
part of science. Publication can often be important to researchers, but
they are sometimes constrained from publishing what they have done by,
for example, the requirements of patent law.
6.8 The form contained scope for a summary of the proposed programme of
work in 17a. But members thought it might helpfully contain a summary
of the number of animals to be used in an experiment, the degree of distress
to which they would be subjected, and the scientific etc advances to which
the application might lead. The welfare costs of the proposed experiment
could properly be specified here. Such a summary would be useful in particular
to lay people involved with processing the application, for instance as
part of the ethical review process (though ethical review panels would
need to see the whole application, not just a summary of it).
6.9 It was also suggested that licences should require that their conditions
be displayed in the place where the work was carried out.
6.10 The Home Office agreed to consider all these points. They would come
back to the Committee on the form and notes in the New Year, after trialling
them.
Action: Home Office
7 Applications involving tobacco - APC(99)31, 31A, 31B
7.1 The papers covered two applications to use rodents in work involving
tobacco smoke whose aim was to investigate treatments for chronic pulmonary
disease brought about by smoking. Before discussion began Dr Purchase
registered a possible interest in that he believed that he knew the companies
from which these applications came and had links of various sorts with
a competitor. Professor Turner thought that he might have a possible similar
interest.
7.2 The Home Office had asked for this item to be placed on the agenda.
Ministers sought the Committee's advice on the two applications, and it
seemed likely that they would require this advice during October following
the next APC meeting on the 13th of that month, when both sets of applicants
would be prepared to attend the Committee for discussion. The Secretariat
had suggested that the Committee use the present meeting to decide how
it wanted to handle the issue - one possibility was to set up a small
sub-group of members to take points made by others and formulate questions
to put to the applicants.
7.3 Members expressed concern that these applications fell foul of the
Government announcement in November 1997 that 'tests which involve animals
.. in the testing of tobacco products . will no longer be allowed'. The
stated purpose of the tests might be to develop ways of dealing with smoking-related
disease, but there was plainly a strong argument that the tobacco smoke
which would be used in the experiments was a 'product' within the sense
of the Government announcement. Indeed it appeared from one of the applications
that the researchers making it had once taken that view themselves.
7.4 The Chairman said that the Committee was not being asked to advise
the Government as to whether the two applications fell within the terms
of its tobacco 'ban'. That was something the Government had to decide
for itself. He took the view that the central question on which the Home
Office sought the Committee's advice was whether, assuming that the applications
did not fall foul of the November 1997 announcement, their scientific
and technical merits would justify the grant of licences under the terms
of the Act. But there was nothing to stop the Committee expressing a view
on the scope or rationale of the ban if it wanted to, and members thought
that if the Committee concluded that the applications were ruled out by
the announcement it should say so.
7.5 The Committee set up a small sub-group, as described in paragraph
7.2 above, to formulate advice and questions for the 13th October meeting.
Its members would be Professor D Clark, Dr Jennings, Dr Langley and Professor
Martin. Home Office ABCU would supply the Secretariat with information
to clarify the policy position, in good time for consideration by the
sub-group and the Committee as a whole.
7.6 Members noted that one of the applications (APC(99)31A) did not clearly
state what its objective was. It also seemed to downplay self-mutilation
as an index of the suffering of experimental animals. The sub-group would
consider these points among others
Action: Home Office ABCU & Secretariat
Handling of infringements - APC(99)32
8.1 The Home Office sought the Committee's views about changes to the
procedure for handling infringements, prior to wider consultation about
them. Members generally welcomed the changes. The document said that all
infringements 'can' be reported to the Committee - the Home Office confirmed
that this would be changed to read 'will'. Minor infringements which were
repeated would move up the scale and be treated more seriously. The Committee
would see all infringements in summary and be in a position to comment
on their classification and on all other aspects of them.
8.2 The Home Office would consult the Committee again when the consultation
exercise was complete.
Action: Home Office ABCU
9 Suspension of a personal licence - APC(99)33
9.1 Mr Wilkes outlined the circumstances. The researcher responsible for
this very serious oversight was now known to have had a health problem
which affected his judgement and performance. He had returned his personal
licence for revocation, but the investigation into the incident would
be carried out in full and taken into account if he ever re-applied.
9.2 Members wondered whether the case cast some doubt on the institution
in which this individual worked. The Chief Inspector said that the Inspectorate
were looking at that. They were also considering what implications the
incident had for 'lone working' in animal laboratories.
10 1998 statistics - APC(99)34
10.1 Members noted the Home Office's 1998 statistics (corresponding material
for Northern Ireland was also available at the meeting).
11: Residential meeting - APC(99)35
11.1 Members noted the suggested programme. More time should be devoted
to discussion of the cost-benefit issue and to the wider philosophical
issues which underlay it. The Secretariat would adjust the programme accordingly.
Action: Secretariat
12 Guidance for members - APC(99)36
12.1 Members noted the revised guidance document. The Home Office explained
that the circulation of 'restricted' papers (paragraph 12) allowed the
Department to give the Committee access to material which would help members
but which they would otherwise be unable to see.
13 Work programme - APC(99)37
13.1 To be taken at the residential meeting.
14 Any other business
14.1 Professor Anderson described the ECVAM conference at Bologna, Italy,
which he had attended as Chairman of the Research & Alternatives sub-Committee.
The 800 delegates who attended gave comprehensive world-wide coverage
on the latest developments on alternatives. Other APC members (including
all his RASC colleagues) had been there too. The APC had had a poster
site (copy of the poster attached to these minutes).
15 Date of next meeting
Wednesday October 13 1999, 10.30, room G21 Queen Anne's Gate.
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