Minutes of Meetings Reports and Publications Consultation Letters Press Releases	Animals (Scientific Procedures) Act 1986 (available on the Home Office website)

Minutes of Meetings - April 1999

Animal Procedures Committee APC (99) 2nd Meeting
Minutes of the meeting held on 7 April 1999

Present
Professor Banner (Chairman) Professor Atterwill Professor Anderson Professor Broom Professor Clark Professor Dunbar Mr Gregory Dr Jennings Dr Langley Professor Martin Dr Purchase Dr Southee Professor Turner Mr Ward	Home Office Mr Evans Inspectorate Dr Richmond Dr J Anderson Secretariat Mr Wilkes Mr Bone

1. Apologies for absence

1.1 Apologies had been received from Mr Baker, Professor Bulfield, Dr Clark, Professor Flecknell, Dr Suckling, Mr Holland, Miss Sinclair and Mr Hartley.

1.2 The Chairman noted that this was the last meeting at which Mr Wilkes would act as Secretary to the Committee. He expressed the Committee's gratitude for Mr Wilkes's contribution.

1.3 The Chairman introduced Mr Bone as the new Committee Secretary.

2. Minutes of the meeting held on 10 February

2.1 Paragraph 2.1 of the February minutes said that the Committee would need to include an assessment of the level of regulation in its future work plan. This was redundant. The Committee had agreed that at its previous (December) meeting ? 10.2 of those minutes. 2.1 of the February minute would be changed accordingly. Action: Secretariat

3. Matters arising

3.1 Minister's forum (para 3.2) The date had been provisionally fixed as Tuesday 22 June. The Committee agreed to consider how it should be represented at the forum at its next meeting (12 May). In answer to questions the Home Office told members that it had no plans to set up another standing body to advise the Home Secretary about animal issues ? the forum was a one-off event, albeit one that could be repeated if successful.

3.2 Primates in liver xenotransplantation research (para 3.3) The Home Office had written to the applicant in November following the response from the UK Xenotransplantation Interim Regulatory Authority (UKXIRA). They had not received a reply, but would put the application back to the Committee if and when they got one. Action: Home Office

3.3 Code of conduct (item 4). The Secretariat would produce a paper giving general advice to members, including guidance material on expenses and insurance. Discussion was held over until that was ready (hopefully by the May meeting). Action: Secretariat

3.4 Work programme (item 5) The Secretariat would prepare a paper for the May meeting setting out the aims of the Committee and of each of the five Sub-Committees and working groups (Primates, Education & Training, Research & Alternatives, Biotechnology, Cost/Benefit) together with a suggested timetable of work. In preparing the paper they would consult the Chairs of the five groups. Action: Secretariat

3.5 Cost/benefit group (para 5.1). It was suggested that the cost-benefit working group should investigate the question of whether there were certain effects on experimental animals which should be ruled out under any circumstances. The group had yet to discuss its remit and would take account of this possibility. Action: Cost/Benefit group

3.6 Primate Sub-Committee (para 5.2) The Committee approved the appointment of Professor Atterwill, Professor McNeilly, and Dr Langley as
new members.

3.7 Residential meeting (para 5.5) The meeting would be put back to September. It would discuss the Committee's work programme and long-term strategy. Action: Secretariat

3.8 Biotechnology review (item10) The Chairman's further letter to the Office of Science and Technology would be tabled for the next meeting.
Action: Secretariat

3.9 Meeting between Home Office & grant-awarding bodies (para 12.3) The meeting had taken place on March 24 and been well attended. The Home Office had gained the impression that while Research Councils generally had a good knowledge of the requirements of the 1986 Act, some Departments and Agencies did not. Professor Martin would let the Home Office have details of a book listing the charities funding animal research. Action: Professor Martin

4. Primate applications

4.1 The Committee had before it two applications, outlined in papers APC(99)9 and APC(99)10.
APC(99)9 - pig to primate kidney transplantation

4.2 The applicant sought approval to continue investigation of immunosuppressive regimes for the control of pig kidneys transplanted into primates. They had previously held a licence covering both this and similar work involving pig to monkey heart transplants. The complexity of that licence had resulted in its being split into two in order to simplify and clarify monitoring and control of the work.

4.3 The heart work was now authorised under a new, separate licence while the kidney work continued under the old licence. The old licence however was due to expire at the end of the month and the applicants were applying to replace it.

4.4 The application had been considered by the Primate Sub-Committee. The questions which the Sub-Committee had raised had been put to the applicant, whose responses to them formed part of paper APC(99)9. These answered the chief points which had been put.

4.5 In extended discussion, Committee members expressed concern about whether the effects on the primates were to be classed as 'moderate' or 'substantial' (though they acceded that the system had been properly applied), the overall numbers of primates that might be involved, the degree to which any lessons that might be learned could be carried over to human medicine, and whether the Committee was competent to take a view on that.

4.6 The Committee then formulated its concerns as follows -

a. that the applicant gives a clearer account of the numbers to be used for each part of the study;

b. that monthly progress reports be supplied to the Inspectorate: and in turn that six monthly summaries be provided to the Committee ? and that it be informed of interim concerns;

c. that the applicant's written response to the Committee's concerns (part of paper APC(99)9) should be appended to the licence as part of the authorised plan of work;

d. that the transplantation of 'control', non-transgenic, kidneys be prohibited until the optimum immunosuppressive regimen has been defined;

e. that the immunosuppressive drugs used be restricted to those already in phase 2 clinical trials or in human clinical use: and that they be used in appropriate therapeutic doses; and

f. that every effort be made to ensure that the surgical programme be tailored to minimise the wastage of potential donor animals.

4.7 The Committee agreed on balance to advise the Secretary of State that the licence be granted, subject to additional conditions aimed at addressing those concerns. Draft conditions were drawn up by the Primate Sub-Committee in consultation with the Home Office and are attached as an Annex to these minutes. Action: Home Office APC(99)10 - mechanisms of akinesia in monkeys

4.8 The Committee had seen this application in September 1998 and had raised a number of concerns and questions. The Primate Sub-Committee had collated these and put them to the applicant, and they formed part of the briefing note together with the applicant's responses to them. The responses dealt with all the questions, but there was still concern about whether the work could instead be done in human patients, without involving monkeys.

4.9 Members also raised concerns about the number of primates involved (4 a year or 2) depending on continuation of collaboration with a similar project in the USA and about the possible limited application of the results to certain categories of human Parkinson's patients. The applicant had however received funding for the work from the Medical Research Council, which indicated the likelihood of useful results.

4.10 The Committee agreed that it would ask the applicant to attend its next meeting (12 May) to answer questions. The Primate Sub-Committee would formulate the areas of questioning so that the applicant could see them in advance. Action: Secretariat & Primate Sub-Committee

5. The Animal Procedures Committee Website - APC(99)11

5.1 The APC site now appeared as part of the Home Office one. The content was the Secretariat's initial effort to get the website up and running quickly. The correct website address (slightly misquoted in the paper) was http://www.homeoffice.gov.uk/animact/apchome.htm.

5.2 The plan was to put APC minutes on the website, though not Sub-Committee minutes. Members were concerned that minutes did not register their individual reactions to particular issues and might be taken as implying they all agreed on every topic. The Secretariat would copy the last twelve sets of minutes to members in time for the May meeting, so that the Committee could discuss their suitability for inclusion on the website and any problems that might cause. The Secretariat would also explore other ways of updating the website and analysing public responses to it for a paper to the May meeting.

5.3 The web page should not refer to members' 'views' on animals issues. It was their expertise that was important. The Secretariat would recast this. Action: Secretariat

6. Draft Annual Report for 1998 - APC(99)12

6.1 Members agreed textual changes in the draft report. They noted its brevity compared with 1997's, though that took in the Committee's review of the 1986 Act. They also thought it seemed bland and did not convey the range of the Committee's responsibilities and achievements during the year.

6.2 The Secretariat would draw up a revised report highlighting particularly important aspects of the Committee's work over the year for consideration at the May meeting. This might need to make reference to the Barry Horne hunger strike. Action: Secretariat 6.3 The Secretariat would investigate the possibility of including information on Home Office-sponsored research which had been completed over the year and material on licensing statistics. Action: Secretariat 6.4 The attendance record could stay in.

7. Any other business

7.1 Members saw a document attacking the Committee put out by the Save the Hillgrove Cats Campaign. They heard that Barry Horne had started a new hunger strike.

7.2 The Secretariat would table material about FRAME's stance on endocrine disruptors for a meeting later in the year (possibly the residential meeting), at which FRAME would be invited to make a presentation. The Chairman's correspondence with the Association of British Pharmaceutical Industries would be tabled for the next meeting. Action: Secretariat 7.3 The Secretariat explained the meaning of the 'RESTRICTED' markings which appear on some Committee papers. These papers should not be shown to anybody outside the Committee but the issues could, in general terms, be discussed with others. When members received such papers for an APC meeting they were welcome to retain them securely if they wished, but they could equally hand them to the Secretariat for disposal afterwards.

8. Date of the next meeting

8.1 Wednesday 12 May, Room G21, 50 Queen Anne's Gate.
SECRETARIAT
APRIL 1999

Annex: Draft additional conditions for pig to primate application

1.By 12/6/99 the project licence holder shall surrender the licence for amendment supplying a revised Study Plan Gantt Chart, acceptable to the Secretary of State, showing the numbers of animals to be used for each study shown on the plan.

2 The project licence holder shall supply the Secretary of State with monthly reports and such other information as he shall require, on the animal use, problems encountered, and progress made. The information shall be forwarded to the Secretary of State via the Animals (Scientific Procedures) Inspectorate.

3 The APC letter requiring supplementary information and the applicant's reply is attached as a normative annex qualifying and further defining the plan of work set at Section 18 of the Schedule to this licence.

4 Procedure 19b3, Allograft comparative study, shall not be performed until the optimum immunosuppressive regimen has been defined, and the express written consent of the Secretary of State is requested and granted.

5 Immunosuppressive pharmaceutical agents (other than 'biologicals') administered as part of procedures 19b2 and 19b3 shall be restricted to agents already in Phase 2 human clinical trials, or used in human clinical practice. The administration regimens shall be tailored to minimise the likely adverse effects required to optimise the clinical benefit.

6 Every effort shall be made to organise the operating schedule to minimise the number of donor animals required.

Minutes of Meetings Reports and Publications Consultation Letters Press Releases	Animals (Scientific Procedures) Act 1986 (available on the Home Office website)