Animal Procedures Committee - Minutes of Meeting December 2000

ANIMAL PROCEDURES COMMITTEE APC (2000) 5th Meeting

MINUTES OF THE MEETING HELD ON 13 DECEMBER 2000

At The Home Office

Present

Professor Banner (Chairman)
Professor Atterwill
Mr Baker
Professor Broom
Professor Bulfield*
Professor D Clark
Mr Gregory
Professor Holland
Dr Jennings
Dr Langley*
Professor Martin
Mr McCracken
Professor McNeilly
Professor Richardson

* Professor Bulfield and Dr Langley were delayed, and joined the meeting during the discussion on item 8.

Home Office
Mr Cobley
Mr Walsh

Inspectorate
Dr Richmond

Secretariat
Mr West
Mr Bourne
Ms Bacon
Mr Brenner

1. Apologies for absence

1.1 Apologies were received from Professor Anderson, Professor S Clark, Professor Dunbar, Professor Flecknell, Professor Purchase, Professor Turner and Dr Anderson (Inspectorate). The Chairman welcomed Ms Bacon (Secretariat) on her return from maternity leave. He noted that Mr Bourne, who had joined the Secretariat as Deputy Secretary on a temporary basis until the return of Ms Bacon, was shortly to move to another post in the Home Office. He thanked Mr Bourne for his work with the Secretariat.

2. Minutes of the meeting of 13 September

2.1 Draft minutes had been circulated to the membership for comment on 27 September. They were accepted as a correct record. Due to an oversight the minutes had not yet been placed on the APC website. The Secretariat would rectify that shortly. Action: Secretariat

3. Matters arising from minutes of 13 September

3.1 Annual report 1999 A corrected Register of members' interests had been circulated to all recipients of the 1999 report. Professor Broom reported that he wished to declare an additional interest as he was a member of the Ethical Review Procedure (ERP) committee for Huntingdon Life Sciences. The Chairman thanked Professor Broom, and reminded other members that membership of ERPs was a declarable interest.

3.2 Primates sub-committee The Secretary read out an e mail from the Chair of the sub-committee, Professor Dunbar, in which he asked the main Committee for a view on how to take forward the sub-committee's report which had been presented to the Committee at its meeting on 28 June. After discussion, it was agreed that Professor Banner, Professor Dunbar and Dr Jennings would discuss how to take the matter forward. Action: Secretariat to arrange meeting

3.3 Biotechnology working group Professor Richardson reported that the working group intended to present its report to the full Committee at the meeting on 14 February.

3.4 Consultation on Cost/Benefit It was noted that the consultation letter on Cost/Benefit would be announced by a press release on Friday 15 December. The Secretariat was asked to circulate to members a list of those organisations which had been sent the letter, so that members could identify any omissions and inform the Secretariat. Action: Secretariat and members

3.5 APC weekend conference 27/28 October. The Chairman thanked all the members who had attended the weekend conference, especially those who had given presentations. He said that the Secretariat was shortly to circulate a pro forma asking for feedback on the weekend conference. Action: Secretariat

3.6 APC membership Mr Cobley reported that Mr O'Brien had agreed to a recruitment exercise to identify three new members of the APC. The first stage was to trawl interested parties for suggested nominations. He confirmed that the APC membership would be included in that exercise. Some members said they had particular recommendations. The Chairman advised them to write to him about those: as a member of the selection panel he would put forward any views he received. Action: Members

3.7 Drug labelling A press cutting in INF(00)32 referred to a proposal that the labels on drug containers should indicate whether the drug had been tested on animals. The Committee noted that the issue was apparently complex. The Secretariat was asked to obtain further clarification from the Department of Health, so that the Committee could return to the subject. Action: Secretariat

4. Infringements (APC(00)18A)

4.1 Mr Walsh introduced the paper, and explained that it referred to 25 infringement cases dealt with centrally in the current year. The infringements ranged from comparatively minor - eg errors in cage labelling - to more serious infringements, such as failure to check whether particular procedures had been authorised. Many of the infringements were self-reported, or had come to light by internal monitoring by the establishment. The Chief Inspector said that besides dealing with each individual case the Inspectorate also sought to identify trends and to disseminate remedial advice. It was explained that current practice was to take strong action where unnecessary suffering had been caused; where the licence holder had not demonstrated contrition; or did not appear to realise the gravity of the infringement; or in repeated offences. Revocation was sometimes an indication that the person involved was not considered capable of functioning safely. Mr Walsh said that the Home Office was currently working on a more detailed summary of the infringements, which would be presented to the Committee at the next meeting.

4.2 Some members expressed the wish that the revised paper should include information about the effects on the animals' welfare of each infringement, and which infringements were self-reported. Information about whether the infringement had been caused by an individual's error or by a management failure would also be important, as would the incidence of repeated offences. Naming the establishments concerned might have the negative effect of discouraging self-reporting, but it was important to know - perhaps by using a system of numbering each establishment in order to anonymise them - whether there were establishments which repeatedly committed infringements. Lastly, members suggested that the revised paper should include a covering note by the Inspectorate or ABCU commenting about trends, numbers of cases etc. Action: Secretariat: to write to ABCU

5. APC/UKXIRA relations (APC(00)19)

5.1 There were two issues - whether the APC could co-opt an UKXIRA member onto the Primates sub-committee; and whether information in the possession of the Home Office about xenotransplantation projects could be passed to UKXIRA. Legal advice was that the first was possible, but that information obtained in confidence by the Home Office could not be passed to UKXIRA unless the permission of the licence holder(s) was obtained. Dr Jennings (a member of UKXIRA) reported that UKXIRA saw liaison with the APC as of increasing importance. The Committee agreed that the Secretariat should liaise with the UKXIRA Secretariat and the Chairman of the Primates sub-committee in order to identify a suitable member of UKXIRA who might be co-opted onto the Primates sub-committee when necessary as a source of expert advice on xenotransplantation issues. A proposal would be put to the Committee at the February meeting. The Committee also agreed that the Home Office should be advised to take forward UKXIRA access to information held by the Home Office on xenotransplantation research by approaching past and present licence holders. Action: Secretariat & ABCU

6. Report by Education and Training sub-committee on training for Named Animal Care and Welfare Officers (NACWOs) (APC(00)20)

6.1 Mr Gregory introduced the paper. The sub-committee was proposing that training for newly appointed NACWOs should be made compulsory, and had drawn up a draft syllabus for an introductory course. Mr Gregory clarified that the course would be designed for professional animal technicians.

6.2 In discussion, it was suggested that the course might need to be expanded to include more detail about welfare observations and a general introduction to ethics training. It was agreed that the Chairman would write to the Minister about the proposals. Action: Secretariat

6.3 The Education and Training sub-committee was engaged in ongoing work on other matters. The Secretariat was asked to liaise with Professor Flecknell and present a work programme at the next meeting. Action: Secretariat

7. APC work programme 2001 (APC(00)21)

7.1 It was agreed that part 4 of the draft programme, which identified subjects for information papers which might be required, should be taken forward by the working group on Cost/Benefit. Part 4 could therefore be deleted from the work programme. Subject to that, the proposed work programme was agreed, and the Secretariat was asked to place it on the website. The Secretariat was also asked to fix a date for a weekend conference in October 2001, to arrange dates of meetings in 2002 and to inform the Committee at the next meeting. Action: Secretariat

8. Reports by working group on openness (APC(00) 17A & APC(00)17B)

8.1 The Chairman thanked the chair of the working group, Professor Atterwill, and the four other members of the group for their hard work involved in the consultation exercise and the consideration of the large number of responses.

8.2 Professor Atterwill introduced the discussion. The consultation letter had been sent out on 13 January 2000 and 2,320 responses had been received. The working group of five APC members had met eight times between March and November to consider the advice which should be offered. The working group were submitting two reports to the main Committee - a majority report, supported by three of the members of the working group, and a minority report, supported by the other two members of the working group.

8.3 After discussion, the Committee noted the continuing disagreements on various matters, in particular in relation to revisions to the project licence application form and the publication of results.

8.4 Disclosure of a summary of the project licence application There was a discussion about revisions to the project licence application form and it was agreed that the Committee should specify in greater detail what should be included in a publicly available summary. Dr Jennings agreed to send the Secretariat a draft note which she had prepared on the preparation of project licence summaries for local Ethical Review Processes. The Secretariat was asked to circulate this to the membership. Action: Dr Jennings and Secretariat

8.5 The Committee discussed the content of the recommendation at length, and decided that that the Project Licence Application form should require the inclusion of a summary of the procedures to be undertaken, and that this summary should be comprehensive and detailed enough to provide a reader with a clear indication of the costs and benefits of the project. Such a summary would be perhaps a maximum of two pages, and would be written in language appropriate to the general reader. The Committee agreed that such a summary should include:-

Key objectives and possible benefits of the project;

Reasons for the need to use animals; what alternatives had been considered; and why these were not appropriate;

Reasons for the choice of species and strains;

Numbers of animals to be used and kept for the specific project;

What would happen to the animals as a result of the project - a synopsis of the main adverse effects covering the lifetime experience of the animal; including factors such as source, husbandry, procedures and their effects, and eventual fate of the animal;

Estimated level of the severity of the project;

Specific measures to minimise adverse effects and improve welfare, including both husbandry and procedures; and

How the applicant had weighed the costs against the benefits to judge whether the use of animals was justified.

8.6 The Committee then discussed the stage at which any summary might be made public. Disclosure could be at the application stage, or when the licence was granted. It was noted that there were advantages and disadvantages to both those options. If the application were made public at the earlier stage:

it would give members of the public time to comment before a licence was granted, so that they could seek to influence the decision making process;

animal protection organisations might be able to refer to possible alternative procedures which had not been considered;

sight of applications which were ultimately turned down would allow the public to see that the licensing process was sufficiently rigorous.

On the other hand, it was suggested that there were also disadvantages in making an application public before the licence had been granted:

it would hamper the iterative process of discussion which went on between the Home Office and applicants;

as applications were progressively developed by that iterative process, more than one version of a changing application would have to be made public;

until a licence was granted, the procedure had not been subject to an exercise of governmental judgement.

8.7 The Committee agreed to advise the Minister that when the Home Office considered the stage at which a summary of a project licence application might be made public, the advantages and disadvantages of both options should be taken into consideration.

8.8 Publication of results Discussion turned on the practicalities of what was agreed to be a difficult and complicated area. The Committee noted that positive outcomes of experiments were usually published in open scientific literature, but projects which yielded no useful results, or failed to prove a project or principle ("negative results") were seldom written up - that was true, in particular, of basic medical research. Failure to publish such results could lead to unnecessary repetition of animal experimentation.

8.9 Mechanisms for making available information on both positive and negative research outcomes would differ depending on whether the research was basic medical research or commercial research. It was considered that one possible mechanism for basic medical research could be to record on the ABCU website the results achieved or an explanation of why the project had been abandoned. However, the effort that that would entail was not be underestimated and it was thought would contribute little to academic progress. Another possibility would be to publish interim reports on grant-funded research. In the commercial sector, the position was not simple. Negative results were rarely published, and for reasons of commercial secrecy even positive results were not published until a patent application had been lodged. If a new medicine failed to reach the market neither positive nor negative results might ever be published. In such circumstances the process of assessing the release of any information would involve commercial lawyers more than scientists, and it would be a lengthy, complex and iterative procedure. Because of those problems, the Committee considered that a more detailed investigation of a workable process should be undertaken.

8.10 The Chairman agreed that he would urge the Minister to commission further examination of possible mechanisms for publishing negative results, as the development of a satisfactory system could result in a reduction of nugatory experiments

8.11 The Committee discussed the other recommendations in the majority report and accepted the following:

The Committee agreed with the recommendation of the working group that total openness, as supported by a number of individuals' and animal protection organisations' responses to the consultation exercise, was not practical chiefly because of concerns in relation to personal security, but also because of issues of commercial confidentiality.

No retrospective amendment to section 24 Any change relating to animal experimentation should not be retrospective. The Committee recognised that because a Project Licence lasted only five years, changes to the disclosure of project licence information would be fully achieved in that time scale.

Increased openness regarding infringements The Committee noted that summaries of major infringements were considered in an anonymised form by the APC, and discussed at Committee meetings. In the case of a more serious infringement a detailed anonymised account was supplied. The Committee believed that information of that kind should be more widely available and expressed willingness to publish the material as an appendix to its annual report.

Increased openness in statistical reporting The Committee noted that annually, a statistical report on animal experimentation was published, and recommended that the usefulness of the information in that report should be improved. For example, it should include numbers of animals kept for experimentation in addition to the existing statistics, which detailed only numbers of animals actually used in experiments. The Committee also recommended that the report should include details of the severity of experiments. That would assist the public to come to an informed view. Although an annual statistical report was produced, there was no annual report of other areas of the work of the Inspectors. The Committee recommended that there should be such an annual report, which might cover areas such as visits to establishments; the results, number and type of licences processed; and the outcome of research renewal applications.

Additional voluntary openness The Committee considered that in order to assist public debate the Life Science institutions should be encouraged to open their facilities to the responsible public.

APC involvement in special investigations The Committee noted that APC minutes were placed on the APC website. It recommended that in the same way, where the APC discussed a report by an APC working group carrying out a "quality assurance audit" of an investigation by the Inspectorate, that discussion, the report of the audit working group and the Inspectorate report should all be made available on the APC website, suitably anonymised.

APC interaction with other bodies The Committee agreed that it should have a programme of regular interaction with other committees, representative bodies and pressure groups in the UK and overseas. That would be for two purposes: to educate and inform members of the APC; and to achieve a mutual and reciprocal educational and information process with other relevant influential bodies. In the UK this would include bodies such as the House of Lords select committee on animal experimentation, the Agriculture and Environment Biotechnology Commission (AEBC), the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA), and representatives of users and animal protection organisations. The aim of international co-operation would be to contribute towards the development of international Freedom of Information legislation relating to animal experimentation, especially within the European Union.

8.12 The Committee then discussed the proposal made by the working group that a standing forum for public debate should be established. It was agreed that the proposal needed further discussion, and should be an agenda item at a future meeting. Action: Secretariat

8.13 At the end of the discussion on this item it was agreed that the Chairman should write to the Minister reflecting the discussion which had taken place and presenting the Committee's recommendations whilst noting the continuing disagreements. The Chairman's letter would be circulated to the Membership. It was agreed that the Chairman would submit a revised report to the Minister in due course. Action: Secretariat [Secretary's note: a copy of the Chairman's letter dated 3 January 2001 is attached to these minutes. It was copied to the Membership the same day.]

9. Allegations by "Uncaged" about xenotransplantation work at Imutran and HLS (INF(00) 30)

9.1 Before discussion began several members declared interests. Professor Atterwill reminded the meeting that he was currently employed by HLS, and offered to withdraw from the meeting. Professor Broom said that he was a member of the HLS Ethical Review Process. Professor Bulfield said that the Roslin Institute had, until three months previously been in commercial competition with Imutran. Dr Jennings said that as part of her RSPCA responsibilities she was engaged in preparing a report on the allegations. Dr Langley said that from July to September 2000 she had received payments for advising "Uncaged", but had no current ongoing pecuniary interest. The Chief Inspector also offered to withdraw from the meeting. It was agreed that having declared their interests, all those identified should remain and participate in the discussion except Professor Atterwill, because of his continuing interest. Professor Atterwill then left the meeting.

9.2 In a brief discussion it was noted that the Secretary of State had decided to ask the Chief Inspector to examine, as part of the Inspectorate's normal statutory inspection and reporting function, the available evidence relating to compliance with the authorities granted to Imutran for its xenotransplantation work between 1995 and 2000. The Chief Inspector had begun that examination. It was suggested that as a first step, the Committee would find it helpful to ask the Minister if he could provide some background on why a special investigation by the Inspectorate, as had occurred with the allegations about Harlan-Hillcrest, had not been commissioned. The Chairman agreed to write to the Minister. Action: Secretariat

9.3 The Committee agreed that it would return to the issue when the Chief Inspector had concluded his examination. Action: Secretariat

10. Any other business

10.1 Dr Jennings distributed a paper which she and Dr Jane Smith had written about ethics training for licensees. She said that the paper was particularly relevant to modules 1 and 5 of the current modular training system.

10.2 Dr Jennings said that LASA were currently planning a meeting which would consider the current Home Office modular licensing training system. The Chairman asked whether Professor Holland, who had expressed an interest in the element of the training relating to ethics, could be involved. Dr Jennings agreed to take this forward. Action: Dr Jennings

11 Date of next meeting

11.1 Wednesday 14 February at the Home Office.

[Secretary's note: Owing to time constraints the Committee were unable to discuss certain agenda items: Oral report by Home Office on recent developments); Statistics of Scientific Procedures 1999; and APC working methods. These will be carried forward to the agenda of the meeting on 14 February 2001.]

Dear Mr O'Brien

ANIMAL PROCEDURES COMMITTEE: RECOMMENDATIONS ON OPENNESS

As you know, the Animal Procedures Committee has been carrying out a consultation exercise on openness in relation to the use of animals in scientific experiments. This letter presents you with the Committee's advice on this important subject. Because of the tight timetable I know you are working under, I am not presenting you with the Committee's full report at this stage. However the Committee will in due course publish a full report setting out the basis of our reasoning.

2. The consultation letter was sent out on 13 January 2000 and 2,320 responses were received. A working group of five APC members had eight meetings between March and November to consider the advice which should be offered. The working group submitted two reports to the main Committee at a meeting on 13 December - a majority report, supported by three of the members of the working group, and a minority report, supported by the other two members of the working group.

3. At the meeting on 13 December, I sought a consensus of views. After discussion, the Committee agreed that I should write to you presenting recommendations for Home Office action. After careful consideration, we have concluded that total openness, as supported by a number of individuals' and animal protection organisations' responses, is not practical chiefly because of concerns in relation to personal security, but also because of issues of commercial confidentiality. Our aim however, has been to recommend measures which will lead to the greatest degree of openness compatible with those concerns. The two most important recommendations are those relating to the revisions to project licence applications, and to the publication of results of experiments.

Recommendation 1: the Project Licence Application form

4. We recommend that the Project Licence Application form should require a summary of the procedures to be undertaken, and that this summary should be comprehensive and detailed enough to provide a reader with a clear indication of the costs and benefits of the project. Such a summary would be perhaps a maximum of two pages, and would be written in language appropriate to the general reader. We recommend that such a summary should include:-

Key objectives and possible benefits of the project;

Reasons for the need to use animals; what alternatives have been considered; and why these are not appropriate;

Reasons for the choice of species and strains;

Numbers of animals to be used and kept for the specific project;

What will happen to the animals as a result of the project - a synopsis of the main adverse effects covering the lifetime experience of the animal; including factors such as source, husbandry, procedures and their effects, and eventual fate of the animal;

Estimated level of the severity of the project;

Specific measures to minimise adverse effects and improve welfare, including both husbandry and procedures; and

How the applicant has weighed the costs against the benefits to judge whether the use of animals is justified.

5. The Committee recognised that there were advantages and disadvantages to whether a summary of a licence application should be made public at the stage when an application was received by the Home Office, or later, at the stage when a licence was granted. If the application were made public at the earlier stage:

it would give members of the public time to comment before a licence was granted, so that they could seek to influence the decision making process;

animal protection organisations might be able to refer to possible alternative procedures which had not been considered;

sight of applications which were ultimately turned down would allow the public to see that the licensing process was sufficiently rigorous.

6. On the other hand, it was also suggested that making an application public before the licence had been granted:

would hamper the iterative process of discussion which goes on between the Home Office and applicants;

as applications are progressively developed by that iterative process, more than one version of a changing application would have to be made public;

until a licence is granted, the procedure has not been subject to an exercise of governmental judgement, and therefore should not be made public.

7. I hope that when the Home Office considers the stage at which a summary of a project licence application should be made public, the advantages and disadvantages of both options will be taken into consideration.

Recommendation 2: Publication of results

8. Positive outcomes of experiments are usually published in open scientific literature, but projects which yield no useful results, or fail to prove a project or principle ("negative results") are seldom written up - this is true, in particular, of basic medical research. Failure to publish such results could lead to unnecessary repetition of animal experimentation.

9. Mechanisms for making available information on both positive and negative research outcomes would differ depending on whether the research was basic medical research or commercial research. One possible mechanism for basic medical research could be to record on the ABCU website the results achieved or an explanation of why the project was abandoned. The effort this would entail should not be underestimated and would contribute little to academic progress. Another possibility would be to publish interim reports on grant-funded research. In the commercial sector, the position is not simple. Negative results are rarely published, and for reasons of commercial secrecy even positive results are not published until a patent application has been lodged. If a new medicine fails to reach the market neither positive nor negative results may ever be published. In such circumstances the process of assessing the release of any information will involve commercial lawyers more than scientists, and it will be a lengthy, complex and iterative procedure. Because of these problems, we recommend that a more detailed investigation of a workable process should be undertaken.

10. The Committee recognised that this was a particularly difficult and complicated area. However, the Committee urges you to commission further examination of possible mechanisms for publishing negative results, as the development of a satisfactory system could result in a reduction of nugatory experiments.

Recommendation 3: no retrospective amendment to section 24

11. Any change relating to animal experimentation should not be retrospective. We recognised that because a Project Licence lasts only five years, changes to the disclosure of project licence information would be fully achieved in that time scale.

Recommendation 4: increased openness regarding infringements

12. Summaries of major infringements are considered in an anonymised form by the APC, and discussed at Committee meetings. In the case of a more serious infringement a detailed anonymised account is supplied. We believe that information of this kind should be more widely available and we would be willing to publish this material as an appendix to our annual report.

Recommendation 5: increased openness in statistical reporting

13. Annually, a statistical report on animal experimentation is published, available from HMSO. We recommend that the usefulness of the information in that report should be improved. For example, it should include numbers of animals kept for experimentation in addition to the existing statistics, which detail only numbers of animals actually used in experiments. We also recommend that the report should include details of the severity of experiments. This would assist the public to come to an informed view.

14. Although an annual statistical report is produced, there is no annual report of other areas of the work of the Inspectors. We recommend that there should be such an annual report, which might cover areas such as visits to establishments; the results, number and type of licences processed; and the outcome of research renewal applications.

Other recommendations

15. You will also wish to be aware of other recommendations which the Committee agreed, although they are for the Committee itself to pursue, rather than the Home Office.

Recommendation 6: additional voluntary openness

16. To assist public debate the Life Science institutions should be encouraged to open their facilities to the responsible public.

Recommendation 7: APC involvement in special investigations

17. We note that APC minutes are placed on the APC website. In the same way, where the APC discusses a report by an APC working group carrying out a "quality assurance audit" of an investigation by the Inspectorate, that discussion, the report of the audit working group and the Inspectorate report should all be made available on the web, suitably anonymised.

Recommendation 8: APC interaction with other bodies

18. The APC should have a programme of regular interaction with other committees, representative bodies and pressure groups in the UK and overseas. This would be for two purposes: to educate and inform members of the APC; and to achieve a mutual and reciprocal educational and information process with other relevant influential bodies. In the UK this would include bodies such as the House of Lords select committee on animal experimentation, the Agriculture and Environment Biotechnology Commission (AEBC), the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA), and representatives of users and animal protection organisations. The aim of international co-operation would be to contribute towards the development of international Freedom of Information legislation relating to animal experimentation, especially within the European Union.

19. On behalf of the Committee I commend these recommendations to you. I hope that our advice will prove helpful to your consideration of this difficult subject.

Yours sincerely

MICHAEL BANNER

Minutes of Meetings - December 2000

ANIMAL PROCEDURES COMMITTEE APC (2000) 5th Meeting

1. Apologies for absence