Minutes of Meetings - May 2001 (final)

1. Apologies were received from Professor Martin and Dr J Anderson.

1.2 Opening the meeting the Chairman congratulated Professor Dunbar and Mr Gregory on their re-appointment as members.

Item 2: Minutes of the meeting held on 14 February

2. The draft minutes had been sent to members 20 March and were available on the APC website. Referring to section 7 (Committee's report on Openness) Mr McCracken commented that he had raised the issue of whether the Openness working group's minority report should be placed on the website. The Chairman said that there had been insufficient time to discuss that at the February meeting, and suggested that it could be discussed under item 14.

[Secretary's note: Written comments were received from Mr Limpkin, who attended the February meeting for the item on openness on behalf of the Home Office Freedom of Information Unit. He commented on paragraph 7.3, second bullet point, suggesting that as the Freedom of Information Act has 8 parts in all it would make more sense to refer to parts I and the exemptions in Part II of the FofI Act rather than to "both parts".]

Item 3: Matters arising

3.1 Report by the Home Office on infringements At the February meeting the Home Office had agreed to supply the criteria used by the DPP to determine whether prosecution was in the public interest; and to give further details about the infringement at establishment 16. Papers about both of these had been incorporated into APC(01)11, which the Committee noted.

3.2 APC website The entry about the membership of the openness working group membership had been amended.

3.3 Mutagenesis screening Dr Langley had provided material which had been passed to the Cost/Benefit working group.

3.4 Experiments using tobacco Dr Langley had written to the Chairman expressing her concerns about the Committee's assessment of these projects. The Chairman had replied. Dr Langley said that she still had concerns, and it was agreed that the matter should be discussed by the Committee at a future meeting.

3.5 Weekend Conference This had been booked for 16 and 17 November. The Secretariat was asked to investigate the possibility of members of the House of Lords Select Committee attending on the Friday evening as guests. Action: Secretariat

3.6 Secretariat working methods The Secretariat confirmed that all "APC" and "INF" papers were being retained in reference files for future reference.

3.7 Recruitment of new APC members The Secretariat confirmed that 75 persons had been nominated for membership of the APC. All nominees had been sent applications forms to complete by 21 May. The sift panel, comprising Mr Cobley, Professor Banner and an independent assessor, would meet in early June.

Item 4: Allegations by "Uncaged" (APC(01)5)

4.1 The Chairman noted that he had written to the Minister on 20 March about the Committee's concerns expressed at the last meeting, and that the Minister had replied on 10 April. [Secretary's note: a copy of Mike O'Brien's letter of 10 April (in PDF format) is attached to these minutes.] The Chief Inspector reported that he had finished his review of the compliance with the authorities given to Imutran and HLS. He said that the report had identified issues that needed to be resolved before the Minister could make decisions. ABCU were pursuing those. Some members expressed concern about that delay. As the Committee was bound to confidentiality by section 24 of the Act, they considered that it was appropriate for the Committee to see the report before it was made public. The Chairman agreed that he would write to the Minister expressing the Committee's concern. Action: Chairman

4.2 Dr Langley then introduced her paper (APC(01)5). She suggested that when the Committee had considered the applications, originally in February 1999, there had been a lack of clarity about whether the severity banding of the kidney transplantation had been moderate or substantial. She suggested that it would be helpful for the Committee's future work if it were retrospectively to review its decision to advise that the applications should be granted, in order to assess whether it had been given the full facts, and to consider whether the correct severity banding had been used.

4.3 Some members suggested that the Committee should discuss the "Uncaged" allegations forthwith, particularly the severity banding question. However, other members noted that any assessment would benefit from the availability of further information: the Chief Inspector's report, and other information, for example about analgesia. After discussion, the Committee agreed to postpone further discussion about the "Uncaged" allegations.

4.4 The Committee discussed the information about severity levels which it had received. The Chief Inspector clarified the severity levels for the different project licences: the licence for pigs donating hearts or kidneys was unclassified, as the pigs had been terminally anaesthetised: the licence for primates donating blood was mild; the licence for primates receiving heterotopically transplanted organs was moderate; and the licence for primates receiving orthotopically transplanted organs was substantial. Several members recalled the consideration given by the Primates sub-committee and the main Committee to these applications. They recalled that there had been extensive discussion about whether the procedures should be classified as moderate or substantial. With appropriate use of analgesia, surgical procedures were correctly classified as moderate. If analgesia was ineffective, there was a risk of the procedure becoming substantial. There had been general acceptance that there was merit in setting severity levels at the lower level to provide for earlier intervention.

4.5 After discussion, it was accepted by some, but not all members that the Committee should not review its decision to advise that the applications should be granted. However, there was agreement that more discussion was needed on severity levels in general, so that the Committee might be better informed in future. For example, were severity levels only for use as an assessment of severity, or were they - as appeared to have occurred in these cases - a control tool as well? It was agreed that an examination of severity levels would be taken forward by the Cost/Benefit working group. Action: Secretariat.

Item 5: Draft annual report 2000 (APC(01)6)

5.1 The draft of the annual report which had been circulated twice to the membership: originally on 31 March, and again on 3 May. Since then,

• The Secretariat had received revisions to the register of interests which would be incorporated;
• Comments had been received from Dr Jennings suggesting that several sections needed a more critical review. These are the sections dealing with allegations against Imutran/HLS; the Primates sub-committee; the Openness working group; and the Overbreeding working group

5.2 The Chairman asked the Secretariat to redraft the report reflecting those comments and to circulate to the membership for final comment. It was hoped to lay the report before Parliament shortly after Parliament reassembled. Action: Secretariat.

Item 6: Home Office consultation on countering animal extremism (APC(01)7)

6. It was agreed after a short discussion that the Committee would not comment, as the consultation had been distributed widely to interested parties in trade bodies, industry and academia. In answer to a question about the effect of the General Election on the legislation to counter animal extremism, Mr Cobley said that the Home Secretary had sought to ensure that the bill would be agreed with the opposition and thereby its passage before the closure of Parliament would be ensured.

Item 7: APC/UKXIRA liaison (APC(01)8)

7. Originally, the Committee had asked UKXIRA to nominate one individual UKXIRA member to be co-opted onto the Primates sub-committee to help with xenotransplantation applications. The proposal by UKXIRA was instead to nominate different members, depending on the expertise required for each particular application. The Committee agreed to accept this proposal, and instructed the Secretary to reply to UKXIRA accordingly. [Action: Secretariat}

Item 8: Labelling of medicines (APC(01)9)

8. The Committee noted that any change to allow medicine labels to give information about whether a medicine had been tested on animals was complicated because of European standards and rules. In addition, there was apparently concern that putting additional information on labels might inhibit patients reading vital information about dosage, warnings not to mix the medicine with alcohol etc. Some members suggested that this was not an issue that the Committee had any relevant expertise. It was agreed that the Committee would not seek to take this issue further, but the Chairman said that he would refer to the issue with the Lords Select Committee when he next attended. [Action: Chairman]

Item 9: Oxford macaques: NAVS campaign (APC(01)10)

9. In a brief discussion members noted that more information would be required from the Home Office before the Committee could take a view on the concerns raised by members of the public who had written to the APC in response to an article in the NAVS "Campaigner" magazine. Members who had attended the House of Lords Select Committee recalled that concern about this project had also been expressed there. The Chairman said that he would ask the Secretariat to obtain further information from the Home Office, and he would then write to the Select Committee. The correspondence would be copied to the membership of the Committee, and the matter discussed at the next meeting. Action: Secretariat

Item 10: Recent Home Office developments (APC(01)11)

10 Mr Walsh reported as follows:

10.1 Increase in Animals (Scientific Procedures) Inspectorate Mr O'Brien had announced an increase in the size of the Inspectorate in a reply to a written parliamentary question. The Inspectorate would increase from 21 to 33 inspectors over the next three years. The first 6 posts had been advertised in March and April. The successful candidates were likely to take up post in October and January.

10.2 Publication of PICTF report The report of the Prime Minister's Pharmaceutical Industry Competitiveness Task Force had been published on 28 March. It committed the Home Office to processing licence applications within an indicative "clock" time of 35 working days. Recommendations touched on issues such as the ERP (under review), the project licence application form and guidance notes (just revised), electronic processing of applications (to be explored), and devoting more resources to the licensing function (more Inspectors were to be appointed - see above). Connected with this, terms of reference were currently being drawn up for a project to enhance and up grade IT systems supporting the licensing operation. Mr Wood said that another issue identified by PICTF and by the Royal Society was the need to review Schedule 1 of the Act (appropriate methods of humane killing). He would be writing to the Secretariat about this shortly.

10.3 Monoclonal antibody production Mr O'Brien had answered a written parliamentary question on 30 March about current policy regarding the licensing of monoclonal antibody production by the ascites method. He had confirmed that authorities for such production would only be granted in exceptional circumstances and had announced that all recommendations for approval of such exceptional authorities would in future be submitted to him. This meant that in future decisions would be made personally by the Minister, whereas previously officials had taken such decisions. As with any other decision, the Minister could seek further advice, either from the Committee or from external assessors.

10.4 Ministerial Working group on Animal Rights Extremism The setting up of a Ministerial Working group on Animal Rights Extremism had been announced on 26 April. The Group would be chaired by the Home Secretary and would co-ordinate policy to protect those working in animal research establishments against intimidation by extremist groups. Mike O'Brien would also be a member of the Group.

10.5 Freedom of Information: Review of Section 24 Work was continuing on the review of Section 24 of the Act.

Item 11: Government response to BSE report: APC comments (APC(01)12)

11. The draft response by the Committee contained in APC(01)12 was briefly discussed. The Chairman said that he would expand the section in the draft about the advantages to be gained from an advisory committee having a dedicated secretariat. He would also consider commenting on the quality assurance of scientific advice. Action: Chairman

Item 12: Accommodation and Care of Animals (APC(01)13)

12.1 Opening the discussion on this item the Chairman said that the Committee's work programme for 2001 had identified the accommodation and care of animals as a useful discussion topic. He thanked Dr Jennings for preparing a paper at very short notice. Introducing her paper Dr Jennings referred to several areas of the Committee's work which touched on accommodation and care, such as in the discussions of the Biotechnology working group and in the Committee's discussions on Codes of Practice for housing and care of transgenic pigs. In the Committee's programme of visits members had noticed variations in the accommodation and care of animals. While all establishments complied with the guidelines, some achieved higher standards than others. Members were also involved in relevant work outside the Committee, for example in the ongoing review of the European Convention on husbandry and care of laboratory species. Dr Jennings suggested that in order to progress this important issue the Committee should

• Gain a better understanding about areas such as codes of practice;
• Consider funding research into issues such as cage size;
• Take forward the recommendations about accommodation and care in the Committee's biotechnology report.

12.2 During discussion it was noted that accommodation and care might have a far greater impact on an animal's welfare than scientific procedures, as the procedures only took a fraction of time compared with the 24 hour impact of the animal's environment. There was general agreement that this important and very large subject should be examined by a working group. The working group might initially identify the status and operation of current codes of practice for all the common laboratory species, and examine what practical contribution the Committee could make. The working group should aim to make an initial presentation to the Committee at the weekend conference. It was agreed that the Chairman would discuss membership and terms of reference of a working group with Dr Jennings and the Secretariat. Action: Secretariat.

12.3 The Chairman then referred to the enforcement of and compliance with the Act, which was another discussion topic identified in the work programme. He said that this appeared to be a difficult issue. For example, was the very small number of infringements identified compared with the millions of procedures taking place evidence that the system was effective or was ineffective? Some members suggested that there was a need to establish how the Inspectorate enforced the Act, and to examine how compliance with rules was ensured in other comparable areas of government. However, it was noted that this was a very large area, and its proper examination by the Committee would require a lot of resources. After further discussion it was agreed that the Secretariat would prepare a background note about the Inspectorate's working methods which could be discussed at a future meeting. Action: Secretariat.

12.4 As far as other items for future work were concerned, the Chairman said that the House of Lords Select Committee might identify items which the Committee could take forward. Also, it was open to members at any time to make suggestions.

Item 13: APC evidence to Lords Select Committee (APC(01)14)

13.1 The Chairman reported that he, Dr Jennings and Professor Purchase had attended the House Of Lords Select Committee on Animal Experimentation on 1 May to give oral evidence. He thanked Dr Jennings and Professor Purchase for the invaluable technical support they had provided in the areas of science and welfare. The Chairman said that he had been asked to attend the Select Committee again later in the year to answer further questions. The Select Committee would shortly provide a draft transcript of the evidence given on 1 May. The Chairman would then send the Select Committee corrections to the transcript and further material which had been requested. He said that copies of the agreed transcript and the further correspondence would be provided to members as an Information paper for the next meeting. Action: Secretariat. That would be an opportunity for members to raise other matters which they considered the Chairman should raise with the Select Committee when he next attended.

Item 14: Openness and Biotechnology reports: progress

14.1 Progress on both these reports had been delayed by the need to devote resources to the House of Lords Committee.

14.2 Openness The Chairman and Professor Atterwill had revised the draft discussed at the February meeting, and had circulated it to Mr McCracken and to the Home Office FoI unit. Although Mr McCracken had earlier registered his objections to the draft of the Committee's report, no further comments had been received, so publication of the Committee's report, announced by a press release, could now go ahead, although that might have to be delayed because the general election had been called. The Chairman drew attention to the letter from Mike O'Brien dated 3 May. This showed that he had broadly accepted all the Committee's recommendations on openness given in the Chairman's letter of 3 January, and had asked officials to take some forward, while noting that others were for the APC to progress. [Secretary's note: a copy of the letter of 3 May (in PDF format) is attached to these minutes.]

14.3 The Committee then discussed whether the minority report of the working group should be made available on the website in addition to the Committee's final report. Some members considered that that would reflect a commitment to openness. However, it was also noted that both the minority and majority reports were working documents, and the Committee's final report was different from, and reflected the differences between the two reports. If the minority report were to be placed on the website, the majority report should be placed there as well. After discussion the Committee decided that only the Committee's final report would be placed on the website. [Action: Secretariat]

14.4 Biotechnology The Chairman said that at the meeting on 14 February he had agreed to incorporate the amendments suggested at that meeting and to circulate a draft with the amendments marked up. Members had responded with several detailed suggested amendments which the Chairman had discussed with Professor Richardson (chair of the Biotechnology working group). The Secretariat would now produce a revised version which would be circulated to the members of the working group. [Action: Secretariat]

Item 15: Any other business

15.1 At the February meeting, during the discussion about infringements, it had been noted that one of the reasons for deciding against prosecution in one of the cases of infringement was because the licensee had been under medical treatment which could have influenced actions. It had been suggested that the Committee might wish to consider whether in future, applicants for personal licences should be required to declare any medical condition which might affect their ability to carry out licensed procedures. During a short discussion of this issue the Chief Inspector commented that from his knowledge of the case referred to, such a requirement would have been unlikely to have prevented the infringement. It was also noted that it was the responsibility of any organisation to ensure - by general medical checks at recruitment and by on-going pro-active personnel management - that their employees were mentally and physically capable of carrying out their responsibilities under the Act.

Item 16: Date of next meeting

16.1 The next meeting will be held on 27 June.

APC Secretariat
4 June 2001 

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