TUESDAY 1 MAY 2001

THE REVEREND PROFESSOR MICHAEL BANNER, DR MAGGY JENNINGS PROFESSOR IAIN PURCHASE AND MR RICHARD WEST

  40. Yes.  (Reverend Professor Banner) The question of whether they are wild-caught or bred for the purpose is relevant. I think the key question I would say—and it is not one understood by the public, it is a key issue in terms of public perception—is it is often thought, and a number of articles written at the time of the Huntingdon Life Sciences issue presuppose, that every animal involved in experiments has a short tortured life and dies in pain; that is plainly false. I think that in terms of any future increase in numbers the key consideration, it is not for me to comment on but in terms of public acceptability, would be a better understanding that an experiment can be the taking of a blood sample, for example, not the pinning of a rat to a table while it is tortured with no anaesthesia, which is I think a popular misconception about what nearly every experiment involves.

  41. May I just ask a question of Professor Purchase. He referred to the industrial aspect of this. I thought he was going to continue by saying "the industry is now using more in vitro genetic methods". My understanding is that just as they are now building aeroplanes without testing them in a wind tunnel, or to some extent, the use of computer modelling is also a part of that business of extending the value of any kind of animal or laboratory experiment. Is that right? Could you comment upon where that trend is leading us to?  (Professor Purchase) Yes. It is true what you say about computer modelling, and nowadays they have methods of measuring the effects of chemicals on genes, which can screen millions of samples a month. All of that provides information into the decision making for selection of novel pharmaceutical products. It turns out that when you look historically compounds are dropped from development in what is called an attrition rate; information which you obtain early on in the development of the compound turns out not to be relevant later on. There is a big attrition in going from computer models and cells in culture to animals. There is also an attrition between going from animal studies to humans and it is only finally when you get a product on the market that you actually know exactly how well it will work.

  Chairman: Lady Warnock, do you have something to ask?

  Baroness Warnock: No, I was going to go on about the question of numbers but I am sure it will come up again.

  42. Professor Banner, the Act stipulates that the committee shall have regard to (a) the effect of animal legislation on science and industry and (b) the protection of animals against avoidable suffering and unnecessary use in scientific procedures. So we have a couple of questions. How does the committee ensure that these considerations are taken into account? How do you have a balanced approach both in terms of membership and in terms of your work programme? We would be interested to hear what are the most common criticisms levelled at the committee by the science community and by the public?  (Reverend Professor Banner) If I could begin at the end, if I may, sir. The criticisms that are levelled I think are that, if I can put it bluntly, we are a bunch of vivisectors, that is how certain bodies would describe us, and we are a bunch of tree hugging anthropomorphic animal lovers by the other. We tend to get it in the neck both ways. The composition of the committee is a matter for the Home Secretary. I would say, though I can only comment it is not a view of the committee, that the effort over the past few years in increasing the membership has been an effort to ensure that there is wide representation of nearly all viewpoints, except those who regard violence as a legitimate means of advancing their ends. We have members who take the view that all vivisection should stop. We are criticised but I think all we can say is that by statute we are required to have certain members and that measures have been taken to ensure we have a very wide representation. In terms of the committee's programme of work, I can only say that they give the Chairman a very hard time. The proposal for the committee's work is a matter for the whole committee. It is a matter for debate in the committee what work we do. The Home Secretary can refer matters to us but the committee decides its own agenda for itself and I would suggest that balance in membership creates some balance in the sort of work we have undertaken. As regards the Act stipulating what the committee must have regard to, I am not a lawyer so I do not know whether we could, we certainly have not been subject to a judicial review. I think we would defend ourselves if we were subject to a judicial review in any case by saying that we had regard to, we had taken note of the requirements of science and industry in the sense of the requirement, if we considered an application to give further advice on it, or if we considered regulations, we would consider what the purpose was of this experimental work, whether it fitted with the Act, how serious it was and so on, whether there was a regulatory requirement and so on. We would be sensitive to those considerations whilst also sensitive to the considerations ensured by those around the table to the value of this work and the possibility for the purposes of the work being pursued in other ways.

  43. Can I just ask, to do with the question of industry, presumably, as you have widened your committee in some sense, has that therefore diluted the role of industrial interest in the committee or does that remain? I just want to ask whether vis a vis the remarks that you made earlier this afternoon, the role, the contribution, the influence of industry in the United Kingdom in this area is comparable with that of other countries?  (Reverend Professor Banner) I cannot comment, I am afraid, on the influence of industry in relation to this committee as opposed to the influence of industry on other animal welfare.

  44. I meant as before in terms of enlargement and so on?  (Reverend Professor Banner) Forgive me, my Lord, I think you would have to do an analysis of the composition of the committee over the years and see whether the balance has changed. We are not a committee that votes very often, not because we are like the Soviet Union or some such, in previous days in that we do not have votes or if we do have votes they are decided in advance, but rather that, as I tried to say in an answer to a question earlier, members are scrupulous in trying to consider the issues in the terms set by the Act and, therefore, it is quite common for someone to say "If I had my say this application would not go forward" or alternatively "If I had my view it would go forward but under the considerations that we are asked to bring into play it should or should not as the case may be". For example, I stress a point that may not have been clear from previous answers, it is not the case that licences are given in this country for work on great apes, there is work on primates but there is no work on great apes. There are members of the committee who would say there should be no work on primates, there are members of the committee who, I imagine, might say it would be acceptable in some circumstances to work on great apes. All members of the committee, in my experience, behave scrupulously in trying to address the considerations as they are laid down in the consideration.

  45. The Act supposes that your committee will seek to reach a balance between the adverse effects on the animals and the likely benefits of the research. Most of the questions so far have been directed about animals. On what evidence does your committee determine the likely benefits of research and in what depth do you consider them?  (Reverend Professor Banner) If I could make one preliminary comment. I should make it clear that although a good deal of interest in the committee's work relates to the few applications that we see, it is a small part of our work. What we are asking about is that particular part of our work. I would say when we consider, and if we do have an application referred to us for advice in a particular case or which we are considering in general, the terms of the applications, the application itself, the license application, will itself detail the supposed benefits or the benefits sought by the researchers in doing the experimentation. We have given further consideration to those claims through discussion and through further enquiry before giving our advice on a particular application. We have the statement made by those seeking the licences for the benefit of those they see and we may question that in the committee.

  46. What sort of statement? Are we talking about a scientific presentation or a sheet of A4?  (Reverend Professor Banner) I think it might be helpful to your Committee, my Lord, to see a licence application.  (Mr West) There is a publication, Guidance on the Operation of the Act,[4] and one of the appendices of that has got a project licence.

  (Reverend Professor Banner) The applicant will set out the benefits. If I could give an example without breaching any confidences. It may well be that in research into Parkinson's Disease, for example, there may be different views as to the methodologies of further research into its treatment and what one would do to, it might be primates or it might be rats. Applicants have come to the committee to give an account of their work at some length and its merits and have been questioned by members present, questions have been prepared in advance. The committee takes quite seriously when an application does come establishing the scientific merits and, therefore, the likelihood of benefits.

  47. I was particularly interested by the experiment which you described in the literature you sent us. It seemed to me an exceptionally crude model chemically poisoning the brain to imitate the process of Parkinson's Disease. How did you make sure that was a useful, valid model for Parkinson's Disease? There was a lot of suffering involved in the way you have described it.  (Reverend Professor Banner) I would like, if I could take the opportunity, to provide you with a detailed note in answer to that question because I cannot, I am afraid, recall the details. The committee is, in relation to any application, extremely sensitive to the claims for scientific validity and if we have reached a judgment with which reasonable people disagree, I would suspect it is a judgment many reasonable people would share.

  48. I just want to know do you find the judgments of the various ethical committees of different institutions helpful to your deliberations, both in general and in particular cases such as we are discussing?  (Reverend Professor Banner) The ethical review procedures?

  49. Yes.  (Reverend Professor Banner) We are not typically privy to those discussions. When we see an application, we would see an application fresh. Neither would we be privy to the recommendation which the Animals Scientific Procedures Inspectorate may have made nor the view of ABCU. So we look at it independently. Can I add one rider, an important qualification. Members of this committee, my Lord, will be aware that many people take the view that there are no benefits from experimentation on animals because all such work is useless, for various reasons, and as part of our consideration of the cost benefit part of the legislation we are, as a preliminary to that, trying to give consideration to the question of scientific validity since that is argued in a way which is often unhelpful, either black and white. We hope as a committee we can make a contribution to a better debate by making an extended statement on that issue.

  50. If you come to some conclusions on that before we have finished our business, it would be useful to have the results transmitted to us?  (Reverend Professor Banner) I suspect it may be vice versa, my Lord.

  Chairman: That is what I was worried about.

  51. This is to do with statistics and, indeed, touches partly on what Lord Brennan was asking. Are you happy with the statistics on animal procedures which are currently produced? Do the statistics differentiate, as licences do, between procedures involving little or no pain and procedures involving moderate to extreme pain? What statistics would you like to see produced?  (Reverend Professor Banner) I cannot offer a view of the committee. We look at the statistics year on year. We have not recently, not under my chairmanship, had a prolonged discussion as to whether there is a better format for the statistics, although we have recently made particular recommendations on particular elements. I have mentioned chiefly that we have taken the view in the report on biotechnology that is coming out that there may be some merits—though there may be some difficulty in achieving it—in removing from the statistics on procedures those animals which are being bred as genetically modified but which are not genetically modified. I have not put that terribly well and one of my colleagues might help me. If large numbers of animals are bred for the purpose of modification, all the animals that are bred will count as experimental procedures which inflates the numbers, even though the majority of those animals will be ordinary unmodified animals. So we have made a recommendation that those numbers should be still counted but excluded from the number of procedures. That is one example. The other thing I would say on the question of pain, the question prompted me obviously to look at the statistics and I am astonished to find—I am sure Members of the Committee have this copy—that the details on the percentage of procedures and therefore, by inference, the number of animals which are used in mild, moderate and substantial procedures is buried on page 96 of the statistics. I would suggest that in terms of public interest and concern, the fact that by a rough estimate something like 90 per cent of animals are used in procedures which are graded as mild and moderate is a very key consideration. It is astonishing to me, I have to say now, having been encouraged to think about it, to find that rather crucial bit of information buried in an appendix to regular statistics. I think there would be considerable merit if it could be done in ensuring that the degrees of pain and the number of animals involved in each of those categories is brought more to the fore.

  52. May I ask a question. I believe for the Falklands Campaign that what they did was they anaesthetised some pigs and gave them, in effect, battlefield wounds. They shot them.  (Reverend Professor Banner) Yes.

  53. So the surgeons could practise sewing them up.  (Reverend Professor Banner) Yes.

  54. These pigs never recovered consciousness and consequently no pain was inflicted upon them. In my view that seems to me an absolutely totally justifiable experiment. You also have the question, and again I am searching for information, let us assume what we have is a vaccination or something which may or may not work. You think it is going to work, you inject your rat and it does not work, does that count? The rat gets the disease. I may be totally scientifically ignorant on this. I think this is the sort of question the public might want to ask. How do you codify those sorts of practices? How do you look at them? I am groping in my question.  (Reverend Professor Banner) On your question, of course, my Lord, you would seek further details from this from the Scientific Procedures Inspectorate. The categories are graded. The Guidance on the Operation of the Act, which is published by the Home Office, gives the categorisation of "mild, moderate, substantial and unclassified". If a procedure involved general anaesthesia from which an animal did not recover consciousness it would be an unclassified procedure. The "mild, moderate and substantial" are characterised in this document, my Lord, and give you an indication of the level at which a procedure is classified in terms of the sort of suffering it would cause. One point to mention is that the categorisation is given at the most severe expected level so that if in an experiment it might be expected that one out of ten animals would suffer moderate rather than mild, the experiment would be categorised as moderate. In fact, the figures which suggest moderate as 50 per cent of all procedures exaggerate the number of animals which will have suffered—if it is read incautiously—the procedures identified as moderate.

  Earl of Onslow: I think I am helped. Thank you.

  Chairman: We will go to the next question. Lady Nicol.

  55. At the beginning of your paragraph 17 in your paper you say the committee have, and continues to have, confidence in the professionalism of the Inspectorate. I wonder then why you feel it is necessary to have an audit of the work of the Inspectorate? Could you at the same time say whether you are satisfied that the numbers of inspectors available are sufficient and that the way that they work is agreeable to you; in that do they, for example, do unexpected visits or is everything done ahead of time? Are they always expected where they go? Could you give a general picture of how the Inspectorate works?  (Reverend Professor Banner) Can I comment, first of all, on the question of the audit team. It relates to one very particular aspect of the Inspectorate's work which is that when allegations are made of serious malpractice or failure to observe regulations, the Home Secretary may in those circumstances establish an investigation into that allegation. In particular, last year there was an investigation into an undercover investigation and report on Harlan-Hillcrest. The committee saw the report which was produced by the Inspectorate on that case but took the view it was not in a position to comment on the merits or otherwise of the allegations and the value of the investigation, simply because it had not been privy to the process by which the investigation had been conducted. We were not suggesting that we wish to have day to day oversight, which we could not have, of the inspectors on a day to day basis. The committee's view is that the Inspectorate is a professional, highly competent body which goes about its work vigorously and in a robust manner. However, we did think that public confidence in such investigations when they occur in future would be enhanced if the so-called independent element, which we believe the Animal Procedures Committee offers, was involved in an investigation which was, in effect, into the work of the Inspectorate. In terms of the day to day operations, again I would say obviously on those matters the Home Office and Inspectorate will wish to comment. My understanding is that, yes, visits are made at random as well as arranged. Random is not the right word, surprise visits, I think is the right phrase. Non pre-arranged visits are made by the Inspectorate.

  56. Unplanned.  (Reverend Professor Banner) We have it as part of our agenda for this year to consider issues of enforcement and compliance and how adequate that is. We have a strong sense that we are in danger of finding ourselves in an area where there is an awful lot of anecdote and little hard evidence. There is one side of the committee which says there are so few prosecutions and so few inspectors that it cannot be that the system is well enforced, and there are others who say there are so few prosecutions that the system is working splendidly. To establish the truth of either of those, I suggest is a matter of some difficulty, though for myself, I am not taking a view of the committee, I would say that it is surprising that there are so few allegations of serious breaches and abuse given the number of experiments that go on in a year.

  57. Has any member of the committee or any party from the committee ever accompanied an inspector on his examination of a body and what was the result?  (Reverend Professor Banner) The committee has made visits to establishments.

  58. With the inspector?  (Reverend Professor Banner) It rather would be that the inspector comes with us on one of our visits. I have no recollection of the committee or a member of the committee accompanying an inspector but I also have no recollection of the committee asking to do that, or seeking to do it, but it may well be something to which we should give consideration.

  59. Has the number of inspectors gone down?  (Reverend Professor Banner) The number of inspectors has recently gone up, my Lord. The Minister responsible in the Home Office, Mr O'Brien, recently announced, I believe, an increase in the number of inspectors—can I turn to the Secretary to help me -  (Mr West) From 21 to 33. That has been announced.

  Lord Hunt of Chesterton: How many will there be in France, for example?