Select Committee on Animals In Scientific Procedures Minutes of Evidence

Examination of Witnesses (Questions 920-939)



  920. If you bred a mouse which had muscular dystrophy by normal methods, would you also have to go through a similar procedure?
  (Dr Matfield) It would be the same.

Earl of Onslow

  921. If you breed a mouse that is prone to muscular dystrophy or any other disease genetically, does the gene override the drugs that you are trying to cure it with? I do not understand how this works; I am not a scientist.
  (Dr Matfield) No. Because it is the same gene with the same defect, you would be looking to find the same drug effect.

  922. Can you overcome a gene defect with drugs?
  (Dr Layward) A perfect example is with a cystic fibrosis mouse whereby how one would cure that mouse is with gene therapy. That would be using the treatment to cure that mouse, adding in a healthy gene to an animal with a genetic defect.

  923. You can give a healthy gene to somebody of my age?
  (Dr Layward) Yes. One hopes that with a genetic disease such as cystic fibrosis this is the way that one is going to be able to cure the lung disease, if not the whole disease, in these people, to be able to replace or add in a healthy functioning gene to replace the defective one.

  924. Even when you are alive and kicking?
  (Dr Layward) Absolutely.

(The Chairman made his apologies and left. Baroness Eccles of Moulton was called to the Chair)

Baroness Eccles of Moulton

  925. The next question implies that we all agree that there is unnecessary bureaucracy. I assume that you would be in agreement with that. Could you suggest how this, in the present regulatory system, could be reduced without acting to the detriment of animal welfare?
  (Dr Matfield) The government has made some efforts and taken some steps which have helped with this problem. However, the single largest source of delays and bureaucracy in the licensing system is the fact that the licences require a very high level of detail. This level of detail is unique in the world, and because it writes that detail into the licence, it sets it in stone and makes it very inflexible. It is not possible to predict how any one area of science will progress over the five year life of a project licence and yet you have to write down and set in stone your research plans for that period in great detail. The more detail, the more difficult it is to respond to some sudden development. The example Professor Page gave happens all the time. Then you need to go back and apply for an amendment to your licence and your amendment request has to go through the ethical review process and the Home Office. A different approach might be if the Home Office took a different interpretation on how much detail was required and had broader, more flexible research plans and protocol in the licence and balanced that with more focus on the detail at the local level. If scientists were allowed to write more flexible project licences, and if a scientist decided he needed to do an experiment in a certain way within that flexibility, getting approval from the named animal care and welfare officer and the named veterinary surgeon at the institution would allow him to proceed with the science rapidly but, I am quite convinced, maintain the same effective standards of animal welfare.

  926. Would that increase the activities of the inspectors?
  (Dr Matfield) This would need oversight. In a system like this the only way you could have oversight of local arrangements is at a national level and that would obviously fall to the inspectorate.

  927. It would be important that the Home Office could be persuaded that, by going down this route, there was not going to be any detriment to animal welfare?
  (Professor Page) I gave an example that, because of the bureaucracy, it is often faster to send somebody abroad to do an experiment on a new genetically modified animal. One of the possible consequences of that is a detriment to animal welfare in the time it takes to introduce some welfare reforms. For example, if a colleague of mine in the United States describes tomorrow that by using a particularly better route of administration of anaesthetic, which I do not have on my project licence, I would have to go through all the bureaucracy but it would improve the welfare of the animals in this country. It is not just the science; it is welfare aspects as well.

Lord Taverne

  928. Are there examples you can give of waste of animals caused by the present bureaucracy?
  (Dr Matfield) There are examples I have come across with transgenic animals where, if there is a delay in getting the approval and the work then gets done elsewhere, of course it becomes redundant to do the research. The animals that have been brought in then have to be killed.
  (Professor Page) They would nonetheless be recorded as experiments.

Earl of Onslow

  929. I was looking at the International Comparison of Animal Experimental Regulations and the United Kingdom is either "yes" or "ban"[1]. Japan is either "no" or permitted to everything. Is there anything on that list which you have seen that you would like relaxed, which would have only a bureaucratically easing effect as opposed to any influence on animal welfare, assuming that you all think that animal welfare is of paramount importance?

  (Dr Matfield) I do not think one could strike off anything on that list in its entirety. There have been concerns about the way that some of those components are used to do their functions. For example, the ethical review process, it is generally well accepted now, has had many positive benefits at the local level, increasing the involvement of vets and animal care technicians in planning projects and so forth. However, when you are dealing with a research project where the science has been peer-reviewed by the Wellcome Trust, the Medical Research Council or any of the major charities, where scientific experts have pored over it, one questions whether it is necessary for the ethical review process to duplicate the same review of the science. Perhaps if the same amount of effort were directed into three Rs activities on the ground in the facility it would be far more effective in improving animal welfare. I think there are ways in which effort could be refocused within some of this to improve animal welfare further and allow a streamlining of the regulatory process.

  930. I was looking at this in your submission: "Personal licences are required in the United Kingdom but nowhere else. Training is required in the United Kingdom but nowhere else. Specific species are required in the United Kingdom but nowhere else." I hope I am trying to make a serious point.
  (Professor Page) Maybe, just related to that, because I think it is an important area, where bureaucracy affects me as a working scientist is if I want to bring over to my laboratory a senior scientist from overseas. At the moment he would have to go through this training and bureaucracy which means that it delays me actually being able to do the experiments or learning a technique or gaining experience from him until he has gone through that process. Since the training programmes are not found frequently in every university you have to wait until the next one comes along. It is often embarrassing to tell colleagues who are senior to you that they have to go back and go through our training procedures. It is clear that they have to understand the law and how we operate in this country but I think it actually makes it very difficult to get people to come here very often. You have to put a lot of planning into it and the spontaneity of allowing research to change direction in the light of recent findings disappears out the window.

Baroness Eccles of Moulton

  931. Can you suggest how safely that could be avoided?
  (Professor Page) With senior scientists I think we have to allow some alternative system so they do not have to go through all the modules. There has been some attempt to do that but we need some system of flexibility whereby if they are recognised as being reputable scientists who have published in peer review journals then we can perhaps write a letter saying these people are reputable and they do not have to go through that process.

Baroness Eccles of Moulton: Maybe you could put something very succinct of that nature in writing to the clerk because I think that could be very useful.

Lord Hunt of Chesterton

  932. In your discussion and in the evidence we have had from GlaxoSmithKline it seems to me partly a question of the innate procedure but also simply the speed with which things happen. If this thing was run by UPS, you could ring somebody up and it will all be on a screen; even with the existing procedures then it could go a lot faster—we had some discussion about computer systems and so on. Is there any glimmer of light in that respect, if everything was run like clockwork—to use an old-fashioned unsatisfactory method of working? What percentage of delay is because the system is not working efficiently and what percentage of it because of the innate nature of the system?
  (Dr Matfield) I think the acknowledgement I have made that the Home Office have started improving the system covers much of this. For example, one of the concerns the scientific community had was that the Home Office were quoting rather long lead times to get information technology systems up to scratch to do the licensing process on computers so you could submit electronic applications, which are becoming the norm among academics. I think it is fair to say that they have responded to this and secured separate funding for the development of a specific Home Office licensing IT system. When that comes in I am sure that it will speed up the process enormously and you will no longer have to wait for files to be moved around physically and the post to move things: you could send an application by e-mail and it would be there in front of the inspector in minutes.

Lord Taverne

  933. Is that the reason why applications take so much longer to be processed in the UK than in Germany or particularly the United States, as we have heard and as Professor Purchase's figures showed us. You mentioned that if you had a broader, more flexible research plan in an application for a licence you would have to have fewer amendments but the application itself seems to take an inordinately long time. Are there any other reasons, apart from lack of technology, why our applications take so long?
  (Dr Matfield) Yes, indeed. I think there are two principal ones. One is the level of detail. The more information you put into an application, the more there is to be justified, to be negotiated, to be checked by the inspector and so forth. There is simply more work to do in the licensing. Second is the complexity of the process. I think that we should be aware that throughout the world when countries were deciding how to regulate animal experimentation they either went for a system based on the government checking what scientists were doing or local self-regulation by committees checking what scientists were doing. Britain is the only country which has both at the same time working one after the other. It is a much more complicated system.

Baroness Eccles of Moulton

  934. I think we had better move on to the next question. I do not think we can spend very much time debating the membership of ERPs but if you would like to say a very quick response to the inclusion of an external lay member or a statistician. More importantly, the role of the ERPs to make minor amendments—that probably follows on from the point you were making earlier.
  (Dr Matfield) Thank you. In principle we certainly support the idea of lay membership of ERPs. Your question uses the term "be obliged to include" and that is where I have a slight reservation. I can easily see a situation where an institution might not find it easy to recruit a lay member or the lay member might resign, perhaps because their job has moved somewhere else. If one is obliged to have a lay member presumably the ERP can no longer function at that point and no licences can go through. I think this is a case for encouragement rather than obligation and that is certainly something we are fully behind. Our principle, as an organisation, is to make the public more aware about how animal experimentation is done and including lay members on ERPs is a very good way of doing that. Our view on the need for relevant statistical knowledge on ERPs is exactly the same, we think it is crucially important. Whether that has to be through someone who has a badge saying "I am a statistician", or through someone who is a biological scientist or an evolutionary biologist who is expert on the application of statistics to research, I think one needs to find what fits best in each institution.

Baroness Nicol

  935. I wonder if any of the witnesses could give us a brief description of how they would define "lay member". It has caused some difficulty in the past.
  (Dr Layward) May I make a comment on this. Many of the medical charities have quite a lot of experience of having lay members on committees and on scientific committees, particularly during the peer review process. Initially this has been viewed, I consider, with a certain amount of concern by the professionals who are on these committees but having somebody who has no knowledge of science or no knowledge of whatever the committee is about is actually proving to be extremely beneficial. We have certainly found it incredibly useful to have lay members as part of our peer review process. They are not obviously going to be able to comment upon the science and the detail but there is a great deal of commonsense that is involved in all of these processes. I would define a lay person as somebody who does not have expertise in the workings of that particular committee, is not a professional in that particular area.

Baroness Eccles of Moulton

  936. That is very helpful, thank you. Could you comment now on the amendments part of the question?
  (Dr Matfield) I think that is almost precisely what I was calling for. One of the concerns I have about Ethical Review Processes is that, in most institutions they tend to act as a committee and they have to have a meeting. The point has been made by the Chief Inspector of the Home Office, not just by us, that this is a process and it is quite important that particular people in it, and I would suggest the named vet and named animal care and welfare officer specifically, are involved at an early stage in project drafting when people start to think of what sort of research they want to do. I think it is far more important that they are involved at that point than a committee sitting in judgment on the finished application because it is at the early stage that the animal welfare improvements happen best.

Baroness Warnock

  937. I am not really clear what the purpose of the ERPs is supposed to be. Would it be possible to adapt them in such a way that they fulfilled your criterion, namely that there was no duplication between the work of the people who originally look at the project and the local people who may be able to deal with minor adjustments, minor additions? I can see the great advantage of eliminating this duplication that now happens first at central and then at local level. I suppose they could still be called ERPs but they might fulfil a rather different function from what they do now if your shift of balance to the local from the central were to be satisfied.
  (Dr Matfield) Indeed, I think that is exactly the way that I would foresee them being able to function far more efficiently and, I would suggest, perhaps more effectively too. As we have discussed already, oversight would be needed, particularly to ensure regulatory compliance. I suspect that it is really a problem that was created in part by the Home Office and in part by the way the Home Office's advice about setting up Ethical Review Processes was interpreted. There was a tendency in the original advice from the Home Office on how these processes should function to put in every possible benefit as a function they were there to fulfil, so it was a bit "kitchen sink" in its approach. In interpreting this, people in institutions wanted to get the nuts and bolts right and put knobs on as well. There was a tendency to make them more complex than they needed to be in some cases. I think what one needs to do is go back and say "How do we reinvent this process?", not tinker with it a bit but reinvent it from the ground up with new objectives of efficiency and effectiveness.

Baroness Eccles of Moulton

  938. So if we go back to the drawing board with the application and granting of licences, the over-bureaucratic aspects there, and also build into that maybe an altered function for ERPs you could, as it were, kill two birds with one stone?
  (Dr Matfield) Indeed. As I said, there is no doubt that the ERPs are doing a great deal of good but I suspect they are not doing that good as efficiently as they could be.

Lord Taverne

  939. The Association of Medical Research Charities have not said very much on the whole question of delays but do I take it that you very much endorse the remarks of the Research Defence Society representatives?
  (Dr Layward) Very much so. We have many of our researchers coming to us telling us that they are having problems being able to complete or even start work that we wish to have done, and have funded, because of delays.

Baroness Eccles of Moulton

1   See Annex 2 to the written memorandum submitted by the Research Defence Society. Back

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