Examination of Witnesses (Questions 920-939)
DR SIMON
FESTING, DR
LORNA LAYWARD,
DR MARK
MATFIELD AND
PROFESSOR CLIVE
PAGE
TUESDAY 15 JANUARY 2002
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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