Examination of Witnesses (Questions 40
WEDNESDAY 30 APRIL 2008
Dr Colin Miles, Professor Veronica van Heyningen
FRS, Professor Joyce Tait, Professor John Dupré and Dr
Q40 Lord Sutherland of Houndwood:
Clearly, knowledge carries responsibility. You know you have responsibilities,
what you do with that power. I want to move on to the electronic
storage of medical information and clearly for genomic studies
that has a very important potential. I do not want to ask you
at the momentwe will probably move on to thisabout
the ethical and legal issues because these are clearly very important,
but just to start with the technicalities. How this information
is recorded and how it is made available will clearly have a big
impact on your capacity to do the kind of research and answer
the questions you want. I just wondered where, if at all, are
discussions taking place between the research community, whether
it is RCUK, and, say, the NHS or the Department of Health on this,
because clearly there is a common interest in getting the interface
Dr Mulkeen: I was explaining the OSCHR programme
of work around e-health. Part of that, which will move us forward
quite a lot, is that we are starting with a map. Quite a lot has
been invested in technology, the development of skills in this
area. For example, there was a Cross-Research Council e-Science
initiative three or four years ago that EPSRC, BBSRC and MRC have
participated in. What we need to do is map that, map other initiatives
that have happened in individual centres of excellence and start
to identify gaps, best practice and future investment needs.
Q41 Lord Sutherland of Houndwood:
But it is not just the centres of excellence. When I see my GP
tapping away when I talk it makes me think, "What am I saying
to him?" But at that level they are all recording information
and is anything being done to ensure that that is user-friendly?
Professor Tait: I do not know enough about this.
Dr Mulkeen: Within Connecting for Health that
data says a lot has been done but, as I mentioned earlier, as
you move down to some of the smaller scale activities we need
to think not just about the IT system but about the time and expert
input needed to curate these well so that when you see a series
of test results in ten years' time you know what the test was,
not just the results.
Professor Tait: There is another initiative,
the UK Clinical Research Collaboration, where the ESRC, MRC and
the Department of Health are collaborating with, among other things,
the aim of making sure that this kind of question is addressed
across these institutions.
Q42 Lord Sutherland of Houndwood:
Is it having beneficial results, this collaboration?
Professor Tait: I am not sure if there are any
beneficial outcomes yet. It has been going for about two and a
Q43 Lord Sutherland of Houndwood:
By "results" I do not mean cures, I mean that actually
people are doing the right thing?
Professor Tait: I think people are beginning
to do the right thing. I am not sure there are any concrete outcomes.
Dr Mulkeen: The National Cancer Research Institute
got off the starting blocks a couple of years before the UKCRC
and in its focused area of cancer it is seeing real benefits in
the way data is curated and shared in particular. Sharing, of
course, does raise some ethical issues as well as practical information.
Lord Sutherland of Houndwood: Indeed,
yes. Thank you.
Q44 Baroness Perry of Southwark:
In the RCUK's submission we were told that one of their concerns
is that the rate of change in scientific areas of research is
going to far outpace the governance, legal and ethical-related
research. Can you tell us how academic, legal and social science
research feeds into policy making? You yourselves have said how
important it is to have these areas still funded generously. The
ESRC and AHRC I am sure have a view on this. How does it happen
at the moment? How does it feed into policy?
Professor Tait: It is feeding into policy partly
because we are very strongly encouraged and motivated by various
performance measures from ESRC to do just that, so it is very
much in our interests to do that, but we are also a fairly pragmatic
research group that wants to see the outcomes of our research
applied in practice. So we have been contributing the outputs
of our research on the interactions between innovation and regulation
and the impact of regulation on slowing down the innovation process
and completely structuring the commercial sector in a way which
is sometimes counter-functional. We have been feeding that into,
for example, the OECD. We have done one or two reports for them.
We are talking tomorrow to three of the major multinational companies
in the UK about how we can get this kind of question addressed
as to how would you effect change within the regulatory system
that might be constructive.
Professor Dupré: As Professor Tait just
mentioned, it is something we are very strongly urged and motivated
to do, and quite rightly, but there is a problem in some of the
kind of work we do in that it is just exceedingly difficult to
measure these kinds of impacts. It is easy enough to talk to people,
just as we are talking here, but demonstrating exactlyparticularly
I am representing here the work I am doing for AHRC, which is
analysis of the development of the science. I think there are
many ways in which that filters down and I have interaction with
colleagues at BBSRC which I hope is productive and I hope eventually
that has policy relevance and economic impacts in terms of possibly
benefiting that work, but to trace that down and see exactly what
difference it makes is very difficult. So I think there are real
problems in answering this kind of question, but we spend a lot
of time thinking about it.
Q45 Baroness Perry of Southwark:
Is there a project anywhere which is looking at the kind of regulatory
mechanisms that would work in the future or would be desirable
in the future?
Professor Tait: I think on what would work and
what would be desirable, one of our conclusions from earlier research
about six years ago was that carrots work better than sticks,
incentives work better than disincentives, so you will get change
in industry behaviour much more quickly if you give them incentives
to do something desirable rather than a disincentive to do something
undesirable. The other key factor in this was that if you have
a blanket regulatory approach which applied equally across all
products regardless of the properties of those products, that
is much less beneficial than one which discriminates among products
on the basis of their properties. You see that in drug development
where fast tracks have been developed for drugs with particularly
publicly desirable properties. The Orphan Drug Act is another
example of that operating very effectively, but what we would
say is that all of that makes it easier for multinational companies
to develop the kinds of products which the public wants to see
coming out of the multinational companies. It does not yet free
up the regulatory system in a way which allow a small company
to take a product all the way through to market and would allow
the much more innovative lifestyle sector more in comparison with
information and communication technology. If you look at the difference
over the last 50 years in the various revolutions, the technology
revolutions which have happened in information technology, and
compare that with the initial promise of the life sciences and
the really rather modest outcomes that have happened as a result
of all this public investment, our conclusion is that it is the
very onerous, long-term and expensive regulatory systemwhich
means that only a big multinational company can afford to develop
the technology, which means that their strategies can rule the
roost and any small company which has got an alternative way of
doing something or something that would maybe undermine the pharmaceutical
industry market has very little chance of taking an innovative
product through to market. I think the key to changing that is
a much more fundamental revision of the regulatory system, and
that is what we would like to talk about.
Q46 Baroness Perry of Southwark:
Are you quoting from a specific study which was done?
Professor Tait: It is a whole series of studies
we have done, talking to small companies about how innovation
takes place, what their aspirations are and what they would really
like to do. We have been doing that with agrochemical companies,
then biotech companies and now pharmaceutical companies. You talk
to small companies and their aspiration is to be bought up by
a multinational at the end of the day. That is what they are aiming
for. They are not aiming to grow big themselves, and it is a big
problem in the life sciences.
Q47 Baroness Perry of Southwark:
I think we would find it very helpful if you could point us to
some references to that.
Professor Tait: There is in the Research Councils
UK submission a list of references, yes.
You have several references. Can I go to this issue: there are
obviously possible beneficial and detrimental impacts of genetic
tests and yes, the Research Councils' business is to promote science
research and not maybe go in that direction, but clearly when
Lady Perry referred earlier on about genetics for common diseases,
particularly those with low penetration you, Professor van Heyningen,
answered by saying that that is going to create problems. But
there are other issuesand Dr Mulkeen mentioned thisabout
who explains about the validity of these tests and who should
have the knowledge about them, and that leads on to education
and therefore those professional organisations responsible for
education, such as colleges. So who interacts with them? Who says,
"At what stage do we need people who are trained to give
information in a way the general public may understand about the
relevance and the implications of genetic tests"?
Professor van Heyningen: There is an NHS National
Genetics Education and Development centre in Birmingham and they
train not clinicians but people who are involved in other aspects
of medicine, and they have a series of programmes for that. I
think there is quite a gap, or at least I do not know the details
of how clinicians these days are being educated in aspects of
modern genetics because now it is not going to be geneticists
and clinical geneticists who are going to be giving out information
in the very near future but general physicians, and surgeons even.
Chairman: Even, yes!
Q49 Lord Sutherland of Houndwood:
Professor van Heyningen: I do not know whether
there is good training for them. As you know, there is a great
deal of discussion about medical training in general, but I think
some of this could be developed. Some of the curriculum aspects
could be developed much more centrally to make sure that they
all get a good basic education in their own medical schools or
go centrally for some courses.
Does it need to be medical people? Does it need to be someone
who is also medically trained?
Professor van Heyningen: As I say, there are
non-clinical people who are already getting some education, and
that should probably be expanded.
Do you know how we compare with other countries?
Professor van Heyningen: No, I do not know.
We are told in the evidence and also in the seminar we had that
genomics, and therefore its implication on medicine, and therefore
genomic medicine (in the wider definition that you use), is going
to impact a lot upon the population, the way we assess risks about
their health, the way healthcare is delivered and the systems
of delivery of that healthcare, and that we need to think ahead
and have the systems in place, or at least some thinking as to
what systems we require. We also need to do some thinking about
what regulatory mechanism we are going to require to be able to
test for these genetic tests and develop treatment for these genetically-based
diseases, what ethical issues it throws up and what legal issues
it throws up, and that we need to be ahead of this game and be
leaders because that would have a wider impact on the population
and society but also on economics?
Professor van Heyningen: Yes.
Are we leaders, and if we are not where are the blocks?
Professor van Heyningen: I think Britain does
punch perhaps above its population size in terms of contribution.
But that is not leading, though, that is just punching above your
Professor van Heyningen: Well, that is one measure
of leading, is it not? I think British science has contributed
a lot to many of the advances we have seen so far and I think
it is still at the forefront, but it does need a lot of further
All right. What about this translation into healthcare and healthcare
systems and are there regulatory and ethical issues to be addressed
that we are not addressing, are there legal issues to be addressed?
Professor Tait: I think we are leading in the
joining up of all these different questions and not treating them
as separate entities. I think we do have a very strong leadership
role there. I am not asking for more money. I think the big investment
which has already been made through the Economic and Social Research
Council has been a large part of enabling that joining up to happen.
I think there is still a task to be done in the creation of intelligent
customers for the products from the science out there in the Health
Service. I am not sure that that is going to be quite as easy
as we imagine. I think there are going to be a lot of entrenched
ideas that will persist for quite a long time in the community
of applying the healthcare. We are close to being leaders. I think
there is an equally strong leadership position developing in the
Netherlands and I think maybe some Scandinavian countries are
maybe even ahead of us in Europe. I really do not know how we
compare with America. I think America is a rather diffuse body.
Maybe Canada. Yes, Canada is an area where I think there is also
Professor Dupré: I would agree entirely
with that and I would have thought, in terms of being joined-up,
that we were still quite well ahead of North America. This really
is a very important issue and given how rapidly the science is
developing and how rapidly it is throwing up social issues, legal
issues, ethical issues and philosophical issues the amount of
connection between the different approachesperhaps I am
an optimist, but I would say we were slightly ahead even of the
small Northern European countries you mentioned, but really I
think we are leaders in that regard.
Professor Tait: Yes.
Professor Dupré: And obviously that would
be pointless if we did not have some excellent medical and biological
research going on too.
Listening to you, we have now joined up with all these issues
and we are addressing them together, so if I were to ask you what
one strong recommendation you would like to see in our report
what would that be?
Professor Tait: I would vote for a really creative
look at the regulatory system and how it could be moderated and
diverted, changed in a way which would actually open up the whole
genomic healthcare area to more creative use of the science that
we are actually developing.
Who would you think should be responsible for that?
Professor Tait: I think it should be a collaboration.
I think it should involve heavily the regulators and industry,
all sizes of companies, and I think there is a role for academics
who have been studying these problems. I think it also has to
be international. You cannot do this at the UK level, it has to
be at least at the European level, and at the moment I think actually
the food and drugs administration in America is ahead of the EMEA
in thinking creatively about this, so it would be nice to bring
them in, too.
You are allowed to dissent from that, so does anybody dissent
from that and would have another recommendation?
Dr Mulkeen: Can I dissent slightly, not in an
opposite direction? As well as addressing regulation, I think
the culture for innovation and the environment for innovation
in healthcare and communications about healthcare is important
as the positive side as well as stopping the undesirable, and
as the pace of research picks up over the next decade I think
we will need to see a more proactive and strategic approach to
innovation and prioritisation of that innovation in health systems.
Chairman: Thank you very much. Thank
you all. You have been most helpful. This is our first session
and we have learned a lot and no doubt we will pursue some of
the things you have brought out when we take other evidence. Can
I say to you that if you have further thoughts which you would
like to send to us, that will be most welcome and that will also
form part of our evidence and therefore will be published, but
I encourage you, if you have any further evidence, to please let
us have it. The document you have, Dr Miles, we will take and
also regard it as further evidence. So thank you again, all of
you, for coming. We appreciate it very much.