Genomic Medicine - Science and Technology Committee Contents

Examination of Witnesses (Questions 40 - 58)


Dr Colin Miles, Professor Veronica van Heyningen FRS, Professor Joyce Tait, Professor John Dupré and Dr Declan Mulkeen

  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 moment—we will probably move on to this—about 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 right?

  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 half years.

  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 exactly—particularly 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 system—which 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.

  Q48  Chairman: 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 issues—and Dr Mulkeen mentioned this—about 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: Especially even!

  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.

  Q50  Chairman: 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.

  Q51  Chairman: Do you know how we compare with other countries?

  Professor van Heyningen: No, I do not know.

  Q52  Chairman: 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.

  Q53  Chairman: 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.

  Q54  Chairman: But that is not leading, though, that is just punching above your weight!

  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 support.

  Q55  Chairman: 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 strong leadership.

  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 approaches—perhaps 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.

  Q56  Chairman: 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.

  Q57  Chairman: 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.

  Q58  Chairman: 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.

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