Select Committee on Health Minutes of Evidence

Examination of witnesses (Questions 40 - 59)



  40. Continuing my colleague's line of questioning, Howard Stoate asked about the take up of advice and knowledge. Do you think that issues about requirements for doctors to re-train, keep up to date, be appraised, might have some bearing on their willingness to take seriously the advice such as it is?
  (Professor Sir Michael Rawlins) There is a lot of discussion, as you are aware, about re-accreditation and one of the criteria that is being contemplated is audit and whether people can demonstrate that they have robust audit in place.
  (Dr Radford) This is also answering Dr Stoate's issue as well. NICE's role is but one piece of the jigsaw in terms of the whole quality agenda, and you cannot expect just one piece of the jigsaw to give you the whole picture. So continuing professional development, self-regulation, performance assessments, looking at comparative data through indicators, et cetera, are all part of this jigsaw to really see whether the standards which are being set by NICE and through the national service frameworks are being delivered on the ground, and then a feed-back loop as to, if not, why not, are there some issues where guidelines are not necessarily user friendly, there are gaps in the knowledge, there are other issues which need to be considered. So NICE by itself cannot do everything, it is part of this overall jigsaw which, as you rightly say, professional self-regulation, continuing professional development are also parts of, to produce this overall improvement in the quality of the care for patients.

  41. Would you see part of your role as impinging on this in a way, inasmuch as there are procedures, for instance, which would be very clinically effective and cost effective if done properly, but it is easy not to do them properly. I have in mind a specific example of what became known colloquially as keyhole surgery. It is not the keyhole surgery which is the problem, it is the —
  (Professor Sir Michael Rawlins) — it is the keyhole surgeons.

  42. — practitioners. Exactly. When things like this come within your orbit, will you feel it is proper for you to make that sort of caveat, that sort of reservation or recommendation?
  (Professor Sir Michael Rawlins) I think at some stage NICE and the Department would obviously engage in discussions with the College of Surgeons and so on about how to carry these new things through, particularly ones which require a lot of operator skill and learning. I am not sure how we would resolve them but I do not think there would be in principle any difficulties. We would undoubtedly say that laparoscopic cholecystectomy is effective if done in the hands of skilled operators, and then perhaps the College of Surgeons would work out what constitutes a skilled operator and how much training is needed.

Mr Gunnell

  43. To go back to Howard's issue, first of all, if one looks at the questions which we get in health questions in Parliament, one of the ones which is frequently raised, which is I think covered by this area, is the issue of Beta Interferon for Multiple Sclerosis. It would seem to me, if I understand the problem correctly, that there are some patients with Multiple Sclerosis who can benefit from this, but there are many others who cannot, therefore it is not sensible that we have got some health authorities where the treatment is available across the board and other health authorities where it is impossible to get it. I would expect that NICE would be able to put forward guidelines as to the type of patients who experience shows has benefited from this, and then I wonder if you put forward such guidelines-I do not know how clearly a line can be drawn-as to the sort of sufferers who would benefit from this, would you be able to suggest that health authorities ought to fund those particular patients as opposed to either funding the lot or funding none?
  (Professor Sir Michael Rawlins) You have put it, if I may say so, very well, that is exactly the sort of thing we would do. We would try and assess those patients who are most likely to benefit and who achieve the greatest benefit in a priority list. Sometimes it might be important to actually persuade the manufacturer or the NHS R&D to look into further whether one can predict which patients are going to respond and which patients are not going to respond. So I think there will be a continual feed-back between producing priorities and encouraging further research.

  44. So you would expect, for instance, that is one of the issues you will look at fairly early on?
  (Professor Sir Michael Rawlins) I would be very surprised if it was not.

  45. Would you have to go through the process of getting the Department to agree if you could identify that group of patients whom you felt were most likely to be helped by the treatment? Would you be able to get the Department to have some mechanisms whereby health authorities were not able simply to say, "We cannot afford this"?
  (Professor Sir Michael Rawlins) Yes, very much so. We would tell the Department it might cost them £10, £20 million a year, and that resources would need to be found. If the Department accepted that, then it is implicit that the resources would be found. Have I said the wrong thing, Dr Radford?
  (Dr Radford) No.

  46. I am interested that you had to check that. If you were able to come to some clear guidelines so you could advise health authorities and know whether the treatment would be funded or not, what sort of ruling would you be able to have over the private sector and the independent sector? Because a person could say, "I cannot get this through the public sector because it is obviously not thought to be particularly beneficial for me ...", though they might not take it that far, "... I will just go to the private sector and get it." What jurisdiction would you have over that?
  (Professor Sir Michael Rawlins) NICE quite clearly does not have any jurisdiction over the private sector, nevertheless the private sector has indicated very clearly, at least the private sector limited by the private health insurance agencies, they would wish wherever possible to adopt the NICE guidelines and NICE appraisals. Nevertheless, individuals might still wish outwith health insurance to purchase Beta Interferon or something and it is a licensed product on the market and that would be their privilege to do so.

  47. So then it would be a position of advice rather than instruction, if you like?
  (Professor Sir Michael Rawlins) Absolutely. I might add that private insurance companies are not very keen on providing Beta Interferon.

  48. I am sure they are not. I wonder if you could look at another aspect that sometimes occurs within the private sector? Are they not sometimes advertising or suggesting that certain treatments which might be relatively expensive are likely to be effective whereas they are not? Can you give negative guidance for the private sector?
  (Professor Sir Michael Rawlins) That would be difficult but there are other mechanisms for handling those sort of issues. If they are claiming that a pharmaceutical product is effective when it is not, then the Medicines Control Agency have an army of enforcement officers who will jump down their throats. So there are other mechanisms which can get rid of most of those. Dr Radford may be more familiar with this type of problem.
  (Dr Radford) Clearly NICE has been established to provide guidance to the NHS about the services provided in the NHS. As Professor Rawlins has said, if the private sector wish to consider that in terms of the way it practises, fine, but we have to be quite clear what NICE's role is, and it is not within the private sector directly or specifically.

Mr Lewis

  49. I want to talk about the structure of the organisation and therefore I suppose how accountable, transparent its decision-making processes will be. I think the word "independent" also comes to mind in the discussions we have just begun to have. First of all, how will the members of the Board and the Partners' Council be appointed and what will their respective roles be?
  (Professor Sir Michael Rawlins) It is envisaged in the Establishment Order that there will be seven non-executives and four executives. The seven non-executives would be appointed by the Secretary of State, the chief executive would be appointed by the Secretary of State, the other executives would be appointed by the NICE Board. The Partners' Council again would be appointed by the Secretary of State, and in fact already a large number of letters have gone out to various organisations proposing individuals, so those names will come up from a wide range of organisations concerned with health care, not just doctors, nurses but other organisations too which have an interest in health care.

  50. How do you see that relationship between the Board and the Partners' Council and how serious will the relationship be or will it be a tokenistic one?
  (Professor Sir Michael Rawlins) I very much intend it should not be tokenistic. It should not be like an annual shareholders' meeting once a year. I think the Establishment Order does propose that it should meet once a year to receive the annual report. If that is all it does, to be honest with you I think it needs to be more than that because it could be very, very useful and very important. Not only do I hope that it will comment on what NICE has done in the past but also I hope it will comment on future plans. I very much hope that it will be a sounding board for ideas that have not fully crystallised. I very much hope that individuals in it will be engaged in NICE and help us on individual issues, for example like the patient associations that Mrs Wise was talking about earlier. I think there is a big role for the Partners' Council. I think the constructive criticism from the Council to NICE is also very important too. I expect a dialogue, I expect it to meet more often than once a year and I expect it to do much more in reality than merely review our annual report.


  51. You are due to come into effect this spring, how soon do you anticipate you can really get into your remit and what are the early issues that you feel you will be addressing?
  (Professor Sir Michael Rawlins) We will come into being on 1 April and I would hope that some of our early outputs would materialise between four to six months. It will take that amount of time. We have no premises, we have no bank account. We need to create some sort of infrastructure to support it. That will all come into being on 1 April. The advertisements for the non-executive directors have already been placed in the press and there was a massive response. There were over 2,500 interests and there have been over 500 applications. The advertisement for the chief executive has also been placed in the press and there have been hundreds of telephone calls and letters of interest but I think it is a bit early to know how many applications.
  (Dr Riley) It is certainly heading towards three figures.
  (Professor Sir Michael Rawlins) We are getting on with the process but it will take time. I hope you will accept that I cannot do miracles.

  52. You must have in your own mind some early agenda other than setting up the fabric of the organisation.
  (Professor Sir Michael Rawlins) Quite clearly we need to get on with the appraisal process particularly of the most urgent things with the Department and we need to start producing the guidelines. In a way the most important thing is for us to gain the confidence of the professions, of the public, of Parliament, of ministers, of the Department as a whole. If we can do that and do that early on then I think that is the most important thing to do. We will do that by the quality of the technical scientific work we do, by being transparent in so far as is humanly possible and in making sure that we can consult and disseminate the output as widely as possible.

Julia Drown

  53. Can I just go back to the appointments. I noticed in the consultation paper where you are talking about the appraisal group, that one of the things you are asking for views on is whether the members of the appraisal group should be kept anonymous to protect the integrity of the group. That would rather go against the goals of openness and transparency that you talked about earlier. Could you just say a bit more about why you think it might be justified to keep the members of the appraisal group anonymous?
  (Professor Sir Michael Rawlins) I think there are two sides to it. On the one hand, if they are known then they might get all sorts of people ringing them up and contacting them morning, noon and night. I think that is perhaps one reason why it has been put that way. On the other hand, I am a member of the Committee on Safety of Medicines and only once have I ever been contacted by a member of the public and it happened many years ago. That was once in 20 years. I do not think that this is too much of an issue. I think it is for consultation and discussion.

Mr Austin

  54. Both the pharmaceutical industries and the health care industries have given a cautious welcome to NICE. I would be interested to know what discussions you are having with them about some of their reservations and how you are going to prevent NICE from becoming a bureaucratic barrier to patients benefiting from new medicines and new technologies?
  (Professor Sir Michael Rawlins) There are several points here. First of all, I very much hope that we do not become a bureaucratic barrier otherwise we would impede patients benefiting from new developments. I think by the process that Dr Radford described earlier, horizon scanning and starting the process well in advance of a new intervention being launched should assist that enormously. It is very important for the Institute to develop good relations with the pharmaceutical industry. I say this very genuinely and I have said it to them in person. First of all, they are the people who invent new technologies, academics like myself do not for practical purposes. Not only that but they are extremely good at developing them. As someone who has sat on the CSM for 20 years I know that pharmaceutical companies can deliver effective clinical trials much, much more effectively and rapidly and rigorously than academics can. In the CSM my heart always used to sink when it was a new drug that had been developed by an academic body, usually in the United States, who made a complete mess of the whole thing and you never knew where you were. We need to make sure that that expertise in the industry is harnessed together with the sorts of research questions that NICE will want for the future and at present. We will need to engage the industry in how to ensure that we can be reasonably satisfied that new interventions are both clinically effective and cost-effective. Industry does not really object to that, it realises that it cannot just assume a market and income without having to demonstrate that you are getting value for money. We also need to join in with industry in the further research that may be necessary, or at least the R&D but proposed by NICE, in order to ensure that the maximum benefits are gained.

  55. Can I pursue that because Howard Stoate earlier asked the question as to whether it is possible to make truly evidence based decisions at the time of launch. You are now talking about cost-effectiveness. One of the issues that the pharmaceutical industry have said is that the introduction of cost-effectiveness trials is inevitably going to lead to an increase in the cost of the drug. They have also pointed out the difficulty in the licensing arrangements where they have to show the safety and the efficacy of the drug compared with other things that are on the market for treating that condition. If you are then going to require evidence about cost-effectiveness how easy is it to do that based on clinical trials rather than on the naturalistic use of the product?
  (Professor Sir Michael Rawlins) You can get a lot of information from clinical trials, particularly if economic appraisal is taken at the same time and particularly if you develop quality of life measures. You may have to resort to some sort of modelling and that actually is remarkably effective. As you know, doctors have been treating high blood pressure for 35/40/45 years and all we knew for many years was that it just lowered the blood pressure and we assumed that was a good thing. It was not until the 1970s, 20 years ago, that we had real good evidence not only that the lowering of blood pressure with drugs was actually lowering blood pressure but also preventing myocardial infarction and stroke and so on. You can actually model that, you can see what happens if you lower blood pressure, what is likely to be the clinical outcome and for a time one may have to do that and one's cost-effectiveness when you are using a surrogate marker may have to be based on modelling of what you know of what happens because, as you say, it could take many years. In the case of hypertension it took 20 years before you knew you were getting real clinical benefit in terms of reduction of myocardial infarction and stroke.

  56. It is only at the end of the day by the use of medicines?
  (Professor Sir Michael Rawlins) Years and years out, yes.

  57. One of the points that one of the pharmaceutical companies has made in the evidence that I would like your comment on is: "It is not possible to undertake Naturalistic Studies prior to launch and indeed clinical trials cannot easily be used or changed to generate naturalistic clinical data pre-launch." They go on to say: "Ethics Committees regard Naturalistic Trials on individual products as unethical." Do you see a problem there?
  (Professor Sir Michael Rawlins) No, I would not really accept that. I do not think they are talking about naturalistic trials, I think they are talking about giving it to some people and seeing what happens to them. That is not the same thing at all and you do not actually get decent, good economic evaluation out of that, you have to do it in the context of one group receiving one treatment and another group receiving another treatment and random allocations to them. Otherwise, you really do not know where you are, it just does not work like that.

  58. Can I then turn away from medicines to devices and other technologies? One of the points which the Association of British Health Care Industries has made is that the appraisal process does not recognise the full complexity of introducing health technologies. What they said in their evidence is "it is not until users have had experience of a new technology, and seen how others have been able to use it, that best practice can be developed: this process may take some years before the ultimate benefits are realised."
  (Professor Sir Michael Rawlins) Yes, we recognise there is a particular problem with devices often made by relatively small sponsors, manufacturers, and of course the regulation of devices is not quite the same as it is of medicines and it is really safety which is being looked for. Nevertheless, I think that it is not unreasonable for the National Health Service to expect some sort of return in terms of benefit on its investment when it purchases devices, and if a device seems like a good idea then that is the moment perhaps when the NHS engages through its R&D programme with the sponsor to try and evaluate whether it really is of benefit or not. So there is a special problem with devices and I think there perhaps needs to be more debate and discussion between the research and development part of the NHS and device manufacturers. Tim, I know this is an area you have been worrying about.
  (Dr Riley) Yes. I think it is worth saying that fortunately we are not starting from a completely blank sheet, there has been a history within the Department of Health of supporting evaluations, in practice using protocol-driven research on various devices, particularly devices from small companies. Indeed there have been examples of that in terms of ventricular assistance devices and so on. So we have in fact got quite a foundation on which to start up a productive debate with the sponsors of those devices to actually ensure there is protocol-driven research we can put in place and bring alongside that economic evaluation informing the deliberations of NICE.

  59. But in order to carry out your appraisals you are going to need data and information from the manufacturer. Ultimately you may have to decide, or you may decide, that it is a product which should not be available on the NHS. Bearing that in mind how co-operative do you expect the manufacturers to be and would you therefore see any need to introduce legislative measures to help you obtain their co-operation if it were not forthcoming?
  (Professor Sir Michael Rawlins) I can understand they would be disappointed, probably more than disappointed, but if NICE had determined that it was not effective or not cost effective and had given its advice to health authorities that that was the case, then I do not think health authorities would take it up. So I would not have thought there was a need for legislation.
  (Dr Radford) Could I just check the question you are asking? You are talking about the industry in its totality and getting information from industry at an early stage to help inform the appraisal process?

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries

© Parliamentary copyright 1999
Prepared 10 March 1999