Select Committee on Health Minutes of Evidence

Examination of witnesses (Questions 60 - 79)



  60. For there to be a requirement.
  (Dr Radford) Certainly the discussions we have had with the industry, both pharmaceutical and devices, have been quite positive in the sense of recognising what this is trying to do and the step forward it is taking, and also recognising that if a drug or device is recognised by NICE in terms of having evidence of clinical and cost effectiveness, that potentially for that company or sponsor is a real endorsement of what it is trying to do. So those producers where there is good evidence should have nothing to fear. What we are trying to stop is the introduction of devices or drugs where the evidence is not there either because the evidence does not show benefit, clinical or cost effectiveness, or the research has not answered the right questions. So for those products which do demonstrate clinical and cost effectiveness NICE is there to ensure a wider and more timely dissemination, so the industry should have nothing to fear from that. Those that do not, well, it would be inappropriate for the NHS to introduce products which are ineffective and do not demonstrate clinical and cost effectiveness, and the industry are aware of that.
  (Professor Sir Michael Rawlins) Can I add one other thing because there is another side to the coin, and I genuinely mean this? Where a new intervention has been shown to be clinically and cost effective then NICE would wish to engage with the sponsor in ensuring its more rapid up-take. There are some really rather embarrassing stories of the slow up-take of certain important, life-saving interventions which have been really remarkably slow, and I think it is very unfortunate when that has happened and NICE would want to engage with the sponsor in getting more rapid up-take in the Health Service.

  61. You will appreciate, Professor Rawlins, we did only receive the discussion paper last night —
  (Professor Sir Michael Rawlins) I am very sorry about that.

  62. — so I may be asking a question which is in there. One of the concerns which was expressed particularly by the pharmaceutical industry was the transitional arrangements and what would happen about products coming through the licensing process before NICE is properly up and running. I wonder if that has been addressed and what discussions are taking place?
  (Professor Sir Michael Rawlins) We are very conscious of the importance of some sort of transitional arrangement and the document does actually seek views from the industry and others on the appropriateness or otherwise of the sorts of transition arrangements we are looking for. We recognise that some at least of the economic data upon which one can base cost effectiveness may be difficult to acquire for products which are about to get marketing authorisation or product licences, so we do understand the need to be somewhat circumspect in the early months and year or so of the Institute's being. But we would hope to engage in a dialogue with manufacturers and companies at an early stage even if they know they have not got all the necessary information and at a later date we would want to have a dialogue with them so they could go and get it.

Audrey Wise

  63. In relation to manufacturers, following up my colleague's point, one of the problems this Committee found when it looked at pharmaceuticals a few years ago was the whole issue of commercial confidentiality. We felt, although we came out actually quite supportive in the end of a lot of the arrangements in relation to Government's relationships with pharmaceutical manufacturers, nevertheless we were very concerned and remained very concerned about the lack of transparency and the perpetual excuse of commercial confidentiality. This strikes me as being potentially a minefield for you and I wondered, Professor Rawlins, how you saw yourself and NICE tackling this? In fact have you given it any thought, do you think it will be a problem?
  (Professor Sir Michael Rawlins) I think it might be and I have long experience of this on the Committee on Safety of Medicines. The difficulty which arises is that the company may submit information which is submitted in confidence and the legal advice that I always had when I was on the CSM was that the law was absolute and it had no time limit, and even things which had been submitted 30 years ago in confidence still had that legal, as it were, embargo on them. Now things might change under a Freedom of Information Act, I would not know, but I think there is that potential difficulty that we may be provided with information that is in confidence, but to reject it or refuse to accept it might deprive patients of important products. If we were to say, "We will not accept anything labelled in that way" we might end up depriving the public of really important new forms of treatment.

  64. But you have got a weapon of your own, have you not, because they might be depriving themselves of a potential market? So it is not all one way, it strikes me that part of this is going to be who has got the strongest nerve.
  (Professor Sir Michael Rawlins) Yes. The other difficulty is, my understanding is, there is another what you might call perverse incentive from full disclosure and that is part of the European Directives relating to pharmaceuticals, the directives which relate to what is known as exclusivity of marketing. An innovator has ten years exclusivity unless the data is in the public domain. That could cause problems. One has to remember that the United Kingdom is only four per cent of a world market.

  65. So I can see that there are real problems. That is going to have a knock-on effect on your work. How much can your own work then be seen to be transparent and stand up to the public and professional gaze because if people do not know the basis for the decisions then it is very difficult for them to know whether to have confidence in those decisions?
  (Professor Sir Michael Rawlins) I very much understand that and I have every sympathy with what you are saying. I will do everything within our power to ensure that we can be transparent in relation to the basis for our assessments. I think there is some hope over it. For example, new drugs that are licensed under the European arrangements, that are centralised, are accompanied by what is called a European Public Assessment Report which actually contains quite a lot of detail from the commercial and confidential reports provided by companies. There have been criticisms of these EPARs but nevertheless the principle that the information can be made available or parts of it, even if the original document is not, has been established in that context.

  66. On the question of what your decisions will be, when you make those decisions known will you be distinguishing and setting out the clinical effectiveness decisions or views of NICE and the cost-effectiveness?
  (Professor Sir Michael Rawlins) Yes.

  67. Because these are different things. I fear very much that we will keep slipping from effectiveness into cost-effectiveness and I am not saying that cost-effectiveness is not important but it does bring in a lot of other factors.
  (Professor Sir Michael Rawlins) Yes.

  68. It is so much easier for people who do not want money to be spent to be able to say "it is not effective" when really what they mean is they do not think that as compared with something else it is cost-effective. This is very much something on which people should have the right to test out your views. Obviously you will be the experts, I hope you will have a lot of credibility, but you are not infallible. People will have a lot more confidence if they can test it out. It is a bit like-a crude example-when I read Which? magazine I see they recommend best buys but I also see the basis on which they make their recommendations and sometimes the criteria that they give the most weight to are not mine, so I can say "well, that might be a better buy for 99 out of 100 but not me" and I know what I am doing. Will those in the field, both patients and professionals, be able to look at it like that as well?
  (Professor Sir Michael Rawlins) We will unquestionably indicate quantitatively as well as qualitatively the clinical efficacy and separately the cost-effectiveness.

Julia Drown

  69. I just want to go back a moment to the scope of NICE. Am I right in thinking that basically everything around health is included, so that in the consultation paper where it says "products and processes to diagnose and prevent disease in individuals are included", that will include vaccines as well?
  (Professor Sir Michael Rawlins) In effect vaccines is handled by the Joint Committee on Vaccination and the Department and I do not think there is any suggestion to bring it in. That, of course, is for the public immunisation policy. On the edges there might be some sort of arrangement but I think it is something that we would sort out with the JCVI. Similarly, there is not an intention at the present to bring the National Screening Committee within NICE's ambit.

  70. Although you have got screening as part of your scope.
  (Professor Sir Michael Rawlins) As a possibility at a future date.
  (Dr Riley) I think it is worth saying that the National Screening Committee set up in 1996 covers all four UK countries; NICE covers England and Wales and will inform Northern Ireland and we will work in a complementary and collaborative way with the structures already established in Scotland. The National Screening Committee has already undertaken appraisals and Members of the Committee may already be aware that there was guidance issued to the NHS about prostate cancer screening, for example, in June 1997. The Screening Committee will be looking forward to having consistency in its approach with that of NICE because that makes common sense. Discussions have already started with the National Screening Committee to ensure that the guidance that it produces for all four UK countries is consistent in its approach and in its rigour with that of NICE. One of the things that we have said about NICE is that it will be a single source of information for the NHS in England and Wales. I think we would want to see that NICE will also feel confident in the guidance produced by the National Screening Committee but it could also release it through its own officers.

  71. If you take out screening and the vaccination programme then all other things will be the remit of NICE, or are there exceptions?
  (Professor Sir Michael Rawlins) It is not health services management issues, it is health technologies, treatments and so on and so forth.

  72. Would you envisage going further? For example, some health authorities are spending money on energy efficiency schemes because they think that will have a pay-off in terms of better health for their populations and other health authorities talk about how if they spent money on speed cameras they could reduce accident rates. Would you be looking into areas such as these as well?
  (Professor Sir Michael Rawlins) Those are issues of standards and so on and that is a different area. I do not think it is envisaged for the time being that NICE will be encompassing that.

Mr Stoate

  73. First of all can I say that I am quite sorry that you are not going to be including screening because if there is an area where there is genuine confusion it is about screening. For example, most of the screening programmes in this country have never been subject to proper evaluations, particularly cervical cytology, mammography, screening for hypertension and screening for lipids. It is a great shame that we are not using this opportunity to have a proper debate because we are spending a huge amount of money on something which has never been shown to have any proven benefit. That is slightly off the point. I want to open another can of worms altogether which is the PPRS, the Pharmaceutical Price Regulation Scheme, which as you will no doubt be aware is currently being negotiated at this very moment with Government and obviously it is something that both sides are rather sensitive about. How do you see NICE affecting some of the outcomes of PPRS? What I am thinking of, of course, is where the industry has spent a lot of money on developing a drug which in your opinion you feel is not right for the NHS. Will that have an effect on PPRS and, if so, what sort of effect?
  (Professor Sir Michael Rawlins) I must ask Dr Radford. My knowledge about PPRS is almost zero because of my Chairmanship of the Committee on Safety of Medicines. Anything to do with money and medicines, it was not just a Chinese wall.

  (Dr Radford) As you know, the PPRS is negotiated with industry as a whole, not with individual companies. I think we need to make this quite clear because I do recognise from your point that individual companies may have a particular stance. PPRS is negotiated with the industry as a whole. Certainly we are not expecting at this stage that NICE will affect the overall profitability of the industry, far from it. In fact it might be possible that medicines in the future will play a larger part in the way we manage and treat patients because unified budgets etc will encourage that. Clearly NICE's appraisals are looking at what works best, whether that be in medicine or device and what gives the maximum health gain which may in fact increase profitability and the use of medicines per se as opposed to some other forms that we currently use for managing patients. Therefore, we are not expecting that NICE will affect the work of the PPRS in terms of the industry as a whole.

  74. That is encouraging. Obviously the Department currently sponsors the pharmaceutical industry effectively through the PPRS. Do you see that there is any role for you to have the industry more closely involved with NICE or do you think that the current relationship is about right?
  (Professor Sir Michael Rawlins) I think the sponsorship role must lie with the Department, it is the sponsoring Government Department. I am not sure that it would be very appropriate if the industry sponsored some of NICE's activities. I think industry sponsored NICE meetings might be a little bit difficult to come back and defend to this Committee at a later stage.

  Audrey Wise: Definitely.

Mr Gunnell

  75. I imagine my question will be handled first by Dr Radford because it is about the funding of NICE. I understand that it is going to be funded in the first instance by re-directing monies from other current methods of appraisal that are going on in the Department or through the Department's funds. That raises two questions really and I would like to explore each of them. One of the questions is what will happen to the bodies which we currently fund if the money is re-directed to NICE? The second is, does that imply that you have a very limited budget for NICE which is what is being spent on this at the moment, and is it not likely that in order to achieve the level of work which is being talked about as the organisation matures that you will actually need some specific additional money going into the system?
  (Professor Sir Michael Rawlins) Shall I start off? There are organisations which are, as it were, coming under the NICE umbrella and the NCCA, the National Centre for Clinical Audit, will be an integral part of NICE.

  76. Does that mean you would take over its staff?
  (Professor Sir Michael Rawlins) Those staff will become eventually NICE staff; very nice staff. A lot of important things though go on in professional associations, royal colleges, for example the confidential inquiries into perinatal deaths and maternal deaths and so on. I envisage the colleges continuing carrying those out. We might have a dialogue about whether they needed quite as much money to do it as they did before, but nevertheless the colleges are the people who have done them in the past. The record of the maternal inquiry which has been going on since 1952 has been outstanding, it is regarded the world over as a most remarkable venture and I do not think any special health authority would get the co-operation of the medical profession in the same way as the obstetricians and gynaecologists have, who really deserve great credit for what they have done. So I would envisage that we would be contracting with them to continue doing that in the same way as they do at the moment. Similarly in relationship to other college audit activities, we would be contracting with them, we might want to reorganise or rearrange the agenda somewhat but I would still expect those arrangements to continue, as indeed we would for the sort of work that is done by the support teams in regions-and there are some very good and sophisticated support teams-helping the development and evaluation committees out in the regions. We would encourage their continuance and their support from NICE. There are, though, quite clearly economies of scale to be made. For example, just one example, I have calculated that the organisations that will, as it were, come under the NICE umbrella send out 30 communications per doctor per year and it costs £50,000 to circulate doctors, so 1Ö million is being spent now. If you did somehow a monthly communication, you immediately save over three-quarters of a million pounds, so there are savings of that sort of order which would have no adverse effects on anybody, which would be relatively easily accomplished. But I think you are right, and here Dr Radford and Dr Riley probably would not wish to comment, at some future date if NICE is really going to fulfil its potential it will need a greater budget and it will be up to the chairman and the board and the chief executive to argue their corner with the Department when that time comes. It could be 2nd April!

Audrey Wise

  77. On this question of relationships with other people who are funded by the Department, can I draw your attention to the National Perinatal Epidemiology Unit at Oxford? Can you say how they will be affected by the existence of NICE, if they will? That is a body which of all has done most work, in my view, in drawing attention to effective care. Their work on effective care in pregnancy and child birth is absolutely magnificent.
  (Professor Sir Michael Rawlins) Yes, Ian Chalmers.

  78. This Committee came in close contact with it when we did our maternity inquiry when it was under the leadership of Ian Chalmers, but even without Ian Chalmers it is still continuing to do very, very good work and I would feel it would give all the wrong messages if good work was going to be interfered with or funding withdrawn-its funding always hangs by a thread anyway. Indeed, I must say, this Committee found it quite hard to persuade the Department of Health at that time to actually look at the work of the NPEU because the Department's own advice was contrary to the evidence produced about effective care and pregnancy; not just the practitioners, the Department. We have moved a long way since then, I sincerely hope, but what will be the relationship with organisations like that and specifically with that one?
  (Professor Sir Michael Rawlins) Dr Riley was intimately involved with this episode you are talking about and would be very pleased to answer that. He is blushing with pride!
  (Dr Riley) Ian Chalmers' unit has always played a critical part in informing the research agenda, if I may use the acronym ECPC, for the effective care in pregnancy and child birth. That has actually been an important benchmark in effectiveness. I think the fact it has also been produced not only as a more detailed tome for professionals' use but also in a more publicly available form has been critically important. Of course, Ian Chalmers is now heading up the Cochrane Collaboration for this country and that is informed by units such as the NPEU, there are others in other areas of course. I think the strength of the Cochrane Collaboration is being able to draw on the evidence produced through the NPEU and in the forms it is produced so it is readily available to a wider audience. Cochrane is actually part of an overall jigsaw, the jigsaw Dr Radford described earlier, the importance of health technology assessment, the importance of the NHS R&D programme and indeed the units supported through the Department of Health. I think we see a clear link between the evidence produced by the NPEU, the collaborations it engenders across the area through the Cochrane Collaboration with other countries, because of course NICE will need to draw on evidence not only from the UK but from far wider too. I think the link between the Cochrane Collaboration which, as I said, is a key part of the NHS R&D programme, will continue to be very, very strong. In the HTA programme I would add that there are already groups that actually consult the NHS on the sort of evidence required and how the NHS R&D programme goes about that, and NICE will be intimately involved in that. So what I am trying to present is a whole picture of activity and I think, in short, the links between units such as the NPEU will be very, very strong with NICE, because, as I say, NICE guidance will want to be very dependent on that sort of evidence.

  79. Right. Can I just say that I will make sure that relationship is closely monitored, and also emphasise that one of the strengths of that unit is that without now the leadership of Ian Chalmers because of the methods he inculcated and the legacy he left it is equally strong, so the organisation, because it was soundly based, has not depended on a single individual. So it is really, really important that NICE should not be seen as a threat but should be seen to be using things like this as a resource on which to draw.
  (Professor Sir Michael Rawlins) Unquestionably.

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