Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 449 - 459)




  449. Colleagues, can I welcome you to this meeting of the Committee. Welcome to our witnesses. We are very grateful for your co-operation and can I thank your departmental colleagues for the detailed evidence we have been given. Can I ask you briefly to introduce yourselves to the Committee, starting with you, Lord Hunt?

  (Lord Hunt of Kings Heath) I am Philip Hunt and I have ministerial responsibility for NICE in the Department of Health.
  (Mr McKeon) I am Andrew McKeon. I am Head of the Medicines, Pharmacy and Industry Group in the Department of Health which has sponsorship responsibility for NICE.

  450. Perhaps I could begin by asking a broad general question. Informed by the experience of this inquiry, we appear to have had a quite marked range of different views on how NICE is operating. The first point I would like to raise with you is how does the Department evaluate the performance of NICE? What kind of performance measures do you set and what conclusions have you arrived arising from those performance measures?
  (Lord Hunt of Kings Heath) NICE is clearly a very important component of the Government's approach to the National Health Service. I would mention it alongside national service frameworks and the Commission for Health Improvement. All of these are mechanisms designed to ensure that we have high quality of service, high consistency throughout the country, ending what I think has been a blur on the NHS for many years which is most evident in postcode prescribing, but generally a wholesale inconsistency in terms of the quality and range of services provided to the public throughout the country. The Government sees NICE as being a very important component for putting that right and ensuring that the best available evidence is brought to the attention of the NHS so that judgements can be made about what is best for patients, new drugs, what new treatments are coming along, how robust are they and, if they are proving to be robust and are cost and clinically effective, how soon can they be implemented generally throughout the National Health Service. My general judgement about NICE—it is very much a leading edge organisation; we are very much leading the world in many of the techniques that are being used here—is that it has made a very solid start. It has conducted a number of appraisals. It has not done so many guidelines but we expect more guidelines in the future. I think it has developed robust processes which are challengeable, subject to appeal, and that through that their decisions have been made in the light of a great deal of evidence and areas where processes are enabled to be challenged and tested out. Overall I feel it has made a good start. It is learning as it goes along. It is making changes. We have discussed certain areas where we wish to see changes made and have discussed that with NICE. As far as the issue of setting targets and judging performance are concerned we have to get the balance right. NICE will only be successful if it is seen to be an organisation which in the decisions it makes is wholly independent of Government and therefore I think it is right that our own role should be setting some clear parameters, as we have done in the framework document, in terms of general philosophy as to the kinds of processes to be used, the enabling of stakeholders to be consulted, ensuring that there are vigorous processes and appeals processes. That I believe is the key area in which we should test whether NICE is being effective or not. We do that. Our officials have regular discussions with NICE. I have an annual accountability meeting with the Chair and the Chief Executive of NICE to make sure that in terms of those processes we do feel that they are robust. In addition, of course, there are issues over workload, the number of appraisals, the number of guidelines that should be undertaken. We also agree their annual business plan and we also discuss with them workload issues in general and agree performance targets and expect them to meet those targets. In a sense that is a second order issue to the more general way in which we can make judgements about whether NICE has got right processes and vigorous processes, but I would stress over and above that that we need to ensure that our own role is assuring ourselves about the legitimacy of what they are doing rather than getting involved in decisions made about guidance.

  451. I understand the issue of independence and the difficulties that that would pose in terms of very close monitoring. What I wonder is how, bearing in mind some of the evidence (not all) we have received, which has been quite robust in attacking NICE, how the Government pick up and respond to areas where there is clear criticism about certain issues (and we will come on to some specifics later on) and what procedures are adopted apart from the appraisal meetings you mentioned. Are there not some specific criteria you work to? Are there mechanisms whereby you pick up this kind of criticism that has come through to the Committee?
  (Lord Hunt of Kings Heath) Perhaps I could give an example. I am obviously well aware that there are organisations and people who are critical of NICE and its processes and procedures. In addition to being responsible for NICE in the Department I am responsible for liaison with the research based pharmaceutical industry and they are not backward in coming forward with criticisms of the NICE process and indeed the fundamental philosophy of NICE. I would say two things. One is that you should not be surprised that there is a great deal of comment about the way NICE works. Its decisions are critical. They are critical for patients, for doctors and nurses, they are critical for the NHS as an organisation as a whole, and they are critical for the drug industry, manufacturers of medical devices. It is not surprising that everything they do very much comes under the microscope. If I take the research based drug industry as an example, one of the key complaints they have is that they do not believe you can make the kind of judgement NICE makes at the time of launch of a new drug. They think that there should be more time given to see how in practice the drug works out when it is given to a large number of patients. The general view that we have taken is that the clinical trials should provide enough evidence in order to make the judgements that NICE makes concerning clinical and cost effectiveness. We have just issued a consultation paper this week which explores this issue in more detail. First, we have encouraged the industry to talk to NICE about these issues and, second, arising out of those discussions there has been a recognition that there may be certain circumstances where undertaking a NICE appraisal at the time of launch or shortly afterwards may not always be appropriate. You may, for instance, have a drug which is treating a degenerative disease where the clinical trial has been relatively short as compared to the length of the degenerative disease. What we are saying in the consultation paper is that as we take through each proposal the appraisal group within the Department of Health that will consider and make recommendations to ministers will also make recommendations in relation to the actual timing of the NICE appraisal. It might well be in relation to a particular drug that it recommends that an appraisal be postponed for some time, perhaps to enable further clinical trials to take place. I have used that in a rather long-winded way to describe how an issue that was raised has been considered and we believe that through this consultative process which we have just launched we are showing flexibility in terms of allowing that to be debated in the public arena. In addition I have always encouraged NICE to talk to stakeholders and others who have criticisms of the NICE process. In my work with the research based industry we have constantly encouraged the industry to talk to NICE. It is the same with the National Health Service. I know that you have had witnesses from the NHS and again I am very anxious that NICE talks to the NHS about any concerns they have. Essentially that is broadly the way we will work and will continue to work with issues and concerns that arise.

  452. You have said in that answer that you encourage NICE to talk to the stakeholders. One of the points I wanted to raise with you is that the Committee was quite surprised that in its evidence NICE seemed genuinely surprised by some of the critical reactions from stakeholders. Does that raise questions about whether they are relating to the stakeholders in the way that you anticipated and the way that you tried to encourage?
  (Lord Hunt of Kings Heath) Certainly from my discussions with NICE I believe that they have engaged in a number of discussions with the various stakeholders and you will know that they have a Partners Council which allows that formula to take place. Equally, in the ministerial appraisal which took place with NICE three or four months ago, this was an issue that I raised with the Institute and encouraged them to, if you like, go the extra mile, and I will continue to do that.

Mr Burns

  453. Several of NICE's decisions have attracted criticism and have been challenged by a number of well respected bodies, like the Drugs and Therapeutic Bulletin and the British National Formulary, and even your own Department apparently has said that NICE has not fully explained their decisions as well as they might. I was wondering if you could accept that NICE sometimes gets it wrong.
  (Lord Hunt of Kings Heath) I think I have already said that NICE is only beginning its third year in operation. This is very much a new field, very much at the leading edge, and it would be very surprising if it got everything 100 per cent right in its first year or so in operation. We have described and NICE has described to you the careful appraisal process through which they go. Obviously one hopes that that is designed to ensure that they get it as near right as they possibly can, but of course lessons are being learned as we go along. Certainly one of the comments that the Department has made to NICE in some of the first appraisals is that they thought more explanation could be given of the decision, relating it back to the methodology and the evidence that was made available. It is my sense that NICE has responded to that and that the reports that are now coming through do very much make that link. I think the key question here is: is NICE taking account of valid criticisms? I think it is but I would certainly want to encourage them to continue to do so in the future. At the end of the day the integrity of what NICE does is absolutely critical to the kinds of changes we want to make to the National Health Service. Just as I am very protective of its independence, I am also very anxious to ensure that it learns as it goes along and that it does engage in dialogue and that even when organisations disagree fundamentally with a decision none the less there should be constructive dialogue.

  454. Do you think then that the integrity of the Government and the credibility of NICE were enhanced or not over the fiddling around with the whole issue of beta interferon?
  (Lord Hunt of Kings Heath) I am not sure what you mean by "fiddling around".

  455. I think you do, Minister.
  (Lord Hunt of Kings Heath) If you take beta interferon, the action the Government took was expressly traceable back to the recommendation made by NICE first of all in their provisional appraisal and then in their final appraisal, which was to have discussions with the drug companies concerned to see if it would be possible for cost effective prices to be negotiated. That is what the Government did. I do not think that that in any sense can be taken as an indication of some kind of failure or that it shows that there is something wrong with the process.

  456. There was a sneaking suspicion, and I do not need to remind you and I do not expect you want to comment except to defend it, that the decisions on the whole issue of beta interferon were to be avoided at any cost prior to the last general election.
  (Lord Hunt of Kings Heath) The point about the beta interferon process is that of course it is not in the gift of the Government.

  457. Ah, well.
  (Lord Hunt of Kings Heath) The process that has been laid down is operated by NICE. You will know that during the course of the appraisal of beta interferon the companies concerned were asked to provide further information. That led to a lengthening of the time of the appraisal process, and at the end of the day—

  458. Who asked them?
  (Lord Hunt of Kings Heath) That would have been done by NICE through its appraisal committees. It certainly has nothing to do with the Government. The Government has no role in terms of the way NICE conducts the appraisals. Our only input in terms of an individual appraisal would be as a consultee. The comments that the Government makes in relation to individual appraisals is very much around either technical issues or asking NICE if it could give further clarification or explanation as to the guidance it is giving. I must fundamentally reject your assertion here. There is no question that this was conducted by NICE without any interference from the Government, that the discussions that we undertook with the industry arose directly from the recommendation made by NICE and that was made both in its provisional appraisal and in its final appraisal.

  459. At the moment, remind me, there is a process going on where there is going to be, although I do not think it has started yet, a trial for beta interferon with a sample of patients. That is correct, is it not?
  (Lord Hunt of Kings Heath) Not quite. Perhaps I could bring Mr McKeon in to talk about the details here.

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