Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 480 - 499)



  480. So it is only those who would be recommended who are in the trial?
  (Mr McKeon) Yes. It is those who are recommended for treatment under the ABN guidelines who will be entered into the scheme.

John Austin

  481. Can I go back to this transparency and accountability that you referred to at the beginning, Minister? The MS Society very clearly said to us that it is not possible to follow the audit trail of decision-making. You believe that it is. How would you counter their criticism?
  (Lord Hunt of Kings Heath) There is a clear appraisal process set out which we have sent to you, and I am very happy to provide further information there, starting from a point where NICE are asked to review a certain technology. There is then work that is undertaken in scoping the remit and nature of the exercise to be undertaken by NICE in which groups who are involved have an input into that. You then move through to the work that is being done by consultees who are asked to nominate people who can have an input into the appraisal committees because the appraisal committees themselves consist of a broad range of people.

  482. One of their specific complaints was that the stakeholders or the patient interest groups are not allowed to attend the full hearings of the appraisal committees.
  (Lord Hunt of Kings Heath) Yes. That is a decision that NICE has made, that they feel that their decisions are better made not in an open forum. There are two reasons for that. One is the question of the commercial confidential nature particularly in relation to drugs. The second is perhaps a more general point that they feel in terms of the discussions that take place that there might be inhibition on the part of the members of the appraisal committees in terms of what they said in an open meeting. That is I think very much for NICE to consider and make a judgement on. The important point is surely that in the work that they produce, the provisional appraisal, the final appraisal, the stakeholders, the people who have a direct interest in a particular appraisal have an opportunity to comment and to make their views known. That is something that we would very much want to encourage.

  483. When it comes to a decision that is disagreed with there is an appeals mechanism. Are you satisfied that the appeals procedure has the qualities of independence and impartiality that are required for a public body exercising their appeals function? One of the criticisms has been that whether you have the right of appeal is determined by the Chairman of NICE who also chairs the Appeals Committee. That does not seem to be a very open and transparent process.
  (Lord Hunt of Kings Heath) My understanding is that neither the Chair nor the non-executives take part in the original appraisal process, so their involvement in relation to an actual specific appraisal would only come in when they sat as members of an appeals committee. I think that is a sensible balance. The Chair and the non-execs are there as guardians of the public interest. They are there to assure themselves of the overall integrity of the process. Given that they do not take part in the appraisal process it seems to me that it is appropriate that they hear the appeals. Obviously, hearing the appeals also gives them a great deal of knowledge and information about how well the whole NICE process is going. There is a very persuasive argument that the way they run it at the moment is satisfactory.

  484. Notwithstanding the fact that the Chairman may not be involved in the appraisal, the public perception, or certainly the perception of some stakeholders, is that this is a cosy arrangement. It is the Chairman of the Committee and he then does chair the appeal. It does not appear to be transparent.
  (Lord Hunt of Kings Heath) I think the proof of the pudding is in the eating. My understanding is that 13 appeals have been made so far, four of which have been upheld. It seems to me that that shows that the Appeals Committee is willing to uphold appeals which have been made against the appraisal process. My view is that, provided the Chair and non-execs continue to have no part in the appraisal process, it is fine for them to undertake the appeals. The other point I would make—

  485. In coming to that conclusion that it is fair and reasonable, have you in that process considered any alternative model?
  (Lord Hunt of Kings Heath) Of course there can be alternative models where you make the appeals process, I suppose, quite independent of NICE, but you do run the risk of substituting one set of experts for another set of experts. You could undermine the whole NICE process if you went down that path, which is why it is probably better, I think, to keep appeals within the NICE family but splitting it so that those involved in the appeal have had no part in the appraisal process.

Andy Burnham

  486. Can I ask, Minister, about NICE's working programme and in particular whether you think that NICE has got the balance right between the development and issuing of clinical guidelines and technology appraisals and the guidance that flows from them? I think I am right in saying that they have issued far more guidance than guidelines. Is that the right balance? You said earlier that you expect more guidelines in the future. Does that suggest that there will be a change in that balance?
  (Lord Hunt of Kings Heath) The figures I have are that so far we have had 31 technology appraisals with 43 in development and four clinical guidelines with another 32 in development. I would just make two comments. One is that guidelines and appraisals are both important. They are not mutually exclusive. Guidelines cover the broader area in a clinical area. Appraisals deal with specific interventions. You need both. I would like to have seen more guidelines produced but there are two reasons why that has not happened. First, NICE, rightly in my view, concluded that it should give priority at the start to dealing with some of the most obvious consequences of postcode prescribing. The second reason is that they took over four guidelines that were being undertaken by other organisations and that, I gather, took them much longer because the methodology is different and they had to pull all that together. We reckon that their current capacity is around being able to undertake up to about 40 appraisal units and 15-20 guidelines so that as we go through I would expect many more guidelines to be produced.

  487. Are they getting quicker at doing that?
  (Lord Hunt of Kings Heath) Yes, they are taking more. There is a balance here too. Obviously I would like to see them do as many as possible but there are some constraints. The first is, members of the Committee will be aware, that this is a fairly long and robust process, so that inevitably it takes time. It is absolutely essential that NICE protects the integrity of the process. It cannot rush at things at the expense and quality of its output. The other reason why one has to be slightly cautious about the numbers it undertakes is the capacity of the NHS to respond to the guidance. The NHS has quite a few challenges on it at the moment and clearly the more guidelines, the more appraisals you do, the more impact it has on the Health Service. We have to get the balance right. What I can say to the Committee is that we will do this on an annual basis and part of the performance framework with NICE is to agree targets and make sure they keep to them.

  488. Can I push a little bit further on this relationship between guidance and guidelines? You mentioned a moment ago that there was clearly a relationship between the two. The ABN said to the Committee in its evidence that it sees a sense that NICE has double vision, that the two separate functions are not particularly well co-ordinated. Would you accept that they need better co-ordination of the two processes so that one helps and informs the other?
  (Lord Hunt of Kings Heath) Yes. Certainly we do not want to, for instance, just target drugs in isolation from the clinical priorities of the NHS or the guidelines. That would not be sensible. I have to say that we in the Department are in a learning process too and I would expect that as we go through further work programmes (and we are just consulting on the seventh potential work programme) we too get the integration right and that there is a consistency of approach. What does inform us over and above all this is the need to ensure that a lot of NICE's work is focused round our key priorities: coronary heart disease, cancer, mental health, because these are the core service priorities that we set for the NHS.

Jim Dowd

  489. Minister, what is your view on the conflicts that have arisen between NICE and other organisations, notably the BNF, from time to time? Do you feel this is perhaps inevitable or does it represent a broader failure by NICE to engage constructively with others in the field?
  (Lord Hunt of Kings Heath) I do not think it is surprising. For the UK, and England and Wales in particular, with NICE, this is very much a developmental concept that we are picking up and making an integral part of our National Health Service. I do not think it is surprising in the first two years of its work that there should be some controversy, that there should be organisations and people who are looking very closely at the work it does and seeking to draw criticisms to the attention of NICE. I do not think we should worry about that. Someone asked earlier, "How do you quality assure the work that NICE does?" As far as I am concerned the more people bring criticism out into the open the more NICE is challenged I believe the more robust it will come. I am very easy about that. However, I have also said that in relation to BNF or the Drug and Therapeutics Bulletin that I would certainly want to encourage NICE to sit down with the people who produce these two services to discuss where there may be differences, why there may be differences, and whether that might lead to any modification of NICE's process. NICE themselves are a pretty robust organisation and they are well able to take part in that kind of dialogue. As I have said earlier, I have encouraged them to do that. I do not think it is appropriate for me to make any comment on the specifics of either the criticism or NICE's response to that because I am absolutely convinced that that has to be left with NICE.

  490. You say you encourage them. Have you any evidence that they are responding to your exhortations?
  (Lord Hunt of Kings Heath) Yes. When I conducted their appraisal of three months ago, and indeed before that, I encouraged them to meet first of all with the research based drug industry some more to discuss some concerns that they had. That has happened. I have also made it clear that I want them to involve the National Health Service much more in their work. That has happened and, for instance, in the appraisal committees now there are two health authority people on each appraisal acting as a kind of proxy for the rest of the NHS. My experience is that when issues are raised with NICE they are prepared to go away and consider them and act upon them. I have not found them an organisation that puts the blinkers up and says, "No, we are not going to do that".

  491. On the question of the progress of NICE over the years what proportion of health care do you expect to be covered by NICE guidance in, say, five years and then ten years?
  (Lord Hunt of Kings Heath) It is very difficult to answer and I cannot give you a really quantifiable answer given the breadth of the NHS and the fact that we are still at a very early stage in NICE's progress. The kinds of things I would like to see are that within five years I would expect there to be clinical guidelines covering most of the current national service frameworks. Say at the end of ten years I would expect all the NSFs, the ones that we have already done, the ones that we are working on, to be covered by clinical guidelines. As far as appraisals are concerned, I would like to think that in five years' time we would be able to pick up every significant new development which looked like there may be some controversy about and that that would have an early appraisal. Within ten years I hope NICE would have been able to go back over most of the existing technologies, which again are significant, and where there may be some controversy. We will keep it under review on an annual basis. I do not think I would go much further than that at the moment.

  492. What estimates then have been made of the need for growth in the budget of running NICE to meet that programme?
  (Lord Hunt of Kings Heath) NICE's current budget I think is around £13.6 million for 2001-2002 and it is due to go up by two million in the next financial year. I do not believe money is an obstacle to NICE developing its work in the way it wants to do so. Obviously, if it was decided that some time in the future that it needed to increase the number of guidelines and appraisals considerably, then we would have to find the resources to enable it to do that. Frankly, I do not think at the moment money is getting in the way of NICE doing its work properly.

  493. Experience of NICE, even though it is only two or three years so far, has that led you to re-evaluate any part of the initial vision for NICE or is that still achievable?
  (Lord Hunt of Kings Heath) I think the vision is achievable. I am absolutely convinced that the vision is right. Remarkably, the NHS, after so many years since 1948, one of the most remarkable things about it is how inconsistent it has been and the fact that you can get a drug in Birmingham which you cannot get in Solihull, the fact that high quality services can be available in one part of the country and not other parts of the country. The big challenge we have set ourselves is to get a high quality service consistent throughout the country. NICE is a crucial part of that. It is not the only part. The national service frameworks are very important and the role of the Commission for Health Improvement in reviewing and inspecting the Health Service also has a big role to play. The vision I am sure is absolutely right. In practice NICE I think has done well, but of course there are areas in which it can improve. The Select Committee's inquiry, the consultation that we are having on timing of an appraisal, all of these activities will help improve the overall quality of NICE's performance.

Dr Taylor

  494. I wish I could share your optimism because it strikes me that the progress of NICE is inevitably so slow that to get to examining enough drugs to really make a difference is going to take a long time. Can I just check? You said 40 appraisals and 15-20 guidelines. Is that per annum?
  (Lord Hunt of Kings Heath) My understanding is that it is up to 40 appraisals per year. At the moment we reckon that NICE can undertake 15-20 guidelines over a two-year period. As part of the NHS plan to set targets and as part of our annual appraisal we want to get them up from that so that they can at least do 20 guidelines a year.

  495. In a subsequent answer you almost welcomed the fact that they were slow because this is a way of limiting expense because the more they recommend the greater the expense that falls on the NHS.
  (Lord Hunt of Kings Heath) I think you have misunderstood me. The point I was making about the capacity of the NHS to deal with appraisal and guidelines was not related to expenditure. It was more to do with the practicalities of the kind of pressure being placed on the National Health Service. You will well understand that in terms of a busy agenda for the NHS one of the considerations you have to take into account is how many guidelines practically an individual hospital could implement over a specified period of time. I share your view that if (I think you implied in your question) we can step up the number of guidelines and appraisals in the future the NHS can cope with that and there is enough expertise around to be able to do it, then that is something we should look at. At the moment my feeling is that we have to make sure we get the process right, we have to make sure that every appraisal and guidance is done in a robust way, which is why we have got the balance of targets at the moment. We are not being absolutely doctrinaire about that. We will look at this from time to time.

  496. With some of the drug treatments it is purely and simply a matter of money. The expertise is there and waiting. Can I go back to appeals? You said that the reason for leaving them within the NICE framework was that otherwise it would rather undermine NICE. That rather implies a complete loss of the opportunity to allow NICE to be really checked by an outside organisation. I would have thought it would have been possible on subjects like beta interferon to have an appeal, if there was going to be an appeal, by an internationally accepted panel of neurologists rather than just NICE itself.
  (Lord Hunt of Kings Heath) There are two things about that. I am not sure that I would put an appeal in the hands of, for instance, if you take beta interferon, just the doctors most intimately involved with a particular drug. I think the benefit of the kind of appraisal committees NICE has is that you can have a balance of people who can take a somewhat more rounded view than maybe doctors intimately concerned with a particular drug. The second issue is that my inhibition about seeing changes made or feeling that NICE had not got it right is that I do think you need to be careful not to establish one group of experts within the NICE appraisal process and then another group of experts who meet outwith NICE, substituting their own professional judgement for each other. I am not sure that that would be particularly helpful. The other point I would make is that the basis for making appeals is not really in terms of second-guessing the original judgement. It is very much around whether the process that has been undertaken is fair, whether through the whole process there has been any action which can be regarded as ultra vires or whether a perverse judgement has been made. In that context the non-executives and the Chair of NICE are well able to make that kind of judgement. The proof of the pudding is in the eating. I think the fact that of the 13 appeals so far held four have been successful shows that it is working pretty well.

  497. Going back to the timing of appraisals, you have already said that there is a consultation paper coming out this week.
  (Lord Hunt of Kings Heath) Yes.

  498. Is that going to be published or just on the web, and who will that be sent to?
  (Mr McKeon) It will be on the web site and we have sent copies to you, the Committee, already. We will be sending it to a number of voluntary and professional organisations conducting the ABPI and the ABHI to give them direct copies.

  499. This would be three months for consultation?
  (Mr McKeon) Yes.

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