Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 40 - 59)



Dr Taylor

  40. Mr Newdick, as our health law expert, I am completely confused about the legal status of NICE guidelines. I would like to know what is the up to date picture. Immediately after the election I, as I am sure many of us were, was besieged by relatives of elderly people who were desperate for the Alzheimer's drugs and I was fascinated that in a debate in Westminster Hall on 4 July Yvette Cooper said, "We were pleased to accept the recommendations of the National Institute for Clinical Excellence", relating to these drugs. "All health authorities must adhere to that guidance ...". Later in the same debate she said, "That is why I agree that the postcode lottery must be addressed, which is what NICE is all about. Health authorities need to fund NICE's recommendations." What is the up to date understanding of the strength of NICE guidelines?
  (Mr Newdick) I fear she may be wrong. Before 1 January this year, NICE guidance was precisely that. It was just guidance. To that extent, it was something that health authorities were duty bound to consider conscientiously and to build into their planning and strategies. That was the obligation. It was not an obligation to fund. The difference now arises from 1 January because directions have been introduced. Directions have the statutory backing of the National Health Service Act 1977, which does impose an obligation on health authorities to follow them. The difficulty is what exactly these directions mandate. From 1 January, to paraphrase, the obligation is that a health authority shall ensure that NICE guidance is normally available. One would have thought that a guarantee of health care—this is what the minister promised before Christmas—would have been preceded by the words, say, "is available." I do not know that I can take you much further than that on legal certainties. Perhaps we should say that there would be a presumption now that NICE guidance would be adhered to by health authorities and primary care trusts. Before, the presumption was merely neutral. Now we would imagine, following the direction, that they would follow it unless there is good reason to the contrary. That is the question: what would such a good reason be?

  41. Are there going to be any developments on that? Is it going to become more definite or do you think it is going to remain like that?
  (Mr Newdick) You might press the minister but otherwise I know of no plans to clarify these directions. Given the promise that was made before Christmas, I am surprised that this adjective is used.

  42. This is another thing that can come out of the report that we produce after this to have it clarified?
  (Mr Newdick) Yes. I would certainly urge for clarification of that word.

  43. Obviously what a health authority does impinges on all its other decisions about health spending, unless it were given specific money for using NICE guidelines, which is unlikely.
  (Mr Newdick) Of course. We made the point five minutes ago that each one of these decisions has considerable opportunity costs. The costs escalate year on year. They accumulate so they are manageable this year but, say, in five years' time five years of NICE costs are going to be very significant and that will eat into the remainder of the budget.

Mr Burns

  44. Mr Newdick, you have said that the obligation to follow NICE will lead to disinvestment elsewhere. I wonder if you would elaborate?
  (Mr Newdick) From a fixed, pharmaceutical drugs budget, if you devote resources to one particular area or a number of areas of care, having used that money previously in different ways, that money has to be taken from areas that would previously have had spending. This is why the word "disinvestment" is useful.

  45. Unless the money increases each year?
  (Mr Newdick) Unless the money increases each year sufficient to cover the cost of the guidance. I think it will increase but I doubt whether it will increase sufficiently to cover the costs.

  46. Logically, I suspect you are probably right. Where do you think the problems will arise? There is only a certain amount of money and if there is a requirement through NICE advice to provide highly expensive drugs to patients which they would be obliged under the guidelines to provide what do you think is going to happen?
  (Mr Newdick) NICE concentrates on technology appraisals and gives advice in relation to particular treatments. I think it has made a decision of its own, for the moment at least, that it will not get into other areas, the non-technicological areas, of health care. For example, I am thinking of a local initiative to reduce waiting lists for orthopaedic patients. That is something that NICE would not look at. An initiative to increase the number of community nurses is also something NICE would not consider but they might be the first targets for a reduction in funding if NICE demands resources are diverted elsewhere.

  47. You have suggested there might be a grading system from NICE. Do you not fear that the implications of bringing in a system like that are that only the top, highest priority grade will ever get any attention paid to it and any obedience to it?
  (Mr Newdick) There would be a danger. My preference would be that the top grade, the must dos, the obligatory, mandatory direction, should be limited to promoting government, public health policy. If it was limited to, for example, promoting the national service frameworks or the objectives of the Modernisation Agency, it would have a coherence at a public policy level. They would be "must dos". The "ought to dos", the "should dos", should be given probably the same status as NICE guidance had before Christmas. They ought to be very seriously and conscientiously considered by health authorities, but remain within local discretion.

  48. What are the should dos in your categorisation?
  (Mr Newdick) Should dos might relate to those treatments where, for example, the evidence is still equivocal. We are still waiting for more evidence before we can be sure of its veracity, of the extent to which it can provide health gain.

  49. When you say "treatments and their veracity", you are talking about drugs?
  (Mr Newdick) Yes.

  50. That is for should dos?
  (Mr Newdick) Yes.

  51. When you were talking about must dos, you were basically talking about the modernisation programme and the national framework. You did not mention drugs. Are they not just as important?
  (Mr Newdick) I am thinking of drugs that would contribute to those programmes. I would favour drugs that would be regarded as essential, effective and affordable. Those would be the sort of treatments that would promote a national objective, pursuing public policy. They should be subject to the must do obligation. I think they should be deliberately limited in their scope and for the remainder we should trust local health authorities and primary care trusts to deal with their own local priorities and demands on their resources because the difficulty for the moment is that NICE seems to be entirely oblivious of the local demands, for example, in Berkshire. NICE could not be expected to be familiar with the local initiatives taken in Berkshire.

Dr Naysmith

  52. Would it still be possible for the money to be available if a health authority or a primary care trust wanted to make it available and still argue against its use? Locally, a decision might be made that they do not want to use it even although there was money available for it under your system. Would you think that a sensible thing to do?
  (Mr Newdick) You mean they would want money for the treatment they were not going to fund?

  53. Yes. If there was general availability of this money and there was not a demand for it by their own consultants.
  (Mr Newdick) Whether the decision is made to deny them the additional money or not I do not know. That is a decision to be made.

Sandra Gidley

  54. I wanted to pursue the professional, ethical judgment issues. It strikes me that NICE will pronounce that drug A is available for treating Z. A patient with Z goes to the GP. They read all about it. We have an increasingly well informed public. They decide they want the latest. They want this newly approved drug. They go to their GP saying, "I want this." The GP may not think that that is the right course of action for this particular patient. Do you think that the statement from the minister saying that NICE guidance should be implemented gives the public a slightly wrong message because it highlights a particular drug for a particular situation? It comes back to not judging a technology within the broader area.
  (Mr Newdick) NICE respects the clinical discretion in this area so that a treatment which is recommended by NICE does not have to be adopted by an individual clinician.

  55. But the public might think that.
  (Mr Newdick) In fairness to NICE, the directions and the press release, they have all made it clear that access to the treatment should depend on the clinical recommendation of the doctor. There is a very serious problem of the perception and, the promises, the expectations generated by government. It is not just this government; it is government in general. One of the disadvantages of distancing government from NICE is that it can detach itself from the debate that we should be having about what we can afford, given the investment we put into the system. What we need is a system for gauging affordability and that should be not on a piecemeal basis but according to a systematic series of values and a framework of ethics which would be vague and imprecise but they would give us some idea about a limit on the demands that can reasonably be made on a cash limited system.

Dr Naysmith

  56. I would like to ask a few questions about the British National Formulary. Could you comment a little more on the evidence you have submitted that NICE advice cannot be used in isolation? What exactly do you mean by that, in practice?
  (Professor Kendall) Our starting point would be that we regard NICE advice, on the whole, highly. In other words, we read it carefully and take notice of it. One has to appreciate that NICE is not one of those things you can take in isolation because it gives guidelines but it does not tell you how to treat the patient in front of you at that moment. We have to read what they have said and try and put it into our Formulary in a way that makes it clear to the doctor what he or she should do. On the whole, we respect NICE advice and we put in the advice we get from NICE highlighted in blue. We say, "This is what NICE says and this is what you should do about it." Sometimes, however, they say things that we find difficult to put in because either they are not quite true or they are not quite clear.

  57. In your evidence you suggest that sometimes you have concerns about the quality of the advice and on occasions you will omit any mention of NICE in your advice.
  (Professor Kendall) Yes.

  58. How often does that happen?
  (Mr Mehta) That is very rare and so far the committee has agreed on omitting just the one guidance on the management of patients who have just had a heart attack.

  59. What was wrong with the quality of that?
  (Mr Mehta) There are two issues here. Firstly, the BNF already provided very good advice on this. We compared NICE advice very carefully with what the BNF already had to say on the subject. On the whole, as you might expect, there was a very good concordance between the two. However, there were some points of detail that did not quite concur. We discussed these at length with our own expert advisers. We used three expert cardiologists to tell us what the truth about these matters was. Their advice was on these occasions that what the BNF said was probably more appropriate than perhaps what NICE was saying. The decision was made that the BNF would continue to give its own guidance and not mention NICE.

previous page contents next page

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

© Parliamentary copyright 2002
Prepared 8 July 2002