Examination of Witnesses (Questions 40
WEDNESDAY 16 JANUARY 2002
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 carethis is what the minister promised
before Christmaswould 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
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.
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"
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
(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
(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.
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.
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.
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.