Examination of witnesses
(Questions 60 - 79)
THURSDAY 4 FEBRUARY 1999
PROFESSOR SIR
MICHAEL RAWLINS,
DR GINA
RADFORD and DR
TIMOTHY RILEY
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.
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