Examination of Witnesses (Questions 720
THURSDAY 8 NOVEMBER 2007
PRIMAROLO MP, DR
Q720 Sandra Gidley: At the time I
am not sure that the drug had even been licensed.
Dawn Primarolo: There was a great
deal of discussion around it and the Secretary of State was making
clear what the policy of the Department is. I would absolutely
stress that it is not the role for ministers to contradict, override
or directly seek to influence a process where NICE are already
engaged in consideration.
Q721 Sandra Gidley: So no minister
at the time tried to influence NICE to speed up a decision or
bring anything forward?
Dawn Primarolo: Not as far as
I am aware, no, and if you have any evidence to the contrary please
do let me know; but not as far as I am aware, no.
Q722 Sandra Gidley: How would you
see the relationship between NICE and ministers developing in
the future because I know from having lobbies that they have had
slightly different approachesI do not want to name names
hereand some have been completely arm's length and some
have seemed more willing to have discussions with appropriate
people. What would your approach be?
Dawn Primarolo: What do you mean
by "appropriate people"that is my question?
Q723 Sandra Gidley: At NICE. As we
all know, some decisions are controversial or looking as though
they are going to be controversial.
Dawn Primarolo: Indeed, and as
a ministercertainly in terms of Members of Parliament and
organisations wanting to speak to me directly on issues regardless
of considerations being undertaken by NICEI could not refuse
to see people and I doubt if my predecessors would on the basis
of, "Sorry, I cannot talk to you at the moment, NICE is considering."
But within the process it seems to me that when the priorities
have been agreed and NICE has undertaken its work then the Department
of Health, including ministers, falls back into a position of
being one of many stakeholders who will have views about what
NICE is doing and may or may not express those views to NICE.
But there is not a route to directly try and circumvent or change
the decision that NICE in its independencequite rightly,
because that is the strength of the organisationboth nationally
and internationally is doing with its expert analysis. Again,
going back to the Chairman's first point about how do you manage
expectations, where is the dialogue, what is the engagement, unless
you are suggesting to me that I should say to you the next time
NICE is considering something that you want to speak to me about,
I say, "No, hang on, wait until NICE has finished and then
I will talk to you," I think that would be unacceptable.
So I think we have to be careful, but let us be clear: there is
no way that a minister can override, circumvent, force NICE to
come to a conclusion that is not the conclusion of NICE based
on their expert analysisno waynor should there be.
Q724 Dr Taylor: Good morning, Minister.
I am very pleased to hear that it is not policy to contradict
NICE but there do seem to be two examples of conflict. The first
one on recommendations for alcohol in pregnancy, and the second
one the Department's working group on VTE and the NICE recommendations,
which do seem to be pretty different. We heard from the Chair
and Chief Executive of NICE earlier that regarding the VTE one
the Department's recommendations were really meant to be interim
before NICE gave its actual ruling, but as they came out at exactly
the same time it is very hard to see how they were interim ones.
Dawn Primarolo: Can I say on the
VTE, they came out very closely together, within about a week
actually, although they had different timeframes and originally
different expectations. For instance, the Chief Medical Officer's
expert working group was looking at recommendations for inpatients
in the medical sphere and was also looking very specifically at
summarising practice in time for the implementation and particularly
when NICE's work came through. I certainly asked this question
in preparing for this Committee todayin the discussions
that inevitably occurred between NICE and the Department we need
to find a way of managing slightly better when the Department
is undertaking work because it needs to be giving guidance to
the health service in the interim and what that relationship is
with NICE. To be honest, in the end there is not a contradiction
between the two; they were looking at slightly different focuses.
But obviously now that NICE has been asked to go on and complete
a fuller position it will be clearer. I think the question was
one of handling rather than contradicting in the different pressures
in giving advice to the NHS and NICE looking at an area.
Q725 Dr Taylor: So if the expert
panel's report had been labelled as interim guidelines rather
than definitive ones and had been brought out when it was actually
completedbecause it appears that it was delayed by six
to nine months at leastthat would have helped. Again, what
clinicians are bothered about is when they get two subtly different
bits of advice.
Dawn Primarolo: Indeed.
Q726 Dr Taylor: So should the Department
not be either retracting something that it has put out, if it
is not the same as NICE? What solution should there be?
Dawn Primarolo: This is a really
complex area. There was guidance being sought from the Department,
and I believe this Committee, in fact, looked at the issue. In
2005 the Chief Medical Officer was taking forward the proposals
about in the here and now and clarification on practice. If I
could answer your question, the essential question is how do we
manage the process of making sure that the NHS has, when it needs
it, and the Chief Medical Officer recommends, the guidance on
practice at the present time, particularly in this area of medical
inpatients and NICE's work. I was not a minister at the time but,
as I understand it, although there was discussion among the experts
as the issue was being developed, and I absolutely concede that
it was not a contradiction, the Department is looking very carefully
at how it managed that and whether it would be possible to avoid
Q727 Dr Taylor: We were all incredibly
impressed with the speed with which the Chief Medical Officer
did respond but then completely perplexed when the interim report,
or whatever it was, was ready and it was not actually published
for months and months so it came out at the same time as the NICE
guidelines. Then when you get two things which are subtly different
people do not know what to do. All I am pleading for is that this
does not happen again and if the Department does put out something
that it views as interim guidelines then it is made absolutely
clear that those no longer stand when NICE comes out.
Dawn Primarolo: We will consider
that very closely. As I am not medically qualified, I am just
a little hesitant in that the advice to me was that the guidance
was important. The experts in the field are perfectly capable
of distinguishing between the subtleties, as you have put it;
that is why they are experts. The essential point that you are
making about the need for care and clarity and the relationship
between advice, whether it be expert group, Chief Medical Officer
or NICE, is certainly one that I think is well taken. I would
be pushed to find a reason to disagree with you, and I am not
Q728 Chairman: Could I ask on that
about the issue of the advice to pregnant women. The Secretary
of State has been making some very relevant comments in terms
of health in terms of life chances at birth, as it were. Here
we had advice initially from the Department saying that pregnant
women should abstain completely from alcohol during pregnancy,
but then NICE guidelines came out to say that they should just
limit their intake to less than one and a half units of alcohol
per day. If it is so crucial to people's lifestyle in terms of
when you are born, as it were, why are we having this contradictory
evidence from these two cathedrals that people look to for advice
in terms of how they should rule their lives? Who is right?
Dawn Primarolo: They both are.
In May 2007 the Chief Medical Officer made two essential points.
First, that pregnant women, or women trying to conceive, should
avoid drinking, and I wish the evidence was much clearer because
it would make the discussion around alcohol consumption generally
easier, not just for pregnant women, but then he went on to say
that if they choose to drink they should really try and minimise
risk by not drinking, I think it was, more than one or two units
once or twice a week. Then NICE put out their guidance which was
basically no drinking, or very little. They are in the same area.
What will be best is when we have the final guidance from NICE.
Both of these areas that you have touched on are areas that are
difficult anyway, particularly the issue with drinking. Maybe
we should go to a precautionary principle with recommendations
for women drinking who are pregnant, or trying to conceive, which
I think is what the Americans do, which is just say "don't",
but at the moment we are still trying to work through this evidence.
I suppose in these contested areas these views will emerge but
NICE's final guidance will be final.
Q729 Chairman: That is likely to
be more evidence-based than the CMO's position.
Dawn Primarolo: I think it will
be very helpful when we have a synthesis of the point so that
it is absolutely clear to pregnant women or women who are trying
Q730 Mr Syms: We have had several
years of large increases in cash for the National Health Service
and yet a lot of the NHS cannot afford to implement a lot of the
guidance produced by NICE. We are now going into a period after
the CSR of rather more modest growth levels and that is going
to throw up a number of challenges. How is the Department and
the National Health Service going to cope with the situation?
Dawn Primarolo: First, the role
that NICE performs is one of not creating more money in the Health
Service but of helping in the most effective and efficient way.
In terms of affordability, as you will know the National Health
Service has a statutory duty to fund the implementation of the
technology appraisals, and that is factored into the spending
plans and allocations to the primary care trusts. It is not ring-fenced
and we do not hold it centrally but we do our best in knowing
the work that is being undertaken by NICE to make those allocations
available. Clearly there are always going to be pressures but
you are talking about the pressures that the National Health Service
itself faces: do we concentrate on giving ever more expensive
drugs or do we concentrate more on services, or do we try and
strike the balance about what is most effective and the best outcomes.
So we try and ensure in the devolving of the monies to the primary
care trusts that that puts them in the best position to do that
and has the two locked together, the requirement to implement
within three months under normal circumstances and the way we
try and work out the funding for the primary care trusts.
Q731 Mr Syms: Clearly we have had
a lot of money going into the service, I think we all acknowledge
that, and people see NICE guidance being produced, they have an
expectation they are going to get a particular drug, but inevitably
things are going to get tougher in the next few years. What I
am really trying to find out is what is the Department going to
do about this? Are they going to put more pressure on NICE maybe
to reduce the cost per QALY threshold? How are you going to manage?
The gap between expectations and resources is there now and it
is going to get bigger.
Dawn Primarolo: There is not an
easy answer. If you accept the proposition that our view as potential
patients of the NHS is that we have unlimited expectations, I
have already tried to answer that by saying that is a complex
web of interactions. Certainly my experience as a constituency
MP is that when put to individuals, "Well, we need to have
what is effective, not who shouts the loudest", they understand
that. That is one set of issues. On the other set of issues, and
you mentioned the use of QALY by NICE, you need lots of cold towels,
it seems to me, to work through the economics, the methodology
and the understanding of how NICE balance this and come to the
particular ratio that they do, and they use a great many experts
to do that. I take advice on the basis that the consensus is that
the methodology currently used by NICE is right, nobody has been
able to come forward and say that it is not. That is reinforced
by the review, which I presume you might have touched on, that
NICE undertakes every three years or so, and there is a consultation
to start quite soon in looking at that. That is the other pressure
point. The final point is yes, you are right, there is always
pressure in the Health Service, but it is true in any health system,
whether it is insurance-based, private-based or tax-funded, as
ourselves, which is expectation and cost, what is possible in
the most advanced technologies and drugs, can be extremely expensive
and how do you decide which ones you use. This comes back to my
first point that we try and do that in as expert and transparent
a way as we can removed from ministers about the optimal use and
Q732 Mr Syms: We have been told that
an independent body should set the threshold used by NICE and
the rest of the NHS. Would you agree with that? Do you think that
is a reasonable way to go forward?
Dawn Primarolo: That presupposes
there is a better way to do it in the sense of how NICE, through
its technologies, and it is a methodology and it is independent,
is consulting, is there to take these decisions and make those
judgments. It does have support mechanisms to look at that. If
there is a proposition that there is a much better way to do this
and it can be demonstrated to us then, of course, why would we
not want to engage in that discussion, but I need to see where
that is as opposed to just a straight proposition that somehow
the current system does not work.
Q733 Sandra Gidley: You said a few
minutes ago that the PCTs basically should be forward planning,
the money was given to PCTs so that they could implement the technology
appraisals guidance. Some of the evidence we have received is
that PCTs are under some pressure to implement guidance and effectively
by doing that they have to reduce money in other areas of spend
which may be more cost-effective. What would your response to
Dawn Primarolo: What, the PCTs
said they are more able to decide on cost-effectiveness rather
than the full body of NICE and all its expert panels?
Q734 Sandra Gidley: No. We are talking
about here you have a drug which has to be prescribed and in any
area of treatments there are non-drug treatments, so the PCT will
possibly have to cut back on those non-drug treatments or even
public health measures in order to implement the technology appraisal
guidance. Do you believe that having to implement within three
months is a good idea given that context?
Dawn Primarolo: We have a National
Health Service and what we ask NICE to do is look at the claims
of the drugs, that is basically the exercise they would undertake,
assess it against the evidence, compare it against what the National
Health Service is currently doing and using, and then it advises
on the therapeutic gain. It is basically talking about optimum
use. If, having come to that conclusion on something, then they
said, "But we're not going to guarantee access through each
PCT", would we not be open to a challenge that we were not
providing a National Health Service?
Q735 Sandra Gidley: But is the three
months fair because PCTs do have to undertake financial planning?
It is difficult to predict, and I know NICE try to help them.
It is difficult for a PCT to predict exactly what the spend will
Dawn Primarolo: Under some circumstances
it can vary. Perhaps I should ask Felicity to come in here.
Dr Harvey: There is a waiver system
and that is if, when NICE has completed its appraisal, it comes
forward to the Department to say, "We think there is a reason
why the NHS would not be able to take this forward within the
three month funding direction", then there is an opportunity
for ministers to be advised by NICE to say, "We think a waiver,
either a full waiver or a partial waiver, might be used".
Those have not been used in terms of costs of drugs. On the occasions
those have been used, and it is not very many occasions, it is
usually around a technology that has implications in terms of
staffing or reconfiguration of the way a service is delivered.
An example of that was surgery for obesity. There have been a
few examples but there are not very many. It is not just when
it is just utilised for a drug. Is it worth just mentioning that
not all NICE technology appraisals on pharmaceuticals are actually
driving up cost. For example, a technology appraisal that we had
on statins, which was the evidence-base that fed into the Better
Care, Better Value indicator for the NHS, said that actually in
terms of statin provision there is evidence to indicate for the
majority of people you should start treatment on a drug that has
a lower cost rather than one of the drugs that is now generic,
and it is only if that is not effective that you then move up.
Particularly with multiple technology appraisals and, indeed,
the clinical guidelines that NICE provides, it is providing advice
to the NHS that is helping them utilise the resources in delivery
of services in slightly different ways. As I think you were discussing
slightly earlier with Sir Michael and Andrew Dillon, they are
now publishing their optimal practice reviews where there is evidence
drawn from their guidelines and technology appraisals to help
the NHS realise the sorts of interventions that are going to be
effective and better help them utilise their resources.
Q736 Sandra Gidley: Sometimes they
are not directly competing services that have to go though. For
example, in a previous inquiry on NICE we were told that various
recommendations for cardiac payments meant that they could not
afford the cardiac nurses to provide rehab and various other things
and, given the choice, they might have felt that was a better
use of resources. What assessment has been made of these perverse
Dr Harvey: If you are talking
about a technology appraisal, that is why NICE would on occasion
advise ministers that, in fact, they think a technology appraisal
should not be supported by the three month funding direction.
If it is around a clinical guideline, also as Sir Michael and
Andrew Dillon said earlier, those are not mandatory in the same
way that technology appraisals are and that is because different
parts of the NHS would be at different positions in terms of the
model of the services they are currently delivering. Some may
be very close to what the guideline is suggesting is the best
way of providing a service and others might have a further distance
to travel. That is why, as they were saying, the expectation is
on those occasions that a PCT would look at what a guideline shows,
where their practice currently is and how they might move to that
over a period of time.
Q737 Sandra Gidley: A change of tack
slightly. Some PCTs play the system quite well and there will
be something they have to implement and to tick the box they provide
a small amount of funding for a particular treatment but that
funding will only treat half or even a quarter of the patients
who could benefit. What levers does the Department have to investigate
those cases where patients are being denied a treatment simply
because they are too far down the waiting list?
Dawn Primarolo: Can you give me
an example before I answer the question?
Q738 Sandra Gidley: I can give you
an example. The drugs for rheumatism. This is a local example.
The PCT would only fund for 12 patients but the consultant had
far more on his list. We eventually got the strategic health authority
involved but it took a lot of time, persistence and energy to
tackle that. It must be happening all around the country in a
similar way to restrict in a finite way what is potentially not
a finite demand.
Dawn Primarolo: In the circumstances
you have touched on, although you said it was extremely difficult
to get the strategic health authority to focus on it, where the
Department is involved through the strategic health authorities
they would be looking at the PCTs that they might consider to
be "outliers", and then get the strategic health authority
to engage with that PCT and produce an indication over what time
period they would come up to where they should be or where the
expectation was. If you have a particular example, particularly
given my period in post is only four months, from your experience
with your PCT and strategic health authority about the operation
of that, I would be happy to look at that. That is the interaction
between the Department and the strategic health authorities trying
to work with the PCTs to bring them to the position where they
should be over an agreed period of time.
Q739 Dr Stoate: Minister, I want
to talk about the PPRS. It has been around for about 50 years
and, generally speaking, I think it has served the country very
well, and broadly speaking your predecessors and industry alike
seem to think it is not a bad system. However, it is quite a blunt
instrument and one of the side-effects of it is that companies
that produce the most useful drugs are not effectively rewarded
any more than companies that do not produce necessarily the most
useful drugs. The question I want to ask is how can you justify
that? Do you think that needs to be looked at to encourage more
Dawn Primarolo: Certainly the
Government has indicated through the work that Lord Ara Darzi
is doing that the role of innovation and the speed at which both
technologies and drugs are available and get to the market is
something that is crucial and needs to be looked at. The Health
Innovation Council which is going to be established is designed
to do that. Its interaction with the current fora where the Government
discusses, whether it be with diagnostics, with the drug industry,
will have to be part of that. If I can put that to one side, Felicity
is leading on that and if you want to ask more specific questions
on that perhaps we could come back to it. On the question of the
PPRS itself, as you will know, I hope, the Department is shortly
to commence negotiations with the industry, the pharmaceutical
industry, and we are hoping to achieve a voluntary agreement that
will replace the agreement we have now. We have laid out the principles
we want to pursue, which is delivering value for money, encouraging
and rewarding innovation and providing stability, sustainability
and predictability in that whole very difficult area which I suppose
we touched on right at the beginning of the questions on rationing.
I am not able to explore that discussion any more but it is an
important interaction around the availability point that you are
making here. I am not quite sure how I can keep the Committee
informed of developments but I am happy to try and do that through
my officials. At this particular time, as we are on the eve of
engaging, it would be a bit remiss of me to lay out our negotiating