Examination of Witnesses (Questions 40
- 55)
MONDAY 4 FEBRUARY 2008
Professor David Harper CBE, Dr Stewart Tyson and
Dr Carole Presern
Q40 Lord Avebury:
My next question follows quite neatly on from the previous one
and is about the Medicines Transparency Alliance, which you referred
to in answer to a previous question and which sounds like a very
important initiative. I am wondering if you could tell us a little
bit more about what is planned and how it is going to help resolve
the problem.
Dr Tyson: I cannot really. I would say it is
work under development and it is building on the perceived success
of the Extractive Industries Transparency Initiative. It has identified
a number of separate entries and it will be trying to build again
on work that, for example, the Global Fund is doing, which is
setting out clear data on pricing. The transparency side in the
fund of highlighting how much countries are paying for the same
product is the starting point, and it might be that one country
is paying seven times the price for antiretrovirals than another
one and that is the first stage of trying to get a more rational
approach. I was asking those who work on the initiative what the
incentives will be for countries to engage in this process and
for international pharmaceutical companies to engage in it, and
it seems that there is a lot of enthusiasm on the part of the
big international pharmaceutical companies but how that translates
down to their local affiliates in countries is another issue.
Lord Avebury: You would think that all
the countries would be keen on it because they would see it as
a means of bargaining down the price. But I cannot see what is
in it for pharmaceuticals, because if this comparison is going
to be done on that sort of basis then surely everybody is going
to demand that those prices are available?
Q41 Chairman:
Has anybody got a view on that? This seems to me to be an important
area but it is a fairly new and emerging area, is that right,
in terms of getting agreement on it?
Dr Tyson: It is an emerging area.
Q42 Chairman:
There must be a struggle going on between money for research,
which will be the companies' argument, and the countries' pricing
mechanisms or whatever?
Dr Tyson: It is an emerging area and it is one
where the preparatory work is being done. Another initiative which
has some overlap is efforts to try and establish a global subsidy
for artemether combination treatment—you know, the new drugs
for malaria—that unfortunately cost about $10 or $12 for
a course rather than ten cents for chloroquine. There are similar
efforts there to deal with many of the issues around transparency
of pricing, making sure that there is competition, that we do
not create a monopoly, putting in place clear and effective systems
to monitor prices and price changes. It is an area where there
is enthusiasm but I think we recognise that it is very difficult
when dealing with the pharmaceutical industry to take at face
value what they say is their cost price.
Q43 Chairman:
Their argument is about research, is it not?
Dr Tyson: Their argument is about research and
that is one side of it. There are also other arguments in countries
where they may not want transparency in the prices that they are
paying for drugs, frankly because of corruption, and historically
we have seen corruption on both sides. It is an issue that we
are going to try and drive forward in these first seven countries
which have indicated enthusiasm for going down this route in the
same way that with the International Health Partnership there
are eight countries there which have taken to this and want to
make it work, and it will be a learning experience for us all.
Q44 Lord Hannay of Chiswick:
We have just begun to talk a little bit about research and we
have talked up to now about programmes and budgets and so on.
To what extent is there international co-operation or discussion
or dialogue about where the main research effort is going? I can
see that this is not terribly easy when you are talking about
big pharmaceutical companies, who indeed may get into antitrust
problems if they did. But to what extent is there a back-up effort
so that the huge resources that are going into research from people
like Wellcome and others are being directed in a consistent way?
Secondly, I saw in the papers a suggestion that, in the event
of a pandemic, there could be consideration given to compulsory
licensing of drugs and vaccines. That sounds a very exciting idea
indeed but one which, I imagine, bristles with innumerable legal
problems. Could you just explain a little bit how you could overcome
problems both at the national level and more widely? What would
be the legal powers? Who would have legal powers to make compulsory
licensing of drugs and vaccines in the event of a pandemic?
Dr Presern: The TRIPS flexibilities allow for
this compulsory licensing in the case of a public health emergency.
As for how it actually operates, I think it has barely been used
by any countries. Thailand has done it and possibly Brazil has
threatened to do so. From our side it seems a sort of last resort
option—and, I think, by most countries—because they
also recognise that you have to be able to give some incentives
to stimulate research and development. It has certainly been used
in AIDS programmes around the world when antiretroviral drugs
prices were very high, and it did help in some cases to bring
down prices.
Q45 Lord Hannay of Chiswick:
So you are talking about it being done by the individual nation
state under its own legislation within its own jurisdiction?
Dr Presern: Yes, but it has international cover.
Q46 Lord Hannay of Chiswick:
But presumably you are talking about a global pandemic. That would
be completely insufficient. That would not actually address the
problem at all if Thailand went for compulsory and nobody else
did. It would not help very much, would it?
Professor Harper: If I could add to that, it
is not entirely clear to me how it is relevant at the moment to
the pandemic influenza situation, not least because, as you indicate,
there is limited global capacity. So the approach at the moment
is to encourage the World Health Organisation to play its lead
role in this. You will be aware that for the likes of Tamiflu,
one of the key anti-virals, we would hope, in a pandemic, WHO
have established a stockpile for use in those countries that do
not have their own materials. When it comes to a vaccine, we touched
earlier on the issue around Indonesia and virus sharing and, of
course, the manufacturers need to have rapid access to the virus.
That is where a lot of the international energy is focused at
the moment. I think we are some way from a situation where I could
see compulsory licensing playing a role for the sort of reason
you allude to.
Q47 Lord Hannay of Chiswick:
Could I have an answer on the other question about co-ordination
of research—to what extent there is intergovernmental effort
to ensure that the main thrust of research goes in the directions
that the international community thinks are the most necessary?
Professor Harper: There is a variety of different
groups that are active, not least within the World Health Organisation
itself. For example, the Department of Health's Director General
for Research and Development is playing one of the key roles in
an area of R&D for the World Health Organisation, but it is
hard to generalise across the breadth of research and development
in some of the areas even that we have been talking about today.
There are some specific areas of good practice. I cannot really
comment on a generalised statement for co-ordination and collaboration.
There are lots of mechanisms through learned societies, through
other government agencies, through the research councils in the
context of the UK, and they are very well linked internationally,
but I am not really in a strong position to comment on the breadth
of co-ordination.
Dr Presern: There were efforts in WHO to get
more of a research strategy in place and there are organisations
like the Global Research Forum which tries to highlight that 90
per cent of the world's research spending is spent on ten per
cent of the world's diseases and is trying to get some international
agreement on redressing the balance.
Dr Tyson: I think DFID's approach has been to
support ongoing connections with a range of partners. Much of
the research effort into new products has been driven by the Gates
Foundation in trying to get the public and private sectors to
work together to develop new generations of health commodities,
whether it is drugs, vaccines, an AIDS vaccine through IAVI, Medicines
for Malaria, and TB drugs through Aeras, and we will continue
to do that as the DFID research budget is about to double. Our
strength is not generally in basic science research. There are
others out there with far greater budgets and far greater capacity,
but where we feel we do have an advantage and a model that has
been built up over many years is in supporting operational research,
getting products into health systems and delivered to the population.
We fund ten or 11 research consortia, bringing together the best
of northern institutions with southern counterparts, often even
working across a number of countries, and their focus is on the
major health challenges of the day. We have such consortia working
on AIDS/TB/malaria but also on mental health. I think in the next
round of proposals we will probably have cause to establish consortia
on nutrition and non-communicable diseases. That is the sort of
role split. We also fund pieces of more basic research with the
MRC and others such as Wellcome. We are working to our particular
strengths. In developing one drug we could spend the entire DFID
budget probably in a year.
Chairman: Do not do that!
Q48 Lord Jay of Ewelme:
My question is related to the access to and distribution of drugs.
It is very striking, travelling even in the most backward parts
of Africa, how much more effective the distribution systems are
for soft drinks and basic commodities than they are for even the
most basic drugs and medicines. I just wondered if you thought
there were lessons to be learned from, or indeed help to be given
by, the private sector in improving the distribution of medicines
to rural areas.
Dr Tyson: I do, very much, and everywhere where
you can buy Coke, if you look behind the Coke you will probably
find chloroquine and aspirin or paracetamol. It gets there. The
Prime Minister is trying to get a revitalised effort around the
Millennium Goals with seven years to 2015 and there is a process
of reaching out to the private sector to get them engaged in development
efforts. It is not just around delivery mechanisms, if you can
get Pepsi or Coke on board with their logistic systems, but we
have seen a major effort in News Corporation to get engaged in
scaling up the effort on insecticide-treated bed nets, so there
is a big effort to reaching out with the private sector and I
am sure there are many opportunities in the future.
Chairman: Finally, I want to turn to
the International Health Regulations.
Q49 Baroness Whitaker:
What difference are they going to make, would you say?
Professor Harper: That is a very good question.
As I said earlier in the context, of the Indonesian virus sharing
issue, the International Health Regs came into effect fully in
June of last year. These regulations have taken a great deal of
time and energy to develop and they replace the old International
Health Regulations which went back, as far as the sixties. They
were a very passive set of regulations and they covered a very
limited number of diseases, four of them to be specific—cholera,
plague, yellow fever and smallpox. The new regulations cover all
public health hazards in the sense of infectious diseases, toxicological
hazards and radiation hazards, and they are far more active. They
put the responsibility on a country that becomes aware of a public
health emergency of international concern to report that to the
World Health Organisation. If there is a weakness at the moment—and
it is very early days, we are only six or seven months into the
implementation—it is that there is no provision for enforcement.
The very example that we have been touching on this afternoon
around virus sharing by Indonesia might be a very significant
one. There are a number of people, colleagues of mine in other
countries, who are concerned about that issue particularly from
that perspective: there is no provision for enforcement. Whether
that proves to be a weakness or not we do not know yet.
Q50 Baroness Whitaker:
As I understand it, it is an opt-out joining system, so presumably
the United Nations members have not opted out.
Professor Harper: That is right.
Q51 Baroness Whitaker:
I think Article 59(3) says that every member's administrative
arrangements were to be fully adjusted by June of last year unless
they made a declaration, in which case they have until June this
year. I do not know if it is known how many member states have
made such a declaration.
Professor Harper: I do not know, is the answer.
Q52 Baroness Whitaker:
How many members are capable of implementing them? What about
their surveillance capacity? What about harmonisation of disease
reporting and things like that? What is your assessment of how
well they can comply, let alone whether they want to or not?
Professor Harper: It is very variable. I think
it is linked inextricably with the sort of discussion we have
had this afternoon on health systems in the broader sense. So
many of the countries most affected, for example, by avian influenza,
are those we are looking to to have improved surveillance systems
in place, so that there is the prospect at least of picking up
human cases and even human-to-human transmission in that specific
disease area. That is a weakness. I do not know numerically how
many countries would have difficulty in fully implementing the
International Health Regulations but it is clearly down to the
global community, not least because, as we say in our Global health
Strategy, global security is one of the key drivers. It is in
the interests of the UK, of course, to do whatever it can to help
health systems and surveillance and other features of public health
systems in those countries that do not currently have them or
where they are not of a standard that we might like to see for
the likes of pandemic influenza. I cannot say what the number
might be. Countries are working hard to do this, and in fact looked
at early implementation of the International Health Regulations
specifically in the context of pandemic influenza.
Q53 Baroness Whitaker:
So is the UK gearing up its support for countries' health monitoring
systems in order to help them comply?
Professor Harper: We have been trying to play
a part for years in trying to make more robust the systems that
exist. We work, as we were saying earlier, at an operational level
with expert advice and with our scientists and public health experts
playing a role either through WHO or bilaterally with other countries
to try and help them, and it is very much part of the development
agenda with pandemic influenza and avian influenza. There has
been a very large international drive to increase the amount of
resources in terms of pledges from a whole variety of countries
over the last two to three years to try to get money into those
countries that really need it to improve facilities and infrastructure.
Dr Tyson: The money going into partnerships
like Roll Back Malaria, Stop TB, UNAIDS, will all contribute to
that sort of work. In addition, we fund the Health Metrics Network,
which is a global initiative set up to try and revitalise and
strengthen the broad health information system, not disease specific
but including vital registration and strengthening census systems,
looking across the board.
Professor Harper: I should just clarify that
that is not driven by the International Health Regulations alone.
However, it would help in terms of the implementation of the International
Health Regulations.
Q54 Lord Hannay of Chiswick:
I noticed somewhere in the papers a suggestion that it would be
highly desirable for the WHO to hold a global exercise to test
people's readiness to deal with a flu pandemic. Could you say
something about where that is getting to and would that in itself
be one means of showing up whether people were applying the regulations
or not? Would it be another instrument to bring them up against
the need to strengthen their implementation of that?
Professor Harper: I think it might well be.
The World Health Organisation are looking at that very actively
at the moment and have been for some time. As you will be aware,
we have had exercises nationally. Last year we had a very large
exercise, Winter Willow, which included something like 5,000 people,
players right from front-line operational workers through to Ministers
in the COBRA system. It is the way to test plans and it is the
way to test preparedness. It is absolutely essential. It is no
good having the plan alone without knowing that it will work.
They are designed to demonstrate where the gaps are. A successful
exercise is one that comes out with the lessons learned. I do
not know exactly where the World Health Organisation are but I
understand that the European Commission and the World Health Organisation
are close to advertising if they have not already done so, for
organisations such as the Health Protection Agency in this country
to run an exercise on their behalf.
Q55 Chairman:
Is there anything that any of the three of you would like to say
to us about the adequacy of intergovernmental organisations or
our interaction with them and about either these four diseases
or any others? Or have we covered all the areas that in your view
needed to be covered?
Professor Harper: I think you have covered the
majority of areas. If there is anything else that we think might
be material to your investigation, then of course, as we have
already identified this afternoon a small number of items, we
will try and submit that evidence to you.
Chairman: Very well. Thank you very much
for your time.
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