Examination of Witnesses (Questions 800
- 819)
TUESDAY 22 APRIL 2008
Dr Julian Lob-Levyt, Mr Geoff Adlide, Ms Linda Bifani
and Ms Magdalena Robert
Q800 Chairman:
Good morning. Thank you very much for your time in this rather
splendid building, if I might say, which is rather admirable.
We have about an hour today. As you know, we are the Select Committee
on Intergovernmental Organisations looking at the question of
communicable diseases and the way that intergovernmental organisations
deal with them and the British Government's contribution to that.
As you can see, there will be a full note taken of the exchanges
at this meeting. That will be sent to you and you can check the
transcript before it is published in the normal way if there are
any factual matters you want to change. I would like to encourage
a very full exchange, so please feel free to intervene on the
various questions that will be asked. I also want to say that
within one hour you cannot always get in all the things that matter;
so, if you feel strongly that we have missed something out or
you want to expand on something, you can write to the Clerk at
the House of Lords. Perhaps I could ask you to introduce yourselves
first so we have an idea of your roles. We have obviously read
your brief.
Dr Lob-Levyt: I am Julian Lob-Levyt. I head
up GAVI as the Executive Secretary. I will ask my colleagues to
introduce themselves.
Ms Robert: My name is Magdalena Robert, I am
in the Programme Funding Team within GAVI and am responsible for
the UK.
Ms Bifani: I am Linda Bifani. I am the Head
of the Programme Funding Team.
Mr Adlide: I am Geoff Adlide. I head the Advocacy
& Public Policy Team here in the GAVI Secretariat.
Q801 Chairman:
Thank you very much indeed. Can I start with one of our main interests,
which is your health system strengthening programme. In fact,
we have just come from a meeting with the pharmaceutical industry,
who have been talking to us about the difficulties of getting
drugs through on the ground and the infrastructure on the ground.
One of the issues we have been struggling with a bit is the problem
between the horizontal, as it is called, and the vertical of disease
treatment options. I suppose what I would like you to do first
is to ask if you could tell us a bit more about what you are doing
on that, how you see it working and any of the strengths and weaknesses.
That would be very helpful to start us off.
Dr Lob-Levyt: Welcome to GAVI, it is nice to
have you here. After the first five years of GAVI, two years ago,
we consulted with stakeholders and principally developing countries
and spoke in quite a structured way to 40 Ministers of Health
of the 73 countries that we support, asking them what did they
think about GAVI. There were positive things and negative things,
but the consistent and very strong message was that, if we wished
to achieve sustainability with introductions of vaccines, GAVI
had to address health system strengthening. We listened to that
very carefully and then ran a process of design with stakeholders
and developing countries as to what might be most suitable for
GAVI to do. This year we have introduced our new policy of opening
up a window for health system support. The overall balance of
funding in GAVI is structured as 70 per cent of our funding is
still for our core mission around vaccines, about 30 per cent
of our money is for systems building. I personally come from a
health systems background, so this is a direction that personally
I think is absolutely necessary. The debate has moved on a little
bit from talking about vertical and horizontal programmes to trying
to avoid saying that from now on and conceptually to think about
service delivery platforms in the public-private and civil society
sectors and defining the outputs they need to deliver, which will
vary from country-to-country determined by the robustness of the
system. The outputs of the system will be things like TB treatment,
HIV treatment and prevention, malaria bednets and vaccinating
children. That is the way we have taken it and that is the way
we have structured this window. We asked countries to put their
proposals to us, demonstrating how they fit within the national
health strategy and what part of that strategy we would be funding,
and we asked them to tackle critical bottlenecks in a way that
would strengthen not only immunisation, which still has to be
measured, but broader maternal and child health services. We have
had the first year of funding proposals. The demand was far greater
than we anticipated and we had to go back to our Board to ask
for additional funding. There is a huge pent-up demand for health
system funding. We were also pleased to see that most of these
proposals, certainly those that were successful, were carefully
designed with national partners at a country level and around
national strategies and partnership. We have some quite good evidence
that our finance catalysed the working together of key partners.
The quality of the proposals was high and a greater proportion
was approved than had been the case when GAVI first started with
just vaccines. This is a reflection of the very good work that,
in particular, WHO undertook working with countries in helping
them to prepare quality proposals. That is another very positive
development. It is too early to see the results and the outcomes,
but the majority of the funding has been for peripheral activities
and has focused a lot on human resource capacity, development
and retention of staff. For example, the proposal in Ethiopia
is part of a programme to train up to 35,000 health extension
workers, linked into the health system to provide maternal and
child health services and immunisation services out into the community,
a programme that has been strongly endorsed by the World Bank
and Partners at the country level. In a nutshell, that is where
we are. We are also very clear that GAVI is a tiny slice of the
necessary financing that will be required. The World Bank, the
Global Fund, ourselves and others, are very clear that no single
institution can deliver this, we all need to play our role collectively
in a well-coordinated framework, and a coordinated effort will
only work if it is country-driven. If we can work around country-driven
strategies, I think it will have a lot of success in playing to
what our institutions can deliver. For GAVI it is more about the
catalytic finance, and then you will be looking to WHO for some
of the normative work and standards and to the World Bank probably
more for the capacity building, long-term institutional financial
mechanisms at country level. It is challenging but, with in particular
the creation of the International Health Partnership (IHP), a
collaborative framework led by UK, France, Norway and others,
at the country level I see that increasingly GAVI will have a
framework into which our finance can fit, that we will not need
separate approval processes, we will not need separate monitoring
processes, we will have a collective process against which our
finance can flow and against which we can measure our results.
Q802 Chairman:
Can you expand on that a little in relation to the country-led
bit. I can understand that in terms of a country that is functioning
tolerably well, but you have straight away got the problem that
an awful lot of countries' governmental structures do not reach
out beyond the capital or whatever. How do you deal with that?
Dr Lob-Levyt: You are absolutely right, it would
be a minority of countries where you have a robust IHP well led
by the government. We are beginning to see the first wave of those
countries coming forward this year and next year. In those countries
where you can rely less on the government financial systems in
particular, we would be looking more to intermediaries to provide
some of that function. For example, the World Bank would take
on much more of a financial stewardship role at the country level
and transfer the finances to the programmes until the capacity
in those countries has been built to operate through national
budgetary systems. We also work in fragile states and some quite
politically difficult countries, such as North Korea or Burma,
where there are real political concerns and concerns as to how
that finance might be used. In these cases we work directly through
the UN, WHO and UNICEF to monitor programmes. You can have a spectrum
of funding modalities between these extremes. The goal should
be to build increasingly along the model of the collaborative
framework of an IHP type process and have that as the developmental
goal which puts the countries in charge. In my experience, because
I have spent most of my working career working in some of the
poorest countries in the world and with different organisations,
we constantly under-estimate the capacities of countries in sub-Saharan
Africa and South Asia that, with well-thought through financial
support, can really use that in an effective way. I happen to
be a very firm believer that, if you can deliver the finance at
the periphery to district managers, by and large they will do
a very excellent job as long as you measure the outcomes against
which they are delivering.
Q803 Chairman:
I would like to pursue that if I could because one of the interesting
points that was put to us a short while ago was about the role
for the World Bank in supporting infrastructure. I hear what you
say, that no single institution can deliver it, but the World
Bank's involvement is pretty crucial?
Dr Lob-Levyt: Yes.
Q804 Chairman:
I am also aware that, in a developing country, just because you
do not have a functioning government, when dealing with a common
enemy, for example disease, it does not follow that the informal
structures do not necessarily work and work tolerably well. Would
it be possible to use that, if you like, informal structure in
these countries, perhaps a bit along the lines you were suggesting,
I am not sure, and having the World Bank funding that infrastructure?
Or is it the sort of infrastructure where the World Bank would
throw up its hands in horror and say, "This is not something
we can measure, it is not something we can see and identify the
right sort of investment"? Is that a problem?
Dr Lob-Levyt: I would say that the Global Fund,
the Global Fund to fight AIDS, TB and Malaria, and GAVI, in a
positive way have challenged the status quo as to how you can
operate in those circumstances and that has enabled governments
to make more innovative and flexible responses, including involving
civil society and the private sector more, NGOs for example, as
routes and mechanisms for programme delivery. In part, it is challenging
WHO, the World Bank and others to think about how they need to
better engage with those other parts of the system in a way that
traditionally they have not done before. That is a very healthy
thing about the growth of Global Health Partnerships which is
sometimes seen as a problem. I think it is a natural development
of a heightened political commitment and interest in development.
When you have Prime Ministers of the UK, Norway and an increasing
number of Presidents committed to development in the G8 and more
finance flowing, you are going to get a mushrooming of effort
and initiatives, partly as a reflection of the lack of progress
made in the past and that you have an urgency to deliver. We are
in this rather exciting stage that I have never been in in my
25-year career in development, of more money, enthusiasm, incredible
political leadership and great pressure to deliver. I think we
are now at the stage of how we bring this rather challenging process
together. This is a natural progression and we should not be frightened
by it, we should be concerned to make it effective. Part of that
is challenging existing institutions to think how they move into
the 21st Century. Fundamentally, it is really about recognising
the increasing and sophisticated capacity of some of the poorest
countries in the world and how we need to tailor our assistance
to support that, and many institutions have yet to fully move
in that direction.
Q805 Chairman:
What you are describing is not just bringing people into the 21st
Century, it is requiring some established institutions which,
for good reason, have got set ways of dealing with financial investment,
which require, for example, very good accountancy to avoid the
corruption problem. You actually need, do you not, the invention
of a system that either takes account of the corruption or the
misuse of funds in some way because, although I am sure you right,
if you use the local network, it can often work very well but
we also know it can work incredibly badly and, particularly where
there has been conflict, drugs might end up with patients on one
side of the conflict but not on the other side of the conflict.
You are asking a lot, and maybe the World Bank is a classic example
where you are asking them to put money into something where you
cannot see a structure which measures the use of that money.
Dr Lob-Levyt: Let me be very clear: unless we
can have accountability for results, we are in a really difficult
position because we will lose the confidence of governments and
electorates that vote the monies for development. The way that
GAVI has come to this is by focusing on results, so that we can
measure independently through audit and UN institutions the performance
against immunisation and health system delivery. If we are satisfied
with those results, we can also have greater confidence in the
finances being used in that direction. We also have the ability
to bring in an external audit when we need to, either on a random
basis or when we suspect there is an issue. All of the governments
we work with fully understand this. It is a partnership, so it
has to be worked out that we are both strengthening and supporting
national systems and not undermining them, but there is accountability,
this is a two-way process.
Q806 Lord Desai:
Have you had any cases where you have had to say, "Enough
is enough"?
Dr Lob-Levyt: Yes, we have. We suspended finance
to Uganda because we became aware that there was a misappropriation
of funds by the Minister of Health. We raised it directly with
the government, the Minister of Health was brought to account
and replace, and we have just come to an agreement with the government.
We used their national audit processes, we were satisfied that
they had found the problem and that they will repay the money
to us. That is about to be officially announced.
Q807 Baroness Whitaker:
I just wondered, when you evaluate results, are you talking about
the delivery of vaccine to a clinic or organisation? Or are you
talking about lowered prevalence, actual change, as the real eventual
outcome?
Dr Lob-Levyt: The relationship between vaccination
coverage and the impact on the disease is quite well understood
and fairly well measured so that we know, for example, in the
case of sub-Saharan Africa that by increasing the vaccination
coverage from just over 40 per cent to over 75 per cent coverage
in the life of GAVI we can model a significant impact on disease,
and WHO has advised us that GAVI has now prevented some 2.9 million
future deaths as a result.
Q808 Baroness Whitaker:
Because they have noticed the absence of illness? Or because the
vaccines are in the clinics?
Dr Lob-Levyt: Because the vaccines are in the
arms of the children, and that can be measured, we have had the
coverage. We also have sentinel surveillance studies which take
place to see what has happened to disease. There has just been
an independent article published with the work of WHO and others
in Uganda, where vaccinating against the disease of Haemophilus
Influenza B, supported by GAVI, a very nasty disease—meningitis—has
been eradicated from that country because that coverage is there.
You are testing by measuring the disease burden and the secondary
check is that a good quality vaccine got into the arm of a child.
We are very confident of the impact that we are having and the
sophistication of our surveillance through WHO and others allows
us to have that confidence.
Q809 Chairman:
Before we move on to the incentives for vaccine development, can
I just clarify how do you use the investment in a way that ensures
the vaccines or inoculations get to the place in a satisfactory
state to be used? Presumably you need some equipment for that?
Are they travelling vehicles, clinics, what are they?
Dr Lob-Levyt: The vaccines have to be internationally
tendered. UNICEF undertakes the purchasing of GAVI vaccines out
of Copenhagen, they are shipped to an African coast and get to
a remote village. Vaccines need a cold chain to do that; a chain
that keeps them within a specific temperature range, and we provide
some of the finance that is necessary to sustain that cold chain
to the village as part of the programme, as part of the system
of support.
Q810 Chairman:
That would be a driver and a vehicle?
Dr Lob-Levyt: A country may decide to use our
finance to do that, or other finance. They mostly use their own
budgets, of course. Most of health, and the necessary staffing,
as we always forget, is funded by African national budgets, it
is not just by donors. It has got pretty sophisticated now. There
is very careful monitoring of the temperature. The vaccines that
we supply now all have to have a little monitor on them, which
is a colour-sensitive chemical strip that changes colour if it
falls out of the temperature range, it is thrown away. This is
constantly audited and measured. The quality of the vaccines when
they arrive at these remote villages is very good on the whole.
It is a remarkable story.
Q811 Chairman:
I hear your enthusiasm. When it gets to this village, there is
a person there trained who understands and knows to throw it away
if the strip has changed colour? And they know how to inject?
Dr Lob-Levyt: Yes.
Q812 Chairman:
Who has paid for that? Is that the healthcare system of the country?
Or is it you?
Dr Lob-Levyt: It is the healthcare system of
the country. Increasingly, we are saying that, to extend coverage
to the remotest and poorest communities, you need to expand the
human resource workforce. That is probably the biggest challenge
for sub-Saharan Africa—the shortage of doctors, nurses,
paramedics and community health workers. That is one of the ways
in which our finance is being used, this new health system finance,
to increase and strengthen that capacity. No vaccine is ever given
except by a well-trained person, that is part of the system. The
people who give it know how to do it and know how to monitor.
Q813 Chairman:
Supposing the World Bank did say, "OK, we are going to put
more money into the infrastructure to ensure vaccines and inoculations
get through", how would they do that? Would it be a matter
of giving it to the health authority in the country? What would
it be?
Dr Lob-Levyt: Again, it would depend on the
country but it would be by providing the finance to budgets for
training and capacity building. It is fairly simple. At the end
of the day you need a well-trained, probably locally-based person
in a reasonable clinic that is clean, is assured that they are
well supervised and supported and their drugs and vaccines arrive
regularly and on time. It is simple if you look at it from that
end, but to put that infrastructure in place is very challenging.
If we keep our minds focused—on what you need at that community
level, or somebody who visits the villages on a regular basis,
and work backwards from there, you can begin to put that system
in place, and many of the countries I have worked in have done
that, some of the poorest countries.
Q814 Lord Avebury:
You mentioned incentives to spur development and I wonder if you
could illustrate that by talking about the successes in Hepatitis
and Yellow Fever. What were the incentives that worked there?
They were not purely intellectual property incentives that applied
across the board, there were some additional ones that you put
in place. I think you developed the Advance Market Commitment?
Dr Lob-Levyt: Yes.
Q815 Lord Avebury:
I wonder if that applied in the case of those two particular vaccines
and if you could go on to say something about the current work
you are doing on Pneumococcal Disease where, again, the Advance
Market Commitment (AMC) is the tool of preference, as I understand
it.
Dr Lob-Levyt: The introduction of Hepatitis
B probably represented the perfect situation. It was a vaccine
that had been around for 15 or 20 years, well-used in the West
but denied to the poorest countries on the basis of cost. When
GAVI arrived, it said, "We have five years of financing,
we are prepared to buy it". There was a lot of competition
out there, a lot of producers. Our volume of financing and our
ability to finance over a number of years to some of the poorest
countries and the demand from countries meant that Hepatitis B
has gone from almost no coverage in the life of GAVI to almost
70 per cent coverage across some of the poorest parts of the world,
so a significant increase very quickly. The price of the vaccine
has dropped because of the competition. That is the perfect world
that you would want to be in, it is off-patent and many manufacturers
secure financing and demand from the countries. That is where
you want to be. In other areas we are not in that situation. Let
me step back from that for a moment. We learnt that five years
of financing is desirable but not sufficient. What has changed
and become a really important dynamic is that GAVI has a track
record now of longer than five years, industry sees we are not
fly-by-night, countries see we are not fly-by-night, Countries
have the confidence that we will not let them down financially,
and we have a better instrument. We have countries such as Norway
and organisations like the Gates Foundation that have pledged
ten years of financing. The International Financing Facility,
for Immunisation (IFFIm), in which the UK Government was a major
driver, allows us to have ten years of legally binding finances.
We can go to countries and say, "We can enter into ten-year
programmes to support you, so that you can build your budgets,
the co-financing of these new products," and industry responds
well when they see a market where there was not a market before
and come into it. So we see the competition build up as more companies
come in, but it takes longer than the five years we first thought
for newer vaccines, it takes five to ten years. The next step
beyond that is the Advance Market Commitment, which is basically
saying, at its simplest, "If you produce a vaccine in this
disease area with this effectiveness and at a price at the end
of the day that is affordable" and we will set that price,
"we will buy it". In the early years we will heavily
subsidise that vaccine because it is an effective vaccine and
it will generate demand from countries. But at the end of the
day we know this is going to be affordable because we are going
to get it at the rock bottom price. We used an independent committee
to identify which disease and which vaccine would be most appropriate
to test this concept, and that was against Pneumonia, the Pneumococcal
vaccine, and then we worked with six governments, together with
the World Bank, to design and build the legally-binding framework
that would mean that US$1.5 billion would be there when the vaccine
became available. Probably the biggest challenge was getting a
multinational agreement that was sufficiently legally secure that
industry would have confidence that, if they did this, it would
happen. It is also designed in such a way that, if somebody comes
up with a better vaccine, it is not the winner takes all the prizes
as it were. If another company comes in with another vaccine further
downstream, we have segmented it such that we can also take up
that other vaccine to promote competition to get more than one
industry coming in. The worst thing would be if it remained with
that monopoly situation; we want to move to that situation where
we have the hepatitis B with more people coming into this market.
Q816 Lord Avebury:
Is that US$1.5 billion in place? Have you got that money?
Dr Lob-Levyt: We have now got the US$1.5 billion
secured. We are finalising the legal documents. We are pretty
confident we will have that by September of this year.
Q817 Lord Avebury:
Is it PneumoADIP you are talking about?
Dr Lob-Levyt: The PneumoADIP was a separate
mechanism that GAVI developed. We recognised that for new vaccines
there was not a well-coordinated and appropriately funded mechanism
to do the other pieces of work that are necessary, the safety
trials in countries, Africa in particular, the other clinical
studies, some of the practical operational work that we needed.
So we set up the ADIP Committee, which was almost a contracted-out
mechanism for GAVI, because even though this looks like a big
conference room we are quite a small organisation, and with institutes,
WHO and other experts, they oversaw the process of the necessary
fieldwork that would need to be done to accelerate the introduction
by having the results we would need—is it safe in Africa?
What happens when you give it to HIV/AIDS populations? So we could
get those answers faster. If you just leave it to the market,
it takes ten years, so we deliberately targeted certain areas
which were more on the operational side to speed up the answers
we would need for when the vaccine was available. That was done
for pneumonia and it was done for diarrhoea, Rotavirus.
Q818 Lord Avebury:
Do you think this is a model which applies more generally than
to particular diseases?
Dr Lob-Levyt: Yes, I think so. We have learnt
a lot of things in GAVI which are applicable elsewhere and for
other diseases.
Q819 Baroness Whitaker:
Lord Avebury and I are both members of the All-Party Parliamentary
Group on Pneumococcal Disease, so we are very interested to hear
your evidence on this. I was very interested to hear that you
got long-term funding from the US Government, because one of the
problems with making the International Financing Facility cover
more than vaccines, and it was meant to be general, was that the
US Government said, "We cannot commit ourselves so long in
advance because Congress likes to renew our arrangements every
year". How did you get around this?
Dr Lob-Levyt: Sadly we did not. I am sorry if
I was not clear. It is from the Gates Foundation as a philanthropic
organisation that we have had ten years of committed financing.
Having said that, the US Government has remained very interested
in the AMC, which is another form of securitised financing, so
we are still working on that and hoping that, with the new Administration,
we might make even better progress, but we shall see. Having said
all that, the US has been a very committed supporter of GAVI.
They provide US$70 million a year and have funded at an increasing
level since the beginning of GAVI. Although they appropriate their
funds annually, we see them as a very committed donor, and an
important one.
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