Examination of Witnesses (Questions 662
- 679)
MONDAY 21 APRIL 2008
Dr Jorge Bermudez and Dr Philippe Duneton
Q662 Chairman:
Thank you very much for coming and for the evidence you have already
given. We have about one hour. You will have an opportunity to
see the transcript, because the events of today are being recorded,
and you will have the chance to correct any factual inaccuracies
or anything you would like to clarify. If you feel you would like
to send us any further information, if at the end you feel you
have not dealt with everything, please do. Perhaps I could start
by asking you to introduce yourself. I understand you are the
Executive Secretary of UNITAID, but perhaps you would give us
a little introduction as to what your job is and then we will
go into questions.
Dr Bermudez: Thank you, my Lord Chairman. About
myself or UNITAID?
Q663 Chairman:
About yourself in relation to UNITAID.
Dr Bermudez: I think you have all the information
we have given you on UNITAID.
Q664 Chairman:
Your role in UNITAID.
Dr Bermudez: I will leave you two advance copies
of the report of 2007. That is our first report. We just finished
it for our Board two weeks ago in Brazil. These are advance copies,
it is being printed. It is a very good overview of what we have
done during the last year.
Q665 Chairman:
Thank you.
Dr Bermudez: My name is Jorge Bermudez. Originally
I was a medical doctor with a Masters in Science in tropical diseases
and a PhD in public health. I come from Brazil. I have worked
almost all my life in the national health system of Brazil, the
Ministry of Health, at the province and state levels. I directed
the National School of Public Health in Brazil. In 2004 I moved
to Washington as a Unit Chief for essential medicines, vaccines
and health technologies for the regions of the Americas. I worked
for almost three years in Washington, responsible for Latin America
and the Caribbean regarding medicines, vaccines and technologies.
As you are aware, UNITAID was launched in September 2006, initially
by five founding countries—Brazil, Chile, France, Norway
and the UK. After UNITAID was launched, a hosting agreement was
decided with the World Health Organisation and all posts have
been filled by the World Health Organisation criteria. I applied
for the post of Executive Secretary to UNITAID and was selected
and came to office in July 2007, almost one year after it was
created. From July 2007 I have been responsible for the day-to-day
activities. I lead a team of 16 professionals from 11 or 12 nationalities.
We are committed to all the bye-laws and principles that were
founded with UNITAID and have been developed and approved during
all the Board meetings. As to our governance structure, we have
an Executive Board composed of 11 members. Those are; the five
founding countries, a representative from the African Union and
a representative of the Asiatic countries, (currently from Korea),
a representative from NGOs, communities living with the diseases,
the private foundations (currently the Gates Foundation) and the
World Health Organisation. That has met seven times up until now
and our last meeting was two weeks ago in Brazil, for the first
time outside Geneva. All of the decisions of UNITAID are taken
by that Board, by all its members, of course instructed and prepared
by the Secretariat, and then it is up to us to implement all the
actions that UNITAID has developed during the last year and a
half.
Q666 Chairman:
Thank you very much, that is a very comprehensive summary. One
of the things that struck me about UNITAID was that it is quite
an unusual organisation in the way that it was born, if I can
say that, and it is also a "coalition of the willing".
I understand you have a few more country members now. How does
that affect the way you work? Is it actually an advantage to have
a coalition of the willing? Or do you feel it would be better
if many more countries of the world were represented on it and
there may be limitations to that structure? Is that right or not?
Dr Bermudez: I do not think there are limitations,
because one of the initial ideas of UNITAID was not to overlap
with what is ongoing, to have an additional value and select specific
niches that were not being addressed to really make a difference.
On the other hand, it is very important for us to have predictable,
long-term --- Dr Duneton .arrives at this point.
Q667 Chairman:
Welcome! We have done the introduction, Dr Duneton. Please complete
your answer, Dr Bermudez.
Dr Bermudez: The basic ideas were additionality,
not overlapping, specific niches to be addressed—and, of
course, having predictable, long-term sustainable funds in order
to comply with our main objectives, namely, to impact market dynamics,
to extend the availability of products (because we only work with
products), lower prices in markets, therefore stabilising the
markets, and adding quality to the products they were using. In
that sense, with eight countries up to this date, we have developed
a model similar to what was proposed by UNITAID as a tax on airline
tickets, so that will be a permanent tax that is predictable,
or a multi-year commitment, as some countries (the UK and Spain)
have already placed for several years. That brings us stable financing
that does not depend on the willingness of the governments to
address other organisations as they have to negotiate every year.
As this is predictable, we can negotiate long-term agreements
with manufacturers, we can stabilise the market as we have forecasts
for several years and, therefore, it is attractive for manufacturers.
I do not think we are a coalition of the willing as you say but,
let us say, committed countries with stable mechanisms that will
ensure predictability. We do not work in the areas that others
are working in, we work in complementarity with them—the
Global Fund, WHO, UNICEF or any other organisations. Let me just
introduce Philippe Duneton, our Deputy Executive Secretary. He
comes from France and he may be the only one who has been there
since the beginning of the creation of UNITAID working on the
proposals and is now the Deputy Executive Secretary.
Q668 Chairman:
You are very welcome. I understand you had a tiny problem getting
here. Just to say to you that these events are recorded and you
will have an opportunity to look at the transcript before it is
made public. Just to finish off that question, in a sense you
have a sort of programming function and a financing function.
But how do you exercise oversight into how that is done to make
sure that what happens on the ground is what you want to happen,
if you like, making sure that your delivery is what you believe
it ought to be?
Dr Bermudez: To continue with my comments on
the last question, as we work in specific niches and only with
products, all of our activities are dedicated to ensure products.
We do not work in other areas, we let our partners work there.
We do not work alone, we work with well-recognised partners that
have field offices, country offices, implementing agencies or
even procurement agencies, or other types of actors that will
ensure within the country that the products that are funded by
us—the products are funded by us, not the strengthening
of the health system or the procurement and supply management
system in the countries—arrive, and that is conducted by
our partners. We work in other key performance indicators. We
have four main objectives: to ensure the availability of products;
to ensure an adequate price of products; quality of products;
and delivery of products. For each one of those objectives we
have developed indicators, and in each one of our programmes we
have analysed all the four indicators to see if we are impacting
on price, quality, availability and lead time. Last year we presented
to our Board in December an analysis of HIV/AIDS—related
programmes and now we are doing that with TB and Malaria. In all
of our programmes we have reached adequate results based on the
indicators that we have developed. Another issue I mentioned previously
was that we only work in specific niches that are not addressed.
For example, in HIV/AIDS everybody knows that the Global Fund
has a very big programme on first-line antiretrovirals, so we
do not know work with first-line antiretrovirals. We discussed
that with the Global Fund and are funding second-line antiretrovirals
for resistance to first-line and paediatric antiretrovirals. There
was a gap in paediatric antiretrovirals because nobody was addressing
that. In TB we are working with multi-drug resistant TB and the
Global Fund says UNITAID is responsible for that, and we work
with them and other organisations addressing multi-drug resistance.
In Malaria we are working with the Artemisium compound, ACTs,
that is the future for Malaria, and we are also engaged in a multi-taskforce
that is dealing with the so-called Affordable Medicines Facility
for Malaria. That puts together WHO, UNICEF, UNAIDS, UNITAID,
the Global Fund and the World Bank, working to make sure that
we will have products available worldwide for Malaria. We will
address quality, the pricing of these medicines, children's medicines.
Thanks to our long-term financing, we have introduced new products
in the market because it is attractive to manufacturers. In TB
and paediatric antiretrovirals we have new fixed-dose combinations
that are much more pleasant for the child to take and much more
quality-assured because they have been pre-qualified by the World
Health Organisation scheme.
Q669 Chairman:
The production of a good quality drug is one thing, the delivery
of that drug to the individual who needs it, given the problems
in some developing nations, is another. How would you have confidence
that you are delivering that sort of quality to the individual
who needs the drug?
Dr Bermudez: Quality for the manufacturer and
the WHO is clear, because we are addressing that and our new product
will be delivered to the market. How you make sure those products
will be delivered to the people who need those products and that
they are of quality, that is why we work in partnership with other
organisations that work in that field, and we ensure that by means
of agreements with the Ministries of Health of other countries.
We do not work out of the health system. All of our programmes
have agreements with the Ministries of Health in the countries
that are receiving the products to make sure those medicines will
flow through the health system and be adequately received, stored
and distributed through the supply system. We have Partners who
have field officers who will monitor that for us as well.
Chairman: Thank you. I think Lord
Avebury would like to ask about your relationship with the World
Health Organisation.
Q670 Lord Avebury:
Just before I come on to that, could I ask whether you are planning
to expand the number of contributors. I think it went up from
an initial five to 27. Are other States coming on board? Is the
airline tax being extended to further carriers beyond those who
signed up originally?
Dr Bermudez: I will answer that in two stages.
We began with five countries supporting that, and now some African
and other countries have said that they want to support that and
have come on board, either by the air tax or by implementing in
other ways or by multi-year stable financing. We have been discussing
this, and other countries have said they want to, but they want
to have more details about how they can implement that. Some countries
are working on that. A new idea that we have had approved by our
Board and in a conference call last week is a proposal—and
you have probably heard that our chair is a former Minister of
Foreign Affairs of France, the Under-Secretary of Ban Ki-Moon,
the United Nations' General Secretary—for innovative mechanisms
for financing development. He has been committed and talking about
the possibility of a voluntary solidarity contribution that would
be managed throughout the global data systems in the world. We
are aware that 65 per cent of air tickets that are issued worldwide
are issued through three main global data systems—Galileo,
Amadeus and Sabre—that generate internet-based transactions.
The three CEOs of those agencies have agreed to work closely with
UNITAID to see the possibility of implementing a voluntary solidarity
contribution, as some other actors have done in hotel bookings.
If correctly addressed, in the most pessimistic situation that
would add about $300 million per year up to $1.8 billion that
could be reached if we implement a voluntary solidarity contribution.
That is an idea that is being rapidly developed and it has been
announced since our chair, Philippe Douste-Blazy, was named Under-Secretary
of the UN.
Q671 Lord Avebury:
It sounds like a terrific idea, except that it conflicts a little
bit with what UNICEF are already doing on airline tickets, does
it not? They have a voluntary contribution that people are asked
to pay when they get on board the aircraft and there is a leaflet
on the seat which invites the passenger to pay something towards
UNICEF. If you are going to require this voluntary contribution
to be made at the time of booking, then a lot of people are going
to say, "Why should I pay twice?"
Dr Bermudez: Then they do not pay twice.
Q672 Lord Avebury:
Otherwise it is a tremendous idea. Could I then come on to your
relationship with WHO and ask why it is that WHO could not have
undertaken the functions that you have described? Was it simply
because there was a limitation in their constitution? If that
was the case, why would it not have been better to alter their
constitution so that they could have done the work that you are
now doing?
Dr Bermudez: First of all, WHO is a UN technical
unit and we do not considers ourselves a technical unit. We rely
on WHO technical expertise. We are an operational unit. WHO has
offices in other countries and other regions, it works mostly
with capacity building, strengthening health systems, and with
guidelines and documents, workshops, seminars, Standard Treatment
Guidelines, and we adopt those for our work. WHO is not a procurement
agency or a funder of products. They have a model list of potential
medicines, they have a pre-qualification scheme that works within
the UN system, but they do not work with procurement and do not
have the lead time that is needed to rapidly disburse and attend
to the country's needs. We think that WHO have their rule and
we respect their rule, we do not do technical activities but we
rely on WHO's technical actions and their solid background. They
do not do procurement unless it is necessary for small issues.
They do not act in the areas that we are acting in.
Q673 Baroness Whitaker:
Could I just ask, is it that WHO would advise you on which drugs
you ought to go for? Is that how they would come in? Or are there
other ways?
Dr Bermudez: WHO has Standard Treatment Guidelines
for paediatric treatment for HIV/AIDS, for TB, for Malaria, and
we use those as guidelines. We see what is addressed by other
Partners and what would be the need for second-line antiretrovirals,
for paediatric antiretrovirals, according to WHO guidelines, because
they have standard guidelines for pregnant women, for adults,
for children, and we make sure we do not overlap with that. For
procurement and delivery we use other Partners and we go to the
countries and the countries' Ministers of Health, sign agreements
to incorporate that into their health systems and we fund it.
Q674 Baroness Whitaker:
Does it suit you how you are lodged within the intergovernmental
machinery? Are there different roles or different powers that
you would like to have? Or, if WHO were differently constituted,
would that help you at all?
Dr Bermudez: It is very clear to us what are
the different roles of the different organisations and it makes
it easy for us to work with WHO, UNAIDS, UNICEF, the Global Fund,
because we have different architectures, different business models,
different financial activities and complement each other. We are
very much aware and have discussions with them. One of our major
partners is the Global Fund. More than a year ago the Global Fund's
Board and UNITAID's Board requested that we work together to see
what roadmap we could develop jointly so that we do not overlap
and what would be the added value that we could have in the strengthening
and scaling up of access to products for the three diseases, because
the Global Fund also works with the three diseases. We have found
our role, their role, the complementarity and we work together
with them.
Q675 Baroness Whitaker:
So structurally you are where you want to be?
Dr Bermudez: Yes, structurally we are a lean
secretariat hosted by the WHO, so we are on the health side and
that is important for us because we work with a health perspective
in delivering products. We are gaining experience with their expertise
in the three diseases. We interact very strongly, almost every
day, with the Department for HIV/AIDS, the Department for TB,
Department for Malaria, the Partnerships they have, as Roll Back
Malaria and Stop TB, and the Medicines Department and the health
system. They do their work and we are an added-value to their
work.
Q676 Baroness Whitaker:
Thank you. Could I finally ask, do you give any priority to local
manufacture and accreditation, because that would have eventual
health benefits in that it would increase growth, it would increase
capacity? For instance, I think Artemisium grows in Tanzania;
I do not know whether Novartis cultivates it there.
Dr Bermudez: We are supportive of that, but
we do not work alone on that because other organisations have
very specific roles, for example UNIDP, the United Nations Industrial
Development Organisation. We have worked with them to see how
they can strengthen local manufacture in areas that we will have
a forecast of and that will justify having local manufacturing.
Your example is very clear where you talk of Artemisium in Africa
in Malaria, where we are working on that. Also, pre-qualification
is not for us, the World Health Organisation will pre-qualify
manufacturers, examine their dosage, make sure that they comply
with good manufacturing procedures, and we can fund the products.
But we will only fund pre-qualified products to make sure that
we have quality. In that sense, WHO is supporting manufacturers
for them to reach this status of pre-qualified drugs and manufacturing.
Q677 Lord Desai:
There are a lot of overlapping agencies around, and one of the
questions is; can you simplify. In your case there is the Global
Drug Facility, and I wonder; is there a rationale for you guys
getting together and going into the Global Fund? Or is there no
advantage to that sort of streamlining?
Dr Bermudez: Initially, the Global Drug Facility
only works with TB. In TB we are Partners with the Global Drug
Facility because in some countries they have Regional Offices.
We established a partnership with them, and for first-line TB,
for multi-drug resistant TB, we work with the Global Drug Facility.
The Global Fund has a completely different architecture. When
we worked with antiretrovirals, when we were assessing the products
that we deliver, one of the issues we compared was the lead time
that we had to deliver products. Let us say we sign an agreement.
How much time does it take between the signing of the agreement
and for the product to be delivered in the country? We compared
that with PEPFAR, the USA programme for AIDS relief and the Global
Fund, and our lead time takes weeks: PEPFAR takes months, sometimes
a year; and the Global Fund takes years. They are not intended
to be a procurement agency. Their strategies are based on rounds
that they discuss with the country and in that sense the country
applies for grants from the Global Fund, and in those grants they
have the strengthening of the health system, human resources,
products and diagnostics. From the signing of that to the end
takes one, two, sometimes three years. They are completely different
architectures. We consider that we have a specific role in funding
products, shortening lead times, supporting WHO pre-qualification
and ensuring the scaling-up and a rapid response. We had two emergencies
last year because of a stock-out of malarial medicines in Liberia
and Burundi in Africa. We discussed this with UNICEF and WHO,
and in four weeks the medicines were arriving in the country,
so we prevented stock-outs of medicines. I can assure you that
the Global Fund does not work with emergencies because they have
long-term financing for the countries.
Q678 Chairman:
You do not see yourself as an organisation that mainly focuses
on an emergency, you see it as more general than that?
Dr Bermudez: Yes.
Q679 Chairman:
I suppose this is what we are struggling with a bit. We have had
people say to us that there are so many actors in this whole international
field that it is difficult to get coordination without overlapping
and, therefore, wasting resources. There is another argument that
says that all of these organisations are doing a good job and
all we have got to do is get the coordination right. Those are
the two arguments. How would you evaluate those arguments, if
you like? Do you think you are quite relaxed about the number
of organisations? Is the coordination good or bad? Or is there
room for rationalisation of the number of organisations?
Dr Bermudez: First of all, the other organisations
are there and we will not discuss whether they should be there
or not. We have a very specific additional role. One of the issues
that needs to be addressed, and we have discussed this with all
the other organisations, is how to coordinate the in-country actions,
because in-country there are several organisations acting with
different Partners, different delivery mechanisms, different quality
standards, so it is very difficult for countries to receive sometimes.
We have discussed the supply systems in several African countries
and are amazed when we see the numbers of organisations that fund,
that deliver, that work with human resource building in the countries,
and sometimes they do not speak to each another, there are four,
five, six or ten organisations working in a country. When we see
countries in crisis, that is worse because we have international
aid flowing and everybody is eager to help and in an emergency
that is very clear. We are very specific in that we only fund
products that others are not funding. We do not work with emergencies,
but we have because, when we realise the only way to avoid new
cases of resistance is to avoid stock-outs, we work with those
emergencies just to cover certain gaps in partnership with other
organisations when we realise that nobody is funding that. Our
main mission is to fund products, let us say commodities, for
diagnostics, for treatment, where they are not currently funded
by other organisations. We always work with the idea of additionality
and not overlapping.
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