18 April 2002
Dear Members of the Board of Directors and Technical Review Panel (TRP),
On behalf of Médecins Sans Frontières (MSF), I am pleased to submit this
letter to you on the occasion of the second Board of Directors meeting of
the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund),
scheduled to take place in New York City, April 23-24, 2002. In November
2001, we submitted a similar letter to all members of the Transitional
Working Group and Technical Support Secretariat as part of the NGO
consultation process. This letter seeks to highlight our ongoing concerns
and priority recommendations at this critical juncture, based on our
experience in the field working to prevent and treat HIV/AIDS, TB, and
malaria, and to request specific, immediate action by Board members
individually and/or collectively in relation to the financing of
desperately needed medicines for the treatment of all three diseases.
Treatment: a medical and ethical imperative
As a medical humanitarian organization, MSF believes that the Global Fund
must provide financing for treatment programmes for HIV/AIDS, TB, and
malaria. This is an ethical imperative. It is now widely accepted that
treatment and prevention are mutually dependent and synergistic; that one
reinforces and strengthens the other, and that prevention-whether through
condom distribution, bednets, or general health education-has failed to
control these three diseases alone. We know this firsthand from our
experience in the field. We are therefore encouraged by the news that
proposals that include well-designed treatment interventions will be
eligible for funding.
However, the Fund has failed to clearly spell out the critical need for
addressing treatment as part of a comprehensive approach to controlling
HIV/AIDS, TB or malaria, relying instead on general statements in support
of "an integrated and balanced approach covering prevention, treatment, and
care and support in dealing with the three diseases." We are deeply
concerned that patients already living with HIV/AIDS, TB, or malaria will
be written off despite pronouncements of support for treatment programmes
that would extend or save their lives because donors and some in the
international health community traditionally favour prevention at the
expense of treatment, and because at least one alternate member of the
Board has indicated that, particularly in the first round of funding,
grants will likely "ramp up" existing programmes rather than starting de
novo to introduce new interventions in order to have the "greatest impact."
This does not bode well, for example, for antiretroviral (ARV) treatment
programmes or malaria programmes using artemisinin-based combination
therapy (ACT), as there are very few existing programmes, particularly in
Africa, that currently offer such treatment interventions. This is due in
large part to the chronic neglect of the donor community over the last two
decades, a lack of political will in some developing countries, and the
high cost of ARVs, ACT, and other essential medicines. It would be a grave
mistake to continue this cycle of neglect.
The Global Fund must take bold steps to support new, scientifically sound,
and life-saving treatment programmes. This means, among other things,
pushing for the acceleration of operational research to increase knowledge
on best practices for implementing new combination treatments and
diagnostic strategies in resource-poor settings. Furthermore, the Fund must
commit itself to ensuring that newer, more effective, field-relevant
medicines and medical technologies are made available to poor countries at
affordable prices as soon as they are developed.
It is vital to improve treatment interventions, not expand use of
ineffective treatments
It is of vital importance that the Global Fund be used to support
improvement of treatment interventions, and that it does not inadvertently
facilitate the expanded use of ineffective treatments. Yet the Fund has not
taken a clear stand on the need to make ARVs, second line TB treatments, or
new, more effective anti-malarials available (at the lowest possible cost).
For instance, in the case of malaria treatment, it would be wrong to
support programmes that continue to use treatments in areas where they have
lost their effectiveness due to resistance on the basis that they are
inexpensive. Where resistance to traditional first-line
treatments-especially chloroquine and sulfadoxine-pyrimethamine (SP)-is
high, malaria treatment must include not only traditional antimalarials,
but also artemisinin-based combination therapy (ACT), as per the
recommendations of the world's leading malaria experts convened by WHO in
April 2001, and the February 2002 statement of Roll Back Malaria on Malaria
and Resistance.
MSF has witnessed this critical need firsthand. For example, in response
to the outbreak of malaria in Burundi at the end of 2000, MSF teams
diagnosed and treated malaria in the hard-hit provinces of Kayanza, Ngozi,
Karuzi and Cankuzo and over a period of six months treated over 1.2 million
patients. The epidemic is estimated to have affected nearly 3 million
people in Burundi and resulted in thousands of deaths. These 3 million
patients were treated with ineffective medicines-not only by the Burundian
health authorities and other NGOs, but also by MSF itself-because
chloroquine remains the first-line treatment in Burundi's national protocol
due in large part to the cost of more effective alternatives such as ACT.
During the course of the epidemic, MSF teams carried out several resistance
studies and found that resistance to chloroquine in Burundi is as high as
90% in some areas, and resistance to SP is as high as 63% in some areas.
The World Health Organization recommends changing treatment protocols when
resistance to first-line drugs reaches 25%.
To address the broader issues raised by our experience in Burundi, MSF
recently released a report about changing malaria treatment protocols in
Africa where resistance to first-line drugs is high (please see the
enclosed report entitled "Changing National Malaria Treatment Protocols:
What Is the Cost and Who Will Pay?"). The central concern of the paper is
with the growing rates of resistance to chloroquine and SP in Africa,
namely in Kenya, Rwanda, Tanzania, Uganda, and Burundi, and the possibility
that these countries, which are ready to change their national malaria
treatment protocols, will, possibly for financial reasons, settle on a
sub-optimal "mid-term" protocol (e.g. amodiaquine + SP) rather than the
clearly more effective choice of ACT. The paper provides a cost analysis
for the region of the proposed mid-term solution versus the proposed
optimal solution, and estimates that US$19 million in additional funding is
needed annually for the five target countries to make the medically
appropriate treatment protocol change-an investment that is surely
worthwhile for the number one killer of African children. MSF's report
urges international donors to step in to provide the necessary funds and
specifically calls on the Global Fund to address this issue. The needed
treatment is already available in Africa, but only at high prices in some
private pharmacies. By financing malaria treatment programmes that include
ACT, the Global Fund can play a crucial role in overcoming this inequity
and ensuring that all people who need it, including the poorest and most
vulnerable, have access to effective malaria treatment.
Purchasing drugs at the lowest possible cost is essential
We are deeply concerned about the sort of technical advice being given to
potential recipient countries-by donor governments, the World Health
Organisation, and others-in relation to purchases of medicines.
Specifically, we are outraged that countries have apparently been advised
that they will only be able to purchase patented drugs for their
programmes. In the proposal to the Global Fund from Malawi, for example,
it clearly states the following:
The TRIPS Agreement can and does have negative consequences for public
health in poor countries. However, it also has safeguards to balance public
and private interests and ensure that patents do not pose a barrier to
access to medicines. At the 4th Ministerial Conference of the World Trade
Organization held in Doha, Qatar, in November 2001, the world's trade
ministers issued a landmark Declaration on the TRIPS Agreement and Public
Health, which stated:
We therefore call on all members of the Board, whether individually and/or
collectively, to issue a clearly articulated public statement during the
Board meeting indicating that the Global Fund explicitly supports purchases
of lowest cost drugs, whether generic or brand-name, and the use of
TRIPS-legal safeguards to override patents when they constitute a barrier
to access. The Global Fund should also clearly specify that these measures
are fully compliant with TRIPS and in keeping with the spirit and letter of
the Doha Declaration.
Without a deliberate strategy to ensure that funding can be used to
purchase quality drugs from both generic and proprietary
producers-including those located in developing countries-funds will be
squandered. To secure drug quality, the Fund should also explicitly
support the WHO's project to pre-qualify manufacturers of drugs and
diagnostics related to HIV/AIDS, and encourage its expansion to other
diseases, including malaria and TB.
These principles related to procurement of drugs and diagnostics are
crucial because prices of medicines and other essential health care goods
will have a profound impact on the reach and effectiveness of the Global
Fund. Antiretroviral drugs for the treatment of HIV/AIDS provide a good
illustration: the cost of ARVs from proprietary companies-even at deeply
discounted prices-are, for certain regimens, three times more expensive
than ARVs from generic manufacturers. Using the lowest cost suppliers will
increase by as much as three times the number of patients who can be
treated with the same amount of money, and will allow for greater
investments in other important components of care and prevention. We know
this firsthand from our experience in the field in our ARV demonstration
projects. For example, in our ARV project in Khayelitsha, a poor township
on the Western Cape in South Africa, the cost-savings generated by
switching from patent-protected brand name ARVs to generic versions made a
tremendous difference in the overall cost of the programme. These
cost-savings have allowed us to expand our programme from a total
enrollment capacity of 180 to 400 on virtually the same budget.
More funds desperately needed
The Global Fund holds a promise-yet unfulfilled-for the millions of people
in Africa, Asia, Latin America, Eastern Europe, and other high-burden
countries living with HIV/AIDS, TB and malaria who desperately need access
to life-saving and life-prolonging treatment. To date, the Fund has
received funding requests totaling US$5 billion over five years, and yet
the total amount of multi-year financing pledged is merely US$1.9 billion
and the amount of funding available for disbursement in the first funding
cycle is approximately US$200 million. This falls drastically short of the
needs and will be a major disappointment for all of those who have placed
great hope in the ability of the Fund to reduce the death rates from these
three treatable diseases. We call on you as members of the Board to take
whatever steps necessary to ensure that donors immediately allocate
additional resources to the Global Fund and other financing mechanisms to
fight these three diseases.
Conclusion
It is essential that a long-term, sustainable solution to the access to
medicines crisis be developed and supported by governments and multilateral
agencies, which are responsible for responding to global public health
needs. Your leadership on the Board of the Global Fund to Fight AIDS,
Tuberculosis and Malaria will be key if it is to succeed, and will
ultimately determine whether it becomes a crucial part of an effective
global response to HIV/AIDS, TB, and malaria. We urge you to strongly
support the recommendations presented in this letter and the enclosed
reports to guarantee access to effective and affordable medicines and
medical technologies at the best possible price. We believe that unless the
Global Fund urgently addresses these issues, it will not be able to make
good on its promise to alleviate the burden of AIDS, TB and malaria. For
millions of people in developing countries, this is a matter of life and
death.
Sincerely,
Bernard Pécoul, MD, MPH
"At present, we are assuming that the Global Fund will only finance
patented drugs. This is in line with consultations with WHO and the
donor community and initial documents from the Technical Support
Secretariat. If however, Global Fund rules permit the use of generic
drugs, the proposal and programme budget will be amended to reflect
this."
To ensure that international funding mechanisms, including the Global Fund,
offer treatment to the highest number of people possible, it is essential
that funds be available for bulk purchases of medicines and medical
technologies at the lowest possible cost, through international tender. In
its statement of underlying principles, the Fund claims that "[i]n making
its funding decisions, the Fund will support proposals which...[a]re
consistent with international law and agreements, respect intellectual
property rights, such as Trade-Related Aspects of Intellectual Property
Rights (TRIPS), and encourage efforts to make quality drugs and products
available at the lowest possible prices for those in need." As we pointed
out in our letter to the TWG and TSS of November 9, 2001-and as confirmed
by the above quotation from the Malawi proposal-this statement is easily
misinterpreted and must be clarified publicly.
"We agree that the TRIPS Agreement does not and should not prevent
members from taking measures to protect public health. Accordingly,
while reiterating our commitment to the TRIPS Agreement, we affirm that
the Agreement can and should be interpreted and implemented in a manner
supportive of WTO members' right to protect public health and, in
particular, to promote access to medicines for all. In this connection,
we reaffirm the right of WTO members to use, to the full, the provisions
in the TRIPS Agreement, which provide flexibility for this purpose."
This Declaration was an important achievement because the text gives clear
primacy to the protection of public health over private intellectual
property, as well as an unambiguous road map to all the key flexibilities
in the TRIPS agreement. The Global Fund must make clear beyond the shadow
of a doubt that applicants have the option of purchasing generics with
Global Fund money.
Director, MSF Access to Essential Medicines Campaign
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