E-drug: MSF Letter to Global Fund Board and TRP
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OPEN LETTER TO MEMBERS OF THE BOARD OF DIRECTORS AND
TECHNICAL REVIEW PANEL OF THE GLOBAL FUND TO FIGHT
AIDS, TUBERCULOSIS AND MALARIA
18 April 2002
Dear Members of the Board of Directors and Technical Review
Panel (TRP),
On behalf of Medecins Sans Frontires (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:
"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.
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 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.
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 Pecoul, MD, MPH
Director, MSF Access to Essential Medicines Campaign
Rachel M. Cohen
U.S. Advocacy Liaison
Access to Essential Medicines Campaign
Doctors Without Borders/Medecins Sans Frontieres (MSF)
6 East 39th Street, 8th Floor * New York, NY 10016 * USA
Phone: (212) 655-3762
Mobile: (917) 331-9077
Fax: (212) 679-7016
E-mail: rachel_cohen@newyork.msf.org
Websites: http://www.doctorswithoutborders.org
http://www.accessmed-msf.org
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