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:

"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.


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.


Bernard Pécoul, MD, MPH
Director, MSF Access to Essential Medicines Campaign

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