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Note: This document is from the archive of the Africa Policy E-Journal, published by the Africa Policy Information Center (APIC) from 1995 to 2001 and by Africa Action from 2001 to 2003. APIC was merged into Africa Action in 2001. Please note that many outdated links in this archived document may not work.


Africa: Global Health Fund Issues Africa: Global Health Fund Issues
Date distributed (ymd): 020422
Document reposted by Africa Action

Africa Policy Electronic Distribution List: an information service provided by AFRICA ACTION (incorporating the Africa Policy Information Center, The Africa Fund, and the American Committee on Africa). Find more information for action for Africa at http://www.africaaction.org

+++++++++++++++++++++Document Profile+++++++++++++++++++++

Region: Continent-Wide
Issue Areas: +economy/development+ +security/peace+ +health+

SUMMARY CONTENTS:

The board of the Global Fund to fight AIDS,Tuberculosis, and Malaria (GFATM) is meeting in New York April 22 to April 24 to make decisions on its first grants. The fund faces enormous challenges, including pledges which only cover 7% of the estimated annual need and the urgent necessity of providing funds for treatment as well as prevention and care.

This e-mail posting contains excerpts from three recent documents highlighting these issues, (1) an article by Tim France, Gorik Ooms, and Bernard Rivers comparing pledges with the equitable contribution each rich country should provide, (2) a letter from Health Gap, Act-Up Paris, and the African Services Committee, and (3) a letter from Medecins sans Frontieres. The full version of the first article is available on the web sites indicated; the full version of the two letters will be available in the web archive of this posting, at http://www.africafocus.org/docs02/gf0204.php>

The web site of the Global Fund is http://www.globalfundatm.org

Also today, the World Health Organization released new guidelines for treatment of HIV/AIDS, unambiguously affirming the need for treatment in "poor" settings as well as in rich countries, and endorsing the inclusion of antiretrovirals in its essential medicines list. See http://www.who.int/inf/en/pr-2002-28.html

+++++++++++++++++end profile++++++++++++++++++++++++++++++

THE GLOBAL FUND: WHICH COUNTRIES OWE HOW MUCH?

By Tim France, Gorik Ooms and Bernard Rivers (21 April 2002)

[excerpts only: for full article, including formatted table, see http://www.hdnet.org and http://www.aidspan.org]

Nearly one year ago, the majority of the world's nations resolved at `UNGASS', a major UN conference on AIDS, to increase annual expenditure on the AIDS epidemic to $7-10 billion by 2005, with much of this money to be raised and disbursed by a new global fund. When the fund was eventually set up, its mandate was extended, and it was named the Global Fund to Fight AIDS, Tuberculosis and Malaria.

AIDS, an unprecedented and accelerating emergency, is already having a devastating impact in Africa, with similar impacts unfolding on other continents. Every day, 8,000 die, and 13,000 more become infected. Experts agree that reasonable expenditures on prevention and treatment of AIDS, tuberculosis and malaria can be of dramatic benefit not only to human health, but also to economic development.

Thus far, efforts have been made to raise the money needed by the Global Fund through ad hoc voluntary donations. These efforts have failed. Governments have pledged a mere $1.8 billion. Contributions from the private sector have been even more disappointing, with not a single meaningful pledge since the Bill & Melinda Gates Foundation offered $100 million ten months ago.

It's time for a new approach. The Global Fund needs to grow rapidly to the point where it raises $10 billion a year. Contributions to the Global Fund should be equitably shared among the countries whose citizens live the most comfortable and unthreatened lives. This means that the wealthiest countries, such as the US, should contribute considerably more than they currently do. But it also means that contributions should come from the likes of Australia, Singapore, and the United Arab Emirates - relatively wealthy countries that have not yet contributed a penny.

Part of the problem is that to date, nobody has proposed which countries should give how much. The following table therefore offers an `Equitable Contributions Framework' that can be used as a starting point for working out an appropriate contribution level for each country, and for measuring how well each country is doing against that level.

The Framework suggests that $1 billion a year should come from the private sector, as a minimum to justify the label `public/private partnership' and the two seats it has out of the 18 voting seats on the Fund board. The remaining $9 billion a year should come, in proportion to Gross Domestic Product (GDP), from the 48 countries that have a `high' Human Development Index, or HDI. (The UN's HDI measures the overall quality of life based on standard of living, life expectancy, and literacy plus school-enrolment.)

The proposed contribution comes to 0.035% of GDP for each country. Not one country has yet given at this level. ...

It is to the credit of countries like Uganda and Nigeria that, poor as they are on a per capita basis, they have made multi-million-dollar contributions to the Fund. And it is to the shame of many of the 48 relatively wealthy countries that they have contributed little or nothing, without even stating why.

The Global Fund represents a bold new approach. The Fund's leaders say that it will be more fast-moving, participatory, transparent and accountable than traditional channels. The Fund needs a chance to prove itself. It would be a shame if it were to fail simply because it did not receive the funding it needs to get properly established and to respond to the most urgent and obvious needs.

The authors are:

Dr. Tim France, Health & Development Networks (US EST +11 hours) Thailand: Tel: +66 9 950 0685; Email: tfran@hdnet.org; Web: http://www.hdnet.org

Gorik Ooms, Medecins Sans Frontieres (MSF) Luxembourg (US EST +7 hours) Mozambique: Tel: +258 82 311 075; Email: msflmoz@teledata.mz; Web: http://www.msf.lu

Bernard Rivers, Aidspan (US EST) USA (New York): Tel: +1 212 662 6800; Email: Rivers@aidspan.org; Web: http://www.aidspan.org


[display table in courier font to line up columns; better formatted versions available on web sites indicated. For accessible format, with more country detail, see http://www.aidspan.org/GlobalFundContributions21April2002.htm. Word, PDF, and Excel versions are also available on that site.]

Table: Equitable Contributions Framework for the Global Fund,
based on GDP (21 April 2002)

1. G7 "high Human Development Index" countries:NI              |  Suggested  |  Total pledge |  Estimated   | I
               | "equitable  | to GF thus far| portion of   | I
               |   annual    |   ($m., and   | total pledge | I
               |contribution"| as % of Col 2)| that applies | I
               |   (US$m)    |               |   to 2002    |
I--------------|-------------| ------ | -----| ---- |------ | I
United States: |    3,479    |   450  | (13%)|  250 |  (7%) | INJapan:         |    1,646    |   200  | (12%)|   68 |  (4%) | I
Germany:       |      658    |   158  | (24%)|   35 |  (5%) | I
United Kingdom:|      498    |   219  | (44%)|   67 | (13%) | I
France:        |      453    |   151  | (33%)|   51 | (11%) | I
Italy:         |      376    |   215  | (57%)|   73 | (19%) | I
Canada:        |      243    |   100  | (41%)|   38 | (15%) |
I--------------|-------------| ------ | -----| ---- |------ | I
G7 total:      |    7,352    | 1,493  | (20%)|  580 |  (8%) |Nb)     Non-G7 "high Human Development Index" countries:NI              |  Suggested  |  Total pledge |  Estimated   | I
               | "equitable  | to GF thus far| portion of   | I
               |   annual    |   ($m., and   | total pledge | I
               |contribution"| as % of Col 2)| that applies | I
               |   (US$m)    |               |   to 2002    |
I--------------|-------------| ------ | -----| ---- |------ | I
Spain:         |      195    |    58  | (29%)|   19 | (10%) | I
Netherlands:   |      128    |   125  | (97%)|   42 | (32%) | I
Switzerland:   |       85    |    10  | (12%)|    3 |  (4%) | I
Belgium:       |       81    |    19  | (24%)|    6 |  (8%) | I
Sweden:        |       80    |    58  | (73%)|   20 | (25%) | I
Austria:       |       67    |     4  |  (5%)|    1 |  (2%) | I
Denmark:       |       57    |     2  |  (4%)|    1 |  (1%) | I
Finland:       |       42    |     2  |  (4%)|    1 |  (1%) | I
Greece:        |       39    |     2  |  (4%)|    1 |  (1%) | I
Portugal:      |       37    |     1  |  (4%)|    0 |  (1%) | I
Ireland:       |       33    |    10  | (31%)|    3 | (10%) | I
Kuwait:        |       10    |     1  | (10%)|    0 |  (3%) | I
Luxembourg:    |        7    |     3  | (41%)|    1 | (14%) | I
Others:        | 1 to 161    |     0  | (0%) |    0 |  (0%) |
I--------------|-------------| ------ | -----| ---- |------ | I
Non-G7 total:  |    1,648    |   294  | (18%)|   99 |  (6%) |

c) Totals from the above table

(i) Total for all 48 high HDI countries:

* Suggested "equitable annual contribution" to Global Fund: US$9,000 million * Total pledge to Global Fund thus far: US$1,788 million * Estimated portion of total pledge that applies to 2002: US$679 million

(ii) Total for all non-'high HDI' countries that have donated**:

* Suggested "equitable annual contribution" to Global Fund: $0 * Total pledge to Global Fund thus far: US$33 million * Estimated portion of total pledge that applies to 2002: US$11 million

(iii) Total for private sector (foundations and corporations) ***:

* Suggested "equitable annual contribution" to Global Fund: US$1,000 million * Total pledge to Global Fund thus far: US$101 million * Estimated portion of total pledge that applies to 2002: US$34 million

(iv) Grand total

* Suggested "equitable annual contribution" to Global Fund: US$10,000 million * Total pledge to Global Fund thus far: US$1,922 million * Estimated portion of total pledge that applies to 2002: US$725 million

The final column is based on private sources plus our own estimates, because the information is not published. We understand that total pledges are: 2002=$725m., 2003=$487m., 2004=$132m., 2005=$67m., 2006=$27m., plus $484m. for which the year(s) are not specified. We also understand that the pledges for 2002 (before adding shares of the EU pledge, when appropriate) include USA=$250m., UK=$60m., Netherlands=$40m., Canada=$37.5m., and Germany=$26.5m. For other countries and for the private sector, the 2002 portion is not known, so we have assumed it to be 33.8% of the total pledge, in order to bring the overall 2002 total to the known figure of $725 m. Further information received will be reflected in future versions of this table.


Accompanying note to readers and editors

The above article was written by three people who work with non-governmental organizations (NGOs) in three different continents. They `met' electronically through their active involvement in the Break-the-Silence (BTS) dedicated e-mail discussion forum, which has over 3,000 members worldwide. BTS serves to support civil society participation in international debates on HIV/AIDS and other health-related issues. Since October 2001, BTS discussions have mainly focused on the Global Fund.

Financial contributions to the Fund have decreased significantly in recent months, and are far below the originally intended level. The first funding requests for grants from the Fund, in March 2002, were already for far more money than the Fund can currently provide in any sustained way. ...

The article, written in response to that frustration, proposes the establishment of an `Equitable Contributions Framework' to serve as a guide to appropriate contribution levels to the Fund.

If you or your organization are encouraging contributions to the Fund from your own country, you can use the Framework to highlight your country's appropriate contribution, its total pledges already made, its apparent pledge for 2002, and the consequent shortfall.

To join the BTS forum, send an e-mail message to: join-break-the-silence@hdnet.org

To read previous BTS postings on the Global Fund process, go to: http://archives.healthdev.net/bts


Health GAP (Global Access Project), Philadelphia, USA Act Up-Paris, France
African Services Committee New York City, USA

18 April 2002

To all Members, Board of Directors, the Global Fund to fight AIDS, Tuberculosis, and Malaria (GFATM):

People living with HIV/AIDS, their allies, and experts around the world will be monitoring closely the outcomes of this second, pivotal Board meeting of the GFATM.

This letter sets out several concerns held by our organizations regarding outstanding policy issues that will come before you for consideration and action during the 22-24 April meeting.

Summary:

We insist on a concerted effort on the part of this Board to correct and redress the devastating cumulative impact of years of indifference to untreated HIV/AIDS in developing countries, where 95% of people with HIV/AIDS live.

The Board must emerge with a clear statement prioritizing massive scale-up and implementation of antiretroviral treatment programs in developing countries.

The acute need for more money for the GFATM must not be reserved for internal, hushed Board discussion. On the contrary, the desperate need for more resources must be publicly emphasized by the Board. Bona fide demand for funding‹especially funding for programs that include antiretroviral treatment, on the scale necessary for substantial impact‹tremendously outpaces the funds available to the Board for spending for the first and subsequent tranches of 2002.

This gross lack of resources is an untenable situation that can either be corrected through advocacy and appeal on the part of the Board, or can be tacitly endorsed by the Board through its inaction.

Without swift and decisive action in these areas, the GFATM will become defined to potential contributors and other influential actors as another irrelevant mechanism supporting only slow, incremental shifts in international response to the global AIDS disaster‹contradicting the consumer-led demand for affordable AIDS drugs that energized leaders to create the GFATM.

1. Prioritizing antiretroviral treatment‹redressing the crisis in HIV medicines access

HIV treatment access is a human rights and public health necessity. As a new, non-duplicative mechanism that includes funding HIV treatment programs among its objectives, the GFATM at its launch was seen as the best hope for sustainable, accelerated scale-up and implementation of antiretroviral treatment programs in developing countries.

However, applicants and potential applicants have received mixed messages from the board and from bilateral donors regarding proposals that include funding requests for antiretroviral treatment. When the historical exclusion of treatment was coupled with donor pressure to scale back the size and scope of proposals at the Country Coordinating Mechanism (CCM) level, many countries chose to submit proposals with very modest treatment components, that under-represented the capacity of a country to deliver medicines for AIDS, tuberculosis, and malaria treatment.

The GFATM as a multi-disease entity is constructed to fund a range of interventions, which require a range of costs. In the traditional language of Ýcost-effectiveness,Ý antiretroviral treatment programs will always be eclipsed by less costly interventions such as HIV prevention, or the treatment and prevention of other infectious diseases. This is unacceptable. Applicants and potential applicants therefore require clear information and guidance about how this Board will prioritize funding among AIDS, tuberculosis and malaria, and among public health responses such as prevention and treatment.

If the GFATM is to take up its task of remedying the disparity in HIV treatment access, the Board must clarify through a public communication that viable antiretroviral treatment programs are feasible, fundable, are a required aspect of a comprehensive, effective response to the AIDS pandemic. Funding requests containing components for AIDS treatment must not be downgraded in consideration because of relative higher cost.

The direct and measurable impact of treatment access on morbidity and mortality, as well as its spillover benefits to HIV prevention efforts, are outcomes necessary to demonstrate for donors the value and impact of GFATM funded interventions. The most dramatic outcomes possible with the scarce resources available will be produced by funding discrete sectors with antiretroviral treatment, effectively delivered.

The Board should encourage exactly such applications, and commit all available resources on hand.

2. Patents and the procurement of medicines by the GFATM

Commitment to the procurement of lowest possible cost, quality medicines‹including quality generic drugs‹must be communicated by Board members.

Generic competition has been shown to be the most powerful tool in exerting downward pressure on drug prices. (2) The procurement of quality generic versions of HIV medicines will increase life-extending treatment access by extending finite resources as efficiently as possible.

In most developing countries, there is little viable market for pharmaceuticals. Given the decimation of adult populations in some countries due to untreated HIV disease, the interest of brand name pharmaceutical companies in guarding patent monopolies and concomitant high prices must not determine the policy of the Board regarding health commodities procurement.

We note with concern the application submitted by the government of Malawi, where the cost of antiretroviral drugs was calculated based on the reference of proprietary medicines, as per 'consultations with WHO and the donor community and initial documents from the Technical Support Secretariat.' (3) It is incumbent on the Board to clarify immediately the potential benefits of the use of lowest cost, generic versions of HIV medicines.

The declaration at the World Trade Organization (WTO) Ministerial at Doha, Qatar clarified the right of WTO Member States to utilize safeguards in international trade agreements medicines to achieve public health goals, such as increasing access to affordable HIV medicines.(4) In addition, the recent list published by the World Health Organizations Essential Drugs and Monitoring Project of initial 'pre-qualified' HIV medicines suppliers includes generic products. (5) Consistent with these and other recent favorable policy developments, the Board must publicly state its support for the procurement of quality generic antiretroviral and other medicines, as a policy of amplifying the impact of the finite resources of the GFATM.

The GFATM is not the appropriate venue to interpret or enforce international trade agreements. There are bi- and multilateral fora established to concerns that arise regarding intellectual property rights. The GFATM has no reason to include itself in these discussions.

3. The cupboard is bare: the Board must communicate publicly the need for billions in additional annual funding

By any estimation the GFATM is being starved of the resources necessary to mount an effective response to the global AIDS disaster. The gap in resources is clearly the result of rich countries' decision not to invest significant resources in the GFATM. Several of the world's wealthiest countries have donated the least to the GFATM as a percentage of overall country wealth. For example, in 2002 Rwanda's contribution was 10 times as generous as the United States', when contributions are measured as a proportion of total country wealth. (6)

The Board should play a critical role in transforming the kind words of wealthy countries into action. Lack of funds is blunting the impact of the GFATM. The Board must call on wealthy countries to contribute the billions of dollars needed in new contributions, primarily to fund HIV treatment access.

As the board meeting takes place, activists and elected officials in the U.S. are campaigning for an additional $750 million contribution from the United States for 2002 through an emergency supplemental spending bill now before the U.S. Congress. If successful, this would increase the U.S. contribution to approximately $1 billion for 2002, leveraging additional donations from donor countries and others. Thus far, every dollar contributed by the U.S. has been matched more than fourfold.

4. The GFATM, technical assistance, and transparency

Until very recently, antiretroviral treatment programs in developing countries have been ineligible for funding by most donor countriesÝ assistance programs. (7) Regardless of political commitment at the country level, developing countries have little-to-no experience in composing comprehensive and accurate grant applications that include provisions for establishing or scaling up antiretroviral treatment access programs.

Supporting applicants in their efforts to secure funds for treatment requires not only unequivocal endorsement of the importance of antiretroviral treatment, but also requires that the GFATM extend technical assistance to applicants. Without this provision, applicants will consistently be rejected for funding not for lack of need or capacity, but for lack of guidance. The Board must quickly develop a basic plan for providing technical assistance, in order to increase the facility with which applicants can complete fundable proposals.

A tenet of the GFATM is transparency in operations. In our experience people with HIV and their allies in developing countries have had extreme difficulty in getting even basic questions answered and comments addressed regarding their CCMs completing applications. We see this as a significant problem, as the expertise of people with HIV, their loved ones and care providers are those often best situated to asses the needs of impacted populations. Disregarding or excluding such participation can lead to corruption and ineffectiveness.

The Board must not disregard these concerns‹conditions at the country level which exclude the substantive participation of people with HIV only worsen the crisis in lack of access to AIDS treatment. Therefore the Board must facilitate involvement of people with HIV in their CCMs, and must rigorously and publicly investigate complaints regarding the exclusion people with HIV.

We also call on this Board to require each applicant to submit a brief summary of the content of their funding request, for public consumption and posting to the GFATM website. This simple step would increase accountability of governments to civil society. In addition, such a measure would go a great distance to address concerns of donors.

Given the relatively poor outcomes of extant interventions that have been restricted to palliative care and prevention, and the international demand from people living with HIV for fulfillment of the human right to affordable AIDS medicines, the Board must take leadership by affirming the need for expanded antiretroviral treatment access and calling for dramatic increases in contributions to the GFATM.

During this meeting, the GFATM will establish itself either as a crucial mechanism, or as an entity making untenable decisions in the midst of an ever-worsening crisis. Your decisions next week will have far-reaching impact, and as such they will be closely monitored by people living with HIV/AIDS and their allies.

Sincerely,

Asia Russell Coordinator, International Advocacy Health GAP (Global Access Project), Philadelphia, USA

Gabrielle Krikorian Coordinator, North/South Commission Act Up-Paris,
France

Kim Nichols, Sc.M., MPH, Development and Policy Director African Services Committee New York City, USA

cc: GFATM Technical Review Panel (TRP) GFATM Technical Support Secretariat (TSS)N


1 Given the expertise and orientation of our organizations, these comments are restricted to policy issues regarding HIV treatment, care, and prevention.

2 eg, 't Hoen, Ellen and Suerie Moon. 'Pills and Pocketbooks: Equity Pricing of Essential Medicines in Developing Countries,' 11 July 2001.
http://www.accessmed-msf.org/prod/publications.asp?scntid=318200146197&contenttype=PARA&

3 Submission to GFATM, Government of Malawi, available at: http://www.cid.harvard.edu/gf/proposals.html

4 http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

5 http://www.who.int/medicines/organization/qsm/activities/pilotproc/pilotproc.shtml

6 Rwanda's GDP (2000) = US$6.4 billion. US GDP (2000) = US$9.963 trillion. Rwanda's donation to the GFATM (2002) = US$1 million. US donation to the GFATM (2002) = US$200 million.

7 The United States Agency for International Development (USAID), for example, a substantial HIV/AIDS funding source, has historically disqualified HIV treatment projects from funding as outside its development mandate.


Medecins Sans Frontieres (MSF)

OPEN LETTER TO MEMBERS OF THE BOARD OF DIRECTORS AND TECHNICAL REVIEW PANEL OF THE GLOBAL FUND TO FIGHT ADS, TUBERCULOSIS AND MALARIA

18 April 2002

Original version with footnotes and malaria report referenced available upon request from: rachel_cohen@newyork.msf.org

Dear Members of the Board of Directors and Technical Review Panel (TRP),

On behalf of M‚decins Sans FrontiŠres (MSF), I m 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


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