The organizations in and around the Health GAP Coalition have worked towards a global fund for over three years, and have followed the process since Abuja closely. While the original intent of this paper was an analysis of the various papers circulating amongst the TWG, a review of the proposals thus far reveal a number of urgent shortcomings that have become increasingly apparent. If access to treatment is not substantively and programmatically addressed by the TWG, then the January 1 launch of the Global Fund for AIDS, Tuberculosis and Malaria will betray the intent and mission included in Secretary Annanšs electrifying call.

"Š there has been a world-wide revolt of public opinion. People no longer accept that the sick and dying, simply because they are poor, should be denied drugs which have transformed the lives of others who are better off." (Annan speech calling for creation of global fund, Abuja OAU meeting 26 April 2001)

Comments on the option papers are included at the end of this document.

We respectfully request that, in spite of tight time-frames and heavy workloads, the TWG members and the TSS display vision, using every statement to inspire hope for the thousands who will die today without treatment. Silence on treatment, or ambiguous references to 'balanced approaches' are not adequate at this late stage of development of the fund.

We must agree on a few baseline truths:

* The Global Fund is the primary way to provide drugs in many countries currently decimated by HIV.

* Medicine is the only way to staunch the torrent of death that is destabilizing a continent and threatening others.

* Without access to medicine, prevention programs plateau at a relatively low level of effectiveness.

* Treatment is feasible. Complexities of HIV treatment are exaggerated.

* Existing infrastructure to deliver critical medicines is underutilized.

* Prevention efforts are made dramatically more effective when coupled with access to medicine.

* AIDS treatment is an ethical imperative.

While country-level processes are being set up and national plans are being revised, immediate grants for the provision of treatment should be fast-tracked for any qualified health providers of a reasonable size, scale and track record. This may be as small as a single hospital.

COMMENTS and RECOMMENDATIONS

A. Because there is a political need to generate dramatic results immediately, the fund should focus on saving lives now. The fastest way to drop mortality rates is to fast-track proposals that quickly deliver treatment to qualified public and private sector care providers in hospitals, clinics, and workplaces. The current structural models being discussed in the papers prepared for the TWG all involve lengthy planning at the country level with multiple layers of repeated vetting, and are always filtered through governments. None of the papers addresses immediately saving lives.

B. To quickly provide measurable results, the Global Fund should quickly begin to provide regional or global bulk procurement services, providing direct grants to governments, NGOs or businesses qualified to deliver care and treatment. Procurement and distribution should be built outwards from existing UNICEF channels.

C. The Health GAP Coalition supports a GAVI-like model where bulk procurement and distribution services are housed within and build outwards from the UNICEF supply division. Procurement and distribution services should be made available to countries, NGOs and workplace programs.

D. Grants of commodities to these entities should be based on performance measures such as reduced mortality and infection rates among targeted population and coordination with prevention services. Where NGOs are providing treatment and care, country- or Secretariat-level audits should use the existing epidemiological monitoring of UNAIDS or WHO to evaluate performance by region.

E. Existing regional UNAIDS or WHO offices should serve to convene or co-convene country-level consortia to advise and quickly clear the proposals to the Secretariat. Country-level groups should be quickly convened with invitations to governments (1/3 seats), UN Agencies (1/3 seats) and NGOs/CBOs (1/3 seats). However, putting drugs into bodies should be 'fast tracked', independent of this process.

F. Bulk Procurement

TWG members are encouraged to start mentioning bulk procurement publicly in THIS TWG meeting. Silence on bulk procurement has already resulted in global bulk purchases being all-but pushed off the table. Affordable purchase systems and efficient use of existing infrastructure should be encouraged.

Although this is to be a meeting about governance and processes, and not overtly addressing program content, TWG members have the opportunity to imbue the fund with hope and vision. If we do not vigorously advocate for bulk procurement to be included in the toolbox now, we will not have the tools necessary to meet this emergency. Silence has thus far meant that treatment falls off the table.

- If it has already become too late for global bulk purchase systems, groups of countries can still be encouraged to pool the Global Fund purchasing power. However, it should be noted that country-driven processes could be encouraged to simply take advantage of an expanded procurement and distribution services of the UNICEF supply division. - The TWG must ensure that the Global Fund does not put strings on procurement proposals, nor review such proposals in any respect beyond the degree to which needed commodities reach intended recipients. It is inappropriate for Global Fund to reverse the gains made by poor countries in the hard fought battle to clarify the TRIPS agreement in Doha. The Fund must not take any steps that prohibit use of TRIPS-compliant generic medicines.

The global fund may not need to take a pro-generics position. However, the TWG must resist pressure for the industry and not allow the Global Fund to exceed the monopoly guarantees for the pharmaceutical industry included in the TRIPS agreement.

G. The role of NGOs and the urgency of mission

It is necessary that NGOs and consortia of NGOs are able to be direct recipients of funds. Non-commercial NGOs must make at least 30% of the governance board, and funds must be made available directly to NGOs. The U.S. has the proper position on NGOs as recipients.

- PWHIV are politically unpopular and stigmatized in almost all countries. Many governments are not fair to people with HIV, and have not prioritized adequately responding to the epidemic. Some governments are in a confused state regarding the AIDS crisis due to poorly informed leadership and the overwhelming nature of the health disaster. Others national governments suffer from internal or external conflicts. Some governments have suppressed civil society.

- Overlapping with the above concerns is the fact that many governments are in need of broad health budget subsidies. Concurrently, TWG members also use caution before advocating broad 'sector-wide approaches' to health development and spending. General subsidy or too broad-brush approaches result in limited resources being thinly spread, without substantial results. While important, broad health sector subsidy is not an appropriate use for a fund that is very short on resources.

To succeed, the fund must quickly produce dramatic results. The only imaginable way to accomplish quick measurable results is if a high priority is placed on getting drugs to people with AIDS as quickly as possible. This necessarily means providing funds to qualified NGOs or groups of NGOs. Funds must go to NGOs without requiring a national government intermediary.

G. Conflict of interest and ethics: - TWG must prohibit not allow any governance or advisory role for pharma. Drug companies are chemists. Drug companies are not development experts or care specialists in resource poor settings. They are salespeople, marketers, and chemists. The only role for drug companies is to sell drugs.

In addition to the obvious commercial conflict of interest, there is a moral imperative that must preclude parties responsible in great part for the current disaster from any participation in the humanitarian response. Millions owe their deaths in great part to pricing polices deliberately pursued by the pharmaceutical industry.

H. A true balance between treatment and prevention: - TWG members must educate other TWG members about the ease with which treatment can be administered to people with HIV. Many TWG members have not been made aware that current treatment regimens consist of taking 1-3 pills in the morning and evening, without difficult schedules or dietary restrictions. Some TWG members may not be aware that disease management based on visually measurable symptoms is being studied by WHO, and is not far removed from current standards of care in wealthy countries. TWG members should share that it has become standard practice to delay the initiation of therapy for people with HIV. Intensive studies of pulsed treatment interruptions are also underway in many countries and settings. WHO is establishing disease monitoring protocols tailored to resource poor settings.

- TWG members should publicly discuss the failings of prevention without access to medicine. There is no "balanced approach" without access to medicine. Without drugs, there is little incentive to seek HIV testing, even if the fund has built numerous clinics with trained counselors. Antiretroviral therapy that lowers levels of HIV in blood and body fluids has been shown to reduce the infectiousness of people living with HIV. Without widespread HIV testing, prevention has a limited plateau of usefulness.

COMMENTS ON 9/14 and 9/17 PAPERS

* TECHNICAL REVIEW PANELS:

Health GAP supports regional review panels, but do not therefore see a need for a global review panel (the paper suggests both a global panel and optional regional panels). Multiple technical review panels by region will make the best use of local epidemiological knowledge and needs assessment. Additionally, regional panels will approve different kinds of programs, which by nature will create a new best-practices portfolio.

* COUNTRY LEVEL PROCESSES:

Problem: NGOs are not mentioned again, excepting a a small gesture hinted at under 'special circumstances"

* FIDUCIARY PAPERS

Health GAP supports UNICEF as fiduciary sponsor, based on an operating assumption that the fund should build outwards from existing infrastructure and resources. Unlike the World Bank, UNICEF has the largest worldwide procurement and distribution network, with flexible contracts and unparalleled geographic reach.

-The fiduciary options paper is inaccurate when it declares that there are not simple indicators for AIDS, TB and malaria. The fund should primarily measure decline in rates of mortality and new infection, by disease. These estimates are already independently monitored and reported to some extent.

Country level groups should be quickly convened and consist of invitations to governments (1/3 seats), UN Agencies (1/3 seats) and NGO+CBOs (1/3 seats). Simultaneously, grants to put medicine in the hands of people with HIV should be fast-tracked, independent of this process.

* APPLICATIONS PROCESS:

Problem: NGOs are not mentioned in the applications process paper.

* GOVERNANCE PAPERS

Problems:

-Leading board structure proposal has only 1 NGO vote, one observer!

-Only UN agency is UNAIDS or IBRD

-Inadequate African country representation

-Country-level body will submit plan for whole nation to board, leaving out NGOs

-Option to include all G8: we oppose, unless size of board is increased significantly (which we do not support).

Health GAP supports the 30% NGO level on board recommended by the recent Brussels NGO consultation.

* THE MODELS:

- The CCC model is likely to simply subsidize government expenditure for broad health spending, offering at best modest benefits. NGOs are not significant factors in the CCC model.

- The "World Bank" model is slow, and not additional. The World Bank has a negative track record on procurement or distribution of essential health commodities, as well as a spotty bad track record on health interventions. NGOS are not a significant factor in the WB model. Finally, the World Bank plan still potentially provides a too-broad array of programs.

- The 'Innovative' model is heavy and slow, creating numerous amorphous levels of vetting and consultation, without providing a strong role for NGOs.

Problem: The lean, efficient GAVI model has fallen off the table since Nov. 14.

* ELIGIBILITY PAPER

Health GAP supports an option where governments are encouraged but not required to be on the nation-level consortia. We support the option allowing for multi-country applications from NGOs. We support the option allowing individual NGOs to apply.

The eligibility paper also seems to erroneously prevent donor countries from receiving funds. This would unintentionally preclude Zimbabwe and Nigeria.

* MONITORING PAPER

- The Global Fund must not require the creation of elaborate country-level national AIDS programs as a prerequisite. Under no circumstances should Global Fund resources be tied to imposed burdens PRSPs that include structural adjustment conditions and a frequently flawed creation process. -ends-

CONTACT: Sharonann Lynch (Brussels mobile): +1 917 612 3058
Paul Davis (U.S. mobile) +1 215 833 4102

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