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Executive Summary

At the G8 meeting in Gleneagles in 2005 and again at the United Nations UNGASS session in 2006, world leaders promised to come as close as possible to providing universal access to AIDS treatment and prevention by 2010. Estimates of HIV incidence and prevalence will change, but by any account, today several million people in desperate need of AIDS treatment do not have access to it. And at the current pace of growth in treatment delivery, several million will not have access by the end of 2010. Broken promises will mean millions of deaths.

Scale up of AIDS treatment is driving unprecedented expansion of health delivery and, in the process, identifying critical challenges to health systems as well as practical solutions to address them. This report identifies many ways in which governments and global agencies must act to correct systems essential to delivery of health. In the area of antiretroviral drug access—a special focus of this report— our research found that in many countries drug registration, procurement, and supply management systems are inadequate, drug stock-outs are common, and most people are not being treated with ARV regimens that are consistent with recent WHO recommendations for improved first-line and standardized second-line treatment combinations.

On-the-ground research by civil society advocates from 17 countries also reveals the close interconnection of AIDS services with other health and social supports. The lessons for successful AIDS treatment are true for all health services: appropriate delivery includes adequate nutrition, clean water, trained health workers, accessible health clinics, integration of prevention and treatment, and free provision of drugs, diagnostic and monitoring tests, and other commodities. Mobilization around AIDS has raised new resources, built consumer-engagement in providing health care, marshaled enduring public support, and promoted the development of results-oriented approaches to global health. Building on these foundations should be a central strategy in developing comprehensive systems of health care. In Haiti and Rwanda, for example, providers are demonstrating how to deliver AIDS treatment as part of a comprehensive program that includes HIV prevention and a wide range of health services.1 2 3

We cannot allow responses to AIDS and other chronic health issues to become bogged down in simplistic dichotomies: prevention vs. treatment; horizontal vs. vertical programming; disease-specific funding vs. strong health systems. There is only one appropriate approach: We must do everything, better, for more people, and in an increasingly coherent way.

In this fifth installment of the Missing the Target report series, we are broadening and deepening our approach to monitoring AIDS service delivery in heavily affected countries. Seventeen teams (from Eastern Europe, Africa, Asia, and Latin America) participated in the development of this report. And we are beginning the process of expanding the focus of the report series to incorporate more of the inextricably interwoven aspects of ending AIDS, including HIV prevention, TB services, and support services.

Scaling up AIDS services

In the first section of MTT5, nine country teams provide first-hand reports on central issues related to AIDS service scale-up in their countries. Each demonstrates that increasing access to AIDS treatment brings not only better life and new hope, but also shines light on challenges and effective approaches to a spectrum of health, poverty, and human rights issues.

The Missing the Target team in Cambodia found that low salaries, inadequate training and other issues have led to a serious human resources shortfall .

Cameroon describes how lack of nutritional resources has emerged as a determining factor in delivering care

In China, a close analysis reveals that multiple charges for AIDS-related health services exist, even in the context of a “free” ARV program

In the Dominican Republic, there is an increasing level of ARV coverage but the government must now address poorly supported public hospitals and limited access to specialized care

In India, the national AIDS authority has just announced a long awaited second-line therapy plan; much greater attention is needed to marginalized populations

In Kenya, the report team documents the devastating impact of stigma and discrimination on health service delivery

The Russia team reviews the deadly combination of poverty, powerlessness and social discrimination among marginalized groups

In Zambia, a district-by-district survey identifies multiple and variable barriers to care, including limited access to diagnostic tests, poor nutrition, and long travel times to clinics

The Zimbabwe team documents advances in service delivery that have been accomplished in the midst of national political and economic turmoil but finds continuing challenges such as fake ARVs and lack of access to clean water

Focus on drug access

In part two of this report, “ARV Procurement, Registration, and Stock-Outs”, 14 national teams review drug access issues, and find that global and national processes for AIDS drug registration are burdened by inefficiencies, duplications, delay, and, in some instances, corruption. In many cases key ARVs, particularly newer and second-line therapies, are not yet registered in high impact countries – an administrative roadblock that puts lifesaving care out of reach for hundreds of thousands of people.

While specifics vary by country, our research reveals that high prices, patent barriers, registration barriers, and misinformation among policy makers and clinicians mean that many countries are using AIDS treatment combinations that are not preferred according to WHO guidelines, such as fixed-dose combinations of stavudine (d4T)+lamivudine (3TC)+nevirapine (NVP). In China there is still wide use of didanosine (ddI)+stavudine (d4T)+ nevirapine (NVP), another combination not recommended by WHO. Drug stock-outs in government-run treatment centers are common in several countries, and they often prompt drug sharing, and with it the potential for the development of resistance, as well as impoverishment as people who are forced to pay out of pocket for medicines in the private sector.

In Argentina, high cost and restrictions on some drugs impede access to some second-line and other medicines

In Belize, human resources shortfalls, price increases and inadequate quality assurance plague drug delivery

In Cambodia, expanded access to drug resistance and viral load testing is needed, as is increased attention to drug quality

In China, access to second-line therapy is extremely limited, new WHO treatment guidelines on improved first-line treatment have not been widely implemented and patents on key medicines are preventing cost-cutting generic competition

In the Dominican Republic, new intellectual property laws and patent enforcement by Merck are leading to higher prices and limited access to some key drugs

In India, drug stock-outs are reported across the country, particularly where IDUs require treatment regimens that are not hepatotoxic

In Malawi, a chronic shortage of health care workers is a major impediment to drug access; while there are no ARV stock-outs, other important drugs are often unavailable

In Morocco, new intellectual property laws threaten the provision of AIDS treatment

In Nigeria, despite a rapid scale up of ARV treatment and a free treatment policy, treatment sites are not easily accessible in many parts of the country, and CD4 and other tests are still being offered at a fee in several locations

In the Philippines, treatment is not yet accessible to all, there is a healthcare worker shortage and diagnostic testing access is limited

In Russia, ARV stock-outs are a severe and ongoing problem

In Uganda, stock-outs are commonplace, and limited support and care services undermine drug access

In Zambia, there is concern that AIDS drug access depends on the work of NGOs and the government is not sufficiently engaged

In Zimbabwe, stock-outs are frequent and the increasingly unfriendly general policy environment remains a cause for concern

Recommendations

The report makes a number of concrete recommendations to the key players who are responsible for making near universal access to AIDS treatment a reality by 2010:

WHO, UNAIDS and other UN technical agencies:

• WHO needs to take the lead to educate countries about changes to standard first- and second-line treatment regimens. This will increase country demand and help contribute to price reductions.

• UN technical agencies must clearly and publicly communicate changes in WHO ARV drug guidelines and provide technical support and guidance to countries to help implement the changes.

• WHO must be much more active and visible as the arbiter in setting norms on the use and availability of life-saving medicines, for example through reinvigorating the AIDS Medicine and Diagnostic Service (AMDS) and through eliminating bottlenecks and increasing support for the WHO prequalification program.

• WHO must reinvigorate the operational urgency of the “3 by 5 Initiative.” Given its focus on building primary care services, WHO should lead global efforts to simultaneously expand AIDS services while strengthening broader care systems.

• UN agencies should provide increased technical and political support to help create political and policy space for governments to overcome patent barriers through use of public health flexibilities in international trade law.

• WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) provides a critical opportunity for much-needed leadership from UN agencies, as well as national governments, to increase access to affordable medicines through a clear international strategy and plan of action.

The Global Fund:

• The Global Fund should encourage countries to switch from outdated and non-optimal AIDS treatment regimens to improved treatment combinations, and develop a plan to support countries making the switch.

• The Global Fund should ensure its grantees are procuring medicines at preferential prices, such as those secured through UNITAID’s partnership with the Clinton Foundation (announced May 2007).

• The Global Fund should act in cases where countries are reporting paying high prices for medicines through the Price Reporting Mechanism by diagnosing the problem and working with partners such as UNITAID to ensure procurement at lowest cost.

• The Fund should proactively support grantees in identifying and correcting procurement bottlenecks and strengthening national procurement systems for ARVs and other medicines.

Bilateral donors including PEPFAR:

• Bilateral programs should work with national treatment programs, community organizations, PLWHA and other partners to support national efforts to switch to optimized first-line treatment. Budgetary allocations should reflect at least the initial increases in costs for optimized first-line treatment.

• PEPFAR and other bilateral donors should work with countries to achieve agreed benchmarks for increasing the national capacity of countries in procurement and supply management.

UNITAID: The international drug purchase facility should work aggressively to support initiatives to increase competition and further reduce the price of new standardized treatment regimens, such as fixed dose combinations of tenofovir (TDF) + lamivudine (3TC) +efavirenz (EFV), as well as generic versions of heat-stable lopinavir+ritonavir (LPV/r) and other ritonavir-boosted protease inhibitors such as atazanavir (ATV).

Drug companies: Pharmaceutical companies must act with enlightened self-interest to expand access to their products by ceasing to intimidate countries that use flexibilities in trade law and, where appropriate, by establishing voluntary licensing arrangements to encourage local production. Both innovator and generic drug companies must work to register their products much more expeditiously where people are in urgent need of treatment.

National governments:

Governments must build local and regional regulatory capacity to assure the quality, safety, and efficacy of medicines and make use of options to accelerate access to drugs, including reliance on the WHO drug prequalification process. National governments must show political will to increase access to affordable medicines by using flexibilities in international trade rules established by the Doha Declaration on TRIPS and Public Health.

The Missing the Target reports illustrate many connections between access to AIDS treatment and wider health and social support issues. In countries such as the Dominican Republic, which we’ve followed across five reports, problems get solved, new problems emerge and, over time, the number of people getting ARVs (and staying alive) increases. Continuing monitoring and civil society pressuring plays a major role in this improvement.

Natural disaster and political and economic upheavals (for example, in Zimbabwe) can set-back but do not have to stop the momentum of increasing access to treatment. The goal of getting AIDS treatment to more and more people is working, saving millions of lives, and transforming people’s relationship to health services around the world.