X. Supportive Interventions for U.S. Government Programs
Supply chain management is critical to ensure the delivery of essential drugs, supplies, and equipment that make HIV/AIDS programs possible. Under the Emergency Plan, attention will be focused on supporting a secure and sustainable supply chain management system that is reliable and coordinated with complementary programs, such as donated ARV drug programs. Efforts will also be targeted toward reducing and eliminating diversion, counterfeiting, and the sale of HIV/AIDS products and supplies on the black market. A robust evidence base is needed to direct the Emergency Plan’s treatment, prevention, and care programs. A strong research program will both provide new knowledge (e.g., more effective ARV therapy or discovery of effective prevention methodologies) as well as give direction to policy and program decisions (operational studies). Moreover, by strengthening linkages between the research community and the Emergency Plan, implementation successes and failures can inform future research agendas. A second set of evidence will be collected through a strategic information system that will track programs to ensure that they are meeting targets (monitoring) and that activities have measurable impact (evaluation). Best practices for HIV/AIDS treatment, prevention, and care will be identified through both of these processes. Public-private partnerships will mobilize private sector resources to build sustainable systems of HIV/AIDS treatment, prevention, and care. The comparative advantages of these partnerships will be maximized to complement the services provided by the public and NGO/FBO sectors. 1. Supply Chain Management
Comprehensive HIV/AIDS programs require a large number of products. Effective supply management is critical to the delivery of these products. To ensure sustainability of HIV/AIDS programs, essential supply chain management personnel will be trained and health logistics systems strengthened. Efforts will need to be taken to minimize drug diversion, counterfeiting, and waste, with a special focus on ARVs, given the high cost of these drugs and the risk of drug resistance if they are administered inappropriately. Opioids also need similar strong management to avoid diversion and misuse. President Bush’s Emergency Plan will coordinate with other donors so that supply chain synergies are maximized and gaps in distribution systems minimized. Currently, the U.S. pharmaceutical industry estimates the cost of distribution from manufacturer to retailer to be about 20 to 25 percent of the drug’s retail cost. The Office of the U.S. Global AIDS Coordinator anticipates investing a comparable percentage of product costs for supply chain management. Supply Chain Management Objective: Supply Chain Management Strategies:
1. Rapidly scale up supply chain management to support HIV/AIDS treatment, prevention, and care The development and implementation of logistics systems to manage the increased volume of products and supplies for the full continuum of care will require both short- and long-term strategies. The focus of all strategies will be on procuring and delivering a continuous and secure supply of high-quality products to patients who need them at all levels of the health system. In the short term, the approach will require a combination of outsourcing some logistics functions to the private sector, rapidly building a vertical distribution and information management system with external technical assistance, and improving the storage conditions, distribution networks, and human capacity skills at sites providing HIV care and treatment. In most countries, the sharp increase in the volume of products provided through President Bush’s Emergency Plan, and other new sources such as the Global Fund, will probably challenge existing national supply systems. To ensure product supply and quality, the Emergency Plan will explore options to enhance the immediate performance of national logistics systems, including:
Key to success will be the seamless collaboration between the supply chain managers and program service managers. Overall program impact will be ensured through coordination of patient enrollment, product availability, and service capacity. Collaboration with other donors and stakeholders is also imperative. For example, a logistics system that manages products procured under the Emergency Plan may be able to take on management of similar products funded through other sources, such as the Global Fund or the World Bank’s Multi-Country HIV/AIDS Program for Africa (MAP), in addition to existing donor basket funds and direct product donations. President Bush’s Emergency Plan will work to facilitate the development of national coordinating bodies to manage donor financial and product/supply commitments, develop medium-term procurement plans, and track actual funds and products received. The coordinating body will promote a synergistic approach to donor inputs to avoid duplication of investment and waste of resources. 2. Build capacity for long-term sustainable pro-curement and distribution President Bush’s Emergency Plan will build on lessons learned through other public health programs, such as those that manage essential drug, immunization, family planning, and child survival initiatives. To improve program effectiveness, procurement and supply management considerations will be built into program design and implementation. The Emergency Plan will provide technical assistance and training to strengthen procurement and distribution systems in the areas of:
Product selection Distribution 3. Ensure quality control of drugs, test kits, andother supplies Under the Emergency Plan, products of the highest quality will be purchased at the lowest price. Ensuring high quality is absolutely essential for HIV/AIDS drugs, test kits, and other supplies. Therefore, products will be procured from reliable manufacturers to ensure product safety and efficacy. The Emergency Plan will enhance in-country capacity to perform quality-testing procedures and, where appropriate, will support the development of regional testing facilities to ensure product quality. 4. Focus on intellectual property law at international and national levels Through President Bush’s Emergency Plan, the Office of the U.S. Global AIDS Coordinator is eager to work with all parties who are interested in contributing to this important effort to combat the global HIV/AIDS epidemic by ensuring that high-quality affordable drugs are available to those in need of them. Within this context, Emergency Plan funds used to purchase products will be directed to obtaining high-quality goods at the lowest possible price. This could mean bioequivalent versions of branded ARV and other medications. Voluntary differential pricing already exists, and there is no evidence that the market is not working or that companies are preparing to rescind their preferential pricing offers for poor countries. Major research-based companies are responding to the evolution of a market in the developing world to bid competitively, even beating per-patient generic prices in some markets in the developing world, and these companies are encouraged to compete for tenders that will use Emergency Plan funds. Brand-name companies have also done an exemplary job of donating their products to roll out treatment and care for patients with HIV/AIDS. Public-private partnerships (like the Merck/Gates Foundation/Harvard collaboration in Botswana or the Global Alliance for Vaccines and Immunization) are providing drugs and vaccines at no or very low cost in many places in the developing world. Voluntary out-licensing proposals to encourage market competition in the production of pharmaceuticals, such as Pharmacia’s arrangement with the International Dispensary Association in the Netherlands for manufacturing one of its AIDS drugs in the developing world, are potential models as well. Grantees will be expected to follow national laws in the countries in which they will be operating and to respect applicable international obligations regarding intellectual property. All procurement under the Emergency Plan will have to fit within the parameters of existing federal and international law for the protection of intellectual property rights. There is a need for balance between the needs of poor countries without the resources to produce or pay for cutting-edge pharmaceuticals and the need to ensure that the patent rights system, which provides the incentives for continued development and creation of new lifesaving and life-extending drugs, is promoted. Because a high percentage of all new medicines are invented in the United States, the new medicines that will solve the health problems both of today and tomorrow will likely come from U.S. companies. In this regard, intellectual property rights are not the problem but a part of the solution – they provide the incentive for innovation in creating new medicines, including vaccines, and private enterprises are the principal entities that bring new health technologies to market. The United States supports the decision of the General Council of the World Trade Organization (WTO) on August 30, 2003, regarding the implementation of Paragraph 6 of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) and Public Health. This decision represents an expeditious solution to the difficulties that developing-country WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face in making effective use of the flexibilities contained in the TRIPS Agreement. The United States expects that all countries will cooperate to ensure that the drugs and active ingredients produced under the terms of the Paragraph 6 solution – as well as other drugs sold or donated in developing countries – are not diverted from countries in need to wealthier markets. There is also insufficient government action in many developing countries to prevent the marketing, sale, and use of substandard and counterfeit drugs, some of which find their way back to developed markets. In the last year, police and drug regulators have discovered crime rings that were diverting donated or reduced-price AIDS drugs from developing nations and selling them in Europe. European nations also are experiencing growing problems with counterfeit or substandard medicines imported from Africa and Asia, and counterfeit AIDS medications have begun to circulate in Africa as well. Tariffs and duties on pharmaceuticals pose another problem. These are barriers that can be important elements in increasing the cost of drugs in developing countries and work at cross-purposes with initiatives that NGOs, governments, and industry are undertaking to improve access to medicines. 2. Evidence-Based Programs Policy and program decisions for the President’s Emergency Plan will be evidence-based. The evidence needed includes:
Research Basic, clinical, social science, translational, and operational clinical research will be supported through the Department of Health and Human Services’ National Institutes of Health (HHS/NIH) and will follow the HHS/NIH Office of AIDS Research (OAR) annual strategic plan for HIV/AIDS research as described in appendix H. The HHS/NIH annual AIDS research strategic plan addresses the following research areas: natural history and epidemiology, etiology and pathogenesis, therapeutics, vaccines, behavioral modification research, microbicides, HIV prevention, women and girls, training and infrastructure, and information dissemination, as well as a component devoted to international AIDS research. Similarly, the U.S. Agency for International Development (USAID) will continue to support applied and operational research as well as focused activities on vaccines and microbicides, as described in appendix I. Although HHS and USAID research activities will generally not be funded through the Emergency Plan, the U.S. Global AIDS Coordinator will work closely with both HHS and USAID leadership to make sure that goals and needs of the Emergency Plan are supported by these research priorities. These collaborative efforts will also work to rapidly translate research into practice in the initiative’s activities. The many programs and activities undertaken to reach the goals of the President’s Emergency Plan will require a certain amount of targeted evaluation and research that addresses special circumstances in the diverse settings of the focus countries. New approaches to prevention, treatment, and care must be rigorously analyzed as to their relative merit and effectiveness. Clinical decision-making will require studies to determine optimal treatment in diverse settings and conditions. While some of these studies will fall under the mandate of HHS or other departments, others may not. In these cases, the Office of the U.S. Global AIDS Coordinator, in consultation with HHS, the U.S. Agency for International Development, the Department of Defense, and other partners and interested parties, may need to fund a program of special studies. The agenda for these special studies includes developing clinical guidelines, addressing optimal program and policy formulation, seeking solutions to barriers to care, and conducting other studies to assist programs in meeting the goals of the President’s Emergency Plan. Finally, global research capacity is a key component of sophisticated health systems development. The NIH research agenda, by developing research capacity in the focus countries and around the world, will enhance clinical care in those countries. At the pinnacle of health systems networks are research institutions that will be able to work with NIH and other international research organizations. This research capacity will, in turn, help support achievement of national HIV/AIDS strategies as well as programmatic efforts to meet the goals of President Bush’s Emergency Plan. Strategic Information We plan, through strategic information, to:
In order to build sustainable management systems over the long term, the strategic information system must take into account the broader health care delivery system in which it will be implemented. A facilitybased MIS structure should permit generation of the necessary strategic information for rational decisionmaking at each level of the health system, from the facility to national and donor levels. As seen below, each user requires reliable and timely information to support its own set of management functions. These functions include individual patient care management, facility management, and health program management at district, national, and international levels.
At the level of the U.S. Global AIDS Coordinator’s Office, USG country offices will report critical indicators into one U.S Government reporting system that is transparent, communicates with other international donors, and provides access for the public to program information. Initial reporting will be on a semiannual basis. This system will need to be built from the ground up. Existing facility-based health information systems in most countries are unable to provide the information support needed to manage a broad range of health system interventions. Some of the main reasons for this are inadequate financial and human resources; irrelevance and consequentially poor data quality collected at the facility level; centralization and/or fragmentation of information system management; and poor health information system infrastructure. Experience in several countries in the last two decades has shown that decentralization of information management is an effective strategy to improve facility-based management information systems. To support this approach we will need to adapt information needs to the specific management functions at each level, produce high-quality information in a timely fashion, and ensure sufficient health information resources and careful management of the system. To measure the “2-7-10” goals of President Bush’s Emergency Plan, surveillance and program reporting systems will need to indicate (1) the total number of clients reached with ART (including through PMTCT initiatives); (2) the total number of clients receiving care and support services, including TB/HIV clinical care and palliative care through home- or community-based programs; and (3) the total number of orphans and vulnerable children reached with care and support. The number of infections prevented will be determined through modeling techniques using both antenatal surveillance clinical information and behavioral surveillance data. Appendix G presents the Emergency Plan’s program-level monitoring framework. The strategic information underlying the President’s Emergency Plan will not be accomplished by U.S. Government efforts alone. It will build upon international strategic information efforts to harmonize informational measures, provide monitoring and evaluation training in affected countries, and share gathered data. Both WHO and UNAIDS have formed donor coordinating groups for strategic information that address surveillance, monitoring and evaluation, and MIS. The United States will actively participate in these groups beginning with adoption of the WHO and UNAIDS guidelines on the construction of core HIV indicators. In consultation with the World Bank and the Global Fund, the Emergency Plan will ensure that informational data collection by donors is aligned in targeted countries to minimize the burden of information collection and to maximize the focus on HIV prevention, treatment, and care. The task of health information system reform is both formidable and complex, particularly in the context of developing countries. The Office of the U.S. Global AIDS Coordinator will provide the leadership, consensus building, and commitment at the U.S. Government level to implement the health information restructuring that is needed to measure progress under the President’s Emergency Plan. 3. Public-Private Partnerships President Bush believes that public-private partnerships offer a unique and sustainable opportunity for the provision of quality HIV/AIDS services with wide reach, as they combine the strengths of government, business, and civil society. Private sector innovations, resources, and expertise are essential to the battle against HIV/AIDS, which has strained government and civil society responses. As one example of the power and reach of public-pri-vate partnerships, innovations in the workplace can have broad impacts on families, communities, and the entire socioeconomic fabric of a country. An estimated 26 million people – more than 60 percent – of the 40 million living with HIV/AIDS are workers between the ages of 15 and 49, the most economically active segment of society and the mainstay of families, communities, enterprises, and national economies. UNAIDS projects that high-prevalence countries will see their workforces decrease by 10 to 34 percent as a result of AIDS by 2015 and that gross domestic product in the hardest-hit countries may decline by as much as 8 percent by 2010. The primary vehicle for protecting the workforce is the workplace. Workplaces, ranging from small businesses to multinational corporations, provide regular access to workers, and by extension, their families and communities. Experience in Africa and the Caribbean has shown that workplace-related programs are often the only source of prevention, treatment, and care services for workers, their families, and their communities, and that combating stigma and discrimination in the workplace is essential to increasing the utilization of HIV/AIDS services. In some cases, multinational companies operating in Africa and the Caribbean have been the first to introduce HIV/AIDS programs and policies and have set standards for the community at large, serving as models for the development of national strategies. President Bush’s Emergency Plan will coordinate with private corporations to provide HIV/AIDS services to community members through corporate health facilities. The capacity of the private sector to reach broad sections of the population through workplaces and information campaigns can promote a supportive culture throughout the community for defeating HIV/AIDS. In addition, public-private partnerships such as twinning of private sector technical expertise with groups developing HIV/AIDS programs can play a crucial role in rapidly scaling up quality HIV/AIDS services. Public-private partners share risks and accomplishments, as well as resources, including finances, infrastructure, information, and people to achieve a common goal. Private sector initiatives contribute resources outside of the traditional health infrastructure and are critical for creating the social, cultural, and political environment that will enable the achievement of Emergency Plan goals. Public-Private Partnerships Objective: Public-Private Partnerships Strategies:
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![President Bush tours Ford Motor Companys automobile assembly plants roundtable on AIDS prevention with Ford employees in Pretoria, South Africa [White House photo office]](https://webarchive.library.unt.edu/eot2008/20081026231453im_/http://www.state.gov/cms_images/chapter_10_photo_250.jpg)
Interventions that support implementation of the President Bush’s Emergency Plan will include an effective and accountable supply chain; a strong research program to provide the evidence base necessary to guide policies and programs, including a coordinated strategic information system; and enhanced public-private partnerships.
The first step in the long-term development of strategic information for HIV/AIDS facility-based interventions will be to define management functions at each level, starting with the patient/client level. This process will ultimately make it easier to identify the information required at each management level for decision support. Basic data elements (e.g., the number of new clients served) should not be lost as they are reported “up.” However, indicators and analysis of the information may differ at each level. Core indicators focus mainly on program management functions at district, national, and international levels. Health facilities require a different set of indicators for patient and facility management.
