This is the accessible text file for GAO report number GAO-06-147R entitled 'Global Malaria Control: U.S. and Multinational Investments and Implementation Challenges' which was released on November 16, 2005. This text file was formatted by the U.S. Government Accountability Office (GAO) to be accessible to users with visual impairments, as part of a longer term project to improve GAO products' accessibility. Every attempt has been made to maintain the structural and data integrity of the original printed product. Accessibility features, such as text descriptions of tables, consecutively numbered footnotes placed at the end of the file, and the text of agency comment letters, are provided but may not exactly duplicate the presentation or format of the printed version. The portable document format (PDF) file is an exact electronic replica of the printed version. We welcome your feedback. Please E-mail your comments regarding the contents or accessibility features of this document to Webmaster@gao.gov. This is a work of the U.S. government and is not subject to copyright protection in the United States. It may be reproduced and distributed in its entirety without further permission from GAO. Because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. November 16, 2005: The Honorable Judd Gregg: Chairman: Committee on the Budget: United States Senate: The Honorable Russell D. Feingold: Ranking Minority Member: Subcommittee on African Affairs: Committee on Foreign Relations: United States Senate: The Honorable Tom Coburn: Chairman: Subcommittee on Federal Financial Management, Government Information, and International Security: Committee on Homeland Security and Governmental Affairs: United States Senate: The Honorable Sam Brownback: United States Senate: Subject: Global Malaria Control: U.S. and Multinational Investments and Implementation Challenges: Each year, hundreds of millions of people are sickened with malaria and more than 1 million people die. Over 80 percent of all malaria deaths occur in Africa, most of them in children under the age of 5. This burden continues despite the existence of relatively simple, safe, effective, and inexpensive methods to prevent and treat malaria. The U.S. government supports the efforts of malaria-endemic countries to control malaria, both directly through agencies such as the U.S. Agency for International Development (USAID) and indirectly through its contributions to multinational organizations such as the Global Fund to Fight HIV/AIDS, Tuberculosis, and Malaria (Global Fund) and its participation in the Roll Back Malaria (RBM) Partnership.[Footnote 1] However, concerns have been raised that current global malaria control efforts may not be as effective as they could be. In light of these concerns, you asked us to examine U.S. involvement in global efforts to combat malaria. In this report, we (1) describe investments that have been made by the U.S. government to support the implementation of national malaria control programs in malaria-endemic countries, both directly and in partnership with other organizations; and (2) describe key challenges to the implementation of national malaria control programs and strategies for addressing those challenges. For the purposes of our report, we reviewed only activities that support the implementation of national malaria control programs. Support for basic and clinical research to develop new tools (such as vaccines) to combat malaria was outside the scope of our review. To describe U.S. investments to support implementation of national malaria control programs, we reviewed financial and program documentation for U.S. agencies--including USAID and the Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH)--and for multinational organizations to which the U.S. government contributes--including the Global Fund, the United Nations Children's Fund (UNICEF), the World Health Organization's (WHO) RBM Department, the RBM Partnership Secretariat,[Footnote 2] and the World Bank. We also interviewed officials from these agencies and other organizations that support malaria control efforts. We checked the financial and program data for reliability and determined that they were sufficiently reliable for our purposes. To describe key implementation challenges and strategies to address those challenges, we reviewed a series of comprehensive country assessments conducted in Bénin, Eritrea, Ethiopia, Ghana, Kenya, Malawi, Mali, Nigeria, Sénegal, Sudan, Tanzania, Uganda, Zambia, and Zimbabwe.[Footnote 3] In addition, we conducted--via e-mail-- structured interviews with officials from USAID country and regional mission offices, as well as CDC field staff, in 13 of these countries.[Footnote 4] We also interviewed other officials from U.S. agencies and partner organizations and reviewed the literature on implementation of malaria control programs. We did not independently evaluate the reported challenges and strategies to address those challenges. We performed our work from January 2005 through November 2005, in accordance with generally accepted government auditing standards. Background: USAID, CDC, and NIH are the primary agencies that receive U.S. funding for global malaria control efforts.[Footnote 5] USAID primarily provides support for implementation of national malaria control programs but also supports some basic research. CDC provides a mix of implementation support and funding for basic research activities. NIH supports malaria research and training of malaria researchers in endemic countries, but does not provide implementation support.[Footnote 6] The U.S. government also funds global malaria control efforts through its contributions to multinational organizations including the Global Fund, agencies within the United Nations (UN) system--such as UNICEF and WHO's RBM Department--and development banks such as the World Bank. (See fig. 1.) Other donor nations, philanthropic foundations, and private-sector companies also provide significant funding to support global malaria control efforts. Figure 1: U.S. Federal Funding for Global Malaria Control Efforts: [See PDF for image] [End of figure] Malaria is transmitted to people by mosquitoes that carry the malaria parasite. Malaria control involves both preventing the disease and treating people who have been infected. Malaria can be prevented by targeting the mosquitoes that transmit malaria or by using medication to prevent malaria infections. The primary prevention strategies that target mosquitoes include using insecticide-treated bed nets (ITN) and spraying the interior of homes with small amounts of insecticides, known as indoor residual spraying (IRS). Intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (S/P) in pregnant women is the primary prevention strategy that relies on the use of medication. Currently, there are no effective vaccines that can be used to prevent malaria. The key medications for treating people with uncomplicated malaria in developing countries include artemisinin-based combination therapies (ACT),[Footnote 7] amodiaquine, chloroquine, and S/P. Some of these medications are available in or used in combination with each other. ACTs are preferable in many countries due to widespread parasite resistance to chloroquine and increasing resistance to S/P, particularly in Africa. However, ACTs are 10 to 20 times more expensive than the other medications and are not used in all countries. The RBM Partnership currently endorses a four-pronged approach to malaria control. This approach, which represents the consensus of all partners, including USAID and CDC, consists of: * improved and prompt access to effective treatment, * increased use of locally appropriate means of mosquito control, * early detection of and response to malaria epidemics, and: * improved prevention and treatment of malaria in pregnant women. There is broad agreement among U.S. and international malaria control experts that national malaria control programs, and the support that donors provide to those programs, should be tailored to the specific needs of each malaria-endemic country. Because of the complex nature of malaria transmission, the appropriate prevention and treatment strategies vary across countries, and sometimes across regions within a country, depending on multiple factors such as local patterns of mosquito and parasite resistance to different insecticides and medications. Results in Brief: The U.S. government's direct investments to support implementation of national malaria control programs in endemic countries--through USAID and CDC--are exceeded by its indirect investments through partner organizations, particularly the Global Fund. More than $68 million of USAID's fiscal year 2004 malaria budget--which increased from almost $30 million in fiscal year 2000 to almost $80 million in fiscal year 2004--was used to provide a range of implementation support, such as updating national prevention and treatment policies and supporting distribution of malaria-related commodities, including ITNs, insecticides, and medications. Almost $6 million of CDC's fiscal year 2004 global malaria budget--which increased from $9 million in fiscal year 2000 to more than $13 million in fiscal year 2004--was used to provide implementation support to national programs, including ITN, IPT, and treatment initiatives. In fiscal year 2004, the U.S. government's indirect investments through the Global Fund alone exceeded all direct investments to support implementation of national malaria control programs. We estimate, based on total Global Fund commitments for malaria control, that more than $142 million of the U.S. government's fiscal year 2004 contribution to the Global Fund goes to support malaria control grants. Using U.S. and other donor contributions, the Global Fund has, as of September 1, 2005, committed to provide more than $1.7 billion over the 5-year course of the malaria grants it has approved. The U.S. government's indirect investments through contributions to U.N. agencies and other multinational organizations also provide support to national malaria control programs. However, in the case of these organizations it is not possible to attribute a specific amount of their malaria funding to the United States. Key challenges to implementation of national malaria control programs include inadequate human resources, specifically, widespread shortages of adequately trained technical and clinical staff; insufficient financial resources for program implementation, donor support activities, and procurement of commodities; coordination challenges, including difficulties coordinating the activities of a range of partners in malaria-endemic countries; and challenges related to limited production, procurement, and distribution capacity for key commodities such as ACTs and long-lasting ITNs (also known as LLINs). Key strategies that are being used to tackle these challenges include addressing human resource and access-to-care issues through training of community health workers and integration of malaria program activities into antenatal care clinics and immunization programs; securing additional funding--particularly from the Global Fund--to support implementation of national programs and obtaining technical assistance from U.S. agencies and partner organizations to help ensure that this funding is used effectively; improving global and local commodity production capacity--particularly for ACTs and LLINs--by reducing or eliminating applicable taxes and fostering technology transfer to local manufacturers, among others; and addressing commodity distribution and use issues through strategies such as using a mix of ITN distribution mechanisms to target different populations, prepackaging medications, and employing extensive community education efforts. Enclosure I contains briefing slides on our findings. Agency Comments and Comments from the World Bank: We provided a draft of this report to HHS, USAID, and the World Bank. In its written comments, HHS did not indicate whether it agreed with the information we presented in our draft report. The agency stated that continued research to develop new medications, insecticides, and a malaria vaccine is critical for long-term efforts to control malaria. HHS noted that in addition to their support for malaria control in Africa, U.S. agencies support malaria control efforts in other regions of the world. Although the challenges we describe were identified primarily by officials working in Africa, our report provides information on all U.S. investments to support implementation of malaria control programs, not just those in Africa. USAID also provided written comments, in which it generally agreed with the information we presented in our draft report and highlighted the contributions that the agency has made toward improving malaria-endemic countries' ability to expand their malaria control programs. However, USAID expressed concern that the complexity of some of the issues we discussed in our draft report, such as supporting updating of national prevention and treatment policies and the subsequent implementation of those policies, was not adequately addressed. We agree that expanding malaria control programs is highly complex and challenging, and a section of our report is focused on identifying the key challenges and strategies that are being used to address those challenges. USAID also provided additional information about the 5-year, $1.2 billion malaria initiative recently announced by the President and updated information in our draft report, most notably regarding the number of countries that have switched their treatment guidelines to recommend ACTs and have adopted IPT prevention policies. HHS, USAID, and the World Bank all provided technical comments, which we incorporated where appropriate. In its technical comments, the World Bank noted that there is need for predictable, medium-to long-term financing for malaria control programs, but that financing from donor nations tends to be short term and unpredictable. We have reprinted HHS's written comments in enclosure II and USAID's written comments in enclosure III. We provided your staff with the information contained in this report on August 25, 2005. We agreed with your staff to issue a report to you containing the information we provided. We are sending copies of this report to the Secretary of State, the Secretary of Health and Human Services, the Administrator of the U.S. Agency for International Development, and other interested parties. We will also make copies available to others upon request. In addition, the report will be available at no charge on GAO's Web site at http://www.gao.gov. If you or your staff have any questions about this report, please call me at (202) 512-7119. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Martin T. Gahart, Assistant Director; Chad Davenport; Keyla Lee; J. Alice Nixon; and Roseanne Price made key contributions to this report. Signed by: Marcia Crosse: Director, Health Care: Enclosures - 3: Enclosure I: [See PDF for slide presentation] [End of slide presentation] [End of section] Enclosure II: Comments from the Department of Health and Human Services: Department of Health and Human Services: Office of Inspector General: Washington, D.C. 20201: Ms. Marcia Crosse: Director, Health Care: U.S. Government Accountability Office: Washington, DC 20548: Dear Ms. Crosse: Enclosed are the Department's comments on the U.S. Government Accountability Office's (GAO's) draft correspondence entitled, "GLOBAL MALARIA CONTROL: U.S. and Multinational Investments and Implementation Challenges" (GAO-06- 147R). These comments represent the tentative position of the Department and are subject to reevaluation when the final version of this report is received. The Department appreciates the opportunity to comment on this draft report before its publication. Sincerely, Signed by: Daniel R. Levinson: Inspector General: Enclosure: The Office of Inspector General (OIG) is transmitting the Department's response to this draft correspondence in our capacity as the Department's designated focal point and coordinator for U.S. Government Accountability Office reports. OIG has not conducted an independent assessment of these comments and therefore expresses no opinion on them. COMMENTS OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES ON THE U.S. GOVERNMENT ACCOUNTABILITY OFFICE'S (GAO) DRAFT _CORRESPONDENCE ENTITLED, "GLOBAL MALARIA CONTROL: U.S. AND MULTINATIONAL INVESTMENTS AND IMPLEMENTATION CHALLENGES" (GAO-06-147R): General Comments: The draft report addresses challenges for implementing the currently available effective methods for controlling malaria. Efforts to develop additional control tools to complement current tools will need to continue. Additional effective therapeutics, new classes of insecticides, and, ultimately, a malaria vaccine are still needed. Research in these areas is critical for a long-term control of malaria, and is a component of the U.S. Government's (USG) balanced efforts on global malaria control. The country assessments included in the draft are all in Africa. Although only 10 percent of malaria deaths occur outside Africa, malaria is a major public health problem in many other areas, particularly in Asia, and USG agencies also are supporting malaria control in other areas of the world. [End of section] Enclosure III: Comments from the U.S. Agency for International Development: US AGENCY FOR INTERNATIONAL DEVELOPMENT: Ms. Marcia Crosse: Director, Health Care: U.S. Government Accountability Office: 441 G Street, N.W. Washington, D.C. 20548: NOV 10 2005: Dear Ms. Crosse: I am pleased to provide the U.S. Agency for International Development's (USAID) formal response on the draft GAO report entitled "Global Malaria Control: U.S. and Multinational Investments and Implementation Challenges (GAO-06-147R)." We very much appreciate the extensive and thoughtful effort that went into this review by the GAO team. Given the relatively short time the team had to complete their work, we were impressed with their grasp of the complex issues at hand and found the report to be a succinct and balanced presentation of some of the critical challenges facing malaria control today, as well as of examples of the kinds of programs and activities USAID has been supporting to address malaria. The enclosed comments identify a few concerns and elaborate on several of the examples and issues identified in your report. Thank you for the opportunity to respond to the GAO draft report and for the courtesies extended by your staff in the conduct of this review. Sincerely, Signed by: Lisa D. Fiely: Chief Financial Officer: Bureau for Management: Enclosure: a/s: United States Agency for International Development's (USAID) Comments on GAO Draft Report: Global Malaria Control: U.S. and Multinational Investments and Implementation Challenges (GAO-06-147R): USAID appreciates the opportunity to review and comment on the GAO draft report on Global Malaria Control. The extensive and thoughtful efforts of the GAO team are reflected in their impressive grasp of the complex issues; however, we have taken this opportunity to identify a few concerns and to elaborate on several of the examples and issues identified in this report. In addition to providing essential, life-saving interventions, USAID's work in malaria over the past decade has laid the groundwork for the exciting opportunities we currently have in scaling up effective anti- malarial programs in Africa as part of the President's Malaria Initiative. We continue to work with countries throughout Africa, as well as Asia and Latin America, to monitor drug resistance and help them change treatment policy to adopt more effective first-line treatments. Thirty countries in Africa, eight in Latin America, and five in Asia now have adopted artemisinin combination therapy (ACT) as their first-line treatment. In seventeen of these countries USAID has helped directly effect this change. USAID supported the research necessary to introduce ACTs in Africa, demonstrating their safety in children under ten kilograms. USAID's support for the insecticide treated net (ITN) trials in Kenya in the 1990s demonstrated their effectiveness in reducing malaria and reducing child mortality in areas with high malaria transmission. USAID also supported the research demonstrating the power of intermittent preventive therapy (IPT) in reducing malaria in pregnant women and the number of low birth weight babies and has been instrumental in helping 25 countries in Africa adopt a policy on IPT. The President's Malaria Initiative builds on this long-standing experience to forge a program capable of reducing mortality attributable to malaria by 50 percent. Under this initiative, the President has proposed $1.2 billion over the next five years, on top of our on-going programs. We will meet these targets by dramatically scaling up proven effective interventions, including use of ITNs, indoor residual spraying, ACTS and IPT in at least fifteen countries in sub-Saharan Africa. USAID will purchase substantial amounts of life- saving commodities and dramatically expand services. In order to deliver these commodities, we will continue to build logistics and management systems, train health care workers and monitor programs, and work in close partnership with National Malaria Control Programs and other partners at the global and country level. Several serious issues noted in your report warrant further elaboration. On page 8 of your slides, you note that ACTs still are not being used in all countries. We are concerned, however, that the complexity of changing and implementing a new drug policy is not given adequate attention. Changing drug policy requires political commitment on the part of affected countries, new drug regulations, changes to the logistics and distribution systems (including phasing out of obsolete medicines), training of health care providers at all levels of the system, and providing clear information to patients. In addition, global supply issues (noted on page 33 of your slides) are proving to be a significant barrier to increased uptake and use of ACTS --even as pharmaceutical companies work to increase their production and resources become available from the Global Fund, USAID, and other donors to purchase ACTS. USAID continues to work to address this critical problem. We are helping pharmaceutical manufacturers to meet prequalification requirements in order to expand the number of manufacturers on the market. We are supporting a coordination mechanism for procurement forecasting to help manufacturers better plan for meeting the demand for ACTs. We also have provided funding to agricultural concerns to grow the Artemisia annua plant in East Africa, which will lead to increased supply of ACTs in early 2006. Your report correctly notes that USAID's implementation support includes updates to prevention and treatment policies and to commodity distribution systems. Without these investments, and the on-going work to build functioning management systems, ACTs, ITNs, and other life- saving commodities would simply sit in a warehouse and never get to those who need them. However, the report highlights only a few examples that, in the aggregate, do not adequately describe the extent of USAID activities. In the past year alone, for example, NetMark spent over $1 million to subsidize the costs of ITNs for the poor (including $248,071 spent through NetMark by ExxonMobil and the Red Cross). Through its formal partnerships with the private sector, including local distributors in Africa, NetMark has distributed over 6 million ITNs and 4.2 million insecticide treatment and re-treatment kits to families in need. This success is due in large part to USAID's large-scale demand generation, marketing support, and provision of payment guarantees to manufacturers to increase credit ceilings for African distributors by between 100 to 400 percent. It also is due to USAID efforts to develop the capacity of local distributors and built sustainable, national level markets to deliver ITNs without the need for perpetual donor support. USAID also has subsidized ITN distribution through antenatal clinics and other health centers in many other countries, including Madagascar, Benin, Angola, Ethiopia, and the Democratic Republic of the Congo. In addition to the data on commodities included on page 17 of your report, USAID allocated about $600,000 for other malaria related commodities, including laboratory equipment and rapid diagnostic tests. The total funding for malaria related commodities in FY 2004 was $6.2 million. [End of section] (290436): FOOTNOTES [1] The RBM Partnership was created in 1998 to coordinate and increase the scale of global efforts to reduce the burden of malaria. The RBM Partnership includes representatives from malaria-endemic countries, multinational development organizations, the Global Fund, donor countries (including the United States), the research and academic community, the private sector, nongovernmental organizations (NGO), and foundations. [2] WHO's RBM Department is responsible for WHO's global malaria control efforts, and is one organization within the RBM Partnership. The RBM Partnership Secretariat is a separate organization that is part of the support structure for the RBM Partnership itself. [3] Assessment reports for Bénin, Mali, and Sénegal were in French. For these countries we relied on structured interviews. [4] We conducted 19 structured interviews in total. We did not interview officials in the USAID field office in Zimbabwe because that office does not provide support for malaria control. In addition, within these countries, CDC has field staff only in Kenya, Malawi, Tanzania, and Uganda. [5] The Department of Defense also provides support for malaria control, focusing primarily on research. [6] In June 2005, the U.S. President announced an initiative that, in addition to existing U.S. funding, would provide $1.2 billion over 5 years to support increased malaria control efforts in 15 or more African countries. [7] The artemisinin components of ACTs are extracted from the plant Artemisia annua.