II 116th CONGRESS 1st Session S. 2438 IN THE SENATE OF THE UNITED STATES August 1, 2019 Mr. Menendez (for himself and Mr. Young ) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To prevent, treat, and cure tuberculosis globally.

1. Short title This Act may be cited as the End Tuberculosis Now Act of 2019 . 2. Findings Congress makes the following findings: (1) Tuberculosis is a preventable, treatable, and curable airborne infection; however more than 25 years after the World Health Organization declared tuberculosis a public health emergency and called on countries to make scaling up tuberculosis control a priority, tuberculosis still kills more people worldwide than any other infectious disease, and is the leading killer of people living with HIV/AIDS. (2) In 2017, 10,000,000 people became ill with tuberculosis, 10 percent of whom were children, and 1,600,000 people died from the disease. In order to achieve the goals of the World Health Organization End TB Strategy by 2035, new tools must be developed and made available. (3) Over one-third of people who become ill with tuberculosis may be undiagnosed, misdiagnosed, or treated but not reported, resulting in unnecessary illness, communicable infections, and increased mortality. (4) Failure to properly treat tuberculosis can cause treatment failure and death, and exacerbates antimicrobial resistance, increasing multi-drug-resistant tuberculosis (MDR–TB) and extensively drug-resistant tuberculosis (XDR–TB), which are significantly costlier and more difficult to treat than drug-sensitive tuberculosis and can also be transmitted from person-to-person, increasing the likelihood that drug-resistant tuberculosis will spread to new geographic areas. (5) Globally, only about half of the $13,000,000,000 required annually as outlined in the Stop TB Partnership's Global Plan to End TB for tuberculosis prevention, diagnosis, and treatment is currently available. (6) There is an annual $1,300,000,000 gap in funding needed for the development of vaccines, additional rapid, point-of-care diagnostic tests, and shorter, less toxic treatments which would facilitate patient adherence to treatment regimens, reduce program costs, and mitigate the growing threat of drug-resistant tuberculosis. The United States Government continues to be a lead funder of global tuberculosis research and development, contributing 40 percent of the total $772,000,000 in global funding in 2017, and can catalyze more investments from other countries. (7) The rate of new cases of tuberculosis in countries that receive United States bilateral assistance for tuberculosis prevention, treatment, and control has fallen by one quarter since 2000 demonstrating the effectiveness of United States programs and activities. (8) In September 2018, United Nations Member States in the first United National High Level Meeting on Tuberculosis committed to ending the epidemic in all countries, and pledge[d] to provide leadership and to work together to accelerate our national and global collective actions, investments, and innovations urgently to fight this preventable and treatable disease, as reflected in United Nations General Assembly Resolution A/RES/73/3. (9) On September 26, 2018, the United Nations convened the first High Level Meeting on Tuberculosis, where 120 countries signed a Political Declaration to accelerate progress against tuberculosis, including commitments to increase funding for tuberculosis control and research and development programs, as well as ambitious goals to successfully treat 40,000,000 people with tuberculosis and prevent at least 30,000,000 from becoming ill between 2018 and 2022. (10) On September 26, 2018, the Administrator for the United States Agency for International Development (USAID) announced a new business model to support the fight to end tuberculosis (TB). Through $30,000,000 in funding and a new performance-based Global Accelerator to End TB, USAID will catalyze investments to meet the target set by the United Nations High-Level Meeting on tuberculosis of treating 40,000,000 people with the disease by 2022. The Accelerator will increase support to governments and local partners as part of a multisectoral approach to ending tuberculosis. (11) It is essential that existing funding for tuberculosis programs be allocated prudently, and with an emphasis on coordination, to ensure that efforts among United States agencies, partner nations, international organizations, nongovernmental organizations, both faith-based and non-faith-based, the private sector and other actors are complementary and not duplicative. Improved data on tuberculosis, access to services, accountability, and program quality can help ensure funding gets to where it is most needed. (12) If progress does not accelerate, the global tuberculosis epidemic, particularly increasing cases of MDR–TB and XDR–TB, where many cases are not curable and vastly more costly to treat, could erase decades of progress in global efforts to end both tuberculosis and HIV/AIDS, much of which has been achieved with United States investment. 3. United States Government actions to end tuberculosis Section 104B of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2151b–3(g) ) is amended by striking subsections (a) through (h) and inserting the following new subsections: (a) Findings Congress makes the following findings: (1) Congress recognizes the continuing challenge of the international tuberculosis epidemic and the deadly impact of its continued existence. (2) The means exist to detect, treat, prevent, and cure tuberculosis to a large extent, but not enough to ensure ending it, due to inadequate means of diagnosis, prevention, and treatment. (3) Absent accelerated efforts to address tuberculosis and increased domestic mobilization of resources from high-burden tuberculosis countries, targets set forth in the End TB Strategy will not be met. (b) Policy It is a major objective of the foreign assistance program of the United States to help end the global tuberculosis epidemic through actions to diagnose and treat all adults and children with all forms of tuberculosis, including tuberculosis infection, and to prevent new tuberculosis infections in adults and children. In all countries in which the United States Government has established development programs, particularly in countries with the highest burden of tuberculosis and other countries with high rates of tuberculosis, it is the policy of the United States to— (1) support the objectives of the World Health Organization End TB Strategy, including goals to— (A) reduce by 95 percent tuberculosis deaths by 2035; (B) reduce by 90 percent the tuberculosis incidence rate by 2035; and (C) reduce by 100 percent the number of families facing catastrophic health costs due to tuberculosis by 2035; (2) support the Stop TB Partnership’s Global Plan to End TB 2016–2020, including support for— (A) development and use of innovative new technologies and therapies to increase active case finding to rapidly diagnose and treat children and adults with all forms of tuberculosis, alleviate suffering, and ensure tuberculosis treatment completion; (B) the diagnosis and treatment of latent tuberculosis infection, in support of the global goal of providing preventive therapy to at least 30,000,000 people, including 4,000,000 children under five years of age, 20,000,000 household contacts of people affected by tuberculosis, and 6,000,000 people living with HIV, by 2022; (C) steps to ensure high-quality tuberculosis care by closing gaps in care cascades, implementing continuous quality improvement at all levels of care, and providing patient support; and (D) sustainable procurement of tuberculosis commodities, to avoid interruptions in supply, procurement of commodities of unknown quality, or payment of excessive commodity costs in countries impacted by tuberculosis; (3) ensure United States funding supports activities that simultaneously emphasize— (A) the development of comprehensive person-centered programs which include diagnosis, treatment, and prevention strategies to ensure that those at high risk for infection are found and treated with preventive therapies in a timely manner; (B) robust tuberculosis infection control practices in all congregate settings, including hospitals and prisons; (C) the deployment of diagnostic and treatment capacity in areas with the highest tuberculosis burdens, as well as for highly at-risk and impoverished populations, including patient support; (D) program monitoring and evaluation based on critical tuberculosis indicators, including infection control, the numbers of patients accessing tuberculosis treatment, along with patient support, and preventative therapy for those at risk, including all close contacts, as well as treatment completion for all forms of tuberculosis; (E) training health care workers on the use of new diagnostic tools and therapies as they become available; (F) coordination with domestic agencies on an aggressive research agenda to develop vaccines as well as new tools to diagnose, treat, and prevent tuberculosis globally; (G) linkages with the private sector on improved diagnosis and treatment of tuberculosis, training for healthcare professionals on use of the most effective diagnostic and therapeutic tools, and research in the areas of vaccine development as well as the development of therapeutics and diagnostic tools; (H) efforts to address barriers to patients seeking care including stigma and costs related to diagnosis and treatment; (I) efforts to address human rights-related barriers to tuberculosis services, including— (i) training health workers; (ii) sensitizing policy makers; (iii) legal literacy and patient empowerment campaigns; (iv) strengthening legal services; and (v) monitoring laws and policies; and (J) the establishment of independent accountability mechanisms and inclusive country level systems to measure progress and ensure that commitments made by governments and relevant stakeholders are met. (c) Authorization To carry out this section and consistent with section 104(c), the President is authorized to furnish assistance, on such terms and conditions as the President may determine, for the prevention, treatment, control, and elimination of tuberculosis. (d) Goals In consultation with the appropriate congressional committees, the President shall establish new goals for United States efforts, based on the policy and indicators described in subsection (b), to reach, cure, and prevent all forms of tuberculosis globally over the 5-year period following the date of the enactment of this subsection by updating the United States Government Tuberculosis Strategy (2015–2019) and the National Action Plan for Combatting Multidrug-Resistant Tuberculosis. (e) Coordination (1) In general In carrying out this section, the President shall coordinate with the World Health Organization, the Stop TB Partnership, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and other organizations with respect to the development and implementation of a comprehensive tuberculosis response program. (2) Bilateral assistance In providing bilateral assistance under this section, the President, acting through the Administrator of the United States Agency for International Development, shall— (A) coordinate and catalyze intensified international tuberculosis research and development, prevention, diagnosis, treatment, and control efforts, particularly to reduce the incidence of, and mortality from, all forms of drug resistant tuberculosis; and (B) ensure coordination among relevant United States Government agencies and programs, including the Centers for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the National Science Foundation, the Department of Defense Congressionally Directed Medical Research Program, and the President’s Emergency Plan for AIDS Relief (PEPFAR), that engage in international tuberculosis activities to ensure accountability and transparency, reduce duplication of efforts, ensure equitable shares in domestic expenditure and advancement on research and development, and ensure appropriate integration and coordination of tuberculosis services into other United States-supported health programs. (f) Priority to End TB Strategy In furnishing assistance under subsection (b), the President shall give priority to— (1) direct, high-quality services for all forms of tuberculosis described in international policies and guidelines, with a preference for programs that implement a coordinated package of active case finding, treatment of all forms of tuberculosis disease and infection, patient support and tuberculosis prevention; (2) individuals infected with both tuberculosis and HIV, and other co-morbidities, treatment for individuals with MDR–TB, XDR–TB, strengthening of health systems, use of the latest International Standards for Tuberculosis Care by all providers, and empowering individuals with tuberculosis; (3) enabling and promoting tuberculosis research to develop innovative new diagnostics, drug therapies, and vaccines, and program-based operational research; and (4) funding for the Stop Tuberculosis Partnership’s Global Drug Facility the Stop Tuberculosis Partnership, and the Global Alliance for Tuberculosis Drug Development. (g) Assistance for the World Health Organization and the Stop Tuberculosis Partnership In carrying out this section, the President, acting through the Administrator of the United States Agency for International Development, is authorized to provide increased resources to the World Health Organization and the Stop Tuberculosis Partnership to improve the capacity of countries with high rates of tuberculosis and other affected countries to implement the Stop Tuberculosis Strategy and specific strategies related to addressing MDR–TB and XDR–TB. (h) Annual report on tuberculosis activities The President shall submit an annual report to Congress that describes the impact of United States foreign assistance on efforts to control tuberculosis, including— (1) the number of people with active tuberculosis and the number with tuberculosis infection diagnosed and treated, including the rate of treatment completion and the number receiving patient support, in countries receiving United States bilateral foreign assistance for tuberculosis control purposes; (2) the number of persons who have been diagnosed and started treatment for MDR–TB and XDR–TB in countries receiving United States bilateral foreign assistance for tuberculosis control programs; (3) a description of the collaboration and coordination of United States anti-tuberculosis efforts with the World Health Organization, the Global Fund, and other major public and private entities; (4) a description of the collaboration and coordination among the United States Agency for International Development and other United States agencies, including the Centers for Disease Control and the Office of the Global AIDS Coordinator, for the purposes of combatting tuberculosis; (5) the constraints on implementation of programs posed by health workforce shortages, heath system limitations, and other capacities; (6) the numbers of people trained by the United States Government in tuberculosis surveillance and control; (7) a breakdown of expenditures for direct patient tuberculosis services, drugs and other commodities, drug management, training in diagnosis and treatment, health systems strengthening, research, and support costs; and (8) for each country receiving bilateral United States assistance for the purpose of tuberculosis prevention, treatment, and control— (A) a description of progress to adopt and implement the most recent World Health Organization guidelines to improve diagnosis, treatment, and prevention of tuberculosis for adults and children, disaggregated by sex, including the proportion of health facilities which have adopted the latest WHO guidelines on strengthening surveillance systems and preventative, diagnostic, and therapeutic methods, including the use of rapid diagnostic tests and orally administered TB treatment regimens; (B) the rate of tuberculosis incidence for adults and children, disaggregated by sex, and a description of progress in implementing measures to reduce incidence, including the number of adults and children receiving tuberculosis preventive therapy, including people with HIV and all close contacts, disaggregated by sex, and the establishment of effective tuberculosis infection control in all congregant settings, including hospitals, clinics, and prisons; (C) a description of progress to expand diagnosis, prevention, and treatment for all forms of tuberculosis, including in pregnant women, children, and other high-risk groups who are vulnerable or in vulnerable situations, such as migrants, prisoners, miners, and others exposed to silica, and people living with HIV/AIDS, disaggregated by sex; (D) the rate of successful completion of tuberculosis treatment for adults and children, disaggregated by sex, and the number of patients receiving support for treatment completion; (E) the number of people, disaggregated by sex, receiving treatment for MDR–TB, the proportion of those treated with the latest regimens endorsed by the World Health Organization, any factors impeding scale up of such treatment, and a description of progress to expand community-based MDR–TB care; (F) a description of tuberculosis commodity procurement challenges, including shortages, stockouts, or failed tenders for tuberculosis drugs or other commodities; (G) the proportion of health facilities with specimen referral linkages to GeneXpert testing sites, and to reference labs for second line drug resistance testing, and a description of the turnaround time for test results; (H) the number of people trained by the United States Government to deliver high-quality tuberculosis surveillance, laboratory services, prevention, treatment, and care; (I) a description of activities that serve to coordinate and leverage countries’ domestic resources, including development of plans, procedures, and disease estimates that support effective use of resources from the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and (J) the full text of any Statement of Partnership agreed to by the ministry of health and the United States Agency for International Development to establish a shared framework combatting tuberculosis. (i) Annual report on tuberculosis research and development The President, acting through the Administrator of the United States Agency for International Development, shall submit to Congress an annual report, to be prepared in coordination with the National Institutes of Health, the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority (BARDA), the Food and Drug Administration, the National Science Foundation, the Department of Defense Congressionally Directed Medical Research Program, and the President’s Emergency Plan for AIDS Relief (PEPFAR)— (1) describing current progress and challenges to the development of new tools for the purpose of tuberculosis prevention, treatment, and control; (2) identifying critical gaps and emerging priorities for research and development, including for rapid and point-of-care diagnostics, shortened treatments and prevention methods, and vaccines; and (3) describing research investments by type, funded entities, and level of investment. (j) Evaluation report (1) In general Not later than one year after the date of the enactment of this subsection, and every 5 years thereafter, the Comptroller General of the United States shall submit to the Administrator of the United States Agency for International Development and the appropriate congressional committees a report that evaluates the performance and impact on tuberculosis prevention, diagnosis, treatment, and care efforts that are supported by United States bilateral assistance funding, including recommendations for improving such programs. (2) Form The report required under paragraph (1) shall be submitted in unclassified form, but may contain a classified annex if necessary. (3) Public availability The Comptroller General shall publish the unclassified portion of the report required under paragraph (1) on a publicly available website of the Government Accountability Office. (k) Definitions In this section: (1) Appropriate congressional committees The term appropriate congressional committees means the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives. (2) Global Alliance for Tuberculosis Drug Development The term Global Alliance for Tuberculosis Drug Development means the public-private partnership that bring together leaders in health, science, philanthropy, and private industry to devise new approaches to tuberculosis. (3) Global Tuberculosis Drug Facility The term Global Tuberculosis Drug Facility (GDF) means the initiative of the Stop Tuberculosis Partnership to increase access to the most advanced, affordable, quality-assured tuberculosis drugs and diagnostics. (4) End TB Strategy The term End TB Strategy means the strategy to eliminate tuberculosis approved by the World Health Assembly in May 2014, which is described in The End TB Strategy: Global Strategy and Targets for Tuberculosis Prevention, Care and Control after 2015. (5) Stop Tuberculosis Partnership The term Stop Tuberculosis Partnership means the partnership of the United Nations Office for Project Services, donors including the United States, high-burden tuberculosis countries, multilateral agencies, and nongovernmental and technical agencies committed to short- and long-term measures required to control and eventually eliminate tuberculosis as a public health problem in the world. .