[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2438 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 2438

           To prevent, treat, and cure tuberculosis globally.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``End Tuberculosis Now Act of 2019''.

SEC. 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.

SEC. 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.''.
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