[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3386 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 3386

           To prevent, treat, and cure tuberculosis globally.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 14, 2021

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 2021''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) More than 25 years after the World Health Organization 
        declared Tuberculosis (referred to in this Act as ``TB'') a 
        public health emergency and called on countries to make scaling 
        up tuberculosis control a priority, TB remains a deadly health 
        threat despite the fact that TB is a preventable, treatable, 
        and curable disease.
            (2) In 2019 alone, an estimated 10,000,000 people became 
        ill with TB, 10 percent of whom were children, and 1,400,000 of 
        whom died. In order to achieve by 2035 the goals of the 
        Political Declaration of the High-Level Meeting of the General 
        Assembly on the Fight Against Tuberculosis, adopted by the 
        United Nations General Assembly October 10, 2018, and of the 
        World Health Organization End TB Strategy, adopted by the World 
        Health Assembly in 2014, new tools must be developed and made 
        available.
            (3) Over \1/3\ of people who become ill with TB may be 
        undiagnosed or misdiagnosed, resulting in unnecessary illness, 
        communicable infections, and increased mortality.
            (4) Since March 2020, the COVID-19 pandemic has severely 
        disrupted TB responses in low- and middle-income countries, 
        stalling and reversing years of progress made against TB, with 
        detection dropping by 50 percent and an estimated 1,000,000 
        fewer people will be diagnosed and enrolled on TB treatment.
            (5) In May 2020, a modeling study conducted by the Stop 
        Tuberculosis Partnership (referred to in this Act as the ``Stop 
        TB Partnership'') in collaboration with the United States 
        Agency for International Development (referred to in this Act 
        as ``USAID'') and partners estimated that a 3-month global 
        lockdown followed by a protracted 10-month restoration could 
        lead to an additional 6,300,000 cases of TB between 2020 and 
        2025 and an additional 1,400,000 TB deaths during this period, 
        causing a setback of at least 5 to 8 years in the fight against 
        TB.
            (6) Findings released by the Stop TB Partnership on March 
        18, 2021, found that TB diagnosis and enrolment on treatment in 
        2020 declined by an estimated total of 1,000,000 cases in 9 
        countries that collectively represent 60 percent of the global 
        TB caseload, pushing the TB response back to 2008 levels in 
        terms of people diagnosed and treated.
            (7) Failure to properly diagnose and treat TB can lead to 
        death and can exacerbate antimicrobial resistance, a key 
        contributor to rising cases of multi-drug-resistant 
        tuberculosis, and extensively drug-resistant tuberculosis, and 
        increasing the probability of the introduction of resistant TB 
        into new geographic areas.
            (8) TB programs have played a central role in responding to 
        COVID-19, including through leveraging the expertise of medical 
        staff with expertise in TB and lung diseases, the repurposing 
        of TB hospitals, and the use of the TB rapid molecular testing 
        platforms and X-Ray equipment for multiple purposes, including 
        COVID-19.
            (9) With sufficient resourcing, TB program expertise, 
        infection control, laboratory capacity, active case finding and 
        contact investigation, can serve as a platform for respiratory 
        pandemic response against existing and new infectious 
        respiratory disease without such a response necessitating the 
        disruption of ongoing TB programs and activities.
            (10) Globally, only about \1/2\ of the $13,000,000,000 
        required annually outlined in the Stop TB Partnership's Global 
        Plan to End TB for tuberculosis prevention, diagnosis, and 
        treatment is currently available.
            (11) An estimated additional $3,500,000,000 will be needed 
        during 2021 for TB programs in countries eligible for Global 
        Fund for AIDS, Tuberculosis, and Malaria programming to recover 
        from the negative impacts of COVID-19, with a total annual gap 
        of at least $8,000,000,000 for TB diagnosis, prevention, and 
        treatment in such countries.
            (12) On September 26, 2018, the United Nations convened the 
        first High-Level Meeting of the General Assembly on the Fight 
        Against Tuberculosis, at which 120 countries--
                    (A) signed a Political Declaration to accelerate 
                progress against TB, including commitments to increase 
                funding for TB control and research and development 
                programs, and ambitious goals to successfully treat 
                40,000,000 people with tuberculosis and prevent at 
                least 30,000,000 from becoming ill with TB between 2018 
                and 2022; and
                    (B) 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.
            (13) The United States Government continues to be a lead 
        funder of global TB research and development, contributing 44 
        percent of the total $901,000,000 in global funding in 2019, 
        and can catalyze more investments from other countries.
            (14) Working with governments and partners around the 
        world, the TB efforts by USAID have saved 60,000,000 lives, 
        demonstrating the effectiveness of United States programs and 
        activities.
            (15) On September 26, 2018, the USAID Administrator 
        announced a new performance-based Global Accelerator to End TB, 
        aimed at catalyzing 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, further 
        demonstrating the critical role that United States leadership 
        and assistance plays in the fight to eliminate TB.
            (16) It is essential to ensure that efforts among United 
        States Government agencies, partner nations, international 
        organizations, nongovernmental organizations, the private 
        sector, and other actors are complementary and not duplicative 
        in order to achieve the goal of ending the TB epidemic in all 
        countries.

SEC. 3. UNITED STATES GOVERNMENT ACTIONS TO END TUBERCULOSIS.

    Section 104B of the Foreign Assistance Act of 1961 (22 U.S.C. 
2151b-3) is amended to read as follows:

``SECTION 104B. ASSISTANCE TO COMBAT TUBERCULOSIS.

    ``(a) Findings.--Congress makes the following findings:
            ``(1) Congress recognizes the continuing challenge of the 
        international spread of tuberculosis, and the deadly impact of 
        the continued existence of TB.
            ``(2) Additional tools and resources are required to 
        effectively diagnose, prevent, and treat tuberculosis.
            ``(3) Effectively resourced tuberculosis programs can serve 
        as a critical platform for respiratory pandemic response 
        against existing and new infectious respiratory disease.
    ``(b) Policy.--It is a major objective of the foreign assistance 
program of the United States to help end the global tuberculosis 
pandemic through actions to support the diagnosis and treatment of all 
adults and children with all forms of tuberculosis, 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--
            ``(1) to support the objectives of the World Health 
        Organization End TB Strategy, including goals--
                    ``(A) to reduce by 95 percent tuberculosis deaths 
                by 2035;
                    ``(B) to reduce by 90 percent the tuberculosis 
                incidence rate by 2035; and
                    ``(C) to reduce by 100 percent the number of 
                families facing catastrophic health costs due to 
                tuberculosis by 2035;
            ``(2) to support the Stop TB Partnership's Global Plan to 
        End TB 2018-2022, and any follow up plan, including support 
        for--
                    ``(A) developing and using 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) providing diagnosis and treatment with the 
                goal of successfully treating 40,000,000 people with 
                tuberculosis by 2022, including 3,500,000 children, and 
                1,500,000 people with drug-resistant tuberculosis in 
                support of the target set by the Political Declaration 
                of the High-Level Meeting of the General Assembly on 
                the Fight Against Tuberculosis;
                    ``(C) diagnosing and treating 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 5 years of age, 
                20,000,000 household contacts of people affected by 
                tuberculosis, and 6,000,000 people living with HIV, by 
                2022;
                    ``(D) ensuring high quality tuberculosis care by 
                closing gaps in care cascades, implementing continuous 
                quality improvement at all levels of care, and 
                providing patient support; and
                    ``(E) sustainably procuring tuberculosis 
                commodities to avoid interruptions in supply, the 
                procurement of commodities of unknown quality, or 
                payment of excessive commodity costs in countries 
                impacted by tuberculosis; and
            ``(3) to ensure that United States funding supports 
        activities that simultaneously emphasize--
                    ``(A) the development of comprehensive person-
                centered programs, including diagnosis, treatment, and 
                prevention strategies to ensure that--
                            ``(i) all people sick with tuberculosis 
                        receive quality diagnosis and treatment through 
                        active case finding; and
                            ``(ii) people at high risk for tuberculosis 
                        infection are found and treated with preventive 
                        therapies in a timely manner;
                    ``(B) robust tuberculosis infection control 
                practices are implemented in all congregate settings, 
                including hospitals and prisons;
                    ``(C) the deployment of diagnostic and treatment 
                capacity--
                            ``(i) in areas with the highest 
                        tuberculosis burdens; and
                            ``(ii) for highly at-risk and impoverished 
                        populations, including patient support;
                    ``(D) program monitoring and evaluation based on 
                critical tuberculosis indicators, including indicators 
                relating to infection control, the numbers of patients 
                accessing tuberculosis treatment, along with patient 
                support services, and preventative therapy for those at 
                risk, including all close contacts, and treatment 
                outcomes for all forms of tuberculosis;
                    ``(E) training and engagement of health care 
                workers on the use of new diagnostic tools and 
                therapies as they become available, and increased 
                support for training frontline health care workers to 
                support expanded tuberculosis active case finding, 
                contact tracing and patient support;
                    ``(F) coordination with domestic agencies and 
                organizations 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--
                            ``(i) research and development of a 
                        vaccine, and on new tools for diagnosis and 
                        treatment of tuberculosis;
                            ``(ii) improving current tools for 
                        diagnosis and treatment of tuberculosis; and
                            ``(iii) training healthcare professionals 
                        on use of the newest and most effective 
                        diagnostic and therapeutic tools;
                    ``(H) the reduction of barriers to care, including 
                stigma and treatment and diagnosis costs, through--
                            ``(i) training for health workers;
                            ``(ii) sensitizing of policy makers;
                            ``(iii) requirements for access and 
                        affordability provisions in all grants and 
                        funding agreements;
                            ``(iv) education and empowerment campaigns 
                        for tuberculosis patients regarding local 
                        tuberculosis services;
                            ``(v) monitoring barriers to accessing 
                        tuberculosis services; and
                            ``(vi) increased support for patient-led 
                        and community-led tuberculosis outreach 
                        efforts; and
                    ``(I) support for country-level, sustainable 
                accountability mechanisms and capacity to measure 
                progress and ensure that commitments made by 
                governments and relevant stakeholders are met.
    ``(c) 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) End tb strategy.--The term `End TB Strategy' means 
        the strategy to eliminate tuberculosis that was approved by the 
        World Health Assembly in May 2014, and is described in The End 
        TB Strategy: Global strategy and targets for tuberculosis 
        prevention, care and control after 2015.
            ``(3) 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.
            ``(4) Global tuberculosis drug facility.--The term `Global 
        Tuberculosis Drug Facility' means the initiative of the Stop 
        Tuberculosis Partnership to increase access to the most 
        advanced, affordable, quality-assured tuberculosis drugs and 
        diagnostics.
            ``(5) MDR-TB.--The term `MDR-TB' means multi-drug-resistant 
        tuberculosis.
            ``(6) 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 tuberculosis burden 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.
            ``(7) XDR-TB.--The term `XDR-TB' means extensively drug-
        resistant tuberculosis.
    ``(d) Authorization.--To carry out this section, the President is 
authorized, consistent with section 104(c), to furnish assistance, on 
such terms and conditions as the President may determine, for the 
prevention, treatment, control, and elimination of tuberculosis.
    ``(e) Goals.--In consultation with the appropriate congressional 
committees, the President shall establish goals, based on the policy 
and indicators described in subsection (b), for United States 
tuberculosis programs to detect, cure and prevent all forms of 
tuberculosis globally for the period between 2023 and 2030 that is 
aligned with the End TB Strategy's 2030 targets, by updating the United 
States Government Tuberculosis Strategy (2015-2019) and the National 
Action Plan for Combating Multidrug-Resistant Tuberculosis.
    ``(f) 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 global 
        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) catalyze support for research and development 
                of new tools to prevent, diagnose, treat, and control 
                tuberculosis worldwide, particularly to reduce the 
                incidence of, and mortality from, all forms of drug-
                resistant tuberculosis;
                    ``(B) ensure United States programs and activities 
                aimed at reaching those infected with tuberculosis 
                provide quality diagnosis and treatment, and reach 
                those at high risk with preventive therapy; and
                    ``(C) ensure coordination among relevant United 
                States Government agencies, 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 (through its Congressionally 
                Directed Medical Research Program), and other Federal 
                agencies that engage in international tuberculosis 
                activities to ensure accountability and transparency, 
                reduce duplication of efforts and ensure appropriate 
                integration and coordination of tuberculosis services 
                into other United States-supported health programs.
    ``(g) Priority To End TB Strategy.--In furnishing assistance under 
subsection (d), the President shall give priority to--
            ``(1) building and strengthening tuberculosis programs to 
        diagnose and treat all people sick with TB, and ensuring 
        everyone who is sick with tuberculosis have access to quality 
        diagnosis and treatment;
            ``(2) direct, high-quality integrated services for all 
        forms of tuberculosis, as described by the World Health 
        Organization, which call for the coordination of active case 
        finding, treatment of all forms of tuberculosis disease and 
        infection, patient support, and tuberculosis prevention;
            ``(3) individuals co-infected with HIV and other co-
        morbidities, and other individuals with tuberculosis who may be 
        at risk of stigma;
            ``(4) strengthening the capacity of health systems to 
        detect, prevent, and treat tuberculosis, including MDR-TB and 
        XDR-TB, as described in the International Standards for 
        Tuberculosis Care, and the latest international guidance 
        related to tuberculosis;
            ``(5) research and development of innovative diagnostics, 
        drug therapies, and vaccines, and program-based operational 
        research;
            ``(6) the Stop Tuberculosis Partnership's Global Drug 
        Facility, and the Global Alliance for Tuberculosis Drug 
        Development, and other organizations promoting the development 
        of new products and drugs for tuberculosis; and
            ``(7) ensuring tuberculosis programs can serve as key 
        platforms for supporting national respiratory pandemic response 
        against existing and new infectious respiratory disease.
    ``(h) 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 burdens or rates of 
tuberculosis and other affected countries to implement the End TB 
Strategy, the Stop TB Global Plan to End TB, their own national 
strategies and plans, other global efforts to control MDR-TB and XDR-
TB.
    ``(i) Annual Report on Tuberculosis Activities.--Not later than 
December 15 of each year until the goals specified in subsection (b)(1) 
are met, the President shall submit an annual report to the appropriate 
congressional committees that describes United States foreign 
assistance to control tuberculosis and the impact of such efforts, 
including--
            ``(1) the number of individuals with active tuberculosis 
        disease that were diagnosed and treated, including the rate of 
        treatment completion and the number receiving patient support;
            ``(2) the number of persons with MDR-TB and XDR-TB that 
        were diagnosed and treated, including the rate of completion, 
        in countries receiving United States bilateral foreign 
        assistance for tuberculosis control programs;
            ``(3) the numbers of people trained by the United States 
        Government in tuberculosis surveillance and control;
            ``(4) the number of individuals with active TB disease 
        identified as a result of engagement with the private sector 
        and other nongovernmental partners in countries receiving 
        United States bilateral foreign assistance for tuberculosis 
        control programs;
            ``(5) a description of the collaboration and coordination 
        of United States anti-tuberculosis efforts with the World 
        Health Organization, the Stop TB Partnership, the Global Fund 
        to Fight AIDS, Tuberculosis and Malaria, and other major public 
        and private entities;
            ``(6) 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 Prevention and the Office of the Global 
        AIDS Coordinator, for the purposes of combating tuberculosis;
            ``(7) the constraints on implementation of programs posed 
        by health workforce shortages, health system limitations, other 
        components of successful implementation, and strategies to 
        address such constraints;
            ``(8) a breakdown of expenditures for patient services 
        supporting TB diagnosis, treatment, and prevention, including 
        procurement of drugs and other commodities, drug management, 
        training in diagnosis and treatment, health systems 
        strengthening that directly impacts provision of TB services, 
        and research; and
            ``(9) 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 that have adopted the latest World 
                Health Organization guidelines on strengthening 
                surveillance systems and preventative, diagnostic, and 
                therapeutic methods, including the use of rapid 
                diagnostic tests and orally administered tuberculosis 
                treatment regimens;
                    ``(B) the number of adults and children receiving 
                tuberculosis preventive therapy, including people with 
                HIV and all close contacts, disaggregated by sex and, 
                as possible, income or wealth quintile, and the 
                establishment of effective tuberculosis infection 
                control in all relevant congregant settings, including 
                hospitals, clinics, and prisons;
                    ``(C) a description of progress in implementing 
                measures to reduce tuberculosis incidence, including 
                actions--
                            ``(i) to expand active case finding and 
                        contact tracing to identify and reach 
                        vulnerable groups; and
                            ``(ii) to expand tuberculosis preventive 
                        therapy, engagement of the private sector, and 
                        diagnostic capacity;
                    ``(D) a description of progress to expand 
                diagnosis, prevention, and treatment for all forms of 
                tuberculosis, including in pregnant women, children, 
                and other high-risk individuals and groups at greater 
                risk of TB, including migrants, prisoners, miners, 
                people exposed to silica, and people living with HIV/
                AIDS, disaggregated by sex;
                    ``(E) the rate of successful completion of 
                tuberculosis treatment for adults and children, 
                disaggregated by sex, and the number of individuals 
                receiving support for treatment completion;
                    ``(F) 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;
                    ``(G) a description of tuberculosis commodity 
                procurement challenges, including shortages, stockouts, 
                or failed tenders for tuberculosis drugs or other 
                commodities;
                    ``(H) 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;
                    ``(I) the number of people trained by the United 
                States Government to deliver high-quality tuberculosis 
                surveillance, laboratory services, prevention, 
                treatment, and care;
                    ``(J) a description of how supported activities are 
                coordinated with--
                            ``(i) country national TB plans and 
                        strategies; and
                            ``(ii) tuberculosis control efforts 
                        supported by the Global Fund to Fight AIDS, 
                        Tuberculosis, and Malaria, and other 
                        international assistance funds, including in 
                        the areas of program development and 
                        implementation; and
                    ``(K) for the first 3 years of the report required 
                under this subsection, a section that describes the 
                progress in recovering from the negative impact of 
                COVID-19 on tuberculosis, including whether there has 
                been the development and implementation of a 
                comprehensive plan to ensure tuberculosis activities 
                recover from diversion of resources, the continued use 
                of bidirectional TB-COVID testing, and progress on 
                increased diagnosis and treatment of active 
                tuberculosis.
    ``(j) Annual Report on Tuberculosis Research and Development.--The 
President, acting through the Administrator of the United States Agency 
for International Development, and in coordination with the National 
Institutes of Health, the Centers for Disease Control and Prevention, 
the Biomedical Advanced Research and Development Authority, the Food 
and Drug Administration, the National Science Foundation, and the 
Office of the Global AIDS Coordinator, shall submit an annual report to 
Congress that--
            ``(1) describes current progress and challenges to the 
        development of new tools for the purpose of tuberculosis 
        prevention, treatment, and control;
            ``(2) identifies 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) describes research investments by type, funded 
        entities, and level of investment.
    ``(k) Evaluation Report.--Not later than 2 years after the date of 
the enactment of the End Tuberculosis Now Act of 2021, and every 5 
years thereafter until 2036, the Comptroller General of the United 
States shall submit a report to the appropriate congressional 
committees 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.''.
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