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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 288 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                 S. 288

           To prevent, treat, and cure tuberculosis globally.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            February 7, 2023

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 2023''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Tuberculosis (referred to in the Act as ``TB'') is a 
        preventable, treatable, and curable disease, yet more than 25 
        years after the World Health Organization declared it to be a 
        public health emergency and called on countries to make scaling 
        up TB control a priority, TB remains a deadly health threat.
            (2) In 2021 alone, an estimated 10,600,000 people became 
        ill with TB, 11 percent of whom were children, and an estimated 
        1,600,000 of these people died from the illness. 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 and 
        existing tools must be developed and scaled-up.
            (3) More than \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. 
        According to the World Health Organization, from 2019 to 2020--
                    (A) global detection of TB dropped by 18 percent;
                    (B) an estimated 1,300,000 fewer people were 
                diagnosed and enrolled on TB treatment; and
                    (C) in some countries, TB case notifications 
                dropped by up to 41 percent, setting progress back by 
                up to 12 years.
            (5) Failure to properly diagnose and treat TB can lead to 
        death, can exacerbate antimicrobial resistance (a key 
        contributor to rising cases of multi-drug-resistant TB and 
        extensively drug-resistant TB), and can increase the 
        probability of the introduction of resistant TB into new 
        geographic areas.
            (6) 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 
        the treatment of COVID-19.
            (7) With sufficient resourcing, TB program expertise, 
        infection control, laboratory capacity, active case finding, 
        and contact investigation can serve as platforms for 
        respiratory pandemic response against existing and new 
        infectious respiratory disease without disrupting ongoing TB 
        programs and activities.
            (8) Globally, only about \1/2\ of the $13,000,000,000 
        required annually, as outlined in the Stop TB Partnership's 
        Global Plan to End TB, is currently available.
            (9) According to estimates by the Global Fund for AIDS, 
        Tuberculosis, and Malaria, an additional $3,500,000,000 was 
        needed during 2021 for TB programs in eligible countries in 
        order to recover from the negative impacts of COVID-19.
            (10) On September 26, 2018, the United Nations convened the 
        first High-Level Meeting of the General Assembly on the Fight 
        Against Tuberculosis, during which 120 countries--
                    (A) signed a Political Declaration to accelerate 
                progress against TB, including through commitments to 
                increase funding for TB prevention, diagnosis, 
                treatment, and research and development programs, and 
                to set ambitious goals to successfully treat 40,000,000 
                people with active TB 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 73/3.
            (11) The United States Government continues to be a lead 
        funder of global TB research and development, contributing 44 
        percent of the total $915,000,000 in global funding in 2020, 
        and can catalyze more investments from other countries.
            (12) Working with governments and partners around the 
        world, USAID's TB programming has saved an estimated 74,000,000 
        lives, demonstrating the effectiveness of United States 
        programs and activities against the illness.
            (13) On September 26, 2018, the USAID Administrator 
        announced a new performance-based Global Accelerator to End TB, 
        aimed at catalyzing investments to meet the treatment target 
        set by the United Nations High-Level Meeting, further 
        demonstrating the critical role that United States leadership 
        and assistance plays in the fight to eliminate TB.
            (14) 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 ASSISTANCE TO COMBAT TUBERCULOSIS.

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

``SEC. 104B. ASSISTANCE TO COMBAT TUBERCULOSIS.

    ``(a) Findings.--Congress makes the following findings:
            ``(1) The international spread of tuberculosis (referred to 
        in this section as `TB') and the deadly impact of TB's 
        continued existence constitutes a continuing challenge.
            ``(2) Additional tools and resources are required to 
        effectively diagnose, prevent, and treat TB.
            ``(3) Effectively resourced TB programs can serve as a 
        critical platform for preventing and responding to future 
        infectious respiratory disease pandemics.
    ``(b) Policy.--
            ``(1) In general.--It is a major objective of the foreign 
        assistance program of the United States to help end the TB 
        public health emergency through accelerated actions--
                    ``(A) to support the diagnosis and treatment of all 
                adults and children with all forms of TB; and
                    ``(B) to prevent new TB infections from occurring.
            ``(2) Support for global plans and objectives.--In 
        countries in which the United States Government has established 
        foreign assistance programs under this Act, particularly in 
        countries with the highest burden of TB and other countries 
        with high rates of infection and transmission of TB, it is the 
        policy of the United States--
                    ``(A) to support the objectives of the World Health 
                Organization End TB Strategy, including its goals--
                            ``(i) to reduce TB deaths by 95 percent by 
                        2035;
                            ``(ii) to reduce the TB incidence rate by 
                        90 percent by 2035; and
                            ``(iii) to reduce the number of families 
                        facing catastrophic health costs due to TB by 
                        100 percent by 2035;
                    ``(B) to support the Stop TB Partnership's Global 
                Plan to End TB 2023-2030, including by providing 
                support for--
                            ``(i) developing and using innovative new 
                        technologies and therapies to increase active 
                        case finding and rapidly diagnose and treat 
                        children and adults with all forms of TB, 
                        alleviate suffering, and ensure TB treatment 
                        completion;
                            ``(ii) expanding diagnosis and treatment in 
                        line with the goals established by the 
                        Political Declaration of the High-Level Meeting 
                        of the General Assembly on the Fight Against 
                        Tuberculosis, including--
                                    ``(I) successfully treating 
                                40,000,000 people with active TB by 
                                2023, including 3,500,000 children, and 
                                1,500,000 people with drug-resistant 
                                TB; and
                                    ``(II) diagnosing and treating 
                                latent tuberculosis infection, in 
                                support of the global goal of providing 
                                preventive therapy to at least 
                                30,000,000 people by 2023, including 
                                4,000,000 children younger than 5 years 
                                of age, 20,000,000 household contacts 
                                of people affected by TB, and 6,000,000 
                                people living with HIV;
                            ``(iii) ensuring high-quality TB care by 
                        closing gaps in care cascades, implementing 
                        continuous quality improvement at all levels of 
                        care, and providing related patient support; 
                        and
                            ``(iv) sustainable procurements of TB 
                        commodities to avoid interruptions in supply, 
                        the procurement of commodities of unknown 
                        quality, or payment of excessive commodity 
                        costs in countries impacted by TB; and
                    ``(C) to ensure, to the greatest extent 
                practicable, that United States funding supports 
                activities that simultaneously emphasize--
                            ``(i) the development of comprehensive 
                        person-centered programs, including diagnosis, 
                        treatment, and prevention strategies to ensure 
                        that--
                                    ``(I) all people sick with TB 
                                receive quality diagnosis and treatment 
                                through active case finding; and
                                    ``(II) people at high risk for TB 
                                infection are found and treated with 
                                preventive therapies in a timely 
                                manner;
                            ``(ii) robust TB infection control 
                        practices are implemented in all congregate 
                        settings, including hospitals and prisons;
                            ``(iii) the deployment of diagnostic and 
                        treatment capacity--
                                    ``(I) in areas with the highest TB 
                                burdens; and
                                    ``(II) for highly at-risk and 
                                impoverished populations, including 
                                patient support services;
                            ``(iv) program monitoring and evaluation 
                        based on critical TB indicators, including 
                        indicators relating to infection control, the 
                        numbers of patients accessing TB treatment and 
                        patient support services, and preventative 
                        therapy for those at risk, including all close 
                        contacts, and treatment outcomes for all forms 
                        of TB;
                            ``(v) 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 TB active case 
                        finding, contact tracing, and patient support 
                        services;
                            ``(vi) coordination with domestic agencies 
                        and organizations to support an aggressive 
                        research agenda to develop vaccines as well as 
                        new tools to diagnose, treat, and prevent TB 
                        globally;
                            ``(vii) linkages with the private sector 
                        on--
                                    ``(I) research and development of a 
                                vaccine, and on new tools for diagnosis 
                                and treatment of TB;
                                    ``(II) improving current tools for 
                                diagnosis and treatment of TB, 
                                including telehealth solutions for 
                                prevention and treatment; and
                                    ``(III) training healthcare 
                                professionals on use of the newest and 
                                most effective diagnostic and 
                                therapeutic tools;
                            ``(viii) the reduction of barriers to care, 
                        including stigma and treatment and diagnosis 
                        costs, including through--
                                    ``(I) training health workers;
                                    ``(II) sensitizing policy makers;
                                    ``(III) requiring that all relevant 
                                grants and funding agreements include 
                                access and affordability provisions;
                                    ``(IV) supporting education and 
                                empowerment campaigns for TB patients 
                                regarding local TB services;
                                    ``(V) monitoring barriers to 
                                accessing TB services; and
                                    ``(VI) increasing support for 
                                patient-led and community-led TB 
                                outreach efforts;
                            ``(ix) support for country-level, 
                        sustainable accountability mechanisms and 
                        capacity to measure progress and ensure that 
                        commitments made by governments and relevant 
                        stakeholders are met; and
                            ``(x) support for the integration of TB 
                        diagnosis, treatment, and prevention activities 
                        into primary health care, as appropriate.
    ``(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 TB 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 TB.
            ``(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 TB drugs and diagnostics.
            ``(5) MDR-TB.--The term `MDR-TB' means multi-drug-resistant 
        TB.
            ``(6) Stop tuberculosis partnership.--The term `Stop 
        Tuberculosis Partnership' means the partnership of 1,600 
        organizations (including international and technical 
        organizations, government programs, research and funding 
        agencies, foundations, nongovernmental organizations, civil 
        society and community groups, and the private sector), donors, 
        including the United States, high TB burden countries, 
        multilateral agencies, and nongovernmental and technical 
        agencies, which is governed by the Stop TB Partnership 
        Coordinating Board and hosted by a United Nations entity, 
        committed to short- and long-term measures required to control 
        and eventually eliminate TB as a public health problem in the 
        world.
            ``(7) XDR-TB.--The term `XDR-TB' means extensively drug-
        resistant TB.
    ``(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 TB.
    ``(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--
            ``(1) United States TB programs to detect, cure, and 
        prevent all forms of TB globally for the period between 2023 
        and 2030 that are aligned with the End TB Strategy's 2030 
        targets and the USAID's Global Tuberculosis (TB) Strategy 2023-
        2030; and
            ``(2) updating 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 
        TB 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 
                TB worldwide, particularly to reduce the incidence of, 
                and mortality from, all forms of drug-resistant TB;
                    ``(B) ensure United States programs and activities 
                focus on finding individuals with active TB disease and 
                provide quality diagnosis and treatment, including 
                through digital health solutions, and reaching those at 
                high risk with preventive therapy; and
                    ``(C) ensure coordination among relevant United 
                States Government agencies, including the Department of 
                State, 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 Programs), 
                and other relevant Federal departments and agencies 
                that engage in international TB activities--
                            ``(i) to ensure accountability and 
                        transparency;
                            ``(ii) to reduce duplication of efforts; 
                        and
                            ``(iii) to ensure appropriate integration 
                        and coordination of TB services into other 
                        United States-supported health programs.
    ``(g) Priority To End TB Strategy.--In furnishing assistance under 
subsection (d), the President shall prioritize--
            ``(1) building and strengthening TB programs--
                    ``(A) to increase the diagnosis and treatment of 
                everyone who is sick with TB; and
                    ``(B) to ensure that such individuals have access 
                to quality diagnosis and treatment;
            ``(2) direct, high-quality integrated services for all 
        forms of TB, as described by the World Health Organization, 
        which call for the coordination of active case finding, 
        treatment of all forms of TB disease and infection, patient 
        support, and TB prevention;
            ``(3) treating individuals co-infected with HIV and other 
        co-morbidities, and other individuals with TB who may be at 
        risk of stigma;
            ``(4) strengthening the capacity of health systems to 
        detect, prevent, and treat TB, including MDR-TB and XDR-TB, as 
        described in the latest international guidance related to TB;
            ``(5) researching and developing innovative diagnostics, 
        drug therapies, and vaccines, and program-based research;
            ``(6) support for the Stop Tuberculosis Partnership's 
        Global Drug Facility, the Global Alliance for Tuberculosis Drug 
        Development, and other organizations promoting the development 
        of new products and drugs for TB; and
            ``(7) ensuring that TB 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--
            ``(1) to provide resources to the World Health Organization 
        and the Stop Tuberculosis Partnership to improve the capacity 
        of countries with high burdens or rates of TB 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; and
            ``(2) to leverage the contributions of other donors for the 
        activities described in paragraph (1).
    ``(i) Annual Report on TB Activities.--Not later than December 15 
of each year until the earlier of the date on which the goals specified 
in subsection (b)(2)(A) are met or the last day of 2030, the President 
shall submit an annual report to the appropriate congressional 
committees that describes United States foreign assistance to control 
TB and the impact of such efforts, including--
            ``(1) the number of individuals with active TB 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 TB control programs;
            ``(3) the number of people trained by the United States 
        Government in TB 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 TB control 
        programs;
            ``(5) a description of the collaboration and coordination 
        of United States anti-TB 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 departments and agencies, including the 
        Centers for Disease Control and Prevention and the Office of 
        the Global AIDS Coordinator, for the purposes of combating TB 
        and, as appropriate, its integration into primary care;
            ``(7) the constraints on implementation of programs posed 
        by health workforce shortages, health system limitations, 
        barriers to digital health implementation, other challenges to 
        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 the provision of TB 
        services, and research; and
            ``(9) for each country, and when practicable, each project 
        site receiving bilateral United States assistance for the 
        purpose of TB prevention, treatment, and control--
                    ``(A) a description of progress toward the adoption 
                and implementation of the most recent World Health 
                Organization guidelines to improve diagnosis, 
                treatment, and prevention of TB for adults and 
                children, disaggregated by sex, including the 
                proportion of health facilities that have adopted the 
                latest World Health Organization guidelines on 
                strengthening monitoring systems and preventative, 
                diagnostic, and therapeutic methods, including the use 
                of rapid diagnostic tests and orally administered TB 
                treatment regimens;
                    ``(B) the number of individuals screened for TB 
                disease and the number evaluated for TB infection using 
                active case finding outside of health facilities;
                    ``(C) the number of individuals with active TB 
                disease that were diagnosed and treated, including the 
                rate of treatment completion and the number receiving 
                patient support;
                    ``(D) the number of adults and children, including 
                people with HIV and close contacts, who are evaluated 
                for TB infection, the number of adults and children 
                started on treatment for TB infection, and the number 
                of adults and children completing such treatment, 
                disaggregated by sex and, as possible, income or wealth 
                quintile;
                    ``(E) the establishment of effective TB infection 
                control in all relevant congregant settings, including 
                hospitals, clinics, and prisons;
                    ``(F) a description of progress in implementing 
                measures to reduce TB incidence, including actions--
                            ``(i) to expand active case finding and 
                        contact tracing to reach vulnerable groups; and
                            ``(ii) to expand TB preventive therapy, 
                        engagement of the private sector, and 
                        diagnostic capacity;
                    ``(G) a description of progress to expand 
                diagnosis, prevention, and treatment for all forms of 
                TB, including in pregnant women, children, and 
                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;
                    ``(H) the rate of successful completion of TB 
                treatment for adults and children, disaggregated by 
                sex, and the number of individuals receiving support 
                for treatment completion;
                    ``(I) 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, factors impeding scale up of such 
                treatment, and a description of progress to expand 
                community-based MDR-TB care;
                    ``(J) a description of TB commodity procurement 
                challenges, including shortages, stockouts, or failed 
                tenders for TB drugs or other commodities;
                    ``(K) the proportion of health facilities with 
                specimen referral linkages to quality diagnostic 
                networks, including established testing sites and 
                reference labs, to ensure maximum access and referral 
                for second line drug resistance testing, and a 
                description of the turnaround time for test results;
                    ``(L) the number of people trained by the United 
                States Government to deliver high-quality TB 
                diagnostic, preventative, monitoring, treatment, and 
                care services;
                    ``(M) a description of how supported activities are 
                coordinated with--
                            ``(i) country national TB plans and 
                        strategies; and
                            ``(ii) TB control efforts supported by the 
                        Global Fund to Fight AIDS, Tuberculosis, and 
                        Malaria, and other international assistance 
                        programs and funds, including in the areas of 
                        program development and implementation; and
                    ``(N) for the first 3 years of the report required 
                under this subsection, a description of the progress in 
                recovering from the negative impact of COVID-19 on TB, 
                including--
                            ``(i) whether there has been the 
                        development and implementation of a 
                        comprehensive plan to recover TB activities 
                        from diversion of resources;
                            ``(ii) the continued use of bidirectional 
                        TB-COVID testing; and
                            ``(iii) progress on increased diagnosis and 
                        treatment of active TB.
    ``(j) Annual Report on TB 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 to the appropriate 
congressional committees until 2030 an annual report that--
            ``(1) describes the current progress and challenges to the 
        development of new tools for the purpose of TB 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, 
        telehealth solutions for prevention and treatment, and 
        vaccines; and
            ``(3) describes research investments by type, funded 
        entities, and level of investment.
    ``(k) Evaluation Report.--Not later than 3 years after the date of 
the enactment of the End Tuberculosis Now Act of 2023, and 5 years 
thereafter, the Comptroller General of the United States shall submit a 
report to the appropriate congressional committees that evaluates the 
performance and impact on TB prevention, diagnosis, treatment, and care 
efforts that are supported by United States bilateral assistance 
funding, including recommendations for improving such programs.''.
                                 <all>
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