[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8654 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 8654

           To prevent, treat, and cure tuberculosis globally.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 5, 2022

 Mr. Bera (for himself and Ms. Salazar) introduced the following bill; 
         which was referred to the Committee on Foreign Affairs

_______________________________________________________________________

                                 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 2022''.

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 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 and existing tools must be 
        developed and scaled-up.
            (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. 
        According to the World Health Organization, global detection 
        dropped by 18 percent between 2019 and 2020 and an estimated 
        1,300,000 fewer people were diagnosed and enrolled on TB 
        treatment, and in some countries 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 and can exacerbate antimicrobial resistance, a key 
        contributor to rising cases of multi-drug-resistant TB and 
        extensively drug-resistant TB, and increasing 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 
        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) 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 
                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 A/RES/73/3.
            (10) 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.
            (11) Working with governments and partners around the 
        world, USAID's TB programming has saved 66,000,000 lives, 
        demonstrating the effectiveness of United States programs and 
        activities.
            (12) 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.
            (13) 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:

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

    ``(a) Findings.--Congress makes the following findings:
            ``(1) The continuing challenge of 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) It is a major objective of the foreign assistance 
        program of the United States to help end the TB pandemic 
        through accelerated actions to support the diagnosis and 
        treatment of all adults and children with all forms of TB, and 
        to prevent new TB infections from occurring.
            ``(2) 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 to--
                    ``(A) support the objectives of the World Health 
                Organization End TB Strategy, including its goals to--
                            ``(i) reduce by 95 percent TB deaths by 
                        2035;
                            ``(ii) reduce by 90 percent the TB 
                        incidence rate by 2035; and
                            ``(iii) reduce by 100 percent the number of 
                        families facing catastrophic health costs due 
                        to TB by 2035;
                    ``(B) continue to support the Stop TB Partnership's 
                Global Plan to End TB 2018-2022, and successor plans, 
                as appropriate, 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, including 4,000,000 
                                children under 5 years of age, 
                                20,000,000 household contacts of people 
                                affected by TB, and 6,000,000 people 
                                living with HIV, by 2023;
                            ``(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) 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; 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 access and 
                                affordability provisions into all 
                                grants and funding agreements;
                                    ``(IV) support education and 
                                empowerment campaigns for TB patients 
                                regarding local TB services;
                                    ``(V) monitor barriers to accessing 
                                TB services; and
                                    ``(VI) increase support for 
                                patient-led and community-led TB 
                                outreach efforts; and
                            ``(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.
    ``(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 TB 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 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, 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 
        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, 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 Program), and 
                other Federal agencies that engage in international TB 
                activities to ensure accountability and transparency, 
                reduce duplication of efforts and 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 give priority to--
            ``(1) building and strengthening TB programs to increase 
        diagnosis and treatment of everyone who is sick with TB, and 
        ensuring 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) 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) research and development of innovative diagnostics, 
        drug therapies, and vaccines, and program-based 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 TB; and
            ``(7) ensuring 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 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, to leverage the 
contributions of other donors for such activities.
    ``(i) Annual Report on TB 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 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 numbers 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 offices and agencies, including the 
        Centers for Disease Control and Prevention and the Office of 
        the Global AIDS Coordinator, for the purposes of combating TB;
            ``(7) the constraints on implementation of programs posed 
        by health workforce shortages, health system limitations, 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 section that describes the 
                progress in recovering from the negative impact of 
                COVID-19 on TB, including whether there has been the 
                development and implementation of a comprehensive plan 
                to ensure TB activities recover from diversion of 
                resources, the continued use of bidirectional TB-COVID 
                testing, and 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 an annual report to 
Congress that--
            ``(1) describes 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, 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 2022, and every 5 
years thereafter until 2035, 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.''.
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