[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.''.
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