[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2438 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 2438
To prevent, treat, and cure tuberculosis globally.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 1, 2019
Mr. Menendez (for himself and Mr. Young) introduced the following bill;
which was read twice and referred to the Committee on Foreign Relations
_______________________________________________________________________
A BILL
To prevent, treat, and cure tuberculosis globally.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``End Tuberculosis Now Act of 2019''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Tuberculosis is a preventable, treatable, and curable
airborne infection; however more than 25 years after the World
Health Organization declared tuberculosis a public health
emergency and called on countries to make scaling up
tuberculosis control a priority, tuberculosis still kills more
people worldwide than any other infectious disease, and is the
leading killer of people living with HIV/AIDS.
(2) In 2017, 10,000,000 people became ill with
tuberculosis, 10 percent of whom were children, and 1,600,000
people died from the disease. In order to achieve the goals of
the World Health Organization End TB Strategy by 2035, new
tools must be developed and made available.
(3) Over one-third of people who become ill with
tuberculosis may be undiagnosed, misdiagnosed, or treated but
not reported, resulting in unnecessary illness, communicable
infections, and increased mortality.
(4) Failure to properly treat tuberculosis can cause
treatment failure and death, and exacerbates antimicrobial
resistance, increasing multi-drug-resistant tuberculosis (MDR-
TB) and extensively drug-resistant tuberculosis (XDR-TB), which
are significantly costlier and more difficult to treat than
drug-sensitive tuberculosis and can also be transmitted from
person-to-person, increasing the likelihood that drug-resistant
tuberculosis will spread to new geographic areas.
(5) Globally, only about half of the $13,000,000,000
required annually as outlined in the Stop TB Partnership's
Global Plan to End TB for tuberculosis prevention, diagnosis,
and treatment is currently available.
(6) There is an annual $1,300,000,000 gap in funding needed
for the development of vaccines, additional rapid, point-of-
care diagnostic tests, and shorter, less toxic treatments which
would facilitate patient adherence to treatment regimens,
reduce program costs, and mitigate the growing threat of drug-
resistant tuberculosis. The United States Government continues
to be a lead funder of global tuberculosis research and
development, contributing 40 percent of the total $772,000,000
in global funding in 2017, and can catalyze more investments
from other countries.
(7) The rate of new cases of tuberculosis in countries that
receive United States bilateral assistance for tuberculosis
prevention, treatment, and control has fallen by one quarter
since 2000 demonstrating the effectiveness of United States
programs and activities.
(8) In September 2018, United Nations Member States in the
first United National High Level Meeting on Tuberculosis
committed to ``ending the epidemic in all countries, and
pledge[d] to provide leadership and to work together to
accelerate our national and global collective actions,
investments, and innovations urgently to fight this preventable
and treatable disease,'' as reflected in United Nations General
Assembly Resolution A/RES/73/3.
(9) On September 26, 2018, the United Nations convened the
first High Level Meeting on Tuberculosis, where 120 countries
signed a Political Declaration to accelerate progress against
tuberculosis, including commitments to increase funding for
tuberculosis control and research and development programs, as
well as ambitious goals to successfully treat 40,000,000 people
with tuberculosis and prevent at least 30,000,000 from becoming
ill between 2018 and 2022.
(10) On September 26, 2018, the Administrator for the
United States Agency for International Development (USAID)
announced a new business model to support the fight to end
tuberculosis (TB). Through $30,000,000 in funding and a new
performance-based Global Accelerator to End TB, USAID will
catalyze investments to meet the target set by the United
Nations High-Level Meeting on tuberculosis of treating
40,000,000 people with the disease by 2022. The Accelerator
will increase support to governments and local partners as part
of a multisectoral approach to ending tuberculosis.
(11) It is essential that existing funding for tuberculosis
programs be allocated prudently, and with an emphasis on
coordination, to ensure that efforts among United States
agencies, partner nations, international organizations,
nongovernmental organizations, both faith-based and non-faith-
based, the private sector and other actors are complementary
and not duplicative. Improved data on tuberculosis, access to
services, accountability, and program quality can help ensure
funding gets to where it is most needed.
(12) If progress does not accelerate, the global
tuberculosis epidemic, particularly increasing cases of MDR-TB
and XDR-TB, where many cases are not curable and vastly more
costly to treat, could erase decades of progress in global
efforts to end both tuberculosis and HIV/AIDS, much of which
has been achieved with United States investment.
SEC. 3. UNITED STATES GOVERNMENT ACTIONS TO END TUBERCULOSIS.
Section 104B of the Foreign Assistance Act of 1961 (22 U.S.C.
2151b-3(g)) is amended by striking subsections (a) through (h) and
inserting the following new subsections:
``(a) Findings.--Congress makes the following findings:
``(1) Congress recognizes the continuing challenge of the
international tuberculosis epidemic and the deadly impact of
its continued existence.
``(2) The means exist to detect, treat, prevent, and cure
tuberculosis to a large extent, but not enough to ensure ending
it, due to inadequate means of diagnosis, prevention, and
treatment.
``(3) Absent accelerated efforts to address tuberculosis
and increased domestic mobilization of resources from high-
burden tuberculosis countries, targets set forth in the End TB
Strategy will not be met.
``(b) Policy.--It is a major objective of the foreign assistance
program of the United States to help end the global tuberculosis
epidemic through actions to diagnose and treat all adults and children
with all forms of tuberculosis, including tuberculosis infection, and
to prevent new tuberculosis infections in adults and children. In all
countries in which the United States Government has established
development programs, particularly in countries with the highest burden
of tuberculosis and other countries with high rates of tuberculosis, it
is the policy of the United States to--
``(1) support the objectives of the World Health
Organization End TB Strategy, including goals to--
``(A) reduce by 95 percent tuberculosis deaths by
2035;
``(B) reduce by 90 percent the tuberculosis
incidence rate by 2035; and
``(C) reduce by 100 percent the number of families
facing catastrophic health costs due to tuberculosis by
2035;
``(2) support the Stop TB Partnership's Global Plan to End
TB 2016-2020, including support for--
``(A) development and use of innovative new
technologies and therapies to increase active case
finding to rapidly diagnose and treat children and
adults with all forms of tuberculosis, alleviate
suffering, and ensure tuberculosis treatment
completion;
``(B) the diagnosis and treatment of latent
tuberculosis infection, in support of the global goal
of providing preventive therapy to at least 30,000,000
people, including 4,000,000 children under five years
of age, 20,000,000 household contacts of people
affected by tuberculosis, and 6,000,000 people living
with HIV, by 2022;
``(C) steps to ensure high-quality tuberculosis
care by closing gaps in care cascades, implementing
continuous quality improvement at all levels of care,
and providing patient support; and
``(D) sustainable procurement of tuberculosis
commodities, to avoid interruptions in supply,
procurement of commodities of unknown quality, or
payment of excessive commodity costs in countries
impacted by tuberculosis;
``(3) ensure United States funding supports activities that
simultaneously emphasize--
``(A) the development of comprehensive person-
centered programs which include diagnosis, treatment,
and prevention strategies to ensure that those at high
risk for infection are found and treated with
preventive therapies in a timely manner;
``(B) robust tuberculosis infection control
practices in all congregate settings, including
hospitals and prisons;
``(C) the deployment of diagnostic and treatment
capacity in areas with the highest tuberculosis
burdens, as well as for highly at-risk and impoverished
populations, including patient support;
``(D) program monitoring and evaluation based on
critical tuberculosis indicators, including infection
control, the numbers of patients accessing tuberculosis
treatment, along with patient support, and preventative
therapy for those at risk, including all close
contacts, as well as treatment completion for all forms
of tuberculosis;
``(E) training health care workers on the use of
new diagnostic tools and therapies as they become
available;
``(F) coordination with domestic agencies on an
aggressive research agenda to develop vaccines as well
as new tools to diagnose, treat, and prevent
tuberculosis globally;
``(G) linkages with the private sector on improved
diagnosis and treatment of tuberculosis, training for
healthcare professionals on use of the most effective
diagnostic and therapeutic tools, and research in the
areas of vaccine development as well as the development
of therapeutics and diagnostic tools;
``(H) efforts to address barriers to patients
seeking care including stigma and costs related to
diagnosis and treatment;
``(I) efforts to address human rights-related
barriers to tuberculosis services, including--
``(i) training health workers;
``(ii) sensitizing policy makers;
``(iii) legal literacy and patient
empowerment campaigns;
``(iv) strengthening legal services; and
``(v) monitoring laws and policies; and
``(J) the establishment of independent
accountability mechanisms and inclusive country level
systems to measure progress and ensure that commitments
made by governments and relevant stakeholders are met.
``(c) Authorization.--To carry out this section and consistent with
section 104(c), the President is authorized to furnish assistance, on
such terms and conditions as the President may determine, for the
prevention, treatment, control, and elimination of tuberculosis.
``(d) Goals.--In consultation with the appropriate congressional
committees, the President shall establish new goals for United States
efforts, based on the policy and indicators described in subsection
(b), to reach, cure, and prevent all forms of tuberculosis globally
over the 5-year period following the date of the enactment of this
subsection by updating the United States Government Tuberculosis
Strategy (2015-2019) and the National Action Plan for Combatting
Multidrug-Resistant Tuberculosis.
``(e) Coordination.--
``(1) In general.--In carrying out this section, the
President shall coordinate with the World Health Organization,
the Stop TB Partnership, the Global Fund to Fight AIDS,
Tuberculosis, and Malaria, and other organizations with respect
to the development and implementation of a comprehensive
tuberculosis response program.
``(2) Bilateral assistance.--In providing bilateral
assistance under this section, the President, acting through
the Administrator of the United States Agency for International
Development, shall--
``(A) coordinate and catalyze intensified
international tuberculosis research and development,
prevention, diagnosis, treatment, and control efforts,
particularly to reduce the incidence of, and mortality
from, all forms of drug resistant tuberculosis; and
``(B) ensure coordination among relevant United
States Government agencies and programs, including the
Centers for Disease Control and Prevention, the
National Institutes of Health, the Biomedical Advanced
Research and Development Authority, the Food and Drug
Administration, the National Science Foundation, the
Department of Defense Congressionally Directed Medical
Research Program, and the President's Emergency Plan
for AIDS Relief (PEPFAR), that engage in international
tuberculosis activities to ensure accountability and
transparency, reduce duplication of efforts, ensure
equitable shares in domestic expenditure and
advancement on research and development, and ensure
appropriate integration and coordination of
tuberculosis services into other United States-
supported health programs.
``(f) Priority to End TB Strategy.--In furnishing assistance under
subsection (b), the President shall give priority to--
``(1) direct, high-quality services for all forms of
tuberculosis described in international policies and
guidelines, with a preference for programs that implement a
coordinated package of active case finding, treatment of all
forms of tuberculosis disease and infection, patient support
and tuberculosis prevention;
``(2) individuals infected with both tuberculosis and HIV,
and other co-morbidities, treatment for individuals with MDR-
TB, XDR-TB, strengthening of health systems, use of the latest
International Standards for Tuberculosis Care by all providers,
and empowering individuals with tuberculosis;
``(3) enabling and promoting tuberculosis research to
develop innovative new diagnostics, drug therapies, and
vaccines, and program-based operational research; and
``(4) funding for the Stop Tuberculosis Partnership's
Global Drug Facility the Stop Tuberculosis Partnership, and the
Global Alliance for Tuberculosis Drug Development.
``(g) Assistance for the World Health Organization and the Stop
Tuberculosis Partnership.--In carrying out this section, the President,
acting through the Administrator of the United States Agency for
International Development, is authorized to provide increased resources
to the World Health Organization and the Stop Tuberculosis Partnership
to improve the capacity of countries with high rates of tuberculosis
and other affected countries to implement the Stop Tuberculosis
Strategy and specific strategies related to addressing MDR-TB and XDR-
TB.
``(h) Annual Report on Tuberculosis Activities.--The President
shall submit an annual report to Congress that describes the impact of
United States foreign assistance on efforts to control tuberculosis,
including--
``(1) the number of people with active tuberculosis and the
number with tuberculosis infection diagnosed and treated,
including the rate of treatment completion and the number
receiving patient support, in countries receiving United States
bilateral foreign assistance for tuberculosis control purposes;
``(2) the number of persons who have been diagnosed and
started treatment for MDR-TB and XDR-TB in countries receiving
United States bilateral foreign assistance for tuberculosis
control programs;
``(3) a description of the collaboration and coordination
of United States anti-tuberculosis efforts with the World
Health Organization, the Global Fund, and other major public
and private entities;
``(4) a description of the collaboration and coordination
among the United States Agency for International Development
and other United States agencies, including the Centers for
Disease Control and the Office of the Global AIDS Coordinator,
for the purposes of combatting tuberculosis;
``(5) the constraints on implementation of programs posed
by health workforce shortages, heath system limitations, and
other capacities;
``(6) the numbers of people trained by the United States
Government in tuberculosis surveillance and control;
``(7) a breakdown of expenditures for direct patient
tuberculosis services, drugs and other commodities, drug
management, training in diagnosis and treatment, health systems
strengthening, research, and support costs; and
``(8) for each country receiving bilateral United States
assistance for the purpose of tuberculosis prevention,
treatment, and control--
``(A) a description of progress to adopt and
implement the most recent World Health Organization
guidelines to improve diagnosis, treatment, and
prevention of tuberculosis for adults and children,
disaggregated by sex, including the proportion of
health facilities which have adopted the latest WHO
guidelines on strengthening surveillance systems and
preventative, diagnostic, and therapeutic methods,
including the use of rapid diagnostic tests and orally
administered TB treatment regimens;
``(B) the rate of tuberculosis incidence for adults
and children, disaggregated by sex, and a description
of progress in implementing measures to reduce
incidence, including the number of adults and children
receiving tuberculosis preventive therapy, including
people with HIV and all close contacts, disaggregated
by sex, and the establishment of effective tuberculosis
infection control in all congregant settings, including
hospitals, clinics, and prisons;
``(C) a description of progress to expand
diagnosis, prevention, and treatment for all forms of
tuberculosis, including in pregnant women, children,
and other high-risk groups who are vulnerable or in
vulnerable situations, such as migrants, prisoners,
miners, and others exposed to silica, and people living
with HIV/AIDS, disaggregated by sex;
``(D) the rate of successful completion of
tuberculosis treatment for adults and children,
disaggregated by sex, and the number of patients
receiving support for treatment completion;
``(E) the number of people, disaggregated by sex,
receiving treatment for MDR-TB, the proportion of those
treated with the latest regimens endorsed by the World
Health Organization, any factors impeding scale up of
such treatment, and a description of progress to expand
community-based MDR-TB care;
``(F) a description of tuberculosis commodity
procurement challenges, including shortages, stockouts,
or failed tenders for tuberculosis drugs or other
commodities;
``(G) the proportion of health facilities with
specimen referral linkages to GeneXpert testing sites,
and to reference labs for second line drug resistance
testing, and a description of the turnaround time for
test results;
``(H) the number of people trained by the United
States Government to deliver high-quality tuberculosis
surveillance, laboratory services, prevention,
treatment, and care;
``(I) a description of activities that serve to
coordinate and leverage countries' domestic resources,
including development of plans, procedures, and disease
estimates that support effective use of resources from
the Global Fund to Fight AIDS, Tuberculosis, and
Malaria; and
``(J) the full text of any Statement of Partnership
agreed to by the ministry of health and the United
States Agency for International Development to
establish a shared framework combatting tuberculosis.
``(i) Annual Report on Tuberculosis Research and Development.--The
President, acting through the Administrator of the United States Agency
for International Development, shall submit to Congress an annual
report, to be prepared in coordination with the National Institutes of
Health, the Centers for Disease Control and Prevention, the Biomedical
Advanced Research and Development Authority (BARDA), the Food and Drug
Administration, the National Science Foundation, the Department of
Defense Congressionally Directed Medical Research Program, and the
President's Emergency Plan for AIDS Relief (PEPFAR)--
``(1) describing current progress and challenges to the
development of new tools for the purpose of tuberculosis
prevention, treatment, and control;
``(2) identifying critical gaps and emerging priorities for
research and development, including for rapid and point-of-care
diagnostics, shortened treatments and prevention methods, and
vaccines; and
``(3) describing research investments by type, funded
entities, and level of investment.
``(j) Evaluation Report.--
``(1) In general.--Not later than one year after the date
of the enactment of this subsection, and every 5 years
thereafter, the Comptroller General of the United States shall
submit to the Administrator of the United States Agency for
International Development and the appropriate congressional
committees a report that evaluates the performance and impact
on tuberculosis prevention, diagnosis, treatment, and care
efforts that are supported by United States bilateral
assistance funding, including recommendations for improving
such programs.
``(2) Form.--The report required under paragraph (1) shall
be submitted in unclassified form, but may contain a classified
annex if necessary.
``(3) Public availability.--The Comptroller General shall
publish the unclassified portion of the report required under
paragraph (1) on a publicly available website of the Government
Accountability Office.
``(k) Definitions.--In this section:
``(1) Appropriate congressional committees.--The term
`appropriate congressional committees' means the Committee on
Foreign Relations of the Senate and the Committee on Foreign
Affairs of the House of Representatives.
``(2) Global alliance for tuberculosis drug development.--
The term `Global Alliance for Tuberculosis Drug Development'
means the public-private partnership that bring together
leaders in health, science, philanthropy, and private industry
to devise new approaches to tuberculosis.
``(3) Global tuberculosis drug facility.--The term `Global
Tuberculosis Drug Facility (GDF)' means the initiative of the
Stop Tuberculosis Partnership to increase access to the most
advanced, affordable, quality-assured tuberculosis drugs and
diagnostics.
``(4) End tb strategy.--The term `End TB Strategy' means
the strategy to eliminate tuberculosis approved by the World
Health Assembly in May 2014, which is described in The End TB
Strategy: Global Strategy and Targets for Tuberculosis
Prevention, Care and Control after 2015.
``(5) Stop tuberculosis partnership.--The term `Stop
Tuberculosis Partnership' means the partnership of the United
Nations Office for Project Services, donors including the
United States, high-burden tuberculosis countries, multilateral
agencies, and nongovernmental and technical agencies committed
to short- and long-term measures required to control and
eventually eliminate tuberculosis as a public health problem in
the world.''.
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