[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4847 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 4847
To facilitate effective research on and treatment of neglected tropical
diseases through coordinated domestic and international efforts.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 11, 2014
Mr. Smith of New Jersey (for himself, Mr. Meeks, Mr. Salmon, and Mr.
Johnson of Georgia) introduced the following bill; which was referred
to the Committee on Energy and Commerce, and in addition to the
Committees on Foreign Affairs and Financial Services, for a period to
be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To facilitate effective research on and treatment of neglected tropical
diseases through coordinated domestic and international efforts.
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 Neglected Tropical Diseases
Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Statement of policy.
Sec. 4. Findings.
Sec. 5. Definition.
Sec. 6. Rule of construction.
TITLE I--FOREIGN AFFAIRS
Sec. 101. Expansion of USAID NTDs Program.
Sec. 102. Actions by Department of State.
Sec. 103. Multilateral development and health institutions.
TITLE II--DEPARTMENT OF HEALTH AND HUMAN SERVICES
Sec. 201. Promoting efforts through interagency working groups and
international forums.
Sec. 202. Report on neglected tropical diseases in the United States.
Sec. 203. Centers of excellence.
Sec. 204. Panel on worm infection solutions.
SEC. 3. STATEMENT OF POLICY.
It is the policy of the United States to support a broad range of
implementation and research and development activities that work toward
the achievement of cost-effective and sustainable treatment, control
and, where possible, elimination of neglected tropical diseases for the
economic and social well-being for all people.
SEC. 4. FINDINGS.
Congress finds the following:
(1) The World Health Organization (WHO) has identified 17
neglected tropical diseases (NTDs). Approximately two billion
people--almost one-third of the world's population--are at risk
of contracting an NTD, and more than 1.4 billion people are
currently afflicted with one or more NTDs.
(2) In 2013, WHO adopted a comprehensive resolution on NTDs
recognizing that increased national and international
investments in prevention and control of neglected tropical
diseases have succeeded in improving health and social well-
being in many countries.
(3) NTDs have an enormous impact in terms of disease burden
and quality of life. NTDs cause the loss of up to 534,000 lives
and 57 million disability-adjusted life years each year. NTDs
surpass both malaria and tuberculosis in causing greater loss
of life-years to disability and premature death. Many NTDs
cause disfigurement and disability, leading to stigma, social
discrimination, and societal marginalization.
(4) NTDs create an economic burden of billions of dollars
through the loss of productivity and high costs of health care
required for treatment. People afflicted by NTDs are less
productive than their healthy counterparts. NTDs jeopardize the
ability of people to attend work and school, or to produce at
full capacity. For example, controlling one NTD, hookworm, in
children can result in a 43-percent increase in future wage
earnings.
(5) The social, economic, and health burden of NTDs falls
primarily on low- and middle-income countries, where access to
safe water, sanitation, and health care is limited. At least
100 countries face two endemic NTD burdens, and 30 countries
carry six or more endemic NTDs.
(6) NTDs are not confined to the developing world, however.
Several NTD outbreaks have been reported in the United States
and other developed countries, especially among the poor. In
the United States, NTDs disproportionately affect people living
in poverty, and especially minorities, including up to 2.8
million African-Americans with toxocariasis and 300,000 or more
people, mostly Hispanic-Americans, with Chagas disease.
(7) Many NTDs can be controlled, prevented, and even
eliminated using low-cost, effective, and feasible solutions.
Understanding the economic burden of NTDs on productivity and
health care costs can help to assure governments and donors
that the resources directed toward NTDs represent a good
investment.
(8) Research and development efforts are immediately needed
for all NTDs, especially those for which limited or no
treatment currently exists.
(9) Critical to developing robust NTD control strategies
are epidemiological data that identify at-risk populations,
ensure appropriate treatment frequency, and inform decisions
about when treatment can be reduced or stopped.
(10) Of the 14 most common NTDs, roughly 80 percent of
infections are caused by soil-transmitted helminths (STH) and
schistosomiasis. STH are a group of three parasitic worms
(roundworms, whipworms, and hookworms) that afflict more than
one billion people worldwide, including 600 million school-age
children, of whom more than 300 million suffer from severe
morbidity. Schistosomiasis is another helminth infection
affecting at least 200 million people in developing countries,
but some estimates indicate that the true number of people
affected may be double or even triple that number.
(11) The main health problems caused by STH are related to
their negative effect on childhood nutritional status, which
can cause stunting and wasting. For example, STH infection may
lead to anemia, malabsorption of nutrients, loss of appetite,
nausea, abdominal pain, diarrhea, and reduced food intake. When
such health problems are experienced in early childhood, a peak
growth and development period, the mental and physical damage--
and loss of future productivity and wage-earning potential--
will likely be irreversible. Schistosomiasis causes end-organ
damage to the urinary tract, female genital tract, liver and
intestines. It also results in chronic health conditions in
children.
(12) STH and schistosomiasis are also particularly
detrimental to the health of women of reproductive age and
pregnant women. Their underlying poor iron status makes these
women most susceptible to developing anemia. Iron deficiency
anemia resulting from hookworm infection during pregnancy has
been linked to poor pregnancy outcomes such as prematurity, low
birth weight, and impaired lactation. Female genital
schistosmiasis may be one of the most common gynecologic
conditions in Africa leading to genital pain, itching, and
bleeding and markedly increased susceptibility to HIV/AIDS.
(13) Fortunately, there is a simple, cost-effective
solution to STH and schistosomiasis infections: single-dose
deworming pills that can be safely administered once or twice
annually to those at risk. Pharmaceutical companies have
committed to donate the drugs needed to treat all at-risk,
school-age children in developing countries. Regular
administration of deworming pills reduces morbidity associated
with STH and schistosomiasis infections by reducing prevalence
and transmission rates.
(14) The benefits of deworming are immediate and enduring.
A rigorous randomized controlled trial has shown school-based
deworming treatment to reduce school absenteeism by 25 percent.
School-based deworming also benefits young siblings and other
children who live nearby but are too young to be treated,
leading to large cognitive improvements equivalent to half a
year of schooling.
SEC. 5. DEFINITION.
In this Act, the term ``neglected tropical diseases'' or ``NTDs''--
(1) means infections caused by pathogens, including
viruses, bacteria, protozoa, and helminths that
disproportionately impact individuals living in extreme
poverty, especially in developing countries; and
(2) includes--
(A) Buruli ulcer (Mycobacterium Ulcerans
infection);
(B) Chagas disease;
(C) dengue or severe dengue fever;
(D) dracunculiasis (Guinea worm disease);
(E) echinococcosis;
(F) foodborne trematodiases;
(G) human African trypanosomiasis (sleeping
sickness);
(H) leishmaniasis;
(I) leprosy;
(J) lymphatic filariasis (elephantiasis);
(K) onchocerciasis (river blindness);
(L) rabies;
(M) schistosomiasis;
(N) soil-transmitted helminthiases (STH) (round
worm, whip worm, and hook worm);
(O) taeniasis/cysticercosis;
(P) trachoma; and
(Q) yaws (endemic treponematoses).
SEC. 6. RULE OF CONSTRUCTION.
Nothing in this Act shall be construed to increase authorizations
of appropriations for the United States Agency for International
Development or authorizations of appropriations for the Department of
Health and Human Services.
TITLE I--FOREIGN AFFAIRS
SEC. 101. EXPANSION OF USAID NTDS PROGRAM.
(a) Findings.--Congress finds the following:
(1) Since fiscal year 2006, the United States Government
has been an essential leading partner in advancing control and
elimination efforts for seven targeted neglected tropical
diseases: lymphatic filariasis (elephantiasis), onchocerciasis
(river blindness), schistosomiasis, soil-transmitted
helminthiases (STH) (round worm, whip worm, and hook worm), and
trachoma. Additional information suggests that such efforts
could also produce collateral benefits for at least three other
NTDs: foodborne trematodiases, rabies, and yaws (endemic
treponematoses).
(2) The United States Agency for International Development
(USAID) Neglected Tropical Diseases Program has made important
and substantial contributions to the global fight to control
and eliminate the seven most common NTDs. Leveraging more than
$6.7 billion in donated medicines, USAID has supported the
distribution of more than one billion treatments in 25
countries across Africa, Asia, and Latin America and the
Caribbean.
(3) United States Government leadership has been
instrumental in maintaining the global fight against NTDs and
is a partner in the 2012 London Declaration on NTDs, which
represents a new, coordinated push to accelerate progress
toward eliminating or controlling 10 neglected tropical
diseases by 2020.
(4) The USAID NTDs Program is a clear example of a
successful public-private partnership between the Government
and the private sector and should be judiciously expanded.
(b) Sense of Congress.--It is the sense of Congress that the USAID
NTDs Program (as in effect on the date of the enactment of this Act)
should be modified as follows:
(1) Provide rapid impact package treatments to as many
individuals suffering from NTDs or at risk of acquiring NTDs as
logistically feasible.
(2) Better integrate rapid impact package treatments with
programs to control and eliminate HIV/AIDS and malaria,
including--
(A) by coordinating HIV/AIDS programs with the
control of female genital schistosomiasis, now revealed
as one of Africa's most important co-factors in its
AIDS epidemic; and
(B) by coordinating malaria programs with programs
to control schistosomiasis and hook worm--together
these diseases produce profound and severe anemia.
(3) Establish school-based NTD programs to provide an
opportunity to reach large numbers of school-age children who
require treatments for NTDs, including rapid impact package
treatments as feasible and at very low cost.
(4) For other NTDs, such as human African trypanosomiasis
(sleeping sickness), chagas disease, leishmaniasis, and dengue
fever, develop new approaches to reach the goals relating to
the elimination of NTDs as set forth in the World Health
Organization (WHO) NTD Roadmap.
(c) Expansion of Program.--The Administrator of USAID shall expand
the USAID NTDs Program (as in effect on the date of the enactment of
this Act) as follows:
(1) Carry out monitoring and evaluation to provide accurate
measurements to inform future NTD control and elimination
strategies.
(2) Coordinate with USAID development sectors, such as
sectors relating to water and sanitation, hygiene, food
security and nutrition, and education (both primary and
preprimary), to establish programs that address NTDs and
advance the goals of the 2012 London Declaration on NTDs.
(3) Include morbidity management in treatment plans for
high-burden NTDs, such as lymphatic filariasis (elephantiasis).
(4) Include NTDs that are recognized as high-burden
diseases in the Global Burden of Disease Study 2010, including
foodborne trematodiases, human African trypanosomiasis
(sleeping sickness), chagas disease, leishmaniasis, and dengue
fever and related arbovirus infections.
(5) Include research and development, consistent with other
USAID disease prevention programs, to ensure the tools required
for elimination of these diseases are available, such as drugs,
diagnostics, vaccines.
(d) Research and Development.--
(1) Establishment.--The Administrator of USAID shall
establish a research and development program within the USAID
NTDs Program (as in effect on the date of the enactment of this
Act).
(2) Priority.--The research and development program shall
focus on the prevention and control of those diseases with the
highest need for new treatments, diagnostics, and vaccines,
including soil-transmitted helminthiases (STH) (round worm,
whip worm, and hook worm), schistosomiasis, chagas disease,
human African trypanosomiasis (sleeping sickness),
leishmaniasis, and dengue fever and other arbovirus infections.
SEC. 102. ACTIONS BY DEPARTMENT OF STATE.
(a) Office of the Global AIDS Coordinator.--Section 1(f)(2)(B)(ii)
of the State Department Basic Authorities Act of 1956 (22 U.S.C.
2651a(f)(2)(B)(ii)) is amended by adding at the end the following:
``(XIV) Neglected tropical
diseases.--
``(aa) In general.--
Ensuring coordination of
activities of the United States
(including funding) relating to
combatting HIV/AIDS with
activities of the United States
(including funding) relating to
combatting neglected tropical
diseases to include the control
and elimination of neglected
tropical diseases, particularly
in countries and regions that
are highly endemic for female
genital schistosomiasis.
``(bb) Definition.--In this
subclause, the term `neglected
tropical diseases' has the
meaning given the term in
section 5 of the End Neglected
Tropical Diseases Act.''.
(b) Global Fund.--
(1) In general.--The Secretary of State should seek to
engage the Global Fund in discussions on whether to expand the
authority of the Global Fund for the control and elimination of
neglected tropical diseases.
(2) Global fund.--In this subsection, the term ``Global
Fund'' means the public-private partnership known as the Global
Fund to Fight AIDS, Tuberculosis and Malaria established
pursuant to Article 80 of the Swiss Civil Code.
(c) G-20 Countries.--The Secretary of State, acting through the
Office of Global Health Diplomacy, should engage G-20 countries to
significantly increase their role in the control and elimination of
neglected tropical diseases, particularly Argentina, Brazil, China,
India, Indonesia, Mexico, the Republic of Korea, Saudi Arabia, and
South Africa.
SEC. 103. MULTILATERAL DEVELOPMENT AND HEALTH INSTITUTIONS.
(a) Congressional Finding.--Congress finds that the treatment of
high burden neglected tropical diseases, including school-based
deworming programs, has proven to be a highly cost-effective education
intervention and schools can serve as the best delivery mechanism for
reaching large numbers of children with safe treatment for soil-
transmitted helminthiases (STH) (round worm, whip worm, and hook worm)
in particular.
(b) United Nations.--The President shall direct the United States
permanent representative to the United Nations to use the voice, vote,
and influence of the United States to urge the World Health
Organization, the United Nations Educational, Scientific and Cultural
Organization, and the United Nations Development Programme to take the
actions described in subsection (d).
(c) World Bank Institute.--The President shall direct the United
States Executive Director at the International Bank for Reconstruction
and Development to use the voice, vote, and influence of the United
States to urge the World Bank Institute to take the actions described
in subsection (d).
(d) Actions Described.--The actions described in this subsection
are the following:
(1) Ensure the dissemination of best practices and
programming on NTDs to governments and make data accessible to
practitioners in an open and timely fashion.
(2) Highlight impacts of school-based deworming programs on
children's health and education, emphasizing the cost-
effectiveness of such programs.
(3) Encourage governments to implement deworming campaigns
at the national level.
(4) Designate a portion of grant funds of the institutions
to deworming initiatives and cross-sectoral collaboration with
water and sanitation and hygiene efforts and nutrition or
education programming.
(5) Encourage accurate monitoring and evaluation of NTD
programs, including deworming programs.
(6) Engage governments in cross-border initiatives for the
treatment, control, prevention, and elimination of NTDs, and
assist in developing transnational agreements, when necessary.
TITLE II--DEPARTMENT OF HEALTH AND HUMAN SERVICES
SEC. 201. PROMOTING EFFORTS THROUGH INTERAGENCY WORKING GROUPS AND
INTERNATIONAL FORUMS.
The Secretary of Health and Human Services shall continue to
promote the need for robust programs and activities to diagnose,
prevent, control, and treat neglected tropical diseases--
(1) through interagency working groups on health; and
(2) through relevant international forums on behalf of the
United States, including the post-2015 United Nations
development agenda.
SEC. 202. REPORT ON NEGLECTED TROPICAL DISEASES IN THE UNITED STATES.
(a) In General.--Not later than 12 months after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Director of the Centers for Disease Control and
Prevention, shall submit to the Congress a report on neglected tropical
diseases in the United States.
(b) Contents.--The report required by this section shall--
(1) assess the epidemiology of, impact of, and appropriate
funding required to address neglected tropical diseases in the
United States; and
(2) include the information necessary--
(A) to guide future health policy with respect to
such diseases;
(B) to accurately evaluate the current state of
knowledge concerning such diseases; and
(C) to define gaps in such knowledge.
SEC. 203. CENTERS OF EXCELLENCE.
Part P of title III of the Public Health Service Act is amended by
inserting after section 399V-5 of such Act (42 U.S.C. 280g-16) the
following:
``SEC. 399V-6. NEGLECTED TROPICAL DISEASE CENTERS OF EXCELLENCE.
``(a) Cooperative Agreements and Grants.--
``(1) In general.--The Secretary, acting through the
Director of the National Institute of Allergy and Infectious
Diseases or the Administrator of the Health Resources and
Services Administration, as appropriate, may enter into
cooperative agreements with, and make grants to, public or
private nonprofit entities to pay all or part of the cost of
planning, establishing, or strengthening, and providing basic
operating support for, one or more centers of excellence for
research into, training in, and development of diagnosis,
prevention, control, and treatment methods for neglected
tropical diseases.
``(2) Eligibility.--To be eligible for a cooperative
agreement or grant under this section, an entity must--
``(A) have demonstrated expertise in research on,
and the epidemiology and surveillance of, the major
neglected tropical diseases that are endemic to the
United States, such as Chagas disease, dengue,
leishmaniasis, and West Nile virus infection, and
helminth infections; and
``(B) participate in one or more not-for-profit
product development partnerships.
``(b) Policies.--A cooperative agreement or grant under paragraph
(1) shall be entered into or awarded in accordance with policies
established by the Director of the National Institutes of Health or the
Health Resources and Services Administration, as applicable.
``(c) Coordination With Other Institutes.--The Secretary shall
coordinate the activities under this section with similar activities
conducted by other national research institutes, centers, and agencies
of the National Institutes of Health to the extent that such
institutes, centers, and agencies have responsibilities that are
related to neglected tropical diseases.
``(d) Uses of Funds.--A cooperative agreement or grant under
subsection (a) may be used for--
``(1) staffing, administrative, and other basic operating
costs, including such patient care costs as are required for
research;
``(2) clinical training, including training for allied
health professionals, continuing education for health
professionals and allied health professions personnel, and
information programs for the public with respect to neglected
tropical diseases; and
``(3) research and development programs.
``(e) Period of Support; Additional Periods.--
``(1) In general.--Support of a center of excellence under
this section may be for a period of not more than 5 years.
``(2) Extensions.--The period specified in paragraph (1)
may be extended by the Secretary for additional periods of not
more than 5 years if--
``(A) the operations of the center of excellence
involved have been reviewed by an appropriate technical
and scientific peer review group; and
``(B) such group has recommended to the Secretary
that such period should be extended.
``(f) Definitions.--In this section:
``(1) The term `neglected tropical disease' has the meaning
given to that term in section 5 of the End Neglected Tropical
Diseases Act.
``(2) The term `product development partnership' means a
partnership to bring together public and private sector
researchers to develop new, or improve on current, global
health tools, such as drugs, diagnostics, insecticides,
vaccines, and vector management strategies--
``(A) that are for neglected tropical diseases; and
``(B) for which there is generally no profitable
market.
``(g) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2015 through 2019.''.
SEC. 204. PANEL ON WORM INFECTION SOLUTIONS.
(a) Establishment.--The Director of the National Institutes of
Health, in consultation with the Administrator of the United States
Agency for International Development, shall establish a panel to
conduct an evaluation of issues relating to worm infections, including
potential solutions such as deworming medicines (in this section
referred to as the ``panel'').
(b) Strategies.--The panel shall develop recommendations for
strategies for solutions with respect to--
(1) repeat infections;
(2) vector control;
(3) clean water solutions;
(4) identifying incentives to encourage basic research for
less toxic, more effective medicines; and
(5) improving the success and cost efficiency of current
programs in these areas, based on a thorough scan of
initiatives already underway in both the public and private
sectors.
(c) Appointment of Members.--The Director of the National
Institutes of Health shall appoint as members of the panel individuals
from the public and private sectors who are knowledgeable about or
affected by worm infections, including--
(1) at least 2 representatives of nongovernmental
organizations;
(2) at least 2 representatives of private industry involved
in the development of de-worming medications;
(3) at least 2 representatives from academia; and
(4) representatives of industries relating to sanitation,
clean water, and vector control.
(d) Report.--Not later than 1 year after the date of the enactment
of this Act, the panel shall submit to Congress and the Director of the
National Institutes of Health a report on its findings and recommended
strategies, including recommendations for such administrative action
and legislation as the panel determines to be appropriate.
(e) Termination.--The panel shall terminate not later than 6 months
after submitting the report required by subsection (d).
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