```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 826 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 826

To facilitate effective research on and treatment of neglected tropical 
      diseases, including Ebola, through coordinated domestic and 
                         international efforts.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            January 28, 2019

    Mr. Smith of New Jersey (for himself, Ms. Bass, and Mr. Meeks) 
 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, including Ebola, 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 United States Agency for International 
                            Development's Neglected Tropical Diseases 
                            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, 
including Ebola, 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) In 2014, an outbreak of Ebola Virus Diseases (Ebola) 
        caused a pandemic that infected more than 20,000 people, 
        including more than 8,000 deaths. Although not listed as an NTD 
        by the World Health Organization, Ebola shares the same 
        characteristics as other NTDs by affecting people living 
        ``under conditions of poverty'' and is ``concentrated almost 
        exclusively in impoverished populations in the developing 
        world''. Even when the disease had spread to the United States 
        and other developed countries, it was contained and controlled 
        by the well-equipped health systems in those areas.
            (8) 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.
            (9) Research and development efforts are immediately needed 
        for all NTDs, especially those for which limited or no 
        treatment currently exists.
            (10) 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.
            (11) 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.
            (12) 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.
            (13) 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.
            (14) 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.
            (15) Improved access to water, sanitation, and hygiene 
        (WASH) can also reduce the transmission of NTDs, particularly 
        intestinal worms.
            (16) 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 UNITED STATES AGENCY FOR INTERNATIONAL 
              DEVELOPMENT'S NEGLECTED TROPICAL DISEASES 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, scabies, and yaws (endemic 
        treponematoses).
            (2) The United States Agency for International 
        Development's (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 London Declaration on Neglected Tropical 
        Diseases (2012), which represents a new, coordinated 
        international push to accelerate progress toward eliminating or 
        controlling 10 neglected tropical diseases by 2020.
            (4) USAID's Neglected Tropical Diseases Program is a clear 
        example of a successful public-private partnership between the 
        Government and the private sector and should be judiciously 
        expanded, as practicable and appropriate.
            (5) While many of the most common NTDs have treatments that 
        are safe, easy to use, and effective, treatment options for 
        NTDs with the highest death rates, including human African 
        trypanosomiasis, visceral leishmaniasis, and Chagas disease, 
        are extremely limited.
            (6) Since 2014, USAID's Neglected Tropical Diseases Program 
        has been investing in gathering research on treatment for 
        certain NTDs to ensure that promising new breakthrough 
        medicines can be rapidly evaluated, registered, and made 
        available to patients.
    (b) Sense of Congress.--It is the sense of Congress that USAID's 
Neglected Tropical Diseases Program should--
            (1) provide integrated drug treatment packages to as many 
        individuals suffering from NTDs or at risk of acquiring NTDs as 
        logistically feasible;
            (2) better integrate control and treatment tools and 
        approaches for NTDs into complementary development and global 
        health programs by coordinating across multiple sectors, 
        including sectors relating to HIV/AIDS, malaria, and other 
        infectious diseases and development sectors relating to 
        education (including primary and pre-primary education), food 
        and nutrition security, maternal and child health, and water, 
        sanitation, and hygiene (WASH), as practicable and appropriate;
            (3) establish low-cost, high-impact community and school-
        based NTD programs to reach large at-risk populations, 
        including school-age children who require treatments for NTDs, 
        with integrated drug treatment packages as feasible;
            (4) for other NTDs, such as human African trypanosomiasis 
        (sleeping sickness), Chagas disease, leishmaniasis, and dengue 
        fever, engage in research and development of new tools and 
        approaches to reach the goals relating to the elimination of 
        NTDs as set forth in the World Health Organization's 
        ``Accelerating Work to Overcome the Global Impact of Neglected 
        Tropical Diseases: A Roadmap for Implementation'' (2012), as 
        opportunities emerge and resources allow; and
            (5) monitor the research on and developments in the 
        prevention and treatment of other NTDs so they can be 
        incorporated into the program, as practicable and appropriate.
    (c) Program Priorities.--The Administrator of USAID should 
incorporate the following priorities into USAID's Neglected Tropical 
Diseases Program:
            (1) Planning for and conducting robust monitoring and 
        evaluation of program investments in order to accurately 
        measure impact, identify and share lessons learned, and inform 
        future NTD control and elimination strategies.
            (2) Coordinating program activities with USAID development 
        sectors, including development sectors relating to education 
        (including primary and pre-primary education), food and 
        nutrition security, and water, sanitation, and hygiene (WASH), 
        in order to advance the goals of the London Declaration on 
        Neglected Tropical Diseases (2012).
            (3) Including morbidity management in treatment plans for 
        high-burden NTDs.
            (4) Incorporating NTDs that are recognized as high-burden 
        diseases in the Global Burden of Disease Study 2010 into the 
        program as opportunities emerge, to the extent practicable and 
        appropriate.
            (5) Continuing investments in research and development for 
        new tools, including diagnostics, drugs, and vaccines, for NTDs 
        to ensure that new discoveries make it through the pipeline and 
        become available to individuals who need them most.

SEC. 102. ACTIONS BY DEPARTMENT OF STATE.

    (a) Office of the Global AIDS Coordinator.--It is the sense of 
Congress that the Coordinator of United States Government Activities to 
Combat HIV/AIDS Globally should fully consider evolving research on the 
impact of neglected tropical diseases on efforts to control HIV/AIDS 
when making future programming decisions, as necessary and appropriate.
    (b) Global Programming.--
            (1) In general.--The Secretary of State should encourage 
        the Global Fund to take into consideration evolving research on 
        the impact of NTDs on efforts to control HIV/AIDS when making 
        programming decisions, particularly with regard to female 
        genital schistosomiasis, which has been revealed as one of the 
        most significant co-factors in the AIDS epidemic in Africa, as 
        necessary and appropriate.
            (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 encourage G-20 countries, 
particularly Argentina, Brazil, China, India, Indonesia, Mexico, the 
Republic of Korea, Saudi Arabia, and South Africa, to significantly 
increase their role in the control and elimination of NTDs.

SEC. 103. MULTILATERAL DEVELOPMENT AND HEALTH INSTITUTIONS.

    (a) Congressional Finding.--Congress finds that the treatment of 
high burden neglected tropical diseases, including community and 
school-based deworming programs, can be a highly cost-effective 
education intervention and schools can serve as an effective 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 should 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 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 community and 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 relevant agencies of the Department of Health and Human 
Services, 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-6 of such Act (42 U.S.C. 280g-17) the 
following:

``SEC. 399V-7. NEGLECTED TROPICAL DISEASE CENTERS OF EXCELLENCE.

    ``(a) Cooperative Agreements and Grants.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 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, including tools to support elimination.
            ``(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 or the epidemiology and surveillance of, major 
                neglected tropical diseases that are endemic to the 
                United States, such as Chagas disease, dengue, 
                leishmaniasis, West Nile virus, 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 established 
policies.
    ``(c) Coordination.--The Secretary shall ensure that activities 
under this section are coordinated with similar activities of the 
Department of Health and Human Services relating 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 diseases' 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, 
                including Ebola; and
                    ``(B) for which there is generally no profitable 
                market.''.

SEC. 204. PANEL ON WORM INFECTION SOLUTIONS.

    (a) Establishment.--The Secretary of Health and Human Services 
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.--In addition to representatives from 
the Centers for Disease Control and Prevention and other relevant 
agencies working on neglected tropical diseases, the Secretary of 
Health and Human Services 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 Secretary of 
Health and Human Services 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).
                                 <all>
```