II 115th CONGRESS 2d Session S. 3212 IN THE SENATE OF THE UNITED STATES July 12, 2018 Mr. Brown (for himself, Mr. Wicker , and Mr. Booker ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To facilitate effective research on and treatment of neglected tropical diseases through coordinated domestic and international efforts.

1. Short title This Act may be cited as the End Neglected Tropical Diseases Act . 2. Table of contents The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. Statement of policy. Sec. 4. Findings. Sec. 5. Definitions. Sec. 6. Rule of construction. Title I—Foreign Affairs Sec. 101. United States Agency for International Development 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. 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 of all people. 4. Findings Congress finds the following: (1) In 2012, the London Declaration on Neglected Tropical Diseases identified 10 neglected tropical diseases (NTDs). Approximately 2,000,000,000 people (almost 1/3 of the world’s population) are at risk of contracting an NTD, and more than 1,400,000,000 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 up to 57,000,000 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, in addition to significant morbidity and mortality, 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 1 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 2 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 2,800,000 African-Americans with toxocariasis and 300,000 or more people, who are 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) 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 1/2 of a year of schooling. (11) Improved access to water, sanitation, and hygiene can also reduce the transmission of NTDs, particularly intestinal worms. 5. Definitions In this Act: (1) Global Fund 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. (2) Neglected tropical diseases; NTDs The terms neglected tropical diseases and NTDs — (A) mean infections caused by pathogens, including viruses, bacteria, protozoa, and helminths, that disproportionately impact individuals living in extreme poverty, especially in developing countries; and (B) include— (i) Chagas disease; (ii) dracunculiasis (Guinea worm disease); (iii) human African trypanosomiasis (sleeping sickness); (iv) leishmaniasis; (v) leprosy (Hansen’s disease); (vi) lymphatic filariasis (elephantiasis); (vii) onchocerciasis (river blindness); (viii) schistosomiasis; (ix) soil-transmitted helminthiases (STH), such as round worm, whip worm, and hook worm; and (x) trachoma. 6. Rule of construction Nothing in this Act may be construed to increase the authorization of appropriations for— (1) the United States Agency for International Development; or (2) the Department of Health and Human Services. I Foreign Affairs 101. United States Agency for International Development Neglected Tropical Diseases Program (a) Findings Congress finds the following: (1) Since fiscal year 2006, the United States Agency for International Development (USAID) has been an essential leading partner in advancing control and elimination efforts for 5 targeted neglected tropical diseases: lymphatic filariasis (elephantiasis), onchocerciasis (river blindness), schistosomiasis, soil-transmitted helminthiases (round worm, whip worm, and hook worm), and trachoma. (2) USAID is an original endorser of the London Declaration on Neglected Tropical Diseases , signed in London on January 30, 2012, which represents a new, coordinated international push to accelerate progress toward eliminating or controlling 10 NTDs by 2020. (3) The USAID Neglected Tropical Diseases Program has made important and substantial contributions to the global fight to control and eliminate the 5 targeted NTDs. Leveraging more than $15,700,000,000 in donated medicines, USAID has supported the distribution of more than 2,000,000,000 treatments in 31 countries across Africa, Asia, Latin America, and the Caribbean. (4) Since 2014, the USAID Neglected Tropical Diseases Program has been investing in gathering research and development for the treatment of certain NTDs to ensure that promising new breakthrough medicines can be rapidly evaluated, registered, and made available to patients. (5) The USAID Neglected Tropical Diseases Program— (A) is a clear example of a successful public-private partnership between the Government and the private sector; and (B) already has contributed to the elimination of at least 1 NTD in 7 different countries. (b) Sense of Congress It is the sense of Congress that the USAID Neglected Tropical Diseases Program, as in effect on the date of the enactment of this Act— (1) should be continued and may be judiciously expanded, as practicable and appropriate; (2) should continue to provide treatment to as many individuals suffering from an NTD or at risk of acquiring an NTD, including individuals displaced by manmade and natural disasters, as logistically feasible; (3) should integrate NTD control, treatment tools, and approaches into complementary development and global health programs by coordinating, to the extent practicable and appropriate, across multiple sectors, including sectors relating to HIV/AIDS, malaria, tuberculosis, education, nutrition, other infectious diseases, maternal and child health, and water, sanitation, and hygiene; (4) should continue to conduct low-cost, high-impact community and school-based NTD programs to reach large at-risk populations, including school-age children, with integrated drug treatment packages, as feasible; (5) should engage in research and development of new tools and approaches, as opportunities emerge and resources allow, to reach the goals relating to the elimination of NTDs set forth in the 2012 World Health Organization publication entitled, Accelerating Work to Overcome the Global Impact of Neglected Tropical Diseases: A Roadmap for Implementation , including for Chagas disease, Guinea worm disease, human African trypanosomiasis (sleeping sickness), leprosy, and visceral leishmaniasis; and (6) should monitor research on and developments in the prevention and treatment of other NTDs so breakthroughs can be incorporated into the USAID Neglected Tropical Diseases Program, as practicable and appropriate. (c) Program priorities The Administrator of USAID should incorporate the following priorities into USAID’s Neglected Tropical Diseases Program (as in effect on the date of the enactment of this Act): (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 complementary USAID development and global health programs, including programs relating to water, sanitation, and hygiene, food and nutrition security, and primary and secondary education in order to advance the goals of the London Declaration on Neglected Tropical Diseases. (3) Including morbidity management in treatment plans for high-burden NTDs. (4) Incorporating NTDs included in the Global Burden of Disease Study 2010 into the program as opportunities emerge, to the extent practicable and appropriate. (5) Continuing investments in the research and development of new tools and approaches that— (A) complement existing research investments; and (B) ensure that new discoveries make it through the pipeline and become available to individuals who need them. 102. Actions by Department of State (a) Sense of Congress It is the sense of Congress that the Coordinator of United States Government Activities to Combat HIV/AIDS Globally should fully consider, as necessary and appropriate, evolving research on the impact of neglected tropical diseases on efforts to control HIV/AIDS when making future programming decisions. (b) Global programming The Secretary of State should encourage the Global Fund to consider, as necessary and appropriate, evolving research on the impact of NTDs on efforts to control HIV/AIDS, tuberculosis, and malaria when making programming decisions, particularly with regard to female genital schistosomiasis, which studies suggest may be a significant co-factor in the AIDS epidemic in Africa. (c) G–20 countries The Secretary of State, acting through the Office of Global Health Diplomacy, should encourage G–20 countries to significantly increase their role in the control and elimination of NTDs. 103. Multilateral development and health institutions (a) Finding Congress finds that the treatment of NTDs, 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 (round worm, whip worm, and hook worm). (b) Sense of Congress 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— (1) to 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) to highlight impacts of community and school-based deworming programs on children’s health and education, emphasizing the cost-effectiveness of such programs; (3) to encourage governments to implement deworming campaigns at the national level; (4) to consider designating a portion of grant funds of the institutions to deworming initiatives and cross-sectoral collaboration with water, sanitation, and hygiene efforts and nutrition or education programming, as practicable and appropriate; (5) to encourage accurate monitoring and evaluation of NTD programs, including deworming programs; and (6) to engage governments in cross-border initiatives for the treatment, control, prevention, and elimination of NTDs, and assist in developing transnational agreements, when and where necessary. II Department of Health and Human Services 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. 202. Report on neglected tropical diseases in the United States (a) In general Not later than 1 year after the date of the 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 a report to the Congress on neglected tropical diseases in the United States. (b) Contents The report required under 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 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. 203. Centers of excellence Part P of title III of the Public Health Service Act is amended by inserting after section 399V–6 ( 42 U.S.C. 280g–17 ) the following: 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 award 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 by building capacity for sustainable prevention efforts once epidemiology has been characterized and initial control achieved. (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 subsection (a) 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 patient care costs that 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 Except as provided in paragraph (2), 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 each if— (A) the operations of the center of excellence involved have been reviewed by an appropriate technical and scientific peer review group; and (B) group referred to in subparagraph (A) 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 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. . 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. (b) Strategies The panel established pursuant to subsection (a) 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 established pursuant to subsection (a), 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 a report to Congress and to the Secretary of Health and Human Services that includes— (1) the findings and recommended strategies of the panel; and (2) 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 the submission of the report required under subsection (d).