H.R.4847 - End Neglected Tropical Diseases Act113th Congress (2013-2014)
|Sponsor:||Rep. Smith, Christopher H. [R-NJ-4] (Introduced 06/11/2014)|
|Committees:||House - Energy and Commerce; Foreign Affairs; Financial Services|
|Latest Action:||House - 06/13/2014 Referred to the Subcommittee on Health. (All Actions)|
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Text: H.R.4847 — 113th Congress (2013-2014)All Information (Except Text)
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Introduced in House (06/11/2014)
To facilitate effective research on and treatment of neglected tropical diseases through coordinated domestic and international efforts.
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
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,
This Act may be cited as the “End Neglected Tropical Diseases Act”.
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.
Sec. 101. Expansion of USAID NTDs Program.
Sec. 102. Actions by Department of State.
Sec. 103. Multilateral development and health institutions.
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.
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.
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.
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
(A) Buruli ulcer (Mycobacterium Ulcerans infection);
(B) Chagas disease;
(C) dengue or severe dengue fever;
(D) dracunculiasis (Guinea worm disease);
(F) foodborne trematodiases;
(G) human African trypanosomiasis (sleeping sickness);
(J) lymphatic filariasis (elephantiasis);
(K) onchocerciasis (river blindness);
(N) soil-transmitted helminthiases (STH) (round worm, whip worm, and hook worm);
(P) trachoma; and
(Q) yaws (endemic treponematoses).
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.
(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.
(1) Provide rapid impact package treatments to as many individuals suffering from NTDs or at risk of acquiring NTDs as logistically feasible.
(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.
(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.
(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.
(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:
“(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.”.
(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.
(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).
(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.
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.
(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.
(1) assess the epidemiology of, impact of, and appropriate funding required to address neglected tropical diseases in the United States; and
(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.
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:
“(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.
“(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.
“(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.
“(1) IN GENERAL.—Support of a center of excellence under this section may be for a period of not more than 5 years.
“(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.
“(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.”.
(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”).
(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).