HR6424-118

1. Short title This Act may be cited as the Supporting Innovative Global Health Technologies Act of 2023 or the SIGHT Act.

2. Findings Congress finds the following: The United States Agency for International Development has a unique role in the research and development of health technologies for global health that complements the work of other departments and agencies of the United States Government, having both an advantage and unique mandate for development of health technologies for use in low-resource settings. It is in the national interest of the United States to build greater country capacity for research and development of new health technologies in low and middle-income countries. Investments by the United States Government in global health research and development should be coordinated with and leverage investments from partner country governments, other government donors, and the private sector. Human immunodeficiency virus, tuberculosis, malaria, neglected tropical diseases, emerging infectious diseases (such as COVID–19, Ebola, and Zika), and many other health conditions (such as complications in pregnancy) have a disproportionate public health burden in low- and middle-income countries. Health technologies that were developed for use in high-income countries often cannot be implemented in low-resource settings in low- and middle-income countries or require adaptation to be effective. Due to poverty or to low incidence, many neglected tropical diseases and emerging infectious diseases either lack or have limited commercial markets to drive health technology innovation. Achieving the ambitious goals set through initiatives such as the President's Emergency Plan for AIDS Relief (commonly referred to as PEPFAR) and the President’s Malaria Initiative (commonly referred to as PMI) will not be possible without the development and scale-up of new health technologies designed for use in low-resource settings, which are needed to address both long-standing endemic diseases and prepare for potential pandemic threats. Public funding has proven highly successful at incentivizing the development of health technologies for global health that are high-impact, accessible, and cost-saving. COVID–19 has demonstrated the importance of global access to health technologies designed for low-resource settings. Support for the development of accessible health technologies for low-resource settings can have reciprocal value and produce tools that reduce health care costs, improve public health, and strengthen health security for the United States. For decades, the United States Agency for International Development has been a catalyst in the global health innovation ecosystem. While other Federal departments and agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, and the Department of Defense, provide support for global health technologies, the United States Agency for International Development is the only Federal agency that provides broad support for the late-stage development of new health technologies to combat neglected tropical diseases and emerging infectious diseases and other health conditions for low-resource settings specifically. While the need for new tools to tackle disease threats has grown, in recent years, investments by the United States Agency for International Development in research and development have shrunk as a proportion of its overall global health spending, squeezed by both stagnant budgets and growing needs. Innovation at the United States Agency for International Development is primarily supported from siloed disease- and population-specific appropriations accounts, resulting in the limitation of its ability to seek shared value across health sectors or health threats. The United States Agency for International Development is compelled to prioritize support for immediate program needs with imperfect tools at the expense of support for technologies that can improve clinical effectiveness, increase access to care, save costs, and build capacity and ownership by partner countries.

3. Statement of policy It is the policy of the United States that— research and development for new health technologies is essential for the success of the global health programs of the United States Government, by providing for the improved effectiveness, cost-effectiveness, and sustainability of such programs; and funding and other support for global health research and development under this Act shall be additional and complementary to, and may not replace, displace, or otherwise compromise, funding otherwise provided for existing and ongoing global health research and development of the United States Government or activities relating to the implementation of the global health programs of the United States Government.

4. Chief Innovation Officer for Health There is established within the Bureau for Global Health of the Agency the position of Chief Innovation Officer for Health. Such position is at the level of Deputy Assistant Administrator or equivalent. The Administrator shall appoint the Chief Innovation Officer for Health from among such individuals as the Administrator determines have relevant experience within private sector industry and an expert understanding of health finance and of the research, development, testing, evaluation, deployment, and implementation of new health technology. The Chief Innovation Officer for Health shall— serve as the principal advisor to the Assistant Administrator for Global Health on global health research and development necessary to meet the requirements of the United States Government and the governments of partner countries for improving global health; and report directly to the Assistant Administrator for Global Health. The Chief Innovation Officer for Health shall be responsible for the following: Ensuring cross-sector, Agency-wide cooperation, support, and programming for global health research and development, for the purpose of increasing the effectiveness of international development programs of the Agency and supporting the foreign policy and development goals of the United States Government. Drawing on the expertise of other departments and agencies of the United States Government and of nongovernmental organizations (including affected communities and institutions in low- or middle-income countries, businesses, health and science research organizations, and institutions of higher education) that pursue global health-related research and development, to identify the most pressing requirements for the development of health technologies to improve global health and programs of the Agency relating to global health. Leveraging research and investments by other elements of the Agency, other departments and agencies of the United States Government, and nongovernmental organizations (including businesses, health and science research organizations, institutions of higher education, and governments or other institutions of partner countries) to support the research and development of new health technologies by the Chief Innovation Officer of Health. Administering the processes for the award of grants, entry into partnerships, and joint establishment of other arrangements, to support global health research and development (including by administering the grant program under section 7). Serving as the Chairperson of the Global Health Research and Development Advisory Council established under section 5. The Assistant Administrator for Global Health shall take such steps as may be necessary to ensure that the Chief Innovation Officer for Health has sufficient authority within the Bureau for Global Health to carry out the duties under subsection (d).

5. Global Health Research and Development Advisory Council The Administrator shall establish an advisory council to be known as the Global Health Research and Development Advisory Council (in this section referred to as the Council). The Council shall be composed of the following: The Chief Innovation Officer for Health of the Agency under section 4, who shall serve as the Chairperson of the Council (in this section referred to as the Chairperson). Not more than 8 other members appointed by the Administrator from among individuals— recommended for such appointment by the Chairperson; and who are scientists or other experts with experience in global health research and development through or on behalf of— the Agency; any other department or agency of the United States Government; affected communities in low- or middle-income countries; and nongovernmental organizations, including nonprofit organizations, businesses, and institutes of higher education. Each member other than the Chairperson shall be appointed for a term of 6 years. Any member appointed to fill a vacancy occurring before the expiration of the term for which the predecessor of the member was appointed shall be appointed only for the remainder of that term. A vacancy in the Council shall be filled in the manner in which the original appointment was made. Except as provided in paragraph (2), members of the Council who are full-time officers or employees of the United States may not receive additional pay, allowances, or benefits by reason of their service on the Council. Each member of the Council shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5, United States Code. The Council shall meet at the call of the Chairperson. The Council shall be responsible for advising the Administrator regarding the priorities and objectives for the Agency with respect to global health research and development, including by providing such advice on an individual member basis or as a collective Council, as the Chairperson may direct. Chapter 10 of title 5, United States Code, shall not apply to the Council.

6. Global Health Research and Development program area activities and budget The Administrator shall carry out global health research and development activities with respect to new health technologies with the potential to advance the effectiveness and sustainability of the global health programs of the Agency, including the potential to advance— health technologies with characteristics identified or otherwise prioritized by affected communities and partner countries; health technologies with characteristics that facilitate introduction and access of the respective technology, to ensure use by those in need; and support for capacity-building within partner countries and the transition by such countries to greater country-level ownership, responsibility, and decision-making with respect to global health. The Administrator shall— not later than 90 days after the date of the enactment of this Act, establish a single, separate budget line for the activities under subsection (a), under which funds authorized to be appropriated or otherwise made available to the Administrator for the purpose of carrying out such activities shall be categorized; and include information regarding amounts expended and requested to be expended under such budget line in the budget justification materials submitted in support of the budget of the President for any fiscal year beginning on or after the date of such establishment.

7. Grant program for expanded use of global health research and development The Administrator, acting through the Chief Innovation Officer for Health under section 4, shall carry out a grant program under which the Administrator may award grants on a competitive basis to nongovernmental organizations that are determined eligible by the Administrator. Grant amounts awarded under this section may only be used for the following purposes: Developing new health technologies designed for use in low-resource settings to improve global health. Evaluating and improving the implementation, production, and scale-up of health technologies in low-resource settings in partner countries. Investing in the research capacity of institutions in low- and middle-income partner countries to lead and contribute to the development of health technologies. The Administrator may not award a grant to an entity under this section unless— the entity submits to the Administrator a proposal demonstrating sufficient technical standards, as determined by the Administrator, for any of the purposes listed in paragraphs (1) through (3) of subsection (b) for which the entity intends to use such grant amounts; the entity agrees, as a condition of such award, to report to the Administrator regarding the use of such grant amounts on a basis that is not less frequent than annually for the duration of the grant period; and the Administrator certifies to the appropriate congressional committees that such award is in compliance with section 3(2) of this Act. The authority to award grants under this section is in addition to, and not in lieu of, any other authority of the Administrator, including any such authority under part I or II of the Foreign Assistance Act of 1961 (22 U.S.C. 2151 et seq.).

8. Strategy and reports Not later than 180 days after the date of the enactment of this Act, and prior to the submission of the budget justification materials in support of the budget of the President for the first fiscal year following the date of the enactment of this Act, the Administrator shall submit to the appropriate congressional committees, and publish on a publicly available website of the Agency, a report that contains the following: A detailed description of the status of the Global Health Research and Development Advisory Council under section 5. Recommendations by such Global Health Research and Development Advisory Council. Solicitations for grant awards under section 7. Comprehensive accounting of awards and objectives to be included within the annual report to Congress on the health-related research and development strategy of the Agency required pursuant to the Department of State, Foreign Operations, and Related Programs Appropriations Act (or the report accompanying such appropriations bill reported by the Committees on Appropriations of the House or Representatives or Senate) for the respective fiscal year. A detailed description of how the planned investments by the Agency in the activities under section 6(a) align with the multiyear strategy of the Agency titled Global Health Research and Development Strategy 2023–2028 and developed pursuant to section 7019(e) of division K of the Consolidated Appropriations Act, 2022 (Public Law 117–103). A detailed description of how investments made by the Agency in such activities advance the other health-related programming goals of the Agency. Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the next 5 years as part of the annual report specified in subsection (a)(4), the Administrator shall submit to the appropriate congressional committees, and publish on a publicly available website of the Agency, a report that contains, with respect to the year covered by the report, the following: Information on any grants awarded, or other assistance provided, by the Administrator during such year pursuant to an authority under this Act or any other relevant provision of law for the support of global health research and development in support of programs of the Agency. The primary, secondary, and tertiary purposes of— any such grants awarded; and any investments in the activities under section 6(a) made or proposed by the Administrator during such year. A summary of how affected communities and researchers based in partner countries have been consulted with respect to any such investments. A description of the outcomes and status of the activities under section 6(a) carried out or otherwise supported by the Administrator during such year. An identification of any amounts obligated or expended during such year by the Administrator, from any appropriations account, to support global health research and development. Such information shall be presented both as a summary and in a table delineated by— health area; type of research or development activity; and appropriations account. A description of relevant objectives and expected outcomes for the subsequent year.

9. Definitions In this Act: The term Administrator means the Administrator for the United States Agency for International Development. The term Agency means the United States Agency for International Development. The term appropriate congressional committees means— the Committee on Foreign Affairs of the House of Representatives; and the Committee on Foreign Relations of the Senate. The term global health includes efforts to combat and prepare for— neglected tropical diseases; emerging infectious diseases; antimicrobial resistance; and any other condition that may not be easily treated, diagnosed, or prevented in low-resource settings. The term global health research and development includes an activity, or the support for such an activity, related to research, development, testing, evaluation, deployment, or implementation of any new health technology. The term health technology— means a vaccine, therapeutic, diagnostic, device, or other tool designed, modified, or adapted for use in low-resource settings to improve global health; and includes personal protective equipment and insecticide so used. The term low-resource setting means a location with limited or inconsistent access to running water, electricity, refrigeration, supply chains, lab services, medical equipment, trained health care personnel, or other resources important for global health.