[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5278 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
2d Session
S. 5278
To provide additional authorities for the leadership of the United
States Agency for International Development in health technology
innovation for global health in low-resource settings, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 25, 2024
Mr. Booker introduced the following bill; which was read twice and
referred to the Committee on Foreign Relations
_______________________________________________________________________
A BILL
To provide additional authorities for the leadership of the United
States Agency for International Development in health technology
innovation for global health in low-resource settings, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLES; TABLE OF CONTENTS.
(a) Short Titles.--This Act may be cited as the ``Supporting
Innovative Global Health Technologies Act of 2024'' or the ``SIGHT
Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short titles; table of contents.
Sec. 2. Findings.
Sec. 3. Statement of policy.
Sec. 4. Definitions.
Sec. 5. Chief Innovation Officer for Health.
Sec. 6. Global Health Research and Development Advisory Council.
Sec. 7. Global Health Research and Development program area activities
and budget.
Sec. 8. Grant program for expanded use of global health research and
development.
Sec. 9. Strategy and reports.
SEC. 2. FINDINGS.
Congress finds the following:
(1) The United States Agency for International Development
has--
(A) 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; and
(B) both an advantage and a unique mandate for the
development of health technologies to be used in low-
resource settings.
(2) It is in the national interest of the United States to
build greater country capacity for research and development of
new health technologies to be used in low- and middle-income
countries.
(3) 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.
(4) Human immunodeficiency virus (HIV), tuberculosis (TB),
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.
(5) 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.
(6) Due to poverty or low incidence, many neglected
tropical diseases and emerging infectious diseases either lack
or have limited commercial markets to drive health technology
innovation.
(7) 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.
(8) Public funding has proven highly successful at
incentivizing the development of health technologies for global
health that are high-impact, accessible, and cost-saving.
(9) COVID-19 has demonstrated the importance of global
access to health technologies designed for low-resource
settings.
(10) 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.
(11) For decades, USAID 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,
USAID is the only Federal agency that provides broad support
for the late-stage development of new health technologies to
combat neglected tropical diseases, emerging infectious
diseases, and other health conditions for low-resource
settings.
(12) While the need for new tools to tackle disease threats
has grown in recent years, investments by USAID in research and
development have shrunk as a proportion of its overall global
health spending and have been squeezed by stagnant budgets and
growing needs.
(13) Innovation at USAID 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.
(14) USAID 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.
SEC. 3. STATEMENT OF POLICY.
It is the policy of the United States that--
(1) research and development for new health technologies--
(A) is essential for the success of the global
health programs of the United States Government; and
(B) provides for the improved effectiveness, cost-
effectiveness, and sustainability of such programs; and
(2) 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--
(A) existing and ongoing global health research and
development of the United States Government; or
(B) activities relating to the implementation of
the global health programs of the United States
Government.
SEC. 4. DEFINITIONS.
In this Act:
(1) Administrator.--The term ``Administrator'' means the
Administrator of the United States Agency for International
Development.
(2) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Foreign Relations of the
Senate; and
(B) the Committee on Foreign Affairs of the House
of Representatives.
(3) Global health.--The term ``global health'' includes
efforts to combat and prepare for--
(A) neglected tropical diseases;
(B) emerging infectious diseases;
(C) antimicrobial resistance; and
(D) any other condition that may not be easily
treated, diagnosed, or prevented in low-resource
settings.
(4) Global health research and development.--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.
(5) Health technology.--The term ``health technology''--
(A) means a vaccine, therapeutic, diagnostic,
device, or other tool designed, modified, or adapted
for use in low-resource settings to improve global
health; and
(B) includes personal protective equipment and
insecticide so used.
(6) Low-resource setting.--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.
(7) USAID.--The term ``USAID'' means the United States
Agency for International Development.
SEC. 5. CHIEF INNOVATION OFFICER FOR HEALTH.
(a) Establishment.--There is established, within the USAID Bureau
for Global Health, the position of Chief Innovation Officer for Health,
which shall be classified at the level of Deputy Assistant
Administrator or equivalent.
(b) Appointment.--The Administrator shall appoint the Chief
Innovation Officer for Health from among such individuals as the
Administrator determines have--
(1) relevant experience within private sector industry; and
(2) an expert understanding of health finance and the
research, development, testing, evaluation, deployment, and
implementation of new health technology.
(c) Relationship to Assistant Administrator for Global Health.--The
Chief Innovation Officer for Health shall--
(1) serve as the principal advisor to the USAID Assistant
Administrator for Global Health regarding 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
(2) report directly to the USAID Assistant Administrator
for Global Health.
(d) Duties.--The Chief Innovation Officer for Health shall--
(1) ensure cross-sector, USAID-wide cooperation, support,
and programming for global health research and development--
(A) to increase the effectiveness of USAID
international development programs; and
(B) to support the foreign policy and development
goals of the United States Government;
(2) draw on the expertise of other Federal departments and
agencies 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 that will improve global health and USAID
programs relating to global health;
(3) leverage research and investments by other USAID
components, other Federal departments and agencies, 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 for Health;
(4) administer the processes for awarding grants, entering
into partnerships, and jointly establishing other arrangements
to support global health research and development (including by
administering the grant program required under section 8); and
(5) serve as the Chairperson of the Global Health Research
and Development Advisory Council established pursuant to
section 6.
(e) Authorities.--The USAID 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 described in
subsection (d).
SEC. 6. GLOBAL HEALTH RESEARCH AND DEVELOPMENT ADVISORY COUNCIL.
(a) Establishment.--The Administrator shall establish an advisory
council, which shall be known as the ``Global Health Research and
Development Advisory Council'' (referred to in this section as the
``Council'').
(b) Membership.--The Council shall be composed of--
(1) the USAID Chief Innovation Officer for Health, who
shall serve as the Chair of the Council (referred to in this
section as the ``Chair'');
(2) not more than 8 additional members, who shall be
appointed by the Administrator from among individuals who--
(A) have been recommended for such appointment by
the Chair; and
(B) are scientists or other experts with experience
in global health research and development through or on
behalf of--
(i) USAID;
(ii) any other Federal department or
agency;
(iii) affected communities in low- or
middle-income countries; or
(iv) nongovernmental organizations,
including nonprofit organizations, businesses,
and institutes of higher education.
(c) Terms.--
(1) In general.--Each member of the Council other than the
Chair shall be appointed for a 6-year term.
(2) Vacancies.--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 such term. A vacancy in the Council shall
be filled in the manner in which the original appointment was
made.
(d) Compensation.--
(1) Prohibition of compensation of federal employees.--
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.
(2) Travel expenses.--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.
(e) Meetings.--The Council shall meet at the call of the Chair.
(f) Duties.--The Council shall be responsible for advising the
Administrator regarding USAID priorities and objectives 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
Chair may direct.
(g) Nonapplicability of Federal Advisory Committee Act.--Chapter 10
of title 5, United States Code (commonly referred to as the ``Federal
Advisory Committee Act''), shall not apply to the Council.
SEC. 7. GLOBAL HEALTH RESEARCH AND DEVELOPMENT PROGRAM AREA ACTIVITIES
AND BUDGET.
(a) In General.--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 USAID global health programs, including the potential
to advance--
(1) health technologies with characteristics identified or
otherwise prioritized by affected communities and partner
countries;
(2) health technologies with characteristics that
facilitate introduction and access of the respective technology
to ensure use by those in need; and
(3) 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.
(b) Budget.--Not later than 90 days after the date of the enactment
of this Act, the Administrator shall--
(1) establish a single, separate budget line for the
activities described in subsection (a), under which funds made
available to the Administrator to carry out such activities
shall be categorized; and
(2) 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 each fiscal year beginning on or after the
date on which such budget line is established.
SEC. 8. GRANT PROGRAM FOR EXPANDED USE OF GLOBAL HEALTH RESEARCH AND
DEVELOPMENT.
(a) Grant Program.--The Administrator, acting through the Chief
Innovation Officer for Health appointed pursuant to section 5, shall
carry out a grant program under which the Administrator may award
competitive grants to nongovernmental organizations that the
Administrator determines to be eligible.
(b) Use of Amounts.--Grant amounts awarded pursuant to this section
may only be used--
(1) to develop new health technologies designed for use in
low-resource settings to improve global health;
(2) to evaluate and improve the implementation, production,
and scale-up of health technologies in low-resource settings in
partner countries; and
(3) to invest in the research capacity of institutions in
low- and middle-income partner countries to lead and contribute
to the development of health technologies.
(c) Conditions on Grant Award.--The Administrator may not award a
grant to an entity under this section unless--
(1) such 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;
(2) the entity agrees, as a condition of receiving such
grant, to report not less frequently than annually to the
Administrator regarding the use of such grant amounts during
the grant period; and
(3) the Administrator certifies to the appropriate
congressional committees that such award is in compliance with
section 3(2).
(d) Additional Nature of Authority.--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 a