Pharmaceutical Supply Chain Security Act
This bill directs certain agencies to report on and reduce the role of China in pharmaceutical supply chains.
Specifically, the Food and Drug Administration must report on pharmaceutical products and ingredients for which China supplies more than 20% of the quantities available in the United States. In addition, the President must develop a strategy to address the role of China in the global pharmaceutical supply chain and related threats to national security. The United States International Development Finance Corporation must also support manufacturing projects that promote the security of pharmaceutical supply chains, reduce reliance on China, and foster cooperation with other countries.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2454 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 2454
To require reports on and investments in pharmaceutical supply chain
resiliency to reduce reliance on the People's Republic of China for
finished pharmaceutical products and active pharmaceutical ingredients.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 20, 2023
Mr. Lankford introduced the following bill; which was read twice and
referred to the Committee on Foreign Relations
_______________________________________________________________________
A BILL
To require reports on and investments in pharmaceutical supply chain
resiliency to reduce reliance on the People's Republic of China for
finished pharmaceutical products and active pharmaceutical ingredients.
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 ``Pharmaceutical Supply Chain Security
Act''.
SEC. 2. REPORTS ON AND INVESTMENTS IN PHARMACEUTICAL SUPPLY CHAIN
RESILIENCY TO REDUCE RELIANCE ON THE PEOPLE'S REPUBLIC OF
CHINA.
(a) Report on Pharmaceuticals Imported From the People's Republic
of China.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Commissioner of Food and Drugs,
in consultation with the United States Trade Representative,
shall submit to the appropriate congressional committees a
report that sets forth a list of--
(A) each finished pharmaceutical product that is
imported into the United States from the People's
Republic of China in a quantity that exceeds 20 percent
of the quantity of the product available for use in the
United States; and
(B) each active pharmaceutical ingredient that is
imported into the United States from the People's
Republic of China in a quantity that exceeds 20 percent
of the quantity of the ingredient available for use in
the United States.
(2) Confidential.--The report required by paragraph (1)
shall be confidential and may not be disclosed to the public.
(b) Strategy for Pharmaceutical Supply Chain Resiliency.--
(1) In general.--The President shall develop a
comprehensive strategy to address the national security threat
posed by the control by the People's Republic of China of the
global supply of finished pharmaceutical products and active
pharmaceutical ingredients.
(2) Elements.--The strategy required by paragraph (1) shall
include efforts to develop a more reliable and secure supply
chain for finished pharmaceutical products and active
pharmaceutical ingredients, including manufacturing and
production projects that--
(A) contribute to the development of a more
reliable and secure supply chain for such products and
ingredients;
(B) reduce reliance on the People's Republic of
China for such products and ingredients; and
(C) facilitate cooperation with the governments of
other countries in a concerted effort to make
significant strategic investments in research,
development, and manufacturing of such products and
ingredients.
(3) Report required.--
(A) In general.--Not later than 180 days after the
date of the enactment of this Act, the President shall
submit to the appropriate congressional committees a
report on the strategy required by paragraph (1).
(B) Elements.--The report required in paragraph (1)
shall include--
(i) a description of the extent of the
engagement of the United States International
Development Finance Corporation with the
governments of other countries to promote
shared investment in and development of
finished pharmaceutical products and active
pharmaceutical ingredients; and
(ii) a description of the work of the
United States Trade Representative to engage
with the governments of those countries to
decrease trade barriers for the development,
production, refinement, and transportation of
such products and ingredients.
(c) Investments in Pharmaceutical Supply Chain Resiliency.--
(1) In general.--In support of the strategy required by
subsection (b), the United States International Development
Finance Corporation shall prioritize providing support under
title II of the Better Utilization of Investments Leading to
Development Act of 2018 (22 U.S.C. 9621 et seq.) for
manufacturing and production of finished pharmaceutical
products and active pharmaceutical ingredients, including
projects that--
(A) contribute to the development of a more
reliable and secure supply chain for such products and
ingredients;
(B) reduce reliance on the People's Republic of
China for such products and ingredients; and
(C) facilitate cooperation with the governments of
other countries in a concerted effort to make
significant strategic investments in research,
development, and manufacturing of such products and
ingredients.
(2) Certification requirement.--The United States
International Development Finance Corporation may not provide
support under paragraph (1) for a project relating to the
manufacturing or production of a finished pharmaceutical
product unless the entity receiving the support certifies
that--
(A) not more than 25 percent of the active
pharmaceutical ingredients used in the product are
sourced from a single country of origin that is a
nonmarket economy country, as defined by the Secretary
of Commerce; and
(B) the entity is not controlled, in whole or in
part, by an entity organized under the laws of, or
otherwise subject to the jurisdiction of, a nonmarket
economy country.
(d) Appropriate Congressional Committees Defined.--In this section,
the term ``appropriate congressional committees'' means--
(1) the Committee on Health, Education, Labor, and
Pensions, the Committee on Commerce, Science, and
Transportation, the Committee on Foreign Relations, and the
Committee on Finance of the Senate; and
(2) the Committee on Energy and Commerce, the Committee on
Foreign Affairs, and the Committee on Ways and Means of the
House of Representatives.
<all>
Introduced in Senate
Read twice and referred to the Committee on Foreign Relations.
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