I 
118TH CONGRESS 
1ST SESSION H. R. 4307 
To authorize the President to enter into trade agreements for the reciprocal 
elimination of duties or other import restrictions with respect to medical 
goods to contribute to the national security and public health of the 
United States, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 22, 2023 
Mrs. STEEL (for herself and Mr. SCHNEIDER) introduced the following bill; 
which was referred to the Committee on Ways and Means, and in addi-
tion to the Committee on Rules, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To authorize the President to enter into trade agreements 
for the reciprocal elimination of duties or other import 
restrictions with respect to medical goods to contribute 
to the national security and public health of the United 
States, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Supply Chain 
Resiliency Act’’. 
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SEC. 2. FINDINGS; SENSE OF CONGRESS. 
(a) FINDINGS.—Congress makes the following find-
ings: 
(1) The COVID–19 pandemic created signifi-
cant demand pressures on the global medical supply 
chain. 
(2) According to a December 2020 report by 
the United States International Trade Commission, 
global demand significantly exceeded available sup-
ply of many goods critical for the response to the 
COVID–19 pandemic (in this section referred to as 
‘‘COVID–19 critical goods’’). Health care providers 
in the United States faced difficulties in procuring 
such goods in sufficient quantities. Foreign export 
restrictions on finished drugs and active pharma-
ceutical ingredients may have contributed to stress 
on the supply of some critical COVID–19 treatment 
drugs (including anti-infective products), as well as 
hormone medications and vitamins. 
(3) According to the McKinsey Global Institute, 
during the 20 years preceding the date of the enact-
ment of this Act, pharmaceutical supply chains have 
become more globally dispersed and many generic 
small-molecule products have shifted to lower-cost 
production locations, some of which have been iden-
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tified as posing a threat to the national security of 
the United States. 
(4) According to the Organisation for Economic 
Co-operation and Development, while the United 
States is one of the largest exporters of COVID–19 
critical goods, it is also one of the largest importers 
of those goods. 
(5) The World Trade Organization has found 
that, while the United States, Germany, and the 
People’s Republic of China are all major producers 
and importers of COVID–19 critical goods, United 
States import partners are less diversified compared 
to Germany and the People’s Republic of China. In 
the United States, more than half of its imports of 
COVID–19 critical goods came from only 3 part-
ners—the People’s Republic of China (30.6 percent), 
Mexico (15.3 percent), and Malaysia (9.0 percent). 
(6) While some of the countries in which med-
ical supply manufacturing occurs are reliable sup-
pliers and allies to the United States, others have 
adopted or maintained policies that make United 
States supply less secure. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that, given the threat to national security and public 
health that could arise if the United States is unable to 
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swiftly respond to significant demand surges for medical 
products in a future pandemic, it is critical that the 
United States diversify its trade relationships and 
prioritize partners that adopt and maintain reliable supply 
chain policies. 
SEC. 3. PURPOSES. 
The purposes of this Act are— 
(1) to improve overall medical supply chain re-
silience for the United States by establishing a 
framework to enhance medical supply chains with 
trusted trade partners; 
(2) to enhance supply chain security related to 
technology transfer and intellectual property protec-
tion; 
(3) to diversify and expand supplier networks to 
ensure a reliable supply of medical goods, especially 
in the event of emergency situations; 
(4) to eliminate unnecessary trade barriers and 
distortions that weaken or disrupt medical supply 
chains; 
(5) to expedite cross-border movement of crit-
ical medical goods; 
(6) to foster international collaboration, encour-
age new investments, promote cooperation and part-
nership in public and private research and develop-
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ment efforts, facilitate data flows for life science re-
search and development, and expand manufacturing 
capacities for medical devices and pharmaceutical 
goods; 
(7) to promote regulatory cooperation with re-
spect to manufacturing of medical goods; 
(8) to increase access to government procure-
ment markets for medical goods; 
(9) to encourage adoption of and adherence to 
good regulatory practices related to medical goods; 
(10) to enable greater transparency, regulatory 
harmonization, and reliance in authorization and li-
censing procedures for medical devices and pharma-
ceutical goods; 
(11) to facilitate trade in medical goods to the 
most efficient and practicable extent possible; and 
(12) to identify current production capacities, 
address potential weaknesses, and improve overall 
resilience. 
SEC. 4. DEFINITIONS. 
In this Act: 
(1) 
APPROPRIATE
COMMITTEES
OF
CON-
GRESS.—The term ‘‘appropriate committees of Con-
gress’’ means— 
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(A) the Committee on Finance of the Sen-
ate; and 
(B) the Committee on Ways and Means of 
the House of Representatives. 
(2) COUNTRY.—The term ‘‘country’’ means— 
(A) any foreign country or territory, in-
cluding any overseas dependent territory or pos-
session of a foreign country; or 
(B) the Trust Territory of the Pacific Is-
lands. 
(3) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ means a device, as defined in section 201 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321), that is intended for use in humans. 
(4) MEDICAL GOOD.—The term ‘‘medical good’’ 
means any medical device, pharmaceutical good, or 
input for such a device or good. 
(5) MEDICAL SUPPLY CHAIN.—The term ‘‘med-
ical supply chain’’ means any activities involving de-
sign, procurement, manufacturing, production, dis-
tribution, operation, or management related to med-
ical goods. 
(6) PHARMACEUTICAL GOOD.—The term ‘‘phar-
maceutical good’’ means a drug, as defined in sec-
tion 201 of the Federal Food, Drug, and Cosmetic 
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Act (21 U.S.C. 321), that is intended for use in hu-
mans. 
(7) 
TRADE
REPRESENTATIVE.—The 
term 
‘‘Trade Representative’’ means the United States 
Trade Representative. 
(8) TRUSTED
TRADE
PARTNER.—The term 
‘‘trusted trade partner’’ means any country that has 
entered into an agreement with the United States 
under section 5. 
(9) TRUSTED TRADE PARTNER AGREEMENT.— 
The term ‘‘trusted trade partner agreement’’ means 
an agreement entered into under section 5. 
SEC. 5. AUTHORITY TO ENTER INTO TRUSTED TRADE PART-
NER AGREEMENTS. 
(a) IN GENERAL.—Whenever the President deter-
mines, based on the considerations set forth in subsection 
(b), that the reciprocal elimination of existing duties or 
other import restrictions of a country or countries and the 
United States with respect to medical goods would con-
tribute to the national security and public health of the 
United States, the President may, subject to the require-
ments under section 6— 
(1) negotiate, enter into, and enforce a trusted 
trade partner agreement with the country or coun-
tries; and 
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(2) proclaim such modification of any existing 
duty, such continuance of existing duty-free or excise 
treatment, or such additional duties, as the Presi-
dent determines to be required or appropriate to 
carry out any such trade agreement. 
(b) CONSIDERATIONS.—In determining whether to 
enter into negotiations for a trusted trade partner agree-
ment with a country pursuant to subsection (a), the Presi-
dent shall take into account whether the government of 
the country has— 
(1) expressed a desire to be enter into such an 
agreement; 
(2) demonstrated a commitment to contribute 
to global health security, including the national secu-
rity of the United States and the health of United 
States citizens, by maintaining open trade in medical 
goods during a public health emergency, including to 
enable research, development, and manufacturing of 
those goods; 
(3) adhered to and implemented the commit-
ments and obligations under existing free trade 
agreements to which that country and the United 
States are parties; 
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(4) implemented measures to reduce or elimi-
nate unnecessary trade barriers and distorting prac-
tices affecting medical goods; 
(5) maintained the rule of law by enacting and 
enforcing laws and regulations in a clear, publicized, 
transparent, and nondiscriminatory manner; 
(6) adopted and enforced laws that provide ade-
quate and effective protection of intellectual property 
rights reflecting a standard of protection similar to 
that found under United States law; and 
(7) agreed to recognize and promote good regu-
latory practices related to medical goods. 
(c) TRUSTED TRADE PARTNER AGREEMENTS.—A 
trusted trade partner agreement may, with respect to 
medical goods, provide for— 
(1) reduction or elimination of duties, quotas, 
and other trade barriers that undermine the national 
security and public health of the United States by 
disincentivizing research, development, and manufac-
turing in the United States or in countries that are 
reliable suppliers of medical goods to the United 
States; 
(2) diversification and expansion of supplier 
networks to secure a reliable supply of medical 
goods; 
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(3) harmonization or convergence of regulatory 
procedures, regulatory reliance, inspection coopera-
tion, and adoption of international standards (such 
as to streamline post-approval changes) to expedite 
cross-border movement of medical goods; 
(4) increased access to government procurement 
markets for medical goods and, in the case of a mul-
tilateral agreement entered into under the auspices 
of the World Trade Organization, membership in the 
Agreement on Government Procurement of the 
World Trade Organization referred to in section 
101(d)(17) of the Uruguay Round Agreements Act 
(19 U.S.C. 3511(d)(17)); 
(5) adequate and effective protection of intellec-
tual property rights for medical goods reflecting a 
standard of protection similar to that found under 
United States law; 
(6) regulatory cooperation on manufacturing 
standards for medical goods; 
(7) a collaboration framework to promote public 
and private research and development efforts related 
to medical goods, including facilitation of data flows 
for life science research and development; 
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(8) adherence to good regulatory practices for 
sound, affordable, and efficient regulation of medical 
goods; 
(9) promotion of regulatory compatibility and 
cooperation to facilitate trade and investment related 
to medical goods and accelerate manufacturing of 
such goods during a public health emergency; and 
(10) exemption of parties to the agreement 
from trade-restrictive measures imposed with respect 
to medical goods during a public health emergency. 
(d) REPORT REQUIRED.—Not later than 180 days 
after the date of the enactment of this Act, and every 180 
days thereafter, the President shall submit to Congress 
a report on the status of negotiations conducted under 
subsection (a) for trusted trade partner agreements. 
SEC. 6. CONGRESSIONAL OVERSIGHT, NOTICE, CONSULTA-
TIONS, ACCESS TO INFORMATION, AND RE-
VIEW. 
(a) NOTICE.—Not later than 60 days before initi-
ating negotiations with a trusted trade partner under sec-
tion 5(a) for a trusted trade partner agreement, the Presi-
dent shall submit to Congress written notice of the inten-
tion of the President to enter into the negotiations, which 
shall include the date negotiations will begin and the trust-
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ed trade partner with whom the President seeks to enter 
into the agreement. 
(b) CONSULTATION
WITH
MEMBERS
OF
CON-
GRESS.— 
(1) CONSULTATION DURING NEGOTIATIONS AND 
ACCESS TO INFORMATION.—In the course of negotia-
tions under section 5(a) for a trusted trade partner 
agreement, the Trade Representative shall— 
(A) meet upon request with the appro-
priate committees of Congress regarding negoti-
ating objectives, the status of negotiations in 
progress, and potential effects to the laws of 
the United States with respect to the agree-
ment; 
(B) upon request by the appropriate com-
mittees of Congress, provide access to pertinent 
documents relating to the negotiations; and 
(C) consult closely and on a timely basis 
with, and keep fully apprised of the negotia-
tions, the appropriate committees of Congress. 
(2) 
CONSULTATION
BEFORE
ENTRY
INTO 
AGREEMENT.—Before entering into a trusted trade 
partner agreement under section 5, the Trade Rep-
resentative shall consult with— 
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(A) the appropriate committees of Con-
gress; and 
(B) each other committee of the Senate 
and the House of Representatives, and each 
joint committee of Congress, that has jurisdic-
tion over legislation involving a subject matter 
that would be affected by the agreement. 
(c) CONSULTATION WITH FEDERAL AGENCIES.—In 
the course of negotiations under section 5(a) for a trusted 
trade partner agreement, the Trade Representative shall 
inform and consult with any Federal agency having exper-
tise in the matters being negotiated, including the Depart-
ment of Health and Human Services. 
(d) LIMITATION ON ACTION.—Any duty elimination 
or staged rate reduction provided for under section 5 may 
be proclaimed only if the President— 
(1) has obtained advice regarding the proposed 
action from the appropriate advisory committees es-
tablished under section 135 of the Trade Act of 
1974 (19 U.S.C. 2155) and the International Trade 
Commission; 
(2) has submitted to the appropriate commit-
tees of Congress a report that sets forth— 
(A) the action proposed to be proclaimed; 
(B) the reasons for such action; and 
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(C) the advice obtained under paragraph 
(1); and 
(3) has consulted with the appropriate commit-
tees of Congress regarding the proposed action dur-
ing the 60-day period on the date on which the 
President has met the requirements under para-
graphs (1) and (2). 
(e) REPORT TO CONGRESS.—Not later than 60 days 
before the date on which the President enters into a trust-
ed trade partner agreement with a trusted trade partner 
under section 5, the President shall submit to Congress 
a report describing— 
(1) the nature and scope of the agreement; 
(2) the proposed duration of the agreement; 
(3) how and to what extent the agreement will 
achieve the applicable purposes, policies, priorities, 
and objectives of this Act; 
(4) whether sufficient evidence exists dem-
onstrating that— 
(A) the trusted trade partner satisfies the 
conditions under section 5(b); and 
(B) the reciprocal elimination of existing 
duties or other import restrictions of the trust-
ed trade partner or the United States with re-
spect to medical goods would contribute to the 
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