II
119THCONGRESS
1
STSESSION S. 998
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 SENATE OF THE UNITED STATES
MARCH12, 2025
Mr. T
ILLIS(for himself, Mr. COONS, Mr. CORNYN, and Mr. BENNET) intro-
duced the following bill; which was read twice and referred to the Com-
mittee on Finance
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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Medical Supply Chain 4
Resiliency Act’’. 5
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SEC. 2. FINDINGS; SENSE OF CONGRESS. 1
(a) F
INDINGS.—Congress makes the following find-2
ings: 3
(1) The COVID–19 pandemic created signifi-4
cant demand pressures on the global medical supply 5
chain. 6
(2) According to a December 2020 report by 7
the United States International Trade Commission, 8
global demand significantly exceeded available sup-9
ply of many goods critical for the response to the 10
COVID–19 pandemic (in this section referred to as 11
‘‘COVID–19 critical goods’’). Health care providers 12
in the United States faced difficulties in procuring 13
such goods in sufficient quantities. Foreign export 14
restrictions on finished drugs and active pharma-15
ceutical ingredients may have contributed to stress 16
on the supply of some critical COVID–19 treatment 17
drugs (including anti-infective products), as well as 18
hormone medications and vitamins. 19
(3) According to the McKinsey Global Institute, 20
during the 20 years preceding the date of the enact-21
ment of this Act, pharmaceutical supply chains have 22
become more globally dispersed and many generic 23
small-molecule products have shifted to lower-cost 24
production locations, some of which have been iden-25
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tified as posing a threat to the national security of 1
the United States. 2
(4) According to the Organisation for Economic 3
Co-operation and Development, while the United 4
States is one of the largest exporters of COVID–19 5
critical goods, it is also one of the largest importers 6
of those goods. 7
(5) The World Trade Organization has found 8
that, while the United States, Germany, and the 9
People’s Republic of China are all major producers 10
and importers of COVID–19 critical goods, United 11
States import partners are less diversified compared 12
to Germany and the People’s Republic of China. In 13
the United States, more than half of its imports of 14
COVID–19 critical goods came from only 3 part-15
ners—the People’s Republic of China (30.6 percent), 16
Mexico (15.3 percent), and Malaysia (9.0 percent). 17
(6) While some of the countries in which med-18
ical supply manufacturing occurs are reliable sup-19
pliers and allies to the United States, others have 20
adopted or maintained policies that make United 21
States supply less secure. 22
(b) S
ENSE OFCONGRESS.—It is the sense of Con-23
gress that, given the threat to national security and public 24
health that could arise if the United States is unable to 25
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swiftly respond to significant demand surges for medical 1
products in a future pandemic, it is critical that the 2
United States diversify its trade relationships and 3
prioritize partners that adopt and maintain reliable supply 4
chain policies. 5
SEC. 3. PURPOSES. 6
The purposes of this Act are— 7
(1) to improve overall medical supply chain re-8
silience for the United States by establishing a 9
framework to enhance medical supply chains with 10
trusted trade partners; 11
(2) to enhance supply chain security related to 12
technology transfer and intellectual property protec-13
tion; 14
(3) to diversify and expand supplier networks to 15
ensure a reliable supply of medical goods, especially 16
in the event of emergency situations; 17
(4) to eliminate unnecessary trade barriers and 18
distortions that weaken or disrupt medical supply 19
chains; 20
(5) to expedite cross-border movement of crit-21
ical medical goods; 22
(6) to foster international collaboration, encour-23
age new investments, promote cooperation and part-24
nership in public and private research and develop-25
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ment efforts, facilitate data flows for life science re-1
search and development, and expand manufacturing 2
capacities for medical devices and pharmaceutical 3
goods; 4
(7) to promote regulatory cooperation with re-5
spect to manufacturing of medical goods; 6
(8) to increase access to government procure-7
ment markets for medical goods; 8
(9) to encourage adoption of and adherence to 9
good regulatory practices related to medical goods; 10
(10) to enable greater transparency, regulatory 11
harmonization, and reliance in authorization and li-12
censing procedures for medical devices and pharma-13
ceutical goods; 14
(11) to facilitate trade in medical goods to the 15
most efficient and practicable extent possible; and 16
(12) to identify current production capacities, 17
address potential weaknesses, and improve overall 18
resilience. 19
SEC. 4. DEFINITIONS. 20
In this Act: 21
(1) A
PPROPRIATE COMMITTEES OF CON -22
GRESS.—The term ‘‘appropriate committees of Con-23
gress’’ means— 24
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(A) the Committee on Finance of the Sen-1
ate; and 2
(B) the Committee on Ways and Means of 3
the House of Representatives. 4
(2) C
OUNTRY.—The term ‘‘country’’ means— 5
(A) any foreign country or territory, in-6
cluding any overseas dependent territory or pos-7
session of a foreign country; or 8
(B) the Trust Territory of the Pacific Is-9
lands. 10
(3) M
EDICAL DEVICE.—The term ‘‘medical de-11
vice’’ means a device, as defined in section 201 of 12
the Federal Food, Drug, and Cosmetic Act (21 13
U.S.C. 321), that is intended for use in humans. 14
(4) M
EDICAL GOOD.—The term ‘‘medical good’’ 15
means any medical device, pharmaceutical good, or 16
input for such a device or good. 17
(5) M
EDICAL SUPPLY CHAIN.—The term ‘‘med-18
ical supply chain’’ means any activities involving de-19
sign, procurement, manufacturing, production, dis-20
tribution, operation, or management related to med-21
ical goods. 22
(6) P
HARMACEUTICAL GOOD .—The term ‘‘phar-23
maceutical good’’ means a drug, as defined in sec-24
tion 201 of the Federal Food, Drug, and Cosmetic 25
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Act (21 U.S.C. 321), that is intended for use in hu-1
mans. 2
(7) T
RADE REPRESENTATIVE .—The term 3
‘‘Trade Representative’’ means the United States 4
Trade Representative. 5
(8) T
RUSTED TRADE PARTNER .—The term 6
‘‘trusted trade partner’’ means any country that has 7
entered into an agreement with the United States 8
under section 5. 9
(9) T
RUSTED TRADE PARTNER AGREEMENT .— 10
The term ‘‘trusted trade partner agreement’’ means 11
an agreement entered into under section 5. 12
SEC. 5. AUTHORITY TO ENTER INTO TRUSTED TRADE PART-13
NER AGREEMENTS. 14
(a) I
NGENERAL.—Whenever the President deter-15
mines, based on the considerations set forth in subsection 16
(b), that the reciprocal elimination of existing duties or 17
other import restrictions of a country or countries and the 18
United States with respect to medical goods would con-19
tribute to the national security and public health of the 20
United States, the President may, subject to the require-21
ments under section 6— 22
(1) negotiate, enter into, and enforce a trusted 23
trade partner agreement with the country or coun-24
tries; and 25
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(2) proclaim such modification of any existing 1
duty, such continuance of existing duty-free or excise 2
treatment, or such additional duties, as the Presi-3
dent determines to be required or appropriate to 4
carry out any such trade agreement. 5
(b) C
ONSIDERATIONS.—In determining whether to 6
enter into negotiations for a trusted trade partner agree-7
ment with a country pursuant to subsection (a), the Presi-8
dent shall take into account whether the government of 9
the country has— 10
(1) expressed a desire to enter into such an 11
agreement; 12
(2) demonstrated a commitment to contribute 13
to global health security, including the national secu-14
rity of the United States and the health of United 15
States citizens, by maintaining open trade in medical 16
goods during a public health emergency, including to 17
enable research, development, and manufacturing of 18
those goods; 19
(3) adhered to and implemented the commit-20
ments and obligations under existing free trade 21
agreements to which that country and the United 22
States are parties; 23
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(4) implemented measures to reduce or elimi-1
nate unnecessary trade barriers and distorting prac-2
tices affecting medical goods; 3
(5) maintained the rule of law by enacting and 4
enforcing laws and regulations in a clear, publicized, 5
transparent, and nondiscriminatory manner; 6
(6) adopted and enforced laws that provide ade-7
quate and effective protection of intellectual property 8
rights reflecting a standard of protection similar to 9
that found under United States law; and 10
(7) agreed to recognize and promote good regu-11
latory practices related to medical goods. 12
(c) T
RUSTEDTRADEPARTNERAGREEMENTS.—A 13
trusted trade partner agreement may, with respect to 14
medical goods, provide for— 15
(1) reduction or elimination of duties, quotas, 16
and other trade barriers that undermine the national 17
security and public health of the United States by 18
disincentivizing research, development, and manufac-19
turing in the United States or in countries that are 20
reliable suppliers of medical goods to the United 21
States; 22
(2) diversification and expansion of supplier 23
networks to secure a reliable supply of medical 24
goods; 25
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(3) harmonization or convergence of regulatory 1
procedures, regulatory reliance, inspection coopera-2
tion, and adoption of international standards (such 3
as to streamline post-approval changes) to expedite 4
cross-border movement of medical goods; 5
(4) increased access to government procurement 6
markets for medical goods and, in the case of a mul-7
tilateral agreement entered into under the auspices 8
of the World Trade Organization, membership in the 9
Agreement on Government Procurement of the 10
World Trade Organization referred to in section 11
101(d)(17) of the Uruguay Round Agreements Act 12
(19 U.S.C. 3511(d)(17)); 13
(5) adequate and effective protection of intellec-14
tual property rights for medical goods reflecting a 15
standard of protection similar to that found under 16
United States law; 17
(6) regulatory cooperation on manufacturing 18
standards for medical goods; 19
(7) a collaboration framework to promote public 20
and private research and development efforts related 21
to medical goods, including facilitation of data flows 22
for life science research and development; 23
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(8) adherence to good regulatory practices for 1
sound, affordable, and efficient regulation of medical 2
goods; 3
(9) promotion of regulatory compatibility and 4
cooperation to facilitate trade and investment related 5
to medical goods and accelerate manufacturing of 6
such goods during a public health emergency; and 7
(10) exemption of parties to the agreement 8
from trade-restrictive measures imposed with respect 9
to medical goods during a public health emergency. 10
(d) R
EPORTREQUIRED.—Not later than 180 days 11
after the date of the enactment of this Act, and every 180 12
days thereafter, the President shall submit to Congress 13
a report on the status of negotiations conducted under 14
subsection (a) for trusted trade partner agreements. 15
SEC. 6. CONGRESSIONAL OVERSIGHT, NOTICE, CONSULTA-16
TIONS, ACCESS TO INFORMATION, AND RE-17
VIEW. 18
(a) N
OTICE.—Not later than 60 days before initi-19
ating negotiations with a trusted trade partner under sec-20
tion 5(a) for a trusted trade partner agreement, the Presi-21
dent shall submit to Congress written notice of the inten-22
tion of the President to enter into the negotiations, which 23
shall include the date negotiations will begin and the trust-24
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ed trade partner with whom the President seeks to enter 1
into the agreement. 2
(b) C
ONSULTATION WITHMEMBERS OF CON-3
GRESS.— 4
(1) C
ONSULTATION DURING NEGOTIATIONS AND 5
ACCESS TO INFORMATION .—In the course of negotia-6
tions under section 5(a) for a trusted trade partner 7
agreement, the Trade Representative shall— 8
(A) meet upon request with the appro-9
priate committees of Congress regarding negoti-10
ating objectives, the status of negotiations in 11
progress, and potential effects to the laws of 12
the United States with respect to the agree-13
ment; 14
(B) upon request by the appropriate com-15
mittees of Congress, provide access to pertinent 16
documents relating to the negotiations; and 17
(C) consult closely and on a timely basis 18
with, and keep fully apprised of the negotia-19
tions, the appropriate committees of Congress. 20
(2) C
ONSULTATION BEFORE ENTRY INTO 21
AGREEMENT.—Before entering into a trusted trade 22
partner agreement under section 5, the Trade Rep-23
resentative shall consult with— 24
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(A) the appropriate committees of Con-1
gress; and 2
(B) each other committee of the Senate 3
and the House of Representatives, and each 4
joint committee of Congress, that has jurisdic-5
tion over legislation involving a subject matter 6
that would be affected by the agreement. 7
(c) C
ONSULTATIONWITHFEDERALAGENCIES.—In 8
the course of negotiations under section 5(a) for a trusted 9
trade partner agreement, the Trade Representative shall 10
inform and consult with any Federal agency having exper-11
tise in the matters being negotiated, including the Depart-12
ment of Health and Human Services. 13
(d) L
IMITATION ONACTION.—Any duty elimination 14
or staged rate reduction provided for under section 5 may 15
be proclaimed only if the President— 16
(1) has obtained advice regarding the proposed 17
action from the appropriate advisory committees es-18
tablished under section 135 of the Trade Act of 19
1974 (19 U.S.C. 2155) and the International Trade 20
Commission; 21
(2) has submitted to the appropriate commit-22
tees of Congress a report that sets forth— 23
(A) the action proposed to be proclaimed; 24
(B) the reasons for such action; and 25
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(C) the advice obtained under paragraph 1
(1); and 2
(3) has consulted with the appropriate commit-3
tees of Congress regarding the proposed action dur-4
ing the 60-day period on the date on which the 5
President has met the requirements under para-6
graphs (1) and (2). 7
(e) R
EPORT TOCONGRESS.—Not later than 60 days 8
before the date on which the President enters into a trust-9
ed trade partner agreement with a trusted trade partner 10
under section 5, the President shall submit to Congress 11
a report describing— 12
(1) the nature and scope of the agreement; 13
(2) the proposed duration of the agreement; 14
(3) how and to what extent the agreement will 15
achieve the applicable purposes, policies, priorities, 16
and objectives of this Act; 17
(4) whether sufficient evidence exists dem-18
onstrating that— 19
(A) the trusted trade partner satisfies the 20
conditions under section 5(b); and 21
(B) the reciprocal elimination of existing 22
duties or other import restrictions of the trust-23
ed trade partner or the United States with re-24
spect to medical goods would contribute to the 25
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national security and public health of the 1
United States; and 2
(5) the proposed implementation of the agree-3
ment, including the general effect of the agreement 4
on existing laws. 5
(f) C
ONGRESSIONAL RIGHTTOREVIEW ANDDIS-6
APPROVE.— 7
(1) I
N GENERAL.—A trusted trade partner 8
agreement shall not take effect until— 9
(A) the proposed agreement has been sub-10
mitted to Congress, together with the report re-11
quired under subsection (e) with respect to that 12
agreement; and 13
(B) the review period required under para-14
graph (2) following the date on which the pro-15
posed agreement has been submitted to Con-16
gress under subparagraph (A) has been ex-17
hausted, during which period a joint resolution 18
is not enacted under paragraph (4). 19
(2) R
EVIEW.— 20
(A) I
NITIAL REVIEW.—Unless extended 21
under subparagraph (B) or (C), the review pe-22
riod under this paragraph with respect to a 23
trusted trade partner agreement is 30 days, 24
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during which time Congress shall review the 1
proposed agreement with respect to whether— 2
(i) the President failed or refused to 3
provide notice with respect to the agree-4
ment in accordance with subsection (a); 5
(ii) the President failed or refused to 6
consult with respect to the agreement in 7
accordance with subsections (b) and (c); 8
(iii) the President failed or refused to 9
submit to Congress a report with respect 10
to the agreement in accordance with sub-11
section (e); or 12
(iv) the President failed or refused to 13
demonstrate that the agreement would 14
achieve the applicable purposes, policies, 15
priorities, and objectives of this Act and 16
contribute to the national security and 17
public health of the United States. 18
(B) F
URTHER REVIEW.—If, during the 30- 19
day period under subparagraph (A) with re-20
spect to a trusted trade partner agreement, one 21
House of Congress adopts a resolution stating 22
that the House of Congress wishes to further 23
review the proposed agreement, the review pe-24
riod under this paragraph with respect to the 25
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proposed agreement shall be extended by a pe-1
riod of 60 days, during which time the appro-2
priate committees of Congress shall engage the 3
President with respect to the proposed agree-4
ment and the failures or refusals of the Presi-5
dent specified under subparagraph (A). 6
(C) A
DDITIONAL PERIOD.—If, during the 7
60-day period under subparagraph (B) with re-8
spect to a trusted trade partner agreement, one 9
House of Congress adopts a resolution stating 10
that the House of Congress wishes to further 11
review the proposed agreement, the review pe-12
riod under this paragraph with respect to the 13
proposed agreement shall be further extended 14
by a period of 30 days. 15
(3) P
ROCEDURES FOR CONSIDERING RESOLU -16
TIONS.—A resolution under subparagraph (B) or 17
(C) of paragraph (2)— 18
(A) in the Senate— 19
(i) may be introduced by any Member 20
of the Senate; 21
(ii) shall be referred to the Committee 22
on Finance; and 23
(iii) may not be amended; 24
(B) in the House of Representatives— 25
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(i) may be introduced by any Member 1
of the House; 2
(ii) shall be referred to the Committee 3
on Ways and Means or the Committee on 4
Rules; and 5
(iii) may not be amended by either 6
Committee; and 7
(C) the vote on passage of the resolution 8
shall occur immediately following the conclusion 9
of the debate on the trusted trade partner 10
agreement at issue and a single quorum call at 11
the conclusion of the debate. 12
(4) D
ISAPPROVAL.—If, during the review period 13
required under paragraph (2) with respect to a 14
trusted trade partner agreement, a joint resolution 15
is enacted stating that Congress does not favor the 16
agreement, the agreement shall not take effect. 17
SEC. 7. MONITORING AND ENFORCEMENT OF CONTINUED 18
COMPLIANCE WITH TRUSTED TRADE PART-19
NER AGREEMENTS. 20
(a) M
ONITORING.—The Trade Representative shall 21
periodically monitor compliance by a trusted trade partner 22
with the commitments and obligations of the partner 23
under a trusted trade partner agreement. 24
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(b) ACTIONS INRESPONSE TOFAILURETOCOM-1
PLY.— 2
(1) D
ETERMINATION AND REPORT OF TRADE 3
REPRESENTATIVE.—If the Trade Representative de-4
termines that a trusted trade partner has failed to 5
satisfactorily implement, maintain, and enforce the 6
commitments and obligations of the partner under a 7
trusted trade partner agreement, the Trade Rep-8
resentative shall submit to the President a report 9
setting forth— 10
(A) the determination and the findings 11
that support the determination; and 12
(B) based on such findings, the rec-13
ommendations of the Trade Representative for 14
action or inaction under this subsection. 15
(2) D
ETERMINATION OF PRESIDENT .—Not 16
later than 30 days after receiving a report under 17
paragraph (1) with respect to a trusted trade part-18
ner, the President shall— 19
(A) determine whether the President con-20
curs with the determination of the Trade Rep-21
resentative set forth in the report; and 22
(B) if the President concurs, determine 23
whether— 24
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(i) to suspend, withdraw, or prevent 1
the application of the trusted trade partner 2
agreement with the trusted trade partner; 3
(ii) to enter into a binding agreement 4
with the partner that commits the part-5
ner— 6
(I) to eliminate any burden or re-7
striction on the United States result-8
ing from the failure of the partner to 9
comply with the commitments and ob-10
ligations of the partner under a trust-11
ed trade partner agreement; and 12
(II) to provide the United States 13
with such compensatory trade benefits 14
as are negotiated between the Trade 15
Representative and the partner; or 16
(iii) to take such other actions as the 17
Trade Representative considers necessary 18
to encourage the partner to adhere to the 19
commitments and obligations of the part-20
ner under a trusted trade partner agree-21
ment, including suspending the exemption 22
of the partner from trade-restrictive meas-23
ures imposed with respect to medical goods 24
during a public health emergency. 25
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(3) TIMELINE FOR ACTION .—If the President 1
determines under paragraph (2)(B) to take action, 2
the President shall implement that action by not 3
later than the date that is 15 days after the day on 4
which the President determines to take action under 5
that paragraph. 6
Æ
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