119-hr2213

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2213 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 2213

 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

 March 18, 2025

 Ms. Malliotakis (for herself and Mr. Schneider) introduced the 
following bill; which was referred to the Committee on Ways and Means, 
 and in addition to the Committee on Rules, for a period to be 
subsequently determined 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 Representatives 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''.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) 

=== Findings ===
-Congress makes the following findings:

    (1) The COVID-19 pandemic created significant 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 supply 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 pharmaceutical 
 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 enactment 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 
 identified 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 partners--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 medical supply 
 manufacturing occurs are reliable suppliers 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 Congress that, given the 
threat to national security and public health that could arise if the 
United States is unable to 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 resilience 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 protection;

    (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 critical medical 
 goods;

    (6) to foster international collaboration, encourage new 
 investments, promote cooperation and partnership in public and 
 private research and development efforts, facilitate data flows 
 for life science research and development, and expand 
 manufacturing capacities for medical devices and pharmaceutical 
 goods;

    (7) to promote regulatory cooperation with respect to 
 manufacturing of medical goods;

    (8) to increase access to government procurement 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 licensing 
 procedures for medical devices and pharmaceutical 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 congress.--The term 
 ``appropriate committees of Congress'' means--
        (A) the Committee on Finance of the Senate; 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, including any 
 overseas dependent territory or possession of a foreign 
 country; or
        (B) the Trust Territory of the Pacific Islands.

    (3) Medical device.--The term ``medical device'' 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 ``medical supply 
 chain'' means any activities involving design, procurement, 
 manufacturing, production, distribution, operation, or 
 management related to medical goods.

    (6) Pharmaceutical good.--The term ``pharmaceutical good'' 
 means a drug, 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.

    (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 PARTNER AGREEMENTS.

    (a) In General.--Whenever the President determines, 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 contribute to the national security and public health of 
the United States, the President may, subject to the requirements under 

section 6--

    (1) negotiate, enter into, and enforce a trusted trade 
 partner agreement with the country or countries; and

    (2) proclaim such modification of any existing duty, such 
 continuance of existing duty-free or excise treatment, or such 
 additional duties, as the President 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 agreement with a country 
pursuant to subsection

    (a) , the President shall take into account 
whether the government of the country has--

    (1) expressed a desire to enter into such an agreement;

    (2) demonstrated a commitment to contribute to global 
 health security, including the national security 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 commitments and 
 obligations under existing free trade agreements to which that 
 country and the United States are parties;

    (4) implemented measures to reduce or eliminate unnecessary 
 trade barriers and distorting practices 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 adequate 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 regulatory 
 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 manufacturing 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;

    (3) harmonization or convergence of regulatory procedures, 
 regulatory reliance, inspection cooperation, 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 multilateral 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 intellectual 
 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;

    (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, CONSULTATIONS, ACCESS TO 
 INFORMATION, AND REVIEW.

    (a) Notice.--Not later than 60 days before initiating negotiations 
with a trusted trade partner under 

section 5

    (a) for a trusted trade 
partner agreement, the President shall submit to Congress written 
notice of the intention of the President to enter into the 
negotiations, which shall include the date negotiations will begin and 
the trusted trade partner with whom the President seeks to enter into 
the agreement.

    (b) Consultation With Members of Congress.--

    (1) Consultation during negotiations and access to 
 information.--In the course of negotiations under 

section 5

    (a) for a trusted trade partner agreement, the Trade Representative 
 shall--
        (A) meet upon request with the appropriate 
 committees of Congress regarding negotiating 
 objectives, the status of negotiations in progress, and 
 potential effects to the laws of the United States with 
 respect to the agreement;
        (B) upon request by the appropriate committees 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 negotiations, the 
 appropriate committees of Congress.

    (2) Consultation before entry into agreement.--Before 
 entering into a trusted trade partner agreement under 

section 5, the Trade Representative shall consult with--
        (A) the appropriate committees of Congress; and
        (B) each other committee of the Senate and the 
 House of Representatives, and each joint committee of 
 Congress, that has jurisdiction 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 expertise in the matters being negotiated, including the 
Department 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 established 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 committees of Congress 
 a report that sets forth--
        (A) the action proposed to be proclaimed;
        (B) the reasons for such action; and
            (C) the advice obtained under paragraph

    (1) ; and

    (3) has consulted with the appropriate committees of 
 Congress regarding the proposed action during the 60-day period 
 on the date on which the President has met the requirements 
 under paragraphs

    (1) and

    (2) .

    (e) Report to Congress.--Not later than 60 days before the date on 
which the President enters into a trusted 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 demonstrating 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 trusted trade 
 partner or the United States with respect to medical 
 goods would contribute to the national security and 
 public health of the United States; and

    (5) the proposed implementation of the agreement, including 
 the general effect of the agreement on existing laws.

    (f) Congressional Right To Review and Disapprove.--

    (1) In general.--A trusted trade partner agreement shall 
 not take effect until--
        (A) the proposed agreement has been submitted to 
 Congress, together with the report required under 
 subsection

    (e) with respect to that agreement; and
        (B) the review period required under paragraph

    (2) following the date on which the proposed agreement has 
 been submitted to Congress under subparagraph
        (A) has 
 been exhausted, during which period a joint resolution 
 is not enacted under paragraph

    (4) .

    (2) Review.--
        (A) Initial review.--Unless extended under 
 subparagraph
        (B) or
            (C) , the review period under this 
 paragraph with respect to a trusted trade partner 
 agreement is 30 days, during which time Congress shall 
 review the proposed agreement with respect to whether--
            (i) the President failed or refused to 
 provide notice with respect to the agreement in 
 accordance with subsection

    (a) ;
            (ii) the President failed or refused to 
 consult with respect to the agreement in 
 accordance with subsections

    (b) and
            (c) ;
            (iii) the President failed or refused to 
 submit to Congress a report with respect to the 
 agreement in accordance with subsection

    (e) ; or
            (iv) the President failed or refused to 
 demonstrate that the agreement would achieve 
 the applicable purposes, policies, priorities, 
 and objectives of this Act and contribute to 
 the national security and public health of the 
 United States.
        (B) Further review.--If, during the 30-day period 
 under subparagraph
        (A) with respect to a trusted trade 
 partner agreement, one House of Congress adopts a 
 resolution stating that the House of Congress wishes to 
 further review the proposed agreement, the review 
 period under this paragraph with respect to the 
 proposed agreement shall be extended by a period of 60 
 days, during which time the appropriate committees of 
 Congress shall engage the President with respect to the 
 proposed agreement and the failures or refusals of the 
 President specified under subparagraph
        (A) .
            (C) Additional period.--If, during the 60-day 
 period under subparagraph
        (B) with respect to a trusted 
 trade partner agreement, one House of Congress adopts a 
 resolution stating that the House of Congress wishes to 
 further review the proposed agreement, the review 
 period under this paragraph with respect to the 
 proposed agreement shall be further extended by a 
 period of 30 days.

    (3) Procedures for considering resolutions.--A resolution 
 under subparagraph
        (B) or
            (C) of paragraph

    (2) --
        (A) in the Senate--
            (i) may be introduced by any Member of the 
 Senate;
            (ii) shall be referred to the Committee on 
 Finance; and
            (iii) may not be amended;
        (B) in the House of Representatives--
            (i) may be introduced by any Member of the 
 House;
            (ii) shall be referred to the Committee on 
 Ways and Means or the Committee on Rules; and
            (iii) may not be amended by either 
 Committee; and
            (C) the vote on passage of the resolution shall 
 occur immediately following the conclusion of the 
 debate on the trusted trade partner agreement at issue 
 and a single quorum call at the conclusion of the 
 debate.

    (4) Disapproval.--If, during the review period required 
 under paragraph

    (2) with respect to a trusted trade partner 
 agreement, a joint resolution is enacted stating that Congress 
 does not favor the agreement, the agreement shall not take 
 effect.

SEC. 7. MONITORING AND ENFORCEMENT OF CONTINUED COMPLIANCE WITH TRUSTED 
 TRADE PARTNER AGREEMENTS.

    (a) Monitoring.--The Trade Representative shall periodically 
monitor compliance by a trusted trade partner with the commitments and 
obligations of the partner under a trusted trade partner agreement.

    (b) Actions in Response to Failure To Comply.--

    (1) Determination and report of trade representative.--If 
 the Trade Representative determines that a trusted trade 
 partner has failed to satisfactorily implement, maintain, and 
 enforce the commitments and obligations of the partner under a 
 trusted trade partner agreement, the Trade Representative shall 
 submit to the President a report setting forth--
        (A) the determination and the findings that support 
 the determination; and
        (B) based on such findings, the recommendations of 
 the Trade Representative for action or inaction under 
 this subsection.

    (2) Determination of president.--Not later than 30 days 
 after receiving a report under paragraph

    (1) with respect to a 
 trusted trade partner, the President shall--
        (A) determine whether the President concurs with 
 the determination of the Trade Representative set forth 
 in the report; and
        (B) if the President concurs, determine whether--
            (i) to suspend, withdraw, or prevent the 
 application of the trusted trade partner 
 agreement with the trusted trade partner;
            (ii) to enter into a binding agreement with 
 the partner that commits the partner--
            (I) to eliminate any burden or 
 restriction on the United States 
 resulting from the failure of the 
 partner to comply with the commitments 
 and obligations of the partner under a 
 trusted trade partner agreement; and
            (II) to provide the United States 
 with such compensatory trade benefits 
 as are negotiated between the Trade 
 Representative and the partner; or
            (iii) to take such other actions as the 
 Trade Representative considers necessary to 
 encourage the partner to adhere to the 
 commitments and obligations of the partner 
 under a trusted trade partner agreement, 
 including suspending the exemption of the 
 partner from trade-restrictive measures imposed 
 with respect to medical goods during a public 
 health emergency.

    (3) Timeline for action.--If the President determines under 
 paragraph

    (2)
        (B) to take action, the President shall implement 
 that action by not later than the date that is 15 days after 
 the day on which the President determines to take action under 
 that paragraph.
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