[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4307 Introduced in House (IH)]

<DOC>






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 
  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 be 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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