Title: International Pharmaceutical Supply Chain Security Agreement Act of 2021
Policy area: Foreign Trade and International Finance

Summary:
International Pharmaceutical Supply Chain Security Agreement Act of 2021
This bill establishes principal trade negotiating objectives of the United States with respect to pharmaceutical products, including objectives regarding subsidies and government procurement. It also extends through July 1, 2023 (or July 1, 2026, if the President receives an extension) the authority of the President to enter into trade agreements with foreign countries.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4711 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 4711

      To amend the Bipartisan Congressional Trade Priorities and 
Accountability Act of 2015 to include principal negotiating objectives 
of the United States relating to trade in pharmaceutical products, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 27, 2021

 Mr. Joyce of Pennsylvania (for himself and Mr. Banks) 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 amend the Bipartisan Congressional Trade Priorities and 
Accountability Act of 2015 to include principal negotiating objectives 
of the United States relating to trade in pharmaceutical products, 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 ``International Pharmaceutical Supply 
Chain Security Agreement Act of 2021''.

SEC. 2. PRINCIPAL NEGOTIATING OBJECTIVES OF THE UNITED STATES RELATING 
              TO TRADE IN COVERED PHARMACEUTICAL PRODUCTS.

    Section 102(b) of the Bipartisan Congressional Trade Priorities and 
Accountability Act of 2015 (19 U.S.C. 4201(b)) is amended by adding at 
the end the following:
            ``(23) Trade in covered pharmaceutical products.--
                    ``(A) In general.--With respect to an agreement 
                relating to trade in covered pharmaceutical products 
                that is proposed to be entered into with the United 
                States and to which section 103(b) will apply, the 
                principal negotiating objectives of the United States 
                are the following:
                            ``(i) To ensure that a party to the 
                        agreement adopts and maintains measures to 
                        eliminate the imposition or reimposition of 
                        tariffs on imports of such products, 
                        particularly in the event of a declared 
                        emergency.
                            ``(ii) To ensure that a party to the 
                        agreement--
                                    ``(I) will reduce or eliminate 
                                regulatory and other technical barriers 
                                in the pharmaceutical sector;
                                    ``(II) will promote expedited 
                                approval of facilities for the 
                                production of such products being built 
                                by business enterprises that operate 
                                one or more such facilities in the 
                                territory of the party;
                                    ``(III) will promote the use of 
                                good regulatory practices and 
                                streamlined regulatory review and 
                                approval processes for the production 
                                of such products in the territory of 
                                the party;
                                    ``(IV) will eliminate duplicated 
                                actions and other barriers to reduce 
                                the time for approvals of both 
                                facilities and such products; and
                                    ``(V) will expand transparency and 
                                cooperation with other parties and 
                                their manufacturers, working 
                                collaboratively, to ensure regulatory 
                                processes are streamlined and 
                                harmonized among other parties to the 
                                maximum extent possible.
                            ``(iii) To prohibit export restraints 
                        against parties to the agreement, particularly 
                        in the event of a declared emergency.
                            ``(iv) With respect to use of subsidies--
                                    ``(I) to encourage the coordinated 
                                provision of those types of subsidies 
                                that are classified under World Trade 
                                Organization rules as `non-prohibited', 
                                such as subsidies that are not 
                                contingent on exports or import-
                                substitution, to incentivize 
                                manufacturing of such products, 
                                including the provision of grants, 
                                loans, tax incentives, and guaranteed 
                                price and volume contracts;
                                    ``(II) to explicitly permit, among 
                                parties to the agreement, the use of 
                                production subsidies to build 
                                pharmaceutical manufacturing capacity;
                                    ``(III) to affirm that subsidies 
                                provided by parties are not intended to 
                                be used primarily for export or to 
                                distort trade;
                                    ``(IV) to affirm parties' 
                                commitments under the Antidumping 
                                Agreement and the Agreement on 
                                Subsidies and Countervailing Measures, 
                                including the recognition that 
                                `dumping, by which products of one 
                                country are introduced into the 
                                commerce of another country at less 
                                than the normal value of the products, 
                                is to be condemned if it causes or 
                                threatens material injury to an 
                                established industry in the territory 
                                of a contracting party or materially 
                                retards the establishment of a domestic 
                                industry'; and
                                    ``(V) to encourage notification and 
                                consultation among parties as they are 
                                considering pharmaceutical 
                                manufacturing subsidies to increase 
                                coordination and avoid creating 
                                conditions such as oversupply or market 
                                inefficiencies among the parties.
                            ``(v) With respect to government 
                        procurement--
                                    ``(I) to provide reciprocal access 
                                to government procurements for such 
                                products in parties to the agreement;
                                    ``(II) to increase coordination 
                                between participant countries and 
                                facilitate the involvement of 
                                participant countries' companies in 
                                bids to supply such products; and
                                    ``(III) to ensure that any 
                                participant in the agreement that is 
                                not already so designated, becomes 
                                designated for purposes of section 301 
                                of the Trade Agreements Act of 1979 (19 
                                U.S.C. 2511).
                            ``(vi) With respect to trade in services--
                                    ``(I) to obtain fair, open, and 
                                transparent access to supply chain 
                                services in the markets of parties to 
                                the agreement, such as distribution, 
                                logistics, and transportation services;
                                    ``(II) to ensure any restrictions 
                                or regulatory requirements maintained 
                                on such services are adopted and 
                                maintained in a transparent and 
                                efficient manner; and
                                    ``(III) to require parties to 
                                establish an internal process for 
                                identifying restrictions or regulatory 
                                requirements that could be waived in 
                                the event of a declared emergency.
                            ``(vii) With respect to transparency and 
                        trade facilitation--
                                    ``(I) to obtain commitments among 
                                parties to the agreement to develop 
                                mechanisms for sharing information on 
                                pharmaceutical supply chain constraints 
                                and coordinate approaches with parties 
                                to minimize risks that could lead to 
                                supply chain failures; and
                                    ``(II) to the extent they have not 
                                done so yet, to obtain commitments from 
                                parties that they will fully implement 
                                the obligations under the World Trade 
                                Organization's Agreement on Trade 
                                Facilitation prior to the date the 
                                agreement enters into force.
                            ``(viii) With respect to enforcement--
                                    ``(I) to ensure that benefits under 
                                the agreement can only be obtained by 
                                parties that are fully meeting their 
                                obligations under the agreement;
                                    ``(II) to ensure that parties will 
                                not bring a dispute under another 
                                agreement for actions that are 
                                consistent with the agreement; and
                                    ``(III) to provide a dispute 
                                settlement mechanism comparable to the 
                                dispute settlement provisions of the 
                                Agreement between the United States of 
                                America, the United Mexican States, and 
                                Canada.
                            ``(ix) To minimize the ability of parties 
                        to the agreement to undermine the effectiveness 
                        of the agreement by abusing exceptions in the 
                        agreement by including additional procedural 
                        requirements, such as notification of intent to 
                        rely on an exception at the time an 
                        inconsistent action is taken, and limiting the 
                        duration that participants may rely on an 
                        exception.
                    ``(B) Definitions.--In this paragraph:
                            ``(i) Active pharmaceutical ingredient.--
                        The term `active pharmaceutical ingredient'--
                                    ``(I) means any component that is 
                                intended to furnish pharmacological 
                                activity or other direct effect in the 
                                diagnosis, cure, mitigation, treatment, 
                                or prevention of a disease, or to 
                                affect the structure or any function of 
                                the body of a human or animal; and
                                    ``(II) does not include--
                                            ``(aa) intermediates used 
                                        in the synthesis of a drug 
                                        product; or
                                            ``(bb) components that may 
                                        undergo chemical change in the 
                                        manufacture of a drug product 
                                        and be present in a drug 
                                        product in a modified form that 
                                        is intended to furnish such 
                                        activity or effect.
                            ``(ii) Agreement on subsidies and 
                        countervailing measures.--The term `Agreement 
                        on Subsidies and Countervailing Measures' means 
                        the agreement referred to in section 101(d)(12) 
                        of the Uruguay Round Agreements Act (19 U.S.C. 
                        3511(d)(12)).
                            ``(iii) Antidumping agreement.--The term 
                        `Antidumping Agreement' means the Agreement on 
                        Implementation of Article VI of the General 
                        Agreement on Tariffs and Trade 1994 referred to 
                        in section 101(d)(7) of the Uruguay Round 
                        Agreements Act (19 U.S.C. 3511(d)(7)).
                            ``(iv) Biological product.--The term 
                        `biological product' has the meaning given to 
                        such term in section 351(i) of the Public 
                        Health Service Act (42 U.S.C. 262(i)).
                            ``(v) Covered pharmaceutical product.--The 
                        term `covered pharmaceutical product' means--
                                    ``(I) a drug (including a 
                                biological product); or
                                    ``(II) an active pharmaceutical 
                                ingredient.''.

SEC. 3. REAUTHORIZATION OF TRADE AGREEMENTS AUTHORITY.

    Section 103 of the Bipartisan Congressional Trade Priorities and 
Accountability Act of 2015 (19 U.S.C. 4202) is amended--
            (1) in subsection (a)--
                    (A) by striking ``July 1, 2018'' each place it 
                appears and inserting ``July 1, 2023''; and
                    (B) by striking ``July 1, 2021'' each place it 
                appears and inserting ``July 1, 2026'';
            (2) in subsection (b)--
                    (A) by striking ``July 1, 2018'' each place it 
                appears and inserting ``July 1, 2023''; and
                    (B) by striking ``July 1, 2021'' each place it 
                appears and inserting ``July 1, 2026''; and
            (3) in subsection (c)--
                    (A) by striking ``July 1, 2018'' each place it 
                appears and inserting ``July 1, 2023'';
                    (B) by striking ``June 30, 2018'' and inserting 
                ``June 30, 2023'';
                    (C) in paragraph (1)(B), by striking ``July 1, 
                2021'' and inserting ``July 1, 2026'';
                    (D) in paragraph (2), by striking ``April 1, 2018'' 
                and inserting ``April 1, 2023''; and
                    (E) in paragraph (3), by striking ``June 1, 2018'' 
                and inserting ``June 1, 2023''.
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