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<bill bill-stage="Introduced-in-House" dms-id="H4717594DAAFA40B89B6FFFC82B48A12C" public-private="public" key="H" bill-type="olc">
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<dc:title>117 HR 4376 IH: Use Sovereignty To reduce Rx Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-07-09</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<form>
<distribution-code display="yes">I</distribution-code>
<congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session>
<legis-num display="yes">H. R. 4376</legis-num>
<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
<action display="yes">
<action-date date="20210709">July 9, 2021</action-date>
<action-desc><sponsor name-id="A000375">Mr. Arrington</sponsor> introduced the following bill; which was referred to the <committee-name committee-id="HWM00">Committee on Ways and Means</committee-name></action-desc>
</action>
<legis-type>A BILL</legis-type>
<official-title display="yes">To identify and take action against international trade practices of high income countries that unfairly exploit innovation by deviating from market-based policies and unfairly exploit United States innovation, and for other purposes.</official-title>
</form>
<legis-body id="H926366C30EC14EB2AF8A2B4585BADED8" style="OLC">
<section id="H371D0C1F3DED45F98E7C29F1895E5294" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Use Sovereignty To reduce Rx Act</short-title></quote> or the <quote><short-title>USTRx Act</short-title></quote>.</text></section> <section id="H037F72E1E1014498AC5AB60116891DFB"><enum>2.</enum><header>Findings; sense of Congress</header> <subsection id="H2249CF03FD07441CB500723EC93F64EE"><enum>(a)</enum><header>Findings</header><text display-inline="yes-display-inline">Congress finds the following:</text>
<paragraph id="HC6B83BD520B74A499CC42CD5E9AF5DC1"><enum>(1)</enum><text display-inline="yes-display-inline">Pharmaceutical price controls in foreign markets distort global trade flows and competition by depressing the prices of innovative drugs and exploiting pharmaceutical innovations researched and developed in the United States.</text></paragraph> <paragraph id="H3D39D5801697461FADA0D26FCD8A9627"><enum>(2)</enum><text display-inline="yes-display-inline">By setting prices at levels that are not market-based, such price controls undervalue the discovery of new, innovative treatments, diminish opportunities and incentives for global innovation in new medicines, and threaten to restrict access to new treatments and cures for United States patients and consumers.</text></paragraph>
<paragraph id="H19F71EF49F7E4FD1BB67CDE4B825B0B4"><enum>(3)</enum><text display-inline="yes-display-inline">Recognizing these dynamics, it is critical that the United States use all available trade tools to address such free-riding, consistent with the negotiating objectives set forth in the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (<external-xref legal-doc="usc" parsable-cite="usc/19/4201">19 U.S.C. 4201 et seq.</external-xref>), to ensure that foreign government regulatory reimbursement regimes are transparent, provide procedural fairness, are non-discriminatory, and provide full market access to United States products.</text></paragraph></subsection> <subsection id="HA271DB4AF3F44712B3ADEBDED1E2554B"><enum>(b)</enum><header>Sense of Congress</header><text>It is the sense of Congress that—</text>
<paragraph id="H8629FB68D06745728A2E49DF965F7BCE"><enum>(1)</enum><text display-inline="yes-display-inline">ensuring the security of innovative and affordable healthcare is a top priority for Americans and for Congress;</text></paragraph> <paragraph id="HC6A066B7F5804F9C9C8EFCEB76FF01EB"><enum>(2)</enum><text display-inline="yes-display-inline">foreign government policies that mandate artificially low drug prices in foreign markets undermine this priority by reducing global incentives to invest in the development of new medicines;</text></paragraph>
<paragraph id="H978F092A053449E88663435098C6E5F6"><enum>(3)</enum><text>such exploitative behavior unfairly shifts the cost of developing new treatments to the United States and unduly relies on America’s patients and taxpayers to finance global pharmaceutical innovation; and</text></paragraph> <paragraph id="HAA940635E14E4C80AC9AF084CB1ABE9A"><enum>(4)</enum><text display-inline="yes-display-inline">safeguarding access to life-saving treatments for American patients requires combating such behavior so that foreign countries pay their fair share of the costs associated with the development of new drugs.</text></paragraph></subsection></section>
<section id="HEDC27B6C787044CF930C8474BB4E5DE0"><enum>3.</enum><header>Chief Pharmaceutical Trade Negotiator</header>
<subsection id="H407FA29C085D47638024C46C4A62A1F1"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">Section 141(b) of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2171">19 U.S.C. 2171(b)</external-xref>), is amended as follows:</text> <paragraph id="HFCAAF91C497D4F57A57B658011A696CF"><enum>(1)</enum><text>In paragraph (2)—</text>
<subparagraph id="H2843BC27CA4E4A47865E83D446D56191"><enum>(A)</enum><text>in the first sentence, by inserting <quote>one Chief Pharmaceutical Trade Negotiator,</quote> after <quote>one Chief Agricultural Negotiator,</quote>; and</text></subparagraph> <subparagraph id="H34BE7ADD334F4C768D819989A9C12C6E"><enum>(B)</enum><text>by inserting <quote>the Chief Pharmaceutical Trade Negotiator,</quote> after <quote>the Chief Agricultural Negotiator,</quote> each place it appears.</text></subparagraph></paragraph>
<paragraph id="H7434203331394ADA8FDD86A2D515020E"><enum>(2)</enum><text>By adding at the end the following new paragraph:</text> <quoted-block style="traditional" id="H4BEC123206A148CDAB1B09674142C8FD" display-inline="no-display-inline"> <paragraph id="H2C7EA165D1784BAAA183917834E3E803"><enum>(7)</enum><text display-inline="yes-display-inline">The principal functions of the Chief Pharmaceutical Trade Negotiator shall be to conduct trade negotiations, enforce trade agreements relating to United States pharmaceutical products, and take appropriate action to address acts, policies, or practices of high-income countries that have a significant adverse impact on the ability of United States pharmaceutical manufacturers to enjoy full market access. The Chief Pharmaceutical Trade Negotiator shall be a vigorous advocate on behalf of United States manufacturers and consumers of pharmaceutical products and shall perform such other functions as the United States Trade Representative may direct.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H7FE33E857F6A4C7CAB9BB9B896B2BF23"><enum>(b)</enum><header>Annual report</header>
<paragraph id="HCF1C543372F842E9BE6DB6ACB30F2646"><enum>(1)</enum><header>List of high-income countries</header><text display-inline="yes-display-inline">The United States Trade Representative shall compile and annually update a list of each foreign country that is defined as <quote>high-income</quote> by the official statistics of the International Bank for Reconstruction and Development of the World Bank.</text></paragraph> <paragraph id="H9C486845D0954D5AB608DAD3BD705ACB"><enum>(2)</enum><header>Report required</header><text>With respect to each country included on the most recent list required under paragraph (1), the United States Trade Representative, acting through the Chief Pharmaceutical Trade Negotiator, (as established pursuant to the amendments made by subsection (a)) shall annually submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a report that—</text>
<subparagraph id="H6F077023644045D5B80C76D4B0417471"><enum>(A)</enum><text display-inline="yes-display-inline">describes in detail the results of a review of the acts, policies, and practices of such country relating to the trade in pharmaceutical products in the previous fiscal year;</text></subparagraph> <subparagraph id="HB9AF5E4CC7DF43FBA493D85BBDF66672"><enum>(B)</enum><text display-inline="yes-display-inline">determines whether such acts, policies, or practices—</text>
<clause id="HAEFD5813F3574B88B087651971F4928D"><enum>(i)</enum><text display-inline="yes-display-inline">are not developed and implemented in a fair, nondiscriminatory, and transparent manner;</text></clause> <clause id="HAECE30EAB0C44B9C93140426DB15CF45"><enum>(ii)</enum><text display-inline="yes-display-inline">are not market-based or do not appropriately recognize the value of innovative medicines;</text></clause>
<clause id="H426AE6A91710430EB5881F9DA2554F94"><enum>(iii)</enum><text display-inline="yes-display-inline">deny reciprocal market access for United States products;</text></clause> <clause id="HC0AFDD309AA14F8BAA9C738F62D414DC"><enum>(iv)</enum><text display-inline="yes-display-inline">diminish incentives for innovation in a manner that delays, prevents, or otherwise adversely impacts the introduction of new medicines in the United States;</text></clause>
<clause id="H7A949E148F5C4E6C8648A5ECA0929865"><enum>(v)</enum><text display-inline="yes-display-inline">violate or are inconsistent with the provisions of, or otherwise deny benefits to the United States under, any bilateral or multilateral trade agreement with such country; </text></clause> <clause id="H5EABF3677D0248559643AB2BC1409106"><enum>(vi)</enum><text>are unjustifiable or impose a significant burden or unreasonable or discriminatory restriction on United States commerce with such country; and</text></clause></subparagraph>
<subparagraph id="HEF128D678BBE431BAA8B1C31CDF7DAC1"><enum>(C)</enum><text display-inline="yes-display-inline">describes the current status of any responsive actions taken by the United States with respect to acts, policies, or practices for which the United States Trade Representative has determined and included in any prior report, pursuant to subparagraph (B), that the interests of the United States are harmed, including responsive actions pursuant to title III of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2411">19 U.S.C. 2411 et seq.</external-xref>).</text></subparagraph></paragraph></subsection> <subsection id="H729B1B84D20D42679AAB59D2FB409B7B"><enum>(c)</enum><header>Response to adverse actions</header><text display-inline="yes-display-inline">Not later than 30 days after the United States Trade Representative determines that an act, policy, or practice of a country included in the applicable list required under subsection (b)(1) meets any of the criteria described in subsection (b)(2)(B), the United States Trade Representative shall submit to Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a plan to respond to such adverse action, which may include initiating an investigation under chapter 1 title III of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2411">19 U.S.C. 2411 et seq.</external-xref>), in accordance with section 302(b)(1) of such chapter.</text></subsection></section>
</legis-body>
</bill> 


