Protecting American Innovation Act

To establish limitations on modifications to trade agreements, and for other purposes. 1. Short title This Act may be cited as the Protecting American Innovation Act 2. Findings Congress finds the following: (1) Section 8 of article I of the United States Constitution provides Congress with authority over international trade. Congress has used that authority to approve a number of trade agreements, including the WTO Agreement. (2) Section 8 of article I of the United States Constitution provides Congress with authority to provide intellectual property protections in order to promote the progress of science and useful arts (3) The United States may not withdraw or otherwise alter the rights and obligations for the United States arising from a congressionally approved trade agreement without the consent of Congress. (4) The United States is a global leader in containing and ending the COVID–19 pandemic. (5) Innovators in the United States successfully and rapidly brought to fruition vaccines that provide highly effective protection against COVID–19. At facilities across the United States, thousands of United States workers are working around the clock to manufacture COVID–19 vaccines, contributing to the rapid, global scale up of manufacturing that is expected to reach at least 10,000,000,000 doses by the end of 2021. (6) The United States is a founding member of the World Trade Organization. The United States has secured and supported critical commitments in the WTO for protection of intellectual property of United States persons and globally, including under the Trade-Related Aspects of Intellectual Property Rights Agreement or the TRIPS Agreement. (7) In implementing the Uruguay Round, Congress established under section 315 of the Uruguay Round Agreements Act ( 19 U.S.C. 3581 accelerate the implementation seek enactment and effective implementation by foreign countries of laws to protect and enforce intellectual property rights that supplement and strengthen the standards (8) Longstanding intellectual property protections are critical to efforts by the United States and the biopharmaceutical industry to develop and manufacture vaccines for both people in the United States and around the world. (9) The United States is committed to providing global access to COVID–19 vaccines. (10) In order to accelerate production and distribution of COVID–19 vaccines, biopharmaceutical manufacturers in the United States are collaborating at a scale that previously was unimaginable, including by entering into hundreds of voluntary manufacturing, production, and other partnerships around the world. (11) Manufacturing each of the COVID–19 vaccines involves highly specialized and unique infrastructure and equipment, as well as highly trained and experienced personnel. Manufacturing and distributing safe and effective COVID–19 vaccines on a global scale is incredibly challenging. Many experts on vaccine production and distribution are warning that waiving intellectual property protections will undermine the global response to the COVID–19 pandemic and compromise vaccine safety, including by disrupting the distribution of scarce raw materials for vaccines that existing vaccine makers with proven track records for delivering high-quality, safe, and effective vaccines need to continue their own production. (12) The United States Trade Representative announced without any consultation with Congress that the United States will support a waiver of intellectual property protections under the TRIPS Agreement for COVID–19 vaccines. That decision is not consistent with the intellectual property negotiating objectives of the United States set forth in section 315 of the Uruguay Round Agreements Act ( 19 U.S.C. 3581 (13) That waiver announcement created confusion, and raised concerns that a successful effort to suspend protections will weaken already strained supply chains and foster the proliferation of ineffective and potentially dangerous vaccines. (14) The Trade Representative has not explained how a waiver of the TRIPS Agreement will expand vaccine production and access, particularly considering that the major impediments to vaccination efforts include the following: (A) The difficulty in meeting the technical specifications of production and appropriately ensuring that finished vaccines are high-quality, safe, and effective. (B) The scarcity of raw materials for the vaccines. (C) Last-mile distribution and cold-chain storage. (D) Trade barriers to the free flow of inputs and finished products. (15) The Government of the People's Republic of China and the Government of the Russian Federation are engaged in large scale industrial espionage and technology theft of intellectual property of United States persons. The Department of Justice has issued indictments in connection with attempts sponsored by the Government of the People's Republic of China to steal United States vaccine research with respect to COVID–19. (16) The Government of the People's Republic of China and the Government of the Russian Federation are using their vaccines as part of diplomatic efforts that may be contrary to the national security interests of the United States. Vaccines for COVID–19 manufactured by persons in the People's Republic of China and the Russian Federation appear to be less efficacious than those manufactured by producers in the United States. The Academy of Military Science, the scientific arm of the military of the People's Republic of China, is sponsoring the principal effort by the People's Republic of China to develop its own mRNA vaccine. (17) At a hearing before the Committee on Finance of the Senate on May 12, 2021, the Trade Representative would not commit either— (A) to ensure that any waiver of the TRIPS Agreement would exclude the People's Republic of China and the Russian Federation; or (B) to ensure that Congress has advance access to the negotiating proposals of the United States for any such waiver. (18) The innovative biopharmaceutical companies in the United States contribute more than $1,100,000,000,000 annually to the United States economy, and employ more than 500,000 workers making 1.4 times the average earnings in the United States, including 153,000 workers who do not have a college degree. (19) Waiving intellectual property protections, particularly of the mRNA technology platform in which the Defense Advanced Research Project Agency invested not less than $250,000,000, raises serious economic and national security concerns. 3. Sense of Congress It is the sense of Congress that— (1) the United States should continue to act as a global leader to help contain and end the COVID–19 pandemic at home and abroad; (2) innovators in the United States are already heroes for their breakthrough work in developing and producing COVID–19 vaccines; (3) it should be a priority of the global community, with the assistance of the United States, to efficiently and quickly manufacture and distribute COVID–19 vaccines around the world, and in particular to those countries that are most vulnerable; (4) current impediments to further vaccination efforts are due to— (A) the technically difficult manufacturing requirements for vaccines; (B) the need to appropriately ensure that vaccines are high-quality, safe, and effective; (C) raw material constraints; and (D) difficulties in distribution; (5) intellectual property protections for COVID–19 vaccines have not impeded vaccination efforts for COVID–19; (6) intellectual property protections in fact help ensure the safe and efficient manufacturing of COVID–19 vaccines; (7) waiving intellectual property protections could lead to the production of substandard, ineffective, and potentially unsafe COVID–19 vaccines; (8) the Trade Representative must consult with Congress before taking a position on the current TRIPS Agreement waiver proposal before the WTO and any further proposals to waive or weaken intellectual property obligations under the TRIPS Agreement; (9) Congress and the people of the United States are entitled to comprehensive expert analysis regarding the implications of a waiver to the TRIPS Agreement for jobs, economic growth, public health, and national security in the United States; and (10) the United States must oppose any waiver to intellectual property obligations under the TRIPS Agreement for the response to the COVID–19 pandemic until those implications are fully analyzed. 4. Definitions In this Act: (1) Appropriate congressional committees The term appropriate congressional committees (2) Commission The term Commission (3) Ministerial change The term ministerial change (4) Official advisor The term official advisor (5) COVID–19 pandemic The term COVID–19 pandemic (6) State sponsor of terrorism The term state sponsor of terrorism (A) section 1754(c)(1)(A)(i) of the Export Control Reform Act of 2018 ( 50 U.S.C. 4813(c)(1)(A)(i) (B) section 620A of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2371 (C) section 40(d) of the Arms Export Control Act ( 22 U.S.C. 2780(d) (D) any other provision of law. (7) Trade agreement The term trade agreement (8) Trade Representative The term Trade Representative (9) TRIPS agreement The term TRIPS Agreement 19 U.S.C. 3511(d)(15) (10) TRIPS waiver The term TRIPS waiver (11) World Trade Organization; WTO; WTO Agreement The terms World Trade Organization WTO WTO Agreement 19 U.S.C. 3501 5. Prohibition on compromising United States trading rights to China and Russia (a) Prohibition on withdrawal, suspension, or modification (1) In general The President, and any official, employee, or agent of the United States, may not negotiate or conclude any withdrawal, suspension, or modification to a trade agreement that adversely affects, nullifies, or impairs the rights of the United States or United States persons under a trade agreement with respect to the People's Republic of China or the Russian Federation. (2) Discipline Any official, employee, or agent of the United States who violates subsection (a) shall be subject to appropriate discipline, as determined by the President, including suspension from duty without pay or removal from office. (3) Report on violations Immediately following any violation of subsection (a) by an official, employee, or agent of the United States, the President shall submit to the appropriate congressional committees a report setting forth a statement regarding the violation and a description of the actions taken with respect to the official, employee, or agent, as the case may be, including all relevant facts. (b) No effect of amendment or modification to agreement No amendment or other modification to a trade agreement, including a waiver of one or more provisions of the agreement, shall take effect with respect to the United States— (1) if the amendment or modification adversely affects, nullifies, or impairs the benefits to the United States under the agreement with respect to the People's Republic of China or the Russian Federation, including with respect to intellectual property rights; or (2) if the President failed or refused to consult on the amendment or modification pursuant to sections 6 and 7. 6. Limitations and analysis of waiver of obligations under Agreement on Trade-Related Aspects of Intellectual Property Rights with respect to addressing the COVID–19 pandemic (a) TRIPS waiver A TRIPS waiver with respect to addressing the COVID–19 pandemic shall not take effect with respect to the United States if— (1) the President fails to submit the reports required under subsections (b) and (c)(2) pursuant to the requirements of those subsections; (2) the report required under subsection (b) concludes that the TRIPS waiver will not result in an increase in global vaccine access; or (3) the report required under subsection (c)(2) concludes that the TRIPS waiver would adversely impact the national security of the United States. (b) Interagency public health report (1) In general Before any official, employee, or agent of the United States enters into negotiations concerning a TRIPS waiver with respect to addressing the COVID–19 pandemic after the date of the enactment of this Act, and not later than 60 days after such date of enactment, the Secretary of Commerce, in consultation with the Trade Representative, the Secretary of Health and Human Services, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control and Prevention shall submit to Congress a report assessing— (A) how the TRIPS waiver would impact, during the period beginning on the date of the enactment of this Act and ending on December 31, 2022— (i) access to vaccines in the United States; (ii) access to vaccines globally; (iii) global supply chains of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies; (iv) the gross domestic product of the United States; (v) exports and imports by the United States of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies; (vi) manufacturing in the United States of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies; and (vii) investment in vaccine production in the United States and in research and development for future vaccines; (B) what existing flexibilities within the TRIPS Agreement can be used to expedite vaccine access during the one-year period beginning on the date of the enactment of this Act and how those flexibilities may be effectively used; and (C) other reasonably feasible alternatives to the TRIPS waiver that might expedite global vaccine production during that one-year period and the effectiveness of those alternatives relative to a TRIPS waiver, including distribution from the United States or from other countries. (2) Publication of report The Secretary of Commerce shall publish the report required under paragraph (1) on a publicly available website of the Department of Commerce, which shall include a conclusion of whether a TRIPS waiver with respect to addressing the COVID–19 pandemic will increase global vaccine access during the one-year period beginning on the date of the enactment of this Act. (c) National security investigation (1) In general The Secretary of Defense shall conduct an investigation, in consultation with the Secretary of Commerce, the Secretary of Health and Human Services, and the Trade Representative, to determine the effects of a TRIPS waiver with respect to addressing the COVID–19 pandemic on the national security of the United States, in particular whether such a waiver that extends to mRNA technology could contribute to future deployment of that technology by the People's Republic of China, the Russian Federation, or countries designated as state sponsors of terrorism. (2) Report (A) In general Before any official, employee, or agent of the United States enters into negotiations concerning a TRIPS waiver with respect to addressing the COVID–19 pandemic after the date of the enactment of this Act, and not later than 60 days after such date of enactment, the Secretary of Defense shall submit to the President and the appropriate congressional committees a report on the findings of the investigation under paragraph (1), including the recommendations of the Secretary for action or inaction regarding the TRIPS waiver. (B) Advice If the Secretary of Defense determines that a TRIPS waiver with respect to addressing the COVID–19 pandemic threatens to impair national security, the Secretary shall so advise the President and the appropriate congressional committees in the report required under subparagraph (A). 7. Trade agreements: suspensions and other modifications, consultations, and submission to Congress (a) Trade Representative engagement with the public (1) In general Before entering into any negotiation with a trading partner concerning a suspension of or modification to a trade agreement, including a waiver of obligations, the Trade Representative shall publish in the Federal Register a notice identifying— (A) the objectives of the United States for that negotiation; (B) the rationale for why the trade agreement does not presently allow the United States to meet those objectives; and (C) the provision or provisions of the trade agreement that the United States proposes to suspend or modify. (2) Comments The Trade Representative shall allow the public an opportunity to submit comments concerning the notice required under paragraph (1) for a period of not less than 30 days, and shall hold a hearing to hear testimony from members of the public. (b) Initial evaluation by the Commission (1) In general After the end of the comment period under subsection (a)(2), and after an evaluation by the Trade Representative of those comments, if the Trade Representative determines to pursue a suspension of or modification to a trade agreement, the Trade Representative shall submit to the Commission a plan for the negotiation of the suspension or modification, as the case may be, which shall include— (A) the objectives of the United States for the negotiation; (B) a description of the inadequacies of the trade agreement, including by reference to specific provisions that preclude the United States from meeting its objectives; (C) a description of how the Trade Representative plans to remedy those inadequacies; (D) evidence supporting those inadequacies; and (E) a justification for why the suspension or modification would remedy those inadequacies. (2) Hearing and report (A) Publication of report For each suspension of or modification to a trade agreement for which a plan was submitted to the Commission under paragraph (1), the Commission shall publish on an internet website of the Commission a report evaluating— (i) the existence and extent of the purported inadequacies in the trade agreement; (ii) what progress, if any, the plan might make in remedying those inadequacies; and (iii) the likely impact of the suspension or modification on the economy of the United States as a whole and on specific industry sectors, including any impact on gross domestic product, exports and imports, aggregate employment and employment opportunities, production, employment, and competitive position of industries likely to be significantly affected by the suspension or modification, and the interests of consumers. (B) Public hearing The Commission shall conduct a public hearing for each suspension of or modification to a trade agreement for which a plan was submitted to the Commission under paragraph (1) before publishing a report with respect to that suspension or modification under subparagraph (A). (C) Timing The Commission shall publish the report required under subparagraph (A) with respect to a suspension of or modification to a trade agreement for which a plan was submitted to the Commission under paragraph (1) not earlier than 30 days and not later than 120 days after the plan was submitted. (D) Confidential report If the Commission determines that certain aspects of a report required to be published under subparagraph (A) must be kept confidential to protect proprietary data or to protect the interests of the United States with respect to a potential negotiation, the Commission shall— (i) publish a redacted report under subparagraph (A); and (ii) submit to the appropriate congressional committees an unredacted report. (E) Negotiation The Trade Representative may proceed to enter into negotiations with a trading partner with respect to a suspension of or modification to a trade agreement for which a plan was submitted to the Commission under paragraph (1) not earlier than 5 business days following the publication under subparagraph (A) of the report regarding that suspension or modification. (c) Congressional consultation during the course of negotiations (1) Notice Not later than 60 days before entering into any negotiations with a trading partner concerning a suspension of or modification to a trade agreement, including a waiver of one or more provisions or obligations of the agreement, the President shall provide written notice to Congress of the intention of the President to enter into the negotiations, which shall include— (A) the date on which the President intends to initiate the negotiations; (B) the specific objectives of the United States for the negotiations; and (C) an assessment of why it is necessary to suspend or modify the trade agreement in order to meet those objectives. (2) Consultation (A) President Following the notice required under paragraph (1) with respect to negotiations concerning a suspension of or modification to a trade agreement, the President shall consult with Congress with respect to those negotiations as set forth in section 105 of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 ( 19 U.S.C. 4204 (B) Trade Representative With respect to negotiations described in paragraph (1), the Trade Representative shall consult closely and on a timely basis with the appropriate congressional committees, keeping those committees fully apprised of those negotiations, and provide to those committees, including staff with appropriate security clearance, access to the text of any negotiating proposal or any other document presented by the United States that presents concepts or considerations for the negotiations not later than 5 business days before tabling it in the negotiation. (3) Designation of advisors The chair and ranking member of each of the appropriate congressional committees may each designate not more than 4 members of their committee and not more than 3 staffers as official advisors to negotiations described in paragraph (1). (4) Briefing (A) In general The Trade Representative shall brief the appropriate congressional committees before and after every session with respect to negotiations described in paragraph (1). (B) Timing of follow-up briefing A briefing required under subparagraph (A) following a negotiating session shall take place not later than 5 business days following the session. (d) Timing of existing report Notwithstanding the timing requirements under section 135(e)(1) of the Trade Act of 1974 ( 19 U.S.C. 2155(e)(1) 19 U.S.C. 4202 (e) Authority for suspension or modification of a trade agreement The President shall not enter into any suspension of or modification to a trade agreement, unless— (1) the President has complied with all consultation requirements set forth in subsection (c); and (2) an Act of Congress is enacted approving the suspension or modification or a joint resolution is adopted under subsection (f) approving the suspension or modification. (f) Joint resolution (1) In general The President may seek a joint resolution from Congress granting the President authority to enter into a suspension of or modification to a trade agreement as follows: (A) The President shall post the text concerning the relevant changes to the trade agreement on a publicly available website of the Office of the United States Trade Representative for not less than 5 business days. (B) The President shall submit the text concerning the relevant changes to the trade agreement to the Commission, which shall publish on a publicly available website of the Commission a report on how the changes to the trade agreement will impact employment, economic growth, and consumers in the United States. The Commission shall publish that report not earlier than 30 days and not later than 120 days after receiving from the President the text concerning the relevant changes to the trade agreement. (C) The President shall submit to Congress on a day on which both Houses of Congress are in session a copy of the final legal text with respect to which the President seeks authority to commit the United States, together with— (i) the report prepared by the Commission under subparagraph (B); (ii) an identification of any United States laws that may be inconsistent with the text; and (iii) a statement of any administrative action proposed to implement any changes to the trade agreement. (2) Introduction A joint resolution approving a suspension of or modification to a trade agreement may be introduced in either House of Congress by the chair or ranking member of one of the appropriate congressional committees. (3) Procedures in House and Senate The provisions of subsections (b) through (f) of section 152 of the Trade Act of 1974 ( 19 U.S.C. 2192 (4) Hearing and briefings Following introduction of a joint resolution under paragraph (2), the appropriate congressional committees shall, as appropriate, hold hearings and briefings and otherwise obtain information in order to fully review the proposed suspension of or modification to a trade agreement. (5) Discharge If the committee of either House to which a joint resolution introduced under paragraph (2) has been referred has not reported it by the close of the 40th day after its introduction (excluding any day described in section 154(b) of the Trade Act of 1974 ( 19 U.S.C. 2194(b) (6) Consideration (A) In general It is not in order for— (i) the Senate to consider any joint resolution introduced under paragraph (2) unless it has been reported by the Committee on Finance or the committee has been discharged under paragraph (5); or (ii) the House of Representatives to consider any joint resolution introduced under paragraph (2) unless it has been reported by the Committee on Ways and Means or the committee has been discharged under paragraph (5). (B) Motion to proceed in House of Representatives A motion in the House of Representatives to proceed to the consideration of a joint resolution may only be made on the second legislative day after the calendar day on which the Member making the motion announces to the House his or her intention to do so. (7) Rules of Senate and House of Representatives This subsection is enacted by Congress— (A) as an exercise of the rulemaking power of the Senate and the House of Representatives, respectively, and as such is deemed a part of the rules of each House, respectively, and such procedures supersede other rules only to the extent that they are inconsistent with such other rules; and (B) with the full recognition of the constitutional right of either House to change the rules (so far as relating to the procedures of that House) at any time, in the same manner, and to the same extent as any other rule of that House. (g) Application to ministerial changes This section shall not apply with respect to any ministerial changes to a trade agreement.

Summary: Protecting American Innovation Act This bill establishes certain limitations on modifying trade agreements, including those related to the TRIPS Agreement (i.e., the Agreement on Trade-Related Aspects of Intellectual Property Rights). The TRIPS Agreement contains obligations for World Trade Organization members to protect patents and other intellectual property rights. Specifically, the bill prohibits the President (or any U.S. official, employee, or agent) from negotiating or concluding any withdrawal, suspension, or modification to a trade agreement that adversely affects the rights of the United States or U.S. persons under a trade agreement with China or Russia. Additionally, the bill states that a TRIPS waiver to address the COVID-19 pandemic shall not take effect if (1) the President does not submit required reports from the Department of Commerce and the Department of Defense (DOD), (2) the Commerce report concludes that the TRIPS waiver will not result in an increase in global vaccine access, or (3) the DOD report concludes that the TRIPS waiver would adversely impact U.S. national security. Prior to entering into a negotiation with a trading partner concerning a suspension of or modification to a trade agreement, the bill requires (1) the U.S. Trade Representative to publish certain information in the Federal Register and allow for public comment, and (2) the President to provide written notice and consult with Congress. Further, the President shall not enter into any suspension of or modification to a trade agreement unless the President has complied with such consultation requirements and receives congressional approval.