Protecting American Innovation Act

I 117TH CONGRESS 1ST SESSION H. R. 3788 To establish limitations on modifications to trade agreements, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 8, 2021 Mr. NUNES 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 com- mittee concerned A BILL To establish limitations on modifications to trade agreements, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Protecting American 4 Innovation Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 (1) Section 8 of article I of the United States 8 Constitution provides Congress with authority over 9 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 3788 IH international trade. Congress has used that author- 1 ity to approve a number of trade agreements, includ- 2 ing the WTO Agreement. 3 (2) Section 8 of article I of the United States 4 Constitution provides Congress with authority to 5 provide intellectual property protections in order to 6 ‘‘promote the progress of science and useful arts’’. 7 People in the United States rely on those protections 8 to support jobs and continue the highly successful 9 leadership of the United States with respect to inno- 10 vation. 11 (3) The United States may not withdraw or 12 otherwise alter the rights and obligations for the 13 United States arising from a congressionally ap- 14 proved trade agreement without the consent of Con- 15 gress. 16 (4) The United States is a global leader in con- 17 taining and ending the COVID–19 pandemic. 18 (5) Innovators in the United States successfully 19 and rapidly brought to fruition vaccines that provide 20 highly effective protection against COVID–19. At fa- 21 cilities across the United States, thousands of 22 United States workers are working around the clock 23 to manufacture COVID–19 vaccines, contributing to 24 the rapid, global scale up of manufacturing that is 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 3788 IH expected to reach at least 10,000,000,000 doses by 1 the end of 2021. 2 (6) The United States is a founding member of 3 the World Trade Organization. The United States 4 has secured and supported critical commitments in 5 the WTO for protection of intellectual property of 6 United States persons and globally, including under 7 the Trade-Related Aspects of Intellectual Property 8 Rights Agreement or the TRIPS Agreement. 9 (7) In implementing the Uruguay Round, Con- 10 gress established under section 315 of the Uruguay 11 Round Agreements Act (19 U.S.C. 3581) that it is 12 the objective of the United States to ‘‘accelerate the 13 implementation’’ of the TRIPS Agreement and to 14 ‘‘seek enactment and effective implementation by 15 foreign countries of laws to protect and enforce in- 16 tellectual property rights that supplement and 17 strengthen the standards’’ of the TRIPS Agreement. 18 (8) Longstanding intellectual property protec- 19 tions are critical to efforts by the United States and 20 the biopharmaceutical industry to develop and man- 21 ufacture vaccines for both people in the United 22 States and around the world. 23 (9) The United States is committed to pro- 24 viding global access to COVID–19 vaccines. 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 3788 IH (10) In order to accelerate production and dis- 1 tribution of COVID–19 vaccines, biopharmaceutical 2 manufacturers in the United States are collaborating 3 at a scale that previously was unimaginable, includ- 4 ing by entering into hundreds of voluntary manufac- 5 turing, production, and other partnerships around 6 the world. 7 (11) Manufacturing each of the COVID–19 8 vaccines involves highly specialized and unique infra- 9 structure and equipment, as well as highly trained 10 and experienced personnel. Manufacturing and dis- 11 tributing safe and effective COVID–19 vaccines on 12 a global scale is incredibly challenging. Many experts 13 on vaccine production and distribution are warning 14 that waiving intellectual property protections will un- 15 dermine the global response to the COVID–19 pan- 16 demic and compromise vaccine safety, including by 17 disrupting the distribution of scarce raw materials 18 for vaccines that existing vaccine makers with prov- 19 en track records for delivering high-quality, safe, 20 and effective vaccines need to continue their own 21 production. 22 (12) The United States Trade Representative 23 announced without any consultation with Congress 24 that the United States will support a waiver of intel- 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 3788 IH lectual property protections under the TRIPS Agree- 1 ment for COVID–19 vaccines. That decision is not 2 consistent with the intellectual property negotiating 3 objectives of the United States set forth in section 4 315 of the Uruguay Round Agreements Act (19 5 U.S.C. 3581). 6 (13) That waiver announcement created confu- 7 sion, and raised concerns that a successful effort to 8 suspend protections will weaken already strained 9 supply chains and foster the proliferation of ineffec- 10 tive and potentially dangerous vaccines. 11 (14) The Trade Representative has not ex- 12 plained how a waiver of the TRIPS Agreement will 13 expand vaccine production and access, particularly 14 considering that the major impediments to vaccina- 15 tion efforts include the following: 16 (A) The difficulty in meeting the technical 17 specifications of production and appropriately 18 ensuring that finished vaccines are high-quality, 19 safe, and effective. 20 (B) The scarcity of raw materials for the 21 vaccines. 22 (C) Last-mile distribution and cold-chain 23 storage. 24 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 3788 IH (D) Trade barriers to the free flow of in- 1 puts and finished products. 2 (15) The Government of the People’s Republic 3 of China and the Government of the Russian Fed- 4 eration are engaged in large scale industrial espio- 5 nage and technology theft of intellectual property of 6 United States persons. The Department of Justice 7 has issued indictments in connection with attempts 8 sponsored by the Government of the People’s Repub- 9 lic of China to steal United States vaccine research 10 with respect to COVID–19. 11 (16) The Government of the People’s Republic 12 of China and the Government of the Russian Fed- 13 eration are using their vaccines as part of diplomatic 14 efforts that may be contrary to the national security 15 interests of the United States. Vaccines for COVID– 16 19 manufactured by persons in the People’s Repub- 17 lic of China and the Russian Federation appear to 18 be less efficacious than those manufactured by pro- 19 ducers in the United States. The Academy of Mili- 20 tary Science, the scientific arm of the military of the 21 People’s Republic of China, is sponsoring the prin- 22 cipal effort by the People’s Republic of China to de- 23 velop its own mRNA vaccine. 24 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 3788 IH (17) At a hearing before the Committee on Fi- 1 nance of the Senate on May 12, 2021, the Trade 2 Representative would not commit either— 3 (A) to ensure that any waiver of the 4 TRIPS Agreement would exclude the People’s 5 Republic of China and the Russian Federation; 6 or 7 (B) to ensure that Congress has advance 8 access to the negotiating proposals of the 9 United States for any such waiver. 10 (18) The innovative biopharmaceutical compa- 11 nies in the United States contribute more than 12 $1,100,000,000,000 annually to the United States 13 economy, and employ more than 500,000 workers 14 making 1.4 times the average earnings in the United 15 States, including 153,000 workers who do not have 16 a college degree. 17 (19) Waiving intellectual property protections, 18 particularly of the mRNA technology platform in 19 which the Defense Advanced Research Project Agen- 20 cy invested not less than $250,000,000, raises seri- 21 ous economic and national security concerns. 22 SEC. 3. SENSE OF CONGRESS. 23 It is the sense of Congress that— 24 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 3788 IH (1) the United States should continue to act as 1 a global leader to help contain and end the COVID– 2 19 pandemic at home and abroad; 3 (2) innovators in the United States are already 4 heroes for their breakthrough work in developing 5 and producing COVID–19 vaccines; 6 (3) it should be a priority of the global commu- 7 nity, with the assistance of the United States, to ef- 8 ficiently and quickly manufacture and distribute 9 COVID–19 vaccines around the world, and in par- 10 ticular to those countries that are most vulnerable; 11 (4) current impediments to further vaccination 12 efforts are due to— 13 (A) the technically difficult manufacturing 14 requirements for vaccines; 15 (B) the need to appropriately ensure that 16 vaccines are high-quality, safe, and effective; 17 (C) raw material constraints; and 18 (D) difficulties in distribution; 19 (5) intellectual property protections for 20 COVID–19 vaccines have not impeded vaccination 21 efforts for COVID–19; 22 (6) intellectual property protections in fact help 23 ensure the safe and efficient manufacturing of 24 COVID–19 vaccines; 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 9 •HR 3788 IH (7) waiving intellectual property protections 1 could lead to the production of substandard, ineffec- 2 tive, and potentially unsafe COVID–19 vaccines; 3 (8) the Trade Representative must consult with 4 Congress before taking a position on the current 5 TRIPS Agreement waiver proposal before the WTO 6 and any further proposals to waive or weaken intel- 7 lectual property obligations under the TRIPS Agree- 8 ment; 9 (9) Congress and the people of the United 10 States are entitled to comprehensive expert analysis 11 regarding the implications of a waiver to the TRIPS 12 Agreement for jobs, economic growth, public health, 13 and national security in the United States; and 14 (10) the United States must oppose any waiver 15 to intellectual property obligations under the TRIPS 16 Agreement for the response to the COVID–19 pan- 17 demic until those implications are fully analyzed. 18 SEC. 4. DEFINITIONS. 19 In this Act: 20 (1) APPROPRIATE CONGRESSIONAL COMMIT- 21 TEES.—The term ‘‘appropriate congressional com- 22 mittees’’ means the Committee on Finance of the 23 Senate and the Committee on Ways and Means of 24 the House of Representatives. 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 10 •HR 3788 IH (2) COMMISSION.—The term ‘‘Commission’’ 1 means the United States International Trade Com- 2 mission. 3 (3) MINISTERIAL CHANGE.—The term ‘‘min- 4 isterial change’’, with respect to a trade agreement, 5 means a change to address a clerical, typographical, 6 or grammatical error and does not include any 7 change that would change the intended rights or ob- 8 ligations of a party to the trade agreement. 9 (4) OFFICIAL ADVISOR.—The term ‘‘official ad- 10 visor’’ means a person accredited by the Trade Rep- 11 resentative on behalf of the President as an official 12 adviser to the United States delegations to inter- 13 national conferences, meetings, and negotiating ses- 14 sions relating to international trade negotiations, 15 and who may attend any portion of those negotia- 16 tions. 17 (5) COVID–19 PANDEMIC.—The term 18 ‘‘COVID–19 pandemic’’ means the outbreak of novel 19 coronavirus (COVID–19) that was declared by the 20 World Health Organization on March 11, 2020, to 21 be a pandemic. 22 (6) STATE SPONSOR OF TERRORISM.—The term 23 ‘‘state sponsor of terrorism’’ means a country the 24 government of which the Secretary of State has de- 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 11 •HR 3788 IH termined is a government that has repeatedly pro- 1 vided support for acts of international terrorism, for 2 purposes of— 3 (A) section 1754(c)(1)(A)(i) of the Export 4 Control Reform Act of 2018 (50 U.S.C. 5 4813(c)(1)(A)(i)); 6 (B) section 620A of the Foreign Assistance 7 Act of 1961 (22 U.S.C. 2371); 8 (C) section 40(d) of the Arms Export Con- 9 trol Act (22 U.S.C. 2780(d)); or 10 (D) any other provision of law. 11 (7) TRADE AGREEMENT.—The term ‘‘trade 12 agreement’’ means any trade agreement to which the 13 United States is a party that has been approved by 14 Congress, including the TRIPS Agreement. 15 (8) TRADE REPRESENTATIVE.—The term 16 ‘‘Trade Representative’’ means the United States 17 Trade Representative. 18 (9) TRIPS AGREEMENT.—The term ‘‘TRIPS 19 Agreement’’ means the Agreement on Trade-Related 20 Aspects of Intellectual Property Rights referred to in 21 section 101(d)(15) of the Uruguay Round Agree- 22 ments Act (19 U.S.C. 3511(d)(15)). 23 (10) TRIPS WAIVER.—The term ‘‘TRIPS waiv- 24 er’’ means any waiver of an obligation imposed on 25 VerDate Sep 11 2014 00:55 Jul 14, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3788.IH H3788 pbinns on DSKJLVW7X2PROD with BILLS 12 •HR 3788 IH members of the World Trade Organization under the 1 TRIPS Agreement. 2 (11) WORLD TRADE ORGANIZATION; WTO; WTO 3 AGREEMENT.—The terms ‘‘World Trade Organiza- 4 tion’’, ‘‘WTO’’, and ‘‘WTO Agreement’’ have the 5 meanings given those terms in section 2 of the Uru- 6 guay Round Agreements Act (19 U.S.C. 3501). 7 SEC. 5. PROHIBITION ON COMPROMISING UNITED STATES 8 TRADING RIGHTS TO CHINA AND RUSSIA. 9 (a) PROHIBITION ON WITHDRAWAL, SUSPENSION, OR 10 MODIFICATION.— 11 (1) IN GENERAL.—The President, and [Text truncated for display. Full text available on Congress.gov.]