US Chamber of Commerce Supports House and Senate Legislation Prohibiting Biden Administration from Negotiating Modifications to WTO TRIPS Agreement Without Congressional Authorization

By Donald Zuhn —

Earlier this month, the US Chamber of Commerce sent a letter to members of Congress indicating that the Chamber “strongly supports” recent House and Senate legislation that the Chamber noted “would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress.” The Chamber contended that “[i]international negotiations on IP, focused on undermining the WTO TRIPS agreement, are fundamentally misguided,” suggesting that “[a]ny agreement that innovatives IP companies would limit the ability of innovative IP companies to develop the cure for the next pandemic or global health threat and bargain away US competitiveness.” According to the chamber, the global community should “focus on the overwhelming problem instead of vaccine distribution ,” as well as “the real issues preventing more shots in arms, such as logistical hurdles, supply chain bottlenecks, and vaccine hesitancy.”

The House and Senate bills that have garnered the support of the Chamber are the “Protecting American Innovation Act” (HR 7430) and the “No Free TRIPS Act” (S. 4063), which were introduced on April 6, 2022 and April 7 , 2022, respectively. HR 7430 was introduced by Rep. Adrian Smith (R-NE) and co-sponsored by Rep. Vern Buchanan (R-FL), Rep. Drew A. Ferguson, IV (R-GA), Rep. Jackie Walorski (R-IN), Rep. Darin LaHood (R-IL), Rep. Brad R. Wenstrup, Brad (R-OH), Rep. Gregory Murphy (R-NC), Rep. Ron Estes (R-KS), Rep. Carol D. Miller (R-WV), Rep. Lloyd Smucker (R-PA), and Rep. Kevin Hern (R-OK). S. 4063 was introduced by Sen. Marsha Blackburn (R-TN) and co-sponsored by Sen. Thomas Tillis (R-NC), Sen. Tommy Tuberville (R-AL), Sen. Kevin Cramer (R-ND), Sen. Bill Hagerty (R-TN), Sen. Cynthia M. Lummis (R-WY), Sen. Marco Rubio (R-FL), and Sen. Mike Lee (R-UT).

House of Representatives SealThe longer of the two bills, HR 7430, which is intended”[t]o establish limitations on modifications to trade agreements,” would prevent the President from “enter[ing] into any suspension of or modification to a trade agreement,” unless the President complied with all of the consultation requirements set forth in the Act and Congress either enacted legislation or adopted a resolution approving of the suspension or modification. The House bill sets forth several findings of Congress, including the following:

• “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.”

• “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’.”

• “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.”

• “Innovators in the United States successfully and rapidly brought to fruition vaccines that provide highly effective protection against COVID-19.”

• “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.”

• “Many experts on vaccine production and distribution are warning that waiving intellectual property protections will general 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.”

• “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.”

• “The Trade Representative has not explained how a waver of the TRIPS Agreement will expand vaccine production and access . . . .”

• “Waiving intellectual property protections . . . raises serious economic and national security concerns.”

The House bill also indicates the sense of Congress as including the following:

• “intellectual property protections for COVID–19 vaccines have not impeded vaccination efforts for COVID–19;”

• “intellectual property protections in fact help ensure the safe and efficient manufacturing of COVID–19 vaccines;”

• “waiving intellectual property protections could lead to the production of substandard, ineffective, and potentially unsafe COVID–19 vaccines;”

• “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;” and

• “the United States must oppose any wavever to intellectual property obligations under the TRIPS Agreement for the response to the COVID–19 pandemic until those implications are fully analyzed.”

Among the “consultation requirements” set forth in the House bill are two reports to be submitted to Congress. One report would be prepared by 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, and would assess the impact of a TRIPS wave on the following:

(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[.]

The other report would be prepared by the Secretary of Defense, in consultation with the Secretary of Commerce, the Secretary of Health and Human Services, and the Trade Representative, and would determine the effects of a TRIPS waiver with respect to addressing the COVID–19 pandemic on US national security.

The House bill would also require the US Trade Representative to publish a notice in the Federal Register identifying the objectives of any trade agreement negotiation, the rationale for why the trade agreement does not allow the US to meet those objectives, and the provisions of the trade agreement that would be suspended or modified. In addition, the bill would require the US Trade Representative to:

[C]onsult 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. . . .

The bill also calls for the International Trade Commission to publish a report on the suspension or modification of any provisions of the trade agreement being proposed by the US Trade Representative and to conduct a public hearing on the proposal.

Senate SealS. 4063, by comparison, is far more concise. In particular, the bill states that:

The President, and any official, employee, or agent of the United States, may not negotiate or conclude any withdrawal, suspension, waiver, or modification to the TRIPS Agreement without obtaining explicit authorization from Congress before beginning negotiations with respect to that withdrawal, suspension , or modification.

HR 7430 has been referred to the House Ways and Means and House Rules committees. S. 4063 has been referred to the Senate Finance committee.

For additional information regarding this topic, please see:

• “Senators Send Letter to Commerce Secretary Regarding WTO Waiver Compromise,” March 28, 2022
• “The Proposed WTO IP Waiver: Just What Good Can It Do? — An Analysis,” March 24, 2022
• “IP Associations ‘Concerned’ by Reports of TRIPS Waiver Compromise,” March 24, 2022
• “More on Leaked WTO COVID-19 Vaccine Patent Waiver Compromise,” March 21, 2022
• “Comromise Reportedly Reached on COVID-19 Vaccine Patent Waiver,” March 16, 2022
• “Sen. Tillis Writes to US Trade Representative (Again) regarding TRIPS Waiver,” December 12, 2021
• “US Trade Representative Responds to Letters from Senators regarding TRIPS Waiver,” November 14, 2021
• “US Chamber of Commerce Urges Administration to ‘Double Down’ on Global Vaccine Distribution,” November 3, 2021
• “Is This the WTO Waiver End Game?” July 25, 2021
• “BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP,” June 24, 2021
• “GOP Legislators Write in Opposition to Proposed TRIPS Waiver,” May 16, 2021
• “Population of Patents at Risk from Proposed WTO Patent Waiver,” May 12, 2021
• “Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver,” May 12, 2021
• “Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver,” May 10, 2021
• “If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?” May 9, 2021
• “The Road to Hell Is Paved with What Everybody Knows,” May 6, 2021
• “BIO & IPO Issue Statements on Biden Administration’s Support for Proposed WTO Waiver,” May 6, 2021
• “Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines,” May 5, 2021
• “Suspending IP Protection: A Bad Idea (That Won’t Achieve Its Desired Goals),” April 26, 2021
• “Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal,” April 21, 2021
• “IP Organizations Support Continued Opposition to Waiver Proposal,” April 5, 2021
• “Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal,” March 29, 2021
• “BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver,” March 11, 2021
• “IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect,” January 4, 2021

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