Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver – JD Supra

According to a Reuters report published earlier today, the United States, European Union, India, and South Africa have reached an agreement on a waiver with respect to patents for COVID-19 vaccines (see Andrea Shalal and Emma Farge, "U.S., EU, India, S.Africa reach compromise on COVID vaccine IP waiver text," Reuters). Progress on the compromise appears to have been made during a recent meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on March 9-10. In a statement issued by the World Trade Organization (WTO) on March 10, the WTO noted that:

Some of the members participating since December 2021 in the high-level talks the European Union, India, South Africa and the United States expressed cautious optimism about a possible outcome and asked for patience from the rest of the membership. These members said that the small-group discussions continue to take place in good faith, with the objective of finding a landing zone that delivers on the common purpose of ensuring equitable access to vaccines, therapeutics, and diagnostics.

As we reported last year, India and South Africa proposed in the fall of 2020 that the WTO TRIPS Council recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO. The two countries also recommended that "[t]he waiver should continue until widespread vaccination is in place globally." As we reported last May, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."

Although the details of the waiver proposal are still being finalized, and the text of the compromise proposal has not been released, the Biotechnology Innovation Organization (BIO) and U.S. Chamber of Commerce both issued statements this afternoon on the reported compromise. A statement released by Chief Policy Officer John Murphy noted that:

While we have seen the reported outlines of an alleged compromise on the TRIPS waiver, we still need to see and review the full text before rendering a final judgment. However, the irrational fixation on weakening IP is simply a distraction from the real challenge of overcoming global vaccine hesitancy, removing actual trade barriers, and helping countries to strengthen their healthcare infrastructure so that we can get more shots in arms. In 2021 alone, companies produced more than 11 billion doses of COVID vaccines, enough to give two shots to every adult on the planet.

Strong, predictable intellectual property protections are what allowed biopharma companies to produce COVID vaccines and therapeutics in record time. It laid the foundation for cross-border partnerships, global scientific collaboration, and an unprecedented manufacturing scale-up that ensured vaccines could reach every corner of the world. Dismantling the foundation of innovationa strong and predictable IP systemwill only make us less prepared to respond to the next pandemic and weaken our ability to develop new classes of medicines the world needs.

In a statement released by the U.S. Chamber of Commerce Global Innovation Policy Center, Senior Vice President Patrick Kilbride, the Chamber contended that:

This proposal is fundamentally misguided and should be rejected. It ignores that the overwhelming problem is not vaccine production, it is last-mile delivery, and it will erode the ability of innovative companies to develop the cure for the next pandemic or global health threat.

Business is delivering on the promise to manufacture safe and effective COVID-19 vaccines for the whole world. Vaccine production is estimated to reach over 20 billion doses this year, enough for everyone. As of March, over 65% of global population has received at least one dose, and this number is growing every day. Some patients remain hard to reach. Governments and international organizations should avoid political distractions and more quickly achieve comprehensive global vaccination against COVID-19, by focusing on real, practical ongoing issues with last-mile distribution.

Intellectual property waiver proposals distract from the real issues preventing more shots in arms such as logistical hurdles, supply chain bottlenecks, and vaccine hesitancy. Worse yet, dismantling IP rights threatens the licensing arrangements that are enabling rapid global production and technology transfer. Any WTO action undermining IP will harm multiple U.S. industries, who are global leaders in their fields, and who depend on IP protections. Any agreement of this kind would bargain away US competitiveness.

For additional information regarding this topic, please see:

"Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver," December 12, 2021 "U.S. Trade Representative Responds to Letters from Senators Regarding TRIPS Waiver," November 14, 2021 "U.S. 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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Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver - JD Supra