TRIPS Waiver

In fall 2020, the governments of India and South Africa submitted a proposal to the World Trade Organization asking that the multilateral body waive intellectual property protections for Covid-19 vaccines, treatments, diagnostics, and medical devices, as provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Proponents of the waiver claim that suspending IP protections for Covid-19 technologies will expand access to these products worldwide, namely vaccines.

 

But, as the Alliance for Trade Enforcement wrote in a statement condemning the proposal in December 2020, it will do nothing to ramp up Covid-19 vaccine production nor increase access to lifesaving Covid technologies. In fact, as AFTE stated previously, “Adopting this proposal would undermine the very innovators who are working so hard to develop the cures and treatments that we need not just for COVID-19, but for all manner of terrible diseases now and in the future.” The proposed waiver also has the potential to disrupt global supply chains, as more facilities attempt to manufacture vaccines and compete for the inputs, bioreactor bags, glass vials, and shipping materials needed to produce and distribute the Covid-19 vaccine.

 

Dozens of domestic and foreign leaders oppose the proposed waiver due to its lack of short-term benefits and threat of long-term detriments. They include:

 

Chris Coons, a Democrat, represents Delaware in the U.S. Senate and serves as Chair of the Senate Judiciary Subcommittee on Intellectual Property:

“If we were to simply open up to the world all of the IP at the core of these groundbreaking developments, I think we would then be at risk of losing the private sector investment and development that’s critical to this moment of personalized medicine, of breakthrough vaccines, of breakthrough medical diagnostics. And I think, frankly, I think the world would suffer as a result. So as I said, I don’t think that waiving IP rights will suddenly enable other countries the ability to ramp up the manufacturing of complex vaccines.” The Importance of Intellectual Property in Healthcare Innovation during COVID-19, CSIS, April 22, 2021

 

Howard Dean, the former chair of the Democratic National Committee and former governor of Vermont:

“Allowing the World Trade Organization to nullify intellectual property protections on vaccines will not increase short-term production, because companies are already partnering with qualified facilities across the planet to safely manufacture vaccines as quickly as possible.”U.S. Should Give Global Vaccine Effort a Shot in the Arm, Newsweek, June 25, 2021

“India’s petition is a thinly veiled attempt to boost its drug industry. It’d undermine innovation here in the United States and hurt patients around the world for years to come.” India Wants to Copy American Vaccines. Biden Shouldn’t Fall For It., Barron’s, March 11, 2021

 

Mike Crapo, a Republican, represents Idaho in the U.S. Senate and serves as the Ranking Member of the Senate Committee on Finance:

“Chancellor Merkel of Germany asserts, ‘The problem with vaccine distribution is not patents, but manufacturing capacity and production standards.’ Albert Borla, the CEO of Pfizer said ‘the decision will categorically create more problems per vaccine distribution.’ He added that it will be that it will disincentivize anyone else in the future from taking a big risk like Pfizer did laying the groundwork for classic moral hazard. Iconic American innovators like Bill Gates have also said that decision will not advance vaccine distribution. In short, these observers assert a TRIPS waiver will undermine the very objective on which I said the administration showed some progress ending the pandemic.” The President’s 2021 Trade Policy Agenda, U.S. Senate Committee on Finance, May 12, 2021

 

Republican members of the U.S. House of Representatives Committee on Ways and Means, including: Reps. Kevin Brady (TX) Darin LaHood (IL), Devin Nunes (CA), Vern Buchanan (FL), Adrian Smith (NE), Tom Reed (NY), Mike Kelly (PA), Jason Smith (MO), Tom Rice (SC), David Schweikert (AZ), Jackie Walorski (IN), Brad Wenstrup (OH), Jodey Arrington (TX), Drew Ferguson (GA), Ron Estes (KS), Lloyd Smucker (PA), Kevin Hern (OK), and Carol Miller (VA):

“Waiving IP rights will only frustrate ongoing efforts to produce and distribute safe and effective vaccines. The challenges to faster vaccine manufacturing are complex and relate to the technical and logistical barriers to rapidly and safely scaling-up production. To address these challenges, American companies are collaborating on an unprecedented scale to share resources and expertise to address supply chain issues and expand manufacturing capacity as quickly as possible. The misguided proposal before the WTO distracts from addressing these manufacturing issues and logistical hurdles, which constitute actual challenges to getting vaccines and therapeutics to people around the world.”Letter to President Biden, U.S. House of Representatives Committee on Ways and Means Republicans, April 13, 2021

 

Gary Locke, who served as the U.S. Ambassador to China and the U.S. Secretary of Commerce under President Barack Obama. From 1997 to 2005, he served as the Governor of Washington:

“People in developing countries are dying at an alarming rate. They need America and other wealthy nations to do the hard work of expanding manufacturing capacity and distributing vaccines. Some members of Congress seem to think an IP waiver is good politics. But it won’t get shots into arms when people really need it — which is right now.”Weakening IP protections won’t help developing countries fight COVID-19, Seattle Times, September 8, 2021

 

David J. Kappos, who served as the under secretary of commerce for intellectual property and director of the United States Patent and Trademark Office under President Barack Obama, and Paul R. Michel who served as chief judge of the United States Court of Appeals for the Federal Circuit:

“In this moment, leaders and policymakers in the developed world should focus their efforts on helping other nations overcome these challenges, rather than debating the finer points of intellectual property law at the WTO. The latter is a waste of precious time, especially since without intellectual property protections, there might never have been vaccines to debate — at least not yet.”Waiving Covid-19 vaccine patents won’t get shots in arms faster, NBC, May 5, 2021

 

Andrei Iancu, who served as the undersecretary of commerce for intellectual property and director of the U.S. Patent and Trademark Office under President Donald J. Trump:

“Intellectual property protections enabled the creation of ‘people’s vaccines’ in the first place. The choice isn’t between cheap vaccines and even cheaper vaccines — it’s between shots that are protected by strong IP laws or no shots at all.”Biden is trying to undermine America’s world-leading IP protections, Washington Times, August 11, 2021

“The push by India and South Africa appears to be disingenuous, aimed not at curbing the pandemic but at allowing domestic companies to make money off of others’ intellectual property.” – No evidence that patents slow access to vaccines, STAT, April 13, 2021

 

Erik Paulsen, who represented Minnesota’s 3rd congressional district in the U.S. House of Representatives from 2009 to 2019:

“Equally injurious to America, the IP waiver would allow China to become a biotech powerhouse by piggybacking on American innovation. A waiver on IP for COVID-19 vaccines would accelerate the timeline for ‘Made in China 2025.'”We Can Save The World With Our Vaccines — Without Surrendering Our IP To China, International Business Times, July 3, 2021

 

James Pooley, who served as deputy director general of the World Intellectual Property Organization from 2009 to 2014:

“The United States worked for many years to ratify TRIPS, and since then has been pushing back on the populist anti-IP agenda and trying to convince the rest of the world that robust IP regimes can deliver economic development over the long run. Now much of that work will be undone in the process of this chaotic, and ultimately fruitless, waiver discussion.” Drawn-Out Negotiations Over Covid IP Will Blow Back on Biden, MarketWatch, May 26, 2021

 

“The dirty little secret is that the WTO proposal is about more than patents. India also demands that vaccine developers release information about their confidential processes for producing drugs, which would reduce their ability to invest in future research. It would be a huge gift to the generic industries in India, South Africa and elsewhere.”Covid Vaccine Shakedown at the WTO, Wall Street Journal, December 16, 2020

 

Angela Merkel, who has served as Chancellor of Germany since 2005:

“I don’t believe that the waiver of patents is a solution to provide vaccines for more people…Instead, I believe that we need the creativity and innovative force of companies, and for me, this includes patent protection.” ­– EU pushes back on Biden plan to waive coronavirus vaccine patents, Politico, May 8, 2021

 

“For me, the issue of patent protection is not the path that will lead us to more vaccines and better vaccines.” EU pushes back on Biden plan to waive coronavirus vaccine patents, Politico, May 8, 2021

 

“The protection of intellectual property is a source of innovation and it must remain so in the future.” Angela Merkel rejects US move to waive patents on vaccines, Financial Times, May 6, 2021

 

Ursula von der Leyen, who has served as President of the European Commission since 2019:

“We should be open to this discussion, but when we lead this discussion there needs to be a 360-degree view on it, because we need vaccines now for the whole world. And in the short and medium term, the IP waiver will not solve the problems, will not bring a single dose of vaccine in the short and medium term.” EU pushes back on Biden plan to waive coronavirus vaccine patents, Politico, May 8, 2021

“The European Union is the pharmacy of the world and open to the world. Up to today in the European Union, 400 million doses of vaccines have been produced and 50 percent of them — 200 million doses — have been exported to 90 different countries in the world. So we invite others to do the same. This is the best way right now in the short term to approach the bottlenecks and the lack of vaccines worldwide.” EU pushes back on Biden plan to waive coronavirus vaccine patents, Politico, May 8, 2021

 

Valdis Dombrovskis, who has served as European Commission Executive Vice President since 2019:

“[granting the IP waiver] would not help but rather hinder the efforts to ensure the widest distribution of Covid-19 vaccines.” – Politico Weekly Trade, April 19, 2021

“The solutions to rapidly scale up the required manufacturing and distribution of vaccines at this stage can only be delivered through close public-private cooperation and intellectual property is a key element of this equation.” – Politico Weekly Trade, April 19, 2021

 

The Swiss State Secretariat for Economic Affairs (SECO), which oversees national and international economic policy, trade negotiations, and labor policy in Switzerland:

“Like other WTO members, Switzerland remains convinced that a suspension of intellectual property protection rights in the context of the pandemic would not guarantee equitable, affordable and quick access to vaccines, treatments and diagnostic products against Covid-19,” Switzerland pushes back against Covid vaccine patent waiver proposal, The Local, May 7, 2021

 

Simon Manley, who serves as the United Kingdom’s Ambassador and Permanent Representative to the World Trade Organization, United Nations, and other International Organisations:

“Fundamentally, we remain to be convinced how an IP waiver, if agreed, would increase the supply of COVID-19 goods. To date, we have still not seen evidence demonstrating intellectual property as a limiting factor in either the production or the supply of COVID-19 goods.”UK statements during the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council, June 8-9, 2021

“This pandemic is not over and sadly may not be the last one, so we must also consider the long-term consequences of potential short-term action on IP. A key priority for the UK is ensuring the multilateral IP system remains fit-for-purpose to respond both to current and future crises by continuing to encourage innovation and its dissemination. Without that, new vaccines for new pandemics will simply not be developed.” UK statements during the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council, June 8-9, 2021

 

John-Arne Røttingen, MD, PhD, MSc, MPA, who serves as Ambassador for Global Health at the Ministry of Foreign Affairs, Norway:

“John-Arne Røttingen, who chairs the WHO Solidarity Trial of COVID-19 treatments, agrees that technology transfer is crucial, but says that voluntary mechanisms are a better way to achieve this. The patent waiver, he says, is the ‘wrong approach’ to the problem because COVID-19 therapeutics and vaccines are complex biological products in which the main barriers are production facilities, infrastructure, and know-how. ‘IP is the least of the barriers’, he says.” – South Africa and India push for COVID-19 patents ban, The Lancet, December 5, 2020

 

A spokesperson for the Permanent Mission of Norway to the UN and WTO/EFTA in Geneva:

“A balanced and coherent approach requires that both the incentives for the development of new medicines and medical products to tackle covid-19 provided by the availability of intellectual property rights protection – as well as the need for national flexibilities to make exceptions in extreme situations, must be taken into account. The WTO system is in our view already reflecting the required balance in this respect.

To introduce even further and very broad exceptions related specifically to COVID-19 as proposed, seemingly opening for providing no IPR protection at all for covid-19 related products under the discretion of national authorities, would mean a setback for the incentives for innovation in the field of medicines and medical products related to COVID-19, as well as it would provide legal uncertainty with respect to what the relationship would be between such derogation provisions and the already existing provisions on compulsory licensing in TRIPS.

Against this background, Norway believes that the already existing flexibilities of the TRIPS Agreement are sufficient, and cannot support the current proposal.”Norwegian Statement in regard to a proposal from Eswatini, India, Kenya and South Africa for a waiver from certain provisions of the TRIPs agreement for the prevention, containment and treatment of Covid-19, October 16, 2020