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.”

 

Dozens of domestic and foreign leaders and stakeholders oppose the proposed waiver due to its lack of short-term benefits and threat of long-term detriments. Many have also affirmed that intellectual property protections have not hindered vaccine production or distribution – and that the problem facing global vaccination efforts now isn’t a lack of vaccine supply, but rather, vaccine hesitancy and inadequate infrastructure. They include:

 

President Joseph R. Biden,

“We have also moved to do more. For example, we’ve provided more vaccines, as I said, than all other countries in the world combined. And we’ve provided significant vaccines as well to South Africa and that region. As a matter of fact, South Africa doesn’t need any more vaccines; they’re having trouble getting it out into people’s arms, and the reluctance is there.” – Remarks by President Biden Providing an Update on the Omicron Variant, The White House, 11/29/2021

 

Antony Blinken, 71st Secretary of State:

“First, and most important, we’ve got to continue to get more shots into more arms more quickly. That means addressing equity gaps by increasing access to effective vaccines around the world. But we know that increasing supply by itself is not enough to turn vaccines into vaccinations. We must also solve last-mile challenges, like access to cooling technologies for vaccines in transit.” – Secretary Antony J. Blinken at a Virtual COVID-19 Global Action Meeting, 2/14/2022

 

“Right now we have a relative abundance of actual vaccines. What the challenge that we have is, as you said, getting shots into arms, there are many places around the world, nowhere, more so than in Africa with real challenges in making sure that there is cold storage, that their distribution networks, that there are healthcare workers and other experts who could administer the vaccines. Basically with the last mile, we also have real information or misinformation problems, and that contributes to vaccine hesitancy.” – Sec. Blinken speaking before the Senate Foreign Relations Committee, 4/26/2022

 

Jen Psaki, White House Press Secretary:

“Those doses are getting harder to place because countries’ reserves are simply full, We have tens of millions of unclaimed doses because countries lack the resources to build out their cold chains, which basically is the refrigeration systems, to fight disinformation, and to hire vaccinators.” – Failure to address a global surplus of COVID vaccines raises the risk of new variants emerging, health experts warn, Fortune, 5/11/2022

 

Kate O’Brien, Director of Department of Immunization, Vaccines, and Biologicals, World Health Organization (WHO):

“There is plenty of supply now—the real question is doing everything possible to support delivery in countries that are still lagging.”  – Failure to address a global surplus of COVID vaccines raises the risk of new variants emerging, health experts warn, Fortune, 5/11/2022

 

Jeremy Konyndyk, executive director of the COVID task force for the U.S. Agency for International Development:

“The supply issue now is mostly resolved. The challenge has been in a lot of low-income countries. They haven’t had the resources and the technical support to do something they haven’t ever needed to do before: vaccinate their adult populations…” Why this USAID official is optimistic the U.S. can get the world vaccinated, NPR, 2/15/2022

 

Bill Gates, founder of Microsoft and philanthropist committed to eradicating infectious disease through the Bill & Melinda Gates Foundation:

“But if you want to stifle the inventive spirit in the pharmaceutical industry, then the suspension of patents is brilliant. You should always threaten that the companies will not have patent protection.” Gates on patent suspension for Covid vaccines: “The stupidest thing I’ve ever heard”, Focus, 10/29/2021

 

Joe Crowley, who represented New York’s 7th and 14th congressional districts in the U.S. House of Representatives from 1999 to 2019:

“The idea of waiving IP rights makes less sense every day. And doing so would have serious downsides: Strong IP protections ensure long-term investment in pharmaceuticals and many other industries.” Why Healthcare Infrastructure, Not Intellectual Property, Is Key To Defeating COVID, International Business Times, 2/6/2022

 

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

“It signals that the United States is willing to play footsie with India and South Africa on this essential sort of lie, that pulling back on patent protections globally will somehow solve more problems than it creates, and that’s a delusion. And we’re buying into it. That itself will have a dampening effect on the willingness of companies to invest in technologies.” U.S. Buying Into Covid Patent Waiver ‘Delusion,’ Critics Say, Bloomberg Law, 3/17/2022

“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, 5/26/2021

“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, 12/16/2022

 

Republican members of the U.S. Senate Judiciary Committee, Thom Tillis (NC), Tom Cotton (AK), and Marsha Blackburn (TN):

“If implemented, this disastrous plan would destroy high-paying American jobs while handicapping our nation’s ability to develop life-saving medicines in the future. Moreover, waiving intellectual property rights would enable any company or government – including hostile actors like China and Russia – to simply steal cutting-edge American technology.”– Letter to Secretary of Commerce Gina Raimondo, U.S. Senate, 3/23/2022

 

Thomas Kubic, former deputy assistant director of the Federal Bureau of Investigations and former president of the nonprofit Pharmaceutical Security Institute:

“A TRIPS agreement waiver could open the floodgates for all sorts of manufacturers and marketers, large and small, to pump substandard vaccine products into the marketplaces of multiple countries. With narrowing profit margins, the temptation to cut corners on safety will be ever-present. This can easily lead to a frenetic vaccine bazaar of sorts in which counterfeits and defective products could all too rapidly gain a foothold, particularly in countries with little regulation and poorly organized supply chains. For law enforcement to try to police vaccine sanctity and safety in this kind of environment would be incredibly challenging, and would potentially prolong the pandemic indefinitely.” COVID-19 Vaccine Counterfeiting is a Growing Problem. Let’s Not Make It Worse, InsideSources, 11/28/2021

 

Chris Coons, a Democrat, who 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, 4/22/2021

 

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, 6/25/2021

“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, 3/11/2021

 

Seth Berkley, CEO of the Gavi vaccine alliance and point person on the global COVAX initiative:

Most poor countries can absorb all the doses they’re receiving, but when they run their weekly assessments “between 18 and 24 countries come up red.” The challenges range from shortages of supplies like syringes or health care workers to utilize them, issues with the “cold chain” needed to transport and store Pfizer and Moderna doses, vaccines hesitancy, or inadequate logistical planning. – The next big bottleneck in the global vaccination effort, Axios, 11/27/2021

 

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, 5/12/2021

 

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, 4/13/2021

 

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, 9/8/2021

 

Gary Locke, who served as U.S. Ambassador to China and later as the U.S. Secretary of Commerce under President Barack Obama; David J. Kappos, who served as undersecretary of commerce for intellectual property and director of the United States Patent and Trademark Office under President Barack Obama; and 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:

“While voiding IP protections would not increase vaccine production, doing so would strike a severe blow against the United States’ world-leading biotech industry—and the incentives to discover cures for dreaded diseases and future pandemics.” – The Shot Heard around the World: The Strategic Imperative of U.S. Covid-19 Vaccine Diplomacy, CSIS, 11/17/2021

 

David J. Kappos, who served as the undersecretary 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, 5/5/2021

 

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, 8/11/2021

“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, 4/13/2021

 

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, 7/3/2021

 

Charles Boustany, a retired physician who represented Louisiana’s 3rd congressional district in the U.S. House of Representatives from 2005 to 2017:

“…advocates for ending IP rights misrepresent how our system actually works. It may be fashionable to vilify companies for seeking to make a profit. But the fact is, private investment, risk-taking, and the chance to make a return are crucial to the drug development process. No one would invest if they knew governments could nullify the IP protections that prevent the end product from being stolen. But thanks to these laws, the biopharmaceutical industry delivers new and better drugs every year, for killers like heart disease, Alzheimer’s, and cancer. Not to mention vaccines against novel deadly viruses.” – No, Pharmaceutical Companies Are Not ‘War Profiteers’, RealClearPolicy, 11/22/2021

 

Adam Mossoff, Chair of the Forum for Intellectual Property at the Hudson Institute and George Mason University Law School professor:

“The signal that the IP waiver sends to all innovators is that the moment there is a crisis and the byproducts of the fruits of your inventive labors are now needed, they will be taken from you.” – COVID IP Waiver Compromise Bashed By All Sides, Law360, 3/15/2022

 

Carl E. Schmidd II, Executive Director of the HIV+Hepatitis Policy Institute and Marcia K. Horn, J.D., President and CEO of ICAN, International Cancer Advocacy Network:

“Not only would such a waiver [on IP rights] have a devastating impact on medical innovations that are crucial to the world’s ability to find new and more effective treatments and cures, but the Office of the United States Trade Representative (USTR) has also failed to follow established procedures that are meant to give patient communities, the public, and all stakeholders the fair and just opportunity to provide input and participate in the development of trade policy and trade initiatives.” – Continued Opposition to COVID-19 Vaccine Intellectual Property Waiver Proposed at the World Trade Organization TRIPS Council, Letter to USTR Ambassador Tai, 11/24/2021

 

Center for Strategic and International Studies, Washington, D.C.-based nonpartisan leading national security think tank in the world:

“Vaccine diplomacy has never been more important. Yet, the United States has been slow to seize the opportunity while geopolitical rivals eagerly fill the gap.” – CSIS Twitter, 11/18/2021

 

Center for Strategic and International Studies Renewing American Innovation Project, project at the Center for Strategic and International Studies committed to sustaining U.S. competitiveness and innovation:

“Forcing vaccine makers to give up intellectual property will not lower barriers; it will only create new ones.”  CSIS Renewing American Innovation Project Twitter, 11/17/2021

 

International Federation of Pharmaceutical Manufacturers & Associations, Geneva-based global advocate for the world’s research-based biopharmaceutical companies, and regional and national associations:

“The IP TRIPS Waiver proposals should be recognized for what they are – political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics.” – IFPMA statement on TRIPS discussion document, 3/16/2022

 

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations:

“Biopharmaceutical companies reaffirm their position that weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal,” – WTO chief welcomes COVID shot patent plan, drugmakers balk, Reuters, 3/16/2022

 

Patrick Kilbride, Senior Vice President of the U.S. Chamber of Commerce Global Innovation Policy Center:

“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.” – U.S. Chamber of Commerce Opposes Proposal at WTO to Waive Intellectual Property Rights, 3/16/2022

 

Adrian Smitha Republican, represents Nebraska in the U.S. House of Representatives and serves as the Ranking Member of the Ways & Means Subcommittee on Trade:

“We must protect the intellectual property that is at the heart of America’s innovation engine. Pursuing a TRIPS waiver, without Congressional approval, hands over cutting-edge American IP to China, Russia, and other nefarious actors without any analysis of how the waiver would vaccinate the world better than addressing other barriers. It is unacceptable.” – The President’s 2022 Trade Policy Agenda, U.S. House of Representatives Committee on Ways and Means, 3/30/2022

 

Gayle Smith, who served as Coordinator for Global COVID Response and Health Security at the Department of State and is current CEO of the ONE Campaign:

“The problem is that a lot more money is needed for the steps required to get shots into people’s arms: storage, transportation, health workers, campaigns to counter misinformation.” – The goal: Vaccinate 70% of the world against COVID. Scientists are proposing a reboot, NPR, 3/14/2022

 

Angela Merkel, who served as Chancellor of Germany from 2005 to 2021:

“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, 5/8/2021

“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, 5/8/2021

“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, 5/6/2021

 

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, 5/8/2021

“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, 5/8/2021

 

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, 4/19/2021

“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, 4/19/2021

 

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, 5/7/2021

 

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, 6/8 – 6/9/2021

“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, 6/8 – 6/9/2021

 

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, 12/5/2020

 

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, 10/16/2020