“[T]here are lots of reasons to believe that the ‘waiver’ is more good politics than anything else. Vaccinating the planet will still depend on exporting hundreds of millions, probably billions, of doses from the U.S., Europe and India, not on a loosening of any patent rights.” – Justin Hughes, LMU Loyola Law School
Bloomberg first reported today that U.S. Trade Representative Katherine Tai said that the United States will back a proposal by India and South Africa last year to waive intellectual property protections under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposal calls for the suspension of international protections for patents, copyrights, industrial designs, trade secrets and proprietary materials, “in relation to the prevention, containment, or treatment of COVID-19 until widespread vaccination is in place globally and the majority of the world’s population has developed immunity.”
Tai reportedly said “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”
The Bloomberg report added that the Biden administration will take an active role in the negotiations on the text of the waiver and “encourage other countries to back it.”
In the USTR’s formal statement issued later on Wednesday, Tai added:
This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen. Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.
The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible. As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts – working with the private sector and all possible partners – to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines.
IPWatchdog has published many perspectives on this issue. Most in the IP community feel the solution is shortsighted and will not produce the desired results. Earlier today, Eva Bishwal of Uttar Pradesh, India-based Fidus Law Chambers wrote that “the real blockades to vaccine access are state inaction, dearth of raw materials and low production capacity.
Hans Sauer, Deputy General Counsel and Vice President for Intellectual Property at the Biotechnology Innovation Organization (BIO), explained that the proposal presents many practical problems, including that:
Even if it were to pass out of the WTO, the waiver would still have to be implemented under the national laws of the WTO member countries. No explanation has been provided as to how up to 164 countries would be expected to quickly amend multiple statutes in their legal codes, or which form these amendments would take. Curiously, close to half of the waiver-supporting countries are already exempt from TRIPS anyway, and are effectively demanding to be free of rules that don’t apply to them.The most likely result of the proposed waiver would be a chaotic global patchwork of national laws that would linger at various stages of national implementation for years after the end of the pandemic.
Patrick Kilbride of the Global Intellectual Property Center at the U.S. Chamber of Commerce wrote:
Weakening intellectual property protections, as the WTO waiver proposal would do, will not increase access to the tools we need to fight COVID-19; in fact, they would hinder access to the COVID-19 tools we’ve discovered already, and it will stop the search for new tools right in its tracks. Put simply, weakening intellectual property protections won’t help us, and it will hurt us.
Others have taken a less dire view of the proposal. Rachel Thrasher of the Boston University Global Development Policy Center wrote in March that innovation would survive a TRIPS waiver:
In a world where the standard approaches are not doing enough, the TRIPS Waiver is a necessary first step toward facilitating increased, rapid production of vaccines. Rather than undermining the value of innovation or making it less likely in the future, the proposal demonstrates how, for many countries, the traditional balance between innovation and access has tipped toward prioritizing access for the time being.
But many in the IP community will undoubtedly be upset over the remarks. IPWatchdog founder and CEO Gene Quinn said the announcement “signals dark days ahead for the IP world under the Biden Administration”:
If it were not for innovators supported by intellectual property rights, we would never have been in a position to have the vaccine within a year. This is a head in the sand decision by those who care more about being politically correct than being right. Patent owning corporations were already doing everything they could and patent rights were not getting in the way of anyone getting the vaccine. Will this make it easier or quicker for anyone to be vaccinated? No! This is a mistake of epic proportions. Cutting out the innovators and manufacturers will not result in safe vaccines around the world; it is the equivalent of playing Russian roulette with the health of those in undeveloped countries.
Statements on both sides have come in throughout the evening. Here are a few:
Senators Thom Tillis (R-NC) and Tom Cotton (R-AR):
Today’s disastrous decision by President Biden will do little to end the COVID-19 pandemic and help developing nations, but it will hand over America’s medical technology to adversarial states like China and Russia. We support distributing vaccines to countries that need them, but not in a way that jeopardizes America’s successful vaccine development. It’s astonishing that President Biden is now providing the Chinese Communist Party with access to America’s intellectual property, medical research, and innovation.
Justin Hughes, LMU Loyola Law School:
This represents a major change in U.S. policy, one that shows the willingness of the Biden administration to engage with partners internationally to bring an end to the pandemic. But there are lots of reasons to believe that the ‘waiver’ is more good politics than anything else. Vaccinating the planet will still depend on exporting hundreds of millions, probably billions, of doses from the U.S., Europe and India, not on a loosening of any patent rights.
U.S. Chamber of Commerce Executive Vice President and Chief Policy Officer, Neil Bradley:
The administration has gotten this issue wrong; undermining intellectual property rights for complex, hard to manufacture vaccines will not accelerate global production, instead it will take us off track in the ongoing and successful efforts to license and scale global production of vaccines that individuals can be confident are safe and effective. Make no mistake, this move will undermine the global fight against COVID and it will diminish our ability to prepare for and respond to the next pandemic. We urge the administration to reverse course and work with the business community to deliver on the President’s recent promise to make America the ‘arsenal of vaccines.’
Sean Flynn, Director of American University’s Program on Information Justice and Intellectual Property:
Over a year into the COVID-19 pandemic, with a fraction of the world having received available vaccines, it’s time for the members of the WTO to quickly draft a WTO TRIPS waiver to remove all intellectual property barriers in order to stop the COVID-19 pandemic. Emergency measures opening up greater access to vaccines, treatments and research would benefit the entire world and bring us closer to the end of the pandemic…. The statement implicitly supports an intellectual property waiver beyond patents. By signaling support for a waiver of ‘intellectual property for COVID-19 vaccines,’ the statement would presumably extend, for example, to the copyright protection that can exist on the computational algorithms needed to produce mRNA vaccines.
Dr. Kevin P. Gallagher, Director of the Boston University Global Development Policy Center and Professor of Global Development Policy at Boston University:
President Biden took a bold and important step today by choosing multilateralism and humanity over special interest group pressure both inside and outside of his administration. This is a breakthrough that will help the world attack the virus on a global scale so we can collectively focus on building back a better global economy and the set of rules to govern it. The EU, UK, Brazil, Norway and Japan need to follow suit and put humanity first over special interests.
Re:Create Executive Director Joshua Lamel:
U.S. support for the WTO TRIPS waiver is a momentous step forward for balancing intellectual property with the needs of our society at this historic time. Re:Create is encouraged to see the Biden Administration support expanding access to COVID care around the world. This decision puts the lives of people above the interests of IP lobbyists.
But it’s important to remember that the WTO TRIPS Waiver should cover more than just vaccines – it should cover other important issues like access to research and medical equipment right-to-repair. We urge President Biden, U.S. Trade Representative Katherine Tai and other policymakers to clarify and expand their support to encompass a waiver for all IP barriers, including copyright, to prevent, contain and treat COVID-19.
ITIF Vice President of Global Innovation Policy, Stephen Ezell:
The Biden administration’s announcement that it will support a World Trade Organization Trade-related Aspects of Intellectual Property Rights (TRIPS) petition to waive intellectual property (IP) rights on COVID-19-related products and technology represents a shortsighted and misguided effort to meaningfully impact the continuing COVID-19 pandemic.
IP rights have been indispensable to the development of COVID-19 vaccines, therapeutics, and diagnostics to date; they have also further facilitated the 200+ voluntary licensing agreements that COVID-19 innovators have entered into with contract manufacturers worldwide to dramatically scale COVID-19 vaccines and therapeutics manufacturing. Endorsing this waiver petition succumbs to the fundamental fallacy that IP rights represent any kind of significant barrier to access and manufacturing of the medicines needed to overcome this crisis.
While the Biden administration is to be commended for its commitment to helping other nations amidst this crisis, as ITIF has written, there are far better ways to do so rather than abrogating IP rights; some of these include significantly increasing U.S. contributions to COVAX, exporting excess vaccine supply from its stockpile, identifying supply chain bottlenecks, and investing more domestically to dramatically scale up U.S. biopharmaceutical manufacturing capacity of these medicines.
This article was updated on May 5 at 9:20pm