At WTO, a battle for access to COVID-19 vaccines

BERLIN — High-income countries appear to be maneuvering to avoid a showdown at the World Trade Organization’s General Council meeting, beginning Wednesday, over a proposal to temporarily waive intellectual property protections for all COVID-19 vaccines and other technologies.

With the United Kingdom, United States, and Canada already immunizing their citizens and high-income countries laying claim to the vast majority of current and future vaccine doses, supporters of the waiver argue that it is more critical than ever.

For countries like the U.S. and Canada, which oppose the waiver, “to deny other countries that are not getting the benefits of the current system is an immoral choice on their part,” said Brook Baker, a specialist in intellectual property law at Northeastern University. “They’ve gotten theirs and want to stop other countries from getting supplies as well.”

There is some skepticism over whether countries are actually in a position to take advantage of the proposal, introduced by South Africa and India, or if mechanisms already exist to address these concerns. Supporters of the plan are willing to address these issues, as long as that debate is not being used just to sideline the conversations around access to COVID-19 vaccines.

The fate of the proposal

The proposal is a sweeping bid to temporarily suspend the intellectual property rights around products that would protect, contain, and treat COVID-19. That includes waiving protections for patents — as has been done for HIV treatments, among other drugs — but also copyrights, industrial designs, and trade secrets, “until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity.”

Baker said the proposal would protect countries from having a dispute resolution brought against them at the WTO if they take steps to begin producing or distributing the products. “It gives them freedom to operate, to take steps at the national level,” he said, including the potential to manufacture and distribute immunizations at a cost well below what the handful of current distributors are charging.

The proposal was initially tabled in October in the TRIPS Council, a committee dedicated to discussing the implementation of the WTO’s intellectual property agreement, where it has rallied support from other low- and middle-income countries and attracted the co-sponsorship of Kenya, Eswatini, Mozambique, Bolivia, and Pakistan.

At the same time, it has also drawn plenty of criticism, led by pharmaceutical companies. In a recent New York Times op-ed, an industry representative warned “the effort would jeopardize future medical innovation, making us more vulnerable to other diseases.”

Access-to-medicine activists dismiss that argument, pointing out that much of the research was publicly funded or came from charities. Meanwhile, the countries that ponied up the money now appear to be leveraging those funding relationships and their own deep pockets to snap up the majority of the doses, including Canada, which has secured more than 10 doses per citizen.

That led Africa Centres for Disease Control and Prevention Director John Nkengasong to decry “this North-South distrust in respect to vaccines, which is a common good,” during a press conference last week and to warn that the global south was in danger of being left behind in the COVID-19 response, particularly as it faces additional expenses in shoring up cold chains and distribution efforts.

At the same time, the WTO delegations from several of the countries and regions that have reserved most of the vaccines, including the U.S., Canada, and the European Union, have lined up against the proposal, according to human rights observers. Their vetoes would normally signal the proposal’s death knell in the WTO, which tends to operate by consensus, but Baker said it could pass with the vote of three-quarters of the members if it reaches the General Council and LMICs are willing to challenge the higher-income nations.

Instead, the proposal appears likely to remain temporarily locked in the TRIPS Council and may never reach the General Council. At the moment, its sponsors are facing a barrage of questions from waiver opponents about why they cannot use already existing exemptions within the TRIPS framework to achieve the same ends.

The 90-day window for discussion in the council is set to expire at the end of December, which would normally result in a report for the General Council to consider and potentially act on. But following a meeting last week, the TRIPS Council indicated that it will let the deadline pass, with this week’s General Council only receiving an oral status report. Meanwhile, the debate over the proposal will continue into the new year — and perhaps indefinitely.

Alternative methods and challenges

Proponents of the proposal are not certain that the questions are being raised in good faith and not merely to delay its consideration.

But Jayashree Watal, who served 18 years as a counselor in the WTO’s intellectual property division, said there are merits to the queries around whether the proposal is necessary. Speaking in her personal capacity, Watal said there are exemptions within the TRIPS Agreement that could possibly be leveraged to gain legal access to the patents, copyrights, or industrial designs that lower-income countries say they need to begin production.

Those exemptions include the right to issue compulsory licenses and gain access to patents without the holder’s consent, as well as the security exceptions under Article 73 of the TRIPS Agreement that might be broadly interpreted to offer access to copyrights and industrial designs, which are not included in compulsory licenses.

But access-to-medicine activists highlighted a number of hurdles to actually taking advantage of these exemptions, including the time required to issue individual compulsory licenses, which might then be contested by the technology owner, and a history of higher-income countries threatening lower-income countries with WTO disputes when they attempt to claim an exception. There is also uncertainty around the possible reactions to a security exception claim.

The “waiver [that] has been proposed will address all these problems altogether,” said Carlos Correa, executive director at the South Centre, during an online presentation earlier this month. “[It] will address the limitations and pressures that may be exerted in cases that compulsory license system or government use is one of the options.”

The larger problem, critics say, is that neither the waiver nor the existing exemptions will address the fact that most LMICs are not in a position to take advantage of the information after they access it.

“It gets backs up on something that is a non-starter,” Watal said. Production capacity, and not intellectual property, is where the constraints lie, she said. “And you can’t set up capacity overnight. It will take a long, long time.”

Baker is not so sure that’s the case, but it will only be with the full suite of information about what is required to produce the vaccines and therapeutics that companies can begin to explore what capacity they actually have and countries can consider what they might be willing to contribute — particularly if they see this as an investment in the ability to more efficiently and cheaply battle future diseases.

“There is some capacity that could be built for the long term,” he said, particularly with the vaccine calling for “new technologies, platform technologies that are going to be very important for other medicines and other vaccines moving forward.”

An impetus for change

The waiver’s supporters are also framing it as a statement about equity at a moment when the global response to COVID-19 is looking remarkably unequal.

The Access to COVID-19 Tools Accelerator and its COVAX Facility for vaccine distribution, held up as proof of international solidarity in the face of the pandemic, are contending with a $4.3 billion shortfall this year and the need to raise $23.9 billion in 2021. And COVAX was only ever a commitment to deliver 20% of the necessary vaccines, short of the estimated 60% coverage to reach herd immunity.

Meanwhile, the COVID-19 Technology Access Pool proposed by Costa Rica, which allows for the voluntary sharing of health technology-related knowledge, intellectual property, and data, has been virtually unused.

With global solidarity ebbing, the waiver would represent “political symbolism and the impetus for change,” Baker said — “a major reorientation of global cooperation to deal with a global problem like this pandemic.” But if that reorientation is going to happen, it’s not likely to be at this WTO meeting.