On Tuesday, after a year and a half of negotiations over an intellectual property waiver for Covid-related products, the United States, European Union, India and South Africa reportedly reached agreement on a temporary waiver of patent rules for Covid vaccines. “The difficult and protracted process has resulted in a compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome,” said U.S. Trade Representative spokesperson Adam Hodge in a statement. Global health activists, however, are slamming the tentative deal as not only insufficient, but a potential setback, because it excludes tests and treatments, includes a carveout for China, and introduces new barriers for the production of generic treatments that could have implications far beyond the Covid crisis.
“No deal would be better than a bad deal,” Melinda St. Louis, director of Public Citizen’s Global Trade Watch division, a watchdog organization, told In These Times. “This could be interpreted badly and be worse than nothing. This is an example of a lowest common denominator deal to save face.”
The deal, first reported by Politico, is the result of secretive talks between the “quad” — a term that refers to the four blocs involved: the United States, European Union, India and South Africa — ostensibly aimed at achieving progress after a frustrating standstill at the World Trade Organization. The text of the proposed compromise, which has been leaked, will next go to WTO members and EU member states for approval.
In October 2020, India and South Africa proposed a waiver for key intellectual property rules related to Covid vaccines, treatments and diagnostics, to enable access to cheaper, generic versions. The proposal is colloquially called a TRIPS waiver, a reference to the WTO agreement on Trade-Related Aspects of Intellectual Property Rights, which determines intellectual property rules (and was largely shaped by the pharmaceutical industry).
The goal of expanding access to generics has only grown more urgent amid staggering global inequalities access to vaccines, treatments and tests, and a climbing death toll — 4.98 million people around the world have died of Covid-19 since the proposal was introduced. The India-South Africa plan has garnered the support of 65 countries, with the Global South heavily represented among them.
Yet the proposal has been staunchly opposed by the United Kingdom, Switzerland and the European Union, which presented its own counter-proposal. The Biden administration said in May 2021 that it would reverse former President Trump’s opposition to the waiver, but has since come under fire for failing to aggressively push for a meaningful deal. Proponents of the proposal had hoped that the months-long talks between the quad could find a way through the impasse.
The deal authorizes “the use of patented subject matter required for the production and supply of Covid-19 vaccines without the consent of the right holder to the extent necessary to address the Covid-19 pandemic,” for a period of either three or five years (two possibilities are provided in the document).
The agreement also waives a requirement that compulsory licenses — when a government green-lights production without the consent of a patent owner — can only be for domestic use. This could open the door for production of Covid-19 vaccines to be exported to other countries, something that has the potential to provide more supply for Global South countries.
However, there are key shortcomings that activists say undercut these provisions. The waiver only applies to vaccines, not to tests and antivirals, reflecting the Biden administration’s position. The leaked language does stipulate that, “No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of Covid-19 diagnostics and therapeutics.” But experts say that, given the track record of the WTO, delaying such a provision is tantamount to sinking it.
Activists from around the world argue that tests and antivirals are essential to containing the global Covid epidemic. In February, more than 200 global civil society organizations published an open letter insisting that any TRIPS waiver include “diagnostics, therapeutics and vaccines,” so that countries can robustly address all aspects of the pandemic. “Testing and access to diagnostics, especially antigen rapid tests, is essential to peoples’ knowledge of their health status, compliance with public health measures, connection to treatment and care,” the letter says.
The Biden administration has itself championed the vital role that testing and antiviral drugs can play in a pandemic response, the groups note, so why wouldn’t that standard apply to other countries? “New antivirals that prevent serious Covid-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” Dr. Anthony Fauci, chief medical adviser to President Biden, said in June 2021. Global access to such treatments, as well as tests and vaccines, is also critical for stopping the spread of future variants.
Brook Baker is a Northeastern University professor who also serves as a senior policy analyst for Health GAP, a health justice organization. He tells In These Times that, even if vaccines were the only consideration, overriding patents alone is not enough. (The proposal from India and South Africa calls for an intellectual property waiver “in relation to prevention, containment or treatment of Covid-19.”) “Moderna promised in 2020 it would not enforce patents, but it refused to give its trade secrets, manufacturing know-how, or background information that is kept secret under trade secrets law,” he explains. “There’s nothing in the new text that forces companies to divulge this information.”
Baker argues, “There should have been an agreement that countries could bypass protections of confidential information and trade secrets, requiring disclosure from companies or permitting disclosure from drug regulatory authorities of manufacturing and other data submitted to regulators for purposes of regulatory approval. It would be good if the text clarified that countries can share that otherwise confidential information with other producers.”
The deal also imposes geographic limitations, stipulating that the waiver it would only apply to “any developing country member that exported less than 10%of world exports of Covid-19 vaccine doses in 2021.” While India and South Africa would be included under this umbrella, China would not. (China is considered a developing country, according to WTO standards.)
“China has manufacturing capacity that might well be utilized to make products for countries that can’t make them for themselves,” says Baker. “To exclude this country from being part of the game seems silly. Why would we tie an arm behind our back?”
All developed countries would also be excluded, which could hamper the export of generics.
The boundaries between developed and developing countries are not always clear. “There’s some concern about what is a developing country,” says Public Citizen’s St. Louis. “There are some countries that have self-nominated to no longer be developing in the context of the WTO. Does that mean they are excluded?”
Achal Prabhala, coordinator of the accessibsa project, which aims to expand access to medicines, told In These Times that the United States insisted on that exclusion. “They should be ashamed of such an inadequate, inappropriate reaction,” he says. Previous reporting indicates that the United States has been in favor of geographic exclusions.
It’s not just the exclusions that activists are worried about. They say that the agreement introduces new barriers to Article 31 of the TRIPS Agreement, which grants countries some discretion to overrule patents so that generics can be produced. The tentative deal states, for example, that “an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a Covid-19 vaccine. The authorization shall list all patents covered.”
But Baker says this requirement is unnecessarily cumbersome. “The obligation to list all patents will really require someone to do a very comprehensive patent landscape,” he says. “There are 280 components of mRNA vaccines. Someone has to do a patent check on all those products, determine their patent status, notify about it. Right now, we have patents that are filed that are not even public, and more patents being filed every day. Someone is going to have to keep looking at the patent landscape over and over. It’s a procedural morass.”
Sangeeta Shashikant of the Third World Network, a global research and advocacy organization, tells In These Times that this language reflects a demand from the EU that adds an “additional condition” to Article 31. “These are all conditions that never existed in the TRIPS Agreement,” says Shashikant. “This adds conditionality that was never there to begin with.”
Public Citizen’s St. Louis laid fault for this and other conditionalities at the feet of the EU. “The European Union has been the primary obstacle to progress on the waiver, even though many of its member states support the proposal, and the European Parliament has approved three formal calls for a comprehensive waiver,” she wrote in a statement emailed to In These Times. “The EU’s position had been to basically restate existing WTO flexibilities on patents that almost every WTO member already has, while requiring additional conditionalities.”
Over the phone, St. Louis clarified, “There are currently flexibilities in the WTO around using compulsory licensing, and this could further restrict what they can currently do. We don’t want to circumscribe that further.” She noted that such restrictions could apply to generics that have nothing to do with Covid-19.
“Our view is that this is more bad than good at this stage,” she emphasized. “But it’s not a done deal, so our position is they need to keep working.”