Halfway through the six-month period the World Trade Organization set itself to make a decision on easing access to COVID-19 therapeutics and tests, high-income member countries appear to be hardening in their opposition to any deal. Activists warn that an agreement is unlikely by the deadline, if it comes at all, even as low- and middle-income countries are demanding expanded access to COVID-19 treatment.
The six-month deadline emerged after the consensus-driven WTO struck a limited deal — popularly known as the Trade-Related Aspects of Intellectual Property Rights or TRIPS agreement — at its ministerial conference in June to temporarily waive patents on COVID-19 vaccines. At the same time, the trade body pushed a decision on whether to ease access to COVID-19 therapeutics and tests off by six months.
“The WTO is notorious for not fulfilling what it says it’s going to do,” Sangeeta Shashikant, a legal and policy adviser for the Third World Network, told Devex. “This could just be another such situation where they’ve spoken about extending [the agreement] and then just don’t do it.”
The June agreement largely restates existing WTO rules designed to allow countries to gain access to vaccines and drugs in emergencies, though it did temporarily lift some export restrictions on generic vaccines that could ultimately make it easier for countries to access the jabs.
But the agreement fell well short of the original proposal by India and South Africa, which called for a temporary waiver on trade secrets, copyrights, and industrial designs, in addition to patents. It also pushed back the decision on COVID-19 treatments and tests, though they were also included in the original waiver proposal.
That delay was already frustrating activists, who said even the narrow vaccine agreement could actually have a significant impact if it included COVID-19 drugs.
“In comparison to vaccines, where we really needed to see a waiver of more than just patents, with therapeutics, generic manufacturers could make these now even without the knowhow,” Anna Marriott, the policy lead for the People’s Vaccine Alliance, told Devex. “You could see a rapid scaling up of production that would benefit a huge number of countries without access far more quickly than we have with vaccines.”
Shashikant said the same coalition of more than 100 countries that supported the original TRIPS waiver proposal is lining up behind at least extending the June agreement to cover treatments and tests. But they face ongoing opposition by the United Kingdom, Switzerland, and members of the European Union, among others — the same governments that opposed the broader initial waiver proposal.
Their opposition was expected, but the United States also appears to be against an extension, after offering limited support for a waiver on vaccine patents. U.S. Trade Representative Katherine Tai has never publicly endorsed an agreement on treatments or tests.
The pharmaceutical industry also remains opposed to any waiver, with the International Federation of Pharmaceutical Manufacturers and Associations having described the limited June agreement as “a dangerous signal not only to the pharmaceutical industry but to all innovative sectors.”
Shashikant said one of the arguments currently circulating is that there is no mandate to issue an extension of the agreement. The ministerial decision pledges only that, “No later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.”
Countries will have an opportunity to publicly state their positions on a possible deal Monday at an informal meeting of the council on Trade-Related Aspects of Intellectual Property Rights. A Geneva-based trade insider told Devex in an email that the meeting follows initial discussions that took place in July.
“There is no complication here,” Marriott said. “It’s an extension of something that has already been agreed. It’s not a radical proposal.”
Meanwhile, efforts to take advantage of the agreement that was reached in June have so far been limited, despite WTO Director-General Ngozi Okonjo-Iweala’s pledge that its passage would contribute “to ongoing efforts to deconcentrate and diversify vaccine manufacturing capacity, so that a crisis in one region does not leave others cut off.”
“Countries are still getting their head around it,” Shashikant said. “At the national level, they are looking at how to utilize it.” She said a better understanding of the vaccine landscape is emerging, which should help generic providers decide how and whether to move forward with attempting to produce a COVID-19 vaccine.
But hovering over any attempt to take advantage of the flexibilities is the fear that the pharmaceutical companies that developed the vaccines will sue generic manufacturers for infringing on their intellectual property. Those fears were heightened by Moderna’s recent move to sue Pfizer and its German partner, BioNTech, for violating its patents.
Advocates worry the companies might take similar steps to stall the production of generic vaccines, including the ongoing efforts at the World Health Organization-backed mRNA vaccine technology transfer hub in South Africa.
“These big pharma companies are going to protect profits at any cost,” Marriott said.