Discussions began last week within the World Trade Organization over a proposal to temporarily waive patent protections on COVID-19 vaccines. Even as WTO officials press for a resolution ahead of a long-delayed ministerial conference in June, the halting reactions of members to the document signal that reaching consensus in a month — or at all — will not be easy.
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The agreement, described by WTO as an “outcome document,” emerged from discussions between the so-called Quad, comprised of the European Union, the United States, South Africa, and India.
The deal eases some existing barriers to issuing compulsory licenses for patents on COVID-19 vaccines, including forgoing the requirement that most vaccines manufactured under the license be used by the country that issued it. But it also introduces new impediments, particularly a condition that countries list each patent they intend to waive, which experts say is almost impossible given the constantly shifting global patent landscape.
Meanwhile, it has drawn significant criticism from access-to-medicines activists for what it does not include.
The compromise is a response to the proposal tabled by South Africa and India in October 2020, which would waive not only intellectual property protections on patents, but also trade secrets, copyrights, and industrial designs, for COVID-19 treatments, tests, as well as vaccines.
The compromise only covers patents, while pushing any decision about therapeutics and diagnostics until as late as six months after an agreement on vaccines is struck.
“The Quad document seems such a hollow document in some ways,” Matthew Rimmer, a professor in intellectual property and innovation law at Queensland University of Technology, told Devex. “There is such a gap between the document and the enormity of the problem in terms of the uneven distribution of key COVID technologies.”
Meanwhile, the pharmaceutical industry maintains its long-standing opposition to any kind of waiver proposal. Following last week’s discussions, the International Federation of Pharmaceutical Manufacturers and Associations issued a statement reaffirming the industry’s “position that weakening the intellectual property framework is counterproductive” and would undermine the ability to address the current and future pandemics.
Nevertheless, the deal was tabled at Friday’s meeting of the WTO’s Council on Trade-Related Aspects of Intellectual Property, or TRIPS — the first step in the process of trying to achieve consensus. Lansana Gberie, the council’s chair, called it, “the only product we have, the only game in town.” And he urged members to “look at the document on its merits and see whether this is something that we can take forward to the stage of negotiation.”
Instead, several members signaled that they need more time to consider the text, according to a Geneva-based trade insider. That included the Tanzanian delegation, speaking on behalf of the WTO’s Africa group, which has signed on as a co-sponsor of the original waiver proposal. In Friday’s discussions, Tanzania called attention to the importance of therapeutics and diagnostics, as well as technology transfers.
Meanwhile, Switzerland and the United Kingdom seemed to signal that they may extend their ongoing opposition to the TRIPS waiver to the compromise. While neither delegation voiced opposition in the preliminary discussions last week, the insider said that both delegations defended the architecture of the current IP framework.
Even the brokers of the agreement only expressed tepid enthusiasm for it.
Both India and South Africa had been silent on the proposal since it was first leaked in March and their delegations remained vague on whether they actually supported the compromised deal. Indian officials said only that they remained committed to constructive engagement. South Africa pressed for a move to text-based negotiations — the next step in the process of approving any kind of waiver — while indicating they would like those negotiations to include the original waiver proposal, which is also still lingering in front of the TRIPS council.
The U.S., meanwhile, appears unwilling to come out fully in support of the agreement in the face of domestic legislative opposition. That has left the EU as the only enthusiastic defender of the proposal.
That makes sense, Rimmer said, as the “provisions that are there seem to echo the EU’s stance, which has been quite an obstructionist one.”
The initial negotiations did resolve one potential barrier. The leaked draft of the proposal had excluded countries that exported more than 10% of the world’s vaccines in 2021, which would have included China.
There were concerns that would cause Beijing to sink the proposal. Instead, the Chinese delegation suggested replacing the restrictive language with more inclusionary text inviting countries with the capacity to export vaccines to opt out. China then confirmed that, under those terms, it would not take advantage of the waiver.
One hurdle down, but many more to go.