“Lowest-common denominator,” “worse than nothing,” and “an abomination” are some of the ways international health advocates have described a pared down draft of a compromise “TRIPS Waiver” proposal that leaked to the press on March 16.
It's hard to argue with them. Far from being a true compromise that will benefit global public health, the widely anticipated proposal mainly reflects European kowtowing to Big Pharma and the unreasonable U.S. insistence on limiting the waiver to only vaccines. After 18 months of foot-dragging by wealthy countries at the World Trade Organization, including by Canada, a vote for this outcome would be an extreme disappointment.
Originally pitched by India and South Africa in October 2020, the “TRIPS Waiver” proposal would have temporarily frozen a number WTO-protected intellectual property rights on pandemic-related vaccines, diagnostics, therapeutics, and medical goods like ventilators. The idea was to give countries the legal room to circumvent patent, trademark, and trade secret protections in the WTO Agreement on Trade-related aspects of Intellectual Property Rights (TRIPS) in the aim of scaling up production and export of critical vaccines and medications in the battle against COVID-19.
The Canadian Centre for Policy Alternatives, along with dozens of other civil society groups in Canada, support a broad waiver and have encouraged the Canadian government to back it at the WTO. But the proposal ran up against stubborn opposition by self-interested brand-name pharmaceutical companies and countries—like the European Union, Switzerland, Norway, Japan, and, unfortunately, Canada—inclined to cater to their interests. The United States initially opposed a waiver, but the Biden administration made a partial reversal in early 2021, claiming it would support negotiations on a vaccines-only waiver.
The most glaring flaw is that the waiver would apply only to vaccines.
In December, India and South Africa joined the U.S. and European Union in closed-door quadrilateral discussions to try to break the impasse on the waiver at the WTO TRIPS Council. The talks, among the so-called QUAD, while hardly inclusive of broad WTO member interests, had the strong backing of WTO Director-General Ngozi Okonjo-Iweala, who is under pressure to show the trade organization’s relevance in our crisis-prone times.
On March 11, Priti Patnaik at Geneva Health Files reported a compromise text was imminent, though it would be limited to vaccines and stick to clarifying how and when countries can waive certain TRIPS obligations. The compromise waiver draft leaked to Politico last week confirms Patnaik’s earlier scoop.
The most glaring flaw is that the waiver would apply only to vaccines, as pitched by the U.S. Clause 8 says members must decide “no later than six months” on whether to extend the waiver to cover the production and distribution of COVID-19 diagnostics and therapeutics. But given the stalling on the waiver to date, it’s hardly cynical to expect this deadline to be missed.
What’s upsetting about this limitation to COVID-19 vaccines is that we’re now at a stage in the pandemic when rapid, regular, and affordable testing and treatments are just as important as vaccines. Precisely because Northern countries consumed all the vaccines, leaving low-income nations extremely vulnerable to new, more contagious strains, we owe it to the world to not make the same mistake on life-saving medicines.
This month, Pfizer announced it will make 10 million doses of its promising COVID-19 therapeutic, Paxlovid, available to low-income countries. That’s out of 120 million two-dose treatment courses it will produce in 2022, most of them destined for countries who can pay full price. While Pfizer has agreed to let generic firms in several countries produce versions of Paxlovid, these courses will not be available until 2023 and may only be exported to a list of 95 low-income countries representing only 53% of the world’s population.
What’s upsetting about this limitation to COVID-19 vaccines is that we’re now at a stage in the pandemic when rapid, regular, and affordable testing and treatments are just as important as vaccines.
According to Doctors Without Borders, the unequal coverage provided by such voluntary production and export licences, and Pfizer’s refusal to promise that it will not enforce its intellectual property rights tied to Paxlovid, reinforce the need for a broader waiver at the WTO not limited to vaccines.
A second flaw in the compromise waiver is that it does not cover all the intellectual property rights barriers that can get in the way of the production and export of off-patent vaccines. As Public Citizen points out, many key COVID-19 vaccines and medicines are “protected by thorny thickets of intertwined IP protection, not just a patent or two.”
Those thickets include clinical trials data and other proprietary information deemed protected trade secrets in the WTO TRIPS Agreement. While the European Commission claims companies in developing countries will be able to “rely on data produced through earlier trials, without having to re-produce this data themselves,” it’s not clear how this compromise waiver ensures access to all the information generic producers will need.
Another key flaw in the QUAD-brokered waiver is that it only applies to “developing” countries that exported less than 10% of the world’s vaccines in 2021. That excludes China and possibly Brazil, which renounced its developing country status in a deal with the Trump administration. It’s also not clear from the compromise proposal if countries not designated as “developing” at the WTO (e.g., least-developed countries) will be able to import off-patent vaccines, or if they will be relegated to the COVAX stream.
Furthermore, Jamie Love at Knowledge Ecology International notes that, like an earlier EU counterproposal to the original waiver, this compromise text creates new burdensome obligations on countries. For example, point 3(a) of the compromise text clarifies that eligible WTO members “may issue a single authorization to use the [patented] subject matter of multiple patents necessary for the supply of a COVID-19 vaccine.” However, countries are required to “list all patents covered,” which would be an onerous new obligation not currently in the TRIPS agreement.
If there is a chance to make the waiver more effective by covering more than vaccines, and more than patents, Canada should take every opportunity to do so.
Optimistically, Patnaik suggests these are early days for the waiver and that last week’s leak may serve political objectives in Geneva: “It may have helped let off steam steadily building in the WTO fuelled by unmet expectations, and has given its members something to play around with, as they will embark on arduous negotiations, weighing quid pro quos in their consultations in the run up to the Ministerial Conference in June 2022,” she wrote in a recent Geneva Health Files update.
But there are also rumours that the QUAD countries have no intention of adjusting the text any further. Instead, it may be presented as a done deal, akin to the closed-door Green Room tactics of more active WTO days, with member states asked to simply vote yes or no. India and South Africa may be left holding the bag for either failing the multilateral order—by failing to rally lower- and middle-income countries to an outcome, in the case of a “no” vote—or selling those same countries out to the North if the compromise passes.
That said, it's also possible rich countries like the United Kingdom and Switzerland, who felt snubbed for not being part of the QUAD talks, may also reject the compromise on behalf of Big Pharma lobbies who still oppose a waiver even in this much degraded form. The U.S. Chamber of Commerce opposes the waiver compromise as a distraction.
It is not clear as I write this what role the WTO TRIPS Council will play in approving or further refining this copout waiver counter-proposal. At some point soon, Canada may be asked to vote yes or no to this deeply flawed text. Our trade officials in Geneva should vote no if that’s the case. If there is a chance to make the waiver more effective by covering more than vaccines, and more than patents, Canada should take every opportunity to do so.