TRIPS waiver compromise draws mixed response

A potential waiver of some intellectual property restrictions on COVID-19 vaccines negotiated by South Africa, India, the United States, and the European Union leaked this week to mixed reactions.

The potential deal has been celebrated in some corners for finally breaking through negotiations that have been gridlocked for months and delivering a Trade-Related Aspects of Intellectual Property Rights, or TRIPS, agreement that has the potential to at least ease access to vaccines for the global south.

But critics said what has emerged bears little resemblance to the proposal South Africa and India tabled in front of the World Trade Organization in October 2020, which also called for IP waivers on COVID-19 therapeutics and diagnostics.

“I would have loved to have the TRIPS waiver agreed in full, especially covering all health technologies, but that’s what diplomacy is all about,” said Jaume Vidal, a senior policy adviser at Health Action International and a waiver advocate, reflecting the ambivalence that greeted the leak. “It’s compromise. It’s really finding a common ground. And the issue [is] we cannot be negotiating forever.”

The negotiations are far from over, though, as WTO Director-General Ngozi Okonjo-Iweala acknowledged in a statement yesterday.

“This is a major step forward and this compromise is the result of many long and difficult hours of negotiations,” she said. “But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO membership.”

That includes approvals from the four parties — South Africa, India, the U.S. and the EU — involved in the negotiations, before moving to formal adoption in the consensus-based WTO. A decision on diagnostics and therapeutics would follow within six months.

In the original version of the proposal, South Africa and India called for the waiver of patents, but also industrial designs, copyrights, and trade secrets that are guarded by the WTO agreement on TRIPS.

A May 2021 revision specified that the TRIPS waiver would apply to COVID-19-related diagnostics, therapeutics, vaccines, medical devices, and personal protective equipment and remain in force for at least three years.

It has drawn the support of more than 100 countries and tentative backing from U.S. President Joe Biden’s administration, though Washington limited its support to a waiver for vaccines.

Europe has remained steadfastly opposed, arguing that existing TRIPS flexibilities — particularly compulsory licensing — offered a path to access. But the licenses must be issued individually to allow a manufacturer to make use of a patent without the patent-holder’s consent, a process waiver proponents say is too onerous in a global emergency. It is also unclear whether compulsory licensing covers trade secrets.

The compromise proposal that emerged this week indicates “some attempt to ease the burden of the compulsory license mechanism for those supplying medicines and those importing medicines,” Leena Menghaney, the South Asia head of Médecins Sans Frontières’ Access Campaign told Devex. But little beyond that.

The proposal would allow eligible members to issue a single authorization to waive multiple patents, including on ingredients and processes, without fear of a challenge from the patent holders. In the compromise, all countries that exported less than 10% of the world’s vaccines in 2021 are eligible, which appears to exclude only China, the U.S., and the EU. It would also allow countries to export products manufactured under the agreement to other eligible nations. A timeline for the length of the waiver remains to be decided.

But Menghaney said the leaked agreement still retains “burdensome” reporting requirements and does not address the full suite of IP waiver requests made by India and South Africa.

“If the attempt was to address some of the components and difficulties with compulsory licenses, it hasn’t done everything it could have,” she said, even as it punts on therapeutics and diagnostics. The exclusion of therapeutics in particular is “extremely disappointing,” she said, when capacity exists now to jumpstart production of generic versions of the treatments if IP protections were waived.

If the compromise does move to the full WTO for discussion and approval, she called for TRIPS waiver supporters to fight for inclusion of other forms of IP and to expand beyond just vaccines.

The International Federation of Pharmaceutical Manufacturers & Association joined in criticizing the compromise, but for different reasons, calling the waiver “not only the wrong solution, it is also an outdated proposal, that has been overtaken by events,” according to AFP.

The industry group warned that the compromise waiver could undermine future pharmaceutical innovation.

Though the compromise drew criticism from both sides, some greeted the deal with cautious optimism.

If the reports that India and South Africa have acceded to the compromise are accurate, though, "that commands a certain level of trust,” said Luke McDonagh, an expert on intellectual property at the London School of Economics.

Their approval may reflect the evolving landscape around global vaccine production, particularly the advent of the WHO-backed mRNA vaccine technology transfer hub in South Africa. Launched in July 2021, the hub is already producing mRNA vaccines at laboratory scale and will soon be transferring its technology to six African countries.

That signals a rapid increase in capacity in the global south from the outset of the pandemic, which McDonagh called a “remarkable success. Given what has been achieved, the key issue does become about patents,” especially around issues like exports.

“I can’t see why South Africa and India would agree to a compromise unless they thought it would really assist in the boosting of pharmaceutical production,” he said.