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Efforts to suspend patent rules for the production of Covid-19 vaccines have taken a significant step forward as the World Trade Organization (WTO) nears negotiations on a potential waiver text.

The WTO issued a statement last week saying that its members “moved closer to a text-based process” following a formal meeting of its Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).

If successful, the negotiations would result in a temporary relaxation of WTO rules on intellectual property, allowing companies around the world to manufacture their own versions of existing Covid-19 vaccines, rather than rely on the output of major producers such as Pfizer, Moderna or AstraZeneca.

The proposal, which was initially tabled by the governments of India and South Africa, still faces significant opposition – including from the European Union and UK.

But according to Katie Gallogly-Swan, a policy coordinator at Boston University’s Global Development Policy Center, the shift towards talks around a waiver text is “a very significant step forward”.

“There hasn’t been a furore of celebration just yet because there are still hurdles to overcome, but getting into text-based negotiations is where you can move beyond people making speeches in meetings, and start to go through the actual text line-by-line to collaborate on some sort of multilateral-based approach,” she tells GTR.

The development follows the submission of a revised waiver proposal to the WTO in May, which was supported by a group of countries in Africa, Asia and Latin America.

The text had been amended to account for new variants and to narrow down certain definitions, as well as to establish a new approach to the proposed duration of the waiver.

“In the original text, South Africa and India proposed that the waiver would stay for as long as the pandemic lasts,” explains Gallogly-Swan.

“One of the changes in the most recent text is that there is now a three-year time limit, and that’s a point of contention: because some say three years is too long, others say it’s realistic, and some suggest that a three-year waiver wouldn’t be nearly enough to get the poorest countries vaccinated.”

The proposed waiver still faces strong opposition, however.

In an open letter to staff, Pfizer chairman and chief executive Albert Bourla said he believed a relaxation of intellectual property rules could discourage other pharmaceutical companies from investing in research and development.

“We deployed US$2bn before we knew whether we could successfully develop a vaccine because we understood what was at stake,” he wrote. “I am not sure if the same is true for the thousands of small biotech innovators that are totally dependent on accessing capital from investors who invest only on the premise that their intellectual property will be protected.”

Bourla also argued that a waiver would likely “create more problems” in the vaccine supply chain, due to the scarcity of raw materials involved in production.

At national level, the UK government remains opposed to the proposal, despite Prime Minister Boris Johnson urging G7 leaders to target production of a billion vaccines for the developing world by the end of 2022. The waiver is also opposed by South Korea.

The European Commission has registered its own disagreement, submitting a proposed alternative this month built around a compulsory licensing system, though that strategy faces increasing dissent from members of the European Parliament.

One concern over compulsory licensing is that it would likely require changes to domestic legislation in countries looking to produce vaccines, creating complexity for those seeking to manufacture doses domestically and export to neighbouring countries.

However, in early May, calls for a waiver received a significant boost after a U-turn from the US, with President Joe Biden scrapping the country’s previous opposition to the proposal.

“The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines,” announced trade ambassador Katherine Tai. “We will actively participate in text-based negotiations at the WTO needed to make that happen.”

Gallogly-Swan says she believes the arguments against a waiver are flawed.

“There is a rebuttal around protecting strong IP rules in order to foster innovation, but I think that is a false rebuttal as there isn’t really evidence of that happening – particularly for vaccines, which isn’t a hugely profitable part of the pharmaceutical industry’s production,” she says.

“Also, it was upfront investment of public money that got this innovation off the ground in the first place.”

On the concerns over vaccine-related supply chains, Gallogly-Swan acknowledges the “incredible complexity” involved but suggests that should be an incentive for a multilateral, coordinated approach to upscaling production.

“It’s not necessarily true that the pharmaceutical companies are the best people to manage these supply chains, especially when historically they’ve created scarcity as a profit-generating mechanism,” she says.