US Poised for New Donation of 500 Million Pfizer Vaccines as World Trade Organization Agrees to Text-Based Discussions’ Over IP Waiver for COVID Tools  
Demonstrators outside of the European Parliament just before a vote on a controversial proposal to waive IP related to COVID vaccines and treatments

The World Trade Organization’s TRIPS Council agreed on Wednesday to move ahead with a “text-based process” – effectively greenlighting negotiations over a proposal to waive intellectual property associated with COVID tests, treatments and vaccines, Geneva-based trade officials said. The move was  the latest in a series of incremental advances on the controversial initiative by India and South Africa.  

But the agreement reached by the TRIPS Council members Wednesday after a two-day meeting  does not mean that European Union bloc, also backed by the United Kingdom, Republic of Korea and Switzerland, have acceded to the proposal for a blanket waiver, other sources told Health Policy Watch. 

Rather, an alternative EU proposal – which has proposed alternative measures to expand medicines and vaccines production  – would remain on the table side by side with the waiver proposal as part of the overall negotiations, the sources said.   

The EU alternative calls for the better use of existing WTO measures permitting countries to issue “compulsory licenses” to manufacturers to produce needed health products that are still under patent, under the existing provisions of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).  It also calls upon IP holders to step up their issuance of “voluntary licenses” for COVID-related health products in short supply. 

That EU proposal has been under heavy fire from medicines access groups since it was published in early June – including the EU’s own European Parliament.  On Wednesday evening, Parliamentarians voted for a resolution effectively supporting the WTO IP waiver initiative by a one-vote majority.   

The amendment approved expressed “support for proactive, constructive and text-based negotiations for a temporary waiver of the WTO TRIPS Agreement, aiming to enhance global access to affordable COVID-19-related medical products and to address global production constraints and supply

EU Digital COVID Certificate Also Approved 

Earlier in the day, MEPs debated and finally approved, an initiative to establish a system for an EU Digital COVID Certificate, to facilitate travel within the European bloc of countries.  The certificate system will still need to be approved directly by European governments. 

India Wants Text-Based Negotiations to Conclude by end July  

Meanwhile, TRIPS Council members were reportedly set to resume informal talks about the waiver on 17 June.  A statement by India to the WTO meeting set forth a target for concluding the talks by end July. 

“We would like negotiations to begin after this formal meeting, i.e. by mid-June… Looking at the severity of the 2nd and 3rd wave hitting different parts of the world, we have no time to lose, we look at concluding these negotiations by the end of July,” India was reported as saying, adding that “we are in a race against time.  

Typically, TRIPS Council members would need to reach agreement by consensus on a final draft text before submitting it to the WTO General Council – which includes all member states – for a meeting in late July. 

India and South Africa submitted their first proposal for an IP waiver on COVID health products to the WTO TRIPS Council in October 2020. The proposal called for a waiver on all forms of IP associated with medicines, tests and vaccines, including not only patents, but also critical “trade secrets” and copyrights that would be needed to expand the complex processes of vaccine manufacturing. 

For the first few months, the initiative drew broad support only from low- and middle-income countries.  But it  picked up considerable steam after the United States swung its support behind a more limited waiver of IP-related to COVID vaccines. That shift came in a surprise announcement by US Trade Ambassador Katherine Tai in May, coinciding with the last TRIPS Council meeting

Following that, South Africa and India submitted an amended draft, which maintained the broad scope of their original proposal – but set a time limitation of three years for the initial phase of the waiver – after which it would be reviewed in light of the evolution of the COVID pandemic. 

Waiver Proposal Saw Lengthy TRIPS Council Debates 

This week’s two day TRIPS Council meeting,  presided over by Ambassador Dagfinn Sørli of Norway, saw an emerging centrist bloc, led by the United States, Australia, Canada, New Zealand, Brazil, Norway, China and Chinese Taipei (Taiwan), seek a middle ground between the 63 countries that are now supporting the South African/Indian initiative on the IP waiver – and opponents, led by the European Union. 

Sources said that the US called upon both sides to focus on practical actions that would be needed by the WTO body to rapidly scale up the supply and distribution of vaccines.  US support for engaging in a text-based discussion will “spur additional proposals or ideas to be put on the table,” the US representative was reportedly quoted as saying, suggesting that the South African and Indian revisions don’t go far enough yet towards a compromise. 

Moreover, IP issues can only be part of the WTO response to the pandemic – trade and other barriers that are limiting the free movement of vaccines, raw materials and equipment needed for the manufacture of those vaccines must also be addressed, the US-led bloc of delegates stressed.

In contrast, European Union representatives said that they were ready to commence a text-based discussion based on the EU proposal – which is to be further detailed in coming days – while discussing the waiver as well.  The EU-led proposal does move beyond current WTO TRIPS rules, the bloc members asserted, by waiving exisitng requirements that countries undertake lengthy negotiations with the rights holder of a vaccine patent – before issuing a compulsory license. 

 Turkey, Chile, Singapore, Russia, El Salvador, Hong Kong and Mexico reportedly took a wait-and-see attitude on the initiative, in discussions that saw some 48 delegations taking the floor.

US Reportedly Ready For Massive Vaccine Donations

At the same time the TRIPS Council talks were wrapping up,  however, United States President Joe Biden was reportedly preparing an announcement about a massive US donation of 500 million Pfizer vaccines – as part of a new agreement with the pharma company, the New York Times reported.

Citing unnamed sources, the Times said that the US had reached a deal with Pfizer to purchase the doses at cost, with the first 200 million doses to be distributed this year, and the next 300 million in 2021.

Biden hinted at the impending announcement in a brief press statement at Andrews Air Force base, just before boarding Air Force One headed to Cornwall, England, for a meeting with other G7 leaders.

Such a massive donation by the United States would be a game-changer for LMICs that have suffered massive shortfalls of vaccines – effectively reaching WHO’s recent target for developed countries to share 250 million doses by September. But it also might deflate some of the building pressures on WTO members to agree to a sweeping text on an IP waiver.

Asked if the US would come up with a “vaccine strategy for the world,” Biden replied saying, “I have one and I’ll be announcing it.”

Image Credits: Twitter @ABC, @Right2Cure .

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