WTO Seeks Revised Proposal for Covid Vaccine Patent Waiver

The call for waiver of rights in Covid vaccine production gets louder with most major economies backing India's demand for making a cheaper version of the drug.

WTO Chief Ngozi Okonjo-Iweala has urged the proponents of the proposal for temporary waiver of certain provisions of TRIPS agreement for the prevention and treatment of Covid-19 to submit the revised document "as soon as possible" so that text-based negotiations can begin.

Welcoming the statement of US Trade Representative Katherine Tai on the issue, the Director General of the World Trade Organisation (WTO) has said she "warmly" welcomes Tai's willingness to engage with proponents of a temporary waiver of the TRIPS agreement to help in combating the Covid-19 pandemic.

In October 2020, India and South Africa submitted a proposal suggesting a waiver for all World Trade Organization (WTO) members on the implementation of certain provisions of the agreement in relation to the prevention, containment or treatment of Covid-19.

The proposed relaxations in the norms of the agreement are aimed at ensuring quick and affordable access to vaccines and medicines for developing countries.

The agreement on Trade-Related Aspects of Intellectual Property Rights or TRIPS came into effect in January 1995. It is a multilateral agreement on intellectual property (IP) rights such as copyright, industrial designs, patents and protection of undisclosed information or trade secrets.

"I am pleased that the proponents are preparing a revision to their proposal and I urge them to put this on the table as soon as possible so that text-based negotiations can commence," Okonjo-Iweala has said in a statement.

"As I told the General Council yesterday, we need to respond urgently to Covid-19 because the world is watching and people are dying," she said. The statement, dated May 6, is posted on the WTO website.

The proposal of India and South Africa has received support from more than 120 countries. The EU too has stated that they are ready to discuss the patent waiver issue.

The Biden administration has backed the initiative by India and South Africa at the WTO to temporarily waive patent rules on Covid-19 vaccines, seen as a breakthrough in the global fight against the deadly pandemic by potentially expanding the supply of the vaccines and more affordable doses for less wealthy nations.

US support for waiving intellectual property rights on Covid-19 vaccines could be a tactic to convince drug-makers to back less drastic steps like sharing technology and expanding joint ventures to quickly boost global production, lawyers said on Thursday.

"I think the end result that most players are looking for here is not IP waiver in particular, it’s expanded global access to the vaccines," said Professor Lisa Ouellette of Stanford Law School.

"If it is possible to increase the rate of scaling up production, this potentially would give the manufacturers a greater incentive to come to an agreement to make that happen,” Ouellette said.

Vaccine makers like Moderna (MRNA.O), Pfizer (PFE.N) and BioNTEch have argued that patents have not been a limiting factor in supply. New technology and global limits on supplies are frequently cited as challenges, and both Moderna and Pfizer nevertheless have steadily boosted supply forecasts.

"There is no mRNA in manufacturing capacity in the world," Moderna Chief Executive Stephane Bancel said on a conference call with investors on Thursday, referring to the messenger RNA technology behind both the Moderna and Pfizer vaccine.

"This is a new technology. You cannot go hire people who know how to make the mRNA. Those people don't exist. And then even if all those things were available, whoever wants to do mRNA vaccines will have to buy the machine, invent the manufacturing process, invent verification processes and analytical processes."

Announcing the major policy decision after intense internal debate and strong pushback from American drug-makers, Tai on Wednesday has stated that this is a global health crisis and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures.

The proposal has urged WTO to grant a waiver for limited years (which will be negotiated by the TRIPS Council) from the implementation, application and enforcement of specific provisions of the TRIPS agreement for the prevention, containment and treatment of Covid-19. 

This waiver would ensure that the intellectual property rights (like patent, design, and copyrights) do not restrict rapid scaling up of manufacturing and do not hinder equitable and affordable access for vaccines and treatments throughout the globe. 

According to an April 30 statement of the WTO, co-sponsors of the proposal has requested the chair of the TRIPS Council, Ambassador Dagfinn Sørli of Norway, to consider holding a meeting open to all members in the second half of May to discuss the revised proposal before the formal TRIPS Council meeting scheduled for early June.

To increase vaccine production capacity significantly within two years, the Biden administration would need to do much more than waive patents, including providing funding to find and build new manufacturing sites, and backing technology and expertise transfer to the new manufacturers, drug supply chain expert Prashant Yadav told news agency Reuters.