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7 March 2024NewsBig PharmaLiz Hockley

Extension of COVID-19 vaccine waiver uncertain after WTO conference

WTO members failed to reach consensus on whether to expand patent waiver agreed in 2022 | Extended proposal would include tests and treatments for COVID-19.

The World Trade Organization’s (WTO) 13th Ministerial Conference (MC13) closed last week with members failing to reach an agreement on expanding the IP waiver on COVID-19 vaccines to include therapeutics and diagnostics.

MC13 took place in Abu Dhabi from February 26 to March 1, and its conclusion with a lack of consensus about extending the waiver of patent protection comes after years of discussion and heated debate surrounding the issue.

At a meeting of the TRIPS Council on February 13 ahead of the conference, members acknowledged that despite “considerable efforts” to support a fact- and evidence-based discussion on whether tests and treatments should be included in the waiver, no agreement had been reached.

Campaigners have been pushing for an extension of the agreement made at the 12th WTO Ministerial Conference (MC12) in June 2022, when members affirmed a partial waiver of patent protection for COVID-19 vaccines.

Before last month’s conference, the TRIPS Council said it would “continue its work as directed by the ministerial declaration from MC12 to review and build on all the lessons learned and the challenges experienced during the COVID-19 pandemic, and to build effective solutions in case of future pandemics, in an expeditious manner.”

Within this context, areas of interest were cited as the role of IP and, more specifically, voluntary licensing, technology transfer, the operation of the Medicines Patent Pool (MPP), geographical limitations of licences and the operation of Article 31(f) of the TRIPS Agreement.

‘Waiver expansion unnecessary and harmful’

The Chartered Institute of Patent Attorneys (CIPA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have been vocal critics of the IP waiver, viewing it as undermining the value of innovation and competition.

In October last year, PhRMA issued a statement in response to a US International Trade Commission report on COVID-19 and the TRIPS Agreement, arguing that the pandemic was over and that there was an “abundance” of treatments.

“TRIPS waiver expansion is unnecessary and would harm American workers, patients and innovation by handing over IP to foreign competitors. It’s past time for the Biden administration and other world leaders to move beyond this ideological debate and focus on real global health challenges,” PhRMA said.

Prank ‘highlights double standard’

On February 14, the People’s Vaccine Alliance—a coalition of organisations that supports equitable access to medical technologies—released a hoax statement, purportedly from US and EU delegations to the WTO, announcing that they had reversed their opposition to easing IP rules in future pandemics.

Brook Baker, professor at Northeastern University School of Law and senior policy analyst at Health GAP, criticised the “blatant hypocrisy” of the US and EU in failing to support expansion of the waiver.

“We have pulled a prank to highlight this deadly double standard,” he said.

“If the Pandemic Accord doesn’t include clear and comprehensive provisions allowing low- and middle–income countries to overcome Big Pharma’s monopoly control over supply, price, and distribution of vaccines, medicines, and diagnostics, we’ll see the savage inequity of COVID-19 and AIDS repeated in the next pandemic.”

The deadline for deciding on extending the waiver was postponed indefinitely in December last year.

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1 February 2024   Pharma giants raise concerns about Moderna’s COVID-19 vaccine patents | Company's statements to the FDA and PTAB contain "inconsistencies" | Appeals Board urged to scrutinise assertions.
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28 June 2022   Pfizer is facing a lawsuit centring on its COVID-19 antiviral, Paxlovid, after Enanta Pharmaceuticals filed a complaint citing patent infringement.