Groups on Both Sides Slam USTR Support for Delaying IP Waiver Extension Pending ITC Investigation

“Despite waiver proponents’ continued support for this fact-free narrative, IP has never been an impediment to access.” – U.S. Chamber of Commerce

waiverThe Office of the United States Trade Representative (USTR) this morning announced support for delaying the deadline to decide whether to extend a waiver of intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics.

The USTR also said it has asked the United States International Trade Commission (USITC) “to launch an investigation into COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access.” The study will look into issues such as identifying the specific products an extension will affect; manufacturing and production data; the global market for COVID-19 diagnostics and therapeutics, including demand, unmet need, supply and distribution; and how TRIPS is presently impacting access, including which countries have sought to use waiver thus far and which have used access under the United Nations (UN) Medicine Patent Pool (MPP).

According to the USTR Ambassador Katherine Tai, the USTR has actively engaged in discussions with World Trade Organization (WTO) members, U.S. stakeholders, Congress, and others on whether to extend the waiver and “[r]eal questions remain on a range of issues,” including the key question of whether an extension would actually result in increased access to COVID-19 treatments. Tai said the additional time will help all members to “make an informed decision.”

The USTR also provided a summary of consultations on extending waiver.

According to a statement sent out by the People’s Vaccine Alliance, an investigation like the one the USTR has asked the USITC to undertake can take up to nine months.

Kicking the Can

The Alliance called the decision “pathetic” and accused the Biden administration of succumbing to pressure “from pharmaceutical company lobbyists and their henchmen in Congress.” The organization also claimed the U.S. position “will cost countless lives in low and middle-income countries, leading to continued economic devastation, while a handful of pharmaceutical CEOs and shareholders will get even richer.”

But IP rights advocates were also unhappy with the USTR announcement. The U.S. Chamber of Commerce Executive Vice President and Chief Policy Officer Neil Bradley said the administration should have opposed extension outright. Bradley explained:

“Instead of kicking the can down the road by extending the deadline for discussion, the Chamber urges the Biden administration to oppose once and for all the WTO’s failing and harmful IP waiver proposal. Intellectual property played a critical role in discovering COVID-19 therapeutics, diagnostics, and vaccines and empowered companies to voluntarily license these innovative treatments and technologies worldwide. Despite waiver proponents’ continued support for this fact-free narrative, IP has never been an impediment to access.

It is time to end this ideologically driven discussion that would only offshore American innovation and undermine U.S. national security by forfeiting our IP to foreign competitors.”

A deal on waiver of IP rights for COVID-19 vaccine technologies was agreed by WTO members on June 17, 2022. As part of that agreement, members said they would contemplate extending the waiver to “the production and distribution of COVID-19 diagnostics and therapeutics” within six months of adoption, i.e. December 17, 2022. But as negotiations heated up, members disagreed on whether a decision to merely begin discussing extension had to be made by December 17, or if a final decision to extend had to be reached by that date.

The news about the U.S. stance was first reported by Bloomberg, which said the announcement effectively ends prospects for an agreement on extension this year. Other WTO members, including most recently Switzerland and Mexico, have expressed skepticism about extension as well.

The People’s Vaccine Alliance included a number of sources in its statement today that it says prove the need for an extension of waiver. They cite studies showing that:

However, their opponents have repeatedly pointed to statistics showing that no country has yet utilized the waiver of IP rights for vaccines to increase supply of vaccines and demonstrating that logistics and distribution are the main blockades to access.

Image Source: Deposit Photos
Image ID: 108781344
Author: cteconsulting 


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Join the Discussion

2 comments so far.

  • [Avatar for Moocow]
    December 6, 2022 05:16 pm

    “Airfinity’s CEO, Rasmus Hansen, told Health Policy Watch that it was correct that only around 25% of purchased doses of Paxlovid were going to LMICs”
    “But it’s a bit of a mistake only to look at that number without looking at some other demand indicators,” Hansen added.
    One important indicator was the demand for Paxlovid doses from countries that qualified for the medication for free through the ACT Accelerator, he added.
    “Only around 7% of the Paxlovid doses that are available for donation have been accepted by low-income countries.”
    “Meanwhile, the total demand from LMICs for both WHO-approved antivirals – Molnupiravir and Paxlovid – available free via the ACT-Accelerator had only reached 13%, and there had been zero demand for either medication in the fourth quarter of the year, said Hansen.”

  • [Avatar for Rune Berg Johansen]
    Rune Berg Johansen
    December 6, 2022 01:23 pm


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