U.S. punts decision on COVID IP waiver to 2023

Could the Office of the U.S. Trade Representative’s (USTR) position on the COVID IP waiver be shifting?

On December 6, USTR announced support for “extending the deadline to decide whether there should be an extension of the World Trade Organization (WTO) Ministerial Decision on the TRIPS Agreement (Ministerial Decision) to cover the production and supply of COVID-19 diagnostics and therapeutics.”

After widespread pushback on the original waiver, which was agreed to in June, many see this delay as a positive development.

Widespread pushback on IP waiver

While the Biden administration supported the IP waiver for COVID-19 vaccines in the summer, stakeholders have since spoken about the damage the waiver would have on U.S. innovation and investment.

“By agreeing to the TRIPS waiver, the Biden administration has effectively waived IP rights on vaccines for five years, with the possibility of an extension,” U.S. House Reps. Brady and Smith wrote in an October 20 letter to U.S. Trade Representative Ambassador Katherine Tai. “This decision undermines American innovation and exposes American firms to those trying to steal U.S. vaccine research.”

Similarly, eight bipartisan U.S. Senators sent a letter to Ambassador Tai expressing concerns about the proposed expansion and urging the administration to “safeguard American innovation.”

“The United States is a global leader in research and development (R&D) and innovation in part because of our strong protections for IP,” says the letter, led by U.S. Sens. Tom Carper (D-DE) and Pat Toomey (R-PA). “American companies are committed to numerous cooperative agreements to increase global access to therapeutics and diagnostics in addition to vaccines. In fact, many countries that initially proposed this waiver are producing their own products and have not indicated that domestic demand exceeds their own supplies.”

Similarly, every member of the Council of State Bioscience Associations (CSBA) sent a letter to President Biden expressing serious concerns with the proposed expansion of a WTO waiver removing IP protections for COVID-19 technology. (The Biotechnology Innovation Organization, BIO, leads CSBA.)

“Of the over 350 therapeutics being developed in the United States, 86%—totaling 307 therapeutics—originated from SME biotech firms spanning over 28 states,” the letter explains. “For SME biotech firms, the expansion of a TRIPS waiver to therapeutics creates significant market risk for the commercialization of their products for indications unrelated to COVID-19.”

It seems Ambassador Tai and the USTR have been receptive. In a USTR press release, she stated, “Over the past five months, USTR officials held robust and constructive consultations with Congress, government experts, a wide range of stakeholders, multilateral institutions, and WTO Members.”

“Real questions remain on a range of issues, and the additional time, coupled with information from the USITC, will help the world make a more informed decision on whether extending the Ministerial Decision to COVID-19 therapeutics and diagnostics would result in increased access to those products. Transparency is critical and USTR will continue to consult with Congress, stakeholders, and others as we continue working to end the pandemic and support the global economic recovery,” she continued.

“Hopefully, this delay means someone in USTR woke up,” one Washington insider told Good Day BIO.

COVID IP waiver would deter innovation, experts say

The TRIPS waiver did little to nothing to improve vaccine sharing. At the same time, the waiver ignored the fact there are more than enough vaccines to go around, and the boundaries to access have more to do with vaccine hesitancy and infrastructure.

Undoubtedly, further erosion of COVID IP will only do more of the same.

“Two years into the pandemic, the WTO finally [got] around to issuing a patent waiver,” Dr. Dorothy R. Auth, Ph.D., Head of Cadwalader’s Intellectual Property Practice, told Bio.News in September. “But really, it’s yesterday’s story. We have plenty of vaccines and access is not really the issue anymore.”

Plus, the industry was already solving the problems the WTO was stumbling to address.

As we reported, over 20 major biotech companies initiated hundreds of individual IP-sharing partnerships with governments, universities, and communities, to expand COVID-19 production and distribution globally, especially in the middle- and low-income countries. These partnerships started early in the pandemic and were well underway when the WTO finally agreed to the waiver in the summer of 2022. And partnerships continue to expand.

“Intellectual property is the currency by which the innovative biotech industry raises capital and is able to advance the next generation of innovative medicines,” BIO’s Chief Policy Officer John Murphy said last week.

USTR’s next steps

In response to the pushback, USTR will study five key issues with the waiver, including:

  • “An overview of the products, focusing on WHO-approved COVID-19 diagnostics and therapeutics, including key components, the production process, intellectual property protections, and a description of the supply chain (including the level of diversification in the supply chain);
  • Information on the global manufacturing industry for these products, including information on key producing countries, major firms, and production data, if available;
  • Information on the global market for COVID-19 diagnostics and therapeutics, including information on demand and, to the extent practicable, an assessment of where unmet demand exists for key products and contributing factors; market segmentation; and supply accumulation and distribution; Data and information on global trade in COVID-19 diagnostics and therapeutics, if available, or if not, data and information on global trade in diagnostics and therapeutics generally; and
  • A brief overview/background of the relevant aspects of the TRIPS Agreement and the United Nations (U.N.) Medicine Patent Pool (MPP) and a listing of countries seeking to use the Ministerial Decision and those utilizing access to COVID-19 medicines under the MPP.”

“We look forward to seeing the results of the proposed investigation,” continued Murphy, “which we believe will show what we have been saying all along: IP is not the barrier to further access. It is far more important to focus on enhancing the critical infrastructure many countries lack to ensure the current and ample supply of COVID therapies are able to actually be administered to patients who need them.”

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