US Seeks to Delay Talks on Extension of WTO COVID Patent Waivers
WASHINGTON — The United States will not support extending a Dec. 17 deadline for waiving intellectual property protection for COVID-19 tests and treatments, and instead is asking the U.S. International Trade Commission to first investigate market dynamics such as pricing, supply and demand before it chooses whether to endorse expanding the program.
The Biden administration’s position was announced by the U.S. Trade representative on Tuesday.
The U.S. is joining nearly three dozen other nations — including the European Union’s 27 members, the U.K., Singapore, Switzerland, Japan and South Korea — in seeking more time and information about a potential waiver extension.
Each of these governments has said they have not seen any firm proof that their intellectual property rules are hindering the global distribution of COVID-19 tests and treatments.
“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,” said Amb. Katherine Tai in a press release on the agency’s website.
“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,” she said.
“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,” Tai added.
Investigations such as the ones the U.S. is seeking typically take anywhere from nine to 12 months to conclude, meaning the waiver is unlikely to be revisited until late next year or early 2024.
Disagreements over waiving intellectual property rights for COVID-19 tests and treatments have been raging since the World Trade Organization approved a plan this summer to authorize the use of vaccine patents without the right-holder’s consent for a five-year period.
This decision to waive obligations under the WTO’s Trade-Related Aspects of Intellectual Property Rights Agreement is known as the TRIPS waiver.
Since then, a number of developing nations, including India and South Africa, had been pushing to extend the waiver to cover the production of tests and treatment, and WTO negotiators established a deadline of Dec. 17 for amending the existing waiver.
The U.S. International Trade Commission study will explore key issues such as:
- An overview of the products, focusing on World Health Organization-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.
The pharmaceutical industry has been arguing that a waiver is unnecessary because the current supply of COVID-19 therapeutics exceeds global demand and that waiving intellectual property rights for treatments at this juncture would eliminate the incentives for companies to invest in the development of new and even more effective treatments.
In September, PhRMA, a trade association representing the industry based in Washington, D.C., posted a lengthy rebuttal to those hoping to expand the intellectual property waiver beyond vaccines.
According to PhRMA, such a move would compromise global public health and harm patients, cede intellectual property developed in the U.S. to foreign countries, send research and manufacturing jobs overseas, and undercut American innovation while jeopardizing the nation’s ability to respond to future pandemics.
“Biopharmaceutical manufacturers are already sharing their IP and remain committed to providing timely global access to safe and effective COVID-19 vaccines and treatments,” the statement said.
In addition, it said global collaboration is fueling medicine production and access. Citing data from Airfinity, an international data provider based in London, PhRMA said 140 voluntary licensing and manufacturing agreements for COVID-19 treatments have been signed since the start of the pandemic.
These agreements, it said, cover “more than half the world’s population, to ensure that more than 125 low- and middle-income countries can access needed medical innovation.”
In short, it argued, the global intellectual property system enabled the United States’ biopharmaceutical industry to innovate and produce safe and effective vaccines and treatments in record time.
“Policymakers should reject any expansion of the … waiver and focus on last-mile distribution and administration challenges around the world to make a real impact,” it said.
Separately, a number of U.S. lawmakers on both sides of the aisle have also been expressing concerns about expanding the waiver.
In October, Sens. Pat Toomey, R-Pa., and Tom Carper, D-Del., led a bipartisan group of senators in writing the U.S. Trade representative, urging the Biden administration to “safeguard American innovation” during the ongoing talks about expanding the waiver.
“Strong protections for intellectual property are the bedrock of American innovation, as evidenced by the record development of multiple vaccines to combat COVID-19,” Toomey said in a press release revealing the communication with Tai, adding that to allow any further erosion of U.S. intellectual property protections would “have devastating, long-reaching effects on access to treatments beyond those used for COVID-19.”
“The United States must reject any effort to extend the already erroneous waiver for vaccine IP to the much broader categories of therapeutics and diagnostics,” Toomey said.
“As World Trade Organization member countries consider intellectual property waivers for COVID therapeutics and diagnostics, I strongly encourage the Biden administration to consider the impact of these possible waivers on American innovation when developing a negotiating position,” Carper added.
In their letter, the senators said they believe the U.S. can continue to ensure developing countries have access to “the tools and treatments” needed to combat COVID “without undermining U.S. leadership in medical innovation.”
“American companies are committed to numerous cooperative agreements to increase global access to therapeutics and diagnostics in addition to vaccines,” they said. “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.”
The other signers of the letter were Sens. Bill Cassidy, R-La., Chris Coons, D-Del., John Barrasso, R-Wyo., Kyrsten Sinema, D-Ariz., Thom Tillis, R-N.C., Robert Menendez, D-N.J., Richard Burr, R-N.C., and Jon Tester, D-Mont.