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AdvaMed Statement on USITC report, “COVID-19 Diagnostics and Therapeutics, Supply, Demand, and TRIPS Agreement Flexibilities”


The United States International Trade Commission (USITC) released its highly anticipated report,“COVID-19 Diagnostics and Therapeutics, Supply, Demand, and TRIPS Agreement Flexibilities” on October 17. Evidence presented in the 496-page report supports AdvaMed’s position that there is no justification for the World Trade Organization (WTO) to waive intellectual property protection for products used to treat or diagnose COVID-19.

“The report contains and reinforces many of AdvaMed’s objections to limiting IP protection for COVID-19 products,” said Ashley Miller, Executive Vice President, Global Strategy and Analysis. “As we did throughout the pandemic, AdvaMed and our members will continue to work with the U.S. Government, other governments, and multilateral organizations to address impediments to patient access to diagnostics, including those reflected in the report.”

Other key findings for diagnostics in the report include:

First, manufacturers of COVID-directed diagnostics, located in countries with a wide variety of income levels, including China and India, rapidly developed and scaled up production of COVID-19 tests early in the pandemic even before effective vaccines were widely available. New manufacturers entered the market throughout 2022 and 2023 even as demand for testing declined and has since remained low. To achieve this rapid production rise, WTO members did not need to use voluntary or compulsory licenses for COVID-19-directed diagnostics. As the USITC observed, “… the best evidence that patents did not act as a primary barrier to the production of these tests is that many new producers and products, including in developing countries, came online relatively quickly.” The USITC noted, instead, that “only R&D agreements were used in connection with COVID-19-directed diagnostics,” which highlights the industry’s cooperative response through which the industry was able to meet global demand in record time.

Second, the USITC stressed that defining the vast scope of COVID-19 diagnostics covered by patents is “complicated and subject to interpretation,” which means that a potential waiver would risk undermining IP protection for almost any diagnostic and therapeutic device determined by any government as being needed for COVID-19 and could lead to abuse of the IP waiver by countries seeking to gain competitive economic advantage.

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