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U.S. Trade Representative Katherine Tai has requested that the International Trade Commission (ITC) conduct a study on the market dynamics of COVID-19 diagnostics and therapeutics. The study is intended to guide USTR in its negotiations over the extension of the WTO’s waiver of some TRIPS obligations to fight COVID-19, which currently applies only to vaccines. She asked ITC to complete the report by October 2023, which is after the WTO’s working deadline for negotiations over the extension.

Tai is requesting a wide variety of subtopics be included in the report, including “the relationship between patent protection and innovation in the health sector and between patent protection and access to medicine” in LICs, LMICs, UMICs, and HICs;” and “actions taken by WTO Members to use or attempt to use compulsory licenses for the production, importation, or exportation of pharmaceutical products and the outcomes of those actions, including the effect on product access, innovation, and global health.”

Her letter explicitly asks the ITC to solicit public comments and hold a public hearing on the following questions.

• How the TRIPS Agreement promotes innovation in and/or limits access to COVID-19 diagnostics and therapeutics;
• Successes and challenges in using existing TRIPS flexibilities;
• The extent to which products not yet on the market, or new uses for existing products, could be affected by an extension of the Ministerial Decision to diagnostics and therapeutics;
• Whether and how existing TRIPS rules and flexibilities can be deployed to improve access to medicines;
• To what extent further clarifications of existing TRIPS flexibilities would be useful in improving access to medicines;
• The relationship between intellectual property protection and corporate research and development expenditures, taking into account other expenditures, such as share buybacks, dividends, and marketing;
• The relevance, if any, of the fact that diagnostic and therapeutic products used with respect to COVID-19 may also have application to other diseases; and
• The location of jobs associated with the manufacturing of diagnostics and therapeutics, including in the United States.

Click here for USTR’s letter to the ITC

More background can be found in this Inside U.S. Trade story, but it is paywalled.