The U.S. International Trade Commission (USITC) is undertaking a new factfinding investigation to inform consideration of whether to extend flexibilities under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to COVID-19 diagnostics and therapeutics. The USTR requested that the Commission conduct an investigation and prepare a report that identifies the universe of existing COVID-19 diagnostics and therapeutics. The USTR also emphasized the importance of public input to the report, particularly regarding the topics mentioned below.
The investigation, COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596), was requested by the USTR in a letter received on December 16, 2022.
As requested, the USITC, an independent, nonpartisan, factfinding federal agency, will prepare a public report for the USTR. The report will identify the universe of existing COVID-19 diagnostics and therapeutics and provide to the extent practicable with respect to relevant COVID-19 diagnostics and therapeutics:
An overview of production and distribution, including a description of the supply chain;
An overview of demand including market segmentation of global demand and consumption;
Information on availability and pricing; and
Global trade data.
Additionally, the report is to catalog barriers to more diverse geographical distribution of COVID-19 diagnostics and therapeutics manufacturing, the relationship between patent protection and innovation and access to medicines, use of and alternatives to compulsory licenses, and the effect of the Medicines Patent Pool on access to COVID-19 diagnostics and therapeutics.
Consistent with its typical practice, the Commission will solicit public input during the investigation, including holding a public hearing. The USTR also indicated that input from foreign governments, non-governmental health advocates, and diagnostic and therapeutic manufacturers on the following would be particularly salient:
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. Read More→
https://www.usitc.gov/press_room/news_release/2023/er0201_63483.htm