February 1, 2023
News Release 23-011
Inv. No(s). 332-596
Contact: Elizabeth Nesbitt, 202-205-1819
USITC to Report on COVID-19 Diagnostics and Therapeutics and Flexibilities Under the TRIPS Agreement

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.

The USITC expects to submit its report to the USTR on October 17, 2023.

The USITC will hold a public hearing in connection with the investigation at 9:30 a.m. on March 29, 2023. A link to the hearing will be posted on the Commission’s website at https://www.usitc.gov/calendarpad/calendar.html.

Requests to appear at the hearing should be filed no later than 5:15 p.m. on March 15, 2023, with the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. See below for important information regarding filing a request to appear at a USITC hearing.

The USITC also welcomes written submissions for the record. Written submissions should be addressed to the Secretary of the Commission and should be submitted no later than 5:15 p.m. on May 5, 2023. All written submissions, except for confidential business information, will be available for public inspection. See below for important information regarding the filing of written submissions for USITC investigations.

IMPORTANT: All filings to appear at the hearing and written submissions must be made through the Commission’s Electronic Document Information System (EDIS, https://edis.usitc.gov). No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding electronic filing should contact the Office of the Secretary, Docket Services Division ( EDIS3Help@USITC.gov), or consult the Commission’s Handbook on Filing Procedures.

Further information on the scope of the investigation is available in the USITC’s notice of investigation, dated February 1, 2023, which can also be obtained by contacting the Office of the Secretary at commissionhearings@usitc.gov.

About factfinding investigations: USITC general factfinding investigations, such as this one, cover matters related to tariffs, trade, and competitiveness and are generally conducted under section 332(g) of the Tariff Act of 1930 at the request of the U.S. Trade Representative, the House Committee on Ways and Means, or the Senate Committee on Finance. The resulting reports convey the Commission’s objective findings and independent analyses on the subjects investigated. The Commission makes no recommendations on policy or other matters in its general factfinding reports. Upon completion of each investigation, the USITC submits its findings and analyses to the requester. General factfinding investigation reports are subsequently released to the public unless they are classified by the requester for national security reasons.

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