News Release 23-090
Inv. No(s). 332-596
Contact: Elizabeth Nesbitt, 202-205-1819
The U.S. International Trade Commission (USITC) today released a report about COVID-19 diagnostics and therapeutics and certain flexibilities under the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), among other topics. The investigation, COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596), was requested by the U.S. Trade Representative (USTR) in a letter received on December 16, 2022.
USTR’s request letter asked the USITC to provide information on a number of issues and factors concerning COVID-19 diagnostics and therapeutics, as well as to identify where significant data and information gaps exist. As requested, the USITC’s report identifies and defines the universe of COVID-19 diagnostics and therapeutics under patent and in development. It also provides information on relevant COVID-19 diagnostics and therapeutics, including with respect to:
- Intellectual property protections, production, distribution, and trade;
- Demand and factors affecting demand;
- Market segmentation of global demand and consumption, according to the World Bank’s classification of economies—high-income countries (HICs), upper-middle-income countries (UMICs), lower-middle-income countries (LMICs), and low-income countries (LICs); and
- Availability and pricing.
The report additionally catalogs, among other things, barriers to accessing COVID-19 diagnostics and therapeutics and actions taken by WTO members to use or attempt to use compulsory licenses for pharmaceuticals and any alternatives, including voluntary licenses and licensing coordinated by the Medicines Patent Pool.
The report also contains views from the public on specified topics and a literature review.
Detailed highlights can be found in the report's Executive Summary.
Select findings are detailed below.
- The universe of products that are COVID-19 diagnostics and therapeutics is vast. Possible approaches to narrowing the universe of products to a smaller scope of relevant COVID-19 diagnostics and therapeutics could be to look at whether the product is covered by patents, whether the product is directed to COVID-19, and whether the product has received regulatory approval or authorization.
- The two fields of diagnostics and therapeutics are composed of different producers, inputs, and know-how. In general, COVID-19 diagnostics can be brought to market faster than COVID-19 therapeutics. Research and development of COVID-19 diagnostics and therapeutics primarily occurred in HICs, but manufacturing of diagnostics and therapeutics occurred in countries of all income levels except for LICs.
- Voluntary licenses, including licenses coordinated by the Medicines Patent Pool, have been an important mechanism to offer COVID-19 therapeutics for sale at reduced prices in LICs, LMICs, and some UMICs; however, a number of UMICs have been excluded from coverage under voluntary licenses. Compulsory licenses have been used by a small number of countries to access intellectual property associated with certain COVID-19 therapeutics.
- The disparity among countries of different income groups in terms of access to and availability of COVID-19 diagnostics and therapeutics is wide, with key factors affecting demand and availability including access to intellectual property, prices and affordability, regulatory approvals, healthcare infrastructure, and the healthcare priorities of governments. The importance of each of these and other factors impacting availability and demand varies greatly among countries.
COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596, USITC Publication 5469, October 2023) is available on the USITC website at: https://www.usitc.gov/publications/332/pub5469.pdf,
About factfinding investigations: USITC general factfinding investigations, such as this one, cover matters related to tariffs, trade, and competitiveness and are generally conducted 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.