ITC on COVID Testing, Meds Access

Other key factors affecting demand and availability including access to intellectual property, prices and affordability, regulatory approvals, healthcare infrastructure and the healthcare priorities of governments, according to the report.

The ITC report was requested by US Trade Representative Katherine Tai as the Administration seeks to take a position on whether the decision made by World Trade Organization members at last year’s 12th ministerial conference to provide IP flexibilities for COVID-19 vaccine production should be extended to diagnostics and therapeutics.

Washington has been saying it will not take a position on the extension until the ITC report is complete.

The Administration needs to “carefully review” the report’s findings before making a decision, Ms. Tai said yesterday. “We hope that the facts in this report and the record the USITC has meticulously gathered will help inform a thoughtful and constructive policy discussion and deliberative process here at home, around the world, and at the World Trade Organization on matters so critically important to global public health and economic resilience,” she said.

Ms. Tai last year asked the ITC to conduct an investigation into COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around the supply and demand, price points, the relationship between testing and treating and production and access.

Based on the ITC’s findings, the Administration should support the extension, commented Lori Wallach, director of Rethink Trade at the American Economic Liberties Project. “After delaying the WTO decision scheduled for the end of last year with its request for this study, certainly the Biden Administration will not side with pharmaceutical firms who want WTO rules to limit access to affordable COVID medicines and tests that can prevent needless deaths, more long COVID and the prospect for more virulent variants spreading undetected.”

Findings

The report finds:

• 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.

The report also 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.