In June 2022, World Trade Organization (WTO) member states agreed to waive certain WTO intellectual property protections for COVID-19 vaccines. The U.S. Trade Representative (USTR) has been considering a proposal to expand that waiver, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement waiver, to COVID-19 diagnostics and therapeutics. On October 17^th, the U.S. International Trade Commission (USITC) released a report requested by the USTR on the proposal, in which the USITC analyzed various issues and information gaps related to COVID-19 diagnostics and therapeutics.

Although the report stopped short of making any recommendations, BIO’s Chief Policy Officer stated: 

“This report reiterates our stance that there is no credible evidence supporting the need for an expanded TRIPs waiver — or other expansions that would hinder critical intellectual property protections within the biomedical field — to increase global access to COVID-19 diagnostics and therapeutics.  

Innovation and intellectual property go hand-in-hand. We look forward to advocating for American ingenuity and the global innovation ecosystem that ushers in new generations of treatments. We will continue to work with this Administration to find solutions that encourage innovation within the life sciences fields and increase patient access to critical diagnostics, therapeutics, and vaccines.”  

The report delved into issues related to demand for COVID-19 diagnostics and therapeutics, delivery challenges in different countries, and the pros and cons of voluntary licenses (VLs) as opposed to compulsory licenses (CLs). At the end of the day, though, the backdrop for the report is that the waning of the COVID-19 pandemic has meant that demand for the COVID-19 diagnostics and therapeutics at issue has also declined. 

CBSA’s Stance 

CBSA opposes the TRIPS waiver and any expansion of it that further erodes intellectual property (IP) protections for life sciences innovations. Expanding the TRIPS waiver would be ineffective and counterproductive in bolstering the global response to the COVID-19 pandemic.   

CBSA has and will continue to speak out against the TRIPS waiver due to the harmful precedent set by waiving IP protections for the life sciences sector. IP is the foundation of our ecosystem. IP protections are essential to the technology transfer process in life sciences that leads from lab invention to life-saving commercial products.

CBSA advocates for a supportive, pro-innovation business climate for life sciences. We support proposals to strengthen the ability of patent owners to defend their inventions and businesses against infringement. 

Further Background: What Prompted This Report 

During the WTO’s 12^th Ministerial Conference in June 2022, WTO Member States agreed on a decision to waive certain IP provisions of the TRIPS Agreement, altering aspects of existing rules regarding the ability to issue compulsory licenses on patents covering COVID-19 vaccines. On December 16, 2022, the Office of the USTR announced support for extending the deadline to decide whether the WTO’s IP waiver should be expanded to COVID-19 treatments and diagnostics. The Biden administration requested an interagency review of the proposed expanded waiver, including an in-depth analysis from the USITC of COVID-19 diagnostics and therapeutics to “provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access.” 

As part of its investigation, the USITC held an all-day public hearing on March 29, 2023, and “interviewed representatives from more than 120 entities through virtual meetings and fieldwork.” That work led to the USITC putting out its 497-page report entitled “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities.”