It will be recalled that the initial proposal by South Africa and India was focused on vaccines and preventing the purported, expected, or apprehended impediments to development or distribution of vaccines for SARS-CoV-2 during the COVID-19 pandemic.  U.S. support for the initial waiver was surprising (see "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines"), particularly in view of opposition by IP groups (see "IP Associations "Concerned" by Reports of TRIPS Waiver Compromise") and members of Congress (particularly Senator Thom Tills; see "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal" and "Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver").  And when agreement was reached on the waiver (see "Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver"), its provisions raised additional concerns, particularly to the extent they could encompass not only patents but trade secrets and other intellectual property (see "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" and "The Proposed WTO IP Waiver: Just What Good Can It Do? -- An Analysis").

The original waiver agreement contained a provision that a decision on whether to extend the waiver to diagnostic methods and therapeutic agents useful against SARS-CoV-2 and COVID-19 would be reached within six months, which deadline falls on December 17th.

On December 6th, the U.S. Trade Representative joined the growing international chorus at the WTO supporting delay for making a decision on extending the waiver, which includes the UK, the EU, Japan, South Korea, Singapore and most recently Mexico and Switzerland.  In addition, the USTR asked the International Trade Commission (ITC) to open an investigation to assess the extent to which "supply and demand, price points, the relationship between testing and treating, and production and access" affect market dynamics for COVID-19 diagnostics and therapeutics.  The ITC request includes specifics on what products would the proposed extension affect, the global market for these products and the extent to which there is an unmet demand for them or shortfalls in supply or distribution, as well as a report on the countries that have used the existing waiver versus countries using other options like the UN Medicine Patent Pool.  This inquiry could take up to nine months according to some estimates.

This decision raised an expected outcry from groups in favor of the original waiver as well as the extension.  Most vocal in decrying the decision to support delay were representatives from the People's Vaccine Alliance (who termed the decision "heartbreaking") and the Trade Justice Education Fund, who noted the 290,000 COVID-related deaths globally since the WTO decided not to grant a waiver for diagnostics and therapeutics in the initial vaccine waiver earlier this year.  Commentators also cited WHO statistics revealing that 25 (one in 50) COVID tests were administered in low- and middle-income countries (which make up 84% of the global population), and a recent Oxfam analysis estimated that only a quarter of the Paxlovid supply had been sent to developing countries (although under an agreement with the UN Medicines Patent Pool drugmaker Pfizer has licensed generic companies to make the drug in 95 countries).

On the other hand, the U.S. Chamber of Commerce, the Biotechnology Innovation Organization (BIO) and PhARMA have characterized the extension as unnecessary in view of the failure of the initial waiver, which has not been used by any country to increase access to vaccines.  In a talk sponsored by IP advocacy group C4IP last week (see "C4IP Presents Webinar on COVID Waiver Extension"), former U.S. Patent and Trademark Office Directors Andre Iancu and David Kappos and former U.S. Secretary of Commerce Gary Locke were in agreement that the waiver has had no effect, because problems with vaccine access have little to do with IP protection and were caused by logistical and supply chain limitations and failures.

The COVID 19 pandemic provided an opportunity for those opposing patent rights to medicines and vaccines to achieve their goals to turn back the clock on global acceptance of IP that reached its zenith with the TRIPS agreement and establishment of the WTO.  The latest delay in extending the patent (really, IP) waiver in the face of the declining pandemic may thwart these efforts for now, but inherent disparities in global access to medicines is a problem exacerbated although not created by the pandemic and one for which the need for a solution remains.