Possible TRIPS Waiver Compromise Rumored
Up to now there has been little stated progress towards a consensus since India and South Africa first proposed in October 2020 to waive certain IP protections of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) for COVID-19 vaccines and supplies. However, reports of a compromise reached between the European Union, India, South Africa, and the United States have emerged this month.
After the U.S. administration announced their support for some type of IP waiver in late spring 2021, the TRIPS Council had regular meetings to discuss the issue. TRIPS Council reports have regularly referenced small group discussions between the four delegations (the European Union, India, South Africa, and the United States). TRIPS Council minutes also reflect an appreciation that the proposed IP waiver is complex and highly politicized.
Details of the compromise have not been formally announced, but reports indicate that the compromise entails far less than the broad waiver of protections over copyrights, designs, trade secrets, and patents in relation to health products and technologies for the prevention and treatment of COVID-19 that was originally proposed by India and South Africa. In particular, the new proposal focuses on (1) developing countries who exported less than 10% of the world’s COVID-19 vaccine doses in 2021, and (2) allowing those countries to authorize the use of patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the patent holder. For the time being, the proposal is limited to vaccines, but consideration of extending the waiver to COVID-19 therapeutics and diagnostics will occur within six months of enactment.
The next scheduled formal meeting of the TRIPS Council is not until June 8-9, 2022, and it is likely that the final details would be released before such meeting. However, that is the first step in what may likely be a bumpy road – the waiver would need to be agreed upon by all 164 members of the WTO before it could go into effect. Thus, final enactment would still occur only at some unknown time in the future, and history has shown that obtaining such unanimous agreement may take years.
And at present, more than 11 billion doses have been administered worldwide, and it is estimated that 20 billion doses will be produced in 2022. Additional vaccines are entering the market, including one developed in Houston by two researchers at Texas Children’s Hospital Center for Vaccine Development and the Baylor College of Medicine with global vaccine access in mind. Their vaccine is based on older recombinant protein technology at a low cost (less than $3/dose) and requires only basic refrigeration for transport and storage. Most relevant to the proposed TRIPS waiver, the vaccine is not encumbered by patents.
Given that the current IP system provided the incentives over the years for the advancements in mRNA technology that allowed deployment of new vaccines into the global population at a record-breaking pace (as well as the recombinant protein technology that is now in the public domain), it begs the question whether enactment of this proposal is answering a political call that could have a long-term destabilizing and stifling effect on future innovations if our IP system does not provide reliable protections to innovators. Stated differently, by the time the TRIPS waiver is enacted, if ever, it may already have become a problematic solution to a problem that no longer exists.