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         SCongressional
           *   Research Service





The Biden Administration Announces its

Support for a WTO TRIPS Waiver



May   7, 2021
On May  5, 2021, the Biden Administration announced its support for a waiver of intellectual property
rights (IPR) obligations in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) for COVID-19 vaccines. This is a significant development, given
U. S. leadership historically in advancing stronger IPR protections and enforcement globally.
The COVID-19  pandemic has spurred pharmaceutical and biotechnology companies to undertake
intensive, costly, and risky research and development (R&D) to create new vaccines and other products to
respond to COVID-19. Certain stakeholders have expressed concerns over the impact of IPR on access to
these treatments and technologies. The potential waiver was first proposed by India and South Africa in
October 2020. Subsequent discussion of it in the WTO has attracted support from low- and middle-
income countries (LMICs) seeking greater access to vaccines and related products, but has prompted
skepticism largely from high-income countries, reflecting pharmaceutical industry and other concerns
about the impact on incentives to innovate, and on quality and safety. The debate has intensified amid the
recent surge in COVID-19 in certain regions. Meanwhile, India and South Africa plan to amend their
waiver proposal to seek greater support. Whether other high-income countries also change their position
on the waiver remains to be seen; Germany, for instance, has criticized the U.S. decision. WTO activity
on the proposed waiver may enter text-based negotiations, perhaps including discussion of other issues
such as technology transfer. Anumber of Members of Congress have issued statements in support and
opposition to the waiver proposal in the months leading up to and following the Biden Administration's
announcement, and are likely to continue to weigh in on the matter.

Background

The India/South Africa proposal would waive TRIPS obligations with respect to copyrights, patents,
industrial designs, and undisclosed data (e.g., clinical testing data and trade secrets) for the prevention,
containment, and treatment of COVID-19 until widespread vaccination exists. Suspending these rights
would allow countries to authorize generic producers to manufacture COVID-19 vaccines, therapeutics,
testing, and other items, notwithstanding IPR, likely without violating core WTO obligations.


                                                              Congressional Research Service
                                                                https://crsreports.congress.gov
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