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1 1 (June 4, 2021)

handle is hein.crs/govednn0001 and id is 1 raw text is: Congressional SResearch Service informrng the Ieg I aive debate since 1914 ___ Potential WTO TRIPS Waiver and COVID-19 Updated June 4, 2021 On May 5, 2021, the Biden Administration announced its support for a proposed waiver of intellectual property rights (IPR) obligations in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for Coronavirus Disease 2019 (COVID-19) vaccines. This is significant, given the United States' history of advancing stronger IPR protections and enforcement globally. WTO TRIPS Agreement Entering into force in I995,TRIPS requires most WTO members to adhere to minimum standards to protect various types of IP, and to enforce these protections through domestic procedures and remedies, as well as provides for certain limitations and flexibilities to these obligations. Least-developed countries are exempt from meeting substantive TRIPS obligations generally until July 31, 2021,and pharmaceutical patent obligations until January 1, 2033. The balance struck in TRIPSto promote innovation and other societal aims faces ongoing debate. Some of the relevant flexibilities are that a WTO member can: Exclude certain inventions from patentability, including if necessary to protect hunn health or life, and diagnostic, therapeutic, or surgical methods for thetreatment of humans. Issue a compulsory license (CL) fora patented invention, to authorize a third party to use a patented product or process without the patent owner's consent under certain conditions, which may be waived in situations of national emergency or other circumstances of extreme urgency.... A2005 TRlPS amendment permits a CL for the export of a patented product; the amendment aims to address situations in which countries need the product but do not have the domestic nnufacturing capacity. One prior instance of the amendment's use exists, although Bolivia announced it may use it for COVID-19 vaccine imports. Take measures in derogation of TRIPS if necessary for the protection of its essential security interests... taken in time of... other emergency in international relations. First proposed by India and South Africa in October 2020, a potential TRIPS waiver for the COVID-19 response subsequently attracted support from many low- and middle-income countries (LMICs) seeking greater access to vaccines and other health products. The proposed waiver prompted skepticism largely from a number of high-income countries concerned about its adverse effects on innovation incentives and drug quality and safety. The debate intensified amid worsening COVID-19 outbreaks in South Asia and Latin America. On May 21, India, South Africa, and 60 other countries, seeking greater support, submitted a revised proposal that would waive the same IPR obligations as originally proposed-copyrights, patents, industrial designs, and undisclosed data (e.g., test data and trade secrets). The revised proposal specifies Congressional Research Service https://crsreports.congress.gov IN11662 CRS INSIGHT Prepared for Membersand Committeesof Congress- cl

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