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1 1 (March 30, 2020)

handle is hein.crs/govcwyt0001 and id is 1 raw text is: Resarh Service COVID-19: International Trade and Access to Pharmaceutical Products March 30, 2020 As the coronavirus disease (COVID- 19) pandemic continues, governments and the private sector have begun assessing the possibility of developing medical countermeasures (e.g., vaccines, antiviral treatments) to improve patient recovery rates and contain the virus's spread. Some Members of Congress have expressed concern about access to, and the affordability of, any potential countermeasures. As outlined in this CRS Sidebar, Congress can take, and has taken, several steps to address these issues, some of which may raise questions under U.S. law. This Sidebar addresses how certain congressional or executive actions intended to increase access to medical countermeasures might be viewed under the rules of the international trade regime, including: (1) exclusion from patent protection; (2) compulsory licensing of patented products; and (3) increasing domestic capacity. Exclusion from Patent Protection Congress has constitutional authority to design and control the scope of a patent system. Thus, as described in this CRS Sidebar, Congress may consider whether to exclude from patent protection certain medical countermeasures to address the COVID-19 pandemic. The World Trade Organization's (WTO's) Agreement on -rade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) requires all WTO Members to make patents available for any inventions, whether products or processes, in all fields of technology. Thus, excluding medical countermeasures from patentability may raise questions regarding the legality of such an action. However, the TRIPS Agreement includes several potentially relevant exceptions. First, it expressly permits WTO Members to exclude certain inventions from their patent systems if necessary to protect, among other things, human life or health. Second, it allows WTO Members to exclude diagnostic, therapeutic and surgical methods for the treatment of humans from patentability. These exceptions reflect a consensus among WTO Members that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. In particular, WTO Members recognize that the Agreement can and should be interpreted and implemented in a manner.., to promote access to medicines for all. Accordingly, Congress may be able to exclude patent protection for at least some medical countermeasures to address COVID- 19 (e.g., diagnostic and therapeutic methods) without violating WTO obligations. However, the Congressional Research Service https://crsreports.congress.gov LSB10436 CRS LegA! SidebaF Prpred For Meumbers and Comrnm itees of Coqgr ss ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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