1 1 (March 30, 2020)

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                  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

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