I 
117TH CONGRESS 
1ST SESSION H. R. 3694 
To direct the Secretary of Health and Human Services, in consultation 
with the United States Trade Representative and other heads of Federal 
agencies, to submit to Congress a report on the impact of a waiver 
of certain obligations of member nations under the Agreement on Trade- 
Related Aspects of Intellectual Property Rights on global COVID–19 
vaccine access, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 4, 2021 
Mr. CARTER of Georgia introduced the following bill; which was referred to 
the Committee on Ways and Means 
A BILL 
To direct the Secretary of Health and Human Services, 
in consultation with the United States Trade Representa-
tive and other heads of Federal agencies, to submit to 
Congress a report on the impact of a waiver of certain 
obligations of member nations under the Agreement on 
Trade-Related Aspects of Intellectual Property Rights 
on global COVID–19 vaccine access, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. INTERAGENCY PUBLIC HEALTH REPORT ON IM-
PACT OF TRIPS WAIVER ON GLOBAL COVID– 
19 VACCINE ACCESS. 
(a) REPORT AND CONCLUSION.—Not later than 60 
days after the date of the enactment of this section, the 
Secretary of Health and Human Services, in consultation 
with the United States Trade Representative, the Sec-
retary of Commerce, the Commissioner of Food and 
Drugs, and the Director of the Centers for Disease Con-
trol and Prevention, shall submit to Congress, and make 
publicly available on a public website of the Department 
of Health and Human Services, a report containing the 
following: 
(1) An assessment of how the elimination or 
waiver described in subsection (b) would impact each 
of the following during the covered period: 
(A) Access to COVID–19 vaccines in the 
United States. 
(B) Access to COVID–19 vaccines globally. 
(C) Global COVID–19 vaccine manufac-
turing capacity. 
(D) Global supply chains of COVID–19 
vaccines and related technologies and the inputs 
needed to produce those vaccines and related 
technologies. 
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(E) Exports and imports by the United 
States of COVID–19 vaccines and related tech-
nologies and the inputs needed to produce such 
vaccines and related technologies. 
(F) Biopharmaceutical product manufac-
turing in the United States and the inputs 
needed to produce biopharmaceutical products. 
(G) Investment in biopharmaceutical pro-
duction in the United States and in research 
and development in biopharmaceutical products 
to respond to future infectious disease out-
breaks and pandemics. 
(2) The Secretary’s conclusion on whether an 
elimination or waiver, as described in subsection (b), 
during the covered period— 
(A) will materially increase global COVID– 
19 vaccine access; or 
(B) will have a negative impact on any of 
the factors described in subparagraphs (A) 
through (G) of paragraph (1). 
(b) USTR OPPOSITION.—The United States Trade 
Representative shall oppose an elimination or waiver of an 
obligation imposed on members of the World Trade Orga-
nization under the Agreement on Trade-Related Aspects 
of Intellectual Property Rights with respect to vaccines in-
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tended to prevent or mitigate COVID–19, if the Secretary 
concludes under subsection (a)(2) that such elimination or 
waiver— 
(1) will not materially increase global COVID– 
19 vaccine access; or 
(2) will have a negative impact on any of the 
factors described in subparagraphs (A) through (G) 
of subsection (a)(1). 
(c) COVERED PERIOD DEFINED.—The term ‘‘covered 
period’’ means the period beginning on the date of the en-
actment of this section and ending on December 31, 2022. 
Æ 
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