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.

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- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 18:05 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3694.IH H3694 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 3694 IH SECTION 1. INTERAGENCY PUBLIC HEALTH REPORT ON IM- 1 PACT OF TRIPS WAIVER ON GLOBAL COVID– 2 19 VACCINE ACCESS. 3 (a) REPORT AND CONCLUSION.—Not later than 60 4 days after the date of the enactment of this section, the 5 Secretary of Health and Human Services, in consultation 6 with the United States Trade Representative, the Sec- 7 retary of Commerce, the Commissioner of Food and 8 Drugs, and the Director of the Centers for Disease Con- 9 trol and Prevention, shall submit to Congress, and make 10 publicly available on a public website of the Department 11 of Health and Human Services, a report containing the 12 following: 13 (1) An assessment of how the elimination or 14 waiver described in subsection (b) would impact each 15 of the following during the covered period: 16 (A) Access to COVID–19 vaccines in the 17 United States. 18 (B) Access to COVID–19 vaccines globally. 19 (C) Global COVID–19 vaccine manufac- 20 turing capacity. 21 (D) Global supply chains of COVID–19 22 vaccines and related technologies and the inputs 23 needed to produce those vaccines and related 24 technologies. 25 VerDate Sep 11 2014 18:05 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3694.IH H3694 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 3694 IH (E) Exports and imports by the United 1 States of COVID–19 vaccines and related tech- 2 nologies and the inputs needed to produce such 3 vaccines and related technologies. 4 (F) Biopharmaceutical product manufac- 5 turing in the United States and the inputs 6 needed to produce biopharmaceutical products. 7 (G) Investment in biopharmaceutical pro- 8 duction in the United States and in research 9 and development in biopharmaceutical products 10 to respond to future infectious disease out- 11 breaks and pandemics. 12 (2) The Secretary’s conclusion on whether an 13 elimination or waiver, as described in subsection (b), 14 during the covered period— 15 (A) will materially increase global COVID– 16 19 vaccine access; or 17 (B) will have a negative impact on any of 18 the factors described in subparagraphs (A) 19 through (G) of paragraph (1). 20 (b) USTR OPPOSITION.—The United States Trade 21 Representative shall oppose an elimination or waiver of an 22 obligation imposed on members of the World Trade Orga- 23 nization under the Agreement on Trade-Related Aspects 24 of Intellectual Property Rights with respect to vaccines in- 25 VerDate Sep 11 2014 18:05 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3694.IH H3694 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 3694 IH tended to prevent or mitigate COVID–19, if the Secretary 1 concludes under subsection (a)(2) that such elimination or 2 waiver— 3 (1) will not materially increase global COVID– 4 19 vaccine access; or 5 (2) will have a negative impact on any of the 6 factors described in subparagraphs (A) through (G) 7 of subsection (a)(1). 8 (c) COVERED PERIOD DEFINED.—The term ‘‘covered 9 period’’ means the period beginning on the date of the en- 10 actment of this section and ending on December 31, 2022. 11 Æ VerDate Sep 11 2014 18:05 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H3694.IH H3694 pamtmann on DSKBC07HB2PROD with BILLS