Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4640 To require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services. IN THE HOUSE OF REPRESENTATIVES OCTOBER 11, 2019 Mr. DEFAZIO introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require persons who undertake Federally funded research and development of drugs to enter into reasonable pric- ing agreements with the Secretary of Health and Human Services. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Affordable Pricing for 4 Taxpayer-Funded Prescription Drugs Act of 2019’’. 5 SEC. 2. REASONABLE PRICE AGREEMENT. 6 (a) IN GENERAL.—If any Federal agency or any non- 7 profit entity undertakes Federally funded health care re- 8 VerDate Sep 11 2014 23:55 Oct 11, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4640.IH H4640 kjohnson on DSK79L0C42 with BILLS 2 •HR 4640 IH search and development and is to convey or provide a pat- 1 ent for a drug, biologic, or other health care technology 2 developed through such research, such agency or entity 3 shall not make such conveyance or provide such patent 4 until the entity (including a nonprofit entity) that will re- 5 ceive such patent first agrees to a reasonable pricing 6 agreement with the Secretary of Health and Human Serv- 7 ices (referred to in this section as the ‘‘Secretary’’) or the 8 Secretary makes a determination that the public interest 9 is served by a waiver of the reasonable pricing agreement 10 provided in accordance with subsection (c). 11 (b) PROHIBITION OF DISCRIMINATION.— 12 (1) IN GENERAL.—For purposes of subsection 13 (a), any reasonable pricing formula that is utilized 14 shall not result in discriminatory pricing for the 15 drug, biologic, or other health care technology in- 16 volved regardless of the number of bidders involved. 17 In carrying out this subparagraph, the Secretary 18 shall ensure that the Federal Government, with re- 19 spect to the drug, biologic, or other health care tech- 20 nology involved, is charged an amount that is not 21 more than the lowest amount charged to countries in 22 the Organization for Economic Co-Operation and 23 Development for the same drug, biologic, or tech- 24 nology, that have the largest gross domestic product 25 VerDate Sep 11 2014 23:55 Oct 11, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4640.IH H4640 kjohnson on DSK79L0C42 with BILLS 3 •HR 4640 IH with a per capita income that is not less than half 1 the per capita income of the United States. 2 (2) DISCRIMINATORY PRICING.—For the pur- 3 poses of paragraph (1), a cost based reasonable pric- 4 ing formula that is utilized shall be considered to re- 5 sult in discriminatory pricing if the contract for sale 6 of the drug, biologic, or other health care technology 7 places a limit on supply, or employs any other meas- 8 ure, that has the effect of— 9 (A) providing access to such drug, biologic, 10 or technology on terms or conditions that are 11 less favorable than the terms or conditions pro- 12 vided to a foreign purchaser (other than a char- 13 itable or humanitarian organization) of the 14 drug, biologic, or technology; or 15 (B) restricting access to the drug, biologic, 16 or technology under this section. 17 (c) WAIVER.—No waiver shall take effect under sub- 18 section (a) before the public is given notice of the proposed 19 waiver and provided a reasonable opportunity to comment 20 on the proposed waiver. A decision to grant a waiver shall 21 set out the Secretary’s finding that such a waiver is in 22 the public interest. 23 Æ VerDate Sep 11 2014 23:55 Oct 11, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H4640.IH H4640 kjohnson on DSK79L0C42 with BILLS