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 pricing agreements with the Secretary of Health and Human 

Services. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Affordable Pricing for 

5 Taxpayer-Funded Prescription Drugs Act of 2019’’. 

6 SEC. 2. REASONABLE PRICE AGREEMENT. 

7 (a) IN GENERAL.—If any Federal agency or any non8 profit entity undertakes Federally funded health care reVerDate Sep 11 2014 23:55 Oct 11, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4640.IH H4640

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1 search and development and is to convey or provide a pat2 ent for a drug, biologic, or other health care technology 

3 developed through such research, such agency or entity 

4 shall not make such conveyance or provide such patent 

5 until the entity (including a nonprofit entity) that will re6 ceive such patent first agrees to a reasonable pricing 

7 agreement with the Secretary of Health and Human Serv8 ices (referred to in this section as the ‘‘Secretary’’) or the 

9 Secretary makes a determination that the public interest 

10 is served by a waiver of the reasonable pricing agreement 

11 provided in accordance with subsection (c). 

12 (b) PROHIBITION OF DISCRIMINATION.— 

13 (1) IN GENERAL.—For purposes of subsection 

14 (a), any reasonable pricing formula that is utilized 

15 shall not result in discriminatory pricing for the 

16 drug, biologic, or other health care technology in17 volved regardless of the number of bidders involved. 

18 In carrying out this subparagraph, the Secretary 

19 shall ensure that the Federal Government, with re20 spect to the drug, biologic, or other health care tech21 nology involved, is charged an amount that is not 

22 more than the lowest amount charged to countries in 

23 the Organization for Economic Co-Operation and 

24 Development for the same drug, biologic, or tech25 nology, that have the largest gross domestic product 


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1 with a per capita income that is not less than half 

2 the per capita income of the United States. 

3 (2) DISCRIMINATORY PRICING.—For the pur4 poses of paragraph (1), a cost based reasonable pric5 ing formula that is utilized shall be considered to re6 sult in discriminatory pricing if the contract for sale 

7 of the drug, biologic, or other health care technology 

8 places a limit on supply, or employs any other meas9 ure, that has the effect of— 

10 (A) providing access to such drug, biologic, 

11 or technology on terms or conditions that are 

12 less favorable than the terms or conditions pro13 vided to a foreign purchaser (other than a char14 itable or humanitarian organization) of the 

15 drug, biologic, or technology; or 

16 (B) restricting access to the drug, biologic, 

17 or technology under this section. 

18 (c) WAIVER.—No waiver shall take effect under sub19 section (a) before the public is given notice of the proposed 

20 waiver and provided a reasonable opportunity to comment 

21 on the proposed waiver. A decision to grant a waiver shall 

22 set out the Secretary’s finding that such a waiver is in 

23 the public interest. 

Æ 


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