II 

115TH CONGRESS 

1ST SESSION S. 1681 

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 SENATE OF THE UNITED STATES 

JULY 31, 2017 

Mr. SANDERS introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

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. REASONABLE PRICE AGREEMENT. 

4 (a) IN GENERAL.—If any Federal agency or any non5 profit entity undertakes Federally funded health care re6 search and development and is to convey or provide a pat7 ent for a drug, biologic, or other health care technology 

8 developed through such research, such agency or entity 


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•S 1681 IS

1 shall not make such conveyance or provide such patent 

2 until the entity (including a non-profit entity) that will re3 ceive such patent first agrees to a reasonable pricing 

4 agreement with the Secretary of Health and Human Serv5 ices (referred to in this section as the ‘‘Secretary’’) or the 

6 Secretary makes a determination that the public interest 

7 is served by a waiver of the reasonable pricing agreement 

8 provided in accordance with subsection (c). 

9 (b) PROHIBITION OF DISCRIMINATION.— 

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

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

12 shall not result in discriminatory pricing for the 

13 drug, biologic, or other health care technology in14 volved regardless of the number of bidders involved. 

15 In carrying out this subparagraph, the Secretary 

16 shall ensure that the Federal Government, with re17 spect to the drug, biologic, or other health care tech18 nology involved, is charged an amount that is not 

19 more than the lowest amount charged to countries in 

20 the Organization for Economic Co-Operation and 

21 Development for the same drug, biologic, or tech22 nology, that have the largest gross domestic product 

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

24 the per capita income of the United States. 


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1 (2) DISCRIMINATORY PRICING.—For the pur2 poses of paragraph (1), a cost based reasonable pric3 ing formula that is utilized shall be considered to re4 sult in discriminatory pricing if the contract for sale 

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

6 places a limit on supply, or employs any other meas7 ure, that has the effect of— 

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

9 or technology on terms or conditions that are 

10 less favorable than the terms or conditions pro11 vided to a foreign purchaser (other than a char12 itable or humanitarian organization) of the 

13 drug, biologic, or technology; or 

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

15 or technology under this section. 

16 (c) WAIVER.—No waiver shall take effect under sub17 section (a) before the public is given notice of the proposed 

18 waiver and provided a reasonable opportunity to comment 

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

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

21 the public interest. 

Æ 


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