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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4640 Introduced in House (IH)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Pricing for Taxpayer-
Funded Prescription Drugs Act of 2019''.

SEC. 2. REASONABLE PRICE AGREEMENT.

    (a) In General.--If any Federal agency or any nonprofit entity 
undertakes Federally funded health care research and development and is 
to convey or provide a patent for a drug, biologic, or other health 
care technology developed through such research, such agency or entity 
shall not make such conveyance or provide such patent until the entity 
(including a nonprofit entity) that will receive such patent first 
agrees to a reasonable pricing agreement with the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary'') 
or the Secretary makes a determination that the public interest is 
served by a waiver of the reasonable pricing agreement provided in 
accordance with subsection (c).
    (b) Prohibition of Discrimination.--
            (1) In general.--For purposes of subsection (a), any 
        reasonable pricing formula that is utilized shall not result in 
        discriminatory pricing for the drug, biologic, or other health 
        care technology involved regardless of the number of bidders 
        involved. In carrying out this subparagraph, the Secretary 
        shall ensure that the Federal Government, with respect to the 
        drug, biologic, or other health care technology involved, is 
        charged an amount that is not more than the lowest amount 
        charged to countries in the Organization for Economic Co-
        Operation and Development for the same drug, biologic, or 
        technology, that have the largest gross domestic product with a 
        per capita income that is not less than half the per capita 
        income of the United States.
            (2) Discriminatory pricing.--For the purposes of paragraph 
        (1), a cost based reasonable pricing formula that is utilized 
        shall be considered to result in discriminatory pricing if the 
        contract for sale of the drug, biologic, or other health care 
        technology places a limit on supply, or employs any other 
        measure, that has the effect of--
                    (A) providing access to such drug, biologic, or 
                technology on terms or conditions that are less 
                favorable than the terms or conditions provided to a 
                foreign purchaser (other than a charitable or 
                humanitarian organization) of the drug, biologic, or 
                technology; or
                    (B) restricting access to the drug, biologic, or 
                technology under this section.
    (c) Waiver.--No waiver shall take effect under subsection (a) 
before the public is given notice of the proposed waiver and provided a 
reasonable opportunity to comment on the proposed waiver. A decision to 
grant a waiver shall set out the Secretary's finding that such a waiver 
is in the public interest.
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