H. R. 3536
IN THE HOUSE OF REPRESENTATIVES
July 28, 2017
Mr. DeFazio introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
Reasonable price agreement
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).
Prohibition of discrimination
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.
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—
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
restricting access to the drug, biologic, or technology under this section.
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.