Section 1 Short title
This Act may be cited as the “Make Taxpayer-Funded Department of Defense Medical Interventions Affordable Act”.
Make Taxpayer-Funded Department of Defense Medical Interventions Affordable Act
A BILL
To authorize the use of certain drugs, vaccines, and medical technologies to expand military and civilian access to such products, and for other purposes.
Sec. 2 Authorization of use of drugs, vaccines, and medical technologies to expand military and civilian access to such products
Report and identification of products— Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall submit to the Committees on Armed Services of the Senate and the House of Representatives a report on the efforts of the Secretary to comply with the paragraph titled “Licensing of Federally owned medical interventions”, included on page 173 of the report of the Committee on Armed Services of the Senate accompanying S. 1519 of the 115th Congress (S. Rept. 115–125), which shall include the following information:
A description of what steps, if any, the Secretary has taken to comply with such paragraph.
A complete list of the drugs, vaccines, and medical technologies that, as of the date of the enactment of this Act, meet the requirements outlined in such paragraph.
For each drug, vaccine, or medical technology identified under paragraph (2), a discussion of the plans of the Secretary to utilize the authorities of the Secretary under section 203 or 209(d)(1) of title 35, United States Code, to authorize a third party or Federal agency to use the drug, vaccine, or medical technology.
Authorization of use— Not later than one year after the date of the enactment of this Act, the Secretary, pursuant to section 203 or 209(d)(1) of title 35, United States Code, shall authorize third parties or Federal agencies to use not fewer than 10 drugs, vaccines, or medical technologies identified under subsection (a)(2) for the purpose of expanding military and civilian access to such drugs, vaccines, or technologies.
Sec. 3 Department of Defense database on support for biomedical research and development
Database— The Secretary of Defense shall—
compile into a searchable database information relating to any support provided before or after the date of enactment of this Act by the Department of Defense, or an entity acting on its behalf, for biomedical research and development, including with respect to drugs, vaccines, and medical technologies; and
make such database available on a public website of the Department.
Covered information— The information relating to support described in subsection (a)(1) shall include all contracts, funding agreements, licensing arrangements, other transactions, and other arrangements entered into by, or on behalf of, the Department of Defense with respect to the research and development, or the manufacturing and distribution, of a drug (including a biological product), cell or gene therapy, or medical device or other medical technology, including the following:
Licensing agreements pursuant to section 207 or 209 of title 35, United States Code.
Cooperative research and development agreements and licensing agreements entered into pursuant to section 12 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3710a).
Funding agreements, as defined under section 201 of title 35, United States Code.
Transactions, contracts, grants, cooperative agreements, other agreements, and other arrangements entered into pursuant to the following authorities:
Section 2358 of title 10, United States Code.
Section 2371 of such title.
Section 2371a of such title.
Section 2371b of such title.
Section 2373 of such title.
Information required— Notwithstanding any other provision of law, the Secretary shall include in the database under subsection (a) at a minimum, with regard to each contract, funding agreement, licensing agreement, other transaction, or other arrangement, described in subsection (b), the following information:
The element of the Department of Defense providing the grant, cooperative agreement, or other support.
The amount and period of financial support provided by the Department, with an itemized breakdown.
Other nonfinancial support provided by the Department, including the use of personnel, facilities, or equipment of the Department.
The grant number, if applicable.
Associated clinical trial data, upon trial completion.
Associated patents and patent applications, specifying—
any Department ownership in such patents and patent applications;
the expiration date of such patents and filing dates of such patent applications; and
the numbers of such patents and patent applications.
Associated periods of marketing exclusivity under Federal law and the durations of such periods.
The corporation, nonprofit organization, academic institution, person, or other entity receiving the support provided by the Department.
Any products (including repurposed products) approved, authorized, or cleared for marketing, or for which marketing approval, authorization, or clearance is being sought, the development of which was aided by support provided by the Department, including—
the names of such products;
the prices of such products; and
the current and anticipated manufacturing capacity to produce such products.
The full terms of the contract, funding agreement, licensing agreement, other transaction, or other arrangement.
Format of information— The database under subsection (a) shall be—
searchable and filterable according to the categories of information described in subsection (c); and
presented in a user-friendly format.
Timing— The database under subsection (a) shall be—
made publicly available not later than 30 days after the date of enactment of this Act; and
updated not less frequently than once every two weeks.
Disclosure—
In general— Notwithstanding any other provision of law, to the extent necessary for the Secretary to carry out this section, the Secretary may require entities receiving support as described in subsection (a)(1) to disclose to the Secretary any information relating to such support and required to be included in the database under subsection (a).
Intermediary cooperation— Any arrangement entered into by the Department of Defense with an entity providing for such entity to enter into contracts, licensing agreements, grants, other transactions, or other arrangements with third parties on behalf of the Department shall require such entity to disclose in a timely manner any information necessary for the Secretary of Defense to fulfill the duties of the Secretary under this Act. With respect to any such arrangement in place as of the date of enactment of this Act, the Secretary may require the entity to disclose to the Secretary any information required to be included in the database under subsection (a).
Penalty for nondisclosure— If an entity that is required to disclose information pursuant to paragraph (1) or (2) fails to disclose such information by the date that is two weeks after the date on which the Secretary requests such information, or by such reasonable deadline as the Secretary may specify, whichever is sooner, then such entity shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each day on which such failure continues.