Authorization of use of drugs, vaccines, and medical technologies to expand military and civilian access to such products

(a)

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 entitled, Licensing of Federally owned medical interventions included on page 173 of the report of the Committee on Armed Services of the Senate to accompany the National Defense Authorization Act for Fiscal Year 2018 (Public Law 115–91), which shall include the following information:(1)A description of what steps, if any, the Secretary has taken to comply with that paragraph.(2)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 that paragraph.(3)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.(b)

Authorization of use

Not later than one year after the date of the enactment of this Act, the Secretary of Defense, 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.

Transparency in taxpayer-funded biomedical research investments by the Department of Defense

(a)

In general

The Secretary of Defense shall—(1)compile into a searchable database information relating to Federal support (before or after the date of enactment of this Act) provided by the Department of Defense or an entity acting on behalf of the Department of Defense for biomedical research and development, including drugs, vaccines, and medical technologies; and(2)make such database available on the public website of the Department of Defense.(b)

Covered information

The information relating to Federal 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 research and development, manufacturing, and distribution of a drug (including a biological product), cell or gene therapy, medical device, or other medical technology, including the following:(1)Licensing agreements pursuant to section 207 or 209 of title 35, United States Code.(2)Cooperative research and development agreements and licensing agreements pursuant to section 3710a of title 15, United States Code.(3)Funding agreements, as defined in section 201 of title 35, United States Code.(4)Transactions, contracts, grants, cooperative agreements, other agreements, and other arrangements entered into pursuant to the following:(A)The Public Health Service Act (42 U.S.C. 201 et seq.), including sections 301, 319L, 421, and 480 of such Act (42 U.S.C. 241, 247d–7e, 285b–3, 287a).(B)Section 105 of the National Institutes of Health Reform Act of 2006 (42 U.S.C. 284n).(C)Chapter 139 of title 10, United States Code, including sections 2358, 2371, 2371a, 2371b, and 2373.(c)

Information required

Notwithstanding any other provision of law, the Secretary of Defense shall include in the database under subsection (a), with regard to each contract, funding agreement, licensing agreement, other transaction, or other arrangement described in subsection (b), at least the following information:(1)The agency, program, institute, or other entity of the Department of Defense providing the Federal grant, cooperative agreement, or other support.(2)The amount and period of Federal financial support with an itemized breakdown.(3)Other Federal nonfinancial support, including the use of Federal personnel, Federal facilities, and Federal equipment.(4)The grant number, if applicable.(5)Associated clinical trial data, upon trial completion.(6)Associated patents and patent applications, specifying—(A)any Federal ownership in such patents and patent applications;(B)the expiration date of such patents and filing dates of such patent applications; and(C)the numbers of such patents and patent applications.(7)Associated periods of marketing exclusivity under Federal law and the durations of such periods.(8)The corporation, nonprofit organization, academic institution, person, or other entity receiving the Federal support.(9)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 Federal support, including—(A)the names of such products;(B)the prices of such products; and(C)the current and anticipated manufacturing capacity to produce such products.(10)The full terms of the contract, funding agreement, licensing agreement, other transaction, or other arrangement described in subsection (b).(d)

Format of information

The database under subsection (a) shall be—(1)searchable and filterable according to the categories of information described in subsection (c); and(2)presented in a user-friendly format.(e)

Timing

The database under subsection (a) shall be—(1)made publicly available not later than one month after the date of the enactment of this Act; and(2)updated not less frequently than once every two weeks.(f)

Disclosure

(1)

In general

Notwithstanding any other provision of law, to the extent necessary for the Secretary of Defense to carry out this section, the Secretary may require entities receiving Federal support described in subsection (a)(1) to disclose to the Secretary any information relating to such Federal support and required to be included in the database under subsection (a).(2)

Intermediary cooperation

(A)

In general

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 Department to fulfill its duties under this section.(B)

Existing arrangements

With respect to any arrangement described in subparagraph (A) with an entity in place as of the date of the enactment of this Act, the Secretary of Defense may require the entity to disclose to the Secretary any information required to be included in the database under subsection (a).(3)

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 of Defense 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.