[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7854 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 7854
To amend the Public Health Service Act to establish a National
Institute for Biomedical Research and Development, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 5, 2026
Ms. Tlaib (for herself, Ms. Lee of Pennsylvania, and Mrs. Cherfilus-
McCormick) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
the Judiciary, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to establish a National
Institute for Biomedical Research and Development, and for other
purposes.
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 ``Medicines for the People Act''.
SEC. 2. ESTABLISHMENT.
(a) In General.--Part C of title IV of the Public Health Service
Act (42 U.S.C. 285 et seq.) is amended by adding at the end the
following:
``Subpart 21--National Institute for Biomedical Research and
Development
``SEC. 464Z-11. PURPOSE AND FUNCTIONS OF INSTITUTE.
``(a) In General.--The general purposes of the National Institute
for Biomedical Research and Development (referred to in this subpart as
the `Institute') are--
``(1) to engage in full-cycle development of drugs,
devices, and biological products to promote long-term access to
medicines, foster innovation, and ensure prioritization of
public health needs; and
``(2) to make such drugs, devices, and biological products
available to the public at equitable and accessible prices.
``(b) Research and Development Program.--
``(1) In general.--The Director of the Institute (referred
to in this subpart as the `Director') shall carry out a program
for the research and development of drugs, devices, and
biological products for approval, licensure, clearance, or
authorization under section 505, 510(k), 513(f)(2), or 515 of
the Federal Food, Drug, and Cosmetic Act or section 351 of this
Act.
``(2) Activities.--The Director shall carry out the program
described in paragraph (1) through--
``(A) managing direct research and development at
Federal laboratories of the National Institutes of
Health;
``(B) contracting with public or private entities
for research and development;
``(C) acquisition of research and development,
including technologies and related scientific data,
from public or private entities;
``(D) licensing of patents under subsection (f);
``(E) establishment of separate facilities to
conduct the work of the Institute, including, at the
discretion of the Director, the construction of
facilities and the acquisition of land, for the
purposes of the establishment or operation of the
Institute;
``(F) sharing scientific data in a timely manner
for use by research communities and Federal and State
agencies;
``(G) coordinating the activities of the Institute
with related activities of the other agencies of the
National Institutes of Health and with related
activities of other Federal agencies;
``(H) conducting or sponsoring research necessary
to obtain approval from the Food and Drug
Administration, including clinical trials to generate
safety and effectiveness data and information;
``(I) conducting health technology assessments in
accordance with paragraph (3) for drug, devices, and
biological products the research or development of
which is conducted or funded under this section;
``(J) carrying out any other activities necessary
for the successful commercialization of drugs, devices,
and biological products the research or development of
which is conducted or funded under this section; and
``(K) implementing goals, priorities, objectives,
policies, and procedures established by the Board.
``(3) Requirements for health technology assessments.--
``(A) In general.--In conducting health technology
assessments of drugs, devices, and biological products
for purposes of paragraph (2)(I), the Director shall
ensure that such health technology assessments--
``(i) are conducted in a formal,
systematic, and transparent manner;
``(ii) use state-of-the-art methods to
consider the best available evidence;
``(iii) examine the direct, intended
consequences and indirect, unintended
consequences of the use of the applicable drug,
device, or biological product, as compared to
existing alternatives; and
``(iv) consider factors such as clinical
effectiveness, safety, costs and economic
implications, ethical, social, cultural and
legal issues, organizational and environmental
aspects, and implications for patients,
relatives, caregivers, and the broader public.
``(B) Definition of health technology assessment.--
In this section, the term `health technology
assessment' means a multidisciplinary process that uses
explicit methods to determine the value of a drug,
device, or biological product.
``(c) Research Monitoring; Acquisition.--
``(1) In general.--The Director shall monitor the results
of research conducted or supported by the National Institutes
of Health and by other appropriate public and private entities,
such as the Biomedical Advanced Research and Development
Authority of the Department of Health and Human Services or the
Walter Reed Pilot Bioproduction Facility of the Department of
Defense, to identify inventions that, if subjected to
appropriate research and development activities, may be
suitable for approval, licensure, clearance, or authorization
under section 505, 510(k), 513(f)(2), or 515 of the Federal
Food, Drug, and Cosmetic Act or section 351 of this Act as a
drug, biological product, or device.
``(2) Acquisition.--Notwithstanding chapter 18 of title 35,
United States Code, the Director may acquire, and shall have
the right of first refusal for, the rights to an invention
identified under paragraph (1) that is the result of research
conducted or supported by the National Institutes of Health.
``(d) Prioritization.--In allocating the resources of the
Institute, the Board shall establish priorities for research and
development that reflect the magnitude of the potential public health
impact, unmet needs in current product development, and the potential
for scientific breakthrough.
``(e) Transparency.--
``(1) In general.--The Director shall ensure that the
Institute adheres to the highest standards of transparency by--
``(A) sharing with researchers, manufacturers, and
the public preclinical and clinical trial data and data
on costs in an open and timely manner, which data--
``(i) shall include all safety and
effectiveness data and information that has
been submitted in an application to the Food
and Drug Administration, including an
application submitted under section 505 of the
Federal Food, Drug, and Cosmetic Act or section
351 of this Act; and
``(ii) shall be deidentified to protect
patient privacy, but may not otherwise be
withheld from disclosure on any basis;
``(B) making information regarding activities
carried out by the Institute publicly available online,
including--
``(i) information regarding research and
development that is receiving priority;
``(ii) all data developed in carrying out
research and development activities;
``(iii) summary findings made in carrying
out such activities; and
``(iv) copies of all licensing agreements
and contracts entered into with public and
private entities; and
``(C) requiring any entity that conducts research
funded by the Institute--
``(i) to share scientific data generated
from such research not later than the earlier
of the date of the first associated publication
or the end of the period of the award of such
funds;
``(ii) when selecting a repository, to give
priority to--
``(I) data repositories supported
by or affiliated with the National
Institutes of Health; and
``(II) data repositories that--
``(aa) assign datasets
unique persistent identifiers;
``(bb) provide free and
easy access to datasets and
their metadata;
``(cc) make datasets and
metadata available for broad
reuse;
``(dd) have capabilities
for ensuring confidentiality
for sensitive data;
``(ee) have documented
security and integrity
measures; and
``(ff) have documented
procedures to restrict dataset
access and use that are
consistent with participant
consent and changes in consent,
in the case of human
participant data;
``(iii) to take reasonable steps to ensure
data is made available for as long as such data
may be useful for the larger research
community, institutions, or the public; and
``(iv) on acceptance for publication and
consistent with applicable copyright law, to
submit, or have submitted on their behalf, to
the PubMed Central database of the National
Library of Medicine (or any successor archive
or database), an electronic version of the
final, peer-reviewed manuscript describing such
research, which manuscript shall be made
publicly available by the National Library of
Medicine not later than 1 year after the date
on which such manuscript is officially
published.
``(2) Definition of scientific data.--In this subsection,
the term `scientific data' means data commonly accepted in the
scientific community as of sufficient quality to validate and
replicate research findings, regardless of whether the data are
used to support scholarly publications.
``(f) Patents and Trade Secrets.--
``(1) In general.--Notwithstanding chapter 18 of title 35,
United States Code, the Director shall ensure that the Federal
Government owns the rights to any patents and trade secrets
relating to drugs, devices, and biological products the
research or development of which is conducted or funded under
this section, including any research or development conducted
through contracting with a private entity or acquired from a
private entity under this section.
``(2) Management.--The Director shall manage the patents
and trade secrets relating to research and development
conducted or funded under this section in the public interest.
``(3) Patents.--
``(A) In general.--The Director shall obtain
patents, as appropriate, for inventions resulting from
research and development conducted or funded under this
section.
``(B) Standard patent licensing policy.--Unless
otherwise determined by the Director, patents held by
the Institute shall be licensed to the Medicines Patent
Pool.
``(C) Access.--Notwithstanding chapter 18 of title
35, United States Code, the Director shall ensure
public interest access, in terms of both price and
supply, considered independently, including in low- and
middle-income country markets, to patents and trade
secrets relating to drugs, devices, and biological
products the research or development of which is
conducted or funded under this section, including
through--
``(i) stipulating, as a condition of
receipt of Federal extramural biomedical
research funding awarded through the Department
of Health and Human Services, that the
Institute shall be granted rights to all the
data and technical information developed under
a contract, including all necessary
intellectual property, technology, know-how,
and other information (including master batch
records, standard operating procedures, quality
assurance and quality control information,
detailed bill of materials for the drug,
device, or biological product and other
manufacturing documentation) relating to the
drug, device, or biological product necessary
for operationalizing technology transfer;
``(ii) at the discretion of the Director,
stipulating in any contract the Institute
enters into with an extramural party that such
party will provide commercially reasonable
support for technology transfer activities; and
``(iii) non-exclusive licensing to public,
nonprofit, and for-profit entities under
subparagraph (D).
``(D) Licensing.--In any license of the rights to a
patent held by the Institute, the Director shall
license patents--
``(i) to public entities, free of cost;
``(ii) to nonprofit organizations, free of
cost; and
``(iii) to for-profit entities with terms
that protect the public interest, including
non-exclusivity provisions, cost-plus pricing
terms, and reciprocity rules.
``(4) Trade secrets and confidential commercial
information.--
``(A) In general.--The Director may not claim trade
secrets or confidential commercial information with
respect to any drugs, devices, or biological products
the research or development of which is conducted or
funded under this section, including any research or
development conducted through contracting with a
private entity or acquired from a private entity under
this section.
``(B) Confidential commercial information
defined.--In this paragraph, the term `confidential
commercial information' means information that contains
material exempt from disclosure under subsection (b)(4)
of section 552 of title 5, United States Code (commonly
known as the `Freedom of Information Act').
``(g) Public and Private Manufacturing; Licensing; Royalties.--
``(1) In general.--With respect to a drug, biological
product, or device the patent for which is held by the Federal
Government under this section and that is approved, licensed,
cleared, or authorized under section 505, 510(k), 513(f)(2), or
515 of the Federal Food, Drug, and Cosmetic Act or section 351
of this Act, the Director shall provide for--
``(A) the public manufacturing of such drug,
biological product, or device, if practicable; and
``(B) such drugs, biological products, and devices
so manufactured to be sold at cost.
``(2) Licensing; royalties.--If the Director determines
that public manufacturing for a drug, biological product, or
device described in paragraph (1) is not practicable, the
Director--
``(A) may license the patent for such drug,
biological product, or device to a private entity,
based on the value established by a health technology
assessment conducted under subsection (b)(2)(I);
``(B) shall give preference to the manufacturing of
such drug, biological product, or device, by a
nonprofit organization before seeking any manufacturing
by for-profit companies;
``(C) shall, consistent with section 14 of the
Stevenson-Wydler Technology Innovation Act of 1980,
reinvest the royalties received from such licensing
into research and development under this section; and
``(D) may consider the need for diversified,
regional production of medicines to ensure access, or
for other purposes, when granting licenses.
``(h) Supervision.--The work of the Director shall be directed and
supervised by the Secretary, who shall have the authority, after
consulting with the voting members of the Board, to remove the
Director.
``(i) Use of Existing Resources.--In providing for the
establishment and operations of the Institute, the Director of NIH may,
on request of the Director of the Institute--
``(1) transfer to the Institute such personnel of the
National Institutes of Health as the Director of NIH determines
to be appropriate;
``(2) allow the Institute to use such facilities of the
National Institutes of Health as the Director of NIH determines
to be appropriate; and
``(3) obtain administrative support for the Institute from
the other agencies of the National Institutes of Health,
including the other national research institutes.
``SEC. 464Z-12. GOVERNING BOARD.
``(a) In General.--Not later than 180 days after the date of
enactment of the Medicines for the People Act, the Secretary shall
establish a governing board (referred to in this subpart as the
`Board') to assist the Secretary in establishing high-level policy,
conducting long-term planning, and providing overall direction for the
Institute.
``(b) Membership.--
``(1) In general.--The Board shall consist of 15 voting
members, to be appointed by the Secretary, including--
``(A) not fewer than 2 civil society
representatives with a background in identifying and
addressing barriers to the ability of individuals and
populations to acquire medicines needed to achieve
health;
``(B) not fewer than 2 patient advocates from
independent patient organizations that take no funding
from for-profit companies (or foundations or nonprofit
organizations affiliated with for-profit companies)
involved in the production or sale of any drug,
biological product, or device and do not have
executives from such companies (or affiliated
foundations or nonprofit organizations) on their
governing boards;
``(C) not fewer than 2 current or former public
health officials;
``(D) not fewer than 2 current or former members of
the Institute, except in the case of the initial
membership of the Board; and
``(E) such other members as the Secretary
determines appropriate.
``(2) Chair.--The members of the Board shall elect from
among such members a Chair of the Board.
``(3) Nonvoting members.--The Secretary may, after
consulting with the voting members of the Board, appoint not
more than 4 nonvoting members of the Board. Such nonvoting
members shall have relevant experience or expertise not already
represented on the Board.
``(4) Terms.--
``(A) Members.--The term of each member of the
Board shall be not more than 6 years, and the Secretary
shall designate staggered terms for the members first
appointed. Members may serve 1 additional term at the
discretion of the Secretary.
``(B) Chair.--The term of the position of Chair of
the Board shall not exceed 6 years.
``(5) Limitations.--In appointing members under paragraph
(1), the Secretary shall ensure that--
``(A) not more than 5 members are from the for-
profit sector;
``(B) no member is, or has been during the 6-year
period preceding the date of appointment, a lobbyist,
as defined in section 3 of the Lobbying Disclosure Act
of 1995, registered under section 4 of that Act for a
for-profit pharmaceutical manufacturer;
``(C) no member is a current or former senior
executive officer of a covered entity;
``(D) no member is a current or former senior
executive officer of a covered entity during the 6-year
period beginning on the later of--
``(i) the date of a Federal settlement
relating to a violation of sections 3729
through 3733 of title 31, United States Code
(commonly known as the `False Claims Act'), the
Federal Food, Drug, and Cosmetic Act, including
a Federal consent decree, the Sherman Act, the
Clayton Act, or the Federal Trade Commission
Act that was entered into by the relevant
covered entity; and
``(ii) the date on which an enforcement
action relating to a violation by the covered
entity of sections 3729 through 3733 of title
31, United States Code (commonly known as the
`False Claims Act'), the Federal Food, Drug,
and Cosmetic Act, the Sherman Act, the Clayton
Act, or the Federal Trade Commission Act in a
court of the United States or by an Executive
agency has concluded; and
``(E) no member during the time period described in
paragraph (6), with the intent to influence or with the
intent to gain information for use in analyzing
securities or commodities markets or in informing
investment decisions in any securities or commodities
market of the United States, makes any communication to
or appearance before the former public office or
Executive agency of the member for compensation,
provided that any such violation shall be subject to
the penalties set forth in section 216 of title 18,
United States Code.
``(6) Time period.--The time period described in this
paragraph is as follows:
``(A) With respect to an officer or employee of an
Executive agency, the later of--
``(i) the date on which a President other
than the President serving at the time of the
termination of service or employment of the
officer or employee takes office; and
``(ii) the date on which the 2-year period
beginning on the date of the termination of
service or employment as an officer or employee
expires.
``(B) With respect to an officer or employee of an
Executive agency who becomes a corporate lobbyist, the
later of--
``(i) the date on which a President other
than the President serving at the time of the
termination of service or employment of the
officer or employee takes office; and
``(ii) the date on which the 6-year period
beginning on the date of the termination of
service or employment as an officer or employee
expires.
``(c) Duties.--The Board, subject to the supervision of the
Secretary under subsection (e), shall--
``(1) establish goals, priorities, objectives, policies,
and procedures relating to the operation and development of the
Institute, including identifying promising inventions under
subsection (c)(1) of section 464z-11;
``(2) ensure that the Institute effectively carries out the
purposes specified in section 464z-11(a), including that drugs,
devices, or biological products the research or development of
which is conducted or funded under section 464z-11 are
successfully commercialized and available to the public;
``(3) establish such committees or bodies as may be
necessary to facilitate or carry out the duties of the Board;
and
``(4) perform such other duties and responsibilities as may
be necessary to carry out this section.
``(d) Definitions.--In this section:
``(1) Corporate lobbyist.--The term `corporate lobbyist'
means a lobbyist, as defined in section 3 of the Lobbying
Disclosure Act of 1995, who is registered under section 4 of
that Act and who is employed by a corporation, as defined in
section 101(9) of title 11, United States Code.
``(2) Covered entity.--The term `covered entity' means any
entity that is--
``(A)(i) a for-profit company; or
``(ii) a bank holding company, a savings and loan
holding company, or any other financial institution;
and
``(B)(i) operating under a Federal settlement
relating to a violation of sections 3729 through 3733
of title 31, United States Code (commonly known as the
`False Claims Act'), the Federal Food, Drug, and
Cosmetic Act, including a Federal consent decree, the
Sherman Act, the Clayton Act, or the Federal Trade
Commission Act; or
``(ii) the subject of an enforcement action
relating to a violation of sections 3729 through 3733
of title 31, United States Code (commonly known as the
`False Claims Act'), the Federal Food, Drug, and
Cosmetic Act, the Sherman Act, the Clayton Act, or the
Federal Trade Commission Act in a court of the United
States or by an Executive agency.
``(3) Executive agency.--The term `Executive agency'--
``(A) has the meaning given the term in section 105
of title 5, United States Code; and
``(B) includes--
``(i) the Executive Office of the President
and all components thereof, including the White
House Office; and
``(ii) the Office of the Vice President.
``(4) Rights to an invention.--The term `rights to an
invention' includes all rights, title, and interests in an
invention, including--
``(A) any sale, assignment, or other transfer of a
patent on the invention, United States or foreign; and
``(B) any exclusive license to a patent on an
invention, United States or foreign.
``(e) Supervision.--The work of the Board shall be directed and
supervised by the Secretary who shall--
``(1) consult with the Board;
``(2) have the authority to review, approve, modify, or
reject any decision the Board makes pursuant to the duties of
the Board under subsection (c); and
``(3) make public any reasons why the Secretary rejected or
materially modified the decisions of the Board pertaining to
such duties.
``(f) Powers.--
``(1) Hearings and sessions.--The Board may, for the
purpose of carrying out this section, hold hearings, sit and
act at times and places, take testimony, administer oaths or
affirmations to witnesses appearing before the Board, and
receive evidence as the Board considers appropriate.
``(2) Obtaining official data.--The Board may secure
directly from any department or agency of the United States
information necessary to enable the Board to carry out the
duties of the Board under this section.
``(3) Administrative support services.--On request of the
Board, the Administrator of the General Services Administration
shall provide to the Board, on a reimbursable basis, the
administrative support services necessary for the Board to
carry out the duties of the Board under this section.
``(4) Staff.--On request of the Board and on a reimbursable
basis, for the purpose of assisting the Board in carrying out
the duties of the Board, the Secretary may detail to the Board
any personnel of their department.
``(g) Terms of Office.--
``(1) Vacancies.--A member appointed by the Secretary to
fill a vacancy on the Board occurring before the expiration of
the term for which the predecessor of the member was appointed
shall be appointed for the remainder of such term.
``(2) Removal.--A member may be removed from the Board by
the Secretary only for inefficiency, neglect of duty, or
malfeasance in office.
``(h) Pay.--
``(1) Rates of pay.--Members of the Board shall each be
entitled to receive the daily equivalent of the annual rate of
basic pay for level IV of the Executive Schedule under section
5315 of title 5, United States Code, for each day (including
travel time) during which such members are engaged in the
performance of duties of the Board.
``(2) Prohibition of compensation of federal employees.--
Notwithstanding paragraph (1), the members of the Board who are
full-time officers or employees of the United States for
purposes of title 5, United States Code, may not receive
additional pay, allowances, or benefits by reason of their
service on the Board.
``(3) Travel expenses.--Each member shall receive travel
expenses, including per diem in lieu of subsistence, in
accordance with applicable provisions of subchapter I of
chapter 57 of title 5, United States Code.
``(i) Application of Federal Advisory Committee Act.--The Board
shall be subject to chapter 10 of title 5, United States Code (commonly
referred to as the `Federal Advisory Committee Act'), except that
section 1013(a)(2) of such title shall not apply.
``SEC. 464Z-13. EVALUATION; REPORTS.
``(a) In General.--Not later than 5 years after the date of
enactment of the Medicines for the People Act, and annually thereafter,
the Director shall evaluate the activities of the Institute. Such
evaluation shall include the following metrics:
``(1) Number of applications or submissions under section
505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and
Cosmetic Act or section 351 of this Act.
``(2) Number of clinical trial data sets published in the
public domain.
``(3) Number of new drugs, biological products, and devices
developed or brought to market, directly or indirectly.
``(4) Number of licenses acquired from public, nonprofit,
and for-profit entities.
``(5) Number of patents licensed, disaggregated by public,
nonprofit, or private entity.
``(6) Number of patents filed.
``(7) Number of patents purchased or acquired.
``(8) Estimated savings to public health care programs due
to the activities of the Institute.
``(b) Annual Reports.--Not later than 5 years after the date of
enactment of the Medicines for the People Act, and annually thereafter,
the Director shall submit to Congress, and make publicly available, a
report describing the results of the applicable annual evaluation
carried out under subsection (a), including, for patents licensed,
filed, purchased, or acquired, the patent application numbers, filing
dates, names of licensees, dates of licenses, and where license
agreements may be found.
``SEC. 464Z-14. AUTHORIZATION OF APPROPRIATIONS.
``There is authorized to be appropriated to carry out this subpart
$90,000,000,000 for fiscal year 2027, to remain available until
expended.''.
(b) Conforming Amendments.--
(1) Section 401 of the Public Health Service Act (42 U.S.C.
281) is amended--
(A) in subsection (b)--
(ii) by redesignating paragraph (25) as
paragraph (26); and
(iii) by inserting after paragraph (24) the
following:
``(25) The National Institute for Biomedical Research and
Development.''; and
(B) in subsection (d)(1), by striking ``27'' and
inserting ``28''.
(2) Section 405 of the Public Health Service Act (42 U.S.C.
284) is amended--
(A) in subsection (b)(2)(B)(ii), by inserting ``or
governing board'' after ``advisory council''; and
(B) in subsection (c)(3), by inserting ``or
governing board'' after ``advisory council''.
(c) Penalties and Injunctions.--Section 216 of title 18, United
States Code, is amended--
(1) in subsection (a), in the matter preceding paragraph
(1), by inserting ``or section 464z-12 of the Public Health
Service Act'' after ``of this title'';
(2) in subsection (b), by inserting ``or section 464z-12 of
the Public Health Service Act'' after ``of this title''; and
(3) in subsection (c), by inserting ``or section 464z-12 of
the Public Health Service Act'' after ``of this title''.
<all>