H.R. 7854

[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''.
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