HR 7854
Medicines for the People Act
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Bill overview
The Medicines for the People Act establishes the National Institute for Biomedical Research and Development within the Public Health Service Act. This institute’s primary goals are to develop drugs, devices, and biological products for long-term access, foster innovation, and prioritize public health needs, making these products available at equitable prices. The institute will conduct research and development, assess health technology, and manage patents related to its work, with a focus on transparency and public access.
Key provisions
- Establishes the National Institute for Biomedical Research and Development.
- Directs the institute to develop drugs, devices, and biological products for public health needs and equitable access.
- Requires the institute to conduct health technology assessments to evaluate the value of new products.
- Authorizes the institute to acquire inventions related to biomedical research and development.
- Mandates the institute to prioritize research based on public health impact and unmet needs.
- Requires the institute to share research data publicly and ensure transparency in its operations.
- Establishes a governing board to oversee the institute’s activities.
- Provides for the public manufacturing and sale of approved drugs, devices, and biological products, prioritizing cost-effectiveness.
Who is affected
- Patients
- Pharmaceutical companies
- Federal agencies (NIH, FDA)
- Research institutions
- Healthcare providers
Sponsors
Official sponsors from legislative records.
Primary sponsor
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119th CONGRESS — 2d Session
H. R. 7854
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend the Public Health Service Act to establish a National Institute for Biomedical Research and Development, and for other purposes.
This Act may be cited as the Medicines for the People Act
.
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:
The general purposes of the National Institute for Biomedical Research and Development (referred to in this subpart as the Institute) are—
The Director shall carry out the program described in paragraph (1) through—
managing direct research and development at Federal laboratories of the National Institutes of Health;
contracting with public or private entities for research and development;
acquisition of research and development, including technologies and related scientific data, from public or private entities;
licensing of patents under subsection (f);
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;
sharing scientific data in a timely manner for use by research communities and Federal and State agencies;
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;
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;
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
implementing goals, priorities, objectives, policies, and procedures established by the Board.
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.
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.
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.
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
shall be deidentified to protect patient privacy, but may not otherwise be withheld from disclosure on any basis;
all data developed in carrying out research and development activities;
summary findings made in carrying out such activities; and
copies of all licensing agreements and contracts entered into with public and private entities; and
requiring any entity that conducts research funded by the Institute—
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;
when selecting a repository, to give priority to—
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;
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
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.
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.
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.
The Director shall manage the patents and trade secrets relating to research and development conducted or funded under this section in the public interest.
The Director shall obtain patents, as appropriate, for inventions resulting from research and development conducted or funded under this section.
Unless otherwise determined by the Director, patents held by the Institute shall be licensed to the Medicines Patent Pool.
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—
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;
non-exclusive licensing to public, nonprofit, and for-profit entities under subparagraph (D).
In any license of the rights to a patent held by the Institute, the Director shall license patents—
to public entities, free of cost;
to nonprofit organizations, free of cost; and
to for-profit entities with terms that protect the public interest, including non-exclusivity provisions, cost-plus pricing terms, and reciprocity rules.
Freedom of Information Act).
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;
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
may consider the need for diversified, regional production of medicines to ensure access, or for other purposes, when granting licenses.
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.
In providing for the establishment and operations of the Institute, the Director of NIH may, on request of the Director of the Institute—
allow the Institute to use such facilities of the National Institutes of Health as the Director of NIH determines to be appropriate; and
obtain administrative support for the Institute from the other agencies of the National Institutes of Health, including the other national research institutes.
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 theBoard) to assist the Secretary in establishing high-level policy, conducting long-term planning, and providing overall direction for the Institute.
The Board shall consist of 15 voting members, to be appointed by the Secretary, including—
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;
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;
not fewer than 2 current or former public health officials;
not fewer than 2 current or former members of the Institute, except in the case of the initial membership of the Board; and
such other members as the Secretary determines appropriate.
The members of the Board shall elect from among such members a Chair of the Board.
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.
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.
The term of the position of Chair of the Board shall not exceed 6 years.
In appointing members under paragraph (1), the Secretary shall ensure that—
not more than 5 members are from the for-profit sector;
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;
no member is a current or former senior executive officer of a covered entity;
no member is a current or former senior executive officer of a covered entity during the 6-year period beginning on the later of—
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
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
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.
The time period described in this paragraph is as follows:
With respect to an officer or employee of an Executive agency, the later of—
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
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.
With respect to an officer or employee of an Executive agency who becomes a corporate lobbyist, the later of—
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
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.
The Board, subject to the supervision of the Secretary under subsection (e), shall—
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;
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;
establish such committees or bodies as may be necessary to facilitate or carry out the duties of the Board; and
perform such other duties and responsibilities as may be necessary to carry out this section.
In this section:
The term covered entity means any entity that is—
a for-profit company; or
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
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.
The term Executive agency—
has the meaning given the term in section 105 of title 5, United States Code; and
includes—
the Executive Office of the President and all components thereof, including the White House Office; and
the Office of the Vice President.
The term rights to an invention includes all rights, title, and interests in an invention, including—
any sale, assignment, or other transfer of a patent on the invention, United States or foreign; and
any exclusive license to a patent on an invention, United States or foreign.
The work of the Board shall be directed and supervised by the Secretary who shall—
consult with the Board;
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
make public any reasons why the Secretary rejected or materially modified the decisions of the Board pertaining to such duties.
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.
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.
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.
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.
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.
A member may be removed from the Board by the Secretary only for inefficiency, neglect of duty, or malfeasance in office.
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.
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.
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.
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.
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: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.
Number of clinical trial data sets published in the public domain.
Number of new drugs, biological products, and devices developed or brought to market, directly or indirectly.
Number of licenses acquired from public, nonprofit, and for-profit entities.
Number of patents licensed, disaggregated by public, nonprofit, or private entity.
Number of patents filed.
Number of patents purchased or acquired.
Estimated savings to public health care programs due to the activities of the Institute.
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.There is authorized to be appropriated to carry out this subpart $90,000,000,000 for fiscal year 2027, to remain available until expended.
in subsection (b)—
by redesignating paragraph (25) as paragraph (26); and
by inserting after paragraph (24) the following:
The National Institute for Biomedical Research and Development.
in subsection (d)(1), by striking 27
and inserting 28
.
Section 405 of the Public Health Service Act (42 U.S.C. 284) is amended—
or governing boardafter
advisory council; and
in subsection (c)(3), by inserting or governing board
after advisory council
.
Section 216 of title 18, United States Code, is amended—
or section 464z–12 of the Public Health Service Actafter
of this title;
in subsection (b), by inserting or section 464z–12 of the Public Health Service Act
after of this title
; and
in subsection (c), by inserting or section 464z–12 of the Public Health Service Act
after of this title
.