I 
116TH CONGRESS 
1ST SESSION 
H. R. 64 
To intensify stem cell research showing evidence of substantial clinical benefit 
to patients, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 3, 2019 
Mr. BANKS introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To intensify stem cell research showing evidence of substan-
tial clinical benefit to patients, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patients First Act of 
2019’’. 
SEC. 2. PURPOSES. 
It is the purpose of this Act to— 
(1) intensify research that may result in im-
proved understanding of or treatments for diseases 
and other adverse health conditions; 
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(2) promote research and human clinical trials 
using stem cells that are ethically obtained and show 
evidence of providing clinical benefit for human pa-
tients; and 
(3) promote the derivation of pluripotent stem 
cell lines without the creation of human embryos for 
research purposes and without the destruction or 
discarding of, or risk of injury to, a human embryo. 
SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY. 
(a) AUTHORIZATION.—Part B of title IV of the Pub-
lic Health Service Act (42 U.S.C. 284 et seq.) is amended 
by inserting after section 409J the following: 
‘‘SEC. 409K. HUMAN STEM CELL RESEARCH AND THERAPY. 
‘‘(a) IN GENERAL.—The Secretary shall conduct and 
support basic and applied research to develop techniques 
for the isolation, derivation, production, testing, and 
human clinical use of stem cells that may result in im-
proved understanding of or treatments for diseases and 
other adverse health conditions, including pluripotent stem 
cells that have the flexibility of embryonic stem cells 
(whether or not such pluripotent stem cells have an embry-
onic source), prioritizing research with the greatest poten-
tial for near-term clinical benefit in human patients, pro-
vided that such isolation, derivation, production, testing, 
or use will not involve— 
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‘‘(1) the creation of a human embryo for re-
search purposes; 
‘‘(2) the destruction of or discarding of, or risk 
of injury to, a living human embryo; or 
‘‘(3) the use of any stem cell, the derivation or 
provision of which would be inconsistent with the 
standards established in paragraph (1) or (2). 
‘‘(b) GUIDELINES.—Not later than 90 days after the 
date of the enactment of this section, the Secretary, after 
consultation with the Director of NIH, shall issue final 
guidelines implementing subsection (a) to ensure that any 
research (including any clinical trial) supported under 
subsection (a)— 
‘‘(1) is clearly consistent with the standards es-
tablished in subsection (a) if conducted using human 
cells, as demonstrated by animal trials or other sub-
stantial evidence; and 
‘‘(2) is prioritized in terms of potential for 
near-term clinical benefit in human patients, as indi-
cated by substantial evidence from basic research or 
by substantial clinical evidence which may include 
but is not limited to— 
‘‘(A) evidence of improvement in one or 
more human patients suffering from illness or 
injury, as documented in reports by professional 
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medical or scientific associations or in peer-re-
viewed medical or scientific literature; or 
‘‘(B) approval for use in human trials by 
the Food and Drug Administration. 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) HUMAN EMBRYO.—The term ‘human em-
bryo’ includes any organism, not protected as a 
human subject under part 46 of title 45, Code of 
Federal Regulations, as of the date of the enactment 
of this section, that is derived by fertilization, par-
thenogenesis, cloning, or any other means from one 
or more human gametes or human diploid cells. 
‘‘(2) RISK OF INJURY.—The term ‘risk of in-
jury’ means subjecting a human embryo to risk of 
injury or death greater than that allowed for re-
search on fetuses in utero under section 46.204(b) 
of title 45, Code of Federal Regulations (or any suc-
cessor regulation), or section 498(b) of this Act.’’. 
(b) PRIORITY SETTING; REPORTS.—Section 492 of 
the Public Health Service Act (42 U.S.C. 289a) is amend-
ed by adding at the end the following: 
‘‘(d)(1) With respect to human stem cell research, the 
Secretary, acting through the Director of NIH, shall give 
priority to conducting or supporting research in accord-
ance with section 409K. 
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