Patients First Act of 2019

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Patients First Act of 4 2019’’. 5 SEC. 2. PURPOSES. 6 It is the purpose of this Act to— 7 (1) intensify research that may result in im- 8 proved understanding of or treatments for diseases 9 and other adverse health conditions; 10 VerDate Sep 11 2014 00:23 Jan 11, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H64.IH H64 pbinns on DSK79D2C42PROD with BILLS 2 •HR 64 IH (2) promote research and human clinical trials 1 using stem cells that are ethically obtained and show 2 evidence of providing clinical benefit for human pa- 3 tients; and 4 (3) promote the derivation of pluripotent stem 5 cell lines without the creation of human embryos for 6 research purposes and without the destruction or 7 discarding of, or risk of injury to, a human embryo. 8 SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY. 9 (a) AUTHORIZATION.—Part B of title IV of the Pub- 10 lic Health Service Act (42 U.S.C. 284 et seq.) is amended 11 by inserting after section 409J the following: 12 ‘‘SEC. 409K. HUMAN STEM CELL RESEARCH AND THERAPY. 13 ‘‘(a) IN GENERAL.—The Secretary shall conduct and 14 support basic and applied research to develop techniques 15 for the isolation, derivation, production, testing, and 16 human clinical use of stem cells that may result in im- 17 proved understanding of or treatments for diseases and 18 other adverse health conditions, including pluripotent stem 19 cells that have the flexibility of embryonic stem cells 20 (whether or not such pluripotent stem cells have an embry- 21 onic source), prioritizing research with the greatest poten- 22 tial for near-term clinical benefit in human patients, pro- 23 vided that such isolation, derivation, production, testing, 24 or use will not involve— 25 VerDate Sep 11 2014 00:23 Jan 11, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H64.IH H64 pbinns on DSK79D2C42PROD with BILLS 3 •HR 64 IH ‘‘(1) the creation of a human embryo for re- 1 search purposes; 2 ‘‘(2) the destruction of or discarding of, or risk 3 of injury to, a living human embryo; or 4 ‘‘(3) the use of any stem cell, the derivation or 5 provision of which would be inconsistent with the 6 standards established in paragraph (1) or (2). 7 ‘‘(b) GUIDELINES.—Not later than 90 days after the 8 date of the enactment of this section, the Secretary, after 9 consultation with the Director of NIH, shall issue final 10 guidelines implementing subsection (a) to ensure that any 11 research (including any clinical trial) supported under 12 subsection (a)— 13 ‘‘(1) is clearly consistent with the standards es- 14 tablished in subsection (a) if conducted using human 15 cells, as demonstrated by animal trials or other sub- 16 stantial evidence; and 17 ‘‘(2) is prioritized in terms of potential for 18 near-term clinical benefit in human patients, as indi- 19 cated by substantial evidence from basic research or 20 by substantial clinical evidence which may include 21 but is not limited to— 22 ‘‘(A) evidence of improvement in one or 23 more human patients suffering from illness or 24 injury, as documented in reports by professional 25 VerDate Sep 11 2014 00:23 Jan 11, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H64.IH H64 pbinns on DSK79D2C42PROD with BILLS 4 •HR 64 IH medical or scientific associations or in peer-re- 1 viewed medical or scientific literature; or 2 ‘‘(B) approval for use in human trials by 3 the Food and Drug Administration. 4 ‘‘(c) DEFINITIONS.—In this section: 5 ‘‘(1) HUMAN EMBRYO.—The term ‘human em- 6 bryo’ includes any organism, not protected as a 7 human subject under part 46 of title 45, Code of 8 Federal Regulations, as of the date of the enactment 9 of this section, that is derived by fertilization, par- 10 thenogenesis, cloning, or any other means from one 11 or more human gametes or human diploid cells. 12 ‘‘(2) RISK OF INJURY.—The term ‘risk of in- 13 jury’ means subjecting a human embryo to risk of 14 injury or death greater than that allowed for re- 15 search on fetuses in utero under section 46.204(b) 16 of title 45, Code of Federal Regulations (or any suc- 17 cessor regulation), or section 498(b) of this Act.’’. 18 (b) PRIORITY SETTING; REPORTS.—Section 492 of 19 the Public Health Service Act (42 U.S.C. 289a) is amend- 20 ed by adding at the end the following: 21 ‘‘(d)(1) With respect to human stem cell research, the 22 Secretary, acting through the Director of NIH, shall give 23 priority to conducting or supporting research in accord- 24 ance with section 409K. 25 VerDate Sep 11 2014 00:23 Jan 11, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H64.IH H64 pbinns on DSK79D2C42PROD with BILLS 5 •HR 64 IH ‘‘(2) At the end of fiscal year 2020 and each subse- 1 quent fiscal year, the Secretary shall submit to the Con- 2 gress a report outlining the number of research proposals 3 under section 409K that were peer reviewed, a summary 4 and detailed list of all such research proposals that were 5 not funded, and an explanation of why the proposals did 6 not merit funding. The reports under this paragraph shall 7 be in addition to the reporting on stem cell research in- 8 cluded in the biennial report required by section 403.’’. 9 (c) BIENNIAL REPORTS.—Section 403(a)(5) of the 10 Public Health Service Act (42 U.S.C. 283(a)(5)) is 11 amended— 12 (1) by redesignating subparagraph (L) as sub- 13 paragraph (M); and 14 (2) by inserting after subparagraph (K) the fol- 15 lowing: 16 ‘‘(L) Stem cells.’’. 17 Æ VerDate Sep 11 2014 00:23 Jan 11, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H64.IH H64 pbinns on DSK79D2C42PROD with BILLS