Patients First Act of 2019

To intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes. 1. Short title This Act may be cited as the Patients First Act of 2019 2. Purposes It is the purpose of this Act to— (1) intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions; (2) promote research and human clinical trials using stem cells that are ethically obtained and show evidence of providing clinical benefit for human patients; 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. 3. Human stem cell research and therapy (a) Authorization Part B of title IV of the Public Health Service Act ( 42 U.S.C. 284 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 improved 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 embryonic source), prioritizing research with the greatest potential for near-term clinical benefit in human patients, provided that such isolation, derivation, production, testing, or use will not involve— (1) the creation of a human embryo for research 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 under 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 established in subsection (a) if conducted using human cells, as demonstrated by animal trials or other substantial evidence; and (2) is prioritized in terms of potential for near-term clinical benefit in human patients, as indicated by substantial evidence from basic research or by substantial clinical evidence, which may include— (A) evidence of improvement in one or more human patients suffering from illness or injury, as documented in reports by professional medical or scientific associations or in peer-reviewed 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 embryo (2) Risk of injury The term risk of injury . (b) Priority setting; reports Section 492 of the Public Health Service Act ( 42 U.S.C. 289a (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 accordance with section 409K. (2) At the end of fiscal year 2019 and each subsequent fiscal year, the Secretary shall submit to Congress a report outlining the number of research proposals under section 409K that were peer reviewed, a summary and detailed list of all such research proposals that were not funded, and an explanation of why the proposals did not merit funding. The reports under this paragraph shall be in addition to the reporting on stem cell research included in the triennial report required by section 403. . (c) Triennial reports Section 403(a)(5) of the Public Health Service Act ( 42 U.S.C. 283(a)(5) (1) by redesignating subparagraph (L) as subparagraph (M); and (2) by inserting after subparagraph (K) the following: (L) Stem cells. .

Summary: Patients First Act of 2019 This bill requires the National Institutes of Health (NIH) to support stem cell research. Specifically, the NIH must 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 improved understanding of, or treatments for, diseases and other adverse health conditions. However, such techniques must not involve (1) the creation of a human embryo for research purposes; (2) the destruction or discarding of, or risk of injury to, a human embryo; or (3) the use of any stem cell the derivation or provision of which would be inconsistent with this bill. The NIH must also report on peer-reviewed stem cell research proposals that were not funded.