H.R.877 - Patients First Act of 2009
To intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes.
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SECTION 1. SHORT TITLE.
SEC. 2. PURPOSES.
(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.CommentsClose CommentsPermalink
SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY.
‘SEC. 409J. 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--CommentsClose CommentsPermalink
‘(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)--CommentsClose CommentsPermalink
‘(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;CommentsClose CommentsPermalink
‘(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 but is not limited to--CommentsClose CommentsPermalink
‘(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; orCommentsClose CommentsPermalink
‘(3) consistent with the standards established in subsection (a), may take into account techniques outlined by the President’s Council on Bioethics and any other appropriate techniques and research.CommentsClose CommentsPermalink
‘(1) HUMAN EMBRYO- The term ‘human embryo’ 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, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.CommentsClose CommentsPermalink
‘(2) RISK OF INJURY- The term ‘risk of injury’ means subjecting a human embryo to risk of injury or death greater than that allowed for research on fetuses in utero under section 46.204(b) of title 45, Code of Federal Regulations (or any successor regulation), or section 498(b) of this Act.’.CommentsClose CommentsPermalink
‘(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 409J.CommentsClose CommentsPermalink
‘(2) At the end of fiscal year 2010 and each subsequent fiscal year, the Secretary shall submit to the Congress a report outlining the number of research proposals under section 409J 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 biennial report required by section 403.’.CommentsClose CommentsPermalink
SEC. 4. STUDY TO EXPAND ACCESS TO THERAPEUTIC STEM CELL PRODUCTS.
Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall study and submit recommendations to the Congress on any structural changes to the C.W. Bill Young Cell Transplantation Program established under 379 of the Public Health Service Act (