NIHBiomedicine Federal FundUS 20 billion Federal Funding Policy

美國對胚胎管制之立法起源 • 聯邦政府透過NIH支援Biomedicine研究 – Federal Fund的規模每年約US$ 20 billion。 – 條件：獲得支援的研究者必須遵守Federal Funding Policy。 • 管制胚胎用於研究用途的立法起源 – 時空背景：IVF技術尚未成熟（1978年第一例活產試 管嬰兒才出現） – National Research Act 1974 (1974. 7. 12) – 對於使用「胎兒」(“a living human fetus, before or after the induced abortion of such fetus, unless such research is done for the purpose of assuring the survival of such fetus. ”) 的醫學研究，暫緩提供Federal Fund的支援。

以預算管制胚胎研究模式之確立 • 1996 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act & the “Dickey Amendment” – 該法律之本質為提供NIH及DHHS預算的Budget Bill。 – 由Arkansas眾議員Jay Dickey所提案的Dickey Amendment，自 1996年之後每年均成為Health and Human Services Appropriations Bill的一部份。

Dickey Amendment • Dickey Amendment的內容 – None of the funds made available in this Act may be used for— • (1) the creation of a human embryo or embryos for research purposes; or • (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46. 204 and 46. 207, and subsection 498(b) of the Public Health Service Act (42 U. S. C. 289 g(b)). • For purposes of this section, the term ‘human embryo or embryos’ includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

美國現行法律與政策 • 現行法律與政策 – Dickey Amendment – The Current Policy on Federal Government Funding of Human Embryonic Stem Cell Research (especially “Remarks by the President on Stem Cell Research”) • 現行政策的基本精神 – “The life and death decision had already been made. ” By President George W. Bush on 2001. 8. 9

美國現行政策 • The administration’s policy made it possible to use taxpayer funding for research conducted on those preexisting lines, but it refused in advance to support research on any lines created after the date of the announcement. In addition, to be eligible for funding, those preexisting lines would have had to have been derived from excess embryos created solely for reproductive purposes, made available with the informed consent of the donors, and without any financial inducements to the donors—standard research-ethics conditions that had been attached to the previous administration’s short-lived funding guidelines, as well as to earlier attempts to formulate rules for federal funding of human embryo research. The policy denies federal funding not only for research conducted on stem cell lines derived from embryos destroyed after August 9, 2001 (or that fail to meet the above criteria), but also (as the proposed Clinton-era policy would have) for the creation of any human embryos for research purposes and for the cloning of human embryos for any purpose.

目前有資格享有Federal Fund之幹細胞株 • • • • Bresa. Gen, Inc. , Athens, Georgia 4 Cy. Thera, Inc. , San Diego, California 9 ES Cell International, Melbourne, Australia 6 Geron Corporation, Menlo Park, California 7 Göteborg University, Göteborg, Sweden 19 Karolinska Institute, Stockholm, Sweden 6 Maria Biotech Co. Ltd. – Maria Infertility Hospital Medical Institute, Seoul, Korea 3 Miz. Medi Hospital – Seoul National University, Seoul, Korea 1 National Centre for Biological Sciences/ Tata Institute of Fundamental Research, Bangalore, India 3 Pochon CHA University, Seoul, Korea 2 Reliance Life Sciences, Mumbai, India 7 Technion University, Haifa, Israel 4 University of California, San Francisco, California 2 Wisconsin Alumni Research Foundation, Madison, Wisconsin 5

2007年諾貝爾醫學獎得主的成果 • Mario R. Capecchi (University of Utah)、Oliver Smithies (University of North Carolina)以及Sir Martin J. Evans (Cardiff University)研究的重點 – Gene-targeting Technology – Knockout mice – Embryonic Stem Cells

成體幹細胞技術的突破 • 新技術的重點 – Reprogramming human skin cells by add four genes. – Turning human skin cells into what appear to be embryonic stem cells without having to make or destroy an embryo. – That should be able to turn into any of the 220 cell types of the human body.

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