着作权研习-益思科技法律事务所.ppt

美國幹細胞研究之法律現況與台灣未來的發展趨勢 益思科技法律事務所 劉承慶律師 2008/3/15 @輔仁大學幹細胞實驗倫理教育研討會 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. 289g(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. 自胚胎中分離出幹細胞對法律的衝擊 對Dickey Amendment的疑慮與討論 時空背景：University of Wisconsin 研究人員在1998年時首次成功自胚胎分離出幹細胞。 私人資助的研究使用胚胎分離出幹細胞，該幹細胞株以組織培養方法繁殖後，相關的幹細胞株研究仍可能取得Federal Fund。 法律專家試圖從文義來設限：in which, were。 支持者認為政府本應提供獎勵措施，因而政策上無庸過度嚴格。 反對者認為如此一來，仍然會造成鼓勵使用、破壞胚胎的結果。 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