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在美国和欧盟界定“研究”:Sherley v. Sebelius 案和 Brüstle v. Greenpeace 裁决之对比。

Defining "research" in the US and EU: contrast of Sherley v. Sebelius and Brüstle v. Greenpeace rulings.

机构信息

Science and Technology Policy Program, James A. Baker III Institute, Rice University, 6100 Main Street, Houston, TX, 77005, USA.

出版信息

Stem Cell Rev Rep. 2013 Dec;9(6):743-51. doi: 10.1007/s12015-013-9462-3.

Abstract

In 2011, courts in both the United States and European Union handed down decisions related to human embryonic stem cell (hESC) research. In both cases, the definition of research was challenged - but the two courts reached different opinions. In the US case, Sherley v. Sebelius, research was defined as a specific project. The US District Court of Appeals did not link research utilizing existing hESC lines to the act of destroying a human embryo in order to create the line, which is not eligible for federal funding. In contrast, the Court of Justice of the European Union in the Brüstle v. Greenpeace case determined inventions related to hESCs were unpatentable since they resulted from research that involved the destruction of human embryos. In this article, we will compare and contrast these two court cases, the politics related to the rulings, and their impacts. We find that these cases significantly impacted current research and have the potential to negatively impact future stem cell research and development. However, the long-term effects of the cases remain to be seen, and there is a chance that these cases could actually strengthen this area of science. Ultimately, we feel that stem cell polices must be straightforward and supported by the public to prevent courts and judges from making decisions on science, which are disruptive to the progression of research.

摘要

2011 年,美国和欧盟的法院都做出了与人类胚胎干细胞(hESC)研究相关的决定。在这两个案例中,研究的定义都受到了挑战——但这两个法院得出了不同的意见。在美国的 Sherley v. Sebelius 案中,研究被定义为一个具体的项目。美国上诉法院并没有将利用现有 hESC 系进行的研究与为了创建该系而破坏人类胚胎的行为联系起来,因为这种行为不符合联邦资金的资助条件。相比之下,欧盟法院在 Brüstle v. Greenpeace 案中裁定,与 hESC 相关的发明是不可授予专利的,因为它们是涉及破坏人类胚胎的研究的结果。在本文中,我们将比较和对比这两个法院案件、与裁决相关的政治以及它们的影响。我们发现,这些案件对当前的研究产生了重大影响,并有可能对未来的干细胞研究和开发产生负面影响。然而,这些案件的长期影响还有待观察,而且这些案件实际上可能会加强这一科学领域的可能性也存在。最终,我们认为干细胞政策必须简单明了,并得到公众的支持,以防止法院和法官对科学做出决策,从而破坏研究的进展。

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