Nordberg Ana, Minssen Timo, Holm Sune, Horst Maja, Mortensen Kell, Møller Birger Lindberg
Associate Senior Lecturer in Private Law, Faculty of Law, Lund University, 221 00 Lund, Sweden.
Professor of Law, Managing Director, Centre for Advanced Studies in Biomedical Innovation Law, Faculty of Law, University of Copenhagen, 2300 Copenhagen, Denmark.
J Law Biosci. 2018 Jan 18;5(1):35-83. doi: 10.1093/jlb/lsx043. eCollection 2018 May.
Gene-editing technology, such as CRISPR/Cas9, holds great promise for the advancement of science and many useful applications technology. This foundational technology enables modification of the genetic structure of any living organisms with unprecedented precision. Yet, in order to enhance its potential for societal benefit, it is necessary to adapt rules and produce adequate regulations. This requires an interdisciplinary effort in legal thinking. Any legislative initiative needs to consider both the benefits and the problematic aspects of gene editing, from a broader societal and value-based perspective. identify and discuss some of the most pressing legal implications of gene-editing technology and how to address these. While the questions raised by gene editing are global, laws and regulations are to a great extent bound by national borders. This paper presents a European perspective, written for a global audience, and intends to contribute to the global debate. The analysis will include brief references to corresponding USA rules in order to place these European debates in the broader international context. Our legal analysis incorporates interdisciplinary contributes concerning the scientific state of the art, philosophical thinking regarding the precautionary principle and dual-use issues as well as the importance of communication, social perception, and public debate. Focusing mainly in the main regulatory and patent law issues, we will argue that (a) general moratoriums and blank prohibitions do a disservice to science and innovation; (b) it is crucial to carefully consider a complex body of international and European fundamental rights norms applicable to gene editing;
基因编辑技术,如CRISPR/Cas9,对科学进步和许多有益的应用技术有着巨大的前景。这项基础技术能够以前所未有的精度修改任何生物体的基因结构。然而,为了增强其对社会有益的潜力,有必要调整规则并制定适当的监管措施。这需要法律思维方面的跨学科努力。任何立法举措都需要从更广泛的社会和基于价值观的角度考虑基因编辑的益处和问题方面。识别并讨论基因编辑技术一些最紧迫的法律影响以及如何应对这些影响。虽然基因编辑引发的问题是全球性的,但法律法规在很大程度上受国界限制。本文从欧洲视角出发,面向全球读者撰写,旨在为全球辩论做出贡献。分析将简要提及美国的相应规则,以便将这些欧洲辩论置于更广泛的国际背景下。我们的法律分析纳入了关于科学技术现状、有关预防原则和两用问题的哲学思考以及沟通、社会认知和公众辩论重要性的跨学科贡献。主要关注主要的监管和专利法问题,我们将论证:(a) 全面暂停和一概禁止对科学和创新不利;(b) 仔细考虑适用于基因编辑的一系列复杂的国际和欧洲基本权利规范至关重要;