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首页> 美国卫生研究院文献>Frontiers in Bioengineering and Biotechnology >Roads Forward for European GMO Policy—Uncertainties in Wake of ECJ Judgment Have to be Mitigated by Regulatory Reform
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Roads Forward for European GMO Policy—Uncertainties in Wake of ECJ Judgment Have to be Mitigated by Regulatory Reform

机译：欧洲转基因生物政策的前进之路—监管改革必须缓解欧洲法院判决后的不确定性

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This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.
机译：本文概述了有关基因组编辑生物的法律和程序不确定性，以及欧洲GMO政策的可能出路。根据欧洲法院最近的判决（ECJ 2018年7月25日判决，C-528 / 16），通过基因组编辑技术获得的生物是转基因生物，并且承担与转基因生物相同的义务。如果无法将基因组编辑的生物与通过常规技术（例如杂交或随机诱变）培育的生物区分开来，则不确定性就会出现。在这种情况下，由于使用无法确定的技术，相同的生物可能会受到GMO法律的约束或不受监管。长期来看，监管机构可能无法执行GMO法律。由于其他司法管辖区未对转基因生物等生物进行监管，因此可能会发生意外进口，并破坏了欧洲对转基因生物的监管。在不久的将来，欧盟委员会以及欧洲和国家监管机构将决定如何应用法律的最新解释。为了减轻当前的法律和程序不确定性，迈出的第一步在于更新所有指导文档，以专门解决基因组编辑问题，特别是解决基因组编辑问题，包括提供唯一标识符的解决方案。通过利用GMO法律中的现有灵活性，可以部分针对不同类型的生物量身定制GMO发布的授权程序。但是，只有对管理GMO发布授权流程的法规进行修订，才能大大减轻创新者的负担。第二步，任何前进的方式都必须旨在修订，补充或替代欧洲GMO指令（2001/18 / EC）。本文提出的政策选择以政治准备就绪为前提。在当前的政治形势下，这可能不现实。但是，如果仅忽略当前的GMO法的问题，欧洲的竞争力和绿色生物技术的研究将受到影响。

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