Hamburger David J S
Faculty of Law, Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law, University of Passau, Passau, Germany.
Front Bioeng Biotechnol. 2018 Dec 19;6:176. doi: 10.3389/fbioe.2018.00176. eCollection 2018.
Any legal regulation has to take into account fundamental interests and concerns, whether of private or public nature. This applies in particular to the politically and socially sensitive question of regulating plant biotechnology. With the advent of new breeding techniques, such as genome editing, new challenges are arising for legislators around the world. However, in coping with them not only the technical particularities of the new breeding techniques must be taken into account but also the diverse and sometimes conflicting interests of the various stakeholders. In order to be able to draft a suitable regulatory regime for these new techniques, the different interests and concerns at play are identified. Subsequently, a determination is made on how these interests relate to each other, before regulatory concepts to reconcile the conflicting demands are presented. The examined normative criteria, which can have an impact on regulatory decisions regarding genome edited plants and products derived from them, include: industry interests, farmer interests, public opinion, consumer rights and interests, human health and food safety, food security, environmental protection, consistency, and coherence of the regulatory framework and ethical or religious convictions. Since those interests differ from country to country depending on the respective political, economic, and social circumstances, the respective legislator has the task of identifying these normative criteria and must find a suitable balance between them. To this end, a concept is developed on how the different interests can be related to each other and how to deal with conflicting and irreconcilable demands. Additionally, a legislator may have recourse to a number of further analyzed regulatory measures. An approval or notification procedure can be used for a risk assessment or a socio-economic evaluation. Coexistence measures and labeling provisions are able to reconcile interests that are at odds with each other and the precautionary principle can justify certain safeguard measures. As a result, the individual country-specific regulatory outcomes regarding genome edited plants are likely to be as manifold as the interests and regulatory measures at hand.
任何法律法规都必须考虑到基本利益和关切，无论是私人性质还是公共性质的。这尤其适用于植物生物技术监管这一政治和社会敏感问题。随着基因组编辑等新育种技术的出现，世界各地的立法者面临着新的挑战。然而，在应对这些挑战时，不仅要考虑新育种技术的技术特性，还要考虑各利益相关方的不同利益，有时这些利益还相互冲突。为了能够为这些新技术起草合适的监管制度，需要确定其中涉及的不同利益和关切。随后，在提出协调相互冲突的要求的监管概念之前，要确定这些利益之间的相互关系。影响基因组编辑植物及其衍生产品监管决策的规范性标准包括：行业利益、农民利益、公众舆论、消费者权益、人类健康和食品安全、粮食安全、环境保护、监管框架的一致性和连贯性以及伦理或宗教信仰。由于这些利益因国家而异，取决于各自的政治、经济和社会情况，各国立法者的任务是确定这些规范性标准，并在它们之间找到合适的平衡。为此，要制定一个关于如何使不同利益相互关联以及如何处理相互冲突和无法调和的要求的概念。此外，立法者可能会采用一些进一步分析的监管措施。批准或通知程序可用于风险评估或社会经济评估。共存措施和标签规定能够协调相互冲突的利益，预防原则可为某些保障措施提供正当理由。因此，各国关于基因组编辑植物的具体监管结果可能与现有的利益和监管措施一样多种多样。
