The article explores whether the broader regulatory framework applicable to the member states of the EU contains suitable tools to react to the rapid advances in science, especially as to the question of germline editing technologies. From the perspective of EU member states, the regulatory framework is fragmented between norms of international law, secondary EU law and national legislation. The rules and their interpretation are strongly influenced by the concept of precaution, which reflects the concern that there is not enough knowledge to assess the impact of genome editing technology on individuals, society and future populations. However, the argument of precaution loses its strength with every new scientific discovery. The expanding knowledge in the field creates the need to replace regulation, which is based on the lack of knowledge (such as precautionary moratoriums) by the regulation that is based on the actual knowledge. The article reaches a conclusion that the EU framework for advanced treatments and medicinal products is in a state where it can, in principle, address the questions associated with the safety and efficacy of germline editing technologies. The EU framework is, however, not suitable to assess the moral and societal impacts of new technology, which should be left for member states.

本文探讨了适用于欧盟成员国的更广泛的监管框架是否包含合适的工具来应对科学的快速进步，特别是生殖系编辑技术的问题。从欧盟成员国的角度来看，监管框架分散在国际法规范、欧盟二级法律和国家立法之间。这些规则及其解释深受预防概念的影响，这反映出人们担心没有足够的知识来评估基因组编辑技术对个人、社会和未来人口的影响。然而，随着每一项新的科学发现，预防措施的论点就会失去其力量。该领域知识的不断扩展需要以基于实际知识的监管来取代基于知识缺乏的监管（例如预防性暂停）。文章得出的结论是，欧盟先进治疗和医药产品框架原则上可以解决与种系编辑技术的安全性和有效性相关的问题。然而，欧盟框架不适合评估新技术的道德和社会影响，这应该留给成员国。