De Miguel Beriain Iñigo
Cátedra de Derecho y Genoma Humano, Universidad Del País Vasco UPV/EHU, Bilbao, Spain.
Regen Med. 2017 Sep;12(6):669-679. doi: 10.2217/rme-2017-0033. Epub 2017 Oct 4.
The development of clustered regularly interspaced short palindromic repeats (CRISPR)-Cas gene-modification technologies has opened impressive possibilities for the biomedical sciences. However, their application to human embryos and early fetuses has raised huge ethical and legal discussions because it affects the human germline. This paper provides a critical and in-depth analysis of the current legal framework on this topic in the EU context and at the national level in the member states. It also offers an alternative interpretation of the regulation, so as to help researchers, practitioners, policy makers and society as a whole to find efficient responses to challenges that cannot wait for a legally updated answer. As a final result, this paper will show that eugenic uses of CRISP-Cas and any kind of modification intended to alter the human germ line are generally banned in the EU context, while basic research on human embryos is mostly permitted. The legal status of therapeutic applications of CRISPR-Cas on early fetuses, however, has not been adequately addressed by the EU zone regulation.
成簇规律间隔短回文重复序列(CRISPR)-Cas基因编辑技术的发展为生物医学科学带来了令人瞩目的可能性。然而,将其应用于人类胚胎和早期胎儿引发了巨大的伦理和法律讨论,因为这会影响人类生殖系。本文对欧盟范围内以及成员国国家层面关于这一主题的现行法律框架进行了批判性的深入分析。它还对相关规定提供了另一种解读,以帮助研究人员、从业者、政策制定者及整个社会找到应对挑战的有效对策,而这些挑战等不及法律更新后的答案。最终结果表明,在欧盟范围内,CRISPR-Cas的优生学用途以及任何旨在改变人类生殖系的基因编辑通常是被禁止的,而对人类胚胎的基础研究大多是被允许的。然而,欧盟区域法规尚未充分阐明CRISPR-Cas在早期胎儿治疗应用方面的法律地位。