Lysaght Tamra
Centre for Biomedical Ethics, Yong LooLin School of Medicine, National University of Singapore, 119228, Singapore.
Regen Med. 2017 Sep;12(6):657-668. doi: 10.2217/rme-2017-0038. Epub 2017 Oct 4.
In 2014, the Japanese National Diet introduced new laws aimed at promoting the clinical translation of stem cells and regenerative medicine. The basic action of these laws is to allow the early introduction of regenerative medicine products into the Japanese market through an accelerated approval process, while providing patients with access to certain types of stem cell and cell-based therapies in the context of private clinical practice. While this framework appears to offer enormous opportunities for the translation of stem cell science, it raises ethical challenges that have not yet been fully explored. This paper critically analyzes this framework with respect to the prioritization of safety over clinical benefit, distributive justice and public trust in science and medicine. It is argued that the framework unfairly burdens patients and strained healthcare systems without any clear benefits, and may undermine the credibility of the regenerative medicine field as it emerges.
2014年，日本国会出台了旨在促进干细胞与再生医学临床转化的新法律。这些法律的基本举措是，通过加速审批程序，允许再生医学产品早日进入日本市场，同时让患者能够在私人临床实践中接受某些类型的干细胞及基于细胞的疗法。虽然这一框架似乎为干细胞科学的转化提供了巨大机遇，但它也引发了一些尚未得到充分探讨的伦理挑战。本文从安全优先于临床效益、分配正义以及公众对科学和医学的信任等方面，对这一框架进行了批判性分析。有人认为，该框架在没有任何明显益处的情况下，给患者和紧张的医疗系统带来了不公平的负担，并且可能会在再生医学领域初兴之时就损害其可信度。
