Jiang Li, Dong Bing He
Kenneth Wang School of Law, Soochow University, Shi Zi Jie 1 Hao, Suzhou, 215006, China.
Med Health Care Philos. 2016 Sep;19(3):403-10. doi: 10.1007/s11019-016-9692-7.
Stem cell tourism-the flow of patients from home countries to destination countries to obtain stem cell treatment-is a growing business in China. Many concerns have been raised regarding fraudsters that operate unsafe stem cell therapies and an officialdom that turns a blind eye to the questionable technology. The Chinese regulatory approach to stem cell research is based on Guidelines and Administrative Measures, rather than legislation, and may have no binding force on certain institutions, such as military hospitals. There is no liability and traceability system and no visible set of penalties for non-compliance in the stem cell legal framework. In addition to the lack of safety and efficacy systems in the regulations, no specific expert authority has been established to monitor stem cell therapy to date. Recognizing the global nature of stem cell tourism, this article argues that resolving stem cell tourism issues may require not only the Chinese government but also an international mechanism for transparency and ethical oversight. A stringent set of international regulations that govern stem cell therapies can encourage China to improve stem cell regulation and enforcement to fulfill its obligations. Through an international consensus, a minimum standard for clinical stem cell research and a central enforcement system will be provided. As a result, rogue clinics that conduct unauthorized stem cell therapies can be penalized, and countries that are reluctant to implement the reconciled regulations should be sanctioned.
干细胞旅游——即患者从本国前往目的地国家接受干细胞治疗——在中国是一项不断发展的业务。人们对实施不安全干细胞疗法的欺诈者以及对有问题技术视而不见的官僚作风提出了诸多担忧。中国对干细胞研究的监管方法基于指导方针和管理办法，而非立法，可能对某些机构（如军队医院）没有约束力。在干细胞法律框架中，没有责任和可追溯制度，也没有针对违规行为的明确处罚措施。除了法规中缺乏安全和有效性体系外，迄今为止尚未设立专门的专家机构来监管干细胞治疗。认识到干细胞旅游的全球性，本文认为解决干细胞旅游问题可能不仅需要中国政府，还需要一个国际透明和道德监督机制。一套严格的国际干细胞治疗监管规定可以促使中国加强干细胞监管和执法以履行其义务。通过国际共识，将提供临床干细胞研究的最低标准和中央执法系统。这样一来，实施未经授权的干细胞疗法的非法诊所将受到处罚，而不愿执行协调一致规定的国家应受到制裁。
