title: Fraudsters operate and officialdom turns a blind eye: a proposal for controlling stem cell therapy in China.
abstract: 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.
authors.affiliation: Kenneth Wang School of Law, Soochow University, Shi Zi Jie 1 Hao, Suzhou, 215006, China. jiangli36@suda.edu.cn.
authors.forename: Li
authors.initials: L
authors.lastname: Jiang
authors.affiliation: Kenneth Wang School of Law, Soochow University, Shi Zi Jie 1 Hao, Suzhou, 215006, China.
authors.forename: Bing He
authors.initials: BH
authors.lastname: Dong
mesh_terms: D002681:China; D005607:Fraud / Q000331:legislation & jurisprudence / Q000517:prevention & control; D033161:Government Regulation; D006801:Humans; D057193:Medical Tourism / Q000941:ethics / Q000331:legislation & jurisprudence; D057905:Stem Cell Research / Q000331:legislation & jurisprudence; D033581:Stem Cell Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D014480:United Nations
keywords: China; International agreement; Stem cell therapy; Stem cell tourism