Progressive and retrospective: China’s regulation of regenerative medicines

Over the past fifteen years China has reformed its stem cell policies several times in a rather post-hoc pragmatic manner to address international criticisms. This in combination with a ‘soft centralization’ of governance on stem cells policy has hampered growth of China’s regenerative medicine efforts. Examining previous policies illustrates that China’s current 2015 regulations could be successful if accompanied by a pro-active approach to addressing ethical issues and engaging with diverse stakeholders.

What background and points are discussed?

Dr Zhang’s historical perspective of China’s SC regulation begins with Chen Xigu, who had a research team that created the world’s first human-rabbit hybrid embryos in 2001. This spurred international outcry and led to the perception of China as the ‘Wild East’ of SC research. In response the Chinese government established the “Ethical Guidelines for Research on Human Embryonic Stem Cells” in 2003. Over the next few years a growing number of clinics and hospitals began offering unapproved stem cell therapies to desperate patients. This reinforced international perceptions that SC research is largely unregulated in China. In 2009 the “Regulations of Clinical Application of Medical Technology” were issued to reign in unapproved SC treatments. In both cases the policies lacked procedural specificity and penalties for non-compliance. Dr Zhang also points out that the use of ‘soft centralisation’ policies, such as controlling what labs received national funding, meant that these regulations had little effect on self-funded companies. An estimated 200 Chinese hospitals continued to charge patients for unapproved SC treatments. A subsequent ban on unapproved SC research and clinical treatments in 2012 went largely unheeded. In 2013 Chinese regulatory authorities presented three draft regulations that contrasted previous regulations by laying out a more clear and comprehensive framework. It aimed to reduce financial incentives for SC treatments in hospitals, defined various stem cell treatments and practices, required the central registration of clinical trials, and provided guidance on clinical trial standards. After two years these drafts were expanded into a new 2015 SC policy that provided further clarity on how researcher could officially proceed with registration, certification and review of SC research and clinical trials. As institutions began to register and get approvals for SC research, this new policy looked promising. However, these efforts were undercut in 2016 by the death of Wei Zexi, a 21 year-old patient receiving an experimental SC therapy from a Chinese police hospital. Due to the structure and jurisdictions of China’s regulatory bodies, the promising new 2015 regulations did not apply to military/police facilities. In response to Wei‘s death the government halted all clinical applications of SCs for immunotherapy, a large area of clinical stem cell research. Over the past ten years commercial investment for SC research has grown. The 2015 regulations attempt to limit SC clinical studies to elite researchers who are the beneficiaries of state-sponsorship. These regulations doesn’t mesh well with the 200 companies in China currently developing SC treatments and may drive some existing SC practices in this grey area underground.