中國大陸再生醫學進步促進條例立法研究──基於提供幹細胞療法「報喜不報憂」現象之分析

Legislative Recommendation on the Promotion Regulation of Regenerative Medicine Progress of PRC: Based on the Phenomenon Analysis of “Nothing But Good News” in Providing Stem Cell Therapy in China

基於病人安全目標和幹細胞療法與再生醫學發展的要求，從臨床研究倫理和法律的角度，分析、討論當前提供幹細胞療法「報喜不報憂」，進而建議制定再生醫學進步促進條例根治這種反科學現象。條例應當包括七個方面的措施：明確中國化「幹細胞醫學創新」的倫理和安全準則、建設有利於幹細胞治療研究的經濟機制、設計並落實獲得患者知情同意好的做法、倫理干預確保進行風險──效益分析、強化患者安全監督與副作用報告、規範研究結果的發表、建立公共治理型監管機制。

Based on the objectives of patient safety and the requirements of stem cell therapy and regenerative medicine, the article, from the perspective of ethic and the law in clinical trial, analyses and discusses the “glossy” phenomenon in providing stem cell therapy in China, and propose to formulate the promotion regulation of regenerative medicine progress of PRC in order to get rid of the anti-science problem. The seven measures should be taken into the regulation: to follow the ethics and safety standards of stem cell medicine innovation, to construct a conducive economic mechanism for stem cell therapy research, to design the good practice for obtaining informed consent of patients, to take ethical intervention for ensuring riskbenefit analysis, to supervise patient safety and report adverse events, to regulate the publication of research results, and to establish the monitoring mechanism for public governance.