再生醫學發展爭議案例與我國倫理法規現況探討

Controversial Cases in the Development of Regenerative Medicine and the Current Status of Ethical Legal Regulations in Taiwan

台灣於2024年通過《再生醫療法》和《再生醫療製劑條例》，顯示我國再生醫療法規的重大進展。本文首先探討再生醫療發展歷程之各國爭議案例，包括日本、美國、義大利等國及我國有關細胞治療之訴訟與詐欺案例。然後回顧台灣再生醫療法規的發展歷程，從早期的胚胎幹細胞研究規範到近期的細胞治療法規，並引用國際幹細胞研究學會指引與我國再生醫療雙法之內涵進行比較，期望藉此回顧與反思，有助於提升台灣再生醫療的安全性、效益和倫理標準。

Taiwan's recent regulatory developments in regenerative medicine mark significant progress in the field, with the passage of the Regenerative Medicine Act and the Regenerative Medicinal Products Act in 2024. This paper examines the global development and controversies in regenerative medicine, particularly focusing on case studies of cell therapies in Japan, the United States, Italy and Taiwan. Examples include litigation over unproven stem cell therapies in Japan and fraud charges for unverified treatments in Italy. The article also reviews the regulatory evolution of regenerative medicine in Taiwan, from early regulations on embryonic stem cell research to the more recent laws on cell therapy. By comparing international ethical standards with Taiwan's latest legislative reforms, the paper aims to enhance the safety, efficacy, and ethical standards of Taiwan's regenerative medicine sector.