- 期刊
淺談自體幹細胞針灸療法於再生醫療法規下所涉及之法律爭議
Discussion on Legal Controversy Surrounding Application of Autologous Stem Cell Acupuncture Therapy Under Regenerative Medicine Law
摘要
缺血性腦中風所導致神經功能受損為臨床上常見之腦血管疾病，且常難以完全康復。神經幹細胞療法於臨床轉化上仍面臨許多困難，而搭配針灸治療為缺血性腦中風之治療已於臨床上獲得初步的成效。基於維護病患的安全和權益，幹細胞治療技術應用須於法律框架下執行，然而，當前再生醫療雙法之法規管理下仍存在許多爭議。衛生福利部提出《再生醫療製劑管理條例》（草案）以規範再生醫療製劑的生產、註冊、上市和全生命週期等管理。基於參酌日本的監管模式，將自體細胞治療納入可保證安全性和可預期有效性之細胞治療專案中。主管機關於2022年制定「再生醫療三法」，其包括《再生醫療發展法》、《再生醫療施行管理條例》和《再生醫療製劑管理條例》，以便更有效率的管理再生醫療應用領域。後續，主管機關再提出「再生醫療雙法草案」以建立更全面完善之管理機制。然而，草案經歷多次朝野協商，因法案無法明確解釋細胞治療之效果和安全不確定性，故至今大眾仍存在諸多疑慮及醫法界之爭議，而最終未能達成共識。因此，在現今法規尚存在許多修法爭議之下，當有急迫需求之腦損傷病患需介入幹細胞針灸療法時，醫患雙方均面臨許多困難，而本文將針對於臨床施行下可能面臨之法律問題進行初步探討。
並列摘要
Ischemic stroke-induced neurological damage is a prevalent clinical challenge in cerebrovascular disease, frequently leading to challenges in achieving complete recovery. Neural stem cell therapy encounters various complexities in clinical translation, and the conjunction with of acupuncture therapy has demonstrated preliminary effectiveness in ischemic stroke treatment. Application of stem cell treatment techniques, crucial for patient safety and rights, must align with legal frameworks. However, existing regulations under the Dual Regenerative Medicine Laws give rise to numerous controversies. The Ministry of Health and Welfare has proposed the "Regulation of Regenerative Medicine Products" (draft) to govern the production, registration, marketing, and overall life cycle of these products. Emulating Japan regulatory model, autologous cell therapy is incorporated into a specialized project ensuring safety and predictable effectiveness. In 2022, the regulatory authorities enacted the "Three Regenerative Medicine Laws," encompassing the "Regenerative Medicine Development Act," "Enforcement Regulations of Regenerative Medicine," and "Regulation of Regenerative Medicine Products". This aimed at more efficiently managing the realm of regenerative medicine applications. Subsequently, authorities proposed the "Dual Regenerative Medicine Laws" (draft) to establish a more comprehensive and refined management mechanism. However, despite multiple cross-party consultations, the bill failed to gain consensus due to the inability to distinctly interpret the effects and safety uncertainties of cell therapy. Consequently, public concerns and disputes within the medical field persist, with no consensus reached to date. In the current legal landscape marked by ongoing disputes over regulatory amendments, healthcare providers and patients face challenges when urgently needing to implement stem cell acupuncture therapy for brain injury. This article explores preliminary discussions on the legal issues that may arise in clinical practice under these circumstances.