再生醫療法規範與探討： 倫理、法律與政策的跨域探討

Abstract

隨著近年來再生醫療之技術與製藥的不斷創新和研發，為許多在既有醫療手段下無法獲得良好治療成效的急重症（尤其是癌症）病患開啟了一扇新的希望之門，再生醫療的產業發展前景普遍被世人看好。惟再生醫療屬於新興生醫科技領域，不僅其創新研發之過程可能因涉及倫理議題而引發廣泛爭議與討論之外，又因為一般民眾對於再生醫療的知識普遍不足，導致醫病之間存在嚴重的資訊不對稱問題，因此近年來世界多數國家均曾發生不肖分子利用再生醫療進行詐騙的事件。為了保障病患權益，讓再生醫療產業健全發展，多數醫療先進國家均紛紛對再生醫療進行相關立法。 本研究首先對再生醫療法進行政策分析，說明政策目標以及法律和產業的協同發展，進而對再生醫療進行概述，包括技術基礎、法律範疇與重要性，以及面臨的發展與挑戰，並透過國際立法和台灣法規的比較來說明再生醫療的相關法律框架。此外，亦從技術與安全、倫理議題、商業化與監管等角度來探討再生醫療的法律與倫理挑戰。 最後，彙整上述對再生醫療法的各項討論與分析結果，提出本研究的研究結論與研究建議。

With the continuous innovation and research and development of regenerative medicine technology and pharmaceuticals in recent years, a new door of hope has been opened for many patients with acute and severe diseases (especially cancer) who cannot obtain good treatment results with existing medical methods, and the development prospects of the regenerative medicine industry are generally optimistic. However, regenerative medicine belongs to the emerging field of biomedical technology. Its innovative research and development process may cause widespread controversy and discussion due to the ethical issues involved. In addition, the general public's knowledge of regenerative medicine is generally insufficient, resulting in serious information asymmetry between doctors and patients. Therefore, in recent years, unscrupulous elements have used regenerative medicine to commit fraud in most countries in the world. In order to protect patients’ rights and allow the sound development of the regenerative medicine industry, most medically advanced countries have enacted relevant legislation on regenerative medicine. This study first conducts a policy analysis of the Regenerative Medicine Act, explaining the policy objectives and the coordinated development of the law and industry. It then provides an overview of regenerative medicine, including its technical basis, legal scope and importance, as well as the development and challenges it faces. It also explains the relevant legal framework for regenerative medicine through a comparison of international legislation and Taiwan regulations. In addition, the legal and ethical challenges of regenerative medicine are discussed from the perspectives of technology and safety, ethical issues, commercialization and regulation. Finally, based on the above discussions and analysis results of regenerative medicine, the conclusions and suggestions of this study are put forward.