台灣再生醫療法制之研究─以日本立法例為借鏡

Abstract

近年來，全球包含台灣及日本之再生醫療產業蓬勃發展，各國產學界的投入，相關技術以及應用源源不絕的推陳出新。日本自2006年起，即針對再生醫療相關的法制規範，進行多次立法活動，2013年公布「再生醫療推進法」，並於2014年起開始施行。內容包含以安全迅速為原則，規範醫療機構之醫療行為的「再生醫療安全性確保法」，以及作為管理製造銷售再生醫療產品業者之「藥品醫療器材法」，並首創有條件期間限定的核准制度，讓更多更好的藥品及設備更迅速地提供給患者。 我國衛生福利部在制訂再生醫療相關法規之際，也因此參考立法多年的日本管理制度，制訂相關法規 ，並就再生醫療之施行管理及再生醫療製劑訂定「再生醫療法」及「再生醫療製劑條例」。但在過程之中爭議不斷，直到2024年6月4日才三讀通過，比日本晚了整整10年。基此，本文以維護病患安全為核心理念，試圖在台日再生醫療產業發展現狀的分析比較基礎之上，借鏡日本立法例，進行台灣再生醫療產業法制之立法研究，並提出建議，以期完備我國再生醫療產業在施行技術及製劑產品之法規管理，同時以整合各界經驗之方式，提供組織及架構等建議，進一步促進台灣再生醫療法規更臻完備，與國際無縫接軌。

In recent years, the regenerative medicine industry has flourished globally, including in Taiwan and Japan. Industry, official, and university worldwide have proactively invested in this field, leading to continuous advancements in related technologies and applications. Notably, Japan began legislating for regenerative medicine as early as 2006, culminating in the enactment of the “Regenerative Medicine Promotion Act” in 2013, which has been in effect since 2014. This legislation includes the “Act on Safety of Regenerative Medicine (ASRM),” which regulates medical practices in healthcare institutions based on safety and speed principles, and the “Pharmaceutical and Medical Devices Act (PMD Act),” which governs manufacturers and sellers of regenerative medical products. Japan also pioneered a conditional and time-limited approval system, allowing faster access to improved drugs and devices for patients under legal regulation. In Taiwan, the Ministry of Health and Welfare drew inspiration from Japan’s longstanding management system while formulating regulations related to regenerative medicine. Consequently, Taiwan established the “Regenerative Medicine Act” and the “Regenerative Medicine Product Regulations.” Despite ongoing controversies, these laws were finally passed on June 4, 2024, a decade after Japan’s implementation. With patient safety as our primary concern, this paper conducts a legislative study on Taiwan's regenerative medicine industry by comparing its development with that of Japan and referring to Japanese experiences. Suggestions will be provided to improve regulations, integrate resources, and promote the development of Taiwan's regenerative medicine industry in line with international standards.