「特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法」
實施成效評估與展望

中華民國衛生福利部於107年9月6日發布《特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法》修正條文（下稱《特管辦法》），希望盡早提供癌症末期以及特殊需要病患一個新的醫療方式。本研究旨在以《特管辦法》為核心，瞭解病患及家屬的認知及需求，以及如何引導細胞治療產業的發展，帶動醫療院所與生技產業合作，進而開啟更全面的再生醫療產業鍊，進而成為亞洲的生技中心。本研究運用量化問卷方式調查填答者對於《特管辦法》的認知及需求，回收樣本317份。另外擬具專業深度的問題對專家業者進行深度訪談，從不同角度檢視《特管辦法》以至於臺灣再生醫療產業發展的可能方向。研究結果顯示，《特管辦法》相較於歐美日及中國而言，是一個同時兼顧現實與未來發展的立法。我國的再生醫療體系採雙軌制立法，以醫療技術先於醫療產品開放，除了使有需求的病患及早獲得先進的治療外，更可以加速細胞治療產業技術的提升，立意良善；但是《特管辦法》會加劇醫病關係的對立與矛盾，三個關鍵問題需要重視，包括：合格治療機構延宕核准、治療費用居高不下、以及如何處理醫療糾紛等，都值得深入討論。另外，本研究結論肯定《特管辦法》是動態而且先進的醫療法規，在優先照顧有需求的病患之外，能有效促進產業界與醫界的結合，從而加速我國生醫產業成為世界級的醫療中心。本研究最後提出四項建議給主管機關做為決策及施行時的參考依據：一是必須與時間競賽，否則就是被淘汰；二是必須協助降低醫療業者成本降低同時帶動病患費用降低；三是必須加強宣導宣傳；最後則是必須強化病友賠償機制。由於《特管辦法》尚未有實際病例發佈，成效如何仍不明確。期待後續研究者能在實證的基礎上，對於我國的再生醫療法規之立法及實施成效做更有系統的研究！

關鍵字

特管辦法；細胞治療；再生醫療；醫療技；醫療產品；臺灣

並列摘要

On September 6, 107, the Ministry of health and welfare issued the revised provisions of the regulation of the measures for the administration of the implementation or use of special medical technology inspection and medical instruments (hereinafter referred to as the "special measures"), in the hope of providing a new method of medical treatment for terminal cancer and special needs patients as early as possible. The purpose of this study is to understand the cognition and needs of patients and their families as the core, and how the regulation guide the development of the cell therapy industry, and to facilitate the cooperation between the hospital and the biotechnology industry, so as to open up a more comprehensive regenerative medical industry, and thus become a biotechnological center in Asia. In this study, 317 questionnaires were collected to investigate the cognition and demand of the respondents for the “special measures”. In addition, in-depth interviews were conducted with experts to examine the possible direction of the development of the “special measures” and the regenerative medical industry in Taiwan from different perspectives. The results show that, compared with Europe, the United States, Japan and China, the “special measures” is a legislation that reproduces the reality and future development. The health care system of Taiwan adopted two-track legislation to have medical technology implemented prior to that of medical products. This can accelerate the upgrading of industrial technology of cell therapy, in addition to fulfill the patients’ needs for early access to advanced treatment. However three key issues need to be paid attention to, which includ the delay approval of qualified treatment institutions under “special measures”, the high cost of treatment, and how to deal with medical disputes. The research of this study affirms that the "special management" is a dynamic and advanced medical regulation, which can effectively promote the cooperation of industry and medical sector, in addition to giving early access to patients in need. In the future to speed up Taiwan's biomedical industry to become a world-class player. At the end of this study, four suggestions are raised to the competent authority as the reference for decision-making and implementation: first, it is necessary to accelerate the approval for the medical centers; second, it is necessary to help reduce the cost of the bio-companies to further reduce that of patients; third, it is necessary to strengthen advocacy and publicity; and finally, it is necessary to strengthen the mechanism of compensation for the medical accident of patients. As there’s no actual case published since the implementation of “Special Measures”, the effectiveness remains unclear. Researchers can look forward to follow-up on the basis of empirical cases to see if the legislation of“Special Measures” and the regenerative medical regulations of Taiwan work well in a more systematic way!