《特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法》實際運作相關問題評析

Analysis of Issues Derived from the Actual Implementation of ＂Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices＂

施雅薰

《科技法律透析》 32卷2期 (2020/02) Pp. 48-72

摘要

我國於107年9月通過修正《特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法》（以下簡稱「特管辦法」）正式開放臨床治療之細胞治療項目；於特管辦法開放後，實際運作上亦有許多相應而生之問題。經與學界及業者訪談過後，歸納出主要三大問題：細胞治療開放項目之範圍、細胞治療費用問題，利用病患特種個資建立資料追蹤系統之問題。於細胞治療開放項目部分，我國特管辦法主要開放自體細胞治療技術，對於異體細胞從嚴審查，並未開放基因修飾細胞與不含有細胞之衍生物質，相較於其他國家，開放幅度較為保守。於細胞治療費用方面，目前恐有價格居高不下的問題，而影響患者的接受細胞治療的意願，其主要原因可能包括細胞檢驗標準過於嚴格與分階段依結果收費之方式。此外，建立細胞治療追蹤系統具有功能上之必要性，惟病患資料為特種個資，如何有效蒐集、處理、利用該等資料即為問題。本文擬透過對於此些問題之探究，為特管辦法提出建言。

關鍵字

特管辦法 ； 細胞治療 ； 開放範圍 ； 依結果收費 ； 特種個資

並列摘要

On September 2018, Taiwan passed the amended ＂Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices＂ (hereinafter referred to as the ＂Regulations of Special Medical Techniques＂), and officially allowed the cell therapy programs for clinical treatment. However, after the allowance of the Regulations of Special Medical Techniques, in practice there are also a number of corresponding problems. After interviewing with scholars and industrial practitioners, three main issues were concluded: the allowance scope of cell therapy programs, the cost of cell therapy, and the use of sensitive personal information of patients to establish database. For the allowance scope of cell therapy programs, Taiwan Regulations of Special Medical Techniques mainly allow autologous cell therapy program while adopt strict review of allogeneic cells, and does not allow genetically modified cells and cell-free derivatives, which is much conservative than other countries. As for the pricing for cell therapy programs, there is currently a problem of high prices, and the willingness of patients to receive cell therapy would be therefore affected. The main reasons may include the results of too strict cell inspection standards and milestone outcome based payment. Furthermore, the establishment of the cell therapy database is functionally necessary. However, the patient information is sensitive personal information, and thus how to effectively collect, process, and use the information would be a problem. This article intends to make suggestions for Regulations of Special Medical Techniques through the exploration of these issues.

並列關鍵字

Regulations of Special Medical Techniques ； cell therapy ； the allowance scope ； Outcome-Based Payment ； sensitive personal information

參考文獻

張雅雯、黃靜宜，〈熱門話題／細胞治療開放上路自體免疫細胞可當抗癌解藥〉，《好心肝會刊》，87期 (2019)。https://www.liver.org.tw/journalView.php?cat=62&sid=801&page=1 (最後瀏覽日：2020/01/30)

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徐玉君，〈特管法創造商機持續延燒, 「法規」是攸關產業發展的重要推手〉，《先探投資週刊》，2049期，2019/7/25，http://www.investor.com.tw/onlineNews/freeColArticle.asp?articleNo=5447 (最後瀏覽日：2020/01/30)。

中央社，〈高貴細胞治療效果未知三總開放近2週無人申請〉，2019/05/15，https://www.cna.com.tw/news/ahel/201905150193.aspx (最後瀏覽日：2020/01/30)。

《人體生物資料庫管理條例》第3條