{"error":false,"id":["150971"],"data":{"IVOD_ID":150971,"IVOD_URL":"https://ivod.ly.gov.tw/Play/Clip/1M/150971","日期":"2024-04-10","會議資料":{"會議代碼":"委員會-11-1-26-11","會議代碼:str":"第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議","屆":11,"會期":1,"會次":11,"臨時會會次":null,"種類":"委員會","委員會代碼":[26],"委員會代碼:str":["社會福利及衛生環境委員會"],"標題":"第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議"},"影片種類":"Clip","開始時間":"2024-04-10T10:39:27+08:00","結束時間":"2024-04-10T10:50:16+08:00","影片長度":"00:10:49","支援功能":["ai-transcript","gazette"],"video_url":"https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948ebaa4ecbd2697e5e6533009c4a7c43105f8ba9b0039caa7a673d0700f6c74c60f5ea18f28b6918d91.mp4/playlist.m3u8","委員名稱":"蘇清泉","委員發言時間":"10:39:27 - 10:50:16","會議時間":"2024-04-10T09:00:00+08:00","會議名稱":"立法院第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議（事由：一、審查\n(一)委員邱議瑩等25人擬具「再生醫療法草案」案。\n(二)委員謝衣鳯等19人擬具「再生醫療發展法草案」案。\n(三)委員羅廷瑋等21人擬具「再生醫療法草案」案。\n二、審查\n(一)委員邱議瑩等25人擬具「再生醫療製劑條例草案」案。\n(二)委員謝衣鳯等18人擬具「再生醫療製劑管理條例草案」案。\n(三)委員羅廷瑋等21人擬具「再生醫療製劑管理條例草案」案。\n【一、二案採綜合詢答，本日會議僅詢答】\n【4月8日及10日二天一次會】）","gazette":{"lineno":400,"blocks":[["蘇委員清泉：（10時39分）謝謝主席，我請部長。"],["主席：請薛部長。"],["蘇委員清泉：還有署長。"],["主席：請吳署長。"],["薛部長瑞元：委員好。"],["蘇委員清泉：部長辛苦了，我們這個再生醫療的目的，是現階段的醫療技術沒有辦法治療或是恢復，透過基因治療、細胞治療，或者是組織工程等技術來解決癌症、遺傳病或一些不可恢復功能的疾病，所以這個本身是一個主要的醫療還是輔助醫療？"],["薛部長瑞元：以目前來講，有許多還在試驗階段，或者是剛剛通過的，累積的個案數仍然不多，所以以實務上面來看，現在大部分是作為一種輔助的方法。"],["蘇委員清泉：部長講對啦，所以這幾年事實上是用特管辦法來做，已經做了5年……"],["薛部長瑞元：對。"],["蘇委員清泉：這5年的成效是怎麼樣？又有產生什麼問題？"],["薛部長瑞元：成效的部分，其實有一些成果是有公開在我們的網站，這部分我是不是請司長說明？"],["蘇委員清泉：好，簡單講一下。"],["劉司長越萍：組織修復類的已經完全公布在網站上面，對於退化性關節炎或者是困難癒合的傷口，它的療效是真的有幫助，包括了傷口縮小的時間，也包括了退化性組織關節炎的疼痛改善，這個在客觀數據上面都有蠻明顯的成效。"],["蘇委員清泉：這兩個法本來在上一屆就要通過了嘛！"],["薛部長瑞元：對。"],["蘇委員清泉：但到現在這兩個行政院版本都沒有來？"],["薛部長瑞元：啊，就……"],["蘇委員清泉：行政院是在做什麼啊？"],["薛部長瑞元：沒有啦！那個……"],["蘇委員清泉：部長你急得要命，行政院失職啊！"],["薛部長瑞元：沒有啦！"],["蘇委員清泉：我們不能怪你，要怪行政院啦！怠惰啦！要譴責啦！"],["薛部長瑞元：沒有、沒有啦！我們還是必須要走一些必要的程序。"],["蘇委員清泉：沒有啦，這本來上一屆就應該通過，搞到現在連院版都沒來，要怎麼審啊？"],["薛部長瑞元：因為上一屆審查過程當中發生了一些爭議的問題，其實我們也必須要做處理，所以這部分我們也做了細部的修正。"],["蘇委員清泉：日本也搞了很久，日本在2022年做出一個結論，他們也都是98%做臨床治療，只有2%在做研究發展，所以會失焦、會走偏喔！臺灣要通過這兩個法，我當然是樂觀其成，但是後面衍生的問題，一個是醫事司在管相關的申請，製劑的條例又是食藥署在管……"],["薛部長瑞元：對。"],["蘇委員清泉：剛剛有委員希望，如果健保可以給付那更好，但健保署準備好了沒？這兩個部會要分開管，會不會有問題？有的人說這是藥廠GMP嚴格管理，那我們這個不是，成立一個公司就可以搞，我去參觀了將近七、八個實驗室，現在我都不知道這些實驗室的規格是要用P2+或是P3的？"],["薛部長瑞元：其實在這個領域裡面分的大概就GDP跟GMP，GMP大概是類似藥廠那樣子的規格去管，GDP的話就比較像是一些實驗室，尤其是在醫院裡面的，醫院裡面不太可能去符合GMP的標準。"],["蘇委員清泉：對，所以部長說到重點了，我是很怕失控，也就是說不實的廣告、誇大療效、漫天喊價，然後用會員、名不副實等等，這些都要注意，因為日本在做的過程發現有問題，我們就要未雨綢繆，不然的話，到時候……"],["薛部長瑞元：這個裡面除了廣告之外，其實有一個重點，在過去醫療法裡面沒有去做處理的，這一次在再生醫療法裡面就有處理，就是什麼呢？就是針對不是醫療機構去做再生醫療。以前不是醫療機構去做醫療行為的話，是處罰那一個個人，用密醫罪去處理，但是那個機構沒事，比方說有人開公司，裡面有一個人說可以幫人做美容或是整形手術，結果抓到就抓那個人，跟這間公司一點關係都沒有、罰不到，頂多是說容留密醫等等，處罰就不大。這次我們的再生醫療法裡面有一條就是專門在處理這個，如果不是醫療機構絕對不可以做這個，如果做了的話，處罰相對比過去重很多。"],["蘇委員清泉：現在都是在診所、醫院抽血抽一抽，如果這個公司在醫院裡面有實驗室就在醫院裡面做；如果沒有就送到外面的公司實驗室做，做完再拿回來在診所、醫院施打。這中間會出問題，因為已經有很多人陳情了，就是說他現在在標靶治療癌症、用化療治療癌症，然後同時又用再生醫療這些T cell、NK cell、Stem cell等等做輔助療法，花的錢又特多，很貴啦！"],["薛部長瑞元：所以我剛剛跟委員報告的就是要處理這個。一家生技公司如果合法跟醫療機構合作，由醫療機構委託他去做這些細胞製備，那回過頭來執行的時候是在醫療機構，這個沒有問題；但是如果他自己去找民眾來做，這個就是我剛剛講的，我們就會加重處罰。所以生技公司幾乎不可能自己去做，一旦有看到這種再生醫療廣告的話就取締。"],["蘇委員清泉：那這樣很好！","再來，如果發生糾紛或者是出問題、打的時候出問題，這個是他們要用商品保險或者是我們要用藥害基金？"],["薛部長瑞元：這分兩個啦，如果是屬於再生醫療法技術面向，當他們來申請我們核准的時候，我們就要看他是否有這個產品責任險；但是如果他已經走製劑條例、通過FDA的審查，那他就變成再生醫療製劑，這個時候我們就走藥害救濟。"],["蘇委員清泉：沒有在製劑條例裡面的就用他們自己的商品保險，你現在說的意思是這樣嗎？"],["薛部長瑞元：是啊。"],["蘇委員清泉：那這樣會出問題喔！"],["薛部長瑞元：不會啦！"],["蘇委員清泉：不會嗎？"],["薛部長瑞元：不會啦！"],["蘇委員清泉：我是替你擔心。"],["薛部長瑞元：頂多是說要用製劑條例還是藥害救濟。"],["蘇委員清泉：最後一個問題，你說特管辦法實施到現在申請的有九百多個嘛？"],["薛部長瑞元：是。"],["蘇委員清泉：在外面胡亂注射的差不多有10萬個……"],["劉司長越萍：五百多個案件，通過了三百多個案件。"],["蘇委員清泉：幾個？"],["劉司長越萍：五百多個案件，然後……"],["蘇委員清泉：6個疾病可以用嘛，對不對？"],["劉司長越萍：對。"],["蘇委員清泉：有人說外面打的黑數差不多7萬到10萬，有沒有這回事？"],["薛部長瑞元：這可能都是廣告的問題，打著再生醫療的名義做這些，其中有很大一部分就是剛剛我跟委員講的這種狀況，所以我們很期待這個法趕快通過，才有處罰的依據，不然以現在的法要去處理這個，就是只有醫療法的廣告或不當招攬，它的處罰很輕啦，不划算啦！處理一個案子就向人收取幾百萬，他能承受被處罰。"],["蘇委員清泉：現在的藥價太貴啦，一針二十幾萬，法正式通過列管，如果能夠把價格降到三分之一，這樣很多人可以受惠，根據所有資料看起來有效性也差不多是五、六十趴，最好是差不多這樣啦。"],["薛部長瑞元：我是怕有些人這個都達不到！"],["蘇委員清泉：連這樣都沒有？"],["薛部長瑞元：對，很多是號稱回春的那一類，那類的話我不知道他的人體試驗要怎麼做，所以那一類可能都過不了，這要多少人來做、要追蹤幾年才知道他有回春？"],["蘇委員清泉：你就回春啊、你就很英俊啊！"],["薛部長瑞元：沒有，我垂垂老矣！"],["蘇委員清泉：所以這個法趕快通過，我想朝野、藍綠都不會去擋，但是要趕快把這個亂象導正啦！"],["薛部長瑞元：對。"],["蘇委員清泉：這個讓百姓花那麼多錢，有人叫我打幹細胞啊，我想一想、看一看還是不敢打，我要是打了出問題就慘了！"],["薛部長瑞元：對呀。"],["蘇委員清泉：所以這個是很重要的。部長加油，謝謝。"],["薛部長瑞元：謝謝。"],["主席：好，謝謝蘇清泉委員。","我們現在休息10分鐘。","休息（10時50分）","繼續開會（11時）"],["主席：現在繼續開會。","請林淑芬委員發言。"]],"agenda":{"page_end":226,"meet_id":"委員會-11-1-26-11","speakers":["黃秀芳","邱議瑩","羅廷瑋","陳昭姿","林月琴","陳菁徽","王育敏","涂權吉","王正旭","蘇清泉","林淑芬","洪申翰","黃捷","賴士葆","陳瑩","黃國昌","洪孟楷","楊瓊瓔","蘇巧慧","陳冠廷","楊曜","劉建國","邱鎮軍","林德福","邱志偉"],"page_start":155,"meetingDate":["2024-04-10"],"gazette_id":"1132601","agenda_lcidc_ids":["1132601_00004"],"meet_name":"立法院第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議紀錄","content":"一、審查(一)委員邱議瑩等25人擬具「再生醫療法草案」案、(二)委員謝衣鳯等19人擬具「再生\n醫療法草案」案、(三)委員羅廷瑋等21人擬具「再生醫療法草案」案；二、審查(一)委員邱議瑩\n等25人擬具「再生醫療製劑條例草案」案、(二)委員謝衣鳯等18人擬具「再生醫療製劑管理條例\n草案」案、( 三) 委員羅廷瑋等21 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Plus或P3的實驗室我都不知道勒"},{"start":248.632,"end":263.141,"text":"其實是在這個領域裡面分的大概就GDP跟GMP啦。GMP大概類似像藥廠這樣子的規格去管。那GDP的話就比較是就是說一些"},{"start":265.932,"end":294.235,"text":"實驗室,尤其是在醫院裡面的。醫院裡面不太可能去符合GMP的那個標準。所以柏廷說得對。我是很怕失控。失控就是說不實的廣告、誇大療效、漫天喊價、然後用會員、民不符實等等這些都要遇。因為日本在做,在做的問題。"},{"start":295.496,"end":312.367,"text":"藍德艾衛與籌謀,不然的話到時候... 這個裡面除了廣告之外,其實有一個重點,那在過去醫療法裡面沒有去做處理的。那這一次在再生醫療法裡面就有處理,就是什麼呢?"},{"start":312.367,"end":314.889,"text":"不是醫療機構去做這種再生醫療。"},{"start":316.311,"end":334.877,"text":"以前的話不是醫療機構去做這個醫療行為的話是處罰那個個人用那個免疫罪去處理但是那個機構沒有事情比如說有人開公司,裡面一個人說可以幫人做美容或什麼的,整形手術結果抓到那個人,這間公司一條關係都沒有"},{"start":345.384,"end":358.729,"text":"醫療法草案．立法院第11屆第1會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生環境委員會第11屆第2會期社會福利及"},{"start":369.774,"end":392.143,"text":"現在都是在診所啦說醫院抽血抽一抽然後如果這個醫院裡面這個公司有在在醫院裡面有實驗室那就在醫院裡面做那如果沒有送到外面的公司實驗室做做完再拿回來在診所或醫院施打那這中間會出問題"},{"start":394.799,"end":410.835,"text":"福利及衛生環境委員會第11屆第1會期社會福利及衛生環境委員會第2會期社會福利及衛生環境委員會第3會期社會福利及衛生環境委員會第4會期社會福利及衛生環境委員會第5會期社會福利及衛生環境委員會第6會期社會福利及衛生環境委員會第7會期社會福利及衛生環境委員會第8會期社會福利及衛生環境委員會第9會期社會福利及衛生環境委員會第10會期社會福利及衛生環境委員會第11會期社會福利及衛生環境委員會第12會期社會福利及�"},{"start":418.522,"end":439.891,"text":"一家生技公司如果你合法的跟醫療機構合作由醫療機構委託他去做這些細胞的自備那回過頭來在執行的時候是在醫療機構這個沒有問題但是如果他自己去找民眾來做這個就是我剛剛講的那個我們就要加重處罰"},{"start":442.817,"end":465.165,"text":"公司幾乎是不可能自己去做啦。所以一旦有看到這種再生醫療的廣告的話那就取締。那再來如果發生糾紛或者是出問題打的時候出問題這個是他們要用商品保險或者是我們要用要害基金"},{"start":466.383,"end":469.704,"text":"醫療法草案案件事項案件事項案件事項案件事項案件"},{"start":493.809,"end":508.799,"text":"那沒有這個治具條例裡面的那就用他們自己的商品保險你現在說的意思是這樣喔是啊那這樣會出問題喔不會啦不會啦我會替你煩惱喔然後再來最後一個問題你說這個測管辦法實施到現在我們申請的九百多個嘛是嘛五百多個案件通過了三百多"},{"start":524.269,"end":535.096,"text":"五百多個案件然後那6個6個6個疾病可以用嘛對不對那外面在打的他們說黑數差不多7萬到10萬有沒有這回事啊"},{"start":536.604,"end":538.665,"text":"醫療法草案 案 案 案 案 案 案 案 案"},{"start":565.177,"end":569.602,"text":"草案：立法院第11屆第1會期社會福利及衛生環境委員會第12屆第1會期社會福利及衛生環境委員會第12屆第1會期社會福利及衛生環境"},{"start":579.915,"end":586.759,"text":"福利及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會"},{"start":606.912,"end":607.572,"text":"邱議瑩等21人擬具"},{"start":621.789,"end":648.008,"text":"所以這個法要趕快通過我想朝野都不會那個藍綠都不會去擋但是要趕快把這個亂象把它導正啦這個讓百姓花那麼多錢啊人家叫我打幹細胞啊我想一想看一看我還是不敢打啊我還要住在那處很疊的海啊所以這個是很重要的好部長加油謝謝好謝謝蘇清泉委員我們現在休息10分鐘"}]}},"supported_relations":[],"relations":[]}