{"id":150978,"url":"https://ivod.ly.gov.tw/Play/Clip/1M/150978","video_url":"https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948e7254811031145c2a533009c4a7c43105f8ba9b0039caa7a68053b69fbe3a03365ea18f28b6918d91.mp4/playlist.m3u8","委員名稱":"林淑芬","委員發言時間":"11:00:58 - 11:18:36","影片長度":"00:17:38","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】）","meet":{"tmpMeeting":null,"title":"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","term":11,"type":"委員會","sessionPeriod":1,"sessionTimes":11,"committees":[26],"id":"委員會-11-1-26-11"},"date":"2024-04-10","duration":1058,"end_time":"2024-04-10T11:18:36+08:00","start_time":"2024-04-10T11:00:58+08:00","features":["ai-transcript","gazette"],"type":"Clip","gazette":{"lineno":472,"blocks":[["林委員淑芬：（11時1分）主席、各位同仁大家好，還是請薛部長。"],["主席：請薛部長。"],["林委員淑芬：部長，我們今天在談再生醫療法，基本上要將特管辦法法制化，特管辦法從2018年9月6號公告到現在已經多少時間了？2018年到2024年，超過6年了，大概六年了。"],["薛部長瑞元：差不多。"],["林委員淑芬：我們今天在講，現在既有的特管辦法第二十條：「醫療機構執行細胞治療技術，應於每年度終了三個月或中央主管機關要求之期限內，提出施行結果報告。前項報告之內容，應包括下列事項：一、治療案例數。二、治療效果。三、發生之不良反應或異常事件。四、其他經中央主管機關指定之事項。中央主管機關必要時，得公開醫療機構之治療統計結果。」我覺得今天很多的爭議就是發生在這裡，先不談其他的、未來的，因為院的版本還沒有送進來，我先就目前的法規請教部長，在自體免疫細胞治療適應症的範圍裡面，簡單的說，你們治療實體癌第四期、治療第一期到第三期實體癌經標準治療無效的，或是血液惡性腫瘤經標準治療無效的，這三類的施行結果報告有沒有放上衛福部的網站專區供大家參考？"],["薛部長瑞元：我們現在先上的是那個……"],["林委員淑芬：有啦，你們有公布療效，退化性膝關節炎、軟骨缺陷、皮膚缺陷或慢性或滿六週沒有癒合的困難傷口，你們都有公布療效。"],["薛部長瑞元：對。"],["林委員淑芬：可是剛剛大家在講細胞治療，大家看重的不是只有這裡，大家最期待的、案例數最多的都是治療血液腫瘤、一到三期經標準治療無效的或第四期實體癌，你們公告了病人數，可是在這個病人數裡面我也必須要講，以實體癌第四期為例，有798個，可是提早退出治療的、無法評估的有94個，其他538個，在這裡包括血液腫瘤有5個接受治療，也有1個退出，這個狀況到底是什麼，我們不得而知。但你們公告了療效好的、退化性關節炎的、傷口困難癒合的、皮膚缺陷的，那為什麼具體治療癌症，就是大家期待的再生醫療，還有細胞治療最核心的部分，你們只公布了案例數？對於法律裡面講的療效還有不良反應的，你們通通不願意公布呢？"],["薛部長瑞元：我想委員……"],["林委員淑芬：我覺得公布數據是最科學的啊！"],["薛部長瑞元：是啦，這部分當然，但是它有一個比較不好處理的地方，就是療效，一般像癌症治療，我們會去看比方5年的存活率，但現在還沒到那麼久啊。"],["林委員淑芬：現在5年多了，怎麼還沒那麼久？6年了！"],["薛部長瑞元：也不會第一年開始做，每一個治療的方式……"],["林委員淑芬：沒有5年多，不然也可以拿出4年的數字，因為大家所持的理由在這裡，我們都不反對細胞治療，我們都支持再生醫療，但這個前提是大家支持它，除了都認為它是正統的常規醫療、標準醫療之外，大家都相信它是最有療效的，你們都可以公布其他的療效，為什麼光是再生醫療這麼多品項不能公布？"],["薛部長瑞元：這我們可以來再來討論一下。"],["林委員淑芬：你們是選擇性公布。"],["薛部長瑞元：不是，不是，主要是療效這種東西萬一說錯的話，會讓人錯誤解讀。"],["林委員淑芬：所以你連對還是錯都沒辦法判斷？"],["薛部長瑞元：不是這樣，因為時間太短了……"],["林委員淑芬：你現在說錯，會被人家譴責，到底這個方法、細胞治療、細胞製備場所、這間公司跟醫療機構治療的個案是有效還是無效，你現在就沒辦法判斷了嗎？"],["薛部長瑞元：癌症的東西有時候合不合不是這樣看的，不能說一下就一針見血。"],["林委員淑芬：我沒有叫你一針見血。"],["薛部長瑞元：它需要時間去……"],["林委員淑芬：但我跟你講，已經五、六年了，你還在告訴我說你判別不出來，那是要多久你才判別得出來？"],["薛部長瑞元：個別的治療方式要有個別的一些判斷基準，這我們可以來討論。"],["林委員淑芬：2018到2024了，你們對於自體免疫細胞治療項目的施行結果到底有沒有療效，你不知道，但是到底有沒有不良反應，你至少會知道吧？"],["薛部長瑞元：這個有。"],["林委員淑芬：也可以公告吧？"],["薛部長瑞元：這沒有問題啦，這可以公告。"],["林委員淑芬：因為現行的特管辦法已經首開醫療技術免臨床試驗申請核准就能治療的先例，都不用了，違反了正常的醫學的程序。一般正常的醫療，新醫療、新技術、新藥品都必須做完整的人體試驗，所以甚至有的是藥廠要花大錢去找人來做人體試驗，而現在這一種是我給你當實驗白老鼠，我自動花大錢給你，不是藥廠給我們錢，是我們給藥廠錢，在這種狀況下，我們也不反對，因為只要有希望、有機會，我們也可以支持，但是我們都知道它有一個道德上的風險，自古以來就有的，就不是只有有錢人才花得起，一次療法做到完要好幾百萬，不是有錢人才花得起，自古以來為了救最愛的家人和親人，負債也願意，傾家蕩產也願意，然後也有一種狀況是，如果家人不願意，病人在那裡，你也不得不願意，否則的話要背起這個道德上的壓力。我們今天講，沒關係，這麼多公司在做，哪一個才是有療效的，你公告給這些病患和家屬看，至少他還能夠選擇一家是真正療效比較高的機構吧？"],["薛部長瑞元：報告委員，剛剛有一個地方講的不是很準確，所有的這些再生醫療技術通通要經人體試驗。"],["林委員淑芬：沒有完整的人體試驗，我怎麼會不知道？我問你，現在的特管法規定要一期、二期還是三期？"],["薛部長瑞元：沒有，我跟委員報告，就是細胞治療、基因治療的人體試驗跟藥品的臨床試驗是不一樣的。"],["林委員淑芬：我現在問你，現在特管辦法對於細胞製備場所，也就是公司，它抽你的細胞出去，在體外透過實驗室培養大量的細胞，再到醫療機構請醫師給你打回去，然後去治療。"],["薛部長瑞元：對。"],["林委員淑芬：你告訴我，可以做到這樣的治療的，經過你核准通過的這些細胞製備場所，除了一期的安全性以外，它要做二期嗎？它要做三期嗎？"],["薛部長瑞元：通常這一類，一、二期是一起做的。"],["林委員淑芬：我就問你多少人，你告訴我多少人。"],["薛部長瑞元：每一個個案都不太一樣，每一個計畫……"],["林委員淑芬：第一期要做多少人，這個有法律規定，什麼「個案」、「不一樣」！"],["薛部長瑞元：那個哪有什麼法律在規定！"],["林委員淑芬：有啦！"],["薛部長瑞元：每一個……這是技術性……"],["林委員淑芬：通通都是都是幾十個、30個、50個，就是這樣子。"],["薛部長瑞元：沒有，那個是藥品，很多這種技術……"],["林委員淑芬：那是更少嗎？"],["薛部長瑞元：要到30個，你就要一輩子……"],["林委員淑芬：所以更少嘛？沒有啦！人家剛才說實際核准才做的700個，地下做的7萬個，你忘了剛才蘇清泉才說，報導者也報導一個業者的說法，就是這樣子說。"],["薛部長瑞元：那個有時候都……"],["林委員淑芬：人家是拿錢要去做，地下的我也做。說什麼收集不到病人！"],["薛部長瑞元：那就不是啊！那就不是再生醫療。"],["林委員淑芬：我跟你說，要做細胞治療臨床的病人一堆跟山一樣，只是人家不讓他做。輪不到你做，你要拿錢來排隊，我才讓你做。所以你剛才說的就不對，要求很多人來做臨床試驗，找不到人，亂說！"],["薛部長瑞元：那種癌有那麼多人……"],["林委員淑芬：很多人要做啦！得癌症的……"],["薛部長瑞元：你現在說癌症，但又要轉去這裡……"],["林委員淑芬：你跟我說，癌症的人口有多少？罹癌人口。"],["薛部長瑞元：沒有，每一個計畫是對特定的癌症。"],["林委員淑芬：我跟你講，各種癌症都很多人在申請，你現在許可的是這一些……"],["薛部長瑞元：癌症如果標靶治療有成效的話，他根本就不會用再生醫療。"],["林委員淑芬：我現在不是要跟你講這個，我現在是要跟你講，醫療機構向病人所宣稱的療效，都是病人以為找到了救命的那一根稻草，所以都不惜傾家蕩產。我們法規規定要公開的，應該要給大家知道有沒有療效，法規已經5、6年了，有沒有不良反應，你們通通都不公布，我們不得而知，你讓我們的知情權是不對等的狀況，你覺得醫病關係會對等嗎？"],["薛部長瑞元：這部分的話我們來檢討，看用什麼樣的方式來做公布。"],["林委員淑芬：你知道到現在，到111年12月底，治療實體癌第4期的病人到798個、治療1至3期的102個、血液腫瘤的11個，這個已經上千人了。在上千人裡面也陸陸續續有好幾百人，都經過5、6年了，怎麼會沒有辦法公布？那你找一個方法公布，我現在是希望你，民眾、病人帶著錢和希望，就是要尋找這一個治療的機會，所以治療效果絕對是關鍵。而公司這麼多，生技公司一堆跟山一樣，對吧！這個叫做細胞製備場所，細胞製備場所的品質、能力都一樣嗎？實驗室的能力都一樣嗎？所以也難怪，我不知道你有沒有看到，就是一個報導者……"],["薛部長瑞元：我知道。"],["林委員淑芬：報導者那一篇，他主要是在講，檯面上700例，實際執行超過7萬例的地下化。"],["薛部長瑞元：那個會……"],["林委員淑芬：但我不是要講這一個，我是要講，裡面有一個他們訪問的業者，他是特管辦法裡面核可的製備場之一，後期有私下接案，他也執行了許多地下化的細胞治療。他說他3年內治療3億元，我要講的是，他說他的重點，目前特管法通過的治療都以具備安全性為前提，但是他說，這是業者說的，既然是安全性審查，為什麼這麼嚴？為什麼要限制什麼階段的癌症才能治療？他認為前端應該要放寬，但後端要收集數據，公布治療效果。不要像現在，好的生技公司跟不好的生技公司之細胞，差別無從判斷，消費者、用藥人不知道，所以業者的優劣競爭也不會出來。他認為要避免地下化層出不窮的一個關鍵就是要公布治療效果，所以不要讓劣幣驅逐良幣，良幣要突出，讓好的製備場所應該更具有被知道的權利，因為不論業者或是一般民眾，數百萬為家人散盡家財而做的細胞治療，不論是業者，好的業者或者是病患，大家都想知道透明、公開的治療效果，看到底是哪一家。","我們特管法至少還規定多少案例、治療結果、不良反應要公開，但是你們上一屆送到立法院的再生醫療法就沒有了。你們的版本裡面，雖然要求再生機構應該要跟中央主管機關報告它接的案例數、治療效果、不良反應，但是沒有規定，中央主管機關要每年公開醫療機構及細胞製備場所就第一項結果的統計資料，它沒有要求。所以你覺不覺得，如果有院版，你們部已經送到院的版本，有沒有要求應該要公開，讓一般人有知情權，而不是只有你主管機關知道。我們要的是，你如果要市場、要發展，沒關係，那就由市場和大家一起來檢驗，你們的版本有沒有送這個條文？"],["薛部長瑞元：有，我們有這個條文，要公開的這個條文。"],["林委員淑芬：上一屆是沒有。上一屆是沒有，旁邊是……"],["薛部長瑞元：司長。上一屆送的時候，它是有，不過是「得」，得公開。"],["林委員淑芬：上一屆沒有！完全沒有！你不要亂講話。","司長，你是菜鳥嗎？你上一屆的版本完全沒有要求業者要公開，也沒有要求中央主管機關要公開，上一屆只要求業者要通報給中央主管機關，比我們現在特管法要求的公開還不如。特管法至少還寫中央主管機關必要時得公開，但是業者每年都要給中央主管機關報告。"],["薛部長瑞元：一樣啊！"],["林委員淑芬：沒有，這是特管法，我剛剛唸的是特管法。"],["薛部長瑞元：委員，我說原來的那個版本也是這樣子。"],["林委員淑芬：你們上一屆的版本在第二十四條，對不對？要我唸給你聽嗎？醫療機構執行第九條再生技術者，應於每年度終了後六個月內或中央主管機關通知的期限內，提出報告結果，前項報告內容應報告案例數、效果、不良事件及其他規定。只有要求向中央主管機關提出報告結果，沒有談到要公開，你們為什麼都在這裡睜眼瞎說呢？"],["薛部長瑞元：這個部分的話我們會重新提出來……"],["林委員淑芬：這個條文就是不足嘛！因為時間的問題，其實還有要討論的，但是我跟你講，我們談這一點不為過吧？我們不反對，而且做了6年，這6年裡面多少案例了，你一切都講科學嘛！你把你的療效告訴大家，一翻兩瞪眼、數據是最好的見證它就是會說話，而現在你把治療關節炎的、治療皮膚傷口的通通都公告了療效，唯獨治療血癌的、1至3期癌症還有第4期的這個數據你不公開，引人猜疑嘛！"],["薛部長瑞元：我們來處理一下，找出一個適當的公開方式。"],["林委員淑芬：特別是我更擔心，什麼叫有效、什麼叫無效，你們真的有判定的依據嗎？"],["主席：林委員，我們是不是到逐條的時候再深入討論，好不好？"],["林委員淑芬：好，謝謝。"],["主席：謝謝林淑芬委員。接下來請洪申翰委員發言。"]],"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、( 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1052.174, \"end\": 1052.194, \"score\": 0.0}, {\"word\": \"淑\", \"start\": 1052.194, \"end\": 1052.214, \"score\": 0.0}, {\"word\": \"芬\", \"start\": 1052.214, \"end\": 1052.895, \"score\": 0.898}, {\"word\": \"委\", \"start\": 1052.895, \"end\": 1053.375, \"score\": 0.89}, {\"word\": \"員\"}, {\"word\": \"接\", \"start\": 1053.375, \"end\": 1053.535, \"score\": 0.738}, {\"word\": \"下\", \"start\": 1053.535, \"end\": 1053.555, \"score\": 0.0}, {\"word\": \"來\"}, {\"word\": \"請\"}], \"language\": \"zh\"}","srt":"1\n00:00:00,120 --> 00:00:23,321\n法研。」主席各位大家好是不是還是請我們薛部長?請薛部長。部長我們今天在談這個再生醫療法\n\n2\n00:00:27,253 --> 00:00:36,298\n基本上要將特管辦法法制化啦齁但特管辦法從2018年9月6號公告到現在已經多少時間了18到24超過6年了\n\n3\n00:00:41,245 --> 00:00:58,520\n草案案件事宜及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11\n\n4\n00:01:04,085 --> 00:01:21,835\n第二,前項報告的內容應包含治療案例數、治療結果、發生的不良反應或異常事件其他經中央主管機關指定的事項第三,中央主管機關必要時得公開醫療機構的治療統計結果\n\n5\n00:01:25,933 --> 00:01:43,552\n那我覺得今天很多的爭議就是在這裡我光是不談這個其他的這個未來的因為院的版本還沒有送進來嘛那我們先就你目前的法規那我們就要請教就是說你們在這個\n\n6\n00:01:45,914 --> 00:02:11,987\n有沒有將自體免疫細胞治療他這個適應症的範圍裡面中的簡單的說啦你們治療實體癌第四期的啦治療第一到第三期實體癌經標準治療無效的啦或是血液的惡性腫瘤經標準治療無效的這三類的這個施行結果報告有沒有放上衛福部的網站專區\n\n7\n00:02:16,773 --> 00:02:36,345\n藥效有公佈啊,退化性膝關節炎啦,軟骨缺陷的啦,皮膚缺陷的啦,或者是慢性或滿六周沒有癒合的困難的傷口,這個你們都有公佈,療效。\n\n8\n00:02:38,618 --> 00:03:03,409\n但是我們剛剛講大家在講細胞治療大家看重的不是只有這裡大家最期待的案例數最多的都是要治療血液腫瘤一到三期經標準治療無效的或者是實體癌已經第四期的你們公告了病人數可是這個病人數裡面我也必須要講譬如說以實體癌第四期為例798個\n\n9\n00:03:05,530 --> 00:03:16,603\n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次全體委員會第11次全體委員會第11次全體委員會第11次全\n\n10\n00:03:22,310 --> 00:03:45,555\n但你們公告了療效好的退化性關節炎的傷口困難癒合的皮膚缺陷的你們都公告了那為什麼具體治療癌症這就大家期待的再生醫療還有細胞治療的最核心的你們只公布案例數而對於說法律裡面講的說這個療效\n\n11\n00:03:48,916 --> 00:04:10,254\n還有這個不良反應的,你們通通不願意公佈呢?我覺得公佈數據是最科學的啊。但是他有一個比較不好處理的地方,就是療效。這個療效一般像癌症治療的話,他會去看比如說5年的存活率。\n\n12\n00:04:11,215 --> 00:04:18,419\n醫療法草案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事\n\n13\n00:04:32,526 --> 00:04:49,948\n但這個前提是大家都知道大家支持他都認為說他是正統的常規醫療標準醫療之外大家都相信認為是最有療效的可是療效有沒有公佈你們都可以公佈其他的為什麼這個光是再生醫療的這麼多品項裡面\n\n14\n00:04:52,216 --> 00:05:01,649\n最後我們可以再來討論一下你們是選擇性公佈不是不是因為主要是療效這個東西是你如果說不對的話會讓人錯誤解決所以你如果對或不對你就沒辦法判斷啊\n\n15\n00:05:07,316 --> 00:05:15,905\n你現在說不對會被人譴責,到底你的方法、你的細胞治療、你這間細胞整備場所、你這間公司跟醫療機構治療的個案是有效還是沒有效,你現在就沒辦法判斷了嗎?這種癌症的東西有時候有效沒效不是這樣看的,不是說一個就一針見血。\n\n16\n00:05:30,939 --> 00:05:44,301\n我沒有叫你一針見血但我跟你講已經五六年了你還告訴我說你判別不出來那是要多久你才判別的出來2018到2024了你們對於自體免疫情報治療的項目的施行結果那到底有沒有療效你不知道但是\n\n17\n00:05:58,644 --> 00:06:15,613\n到底有沒有不良反應你至少會知道吧也可以公告吧因為現行的套館辦法已經首開了醫療技術的免臨床試驗申請核准就能治療的先例都不用了\n\n18\n00:06:17,393 --> 00:06:23,540\n犯了正常的醫學程序一般正常的醫療新醫療新技術新藥品都必須做完整的人體試驗所以甚至有的是藥廠要花錢花大錢去找人來做人體試驗而現在這一種是我給你當實驗白老鼠\n\n19\n00:06:37,714 --> 00:06:44,220\n我自動花大錢給你不是藥廠給我們錢是我們給藥廠錢在這種狀況裡面我們也不反對因為只要有希望有機會我們也可以支持但是他我們都知道他有一個道德上的風險道德上的風險自古以來就有的\n\n20\n00:06:58,672 --> 00:07:07,237\n福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及\n\n21\n00:07:25,046 --> 00:07:42,874\n但是我們今天講說那沒關係那這麼多公司在做哪一個才是有療效的你公告給這些病患的家屬和病患看至少他還能夠選擇一家是真正療效是比較高的機構吧\n\n22\n00:07:47,181 --> 00:08:12,037\n大委員在剛剛有一個地方講的不是很準確所有的這些再生醫療的技術通通要經過人體試驗沒有完整的人體試驗我要知道你要一期還是二期還是三期你現在特管法規定沒有我跟委員報告就是這個細胞治療基因治療的人體試驗跟藥品的這個臨床試驗是不一樣的\n\n23\n00:08:15,179 --> 00:08:43,508\n我現在問你啦,你現在特管法對於細胞整備場所,就是公司一條列細胞車站在體外透過實驗室培養大量的細胞,再到醫療機構請醫師給你打回去,然後去治療嘛,那你告訴我,你可以做到這樣的治療的,這個你核許通過的這一些細胞整備場所,它除了一期的安全性以外,\n\n24\n00:08:44,568 --> 00:09:11,555\n他要做二期嗎?他要做三期嗎?通常這一類的話一、二期是一起做的。我問你那多少人?你告訴我多少人?每一個個案會不太一樣啦。這每一個計畫第一期要做多少人?這個有法律規定來什麼個案不一樣?有啦!你摸一摸這是技術性。通通都是!都是!\n\n25\n00:09:12,935 --> 00:09:15,636\n幾十個?三十個?五十個?就是這樣子啦!\n\n26\n00:09:15,636 --> 00:09:16,116\n那個是藥品!\n\n27\n00:09:16,116 --> 00:09:19,278\n那個是藥品!很多這種技術的喔!\n\n28\n00:09:19,278 --> 00:09:20,798\n那是更少嗎?\n\n29\n00:09:20,798 --> 00:09:22,839\n你要跟三十個齁?你只要一四人!\n\n30\n00:09:22,839 --> 00:09:24,660\n所以更少嘛!\n\n31\n00:09:24,660 --> 00:09:25,020\n這樣就不對嘛!\n\n32\n00:09:25,020 --> 00:09:25,620\n不一樣啦!\n\n33\n00:09:25,620 --> 00:09:28,961\n人家剛才在說十多個核准在做的七百個!\n\n34\n00:09:28,961 --> 00:09:30,142\n地下在做的七百個!\n\n35\n00:09:30,142 --> 00:09:31,082\n你不記得剛才蘇清泉在說報導者也報導一個業者的說法!\n\n36\n00:09:31,082 --> 00:09:31,322\n就是這樣子說!\n\n37\n00:09:31,322 --> 00:09:31,782\n人家是燒金、拿錢去做!\n\n38\n00:09:31,782 --> 00:09:31,902\n地下我也做!\n\n39\n00:10:26,509 --> 00:10:50,860\n醫療機構向病人所宣稱的療效都是病人以為找到了救命的那個稻草所以都不惜傾家蕩產那我們法規規定的要公開的應該要給大家知道有沒有療效已經法規五六年了然後有沒有不良反應你們通通都不公佈然後我們不得而知然後呢\n\n40\n00:10:52,480 --> 00:11:01,204\n你讓我們這樣子知情全部是不對等的狀況你覺得醫病關係會對等嗎?你知道現在到111年12月月底治療實體癌第4期的病人到798個治療1到3期的102個血液腫瘤的11個這個已經上千人了\n\n41\n00:11:19,711 --> 00:11:46,069\n在上千人裡面也有陸陸續續也好幾百人都經過了五六年了怎麼又怎麼會沒有辦法公佈那你找一個方法公佈我現在叫希望你是說民眾我們病人帶著錢和希望就是要尋找這一個治療的機會所以治療效果絕對是一個關鍵而公司這麼多生技公司一滴那三勒\n\n42\n00:11:46,869 --> 00:11:48,990\n草案案件事務委員委員會委員會委員會委員會委員會委員會委員會委員會委員會\n\n43\n00:12:14,183 --> 00:12:38,003\n有一個他們訪問的業者他是特管辦法裡面合格的自備廠之一後期也有私下接案他也執行了許多地下化的細胞治療他說他3年內治療3億元但是他的重點我要講他說他的重點目前特管法通過的治療都以具備安全性為前提但是他說這是業者說的\n\n44\n00:12:40,285 --> 00:12:46,207\n竟然是安全性審查為什麼這麼嚴為什麼要限制什麼階段癌症才能治療他認為啦前端應該要放寬但後端要收集數據公布治療效果不要像現在好的生技公司細胞這個跟不好生技公司的細胞這種差別無從判斷所以消費者用用藥人也不知道所以業者的優劣競爭也不會出來\n\n45\n00:13:09,935 --> 00:13:30,835\n他認為要避免地下化層出不窮的一個關鍵就是要公佈治療效果所以不要讓劣幣驅逐良幣良幣要突出讓好的自備場所應該更具有這個被知道的權利因為不論業者或是一般民眾數百萬為家人散盡家財來做的細胞治療\n\n46\n00:13:31,596 --> 00:14:00,011\n大家都想要不論是業者好的業者或者是病患都想要知道一個透明公開的治療效果到底是哪一家嗎那我們在這裡說我們特管法至少還規定治療結果多少案例治療結果不良反應要公開但是你們上一屆送到立法院來的再生醫療法就沒有了\n\n47\n00:14:00,953 --> 00:14:02,319\n醫療法草案案案裡面吶!\n\n48\n00:14:04,755 --> 00:14:25,632\n雖然這個要求再生這個機構應該要這個跟中央主管機關報告他接的案例數治療效果不良反應但是沒有規定中央主管機關要每年公開這個醫療機構及細胞自備場所第一項結果的這個統計這個資料\n\n49\n00:14:33,078 --> 00:14:51,648\n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次全體委員會第11次全體委員會第11次全體委員會第11次全\n\n50\n00:14:58,786 --> 00:15:17,171\n你們的版本有沒有送這個條文?我們有這個條文,就是說要公開的這個條文。上一屆是沒有?上一屆是沒有?旁邊這個是我們的師長。上一屆送的時候他是有,但是是得啦。\n\n51\n00:15:19,672 --> 00:15:24,176\n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\n\n52\n00:15:43,590 --> 00:15:59,004\n特管法制裁講說中央主管機關必要使得公開,但是業者要每年都要給中央主管機關報告。沒有,這是特管法。我剛唸的是特管法。\n\n53\n00:16:03,766 --> 00:16:31,860\n好來你們上一屆版本第24條嘛對不對要我念給你聽嗎醫療機構執行第9條再生技術者應於每年度終了後6個月內或中央主管機關通知的期限內提出報告結果前項的報告內容應報告案例數效果不良事件及其他的規定只有要求向中央主管機關提出報告結果沒有談到要公開你們為什麼都在這裡睜眼瞎說呢\n\n54\n00:16:36,124 --> 00:16:40,289\n這條文就是不足嘛,其實因為時間問題還有要討論的,其實還有但是我跟你講說,我們談這一點不為過吧我們不反對,而且做了6年了,這6年裡面多少案例了\n\n55\n00:16:52,722 --> 00:16:54,043\n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\n\n56\n00:17:16,603 --> 00:17:33,555\n我們來處理一下,找出一個適當的公開方法。特別我是更擔心什麼叫有效什麼叫無效,你們真的有判定的依據嗎?林委員我們是不是到主條的時候再深入的討論?好謝謝林淑芬委員接下來請\n\n","tsv":"start\tend\ttext\n120\t23321\t法研。」主席各位大家好是不是還是請我們薛部長?請薛部長。部長我們今天在談這個再生醫療法\n27253\t36298\t基本上要將特管辦法法制化啦齁但特管辦法從2018年9月6號公告到現在已經多少時間了18到24超過6年了\n41245\t58520\t草案案件事宜及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11\n64085\t81835\t第二,前項報告的內容應包含治療案例數、治療結果、發生的不良反應或異常事件其他經中央主管機關指定的事項第三,中央主管機關必要時得公開醫療機構的治療統計結果\n85933\t103552\t那我覺得今天很多的爭議就是在這裡我光是不談這個其他的這個未來的因為院的版本還沒有送進來嘛那我們先就你目前的法規那我們就要請教就是說你們在這個\n105914\t131987\t有沒有將自體免疫細胞治療他這個適應症的範圍裡面中的簡單的說啦你們治療實體癌第四期的啦治療第一到第三期實體癌經標準治療無效的啦或是血液的惡性腫瘤經標準治療無效的這三類的這個施行結果報告有沒有放上衛福部的網站專區\n136773\t156345\t藥效有公佈啊,退化性膝關節炎啦,軟骨缺陷的啦,皮膚缺陷的啦,或者是慢性或滿六周沒有癒合的困難的傷口,這個你們都有公佈,療效。\n158618\t183409\t但是我們剛剛講大家在講細胞治療大家看重的不是只有這裡大家最期待的案例數最多的都是要治療血液腫瘤一到三期經標準治療無效的或者是實體癌已經第四期的你們公告了病人數可是這個病人數裡面我也必須要講譬如說以實體癌第四期為例798個\n185530\t196603\t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次全體委員會第11次全體委員會第11次全體委員會第11次全\n202310\t225555\t但你們公告了療效好的退化性關節炎的傷口困難癒合的皮膚缺陷的你們都公告了那為什麼具體治療癌症這就大家期待的再生醫療還有細胞治療的最核心的你們只公布案例數而對於說法律裡面講的說這個療效\n228916\t250254\t還有這個不良反應的,你們通通不願意公佈呢?我覺得公佈數據是最科學的啊。但是他有一個比較不好處理的地方,就是療效。這個療效一般像癌症治療的話,他會去看比如說5年的存活率。\n251215\t258419\t醫療法草案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事\n272526\t289948\t但這個前提是大家都知道大家支持他都認為說他是正統的常規醫療標準醫療之外大家都相信認為是最有療效的可是療效有沒有公佈你們都可以公佈其他的為什麼這個光是再生醫療的這麼多品項裡面\n292216\t301649\t最後我們可以再來討論一下你們是選擇性公佈不是不是因為主要是療效這個東西是你如果說不對的話會讓人錯誤解決所以你如果對或不對你就沒辦法判斷啊\n307316\t315905\t你現在說不對會被人譴責,到底你的方法、你的細胞治療、你這間細胞整備場所、你這間公司跟醫療機構治療的個案是有效還是沒有效,你現在就沒辦法判斷了嗎?這種癌症的東西有時候有效沒效不是這樣看的,不是說一個就一針見血。\n330939\t344301\t我沒有叫你一針見血但我跟你講已經五六年了你還告訴我說你判別不出來那是要多久你才判別的出來2018到2024了你們對於自體免疫情報治療的項目的施行結果那到底有沒有療效你不知道但是\n358644\t375613\t到底有沒有不良反應你至少會知道吧也可以公告吧因為現行的套館辦法已經首開了醫療技術的免臨床試驗申請核准就能治療的先例都不用了\n377393\t383540\t犯了正常的醫學程序一般正常的醫療新醫療新技術新藥品都必須做完整的人體試驗所以甚至有的是藥廠要花錢花大錢去找人來做人體試驗而現在這一種是我給你當實驗白老鼠\n397714\t404220\t我自動花大錢給你不是藥廠給我們錢是我們給藥廠錢在這種狀況裡面我們也不反對因為只要有希望有機會我們也可以支持但是他我們都知道他有一個道德上的風險道德上的風險自古以來就有的\n418672\t427237\t福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及\n445046\t462874\t但是我們今天講說那沒關係那這麼多公司在做哪一個才是有療效的你公告給這些病患的家屬和病患看至少他還能夠選擇一家是真正療效是比較高的機構吧\n467181\t492037\t大委員在剛剛有一個地方講的不是很準確所有的這些再生醫療的技術通通要經過人體試驗沒有完整的人體試驗我要知道你要一期還是二期還是三期你現在特管法規定沒有我跟委員報告就是這個細胞治療基因治療的人體試驗跟藥品的這個臨床試驗是不一樣的\n495179\t523508\t我現在問你啦,你現在特管法對於細胞整備場所,就是公司一條列細胞車站在體外透過實驗室培養大量的細胞,再到醫療機構請醫師給你打回去,然後去治療嘛,那你告訴我,你可以做到這樣的治療的,這個你核許通過的這一些細胞整備場所,它除了一期的安全性以外,\n524568\t551555\t他要做二期嗎?他要做三期嗎?通常這一類的話一、二期是一起做的。我問你那多少人?你告訴我多少人?每一個個案會不太一樣啦。這每一個計畫第一期要做多少人?這個有法律規定來什麼個案不一樣?有啦!你摸一摸這是技術性。通通都是!都是!\n552935\t555636\t幾十個?三十個?五十個?就是這樣子啦!\n555636\t556116\t那個是藥品!\n556116\t559278\t那個是藥品!很多這種技術的喔!\n559278\t560798\t那是更少嗎?\n560798\t562839\t你要跟三十個齁?你只要一四人!\n562839\t564660\t所以更少嘛!\n564660\t565020\t這樣就不對嘛!\n565020\t565620\t不一樣啦!\n565620\t568961\t人家剛才在說十多個核准在做的七百個!\n568961\t570142\t地下在做的七百個!\n570142\t571082\t你不記得剛才蘇清泉在說報導者也報導一個業者的說法!\n571082\t571322\t就是這樣子說!\n571322\t571782\t人家是燒金、拿錢去做!\n571782\t571902\t地下我也做!\n581766\t601647\t檢測檢測檢測\n602500\t625469\t藥藥藥藥藥藥藥藥\n626509\t650860\t醫療機構向病人所宣稱的療效都是病人以為找到了救命的那個稻草所以都不惜傾家蕩產那我們法規規定的要公開的應該要給大家知道有沒有療效已經法規五六年了然後有沒有不良反應你們通通都不公佈然後我們不得而知然後呢\n652480\t661204\t你讓我們這樣子知情全部是不對等的狀況你覺得醫病關係會對等嗎?你知道現在到111年12月月底治療實體癌第4期的病人到798個治療1到3期的102個血液腫瘤的11個這個已經上千人了\n679711\t706069\t在上千人裡面也有陸陸續續也好幾百人都經過了五六年了怎麼又怎麼會沒有辦法公佈那你找一個方法公佈我現在叫希望你是說民眾我們病人帶著錢和希望就是要尋找這一個治療的機會所以治療效果絕對是一個關鍵而公司這麼多生技公司一滴那三勒\n706869\t708990\t草案案件事務委員委員會委員會委員會委員會委員會委員會委員會委員會委員會\n734183\t758003\t有一個他們訪問的業者他是特管辦法裡面合格的自備廠之一後期也有私下接案他也執行了許多地下化的細胞治療他說他3年內治療3億元但是他的重點我要講他說他的重點目前特管法通過的治療都以具備安全性為前提但是他說這是業者說的\n760285\t766207\t竟然是安全性審查為什麼這麼嚴為什麼要限制什麼階段癌症才能治療他認為啦前端應該要放寬但後端要收集數據公布治療效果不要像現在好的生技公司細胞這個跟不好生技公司的細胞這種差別無從判斷所以消費者用用藥人也不知道所以業者的優劣競爭也不會出來\n789935\t810835\t他認為要避免地下化層出不窮的一個關鍵就是要公佈治療效果所以不要讓劣幣驅逐良幣良幣要突出讓好的自備場所應該更具有這個被知道的權利因為不論業者或是一般民眾數百萬為家人散盡家財來做的細胞治療\n811596\t840011\t大家都想要不論是業者好的業者或者是病患都想要知道一個透明公開的治療效果到底是哪一家嗎那我們在這裡說我們特管法至少還規定治療結果多少案例治療結果不良反應要公開但是你們上一屆送到立法院來的再生醫療法就沒有了\n840953\t842319\t醫療法草案案 案 裡面吶!\n844755\t865632\t雖然這個要求再生這個機構應該要這個跟中央主管機關報告他接的案例數治療效果不良反應但是沒有規定中央主管機關要每年公開這個醫療機構及細胞自備場所第一項結果的這個統計這個資料\n873078\t891648\t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次全體委員會第11次全體委員會第11次全體委員會第11次全\n898786\t917171\t你們的版本有沒有送這個條文?我們有這個條文,就是說要公開的這個條文。上一屆是沒有?上一屆是沒有?旁邊這個是我們的師長。上一屆送的時候他是有,但是是得啦。\n919672\t924176\t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\n943590\t959004\t特管法制裁講說中央主管機關必要使得公開,但是業者要每年都要給中央主管機關報告。沒有,這是特管法。我剛唸的是特管法。\n963766\t991860\t好來你們上一屆版本第24條嘛對不對要我念給你聽嗎醫療機構執行第9條再生技術者應於每年度終了後6個月內或中央主管機關通知的期限內提出報告結果前項的報告內容應報告案例數效果不良事件及其他的規定只有要求向中央主管機關提出報告結果沒有談到要公開你們為什麼都在這裡睜眼瞎說呢\n996124\t1000289\t這條文就是不足嘛,其實因為時間問題還有要討論的,其實還有但是我跟你講說,我們談這一點不為過吧我們不反對,而且做了6年了,這6年裡面多少案例了\n1012722\t1014043\t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\n1036603\t1053555\t我們來處理一下,找出一個適當的公開方法。特別我是更擔心什麼叫有效什麼叫無效,你們真的有判定的依據嗎?林委員我們是不是到主條的時候再深入的討論?好謝謝林淑芬委員接下來請\n","txt":"法研。」主席各位大家好是不是還是請我們薛部長?請薛部長。部長我們今天在談這個再生醫療法\n基本上要將特管辦法法制化啦齁但特管辦法從2018年9月6號公告到現在已經多少時間了18到24超過6年了\n草案案件事宜及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11\n第二,前項報告的內容應包含治療案例數、治療結果、發生的不良反應或異常事件其他經中央主管機關指定的事項第三,中央主管機關必要時得公開醫療機構的治療統計結果\n那我覺得今天很多的爭議就是在這裡我光是不談這個其他的這個未來的因為院的版本還沒有送進來嘛那我們先就你目前的法規那我們就要請教就是說你們在這個\n有沒有將自體免疫細胞治療他這個適應症的範圍裡面中的簡單的說啦你們治療實體癌第四期的啦治療第一到第三期實體癌經標準治療無效的啦或是血液的惡性腫瘤經標準治療無效的這三類的這個施行結果報告有沒有放上衛福部的網站專區\n藥效有公佈啊,退化性膝關節炎啦,軟骨缺陷的啦,皮膚缺陷的啦,或者是慢性或滿六周沒有癒合的困難的傷口,這個你們都有公佈,療效。\n但是我們剛剛講大家在講細胞治療大家看重的不是只有這裡大家最期待的案例數最多的都是要治療血液腫瘤一到三期經標準治療無效的或者是實體癌已經第四期的你們公告了病人數可是這個病人數裡面我也必須要講譬如說以實體癌第四期為例798個\n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次全體委員會第11次全體委員會第11次全體委員會第11次全\n但你們公告了療效好的退化性關節炎的傷口困難癒合的皮膚缺陷的你們都公告了那為什麼具體治療癌症這就大家期待的再生醫療還有細胞治療的最核心的你們只公布案例數而對於說法律裡面講的說這個療效\n還有這個不良反應的,你們通通不願意公佈呢?我覺得公佈數據是最科學的啊。但是他有一個比較不好處理的地方,就是療效。這個療效一般像癌症治療的話,他會去看比如說5年的存活率。\n醫療法草案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事\n但這個前提是大家都知道大家支持他都認為說他是正統的常規醫療標準醫療之外大家都相信認為是最有療效的可是療效有沒有公佈你們都可以公佈其他的為什麼這個光是再生醫療的這麼多品項裡面\n最後我們可以再來討論一下你們是選擇性公佈不是不是因為主要是療效這個東西是你如果說不對的話會讓人錯誤解決所以你如果對或不對你就沒辦法判斷啊\n你現在說不對會被人譴責,到底你的方法、你的細胞治療、你這間細胞整備場所、你這間公司跟醫療機構治療的個案是有效還是沒有效,你現在就沒辦法判斷了嗎?這種癌症的東西有時候有效沒效不是這樣看的,不是說一個就一針見血。\n我沒有叫你一針見血但我跟你講已經五六年了你還告訴我說你判別不出來那是要多久你才判別的出來2018到2024了你們對於自體免疫情報治療的項目的施行結果那到底有沒有療效你不知道但是\n到底有沒有不良反應你至少會知道吧也可以公告吧因為現行的套館辦法已經首開了醫療技術的免臨床試驗申請核准就能治療的先例都不用了\n犯了正常的醫學程序一般正常的醫療新醫療新技術新藥品都必須做完整的人體試驗所以甚至有的是藥廠要花錢花大錢去找人來做人體試驗而現在這一種是我給你當實驗白老鼠\n我自動花大錢給你不是藥廠給我們錢是我們給藥廠錢在這種狀況裡面我們也不反對因為只要有希望有機會我們也可以支持但是他我們都知道他有一個道德上的風險道德上的風險自古以來就有的\n福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及\n但是我們今天講說那沒關係那這麼多公司在做哪一個才是有療效的你公告給這些病患的家屬和病患看至少他還能夠選擇一家是真正療效是比較高的機構吧\n大委員在剛剛有一個地方講的不是很準確所有的這些再生醫療的技術通通要經過人體試驗沒有完整的人體試驗我要知道你要一期還是二期還是三期你現在特管法規定沒有我跟委員報告就是這個細胞治療基因治療的人體試驗跟藥品的這個臨床試驗是不一樣的\n我現在問你啦,你現在特管法對於細胞整備場所,就是公司一條列細胞車站在體外透過實驗室培養大量的細胞,再到醫療機構請醫師給你打回去,然後去治療嘛,那你告訴我,你可以做到這樣的治療的,這個你核許通過的這一些細胞整備場所,它除了一期的安全性以外,\n他要做二期嗎?他要做三期嗎?通常這一類的話一、二期是一起做的。我問你那多少人?你告訴我多少人?每一個個案會不太一樣啦。這每一個計畫第一期要做多少人?這個有法律規定來什麼個案不一樣?有啦!你摸一摸這是技術性。通通都是!都是!\n幾十個?三十個?五十個?就是這樣子啦!\n那個是藥品!\n那個是藥品!很多這種技術的喔!\n那是更少嗎?\n你要跟三十個齁?你只要一四人!\n所以更少嘛!\n這樣就不對嘛!\n不一樣啦!\n人家剛才在說十多個核准在做的七百個!\n地下在做的七百個!\n你不記得剛才蘇清泉在說報導者也報導一個業者的說法!\n就是這樣子說!\n人家是燒金、拿錢去做!\n地下我也做!\n檢測檢測檢測\n藥藥藥藥藥藥藥藥\n醫療機構向病人所宣稱的療效都是病人以為找到了救命的那個稻草所以都不惜傾家蕩產那我們法規規定的要公開的應該要給大家知道有沒有療效已經法規五六年了然後有沒有不良反應你們通通都不公佈然後我們不得而知然後呢\n你讓我們這樣子知情全部是不對等的狀況你覺得醫病關係會對等嗎?你知道現在到111年12月月底治療實體癌第4期的病人到798個治療1到3期的102個血液腫瘤的11個這個已經上千人了\n在上千人裡面也有陸陸續續也好幾百人都經過了五六年了怎麼又怎麼會沒有辦法公佈那你找一個方法公佈我現在叫希望你是說民眾我們病人帶著錢和希望就是要尋找這一個治療的機會所以治療效果絕對是一個關鍵而公司這麼多生技公司一滴那三勒\n草案案件事務委員委員會委員會委員會委員會委員會委員會委員會委員會委員會\n有一個他們訪問的業者他是特管辦法裡面合格的自備廠之一後期也有私下接案他也執行了許多地下化的細胞治療他說他3年內治療3億元但是他的重點我要講他說他的重點目前特管法通過的治療都以具備安全性為前提但是他說這是業者說的\n竟然是安全性審查為什麼這麼嚴為什麼要限制什麼階段癌症才能治療他認為啦前端應該要放寬但後端要收集數據公布治療效果不要像現在好的生技公司細胞這個跟不好生技公司的細胞這種差別無從判斷所以消費者用用藥人也不知道所以業者的優劣競爭也不會出來\n他認為要避免地下化層出不窮的一個關鍵就是要公佈治療效果所以不要讓劣幣驅逐良幣良幣要突出讓好的自備場所應該更具有這個被知道的權利因為不論業者或是一般民眾數百萬為家人散盡家財來做的細胞治療\n大家都想要不論是業者好的業者或者是病患都想要知道一個透明公開的治療效果到底是哪一家嗎那我們在這裡說我們特管法至少還規定治療結果多少案例治療結果不良反應要公開但是你們上一屆送到立法院來的再生醫療法就沒有了\n醫療法草案案 案 裡面吶!\n雖然這個要求再生這個機構應該要這個跟中央主管機關報告他接的案例數治療效果不良反應但是沒有規定中央主管機關要每年公開這個醫療機構及細胞自備場所第一項結果的這個統計這個資料\n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次全體委員會第11次全體委員會第11次全體委員會第11次全\n你們的版本有沒有送這個條文?我們有這個條文,就是說要公開的這個條文。上一屆是沒有?上一屆是沒有?旁邊這個是我們的師長。上一屆送的時候他是有,但是是得啦。\n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\n特管法制裁講說中央主管機關必要使得公開,但是業者要每年都要給中央主管機關報告。沒有,這是特管法。我剛唸的是特管法。\n好來你們上一屆版本第24條嘛對不對要我念給你聽嗎醫療機構執行第9條再生技術者應於每年度終了後6個月內或中央主管機關通知的期限內提出報告結果前項的報告內容應報告案例數效果不良事件及其他的規定只有要求向中央主管機關提出報告結果沒有談到要公開你們為什麼都在這裡睜眼瞎說呢\n這條文就是不足嘛,其實因為時間問題還有要討論的,其實還有但是我跟你講說,我們談這一點不為過吧我們不反對,而且做了6年了,這6年裡面多少案例了\n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\n我們來處理一下,找出一個適當的公開方法。特別我是更擔心什麼叫有效什麼叫無效,你們真的有判定的依據嗎?林委員我們是不是到主條的時候再深入的討論?好謝謝林淑芬委員接下來請\n","vtt":"WEBVTT\n\n00:00.120 --> 00:23.321\n法研。」主席各位大家好是不是還是請我們薛部長?請薛部長。部長我們今天在談這個再生醫療法\n\n00:27.253 --> 00:36.298\n基本上要將特管辦法法制化啦齁但特管辦法從2018年9月6號公告到現在已經多少時間了18到24超過6年了\n\n00:41.245 --> 00:58.520\n草案案件事宜及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11\n\n01:04.085 --> 01:21.835\n第二,前項報告的內容應包含治療案例數、治療結果、發生的不良反應或異常事件其他經中央主管機關指定的事項第三,中央主管機關必要時得公開醫療機構的治療統計結果\n\n01:25.933 --> 01:43.552\n那我覺得今天很多的爭議就是在這裡我光是不談這個其他的這個未來的因為院的版本還沒有送進來嘛那我們先就你目前的法規那我們就要請教就是說你們在這個\n\n01:45.914 --> 02:11.987\n有沒有將自體免疫細胞治療他這個適應症的範圍裡面中的簡單的說啦你們治療實體癌第四期的啦治療第一到第三期實體癌經標準治療無效的啦或是血液的惡性腫瘤經標準治療無效的這三類的這個施行結果報告有沒有放上衛福部的網站專區\n\n02:16.773 --> 02:36.345\n藥效有公佈啊,退化性膝關節炎啦,軟骨缺陷的啦,皮膚缺陷的啦,或者是慢性或滿六周沒有癒合的困難的傷口,這個你們都有公佈,療效。\n\n02:38.618 --> 03:03.409\n但是我們剛剛講大家在講細胞治療大家看重的不是只有這裡大家最期待的案例數最多的都是要治療血液腫瘤一到三期經標準治療無效的或者是實體癌已經第四期的你們公告了病人數可是這個病人數裡面我也必須要講譬如說以實體癌第四期為例798個\n\n03:05.530 --> 03:16.603\n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次全體委員會第11次全體委員會第11次全體委員會第11次全\n\n03:22.310 --> 03:45.555\n但你們公告了療效好的退化性關節炎的傷口困難癒合的皮膚缺陷的你們都公告了那為什麼具體治療癌症這就大家期待的再生醫療還有細胞治療的最核心的你們只公布案例數而對於說法律裡面講的說這個療效\n\n03:48.916 --> 04:10.254\n還有這個不良反應的,你們通通不願意公佈呢?我覺得公佈數據是最科學的啊。但是他有一個比較不好處理的地方,就是療效。這個療效一般像癌症治療的話,他會去看比如說5年的存活率。\n\n04:11.215 --> 04:18.419\n醫療法草案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事\n\n04:32.526 --> 04:49.948\n但這個前提是大家都知道大家支持他都認為說他是正統的常規醫療標準醫療之外大家都相信認為是最有療效的可是療效有沒有公佈你們都可以公佈其他的為什麼這個光是再生醫療的這麼多品項裡面\n\n04:52.216 --> 05:01.649\n最後我們可以再來討論一下你們是選擇性公佈不是不是因為主要是療效這個東西是你如果說不對的話會讓人錯誤解決所以你如果對或不對你就沒辦法判斷啊\n\n05:07.316 --> 05:15.905\n你現在說不對會被人譴責,到底你的方法、你的細胞治療、你這間細胞整備場所、你這間公司跟醫療機構治療的個案是有效還是沒有效,你現在就沒辦法判斷了嗎?這種癌症的東西有時候有效沒效不是這樣看的,不是說一個就一針見血。\n\n05:30.939 --> 05:44.301\n我沒有叫你一針見血但我跟你講已經五六年了你還告訴我說你判別不出來那是要多久你才判別的出來2018到2024了你們對於自體免疫情報治療的項目的施行結果那到底有沒有療效你不知道但是\n\n05:58.644 --> 06:15.613\n到底有沒有不良反應你至少會知道吧也可以公告吧因為現行的套館辦法已經首開了醫療技術的免臨床試驗申請核准就能治療的先例都不用了\n\n06:17.393 --> 06:23.540\n犯了正常的醫學程序一般正常的醫療新醫療新技術新藥品都必須做完整的人體試驗所以甚至有的是藥廠要花錢花大錢去找人來做人體試驗而現在這一種是我給你當實驗白老鼠\n\n06:37.714 --> 06:44.220\n我自動花大錢給你不是藥廠給我們錢是我們給藥廠錢在這種狀況裡面我們也不反對因為只要有希望有機會我們也可以支持但是他我們都知道他有一個道德上的風險道德上的風險自古以來就有的\n\n06:58.672 --> 07:07.237\n福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及\n\n07:25.046 --> 07:42.874\n但是我們今天講說那沒關係那這麼多公司在做哪一個才是有療效的你公告給這些病患的家屬和病患看至少他還能夠選擇一家是真正療效是比較高的機構吧\n\n07:47.181 --> 08:12.037\n大委員在剛剛有一個地方講的不是很準確所有的這些再生醫療的技術通通要經過人體試驗沒有完整的人體試驗我要知道你要一期還是二期還是三期你現在特管法規定沒有我跟委員報告就是這個細胞治療基因治療的人體試驗跟藥品的這個臨床試驗是不一樣的\n\n08:15.179 --> 08:43.508\n我現在問你啦,你現在特管法對於細胞整備場所,就是公司一條列細胞車站在體外透過實驗室培養大量的細胞,再到醫療機構請醫師給你打回去,然後去治療嘛,那你告訴我,你可以做到這樣的治療的,這個你核許通過的這一些細胞整備場所,它除了一期的安全性以外,\n\n08:44.568 --> 09:11.555\n他要做二期嗎?他要做三期嗎?通常這一類的話一、二期是一起做的。我問你那多少人?你告訴我多少人?每一個個案會不太一樣啦。這每一個計畫第一期要做多少人?這個有法律規定來什麼個案不一樣?有啦!你摸一摸這是技術性。通通都是!都是!\n\n09:12.935 --> 09:15.636\n幾十個?三十個?五十個?就是這樣子啦!\n\n09:15.636 --> 09:16.116\n那個是藥品!\n\n09:16.116 --> 09:19.278\n那個是藥品!很多這種技術的喔!\n\n09:19.278 --> 09:20.798\n那是更少嗎?\n\n09:20.798 --> 09:22.839\n你要跟三十個齁?你只要一四人!\n\n09:22.839 --> 09:24.660\n所以更少嘛!\n\n09:24.660 --> 09:25.020\n這樣就不對嘛!\n\n09:25.020 --> 09:25.620\n不一樣啦!\n\n09:25.620 --> 09:28.961\n人家剛才在說十多個核准在做的七百個!\n\n09:28.961 --> 09:30.142\n地下在做的七百個!\n\n09:30.142 --> 09:31.082\n你不記得剛才蘇清泉在說報導者也報導一個業者的說法!\n\n09:31.082 --> 09:31.322\n就是這樣子說!\n\n09:31.322 --> 09:31.782\n人家是燒金、拿錢去做!\n\n09:31.782 --> 09:31.902\n地下我也做!\n\n10:26.509 --> 10:50.860\n醫療機構向病人所宣稱的療效都是病人以為找到了救命的那個稻草所以都不惜傾家蕩產那我們法規規定的要公開的應該要給大家知道有沒有療效已經法規五六年了然後有沒有不良反應你們通通都不公佈然後我們不得而知然後呢\n\n10:52.480 --> 11:01.204\n你讓我們這樣子知情全部是不對等的狀況你覺得醫病關係會對等嗎?你知道現在到111年12月月底治療實體癌第4期的病人到798個治療1到3期的102個血液腫瘤的11個這個已經上千人了\n\n11:19.711 --> 11:46.069\n在上千人裡面也有陸陸續續也好幾百人都經過了五六年了怎麼又怎麼會沒有辦法公佈那你找一個方法公佈我現在叫希望你是說民眾我們病人帶著錢和希望就是要尋找這一個治療的機會所以治療效果絕對是一個關鍵而公司這麼多生技公司一滴那三勒\n\n11:46.869 --> 11:48.990\n草案案件事務委員委員會委員會委員會委員會委員會委員會委員會委員會委員會\n\n12:14.183 --> 12:38.003\n有一個他們訪問的業者他是特管辦法裡面合格的自備廠之一後期也有私下接案他也執行了許多地下化的細胞治療他說他3年內治療3億元但是他的重點我要講他說他的重點目前特管法通過的治療都以具備安全性為前提但是他說這是業者說的\n\n12:40.285 --> 12:46.207\n竟然是安全性審查為什麼這麼嚴為什麼要限制什麼階段癌症才能治療他認為啦前端應該要放寬但後端要收集數據公布治療效果不要像現在好的生技公司細胞這個跟不好生技公司的細胞這種差別無從判斷所以消費者用用藥人也不知道所以業者的優劣競爭也不會出來\n\n13:09.935 --> 13:30.835\n他認為要避免地下化層出不窮的一個關鍵就是要公佈治療效果所以不要讓劣幣驅逐良幣良幣要突出讓好的自備場所應該更具有這個被知道的權利因為不論業者或是一般民眾數百萬為家人散盡家財來做的細胞治療\n\n13:31.596 --> 14:00.011\n大家都想要不論是業者好的業者或者是病患都想要知道一個透明公開的治療效果到底是哪一家嗎那我們在這裡說我們特管法至少還規定治療結果多少案例治療結果不良反應要公開但是你們上一屆送到立法院來的再生醫療法就沒有了\n\n14:00.953 --> 14:02.319\n醫療法草案案案裡面吶!\n\n14:04.755 --> 14:25.632\n雖然這個要求再生這個機構應該要這個跟中央主管機關報告他接的案例數治療效果不良反應但是沒有規定中央主管機關要每年公開這個醫療機構及細胞自備場所第一項結果的這個統計這個資料\n\n14:33.078 --> 14:51.648\n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次全體委員會第11次全體委員會第11次全體委員會第11次全\n\n14:58.786 --> 15:17.171\n你們的版本有沒有送這個條文?我們有這個條文,就是說要公開的這個條文。上一屆是沒有?上一屆是沒有?旁邊這個是我們的師長。上一屆送的時候他是有,但是是得啦。\n\n15:19.672 --> 15:24.176\n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\n\n15:43.590 --> 15:59.004\n特管法制裁講說中央主管機關必要使得公開,但是業者要每年都要給中央主管機關報告。沒有,這是特管法。我剛唸的是特管法。\n\n16:03.766 --> 16:31.860\n好來你們上一屆版本第24條嘛對不對要我念給你聽嗎醫療機構執行第9條再生技術者應於每年度終了後6個月內或中央主管機關通知的期限內提出報告結果前項的報告內容應報告案例數效果不良事件及其他的規定只有要求向中央主管機關提出報告結果沒有談到要公開你們為什麼都在這裡睜眼瞎說呢\n\n16:36.124 --> 16:40.289\n這條文就是不足嘛,其實因為時間問題還有要討論的,其實還有但是我跟你講說,我們談這一點不為過吧我們不反對,而且做了6年了,這6年裡面多少案例了\n\n16:52.722 --> 16:54.043\n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\n\n17:16.603 --> 17:33.555\n我們來處理一下,找出一個適當的公開方法。特別我是更擔心什麼叫有效什麼叫無效,你們真的有判定的依據嗎?林委員我們是不是到主條的時候再深入的討論?好謝謝林淑芬委員接下來請\n\n","segments":[{"start":0.12,"end":23.321,"text":"法研。」主席各位大家好是不是還是請我們薛部長?請薛部長。部長我們今天在談這個再生醫療法"},{"start":27.253,"end":36.298,"text":"基本上要將特管辦法法制化啦齁但特管辦法從2018年9月6號公告到現在已經多少時間了18到24超過6年了"},{"start":41.245,"end":58.52,"text":"草案案件事宜及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11"},{"start":64.085,"end":81.835,"text":"第二,前項報告的內容應包含治療案例數、治療結果、發生的不良反應或異常事件其他經中央主管機關指定的事項第三,中央主管機關必要時得公開醫療機構的治療統計結果"},{"start":85.933,"end":103.552,"text":"那我覺得今天很多的爭議就是在這裡我光是不談這個其他的這個未來的因為院的版本還沒有送進來嘛那我們先就你目前的法規那我們就要請教就是說你們在這個"},{"start":105.914,"end":131.987,"text":"有沒有將自體免疫細胞治療他這個適應症的範圍裡面中的簡單的說啦你們治療實體癌第四期的啦治療第一到第三期實體癌經標準治療無效的啦或是血液的惡性腫瘤經標準治療無效的這三類的這個施行結果報告有沒有放上衛福部的網站專區"},{"start":136.773,"end":156.345,"text":"藥效有公佈啊,退化性膝關節炎啦,軟骨缺陷的啦,皮膚缺陷的啦,或者是慢性或滿六周沒有癒合的困難的傷口,這個你們都有公佈,療效。"},{"start":158.618,"end":183.409,"text":"但是我們剛剛講大家在講細胞治療大家看重的不是只有這裡大家最期待的案例數最多的都是要治療血液腫瘤一到三期經標準治療無效的或者是實體癌已經第四期的你們公告了病人數可是這個病人數裡面我也必須要講譬如說以實體癌第四期為例798個"},{"start":185.53,"end":196.603,"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次全體委員會第11次全體委員會第11次全體委員會第11次全"},{"start":202.31,"end":225.555,"text":"但你們公告了療效好的退化性關節炎的傷口困難癒合的皮膚缺陷的你們都公告了那為什麼具體治療癌症這就大家期待的再生醫療還有細胞治療的最核心的你們只公布案例數而對於說法律裡面講的說這個療效"},{"start":228.916,"end":250.254,"text":"還有這個不良反應的,你們通通不願意公佈呢?我覺得公佈數據是最科學的啊。但是他有一個比較不好處理的地方,就是療效。這個療效一般像癌症治療的話,他會去看比如說5年的存活率。"},{"start":251.215,"end":258.419,"text":"醫療法草案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事"},{"start":272.526,"end":289.948,"text":"但這個前提是大家都知道大家支持他都認為說他是正統的常規醫療標準醫療之外大家都相信認為是最有療效的可是療效有沒有公佈你們都可以公佈其他的為什麼這個光是再生醫療的這麼多品項裡面"},{"start":292.216,"end":301.649,"text":"最後我們可以再來討論一下你們是選擇性公佈不是不是因為主要是療效這個東西是你如果說不對的話會讓人錯誤解決所以你如果對或不對你就沒辦法判斷啊"},{"start":307.316,"end":315.905,"text":"你現在說不對會被人譴責,到底你的方法、你的細胞治療、你這間細胞整備場所、你這間公司跟醫療機構治療的個案是有效還是沒有效,你現在就沒辦法判斷了嗎?這種癌症的東西有時候有效沒效不是這樣看的,不是說一個就一針見血。"},{"start":330.939,"end":344.301,"text":"我沒有叫你一針見血但我跟你講已經五六年了你還告訴我說你判別不出來那是要多久你才判別的出來2018到2024了你們對於自體免疫情報治療的項目的施行結果那到底有沒有療效你不知道但是"},{"start":358.644,"end":375.613,"text":"到底有沒有不良反應你至少會知道吧也可以公告吧因為現行的套館辦法已經首開了醫療技術的免臨床試驗申請核准就能治療的先例都不用了"},{"start":377.393,"end":383.54,"text":"犯了正常的醫學程序一般正常的醫療新醫療新技術新藥品都必須做完整的人體試驗所以甚至有的是藥廠要花錢花大錢去找人來做人體試驗而現在這一種是我給你當實驗白老鼠"},{"start":397.714,"end":404.22,"text":"我自動花大錢給你不是藥廠給我們錢是我們給藥廠錢在這種狀況裡面我們也不反對因為只要有希望有機會我們也可以支持但是他我們都知道他有一個道德上的風險道德上的風險自古以來就有的"},{"start":418.672,"end":427.237,"text":"福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及衛生環境委員會第11期社會福利及"},{"start":445.046,"end":462.874,"text":"但是我們今天講說那沒關係那這麼多公司在做哪一個才是有療效的你公告給這些病患的家屬和病患看至少他還能夠選擇一家是真正療效是比較高的機構吧"},{"start":467.181,"end":492.037,"text":"大委員在剛剛有一個地方講的不是很準確所有的這些再生醫療的技術通通要經過人體試驗沒有完整的人體試驗我要知道你要一期還是二期還是三期你現在特管法規定沒有我跟委員報告就是這個細胞治療基因治療的人體試驗跟藥品的這個臨床試驗是不一樣的"},{"start":495.179,"end":523.508,"text":"我現在問你啦,你現在特管法對於細胞整備場所,就是公司一條列細胞車站在體外透過實驗室培養大量的細胞,再到醫療機構請醫師給你打回去,然後去治療嘛,那你告訴我,你可以做到這樣的治療的,這個你核許通過的這一些細胞整備場所,它除了一期的安全性以外,"},{"start":524.568,"end":551.555,"text":"他要做二期嗎?他要做三期嗎?通常這一類的話一、二期是一起做的。我問你那多少人?你告訴我多少人?每一個個案會不太一樣啦。這每一個計畫第一期要做多少人?這個有法律規定來什麼個案不一樣?有啦!你摸一摸這是技術性。通通都是!都是!"},{"start":552.935,"end":555.636,"text":"幾十個?三十個?五十個?就是這樣子啦!"},{"start":555.636,"end":556.116,"text":"那個是藥品!"},{"start":556.116,"end":559.278,"text":"那個是藥品!很多這種技術的喔!"},{"start":559.278,"end":560.798,"text":"那是更少嗎?"},{"start":560.798,"end":562.839,"text":"你要跟三十個齁?你只要一四人!"},{"start":562.839,"end":564.66,"text":"所以更少嘛!"},{"start":564.66,"end":565.02,"text":"這樣就不對嘛!"},{"start":565.02,"end":565.62,"text":"不一樣啦!"},{"start":565.62,"end":568.961,"text":"人家剛才在說十多個核准在做的七百個!"},{"start":568.961,"end":570.142,"text":"地下在做的七百個!"},{"start":570.142,"end":571.082,"text":"你不記得剛才蘇清泉在說報導者也報導一個業者的說法!"},{"start":571.082,"end":571.322,"text":"就是這樣子說!"},{"start":571.322,"end":571.782,"text":"人家是燒金、拿錢去做!"},{"start":571.782,"end":571.902,"text":"地下我也做!"},{"start":581.766,"end":601.647,"text":"檢測檢測檢測"},{"start":602.5,"end":625.469,"text":"藥藥藥藥藥藥藥藥"},{"start":626.509,"end":650.86,"text":"醫療機構向病人所宣稱的療效都是病人以為找到了救命的那個稻草所以都不惜傾家蕩產那我們法規規定的要公開的應該要給大家知道有沒有療效已經法規五六年了然後有沒有不良反應你們通通都不公佈然後我們不得而知然後呢"},{"start":652.48,"end":661.204,"text":"你讓我們這樣子知情全部是不對等的狀況你覺得醫病關係會對等嗎?你知道現在到111年12月月底治療實體癌第4期的病人到798個治療1到3期的102個血液腫瘤的11個這個已經上千人了"},{"start":679.711,"end":706.069,"text":"在上千人裡面也有陸陸續續也好幾百人都經過了五六年了怎麼又怎麼會沒有辦法公佈那你找一個方法公佈我現在叫希望你是說民眾我們病人帶著錢和希望就是要尋找這一個治療的機會所以治療效果絕對是一個關鍵而公司這麼多生技公司一滴那三勒"},{"start":706.869,"end":708.99,"text":"草案案件事務委員委員會委員會委員會委員會委員會委員會委員會委員會委員會"},{"start":734.183,"end":758.003,"text":"有一個他們訪問的業者他是特管辦法裡面合格的自備廠之一後期也有私下接案他也執行了許多地下化的細胞治療他說他3年內治療3億元但是他的重點我要講他說他的重點目前特管法通過的治療都以具備安全性為前提但是他說這是業者說的"},{"start":760.285,"end":766.207,"text":"竟然是安全性審查為什麼這麼嚴為什麼要限制什麼階段癌症才能治療他認為啦前端應該要放寬但後端要收集數據公布治療效果不要像現在好的生技公司細胞這個跟不好生技公司的細胞這種差別無從判斷所以消費者用用藥人也不知道所以業者的優劣競爭也不會出來"},{"start":789.935,"end":810.835,"text":"他認為要避免地下化層出不窮的一個關鍵就是要公佈治療效果所以不要讓劣幣驅逐良幣良幣要突出讓好的自備場所應該更具有這個被知道的權利因為不論業者或是一般民眾數百萬為家人散盡家財來做的細胞治療"},{"start":811.596,"end":840.011,"text":"大家都想要不論是業者好的業者或者是病患都想要知道一個透明公開的治療效果到底是哪一家嗎那我們在這裡說我們特管法至少還規定治療結果多少案例治療結果不良反應要公開但是你們上一屆送到立法院來的再生醫療法就沒有了"},{"start":840.953,"end":842.319,"text":"醫療法草案案 案 裡面吶!"},{"start":844.755,"end":865.632,"text":"雖然這個要求再生這個機構應該要這個跟中央主管機關報告他接的案例數治療效果不良反應但是沒有規定中央主管機關要每年公開這個醫療機構及細胞自備場所第一項結果的這個統計這個資料"},{"start":873.078,"end":891.648,"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次全體委員會第11次全體委員會第11次全體委員會第11次全"},{"start":898.786,"end":917.171,"text":"你們的版本有沒有送這個條文?我們有這個條文,就是說要公開的這個條文。上一屆是沒有?上一屆是沒有?旁邊這個是我們的師長。上一屆送的時候他是有,但是是得啦。"},{"start":919.672,"end":924.176,"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"},{"start":943.59,"end":959.004,"text":"特管法制裁講說中央主管機關必要使得公開,但是業者要每年都要給中央主管機關報告。沒有,這是特管法。我剛唸的是特管法。"},{"start":963.766,"end":991.86,"text":"好來你們上一屆版本第24條嘛對不對要我念給你聽嗎醫療機構執行第9條再生技術者應於每年度終了後6個月內或中央主管機關通知的期限內提出報告結果前項的報告內容應報告案例數效果不良事件及其他的規定只有要求向中央主管機關提出報告結果沒有談到要公開你們為什麼都在這裡睜眼瞎說呢"},{"start":996.124,"end":1000.289,"text":"這條文就是不足嘛,其實因為時間問題還有要討論的,其實還有但是我跟你講說,我們談這一點不為過吧我們不反對,而且做了6年了,這6年裡面多少案例了"},{"start":1012.722,"end":1014.043,"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":1036.603,"end":1053.555,"text":"我們來處理一下,找出一個適當的公開方法。特別我是更擔心什麼叫有效什麼叫無效,你們真的有判定的依據嗎?林委員我們是不是到主條的時候再深入的討論?好謝謝林淑芬委員接下來請"}]}}}}