{"id":150952,"url":"https://ivod.ly.gov.tw/Play/Clip/1M/150952","video_url":"https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948e7fd7bacdc699860f533009c4a7c43105f8ba9b0039caa7a68b921a11807ddc9c5ea18f28b6918d91.mp4/playlist.m3u8","委員名稱":"陳昭姿","委員發言時間":"09:24:20 - 09:36:33","影片長度":"00:12:13","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":733,"end_time":"2024-04-10T09:36:33+08:00","start_time":"2024-04-10T09:24:20+08:00","features":["ai-transcript","gazette"],"type":"Clip","gazette":{"lineno":112,"blocks":[["陳委員昭姿：（9時24分）謝謝主席。麻煩請薛部長。"],["主席：請薛部長。"],["薛部長瑞元：委員好。"],["陳委員昭姿：部長早。部長，請看這一張海報，您熟悉這張海報嗎？這個說明會的海報的指導單位是衛福部，但是主辦單位是達文西個資暨高科技法律事務所，時間是20天前的3月21號，右邊的對照表寫到「並未代表任何機關之正式意見」。部長，為什麼要讓這麼多人去聽一個事務所的意見呢？這個作法是在測風向、試水溫嗎？"],["薛部長瑞元：沒有，這是我們對外說明時，有一些事務性事務要委託其他機構來辦理。"],["陳委員昭姿：部長，今天是不是要講清楚，學界跟業界看到這種對照表會不會恐慌？是不是今天要講清楚，到底最後要哪個版本？是用院版，還是用事務所版？不要讓各界繼續摸索、無所適從。"],["薛部長瑞元：沒有所謂的事務所版，這一次只是我們原來的版本做了修正……"],["陳委員昭姿：所以由這個機構來主辦部長是知情的。我們都清楚之前最大的爭議在於免除藥品許可證的三個條件，我就談第二個條件：經執行人體試驗結果，證實其安全性及初步療效。部長，什麼叫人體試驗？人體試驗不是寫在上面就叫人體試驗，不是打到人體就叫人體試驗。人體試驗在全世界執行了半世紀以上，有一定的規則、一定的管理方式。什麼叫人體試驗？這是第一個。第二個，什麼叫初步療效？我陳昭姿從事藥學四十年，我不認識什麼叫初步療效。世界上沒有「初步療效」這個字！如果把「人體實驗」、「初步療效」放在一起是貽笑世界、貽笑全球！部長，任何加諸人體的治療，首先要先確認安全性與療效，這兩件事是要科學來佐證的，但現在不僅缺乏二期、三期，搞不好這連第一期都不是！請問這個作法最後誰來負責醫療品質與法律責任呢？這完全違背醫學倫理，罔顧病人權益！難怪外界質疑這是在為廠商跟某些醫療機構開後門！部長，你也知道這條法條是非常寬鬆的，我相信你知道。為什麼？您在2023年4月朝野協商時說了一段話，不管記不記得，我都把它畫線了。部長，您當時解釋，原部版第九條第二、三款範圍過大，太過普遍，有門放得太寬的疑慮。若已經證實安全且有療效，就應該走第八條的路，而非造成各界的疑慮，擔憂未來可能會直接引用第九條，而不按第八條來做，將無法有效把關品質與安全。部長，您當時講得非常好，我想問你，您今天的立場改變了嗎？"],["薛部長瑞元：立場並沒有變。這一次行政院正在審議的版本，已經把這點修正了，有兩個點：第一，原來版本的前提部分、前言部分寫得不好，因為這一條要解決的是，所有再生醫療技術都必須經過人體試驗，才能夠……"],["陳委員昭姿：部長，我剛剛問了什麼叫人體試驗？臨床上對人體試驗分三期，要規範得非常清楚，不是我們自己發明，也不是你寫的。"],["薛部長瑞元：這沒有錯，所以這個……"],["陳委員昭姿：好，我們回到臨床試驗……"],["薛部長瑞元：我先說明一下，因為事關重要。所有都需要先經過人體試驗；人體試驗之後有結果才能申請……"],["陳委員昭姿：有了結果，而且是全球公認的臨床試驗結果，不是臺灣自己發明，也不是衛福部定義的臨床試驗……"],["薛部長瑞元：當然，我再補一句，但是有兩種情形，本來寫的是三種，後來我們檢討結果把第二款那個拿掉了，有兩種情形可以在沒有完成人體試驗就先來使用……"],["陳委員昭姿：就是原來的那兩條嗎？"],["薛部長瑞元：第一個是恩慈，第二個是已經在特管辦法裡開始執行的，這些不必再重複……"],["陳委員昭姿：謝謝部長提到恩慈。沒有經過臨床試驗就不能收費，這是我們要討論的另外一個問題。臨床試驗是不能收費的，而且要保護病人，甚至有很多的法律要保護病人。部長，當醫師或業者鼓吹再生醫療，面對這些研究報告，其實病人家屬根本看不懂，這是相對的資訊弱勢，他就是在資訊不對等的情況下，因為面臨生死關頭，難免會想爭取一線希望，所以可能會做出不理性的決定，然後花了幾百萬元。但事實上，即便背負上沉重的經濟壓力卻沒有任何保障，為什麼？因為沒有科學實證做證明！部長，很多癌症病人確實在等待一線生機，他們也可能願意耗盡家財來挽救自己或家屬，換取短短幾年的壽命。但是部長，你要知道，即便如此，他們還是對這個版本有高度質疑。這些話不是我講的，他們對於初步療效的定義也覺得非常模糊。部長剛剛是不是承諾「初步療效」這一條不見了？"],["薛部長瑞元：是，拿掉了。"],["陳委員昭姿：謝謝部長。我再請教部長，根據再生醫療法規定，醫院施行再生技術卻發生副作用、不良反應時，適用藥害救濟嗎？"],["薛部長瑞元：藥害救濟部分在製劑條例裡面，至於再生醫療法則是來衛福部這邊申請可以執行時，我們要在計畫書裡看到對於發生不良事件時的責任保險……"],["陳委員昭姿：我擔任過藥害救濟董事長，很多規範我非常清楚。很多衛福部官員說另外設責任保險，但是我們來看一下，其實責任保險有兩個關鍵：不但需要證明其傷害與醫院施行再生技術間有因果關係，還必須證明醫院在執行該再生技術的細胞製備及施行施打過程中有過失。請問因果關係跟過失，民眾哪有能力舉證？如果沒有實在證據，他拿什麼比對做舉證呢？這完全沒有保護力，完全是不可能的任務！"],["薛部長瑞元：也不能這樣講，因為這是舉證責任的問題。相反的，如果由醫療機構來舉證這部分的話沒有問題。"],["陳委員昭姿：受害者是病人，病人要舉證啊！"],["薛部長瑞元：沒有，他……"],["陳委員昭姿：舉證的問題在於：你有證據，所以我可以去比對，他做錯什麼了？哪裡沒有做好？"],["薛部長瑞元：所謂舉證責任是病人只要舉證有受損害就好，至於有沒有因果關係……"],["陳委員昭姿：部長，這過程很漫長，我擔任過藥害救濟董事長……"],["薛部長瑞元：那是醫療機構要去舉證……"],["陳委員昭姿：但我們還是要保護病人的權益。"],["薛部長瑞元：對。"],["陳委員昭姿：如果立法太寬鬆，等於是我們幫他背書！假設廠商不需要花錢就可以有收入，那他為什麼要做臨床試驗呢？他沒有動機去做臨床試驗！"],["薛部長瑞元：不是，他就一定要做的！"],["陳委員昭姿：這個臨床試驗要符合國際規範？"],["薛部長瑞元：對，當然是符合國際規範。"],["陳委員昭姿：他就沒有動機再投入更多經費。"],["薛部長瑞元：現在的法就是有，一定要做啊！"],["陳委員昭姿：所以我們還等著看，因為今天沒有看到這東西。還有，如果細胞治療搭配其他治療來用，在這個情況下，如果前面不講清楚所搭配的正規治療的話，那我們會不知道傷害來自何處，也不知道療效來自何處，這些都是很大的問題。部長，根據貴部資料顯示，去年全國有39家醫院提供954人次的細胞治療服務，有超過七成病人花超過100萬到200萬的經費，有9%的病人超過200萬。病人付了這麼多錢，卻只能仰賴有效的，或很薄弱的所謂的初步療效，當然，你說要把這個拿掉，我也很謝謝部長，但這樣合理嗎？花了這麼多錢，如果沒有足夠的科學佐證，然後讓他買那一線希望合理嗎？"],["薛部長瑞元：這當然是……"],["陳委員昭姿：這個理是指……"],["薛部長瑞元：一定要先有人體試驗通過才可以做！"],["陳委員昭姿：有科學道理加醫學倫理，雙理。部長，美國、歐盟和日本針對再生醫療都採用嚴格的品質規範，如CGMP或PIC/S等等，目的就是要有一個優良製造規範的版本，但上屆院版根本都沒有提到執行細胞治療的操作要符合什麼樣的品質規範，甚至連談都沒有談，這樣怎麼保障病人的權益呢？"],["薛部長瑞元：有……"],["陳委員昭姿：這次有嗎？"],["薛部長瑞元：應該是要符合GTP，在醫療機構裡面做的。"],["陳委員昭姿：G……"],["薛部長瑞元：Good Tissue Practice。"],["陳委員昭姿：這個我們等會再來檢查，因為今天完全沒有看到版本，至少品質部分要規範得很清楚，而且是根據哪一個品質規範標準來做。如果不這樣做的話，臺灣的再生醫療以後如何與國際接軌？總不能就在臺灣這樣子做啊？","我還要談一件事，楊志良前署長說公立醫院與財團法人都是非營利機構，不用繳地價稅，不用繳房屋稅，也不用繳營利事業所得稅，且其盈餘要用於提高醫療品質，回饋社會，提高醫療人員待遇。醫療法的精神是這樣，所以連核心的醫療業務都不准外包，請問醫院怎麼可以經營公司呢？部長，上屆院版第十一條提到，醫院案量達到一定程度時，可以成立營利性的再生醫療生技醫藥公司……"],["薛部長瑞元：我們送……"],["陳委員昭姿：這是衝突啊！利益衝突啊！"],["薛部長瑞元：我們現在送行政院審查的版本這一條已經沒有了。"],["陳委員昭姿：拿掉了？好，謝謝部長。我也相信大多數醫師是有良知，但制度如果不完整，少數的人就會去營利，這樣一來就如同陳培哲醫師所講的，把醫師的白袍染成黑袍！有關異種細胞的部分，必須要以更嚴謹的方式來面對，上一版的特管法還比較嚴謹，對於所謂自體適用同源優先的管得還更嚴，你原來的版本對異體異種細胞放得更寬，這一次呢？"],["薛部長瑞元：這個部分我認為是不應該特別去管制，只限於這一個同種的……"],["陳委員昭姿：你現在不限於自體嗎？還有開放異體嗎？"],["薛部長瑞元：對，不限於，因為未來的發展，這是一個重要的……"],["陳委員昭姿：你這一次就要放進去了嗎？"],["薛部長瑞元：本來就有。"],["陳委員昭姿：異體本身細胞的安全性、複雜性，它不是小細胞那麼穩定喔，整個製備的過程非常繁瑣，法制局也說這個風險很高喔，以前的前立委林靜儀還說什麼打messengerRNA疫苗就是屬於異體，messengerRNA跟細胞無關，messengerRNA不是細胞欸，這個是細胞自體跟異體，所以部長，您這一次有把異體的部分放進去嗎？"],["薛部長瑞元：有，這個是未來的趨勢啦。"],["陳委員昭姿：風險很高喔。","最後，因為時間到了，主席已經站起來了，不好意思，主席。部長，當你跟我年老的時候，有一天我們去回想，我們這輩子有沒有做過有愧於心的事情，我希望這個法案不是因為造成這件事情……"],["薛部長瑞元：也有可能……"],["陳委員昭姿：科學實證，我們雖然給病人一個選項……"],["薛部長瑞元：我們年老的時候也許會覺得說還好那個時候有通過這個法案。"],["陳委員昭姿：實證很重要。"],["薛部長瑞元：對，當然就靠科學實證。"],["陳委員昭姿：實證非常重要，讓病人花錢花的值得，謝謝部長。"],["薛部長瑞元：謝謝。"],["陳委員昭姿：這個是影響深遠的事情，我希望部長三思，謝謝部長。"],["主席：謝謝陳昭姿委員發言。","接下來請林月琴委員發言。"]],"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 人擬具「再生醫療製劑管理條例草案」案【一、二案採綜合詢\n答，本日會議僅詢答】","agenda_id":"1132601_00003"}},"transcript":{"id":"150952","pyannote":{"name":"ronny","tool":"pyannote","data":{"url":"https://ivod.ly.gov.tw/Play/Clip/1M/150952","tool":"pyannote","id":"150952-pyannote"},"job_id":"GOqSL5aL37DTRE5W","queued_at":"2024-06-01 12:57:54","status":"done","log":[{"time":"2024-06-01 12:59:12","msg":"downloading https://ivod.ly.gov.tw/Play/Clip/1M/150952"},{"time":"2024-06-01 12:59:13","msg":"downloading https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948e7fd7bacdc699860f533009c4a7c431059cf12f16b805e0f45298a28bd9a4829e5ea18f28b6918d91.mp4/playlist.m3u8"},{"time":"2024-06-01 12:59:35","msg":"converting mp4 to wav"},{"time":"2024-06-01 12:59:36","msg":"running pyannote"},{"time":"2024-06-01 12:59:48","msg":"status: 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0.894}, {\"word\": \"案\", \"start\": 709.195, \"end\": 710.456, \"score\": 0.949}, {\"word\": \"不\", \"start\": 710.456, \"end\": 710.596, \"score\": 0.987}, {\"word\": \"是\", \"start\": 710.596, \"end\": 710.696, \"score\": 0.999}, {\"word\": \"因\", \"start\": 710.696, \"end\": 711.016, \"score\": 0.937}, {\"word\": \"為\"}, {\"word\": \"造\", \"start\": 711.016, \"end\": 711.196, \"score\": 0.99}, {\"word\": \"成\", \"start\": 711.196, \"end\": 711.376, \"score\": 0.918}, {\"word\": \"這\"}, {\"word\": \"件\", \"start\": 711.376, \"end\": 711.796, \"score\": 0.875}, {\"word\": \"事\", \"start\": 711.796, \"end\": 711.956, \"score\": 0.993}, {\"word\": \"情\", \"start\": 711.956, \"end\": 712.837, \"score\": 0.925}, {\"word\": \"科\", \"start\": 712.837, \"end\": 713.377, \"score\": 0.904}, {\"word\": \"學\", \"start\": 713.377, \"end\": 713.637, \"score\": 0.899}, {\"word\": \"實\"}, {\"word\": \"證\"}, {\"word\": \"我\", \"start\": 713.637, \"end\": 713.937, \"score\": 0.867}, {\"word\": \"們\"}, {\"word\": \"雖\"}, {\"word\": \"然\", \"start\": 713.937, \"end\": 714.177, \"score\": 0.834}, {\"word\": \"給\"}, {\"word\": \"病\", \"start\": 714.177, \"end\": 714.297, \"score\": 0.837}, {\"word\": \"人\", \"start\": 714.297, \"end\": 714.457, \"score\": 0.986}, {\"word\": \"有\", \"start\": 714.457, \"end\": 714.918, \"score\": 0.91}, {\"word\": \"一\", \"start\": 714.918, \"end\": 714.938, \"score\": 0.98}, {\"word\": \"個\"}, {\"word\": \"選\"}, {\"word\": \"項\"}, {\"word\": \"邱\", \"start\": 716.058, \"end\": 716.198, \"score\": 0.745}, {\"word\": \"議\"}, {\"word\": \"瑩\"}, {\"word\": \"等\", \"start\": 716.198, \"end\": 716.419, \"score\": 0.903}, {\"word\": \"2\"}, {\"word\": \"1\"}, {\"word\": \"人\", \"start\": 716.419, \"end\": 716.599, \"score\": 0.873}, {\"word\": \"擬\"}, {\"word\": \"具\", \"start\": 716.599, \"end\": 716.879, \"score\": 0.916}, {\"word\": \":\"}, {\"word\": \"「\"}, {\"word\": \"再\", \"start\": 716.879, \"end\": 717.039, \"score\": 0.828}, {\"word\": \"生\", \"start\": 717.039, \"end\": 717.059, \"score\": 0.0}, {\"word\": \"醫\"}, {\"word\": \"療\"}, {\"word\": \"發\"}, {\"word\": \"展\", \"start\": 717.059, \"end\": 717.159, \"score\": 0.8}, {\"word\": \"法\", \"start\": 717.159, \"end\": 717.22, \"score\": 0.657}, {\"word\": \"草\", \"start\": 717.22, \"end\": 717.4, \"score\": 0.886}, {\"word\": \"案\", \"start\": 717.4, \"end\": 717.7, \"score\": 0.93}, {\"word\": \"案\", \"start\": 717.7, \"end\": 717.84, \"score\": 0.843}, {\"word\": \"案\", \"start\": 717.84, \"end\": 718.001, \"score\": 0.873}, {\"word\": \"件\", \"start\": 718.001, \"end\": 718.401, \"score\": 0.943}, {\"word\": \"事\", \"start\": 718.401, \"end\": 718.601, \"score\": 0.89}, {\"word\": \"件\", \"start\": 718.601, \"end\": 718.802, \"score\": 0.899}, {\"word\": \"事\", \"start\": 718.802, \"end\": 718.922, \"score\": 0.833}, {\"word\": \"件\", \"start\": 718.922, \"end\": 719.062, \"score\": 0.853}, {\"word\": \"事\", \"start\": 719.062, \"end\": 719.242, \"score\": 0.887}, {\"word\": \"件\", \"start\": 719.242, \"end\": 719.563, \"score\": 0.894}, {\"word\": \"事\", \"start\": 719.563, \"end\": 719.583, \"score\": 0.0}, {\"word\": \"件\", \"start\": 719.583, \"end\": 719.883, \"score\": 0.912}, {\"word\": \"事\", \"start\": 719.883, \"end\": 720.123, \"score\": 0.903}, {\"word\": \"件\", \"start\": 720.123, \"end\": 720.143, \"score\": 0.0}], \"language\": \"zh\"}","srt":"1\n00:00:00,009 --> 00:00:09,030\n福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n\n2\n00:00:15,215 --> 00:00:26,383\n邱議瑩等21人擬具:「再生醫療法草案案案件事務所﹑立法院第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛\n\n3\n00:00:44,195 --> 00:01:02,761\n這是我們都在說明的時候有一些事務性的事務要委託其他機構來辦理那今天是不是說要講清楚學界跟業界到底看到這種對照表會恐慌是不是今天要講清楚到底最後要用哪個版本是用院版還是用事務所版那這是不要讓各界繼續摸索無所適從\n\n4\n00:01:09,623 --> 00:01:21,391\n這個沒有所謂的事務所版啦。這個只是說在做一個我們這一次在原來的版本做了一個修正。我們都清楚上一次之前我們最大的爭議就是在這個所謂的免除這個藥品這個許可證的三個條件。我就談第二個條件。經執行人體試驗,證實其安全性是初步療效。\n\n5\n00:01:37,222 --> 00:02:06,273\n部長什麼叫人體試驗人體試驗不是你寫在上面叫人體試驗不是打到人體就叫人體試驗人體試驗在全世界執行了半個世紀以上他有一定的規則一定的管理方式什麼叫人體試驗這是第一個第二個什麼叫初步療效我陳昭之從事藥學40年我不認識什麼叫初步療效世界上沒有初步療效這個字如果你把人體試驗初步療效放在一起這是移校全世界移校全球\n\n6\n00:02:07,455 --> 00:02:31,386\n部長任何加諸人體的治療首先就要確認安全性跟療效這兩件事需要科學來佐證的你缺乏二期三期這搞不好連第一期都不是請問這個做法最後誰來負責醫療品質跟這個法律責任呢這個完全是違背醫學倫理罔顧病人權益難怪外界會質疑這個是為為廠商跟某些醫療機構開後門\n\n7\n00:02:33,942 --> 00:02:55,362\n部長您也知道這個法條是非常寬鬆的我相信你知道為什麼呢您在2023年4月朝野協商說了一段話如果您不管記不記得我把它underline畫線部長您當時解釋在原部版的第9條第23款範圍過大太過普遍有門放得太寬的疑慮\n\n8\n00:02:56,463 --> 00:03:05,953\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\n9\n00:03:19,726 --> 00:03:40,031\n這個立場並沒有變。那這一次我們現在正在行政審議的版本我們把這一個已經修正了。那有兩個點。第一個點,它的意思原來的這一個版本的這個前提的部分的話、前言的這個部分的話寫得不好。因為這一條要解決的是\n\n10\n00:03:44,214 --> 00:04:04,431\n所有的再生醫療的技術都必須要經過人體試驗才能夠不是我剛剛你知道什麼叫人體試驗人體試驗理想有分三期要規範的非常清楚不是我們自己發表也不是你寫的這個沒有錯所以我們這個人體試驗好我們回到臨床試驗不過我先說明一下因為這個事關重要\n\n11\n00:04:05,131 --> 00:04:09,057\n那所有的都需要先經過人體試驗,人體試驗之後的話有了這一個結果才能夠申請查驗登記。有了這個結果,全球公認的臨床試驗的結果不是台灣自己發明,也不是衛福部定義的臨床試驗。\n\n12\n00:04:21,915 --> 00:04:39,973\n我再補一句但是有兩種情形本來這邊寫的是三種後來我們檢討的結果就把第二款那個拿掉了就只有兩種情形可以沒有完成人體試驗的時候就可以進來使用就是原來的那兩條嗎第一個就是恩恥\n\n13\n00:04:40,894 --> 00:04:56,322\n第二、已經在特管辦法裏面開始執行的這些不必再重複做得明白沒有經過臨床試驗就不能收費這是另外一個問題我們要討論臨床試驗是不能收費而且甚至要保護病人有很多的法律要保護病人\n\n14\n00:04:57,082 --> 00:05:22,380\n部長當醫師或業者鼓吹再生醫療面對的研究報告其實病人這樣子都看不懂啦這相對是這個資訊弱勢嘛他就在資訊不對等情況下因為面臨生死關頭他難免會這個因為想要爭取一線希望所以他可能會做出不理性的決定花了幾百萬元但是事實上背負著沉重的這個經濟壓力但是沒有任何保障為什麼因為你沒有科學實證來做證明嘛\n\n15\n00:05:25,562 --> 00:05:38,268\n其實很多癌症病人他確實是在等待這一線生機啦那他們也可能願意耗盡家財來挽救自己或家屬可能換取短短幾年的壽命但是你要知道部長即便如此他們還是對這個版本有高度質疑這句話不是我講的他們對於這個初步療效的定義也是覺得非常模糊那部長你剛剛是不是承諾初步療效這一條是不見的這拿掉了好謝謝部長\n\n16\n00:05:54,275 --> 00:06:00,348\n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1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第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1會期社\n\n17\n00:06:05,305 --> 00:06:28,117\n藥害救濟的部分的話是在治劑條例裡面那再生醫療法是當你要來衛福部這邊申請他來可以執行的時候我們就要在他的計畫書裡面看到他對於這一個發生不良事件的時候有這個責任保險很多規範我非常清楚因為很多衛福部官員都說那我們另外來設一個責任保險但是我們來看一下這個責任保險裡面有兩個關鍵\n\n18\n00:06:32,719 --> 00:06:43,130\n草案：立法院第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會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生�\n\n19\n00:06:55,223 --> 00:07:22,825\n這個完全就是沒有保護力,這完全就是不可能的任務啊。因為我不能這樣講啦,因為這一個部分的話是舉證責任的問題。如果是相反的是要由醫療機構來舉證說他這一個部分沒有問題。受害者是病人啊,病人要舉證啊。沒有沒有,他...你這舉證的問題是你有證據,所以我可以去比對,他做錯什麼哪裡都做好。這個所謂舉證責任導致是病人只要舉證說他有受有損害就好。\n\n20\n00:07:23,442 --> 00:07:26,728\n那有沒有因果關係跟這個社會的護理過程?那個是醫療機構要去討論的。就是說我們還在保護病人的前提嘛。\n\n21\n00:07:33,919 --> 00:07:34,399\n邱議瑩等21人擬具\n\n22\n00:07:56,175 --> 00:08:17,641\n還有就是說如果細胞治療他會搭配他會搭配其他的治療來用那這個請問如果說我們這個前面不清楚你搭配的正規治療我們都不知道傷害來自何處我們也不知道療效來自何處所以這個是都是很大的問題部長那個根據衛部的資料去年全國有39家醫院提供954人次的細胞治療服務\n\n23\n00:08:18,081 --> 00:08:23,522\n超過7成的病人經費發過100萬到200萬之間有9%的病人超過200萬病人付了這麼多錢那只能仰賴在有效的或是說很薄弱的一個所謂的初步有療效當然你說要把這個字拿掉我也很謝謝部長這樣合理嗎?花了這麼多錢如果你沒有足夠的科學佐證讓他買那一線希望這樣合理嗎?\n\n24\n00:08:43,223 --> 00:08:49,805\n科學道理加醫學倫理。雙理。美國、歐盟在日本針對這個再生醫療他們都用嚴格的這個品質的規範譬如說他們採用這邊有些名詞沒有關係CGMP、PIXA等等但是他目的他就是造一個這個優良製造規範這個版本但是上一版的時候\n\n25\n00:09:07,492 --> 00:09:19,946\n根本都沒有想執行細胞治療的操作要符合什麼樣的品質規範連談都沒有談這樣怎麼保障病人的權益呢?這次有嗎?應該是要符合GDP啦在醫療機構裡面做的\n\n26\n00:09:22,432 --> 00:09:28,555\n藥品實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實�\n\n27\n00:09:50,908 --> 00:10:02,234\n醫療法草案（事由．立法院第11會期社會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\n\n28\n00:10:17,942 --> 00:10:31,296\n醫療公司,這是衝突啊,利益衝突啊。我們現在送行政院審查版本這一條已經沒有了。拿掉了,好,謝謝部長。我也相信大多數醫師是有良知的,但是你不能反映制度如果不完整會少數人會去做營利,但這樣就是陳培哲醫師講的啊,把醫師的白袍染成黑袍嗎?\n\n29\n00:10:36,161 --> 00:10:40,344\n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次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n\n30\n00:10:53,300 --> 00:10:54,141\n邱議瑩等21人擬具\n\n31\n00:11:09,286 --> 00:11:30,646\n疫體本身細胞的安全性、複雜性,它不是小細胞那麼穩定喔,整個支配過程非常繁瑣。法治局也說這個風險很高喔。以前前前立委林靜雲還說這個就是什麼打messageRNA疫苗就是所謂疫體。messageRNA跟細胞無關欸,messageRNA不是細胞欸。這個是細胞自體跟疫體,所以部長您這次有把疫體的部分放進去嗎?\n\n32\n00:11:30,646 --> 00:11:30,666\n有。\n\n33\n00:11:32,367 --> 00:11:54,938\n有,這個是未來一個趨勢啊。你風險很高喔。部長我在講說我最後因為時間夠了主席已經站起來了不好意思部長當你跟我年老的時候有一天我們就回想我們這輩子有沒有做過這個有愧疑心的事情我希望這個法案不是因為造成這件事情科學實證我們雖然給病人有一個選項\n\n34\n00:11:56,058 --> 00:12:00,143\n邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件\n\n","tsv":"start\tend\ttext\n9\t9030\t福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n15215\t26383\t邱議瑩等21人擬具:「再生醫療法草案案案件事務所﹑立法院第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛\n44195\t62761\t這是我們都在說明的時候有一些事務性的事務要委託其他機構來辦理那今天是不是說要講清楚學界跟業界到底看到這種對照表會恐慌是不是今天要講清楚到底最後要用哪個版本是用院版還是用事務所版那這是不要讓各界繼續摸索無所適從\n69623\t81391\t這個沒有所謂的事務所版啦。這個只是說在做一個我們這一次在原來的版本做了一個修正。我們都清楚上一次之前我們最大的爭議就是在這個所謂的免除這個藥品這個許可證的三個條件。我就談第二個條件。經執行人體試驗,證實其安全性是初步療效。\n97222\t126273\t部長什麼叫人體試驗人體試驗不是你寫在上面叫人體試驗不是打到人體就叫人體試驗人體試驗在全世界執行了半個世紀以上他有一定的規則一定的管理方式什麼叫人體試驗這是第一個第二個什麼叫初步療效我陳昭之從事藥學40年我不認識什麼叫初步療效世界上沒有初步療效這個字如果你把人體試驗初步療效放在一起這是移校全世界移校全球\n127455\t151386\t部長任何加諸人體的治療首先就要確認安全性跟療效這兩件事需要科學來佐證的你缺乏二期三期這搞不好連第一期都不是請問這個做法最後誰來負責醫療品質跟這個法律責任呢這個完全是違背醫學倫理罔顧病人權益難怪外界會質疑這個是為為廠商跟某些醫療機構開後門\n153942\t175362\t部長您也知道這個法條是非常寬鬆的我相信你知道為什麼呢您在2023年4月朝野協商說了一段話如果您不管記不記得我把它underline畫線部長您當時解釋在原部版的第9條第23款範圍過大太過普遍有門放得太寬的疑慮\n176463\t185953\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\n199726\t220031\t這個立場並沒有變。那這一次我們現在正在行政審議的版本我們把這一個已經修正了。那有兩個點。第一個點,它的意思原來的這一個版本的這個前提的部分的話、前言的這個部分的話寫得不好。因為這一條要解決的是\n224214\t244431\t所有的再生醫療的技術都必須要經過人體試驗才能夠不是我剛剛你知道什麼叫人體試驗人體試驗理想有分三期要規範的非常清楚不是我們自己發表也不是你寫的這個沒有錯所以我們這個人體試驗好我們回到臨床試驗不過我先說明一下因為這個事關重要\n245131\t249057\t那所有的都需要先經過人體試驗,人體試驗之後的話有了這一個結果才能夠申請查驗登記。有了這個結果,全球公認的臨床試驗的結果不是台灣自己發明,也不是衛福部定義的臨床試驗。\n261915\t279973\t我再補一句但是有兩種情形本來這邊寫的是三種後來我們檢討的結果就把第二款那個拿掉了就只有兩種情形可以沒有完成人體試驗的時候就可以進來使用就是原來的那兩條嗎第一個就是恩恥\n280894\t296322\t第二、已經在特管辦法裏面開始執行的這些不必再重複做得明白沒有經過臨床試驗就不能收費這是另外一個問題我們要討論臨床試驗是不能收費而且甚至要保護病人有很多的法律要保護病人\n297082\t322380\t部長當醫師或業者鼓吹再生醫療面對的研究報告其實病人這樣子都看不懂啦這相對是這個資訊弱勢嘛他就在資訊不對等情況下因為面臨生死關頭他難免會這個因為想要爭取一線希望所以他可能會做出不理性的決定花了幾百萬元但是事實上背負著沉重的這個經濟壓力但是沒有任何保障為什麼因為你沒有科學實證來做證明嘛\n325562\t338268\t其實很多癌症病人他確實是在等待這一線生機啦那他們也可能願意耗盡家財來挽救自己或家屬可能換取短短幾年的壽命但是你要知道部長即便如此他們還是對這個版本有高度質疑這句話不是我講的他們對於這個初步療效的定義也是覺得非常模糊那部長你剛剛是不是承諾初步療效這一條是不見的這拿掉了好謝謝部長\n354275\t360348\t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1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第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1會期社\n365305\t388117\t藥害救濟的部分的話是在治劑條例裡面那再生醫療法是當你要來衛福部這邊申請他來可以執行的時候我們就要在他的計畫書裡面看到他對於這一個發生不良事件的時候有這個責任保險很多規範我非常清楚因為很多衛福部官員都說那我們另外來設一個責任保險但是我們來看一下這個責任保險裡面有兩個關鍵\n392719\t403130\t草案：立法院第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會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生�\n415223\t442825\t這個完全就是沒有保護力,這完全就是不可能的任務啊。因為我不能這樣講啦,因為這一個部分的話是舉證責任的問題。如果是相反的是要由醫療機構來舉證說他這一個部分沒有問題。受害者是病人啊,病人要舉證啊。沒有沒有,他...你這舉證的問題是你有證據,所以我可以去比對,他做錯什麼哪裡都做好。這個所謂舉證責任導致是病人只要舉證說他有受有損害就好。\n443442\t446728\t那有沒有因果關係跟這個社會的護理過程?那個是醫療機構要去討論的。就是說我們還在保護病人的前提嘛。\n453919\t454399\t邱議瑩等21人擬具\n476175\t497641\t還有就是說如果細胞治療他會搭配他會搭配其他的治療來用那這個請問如果說我們這個前面不清楚你搭配的正規治療我們都不知道傷害來自何處我們也不知道療效來自何處所以這個是都是很大的問題部長那個根據衛部的資料去年全國有39家醫院提供954人次的細胞治療服務\n498081\t503522\t超過7成的病人經費發過100萬到200萬之間有9%的病人超過200萬病人付了這麼多錢那只能仰賴在有效的或是說很薄弱的一個所謂的初步有療效當然你說要把這個字拿掉我也很謝謝部長這樣合理嗎?花了這麼多錢如果你沒有足夠的科學佐證讓他買那一線希望這樣合理嗎?\n523223\t529805\t科學道理加醫學倫理。雙理。美國、歐盟在日本針對這個再生醫療他們都用嚴格的這個品質的規範譬如說他們採用這邊有些名詞沒有關係CGMP、PIXA等等但是他目的他就是造一個這個優良製造規範這個版本但是上一版的時候\n547492\t559946\t根本都沒有想執行細胞治療的操作要符合什麼樣的品質規範連談都沒有談這樣怎麼保障病人的權益呢?這次有嗎?應該是要符合GDP啦在醫療機構裡面做的\n562432\t568555\t藥品實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實�\n590908\t602234\t醫療法草案（事由．立法院第11會期社會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\n617942\t631296\t醫療公司,這是衝突啊,利益衝突啊。我們現在送行政院審查版本這一條已經沒有了。拿掉了,好,謝謝部長。我也相信大多數醫師是有良知的,但是你不能反映制度如果不完整會少數人會去做營利,但這樣就是陳培哲醫師講的啊,把醫師的白袍染成黑袍嗎?\n636161\t640344\t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次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n653300\t654141\t邱議瑩等21人擬具\n669286\t690646\t疫體本身細胞的安全性、複雜性,它不是小細胞那麼穩定喔,整個支配過程非常繁瑣。法治局也說這個風險很高喔。以前前前立委林靜雲還說這個就是什麼打message RNA疫苗就是所謂疫體。messageRNA跟細胞無關欸,messageRNA不是細胞欸。這個是細胞自體跟疫體,所以部長您這次有把疫體的部分放進去嗎?\n690646\t690666\t有。\n692367\t714938\t有,這個是未來一個趨勢啊。你風險很高喔。部長我在講說我最後因為時間夠了主席已經站起來了不好意思部長當你跟我年老的時候有一天我們就回想我們這輩子有沒有做過這個有愧疑心的事情我希望這個法案不是因為造成這件事情科學實證我們雖然給病人有一個選項\n716058\t720143\t邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件\n","txt":"福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n邱議瑩等21人擬具:「再生醫療法草案案案件事務所﹑立法院第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛\n這是我們都在說明的時候有一些事務性的事務要委託其他機構來辦理那今天是不是說要講清楚學界跟業界到底看到這種對照表會恐慌是不是今天要講清楚到底最後要用哪個版本是用院版還是用事務所版那這是不要讓各界繼續摸索無所適從\n這個沒有所謂的事務所版啦。這個只是說在做一個我們這一次在原來的版本做了一個修正。我們都清楚上一次之前我們最大的爭議就是在這個所謂的免除這個藥品這個許可證的三個條件。我就談第二個條件。經執行人體試驗,證實其安全性是初步療效。\n部長什麼叫人體試驗人體試驗不是你寫在上面叫人體試驗不是打到人體就叫人體試驗人體試驗在全世界執行了半個世紀以上他有一定的規則一定的管理方式什麼叫人體試驗這是第一個第二個什麼叫初步療效我陳昭之從事藥學40年我不認識什麼叫初步療效世界上沒有初步療效這個字如果你把人體試驗初步療效放在一起這是移校全世界移校全球\n部長任何加諸人體的治療首先就要確認安全性跟療效這兩件事需要科學來佐證的你缺乏二期三期這搞不好連第一期都不是請問這個做法最後誰來負責醫療品質跟這個法律責任呢這個完全是違背醫學倫理罔顧病人權益難怪外界會質疑這個是為為廠商跟某些醫療機構開後門\n部長您也知道這個法條是非常寬鬆的我相信你知道為什麼呢您在2023年4月朝野協商說了一段話如果您不管記不記得我把它underline畫線部長您當時解釋在原部版的第9條第23款範圍過大太過普遍有門放得太寬的疑慮\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這個立場並沒有變。那這一次我們現在正在行政審議的版本我們把這一個已經修正了。那有兩個點。第一個點,它的意思原來的這一個版本的這個前提的部分的話、前言的這個部分的話寫得不好。因為這一條要解決的是\n所有的再生醫療的技術都必須要經過人體試驗才能夠不是我剛剛你知道什麼叫人體試驗人體試驗理想有分三期要規範的非常清楚不是我們自己發表也不是你寫的這個沒有錯所以我們這個人體試驗好我們回到臨床試驗不過我先說明一下因為這個事關重要\n那所有的都需要先經過人體試驗,人體試驗之後的話有了這一個結果才能夠申請查驗登記。有了這個結果,全球公認的臨床試驗的結果不是台灣自己發明,也不是衛福部定義的臨床試驗。\n我再補一句但是有兩種情形本來這邊寫的是三種後來我們檢討的結果就把第二款那個拿掉了就只有兩種情形可以沒有完成人體試驗的時候就可以進來使用就是原來的那兩條嗎第一個就是恩恥\n第二、已經在特管辦法裏面開始執行的這些不必再重複做得明白沒有經過臨床試驗就不能收費這是另外一個問題我們要討論臨床試驗是不能收費而且甚至要保護病人有很多的法律要保護病人\n部長當醫師或業者鼓吹再生醫療面對的研究報告其實病人這樣子都看不懂啦這相對是這個資訊弱勢嘛他就在資訊不對等情況下因為面臨生死關頭他難免會這個因為想要爭取一線希望所以他可能會做出不理性的決定花了幾百萬元但是事實上背負著沉重的這個經濟壓力但是沒有任何保障為什麼因為你沒有科學實證來做證明嘛\n其實很多癌症病人他確實是在等待這一線生機啦那他們也可能願意耗盡家財來挽救自己或家屬可能換取短短幾年的壽命但是你要知道部長即便如此他們還是對這個版本有高度質疑這句話不是我講的他們對於這個初步療效的定義也是覺得非常模糊那部長你剛剛是不是承諾初步療效這一條是不見的這拿掉了好謝謝部長\n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1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第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1會期社\n藥害救濟的部分的話是在治劑條例裡面那再生醫療法是當你要來衛福部這邊申請他來可以執行的時候我們就要在他的計畫書裡面看到他對於這一個發生不良事件的時候有這個責任保險很多規範我非常清楚因為很多衛福部官員都說那我們另外來設一個責任保險但是我們來看一下這個責任保險裡面有兩個關鍵\n草案：立法院第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會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生�\n這個完全就是沒有保護力,這完全就是不可能的任務啊。因為我不能這樣講啦,因為這一個部分的話是舉證責任的問題。如果是相反的是要由醫療機構來舉證說他這一個部分沒有問題。受害者是病人啊,病人要舉證啊。沒有沒有,他...你這舉證的問題是你有證據,所以我可以去比對,他做錯什麼哪裡都做好。這個所謂舉證責任導致是病人只要舉證說他有受有損害就好。\n那有沒有因果關係跟這個社會的護理過程?那個是醫療機構要去討論的。就是說我們還在保護病人的前提嘛。\n邱議瑩等21人擬具\n還有就是說如果細胞治療他會搭配他會搭配其他的治療來用那這個請問如果說我們這個前面不清楚你搭配的正規治療我們都不知道傷害來自何處我們也不知道療效來自何處所以這個是都是很大的問題部長那個根據衛部的資料去年全國有39家醫院提供954人次的細胞治療服務\n超過7成的病人經費發過100萬到200萬之間有9%的病人超過200萬病人付了這麼多錢那只能仰賴在有效的或是說很薄弱的一個所謂的初步有療效當然你說要把這個字拿掉我也很謝謝部長這樣合理嗎?花了這麼多錢如果你沒有足夠的科學佐證讓他買那一線希望這樣合理嗎?\n科學道理加醫學倫理。雙理。美國、歐盟在日本針對這個再生醫療他們都用嚴格的這個品質的規範譬如說他們採用這邊有些名詞沒有關係CGMP、PIXA等等但是他目的他就是造一個這個優良製造規範這個版本但是上一版的時候\n根本都沒有想執行細胞治療的操作要符合什麼樣的品質規範連談都沒有談這樣怎麼保障病人的權益呢?這次有嗎?應該是要符合GDP啦在醫療機構裡面做的\n藥品實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實�\n醫療法草案（事由．立法院第11會期社會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\n醫療公司,這是衝突啊,利益衝突啊。我們現在送行政院審查版本這一條已經沒有了。拿掉了,好,謝謝部長。我也相信大多數醫師是有良知的,但是你不能反映制度如果不完整會少數人會去做營利,但這樣就是陳培哲醫師講的啊,把醫師的白袍染成黑袍嗎?\n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次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n邱議瑩等21人擬具\n疫體本身細胞的安全性、複雜性,它不是小細胞那麼穩定喔,整個支配過程非常繁瑣。法治局也說這個風險很高喔。以前前前立委林靜雲還說這個就是什麼打message RNA疫苗就是所謂疫體。messageRNA跟細胞無關欸,messageRNA不是細胞欸。這個是細胞自體跟疫體,所以部長您這次有把疫體的部分放進去嗎?\n有。\n有,這個是未來一個趨勢啊。你風險很高喔。部長我在講說我最後因為時間夠了主席已經站起來了不好意思部長當你跟我年老的時候有一天我們就回想我們這輩子有沒有做過這個有愧疑心的事情我希望這個法案不是因為造成這件事情科學實證我們雖然給病人有一個選項\n邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件\n","vtt":"WEBVTT\n\n00:00.009 --> 00:09.030\n福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n\n00:15.215 --> 00:26.383\n邱議瑩等21人擬具:「再生醫療法草案案案件事務所﹑立法院第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛\n\n00:44.195 --> 01:02.761\n這是我們都在說明的時候有一些事務性的事務要委託其他機構來辦理那今天是不是說要講清楚學界跟業界到底看到這種對照表會恐慌是不是今天要講清楚到底最後要用哪個版本是用院版還是用事務所版那這是不要讓各界繼續摸索無所適從\n\n01:09.623 --> 01:21.391\n這個沒有所謂的事務所版啦。這個只是說在做一個我們這一次在原來的版本做了一個修正。我們都清楚上一次之前我們最大的爭議就是在這個所謂的免除這個藥品這個許可證的三個條件。我就談第二個條件。經執行人體試驗,證實其安全性是初步療效。\n\n01:37.222 --> 02:06.273\n部長什麼叫人體試驗人體試驗不是你寫在上面叫人體試驗不是打到人體就叫人體試驗人體試驗在全世界執行了半個世紀以上他有一定的規則一定的管理方式什麼叫人體試驗這是第一個第二個什麼叫初步療效我陳昭之從事藥學40年我不認識什麼叫初步療效世界上沒有初步療效這個字如果你把人體試驗初步療效放在一起這是移校全世界移校全球\n\n02:07.455 --> 02:31.386\n部長任何加諸人體的治療首先就要確認安全性跟療效這兩件事需要科學來佐證的你缺乏二期三期這搞不好連第一期都不是請問這個做法最後誰來負責醫療品質跟這個法律責任呢這個完全是違背醫學倫理罔顧病人權益難怪外界會質疑這個是為為廠商跟某些醫療機構開後門\n\n02:33.942 --> 02:55.362\n部長您也知道這個法條是非常寬鬆的我相信你知道為什麼呢您在2023年4月朝野協商說了一段話如果您不管記不記得我把它underline畫線部長您當時解釋在原部版的第9條第23款範圍過大太過普遍有門放得太寬的疑慮\n\n02:56.463 --> 03:05.953\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\n03:19.726 --> 03:40.031\n這個立場並沒有變。那這一次我們現在正在行政審議的版本我們把這一個已經修正了。那有兩個點。第一個點,它的意思原來的這一個版本的這個前提的部分的話、前言的這個部分的話寫得不好。因為這一條要解決的是\n\n03:44.214 --> 04:04.431\n所有的再生醫療的技術都必須要經過人體試驗才能夠不是我剛剛你知道什麼叫人體試驗人體試驗理想有分三期要規範的非常清楚不是我們自己發表也不是你寫的這個沒有錯所以我們這個人體試驗好我們回到臨床試驗不過我先說明一下因為這個事關重要\n\n04:05.131 --> 04:09.057\n那所有的都需要先經過人體試驗,人體試驗之後的話有了這一個結果才能夠申請查驗登記。有了這個結果,全球公認的臨床試驗的結果不是台灣自己發明,也不是衛福部定義的臨床試驗。\n\n04:21.915 --> 04:39.973\n我再補一句但是有兩種情形本來這邊寫的是三種後來我們檢討的結果就把第二款那個拿掉了就只有兩種情形可以沒有完成人體試驗的時候就可以進來使用就是原來的那兩條嗎第一個就是恩恥\n\n04:40.894 --> 04:56.322\n第二、已經在特管辦法裏面開始執行的這些不必再重複做得明白沒有經過臨床試驗就不能收費這是另外一個問題我們要討論臨床試驗是不能收費而且甚至要保護病人有很多的法律要保護病人\n\n04:57.082 --> 05:22.380\n部長當醫師或業者鼓吹再生醫療面對的研究報告其實病人這樣子都看不懂啦這相對是這個資訊弱勢嘛他就在資訊不對等情況下因為面臨生死關頭他難免會這個因為想要爭取一線希望所以他可能會做出不理性的決定花了幾百萬元但是事實上背負著沉重的這個經濟壓力但是沒有任何保障為什麼因為你沒有科學實證來做證明嘛\n\n05:25.562 --> 05:38.268\n其實很多癌症病人他確實是在等待這一線生機啦那他們也可能願意耗盡家財來挽救自己或家屬可能換取短短幾年的壽命但是你要知道部長即便如此他們還是對這個版本有高度質疑這句話不是我講的他們對於這個初步療效的定義也是覺得非常模糊那部長你剛剛是不是承諾初步療效這一條是不見的這拿掉了好謝謝部長\n\n05:54.275 --> 06:00.348\n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1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第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1會期社\n\n06:05.305 --> 06:28.117\n藥害救濟的部分的話是在治劑條例裡面那再生醫療法是當你要來衛福部這邊申請他來可以執行的時候我們就要在他的計畫書裡面看到他對於這一個發生不良事件的時候有這個責任保險很多規範我非常清楚因為很多衛福部官員都說那我們另外來設一個責任保險但是我們來看一下這個責任保險裡面有兩個關鍵\n\n06:32.719 --> 06:43.130\n草案：立法院第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會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生�\n\n06:55.223 --> 07:22.825\n這個完全就是沒有保護力,這完全就是不可能的任務啊。因為我不能這樣講啦,因為這一個部分的話是舉證責任的問題。如果是相反的是要由醫療機構來舉證說他這一個部分沒有問題。受害者是病人啊,病人要舉證啊。沒有沒有,他...你這舉證的問題是你有證據,所以我可以去比對,他做錯什麼哪裡都做好。這個所謂舉證責任導致是病人只要舉證說他有受有損害就好。\n\n07:23.442 --> 07:26.728\n那有沒有因果關係跟這個社會的護理過程?那個是醫療機構要去討論的。就是說我們還在保護病人的前提嘛。\n\n07:33.919 --> 07:34.399\n邱議瑩等21人擬具\n\n07:56.175 --> 08:17.641\n還有就是說如果細胞治療他會搭配他會搭配其他的治療來用那這個請問如果說我們這個前面不清楚你搭配的正規治療我們都不知道傷害來自何處我們也不知道療效來自何處所以這個是都是很大的問題部長那個根據衛部的資料去年全國有39家醫院提供954人次的細胞治療服務\n\n08:18.081 --> 08:23.522\n超過7成的病人經費發過100萬到200萬之間有9%的病人超過200萬病人付了這麼多錢那只能仰賴在有效的或是說很薄弱的一個所謂的初步有療效當然你說要把這個字拿掉我也很謝謝部長這樣合理嗎?花了這麼多錢如果你沒有足夠的科學佐證讓他買那一線希望這樣合理嗎?\n\n08:43.223 --> 08:49.805\n科學道理加醫學倫理。雙理。美國、歐盟在日本針對這個再生醫療他們都用嚴格的這個品質的規範譬如說他們採用這邊有些名詞沒有關係CGMP、PIXA等等但是他目的他就是造一個這個優良製造規範這個版本但是上一版的時候\n\n09:07.492 --> 09:19.946\n根本都沒有想執行細胞治療的操作要符合什麼樣的品質規範連談都沒有談這樣怎麼保障病人的權益呢?這次有嗎?應該是要符合GDP啦在醫療機構裡面做的\n\n09:22.432 --> 09:28.555\n藥品實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實�\n\n09:50.908 --> 10:02.234\n醫療法草案（事由．立法院第11會期社會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\n\n10:17.942 --> 10:31.296\n醫療公司,這是衝突啊,利益衝突啊。我們現在送行政院審查版本這一條已經沒有了。拿掉了,好,謝謝部長。我也相信大多數醫師是有良知的,但是你不能反映制度如果不完整會少數人會去做營利,但這樣就是陳培哲醫師講的啊,把醫師的白袍染成黑袍嗎?\n\n10:36.161 --> 10:40.344\n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次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n\n10:53.300 --> 10:54.141\n邱議瑩等21人擬具\n\n11:09.286 --> 11:30.646\n疫體本身細胞的安全性、複雜性,它不是小細胞那麼穩定喔,整個支配過程非常繁瑣。法治局也說這個風險很高喔。以前前前立委林靜雲還說這個就是什麼打messageRNA疫苗就是所謂疫體。messageRNA跟細胞無關欸,messageRNA不是細胞欸。這個是細胞自體跟疫體,所以部長您這次有把疫體的部分放進去嗎?\n\n11:30.646 --> 11:30.666\n有。\n\n11:32.367 --> 11:54.938\n有,這個是未來一個趨勢啊。你風險很高喔。部長我在講說我最後因為時間夠了主席已經站起來了不好意思部長當你跟我年老的時候有一天我們就回想我們這輩子有沒有做過這個有愧疑心的事情我希望這個法案不是因為造成這件事情科學實證我們雖然給病人有一個選項\n\n11:56.058 --> 12:00.143\n邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件\n\n","segments":[{"start":0.009,"end":9.03,"text":"福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會"},{"start":15.215,"end":26.383,"text":"邱議瑩等21人擬具:「再生醫療法草案案案件事務所﹑立法院第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛"},{"start":44.195,"end":62.761,"text":"這是我們都在說明的時候有一些事務性的事務要委託其他機構來辦理那今天是不是說要講清楚學界跟業界到底看到這種對照表會恐慌是不是今天要講清楚到底最後要用哪個版本是用院版還是用事務所版那這是不要讓各界繼續摸索無所適從"},{"start":69.623,"end":81.391,"text":"這個沒有所謂的事務所版啦。這個只是說在做一個我們這一次在原來的版本做了一個修正。我們都清楚上一次之前我們最大的爭議就是在這個所謂的免除這個藥品這個許可證的三個條件。我就談第二個條件。經執行人體試驗,證實其安全性是初步療效。"},{"start":97.222,"end":126.273,"text":"部長什麼叫人體試驗人體試驗不是你寫在上面叫人體試驗不是打到人體就叫人體試驗人體試驗在全世界執行了半個世紀以上他有一定的規則一定的管理方式什麼叫人體試驗這是第一個第二個什麼叫初步療效我陳昭之從事藥學40年我不認識什麼叫初步療效世界上沒有初步療效這個字如果你把人體試驗初步療效放在一起這是移校全世界移校全球"},{"start":127.455,"end":151.386,"text":"部長任何加諸人體的治療首先就要確認安全性跟療效這兩件事需要科學來佐證的你缺乏二期三期這搞不好連第一期都不是請問這個做法最後誰來負責醫療品質跟這個法律責任呢這個完全是違背醫學倫理罔顧病人權益難怪外界會質疑這個是為為廠商跟某些醫療機構開後門"},{"start":153.942,"end":175.362,"text":"部長您也知道這個法條是非常寬鬆的我相信你知道為什麼呢您在2023年4月朝野協商說了一段話如果您不管記不記得我把它underline畫線部長您當時解釋在原部版的第9條第23款範圍過大太過普遍有門放得太寬的疑慮"},{"start":176.463,"end":185.953,"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":199.726,"end":220.031,"text":"這個立場並沒有變。那這一次我們現在正在行政審議的版本我們把這一個已經修正了。那有兩個點。第一個點,它的意思原來的這一個版本的這個前提的部分的話、前言的這個部分的話寫得不好。因為這一條要解決的是"},{"start":224.214,"end":244.431,"text":"所有的再生醫療的技術都必須要經過人體試驗才能夠不是我剛剛你知道什麼叫人體試驗人體試驗理想有分三期要規範的非常清楚不是我們自己發表也不是你寫的這個沒有錯所以我們這個人體試驗好我們回到臨床試驗不過我先說明一下因為這個事關重要"},{"start":245.131,"end":249.057,"text":"那所有的都需要先經過人體試驗,人體試驗之後的話有了這一個結果才能夠申請查驗登記。有了這個結果,全球公認的臨床試驗的結果不是台灣自己發明,也不是衛福部定義的臨床試驗。"},{"start":261.915,"end":279.973,"text":"我再補一句但是有兩種情形本來這邊寫的是三種後來我們檢討的結果就把第二款那個拿掉了就只有兩種情形可以沒有完成人體試驗的時候就可以進來使用就是原來的那兩條嗎第一個就是恩恥"},{"start":280.894,"end":296.322,"text":"第二、已經在特管辦法裏面開始執行的這些不必再重複做得明白沒有經過臨床試驗就不能收費這是另外一個問題我們要討論臨床試驗是不能收費而且甚至要保護病人有很多的法律要保護病人"},{"start":297.082,"end":322.38,"text":"部長當醫師或業者鼓吹再生醫療面對的研究報告其實病人這樣子都看不懂啦這相對是這個資訊弱勢嘛他就在資訊不對等情況下因為面臨生死關頭他難免會這個因為想要爭取一線希望所以他可能會做出不理性的決定花了幾百萬元但是事實上背負著沉重的這個經濟壓力但是沒有任何保障為什麼因為你沒有科學實證來做證明嘛"},{"start":325.562,"end":338.268,"text":"其實很多癌症病人他確實是在等待這一線生機啦那他們也可能願意耗盡家財來挽救自己或家屬可能換取短短幾年的壽命但是你要知道部長即便如此他們還是對這個版本有高度質疑這句話不是我講的他們對於這個初步療效的定義也是覺得非常模糊那部長你剛剛是不是承諾初步療效這一條是不見的這拿掉了好謝謝部長"},{"start":354.275,"end":360.348,"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1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第1會期社會福利及衛生環境委員會第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1會期社"},{"start":365.305,"end":388.117,"text":"藥害救濟的部分的話是在治劑條例裡面那再生醫療法是當你要來衛福部這邊申請他來可以執行的時候我們就要在他的計畫書裡面看到他對於這一個發生不良事件的時候有這個責任保險很多規範我非常清楚因為很多衛福部官員都說那我們另外來設一個責任保險但是我們來看一下這個責任保險裡面有兩個關鍵"},{"start":392.719,"end":403.13,"text":"草案：立法院第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會期社會福利及衛生環境委員會第11屆第2會期社會福利及衛生�"},{"start":415.223,"end":442.825,"text":"這個完全就是沒有保護力,這完全就是不可能的任務啊。因為我不能這樣講啦,因為這一個部分的話是舉證責任的問題。如果是相反的是要由醫療機構來舉證說他這一個部分沒有問題。受害者是病人啊,病人要舉證啊。沒有沒有,他...你這舉證的問題是你有證據,所以我可以去比對,他做錯什麼哪裡都做好。這個所謂舉證責任導致是病人只要舉證說他有受有損害就好。"},{"start":443.442,"end":446.728,"text":"那有沒有因果關係跟這個社會的護理過程?那個是醫療機構要去討論的。就是說我們還在保護病人的前提嘛。"},{"start":453.919,"end":454.399,"text":"邱議瑩等21人擬具"},{"start":476.175,"end":497.641,"text":"還有就是說如果細胞治療他會搭配他會搭配其他的治療來用那這個請問如果說我們這個前面不清楚你搭配的正規治療我們都不知道傷害來自何處我們也不知道療效來自何處所以這個是都是很大的問題部長那個根據衛部的資料去年全國有39家醫院提供954人次的細胞治療服務"},{"start":498.081,"end":503.522,"text":"超過7成的病人經費發過100萬到200萬之間有9%的病人超過200萬病人付了這麼多錢那只能仰賴在有效的或是說很薄弱的一個所謂的初步有療效當然你說要把這個字拿掉我也很謝謝部長這樣合理嗎?花了這麼多錢如果你沒有足夠的科學佐證讓他買那一線希望這樣合理嗎?"},{"start":523.223,"end":529.805,"text":"科學道理加醫學倫理。雙理。美國、歐盟在日本針對這個再生醫療他們都用嚴格的這個品質的規範譬如說他們採用這邊有些名詞沒有關係CGMP、PIXA等等但是他目的他就是造一個這個優良製造規範這個版本但是上一版的時候"},{"start":547.492,"end":559.946,"text":"根本都沒有想執行細胞治療的操作要符合什麼樣的品質規範連談都沒有談這樣怎麼保障病人的權益呢?這次有嗎?應該是要符合GDP啦在醫療機構裡面做的"},{"start":562.432,"end":568.555,"text":"藥品實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實施實�"},{"start":590.908,"end":602.234,"text":"醫療法草案（事由．立法院第11會期社會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"},{"start":617.942,"end":631.296,"text":"醫療公司,這是衝突啊,利益衝突啊。我們現在送行政院審查版本這一條已經沒有了。拿掉了,好,謝謝部長。我也相信大多數醫師是有良知的,但是你不能反映制度如果不完整會少數人會去做營利,但這樣就是陳培哲醫師講的啊,把醫師的白袍染成黑袍嗎?"},{"start":636.161,"end":640.344,"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11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會"},{"start":653.3,"end":654.141,"text":"邱議瑩等21人擬具"},{"start":669.286,"end":690.646,"text":"疫體本身細胞的安全性、複雜性,它不是小細胞那麼穩定喔,整個支配過程非常繁瑣。法治局也說這個風險很高喔。以前前前立委林靜雲還說這個就是什麼打message RNA疫苗就是所謂疫體。messageRNA跟細胞無關欸,messageRNA不是細胞欸。這個是細胞自體跟疫體,所以部長您這次有把疫體的部分放進去嗎?"},{"start":690.646,"end":690.666,"text":"有。"},{"start":692.367,"end":714.938,"text":"有,這個是未來一個趨勢啊。你風險很高喔。部長我在講說我最後因為時間夠了主席已經站起來了不好意思部長當你跟我年老的時候有一天我們就回想我們這輩子有沒有做過這個有愧疑心的事情我希望這個法案不是因為造成這件事情科學實證我們雖然給病人有一個選項"},{"start":716.058,"end":720.143,"text":"邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件"}]}}}}