{"id":150997,"url":"https://ivod.ly.gov.tw/Play/Clip/1M/150997","video_url":"https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948e3a4cee9c31b7cadb533009c4a7c43105f8ba9b0039caa7a67e7c4e88479a19625ea18f28b6918d91.mp4/playlist.m3u8","委員名稱":"邱議瑩","委員發言時間":"12:29:41 - 12:37:25","影片長度":"00:07:44","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":464,"end_time":"2024-04-10T12:37:25+08:00","start_time":"2024-04-10T12:29:41+08:00","features":["ai-transcript","gazette"],"type":"Clip","gazette":{"lineno":926,"blocks":[["邱委員議瑩：（12時29分）謝謝主席。部長需要休息一下嗎？不用？好，那我請部長，還有醫事司。"],["主席：請薛部長，請劉司長。"],["薛部長瑞元：委員好。"],["邱委員議瑩：部長好。剛剛我聽到您答詢的時候有特別提到，行政院是預計什麼時候就再生醫療法及再生醫療製劑管理條例作審查？"],["薛部長瑞元：4月19。"],["邱委員議瑩：4月19號？"],["薛部長瑞元：對。"],["邱委員議瑩：您覺得順利出行政院的機會有多大？還是說現在有沒有哪一個條次、哪一個條文內容是有一點卡關的？有沒有？"],["薛部長瑞元：目前我們並沒有收到行政院其他各部門對這一個有什麼樣的……"],["邱委員議瑩：有什麼不同的意見嘛，是不是？"],["薛部長瑞元：對，所以我想會順利啦！"],["邱委員議瑩：好，我們其實都很期待它順利啦，老實講，針對這個案子，我應該是第三次在這裡跟衛福部部長詢問再生醫療法的進度。剛剛其實我們有幾位委員也特別提到，我還是想要聽一下部長的意見，就是在你們3月21號跟28號舉辦的說明會裡頭，其實有一些生技業者對於人體試驗這件事情的施作，到底未來在再生醫療製劑人體試驗怎麼施作、要不要施作、要到什麼樣的程度，以及你所謂的人體試驗跟臨床試驗的區別是怎麼樣去做一些區隔？這個部分是不是衛福部已經有擬好你們的作法跟說法了？"],["薛部長瑞元：這個部分的話，就是我們重新再送給行政院的版本裡面，首先是我們條次變更，把原來寫在後面的人體試驗搬到前面來，這個目的就是要彰顯所有再生醫療技術一定要經過人體試驗，人體試驗完成之後才可以接受所謂的登記、核准。這裡面有一個重點就是，像基因治療、細胞治療這種人體試驗，跟藥品的臨床試驗是不一樣的，第一個就是在第一期或者任何一期，它沒有辦法做雙盲的試驗。第二個就是沒有辦法做第一期，就找健康人做第一期。"],["邱委員議瑩：是。"],["薛部長瑞元：因為健康人在……"],["邱委員議瑩：不可能做這樣的人體試驗。"],["薛部長瑞元：不可能，這違反醫學倫理。"],["邱委員議瑩：所以剛剛林淑芬委員一直在說要參加你們人體試驗的人一大堆，怎麼可能找不到人？基本上，我覺得這個邏輯論述是有一點落差的。"],["薛部長瑞元：對，他把藥品的臨床試驗拿到這邊來做比較。這個部分的話，其實美國FDA有guide line出來，他們對於細胞治療、基因治療的人體試驗guide line有出來。"],["邱委員議瑩：所以我們會follow FDA這樣的……"],["薛部長瑞元：我們會follow，因為這是國際的……"],["邱委員議瑩：是。"],["薛部長瑞元：所以在case number的部分，也就是說在參加人體試驗個案數的部分會有一些規定，這跟藥品臨床試驗的部分完全不一樣，因為case可能蒐集的會比較少，要不然的話會永遠做不完。"],["邱委員議瑩：對。"],["薛部長瑞元：因為很多技術都是針對比較特殊的疾病。"],["邱委員議瑩：部長，我覺得在這個同時，就是在你們要送行政院審查的同時，您剛剛講的美國FDA這些人體試驗的guide line，或者是說有一些我們其實是可以同步去進行，同步跟業者或者是跟病患、跟醫院做說明的部分，這個大概也是比較細節、比較施行細則的部分。"],["薛部長瑞元：對。"],["邱委員議瑩：是不是也能夠請衛福部你們現在就應該把這些東西都準備好？"],["薛部長瑞元：對，所以那兩次的說明會就是在談這個。"],["邱委員議瑩：好。我接下來要再跟您請教，剛剛我聽到有委員在說我們的特管辦法裡面對於細胞治療的成效，你們公布了包括自體脂肪幹細胞治療退化性膝關節炎、軟骨細胞治療膝關節軟骨缺損等等，獨獨沒有公布癌症治療的療效，其實我應該是這樣想，就是說，癌症治療療效的觀察期其實是必須更長的。"],["薛部長瑞元：對。"],["邱委員議瑩：我們的特管辦法只推了6年，6年裡頭要去追蹤癌症患者在接受細胞治療療效的成績上面、追蹤期上面，要立刻說它是非常有效，或者是非常無效，其實我覺得這個大數據上面來講其實不夠精準，也不夠完整。"],["薛部長瑞元：不夠。"],["邱委員議瑩：而且我們的特管辦法裡頭只有第四期，或者是第一期、第三期經基本治療無效者，才能來接受特管辦法的細胞治療。"],["薛部長瑞元：對。"],["邱委員議瑩：這樣子的數據做起來，基本上在整個療效的數據分析上，它其實也是不夠完整的。所以我覺得未來委員在這一方面的詢問，我認為你們的醫師專業應該要更詳盡地把這個區塊去做說明，又甚或是接受細胞治療的癌症患者在接受細胞治療之後的幾年內，他的腫瘤細胞由多大縮小到多大，或者是無效，或者是又繼續擴大，我覺得你們應該會有這些data的整理，maybe把這些data的整理彙整出來，也會讓大家更清楚地瞭解，在整個癌症的細胞治療上面到現在施作的情況，可能這個可以麻煩衛福部做一些整理。"],["薛部長瑞元：這個部分跟委員報告，它牽涉到兩個點，第一點就是剛剛委員提到的，它的療效判定有時候需要時間，現在說已經實行6年，但是不是所有的通通是在開始的第一年就開始做嘛！"],["邱委員議瑩：沒錯，我知道。"],["薛部長瑞元：所以有一些根本就不足以來判定，這是第一點。但是我們還是會找出一些數據是可以來支持的，讓外界知道。"],["邱委員議瑩：好。"],["薛部長瑞元：第二點是比較麻煩的，就是同樣一個技術，我們現在的規範是每一家醫療院所……"],["邱委員議瑩：都要重新申請。"],["薛部長瑞元：它都要重新申請，所以當這個療效公布如果不是很好的時候，等於是在對某一些醫療機構做宣傳，這是我們要避免的。所以我們未來在公布這個的時候，可能不會每一家，每一家去公布它的療效，而是會變成用整體性的方式去做。"],["邱委員議瑩：對，我要談的就是可能可以整體性的公布，而不是針對哪一家的哪一個品項公布，因為這也會涉及到病人隱私的部分，因為都是case by case去申請，所以只要一公布哪一家醫療院所、哪一個生技業者，很容易就可以去追蹤到那一個患者的名字，所以我覺得這個部分可能要避免。"],["薛部長瑞元：所以我才說這個要怎麼樣公布需要我們內部再來做一些討論。"],["邱委員議瑩：好，部長，因為我時間已經到了，但是我覺得我還是期待我們能夠共同努力，趕快把再生醫療法推行通過，好不好？"],["薛部長瑞元：好，謝謝。"],["主席：好，謝謝邱議瑩委員。接下來請蘇巧慧委員發言。"]],"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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375.288, \"score\": 0.909}, {\"word\": \"需\", \"start\": 375.288, \"end\": 375.408, \"score\": 0.834}, {\"word\": \"要\", \"start\": 375.408, \"end\": 375.428, \"score\": 0.99}, {\"word\": \"時\"}, {\"word\": \"間\"}, {\"word\": \"。\"}]}, {\"start\": 378.197, \"end\": 385.402, \"text\": \"草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\", \"words\": [{\"word\": \"草\", \"start\": 378.197, \"end\": 378.317, \"score\": 0.801}, {\"word\": \"案\", \"start\": 378.317, \"end\": 378.397, \"score\": 0.749}, {\"word\": \"：\"}, {\"word\": \"一\", \"start\": 378.397, \"end\": 378.437, \"score\": 0.499}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 378.437, \"end\": 378.778, \"score\": 0.939}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 378.778, \"end\": 379.218, \"score\": 0.908}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 379.218, \"end\": 379.318, \"score\": 0.8}, {\"word\": \"\"}, {\"word\": \"一\", 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{\"word\": \"\"}, {\"word\": \"一\", \"start\": 381.9, \"end\": 382.2, \"score\": 0.933}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 382.2, \"end\": 382.32, \"score\": 0.804}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 382.32, \"end\": 382.44, \"score\": 0.832}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 382.44, \"end\": 382.62, \"score\": 0.848}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 382.62, \"end\": 382.78, \"score\": 0.871}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 382.78, \"end\": 382.88, \"score\": 0.799}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 382.88, \"end\": 382.94, \"score\": 0.663}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 382.94, \"end\": 383.04, \"score\": 0.799}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 383.04, \"end\": 383.1, \"score\": 0.666}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 383.1, \"end\": 383.581, \"score\": 0.875}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 383.581, \"end\": 383.721, \"score\": 0.999}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 383.721, \"end\": 383.921, \"score\": 0.899}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 383.921, \"end\": 384.121, \"score\": 0.894}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 384.121, \"end\": 384.241, \"score\": 0.833}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 384.241, \"end\": 384.341, \"score\": 0.797}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 384.341, \"end\": 384.521, \"score\": 0.886}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 384.521, \"end\": 384.661, \"score\": 0.857}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", \"start\": 384.661, \"end\": 385.141, \"score\": 0.955}, {\"word\": \"\"}, {\"word\": \"一\", \"start\": 385.141, \"end\": 385.262, \"score\": 0.832}, {\"word\": \"、\"}, {\"word\": \"審\"}, {\"word\": \"查\", 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\"score\": 0.961}, {\"word\": \"生\", \"start\": 458.592, \"end\": 458.953, \"score\": 0.813}, {\"word\": \"醫\"}, {\"word\": \"療\"}, {\"word\": \"法\", \"start\": 458.953, \"end\": 459.213, \"score\": 0.842}, {\"word\": \"來\"}, {\"word\": \"把\", \"start\": 459.213, \"end\": 459.333, \"score\": 0.992}, {\"word\": \"它\", \"start\": 459.333, \"end\": 459.473, \"score\": 0.678}, {\"word\": \"推\", \"start\": 459.473, \"end\": 459.633, \"score\": 0.94}, {\"word\": \"行\", \"start\": 459.633, \"end\": 459.813, \"score\": 0.984}, {\"word\": \"通\", \"start\": 459.813, \"end\": 459.993, \"score\": 0.869}, {\"word\": \"過\"}, {\"word\": \"好\", \"start\": 459.993, \"end\": 460.013, \"score\": 0.0}, {\"word\": \"不\", \"start\": 460.013, \"end\": 460.173, \"score\": 0.848}, {\"word\": \"好\", \"start\": 460.173, \"end\": 460.193, \"score\": 0.005}, {\"word\": \",\"}, {\"word\": \"謝\"}, {\"word\": \"謝\"}, {\"word\": \"。\"}, {\"word\": \"邱\", \"start\": 462.403, \"end\": 462.604, \"score\": 0.814}, {\"word\": \"議\"}, {\"word\": \"瑩\"}, {\"word\": \"等\", \"start\": 462.604, \"end\": 462.725, \"score\": 0.833}, {\"word\": \"2\"}, {\"word\": \"5\"}, {\"word\": \"人\", \"start\": 462.725, \"end\": 462.946, \"score\": 0.909}, {\"word\": \"擬\"}, {\"word\": \"具\", \"start\": 462.946, \"end\": 462.966, \"score\": 0.0}], \"language\": \"zh\"}","srt":"1\n00:00:04,923 --> 00:00:05,825\n醫療法草案案。\n\n2\n00:00:16,817 --> 00:00:19,598\n委員邱議瑩等25人擬具:「再生醫療法草案案件事項案件事項案件事項案件事項案件事項案件事項案件事項\n\n3\n00:00:47,371 --> 00:01:08,649\n医疗法草案案案件,有什麽不同的意见嗎?所以我想会顺利。好,我们其实都很期待他顺利啦,老实讲这个案子我应该是第三次在这里跟会福部的部长来询问再生医疗法的进度。那刚刚其实我们有几位委员也特别提到,我还是想要\n\n4\n00:01:11,028 --> 00:01:35,589\n那個聽一下部長的意見就是說在你們3月21號跟28號舉辦的這個說明會裡頭其實有一些生技的業者他們對於人體試驗這件事情的施作到底未來在我們再生醫療製劑的人體試驗怎麼施作要不要施作要到什麼樣的程度以及你所謂的人體試驗跟臨床試驗的區別\n\n5\n00:01:38,231 --> 00:02:05,401\n是怎麼樣去做一些區隔?這個部分是不是衛福部已經有擬好你們的做法跟說法了?這一個部分的話就是說我們送給重新再送給這個行政院的版本裡面就是第一個我們調次變更把原來寫在後面的整體試驗搬到前面來那這個目的就是要彰顯就是說所有的再生醫療的技術的話一定要經過整體試驗\n\n6\n00:02:07,691 --> 00:02:31,948\n人體試驗完成之後才可以接受所謂的登記核准。這裡面的話有一個重點就是這一類的像基因治療、細胞治療的這種人體試驗跟藥品的臨床試驗是不一樣的。第一個就是說在第一期或者說任何一期他沒有辦法做這種雙盲的處理。\n\n7\n00:02:34,729 --> 00:02:37,151\n藥品的臨床試驗拿到這邊來做比較。\n\n8\n00:03:02,863 --> 00:03:21,778\n這個部分的話其實美國的FDA他們有guideline出來對於細胞治療基因治療的人體試驗的guideline他們有出來所以我們會followFDA的這樣的因為是國際的所以他在casenumber的部分也就是說這個參加人體試驗的這個個案數的部分的話\n\n9\n00:03:24,460 --> 00:03:37,374\n福利及衛生環境委員會有一些規定,那跟那個藥品的臨床試驗的這個部分完全不一樣,因爲他case可能會收集的是比較少,要不然的話會永遠做不完,因爲這很多的技術都是針對\n\n10\n00:03:39,957 --> 00:03:50,306\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\n11\n00:04:09,221 --> 00:04:36,533\n草案案件事項〔議題〕我接下來要再跟您請教剛剛當然我聽到有委員在講說我們的特管辦法裡面對於細胞治療的成效你們公布了包括肢體脂肪幹細胞治療退化性膝關節炎軟骨細胞治療膝關節軟骨缺損等等獨獨沒有公布癌症治療的療效其實我應該是這樣想就是說\n\n12\n00:04:37,213 --> 00:04:58,707\n疫苗治療的療效他的觀察期其實是必須更長的我們在特管辦法只推了6年6年裡頭你要去追蹤癌症患者在接受細胞治療的療效的這個成績上面追蹤期上面你要立刻說他是非常有效或者是非常無效其實我覺得這個\n\n13\n00:05:00,168 --> 00:05:24,256\n大數據上來講其實不夠精準也不夠完整而且我們的特管辦法裡頭是只有第四期或者是第一期第三期經基本治療無效者才能來接受特管辦法的細胞治療那這樣子的數據做起來基本上你在就整個療效的數據分析上它其實也是不夠完整的所以我覺得\n\n14\n00:05:25,456 --> 00:05:40,342\n未來委員在這一方面的詢問我認為你們應該你們的醫師專業應該要更詳盡的把這個區塊去做說明又甚或是接受細胞治療的癌症患者他在接受細胞治療之後\n\n15\n00:05:40,902 --> 00:05:43,584\n醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),\n\n16\n00:06:06,856 --> 00:06:15,428\n這部分跟我們報告牽涉到兩個點。第一點就是剛剛委員提到的,它的療效的判定有時候需要時間。\n\n17\n00:06:18,197 --> 00:06:25,402\n草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n\n18\n00:06:45,354 --> 00:07:12,296\n草案：一、審查»:都要重新申請。所以當你這個療效公布如果不是很好的時候等於是在對某一些醫療機構來做宣傳這是我們要避免的所以我們未來在公布這個時候可能不會每一家每一家去公布說它的療效而是會變成是用整體性的方式去做。我要談就是說你可能是可以整體性的公布而不是針對哪一家的哪一個品項\n\n19\n00:07:13,177 --> 00:07:40,193\n醫療法草案案件事項公佈,因為這個也會涉及到病人的隱私的部分,因為你都是casebyCase去申請,所以你只要一公佈哪一家醫療院所哪一個生技業者,你很容易就可以去追蹤到那一個患者的名字,所以我覺得這個部分可能要避免。所以我才說這個要怎麼樣公佈這個需要我們內部再來做一些討論。好,部長因為我時間已經到了,但是我覺得我還是期待這個我們能夠共同努力趕快來把這個再生醫療法來把它推行通過好不好,謝謝。\n\n20\n00:07:42,403 --> 00:07:42,966\n邱議瑩等25人擬具\n\n","tsv":"start\tend\ttext\n4923\t5825\t醫療法草案 案。\n16817\t19598\t委員邱議瑩等25人擬具:「再生醫療法草案案件事項案件事項案件事項案件事項案件事項案件事項案件事項\n47371\t68649\t医疗法草案案案件,有什麽不同的意见嗎?所以我想会顺利。好,我们其实都很期待他顺利啦,老实讲这个案子我应该是第三次在这里跟会福部的部长来询问再生医疗法的进度。那刚刚其实我们有几位委员也特别提到,我还是想要\n71028\t95589\t那個聽一下部長的意見就是說在你們3月21號跟28號舉辦的這個說明會裡頭其實有一些生技的業者他們對於人體試驗這件事情的施作到底未來在我們再生醫療製劑的人體試驗怎麼施作要不要施作要到什麼樣的程度以及你所謂的人體試驗跟臨床試驗的區別\n98231\t125401\t是怎麼樣去做一些區隔?這個部分是不是衛福部已經有擬好你們的做法跟說法了?這一個部分的話就是說我們送給重新再送給這個行政院的版本裡面就是第一個我們調次變更把原來寫在後面的整體試驗搬到前面來那這個目的就是要彰顯就是說所有的再生醫療的技術的話一定要經過整體試驗\n127691\t151948\t人體試驗完成之後才可以接受所謂的登記核准。這裡面的話有一個重點就是這一類的像基因治療、細胞治療的這種人體試驗跟藥品的臨床試驗是不一樣的。第一個就是說在第一期或者說任何一期他沒有辦法做這種雙盲的處理。\n154729\t157151\t藥品的臨床試驗拿到這邊來做比較。\n182863\t201778\t這個部分的話其實美國的FDA他們有guideline出來對於細胞治療基因治療的人體試驗的guideline他們有出來所以我們會followFDA的這樣的因為是國際的所以他在case number的部分也就是說這個參加人體試驗的這個個案數的部分的話\n204460\t217374\t福利及衛生環境委員會有一些規定,那跟那個藥品的臨床試驗的這個部分完全不一樣,因爲他case可能會收集的是比較少,要不然的話會永遠做不完,因爲這很多的技術都是針對\n219957\t230306\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\n249221\t276533\t草案案件事項 〔議題〕我接下來要再跟您請教剛剛當然我聽到有委員在講說我們的特管辦法裡面對於細胞治療的成效你們公布了包括肢體脂肪幹細胞治療退化性膝關節炎軟骨細胞治療膝關節軟骨缺損等等獨獨沒有公布癌症治療的療效其實我應該是這樣想就是說\n277213\t298707\t疫苗治療的療效他的觀察期其實是必須更長的我們在特管辦法只推了6年6年裡頭你要去追蹤癌症患者在接受細胞治療的療效的這個成績上面追蹤期上面你要立刻說他是非常有效或者是非常無效其實我覺得這個\n300168\t324256\t大數據上來講其實不夠精準也不夠完整而且我們的特管辦法裡頭是只有第四期或者是第一期第三期經基本治療無效者才能來接受特管辦法的細胞治療那這樣子的數據做起來基本上你在就整個療效的數據分析上它其實也是不夠完整的所以我覺得\n325456\t340342\t未來委員在這一方面的詢問我認為你們應該你們的醫師專業應該要更詳盡的把這個區塊去做說明又甚或是接受細胞治療的癌症患者他在接受細胞治療之後\n340902\t343584\t醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),\n366856\t375428\t這部分跟我們報告牽涉到兩個點。第一點就是剛剛委員提到的,它的療效的判定有時候需要時間。\n378197\t385402\t草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n405354\t432296\t草案：一、審查 »: 都要重新申請。所以當你這個療效公布如果不是很好的時候等於是在對某一些醫療機構來做宣傳這是我們要避免的所以我們未來在公布這個時候可能不會每一家每一家去公布說它的療效而是會變成是用整體性的方式去做。我要談就是說你可能是可以整體性的公布而不是針對哪一家的哪一個品項\n433177\t460193\t醫療法草案案件事項公佈,因為這個也會涉及到病人的隱私的部分,因為你都是case by Case去申請,所以你只要一公佈哪一家醫療院所哪一個生技業者,你很容易就可以去追蹤到那一個患者的名字,所以我覺得這個部分可能要避免。所以我才說這個要怎麼樣公佈這個需要我們內部再來做一些討論。好,部長因為我時間已經到了,但是我覺得我還是期待這個我們能夠共同努力趕快來把這個再生醫療法來把它推行通過好不好,謝謝。\n462403\t462966\t邱議瑩等25人擬具\n","txt":"醫療法草案 案。\n委員邱議瑩等25人擬具:「再生醫療法草案案件事項案件事項案件事項案件事項案件事項案件事項案件事項\n医疗法草案案案件,有什麽不同的意见嗎?所以我想会顺利。好,我们其实都很期待他顺利啦,老实讲这个案子我应该是第三次在这里跟会福部的部长来询问再生医疗法的进度。那刚刚其实我们有几位委员也特别提到,我还是想要\n那個聽一下部長的意見就是說在你們3月21號跟28號舉辦的這個說明會裡頭其實有一些生技的業者他們對於人體試驗這件事情的施作到底未來在我們再生醫療製劑的人體試驗怎麼施作要不要施作要到什麼樣的程度以及你所謂的人體試驗跟臨床試驗的區別\n是怎麼樣去做一些區隔?這個部分是不是衛福部已經有擬好你們的做法跟說法了?這一個部分的話就是說我們送給重新再送給這個行政院的版本裡面就是第一個我們調次變更把原來寫在後面的整體試驗搬到前面來那這個目的就是要彰顯就是說所有的再生醫療的技術的話一定要經過整體試驗\n人體試驗完成之後才可以接受所謂的登記核准。這裡面的話有一個重點就是這一類的像基因治療、細胞治療的這種人體試驗跟藥品的臨床試驗是不一樣的。第一個就是說在第一期或者說任何一期他沒有辦法做這種雙盲的處理。\n藥品的臨床試驗拿到這邊來做比較。\n這個部分的話其實美國的FDA他們有guideline出來對於細胞治療基因治療的人體試驗的guideline他們有出來所以我們會followFDA的這樣的因為是國際的所以他在case number的部分也就是說這個參加人體試驗的這個個案數的部分的話\n福利及衛生環境委員會有一些規定,那跟那個藥品的臨床試驗的這個部分完全不一樣,因爲他case可能會收集的是比較少,要不然的話會永遠做不完,因爲這很多的技術都是針對\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草案案件事項 〔議題〕我接下來要再跟您請教剛剛當然我聽到有委員在講說我們的特管辦法裡面對於細胞治療的成效你們公布了包括肢體脂肪幹細胞治療退化性膝關節炎軟骨細胞治療膝關節軟骨缺損等等獨獨沒有公布癌症治療的療效其實我應該是這樣想就是說\n疫苗治療的療效他的觀察期其實是必須更長的我們在特管辦法只推了6年6年裡頭你要去追蹤癌症患者在接受細胞治療的療效的這個成績上面追蹤期上面你要立刻說他是非常有效或者是非常無效其實我覺得這個\n大數據上來講其實不夠精準也不夠完整而且我們的特管辦法裡頭是只有第四期或者是第一期第三期經基本治療無效者才能來接受特管辦法的細胞治療那這樣子的數據做起來基本上你在就整個療效的數據分析上它其實也是不夠完整的所以我覺得\n未來委員在這一方面的詢問我認為你們應該你們的醫師專業應該要更詳盡的把這個區塊去做說明又甚或是接受細胞治療的癌症患者他在接受細胞治療之後\n醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),\n這部分跟我們報告牽涉到兩個點。第一點就是剛剛委員提到的,它的療效的判定有時候需要時間。\n草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n草案：一、審查 »: 都要重新申請。所以當你這個療效公布如果不是很好的時候等於是在對某一些醫療機構來做宣傳這是我們要避免的所以我們未來在公布這個時候可能不會每一家每一家去公布說它的療效而是會變成是用整體性的方式去做。我要談就是說你可能是可以整體性的公布而不是針對哪一家的哪一個品項\n醫療法草案案件事項公佈,因為這個也會涉及到病人的隱私的部分,因為你都是case by Case去申請,所以你只要一公佈哪一家醫療院所哪一個生技業者,你很容易就可以去追蹤到那一個患者的名字,所以我覺得這個部分可能要避免。所以我才說這個要怎麼樣公佈這個需要我們內部再來做一些討論。好,部長因為我時間已經到了,但是我覺得我還是期待這個我們能夠共同努力趕快來把這個再生醫療法來把它推行通過好不好,謝謝。\n邱議瑩等25人擬具\n","vtt":"WEBVTT\n\n00:04.923 --> 00:05.825\n醫療法草案案。\n\n00:16.817 --> 00:19.598\n委員邱議瑩等25人擬具:「再生醫療法草案案件事項案件事項案件事項案件事項案件事項案件事項案件事項\n\n00:47.371 --> 01:08.649\n医疗法草案案案件,有什麽不同的意见嗎?所以我想会顺利。好,我们其实都很期待他顺利啦,老实讲这个案子我应该是第三次在这里跟会福部的部长来询问再生医疗法的进度。那刚刚其实我们有几位委员也特别提到,我还是想要\n\n01:11.028 --> 01:35.589\n那個聽一下部長的意見就是說在你們3月21號跟28號舉辦的這個說明會裡頭其實有一些生技的業者他們對於人體試驗這件事情的施作到底未來在我們再生醫療製劑的人體試驗怎麼施作要不要施作要到什麼樣的程度以及你所謂的人體試驗跟臨床試驗的區別\n\n01:38.231 --> 02:05.401\n是怎麼樣去做一些區隔?這個部分是不是衛福部已經有擬好你們的做法跟說法了?這一個部分的話就是說我們送給重新再送給這個行政院的版本裡面就是第一個我們調次變更把原來寫在後面的整體試驗搬到前面來那這個目的就是要彰顯就是說所有的再生醫療的技術的話一定要經過整體試驗\n\n02:07.691 --> 02:31.948\n人體試驗完成之後才可以接受所謂的登記核准。這裡面的話有一個重點就是這一類的像基因治療、細胞治療的這種人體試驗跟藥品的臨床試驗是不一樣的。第一個就是說在第一期或者說任何一期他沒有辦法做這種雙盲的處理。\n\n02:34.729 --> 02:37.151\n藥品的臨床試驗拿到這邊來做比較。\n\n03:02.863 --> 03:21.778\n這個部分的話其實美國的FDA他們有guideline出來對於細胞治療基因治療的人體試驗的guideline他們有出來所以我們會followFDA的這樣的因為是國際的所以他在casenumber的部分也就是說這個參加人體試驗的這個個案數的部分的話\n\n03:24.460 --> 03:37.374\n福利及衛生環境委員會有一些規定,那跟那個藥品的臨床試驗的這個部分完全不一樣,因爲他case可能會收集的是比較少,要不然的話會永遠做不完,因爲這很多的技術都是針對\n\n03:39.957 --> 03:50.306\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\n04:09.221 --> 04:36.533\n草案案件事項〔議題〕我接下來要再跟您請教剛剛當然我聽到有委員在講說我們的特管辦法裡面對於細胞治療的成效你們公布了包括肢體脂肪幹細胞治療退化性膝關節炎軟骨細胞治療膝關節軟骨缺損等等獨獨沒有公布癌症治療的療效其實我應該是這樣想就是說\n\n04:37.213 --> 04:58.707\n疫苗治療的療效他的觀察期其實是必須更長的我們在特管辦法只推了6年6年裡頭你要去追蹤癌症患者在接受細胞治療的療效的這個成績上面追蹤期上面你要立刻說他是非常有效或者是非常無效其實我覺得這個\n\n05:00.168 --> 05:24.256\n大數據上來講其實不夠精準也不夠完整而且我們的特管辦法裡頭是只有第四期或者是第一期第三期經基本治療無效者才能來接受特管辦法的細胞治療那這樣子的數據做起來基本上你在就整個療效的數據分析上它其實也是不夠完整的所以我覺得\n\n05:25.456 --> 05:40.342\n未來委員在這一方面的詢問我認為你們應該你們的醫師專業應該要更詳盡的把這個區塊去做說明又甚或是接受細胞治療的癌症患者他在接受細胞治療之後\n\n05:40.902 --> 05:43.584\n醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),\n\n06:06.856 --> 06:15.428\n這部分跟我們報告牽涉到兩個點。第一點就是剛剛委員提到的,它的療效的判定有時候需要時間。\n\n06:18.197 --> 06:25.402\n草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n\n06:45.354 --> 07:12.296\n草案：一、審查»:都要重新申請。所以當你這個療效公布如果不是很好的時候等於是在對某一些醫療機構來做宣傳這是我們要避免的所以我們未來在公布這個時候可能不會每一家每一家去公布說它的療效而是會變成是用整體性的方式去做。我要談就是說你可能是可以整體性的公布而不是針對哪一家的哪一個品項\n\n07:13.177 --> 07:40.193\n醫療法草案案件事項公佈,因為這個也會涉及到病人的隱私的部分,因為你都是casebyCase去申請,所以你只要一公佈哪一家醫療院所哪一個生技業者,你很容易就可以去追蹤到那一個患者的名字,所以我覺得這個部分可能要避免。所以我才說這個要怎麼樣公佈這個需要我們內部再來做一些討論。好,部長因為我時間已經到了,但是我覺得我還是期待這個我們能夠共同努力趕快來把這個再生醫療法來把它推行通過好不好,謝謝。\n\n07:42.403 --> 07:42.966\n邱議瑩等25人擬具\n\n","segments":[{"start":4.923,"end":5.825,"text":"醫療法草案 案。"},{"start":16.817,"end":19.598,"text":"委員邱議瑩等25人擬具:「再生醫療法草案案件事項案件事項案件事項案件事項案件事項案件事項案件事項"},{"start":47.371,"end":68.649,"text":"医疗法草案案案件,有什麽不同的意见嗎?所以我想会顺利。好,我们其实都很期待他顺利啦,老实讲这个案子我应该是第三次在这里跟会福部的部长来询问再生医疗法的进度。那刚刚其实我们有几位委员也特别提到,我还是想要"},{"start":71.028,"end":95.589,"text":"那個聽一下部長的意見就是說在你們3月21號跟28號舉辦的這個說明會裡頭其實有一些生技的業者他們對於人體試驗這件事情的施作到底未來在我們再生醫療製劑的人體試驗怎麼施作要不要施作要到什麼樣的程度以及你所謂的人體試驗跟臨床試驗的區別"},{"start":98.231,"end":125.401,"text":"是怎麼樣去做一些區隔?這個部分是不是衛福部已經有擬好你們的做法跟說法了?這一個部分的話就是說我們送給重新再送給這個行政院的版本裡面就是第一個我們調次變更把原來寫在後面的整體試驗搬到前面來那這個目的就是要彰顯就是說所有的再生醫療的技術的話一定要經過整體試驗"},{"start":127.691,"end":151.948,"text":"人體試驗完成之後才可以接受所謂的登記核准。這裡面的話有一個重點就是這一類的像基因治療、細胞治療的這種人體試驗跟藥品的臨床試驗是不一樣的。第一個就是說在第一期或者說任何一期他沒有辦法做這種雙盲的處理。"},{"start":154.729,"end":157.151,"text":"藥品的臨床試驗拿到這邊來做比較。"},{"start":182.863,"end":201.778,"text":"這個部分的話其實美國的FDA他們有guideline出來對於細胞治療基因治療的人體試驗的guideline他們有出來所以我們會followFDA的這樣的因為是國際的所以他在case number的部分也就是說這個參加人體試驗的這個個案數的部分的話"},{"start":204.46,"end":217.374,"text":"福利及衛生環境委員會有一些規定,那跟那個藥品的臨床試驗的這個部分完全不一樣,因爲他case可能會收集的是比較少,要不然的話會永遠做不完,因爲這很多的技術都是針對"},{"start":219.957,"end":230.306,"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":249.221,"end":276.533,"text":"草案案件事項 〔議題〕我接下來要再跟您請教剛剛當然我聽到有委員在講說我們的特管辦法裡面對於細胞治療的成效你們公布了包括肢體脂肪幹細胞治療退化性膝關節炎軟骨細胞治療膝關節軟骨缺損等等獨獨沒有公布癌症治療的療效其實我應該是這樣想就是說"},{"start":277.213,"end":298.707,"text":"疫苗治療的療效他的觀察期其實是必須更長的我們在特管辦法只推了6年6年裡頭你要去追蹤癌症患者在接受細胞治療的療效的這個成績上面追蹤期上面你要立刻說他是非常有效或者是非常無效其實我覺得這個"},{"start":300.168,"end":324.256,"text":"大數據上來講其實不夠精準也不夠完整而且我們的特管辦法裡頭是只有第四期或者是第一期第三期經基本治療無效者才能來接受特管辦法的細胞治療那這樣子的數據做起來基本上你在就整個療效的數據分析上它其實也是不夠完整的所以我覺得"},{"start":325.456,"end":340.342,"text":"未來委員在這一方面的詢問我認為你們應該你們的醫師專業應該要更詳盡的把這個區塊去做說明又甚或是接受細胞治療的癌症患者他在接受細胞治療之後"},{"start":340.902,"end":343.584,"text":"醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),委員羅廷瑋等21人擬具:「再生醫療法草案．一),"},{"start":366.856,"end":375.428,"text":"這部分跟我們報告牽涉到兩個點。第一點就是剛剛委員提到的,它的療效的判定有時候需要時間。"},{"start":378.197,"end":385.402,"text":"草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、"},{"start":405.354,"end":432.296,"text":"草案：一、審查 »: 都要重新申請。所以當你這個療效公布如果不是很好的時候等於是在對某一些醫療機構來做宣傳這是我們要避免的所以我們未來在公布這個時候可能不會每一家每一家去公布說它的療效而是會變成是用整體性的方式去做。我要談就是說你可能是可以整體性的公布而不是針對哪一家的哪一個品項"},{"start":433.177,"end":460.193,"text":"醫療法草案案件事項公佈,因為這個也會涉及到病人的隱私的部分,因為你都是case by Case去申請,所以你只要一公佈哪一家醫療院所哪一個生技業者,你很容易就可以去追蹤到那一個患者的名字,所以我覺得這個部分可能要避免。所以我才說這個要怎麼樣公佈這個需要我們內部再來做一些討論。好,部長因為我時間已經到了,但是我覺得我還是期待這個我們能夠共同努力趕快來把這個再生醫療法來把它推行通過好不好,謝謝。"},{"start":462.403,"end":462.966,"text":"邱議瑩等25人擬具"}]}}}}