| IVOD_ID |
15895 |
| IVOD_URL |
https://ivod.ly.gov.tw/Play/Full/1M/15895 |
| 日期 |
2024-05-09 |
| 會議資料.會議代碼 |
委員會-11-1-26-15 |
| 會議資料.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15次全體委員會議 |
| 會議資料.屆 |
11 |
| 會議資料.會期 |
1 |
| 會議資料.會次 |
15 |
| 會議資料.種類 |
委員會 |
| 會議資料.委員會代碼[0] |
26 |
| 會議資料.委員會代碼:str[0] |
社會福利及衛生環境委員會 |
| 會議資料.標題 |
第11屆第1會期社會福利及衛生環境委員會第15次全體委員會議 |
| 影片種類 |
Full |
| 開始時間 |
2024-05-09T08:31:20+08:00 |
| 結束時間 |
2024-05-09T12:44:00+08:00 |
| 影片長度 |
04:12:40 |
| 支援功能[0] |
ai-transcript |
| video_url |
https://h264media01.ly.gov.tw:443/vod_1/_definst_/mp4:1M/bfaf9b39ac01a6855da7963983a35b0d1fc48310b441d33d3be8d109af184be4f97c7be573c321335ea18f28b6918d91.mp4/playlist.m3u8 |
| 會議時間 |
2024-05-09T09:00:00+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15次全體委員會議（事由：一、
（一）審查行政院函請審議「再生醫療法草案」案。
（二）繼續審查委員邱議瑩等25人擬具「再生醫療法草案」案。
（三）繼續審查委員謝衣鳯等19人擬具「再生醫療發展法草案」案。
（四）繼續審查委員羅廷瑋等21人擬具「再生醫療法草案」案。
（五）審查委員黃秀芳等18人擬具「再生醫療法草案」案。
（六）審查委員王正旭等20人擬具「再生醫療法草案」案。
（七）審查台灣民眾黨黨團擬具「再生醫療法草案」案。
（八）審查委員陳菁徽等19人擬具「再生醫療法草案」案。
（九）審查委員楊瓊瓔等25人擬具「再生醫療法草案」案。
二、
（一）審查行政院函請審議「再生醫療製劑條例草案」案。
（二）繼續審查委員邱議瑩等25人擬具「再生醫療製劑條例草案」案。
（三）繼續審查委員謝衣鳯等18人擬具「再生醫療製劑管理條例草案」案。
（四）繼續審查委員羅廷瑋等21人擬具「再生醫療製劑管理條例草案」案。
（五）審查委員劉建國等17人擬具「再生醫療製劑管理條例草案」案。
（六）審查委員黃秀芳等18人擬具「再生醫療製劑條例草案」案。
（七）審查委員王正旭等20人擬具「再生醫療製劑條例草案」案。
（八）審查台灣民眾黨黨團擬具「再生醫療製劑條例草案」案。
（九）審查委員楊瓊瓔等26人擬具「再生醫療製劑條例草案」案。
【一(一)、(八)、(九)及二(一)、(九)，如未經各黨團簽署不復議同意書，則不予審查。】
【本次會議逐條討論】
【5月8日及9日二天一次會】） |
| 委員名稱 |
完整會議 |
| 委員發言時間 |
08:31:20 - 12:44:00 |
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三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1].start |
1317.473 |
| transcript.whisperx[1].end |
1317.717 |
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三）繼續審查委員 |
| transcript.whisperx[2].start |
2546.06 |
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2573.919 |
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現在繼續開會首先先介紹在場的委員及列席官員陳昭芝委員邱議瑩委員王振旭委員林月琴委員盧憲一委員王育明委員林淑芬委員今天列席的官員有薛瑞元部長 |
| transcript.whisperx[3].start |
2575.888 |
| transcript.whisperx[3].end |
2592.472 |
| transcript.whisperx[3].text |
醫事司劉月萍司長十奧署吳秀梅署長中央健康保險署龐一鳴副署長法規會陳信成參事國家發展委員會產業發展處林俊儒專門委員國家科學及技術委員會生命科學研究發展處楊台鴻處長經濟部產業技術司 |
| transcript.whisperx[4].start |
2605.646 |
| transcript.whisperx[4].end |
2619.232 |
| transcript.whisperx[4].text |
再建成檢任計政．產業發展署李家豐組長．法務部汪南軍參事．數位發展部數位產業署胡貝蒂副署長． |
| transcript.whisperx[5].start |
2621.138 |
| transcript.whisperx[5].end |
2641.529 |
| transcript.whisperx[5].text |
公平交易委員會法律事務處齊雪莉專門委員。好,那我們現在繼續進行討論事項第一案,再生醫療法草案保留條文的審查。那每個條文仍然先請行政單位說明,接著再請委員表示意見。那現在先從第一案開始。 |
| transcript.whisperx[6].start |
2642.312 |
| transcript.whisperx[6].end |
2643.433 |
| transcript.whisperx[6].text |
再生醫療法草案案 |
| transcript.whisperx[7].start |
2661.235 |
| transcript.whisperx[7].end |
2687.902 |
| transcript.whisperx[7].text |
第一條條文的部分的話也謝謝各位委員的昨天的討論然後那我們建議的條文是為確保再生醫療之安全品質及有效性維護病人權益及醫學倫理特制定本法然後修正的增加了就是說醫學倫理然後刪除了普惠國民使用以上是醫療倫理還是醫學倫理你上面醫療喔醫療倫理不好意思 |
| transcript.whisperx[8].start |
2693.735 |
| transcript.whisperx[8].end |
2694.775 |
| transcript.whisperx[8].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[9].start |
2707.438 |
| transcript.whisperx[9].end |
2733.758 |
| transcript.whisperx[9].text |
第三條第三條的部分的話我們經過在座的委員的建議之後其實我們昨天在整個維護的整個再生醫療不管是製劑也好不管是技術也好我們整個的把關過程當中大家可以發現是第一關不管是技術或者是我們的製劑都需要做人體試驗在人體試驗的有成果的才會繼續往下走成為製劑 |
| transcript.whisperx[10].start |
2734.739 |
| transcript.whisperx[10].end |
2735.58 |
| transcript.whisperx[10].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[11].start |
2766.509 |
| transcript.whisperx[11].end |
2782.536 |
| transcript.whisperx[11].text |
請委員表示意見。王玉明委員。大家好。有關於那個第三條,我剛剛事先有去請教一下部長。就是現在有關於幹細胞外密體的部分, |
| transcript.whisperx[12].start |
2783.12 |
| transcript.whisperx[12].end |
2793.907 |
| transcript.whisperx[12].text |
三）繼續審查委員羅廷瑋等21人擬具〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療 |
| transcript.whisperx[13].start |
2811.198 |
| transcript.whisperx[13].end |
2811.719 |
| transcript.whisperx[13].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[14].start |
2826.186 |
| transcript.whisperx[14].end |
2826.746 |
| transcript.whisperx[14].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[15].start |
2850.611 |
| transcript.whisperx[15].end |
2851.211 |
| transcript.whisperx[15].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[16].start |
2878.983 |
| transcript.whisperx[16].end |
2906.946 |
| transcript.whisperx[16].text |
陳昭芝委員那我除了這個就是在定義清楚我們要求有紙板吧這樣大家都要看那個螢幕這個我昨天有一直強調不得利用那個異種異體雖然我們對翻譯有一些不同的見解那這裡都不見了耶就是不得利用異種異體他現在這個還是按照願板啦他是希望大家能夠支持願板啦對就是願板那我要求保留 |
| transcript.whisperx[17].start |
2908.803 |
| transcript.whisperx[17].end |
2937.266 |
| transcript.whisperx[17].text |
您是不是先再講一下您的意見?因為昨天我也談得很清楚嘛那一種意義連我們鄰近國家它已經發展到一個程度像日本、韓國他們這個產業分布而且比我們台灣還成熟他們到今天都還在禁止禁止這個一直有這個風險性等等今天就是貿然就把它沒有排除掉我昨天就是一直在說明我記得說 |
| transcript.whisperx[18].start |
2939.11 |
| transcript.whisperx[18].end |
2939.731 |
| transcript.whisperx[18].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[19].start |
2959.011 |
| transcript.whisperx[19].end |
2959.532 |
| transcript.whisperx[19].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[20].start |
2976.947 |
| transcript.whisperx[20].end |
2977.807 |
| transcript.whisperx[20].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[21].start |
3004.542 |
| transcript.whisperx[21].end |
3006.725 |
| transcript.whisperx[21].text |
陳委員剛剛提到,就是說有提到 |
| transcript.whisperx[22].start |
3022.086 |
| transcript.whisperx[22].end |
3036.16 |
| transcript.whisperx[22].text |
現在在使用細胞組織這些的話大概有三種來源第一種是同一個人的同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞同一個人的細胞 |
| transcript.whisperx[23].start |
3038.542 |
| transcript.whisperx[23].end |
3055.077 |
| transcript.whisperx[23].text |
二）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案案案 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 同種液體細胞 |
| transcript.whisperx[24].start |
3066.007 |
| transcript.whisperx[24].end |
3088.257 |
| transcript.whisperx[24].text |
所以如果要寫的話就我是建議只寫異種就好而且大家那時候擔心說什麼意志科學發展但是我們強調說這個東西是在醫療行為就已經要行為而不是跟研究室的發展什麼那不相關的那個異種的細胞要拿來人體使用陳委員是反對這一個啦 |
| transcript.whisperx[25].start |
3091.418 |
| transcript.whisperx[25].end |
3115.131 |
| transcript.whisperx[25].text |
我昨天其實也有做說明就是說事實上這個會有可能的影響比方說你使用的是細胞單細胞或其他的動物比方說比較簡單的牆上動物等等這些那未來也許會有這一方面的發展 |
| transcript.whisperx[26].start |
3116.032 |
| transcript.whisperx[26].end |
3116.392 |
| transcript.whisperx[26].text |
五）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[27].start |
3136.115 |
| transcript.whisperx[27].end |
3159.923 |
| transcript.whisperx[27].text |
當然委員是說那個還在研究階段等到研究有了結果之後再來修法把這個一種使用把它放寬這是我們第一次要立法那這個時候就把它放在裡面 |
| transcript.whisperx[28].start |
3161.309 |
| transcript.whisperx[28].end |
3181.296 |
| transcript.whisperx[28].text |
那當然因為這個研究到可以臨床上面去使用的話可能還有一段時間不過因為未來不管是你用同種異種的這種細胞的話都必須要經過人體試驗或跟臨床前的試驗那我們現在就是 |
| transcript.whisperx[29].start |
3183.377 |
| transcript.whisperx[29].end |
3184.117 |
| transcript.whisperx[29].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[30].start |
3204.503 |
| transcript.whisperx[30].end |
3221.399 |
| transcript.whisperx[30].text |
對,但是其實以國際上面有一些臨床試驗已經在做,不用我這邊收集到... 部長,我們錄得到嗎?我們心知肚明啦。我們這次人家做很久的國家,我們都還這個經驗啊,這個... 特殊性不透明。我幫你補充一下好不好? |
| transcript.whisperx[31].start |
3221.399 |
| transcript.whisperx[31].end |
3221.679 |
| transcript.whisperx[31].text |
好,謝謝。 我來補充一下。 |
| transcript.whisperx[32].start |
3227.404 |
| transcript.whisperx[32].end |
3251.895 |
| transcript.whisperx[32].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事宜和醫療分開,醫療限於同種同體,那治劑的話或許這個同種異體可以繼續開放,但是異種的我們也限縮在於非完成國外臨床試驗不得,或者是說你要正面說已完成臨床試驗的就可以, |
| transcript.whisperx[33].start |
3253.407 |
| transcript.whisperx[33].end |
3253.667 |
| transcript.whisperx[33].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[34].start |
3268.527 |
| transcript.whisperx[34].end |
3275.131 |
| transcript.whisperx[34].text |
你這個製劑你同種議題大家可以廣泛使用的這個沒有關係那我們也開放同種議題可是異種異種就一定是議題可是這個東西我們可以只要是國外有完成的或是國內有完成完整的臨床試驗的也可以這樣子就好了嘛不是嗎只要完成正規的正規的臨床程序的為什麼不能 |
| transcript.whisperx[35].start |
3297.891 |
| transcript.whisperx[35].end |
3309.089 |
| transcript.whisperx[35].text |
那就是這一句話那就是一種一體細胞進行醫療行為之前必須完成這個不在母法裡這個事關重大欸或立法說明欄把這三項放進去 |
| transcript.whisperx[36].start |
3310.199 |
| transcript.whisperx[36].end |
3311.26 |
| transcript.whisperx[36].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[37].start |
3331.121 |
| transcript.whisperx[37].end |
3331.641 |
| transcript.whisperx[37].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[38].start |
3360.519 |
| transcript.whisperx[38].end |
3361.34 |
| transcript.whisperx[38].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[39].start |
3378.752 |
| transcript.whisperx[39].end |
3379.933 |
| transcript.whisperx[39].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[40].start |
3392.411 |
| transcript.whisperx[40].end |
3393.012 |
| transcript.whisperx[40].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[41].start |
3413.015 |
| transcript.whisperx[41].end |
3432.691 |
| transcript.whisperx[41].text |
我想是這樣子同種議題的部分的話不要去區分說製劑或者是說技術啦同種的都是使用在人啦但是是別人的細胞啦這部分我是建議不要限制說只有製劑可以 |
| transcript.whisperx[42].start |
3433.792 |
| transcript.whisperx[42].end |
3442.938 |
| transcript.whisperx[42].text |
那我們的例外條款要適用這一些嗎?要適用照這個沒有經完整程序的吧?因為我們同種同體的,所以我們讓他有例外條款,不用跑完臨床實驗程序,同種同...自己的啦,應該講的講白話文,自己的細胞在緊急救命的時候,我們允許他做細胞治療,不用經過什麼這個實驗階段,這個是合理的嘛。 |
| transcript.whisperx[43].start |
3461.01 |
| transcript.whisperx[43].end |
3489.873 |
| transcript.whisperx[43].text |
那現在別人的要拿來要打到治療緊急的時候危害很大迫不及待這種狀態要不要開放別人的也可以打我是建議還是開放你開放的時候如果又要搭配第幾條我們還有一個是完全連安全性試驗都沒有那是第8條裡面連安全性試驗你都沒有 |
| transcript.whisperx[44].start |
3492.305 |
| transcript.whisperx[44].end |
3493.346 |
| transcript.whisperx[44].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[45].start |
3509.798 |
| transcript.whisperx[45].end |
3523.526 |
| transcript.whisperx[45].text |
我想是這樣子,我們先把這個問題的本質先釐清一下。現在是第一個就是說必須要人體試驗通過。我的意思就是原則上是這樣子。 |
| transcript.whisperx[46].start |
3524.566 |
| transcript.whisperx[46].end |
3551.42 |
| transcript.whisperx[46].text |
那只有第8條的兩個情形需要去做就不必完全完成或者是說不必進行那第8條的部分的話有兩款嘛第一款的部分就是剛剛林書文委員在講的第一款的部分的話就一般我們俗稱的恩慈那如果說恩慈療法本來我們是說他用他這一條要申請的時候是每一個個案要去做審查 |
| transcript.whisperx[47].start |
3552.503 |
| transcript.whisperx[47].end |
3557.784 |
| transcript.whisperx[47].text |
為什麼呢?因為我們器官移植都是用別人的 |
| transcript.whisperx[48].start |
3579.215 |
| transcript.whisperx[48].end |
3580.276 |
| transcript.whisperx[48].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[49].start |
3607.41 |
| transcript.whisperx[49].end |
3608.91 |
| transcript.whisperx[49].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[50].start |
3637.792 |
| transcript.whisperx[50].end |
3639.353 |
| transcript.whisperx[50].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[51].start |
3667.193 |
| transcript.whisperx[51].end |
3668.794 |
| transcript.whisperx[51].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[52].start |
3687.667 |
| transcript.whisperx[52].end |
3715.157 |
| transcript.whisperx[52].text |
那等到說真的有實際上部長昨天才剛剛有一則新聞才剛出來那個基因用豬的這個基因改造的那個腎臟移植病人三個月內心肌梗塞死亡他們現在正在查我相信你有看到這個那個的確他還在做臨床試驗那這可能是一個失敗的案例啦那這一個部分也就是說我們要不要開 |
| transcript.whisperx[53].start |
3717.077 |
| transcript.whisperx[53].end |
3742.588 |
| transcript.whisperx[53].text |
這個是我是覺得就是說委員大家的一致來做決定在行政計劃這邊並沒有堅持說疫種一定在現階段要開並不堅持但是我要把利害關係講清楚就是說如果說疫種我們在這裡是不開那未來就會通通跑到研究去了 |
| transcript.whisperx[54].start |
3743.248 |
| transcript.whisperx[54].end |
3769.667 |
| transcript.whisperx[54].text |
那研究如果真的是有成效的話那他就不屬於再生醫療他是變成不屬於再生醫療因為我們現在是定義的條款我們說定義再生醫療或再生醫療製劇不包括使用異種的細胞那未來如果真的有這樣子的細胞可用的時候他就不屬於再生醫療而是回到一般的醫療去那這樣子是不是有比較好 |
| transcript.whisperx[55].start |
3771.152 |
| transcript.whisperx[55].end |
3798.821 |
| transcript.whisperx[55].text |
這個研究齁你這個我們講說未來的研究多久這第一個你完全都不知道第二個我在執行的時候我有跟你提到你一直講人體試驗齁我個人覺得我最後一定會提齁我們要專屬的再生醫療法醫療的那個人體試驗你的人體試驗內容是什麼不是等四個字就把它蓋掉了人體試驗本身我就就很擔心齁這部分的話齁在我們的那個第因為這個都相關啦我也不知道放到哪一條 |
| transcript.whisperx[56].start |
3799.761 |
| transcript.whisperx[56].end |
3813.334 |
| transcript.whisperx[56].text |
第七條的立法說明裡面我們有提到如果說各位委員手上如果有資料的話可以看一下如果沒有的話也沒有關係我在這邊稍微提示一下 |
| transcript.whisperx[57].start |
3814.502 |
| transcript.whisperx[57].end |
3834.683 |
| transcript.whisperx[57].text |
那有關於再生醫療也就是說像美國那邊有一個基因與細胞治療學會他們就簡稱叫ASGCT他對於這個這種基因治療或細胞治療他們是這樣分的沒有另外另創一個再生醫療的這樣的名詞 |
| transcript.whisperx[58].start |
3836.144 |
| transcript.whisperx[58].end |
3859.541 |
| transcript.whisperx[58].text |
但是我們的再生醫療指的就是這一類那有關這一類的人體或者是臨床試驗的流程他有定了一個指引在那裡面的話比方說比較明顯的一個就是他沒有第一期也就是說他的臨床試驗第一期跟第二期是合在一起算的 |
| transcript.whisperx[59].start |
3860.307 |
| transcript.whisperx[59].end |
3885.38 |
| transcript.whisperx[59].text |
因為如果是藥品的第一期通常指的是找健康人然後去試那個藥品的度子然後要找出他的安全性還有他的安全劑量但是在這種再生醫療的話我們不可能去找一個健康人把他的細胞抽出來然後到實驗室去做不管是基因或者是說那個 |
| transcript.whisperx[60].start |
3888.903 |
| transcript.whisperx[60].end |
3900.311 |
| transcript.whisperx[60].text |
這些基因工程或者是其他的這種處理全部的您講的會文字化嗎?還是您在說明?因為第7條有那個立法說明我們是放在立法說明我們還是要反對一種議題那個有講過是不是先讓那個還沒有講過的委員先講一輪好不好? |
| transcript.whisperx[61].start |
3913.661 |
| transcript.whisperx[61].end |
3926.927 |
| transcript.whisperx[61].text |
接下來請邱議瑩委員還有王振旭委員。先邱議瑩委員。王委員。謝謝主席。我想剛剛在爭議或者是討論的就是有關於這個疫種。 |
| transcript.whisperx[62].start |
3928.744 |
| transcript.whisperx[62].end |
3952.471 |
| transcript.whisperx[62].text |
一種當然現在是無法見到我們目前的執行理念不過我個人的建議這是一個前瞻性的立法那我們很期待的就是未來未來再生醫療對國人的健康或者是疾病的治療是有他需要更關注的地方所以如果我們立法能夠把這樣的精神納進來 |
| transcript.whisperx[63].start |
3954.091 |
| transcript.whisperx[63].end |
3977.431 |
| transcript.whisperx[63].text |
在未來在執行的時候必須要嚴謹的來做管控這樣才能夠達到這個前瞻性立法的重要的意義以上補充好 邱議瑩委員我謝謝主席我接續一下王醫師剛的談話我們八年前第一次在討論在安置劑的時候其實那個時候沒有所謂的外密體這件事情 |
| transcript.whisperx[64].start |
3978.272 |
| transcript.whisperx[64].end |
4003.952 |
| transcript.whisperx[64].text |
所以剛剛王玉敏委員在問說在再生醫療的那個定義裡面外秘體算不算在這個裡頭那我剛剛其實也問了一下秀美所以在再生的細胞及其衍生物可以涵蓋外秘體可是對於很多執行的比如說生技業者來講他覺得這樣的定義其實還是不夠明確所以才會希望你們在立法說明裡頭把有可能相關的這些衍生物把它放進去 |
| transcript.whisperx[65].start |
4004.574 |
| transcript.whisperx[65].end |
4027.297 |
| transcript.whisperx[65].text |
那我要說的就是說八年前在開始討論再生醫療跟再生醫療之際的時候還沒有外密體所以我們不知道要把外密體放進去就如同現在沒有一種的東西沒有一種的產品是在現在的再生醫療裡頭可以做如果有也可能還在試驗的階段但是我們如果現在就直接明文的把它排除掉的話 |
| transcript.whisperx[66].start |
4028.178 |
| transcript.whisperx[66].end |
4052.771 |
| transcript.whisperx[66].text |
其實未來有可能就會像部長所說的他就不會算在再生醫療裡面因為再生醫療我們已經把這個東西把它排除掉了所以是不是大家考慮一下我們現在不限縮任何的醫學發展的可能性但是不代表他不需要做人體試驗不需要安全有效就可以直接施作在人體上就可以直接施作在我們的醫療上面所有的施作都還是必須經過很嚴謹的 |
| transcript.whisperx[67].start |
4054.472 |
| transcript.whisperx[67].end |
4056.313 |
| transcript.whisperx[67].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[68].start |
4081.243 |
| transcript.whisperx[68].end |
4082.284 |
| transcript.whisperx[68].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[69].start |
4108.018 |
| transcript.whisperx[69].end |
4126.065 |
| transcript.whisperx[69].text |
國際上發展的腳步還有目前這個醫療的未來性。」您數分委員。要這樣子說也並不是不行。我覺得要有個限制就是第8條的例外條款這個是不能夠適用這一種、一種。 |
| transcript.whisperx[70].start |
4127.654 |
| transcript.whisperx[70].end |
4128.495 |
| transcript.whisperx[70].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[71].start |
4148.169 |
| transcript.whisperx[71].end |
4149.99 |
| transcript.whisperx[71].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[72].start |
4173.894 |
| transcript.whisperx[72].end |
4174.374 |
| transcript.whisperx[72].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[73].start |
4188.653 |
| transcript.whisperx[73].end |
4210.743 |
| transcript.whisperx[73].text |
對,那我要跟你講就是說,像美國他們的制度其實也都要經過安全性測試啊。即便是這個緊急狀況的使用的這個技術也是要經過安全性測試的啊。那所以就是說,抱歉,如果我們限縮回來談疫種這件事情啊,就直接談啦。那就是我自己認為是第八條 |
| transcript.whisperx[74].start |
4212.003 |
| transcript.whisperx[74].end |
4240.071 |
| transcript.whisperx[74].text |
不許就可以了,不許就勉強走正常程序啦。我不曉得我想的對不對,但是我覺得這樣好像蠻合理的。風險,第八條就是風險,排除我就最後一個機會要企劃的,不會特別企劃的。譬如說,你不會特別,你再把那個風險管再把它放下去。這樣,這個真的是可能就風險上再加風險。我覺得對第八條,使用第八條去治療的人來講,風險太大了。 |
| transcript.whisperx[75].start |
4244.196 |
| transcript.whisperx[75].end |
4244.596 |
| transcript.whisperx[75].text |
陳昭芝委員 |
| transcript.whisperx[76].start |
4274.091 |
| transcript.whisperx[76].end |
4300.844 |
| transcript.whisperx[76].text |
那是要明文寫進去寫在母法不要在立法說明了就是在母法寫得非常清楚那我這就可以討論了可以討論部長你應該去瞭解為什麼應該醫師要去瞭解為什麼日本韓國不敢呢?迄今不敢了人家已經做了幾年了他的風險管理制度人家為什麼迄今不敢有所謂的這個一種一體呢?人家做那麼多還不敢?我們很勇敢嗎?阿不然你健保都比照在日韓喔 |
| transcript.whisperx[77].start |
4305.06 |
| transcript.whisperx[77].end |
4305.28 |
| transcript.whisperx[77].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[78].start |
4325.003 |
| transcript.whisperx[78].end |
4353.011 |
| transcript.whisperx[78].text |
第一項的第一款。」我們也說要主案申請也要繳交資料而不是是說你想試就試的這件事情我覺得在整個制度設計第三條裡面的定義我們會希望給大家一個比較寬廣的空間因為從動物實驗到人體實驗它中間需要做轉移如果我今天人體這一塊的後面的臨床應用看到沒有前景我連動物實驗我可能只是發表學術論文 |
| transcript.whisperx[79].start |
4353.991 |
| transcript.whisperx[79].end |
4354.611 |
| transcript.whisperx[79].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[80].start |
4373.723 |
| transcript.whisperx[80].end |
4393.799 |
| transcript.whisperx[80].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事件的那個是議題的然後那我們的國人的病人有沒有機會碰到這麼嚴重的情況下面的時候可以試試看所以我們才會是說在這樣子的一個狀況下面的時候盡可能的把通案的部分都要更完整的一個review |
| transcript.whisperx[81].start |
4394.019 |
| transcript.whisperx[81].end |
4416.652 |
| transcript.whisperx[81].text |
科學證據,可是對於緊急狀況的時候,這個能夠有嘗試權的這件事情是我們在這樣子的一個法制上面特別希望創製出來的。以上。好,王委員,王崔旭委員。是,好,謝謝。我想會同意剛剛司長還有署委員所提到的,在第8條的時候我們會把這個第一款 |
| transcript.whisperx[82].start |
4417.953 |
| transcript.whisperx[82].end |
4418.173 |
| transcript.whisperx[82].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[83].start |
4450.544 |
| transcript.whisperx[83].end |
4450.964 |
| transcript.whisperx[83].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[84].start |
4465.944 |
| transcript.whisperx[84].end |
4480.153 |
| transcript.whisperx[84].text |
我記得美國今年FDA年初就通過了一個治療帕金森臨床實驗完成的一個藥物到現在衛福部都還沒有許可美國已經通過了衛福部也沒有許可衛福部什麼時候要許可也不知道 |
| transcript.whisperx[85].start |
4481.934 |
| transcript.whisperx[85].end |
4484.955 |
| transcript.whisperx[85].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[86].start |
4508.072 |
| transcript.whisperx[86].end |
4508.433 |
| transcript.whisperx[86].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[87].start |
4518.24 |
| transcript.whisperx[87].end |
4519.061 |
| transcript.whisperx[87].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[88].start |
4549.741 |
| transcript.whisperx[88].end |
4576.001 |
| transcript.whisperx[88].text |
邱議瑩謝謝主席我們是不是把它再更聚焦一點如果說剛剛我聽司長的談話好像你們也不拒絕剛剛淑芬委員的建議你如果說在第8條危急的狀態底下我們先暫時把所謂的異種先排除但是在整個再生治療的定義上面我們其實沒有去特別限縮所謂的異種細胞 |
| transcript.whisperx[89].start |
4577.982 |
| transcript.whisperx[89].end |
4603.38 |
| transcript.whisperx[89].text |
我不曉得這樣子陳昭芝委員能不能接受那或者是在立法說明的部分我們再把它補充強調進去那這樣是不是會比較更更完整一些也兼具這部法令像王委員所講的他其實是有一些前瞻性但是在安全性上面在操作的安全性上面我們用第八條去規範他第三條不提及但第八條一定要提及要要正面提及這件事情部長 |
| transcript.whisperx[90].start |
4604.3 |
| transcript.whisperx[90].end |
4623.151 |
| transcript.whisperx[90].text |
我再稍微做一點補充,即使在美國、歐盟的這些可能也包括日本、韓國的相關的法規裡面在指再生醫療時候的定義並沒有把一種排除剛剛同仁有給我這一個資料 |
| transcript.whisperx[91].start |
4624.171 |
| transcript.whisperx[91].end |
4639.46 |
| transcript.whisperx[91].text |
不過我們很多事沒有比照美國美國有代孕30年你同意了嗎你也是不同意啊那另外一件事啦齁我只是說在法規上面的定義那再生的醫療的技術的話並沒有排除一種第一個是這樣子 |
| transcript.whisperx[92].start |
4640.36 |
| transcript.whisperx[92].end |
4662.84 |
| transcript.whisperx[92].text |
第二我剛剛也是再重申一下如果我們在再生醫療法裡面把這個異種細胞的治療把它排除掉所以以後的話如果用異種的細胞去做治療假設說未來真的是有這種臨床試驗成功的它就會變成跑到醫療法去 |
| transcript.whisperx[93].start |
4663.683 |
| transcript.whisperx[93].end |
4692.719 |
| transcript.whisperx[93].text |
那醫療法的跟在我們這一部再生醫療法或致濟條例裡面的差異點是怎麼樣我們這邊比較嚴我們這邊是比較嚴的那包括我們看後面的法則其實都比醫療法的法則是重的所以可能就是說你想要去禁止但是在這個定義性的條文把它排除的話反而可能造成 |
| transcript.whisperx[94].start |
4694.049 |
| transcript.whisperx[94].end |
4695.271 |
| transcript.whisperx[94].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[95].start |
4714.79 |
| transcript.whisperx[95].end |
4743.23 |
| transcript.whisperx[95].text |
那一些所謂的未來的療效的這些數據我們也收集不到但是在再生醫療法裡面的話是有我們等可能後續我們會討論到所以我會比較贊成就是說OK在這一個定義性的條文的第三條裡面不要去排除但是第八條的那所謂的恩恥的部分的話要把這個使用異種細胞排除這我沒有意見 |
| transcript.whisperx[96].start |
4744.631 |
| transcript.whisperx[96].end |
4747.315 |
| transcript.whisperx[96].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[97].start |
4762.399 |
| transcript.whisperx[97].end |
4785.002 |
| transcript.whisperx[97].text |
第四條的部分昨天在討論的過程當中我們會希望支持院辦所以我們這邊也沒有特別在做補充然後因為陳昭芝委員那邊的話是希望在第一項增加就是說能夠做再生醫療倫理的相關的規範的部分的話那就提起各位委員的討論我在這裡是有提到說 |
| transcript.whisperx[98].start |
4787.164 |
| transcript.whisperx[98].end |
4787.564 |
| transcript.whisperx[98].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[99].start |
4806.633 |
| transcript.whisperx[99].end |
4807.394 |
| transcript.whisperx[99].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[100].start |
4826.934 |
| transcript.whisperx[100].end |
4827.275 |
| transcript.whisperx[100].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[101].start |
4838.789 |
| transcript.whisperx[101].end |
4859.129 |
| transcript.whisperx[101].text |
所以這個三律醫療規範我認為是一定要再寫一次。那這個部分也是由衛福部來處理就可以了。但是未來的發展政策也不能帶幾句嗎?你有政策你才會有後續的這些法跟這個管理啊。那我們也不知道特管法兩個會不會干擱啊?會不會就怎麼辦? |
| transcript.whisperx[102].start |
4859.79 |
| transcript.whisperx[102].end |
4860.13 |
| transcript.whisperx[102].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[103].start |
4873.215 |
| transcript.whisperx[103].end |
4874.056 |
| transcript.whisperx[103].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[104].start |
4895.515 |
| transcript.whisperx[104].end |
4911.622 |
| transcript.whisperx[104].text |
再生醫療發展法草案案 條款 等確認再生醫療法通過之後我的特管辦法裡面那一張其實我們就會同時公告會把它取消市長這個有寫出來嗎在你們內部有寫出來嗎因為說我才寫說希望中關機關 |
| transcript.whisperx[105].start |
4912.682 |
| transcript.whisperx[105].end |
4915.466 |
| transcript.whisperx[105].text |
再生醫療發展法草案案 規定再生醫療發展政策及推動計劃。」 |
| transcript.whisperx[106].start |
4930.566 |
| transcript.whisperx[106].end |
4958.764 |
| transcript.whisperx[106].text |
同一篇我就是廢止我們原本的那一章因為在我們的設計裡面特管辦法細胞資料他是特別的一章在處理裡面的聯動性跟其他的條件的聯動性其實是獨立的比較容易處理這是在行政程序裡面本來就可以處理的這是第一點第二點委員在講的是說政策發展的這一邊因擬定再生醫療發展政策及推動計劃因為本來你就只有推動計劃對我在前面加了一個因擬定 |
| transcript.whisperx[107].start |
4960.185 |
| transcript.whisperx[107].end |
4979.096 |
| transcript.whisperx[107].text |
這是請你們來擬定嘛我想這一個條文我們的意見大概是這樣第一個就是說陳委員所提到的那個要把再生醫療倫理規範要去制定然後由中央主管機關來訂定 |
| transcript.whisperx[108].start |
4980.297 |
| transcript.whisperx[108].end |
4999.962 |
| transcript.whisperx[108].text |
此事我認為我們可以接受,這就是第一項的部分。第二項的部分的話,本來我們是只有推動計劃,要去定論發展政策。這個文字上面也...那第四條就請接受民眾黨版本吧,我們就是...等一下,我把事情講完。 |
| transcript.whisperx[109].start |
5002.544 |
| transcript.whisperx[109].end |
5025.424 |
| transcript.whisperx[109].text |
這一個文字的部分的話其實也可以接受但是第三個部分的話就委員在提到了未來如果說這個再生醫療法通過之後那我們會有第八條第一項的第二款就已經在執行的這一些特管辦法的這一個部分的話如果他的實現還沒有到那應該還可以繼續來執行 |
| transcript.whisperx[110].start |
5029.326 |
| transcript.whisperx[110].end |
5045.651 |
| transcript.whisperx[110].text |
如果實現已經到了,他可能就必須要來依我們本法的12條來再重新做一個申請。這一個申請的話就是等於說再度我們把它審查合格,本來他的效期就到了。 |
| transcript.whisperx[111].start |
5046.831 |
| transcript.whisperx[111].end |
5071.678 |
| transcript.whisperx[111].text |
議長你們一直強調前瞻前瞻前瞻就是要發展政策啊所以我說我那個政策的部分我可以接受我說這一部分我可以接受我只是在說明說未來特管辦法跟再生醫療法要怎麼樣來銜接的問題那這個是委員是可以不用擔心因為我們會讓行政院院去做處理因為特管辦法是屬於醫療法所 |
| transcript.whisperx[112].start |
5073.8 |
| transcript.whisperx[112].end |
5076.607 |
| transcript.whisperx[112].text |
受權去訂定的執法規。」所以 |
| transcript.whisperx[113].start |
5078.114 |
| transcript.whisperx[113].end |
5079.314 |
| transcript.whisperx[113].text |
委員可以用附帶決議來提醒 |
| transcript.whisperx[114].start |
5105.899 |
| transcript.whisperx[114].end |
5120.143 |
| transcript.whisperx[114].text |
如果這本法通過之後,那特管辦法在執行當中以及未來怎麼樣落日的話,要求我們去把它制定好。如果有這樣一個附帶決議的話,我們也可以接受。 |
| transcript.whisperx[115].start |
5127.509 |
| transcript.whisperx[115].end |
5149.728 |
| transcript.whisperx[115].text |
那那個主席我是不是具體建議因為剛剛部長的回答就是說他們可以同意加入陳昭芝委員的所謂的這個再生醫療的發展政策的這幾個文字嘛所以是不是144這邊把那個文字順一下我們就把它加上去那至於特管辦法跟再生醫療法的這個銜接 |
| transcript.whisperx[116].start |
5151.229 |
| transcript.whisperx[116].end |
5177.615 |
| transcript.whisperx[116].text |
到底特管辦法什麼時候要落日那個施行細則的部分是不是我請那個黨衡助理我們現在寫一個附帶決議那待會讓大家看一下我們就也並帶通過好不好也有附帶決議三位委員連署的附帶決議對對對因為剛好就是我們我們準備一下那個第四條的附帶決議那等一下也讓主席採視一下好 |
| transcript.whisperx[117].start |
5180.134 |
| transcript.whisperx[117].end |
5186.54 |
| transcript.whisperx[117].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[118].start |
5215.157 |
| transcript.whisperx[118].end |
5223.785 |
| transcript.whisperx[118].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事宜,請審查委員羅廷瑋等21人擬具 «再生醫療法草案案件事宜,請審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[119].start |
5240.73 |
| transcript.whisperx[119].end |
5266.843 |
| transcript.whisperx[119].text |
第8條我先講一下啦主席我剛剛已經講了這個美國的right to try的那個法案其實也是要求要有這個安全性的這個前提所以並不是完全免這個人體試驗那我也講過國內的生技公司現在在做細胞治療的其實很多也都是已經有取得安全性的這個試驗的程序了 |
| transcript.whisperx[120].start |
5267.483 |
| transcript.whisperx[120].end |
5267.823 |
| transcript.whisperx[120].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[121].start |
5285.798 |
| transcript.whisperx[121].end |
5293.023 |
| transcript.whisperx[121].text |
最小操作的範圍內我覺得也是蠻值得討論的那依照美國的這個規範的最小操作範圍當然就是在講說這個再生治療就他必須要功能構造不能改變然後像美國的定義就是說他的最小操作範圍的定義就針對結構組織製造並為改變組織原有相關特性例如說與組織的重建修復或替代功能有關第二 |
| transcript.whisperx[122].start |
5313.055 |
| transcript.whisperx[122].end |
5314.637 |
| transcript.whisperx[122].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[123].start |
5333.177 |
| transcript.whisperx[123].end |
5356.297 |
| transcript.whisperx[123].text |
我講這麼多就是第一個安全性要確立但在不用完成所有的程序的那個臨床試驗但他的安全性要確立第二個就是說安全性確立以外他的技術也不要的限縮在於說不要在最小操作範圍範圍裡面那我們是不是也應該要限縮在最小操作範圍裡面這樣子讓風險 |
| transcript.whisperx[124].start |
5358.699 |
| transcript.whisperx[124].end |
5359.62 |
| transcript.whisperx[124].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[125].start |
5381.42 |
| transcript.whisperx[125].end |
5382.981 |
| transcript.whisperx[125].text |
陳昭芝委員陳昭芝委員陳昭芝委員 |
| transcript.whisperx[126].start |
5398.79 |
| transcript.whisperx[126].end |
5399.771 |
| transcript.whisperx[126].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[127].start |
5419.125 |
| transcript.whisperx[127].end |
5419.846 |
| transcript.whisperx[127].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[128].start |
5453.826 |
| transcript.whisperx[128].end |
5465.25 |
| transcript.whisperx[128].text |
因為剛剛淑芬委員已經提到第8條那第8條因為那個東西本身是一個概念嘛一個是非常主觀的無生命無責任重症等等等等無適當的那這個要有一些指引讓專家來審嘛 |
| transcript.whisperx[129].start |
5467.638 |
| transcript.whisperx[129].end |
5486.312 |
| transcript.whisperx[129].text |
當然啦,這個有關於恩恥的這部分的話,那要怎麼樣審,有哪一些criteria,有哪一些標準要去處理。對對對,我知道,但是不是寫在委員的意思,並不是要寫在這個母法裡面嘛。所以應該不需要寫在母法啦。 |
| transcript.whisperx[130].start |
5487.68 |
| transcript.whisperx[130].end |
5511.342 |
| transcript.whisperx[130].text |
但是母法不會很複雜啊?不會很複雜?因為大家關注,這幾年大家關注就是這一點。不是,剛剛委員在提到的說,那要申請恩慈,就是說第一項第一款的部分,要去做申請的時候,要提供什麼樣的資料嗎?剛剛委員在講的是這樣子。那其中有一個就是,剛剛委員提到的第一個是說,那個 |
| transcript.whisperx[131].start |
5512.643 |
| transcript.whisperx[131].end |
5517.065 |
| transcript.whisperx[131].text |
對,後面那些應該都不會有太大問題傳統治療無效是證明這個會有問題這等於就是說我們在做這個的話就排除掉部長你的條款自己寫國內尚無適當的藥品你自己寫上去啦是啦是啦 |
| transcript.whisperx[132].start |
5538.423 |
| transcript.whisperx[132].end |
5557.318 |
| transcript.whisperx[132].text |
這就國內沒有,但是這個並不表示說傳統治療就是無效。也就是說國內沒有這個,比方說在美國那邊已經可以執行的,他們也已經這個所謂的像是查案登記已經通過的,但是我們國內還沒有。 |
| transcript.whisperx[133].start |
5559.378 |
| transcript.whisperx[133].end |
5560.058 |
| transcript.whisperx[133].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[134].start |
5579.57 |
| transcript.whisperx[134].end |
5599.521 |
| transcript.whisperx[134].text |
我昨天有講不是一定要都試過你在申請這個動作的時候你要有一些說法但是也許用說傳統治療無效之證明這件事我自己可以討論但是我是比較不建議把這種細節的東西寫在裡面國內尚無適當這個才是模糊咧 |
| transcript.whisperx[135].start |
5603.803 |
| transcript.whisperx[135].end |
5604.744 |
| transcript.whisperx[135].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[136].start |
5629.966 |
| transcript.whisperx[136].end |
5630.606 |
| transcript.whisperx[136].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[137].start |
5645.174 |
| transcript.whisperx[137].end |
5668.513 |
| transcript.whisperx[137].text |
或免完成人體試驗免進行或這四個字劃掉我覺得這個是有道理啦就是說我們所有的不管是在治療危急的狀態底下某個程度上他還是會完成幾個人體試驗才能才能做嘛所以你的免進行可能會引起誤解就是說你這個療法這個技術可能完全都沒有經過任何的人體試驗就直接施作 |
| transcript.whisperx[138].start |
5669.494 |
| transcript.whisperx[138].end |
5669.794 |
| transcript.whisperx[138].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[139].start |
5685.806 |
| transcript.whisperx[139].end |
5713.921 |
| transcript.whisperx[139].text |
舉例來講比如說當時我們在談那個日本的則芳樹醫教授在處理心臟層片的時候他在幫平剛立美做完心臟層片當時他一年做了五例還六例日本就直接讓他免完成人體試驗就直接發給他這樣的一個合格的藥證顯示他的心臟層片技術是有效的那那個是治療危急的狀態日本就會用這樣子的方式去處理 |
| transcript.whisperx[140].start |
5714.821 |
| transcript.whisperx[140].end |
5715.321 |
| transcript.whisperx[140].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[141].start |
5733.775 |
| transcript.whisperx[141].end |
5734.115 |
| transcript.whisperx[141].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[142].start |
5750.908 |
| transcript.whisperx[142].end |
5752.348 |
| transcript.whisperx[142].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[143].start |
5774.23 |
| transcript.whisperx[143].end |
5792.918 |
| transcript.whisperx[143].text |
陳昭芝委員我現在讀第8條我現在看紙板的我現在有在看也是經標準治療無效後你用的是標準治療或經所有人沒有反應那現在請問部長這個東西要拿出文件吧他申請的時候是用概念還是用文件呢 |
| transcript.whisperx[144].start |
5794.532 |
| transcript.whisperx[144].end |
5802.521 |
| transcript.whisperx[144].text |
這應該是一個說明啦不是證明啦因為是醫療機構去做申請嘛醫療機構必須要對於這個所謂的那個標準治療無效去做說明但是你要說證明的話這有點困難 |
| transcript.whisperx[145].start |
5813.795 |
| transcript.whisperx[145].end |
5815.277 |
| transcript.whisperx[145].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[146].start |
5828.592 |
| transcript.whisperx[146].end |
5829.012 |
| transcript.whisperx[146].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[147].start |
5846.38 |
| transcript.whisperx[147].end |
5847.141 |
| transcript.whisperx[147].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[148].start |
5872.583 |
| transcript.whisperx[148].end |
5886.362 |
| transcript.whisperx[148].text |
對阿,申請文件是一定要的。因為恩,對,因為恩慈療法以前是,這樣是給廠商阿,我知道給廠商阿。對,對,對不起,就是說我剛剛在跟那個陳,陳教育委員在,在argue的事情,不是說, |
| transcript.whisperx[149].start |
5887.603 |
| transcript.whisperx[149].end |
5907.139 |
| transcript.whisperx[149].text |
我反對說一定是要標準治療那沒有反應的時候再來做恩賜我的意思是說不要有那個證明啦因為你要提出說這個傳統醫那個或標準治療無效的證明沒有一個醫生敢這樣開啦 |
| transcript.whisperx[150].start |
5909.003 |
| transcript.whisperx[150].end |
5922.96 |
| transcript.whisperx[150].text |
我沒有強調那個部分我現在看那個文字OK我只強調說你們會落實而且有申請資料所以他一定要把這一個申請資料送過來其中就是他要去說明說為什麼他認為那個傳統的資料無效 |
| transcript.whisperx[151].start |
5928.386 |
| transcript.whisperx[151].end |
5954.815 |
| transcript.whisperx[151].text |
所以這個我們就有共識了那第二點就是說這一個所謂的那個免進刑要把它劃掉我是覺得這個大家再思考一下因為這種恩恥的部分的話如果說把那個免進刑劃掉的話就是那你要用恩恥的必須在國內這個已經進行人體試驗只是還沒有完成 |
| transcript.whisperx[152].start |
5955.855 |
| transcript.whisperx[152].end |
5972.249 |
| transcript.whisperx[152].text |
那文字上面就會變成就是說那下流情形之一者免完成那也就表示說他一定有人理事業在進行當中那我們現在在想的為什麼選免進行就是說可能國外已經有了 |
| transcript.whisperx[153].start |
5972.589 |
| transcript.whisperx[153].end |
5990.074 |
| transcript.whisperx[153].text |
只是說在國內沒有人做人體試驗也沒有人來申請查案登記所以這時候就國內沒有這一個那其實在藥品的情形也是類似所以在這一個部分的話我是建議就是說我們可以在文字上面做一點修正 |
| transcript.whisperx[154].start |
5991.354 |
| transcript.whisperx[154].end |
6013.331 |
| transcript.whisperx[154].text |
就是說免進行或免完成人理試驗那所謂的免進行是什麼樣的狀況就是說那國外已經有或者是他已經完成那你那個立法說明的部分去補充說明嘛是不是這樣或者說他已經通過了啊 |
| transcript.whisperx[155].start |
6014.758 |
| transcript.whisperx[155].end |
6015.479 |
| transcript.whisperx[155].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[156].start |
6035.469 |
| transcript.whisperx[156].end |
6036.41 |
| transcript.whisperx[156].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[157].start |
6058.297 |
| transcript.whisperx[157].end |
6059.177 |
| transcript.whisperx[157].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[158].start |
6076.114 |
| transcript.whisperx[158].end |
6088.639 |
| transcript.whisperx[158].text |
三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三 |
| transcript.whisperx[159].start |
6104.51 |
| transcript.whisperx[159].end |
6105.611 |
| transcript.whisperx[159].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[160].start |
6133.99 |
| transcript.whisperx[160].end |
6158.143 |
| transcript.whisperx[160].text |
但是因為看不到啊那個表示有機制在那個立法說明可以表示就看看委員如果我們可以在立法說明寫的話就文字就不怕說太冗長了但是如果要寫到母法裡面去的話那文字他昨天一直在問這件事你在這裡講的是免完成的意思是什麼就國內有在做 |
| transcript.whisperx[161].start |
6159.105 |
| transcript.whisperx[161].end |
6184.867 |
| transcript.whisperx[161].text |
要做到哪裡啊?還沒完成啊。對啦,要做到哪裡?我在講的是要做到哪一個階段啊?在這裡的話我們是…免進行我們要意思是說國外已經有在做的我們就直接免進行可是那免…或者是那你要想想看搞不好我們台灣的生技界也有自己專屬的技術然後要超越國外的那它免完成但是免完成是要做到哪一個階段? |
| transcript.whisperx[162].start |
6186.457 |
| transcript.whisperx[162].end |
6200.871 |
| transcript.whisperx[162].text |
這可以大家來考慮看看啦那也許就是因為我剛剛提到過嘛這種細胞治療這些的技術齁在做人體試驗的時候是一二期並一起進行嘛所以大家要嚴格一點就是完成二期 |
| transcript.whisperx[163].start |
6202.071 |
| transcript.whisperx[163].end |
6219.876 |
| transcript.whisperx[163].text |
三期還沒做還沒做完可是我們要不要這樣我很具體的建議就是說免進行或這四個字拿掉我們就直接就是免完成了嘛那我們立法說明欄裡面就講這個免完成的涵蓋的意義有哪些就在立法說明欄裡面講清楚 |
| transcript.whisperx[164].start |
6222.932 |
| transcript.whisperx[164].end |
6240.554 |
| transcript.whisperx[164].text |
如果你覺得母法裡面放進去太冗長的話立法說明欄裡面要把這個東西也要講清楚啦就是說你要經過到二期的那個國外是國外也是二期我們就是通通都二期這樣子二期可以接受 |
| transcript.whisperx[165].start |
6242.89 |
| transcript.whisperx[165].end |
6268.541 |
| transcript.whisperx[165].text |
那這樣會比較嚴格啦,這樣如果是這樣定的話,那恩賜…啊你剛才說國外的這樣啊,那會比較嚴格?不是啊,不是啊,我的意思是說,如果我們定在二期,已經完成二期的才可以做恩賜,不管它是國內免完成或是國外免進行,那這樣子的話,其實是條件是比較高的。 |
| transcript.whisperx[166].start |
6270.683 |
| transcript.whisperx[166].end |
6270.823 |
| transcript.whisperx[166].text |
邱議瑩委員 |
| transcript.whisperx[167].start |
6288.001 |
| transcript.whisperx[167].end |
6300.406 |
| transcript.whisperx[167].text |
那個部長如果說你所謂的免完成人體試驗我們要把它很完整的寫限縮在二期的話那其實就會失去這一條的意義了 |
| transcript.whisperx[168].start |
6301.721 |
| transcript.whisperx[168].end |
6325.038 |
| transcript.whisperx[168].text |
那如果說您剛剛最後面的那個文字比如說國外免進行或國內免完成那個委員們可以接受的話那其實他的空間其實是有的那也會比較符合這一條在危急的狀態底下來操作再生醫療的這樣的一個精神那請看看委員們可不可以接受這樣的文字修正 |
| transcript.whisperx[169].start |
6325.939 |
| transcript.whisperx[169].end |
6340.221 |
| transcript.whisperx[169].text |
但是如果你要把它很清楚寫要完成二期的話那真的會失去我們這個在緊急操作的情況之下的這個醫療治療我可以問一下就是第8條事實上它就是一個例外條款 |
| transcript.whisperx[170].start |
6340.782 |
| transcript.whisperx[170].end |
6360.562 |
| transcript.whisperx[170].text |
那例外條款可不可以就是採取許可?我覺得它最重要的精神不是在前面的文字,而是主案跟你們申請核准。那個核准的程序我覺得才是最重要。這一條等於是授權讓中央主管機關你要一案一案,因為它是例外,所以必須由你們,由專家學者來做比較嚴謹的。 |
| transcript.whisperx[171].start |
6362.17 |
| transcript.whisperx[171].end |
6386.102 |
| transcript.whisperx[171].text |
申請的程序。」所以坦白講在前面去強調免進行或免完成我覺得那個意義不大這一條事實上應該要把因族案向中央主管機關申請核准使得為之這個是這一條應該是最重要的精神它應該是開宗明義放到最上面如果要把那個免進行或免完成人體試驗整個拿掉的話我覺得 |
| transcript.whisperx[172].start |
6390.25 |
| transcript.whisperx[172].end |
6390.691 |
| transcript.whisperx[172].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[173].start |
6406.534 |
| transcript.whisperx[173].end |
6409.895 |
| transcript.whisperx[173].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[174].start |
6430.422 |
| transcript.whisperx[174].end |
6430.722 |
| transcript.whisperx[174].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[175].start |
6446.519 |
| transcript.whisperx[175].end |
6450.42 |
| transcript.whisperx[175].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[176].start |
6475.084 |
| transcript.whisperx[176].end |
6475.504 |
| transcript.whisperx[176].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[177].start |
6495.871 |
| transcript.whisperx[177].end |
6518.161 |
| transcript.whisperx[177].text |
就是他才是一個嚴格的審查方法。主案審查要有一些審查規則啦。是啊。我覺得重點是他必須得要主案審查。這個才是這個例外的這個。他本來就主案審查了啦。現在我要講的意思是說第8條的例外條款哪裡例外?例外在哪裡?因為沒有第8條大家都第一個要確認安全性。第二個要確認療效。第三個要確認沒有這個不良反應的這個問題很嚴重的。 |
| transcript.whisperx[178].start |
6524.784 |
| transcript.whisperx[178].end |
6540.776 |
| transcript.whisperx[178].text |
那我們今天讓他例外是在最後面要求命我就只要是安全的到底有沒有療效那不良反應會不會很大那我們就沒有那麼苛責反正我們實驗看我們就治療看看嘛 |
| transcript.whisperx[179].start |
6541.937 |
| transcript.whisperx[179].end |
6560.095 |
| transcript.whisperx[179].text |
那所以在這裡只要求一個就是安全啦對我來講那你說竹案審查那些專家要審查什麼內容我覺得這個是這個指引怎麼定交給衛福部去定可能定出來大家也不放心那最好的方法當然就是照制度規範來嘛 |
| transcript.whisperx[180].start |
6561.536 |
| transcript.whisperx[180].end |
6576.581 |
| transcript.whisperx[180].text |
但是制度規範當然就是臨床正規長度就臨床一二三四起這樣子做下去但我們這裡又擺脫正常的制度規範那所以我們才說我都踩著說那只要安全上的確定這是最基本的 |
| transcript.whisperx[181].start |
6579.342 |
| transcript.whisperx[181].end |
6582.986 |
| transcript.whisperx[181].text |
國外免進刑國外免進刑你在立法說明欄裡面要講你具體告訴我們比如說以美國來講 |
| transcript.whisperx[182].start |
6594.757 |
| transcript.whisperx[182].end |
6615.082 |
| transcript.whisperx[182].text |
國外他們是通過什麼階段然後就可以治療,他們是美國是怎麼規範好了這樣子講,因為我們知道的right to try,試看螞蟻法案,它就是right to try嘛,但是它也是安全上的要求,那這個東西精神要放進來,我們當然就可以同意。 |
| transcript.whisperx[183].start |
6616.002 |
| transcript.whisperx[183].end |
6618.564 |
| transcript.whisperx[183].text |
國內免完成,我們還是要對他要求說那你要做到什麼程度這樣子那立法說明欄裡面也要講清楚所以你要具體回答美國是怎麼規定的 |
| transcript.whisperx[184].start |
6639.137 |
| transcript.whisperx[184].end |
6639.778 |
| transcript.whisperx[184].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[185].start |
6656.929 |
| transcript.whisperx[185].end |
6657.389 |
| transcript.whisperx[185].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[186].start |
6673.885 |
| transcript.whisperx[186].end |
6699.234 |
| transcript.whisperx[186].text |
再生醫療法草案案案件事宜,此文字加進去的話就會變得是說我必須在定義欄裏面還要去定義一個叫做最小操作因為這個在我們國內的法規裏面就是在這樣子的一個再生技術裏面並沒有看到一個最小操作所以加或不加這邊的話就提請委員討論在我們原本的細胞治療裏面他就已經講了細胞治療我們通過的就已經是使用無結合藥物之人體細胞組織物 |
| transcript.whisperx[187].start |
6701.355 |
| transcript.whisperx[187].end |
6703.217 |
| transcript.whisperx[187].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[188].start |
6724.637 |
| transcript.whisperx[188].end |
6725.878 |
| transcript.whisperx[188].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[189].start |
6756.144 |
| transcript.whisperx[189].end |
6757.125 |
| transcript.whisperx[189].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[190].start |
6782.461 |
| transcript.whisperx[190].end |
6808.813 |
| transcript.whisperx[190].text |
所以兩個本來在處理過程當中小規模客製化讓病人比較快得到就是說相對的技術他的要求的製程的部分其實在管理部分也就是我們跟日本一樣就是走雙軌技術跟成品類那我可以再請教一下但你講這樣子是美國包括治療和這個治劑全部都要完成所有臨床實驗 |
| transcript.whisperx[191].start |
6809.738 |
| transcript.whisperx[191].end |
6812.08 |
| transcript.whisperx[191].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[192].start |
6833.379 |
| transcript.whisperx[192].end |
6859.294 |
| transcript.whisperx[192].text |
再生醫療法草案案案在人體研究法裡面的架構下面的時候才有針對藥品發展的這邊才會有那個像趙志偉委員一直很熟悉的那個所謂的臨床試驗這是那個臨床試驗的中文翻譯他是based on我們的藥事法可是藥事法裡面我們在講的全部裡面要去規範的他是在人體研究法裡面所以人體研究法裡面我們醫療法裡面也有規定就是說 |
| transcript.whisperx[193].start |
6862.156 |
| transcript.whisperx[193].end |
6865.88 |
| transcript.whisperx[193].text |
再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[194].start |
6878.331 |
| transcript.whisperx[194].end |
6894.005 |
| transcript.whisperx[194].text |
再生醫療法草案案案件事宜和醫療機構才能夠做因為後面會產生人體這一塊的一個病人的損害病人權益的保障的這樣子的大架構所以雙軌管理的部分並不是我們醫療技術再生技術這邊就不要人體事業我覺得聽你這麼一說的話沒什麼大困難就是把四個字劃掉沒什麼問題耶就是第一項裡面的第一項裡面 |
| transcript.whisperx[195].start |
6906.426 |
| transcript.whisperx[195].end |
6907.567 |
| transcript.whisperx[195].text |
第二行免進行禍 |
| transcript.whisperx[196].start |
6921.291 |
| transcript.whisperx[196].end |
6942.045 |
| transcript.whisperx[196].text |
因為照道理說不管是日本因為我們跟日本已經走在世界的最前面了啦聽起來已經像是這樣子台灣跟日本是超越美國了啦那這些技術其實從美國來的這個美國研究最多的但我們的規範管理已經超越美國的開放和先進啦 |
| transcript.whisperx[197].start |
6943.205 |
| transcript.whisperx[197].end |
6971.628 |
| transcript.whisperx[197].text |
讓部長說明一下那我的意思是說那部長其實這個四個字劃掉沒什麼你就免完成人體試驗然後你再仔細的去規範因為我在這裡一直講就是安全上因為我們其實不要求療效要證明也沒有要求你說這個嚴重不良反應怎麼辦怎麼辦我們就是說你要這麼的先進這麼的創新反正就是實驗性治療啦實驗性的治療裡面那你至少安全要確保這是最基本的啦 |
| transcript.whisperx[198].start |
6973.781 |
| transcript.whisperx[198].end |
6992.36 |
| transcript.whisperx[198].text |
兩件事情,第一個如果是按照所謂委員他講的要把免進刑這個拿掉的話,那就是在說明欄裡面我們必須要講說所謂的免完成人體試驗是包括在國內跟國外的,人體試驗不是在國內什麼? |
| transcript.whisperx[199].start |
6996.398 |
| transcript.whisperx[199].end |
7021.254 |
| transcript.whisperx[199].text |
就是說在國內的也就是說這個人體試驗不限於是只有在國內做在國外也在做人體試驗的也是同樣是免完成就可以來做國外會不會有比我們更進步的像東南亞或者是哪個國家他們是連那個因為這個回到剛剛嘛就是他還必須經過審查 |
| transcript.whisperx[200].start |
7023.882 |
| transcript.whisperx[200].end |
7047.136 |
| transcript.whisperx[200].text |
另外一個就是說我還在這邊稍微做一點說明為什麼美國的制度我們會想要學習日本的制度的原因是美國它是產品來規範但是它在技術上面的話是完全交給臨床臨床醫師他們去做決定他們自己負責 |
| transcript.whisperx[201].start |
7048.26 |
| transcript.whisperx[201].end |
7060.911 |
| transcript.whisperx[201].text |
所以美國沒有在管醫生的啦但是我們在這一種齁所謂的試驗性的齁這種這種醫療的部分的話其實包括傳統的醫療我們都管得比較嚴啦 |
| transcript.whisperx[202].start |
7062.116 |
| transcript.whisperx[202].end |
7062.996 |
| transcript.whisperx[202].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[203].start |
7086.002 |
| transcript.whisperx[203].end |
7106.659 |
| transcript.whisperx[203].text |
所以我們是覺得說以臺灣的制度來看的話也許美國這樣子一套的話是民眾會比較沒有信心所以我們認為還是雙軌都要管這是從以前醫療法美國醫療就法很大美國人是比我們很小心的不是這樣比喻的邱議瑩委員 |
| transcript.whisperx[204].start |
7110.827 |
| transcript.whisperx[204].end |
7135.729 |
| transcript.whisperx[204].text |
我其實還想提醒各位委員這一條其實講的就是危險的狀況底下所以我同意剛剛王玉明委員講其實他的重點在竹案審查這一塊那我們前面寫的免進行或免完成人體試驗只是讓衛福部他有更多的裁量權去做竹案審查的這一個行為 |
| transcript.whisperx[205].start |
7137.13 |
| transcript.whisperx[205].end |
7137.691 |
| transcript.whisperx[205].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[206].start |
7157.791 |
| transcript.whisperx[206].end |
7165.747 |
| transcript.whisperx[206].text |
那我們如果讓衛福部有這樣的一個裁量權才符合我們在處理再生醫療法第8條的這個危急狀況底下 |
| transcript.whisperx[207].start |
7168.052 |
| transcript.whisperx[207].end |
7193.77 |
| transcript.whisperx[207].text |
能夠讓病人可以得到治療。」所以主案審查才是這一條的基本精神當然我不排除大家的論點就是維持一定要安全這件事情但是請相信衛福部他們那種嚴格的精神而且我們還有一個所謂的審議委員會可不可以讓我講完好不好 |
| transcript.whisperx[208].start |
7196.618 |
| transcript.whisperx[208].end |
7212.55 |
| transcript.whisperx[208].text |
可不可以讓我講完好不好?你不要我講話的時候你一直插嘴啦拜託拜託就是說在這種很危急的狀況底下如果我們又讓他更多的限縮的時候其實你是幫不了病人的 |
| transcript.whisperx[209].start |
7214.189 |
| transcript.whisperx[209].end |
7215.289 |
| transcript.whisperx[209].text |
三）繼續審查委員羅廷瑋等21人擬具、「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[210].start |
7240.516 |
| transcript.whisperx[210].end |
7246.924 |
| transcript.whisperx[210].text |
讓專家學者能夠有更多的裁量權去依詢。」這是我對大家唯一的建議。謝謝。 |
| transcript.whisperx[211].start |
7251.626 |
| transcript.whisperx[211].end |
7275.215 |
| transcript.whisperx[211].text |
我個人在醫院當藥劑科主任將近三年我辦過一千萬件的這個一千件的這個端案進口但是這不是說我們就是為了病人才有這條管道但是那個端案進口病人你現在看到正面這我有一線希望我們正是怕花這麼多錢幾百萬就買的希望是一場空因為這個希望是要有科學做佐證的 |
| transcript.whisperx[212].start |
7276.001 |
| transcript.whisperx[212].end |
7276.381 |
| transcript.whisperx[212].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[213].start |
7302.857 |
| transcript.whisperx[213].end |
7303.798 |
| transcript.whisperx[213].text |
三）繼續審查委員羅廷瑋等21人擬具〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案 |
| transcript.whisperx[214].start |
7332.575 |
| transcript.whisperx[214].end |
7334.837 |
| transcript.whisperx[214].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[215].start |
7356.67 |
| transcript.whisperx[215].end |
7382.022 |
| transcript.whisperx[215].text |
十大先進國等等依據你們在處理草案進口就是為了像這個邱委員他講到病人要緊急進來我辦太平洋子山族我三天就把它辦進來啊三十年前啊三天我就把它太平洋子那是一個非常大的突破啊所以我覺得還是有方法不是空的不是空的那那個安全性還是有你們有個參考你們可以提啊其實這本來是你們的功課不是我們在教怎麼做 |
| transcript.whisperx[216].start |
7383.929 |
| transcript.whisperx[216].end |
7410.424 |
| transcript.whisperx[216].text |
我是不是在這邊建議一下就是衛福部針對剛剛第8條的這個文字要怎麼修正是不是可以先部長可以可以做怎樣的調整最小操作範圍最小操作範圍最小操作不在此限制放在第一項我剛才有念過我剛才不是講美國那個定義嗎美國的定義 |
| transcript.whisperx[217].start |
7423.394 |
| transcript.whisperx[217].end |
7441.003 |
| transcript.whisperx[217].text |
我補充一下因為我們當初在制定特管辦法的時候細胞治療的部分其實就已經參考美國最小操作這邊我們就把定義定為使用無結合藥物之人體細胞組織物重建人體構造機能或疾病治療之技術 |
| transcript.whisperx[218].start |
7442.243 |
| transcript.whisperx[218].end |
7465.737 |
| transcript.whisperx[218].text |
然後那所以所以是說在要不要加入那個最小操作這件事情其實已經融入了然後所以在第8項第1第8條第1項第2款裏面在講的經我們核准經中央主管機關核准的再生技術其實在本法施行前的就是指責細胞治療技術由我們特管辦法所定定的其實已經內涵在裏面我做以上資料的補充 |
| transcript.whisperx[219].start |
7469.27 |
| transcript.whisperx[219].end |
7481.12 |
| transcript.whisperx[219].text |
抱歉因為我沒有看恩慈療法的那個內容不過我剛才講說對美國來講美國這個依據這個21CFR1271.3的最小操作的定義是針對結構組織製成及為改變組織原有相關特性與組織之重建修復或替代功能有關那第二針對細胞或非結構 |
| transcript.whisperx[220].start |
7498.995 |
| transcript.whisperx[220].end |
7523.203 |
| transcript.whisperx[220].text |
組織製成並未改變細胞或非結構組織的相關生物特性。」這樣子是一致的嗎?休息。好。 |
| transcript.whisperx[221].start |
7524.471 |
| transcript.whisperx[221].end |
7529.317 |
| transcript.whisperx[221].text |
好,那我們先休息10分鐘好不好先休息10分鐘。 |
| transcript.whisperx[222].start |
7540.982 |
| transcript.whisperx[222].end |
7561.165 |
| transcript.whisperx[222].text |
三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三 |
| transcript.whisperx[223].start |
7561.865 |
| transcript.whisperx[223].end |
7563.186 |
| transcript.whisperx[223].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[224].start |
7591.345 |
| transcript.whisperx[224].end |
7591.627 |
| transcript.whisperx[224].text |
三）繼續審查委員 |
| transcript.whisperx[225].start |
8266.542 |
| transcript.whisperx[225].end |
8288.018 |
| transcript.whisperx[225].text |
我們現在繼續開會,那剛剛第4條的部分,大家都同意嗎?你是不是文字的部分先念一下?我們現在回到第4條,部裡面建議的修正的內容第4條,我把文字念一遍。 |
| transcript.whisperx[226].start |
8289.639 |
| transcript.whisperx[226].end |
8302.85 |
| transcript.whisperx[226].text |
第四條,中央主管機關應擬定在……不好意思,拿錯版本。第四條,再生醫療之執行應遵行再生醫療倫理規範。 |
| transcript.whisperx[227].start |
8305.205 |
| transcript.whisperx[227].end |
8321.922 |
| transcript.whisperx[227].text |
尊守再生醫療倫理規範 其內容由中央主管機關公告之。第二項中央主管機關因擬定再生醫療發展政策及推動計劃並定期檢討修正以推動再生醫療。第三項 |
| transcript.whisperx[228].start |
8323.784 |
| transcript.whisperx[228].end |
8349.256 |
| transcript.whisperx[228].text |
各級主管機關得要求相關機關構、學校、法人或團體協助前項計畫之推動。然後因為前面的條文新增了第一項所以我們後面的說明建於近年來國際上連續發生多體幹細胞研究及組織工程試驗的試驗數據或論文造假事件且再生醫療範疇涉及組織細胞捐贈及商業利益等議題為避免再生醫療與發酵或執行過程中越淪離 |
| transcript.whisperx[229].start |
8352.978 |
| transcript.whisperx[229].end |
8375.795 |
| transcript.whisperx[229].text |
醫療倫理階限損害病的權益或人類尊嚴原於第一項明定之並授權將主管機關就再生醫療倫理規範內容另訂定並公告之以上。那是不是這個第4條就照行政院版修正通過。好。好。那再回到第8條。 |
| transcript.whisperx[230].start |
8377.489 |
| transcript.whisperx[230].end |
8394.858 |
| transcript.whisperx[230].text |
第8條的立法說明我們還在處理還在處理是不是能夠先進行下面然後我們等一下把立法說明完善之後再來討論好那就第14條14條的部分的話我們在處理的的 |
| transcript.whisperx[231].start |
8398.891 |
| transcript.whisperx[231].end |
8400.691 |
| transcript.whisperx[231].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[232].start |
8418.856 |
| transcript.whisperx[232].end |
8445.648 |
| transcript.whisperx[232].text |
細胞組織物的一個特性以及使用的風險還有安全性避免因為操作不當導致的偶然等風險在執行細胞操作的機構應該依據前述的情形符合相關的品質規範如人體細胞組織優養操作規範、藥物優良製造準則及西藥優良運銷準則。源於第四項授權中央主管機關就第二項與細胞操作相關事 |
| transcript.whisperx[233].start |
8446.488 |
| transcript.whisperx[233].end |
8457.787 |
| transcript.whisperx[233].text |
事項與及與許可查核有關事項另訂定辦法規範之。」我們就新增了就是一些品質要求的一些文字在這邊。以上。淑芬委員。 |
| transcript.whisperx[234].start |
8461.53 |
| transcript.whisperx[234].end |
8476.627 |
| transcript.whisperx[234].text |
昨天講很久就是說我再跟大家解釋因為就是說醫療機構要執行再生技術所以有培養細胞還有處理及保存的必要者可以委託外面的生技公司 |
| transcript.whisperx[235].start |
8477.828 |
| transcript.whisperx[235].end |
8506.977 |
| transcript.whisperx[235].text |
那我在講是說再生醫療裡面其實最大一個風險來自於汙染所以我這裡講的並不是你們談的GMP或GTP這個事情我在講是說外面的生技公司或者是要做操作這個細胞培養的這種實驗室要有什麼樣的生物安全上面的這個規範嗎那我指的是說我們的實驗室的這個抱歉我忘了那個叫什麼 |
| transcript.whisperx[236].start |
8507.817 |
| transcript.whisperx[236].end |
8508.238 |
| transcript.whisperx[236].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[237].start |
8522.714 |
| transcript.whisperx[237].end |
8523.774 |
| transcript.whisperx[237].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[238].start |
8547.685 |
| transcript.whisperx[238].end |
8547.946 |
| transcript.whisperx[238].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[239].start |
8566.27 |
| transcript.whisperx[239].end |
8578.619 |
| transcript.whisperx[239].text |
三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事務委員羅廷瑋等21人擬具:「再生醫療法草案案件事 |
| transcript.whisperx[240].start |
8593.51 |
| transcript.whisperx[240].end |
8593.89 |
| transcript.whisperx[240].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[241].start |
8621.866 |
| transcript.whisperx[241].end |
8622.666 |
| transcript.whisperx[241].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[242].start |
8640.271 |
| transcript.whisperx[242].end |
8641.352 |
| transcript.whisperx[242].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[243].start |
8662.452 |
| transcript.whisperx[243].end |
8686.649 |
| transcript.whisperx[243].text |
第二集要求的是什麼?第三集是什麼?那我們要看要不要實驗室是應該要研究你在做細胞自備場所就等於是細胞自備場所因為你醫療機構委他去細胞培養了嘛所以細胞自備場所你要大量複製細胞再打回體內那你這個實驗室的規範你要不要定出來? |
| transcript.whisperx[244].start |
8689.325 |
| transcript.whisperx[244].end |
8695.848 |
| transcript.whisperx[244].text |
實驗室規範指的是細胞自備的場所,那剛剛所謂委員在講的那個是Biosafety的level,就是生活安全規範,那BS1、BS2,這到BS4, |
| transcript.whisperx[245].start |
8714.456 |
| transcript.whisperx[245].end |
8740.621 |
| transcript.whisperx[245].text |
這些生物安全規範的對實驗室的規範主要在規範的實驗室是他在操作病毒、細菌等等可能造成傳染病的這些對象所以他要去訂這個所謂的BioSafety的1、2所以這樣子上去的所以其實他要管的兩套制度是不一樣 |
| transcript.whisperx[246].start |
8741.361 |
| transcript.whisperx[246].end |
8765.517 |
| transcript.whisperx[246].text |
在國內做Biosafety的檢核的是CDC,並不是SARS。SARS管的是細胞在處理的過程。當然在GDP或GMP裡面對於污染還是有一些管制的措施在規範裡面。 |
| transcript.whisperx[247].start |
8767.398 |
| transcript.whisperx[247].end |
8786.256 |
| transcript.whisperx[247].text |
但是同時要去符合這兩個的話,可能這個還是要從長期,因為管制對象不一樣,因為這個細胞被制的不一定會使用到這些病毒。 |
| transcript.whisperx[248].start |
8787.657 |
| transcript.whisperx[248].end |
8788.458 |
| transcript.whisperx[248].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[249].start |
8806.455 |
| transcript.whisperx[249].end |
8821.1 |
| transcript.whisperx[249].text |
等級一般在講說病毒不要外散但我們今天講的是病毒不要進來那第一等級就講說你必須要設有實驗工作台洗手台定有操作微生物操作規範定有標準微生物的操作規範類似這樣子 |
| transcript.whisperx[250].start |
8822.72 |
| transcript.whisperx[250].end |
8852.132 |
| transcript.whisperx[250].text |
但是我們第二等級的他說你可能要必須要有生物安全櫃或其他物理性的防護機制那實驗室應有感染性廢棄物處理的標準流程那我們今天想的是說從外面進來的污染的程序他很具體像第二等級就是說你要這個進來的人要限制人員出入然後你醫學的監視的政策也要有進來然後操作的時候你可能要怎麼樣避免這個感染 |
| transcript.whisperx[251].start |
8853.134 |
| transcript.whisperx[251].end |
8854.375 |
| transcript.whisperx[251].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[252].start |
8875.014 |
| transcript.whisperx[252].end |
8875.314 |
| transcript.whisperx[252].text |
二）繼續審查委員邱議瑩 |
| transcript.whisperx[253].start |
8892.145 |
| transcript.whisperx[253].end |
8894.887 |
| transcript.whisperx[253].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[254].start |
8917.907 |
| transcript.whisperx[254].end |
8919.368 |
| transcript.whisperx[254].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[255].start |
8935.937 |
| transcript.whisperx[255].end |
8937.998 |
| transcript.whisperx[255].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[256].start |
8960.811 |
| transcript.whisperx[256].end |
8965.3 |
| transcript.whisperx[256].text |
應該是說你定一個這個細胞自備場所的規範 |
| transcript.whisperx[257].start |
8968.186 |
| transcript.whisperx[257].end |
8992.403 |
| transcript.whisperx[257].text |
我是建議這樣子在我們現在再加上去的這個立法說明裡面除了就是說如人體細胞組織優良操作規範要務優良製造準則以及需要優良運銷準則那到點必要時也是再加上必要時也應符合這個生活安全規範 |
| transcript.whisperx[258].start |
8994.104 |
| transcript.whisperx[258].end |
9004.351 |
| transcript.whisperx[258].text |
因為那個必要是說因為你有操作那種具傳染性的病毒或者細菌等等的時候你才需要去符合那個生活安全規範啦 |
| transcript.whisperx[259].start |
9008.536 |
| transcript.whisperx[259].end |
9009.177 |
| transcript.whisperx[259].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[260].start |
9031.275 |
| transcript.whisperx[260].end |
9052.022 |
| transcript.whisperx[260].text |
需以法律定制若權利義務明定法律明確性定下來那主管機關要做什麼我們授權給主管機關去做那主管機關可能必須訂定這個執行操作細胞操作的這個方法程序設施設備管理的相關管理辦法然後我們對他你後面有寫最後一項有寫嗎但是你最後一項講的是第二項 |
| transcript.whisperx[261].start |
9060.677 |
| transcript.whisperx[261].end |
9077.763 |
| transcript.whisperx[261].text |
但是我們意思是說不是只有第二項或是第二項要怎麼樣再放一個什麼概念進去如果我們不要用這種大規模的不是大規模的GMP的概念啦GTP以外還要還有什麼可以嗎 |
| transcript.whisperx[262].start |
9092.646 |
| transcript.whisperx[262].end |
9094.69 |
| transcript.whisperx[262].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[263].start |
9106.138 |
| transcript.whisperx[263].end |
9126.7 |
| transcript.whisperx[263].text |
好,好,沒關係好了。你立法說明欄裡面就放到你講的生物安全上的那個審核。對,好啦,部長你講的好。好,那14條就照院版通過,那立法說明就剛剛文字有做一個修正啦。要加入這個生物安全性的規範。好,就照剛剛這樣子做文字修正,這樣可以嗎? |
| transcript.whisperx[264].start |
9127.915 |
| transcript.whisperx[264].end |
9129.256 |
| transcript.whisperx[264].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[265].start |
9147.275 |
| transcript.whisperx[265].end |
9171.593 |
| transcript.whisperx[265].text |
為什麼只有必要時?因為只有在這個實驗室裡面有操作到那種傳染性的病原體,比如說病毒、細菌等這些衛生物的時候,它才需要符合生物安全規範。並不是每一個細胞自備場所的這種實驗室都會用到那些,不一定。好不好? |
| transcript.whisperx[266].start |
9176.519 |
| transcript.whisperx[266].end |
9185.611 |
| transcript.whisperx[266].text |
因為你訂的話就要去查啦那我剛剛提到過嘛那個BS12所以那一個是CDC在查啦 |
| transcript.whisperx[267].start |
9186.861 |
| transcript.whisperx[267].end |
9206.531 |
| transcript.whisperx[267].text |
您的困難是說隨時要去查執行面是不容易的?沒有就是說這個實驗室他要定期去查去做這種稽查但是又不是需要但我們不要用實驗室那麼高的強度的話就是你們自己定一個生物安全性的這個規範準則這樣子那個本來就是針對實驗室 |
| transcript.whisperx[268].start |
9208.752 |
| transcript.whisperx[268].end |
9233.06 |
| transcript.whisperx[268].text |
所以我們有說P1、P2、P3這些實驗室的意識就是在這裏對啦那這裏是細胞自備場所細胞自備場所不一定會需要去操作到那種病原體我們比較大的風險是別人來汙染他那個在GDP、GMP本來就會有他就有這些規範去防止這種把病原體帶進來 |
| transcript.whisperx[269].start |
9235.066 |
| transcript.whisperx[269].end |
9235.907 |
| transcript.whisperx[269].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[270].start |
9246.752 |
| transcript.whisperx[270].end |
9274.488 |
| transcript.whisperx[270].text |
三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案案的19條部分的話是針對就是說取得那個算是檢體這一塊的提供者的這邊的權益的保障然後昨天在討論的過程當中的話我們這一次新的修正的話我念一下我們修正的地方在第19條的第一項的部分的話我們新增了治療特定人口群或未能以其他對象 |
| transcript.whisperx[271].start |
9275.148 |
| transcript.whisperx[271].end |
9275.608 |
| transcript.whisperx[271].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[272].start |
9298.766 |
| transcript.whisperx[272].end |
9299.767 |
| transcript.whisperx[272].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[273].start |
9321.764 |
| transcript.whisperx[273].end |
9331.279 |
| transcript.whisperx[273].text |
知人或無意識行為能力之身體法役於第六項規定其同意書應經公證使生效力,以為保護效果之強化。」以上。 |
| transcript.whisperx[274].start |
9334.411 |
| transcript.whisperx[274].end |
9351.683 |
| transcript.whisperx[274].text |
陳昭芝委員請問胎兒怎麼保護法?胎兒就是別人替他行使嗎?對,就是母親。母親替他行使。昨天我們有講到胎兒是胎兒本身還是講其他的? |
| transcript.whisperx[275].start |
9353.199 |
| transcript.whisperx[275].end |
9380.511 |
| transcript.whisperx[275].text |
昨天我們講的是這樣子啦是不是要就是說這個皮弓細胞的人不包括胎兒啦那如果是要這樣定的話那我們希望就是說那就不要把羊水幾袋胎盤算進來就是說因為那一些還是可以用而且事實上那個對胎兒的侵害性小昨天我們談到的是這個樣子 |
| transcript.whisperx[276].start |
9381.533 |
| transcript.whisperx[276].end |
9382.653 |
| transcript.whisperx[276].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[277].start |
9403.32 |
| transcript.whisperx[277].end |
9404.281 |
| transcript.whisperx[277].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[278].start |
9427.233 |
| transcript.whisperx[278].end |
9427.934 |
| transcript.whisperx[278].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[279].start |
9444.525 |
| transcript.whisperx[279].end |
9445.927 |
| transcript.whisperx[279].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[280].start |
9470.186 |
| transcript.whisperx[280].end |
9489.45 |
| transcript.whisperx[280].text |
所以立法上面如果是委員們的意見一致的話就我們就不放胎兒但是我必須在那個立法說明去講說那羊水那個那個胎盤幾代就不在胎兒的範圍之內退嗎?蘇芬委員 |
| transcript.whisperx[281].start |
9501.612 |
| transcript.whisperx[281].end |
9528.348 |
| transcript.whisperx[281].text |
這一條也是談例外條款嘛都必須要成年人才能提供但有什麼狀況可以例外那這個例外我是說我們治療特定人口群要治療是以疾病治療為核心的那且你在別的地方都沒有且不是或而且你未能以其他對象取代者如果你有其他成年人的對象可以取代我們幹嘛去取代而 |
| transcript.whisperx[282].start |
9529.008 |
| transcript.whisperx[282].end |
9550.644 |
| transcript.whisperx[282].text |
但是為了治療疾病在未成年只有未成年身上才有的甚至到胎兒才有的我們就允許例外所以這個字應該是且不是或就是治療治療為限那在別的成人身上找不到了我們就開放我覺得應該是這樣子啦邏輯上是這樣子啦 |
| transcript.whisperx[283].start |
9566.726 |
| transcript.whisperx[283].end |
9588.001 |
| transcript.whisperx[283].text |
我的意思是說這個治療是充分條件喔,必要條件喔,充分來必要。就是說一定是要基於治療。那第二個條件就是你其他成年人身上沒有,所以這兩個條件都必須滿足才可以。是這樣啦。 |
| transcript.whisperx[284].start |
9590.41 |
| transcript.whisperx[284].end |
9591.251 |
| transcript.whisperx[284].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[285].start |
9617.626 |
| transcript.whisperx[285].end |
9618.306 |
| transcript.whisperx[285].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[286].start |
9641.075 |
| transcript.whisperx[286].end |
9662.02 |
| transcript.whisperx[286].text |
提供者把胎兒然後把那個羊水跟龍毛膜那個胎盤期待給他排除。對,就是可以用啦。對,OK。好,那就等你們的那個文字,然後那我們繼續往下,第24條。24條的,等一下。 |
| transcript.whisperx[287].start |
9671.428 |
| transcript.whisperx[287].end |
9672.39 |
| transcript.whisperx[287].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[288].start |
9679.189 |
| transcript.whisperx[288].end |
9680.109 |
| transcript.whisperx[288].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[289].start |
9707.772 |
| transcript.whisperx[289].end |
9732.446 |
| transcript.whisperx[289].text |
細胞庫設置機構取得第19條所定提供者或其他有同意權之書面同意前因告知事項,為避免取得者隨意變更原取的目的而為使用,對於剩餘組織細胞之後續處置或其他超出原取的目的之使用範圍均應事前告知,以保障同意權者之權益。 |
| transcript.whisperx[290].start |
9734.775 |
| transcript.whisperx[290].end |
9736.156 |
| transcript.whisperx[290].text |
二）繼續審查委員羅廷瑋等22人擬具 |
| transcript.whisperx[291].start |
9753.052 |
| transcript.whisperx[291].end |
9761.558 |
| transcript.whisperx[291].text |
再生醫療為輔助醫療不應為唯一治療模式為提供民眾做出適切之醫療決定願第四項授權中央主管機關就第一項廣告得刊播與不得刊播之內容等事項另定辦法規範之增加而這樣子的立法說明 |
| transcript.whisperx[292].start |
9783.212 |
| transcript.whisperx[292].end |
9786.573 |
| transcript.whisperx[292].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[293].start |
9810.481 |
| transcript.whisperx[293].end |
9824.778 |
| transcript.whisperx[293].text |
會確保醫療品質維護病人安全中央主管機關應分析統計第一項報告並每年公開其內容如何準資醫療機構加速總送案人數包含完整療程人數未完成 |
| transcript.whisperx[294].start |
9826.5 |
| transcript.whisperx[294].end |
9840.086 |
| transcript.whisperx[294].text |
未完成療程人數、不良事件及臨床評估指標如傷口面積存活天數等相關醫療品質資訊,原為第三項規定。」我們做這樣子的一個補充。好,委員有沒有意見? |
| transcript.whisperx[295].start |
9843.812 |
| transcript.whisperx[295].end |
9868.774 |
| transcript.whisperx[295].text |
處分委員我們是不是提一個修正就是第二項裡面行政院版本是說這個包含案例數那效果不良事件及其他中央主管機關指定的事項這個效果可不可以再明確一點效果就是治療效果那再來講第三項講的是定期那我們講的是不是每年每年定期公開這個補充一句叫各醫療機構執行的結果報告 |
| transcript.whisperx[296].start |
9873.206 |
| transcript.whisperx[296].end |
9893.975 |
| transcript.whisperx[296].text |
因公開的內容,定期是定多久?明定每年。因公開的內容是什麼?就是執行的結果報告。行政單位。第一個就是說,我們提到說效果的部分的話是可以同意的。 |
| transcript.whisperx[297].start |
9900.079 |
| transcript.whisperx[297].end |
9913.913 |
| transcript.whisperx[297].text |
所謂的定期指的是每年那這個我們也可以同意但是各醫療機構這我必須要跟那個委員說明一下其實在過去我記得應該是美國那邊還是哪一個國家 |
| transcript.whisperx[298].start |
9917.416 |
| transcript.whisperx[298].end |
9939.159 |
| transcript.whisperx[298].text |
他們也有這種report card的這種制度在醫院那個醫院的這個醫療品質也就是說各種比如說心臟手術啦什麼各種手術啦他的效果是什麼樣子這個是曾經有但是那個是在美國 |
| transcript.whisperx[299].start |
9940.16 |
| transcript.whisperx[299].end |
9962.531 |
| transcript.whisperx[299].text |
台灣曾經也想要引進來但是經過這一個大家討論的結果是說不太不太妥當為什麼因為各個醫院可能為了要讓他的數據是美化的是比較漂亮的所以他就把那些複雜嚴重的病人就往外丟 |
| transcript.whisperx[300].start |
9963.792 |
| transcript.whisperx[300].end |
9968.054 |
| transcript.whisperx[300].text |
三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[301].start |
9991.612 |
| transcript.whisperx[301].end |
10009.681 |
| transcript.whisperx[301].text |
所以有一些數據其實我們在某一些那個醫療品質相關的這些結果的指標裡面我們也在預測方面也曾經收集發現就是說臺大就那個數字就 |
| transcript.whisperx[302].start |
10010.842 |
| transcript.whisperx[302].end |
10012.184 |
| transcript.whisperx[302].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[303].start |
10033.546 |
| transcript.whisperx[303].end |
10053.125 |
| transcript.whisperx[303].text |
但是會有這樣子的風險。其實就說這個也曾經是討論過的。所以要不要到去公布個別醫院的各項這個這個再生醫療的成果,我會覺得這個可能大家要考慮一下。 |
| transcript.whisperx[304].start |
10056.207 |
| transcript.whisperx[304].end |
10056.728 |
| transcript.whisperx[304].text |
三）繼續審查委員 |
| transcript.whisperx[305].start |
10072.566 |
| transcript.whisperx[305].end |
10074.247 |
| transcript.whisperx[305].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[306].start |
10093.362 |
| transcript.whisperx[306].end |
10117.537 |
| transcript.whisperx[306].text |
其實你講了臺大那個核心醫院都是收罪人家不要收的癌症病人啦其實大家都還是有一些東西不是那麼簡單的說這樣的病人就是這樣的結果那個那個發表東西還要做專家的一些分析或是一些說明嘛你看癌症也有奇別嘛等等這些狀況所以部長其實我們很落後欸臺灣到底是進步國家還是落後到現在品質都不敢丟出來還在每天都用量來處理問題 |
| transcript.whisperx[307].start |
10118.618 |
| transcript.whisperx[307].end |
10118.958 |
| transcript.whisperx[307].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[308].start |
10149.278 |
| transcript.whisperx[308].end |
10149.578 |
| transcript.whisperx[308].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[309].start |
10175.387 |
| transcript.whisperx[309].end |
10175.987 |
| transcript.whisperx[309].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[310].start |
10202.319 |
| transcript.whisperx[310].end |
10223.472 |
| transcript.whisperx[310].text |
你講的是有道理過去的啦但是那個不是在講這種比較像是實驗性治療但是講標準治療而且這屬性不一樣那我們今天你都知道說再生醫療其實是做一種輔助醫療而且昨天我們一直講它都是合併治療 |
| transcript.whisperx[311].start |
10224.953 |
| transcript.whisperx[311].end |
10244.039 |
| transcript.whisperx[311].text |
合併治療、輔助治療、所以這不是標準療法,然後你在擔心說會變成人家都變成不做了,那我覺得你這個把一般正規醫療標準治療的這個例子舉到這個實驗性治療的這個再生醫療裡面,其實是我覺得這樣子直接推論過來,這個不恰當。再來就是說, |
| transcript.whisperx[312].start |
10247.04 |
| transcript.whisperx[312].end |
10247.6 |
| transcript.whisperx[312].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[313].start |
10275.036 |
| transcript.whisperx[313].end |
10299.717 |
| transcript.whisperx[313].text |
機構的品質醫療品質資訊公開機構執行的醫療品質這個醫療品質諮詢你有沒有看一下他的那個說明那個立法說明因為昨天討論的時候他有增加立法說明所以剛剛那個司長有唸的但我講的不是立法說明我們要人家公開需要法律明確性所以要法律保留原則 |
| transcript.whisperx[314].start |
10300.578 |
| transcript.whisperx[314].end |
10321.878 |
| transcript.whisperx[314].text |
法律保留原則你叫我做可是你法律又沒有法律你單憑一個立法說明就叫我要做他可以打官司他是可以不用遵循的所以在這種狀況裡面因公開的內容加速總受案人數不良人數我們講的是相關醫療品質資訊我是希望到第一個 |
| transcript.whisperx[315].start |
10322.947 |
| transcript.whisperx[315].end |
10324.608 |
| transcript.whisperx[315].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[316].start |
10332.703 |
| transcript.whisperx[316].end |
10333.843 |
| transcript.whisperx[316].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[317].start |
10360.931 |
| transcript.whisperx[317].end |
10384.649 |
| transcript.whisperx[317].text |
條文裡面的話現在有爭議剛剛講的那個第二項第二項的部分把治療效果寫上去之後沒有問題那現在有爭議是在第三項那第三項的每年公開這個也沒有問題定期把它改成每年這個也沒有問題 |
| transcript.whisperx[318].start |
10385.77 |
| transcript.whisperx[318].end |
10414.605 |
| transcript.whisperx[318].text |
現在正義點就要最後一個醫療品質資訊這個部分的話要算到什麼樣那我是比較建議是這樣就維持這樣子的文字那事實上在公開這些資訊的時候我們是可以就是說在每年公開那大家去檢視檢視結果的話發現說我們需要更多的資訊公開那我們就每年來做調整 |
| transcript.whisperx[319].start |
10415.943 |
| transcript.whisperx[319].end |
10430.121 |
| transcript.whisperx[319].text |
因為現在你會如果要去把這些各種的除了就要第二項的那些案例數啦效果治療效果啦不良事件啦那另外還有一個主管機關指定的事項嘛 |
| transcript.whisperx[320].start |
10430.748 |
| transcript.whisperx[320].end |
10431.508 |
| transcript.whisperx[320].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[321].start |
10451.837 |
| transcript.whisperx[321].end |
10478.819 |
| transcript.whisperx[321].text |
大概沒有辦法在這整個的條文裡面去把具姓名的說要公開的東西通通再寫在這裡我是覺得那樣的立法技術不是很OK啦原特管辦法 |
| transcript.whisperx[322].start |
10481.636 |
| transcript.whisperx[322].end |
10497.482 |
| transcript.whisperx[322].text |
那我們先休息5分鐘好不好。 |
| transcript.whisperx[323].start |
10924.913 |
| transcript.whisperx[323].end |
10933.125 |
| transcript.whisperx[323].text |
繼續開會那行政單位是不是再說明一下好接下來的不好意思24條24對 |
| transcript.whisperx[324].start |
10942.112 |
| transcript.whisperx[324].end |
10955.198 |
| transcript.whisperx[324].text |
二、四條的部分的話剛剛跟林淑芬委員討論他是希望我們的那個文字的部分的話是照我們的那個在第一等一下齁在 |
| transcript.whisperx[325].start |
10958.573 |
| transcript.whisperx[325].end |
10981.189 |
| transcript.whisperx[325].text |
我這樣講好了是不是有一個折衷的方法就是照特管辦法的最後一項但是我有一個修正就是醫療機構應該是每年定期公開然後醫療機構的治療效果及統計之醫療品質資訊以維護民眾權益然後說明欄就是要放你們的那些內容進去 |
| transcript.whisperx[326].start |
10988.36 |
| transcript.whisperx[326].end |
10990.681 |
| transcript.whisperx[326].text |
每年要定期公開醫療機構的治療效果及統計的醫療品質資訊。 |
| transcript.whisperx[327].start |
11020.523 |
| transcript.whisperx[327].end |
11021.364 |
| transcript.whisperx[327].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[328].start |
11039.775 |
| transcript.whisperx[328].end |
11042.458 |
| transcript.whisperx[328].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[329].start |
11057.938 |
| transcript.whisperx[329].end |
11079.046 |
| transcript.whisperx[329].text |
所以我們在這邊討論之後我們本來的本來只有在立法說明這邊就是講是說我們增加了及長期追蹤機制然後就並授權中央主管機關就通報的期限方式內容及其他應遵循事項這個部分做了一個強化的說明 |
| transcript.whisperx[330].start |
11080.366 |
| transcript.whisperx[330].end |
11101.712 |
| transcript.whisperx[330].text |
則目前我們的版本是希望能夠這樣,然後剛剛在休息的過程當中,食藥署同仁有跟我們在做一個討論,也有跟委員這邊做一個討論。我先把一個建議的文字的部分的話念一次,然後等一下在那個螢幕這邊會做一個顯示。 |
| transcript.whisperx[331].start |
11104.667 |
| transcript.whisperx[331].end |
11105.748 |
| transcript.whisperx[331].text |
醫療機構使用中央主管機關指定之再生製劑或執行再生技術斗點因 |
| transcript.whisperx[332].start |
11119.847 |
| transcript.whisperx[332].end |
11123.008 |
| transcript.whisperx[332].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[333].start |
11138.14 |
| transcript.whisperx[333].end |
11159.113 |
| transcript.whisperx[333].text |
再生醫療乃新興之專業領域具相當之風險性與不確定性為落實其安全監控及長期追蹤機制規定醫療機構通報嚴重不良反應情勢之異物以利中央主管機關評估相關風險 並授權中央主管機關就通報期限 |
| transcript.whisperx[334].start |
11160.274 |
| transcript.whisperx[334].end |
11187.759 |
| transcript.whisperx[334].text |
端號方式內容及其他應遵循事項令定定辦法規範之以公遵循。第二項對有關藥商對再生製劑之安全監視另一再生醫療製劑條例規定辦理。我們建議新修正的條文是以這樣子的方式呈現,就是現在畫面上面呈現的以上。好,各位委員有沒有意見?沒有。那就照院板的修正文字通過。好。 |
| transcript.whisperx[335].start |
11191.195 |
| transcript.whisperx[335].end |
11212.248 |
| transcript.whisperx[335].text |
謝寫。接下來是28條罰則的部分。罰則的部分的話昨天在討論的過程當中是希望把那個累計的這件事情所以我們在立法說明裡面增加了第二項也就是說如果違反第21條到22條廣告規定者由中央主管機關審著違反情節累計 |
| transcript.whisperx[336].start |
11215.11 |
| transcript.whisperx[336].end |
11243.969 |
| transcript.whisperx[336].text |
違反次數及其他審酌因素作為罰還額度裁量之依據。」我們增加了這個文字說明。以上。各位委員有沒有意見?沒有齁。這個我問一下。那個這邊主要規範到22條的那個廣告規定齁。我現在比較擔心的就是其實會有蠻,其實現在已經有了齁。蠻多人就是在大打廣告了齁。甚至有的就是去籌資啊什麼股票啊說它是 |
| transcript.whisperx[337].start |
11244.448 |
| transcript.whisperx[337].end |
11247.95 |
| transcript.whisperx[337].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[338].start |
11272.551 |
| transcript.whisperx[338].end |
11279.756 |
| transcript.whisperx[338].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三） |
| transcript.whisperx[339].start |
11301.701 |
| transcript.whisperx[339].end |
11327.15 |
| transcript.whisperx[339].text |
一、現在的狀況是非醫療機構比醫療機構嚴重。所以非醫療機構的部分的話,我們拉高了法則就是兩百到兩千萬。所以它的成本這邊的增加其實就變得是比之前困難。第二件事情是必須透過事前的審查。也就是說法律通過之後那些廣告其實它都是不合法的。 |
| transcript.whisperx[340].start |
11327.87 |
| transcript.whisperx[340].end |
11328.531 |
| transcript.whisperx[340].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[341].start |
11347.327 |
| transcript.whisperx[341].end |
11373.104 |
| transcript.whisperx[341].text |
在目前的機制下面對於非醫療機構我們的處罰這邊比較難以處理的必須透過新的法律我們來創造這樣子的一個算是法治環境才有效能夠遏止這樣子的一個不當的廣告的產生對我在問的是除了罰還額度增加之外會不會到什麼情況你是會有一個就是最重的就是停業就要求他 |
| transcript.whisperx[342].start |
11375.916 |
| transcript.whisperx[342].end |
11403.242 |
| transcript.whisperx[342].text |
有第一項各款或前項第三款規定情形者除一該項規定處罰外並得公布其名稱這是第一個會公開那個場域第二個事情是有第一項第一款違規之情形令得沒入其執行再生醫療之設備及再生製劑 |
| transcript.whisperx[343].start |
11404.302 |
| transcript.whisperx[343].end |
11416.08 |
| transcript.whisperx[343].text |
因為非醫療機構他不是按照我醫療機構這邊的管理可是當我陌入他的一個就是執行這些業務的一個設備的時候其實就如同他沒辦法再進行 |
| transcript.whisperx[344].start |
11417.475 |
| transcript.whisperx[344].end |
11418.556 |
| transcript.whisperx[344].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[345].start |
11444.477 |
| transcript.whisperx[345].end |
11458.226 |
| transcript.whisperx[345].text |
因為其他醫療機構其實並不是衛福部管的因為他可能是公司啊那這樣會不會有什麼漏洞就是說他照賣啊反正我獲利很高管你你罰我200萬我繼續這是一次立法得連續處罰 |
| transcript.whisperx[346].start |
11466.233 |
| transcript.whisperx[346].end |
11494.876 |
| transcript.whisperx[346].text |
昨天討論過程當中第一個是可以連續處罰第二件事情是我們把他的那個設備或自己全部沒收沒收以後其實對於這個所謂的公司好了他非法執行的部分的話他其實就沒有了可以繼續販賣的東西所以就等於是利用另外一個行政手段讓他沒辦法繼續開業的概念所以你們沒有辦法停業就是這邊可以去沒收設備但是 |
| transcript.whisperx[347].start |
11495.66 |
| transcript.whisperx[347].end |
11497.541 |
| transcript.whisperx[347].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[348].start |
11525.643 |
| transcript.whisperx[348].end |
11528.465 |
| transcript.whisperx[348].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[349].start |
11536.65 |
| transcript.whisperx[349].end |
11537.85 |
| transcript.whisperx[349].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[350].start |
11556.337 |
| transcript.whisperx[350].end |
11558.219 |
| transcript.whisperx[350].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[351].start |
11584.195 |
| transcript.whisperx[351].end |
11589.479 |
| transcript.whisperx[351].text |
昨天還有保留第29條是因為罰則的關係啊昨天29條是因為罰則的關係對有牽涉到前面的罰則的關係所以做一個保留 |
| transcript.whisperx[352].start |
11615.529 |
| transcript.whisperx[352].end |
11621.71 |
| transcript.whisperx[352].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[353].start |
11644.542 |
| transcript.whisperx[353].end |
11648.746 |
| transcript.whisperx[353].text |
二）繼續審查委員羅廷瑋等19人擬具 «再生醫療法草案案案 案件中有14條的罰則,是正確還是不正確? |
| transcript.whisperx[354].start |
11666.826 |
| transcript.whisperx[354].end |
11674.67 |
| transcript.whisperx[354].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事宜等19人擬具《再生醫療法草案案件事宜等19人擬具《再生醫療法草案案件事宜等19人擬具 |
| transcript.whisperx[355].start |
11695.077 |
| transcript.whisperx[355].end |
11699.218 |
| transcript.whisperx[355].text |
五、六、七條。我們先針對五、六、七的說明然後後面再處理剛剛保留的地方。然後第五條的部分。 |
| transcript.whisperx[356].start |
11725.168 |
| transcript.whisperx[356].end |
11747.617 |
| transcript.whisperx[356].text |
第五條的部分的話我們就照大家的一個昨天討論的共識第五條的條文裡面我重新念一次中央主管金官應組成再生醫療審議會以下簡稱審議會致委員若干人就醫藥生技倫理法律相關專業學者專家及並有團體聘派兼職由衛福 |
| transcript.whisperx[357].start |
11751.858 |
| transcript.whisperx[357].end |
11776.315 |
| transcript.whisperx[357].text |
衛生福利部部長或部長就委員中指定一人擔任召集人。第一項第二項前項審議會辦理下列再生醫療事項一、發展創新及推動政策之諮詢二、正確知識及觀念宣導之諮詢三、病人安全及醫療品質提升之諮詢四、人才培育推動之諮詢五、研究發展及獎勵補助之諮詢審議 |
| transcript.whisperx[358].start |
11778.797 |
| transcript.whisperx[358].end |
11805.675 |
| transcript.whisperx[358].text |
六（再生製劑及再生技術管理之諮詢。七（何與再生製劑有付付款許可之審議。八（執行成效評估之諮詢。九（其他再生醫療相關事項之諮詢。第一項審議會之組成一是利益迴避及其他應遵行事項之辦法由中央主管機關定之。第一項審議會任意性別委員不得少於委員總數三分之一。 |
| transcript.whisperx[359].start |
11806.115 |
| transcript.whisperx[359].end |
11811.057 |
| transcript.whisperx[359].text |
三）繼續審查委員羅廷瑋等21人擬具〈再生醫療法草案案〉案〈再生醫療法草案案〉案〈再生醫療法草案案〉案〈再生醫療法草案案〉案〈再生醫療法草案案〉案 |
| transcript.whisperx[360].start |
11834.745 |
| transcript.whisperx[360].end |
11854.096 |
| transcript.whisperx[360].text |
規定中央主管機關的相關的規定。」我們這邊的立法說明就增加了前面的。然後第二項是為確保審議會之公正性。源於第三項規定也就是相關的組成議事利益回避的應該遵循的事項。然後第三項是在講第四項的芯片比例的規定以上。 |
| transcript.whisperx[361].start |
11855.546 |
| transcript.whisperx[361].end |
11879.263 |
| transcript.whisperx[361].text |
各位委員有一些嗎?呃,劉建國委員。不好意思,不好意思。部長還有各位聽聽看看好不好,因為這一個昨天我來有提修正動議,把委員有的那個修正動議有一些漏掉,我想這個大家的共識我就尊重了。不過法律,法律完了之後就法律相關專業學者, |
| transcript.whisperx[362].start |
11881.784 |
| transcript.whisperx[362].end |
11900.825 |
| transcript.whisperx[362].text |
法律相關專業學者,應該是法律及其他相關專業學者才對,這應該是文字的漏掉,不然你就變成法律相關,那就一大堆的法律相關都可以來了,這其一,所以這應該是漏掉文字。其二,請部長我們再審視一下, |
| transcript.whisperx[363].start |
11905.808 |
| transcript.whisperx[363].end |
11929.334 |
| transcript.whisperx[363].text |
這個這再生醫療審議會我我我我越看越怪怪的第一在第二項裡面的針對相關的事項我們的審議會的主要功能是在做什麼做第一發展創新推動政策諮詢第二正確知識諮詢第三病人安全嘟嘟嘟諮詢第四人才培育諮詢 |
| transcript.whisperx[364].start |
11930.334 |
| transcript.whisperx[364].end |
11958.808 |
| transcript.whisperx[364].text |
第五研究發展獎勵補助諮詢審議。第一個審議出現了研究發展獎勵補助諮詢。第六個再生資技及再生技術管理諮詢。到了第六項才有一個審議而已。第七何與再生資技有付款許可之審議。這是第二個審議。 |
| transcript.whisperx[365].start |
11960.854 |
| transcript.whisperx[365].end |
11971.898 |
| transcript.whisperx[365].text |
只有針對付款許可。第八執行成效評估諮詢。第九其他再生醫療相關事項諮詢。感覺就是諮詢委員會。他們在審再生醫療的技術再生治劑的事項。這個叫做再生醫療審議會。名不符實。 |
| transcript.whisperx[366].start |
11993.089 |
| transcript.whisperx[366].end |
11994.83 |
| transcript.whisperx[366].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[367].start |
12019.665 |
| transcript.whisperx[367].end |
12040.65 |
| transcript.whisperx[367].text |
政府機構要負最後責任,就是說你不可以推給專家,就像藥嘛,你們都推給專家啊,啊專家要不要公開透明,就是說這樣子,所以我昨天本來也想第七項是要是只有學術研究啊那個可以用審議,但是那個實際治療我也是希望說用諮議,那那個意思是一個是做建議,一個是做最後的責任承擔啦, |
| transcript.whisperx[368].start |
12043.01 |
| transcript.whisperx[368].end |
12043.23 |
| transcript.whisperx[368].text |
王振興委員 |
| transcript.whisperx[369].start |
12061.403 |
| transcript.whisperx[369].end |
12063.865 |
| transcript.whisperx[369].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[370].start |
12089.861 |
| transcript.whisperx[370].end |
12112.787 |
| transcript.whisperx[370].text |
邱議瑩還有意見嗎?我想聽部長說明因為王委員的看法我尊重不過基本上因為你在這9項裡面就是有兩個審議嘛這是明確的嘛我們又叫做再生醫療的審議會那你不去針對醫療的技術再生的試劑去審議你去做其他的審議這就...不然你笑成這樣我也不知道怎麼演 |
| transcript.whisperx[371].start |
12119.389 |
| transcript.whisperx[371].end |
12129.457 |
| transcript.whisperx[371].text |
我還是再重複再說明一次本來在上一屆的時候那原本提出來的是通通都是諮詢各項都是用諮詢後來是在討論的時候 |
| transcript.whisperx[372].start |
12135.701 |
| transcript.whisperx[372].end |
12163.83 |
| transcript.whisperx[372].text |
當時的邱太元委員認為說付付款許可的再生醫療字跡的話那應該要有人double check所以除了在再生醫療字跡那是在食藥署那邊有一個專家小組去去審查之後的話還是應該到這一個我們再生醫療法裡面的這一個這一個會議來再度去做審查 |
| transcript.whisperx[373].start |
12164.97 |
| transcript.whisperx[373].end |
12193.085 |
| transcript.whisperx[373].text |
所以那時候就是很堅持就是說這一個部分付付款的這一個再生醫療資金的就是說付付款同意的這一個部分的話還要送到這邊來做審議所以那另外一個當然比較沒有那麼嚴重就是有關於那個獎勵發展這部分的話其實諮詢跟審議並沒有太大的差別 |
| transcript.whisperx[374].start |
12194.945 |
| transcript.whisperx[374].end |
12217.876 |
| transcript.whisperx[374].text |
因為那個錢要獎勵要獎勵多少主案去做審查這個其實是比較沒有影響沒有那麼大但是因為第7款加入的關係就是付付款許可的這個加入的關係所以變成是要把本來我們也是寫的知醫會要改成審醫會那我想 |
| transcript.whisperx[375].start |
12220.997 |
| transcript.whisperx[375].end |
12247.268 |
| transcript.whisperx[375].text |
這是當時邱委員很堅持的一點,在討論的過程當中他很堅持的一點。邱委員重要嗎?不是重要不重要的問題。我是講那個過程。因為邱志偉是這一屆才來,那是上一屆的。當然他重要,因為再過來他就是坐在這個地方跟你對話。 |
| transcript.whisperx[376].start |
12250.222 |
| transcript.whisperx[376].end |
12251.303 |
| transcript.whisperx[376].text |
邱議瑩委員 |
| transcript.whisperx[377].start |
12276.024 |
| transcript.whisperx[377].end |
12280.708 |
| transcript.whisperx[377].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[378].start |
12306.159 |
| transcript.whisperx[378].end |
12308.021 |
| transcript.whisperx[378].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[379].start |
12323.951 |
| transcript.whisperx[379].end |
12324.652 |
| transcript.whisperx[379].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[380].start |
12346.024 |
| transcript.whisperx[380].end |
12365.884 |
| transcript.whisperx[380].text |
那剛剛有那個文字修正是不是再念一下?不是不是我還是再講一下啦齁這個不是或啦是及其他啦齁那文字是這樣法律及其他法律及其他沒事沒事沒事我是提醒一下就是說 |
| transcript.whisperx[381].start |
12369.349 |
| transcript.whisperx[381].end |
12382.727 |
| transcript.whisperx[381].text |
因為現在在審的是薛部長未來那個邱部長是不是如期可以到任我們都很難去預估嘛不是不是這個 |
| transcript.whisperx[382].start |
12384.028 |
| transcript.whisperx[382].end |
12402.435 |
| transcript.whisperx[382].text |
是在這個任期要去學部長的任內而且部長是最後一天要完成這個很重要的事情但是因為部長也有法律的背景嘛所以我才特別希望他講清楚的原因但部長剛才又講諮詢跟審議好像那個界線也沒有太大 |
| transcript.whisperx[383].start |
12403.994 |
| transcript.whisperx[383].end |
12407.719 |
| transcript.whisperx[383].text |
因為我們希望把事情處理好嘛所以這一個這個這個再生醫療審議會 |
| transcript.whisperx[384].start |
12418.954 |
| transcript.whisperx[384].end |
12420.175 |
| transcript.whisperx[384].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[385].start |
12444.136 |
| transcript.whisperx[385].end |
12459.082 |
| transcript.whisperx[385].text |
所以我才會再提醒一下就是就是通通的針對再生醫療的這個醫療技術啦還是繼續做審議然後只有只有這個何以而且何以再生自己有戶款許可之審議 |
| transcript.whisperx[386].start |
12460.642 |
| transcript.whisperx[386].end |
12475.745 |
| transcript.whisperx[386].text |
我跟這行人很牽強第二件事情第三件事情就是我們是已經把各類別的人盡量可以納入到審議會都把他納進來了就醫、藥、生技、倫理、法律及相關專業學者、專家還有所謂講的病友團體 |
| transcript.whisperx[387].start |
12488.448 |
| transcript.whisperx[387].end |
12505.548 |
| transcript.whisperx[387].text |
但是這個好像我們只是把很多的類別大鍋槽放進來這個審議會都不需要的委員都不需要任何的資格限定就這個應該我是希望把這個審議會真的是要定位非常清楚啦就這樣而已 |
| transcript.whisperx[388].start |
12508.828 |
| transcript.whisperx[388].end |
12526.598 |
| transcript.whisperx[388].text |
因為現在我們的這一個條文的第二項對於這一些組成成員的資格的話我們會去訂第二項的話是第三項第三項的部分的話中央主管機關會 |
| transcript.whisperx[389].start |
12531.18 |
| transcript.whisperx[389].end |
12555.417 |
| transcript.whisperx[389].text |
對於審議會的組成、議事等等這些會定所以資格的部分會在那個地方去定第三項的部分我們就會定那個審議會的那個組成組成要包括人員有幾名然後資格各種專業的資格是什麼樣的資格這我們會去定 |
| transcript.whisperx[390].start |
12560.501 |
| transcript.whisperx[390].end |
12561.122 |
| transcript.whisperx[390].text |
二）繼續審查委員邱議瑩等21人擬具 |
| transcript.whisperx[391].start |
12580.654 |
| transcript.whisperx[391].end |
12594.232 |
| transcript.whisperx[391].text |
他有這個背後是醫事公會的這樣子的一個訴求認為說對於付付款的這種許可的這種字跡的許可 |
| transcript.whisperx[392].start |
12594.973 |
| transcript.whisperx[392].end |
12597.295 |
| transcript.whisperx[392].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[393].start |
12622.216 |
| transcript.whisperx[393].end |
12624.417 |
| transcript.whisperx[393].text |
這一個審議會是由衛生福利部部長或其指定之人來擔任召集人。 |
| transcript.whisperx[394].start |
12641.906 |
| transcript.whisperx[394].end |
12664.465 |
| transcript.whisperx[394].text |
所以當他在這個審議會裡面做了決定其實就等到衛福部的決定了大概是這樣子所以如果我們只用知議的話那也就是說這個知議會做出來的一個決定只是一個建議那必須要到衛福部去那最後還是部長 |
| transcript.whisperx[395].start |
12665.866 |
| transcript.whisperx[395].end |
12667.548 |
| transcript.whisperx[395].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[396].start |
12694.136 |
| transcript.whisperx[396].end |
12695.321 |
| transcript.whisperx[396].text |
以前（就算現在（ |
| transcript.whisperx[397].start |
12696.263 |
| transcript.whisperx[397].end |
12724.202 |
| transcript.whisperx[397].text |
在我們衛福部裡面的醫學相關的委員會裡面用審議委員會的大概主要就是那個醫事審議委員會那醫事審議委員會大概分三個小組在進行其中只有一個小組他做出來的決定是用這一個醫審會的名義發文的他就是醫療糾紛鑑定小組 |
| transcript.whisperx[398].start |
12734.187 |
| transcript.whisperx[398].end |
12752.275 |
| transcript.whisperx[398].text |
其他部分的話,包括醫療資源的配置等等這些,他還是必須要經過衛福部,那是由部長這邊去,也就像我們那個分區,那個次區域的劃分等等這些,那醫事審議委員會做出這個決定。 |
| transcript.whisperx[399].start |
12754.996 |
| transcript.whisperx[399].end |
12755.777 |
| transcript.whisperx[399].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[400].start |
12780.454 |
| transcript.whisperx[400].end |
12780.995 |
| transcript.whisperx[400].text |
負責審查委員 |
| transcript.whisperx[401].start |
12797.279 |
| transcript.whisperx[401].end |
12814.466 |
| transcript.whisperx[401].text |
資格審查及應該是要放進去,不然就沒有任何的依循。這是其一。我是建議這樣。第二,因為是部長講的,不管是怎樣,不管是這個委員會還是 |
| transcript.whisperx[402].start |
12818.528 |
| transcript.whisperx[402].end |
12841.728 |
| transcript.whisperx[402].text |
還是未來就是說如果沒有諮詢會還是會到部長的這個位階裡面去做處理這基本上就是以實務操作這樣我可以認可但是也不能也不能有一些沒有必要衝突你看要證許可這個付款許可其實它都歸屬在我們的資金條例的管理範疇這主管機關是FDA |
| transcript.whisperx[403].start |
12845.291 |
| transcript.whisperx[403].end |
12846.152 |
| transcript.whisperx[403].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[404].start |
12860.666 |
| transcript.whisperx[404].end |
12861.606 |
| transcript.whisperx[404].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[405].start |
12879.872 |
| transcript.whisperx[405].end |
12881.633 |
| transcript.whisperx[405].text |
我可不可以在第一項審議委員會之委員資格組成 |
| transcript.whisperx[406].start |
12908.891 |
| transcript.whisperx[406].end |
12919.774 |
| transcript.whisperx[406].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三） |
| transcript.whisperx[407].start |
12938.18 |
| transcript.whisperx[407].end |
12939.341 |
| transcript.whisperx[407].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[408].start |
12967.662 |
| transcript.whisperx[408].end |
12991.92 |
| transcript.whisperx[408].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案 第5條和立法說明就照行政院的修正版本通過。接下來是第6條的立法說明。第6條的部分的話是因為我們第6條新增了一些委託方式必須有主管機關公告所以我們就增加了說明的第二項就是考量再生 |
| transcript.whisperx[409].start |
12993.421 |
| transcript.whisperx[409].end |
13016.13 |
| transcript.whisperx[409].text |
醫療具新興生物醫學之特性,為確保其所需之組織細胞來源之品質等相關事項,源於第二項授權中關主管機關就委託方式資格條件另訂定並公告之以上。委員有意見嗎?沒有。那就照行政院修正的這個版本通過。 |
| transcript.whisperx[410].start |
13018.342 |
| transcript.whisperx[410].end |
13036.954 |
| transcript.whisperx[410].text |
接下來第7條的立法說明第7條的部分的話是因為昨天委員這邊決議是說把執行再生技術然後這邊特別要強調的是人體試驗所以我們在這邊的話是在第一項的這邊再增加說明就是再生技術為醫療法規所規定之醫療行為並具有專業技術性 |
| transcript.whisperx[411].start |
13042.157 |
| transcript.whisperx[411].end |
13066.662 |
| transcript.whisperx[411].text |
治療方法與合併使用再生醫療製劑之複雜度高且發展快速多變之特性。」然後這樣子的一個前面的規定我們就是把再生技術的特性寫出來後面增加的修正的是原規定醫療機構執行再生技術前除有第8條第一項規定提醒外因醫療法第8條規定進行並完成人體試驗並再生 |
| transcript.whisperx[412].start |
13070.482 |
| transcript.whisperx[412].end |
13085.707 |
| transcript.whisperx[412].text |
醫療製劑因依再生醫療製劑管理條例完成查驗登記並取得藥品許可證或有付款許可,使得上市急功臨床使用並與說明。就是再次強調這個人體試驗的這個重要性以上。 |
| transcript.whisperx[413].start |
13087.745 |
| transcript.whisperx[413].end |
13107.492 |
| transcript.whisperx[413].text |
委員有意見嗎?我們那個立法說明我今天有簽署那個附帶決議就是因為最後那個不確定性很高疫情的沿江市整體發展狀況另訂定相關指揮公約就參考那我們今天是像應訂定專屬再生醫療人體實驗辦法這個比較約束力啊 |
| transcript.whisperx[414].start |
13111.733 |
| transcript.whisperx[414].end |
13126.503 |
| transcript.whisperx[414].text |
就是比較具有就是在在你們說明的最後面那幾行而在臨床試驗中傳統期緣模式不再明確這個我們接受且人體試驗之範圍以目的性有異於臨床試驗原將是整體 |
| transcript.whisperx[415].start |
13128.325 |
| transcript.whisperx[415].end |
13129.025 |
| transcript.whisperx[415].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[416].start |
13144.386 |
| transcript.whisperx[416].end |
13145.226 |
| transcript.whisperx[416].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[417].start |
13168.656 |
| transcript.whisperx[417].end |
13192.73 |
| transcript.whisperx[417].text |
稍微怎麼樣寫會是比較符合你現在寫的這個發展狀況,欸這個這樣可以這樣講嗎?看發展狀況。定定這個相關資源。我是不是可以這樣的建議啦,就不要用辦法,因為辦法的話就必須要在法律裡面去、母法裡面去定要有授權。要改成指引啦,我們就可以接受。 |
| transcript.whisperx[418].start |
13192.93 |
| transcript.whisperx[418].end |
13193.59 |
| transcript.whisperx[418].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[419].start |
13218.551 |
| transcript.whisperx[419].end |
13244.298 |
| transcript.whisperx[419].text |
你可以寫這麼多你可以直接在下面啊就是最後說明就是立法說明最下面立法說明的部分齁對啊你最後那幾個行字你看岩江那個倒數倒數第二三行啊再拉高一點你覺得寫直譯有彈性OK啊對所以那個文字要怎麼樣改委員的意思 |
| transcript.whisperx[420].start |
13246.353 |
| transcript.whisperx[420].end |
13247.373 |
| transcript.whisperx[420].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[421].start |
13272.807 |
| transcript.whisperx[421].end |
13273.087 |
| transcript.whisperx[421].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[422].start |
13300.6 |
| transcript.whisperx[422].end |
13325.567 |
| transcript.whisperx[422].text |
你說不要辦法嘛,辦法太硬嘛。所以就是說解人體試驗之範圍與目的性有異於臨床試驗之艱險。我覺得訂定相關時就可以。對阿應該那句就那個原將是整體發展狀況的三段。相關就是再生醫療阿,不能把再生醫療這四個字寫進去嗎? |
| transcript.whisperx[423].start |
13340.29 |
| transcript.whisperx[423].end |
13342.672 |
| transcript.whisperx[423].text |
三）繼續審查委員羅廷瑋等21人擬具 «三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[424].start |
13363.905 |
| transcript.whisperx[424].end |
13387.163 |
| transcript.whisperx[424].text |
然後然後後面的就是維持原案就是定定令相關指引供醫療機構參考運用並與續名並與續名好好那第7條就照剛剛話這個行政院的修正版本通過好那剛剛呃有暫時保留是第8條第19條還有24條那個文字是不是對已經哦在這裡OK好對 |
| transcript.whisperx[425].start |
13399.476 |
| transcript.whisperx[425].end |
13418.708 |
| transcript.whisperx[425].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事宜及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生福利及衛生 |
| transcript.whisperx[426].start |
13424.264 |
| transcript.whisperx[426].end |
13443.67 |
| transcript.whisperx[426].text |
我們先就那個第8條我們確定的建議文字我重新念一遍醫療機構執行再生技術有下列情形之一者免完成人體試驗一治療危及生命或嚴重失能之疾病且國內尚無適當之藥品醫療器材或醫療技術 |
| transcript.whisperx[427].start |
13444.79 |
| transcript.whisperx[427].end |
13462.357 |
| transcript.whisperx[427].text |
二）本法施行前醫療機構經中央主管機關核准執行之再生技術,前向第一款之條件申請案例數限制,倫理規範及其他應遵循事項由中央主管機關公告之,但其治療應排除液體細胞組織。 |
| transcript.whisperx[428].start |
13465.581 |
| transcript.whisperx[428].end |
13485.629 |
| transcript.whisperx[428].text |
醫療機構執行第一項,下面的這兩項其實都跟之前一樣,所以我就沒有要再念,然後我們增加了新的說明的部分的主要是在第一項。第七條規定醫療機構執行在生技術前應進行並完成人體試驗,但臨床上病情危急, |
| transcript.whisperx[429].start |
13486.409 |
| transcript.whisperx[429].end |
13488.57 |
| transcript.whisperx[429].text |
三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[430].start |
13507.02 |
| transcript.whisperx[430].end |
13531.297 |
| transcript.whisperx[430].text |
然後或後面大概都一樣就是說針對的是第二款的部分然後我們補充的說明是考量原科轉計畫以明定效期藉其責案本法第12條規定申請均得例外免於國內完成人體試驗這是我們說做的第一部分的修正然後第四點的部分的話我們是在特別強調的是其 |
| transcript.whisperx[431].start |
13532.418 |
| transcript.whisperx[431].end |
13542.627 |
| transcript.whisperx[431].text |
治療或有輸入再生之機。強調治療的部分。第8條的部分我們做了以上的修正。王委員。確定一下是異種還是異體。異種嘛。所以這邊寫異體。異種。異種。沒有。排除異種。排除異種。對對對。寫錯了。寫錯了。寫錯了。 |
| transcript.whisperx[432].start |
13566.015 |
| transcript.whisperx[432].end |
13589.205 |
| transcript.whisperx[432].text |
對一種細胞好那委員還有意見嗎沒有那就照呃這個行政院的建議修正版本通過在19條19條的部分的話我們就是呃經過剛剛討論我們的建議條文吼第一個就是在第一項裡面我們就是維持治療然後這個是 |
| transcript.whisperx[433].start |
13595.889 |
| transcript.whisperx[433].end |
13613.502 |
| transcript.whisperx[433].text |
且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且,且, |
| transcript.whisperx[434].start |
13626.164 |
| transcript.whisperx[434].end |
13640.997 |
| transcript.whisperx[434].text |
第二項提供者我們把胎兒為胎兒的這一部分也做刪除所以只剩下提供者為限制行為能力或受輔助先告人支持我們留著這個然後接下來的話是第六項 |
| transcript.whisperx[435].start |
13642.438 |
| transcript.whisperx[435].end |
13659.581 |
| transcript.whisperx[435].text |
第六項,第六項的部分的話就是第三項第四項規定再生醫療組織細胞來源之提供者我們也刪除了原本的建議把胎兒拿掉然後那也因為這樣子所以我的立法說明的第二項裡面在講為保護限制行為人 |
| transcript.whisperx[436].start |
13660.99 |
| transcript.whisperx[436].end |
13683.26 |
| transcript.whisperx[436].text |
然後,受輔助宣告之人、無行為人、受監護宣告之人或無意識能力之成年人之身體法醫於第六項規定其統一書應經公正使生效力以為保護效果之強化,令羊水其袋及胎盤不受遣述規定,做了以上的修正。 |
| transcript.whisperx[437].start |
13685.214 |
| transcript.whisperx[437].end |
13710.824 |
| transcript.whisperx[437].text |
這裡的文字可能稍微再做一點調整就立法說明了這個部分令最後一段令養水的令後面的話我建議是令胎兒不作為那個細胞或組織的提供來源但養水幾代及胎盤不受這個前述規定限制 |
| transcript.whisperx[438].start |
13722.079 |
| transcript.whisperx[438].end |
13739.418 |
| transcript.whisperx[438].text |
那個座位的座是要另外那一個座規定限制最後要加一個限制 |
| transcript.whisperx[439].start |
13742.432 |
| transcript.whisperx[439].end |
13764.336 |
| transcript.whisperx[439].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三 |
| transcript.whisperx[440].start |
13776.705 |
| transcript.whisperx[440].end |
13804.132 |
| transcript.whisperx[440].text |
三）繼續審查委員羅廷瑋等22人擬具〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療法草案〉案〈再生醫療 |
| transcript.whisperx[441].start |
13808.256 |
| transcript.whisperx[441].end |
13829.058 |
| transcript.whisperx[441].text |
三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案件事宜、三 |
| transcript.whisperx[442].start |
13830.499 |
| transcript.whisperx[442].end |
13832.42 |
| transcript.whisperx[442].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[443].start |
13860.373 |
| transcript.whisperx[443].end |
13884.532 |
| transcript.whisperx[443].text |
可不可以改成組織細胞?因為前面都是組織細胞。各位委員在針對文字的部分再確認一下。組織跟細胞中間要頓耗嗎? |
| transcript.whisperx[444].start |
13888.832 |
| transcript.whisperx[444].end |
13889.512 |
| transcript.whisperx[444].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[445].start |
13927.585 |
| transcript.whisperx[445].end |
13936.411 |
| transcript.whisperx[445].text |
第二四條的部分的話我念一次齁就是修正的地方的話會是在第三項第三項中央主管機關 |
| transcript.whisperx[446].start |
13946.429 |
| transcript.whisperx[446].end |
13952.313 |
| transcript.whisperx[446].text |
因每年公開第一項醫療機構之治療效果及統計之醫療品質資訊都好以維護民眾權益這是做的文字修正 |
| transcript.whisperx[447].start |
13975.623 |
| transcript.whisperx[447].end |
13976.043 |
| transcript.whisperx[447].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[448].start |
14006.809 |
| transcript.whisperx[448].end |
14033.725 |
| transcript.whisperx[448].text |
每年……然後 這個改完之後就跳到第二項第二項有一個治療效果前項報告內容應包括案例數治療效果這是內文的部分好好 |
| transcript.whisperx[449].start |
14036.065 |
| transcript.whisperx[449].end |
14045.069 |
| transcript.whisperx[449].text |
第24條就照行政院的版本建議修正通過。還有附帶決議。附帶決議第一案。 |
| transcript.whisperx[450].start |
14062.227 |
| transcript.whisperx[450].end |
14063.529 |
| transcript.whisperx[450].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[451].start |
14075.768 |
| transcript.whisperx[451].end |
14093.331 |
| transcript.whisperx[451].text |
再生醫療法附帶決議第1案有鑒於再生醫療法之立法目的為取代現行特管法,原要求主管機關針對目前特管法已核准執行之再生技術訂定落日條款。提案人委員陳昭姿、王育敏、林淑芬第二案 |
| transcript.whisperx[452].start |
14094.79 |
| transcript.whisperx[452].end |
14108.117 |
| transcript.whisperx[452].text |
本次我國再生醫療法再生醫療製劑條例立法所採用之醫療技術與製劑的雙軌制模式與日本制度相同,應可借盡其經驗,原要求衛生福利部應嚴格規範與醫療機構內執行之再生醫療技術與最小操作 |
| transcript.whisperx[453].start |
14114.48 |
| transcript.whisperx[453].end |
14130.551 |
| transcript.whisperx[453].text |
最小操作下執行避免出現規避查驗登記程序平白讓患者付出昂貴醫療費用卻僅得到療效未經證實之治療等違背醫學倫理之狀況。提案人委員陳昭芝、王育敏、林淑芬 |
| transcript.whisperx[454].start |
14131.151 |
| transcript.whisperx[454].end |
14153.989 |
| transcript.whisperx[454].text |
第三）為維護病人之健康安全與權益,原要求中央主管機關參考美國《適用權法案》明確規範醫療機構施用此類技術時,需通過嚴謹病情評估與治療方法審查之辦法。提案人委員陳昭姿、王玉敏、林淑芬。第四案,在《新醫療法》正式施行後, |
| transcript.whisperx[455].start |
14154.87 |
| transcript.whisperx[455].end |
14169.963 |
| transcript.whisperx[455].text |
特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法第二章第一節細胞治療技術及公告廢止提案人委員王振旭、林淑芬、林月琴、劉建國、邱議瑩。第五案 |
| transcript.whisperx[456].start |
14170.623 |
| transcript.whisperx[456].end |
14187.72 |
| transcript.whisperx[456].text |
有關再生醫療法草案第五條審議會之辦理事項審議諮詢之規定主管機關應定出相關辦法明確規範上述事項確保審議會之運作以及病人權益提案人委員劉建國林月琴王正旭 |
| transcript.whisperx[457].start |
14188.661 |
| transcript.whisperx[457].end |
14214.299 |
| transcript.whisperx[457].text |
第六案有關再生醫療法草案第五條第一項第七款所稱再生致濟有付款許可之審議系審查有付款許可之再生致濟其整體風險效益及付款要求考量疾病危及生命或嚴重失能之要件符合性以確屬有益於病人之治療選擇提案人委員劉建國林月琴王振旭宣讀完畢 |
| transcript.whisperx[458].start |
14215.865 |
| transcript.whisperx[458].end |
14235.489 |
| transcript.whisperx[458].text |
二）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案．一）繼續審查委員羅廷瑋等21人擬 |
| transcript.whisperx[459].start |
14245.828 |
| transcript.whisperx[459].end |
14258.299 |
| transcript.whisperx[459].text |
再生醫療法草案 總共有9案審查完略並按擬具審查報告提報院會討論。院會討論本案時由黃昭吉委員秀芳補充說明那不須交由黨團協商 |
| transcript.whisperx[460].start |
14276.717 |
| transcript.whisperx[460].end |
14278.407 |
| transcript.whisperx[460].text |
呃（本法案條次．有嗎? |
| transcript.whisperx[461].start |
14292.754 |
| transcript.whisperx[461].end |
14308.548 |
| transcript.whisperx[461].text |
那本法案的條次及援引條次授權醫師人員調整相關立法說明授權行政單位提供好那我們這個再生醫療法草案就先這樣通過了那接下來還有 |
| transcript.whisperx[462].start |
14311.026 |
| transcript.whisperx[462].end |
14329.801 |
| transcript.whisperx[462].text |
現在繼續進行討論事項第二案,再生醫療治劑條例草案。那保留的條文的審查每條條文仍先請行政單位說明,接著由委員來表示意見。那我們保留的條文是第12條。第三條。第三。有嗎? |
| transcript.whisperx[463].start |
14343.171 |
| transcript.whisperx[463].end |
14362.853 |
| transcript.whisperx[463].text |
第三條我們有加前項再生醫療制計屬於藥事法第6條規定之藥品昨天保留就12條 |
| transcript.whisperx[464].start |
14366.748 |
| transcript.whisperx[464].end |
14383.333 |
| transcript.whisperx[464].text |
第12條因為委員建議我們在第一項的部分就是但顯有益於治療特定人口群所以在這邊我們就另外是要把治療加上去這個我們電腦電腦螢幕那另外在 |
| transcript.whisperx[465].start |
14398.479 |
| transcript.whisperx[465].end |
14424.475 |
| transcript.whisperx[465].text |
第六項的部分我們增加的是第三項第四項規定再生醫療組織細胞來源之提供者為胎兒限制行為能力人受輔助宣告之人無行為能力人受肩負宣告之人或無意識能力之成年人取得之書面同意應經公正使生效力所以這裡 |
| transcript.whisperx[466].start |
14425.976 |
| transcript.whisperx[466].end |
14445.205 |
| transcript.whisperx[466].text |
三）繼續審查委員羅廷瑋等21人擬具 «再生醫療法草案案案件事宜,為保護胎兒,限制行為能力人,受輔助宣告之人,無行為能力人,受肩負宣告之人,或無意識能力之成年人之身體法役。 |
| transcript.whisperx[467].start |
14446.286 |
| transcript.whisperx[467].end |
14455.957 |
| transcript.whisperx[467].text |
與第六項規定其同意書應經公正使生效力,以為保護效果之強化。」所以這是我們整個修改的部分。 |
| transcript.whisperx[468].start |
14459.12 |
| transcript.whisperx[468].end |
14460.061 |
| transcript.whisperx[468].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[469].start |
14481.966 |
| transcript.whisperx[469].end |
14498.312 |
| transcript.whisperx[469].text |
就是要把胎兒拿掉因為我們第12條的最前面的部分是衛工製造再生醫療製劑就是說他已經是一個再生醫療製劑了 |
| transcript.whisperx[470].start |
14500.805 |
| transcript.whisperx[470].end |
14518.292 |
| transcript.whisperx[470].text |
但是它在成為字跡之前是必須要有提供者那提供者為胎兒時這就會跟再生醫療法剛剛我們審查的是不一致我是認為你這邊也不會有用到胎兒的東西啦 |
| transcript.whisperx[471].start |
14519.451 |
| transcript.whisperx[471].end |
14520.212 |
| transcript.whisperx[471].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[472].start |
14537.379 |
| transcript.whisperx[472].end |
14557.693 |
| transcript.whisperx[472].text |
主席對不起我稍微再提醒一下就是第12條條文裡面的第一項但有顯有益於治療特定人口群這邊寫或可是我們之前在再生醫療法上面寫且所以這邊要確認一下這也可以改且對這是可以一致的是這一條的話你們在哪裏就在跟那個剛剛再生醫療 |
| transcript.whisperx[473].start |
14564.969 |
| transcript.whisperx[473].end |
14592.428 |
| transcript.whisperx[473].text |
就胎兒的部分都把它拿掉這樣是好好不好那要不要現在直接改好不好就在螢幕上面好嗎第一段的已經改了嗎然後再來第一項我看一下第三項第三項提供者那從為胎兒死那裡開始就刪掉就改的是不是 |
| transcript.whisperx[474].start |
14594.429 |
| transcript.whisperx[474].end |
14595.69 |
| transcript.whisperx[474].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[475].start |
14638.394 |
| transcript.whisperx[475].end |
14646.636 |
| transcript.whisperx[475].text |
各位委員有沒有意見?沒有,那就照行政院版本建議修正通過。 |
| transcript.whisperx[476].start |
14647.705 |
| transcript.whisperx[476].end |
14649.127 |
| transcript.whisperx[476].text |
第5條的說明。 |
| transcript.whisperx[477].start |
14663.322 |
| transcript.whisperx[477].end |
14684.927 |
| transcript.whisperx[477].text |
第五條的說明是在第三項的部分就是因為我們在我們在條文的部分那時候有陣列應由專任藥師駐場監製這個所以在說明欄的第三項又再生醫療之際本屬藥品依藥事法第29條第一項規定應由專任藥師駐場監製為求明確源於第二項明定之 |
| transcript.whisperx[478].start |
14696.502 |
| transcript.whisperx[478].end |
14707.278 |
| transcript.whisperx[478].text |
各位委員有沒有意見?沒有。那就照行政院版本建議修正通過。再來是第20。 |
| transcript.whisperx[479].start |
14713.209 |
| transcript.whisperx[479].end |
14735.221 |
| transcript.whisperx[479].text |
第二十條也是說明欄的部分因為委員希望我們對於裁罰三萬以上兩百萬以下的這個能夠有更明確的說明所以在說明欄有加了裁處時因審酌違反情節累計違反次數違反所得利益及其他審酌因素為緩緩而度之依據各位委員有沒有意見 |
| transcript.whisperx[480].start |
14741.067 |
| transcript.whisperx[480].end |
14741.527 |
| transcript.whisperx[480].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[481].start |
14750.681 |
| transcript.whisperx[481].end |
14777.323 |
| transcript.whisperx[481].text |
第二十一條因為那時候有增加了要去公證的部分所以在第十二條就有第三項就是也多了一個第六項那第六項如果他們沒有去辦公證那到這邊我們華環也跟著同步所以在第21條的第一項第六款的部分我們有加一個就是後面那裡 |
| transcript.whisperx[482].start |
14778.584 |
| transcript.whisperx[482].end |
14803.431 |
| transcript.whisperx[482].text |
或為依同條第三項至第六項有關同意權行使規定者違反的,這個一樣會裁罰,所以是因為增加那個6。各位委員有沒有意見?沒有。那就照這個行政院的版本建議修正的通過。還有哪個?第三案本來是第17條,現在多了一個21條。 |
| transcript.whisperx[483].start |
14806.687 |
| transcript.whisperx[483].end |
14813.481 |
| transcript.whisperx[483].text |
負貸決議。」好,那負貸決議請宣讀。再生醫療制計條例草案負貸決議第三案。 |
| transcript.whisperx[484].start |
14815.12 |
| transcript.whisperx[484].end |
14841.753 |
| transcript.whisperx[484].text |
行政院版再生醫療自治條例草案第17條及第21條定名中央主管機關指定品項於上市後指定期間內需進行安全監視為平衡安全監視與病人隱私之考量應比照藥品安全監視管理辦法第15條規定當藥商執行藥品的安全監視時若有必要收集、處理或利用個人資料 |
| transcript.whisperx[485].start |
14842.253 |
| transcript.whisperx[485].end |
14865.032 |
| transcript.whisperx[485].text |
因嚴格遵守個人資料保護法及其相關法規之規定,提案人委員陳昭芝、王玉敏、林淑芬宣讀完畢。來,行政單位有沒有意見?這是有關藥品安全監視辦法這個,我們可以遵照辦理。好,那附帶決議就 |
| transcript.whisperx[486].start |
14868.072 |
| transcript.whisperx[486].end |
14870.653 |
| transcript.whisperx[486].text |
二）繼續審查委員羅廷瑋等21人擬具二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[487].start |
14893.326 |
| transcript.whisperx[487].end |
14894.166 |
| transcript.whisperx[487].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[488].start |
14918.251 |
| transcript.whisperx[488].end |
14944.205 |
| transcript.whisperx[488].text |
但是到了製劑製劑的部分的話他就是大規模大量的製造那他的這個公司就是說藥廠嘛他基本上是可能就是規模是比較大的所以對藥廠稍微提高提高法環的那個上限是比較好 |
| transcript.whisperx[489].start |
14944.608 |
| transcript.whisperx[489].end |
14945.389 |
| transcript.whisperx[489].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[490].start |
14973.408 |
| transcript.whisperx[490].end |
14974.912 |
| transcript.whisperx[490].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[491].start |
14985.083 |
| transcript.whisperx[491].end |
14985.743 |
| transcript.whisperx[491].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[492].start |
15009.657 |
| transcript.whisperx[492].end |
15010.458 |
| transcript.whisperx[492].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[493].start |
15029.196 |
| transcript.whisperx[493].end |
15042.224 |
| transcript.whisperx[493].text |
再生醫療制計條例草案總共9案審查完略並按擬具審查報告提報院會討論。院會討論本案時由黃昭吉委員秀芳補充說明,不須交由黨團協商。 |
| transcript.whisperx[494].start |
15044.105 |
| transcript.whisperx[494].end |
15059.594 |
| transcript.whisperx[494].text |
本法案條次及援引條次授權醫事人員調整相關立法說明授權行政單位提供。那這個快散會之前我先感謝部長因為看下禮拜的這個議程部長可能就不會再進來委員會了所以 |
| transcript.whisperx[495].start |
15063.536 |
| transcript.whisperx[495].end |
15084.856 |
| transcript.whisperx[495].text |
所以感謝部長在一年多對所有衛福部的一些法案這麼用心我們等一下在散會前是不是所有的委員到前面來感謝部長那我們也做一個合影謝謝本次會議到此結束散會 |
| transcript.whisperx[496].start |
15095.253 |
| transcript.whisperx[496].end |
15103.541 |
| transcript.whisperx[496].text |
三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案案 案 等19人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[497].start |
15119.326 |
| transcript.whisperx[497].end |
15120.647 |
| transcript.whisperx[497].text |
三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[498].start |
15149.054 |
| transcript.whisperx[498].end |
15149.398 |
| transcript.whisperx[498].text |
三）繼續審查委員 |
| transcript.whisperx[499].start |
15166.879 |
| transcript.whisperx[499].end |
15171.343 |
| transcript.whisperx[499].text |
三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案案。 |