| IVOD_ID |
15887 |
| IVOD_URL |
https://ivod.ly.gov.tw/Play/Full/1M/15887 |
| 日期 |
2024-05-08 |
| 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 |
2024-05-08T08:30:59+08:00 |
| 結束時間 |
2024-05-08T17:20:00+08:00 |
| 影片長度 |
08:49:01 |
| 支援功能[0] |
ai-transcript |
| video_url |
https://h264media01.ly.gov.tw:443/vod_1/_definst_/mp4:1M/bfaf9b39ac01a68535675eb71f9bc6ae819ba3698dbd896e3be8d109af184be4564b895b3141708b5ea18f28b6918d91.mp4/playlist.m3u8 |
| 會議時間 |
2024-05-08T09:00:00+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 |
08:30:59 - 17:20:00 |
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1796.468 |
| transcript.whisperx[0].text |
請審查委員羅廷瑋等21人擬具、「再生醫療法草案案 案 、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案 、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案 、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案 、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案 、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療法草案 、三）繼續審查委員羅廷瑋等21人擬具、「再生醫療 |
| transcript.whisperx[1].start |
1811.249 |
| transcript.whisperx[1].end |
1817.073 |
| transcript.whisperx[1].text |
這個講話你知道嗎?因為我們今天很大風暴,那個你要解釋的話報告完以後,這個大概就結束了。謝謝。 |
| transcript.whisperx[2].start |
1857.482 |
| transcript.whisperx[2].end |
1858.564 |
| transcript.whisperx[2].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[3].start |
1871.001 |
| transcript.whisperx[3].end |
1884.191 |
| transcript.whisperx[3].text |
好,出席委員已逐法定人數現在開會請議事人員宣讀上次會議議事錄立法院第11屆第1會期社會福利及衛生環境委員會第14次全體委員會議議事錄時間113年5月2日星期四9時至13時19分地點群賢羅801會議室出席委員陳昭芝等15人列席委員林德福等19人 |
| transcript.whisperx[4].start |
1894.119 |
| transcript.whisperx[4].end |
1913.214 |
| transcript.whisperx[4].text |
列席官員衛生福利部部長薛瑞元等相關人員主席王兆吉委員玉敏報告事項宣讀上次會議議事錄決定確定討論事項審查委員王玉敏等19人委員蘇清泉等28人國民黨黨團分別擬具全民健康保險法第62條條文修正草案等3案 |
| transcript.whisperx[5].start |
1913.874 |
| transcript.whisperx[5].end |
1933.25 |
| transcript.whisperx[5].text |
本次會議經委員蘇清泉並代表國民黨黨團委員王玉敏說明提案指去並由衛生福利部部長說明後委員陳昭芝等21人提出質詢均經衛生福利部部長及行政院主計總處基金預算處專門委員黃厚吉及各相關主管等即席答覆委員質詢未及答覆或請補充資料者請相關機關於二周內以書面答覆 |
| transcript.whisperx[6].start |
1937.193 |
| transcript.whisperx[6].end |
1947.325 |
| transcript.whisperx[6].text |
委員令要求期限者從其所定。本次會議由委員陳金輝、廖偉祥及王玉敏等3人提出第62條條文修正動議。決議一、說明及詢答完畢。二、委員王玉敏等19人擬具全民健康保險法第62條條文修正草案等3案審查完均。 |
| transcript.whisperx[7].start |
1954.713 |
| transcript.whisperx[7].end |
1958.398 |
| transcript.whisperx[7].text |
全案均保留含修正動議一案附帶決議三項送院會處理並按擬具審查報告提報院會討論。院會討論時由王兆琪委員玉敏補充說明需交由黨團協商。宣讀完畢。 |
| transcript.whisperx[8].start |
1970.227 |
| transcript.whisperx[8].end |
1993.84 |
| transcript.whisperx[8].text |
請問委員會上次議事錄有無錯誤或遺漏之處?沒有。好。那議事錄確定本次會議議程為審查行政院函請審議委員台灣民眾黨黨團分別擬具再生醫療法草案等6案以及繼續審查委員分別擬具再生醫療法草案等3案。二、審查行政院函請審議委員台灣民眾黨黨團分別擬具 |
| transcript.whisperx[9].start |
1997.722 |
| transcript.whisperx[9].end |
2025.592 |
| transcript.whisperx[9].text |
再生醫療治濟條例草案等6案。」以及繼續審查委員分別擬具:「再生醫療治濟條例草案等3案。」好,那現在介紹在場委員及列席官員。陳昭芝委員。王振旭委員。林月琴委員。陳金輝委員。好,那今天與會的官員有衛福部薛瑞元部長。 |
| transcript.whisperx[10].start |
2027.734 |
| transcript.whisperx[10].end |
2040.328 |
| transcript.whisperx[10].text |
醫事司劉月平司長、食品藥物管理署吳秀美署長、中央健康保險署龐一鳴副署長、法規會陳信成參事、 |
| transcript.whisperx[11].start |
2042.93 |
| transcript.whisperx[11].end |
2069.202 |
| transcript.whisperx[11].text |
國家發展委員會產業發展處上午是副處長陳瓊華副處長那下午是由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周崇斌副司長還有檢任記者戴建成檢任記者 |
| transcript.whisperx[12].start |
2071.525 |
| transcript.whisperx[12].end |
2086.683 |
| transcript.whisperx[12].text |
產業發展署李嘉峰組長．法務部汪南軍參事．數位發展部數位產業署胡貝蒂副署長公平交易委員會法律事務處齊雪莉專門委員 |
| transcript.whisperx[13].start |
2091.357 |
| transcript.whisperx[13].end |
2093.778 |
| transcript.whisperx[13].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[14].start |
2119.904 |
| transcript.whisperx[14].end |
2141.125 |
| transcript.whisperx[14].text |
謝謝主席、各位委員還有各位衛福部的官員還有在座大家早。針對於再生醫療法的部分本院委員包括我在內一共有20位委員針對再生醫療系利用基因、細胞及其原生物用以治療、修護 |
| transcript.whisperx[15].start |
2142.126 |
| transcript.whisperx[15].end |
2148.237 |
| transcript.whisperx[15].text |
或替代人體細胞、組織及器官其範圍包含再生醫療製劑及再生醫療技術 |
| transcript.whisperx[16].start |
2152.168 |
| transcript.whisperx[16].end |
2171.059 |
| transcript.whisperx[16].text |
在目前新興生物醫學科技迅速發展的時代,再生醫療相關領域的技術與智能已逐漸成熟,並加速擴大應用到臨床醫學。建於再生醫療之特質性、特殊性及治療之複雜性,應就醫療機構執行再生醫療的相關管理機制、制定專法來加以規範, |
| transcript.whisperx[17].start |
2179.904 |
| transcript.whisperx[17].end |
2198.603 |
| transcript.whisperx[17].text |
以順應當前醫療發展的趨勢並符合實務管理的需求為了確保再生醫療的品質、安全以及有效性維護病人接受治療的權益對於再生醫療之執行包括醫療機構得執行再生醫療的範疇再生醫療組織細胞來源管理 |
| transcript.whisperx[18].start |
2203.248 |
| transcript.whisperx[18].end |
2222.727 |
| transcript.whisperx[18].text |
人體試驗與研究及監督與預防等事項予以規範所以要供這個醫療機構及其他相關業者有所遵循能依據再生醫療法草案是否有當敬請公決這是有關於再生醫療法提案的部分 |
| transcript.whisperx[19].start |
2224.248 |
| transcript.whisperx[19].end |
2248.742 |
| transcript.whisperx[19].text |
有關於再生醫療治劑提案的相關說明包括本院王振旭等二）將再生醫療細將基因細胞及其衍生物用於人體構造或功能的重建或修復以達到治療或預防人類疾病目的其範圍包括再生醫療技術及再生治劑再生醫療治劑目前再生醫療技術西醫療法 |
| transcript.whisperx[20].start |
2253.064 |
| transcript.whisperx[20].end |
2273.731 |
| transcript.whisperx[20].text |
及其第62條第二項授權定定之特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法管理而再生醫療治劑規列為生物藥品以藥事法管理特有相關審查基準等規範為再生醫療之形態 |
| transcript.whisperx[21].start |
2275.712 |
| transcript.whisperx[21].end |
2300.749 |
| transcript.whisperx[21].text |
技術新營現行管理架構恐難以完全滿足再生醫療需求及促進再生醫療之發展,為推動我國再生醫療產業發展,分別制定再生醫療執行之管理規範,再生醫療法及再生醫療治劑之管理規範,再生醫療治劑條例有其必要性,建立再生醫療治劑之成分益質性, |
| transcript.whisperx[22].start |
2301.63 |
| transcript.whisperx[22].end |
2330.629 |
| transcript.whisperx[22].text |
自成特殊性及治療複雜性風險管制有別於化學或生物製劑現行藥事法相關規範無法完全涵蓋或一體適用參著國際間對再生醫療製劑之立法管理會兼顧我國再生醫療產業發展趨勢建構符合我國實務管理之架構針對再生醫療製劑之組織細胞提供者合適性評估提供者執行同意與招募廣告病人接受先進治療權益及上市後 |
| transcript.whisperx[23].start |
2331.61 |
| transcript.whisperx[23].end |
2360.371 |
| transcript.whisperx[23].text |
流向管理強化等規範予以規範明確提供業者遵循從事細胞及基因之商品化規格化製成加工達到標準而且一致化之再生醫療製劑規範使民眾得以及早接受再生醫療製劑治療會促進再生醫療法之蓬勃發展願擬具再生醫療製劑條例草案作為要施法之特別法健全對再生醫療製劑之管理事為有當敬請公決 |
| transcript.whisperx[24].start |
2365.58 |
| transcript.whisperx[24].end |
2369.814 |
| transcript.whisperx[24].text |
謝謝王建旭委員的說明。那請陳昭芝委員有要代表臺灣民眾黨說明嗎? |
| transcript.whisperx[25].start |
2376.573 |
| transcript.whisperx[25].end |
2376.833 |
| transcript.whisperx[25].text |
謝衣鳯等21人擬具 |
| transcript.whisperx[26].start |
2405.06 |
| transcript.whisperx[26].end |
2429.282 |
| transcript.whisperx[26].text |
第一個要件是要安全。安全然後品質才是療效。那這些都需要這個科學佐證。那因為顧及這個費用比較高昂。所以在倫理學要病人安全跟這個醫學倫理的部分也要有所顧及。那本黨就僅這幾個基本原則提出這個修正草案。那等一下在審查法案的時候會提出這個說明。謝謝主席。謝謝。 |
| transcript.whisperx[27].start |
2430.794 |
| transcript.whisperx[27].end |
2433.509 |
| transcript.whisperx[27].text |
好謝謝陳昭芝委員的說明那接下來請陳金輝委員說明 |
| transcript.whisperx[28].start |
2442.25 |
| transcript.whisperx[28].end |
2462.124 |
| transcript.whisperx[28].text |
主席各位委員各位官員大家早安台灣的醫事人員還有實驗室人才的精良和專業是舉世聞名的所以近年來呢隨著細胞治療技術的進展還有再生醫療技術的突飛猛進特別台灣在組織修復還有慢性疾病的治療上展現了巨大的潛力 |
| transcript.whisperx[29].start |
2462.904 |
| transcript.whisperx[29].end |
2463.504 |
| transcript.whisperx[29].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[30].start |
2481.869 |
| transcript.whisperx[30].end |
2497.147 |
| transcript.whisperx[30].text |
然而由於我國在再生醫療方面的法規尚未完善許多病患被迫前往國外尋求治療面臨著巨大的風險和不確定性這不僅僅是一場身體和疾病的抗戰更是對心理和經濟狀況的雙重折磨 |
| transcript.whisperx[31].start |
2499.449 |
| transcript.whisperx[31].end |
2527.867 |
| transcript.whisperx[31].text |
民國107年衛福部公告特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法這是一個進步但仍然不夠我們需要更全面的法規和監管機制來保障再生醫療的安全性品質還有有效性因此本席提案制定再生醫療專法不僅僅是為了順應醫療科技的進步更是為了保護那些在病痛中尋找希望的個案 |
| transcript.whisperx[32].start |
2528.527 |
| transcript.whisperx[32].end |
2550.012 |
| transcript.whisperx[32].text |
我們希望可以儘速趕快通過專法確保每一位需要服務的個案都能夠安全的及時的而且有效的接受到進步的醫療服務協助重新找回他們人生的希望謝謝好謝謝呃陳敬輝委員的說明吼那接下來請衛生福利部薛瑞元部長說明時間10分鐘 |
| transcript.whisperx[33].start |
2561.146 |
| transcript.whisperx[33].end |
2575.017 |
| transcript.whisperx[33].text |
主席、各位委員、女士先生今天是大院第11屆第1會期社會福利及衛生環境委員會召開的全體委員會議本部呈押列席報告深感榮幸 |
| transcript.whisperx[34].start |
2576.639 |
| transcript.whisperx[34].end |
2594.941 |
| transcript.whisperx[34].text |
維護全民的健康,提供國人良好的醫療品質,創造安全的就醫環境,一直都是本部的使命與持續努力的目標。今天藉由這個《再生醫療法草案》及《再生醫療治劑條例草案》提出專案報告,請各位委員不吝指教。 |
| transcript.whisperx[35].start |
2596.142 |
| transcript.whisperx[35].end |
2614.797 |
| transcript.whisperx[35].text |
第一,再生醫療法草案一共有35條,重點如下。第一,確保提供病人安全有效之治療。醫療機構執行再生醫療前應該進行並完成人體試驗以及一些例外的情形。 |
| transcript.whisperx[36].start |
2616.118 |
| transcript.whisperx[36].end |
2638.234 |
| transcript.whisperx[36].text |
以確保醫療機構之執行或細胞之操作具有一定的成熟度及穩定性。」這是在草案的第七條跟第八條。第二,鼓勵再生醫療研究發展,為了促進再生醫療的臨床應用、量能提升,給予獎勵或補助。這是在草案第十條。 |
| transcript.whisperx[37].start |
2639.395 |
| transcript.whisperx[37].end |
2658.442 |
| transcript.whisperx[37].text |
明定醫療機構執行再生醫療的範疇以及執行醫師的資格,那再生醫療的執行是屬於醫療行為,執行場所應以醫療機構為限,且醫療機構應該經中央主管機關核准才可以來執行再生醫療的技術或使用再生醫療的治劑。 |
| transcript.whisperx[38].start |
2660.162 |
| transcript.whisperx[38].end |
2677.29 |
| transcript.whisperx[38].text |
執行再生醫療的醫師應為該疾病相關領域的專科醫師並具備再生醫療相關的知識。這是在草案的第11條到13條。第四,執行細胞操作機構及人員應符合之規範。 |
| transcript.whisperx[39].start |
2679.611 |
| transcript.whisperx[39].end |
2696.004 |
| transcript.whisperx[39].text |
醫療機構可自行或委託再生醫療、生技醫藥公司、其他醫療機構來執行細胞操作。三）該執行細胞操作的機構免依醫藥事法之規定取得藥品製造業的許可執照。 |
| transcript.whisperx[40].start |
2699.091 |
| transcript.whisperx[40].end |
2719.683 |
| transcript.whisperx[40].text |
細胞操作的方法、設施、設備、管制、測試、運銷、操作人員資格與應完成的相關訓練查核許可的申請條件以及其他應遵行的事項另訂辦法來規範之。這是在草案的第14條。第五,執行再生醫療應盡的義務。 |
| transcript.whisperx[41].start |
2723.245 |
| transcript.whisperx[41].end |
2745.693 |
| transcript.whisperx[41].text |
醫療機構如果要執行再生醫療前,應該向病人充分說明所執行之再生醫療風險、效果以及所涉的相關權利義務,經過同意之後使得為之。醫療機構執行再生技術或使用再生製劑,應該製作這個紀錄並保存至少15年,這是在草案的第15條到16條。 |
| transcript.whisperx[42].start |
2748.896 |
| transcript.whisperx[42].end |
2764.357 |
| transcript.whisperx[42].text |
第六,管理組織細胞的來源。細胞操作執行機構以及細胞保存庫應對組織細胞提供者進行合適性判定。有關細胞保存庫的設置 |
| transcript.whisperx[43].start |
2765.758 |
| transcript.whisperx[43].end |
2782.685 |
| transcript.whisperx[43].text |
品質管理及保存費用收取等事項認定辦法予以規範。」這是在草案的第17條到20條。第七,確保再生醫療的品質與安全。為確保再生醫療的安全與品質,並維護民眾及病人的權益,規範得為再生醫療 |
| transcript.whisperx[44].start |
2788.216 |
| transcript.whisperx[44].end |
2806.366 |
| transcript.whisperx[44].text |
組織細胞提供者招募廣告與再生醫療廣告的主體及廣告管理的規定,執行結果的報告,主動通報機制以及救濟措施等等事項,並明定停止或終止執行再生醫療的管制措施。」這是在草案的第21條到27條。 |
| transcript.whisperx[45].start |
2810.306 |
| transcript.whisperx[45].end |
2830.896 |
| transcript.whisperx[45].text |
其次,再生醫療製劑一共有23條,重點如下。有鑒於再生醫療製劑的成分、一直性、製程的特殊性以及治療的複雜性。現行藥事法相關的規範無法完全涵蓋或一體適用。所以委員會我 |
| transcript.whisperx[46].start |
2832.273 |
| transcript.whisperx[46].end |
2856.298 |
| transcript.whisperx[46].text |
為我國的再生醫療產業的整體發展,維護病人接受治療的權益並確保再生醫療製劑的品質、安全性及有效性,擬具了這個再生醫療製劑條例草案,再生醫療製劑管理條例草案,以健全對再生醫療製劑全生命周期的管理, |
| transcript.whisperx[47].start |
2857.278 |
| transcript.whisperx[47].end |
2880.855 |
| transcript.whisperx[47].text |
本部已研擬再生醫療治劑條例草案,經行政院審查後,在113年4月25日避交答案來審議。委員所提的版本跟行政院版本方向一致,期盼透過本條例草案之立法,健全對再生醫療治劑全生命周期的管理,並促進再生醫療產業之蓬勃發展。 |
| transcript.whisperx[48].start |
2882.896 |
| transcript.whisperx[48].end |
2899.31 |
| transcript.whisperx[48].text |
那兩項的法案與各委員的版本的差異的評估,那已經詳列在本部的書面報告,請各位委員參閱。那本部曾答應各委員的指教及監督,在此敬致謝誠,並請各位委員繼續予以支持。以上。 |
| transcript.whisperx[49].start |
2903.815 |
| transcript.whisperx[49].end |
2912.324 |
| transcript.whisperx[49].text |
有關本次會議各項書面資料均列入紀錄刊登公報,現在請宣讀提案條文內容,若有修正動議請一併宣讀。 |
| transcript.whisperx[50].start |
2914.454 |
| transcript.whisperx[50].end |
2938.721 |
| transcript.whisperx[50].text |
行政院函請審議再生醫療法草案案。委員邱議瑩等25人擬具再生醫療法草案案。委員謝衣鳯等19人擬具再生醫療發展法草案案。委員羅廷瑋等21人擬具再生醫療法草案案。委員黃秀芳等18人擬具再生醫療法草案案。委員王振旭等20人擬具再生醫療法草案案。台灣民眾黨黨團擬具再生醫療法草案案。委員陳金輝等19人擬具再生醫療法草案案。 |
| transcript.whisperx[51].start |
2942.202 |
| transcript.whisperx[51].end |
2953.106 |
| transcript.whisperx[51].text |
委員楊崇英等25人擬具再生醫療法草案案條文對照表行政院提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案臺灣民眾黨黨團提案委員陳金輝等19人提案委員楊崇英等25人提案名稱再生醫療法草案委員謝衣鳯等19人提案名稱 |
| transcript.whisperx[52].start |
2963.729 |
| transcript.whisperx[52].end |
2990.639 |
| transcript.whisperx[52].text |
再生醫療發展法草案 行政院提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案台灣民眾黨黨團提案委員陳金輝等19人提案委員楊崇英等25人提案第一章總則行政院提案委員王振旭等20人提案委員陳金輝等19人提案第一條為確保再生醫療之安全品質及有效性維護病人權益普惠國民使用特制定本法 |
| transcript.whisperx[53].start |
2991.679 |
| transcript.whisperx[53].end |
2995.501 |
| transcript.whisperx[53].text |
委員邱議瑩等25人提案委員黃秀芳等18人提案委員楊聰英等25人提案第一條為確保再生醫療之品質安全及有效性維護病人權益普惠國民使用特制定本法委員謝衣鳯等19人提案第一條為確立政府發展再生醫療推動及創新方針運用科技建構研究環境健全人才培育促進產業永續發展 |
| transcript.whisperx[54].start |
3014.429 |
| transcript.whisperx[54].end |
3035.725 |
| transcript.whisperx[54].text |
普及國民安全有效使用提升醫療品質及全民健康特制定本法。」委員羅廷瑋等21人提案第一條為確保再生醫療之品質安全及有效性並維護接受再生醫療病人之權益普惠國民使用特制定本法。台灣民眾黨黨團提案第一條為確保再生醫療之安全品質及有效性維護病人權益及醫療倫理普惠國民使用特制定本法。 |
| transcript.whisperx[55].start |
3039.528 |
| transcript.whisperx[55].end |
3044.174 |
| transcript.whisperx[55].text |
行政院提案、委員邱議瑩等25人提案、委員羅廷瑋等21人提案、委員黃秀芳等18人提案、委員王振旭等20人提案、台灣民眾黨黨團提案、委員陳金輝等19人提案、委員楊崇英等25人提案。第二條,本法所稱主管機關在中央為衛生福利部 |
| transcript.whisperx[56].start |
3056.57 |
| transcript.whisperx[56].end |
3080.56 |
| transcript.whisperx[56].text |
再直轄市為直轄市政府、再縣市為縣市政府。」委員謝衣鳯等19人提案。第二條本法之主管機關為衛生福利部本法所定事項涉及各中央目的事業主管機關執掌者各該主管機關應配合辦理。行政院提案委員邱議瑩等25人提案委員黃秀邦等18人提案委員王振旭等20人提案委員陳金輝等19人提案委員楊崇英等25人提案。第三條 |
| transcript.whisperx[57].start |
3081.42 |
| transcript.whisperx[57].end |
3107.558 |
| transcript.whisperx[57].text |
本法用詞定義如下。一、再生醫療,只利用基因、細胞及其衍生物用以治療、修復或替換人體細胞、組織及器官之製劑或技術。二、再生醫療製劑,以下簡稱再生製劑,只含有基因、細胞及其衍生物供人體使用之製劑。三、再生醫療技術,以下簡稱再生技術,只與人體執行再生醫療之技術,但下列技術不包括在內。一、輸血。 |
| transcript.whisperx[58].start |
3108.359 |
| transcript.whisperx[58].end |
3136.138 |
| transcript.whisperx[58].text |
二、使用血液製劑。三、骨髓造血幹細胞移植。周邊血造血幹細胞移植。四、人工生殖。五、其他經中央主管機關公告之技術。四、再生醫療人體試驗。以下簡稱人體試驗。指教學醫院或經中央主管機關同意之醫療機構以發現或證明再生製劑或再生技術與臨床藥理之作用或疾病治療為目的而對受試者人體所為之研究。五、再生醫療細胞保存庫。 |
| transcript.whisperx[59].start |
3137.099 |
| transcript.whisperx[59].end |
3159.178 |
| transcript.whisperx[59].text |
以下簡稱細胞保存庫只為再生醫療所需保存、處理或提供人體組織、細胞或其衍生物資場所或設施。六、再生醫療生技醫藥公司指生技醫藥產業醫公司法設立研發、製造或受託開發、製造與再生醫療相關製劑或技術之公司。委員謝衣鳯等19人提案第三條,頒發所稱 |
| transcript.whisperx[60].start |
3160.899 |
| transcript.whisperx[60].end |
3175.153 |
| transcript.whisperx[60].text |
所稱再生醫療指利用基因細胞、包氣或其衍生物用於人體構造、功能之重建或修復以達到治療或預防為目的並經中央目的事業主管機關審定之藥品、醫療器材、產品或技術。 |
| transcript.whisperx[61].start |
3176.721 |
| transcript.whisperx[61].end |
3193.871 |
| transcript.whisperx[61].text |
委員羅廷瑋等21人提案第三條本條例用詞定義如下一、再生醫療自再生醫療發展法所定利用人類自體或一體細胞包氣或基因之再生功能修復或替換人體細胞組織其器官之製劑或技術二、再生醫療製劑以下簡稱再生製劑 |
| transcript.whisperx[62].start |
3196.693 |
| transcript.whisperx[62].end |
3218.78 |
| transcript.whisperx[62].text |
指再生醫療製劑管理條例所定以治療或預防人類疾病為目的所製造且符合下列各目的之一製劑一、對細胞加工製成者二、對人體內含有蟲組基因者三、對細胞加工使之具有組織結構或機能用以移植、修復或重建人類之組織或器官者四、前三目製劑與具有醫療器材屬性之結構材料牽合者 |
| transcript.whisperx[63].start |
3221.961 |
| transcript.whisperx[63].end |
3236.289 |
| transcript.whisperx[63].text |
三、再生醫療技術與人體實行再生醫療之技術但下列技術不包括在內一、輸血二、使用血液製劑三、骨髓造血幹細胞移植周邊血造血幹細胞移植四、人工生殖 |
| transcript.whisperx[64].start |
3236.929 |
| transcript.whisperx[64].end |
3243.952 |
| transcript.whisperx[64].text |
其他經中央主管機關公告之項目 再生醫療臨床試驗以下簡稱臨床試驗指醫療機構或經中央主管機關公告之機構以下並稱臨床試驗機構以發現或證明再生製劑或再生醫療技術與臨床藥理之作用或疾病治療為目的而對受試者人體所為之研究 人體細胞保存庫 |
| transcript.whisperx[65].start |
3258.399 |
| transcript.whisperx[65].end |
3271.283 |
| transcript.whisperx[65].text |
只為再生醫療所需保存、處理或提供人體細胞組織或其衍生物質場所或設施六、生技醫藥公司只生技醫藥產業依公司法設立之研發或製造新藥、高風險醫療器材、再生醫療、精準醫療 |
| transcript.whisperx[66].start |
3274.524 |
| transcript.whisperx[66].end |
3292.27 |
| transcript.whisperx[66].text |
數位醫療及其他策略生技醫藥產品及公司臺灣民眾黨黨團提案第三條第一款莫具為但不得利用異種異體細胞進行醫療行為第五款具首為再生醫療人體細胞保存庫以下簡稱人體細胞保存庫其與院版同 |
| transcript.whisperx[67].start |
3293.01 |
| transcript.whisperx[67].end |
3305.845 |
| transcript.whisperx[67].text |
行政院提案、委員邱瑩等25人提案、委員羅廷瑋等21人提案、委員黃秀芳等18人提案、委員王振旭等20人提案、委員陳金輝等19人提案、委員楊瓊英等25人提案。第四條,中央主管機關應訂定再生醫療推動計畫並定期檢討修正以推動再生醫療。 |
| transcript.whisperx[68].start |
3310.33 |
| transcript.whisperx[68].end |
3330.074 |
| transcript.whisperx[68].text |
各級主管機關得要求相關機關構、學校、法輪或團體協助前向計畫之推動。委員謝衣鳯等19人提案第4條。主管機關應擬定再生醫療發展政策並每兩年檢討修正報行政院核定作為推動再生醫療發展之政策依據。中央目的事業主管機關應依再生醫療政策訂定具體計畫或擬定法規辦理本法所定事項。台灣民眾黨黨團提案第4條。 |
| transcript.whisperx[69].start |
3335.475 |
| transcript.whisperx[69].end |
3347.495 |
| transcript.whisperx[69].text |
再生醫療制執行應遵守再生醫療倫理規範,其內容由中央主管機關定定之。中央主管機關應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。 |
| transcript.whisperx[70].start |
3349.315 |
| transcript.whisperx[70].end |
3370.344 |
| transcript.whisperx[70].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劃之推動。行政院提案委員邱議瑩等25人提案委員黃秀邦等18人提案第5條。中央主管機關應組成再生醫療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。 |
| transcript.whisperx[71].start |
3371.484 |
| transcript.whisperx[71].end |
3395.042 |
| transcript.whisperx[71].text |
人才培育推動之諮詢五．研究發展及獎勵補助之諮詢審議六．再生製器及再生技術管理之諮詢七．合與再生製器有付款許可之審議八．執行成效評估之諮詢九．其他再生醫療相關事項之諮詢前向審議會任意性別委員不得少於委員總數三分之一委員謝衣鳯等19人提案第五條主管機關應涉再生醫療之議會 |
| transcript.whisperx[72].start |
3396.843 |
| transcript.whisperx[72].end |
3406.654 |
| transcript.whisperx[72].text |
至委員羅桿仁、就學者、專家及機關機構法人或團體代表聘派兼之其任務為下列再生醫療事項之諮詢審議一、發展創新及推動政策二、正確知識及觀念宣導政策三、研究及醫療品質提升四、人才培育推動 |
| transcript.whisperx[73].start |
3413.482 |
| transcript.whisperx[73].end |
3439.863 |
| transcript.whisperx[73].text |
五（相關產業發展政策及獎勵方案。六（再生醫療自治及技術管理。七（成效評估及增進。八（其他再生醫療相關事項,前向委員之名額、產生方式、意識、規範、代表利益之自我揭露及資訊公開等有關事項之辦法由主管機關定之,但任意性別委員不得少於委員總數三分之一。委員羅廷瑋等21人提案第五條,主管機關應召及醫療科技人員、倫理法律等專家設再生醫療之議會。 |
| transcript.whisperx[74].start |
3441.684 |
| transcript.whisperx[74].end |
3459.396 |
| transcript.whisperx[74].text |
社、智、委員、若干人、就學者、專家及機關、機構法人或團體代表聘派兼職並由衛生福利部部長擔任召集人。前向自議會提供下列事項之諮詢或建議一、發展創新及推動政策二、正確知識及觀念宣導政策三、病人安全及醫療品質提升 |
| transcript.whisperx[75].start |
3460.016 |
| transcript.whisperx[75].end |
3486.425 |
| transcript.whisperx[75].text |
人才培育推動、五相關產業研究發展、補助及獎勵方案、六、再生醫療自治及技術管理、七、執行成效評估及增進、八、再生醫療發展法及再生醫療自治條例所授權、辦法及準則之訂定及修正、九、再生醫療應進行安全監視及其安全監督計畫之公告和訂及安全監視情形之公開、十、使用有付款許可自治聘員之救濟措施與費用收取方式、十一、其他中央主管機關所定事項、 |
| transcript.whisperx[76].start |
3487.065 |
| transcript.whisperx[76].end |
3507.87 |
| transcript.whisperx[76].text |
第一項自議會之組成議事利益迴避及其他應遵行事項之辦法由中央主管機關定之。第一項自議會任意性別委員不得少於委員總數三分之一。委員王正旭等20人提案第五條第一項中央主管機關應組成再生醫療審議會以下簡稱審議會至委員羅桿仁就醫療科技倫理法律及其他與其他相關專業學者專家 |
| transcript.whisperx[77].start |
3510.05 |
| transcript.whisperx[77].end |
3530.59 |
| transcript.whisperx[77].text |
併派兼職由衛生福利部部長或部長就委員中指定一人擔任召集人第二項第五款五研究發展及獎勵補助之諮詢第三項及第四項第一項審議會之組成議事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其餘願反同 |
| transcript.whisperx[78].start |
3532.079 |
| transcript.whisperx[78].end |
3552.336 |
| transcript.whisperx[78].text |
台灣民眾黨黨團提案第五條第一項中央主管機關應組成再生醫療審議會以下簡稱審議會臨聘派醫學藥學倫理法律與其他相關專業學者專家共同組成之由衛生福利部部長或部長就委員中指定一人擔任召集人第二項第九款及第十款如下九一本法第九條執行再生技術之審議時其他再生醫療相關事項之諮詢第三項及第四項如下 |
| transcript.whisperx[79].start |
3557.961 |
| transcript.whisperx[79].end |
3584.928 |
| transcript.whisperx[79].text |
前向審議會委員致明而產生方式意識規範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其餘願反同委員陳金輝等19人提案第五條中央主管機關應組成再生醫療審議會辦理下列再生醫療事項之審議及諮詢一、發展創新及推動政策二、正確知識及觀念宣導三、病人安全及醫療品質提升四、人才培育推動五、研究發展及獎勵補助 |
| transcript.whisperx[80].start |
3585.888 |
| transcript.whisperx[80].end |
3607.561 |
| transcript.whisperx[80].text |
六（再生製劑及再生技術管理。七（何與再生製劑有付款許可。八（執行成效評估。九（其他再生醫療相關事項。前向審議會委員由相關機關代表、醫學、藥學與法律倫理領域之專家學者組成。任意性別委員不得少於委員總數三分之一。委員楊瓊英等25人提案第五條。第一項第五款。五（研究發展及獎勵補助資諮詢其以願反同。 |
| transcript.whisperx[81].start |
3610.243 |
| transcript.whisperx[81].end |
3624.597 |
| transcript.whisperx[81].text |
委員謝衣鳯等19人提案第6條政府孕育國家財政能力範圍內寬列預算採取必要措施持續確保再生醫療經費符合推行政策所需委員謝衣鳯等19人提案第7條為充實再生之醫療機構學術研究機構學校生技醫藥公司以下簡稱再生機構所需再生醫療人才行政院應指定機關建立再生醫療人才資源發展 |
| transcript.whisperx[82].start |
3635.887 |
| transcript.whisperx[82].end |
3656.501 |
| transcript.whisperx[82].text |
協調整合機制、辦理下列事項﹖一、協調主管機關及各中央目的事業主管機關辦理人才供需調查及推估﹖二、整合人才供需資訊﹖三、訂定人才資源發展計畫﹖四、促進再生機構兼職人才交流﹖五、其他再生醫療人才資源發展之推動事項﹖委員謝衣鳯等19人提案第8條。 |
| transcript.whisperx[83].start |
3658.444 |
| transcript.whisperx[83].end |
3680.623 |
| transcript.whisperx[83].text |
政府因依實際需要、合理分配、益助資源或補助再生機構、充實人才、設施與設備及技術、促進產學國際交流合作共同推動再生醫療事務及措施。主管機關得設立再生醫療基金、辦理再生醫療發展相關事項。基金來源如下。一、違反再生醫療自治管理條例及再生醫療之施行及管理條例收取罰還之部分提撥。 |
| transcript.whisperx[84].start |
3681.644 |
| transcript.whisperx[84].end |
3700.13 |
| transcript.whisperx[84].text |
二）一）再生醫療制計管理條例及再生醫療之施行及管理條例收取之規費,三）受證收入,四）基金之知習收入,五）其他收入,前向基金之用途如下,一）為增進再生醫療技術研究發展所需支出,二）延攬及培訓傑出再生醫療領域人才所需支出, |
| transcript.whisperx[85].start |
3700.55 |
| transcript.whisperx[85].end |
3715.836 |
| transcript.whisperx[85].text |
三）修正收入指定用途支出。四）辦理第9條各款事項之補助。五）辦理第15條之獎勵。六）管理及總務支出。七）其他有關支出。行政院提案委員陳金輝等19人提案。第6條中央主管機關德委由其他政府機關購物醫療機構 |
| transcript.whisperx[86].start |
3717.657 |
| transcript.whisperx[86].end |
3729.671 |
| transcript.whisperx[86].text |
學術研究機構學校或法人辦理下列事項必要時得專注設立財團法人為之一、特定細胞提供者之篩選與其細胞之處理保存及提供二、高技術性組織細胞之處理及製造三、總原細胞之蒐集及保存 |
| transcript.whisperx[87].start |
3733.035 |
| transcript.whisperx[87].end |
3748.696 |
| transcript.whisperx[87].text |
四（人體組織細胞提供之招募及推廣五（其他配合政府推動再生醫療相關政策之事項委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案委員楊瓊英等25人提案第6條第4款如下 |
| transcript.whisperx[88].start |
3749.677 |
| transcript.whisperx[88].end |
3767.572 |
| transcript.whisperx[88].text |
四（人體組織細胞提供之勸募及推廣其予院版同委員謝衣鳯等19人提案第9條主管機關得遵住設置財團法人或委由其他政府機關醫療機構學術研究機構學校或法人辦理下的事項一、特定細胞提供者之篩選及其細胞之處理保存與提供 |
| transcript.whisperx[89].start |
3768.172 |
| transcript.whisperx[89].end |
3789.183 |
| transcript.whisperx[89].text |
二（高技術性細胞組織之處理及製造,三（總原細胞之收集及儲存,四（人體細胞組織提供之勸募及推廣,五（其他配合政府推動再生醫療相關政策之事項,台灣民眾黨黨團提案第6條,第4款如下,四（人體組織細胞提供之勸募及推廣,其以願版同。委員謝衣鳯等19人提案第10條, |
| transcript.whisperx[90].start |
3789.943 |
| transcript.whisperx[90].end |
3810.662 |
| transcript.whisperx[90].text |
政府應積極協助輔導再生醫療產業即時結合財稅及金融優惠制度提供產業穩健發展培植國內人才及產業鏈促成再生醫療及經濟發展委員謝衣鳯等19人提案第12條政府應規劃國民得及早、合理、公平且安全地使用再生醫療之制度採取必要之制度 |
| transcript.whisperx[91].start |
3811.222 |
| transcript.whisperx[91].end |
3832.996 |
| transcript.whisperx[91].text |
知法制、財政、稅制或其他相關措施。」行政院提案委員陳金輝等19人提案第二章:「再生醫療人體試驗及研究。」委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀剛等18人提案委員王正旭等20人提案台灣民眾黨黨團提案委員楊崇英等25人提案第4章:「再生醫療人體試驗及研究。」 |
| transcript.whisperx[92].start |
3835.748 |
| transcript.whisperx[92].end |
3858.177 |
| transcript.whisperx[92].text |
行政院提案委員陳金輝等19人提案第7條醫療機構執行再生醫療前除有第8條第一項規定情形外應進行並完成人體試驗。行政院提案委員陳金輝等19人提案第8條醫療機構執行再生技術有下列情形之一者免進行或免完成人體試驗。依治療危及生命或嚴重失能之疾病且國內尚無適當之藥品、醫藥器材或醫療技術 |
| transcript.whisperx[93].start |
3862.259 |
| transcript.whisperx[93].end |
3888.132 |
| transcript.whisperx[93].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行事項由中央主管機關定之。醫療機構執行第一項第一款再生技術前應主案向中央主管機關申請核准時得為之。醫療機構執行再生技術有第一項第一款情形者免依再生醫療自治條例規定申請藥品許可,正或有付款許可。 |
| transcript.whisperx[94].start |
3888.812 |
| transcript.whisperx[94].end |
3905.023 |
| transcript.whisperx[94].text |
委員邱瑩等25人擬具、委員羅廷瑋等21人擬具、委員黃秀邦等18人擬具、委員王振旭等20人擬具、委員台灣民眾黨黨團擬具、委員楊瓊英等25人擬具第18條。醫療機構執行再生醫療前應進行人體試驗,但有下列情形之一者不在此限,因使用取得。 |
| transcript.whisperx[95].start |
3905.923 |
| transcript.whisperx[95].end |
3932.746 |
| transcript.whisperx[95].text |
經中央主管機關核准發給藥品許可證或有付款許可之再生製劑。二）執行議第8條第1項規定經中央主管機關核准之再生技術。三）執行其他經中央主管機關公告之再生醫療。行政院提案第9條。委員王正旭等20人提案第19條。台灣民眾黨黨團提案第19條。委員陳金輝等19人提案第9條。再生醫療研究涉及胚胎或胚胎幹細胞不得以下列方式為之。一、以人工受精方式製造胚胎。 |
| transcript.whisperx[96].start |
3933.246 |
| transcript.whisperx[96].end |
3951.473 |
| transcript.whisperx[96].text |
二）製造雜交體,三）以其他物種細胞和植入去核之人類卵細胞,四）繁衍研究用胚胎,五）將研究用胚胎植入人類或其他物種之子宮,六）製造或繁衍具有人類生殖細胞之氫核物種,七）其他經中央主管機關公告禁止之材料或研究方式。 |
| transcript.whisperx[97].start |
3952.273 |
| transcript.whisperx[97].end |
3958.054 |
| transcript.whisperx[97].text |
委員邱瑩等25人擬具委員羅廷瑋等21人擬具委員黃秀芳等18人擬具委員楊瓊瑩等25人擬具第19條第一項之序為如下再生醫療研究涉及胚胎或胚胎幹細胞除申請中央主管機關核准外不得以下類方式為之第二項如下前項申請之條件程序廢止核准事項變更及其他應遵行事項之辦法由中央主管機關定之至於院版第9條同行政院提案委員陳金輝等19人提案第10條 |
| transcript.whisperx[98].start |
3980.638 |
| transcript.whisperx[98].end |
4007.723 |
| transcript.whisperx[98].text |
中央主管機關或中央目的事業主管機關得就再生醫療之研究發展給予獎勵或補助前向獎勵或補助之對象條件申請程序獎勵或補助方式審查基準費值或其他相關事項之辦法由中央主管機關會商中央目的事業主管機關定之委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案台灣民眾黨黨團提案委員楊崇英等25人提案第20條與院版第10條同 |
| transcript.whisperx[99].start |
4008.983 |
| transcript.whisperx[99].end |
4022.807 |
| transcript.whisperx[99].text |
委員謝衣鳯等19人提案第15條政府對於從事再生醫療研究或施行住有公積資再生機構或自然人應編列預算給予必要獎金、獎勵並表揚之,依本法發給之獎金,由主管機關應全責編列預算。以上。 |
| transcript.whisperx[100].start |
4028.317 |
| transcript.whisperx[100].end |
4047.415 |
| transcript.whisperx[100].text |
行政院提案委員陳金輝等19人提案第三章委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊瑩等25人臺灣民眾黨黨團提案第二章再生醫療執行行政院委員 |
| transcript.whisperx[101].start |
4048.736 |
| transcript.whisperx[101].end |
4059.341 |
| transcript.whisperx[101].text |
陳金輝等19人提案第11條委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊瑩等25人臺灣民眾黨黨團提案第7條非醫療機構不得執行再生醫療 |
| transcript.whisperx[102].start |
4064.884 |
| transcript.whisperx[102].end |
4083.014 |
| transcript.whisperx[102].text |
行政院提案委員陳金輝等19人提案第12條醫療機構執行再生技術或使用中央主管機關指定之再生製劑應向中央主管機關申請核准。經核准後並向直轄市縣市主管機關登記。此得為之。 |
| transcript.whisperx[103].start |
4084.255 |
| transcript.whisperx[103].end |
4108.571 |
| transcript.whisperx[103].text |
中央主管機關得就前項之核准,委任所屬機關或委託其他機關構法人團體辦理。第一項再生製劑之指定申請核准之條件與程序,核准效期與展延廢止,核准四項變更、費用審查與收取、退費及其他應遵行四項之辦法由中央主管機關定之。 |
| transcript.whisperx[104].start |
4110.421 |
| transcript.whisperx[104].end |
4137.753 |
| transcript.whisperx[104].text |
委員邱議瑩等25人擬具委員羅廷瑋等21人擬具委員黃秀帆等18人擬具委員王振旭等20人擬具委員楊瓊瑩等25人擬具臺灣民眾黨黨團提案第八條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應向中央主管機關申請核准。經核准後並向直轄市縣市主管機關登記。使得為之,取於同行政院提案第十二條第二三項 |
| transcript.whisperx[105].start |
4140.27 |
| transcript.whisperx[105].end |
4155.168 |
| transcript.whisperx[105].text |
委員邱議瑩等25人擬具委員黃秀芳等18人提案第9條。醫療機構執行再生技術有下列情形之一者免依再生醫療制計條例之規定,申請藥品許可證或有付款許可。 |
| transcript.whisperx[106].start |
4157.29 |
| transcript.whisperx[106].end |
4177.947 |
| transcript.whisperx[106].text |
醫療機構為治療危及生命或嚴重失能且國內尚無適當之藥品、醫療器材或醫療技術可資適用之特定病人,得檢據相關文件資料向中央主管機關申請核准使用,未經主管機關一第八條第一項規定指定之再生製劑或執行再生技術, |
| transcript.whisperx[107].start |
4180.153 |
| transcript.whisperx[107].end |
4195.011 |
| transcript.whisperx[107].text |
醫療機構執行再生技術之人體試驗以證實其安全性及初步療效且於臨床治療得提升治療效益者得向中央主管機關申請核准執行該再生技術 |
| transcript.whisperx[108].start |
4196.112 |
| transcript.whisperx[108].end |
4212.344 |
| transcript.whisperx[108].text |
第二項及第三項申請核准資格條件、證明文件、資料、申請核准之程序、核准效期與展延廢止、核准事項變更及其他應遵行事項之辦法由中央主管機關定之。醫療機構依前條 |
| transcript.whisperx[109].start |
4214.795 |
| transcript.whisperx[109].end |
4231.312 |
| transcript.whisperx[109].text |
第一項規定申請核准及辦理登記,屬提供不含基因改造或轉植之人類細胞及其衍生物質細胞治療者,其項目由中央主管機關公告之。」委員羅廷瑋等21人提案第九條, |
| transcript.whisperx[110].start |
4233.194 |
| transcript.whisperx[110].end |
4256.846 |
| transcript.whisperx[110].text |
醫療機構有下列情形之一者得施行再生醫療免醫再生醫療自治管理條例規定申請再生自治許可證或付款許可。依治療危及生命或嚴重私人之疾病且國內尚無適當之醫療或醫療器材。二）經完成第二期臨床試驗證實其安全性及初步療效。 |
| transcript.whisperx[111].start |
4257.867 |
| transcript.whisperx[111].end |
4286.003 |
| transcript.whisperx[111].text |
二）提供不含基因改造或轉植之人類細胞或其包棄之自體細胞治療。前向第三款自體細胞治療項目由中央主管機關公告之委員王振旭等20人委員楊瓊英等25人提案第九條醫療機構執行再生技術有下列情形之一者免依再生醫療治劑條例規定申請藥品許可證或有付款許可。 |
| transcript.whisperx[112].start |
4286.863 |
| transcript.whisperx[112].end |
4294.556 |
| transcript.whisperx[112].text |
一、治療危及生命或嚴重私人之疾病且國內尚無適當之藥品或醫療器材。二、今 |
| transcript.whisperx[113].start |
4296.463 |
| transcript.whisperx[113].end |
4317.783 |
| transcript.whisperx[113].text |
經執行人體試驗結果,證實其安全性及初步療效。三）提供不含基因改造或轉植之人類細胞及其衍生物質細胞治療。前項第二款應執行人體試驗之其別條件與其他應遵行事項及第三款細胞治療項目由中央主管機關公告之。 |
| transcript.whisperx[114].start |
4318.544 |
| transcript.whisperx[114].end |
4344.301 |
| transcript.whisperx[114].text |
台灣民眾黨黨團提案第9條醫療機構為治療危及生命或嚴重私人之疾病且國內尚無適當之藥品而執行再生技術得檢附下列文件向中央主管機關提出申請經審議會審議通過後由中央主管機關核准一傳統治療無效之證明二人體試驗倫理審查委員會核准之證明三治療計畫書 |
| transcript.whisperx[115].start |
4345.942 |
| transcript.whisperx[115].end |
4356.699 |
| transcript.whisperx[115].text |
四、病人同意書五、細胞治療自備場所之證明。前項各款得檢附相關資料之內容由中央主管機關定之。 |
| transcript.whisperx[116].start |
4359.198 |
| transcript.whisperx[116].end |
4384.719 |
| transcript.whisperx[116].text |
行政院提案委員陳金輝等19人提案第13條委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊瑩等25人臺灣民眾黨黨團提案第10條執行再生醫療之醫師應為該疾病相關領域之專科醫師其資格由中央主管機關公告之行政院提案委員陳金輝等19人提案第14條 |
| transcript.whisperx[117].start |
4387.101 |
| transcript.whisperx[117].end |
4397.998 |
| transcript.whisperx[117].text |
醫療機構執行再生技術有細胞培養、處理及保存以下並稱細胞操作必要者得自行或委託再生醫療生技醫藥公司或醫療機構以下並稱受託機構為之。 |
| transcript.whisperx[118].start |
4402.608 |
| transcript.whisperx[118].end |
4430.587 |
| transcript.whisperx[118].text |
前向執行細胞操作之醫療機構受託機構免醫藥釋法之規定取得藥品製造業許可執照其執行細胞操作因經中央主管機關查核及許可後,使得為之中央主管機關得就前向之查核、許可及其他相關管理事項委任所屬機關或委託其他機關構法人團體辦理第二項醫療機構 |
| transcript.whisperx[119].start |
4432.788 |
| transcript.whisperx[119].end |
4459.367 |
| transcript.whisperx[119].text |
受託機構執行細胞操作之方法設施設備管制措施運銷操作人員資格與應完成之相關訓練查核許可之申請條件與程序核准效期與展延廢止許可事項變更及其他應遵行事項之辦法由中央主管機關定之。委員邱議瑩等25人委員王振旭等20人委員楊瓊瑩等25人提案第11條 |
| transcript.whisperx[120].start |
4461.789 |
| transcript.whisperx[120].end |
4480.387 |
| transcript.whisperx[120].text |
醫療機構執行再生技術由細胞培養、處理及保存以下並稱細胞操作必要者得自行或委託再生醫療生技醫藥公司或醫療機構以下並稱受託機構為之。前項執行細胞操作之機構免疫藥事法規定取得藥品製造業許可執照。 |
| transcript.whisperx[121].start |
4482.739 |
| transcript.whisperx[121].end |
4492.05 |
| transcript.whisperx[121].text |
其執行細胞操作應經中央主管機關查核及許可後史的為之。第三項同行政院提案。第二項執行細胞操作之機構 |
| transcript.whisperx[122].start |
4493.484 |
| transcript.whisperx[122].end |
4513.661 |
| transcript.whisperx[122].text |
其執行之方法、設施、設備、管制措施、運銷、操作人員資格與應完成之相關訓練查核許可之申請條件與程序、核准效期與展延廢止許可事項變更及其他應遵遵行事項之辦法由中央主管機關定之。 |
| transcript.whisperx[123].start |
4515.417 |
| transcript.whisperx[123].end |
4531.716 |
| transcript.whisperx[123].text |
醫療法人所設醫療機構或學校法人所設私立學校之附屬醫療機構自行執行第一項規定之細胞操作案操作量、病人數或其他四項達一定規模者 |
| transcript.whisperx[124].start |
4532.777 |
| transcript.whisperx[124].end |
4551.704 |
| transcript.whisperx[124].text |
該法得經其中央目的事業主管機關核准後,依公司法第128條第三項第三款規定發起設立再生醫療生技醫療公司專辦細胞操作業務,前項一定規模之認定基準由中央主管機關公告之。 |
| transcript.whisperx[125].start |
4555.422 |
| transcript.whisperx[125].end |
4570.006 |
| transcript.whisperx[125].text |
第二項,前項執行細胞操作之機構免依藥事法之規定取得藥品製造業許可執照,其執行細胞操作應符合西藥藥品優良製造規範和西藥藥品優良運銷規範及其他 |
| transcript.whisperx[126].start |
4575.888 |
| transcript.whisperx[126].end |
4599.303 |
| transcript.whisperx[126].text |
中央主管機關公告之規定,並經其查核及許可後,使得為之徐一彤委員邱議瑩等25人提案。委員黃秀芳等18人提案第11條醫療機構執行再生技術有細胞培養處理及保存以下並稱細胞操作必要者得委託再生醫療生技醫藥公司或醫療機構以下並稱受託機構為之 |
| transcript.whisperx[127].start |
4602.947 |
| transcript.whisperx[127].end |
4606.643 |
| transcript.whisperx[127].text |
舉同委員邱議瑩等25人提案 |
| transcript.whisperx[128].start |
4608.442 |
| transcript.whisperx[128].end |
4636.155 |
| transcript.whisperx[128].text |
台灣民眾黨黨團提案第11條第二項前項執行細胞操作之機構免疫藥事法之規定取得藥品製造業許可執照其執行細胞操作應符合西藥藥品優良製造規範與西藥藥品優良運銷規範及其他中央主管機關公告之規定並經中央主管機關查核及許可厚實的為之其餘同委員邱議瑩等25人提案 |
| transcript.whisperx[129].start |
4642.406 |
| transcript.whisperx[129].end |
4665.66 |
| transcript.whisperx[129].text |
行政院提案委員陳金威等19人提案第15條委員邱議瑩等25人委員羅廷瑋等21人委員黃秀帆等18人委員王振旭等20人委員楊瓊英等25人臺灣民眾黨黨團提案第12條醫療機構執行再生醫療前應向病人或其法定代理人配偶親屬或關係人說明可能效果與不良反應 |
| transcript.whisperx[130].start |
4666.48 |
| transcript.whisperx[130].end |
4686.666 |
| transcript.whisperx[130].text |
費用、救濟措施及相關必要事項。醫療機構執行再生醫療前應經病人或其法定代理人配偶、親屬或關係人同意。簽具同意書後,使得為之。前項同意書應具備之內容由中央主管機關定之。行政院提案委員陳晶薇等19人提案第16條 |
| transcript.whisperx[131].start |
4689.248 |
| transcript.whisperx[131].end |
4708.528 |
| transcript.whisperx[131].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應製作記錄至少保存15年,並就中央主管機關指定之項目登錄於中央主管機關建置之資訊系統,但未成年者之記錄至少應保存至其成年後15年。 |
| transcript.whisperx[132].start |
4710.546 |
| transcript.whisperx[132].end |
4724.113 |
| transcript.whisperx[132].text |
前相記錄內容應包括使用或執行之日期、場所、程序、使用之再生之際與執行之再生技術、嚴重不良事件及其他經中央主管機關指定之事項。 |
| transcript.whisperx[133].start |
4725.39 |
| transcript.whisperx[133].end |
4750.345 |
| transcript.whisperx[133].text |
委員邱議瑩等25人擬具委員黃秀芳等18人擬具委員楊瓊瑩等25人擬具臺灣民眾黨黨團提案第13條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應製作紀錄至少保存15年並就中央主管機關指定之項目登錄於中央主管機關建置之資訊系統第二項同行政院提案第16條第二項 |
| transcript.whisperx[134].start |
4752.408 |
| transcript.whisperx[134].end |
4776.377 |
| transcript.whisperx[134].text |
委員羅廷瑋等21人擬具委員王振旭等20人提案第13條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應製作紀錄至少保存15年但未成年者之紀錄至少應保存至其成年後15年並就中央主管機關指定之項目登錄於中央主管機關建置之資訊系統第二項同行政院提案第16條第二項 |
| transcript.whisperx[135].start |
4778.908 |
| transcript.whisperx[135].end |
4805.978 |
| transcript.whisperx[135].text |
行政院提案委員陳金輝等19人提案第4章委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊英等25人臺灣民眾黨黨團提案第3章再生醫療組織細胞管理行政院提案委員陳金輝等19人提案第17條委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊英等25人提案第14條 |
| transcript.whisperx[136].start |
4808.219 |
| transcript.whisperx[136].end |
4822.619 |
| transcript.whisperx[136].text |
醫療機構或受託機構執行細胞操作,除組織細胞取締經中央主管機關許可設置之細胞保存庫者外,應確保人體組織細胞來源提供者之合適性。 |
| transcript.whisperx[137].start |
4824.585 |
| transcript.whisperx[137].end |
4844.037 |
| transcript.whisperx[137].text |
台灣民眾黨黨團提案第14條出人體細胞保存負責等文字不同外取同行政院提案第17條委員謝衣鳯等19人提案第11條再生機構於進行醫療研究及實施時應善盡對生命尊嚴人性倫理之維護義務 |
| transcript.whisperx[138].start |
4846.397 |
| transcript.whisperx[138].end |
4868.106 |
| transcript.whisperx[138].text |
行政院提案委員陳金威等19人提案第18條委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊英等25人提案第15條。細胞保存複製設置應經中央主管機關許可其保存人體組織細胞得收取費用並應確保組織細胞來源 |
| transcript.whisperx[139].start |
4872.088 |
| transcript.whisperx[139].end |
4898.405 |
| transcript.whisperx[139].text |
提供者之合適性、前項細胞保存庫設置資格、申請條件與程序保存項目許可效期與展延廢止許可事項變更應具備之設施、設備與人員資格、品質管理費用審查與收取退費、商業運用利益回饋及其他應遵行事項之辦法由中央主管機關定之。前條及第一項提供 |
| transcript.whisperx[140].start |
4899.286 |
| transcript.whisperx[140].end |
4926.703 |
| transcript.whisperx[140].text |
提供者合適性之判定條件篩選測試項目及其他相關事項之辦法由中央主管機關定之。中央主管機關得就第一項之許可及其他相關管理事項委任所屬機關或委託其他機關構法人團體辦理。台灣民眾黨黨團提案第15條除第一、二項人體細胞保存庫等文字不同外其餘同行政院提案第18條。 |
| transcript.whisperx[141].start |
4928.615 |
| transcript.whisperx[141].end |
4931.961 |
| transcript.whisperx[141].text |
行政院提案委員陳金輝等19人提案第19條 |
| transcript.whisperx[142].start |
4935.138 |
| transcript.whisperx[142].end |
4961.437 |
| transcript.whisperx[142].text |
醫療機構或細胞保存庫設置機構取得再生醫療組織細胞來源之提供者以有意識能力之成年人為限,但顯有益於特定人口群或未能以其他對象取代者,不在此限。前項之組織細胞應於取得前獲得提供者之書面同意。前項書面同意提供者為胎兒時應得其母書面同意。 |
| transcript.whisperx[143].start |
4962.846 |
| transcript.whisperx[143].end |
4986.472 |
| transcript.whisperx[143].text |
為限制行為人力或受輔助宣告之人時應得其本人及法定代理人或輔助人書面同意,為無行為人力人或受監護宣告之人時應得其法定代理人或監護人書面同意,提供者為無意識人力之成年人為人依前項規定辦理時, |
| transcript.whisperx[144].start |
4987.552 |
| transcript.whisperx[144].end |
5002.684 |
| transcript.whisperx[144].text |
因案下列順序之人員取得其書面同意,一配偶,二成年子女,三父母,四兄弟姊妹,五祖父母,前向第二款至第五款規定人員所為之書面同意,得以一人為之。 |
| transcript.whisperx[145].start |
5004.145 |
| transcript.whisperx[145].end |
5030.402 |
| transcript.whisperx[145].text |
同意順序之人意識表示不一致時以與無意識人力之成年人同居親屬為先。其同居親屬有二人以上者以連長者為先,無同居親屬者以連長者為先。本條及第20條書面同意之內容得以完整呈現,並於日後取出公查驗者得以電子文件為之。 |
| transcript.whisperx[146].start |
5032.984 |
| transcript.whisperx[146].end |
5039.007 |
| transcript.whisperx[146].text |
委員邱議瑩等25人委員黃秀帆等18人委員王振旭等20人委員楊瓊英等25人提案第16條。醫療機構或細胞保存庫設置機構取得再生醫療組織細胞來源之提供者 |
| transcript.whisperx[147].start |
5048.112 |
| transcript.whisperx[147].end |
5069.109 |
| transcript.whisperx[147].text |
以有意識人力之成年人為限,但顯有益於特定人口群或為人以其他對象取代者,不在此限。前項之組織細胞應於取得前獲得提供者之書面同意。前項書面同意提供者為胎兒時應得其母書面同意,為限制行為人力人, |
| transcript.whisperx[148].start |
5070.05 |
| transcript.whisperx[148].end |
5094.233 |
| transcript.whisperx[148].text |
獲受輔助宣告之人時應得其本人及法定代理人或輔助人書面同意,為無行為人役人或受監護宣告之人時應得其法定代理人或監護人書面同意,提供者為無醫師人役之成年人為人依前項規定辦理時應按下列順序之人緣取得其書面同意, |
| transcript.whisperx[149].start |
5095.441 |
| transcript.whisperx[149].end |
5118.371 |
| transcript.whisperx[149].text |
一、配偶二、成年子女三、父母四、兄弟姊妹五、祖父母。請向第二款至第五款規定人員所為之書面同意,得以一人為之。同一順序之人亦是表示不一致時,亦與無意識人力之成年人同居親屬為先。其同居親屬有二人已戰者,以連戰者為先,無同居親屬者,以連戰者為先。 |
| transcript.whisperx[150].start |
5122.436 |
| transcript.whisperx[150].end |
5136.551 |
| transcript.whisperx[150].text |
議員羅廷瑋等21人提案第16條醫療機構或細胞保存庫設置機構取得再生醫療組織細胞來源之提供者以有意識能力之成年人為限但為治療疾病且 |
| transcript.whisperx[151].start |
5137.412 |
| transcript.whisperx[151].end |
5162.91 |
| transcript.whisperx[151].text |
且顯有異於特定人口群或未能以其他對象取代者不在此限。」其餘同委員邱議瑩等25人提案。台灣民眾黨黨團提案第16條醫療機構或人體細胞保存庫設置機構取得再生醫療組織細胞來源之提供者以有意識能力之成年人為限但顯有異於特定人口群或未能以其他 |
| transcript.whisperx[152].start |
5168.393 |
| transcript.whisperx[152].end |
5196.016 |
| transcript.whisperx[152].text |
但顯有異於特定人口群或未能以其他對象取代者除胎兒無行為能力人外不在此限。前項之組織細胞應於取得前獲得提供者之書面同意。第一項書面同意提供者為限制行為能力人或受輔助宣告之人時應得其本人及法定代理人或輔助人書面同意。第一項提供者為受監護宣告之人或無意識能力之成年人時 |
| transcript.whisperx[153].start |
5196.897 |
| transcript.whisperx[153].end |
5213.133 |
| transcript.whisperx[153].text |
以同意時具意識能力者為限,其書面同意有效。」行政院提案委員陳慶輝等19人提案第20條委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員黃旭政等20人委員楊瓊英等25人臺灣民眾黨黨團提案 |
| transcript.whisperx[154].start |
5220.404 |
| transcript.whisperx[154].end |
5238.277 |
| transcript.whisperx[154].text |
委員邱議第17條一前條規定取得同意前應告之下列事項一機構名稱二組織細胞之取得方式可能產生之副作用與併發症發生率與處理方法禁忌限制及其他因 |
| transcript.whisperx[155].start |
5238.917 |
| transcript.whisperx[155].end |
5253.005 |
| transcript.whisperx[155].text |
相關因配合事項 提供者合適性判定條件 剩餘組織、細胞之後續處置或可能之使用範圍 提供行為之補助內容及方法 後續追蹤內容及方式 |
| transcript.whisperx[156].start |
5254.025 |
| transcript.whisperx[156].end |
5271.237 |
| transcript.whisperx[156].text |
七、退出終止及終止之權利。八、取得組織細胞過程發生不良反應之醫療照護補償及處理。九、預期可能衍生之利益及歸屬。十、個人資料保密措施。十一、其他經中央主管機關公告之事項。 |
| transcript.whisperx[157].start |
5272.816 |
| transcript.whisperx[157].end |
5298.459 |
| transcript.whisperx[157].text |
前向同意之告知方式、程序及其他應遵行事項之辦法由中央主管機關定之。行政院提案委員陳金威等19人提案第5條監督及救濟委員邱議瑩等25人委員羅廷瑋等21人委員黃秀帆等18人委員黃振旭等20人委員楊群英等25人臺灣民眾黨黨團提案第5章監督及預防 |
| transcript.whisperx[158].start |
5300.003 |
| transcript.whisperx[158].end |
5310.315 |
| transcript.whisperx[158].text |
行政院提案委員陳金威等19人提案第21條,招募再生醫療組織細胞提供者之廣告,以下稱招募廣告。 |
| transcript.whisperx[159].start |
5311.641 |
| transcript.whisperx[159].end |
5334.99 |
| transcript.whisperx[159].text |
除招募再生致濟組織細胞提供者之管告現由藥商為之外以由經核准執行再生醫療之醫療機構或保存組織細胞之細胞保存庫設置機構或受中央主管機關所托辦理第六條第四款招募及推管人體組織細胞提供之其他政府機關機關構醫療機構學術研究機構學校法人 |
| transcript.whisperx[160].start |
5340.532 |
| transcript.whisperx[160].end |
5355.1 |
| transcript.whisperx[160].text |
或捐助設立之財團法人為之違憲。再生醫療之廣告現由經核准執行再生醫療之醫療機構為之。再生致濟廣告依藥事法藥品廣告之規定。 |
| transcript.whisperx[161].start |
5356.181 |
| transcript.whisperx[161].end |
5381.522 |
| transcript.whisperx[161].text |
委員邱議瑩等25人擬具委員羅廷瑋等21人擬具委員王秀芳等18人擬具委員王振旭等20人擬具委員楊瓊瑛等25人提案第21條招募再生醫療組織細胞提供者之廣告以下稱招募廣告除招募再生致濟組織細胞提供者之廣告現由藥商為之外以執行再生醫療之醫療機構或保存組織細胞之細胞保存庫設置機構為之違憲 |
| transcript.whisperx[162].start |
5386.085 |
| transcript.whisperx[162].end |
5402.233 |
| transcript.whisperx[162].text |
執行再生醫療之廣告現由醫療機構為之,再生致濟廣告依藥事法藥品廣告之規定。台灣民眾黨黨團提案第二十一條,莊木再生醫療組織細胞提供者之廣告,以下稱莊木廣告,除莊木再生致濟 |
| transcript.whisperx[163].start |
5403.013 |
| transcript.whisperx[163].end |
5429.787 |
| transcript.whisperx[163].text |
致濟組織細胞提供者之廣告現由藥商為之外以執行再生醫療之醫療機構或保存組織細胞之人體細胞保存庫設置機構為之違憲取於同委員邱議瑩等25人提案。行政院提案委員陳金威等19人提案第22條招募廣告及再生醫療廣告以下並稱廣告不得就 |
| transcript.whisperx[164].start |
5432.538 |
| transcript.whisperx[164].end |
5460.097 |
| transcript.whisperx[164].text |
醫療效能有誇大、不實或無科學實證之標示宣傳,前向廣告廣告者應於刊播前將其內容、刊播方式、刊播文件及影音錄製之內容向中央主管機關建置之資訊系統登錄。經中央主管機關或其委任委託之機關構或法人核准委託傳播業者刊播並應提具核准文件後,使得為之。 |
| transcript.whisperx[165].start |
5460.757 |
| transcript.whisperx[165].end |
5484.796 |
| transcript.whisperx[165].text |
看播期間未經核准不得變更原核准廣告內容或看播方式,直轄市縣市主管機關發現廣告內容有違反第一項或前項規定時應立即停止看播並限其改善,藉其未改善者應禁止其繼續看播,並通知前項之中央主管機關、機關構或法人廢止其核准。 |
| transcript.whisperx[166].start |
5486.584 |
| transcript.whisperx[166].end |
5503.712 |
| transcript.whisperx[166].text |
第一項廣告得看播與不得看播之文字、言詞、圖畫或其其他內容、招募對象、看播方式、看播地點及其他應遵行事項之辦法由中央主管機關定之。第八條第一項第一款之再生技術不得廣告。 |
| transcript.whisperx[167].start |
5504.755 |
| transcript.whisperx[167].end |
5520.046 |
| transcript.whisperx[167].text |
委員邱議瑩等25人擬具委員羅廷瑋等21人擬具委員黃秀帆等18人擬具委員王振旭等20人擬具委員楊瓊英等25人擬具臺灣民眾黨黨團提案第22條。週末廣告及再生醫療廣告以下並稱廣告不得就醫療效能有誇大不實 |
| transcript.whisperx[168].start |
5520.766 |
| transcript.whisperx[168].end |
5522.087 |
| transcript.whisperx[168].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[169].start |
5547.32 |
| transcript.whisperx[169].end |
5552.614 |
| transcript.whisperx[169].text |
應令立即停止康撥並限其改善,藉其為改善者應廢止核准。」 |
| transcript.whisperx[170].start |
5554.386 |
| transcript.whisperx[170].end |
5577.285 |
| transcript.whisperx[170].text |
第一項廣告得看播與不得看播之文字、言詞、圖畫或內容、招募對象、看播方式、地點及其他應遵行事項之辦法由中央主管機關定之。行政院提案委員陳金輝等19人提案第23條傳播業者不得看播未經核准與核准事項不符以廢止核准禁令立即停止看播或 |
| transcript.whisperx[171].start |
5578.046 |
| transcript.whisperx[171].end |
5596.326 |
| transcript.whisperx[171].text |
經禁止繼續刊播之廣告。傳播業者接受委託刊播廣告,應自廣告之日起六個月內保存委託刊播廣告之內容,委託刊播機構名稱、地址、電話及前條第二項之合總文件影本資料。 |
| transcript.whisperx[172].start |
5597.307 |
| transcript.whisperx[172].end |
5607.898 |
| transcript.whisperx[172].text |
委託勘剝者為醫療機構者並保存開業執照字號。主管機關要求提供前項文件資料時,傳播業者不得規避、妨礙或拒絕。 |
| transcript.whisperx[173].start |
5610.171 |
| transcript.whisperx[173].end |
5629.162 |
| transcript.whisperx[173].text |
委員邱議瑩等25人委員羅廷瑋等21人委員王秀帆等18人委員王振旭等20人委員楊瓊英等25人臺灣民眾黨黨團提案第23條傳播業者不得看播以廢止或禁令立即停止看播並限期改善而尚未改善之廣告第二項同行政院提案 |
| transcript.whisperx[174].start |
5630.183 |
| transcript.whisperx[174].end |
5652.343 |
| transcript.whisperx[174].text |
中央主管機關要求提供前項文件資料時,傳播業者不得規避、妨礙或拒絕。行政院提案委員陳金威等19人提案第24條。醫療機構執行第8條第1項及第12條第1項再生技術者,應於每年度中了後6個月內或中央主管機關通知之期限內提出結果報告。前項報告內容 |
| transcript.whisperx[175].start |
5653.624 |
| transcript.whisperx[175].end |
5681.018 |
| transcript.whisperx[175].text |
因包括案例數效果不良事件及其他中央主管機關之事項中央主管機關應定期公開第一項報告統計之醫療品質資訊。委員邱議瑩等25人委員王秀芳等18人委員楊瓊英等25人提案第24條醫療機構執行第9條再生技術者應於每年度終了後6個月內或中央主管機關通知之期限內提出結果報告。其餘同行政院提案 |
| transcript.whisperx[176].start |
5682.299 |
| transcript.whisperx[176].end |
5700.496 |
| transcript.whisperx[176].text |
委員羅廷瑋等21人提案第24條醫療機構施行第9條再生醫療者應於每年度中養後3個月內或中央主管機關通知之期限內提出結果報告。前項報告內容應包括案例數、效果、不良事件及其他中央主管機關指定之事項。 |
| transcript.whisperx[177].start |
5701.437 |
| transcript.whisperx[177].end |
5724.591 |
| transcript.whisperx[177].text |
其格式由中央主管機關定之。中央主管機關應定期公開醫療機構第一項報告之統計結果。委員王振旭等20人提案。第24條,醫療機構執行第8條及第9條再生技術者應於每年度終了後6個月內或中央主管機關通知之期限內提出結果報告區域同行政院提案。 |
| transcript.whisperx[178].start |
5726.963 |
| transcript.whisperx[178].end |
5751.803 |
| transcript.whisperx[178].text |
行政院提案委員陳金輝等19人委員邱議瑩等25人委員羅廷瑋等21人委員黃秋帆等18人委員王振旭等20人委員楊秋英等25人臺灣民眾黨黨團提案第25條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發生嚴重不良反應時應通報中央主管機關其通報之期限方式內容及其他應遵行之事項 |
| transcript.whisperx[179].start |
5753.064 |
| transcript.whisperx[179].end |
5774.117 |
| transcript.whisperx[179].text |
由中央主管機關定之委員謝衣鳯等19人提案第14條製造輸入與販賣再生醫療製劑及對病人提供再生醫療製劑及施行再生醫療技術者因實施必要措施保障使用病人之權益。行政院提案委員陳清輝等19人提案第26條 |
| transcript.whisperx[180].start |
5776.178 |
| transcript.whisperx[180].end |
5801.616 |
| transcript.whisperx[180].text |
醫療機構有下列影響病人權益安全情形之一者中央主管機關得令其停止或終止執行再生醫療之全部或一部並公告之一違反第八條第二項中央主管機關公告應遵行之事項或違依第十二條第一項規定經中央主管機關核准之內容執行再生醫療二不良事件發生案例數或嚴重度顯有異常 |
| transcript.whisperx[181].start |
5804.418 |
| transcript.whisperx[181].end |
5828.185 |
| transcript.whisperx[181].text |
三、未依前條前段規定進行通報。四、執行細胞操作未符合第14條第4項鎖定辦法之規定。五、其他影響病人權益安全之情勢。醫療機構自行停止或終止經第12條第1項規定核准之再生醫療全部或一部者 |
| transcript.whisperx[182].start |
5829.352 |
| transcript.whisperx[182].end |
5837.755 |
| transcript.whisperx[182].text |
因事先續名理由向中央主管機關申請同意。且而向中指執行再生醫療之醫療機構應於中央主管機關鎖定期限內檢據內容包括組織細胞檢體及執行記錄之後續處理計劃書報中央主管機關核定,於核定後應依後續處理計劃書執行。 |
| transcript.whisperx[183].start |
5854.4 |
| transcript.whisperx[183].end |
5861.488 |
| transcript.whisperx[183].text |
委員邱議瑩等25人委員羅廷瑋等21人委員黃秋帆等18人委員王振旭等20人委員楊瓊英等25人臺灣民眾黨黨團提案第26條 |
| transcript.whisperx[184].start |
5867.455 |
| transcript.whisperx[184].end |
5884.937 |
| transcript.whisperx[184].text |
醫療機構有下列影響病人權益安全情形之一者中央主管機關得令其停止或終止執行再生醫療之全部或一部並公告之為依第八條第一項規定經中央主管機關核准之內容執行再生醫療 |
| transcript.whisperx[185].start |
5886.078 |
| transcript.whisperx[185].end |
5902.063 |
| transcript.whisperx[185].text |
第二至五款同行政院提案醫療機構自行停止或終止經依第八條第一項規定核准之再生醫療全部或一部者因事先續名理由向中央主管機關申請同意第三項同行政院提案 |
| transcript.whisperx[186].start |
5904.454 |
| transcript.whisperx[186].end |
5932.689 |
| transcript.whisperx[186].text |
行政院提案委員陳慶威等19人提案第二十七條醫療機構執行第八條第一項第二款或第十二條第一項之再生技術應有發生不良反應致重大傷害或死亡之救濟措施其方式範圍及其他應遵行事項由中央主管警官公告之前項救濟措施得以投保相關責任保險為之 |
| transcript.whisperx[187].start |
5934.17 |
| transcript.whisperx[187].end |
5957.626 |
| transcript.whisperx[187].text |
委員邱議瑩等25人委員黃秀帆等18人提案第27條醫療機構執行第九條第三項或第五項之再生技術應有發生不良反應致重大傷害或死亡之救濟措施其方式範圍及其他應遵行四項由中央主管機關公告之第二項同行政院提案委員羅廷 |
| transcript.whisperx[188].start |
5958.386 |
| transcript.whisperx[188].end |
5982.024 |
| transcript.whisperx[188].text |
國庭委等21人委員王振旭等20人委員楊瓊英等25人提案第27條醫療機構執行第9條第一項第二款或第三款之再生技術因有發生不良反應致重大傷害或死亡之救濟措施其方式範圍及其他應遵行事項由中央主管機關公告之第二項同行政院提案 |
| transcript.whisperx[189].start |
5982.805 |
| transcript.whisperx[189].end |
6000.992 |
| transcript.whisperx[189].text |
台灣民眾黨黨團提案第27條醫療機構執行第8條再生技術因有發生不良反應致重大傷害或死亡致救濟措施其方式範圍及其他應遵行事項由中央主管機關公告之第二項同行政院提案。以上。 |
| transcript.whisperx[190].start |
6004.727 |
| transcript.whisperx[190].end |
6016.493 |
| transcript.whisperx[190].text |
行政院提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀邦等18人提案委員王振旭等20人提案台灣民眾黨黨團提案委員陳敬輝等19人提案委員楊崇英等25人提案第6章法則行政院提案委員陳敬輝等19人提案第28條 |
| transcript.whisperx[191].start |
6021.195 |
| transcript.whisperx[191].end |
6029.637 |
| transcript.whisperx[191].text |
非醫療機構有下列情形之一者處心臺幣200萬元以上、2000萬元以下罰還一、違反第11條規定執行再生醫療二、違反第21條第二項規定為再生醫療廣告有下列情形之一者處心臺幣20萬元以上、200萬元以下罰還一、違反第7條規定執行再生醫療前未進行或未完成人體試驗二、違反第8條第三項規定未經中央主管機關核准執行同條第一項第一款之再生技術三、 |
| transcript.whisperx[192].start |
6047.06 |
| transcript.whisperx[192].end |
6071.308 |
| transcript.whisperx[192].text |
違反第14條第二項後段規定未經許可執行細胞操作,四）違反第18條第一項前段規定未經許可設置細胞保存庫,五）違反第21條第一項規定未經核准執行再生醫療之醫療機構非保存組織細胞保存庫設置機構或非受中央主管機關所託辦理第6條第4款招募及推廣人體組織細胞提供者 |
| transcript.whisperx[193].start |
6072.228 |
| transcript.whisperx[193].end |
6087.561 |
| transcript.whisperx[193].text |
刊破招募廣告．六．違反第二十一條第二項規定．被禁核准執行再生醫療之醫療機構為再生醫療廣告．七．違反第二十二條第二項規定．未經核准或未向傳播業者提據．核准文件或刊破廣告． |
| transcript.whisperx[194].start |
6088.081 |
| transcript.whisperx[194].end |
6109.021 |
| transcript.whisperx[194].text |
或未經核准變根源核准之廣告內容或刊播方式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委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案第28條 |
| transcript.whisperx[195].start |
6110.242 |
| transcript.whisperx[195].end |
6119.126 |
| transcript.whisperx[195].text |
有下列情形記憶者處心台幣20萬元以上、200萬元以下罰還。一、違反第7條規定非醫療機構執行再生醫療。二、違反第11條第二項後段規定未經許可執行細胞操作。三、違反第15條第一項前段規定未經許可設置細胞保存庫。四、違反第18條規定執行再生醫療前未進行人體試驗。五、違反第21條第一項規定非執行再生醫療至醫療機構或非細胞保存庫設置機構刊破招募廣告。 |
| transcript.whisperx[196].start |
6139.674 |
| transcript.whisperx[196].end |
6156.35 |
| transcript.whisperx[196].text |
六（違反第二十一條第二項規定非醫療機構為再生醫療廣告。七（違反第二十二條第二項前段規定未經核准或未向傳播業者提具核准文件刊破廣告。有前項第一款第二款或第六款規定情形者處以該項規定處罰外並被公布其名稱。 |
| transcript.whisperx[197].start |
6157.251 |
| transcript.whisperx[197].end |
6183.853 |
| transcript.whisperx[197].text |
委員王振旭等20人提案第28條有下列情形之一者處心臺幣200萬元以上2000萬元以下罰還一違反第7條規定非醫療機構執行再生醫療二違反第21條第二項規定非醫療機構為再生醫療廣告有下列情形之一者處心臺幣20萬元以上200萬元以下罰還一違反第11條第二項後段規定未經許可執行細胞操作二違反第15條第一項前段規定未經許可設置細胞保存庫 |
| transcript.whisperx[198].start |
6185.478 |
| transcript.whisperx[198].end |
6207.39 |
| transcript.whisperx[198].text |
第三、違反第18條規定執行再生醫療前未進行人體試驗。四、違反第21條第一項規定非執行再生醫療之醫療機構或非細胞保存庫設置機構刊破招募廣告。五、違反第二項前段規定未經核准或未向傳播業者提據核准文件刊破廣告。有第一項各款或前項第一款規定情形者。 |
| transcript.whisperx[199].start |
6207.95 |
| transcript.whisperx[199].end |
6223.3 |
| transcript.whisperx[199].text |
除一該項規定處罰外並得公佈其名稱。台灣民眾黨黨團提案第28條第一項續文及第三款第五款如下有下列情形之一者處新台幣200萬元以上2000萬元以下罰款。三違反第15條第一項前段規定未經許可設置人體細胞保存庫。五違反第二十一條第一項規定非執行再生醫療之醫療機構或非人體細胞保存庫設置機構刊播招募廣告。第二項如下有前項各款情形 |
| transcript.whisperx[200].start |
6235.928 |
| transcript.whisperx[200].end |
6261.553 |
| transcript.whisperx[200].text |
有前項各款規定情形者,除一該項規定處罰外,並得公布其名稱。其餘委員邱議瑩等25人提案第28條同。委員楊聰英等25人提案第28條第一項第一款第7款如下。一、違反第7條規定被醫療機構執行再生醫療業務。七、違反第22條第二項前段規定未經核准或未向傳播業者提供具核准文件刊破廣告。其餘委員邱議瑩等25人提案第28條同。 |
| transcript.whisperx[201].start |
6262.933 |
| transcript.whisperx[201].end |
6283.752 |
| transcript.whisperx[201].text |
行政院提案委員陳金輝等19人提案第29條有下列情形之一者處刑臺幣20萬元以上200萬元以下罰還並另限其改善藉其為改善者按次處罰至改善為止。一、違反第14條第4項所定辦法中有關細胞操作之方法管制措施運銷或許可事項變更之規定 |
| transcript.whisperx[202].start |
6284.472 |
| transcript.whisperx[202].end |
6303.137 |
| transcript.whisperx[202].text |
二、違反第17條或第18條第一項規定為確保提供者之合適性。三、違反第18條第二項鎖定辦法中有關保存項目許可事項變更因具備之設施、設備、品質、管理、費用、收取、退費或商業運用利益回饋之規定。四、違反第22條第三項規定刊破以 |
| transcript.whisperx[203].start |
6305.838 |
| transcript.whisperx[203].end |
6326.572 |
| transcript.whisperx[203].text |
廢紙核准 禁令立即停止刊播或禁禁止繼續刊播至廣告五（違反第二十二條第四項所定辦法中有關廣告刊播地點之規定六（違反第二十二條第五項規定刊播第八條第一項第一款之再生技術廣告七（違反第二十二條第一項規定刊播未經核准與核准事項不符以廢紙核准 |
| transcript.whisperx[204].start |
6327.112 |
| transcript.whisperx[204].end |
6352.278 |
| transcript.whisperx[204].text |
經令立即停止刊播或經禁止繼續刊播至廣告。依必項規定令限其改善改善期間或藉其為改善者得令停止一部或全部細胞操作及保存其情節重大有損害病人生命身體或健康之事實或有損害之餘者病的廢止其一部或全部許可。委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王真旭等20人提案。 |
| transcript.whisperx[205].start |
6353.058 |
| transcript.whisperx[205].end |
6368.641 |
| transcript.whisperx[205].text |
台灣民眾黨黨團提案委員楊瓊英等25人提案第29條有下列情形之意者處新台幣20萬元以上200萬元以下罰還並令限期改善藉其為改善者按次處罰至改善為止依違反第11條第4項所定辦法中有關細胞操作之方法 |
| transcript.whisperx[206].start |
6369.042 |
| transcript.whisperx[206].end |
6369.322 |
| transcript.whisperx[206].text |
規定規定規定規定規定規定規定規定規定規定 |
| transcript.whisperx[207].start |
6388.76 |
| transcript.whisperx[207].end |
6407.929 |
| transcript.whisperx[207].text |
第22條第二項後段規定未經核准變更原核准之廣告內容五（第23條第一項規定刊破以廢止或禁令立即停止刊破並限期改善而未改善之廣告有前項第四款規定情形者除一該規定處罰外並得公布其名稱第三項與院版第二項同 |
| transcript.whisperx[208].start |
6409.372 |
| transcript.whisperx[208].end |
6422.299 |
| transcript.whisperx[208].text |
行政院提案委員陳金輝等19人提案第30條醫療機構違反第12條第一項規定未經核准及登記執行再生技術或使用中央主管機關指定之再生製劑處新台幣10萬元以上100萬元以下罰還並得公佈其名稱 |
| transcript.whisperx[209].start |
6425.541 |
| transcript.whisperx[209].end |
6445.231 |
| transcript.whisperx[209].text |
有下列情形之一者處新台幣10萬元以上100萬元以下罰還,並另限其改善,藉其為改善者按次處罰至改善為止。一、違反第12條第三項所定辦法中有關核准事項變更、費用收取或退費之規定。二、違反第27條第一項規定無救濟措施或其措施未符合中央主管機關公告之規定。 |
| transcript.whisperx[210].start |
6446.011 |
| transcript.whisperx[210].end |
6461.485 |
| transcript.whisperx[210].text |
有前向第一款規定情形者除一該項規定處罰外,並得公布其名稱,一、第二項規定令限期改善期間或藉其為改善者得令停止一部或全部再生醫療執行作業,其情節重大有損害病人生命身體或健康之事實, |
| transcript.whisperx[211].start |
6462.465 |
| transcript.whisperx[211].end |
6488.318 |
| transcript.whisperx[211].text |
會有損害之餘者,並得廢止其一部或全部核准十項。」委員邱議瑩等25人提案。委員羅廷瑋等21人提案。委員黃秀芳等18人提案。委員王振旭等20人提案。台灣民眾黨黨團提案第30條第一項如下。醫療機構違反第8條第一項規定,未經核准使用中央主管機關指定之再生製劑或執行再生技術,處新台幣10萬元以上、100萬元以下罰還,並得公布其名稱。第二項第一款如下。 |
| transcript.whisperx[212].start |
6488.798 |
| transcript.whisperx[212].end |
6514.414 |
| transcript.whisperx[212].text |
一、違反第八條第三項所定辦法中有關核准事項變更費用收取或退費之規定其餘與原版同。委員楊瓊瑩等25人提案第四項分號前二字為業務其餘委員邱瑩等25人提案同。行政院提案委員陳金輝等19人提案第31條有效的情形之一者處心臺幣5萬元以上50萬元以下罰款。一、以第九條規定之方式進行涉及胚胎或胚胎幹細胞之再生醫療研究 |
| transcript.whisperx[213].start |
6515.575 |
| transcript.whisperx[213].end |
6541.542 |
| transcript.whisperx[213].text |
二、執行再生醫療之一是未符合中央儲管機關一第13條後段規定公告之資格。三、違反第14條第4項鎖定辦法中有關細胞操作人員資格之規定。四、違反第18條第2項鎖定辦法中有關細胞保存庫人員資格之規定。五、違反第19條第1項規定提供者非為有意識能力之成年人。六、違反第23條第2項規定未依規定期限保存資料或保存資料不全。 |
| transcript.whisperx[214].start |
6542.202 |
| transcript.whisperx[214].end |
6563.18 |
| transcript.whisperx[214].text |
委員邱議瑩等25人提案委員黃秀芳等18人提案第31條有下列情形之一者處新台幣5萬元以上50萬元以下罰款一違反第九條第二項規定未經申請核准使用第八條第一項規定指定之再生製劑或執行再生技術者二違反第九條第三項規定執行尚未完成第三期人體試驗之再生技術 |
| transcript.whisperx[215].start |
6564.381 |
| transcript.whisperx[215].end |
6580.851 |
| transcript.whisperx[215].text |
三、醫療機構違反第9條第4項所定辦法中有關執行資格條件申請核准之程序、核准效期、核准事項變更之規定。四、執行或非提供第9條第5項公告之不含基因改造或轉植之人類細胞及其衍生物質細胞治療項目。 |
| transcript.whisperx[216].start |
6582.552 |
| transcript.whisperx[216].end |
6592.877 |
| transcript.whisperx[216].text |
五、執行再生醫療之一是未符合中央主管機關一第10條後段規定公告之資格。六、違反第11條第4項鎖定辦法中有關細胞操作人員資格之規定。七、違反第15條第2項鎖定辦法中有關細胞保存庫人員資格之規定。八、違反第16條第1項規定提供者 |
| transcript.whisperx[217].start |
6600.661 |
| transcript.whisperx[217].end |
6622.342 |
| transcript.whisperx[217].text |
非為有意思能力之成年人．違反第19條第一項規定以禁止之方式進行涉及胚胎或胚胎幹細胞之再生醫療研究,時違反第23條第二項規定,為依規定期限保存資料或保存資料不全,委員羅廷瑋等21人提案,委員王正旭等20人提案,委員楊瓊英等25人提案。第三十一條 |
| transcript.whisperx[218].start |
6623.303 |
| transcript.whisperx[218].end |
6646.559 |
| transcript.whisperx[218].text |
有下列情形之一者處心臺幣5萬元以上50萬元以下罰還一、執行再生醫療之一是未符合中央主管機關一第10條後段規定公告之資格二、違反第11條第4項鎖定辦法中有關細胞操作人員資格之規定三、違反第15條第2項鎖定辦法中有關細胞保存庫人員資格之規定四、違反第16條第1項規定提供者非為有意思能力之成年人 |
| transcript.whisperx[219].start |
6647.159 |
| transcript.whisperx[219].end |
6671.178 |
| transcript.whisperx[219].text |
五、未經核准以第19條第一項規定之方式進行涉及胚胎或胚胎幹細胞之再生醫療研究。六、違反第23條第二項規定為依規定期限保存資料或保存資料不全。台灣民眾黨黨團提案第31條第一款如下。一、執行再生醫療之一是未符合中央主管機關一第10條後段規定公告之資格。其餘委員羅廷瑋等21人提案同。 |
| transcript.whisperx[220].start |
6672.884 |
| transcript.whisperx[220].end |
6689.831 |
| transcript.whisperx[220].text |
行政院提案委員陳金輝等19人提案第32條有效類情形之一者處新台幣5萬元以上50萬元以下罰還並令限期改善。藉其為改善者按次處罰至改善為止。依違反第14條第4項所定辦法中有關細胞操作人員應完成相關訓練之規定 |
| transcript.whisperx[221].start |
6691.252 |
| transcript.whisperx[221].end |
6718.081 |
| transcript.whisperx[221].text |
二（違反第15條第一項規定執行再生醫療前未違相關說明。三（違反第15條第二項規定未予執行再生醫療前取得同意書。四（未依第16條第一項規定製作記錄保存或登錄資訊系統。五（記錄內容未包括第16條第二項所定事項。六（違反第19條第二項規定未予取得組織細胞前獲得提供者之書面同意或未依同條第三項至第五項有關同意權行使之規定辦理。 |
| transcript.whisperx[222].start |
6719.281 |
| transcript.whisperx[222].end |
6740.622 |
| transcript.whisperx[222].text |
七（一（二十條第一項規定與取得同意前告知該項所列事項。八（一（二十條第二項所定辦法中有關告知方式程序之規定。九（一（二十三條第三項規定迴避、妨礙或拒絕提供、接受、委託刊播之廣告文件資料。十（一（二十四條第一項所定期限提出結果報告。 |
| transcript.whisperx[223].start |
6741.363 |
| transcript.whisperx[223].end |
6762.277 |
| transcript.whisperx[223].text |
十一、結果報告內容未包括第24條第二項鎖定事項。十二、違反第25條前項規定發生嚴重不良反應未為通報或為為或為依同條後段鎖定辦法規定通報。十三、未遵循中央主管機關依第26條第一項規定所為停止或終止執行再生醫療全部或一部之命令。 |
| transcript.whisperx[224].start |
6762.857 |
| transcript.whisperx[224].end |
6787.128 |
| transcript.whisperx[224].text |
十四（違反第二十六條第二項規定為事先申請同意而自行停止或終止經核准之再生醫療。十五（違反第二十六條第三項規定為檢舉後續處理計劃書到中央主管機關核定或為依核定之後續處理計劃書執行。委員邱議瑩等25人提案為黃秀芳等18人提案第三十二條違反條項如下一、第十一條第四項二、第十二條第一項 |
| transcript.whisperx[225].start |
6788.248 |
| transcript.whisperx[225].end |
6802.195 |
| transcript.whisperx[225].text |
三．12條第二項、四．13條第一項、五．13條第二項、六．16條第二項、七．17條第一項、八．違反第17條第二項所定辦法中有關告知方式或程序之規定,其予以願反同。 |
| transcript.whisperx[226].start |
6805.693 |
| transcript.whisperx[226].end |
6828.524 |
| transcript.whisperx[226].text |
委員羅廷瑋等21人提案第32條、第一款、第二款、第十款如下。一、違反第11條第4項所定辦法中有關細胞操作人員應完成相關訓練之規定。二、違反第12條第1項規定執行再生醫療前未為相關說明。十、違反第19條第2項所定辦法中有關核准事項變更之規定。第三款至第9款及第11款至第17款。 |
| transcript.whisperx[227].start |
6829.364 |
| transcript.whisperx[227].end |
6853.058 |
| transcript.whisperx[227].text |
與委員邱議瑩等25人提案第二款至第八款及第九款至第十五款同,其餘與其同。委員王志趣等20人提案委員楊崇英等25人提案第32條第九款如下。九、違反第19條第二項鎖定辦法中有關核准事項變更之規定第十款至第十六款,與委員邱議瑩等25人提案第九款至第十五款同,其餘與其同。台灣民眾黨黨團提案第32條第六款後段如下。 |
| transcript.whisperx[228].start |
6856.38 |
| transcript.whisperx[228].end |
6876.947 |
| transcript.whisperx[228].text |
或未依同條第三項或第四項有關同意權行使之規定辦理,其餘委員邱議瑩等25人提案同,台灣民眾黨黨團提案第33條違反第21條至第23條廣告規定者,中央主管機關應訂定廣告處理原則,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罰還額度之依據。 |
| transcript.whisperx[229].start |
6879.727 |
| transcript.whisperx[229].end |
6906.727 |
| transcript.whisperx[229].text |
行政院提案委員陳慶輝等19人提案第33條本法所定法環與私立醫療機構處罰其負責醫師與醫療法人設立之醫療機構處罰醫療法人委員邱瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案委員楊崇英等25人提案第33條台灣民眾黨黨團提案第34條依本法所為處分由中央主管機關為之 |
| transcript.whisperx[230].start |
6907.748 |
| transcript.whisperx[230].end |
6926.073 |
| transcript.whisperx[230].text |
本法所定法環與私立醫療機構處罰其負責醫師與醫療法人設立之醫療機構處罰醫療法人。行政院提案委員邱瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王正旭等20人提案台灣民眾黨黨團提案委員陳金輝等19人提案委員楊聰英等25人提案第7章負責 |
| transcript.whisperx[231].start |
6932.555 |
| transcript.whisperx[231].end |
6954.625 |
| transcript.whisperx[231].text |
委員謝衣鳯等19人提案第16條政府應依本法規定檢討所主管之法規及行政措施有妨礙再生醫療政策推動不符合本法規定或無法規可知適用者因自本法施行後一年內完成法令之制定令修正或廢止及行政措施之改進前項法規完成制定令 |
| transcript.whisperx[232].start |
6955.405 |
| transcript.whisperx[232].end |
6977.501 |
| transcript.whisperx[232].text |
修正前由主管機關會同中央目的事業主管機關依規定解釋使用。委員謝衣鳯等19人提案第13條《再生醫療制計另一法律定制》。行政院提案委員邱議瑩等25人提案。委員羅廷瑋等21人提案。委員黃秀芳等18人提案。委員王振旭等20人提案。委員陳金輝等19人提案。委員楊瓊英等25人提案第34條。 |
| transcript.whisperx[233].start |
6978.962 |
| transcript.whisperx[233].end |
7006.314 |
| transcript.whisperx[233].text |
台灣民眾黨黨團提案第35條本法施行細則由中央主管機關定之行政院提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王正旭等20人提案委員陳金輝等19人提案委員楊瓊英等25人提案第35條台灣民眾黨黨團提案第36條本法施行日期由行政院定之委員謝衣鳯等19人提案第17條本法自公佈日施行 |
| transcript.whisperx[234].start |
7009.029 |
| transcript.whisperx[234].end |
7027.982 |
| transcript.whisperx[234].text |
繼續宣讀再生醫療致記條例草案再生醫療致記管理條例草案條文對照表行政院提案臺灣民眾黨黨團提案委員邱議瑩等25人委員黃秀芳等18人委員王振旭等20人委員楊秋瑩等26人提案名稱再生醫療致記條例委員謝衣鳯等18人委員羅廷瑋等21人委員劉建國等17人提案 |
| transcript.whisperx[235].start |
7038.746 |
| transcript.whisperx[235].end |
7063.36 |
| transcript.whisperx[235].text |
再生醫療致濟管理條例行政院提案台灣民眾黨黨團提案第一條為確保再生醫療致濟之安全品質及有效性維護病人權益特制定本條例本條例未規定者依藥事法及其他相關法律之規定委員邱議瑩等25人委員黃秀帆等18人委員王振旭等20人委員楊瓊英等26人提案第一條 |
| transcript.whisperx[236].start |
7065.076 |
| transcript.whisperx[236].end |
7085.151 |
| transcript.whisperx[236].text |
為確保再生醫療致濟之品質、安全及有效性、維護病人權益特制定本條例。本條例為規定著醫藥司法及其他相關法律之規定。委員謝衣鳯等18人提案。第一條,為確保再生醫療致濟之品質、安全及有效性,並維護病人 |
| transcript.whisperx[237].start |
7086.892 |
| transcript.whisperx[237].end |
7111.549 |
| transcript.whisperx[237].text |
接受治療之權益特制定本條例本條例為規定者得適用其他相關法律之規定委員羅廷瑋等21人委員劉建國等17人提案第一條為確保再生醫療自治品質安全及有效性並維護病人接受治療之權益特制定本條例本條例為規定者醫藥事法等相關規定 |
| transcript.whisperx[238].start |
7112.91 |
| transcript.whisperx[238].end |
7139.356 |
| transcript.whisperx[238].text |
自規定行政院委員各委員短團提案第二條本條例所稱主管機關在中央為衛生福利部在直轄市為直轄市政府在縣市為縣市政府行政院提案委員邱議瑩等25人委員黃秋帆等18人委員王正旭等20人委員楊秋英等26人提案第三條本條例所稱再生醫療之際只含有基因細胞及 |
| transcript.whisperx[239].start |
7141.382 |
| transcript.whisperx[239].end |
7165.695 |
| transcript.whisperx[239].text |
及其衍生物、供人體使用之治劑。」 TALI（台湾民眾黨黨團提案第三條本條例所稱:「再生醫療治劑屬要事法第六條之藥品,只含有基因、細胞及其衍生物、供人體使用之治劑。」ortunately,羅廷瑋等21人提案第三條本條例所稱:「再生醫療治劑屬要事法第六條之藥品,只含有基因、人類細胞及其衍生物、供人體使用之治劑。」 |
| transcript.whisperx[240].start |
7166.696 |
| transcript.whisperx[240].end |
7193.379 |
| transcript.whisperx[240].text |
行政院提案〈臺灣民眾黨黨團〉委員邱議瑩等25人委員黃秀帆等18人委員文正旭等20人委員楊瓊英等26人提案第四條再生醫療治劑分類如下一、基因治療治劑將從主基因嵌入或輸注入體內以治療、預防或診斷疾病之治劑二、細胞治療治劑 |
| transcript.whisperx[241].start |
7195.923 |
| transcript.whisperx[241].end |
7218.851 |
| transcript.whisperx[241].text |
將細胞或其衍生物加工製造以治療預防或診斷疾病之製劑。三）組織工程製劑將含有經加工改造之組織或細胞修復再生或替代人體組織器官之製劑。四）複合製劑將具有醫療器材屬性之結構材料簽合前三款全部或部分之製劑。 |
| transcript.whisperx[242].start |
7221.031 |
| transcript.whisperx[242].end |
7249.591 |
| transcript.whisperx[242].text |
委員羅廷瑋等21人提案第四條本條例所稱再生醫療之際指下列各款之一之際但不包括醫療機構依據醫療法第62條第二項所定辦法施行細胞治療技術所製成者各款內容除第二款將人類細胞或其衍生物加工製造及第三款改造人類細胞或細胞等文字不同外其餘同行政院提案 |
| transcript.whisperx[243].start |
7250.987 |
| transcript.whisperx[243].end |
7275.712 |
| transcript.whisperx[243].text |
委員謝衣鳯等18人提案第三條本條例所稱再生醫療製劑指下列各款之一之製劑一以治療或預防人類疾病為目的對細胞施以加工製成者二以治療或預防人類疾病為目的使人體內含有重組基因者三以移植、修復或重建人類之組織或器官為目的 |
| transcript.whisperx[244].start |
7277.152 |
| transcript.whisperx[244].end |
7296.463 |
| transcript.whisperx[244].text |
對細胞施以加工而使之具有組織結構或機能者。」委員劉建國等17人提案第三條除第一款對細胞加工製成者及第三款對細胞加工而使之具有組織結構或機能者等文字不同外其餘同委員謝衣鳯等18人提案。 |
| transcript.whisperx[245].start |
7298.567 |
| transcript.whisperx[245].end |
7312.207 |
| transcript.whisperx[245].text |
行政院提案台灣民眾黨團提案委員邱議瑩等25人委員羅廷瑋等21人委員王秀芳等18人委員王振旭等20人提案第5條再生醫療致記之販賣業者及製造業者以下並稱要三 |
| transcript.whisperx[246].start |
7314.69 |
| transcript.whisperx[246].end |
7334.64 |
| transcript.whisperx[246].text |
為醫藥事法第15條第一款之藥品販賣業者及第16條第一項之藥品製造業者,前項製造業者應聘用國內外大學院校以上醫藥或生命科學等相關科系畢業,並具有細胞學、維生物學或免疫學專門知識之專任人員助產參與製造。 |
| transcript.whisperx[247].start |
7337.782 |
| transcript.whisperx[247].end |
7357.194 |
| transcript.whisperx[247].text |
委員謝衣鳯等18人提案第4條:「再生醫療致濟之販賣業者及製造業者為藥事法第15條第一款之藥品販賣業者及第16條第一項之藥品製造業者。」委員劉建國等17人提案第4條:「再生醫療致濟之販賣業者及製造業者為藥事法第15條第一款之藥品販賣業者及第16條第一項之藥品製造業者。」 |
| transcript.whisperx[248].start |
7365.177 |
| transcript.whisperx[248].end |
7379.412 |
| transcript.whisperx[248].text |
從事製造再生醫療自給之法人、醫療機構、研究機構、准用前項藥品製造業者之規定,委員楊瓊英等26人提案第5條,同行政院第5條提案第1項。行政院提案 |
| transcript.whisperx[249].start |
7380.455 |
| transcript.whisperx[249].end |
7404.85 |
| transcript.whisperx[249].text |
委員邱議瑩等25人委員羅廷瑋等21人委員黃秀帆等18人委員黃正旭等20人委員楊瓊英等26人提案第6條。要山製造輸入再生醫療制計應向中央主管機關申請查驗登記並經核准發給藥品許可證或合與有付款許可後使得為之。中央主管機關合與前項有付款許可應先經再生醫療審議會之審議通過。 |
| transcript.whisperx[250].start |
7408.759 |
| transcript.whisperx[250].end |
7429.19 |
| transcript.whisperx[250].text |
輸入第一項再生醫療製劑應由藥品許可證或有付款許可之所有人或其授權者為之。台灣民眾黨黨團提案第六條,藥商製造輸入再生醫療製劑應向中央主管機關申請查驗登記,並經核准發給藥品許可證或合與有付款 |
| transcript.whisperx[251].start |
7430.111 |
| transcript.whisperx[251].end |
7430.371 |
| transcript.whisperx[251].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[252].start |
7445.748 |
| transcript.whisperx[252].end |
7470.978 |
| transcript.whisperx[252].text |
第三（同行政院提案。委員謝衣鳯等18人提案第五條製造輸入再生醫療治濟應向中央主管機關申請查驗登記並經核准發給再生醫療治濟許可證後使得為之輸入前項再生醫療治濟應由許可證所有人或其授權者為之委員劉建國等17人提案第五條第一項同委員謝衣鳯等18人提案 |
| transcript.whisperx[253].start |
7472.018 |
| transcript.whisperx[253].end |
7492.883 |
| transcript.whisperx[253].text |
輸入前項再生醫療制計應由許可證或有條件期限許可之所有人或其授權者為之。行政院提案台灣民眾黨黨等提案委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振訊等20人委員楊求英等26人提案第7條 |
| transcript.whisperx[254].start |
7495.24 |
| transcript.whisperx[254].end |
7514.145 |
| transcript.whisperx[254].text |
經核准製造輸入之再生醫療制計應經中央主管機關核准使得變更藥品許可證或有付款許可及原查驗登記事項。藥品許可證及有付款許可移轉時應辦理移轉登記。委員謝衣鳯等18人委員劉建國等17人提案第6條經核准 |
| transcript.whisperx[255].start |
7516.766 |
| transcript.whisperx[255].end |
7529.834 |
| transcript.whisperx[255].text |
製造輸入之再生醫療制計非經中央主管機關核准不得變更查驗登記及許可證原登記事項許可證移轉時應辦理移轉登記行政院提案第8條 |
| transcript.whisperx[256].start |
7531.095 |
| transcript.whisperx[256].end |
7553.963 |
| transcript.whisperx[256].text |
一、第六條第一項規定,發給至藥品許可證有效期間為五年,期滿能需繼續製造輸入者,應於有效期間屆滿三個月前至六個月間,申請中央主管機關核准展言。每次展言不得超過五年,藥品許可證效期屆滿未申請或經否准展言者。 |
| transcript.whisperx[257].start |
7555.063 |
| transcript.whisperx[257].end |
7582.367 |
| transcript.whisperx[257].text |
原許可證施其效力並由中央主管機關注銷之。前向許可證有污損或遺失時應續名理由向中央主管機關申請換發或補發。換發者並應同時將原許可證繳銷。前二條申請查驗登記、醫管登記、藥品許可有付款許可與原查驗登記事項之變更及 |
| transcript.whisperx[258].start |
7583.905 |
| transcript.whisperx[258].end |
7603.522 |
| transcript.whisperx[258].text |
前二項藥品許可證之展言,換發與補發者其申請條件應檢複之文件資料審查程序核准基準收費及其他相關事項資準則由中央主管機關定之。 |
| transcript.whisperx[259].start |
7609.192 |
| transcript.whisperx[259].end |
7626.257 |
| transcript.whisperx[259].text |
台灣民眾黨黨團提案委員邱議瑩等25人委員羅廷瑋等21人委員黃秀寬等18人委員王振旭等20人委員楊瓊英等26人提案第8條除第1項應有效期間屆滿前6個月內申請中央主管機關核准展言之內容不同外其餘同行政院提案 |
| transcript.whisperx[260].start |
7627.017 |
| transcript.whisperx[260].end |
7644.87 |
| transcript.whisperx[260].text |
委員謝衣鳯等18人委員由建國審17人提案第7條:「再生醫療致濟製造輸入許可證有效期間為5年,起碼能需繼續製造輸入者應事先申請中央主管機關核准展延,每次展延不得超過5年,藉其未申請或經否準展延者, |
| transcript.whisperx[261].start |
7646.175 |
| transcript.whisperx[261].end |
7665.978 |
| transcript.whisperx[261].text |
原許可證施其效力,並由中央主管機關註銷之,前二條及前項規定申請再生醫療致濟許可證查驗登記、變更、離轉及展延者,其申請條件應檢複資料、審查程序核准、基準及其他應遵行事項之準則,由中央主管機關定之。 |
| transcript.whisperx[262].start |
7668.092 |
| transcript.whisperx[262].end |
7682.373 |
| transcript.whisperx[262].text |
行政院提案委員邱議瑩等25人委員黃秀寬等18人委員王振旭等20人提案第9條中央主管機關受理第6條第一項諮查院登記申請後未診治及危及生命或嚴重私人之疾病 |
| transcript.whisperx[263].start |
7683.214 |
| transcript.whisperx[263].end |
7700.924 |
| transcript.whisperx[263].text |
於完成第二期臨床試驗並經審查風險效益具安全性及初步療效者得附加付款和與有效期間不超過5年之許可,起碼不得展延。前項危及生命或嚴重私人之疾病得於申請查驗登記前向中央主管機關申請認定。 |
| transcript.whisperx[264].start |
7702.225 |
| transcript.whisperx[264].end |
7717.803 |
| transcript.whisperx[264].text |
委員楊瓊英等26人提案第9條,中央主管機關受理第6條第一項諮查驗證記申請後,為治療危及生命或嚴重私人疾病且國內尚無適當藥物或合適替代療法者,得附加付款。 |
| transcript.whisperx[265].start |
7718.484 |
| transcript.whisperx[265].end |
7735.812 |
| transcript.whisperx[265].text |
何以有效期間不超過5年之許可?其滿不得展言。」取於同行政院提案。台灣民眾黨黨團提案第9條第一項除為治療危及生命或嚴重四人之疾病等文之不同外,取於同行政院提案。前項查驗登記不得重複 |
| transcript.whisperx[266].start |
7737.199 |
| transcript.whisperx[266].end |
7761.711 |
| transcript.whisperx[266].text |
重復合給有付款許可。」第一項為及生命或嚴重四人之疾病得於申請查驗登記前向中央主管機關申請認定。委員謝衣鳯等18人提案第8條第一項除並經評估風險效益得以確保安全性及初步療效之前提下等文字不同外。及第三項無得於申請查驗登記前等文字外。其餘同臺灣民眾黨黨團提案第9條。 |
| transcript.whisperx[267].start |
7764.797 |
| transcript.whisperx[267].end |
7779.788 |
| transcript.whisperx[267].text |
議員羅廷瑋等21人提案第9條要三你申請製造輸入之再生醫療製劑符合以下各款情形者中央主管機關得於再生醫療諮詢會通過後附加確保妥善使用之付款 |
| transcript.whisperx[268].start |
7781.016 |
| transcript.whisperx[268].end |
7803.096 |
| transcript.whisperx[268].text |
給予該再生醫療製劑有效期間不得超過5年之許可。一、為整治危及生命或嚴重失人之疾病。二、完成第二期臨床試驗並有證據可推定具備申請之效能、效果或性能。三、與申請之效能、效果或性能相較,無明顯有害之作用。 |
| transcript.whisperx[269].start |
7804.249 |
| transcript.whisperx[269].end |
7822.945 |
| transcript.whisperx[269].text |
前向查驗登記不得重複和給有付款許可。前向危及生命或嚴重私人之疾病得於申請查驗登記前向中央主管機關申請認定。中央主管機關對取得第一項有條件期限許可之治劑得依風險程度公告使用 |
| transcript.whisperx[270].start |
7823.545 |
| transcript.whisperx[270].end |
7847.306 |
| transcript.whisperx[270].text |
該治劑之醫療機構範圍及醫師資格,未符合前項公告範圍之醫療機構或資格之醫師,不得使用該再生醫療治劑。」委員劉建國等17人提案第8條,中央主管機關受理第5條第一項查驗登記申請後,為預防治療危及生命或嚴重私人之疾病,得附加付款。 |
| transcript.whisperx[271].start |
7847.967 |
| transcript.whisperx[271].end |
7865.521 |
| transcript.whisperx[271].text |
何以有效期間不超過五年之有條件期限許可?前項危及生命或嚴重私人之疾病需經中央主管機關事前審查認定者違憲。舉同委員羅廷瑋等21人提案第九條第四五項。 |
| transcript.whisperx[272].start |
7867.068 |
| transcript.whisperx[272].end |
7881.842 |
| transcript.whisperx[272].text |
行政院提案委員邱議瑩等25人委員羅廷瑋等21人委員黃秀芳等18人委員王振旭等20人委員楊瓊英等26人提案第10條前條第一項所定付款應包括下列事項一執行療效試驗 |
| transcript.whisperx[273].start |
7883.343 |
| transcript.whisperx[273].end |
7901.704 |
| transcript.whisperx[273].text |
療效驗證試驗並定其或與指定期限內繳交試驗報告。二）廢而及其收取方式。三）病人因使用致近發生不良反應致死亡障礙或嚴重疾病之救濟措施。四）其他經中央主管機關 |
| transcript.whisperx[274].start |
7902.785 |
| transcript.whisperx[274].end |
7928.362 |
| transcript.whisperx[274].text |
指定之事項,依前條第一項規定何與有付款許可者與履行所附加之付款後,得向中央主管機關申請查驗登記並經核准後發給藥品許可證。為履行所附加之付款或經評估有重大安全疑慮者,中央主管機關得廢止其付款許可。委員謝衣鳯等18人提案第9條,前條第一項 |
| transcript.whisperx[275].start |
7930.612 |
| transcript.whisperx[275].end |
7958.71 |
| transcript.whisperx[275].text |
負款包括執行療效驗證試驗定期或於指定期限內繳交試驗報告及完成其他相關事項。為依前項負款執行試驗案期繳交報告完成其他相關事項或經評估有重大安全疑慮者中央主管機關得廢止及暫時信許可。委員劉建國等17人提案第9條 |
| transcript.whisperx[276].start |
7960.54 |
| transcript.whisperx[276].end |
7986.483 |
| transcript.whisperx[276].text |
第一項同委員謝衣鳯等18人提案。一、前條第一項合宇有條件期限許可者與履行所附加之付款後,向中央主管機關申請查驗登記病經核准者,發給再生醫療制計許可證。未履行有條件期限許可所附加之付款或經評估有重大安全疑慮者,中央主管機關得廢止其有條件期限許可。 |
| transcript.whisperx[277].start |
7988.396 |
| transcript.whisperx[277].end |
8010.69 |
| transcript.whisperx[277].text |
行政院提案委員邱議瑩等25人委員劉廷瑋等21人委員黃秀帆等18人委員王正旭等20人委員楊全英等26人提案第11條再生醫療製劑取締人體組織細胞製造者及製造或輸入業者應確保該製劑來源提供者之合適性使得製造或輸入 |
| transcript.whisperx[278].start |
8011.59 |
| transcript.whisperx[278].end |
8025.246 |
| transcript.whisperx[278].text |
前向提供者合適性之判定條件篩選測試項目及其他相關事項之辦法由中央主管機關定之。台灣民眾黨黨團提案第11條,再生醫療製劑取締人體組織、細胞製造者及製造或輸入業者,應確保該製劑來源提供者之合適性。 |
| transcript.whisperx[279].start |
8032.734 |
| transcript.whisperx[279].end |
8049.919 |
| transcript.whisperx[279].text |
包括 執行相關傳染病及其病原篩檢及測試,無導入傳播或擴散相關傳染病原或疾病之風險時,使得製造或輸入,及同行政院提案。 |
| transcript.whisperx[280].start |
8050.859 |
| transcript.whisperx[280].end |
8066.769 |
| transcript.whisperx[280].text |
委員謝衣鳯等18人提案第10條,第三項經中央主管機關核准為自體使用者,因依前項所定之辦法接受篩選及測試,但其核四性質判定得不受該辦法之限制,須與同行政院提案第11條。 |
| transcript.whisperx[281].start |
8067.89 |
| transcript.whisperx[281].end |
8092.979 |
| transcript.whisperx[281].text |
委員劉建國等17人提案第10條第一項同行政院提案第11條第一項。前項所稱合適性指捐贈者之組織或細胞未有導入傳播或擴散相關傳染性病原或疾病之風險。第一項捐贈者合適性之判定條件篩選測試項目及其他相關事項之辦法由中央主管機關定之。 |
| transcript.whisperx[282].start |
8095.034 |
| transcript.whisperx[282].end |
8105.18 |
| transcript.whisperx[282].text |
行政院提案第12條未公製造再生醫療之際由於國內取得人體組織細胞者其提供者以有意思能力之成年人為限但顯有異於特定人口 |
| transcript.whisperx[283].start |
8106.55 |
| transcript.whisperx[283].end |
8134.617 |
| transcript.whisperx[283].text |
人口群或未能與其他對象取代者不在此限。前向之組織細胞應於取得前獲得提供者之書面同意。前向書面同意提供者為胎兒時應得其母書面同意。為限制行為能力人或受輔助宣告之人時應得其本人及法定代理人或輔助人書面同意。無行為能力人或受監護宣告之人時應得其法定代理人或監護人書面同意。提供者為無意識能力之成年人 |
| transcript.whisperx[284].start |
8135.097 |
| transcript.whisperx[284].end |
8159.527 |
| transcript.whisperx[284].text |
未能依前項規定辦理時,應按下列順序之人員取得其書面同意。一、配偶。二、成年子女。三、父母。四、兄弟姐妹。五、族父母。前項第二款至第五款規定人員所為之書面同意,得以一人為之。同順序之人意思表示不一致時,以與無意思能力之成年人同居親屬為先。其同居親屬有二人以上者,以年長者為先。無同居親屬者,以年長者為先。 |
| transcript.whisperx[285].start |
8162.808 |
| transcript.whisperx[285].end |
8189.145 |
| transcript.whisperx[285].text |
本條及第13條書面同意之內容得以完整呈現並於日後取出公查驗者得以電子文件為之。台灣民眾黨黨團提案第12條未公製造再生醫療製劑而於國內取得人體組織細胞者其提供者已有異似能力之成年人為限但顯有異於特定人口群或未能以其他對象取代者除胎兒無行為能力人外不在此限。前項之細胞 |
| transcript.whisperx[286].start |
8190.606 |
| transcript.whisperx[286].end |
8212.984 |
| transcript.whisperx[286].text |
前向之組織細胞應於取得前獲得提供者之書面同意。第1項書面同意提供者為限制行為能力人或受輔助宣告之人時應得其本人及法定代理人或輔助人書面同意。第1項提供者為受監護宣告之人或無意思能力之成年人時以同意時具意思表示能力者為限,其書面同意有效。 |
| transcript.whisperx[287].start |
8213.664 |
| transcript.whisperx[287].end |
8241.161 |
| transcript.whisperx[287].text |
委員邱議瑩等25人擬具委員羅廷瑋等21人擬具委員黃秀芳等18人擬具委員王振旭等20人擬具委員楊崇英等26人擬具與院版第一項至第五項同委員謝衣鳳等18人擬具第11條為工作製造再生醫療製劑與國內取得人體組織細胞者應於取得前依一定方式程序並將相關事項以可以理解之方式告知捐贈者或其他有同意權者而獲得其書面同意 |
| transcript.whisperx[288].start |
8241.621 |
| transcript.whisperx[288].end |
8269.338 |
| transcript.whisperx[288].text |
而獲得其書面之情同意後,使得為之。請向其他有同意權者之適用情形與資格應告知事項、方式、程序、記載內容及其他應遵行事項之辦法由中央主管機關定之。委員劉正國等17人提案第11條為工作製造再生醫療製劑與國內取得人體組織細胞者應於取得前一一定方式、程序獲得捐贈者或其他有同意權者之書面同意,使得為之。 |
| transcript.whisperx[289].start |
8270.359 |
| transcript.whisperx[289].end |
8288.292 |
| transcript.whisperx[289].text |
前向其他有同意權者之適用情形與資格應告知事項、方式、程序、記載內容及其他相關事項之辦法由中央主管機關定之。行政院提案第13條再生醫療製劑製造業者依前條規定取得同意前應告知下列事項依再生醫療製劑造 |
| transcript.whisperx[290].start |
8289.733 |
| transcript.whisperx[290].end |
8309.427 |
| transcript.whisperx[290].text |
一、再生醫療製劑製造業者名稱二、組織細胞之用途三、所製成再生醫療製劑預定之適應證及適用對象四、組織細胞之取得方式可能產生之副作用與併發證、發生率與處理方法、禁忌、限制及其他相關因配合事項五、提供者合適性判定條件 |
| transcript.whisperx[291].start |
8310.208 |
| transcript.whisperx[291].end |
8325.405 |
| transcript.whisperx[291].text |
六、剩餘組織細胞之後續處置或可能之使用範圍。七、對提供行為之補助內容及方式。八、後續追蹤內容及方式。九、退出終止及終止之權利。十、取得組織細胞過程發生不良反應之醫療照護補償及處理。 |
| transcript.whisperx[292].start |
8328.965 |
| transcript.whisperx[292].end |
8346.193 |
| transcript.whisperx[292].text |
十一,預期可能衍生之利益及歸屬。十二,個人資料保密措施。十三,其他經中央主管機關公告之事項。前項同意之告知方式程序及其他應遵行事項之辦法由中央主管機關定之。台灣民眾黨黨團提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀剛等18人提案委員王振旭等20人提案委員楊崇英等26人提案第13條 |
| transcript.whisperx[293].start |
8355.037 |
| transcript.whisperx[293].end |
8371.307 |
| transcript.whisperx[293].text |
第二項首具為前項告知方式契約院版同行政院提案臺灣民眾黨黨團提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王正旭等20人提案委員楊春英等26人提案第14條 |
| transcript.whisperx[294].start |
8372.628 |
| transcript.whisperx[294].end |
8390.334 |
| transcript.whisperx[294].text |
招募再生醫療制劑組織細胞提供者之廣告以下稱招募廣告現由藥商為之。再生醫療制劑廣告依藥事法藥品廣告之規定。委員謝衣鳯等18人提案第15條非再生醫療制劑藥商不得為細胞或組織提供者招募廣告。 |
| transcript.whisperx[295].start |
8391.374 |
| transcript.whisperx[295].end |
8408.231 |
| transcript.whisperx[295].text |
行政院提案第15條,招募廣告不得有誇大不實或無科學實證之標示宣傳。要將刊破前項招募廣告時,應於刊破前將其內容及刊破方式向中央主管機關或其委任委託之機關構或法人申請核准,並向傳播業者提具核准文件後使得為之。刊破期間未經核准,不得變更原核 |
| transcript.whisperx[296].start |
8414.817 |
| transcript.whisperx[296].end |
8425.206 |
| transcript.whisperx[296].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:「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 |
| transcript.whisperx[297].start |
8442.12 |
| transcript.whisperx[297].end |
8460.152 |
| transcript.whisperx[297].text |
傳播業者接受委託刊播招募廣告因自廣告之日起6個月內保存委託刊播招募廣告之藥商名稱、藥商許可執照字號、營業所地址、電話及第二項之核准文件影本資料經中央主管機關要求提供時不得規避妨礙或拒絕。 |
| transcript.whisperx[298].start |
8461.613 |
| transcript.whisperx[298].end |
8487.008 |
| transcript.whisperx[298].text |
第二項招募廣告的刊貨與不得刊貨之文字、言詞、圖畫或其他內容、招募對象、刊貨方式、刊貨地點及其他應遵行事項之辦法由中央主管機關定之。台灣民眾黨黨團提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案委員楊聰英等26人提案第15條第二項、第四項、第六項如下 |
| transcript.whisperx[299].start |
8488.638 |
| transcript.whisperx[299].end |
8507.799 |
| transcript.whisperx[299].text |
要將刊破前向招募廣告時,應於刊破前將所有文字、言詞、圖畫或內容向中央主管機關或其委任委託之機關購或法人申請核准,並向傳播業者提具核准文件後,使得為之刊破期間未經核准,不得變更原核准招募廣告內容。 |
| transcript.whisperx[300].start |
8509.444 |
| transcript.whisperx[300].end |
8532.53 |
| transcript.whisperx[300].text |
傳播業者不得刊播未經核准與核准事項不符,以廢止或禁令立即停止刊播,並獻其改善而未改善之招募廣告。第二項招募廣告得刊播與不得刊播之文字、言詞、圖畫或內容、招募對象、刊播地點及其他應遵行事項之辦法由中央主管機關定之,其餘與院版同。委員謝衣鳯等18人提案第16條:「再生醫療至極藥商、刊播細胞或組織提供者招募廣告時, |
| transcript.whisperx[301].start |
8538.192 |
| transcript.whisperx[301].end |
8559.763 |
| transcript.whisperx[301].text |
因於勘破前將所有文字、圖畫或言詞申請中央或直轄市主管機關核准並向傳播業者送驗核准文件。原核准機關發現以核准之招募廣告內容或勘破方式危害民眾健康或有重大危害之餘時應令藥商立即停止勘破並限其改善,藉其為改善者備止之。 |
| transcript.whisperx[302].start |
8561.109 |
| transcript.whisperx[302].end |
8585.018 |
| transcript.whisperx[302].text |
召募廣告在核准登載堪破期間不得變更原核准事項傳播業者不得堪破未經中央或直轄市主管機關核准與核准事項不符以廢止或禁令立即停止堪破並限期改善而尚未改善之召募廣告接受委託堪破之傳播業者因自廣告之日起6個月內保存委託堪破廣告者之姓名法人或團體名稱身份證或事業登記證字號住居所 |
| transcript.whisperx[303].start |
8589.6 |
| transcript.whisperx[303].end |
8614.552 |
| transcript.whisperx[303].text |
事務所或營業所及電話等資料且與主管機關要求提供時不得規避妨礙或拒絕第一項招募廣告之有效期限招募對象與刊登標的之限制及其他應遵循事項由中央主管機關公告之行政院提案台灣民眾黨黨團提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王振旭等20人提案委員楊瓊英等26人提案第16條 |
| transcript.whisperx[304].start |
8617.046 |
| transcript.whisperx[304].end |
8625.374 |
| transcript.whisperx[304].text |
藥商因依藥事法第53條之一及第57條規定取得運銷製造許可並符合藥物優良製造準則及西藥優良運銷準則之規定,使得製造及運銷再生醫療之際違反前項規定未經許可擅自製造或運銷或未符合藥物優良製造準則或西藥優良運銷準則之規定製造或運銷者依藥事法規定才處。 |
| transcript.whisperx[305].start |
8643.49 |
| transcript.whisperx[305].end |
8646.712 |
| transcript.whisperx[305].text |
委員謝衣鳯等18人提案第12條:「再生醫療製劑製造業者應依工廠管理輔導法規定辦理工廠登記,但依工廠管理輔導法規定免辦理工廠登記或經中央主管機關核轉之法人、醫療機構及研究機構之製造業者不在此限。」 |
| transcript.whisperx[306].start |
8662.279 |
| transcript.whisperx[306].end |
8679.693 |
| transcript.whisperx[306].text |
再生醫療製劑製造及運銷其組織人士、作業場所、設施、設備、文件、原物料、生產、品質管制、委外作業、儲存、運輸、客戶申訴、退回與回收及其他應遵行事項應符合再生醫療製劑優良製造及運銷準則並經中央主管機關檢查合格取得製造及運銷許可後使得為之。 |
| transcript.whisperx[307].start |
8686.238 |
| transcript.whisperx[307].end |
8691.201 |
| transcript.whisperx[307].text |
主管機關得派員檢查第五條再生醫療製劑製造業者販賣業者之處所、設施及有關業務,並得出具單據抽驗其製劑,業者不得無故拒絕,但抽驗數量以足供檢驗之用者為限。 |
| transcript.whisperx[308].start |
8702.468 |
| transcript.whisperx[308].end |
8727.096 |
| transcript.whisperx[308].text |
輸入再生醫療製劑之國外製造廠準用前二項規定並由中央主管機關定其過一實際需要赴國外製造場所檢查之第二項之準則與許可申請條件檢查程序、審查基準、效期、核發、變更、移轉、展延、廢止、收費及其他應遵行事項之辦法由中央主管機關定之委員劉建國等17人提案第12條再生醫療製劑之製造及運銷其組織人士、作業場所 |
| transcript.whisperx[309].start |
8732.259 |
| transcript.whisperx[309].end |
8741.933 |
| transcript.whisperx[309].text |
設施、設備、文件、原物料、生產、品質管制、委外作業、儲存、運輸、客戶申訴、退回與回收及其他應遵行事項,應符合再生醫療制計優良製造及運銷準則,並應中央主管機關檢查合格。 |
| transcript.whisperx[310].start |
8748.082 |
| transcript.whisperx[310].end |
8768.087 |
| transcript.whisperx[310].text |
取得製造及運輸許可後使得為之,輸入再生醫療製劑之國外製造場準用全項規定,並由中央主管機關定期或依實際需要赴國外製造場所檢查之。法人醫療機構研究機構設置之製造場所準用第一項規定,並由中央主管機關定期或依實際需要赴場所檢查之。 |
| transcript.whisperx[311].start |
8768.707 |
| transcript.whisperx[311].end |
8790.043 |
| transcript.whisperx[311].text |
第一項之準則與許可申請條件檢查程序審查基準效其合法變更轉移轉展延廢止收費及其他應遵行事項之辦法由中央主管機關定之行政院提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王正旭等20人提案委員楊崇英等26人提案第17條 |
| transcript.whisperx[312].start |
8792.53 |
| transcript.whisperx[312].end |
8810.969 |
| transcript.whisperx[312].text |
經核准製造輸入之再生醫療之際,中央主管機關得指定品項期間令藥品許可證或有付款許可之所有人依公告或核定之安全監視計劃,監視其安全性。醫療機構應提供相關安全監視資料與該許可證或有付款許可之所有人。 |
| transcript.whisperx[313].start |
8811.69 |
| transcript.whisperx[313].end |
8828.706 |
| transcript.whisperx[313].text |
前向許可證或有付款許可之所有人,應定期製作安全監視報告繳交中央主管機關,為定期繳交或經中央主管機關,任該至極有安全疑慮或安全監視計劃執行之方式,內容與原公告或核定不符者,得令其限期改善或延長監視期間。 |
| transcript.whisperx[314].start |
8830.347 |
| transcript.whisperx[314].end |
8849.446 |
| transcript.whisperx[314].text |
必要時得令其暫停製造輸入或販賣,情節重大者得盡以廢止其藥品許可證或有付款許可,前二項安全監視資料及報告及繳交方式期限,內容格式收集資料之限制與維護,監視期間評估及其他應遵行事項之辦法,由中央主管機關定之。台灣民眾黨黨團提案第17條第一項後段為 |
| transcript.whisperx[315].start |
8853.83 |
| transcript.whisperx[315].end |
8873.994 |
| transcript.whisperx[315].text |
醫療機構應提供無法辨識當事人之相關安全監視資料與該許可證或有付款許可之所有人。其欲與願反同。委員謝衣鳯等18人提案第13條經核准製造輸入資再生醫療製劑中央主管機關得指定品項期間利用再生醫療製劑許可證所有人依核定之安全監視計劃監視其安全性醫療機構應提供相關安全監視資料與許可證所有人取得證實性許可 |
| transcript.whisperx[316].start |
8881.375 |
| transcript.whisperx[316].end |
8905.711 |
| transcript.whisperx[316].text |
再生醫療治劑准用前項規定、前二項安全監視計畫資料及報告其提供或繳交方式、期限內容、格式及其他應遵形式向之辦法由中央主管機關定之。委員劉建國等17人提案第13條經核准製造輸入自再生醫療治劑中央主管機關得指定品項期間令再生醫療治劑許可證所有人依公告或核定之安全監視計畫監視其安全性。醫療機構應提供相關安全監視資料與許可證。 |
| transcript.whisperx[317].start |
8912.256 |
| transcript.whisperx[317].end |
8933.852 |
| transcript.whisperx[317].text |
前向許可證所有人應定期製作安全監視報告繳交中央主管機關,為定期繳交或經中央主管機關認該產品有安全疑慮或安全監視計畫執行之方式,內容與原公告或核定不符者,得令其限期改善或延長監視期間,必要時得令其暫停製造、輸入或販賣,情節重大者得禁與廢止其許可證。 |
| transcript.whisperx[318].start |
8934.753 |
| transcript.whisperx[318].end |
8949.242 |
| transcript.whisperx[318].text |
前二項安全監視資料及報告及繳交方式期限內容格式收集資料之限制與維護監視期間評估及其他相關事項之辦法由中央主管機關定之。取得有條件期限許可之再生醫療製劑準用前三項規定。 |
| transcript.whisperx[319].start |
8951.863 |
| transcript.whisperx[319].end |
8979.404 |
| transcript.whisperx[319].text |
行政院提案、台灣民眾黨黨團提案、委員邱議瑩等25人提案、委員羅廷瑋等21人提案、委員黃秀芳等18人提案、委員王振旭等20人提案、委員楊崇英等26人提案。第18條,藥商及醫療機構應保存再生醫療字跡供應來源及流向之資料,前向資料之範圍保存方式與期限及其他應遵行事項之辦法,由中央主管機關定之。委員謝衣鳯等18人提案、委員劉建國等17人提案。第14條, |
| transcript.whisperx[320].start |
8980.825 |
| transcript.whisperx[320].end |
9002.091 |
| transcript.whisperx[320].text |
再生醫療之際之製造販賣業者及使用之醫療機構應建立與保存產品直接供應來源及流向之資料,前向資料之範圍建立與保存方式及期限以及其他應遵行事項之辦法,由中央主管機關定之。前向中央主管機關定定之資料保存期限至少為10年,其涉及重組基因者至少為20年。 |
| transcript.whisperx[321].start |
9004.181 |
| transcript.whisperx[321].end |
9020.715 |
| transcript.whisperx[321].text |
行政院提案、台灣民眾黨黨團提案、委員邱議瑩等25人提案、委員羅廷瑋等21人提案、委員黃秀芳等18人提案、委員王正旭等20人提案、委員楊瓊英等26人提案。第19條使用取得有付款許可之再生醫療之際發生不良反應致死亡 |
| transcript.whisperx[322].start |
9021.095 |
| transcript.whisperx[322].end |
9049.549 |
| transcript.whisperx[322].text |
障礙或嚴重疾病時依所附加之第十條第一項第三款救濟措施辦理使用取得藥品許可正值再生醫療之際適用藥害救濟法之規定。行政院提案第二十條有下列各款情形之一者由中央主管機關處新台幣三萬元以上二百萬元以下罰款依違反第十五條第二項規定未經核准或未向傳播業者提具核准文件刊播招募廣告或未經核准變更員核准之招募廣告內容或刊播方式 |
| transcript.whisperx[323].start |
9050.049 |
| transcript.whisperx[323].end |
9075.166 |
| transcript.whisperx[323].text |
二）違反第15條第4項規定堪破未經核准與核准事項不符以廢止核准或禁令立即停止堪破之招募廣告。三）違反第15條第5項規定違依規定期限保存資料或保存資料不全或規避妨礙或拒絕提供資料。四）違反第15條第6項鎖定辦法中有關招募廣告堪破地點之規定。第二十一條有下列各款情形之一者由直轄市縣市主管機關處心台幣3萬元以上200萬元以下罰還。一）違依第5條 |
| transcript.whisperx[324].start |
9080.189 |
| transcript.whisperx[324].end |
9108.57 |
| transcript.whisperx[324].text |
第二項規定聘用具相關學歷及專門知識及專任人員二違反第六條第一項規定未取得藥品許可證或有付款許可製造或輸入再生醫療至極三違反第七條規定未經核准擅自變更藥品許可證有付款許可或原查驗登記事項或擅自移轉藥品許可證或有付款許可四違反第十一條第一項規定為確保提供者合適性擅自製造或輸入再生醫療至極五違反第十二條第一項本文規定 |
| transcript.whisperx[325].start |
9109.531 |
| transcript.whisperx[325].end |
9134.279 |
| transcript.whisperx[325].text |
非已有意思能力致成年人之組織細胞製造再生醫療致濟。六（第12條第二項規定為予取得組織細胞前獲得提供者書面同意或為依同條第三項至第五項有關同意權行使規定辦理。七（第13條第一項規定予取得同意前告知該項所列事項。八（第13條第二項所定辦法中有關告知方式或程序之規定。九（第14條第一項規定 |
| transcript.whisperx[326].start |
9135.959 |
| transcript.whisperx[326].end |
9162.536 |
| transcript.whisperx[326].text |
非藥杉為招募廣告。十、違反第17條第一項規定,藥品許可證或有付款許可之所有人為供告或核定之安全監視計劃執行或醫療機構為提供安全監視資料。十一違反第17條第三項鎖定辦法中有關安全監視報告內容、繳交期限或監視期間之規定。十二違反第18條第一項規定為保存資料。十三違反第18條第二項鎖定辦法中有關保存資料之範圍、保存方式或保存期限之規定。 |
| transcript.whisperx[327].start |
9163.436 |
| transcript.whisperx[327].end |
9181.892 |
| transcript.whisperx[327].text |
台灣民眾黨黨團提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員王正旭等20人提案委員楊崇英等26人提案第二十條第二款默劇為以廢止或經令其停止刊播並限其改善而未改善之招募廣告其餘願版同 |
| transcript.whisperx[328].start |
9182.813 |
| transcript.whisperx[328].end |
9198.738 |
| transcript.whisperx[328].text |
台灣民眾黨黨團提案第21條第10款莫具為或醫療機構為提供無法辨識當事人之安全監視資料期遇與願反同委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃修芳等18人提案委員王振旭等20人提案第21條與願反同委員謝衣鳯等18人提案第17條 |
| transcript.whisperx[329].start |
9202.799 |
| transcript.whisperx[329].end |
9230.411 |
| transcript.whisperx[329].text |
有下列各款情形之一者處心臺幣三萬元以上二百萬元以下罰還一、違反第五條第一項規定為向中央主管機關申請查驗登記並經核准發給再生醫療自給許可證或合與有條件期限許可製造輸入再生醫療自給二、違反第六條規定為經核准擅自變更查驗登記許可證原登記時項或許可證移轉時未辦理移轉登記三、違反第八條第三項規定為依公告範圍或資格使用再生醫療自給 |
| transcript.whisperx[330].start |
9231.611 |
| transcript.whisperx[330].end |
9234.454 |
| transcript.whisperx[330].text |
第10條規定製造或輸入業者為確保捐贈者合適性,擅自製造或輸入再生醫療之際。第11條規定為工作製造再生醫療之際與國內取得人體組織細胞前為獲得捐贈者或其他有同意權者之書面同意。 |
| transcript.whisperx[331].start |
9249.489 |
| transcript.whisperx[331].end |
9257.316 |
| transcript.whisperx[331].text |
六、違反第12條第一項或第二項規定為取得製造或運銷許可製造輸入或運銷再生醫療製劑。七、違反第14條第一項規定為建立或保存產品供應來源及流向資料或違反中央主管機關第14條第二項鎖定辦法有關範圍保存方式或期限制規定。八、違反第15條規定非再生醫療製劑藥商不得為細胞或組織提供者招募廣告。違反第16條第一項或第二項或第三項規定者 |
| transcript.whisperx[332].start |
9276.932 |
| transcript.whisperx[332].end |
9283.319 |
| transcript.whisperx[332].text |
除新台幣20萬元以上500萬元以下罰還違反第12條第1項或第2項除1第1項規定處罰外中央主管機關的公佈製造或販賣業者名單並令其限期改善改善期間得停止其一部或全部製造批發輸入輸出及營業藉其為改善者不得斬鹽再生醫療自給許可證 |
| transcript.whisperx[333].start |
9297.433 |
| transcript.whisperx[333].end |
9305.685 |
| transcript.whisperx[333].text |
且不受理該製造廠其他再生醫療製劑之新申請案件。其清潔重大責任則廢止其一部或全部之製造或運銷許可。 |
| transcript.whisperx[334].start |
9308.274 |
| transcript.whisperx[334].end |
9328.84 |
| transcript.whisperx[334].text |
違反第14條第一項關於許可證所有人未依合定之安全監視計劃監視其安全行之規定或經中央主管機關任該再生醫療自己有安全疑慮得令其限期改善或延長監視期間請接重大者得禁與廢止其許可證。委員劉靖國等17人提案第15條第一項第一款至第7款與委員謝衣鳳等18人提案第17條第一項第一款至第7款同 |
| transcript.whisperx[335].start |
9334.002 |
| transcript.whisperx[335].end |
9342.127 |
| transcript.whisperx[335].text |
第二項前額具違違反第12條第一項或第二項規定者除一前項規定處罰外其餘與委員謝衣鳯等18人提案第17條第三項同委員楊瓊英等26人提案第21條續文及第一款至第12款與台灣民眾黨黨團提案第21條續文及第二款至第13款同行政院提案台灣民眾黨黨團提案委員邱議瑩等25人提案委員羅廷瑋等21人提案委員黃秀芳等18人提案委員 |
| transcript.whisperx[336].start |
9362.921 |
| transcript.whisperx[336].end |
9373.891 |
| transcript.whisperx[336].text |
王振旭等20人擬具委員楊瓊英等26人擬具第22條本條例有關再生醫療制計之管理事項主管機關得定期或不定期積查行政院擬具第23條台灣民眾黨黨團擬具委員邱議瑩等25人擬具委員羅廷瑋等21人擬具委員黃秀當等18人擬具委員王振旭等20人擬具委員楊瓊英等20人擬具第23條 |
| transcript.whisperx[337].start |
9386.903 |
| transcript.whisperx[337].end |
9402.532 |
| transcript.whisperx[337].text |
委員謝衣鳯等18人提案第18條委員劉建國等17人提案第16條本條例施行日期由行政院定之繼續宣讀修正動議第一案。第一條增列推動產業發展之文字 |
| transcript.whisperx[338].start |
9404.278 |
| transcript.whisperx[338].end |
9421.968 |
| transcript.whisperx[338].text |
第五條增訂第三項再生醫療審議會之委員與第一項第五款第七款規定之受審議人有利益衝突應迴避。第七條第一項後段文字或本法施行前醫療機構已經中央主管機關核准執行再生醫療技術之情形外 |
| transcript.whisperx[339].start |
9422.748 |
| transcript.whisperx[339].end |
9439.078 |
| transcript.whisperx[339].text |
第八條第一項醫療機構執行再生技術有治療危及生命或嚴重失能之疾病且國內上無適當之藥品醫療器材或醫療技術者免進行或免完成人體試驗。第十二條增列第四項 |
| transcript.whisperx[340].start |
9440.868 |
| transcript.whisperx[340].end |
9456.755 |
| transcript.whisperx[340].text |
本法實行前醫療機構經主管機關核准執行之再生技術依據本法實行前之核准條件為第一項規定之登記。第19條第三項第二句提供者為胎兒或未成年人時。第六項 |
| transcript.whisperx[341].start |
9458.871 |
| transcript.whisperx[341].end |
9478.725 |
| transcript.whisperx[341].text |
第三）第四）規定再生醫療組織細胞來源之提供者為胎兒未成年人、限制行為能力人、受輔助宣告之人、無行為能力人、受監護宣告之人或無意識能力之成年人,取得之書面同意應經法院公正使得深效力。第二十八條第二項第三款 |
| transcript.whisperx[342].start |
9482.091 |
| transcript.whisperx[342].end |
9509.521 |
| transcript.whisperx[342].text |
三（違反第九條規定以禁止這方式進行涉及胚胎或胚胎幹細胞之再生醫療研究。第三項後段五年內再犯者最高得儲規定上限之十倍以下罰款。第四項第二句得儲六個月以上五年以下有期徒刑。第二十九條第一項第四款違反第十九條第五項為完備同意程序使用再生醫療組織細胞 |
| transcript.whisperx[343].start |
9512.096 |
| transcript.whisperx[343].end |
9538.726 |
| transcript.whisperx[343].text |
第30條第三項有前項第一款規定情形者除一該項規定處罰外並應公佈其名稱五年內在犯者最高得處規定上限之十倍以下之罰還。第四項後段其情節重大有損害病人生命身體或健康之事實或有損害之餘者應廢止其一部或全部核准事項並得另行移送移交司法機關辦理。 |
| transcript.whisperx[344].start |
9540.458 |
| transcript.whisperx[344].end |
9547.66 |
| transcript.whisperx[344].text |
第三十三條本法所定法環以及第28條第4項第29條第4項之刑事處罰於私立醫療機構處罰其負責醫師與醫療法人設立之醫療機構處罰醫療法人與非醫療機構處罰機構負責人或執行業務之負責人提案人委員林月琴聯署人委員王振旭黃秀芳 |
| transcript.whisperx[345].start |
9563.365 |
| transcript.whisperx[345].end |
9588.057 |
| transcript.whisperx[345].text |
第二案,第八條,醫療機構執行再生技術有下列情形之一者,免醫再生醫療制計條例之規定,申請藥品許可或有付款許可。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或醫療器材。二、以完成第二期臨床試驗之細胞治療技術。三、提供不含基因改造或轉植之人類細胞及其衍生物之細胞治療。 |
| transcript.whisperx[346].start |
9589.398 |
| transcript.whisperx[346].end |
9604.099 |
| transcript.whisperx[346].text |
前項第二款自完成第二期臨床試驗之日起超過五年者排除第一項之適用。第一項第三款細胞治療項目由中央主管機關公告之。提案人委員王育敏蘇清泉盧憲一鄭正前 |
| transcript.whisperx[347].start |
9605.18 |
| transcript.whisperx[347].end |
9618.356 |
| transcript.whisperx[347].text |
第三案第6條第二項前項所述之其他政府機關構醫療機構學術研究機構學校或法人所需之條件與委託方式由中央主管機關令定之第7條第一項守據醫療機構除執行臨床再生醫療試驗外 |
| transcript.whisperx[348].start |
9623.783 |
| transcript.whisperx[348].end |
9640.832 |
| transcript.whisperx[348].text |
第14條第三項醫療機構為執行業務之必要得供應業務相關之再生醫療製劑並得免請藥商許可執照但非屬執行業務提供病人使用而系販賣零售再生醫療製劑者人因醫藥事法第15條第一項第一款申請為藥品販賣業者 |
| transcript.whisperx[349].start |
9644.346 |
| transcript.whisperx[349].end |
9655.418 |
| transcript.whisperx[349].text |
第20條第1項第4款四（剩餘組織細胞之後續處置與使用範圍提案人委員陳金輝、蘇清泉、邱振鈞第4案 |
| transcript.whisperx[350].start |
9657.708 |
| transcript.whisperx[350].end |
9679.358 |
| transcript.whisperx[350].text |
第五條第二項前項審議會應廣納醫學、藥學、生醫、化學、醫學工程學以及法律倫理學等專家學者共同組成任意性別委員不得少於委員總數三分之一提案人委員劉建國、連署人委員王振旭、林月琴。第五案第五條專案主管機關應組成再生醫療審議會以下簡稱審議會 |
| transcript.whisperx[351].start |
9688.092 |
| transcript.whisperx[351].end |
9712.25 |
| transcript.whisperx[351].text |
自委員若干人就醫療科技倫理法律與其他相關專業學者專家聘派兼職由衛生福利部部長或部長就委員中指定一人擔任召集人。前項審議會辦理下列再生醫療事項。第六款 |
| transcript.whisperx[352].start |
9713.615 |
| transcript.whisperx[352].end |
9741.637 |
| transcript.whisperx[352].text |
再生治劑及再生技術管理諮詢審議。其餘各款同行政院版。第一項審議會之組成亦是利益迴避及其他應遵行四項之辦法由中央主管機關定之。其餘同行政院版。第七條醫療機構執行再生技術前除有第八條第一項規定情形外應進行並完成人體試驗。 |
| transcript.whisperx[353].start |
9743.817 |
| transcript.whisperx[353].end |
9762.448 |
| transcript.whisperx[353].text |
第六條第二項前向其他政府機關構、醫療機構、學術研究機構、學校或法人之委託方式、資格條件由中央主管機關定之。其餘同行政院版。第十三條 |
| transcript.whisperx[354].start |
9764.863 |
| transcript.whisperx[354].end |
9782.453 |
| transcript.whisperx[354].text |
其資格由中央主管機關定定公告之。其同院版。第20條第一項第4款剩餘組織細胞之後續處置與使用範圍。其同行政院版。第14條第三項 |
| transcript.whisperx[355].start |
9787.599 |
| transcript.whisperx[355].end |
9808.355 |
| transcript.whisperx[355].text |
醫療機構為執行業務之必要得供應業務相關之再生醫療制計並得免請藥商許可執照但非屬執行業務提供並能使用而係販賣零售再生醫療制計者仍因依藥事法第15條第一項第一款申請為藥品販賣業者。 |
| transcript.whisperx[356].start |
9811.383 |
| transcript.whisperx[356].end |
9834.653 |
| transcript.whisperx[356].text |
其於同行政院版。第二十一條第二項再生醫療之廣告現由經核准執行再生醫療之醫療機構與經核准執行再生醫療技術之醫師為之再生之際廣告依藥事法藥品廣告之規定提案人委員王振旭、林月琴、陳盈 |
| transcript.whisperx[357].start |
9836.785 |
| transcript.whisperx[357].end |
9862.281 |
| transcript.whisperx[357].text |
繼續宣讀再生醫療治劑草案修正動議第一案。第七條經核准製造輸入之再生醫療治劑非經中央主管機關核准不得變更查驗登記藥品許可證登記或有付款許可證登記事項。藥品許可證及有付款許可移轉時應辦理移轉登記。 |
| transcript.whisperx[358].start |
9866.303 |
| transcript.whisperx[358].end |
9886.712 |
| transcript.whisperx[358].text |
第八條正列第一項前段文字為《再生醫療試劑製造輸入之許可證》,即中段文字兼改為其間,令末段手具文字藉其未申請或經否準展言者。其同行政院版第八條第一項,第二項同行政院版第八條第二項。 |
| transcript.whisperx[359].start |
9888.188 |
| transcript.whisperx[359].end |
9913.918 |
| transcript.whisperx[359].text |
一、前二條及前二項規定申請再生醫療製劑查驗登記藥品許可有付款許可之變更已轉及展延者換發與補發其申請條件應檢複之資料審查程序核准基準收費及其他相關事項之準則由中央主管機關定之。第九條中央主管機關受理第五條第一項查驗登記申請後 |
| transcript.whisperx[360].start |
9914.938 |
| transcript.whisperx[360].end |
9931.068 |
| transcript.whisperx[360].text |
未診治危及生命或嚴重私人之疾病且國內尚無適當藥物或合適替代療法者於完成第二期臨床試驗並經審查風險效益具安全性及初步療效者得附加付款。 |
| transcript.whisperx[361].start |
9931.969 |
| transcript.whisperx[361].end |
9958.049 |
| transcript.whisperx[361].text |
何以有效期間不超過5年之有條件期限許可,並以合給一次為限,且期盼不得展延。第二項除所具前項二致不同外,其餘內容及第三項同委員羅廷瑋等21人提案第9條第4、5項。第11條第一項、第二項同行政院提案第11條,第三項同委員謝衣鳯等18人提案第10條第三項。 |
| transcript.whisperx[362].start |
9959.73 |
| transcript.whisperx[362].end |
9974.267 |
| transcript.whisperx[362].text |
第12條第1、2、4、5、7項同行政院提案第12條第1、2、4、5、6項。第三項前段除提供者為胎兒或未成年人時等文字不同外其餘同行政院提案第12條第三項。 |
| transcript.whisperx[363].start |
9975.749 |
| transcript.whisperx[363].end |
9998.906 |
| transcript.whisperx[363].text |
令第六項內容為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未成年人、限制行為能力人、受輔助宣告之人、無行為能力人、受監護宣告之人或無意識能力之成年人,取得之書面同意應經法院公正死生效力。第十三條第一項第七款 |
| transcript.whisperx[364].start |
10000.748 |
| transcript.whisperx[364].end |
10022.137 |
| transcript.whisperx[364].text |
提供程序可能產生之風險、發生率及處理方法及對提供行為之補助內容及方式,取於同行政院版第13條。第15條,對方行政院提案第15條內容除刪除第二項前段或其委任、委託之機關構或法人等文字外,取於同行政院提案。 |
| transcript.whisperx[365].start |
10023.177 |
| transcript.whisperx[365].end |
10047.253 |
| transcript.whisperx[365].text |
第18條徵定第三項,前項中央主管機關定定資料保存期限至少為15年,其餘同行政院提案第18條。第18條之一,再生醫療製劑製造販賣業者及醫療機構應建立長期追蹤機制,以追蹤施用再生醫療製劑病患受試者延遲性不良反應, |
| transcript.whisperx[366].start |
10048.754 |
| transcript.whisperx[366].end |
10062.262 |
| transcript.whisperx[366].text |
對應再生醫療制計所引起之未預期嚴重不良反應應行通報。中央主管機關應邀集醫療科技人員、法律專家及社會公正人士或民間團體代表組成委員會。 |
| transcript.whisperx[367].start |
10063.243 |
| transcript.whisperx[367].end |
10083.284 |
| transcript.whisperx[367].text |
已定期審議再生醫療致濟安全監視及長期追蹤報告並公開相關報告委員會成員任意性別不得低於三分之一前二項規定之長期追蹤機制之執行方式追蹤條件與時程及未預期嚴重不良反應之通報再生醫療致濟安全監視及長期追蹤報告之審議 |
| transcript.whisperx[368].start |
10086.147 |
| transcript.whisperx[368].end |
10099.493 |
| transcript.whisperx[368].text |
以及其他應遵行事項諮辦法由中央主管機關定製提案人委員林月琴、王振旭、黃秀芳、賴慧媛。修正動議第二案。第九條。 |
| transcript.whisperx[369].start |
10101.806 |
| transcript.whisperx[369].end |
10128.892 |
| transcript.whisperx[369].text |
中央主管機關受理第6條第一項諮查院登記申請後有下列情形之一者得附加付款,何以有效期間不超過5年之許可?其滿不得展言。一、治療危及生命或嚴重私人之疾病且國內尚無適當之藥品或醫療器材。二、已完成細胞治療技術第二期臨床試驗之再生醫療製劑。 |
| transcript.whisperx[370].start |
10130.552 |
| transcript.whisperx[370].end |
10157.067 |
| transcript.whisperx[370].text |
前向第一款為及生命或嚴重私人之疾病得於申請查驗登記前向中央主管機關申請認定。提案人委員蘇清泉、盧憲伊、圖泉吉、鄭正前。第三案第三條第二項前向再生醫療治劑屬藥師法第六條規定之藥品。第五條第二項前段前向製造業者應由專任藥師 |
| transcript.whisperx[371].start |
10159.116 |
| transcript.whisperx[371].end |
10182.808 |
| transcript.whisperx[371].text |
助產監製及應聘用國內外大學院校以上醫藥或生命科學等相關科系畢業。」提案人委員劉建國、王振旭、林月琼。宣讀完畢。條文及修正動議宣讀完畢。現在先休息10分鐘,休息過後繼續法條的逐條審查。謝謝。 |
| transcript.whisperx[372].start |
10767.196 |
| transcript.whisperx[372].end |
10767.38 |
| transcript.whisperx[372].text |
三）繼續審查委員 |
| transcript.whisperx[373].start |
10804.824 |
| transcript.whisperx[373].end |
10824.658 |
| transcript.whisperx[373].text |
我先做一個預告中午我們是12點30分到1點休息今天預計處理主條到下午4點左右休息明天繼續開會處理我們現在進行討論事項第一案再生醫療法草案主條審查 |
| transcript.whisperx[374].start |
10825.999 |
| transcript.whisperx[374].end |
10848.719 |
| transcript.whisperx[374].text |
以行政院提案條次為準,進行討論。」每條條文先請行政單位說明,接著請委員表示意見。好。第一個法案名稱。麥克風先把它發下去。 |
| transcript.whisperx[375].start |
10868.373 |
| transcript.whisperx[375].end |
10892.75 |
| transcript.whisperx[375].text |
好,第一個法案名稱法案名稱的部分的話除了謝衣鳯委員有加發展法其他委員的名稱都跟我們行政院的提案一樣希望委員就支持院版是不是我們就以行政院的版本那就以行政院的提案版本來通過 |
| transcript.whisperx[376].start |
10896.876 |
| transcript.whisperx[376].end |
10904.4 |
| transcript.whisperx[376].text |
接下來的第一張總則的名稱所有的委員其實都一致。是,好,那就以行政院提案的版本通過。 |
| transcript.whisperx[377].start |
10906.86 |
| transcript.whisperx[377].end |
10929.731 |
| transcript.whisperx[377].text |
接下來第一條第一條的部分的話重點是在立法目的然後立法目的的部分的話委員的部分其實是在後面的到底是以安全品質有效這特別是安全跟品質這個之間然後那我們會覺得是說在再生醫療法他的特殊性的部分的話我們會建議支持院板的是把安全擺在前面 |
| transcript.whisperx[378].start |
10930.251 |
| transcript.whisperx[378].end |
10931.332 |
| transcript.whisperx[378].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[379].start |
10942.016 |
| transcript.whisperx[379].end |
10943.057 |
| transcript.whisperx[379].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[380].start |
10964.108 |
| transcript.whisperx[380].end |
10965.789 |
| transcript.whisperx[380].text |
其他委員還有沒有意見?沒有,那請行政單位說明一下。 |
| transcript.whisperx[381].start |
10990.383 |
| transcript.whisperx[381].end |
11011.436 |
| transcript.whisperx[381].text |
在病人權益的部分的話它的基礎就是醫學倫理所以我們會建議原本的文字就可以然後另外的部分的話因為這個法案的主要的目的是在於做所謂的再生醫療這樣子的一個行為的一個規範然後產業發展的部分的部分是因為我們本來就有產業發展條例跟生技產業創新條例裡面來做處理 |
| transcript.whisperx[382].start |
11014.898 |
| transcript.whisperx[382].end |
11034.645 |
| transcript.whisperx[382].text |
所以才會在院討論的時候我們這個地方主要是以再生醫療行為規範為主體所以才會強調的他的立法目的會是以安全品質有效然後維護病人的權益讓民眾能夠及時的使用所以用普惠國民使用所以建議支持院板以上 |
| transcript.whisperx[383].start |
11037.566 |
| transcript.whisperx[383].end |
11058.331 |
| transcript.whisperx[383].text |
我個人認為病人權益跟醫療倫理是兩件事情病人有權益接受最好也許最安全的治療但是在資訊不對等情況下我們要在尤其這個是完全新興的一個法案我希望還是能夠加入的醫療倫理應該也不違背這個市長剛剛說明的就是加入這幾個字 |
| transcript.whisperx[384].start |
11060.492 |
| transcript.whisperx[384].end |
11061.853 |
| 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 |
11073.176 |
| transcript.whisperx[385].end |
11094.179 |
| transcript.whisperx[385].text |
王建旭委員謝謝主席我想趙志偉也是有提到醫療倫理沒有加進來的話會不會影響到病人的權益如果依照我們對倫理的了解他其實是已經含括在病人權益的範圍之內所以我會支持院板以上楊耀委員 |
| transcript.whisperx[386].start |
11097.695 |
| transcript.whisperx[386].end |
11111.66 |
| transcript.whisperx[386].text |
我有一個問題就是我覺得第一條裡面我們寫到了普惠國民使用這幾個文字就是說再生醫療 |
| transcript.whisperx[387].start |
11113.26 |
| transcript.whisperx[387].end |
11114.14 |
| transcript.whisperx[387].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[388].start |
11142.89 |
| transcript.whisperx[388].end |
11144.09 |
| transcript.whisperx[388].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[389].start |
11165.56 |
| transcript.whisperx[389].end |
11188.307 |
| transcript.whisperx[389].text |
王玉銘委員,剛剛那個楊耀委員的發言我很同意,因為這個是再生醫療法,那在第一條開宗明義放入普惠國民使用還蠻奇怪的,因為事實上再生醫療他應該是適用特定人,不會普惠國民,他不是什麼保健食品,所以 |
| transcript.whisperx[390].start |
11189.187 |
| transcript.whisperx[390].end |
11198.767 |
| transcript.whisperx[390].text |
加入普惠國民使用這樣的語意的確在這個特別的醫療法裡面放入這樣的字眼我也覺得是比較不適當的 |
| transcript.whisperx[391].start |
11202.366 |
| transcript.whisperx[391].end |
11220.802 |
| transcript.whisperx[391].text |
還有沒有其他委員要表示意見陳昭芝委員我三度發言那最後尊重大家決定醫療倫理跟病人提議我覺得還是有差別的醫療倫理的最重要就是病人要充分被告知而且有自主性這個跟他的權益本身我覺得還是可以有一些區隔 |
| transcript.whisperx[392].start |
11222.423 |
| transcript.whisperx[392].end |
11223.083 |
| transcript.whisperx[392].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[393].start |
11251.582 |
| transcript.whisperx[393].end |
11271.534 |
| transcript.whisperx[393].text |
針對楊耀委員跟王玉明委員的意見。像這種法案在第一條的部分就等於是立法的一個目的。通常大家意見就會很多,有的要寫多一點,有的要寫少一點。就是說 |
| transcript.whisperx[394].start |
11277.697 |
| transcript.whisperx[394].end |
11303.59 |
| transcript.whisperx[394].text |
就是說這種第一條的這種立法目的的部分的話經常在討論的過程當中一定會有委員覺得說寫的太少要多加一點有的會覺得說寫的太多哪一個可以拿掉那我是建議是這樣是不是我們先保留那等全部的條文都看完之後的話再回過來看這一條這樣可能會比較有效 |
| transcript.whisperx[395].start |
11304.261 |
| transcript.whisperx[395].end |
11330.28 |
| transcript.whisperx[395].text |
好,那我們就先第一條先保留那接下來第二條第二條的部分的話是明定主管機關然後相關委員的提案裡面其實是跟我們衛福部行政院的版本是一致那除了謝衣鳯委員的版本是因為他有在講發展所以才會涉及到中央各目的社會主管機關委員有沒有什麼意見 |
| transcript.whisperx[396].start |
11333.413 |
| transcript.whisperx[396].end |
11333.854 |
| transcript.whisperx[396].text |
三）繼續審查委員邱議瑩等21人擬具 |
| transcript.whisperx[397].start |
11348.072 |
| transcript.whisperx[397].end |
11373.611 |
| transcript.whisperx[397].text |
三）繼續審查委員羅廷瑋等21人擬具《再生醫療法草案》案。接下來第三條。第三條是針對定義的部分。然後那我就起點做一個回應。因為在委員的版本裡面其實特別是對再生醫療的部分。因為我們這邊的院版的跟很多委員的版本的文字一致的地方在於是說再生醫療只利用基因、細胞及其衍生物 |
| transcript.whisperx[398].start |
11373.951 |
| transcript.whisperx[398].end |
11401.264 |
| transcript.whisperx[398].text |
用於治療、修復或替代人體的細胞組織器官之致技或技術。」所以在這個裡面其實是開放了是說我們未來像我們現在是主要是自體致技的部分也有議題的一個通過然後所以我們才會覺得是說在這個上面的話是以願版的文字可能在未來執行的部分甚至在研究發展的部分其實是比較有利的 |
| transcript.whisperx[399].start |
11401.664 |
| transcript.whisperx[399].end |
11402.085 |
| transcript.whisperx[399].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[400].start |
11419.964 |
| transcript.whisperx[400].end |
11434.86 |
| transcript.whisperx[400].text |
其他的部分的話就是對於我們的生技公司的部分的話因為我們這個是跟生技創產條例裡面的那個文字差不多是一致的所以建議是不是也能夠支持我們的行政院的版本以上 |
| transcript.whisperx[401].start |
11437.202 |
| transcript.whisperx[401].end |
11452.655 |
| transcript.whisperx[401].text |
陳昭芝委員在第三條的第一款我們認為在這個再生醫療部分要增加因為剛剛本來要請問不過司長已經明說了我們這裡要求增加但不得利用異種異體細胞進行醫療行為 |
| transcript.whisperx[402].start |
11456.178 |
| transcript.whisperx[402].end |
11456.979 |
| transcript.whisperx[402].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[403].start |
11474.378 |
| transcript.whisperx[403].end |
11475.418 |
| transcript.whisperx[403].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[404].start |
11497.603 |
| transcript.whisperx[404].end |
11519.995 |
| transcript.whisperx[404].text |
所以我像就保護國人醫療的權益以及這個這個技術利用的安全性未來如果有已經到成熟穩定到一個程度我們再來修改這個法條所以我希望能夠加入但不得利用異種異體細胞進行醫療評委在這個第三條的這個第一項謝謝好接下來邱議瑩委員 |
| transcript.whisperx[405].start |
11522.332 |
| transcript.whisperx[405].end |
11541.685 |
| transcript.whisperx[405].text |
關於陳昭芝委員提到的這個部分其實我們在上一屆也進行很多的討論那其實在生醫療製劑我們現在要談的主要是要針對液體細胞可以讓他量化量產化來對人體做治療至於液種 |
| transcript.whisperx[406].start |
11543.686 |
| transcript.whisperx[406].end |
11544.707 |
| transcript.whisperx[406].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[407].start |
11561.669 |
| transcript.whisperx[407].end |
11562.109 |
| transcript.whisperx[407].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[408].start |
11590.063 |
| transcript.whisperx[408].end |
11618.642 |
| transcript.whisperx[408].text |
那到時候要再來修法可能要不知道要等到何年何月何日啊再生醫療法我就已經推了10年所以我不知道如果你們現在直接把它限縮掉的話會不會扼殺了整個科學研究的這樣的一個發展所以我是建議還是保留一些空間讓這個醫學的研究它其實是有無限的可能的是不是以上建議好請王振旭委員 |
| transcript.whisperx[409].start |
11619.783 |
| transcript.whisperx[409].end |
11646.881 |
| transcript.whisperx[409].text |
謝謝主席我本身是一個癌症科醫師所以我每天在面對的就是這些癌症病人當他需要醫療的時候有沒有機會能夠得到更好的醫療處理那我們所知道的再生醫療其實它進步真的非常非常的快如果我們現在把它一些未來有機會研發出來的對癌症病人或其他相關的病人有幫助的部分 |
| transcript.whisperx[410].start |
11647.581 |
| transcript.whisperx[410].end |
11675.379 |
| transcript.whisperx[410].text |
現在把他框架住其實真的非常可惜我們期待透過剛剛議員委員所說明的我非常支持院板目前我們可以用這樣的方式不要再特別去限定異種異體細胞因為事實上現在是沒有在執行的所以我們不需要這個時候就急著把他框架住這樣對我們醫療的發展對我們生物科技的發展其實是會很受到影響以上 |
| transcript.whisperx[411].start |
11676.462 |
| transcript.whisperx[411].end |
11700.511 |
| transcript.whisperx[411].text |
陳昭芷委員謝謝主席因為剛剛兩位委員擔心的部分當然所以我這邊要強調的是這個部分我們是放在這個因為再生醫療只允許在非醫療機構不得執行再生醫療所以我現在談的是臨場面的東西那至於這個研究發展這個是在不會是就在研究發展部分沒有受限於這個部分我們只是在這個限定在醫療機構內部進行醫療行為時 |
| transcript.whisperx[412].start |
11703.692 |
| transcript.whisperx[412].end |
11704.153 |
| transcript.whisperx[412].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[413].start |
11723.973 |
| transcript.whisperx[413].end |
11727.775 |
| transcript.whisperx[413].text |
再生醫療人體試驗 指教學醫院或金鐘主管機關同意指醫療機構。當然我們理解教學醫院跟醫療機構的差異,但是 |
| transcript.whisperx[414].start |
11752.691 |
| transcript.whisperx[414].end |
11753.611 |
| transcript.whisperx[414].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[415].start |
11775.578 |
| transcript.whisperx[415].end |
11776.158 |
| transcript.whisperx[415].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[416].start |
11794.991 |
| transcript.whisperx[416].end |
11813.516 |
| transcript.whisperx[416].text |
再生醫療法草案案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫療法草案件事宜等19人擬具:「再生醫 |
| transcript.whisperx[417].start |
11823.089 |
| transcript.whisperx[417].end |
11823.47 |
| transcript.whisperx[417].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[418].start |
11838.243 |
| transcript.whisperx[418].end |
11859.082 |
| transcript.whisperx[418].text |
就像我不支持國民黨﹖暫時不支持國民黨一直在主張了SMR的核能一樣研究是研究但它要正式安全相轉是一回事那在治療上面我們當然是採取保守的態度從研究到臨床到醫療上的許可其實是不一樣的 |
| transcript.whisperx[419].start |
11861.384 |
| transcript.whisperx[419].end |
11876.655 |
| transcript.whisperx[419].text |
現在我們有沒有辦法提出一種就是說現在應該對於技術還不是很成熟或者是臨床數據也看不顯著的或者是說還在研究階段的我們現在認為是不適宜但是在未來我們應該更正面的去講說到什麼階段的話我們才可以接受這種一體一種的這個技術 |
| transcript.whisperx[420].start |
11890.104 |
| transcript.whisperx[420].end |
11890.484 |
| transcript.whisperx[420].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[421].start |
11912.056 |
| transcript.whisperx[421].end |
11912.816 |
| transcript.whisperx[421].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[422].start |
11941.363 |
| transcript.whisperx[422].end |
11943.224 |
| transcript.whisperx[422].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[423].start |
11957.066 |
| transcript.whisperx[423].end |
11957.907 |
| transcript.whisperx[423].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[424].start |
11972.742 |
| transcript.whisperx[424].end |
11973.563 |
| transcript.whisperx[424].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[425].start |
11998.738 |
| transcript.whisperx[425].end |
11999.038 |
| transcript.whisperx[425].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[426].start |
12019.08 |
| transcript.whisperx[426].end |
12047.5 |
| transcript.whisperx[426].text |
首先是那個陳委員剛剛提到的人體試驗的這一個部分他是這樣子啦生技公司或是國務院或是工人院他是不可以直接做人體試驗因為人體試驗最重要的一件事情就要受試者的保護受試者就是在這裡面當然因為那個再生醫療不會有第一期的臨床試驗也就不會找健康人來做 |
| transcript.whisperx[427].start |
12048.16 |
| transcript.whisperx[427].end |
12049.001 |
| transcript.whisperx[427].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[428].start |
12064.063 |
| transcript.whisperx[428].end |
12088.914 |
| transcript.whisperx[428].text |
國衛院、公園院、生技公司沒有直接接觸病人的,病人一定是在醫療機構。所以我這樣回答,所以為什麼一定是要醫療機構來做,尤其是可以做這個人體試驗的教學醫院等等,或者其他的醫療機構,這是第一點。第二點,我先回答那個趙志偉委員的, |
| transcript.whisperx[429].start |
12090.134 |
| transcript.whisperx[429].end |
12108.774 |
| transcript.whisperx[429].text |
三）繼續審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審查委員邱議瑩等21人擬具:「再生醫療發展法草案．審 |
| transcript.whisperx[430].start |
12113.876 |
| transcript.whisperx[430].end |
12134.631 |
| transcript.whisperx[430].text |
所以在談議題的時候都是同種議題啦一樣都是人但是現在都是自體的自己的細胞拿出來操作之後的話再打回去那很快的我想就會有很多技術是用議題的就別人的細胞也可以來用但是同樣都是人 |
| transcript.whisperx[431].start |
12135.572 |
| transcript.whisperx[431].end |
12150.282 |
| transcript.whisperx[431].text |
所以這是同種議題。同種議題我想民眾黨的這個提案裡面也不是去反對同種議題。剛剛趙志偉在解釋的時候我聽起來並沒有反對說同種議題的可以再來做。 |
| transcript.whisperx[432].start |
12152.964 |
| transcript.whisperx[432].end |
12167.441 |
| transcript.whisperx[432].text |
而且如果說要做大量製造的話如果說同種液體的細胞本身沒有這種排斥的可能因為不是每一種細胞都會有產生排斥的現象 |
| transcript.whisperx[433].start |
12168.041 |
| transcript.whisperx[433].end |
12193.818 |
| transcript.whisperx[433].text |
以前陳家華委員就是誤解了這一點他以為所有的液體的那液體的細胞都會產生排斥都會有免疫的這種作用出來但是不見得不見得會是這樣子所以我認為就是說民政黨的版本並沒有排除同種液體所以現在要討論的就是異種 |
| transcript.whisperx[434].start |
12195.523 |
| transcript.whisperx[434].end |
12220.099 |
| transcript.whisperx[434].text |
好那異種的部分的話有一個地方就是我們在思考的時候經常會想說是豬啦是牛啦這些當然這一種的細胞的這個取這種豬牛羊的細胞來做操作之後再打回去當然它的風險會是比較大的但是異種不是只有這個 |
| transcript.whisperx[435].start |
12221.78 |
| transcript.whisperx[435].end |
12227.401 |
| transcript.whisperx[435].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:「 |
| transcript.whisperx[436].start |
12253.608 |
| transcript.whisperx[436].end |
12255.809 |
| transcript.whisperx[436].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[437].start |
12272.998 |
| transcript.whisperx[437].end |
12301.284 |
| transcript.whisperx[437].text |
但是,如果我們臨床把它禁掉的話,大概研究就不會有人會去做。因為你就研究沒有那個目的。研究的話要用在人身上才會有研究的價值嘛,不然覺得說,是不是裡面這樣做做paper,那有什麼意義?當然是這樣嘛,對啊,本來就是都有研究開始啊,但是你一旦把那個目的擋掉的話,是不是研究就會停擺? |
| transcript.whisperx[438].start |
12304.715 |
| transcript.whisperx[438].end |
12306.976 |
| transcript.whisperx[438].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[439].start |
12333.283 |
| transcript.whisperx[439].end |
12334.404 |
| transcript.whisperx[439].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[440].start |
12353.667 |
| transcript.whisperx[440].end |
12366.975 |
| transcript.whisperx[440].text |
一種的方法或者是同種議題同種議題會不會有排斥不是你在這裡講你要拿數據拿paper人家發表的paper來出來看或者是實務醫療界已經在進行了拿來看我覺得這樣才有說服力說同種議題即使這個東西外國誰都已經在做這種治療療法都已經是發達的而且是成熟的而且你說很快到底是有多快 |
| transcript.whisperx[441].start |
12381.263 |
| transcript.whisperx[441].end |
12381.623 |
| transcript.whisperx[441].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[442].start |
12407.233 |
| transcript.whisperx[442].end |
12409.515 |
| transcript.whisperx[442].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[443].start |
12433.53 |
| transcript.whisperx[443].end |
12433.81 |
| transcript.whisperx[443].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[444].start |
12457.374 |
| transcript.whisperx[444].end |
12457.855 |
| transcript.whisperx[444].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[445].start |
12477.768 |
| transcript.whisperx[445].end |
12478.008 |
| transcript.whisperx[445].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[446].start |
12498.67 |
| transcript.whisperx[446].end |
12498.97 |
| transcript.whisperx[446].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[447].start |
12515.055 |
| transcript.whisperx[447].end |
12542.382 |
| transcript.whisperx[447].text |
我在這邊跟各位委員報告目前國際間已經核准的這一個細胞治療裡面那有一個叫做Alophis那這個是在歐盟跟日本核准的他是用液體的細胞治療他在治療的是傳統治療無效的克隆士症的成人病人的複雜性的肛門肉管那這個是已經核准的 |
| transcript.whisperx[448].start |
12543.102 |
| transcript.whisperx[448].end |
12559.069 |
| transcript.whisperx[448].text |
另外在美國有三個是液體的細胞治療的。一個是取自死亡的捐贈者的胰島核Beta細胞注射到病人的肝膜靜脈製造治療第一型的糖尿病的病人。 |
| transcript.whisperx[449].start |
12559.769 |
| transcript.whisperx[449].end |
12581.706 |
| transcript.whisperx[449].text |
這都已經核准了美國第二個液體細胞治療的他是用液體的幾代血幹細胞來治療增加體內室中性白血球的恢復降低感染的風險他是適用於在做 |
| transcript.whisperx[450].start |
12582.446 |
| transcript.whisperx[450].end |
12599.501 |
| transcript.whisperx[450].text |
放射性治療或化學骨髓淨除式治療後進行幾代血移植,12歲以上的血癌病人。第三個在美國所做的,不過這是自體,這我就先不講。 |
| transcript.whisperx[451].start |
12600.805 |
| transcript.whisperx[451].end |
12601.485 |
| transcript.whisperx[451].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[452].start |
12630.273 |
| transcript.whisperx[452].end |
12630.834 |
| transcript.whisperx[452].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[453].start |
12646.489 |
| transcript.whisperx[453].end |
12647.51 |
| transcript.whisperx[453].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[454].start |
12667.014 |
| transcript.whisperx[454].end |
12670.756 |
| transcript.whisperx[454].text |
王振旭委員王振旭委員王振旭委員 |
| transcript.whisperx[455].start |
12696.568 |
| transcript.whisperx[455].end |
12722.522 |
| transcript.whisperx[455].text |
讓這個病人可以不需要因為他是低型的糖尿病無法自己製造胰島素那這個就是一種可行性這個類似這個樣的概念那至於說他能不能直接這樣用當然一定要經過好的臨床試驗才能夠處理到這個程度所以我剛剛很認同大家如果我們在這個立法說明裡面針對於可能造成的 |
| transcript.whisperx[456].start |
12723.803 |
| transcript.whisperx[456].end |
12725.045 |
| transcript.whisperx[456].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[457].start |
12739.093 |
| transcript.whisperx[457].end |
12762.207 |
| transcript.whisperx[457].text |
林淑芬委員主席我聽了這樣的意見剛才那個一種議題我覺得就是可能就是應該要放到正常完成正常的臨床實驗裡面其實就可以用如果照王醫師的講法他就不能夠在特許的例外條款裡面使用就是這樣子就是說一種議題要限縮在那個程序那同種議題的話剛才這個講的這個 |
| transcript.whisperx[458].start |
12766.269 |
| transcript.whisperx[458].end |
12767.09 |
| transcript.whisperx[458].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[459].start |
12788.609 |
| transcript.whisperx[459].end |
12789.389 |
| transcript.whisperx[459].text |
二）繼續審查委員邱議瑩等21人擬具 |
| transcript.whisperx[460].start |
12809.366 |
| transcript.whisperx[460].end |
12810.427 |
| transcript.whisperx[460].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[461].start |
12830.559 |
| transcript.whisperx[461].end |
12831.4 |
| transcript.whisperx[461].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[462].start |
12850.401 |
| transcript.whisperx[462].end |
12850.681 |
| transcript.whisperx[462].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[463].start |
12865.469 |
| transcript.whisperx[463].end |
12865.729 |
| transcript.whisperx[463].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[464].start |
12889.48 |
| transcript.whisperx[464].end |
12916.29 |
| transcript.whisperx[464].text |
第8條是非常危急的時候才有使用。他即使是在治療的當下免除正常程序但是他後來他還是必須拿到藥證才能成為正規的治療只是在非常危急的時候你去做這樣的處理。但危急的時候我們要把風險更大的異種液體跟同種液體也許可他使用嗎? |
| transcript.whisperx[465].start |
12918.652 |
| transcript.whisperx[465].end |
12918.753 |
| transcript.whisperx[465].text |
接下來第4條。 |
| transcript.whisperx[466].start |
12935.156 |
| transcript.whisperx[466].end |
12954.08 |
| transcript.whisperx[466].text |
第四條的部分的話我們跟很多委員其實的那個條文是一樣因為主要是在中央主管機關應該就會制定一個推動的計畫定期討論然後來推動再生醫療然後我們也各級的主管機關也可以要求相關的一個機關構學校法人或團體來協助推動 |
| transcript.whisperx[467].start |
12955.66 |
| transcript.whisperx[467].end |
12956.701 |
| transcript.whisperx[467].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[468].start |
12985.94 |
| transcript.whisperx[468].end |
12987.001 |
| transcript.whisperx[468].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[469].start |
13005.735 |
| transcript.whisperx[469].end |
13021.929 |
| transcript.whisperx[469].text |
然後就是說我必須再提到現在很多學者希望特管法第20條第三條有規定中央主管監獄必要時得公開醫療結果是治療統計結果但目前為止我們都看不到就特管法這樣執行的所有的成果我們目前都看不到所以衛福部是有選擇權的那這樣是我們就是會擔心的 |
| transcript.whisperx[470].start |
13025.532 |
| transcript.whisperx[470].end |
13025.952 |
| transcript.whisperx[470].text |
邱議瑩等25人擬具 |
| transcript.whisperx[471].start |
13057.351 |
| transcript.whisperx[471].end |
13082.598 |
| transcript.whisperx[471].text |
我本來想說因為大家的版本基本上都跟行政院版差不多那這個剛剛民眾黨的委員說要提政策制定再生醫療法跟制定再生醫療製劑的推動通過這個就是國家對於再生醫療推動的政策重大政策之一那這個政策被延宕了8年 |
| transcript.whisperx[472].start |
13083.652 |
| transcript.whisperx[472].end |
13095.624 |
| transcript.whisperx[472].text |
所以,懇請各位委員支持啦,如果大家覺得再生醫療法的發展非常重要,這個其實就是一個重大的政策之一。那要把它放進去我也沒有什麼太大的意見啦。好,黃建旭委員 |
| transcript.whisperx[473].start |
13098.438 |
| transcript.whisperx[473].end |
13115.93 |
| transcript.whisperx[473].text |
謝謝趙委謝謝主席我想剛剛趙副委員一直很希望把這個醫療倫理寫到這個法案裡面其實醫療倫理是我們每天每天都要執行而且都要奉行的所以如果只是針對再生醫療認為需要醫療倫理這樣其實範圍太小了 |
| transcript.whisperx[474].start |
13119.412 |
| transcript.whisperx[474].end |
13146.412 |
| transcript.whisperx[474].text |
因為我們每天在看病人就是需要遵守醫療倫理所以其實這個是可以不用在這個地方在另外特別規範的我支持院辦以上主席不好意思這個當然自律的醫師如這個是沒有問題但是這個就是再生醫療倫理規範為什麼呢其實它涉及我們剛剛講安全品質有效性其實還涉及一個費用這個是相對非常昂貴的一個費用所以我們覺得在這個倫理的部分 |
| transcript.whisperx[475].start |
13147.413 |
| transcript.whisperx[475].end |
13150.335 |
| transcript.whisperx[475].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[476].start |
13175.171 |
| transcript.whisperx[476].end |
13175.772 |
| transcript.whisperx[476].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[477].start |
13193.572 |
| transcript.whisperx[477].end |
13194.272 |
| transcript.whisperx[477].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[478].start |
13214.255 |
| transcript.whisperx[478].end |
13214.716 |
| transcript.whisperx[478].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[479].start |
13229.192 |
| transcript.whisperx[479].end |
13233.054 |
| transcript.whisperx[479].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[480].start |
13258.208 |
| transcript.whisperx[480].end |
13258.548 |
| transcript.whisperx[480].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[481].start |
13280.653 |
| transcript.whisperx[481].end |
13286.775 |
| transcript.whisperx[481].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[482].start |
13309.284 |
| transcript.whisperx[482].end |
13324.063 |
| transcript.whisperx[482].text |
請容許我再做補充說明我們會覺得為什麼定義倫理規範因為這近幾年國際上連續發生多起幹細胞研究及組織工程這個試驗的試驗數據或論文造假這個大家可以google到而且再生醫療涉及組織細胞捐贈及商業利益 |
| transcript.whisperx[483].start |
13324.804 |
| transcript.whisperx[483].end |
13325.625 |
| transcript.whisperx[483].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[484].start |
13346.644 |
| transcript.whisperx[484].end |
13347.645 |
| transcript.whisperx[484].text |
再生醫療法草案案案 |
| transcript.whisperx[485].start |
13363.661 |
| transcript.whisperx[485].end |
13384.229 |
| transcript.whisperx[485].text |
不過因為在法條裡面包括說收費等等這一些其實後面的條文應該是有這個收費也會受到主管機關的管制所以他的倫理規範可能是剛剛那個趙志偉在談的那有一些造假啦有一些 |
| transcript.whisperx[486].start |
13385.789 |
| transcript.whisperx[486].end |
13388.45 |
| transcript.whisperx[486].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[487].start |
13412.114 |
| transcript.whisperx[487].end |
13431.062 |
| transcript.whisperx[487].text |
那至於政策跟推動的計畫這個也沒有關係啦因為再把政策講清楚一點也OK啦就是我們在推動再生醫療是我們國家重要政策至於要怎麼樣推動就是後面的計畫這我是覺得是可以接受好謝謝部長 |
| transcript.whisperx[488].start |
13433.206 |
| transcript.whisperx[488].end |
13434.568 |
| transcript.whisperx[488].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[489].start |
13448.946 |
| transcript.whisperx[489].end |
13473.276 |
| transcript.whisperx[489].text |
我是覺得此肯定的態度肯定我們部長因為牽扯到人體細胞牽扯到人體基因這種很東西很私密的東西我們其實都一直認為應該要高度規範尤其是在倫理方面本來就一定要規管所以有規管有規範還不一定能夠執行的好那更何況沒有任何規範所以也是樂見其成說部裡面願意把這方面的規範放進來 |
| transcript.whisperx[490].start |
13477.722 |
| transcript.whisperx[490].end |
13478.483 |
| transcript.whisperx[490].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[491].start |
13496.772 |
| transcript.whisperx[491].end |
13498.033 |
| transcript.whisperx[491].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[492].start |
13517.888 |
| transcript.whisperx[492].end |
13519.328 |
| transcript.whisperx[492].text |
再生醫療法草案案 案 規範規範規範規範規範規範規範規範規範規範規範規範規範規範規範 |
| transcript.whisperx[493].start |
13540.854 |
| transcript.whisperx[493].end |
13542.276 |
| transcript.whisperx[493].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[494].start |
13563.157 |
| transcript.whisperx[494].end |
13585.347 |
| transcript.whisperx[494].text |
因為這個我也個人意見我覺得要想一下下啊到底民眾黨文字是不是最妥當我覺得我們也有思考的空間啊好啦那我們就先保留啦好不好先保留先保留好你就請衛生部原則他是同意倫理規範這幾個字但是現在就是說那個規範的內容是什麼東西 |
| transcript.whisperx[495].start |
13588.168 |
| transcript.whisperx[495].end |
13589.249 |
| transcript.whisperx[495].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[496].start |
13614.605 |
| transcript.whisperx[496].end |
13615.005 |
| transcript.whisperx[496].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[497].start |
13636.172 |
| transcript.whisperx[497].end |
13640.515 |
| transcript.whisperx[497].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 |
| transcript.whisperx[498].start |
13665.973 |
| transcript.whisperx[498].end |
13694.42 |
| transcript.whisperx[498].text |
因為在行政程序法裡面有基本的規定所以在我們的院版的條文裡面沒有特別的規定是因為這樣然後那還有部分是說對於就是說更明確的是希望在字跡啊或者是那個諮詢的建議或政策這邊的話我們因為覺得是說跟我們原本的院版裡面的文字其實是有一些雷同的部分所以也希望那個委員能夠支持院版以上 |
| transcript.whisperx[499].start |
13696.642 |
| transcript.whisperx[499].end |
13697.703 |
| transcript.whisperx[499].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[500].start |
13710.057 |
| transcript.whisperx[500].end |
13710.938 |
| transcript.whisperx[500].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[501].start |
13731.892 |
| transcript.whisperx[501].end |
13751.157 |
| transcript.whisperx[501].text |
第7款和與再生資金有付款許可。」付款許可,這是資益,它不是審議,是資益。資益跟審議的差別,我想在,譬如在我個人過去在健保署參與了那麼多的這個新藥資益小組,事實上到最後的決定是在 |
| transcript.whisperx[502].start |
13752.317 |
| transcript.whisperx[502].end |
13752.898 |
| transcript.whisperx[502].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[503].start |
13781.937 |
| transcript.whisperx[503].end |
13786.459 |
| transcript.whisperx[503].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[504].start |
13809.847 |
| transcript.whisperx[504].end |
13825.419 |
| transcript.whisperx[504].text |
再生醫療法草案．一）繼續審查委員謝衣鳯等21人擬具:「再生醫療法草案．一）繼續審查委員謝衣鳯等21人擬具:「再生醫療法草案．一）繼續審查委員謝衣鳯等21人擬具:「再生醫療法草案．一）繼續審查委員謝衣鳯等21人擬具:「再生醫療法草案．一）繼續審查委員謝衣鳯等21人擬具:「再生醫療法草案．一）繼續審查委員謝衣鳯等21人擬具:「再生醫療法草案．一）繼續審查 |
| transcript.whisperx[505].start |
13840.11 |
| transcript.whisperx[505].end |
13866.99 |
| transcript.whisperx[505].text |
第5款和第7款規定的所受的審議人有利益衝突應該迴避。」以上。好。接下來請陳金輝委員。這個我之前質詢有講到過,因為很少數的項目可以審議,這樣就失去審議委員會的作用,所以我希望可以在第一項把諮詢還有審議都一起納入。剛剛司長有提到說本來就有規範委員會組成,但剛剛很明顯的 |
| transcript.whisperx[506].start |
13868.651 |
| transcript.whisperx[506].end |
13884.585 |
| transcript.whisperx[506].text |
醫學倫理、藥學、醫學這個是主要的爭點所以如果可以具體的列入說相關機關代表、藥學、醫學還有法律倫理領域的專家組成而不是只有講到性別我覺得這樣是比較完整謝謝接下來請林淑芬委員 |
| transcript.whisperx[507].start |
13887.288 |
| transcript.whisperx[507].end |
13904.765 |
| transcript.whisperx[507].text |
這個我是看到行政院版本他這個第6款第7款他第一個是在講再生製劑和再生技術管理的只有諮詢那第7款是說他如果有許可的時候會有付款那這付款還要審議 |
| transcript.whisperx[508].start |
13906.721 |
| transcript.whisperx[508].end |
13908.704 |
| transcript.whisperx[508].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[509].start |
13921.089 |
| transcript.whisperx[509].end |
13922.85 |
| transcript.whisperx[509].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[510].start |
13940.936 |
| transcript.whisperx[510].end |
13941.196 |
| transcript.whisperx[510].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[511].start |
13962.371 |
| transcript.whisperx[511].end |
13977.096 |
| transcript.whisperx[511].text |
我個人提案是在第7款的部分我認為在付款許可還是要用審議因為就像剛才薛部長所說的他沒有委外嘛是不是部長全部沒有委外嗎 |
| transcript.whisperx[512].start |
13978.693 |
| transcript.whisperx[512].end |
13980.015 |
| transcript.whisperx[512].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[513].start |
13996.334 |
| transcript.whisperx[513].end |
14011.844 |
| transcript.whisperx[513].text |
對阿上一屆的時候我們討論到最後的話就是說那付付款許可的這一個的話除了在這一個食藥署主管機關的這邊的審查之後的話還要送到這裡來對阿審議委員會阿審議委員會就直接審議並沒有在委外 |
| transcript.whisperx[514].start |
14015.086 |
| transcript.whisperx[514].end |
14015.727 |
| transcript.whisperx[514].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[515].start |
14035.646 |
| transcript.whisperx[515].end |
14036.206 |
| transcript.whisperx[515].text |
三）繼續審查委員邱議瑩等22人擬具 |
| transcript.whisperx[516].start |
14049.678 |
| transcript.whisperx[516].end |
14075.779 |
| transcript.whisperx[516].text |
謝謝主席這個我可能跟幾位委員做一下背景說明這個我們上一屆討論的時候對於到底這個委員會要叫審議會還是叫資議會也有一番很長的討論所以最後邱太元委員建議我們就把它改成審議會所以這一次的行政院的版本就依照上一屆最後的協商的結論提出來的名稱就叫審議會那 |
| transcript.whisperx[517].start |
14077.62 |
| transcript.whisperx[517].end |
14078.221 |
| transcript.whisperx[517].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[518].start |
14101.317 |
| transcript.whisperx[518].end |
14101.817 |
| transcript.whisperx[518].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[519].start |
14125.632 |
| transcript.whisperx[519].end |
14140.858 |
| transcript.whisperx[519].text |
再生治劑跟再生技術管理就是第6款的部分如果你要諮詢再加審議的話我覺得可能會剝奪到原來的包括食藥署跟醫事司他們原來在審核上面的這樣的一個權利 |
| transcript.whisperx[520].start |
14142.419 |
| transcript.whisperx[520].end |
14165.966 |
| transcript.whisperx[520].text |
所以我的具體建議是不是如果大家要把這個委員會改成資議會我也沒有意見但是那個設置的相關的成員組成的部分是不是照王振旭委員的修正動議把這些把它列入加入然後但是我不是很我個人不是很贊成就是說第六款的部分還要再加審議這樣子好以上 |
| transcript.whisperx[521].start |
14169.137 |
| transcript.whisperx[521].end |
14170.359 |
| transcript.whisperx[521].text |
接下來請王正旭委員發言。 |
| transcript.whisperx[522].start |
14187.034 |
| transcript.whisperx[522].end |
14213.102 |
| transcript.whisperx[522].text |
就是針對於審議會應該要自委員若干人就醫療科技倫理法律與其他相關專業學者專家聘派兼職由衛生福利部部長或部長就委員中指定一人擔任召集人我們期待的就是審議會能夠發揮他重要的功能那在目前的 |
| transcript.whisperx[523].start |
14214.882 |
| transcript.whisperx[523].end |
14238.915 |
| transcript.whisperx[523].text |
相關的法案裡面我們也知道如果有這樣的審議會對於未來的把關有他的重要性所以在第九款後面再追加第一項審議會是組成議事利益迴避及其他應遵循四項的辦法由中央主管機關定制來加強補足我們前面所要 |
| transcript.whisperx[524].start |
14239.616 |
| transcript.whisperx[524].end |
14248.277 |
| transcript.whisperx[524].text |
希望透過這個審議會的成員來讓整個運作或者是在把關的部分可以能夠更符合整個法案的要求 |
| transcript.whisperx[525].start |
14248.823 |
| transcript.whisperx[525].end |
14250.204 |
| transcript.whisperx[525].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[526].start |
14279.283 |
| transcript.whisperx[526].end |
14280.264 |
| transcript.whisperx[526].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[527].start |
14292.248 |
| transcript.whisperx[527].end |
14306.001 |
| transcript.whisperx[527].text |
首先我要和先續名一下因為上一屆現在在會場上面上一屆有一起坐在這個會議室裡面審查的應該是我跟邱議瑩委員當然還有主席所以在這樣的狀況下我覺得我必須先附議邱議瑩委員剛剛所說的確實是上一屆我們討論的狀況一致不差 |
| transcript.whisperx[528].start |
14316.05 |
| transcript.whisperx[528].end |
14339.602 |
| transcript.whisperx[528].text |
所以在這樣的狀況下第一關於名稱的部分呢確實大家如果是共識比較多要用審議會表示他的項目的話那當然名稱可以不過其實當時的狀況我們確實是覺得說有些事情最後要負責任的還是衛福部啊所以12345678這些事情包括你看看就是說我們要發展創新及推動政策 |
| transcript.whisperx[529].start |
14340.362 |
| transcript.whisperx[529].end |
14340.602 |
| transcript.whisperx[529].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[530].start |
14362.119 |
| transcript.whisperx[530].end |
14362.479 |
| transcript.whisperx[530].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[531].start |
14383.466 |
| transcript.whisperx[531].end |
14409.884 |
| transcript.whisperx[531].text |
我今天也可以同意就是證據委員這邊如果他的修正動議上面就前面的組成和後面的這個意思規定等等的組成的方式能夠再加強規範的話我是覺得是可以的啦我也可以表示支持但是在過程當中哪一些是諮詢哪一些是審議我目前是比較傾向支持院版的部分也就是上一屆討論出來的結論 |
| transcript.whisperx[532].start |
14412.416 |
| transcript.whisperx[532].end |
14413.477 |
| transcript.whisperx[532].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[533].start |
14436.423 |
| transcript.whisperx[533].end |
14440.606 |
| transcript.whisperx[533].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[534].start |
14466.461 |
| transcript.whisperx[534].end |
14492.102 |
| transcript.whisperx[534].text |
誰最後負最後責任然後是目前有跌床駕屋的一個感受我剛剛已經舉例了我在呈要資質要求我讓after pill事後批判過關2015年16年但是我後來被這個食藥署篡改會議記錄然後到今天都還沒收這個條款到現在都沒有去執行所以我覺得質疑OK啊我們就留他質疑啊那這個最後的結果跟責任就是由最後由衛福部的所屬單位來承擔來負責 |
| transcript.whisperx[535].start |
14494.124 |
| transcript.whisperx[535].end |
14494.425 |
| transcript.whisperx[535].text |
邱議瑩等25人擬具 |
| transcript.whisperx[536].start |
14506.637 |
| transcript.whisperx[536].end |
14524.965 |
| transcript.whisperx[536].text |
再生醫療審議會的話因為他審查的內容其實他的高度是蠻專業的所以我是建議是能明定清楚一點然後審議的委員那如果醫學藥學還有法律倫理學這些專家比較適合好那請行政班位是不是再說明一下好淑芬委員 |
| transcript.whisperx[537].start |
14525.865 |
| transcript.whisperx[537].end |
14539.53 |
| transcript.whisperx[537].text |
抱歉因為你們建議照王委員的修正動議通過可是我現在看到第五條的修正動議裡面最後一項最後倒數第二項他講的是說第一項審議委員會的組成 |
| transcript.whisperx[538].start |
14541.351 |
| transcript.whisperx[538].end |
14569.24 |
| transcript.whisperx[538].text |
意識利益迴避及其他應遵循事項的辦法由中央主管機關定制直接授權給中央主管機關可是我們在這裡還是希望明定這個組成要有哪些領域的比如說要並有團體因為到時候我們沒有在這裡明定到時候行政部門定出來搞不好他沒有並有團體也沒有什麼其他我們期待的所以我們是不是應該要明定上去 |
| transcript.whisperx[539].start |
14570.925 |
| transcript.whisperx[539].end |
14591.213 |
| transcript.whisperx[539].text |
劉建國委員王委員的第5條上面應該就有了,第一項就有了對,那就就醫療科技倫理法律與其他相關專業學者專家聘派建設他裡面沒有並有團體 |
| transcript.whisperx[540].start |
14592.58 |
| transcript.whisperx[540].end |
14593.36 |
| transcript.whisperx[540].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[541].start |
14610.149 |
| transcript.whisperx[541].end |
14638.398 |
| transcript.whisperx[541].text |
化學、醫學、工程學以及法律倫理學等專家學者共同鑄成。」如果林委員要再把病友團體納進去,我也沒有意見。為什麼我會把它放在最後面?因為我想再生醫療基本上是一個嶄新複雜又需高花費的醫療科技領域。我想也不是一個單一的職業單獨可以去完成的龐雜業務。所以如果我們可以把 |
| transcript.whisperx[542].start |
14639.238 |
| transcript.whisperx[542].end |
14640.399 |
| transcript.whisperx[542].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[543].start |
14660.865 |
| transcript.whisperx[543].end |
14684.371 |
| transcript.whisperx[543].text |
好,是不是請行政單位再說明一下。好,那幾個問題啊。第一個問題王委員這邊有提到的是審議的部分的話是有包括第六款再生醫療資計、再生資計及再生技術管理諮詢,然後加了一個審議。這個部分我們是覺得比較不妥當。 |
| transcript.whisperx[544].start |
14685.311 |
| transcript.whisperx[544].end |
14691.126 |
| transcript.whisperx[544].text |
因為這個是在講管理管理的主要的機關就是衛福部 |
| transcript.whisperx[545].start |
14692.65 |
| transcript.whisperx[545].end |
14720.566 |
| transcript.whisperx[545].text |
二部管理的方式還要經過審議會的審議這有一點奇怪所以我是建議這一點的話是不是就還是維持原來的資訊的部分交付款許可的這個審議是上一次上一屆的這個委員會討論後來大家得出的一個折衷版本 |
| transcript.whisperx[546].start |
14721.306 |
| transcript.whisperx[546].end |
14723.488 |
| transcript.whisperx[546].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[547].start |
14743.681 |
| transcript.whisperx[547].end |
14763.96 |
| transcript.whisperx[547].text |
但是我要跟各位報告就是說像這種審議會或諮議會的話通常他會有5委員的人數的限制15到25人大部分是這樣但是其他的專業的話會看個案每一個要審議或者是諮詢的這個個案來找相關的專家 |
| transcript.whisperx[548].start |
14768.564 |
| transcript.whisperx[548].end |
14783.434 |
| transcript.whisperx[548].text |
差別只是相關的專家列席之後陳述意見但是遇到需要做表決決定的時候他不能投票其他的固定委員是可以投票但是從我們衛福部這邊過去的經驗來看的話 |
| transcript.whisperx[549].start |
14786.675 |
| transcript.whisperx[549].end |
14813.842 |
| transcript.whisperx[549].text |
這種專業的委員會很少有投票的大概都是共識決啦所以事實上列席跟列名的委員其實在會議中的討論其實並沒有太大的差異啦所以是否一定要把化學生醫醫學工程學這個把它列進來我想就是說這針對那個劉委員的版本是不是可以再斟酌 |
| transcript.whisperx[550].start |
14817.273 |
| transcript.whisperx[550].end |
14820.315 |
| transcript.whisperx[550].text |
林月琴委員林月琴委員 |
| transcript.whisperx[551].start |
14841.701 |
| transcript.whisperx[551].end |
14844.363 |
| transcript.whisperx[551].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[552].start |
14872.398 |
| transcript.whisperx[552].end |
14872.679 |
| transcript.whisperx[552].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[553].start |
14889.965 |
| transcript.whisperx[553].end |
14895.59 |
| transcript.whisperx[553].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）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[554].start |
15202.408 |
| transcript.whisperx[554].end |
15202.912 |
| transcript.whisperx[554].text |
三）繼續審查委員羅廷瑋 |
| transcript.whisperx[555].start |
17023.697 |
| transcript.whisperx[555].end |
17035.12 |
| transcript.whisperx[555].text |
現在繼續開會那是不是請各位委員先參照上面這個條文的這個文字修正建議是大家先參考一下因為剛剛大家有溝通但是他們說要用說明來彌補我們這裡面的疑慮那我們是不是要看到文字 |
| transcript.whisperx[556].start |
17049.942 |
| transcript.whisperx[556].end |
17050.403 |
| transcript.whisperx[556].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[557].start |
17068.06 |
| transcript.whisperx[557].end |
17069.261 |
| transcript.whisperx[557].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[558].start |
17095.563 |
| transcript.whisperx[558].end |
17122.62 |
| transcript.whisperx[558].text |
那說明欄是不是這邊先我們進去那個要到明天好不好那就授權你們明天還會繼續開會嗎好不好明天再再補上來然後讓委員就是文字文字可以啦這個條文的文字我們現在同意啦然後那個補充說明的部分立法說明的部分是不是包括要聘用的人有包括那個剛剛有建國委員起義的那些區塊 |
| transcript.whisperx[559].start |
17124.221 |
| transcript.whisperx[559].end |
17124.782 |
| transcript.whisperx[559].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[560].start |
17150.964 |
| transcript.whisperx[560].end |
17151.525 |
| transcript.whisperx[560].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[561].start |
17171.363 |
| transcript.whisperx[561].end |
17194.324 |
| transcript.whisperx[561].text |
但是這樣子會變成說每一個領域都要有人這樣子執行上會不會專家審議會就會不會有可是大家則有相關就可以了就是這幾個每一個都要有還是只要有一兩個有就特別寫的就每一項都要有那就是醫頓號藥頓號可是科技 |
| transcript.whisperx[562].start |
17198.643 |
| transcript.whisperx[562].end |
17203.846 |
| transcript.whisperx[562].text |
邱議瑩等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:「 |
| transcript.whisperx[563].start |
17228.657 |
| transcript.whisperx[563].end |
17251.396 |
| transcript.whisperx[563].text |
呃,各位委員,那是不是照現在,大家看一下齁,就是照這個修正文字。哪一個?哦,好啊好啊。欸? |
| transcript.whisperx[564].start |
17256.138 |
| transcript.whisperx[564].end |
17281.799 |
| transcript.whisperx[564].text |
可不可以把病友團體放在最後我們再調一次法律的就麻煩第7款的那個審議的責任者最終者還是麻煩說明一下因為只有這一條跑出審議是不是我們有做文字修正的部分是不是念念一下好不好然後看各位委員有沒有意見沒有意見的話我們第5條就照文字修正通過這樣子好不好 |
| transcript.whisperx[565].start |
17284.943 |
| transcript.whisperx[565].end |
17285.323 |
| transcript.whisperx[565].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[566].start |
17312.788 |
| transcript.whisperx[566].end |
17321.373 |
| transcript.whisperx[566].text |
就醫藥科技論理法律相關專業學者專家及並有團體 |
| transcript.whisperx[567].start |
17335.169 |
| transcript.whisperx[567].end |
17359.342 |
| transcript.whisperx[567].text |
主席我會針對科技的部分改成生技生技我覺得生技會比較好一點生技會生物科技嘛科技就很多不同的科技會比較模糊生技那倫理法律那個其他先拿掉相關那個逗點也不用 |
| transcript.whisperx[568].start |
17360.97 |
| transcript.whisperx[568].end |
17375.928 |
| transcript.whisperx[568].text |
相關專業學者專家及病友團體,應該這樣就夠了,因為後面有相關的嘛,所以其他的大概就會還是會在這個範圍裡面 |
| transcript.whisperx[569].start |
17379.648 |
| transcript.whisperx[569].end |
17406.784 |
| transcript.whisperx[569].text |
至於剛剛趙志偉在提到的審議跟質疑的差異審議大概是這個樣子就審議有決定權如果他是審議事項的話那這個這個審議會就可以做決定如果質疑的話是只有建議權那做出來的一個決定的話如果仍然還是要衛福部的同意但是因為這個條文如果現在這樣寫的話那 |
| transcript.whisperx[570].start |
17409.425 |
| transcript.whisperx[570].end |
17425.773 |
| transcript.whisperx[570].text |
這一個審議會的那個召集人還是衛福部的部長或者指定之人那事實上就沒有太大的差異啦因為審議會也是保定管理嘛在那做出決議 |
| transcript.whisperx[571].start |
17427.113 |
| transcript.whisperx[571].end |
17444.271 |
| transcript.whisperx[571].text |
如果說他是審議,他要去負責,那還是部長在決。但是如果說是質疑的話,那就是做出來的就是一個建議,還是要呈到部裡面有部,部裡面一一銷售進去。反正他的最高決定人都還是同一個人,都是部長。 |
| transcript.whisperx[572].start |
17450.677 |
| transcript.whisperx[572].end |
17451.357 |
| transcript.whisperx[572].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[573].start |
17483.097 |
| transcript.whisperx[573].end |
17506.182 |
| transcript.whisperx[573].text |
所以我們所有委員齁就剛剛的這個文字修正第5條的部分還有沒有其他意見主席他明天要看到說明明天他們之前他說明天才能提供那個對明天那個說明的部分明天再補上來那針對文字的部分是不是沒有意見齁那就要照剛剛的這個文字修正通過第5條 |
| transcript.whisperx[574].start |
17507.822 |
| transcript.whisperx[574].end |
17508.883 |
| transcript.whisperx[574].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[575].start |
17536.223 |
| transcript.whisperx[575].end |
17536.803 |
| transcript.whisperx[575].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[576].start |
17556.954 |
| transcript.whisperx[576].end |
17557.955 |
| transcript.whisperx[576].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[577].start |
17583.038 |
| transcript.whisperx[577].end |
17585.2 |
| transcript.whisperx[577].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[578].start |
17609.74 |
| transcript.whisperx[578].end |
17612.081 |
| transcript.whisperx[578].text |
謝衣鳯委員有第6條、第7條、第8條。那我們剛剛沒有...喔!對對對。第13頁第6條。謝衣鳯委員...對。 |
| transcript.whisperx[579].start |
17624.96 |
| transcript.whisperx[579].end |
17640.488 |
| transcript.whisperx[579].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6條6、7、8的部分是因為他主要在處理的部分的話就是會在促進這邊跟產業發展這邊是有關係的比如說他在講的會是說在那個能力範圍內要跨列預算 |
| transcript.whisperx[580].start |
17640.908 |
| transcript.whisperx[580].end |
17641.248 |
| transcript.whisperx[580].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[581].start |
17664.648 |
| transcript.whisperx[581].end |
17670.473 |
| transcript.whisperx[581].text |
好,那就謝衣鳯委員的第六、第七、第八就不予以處理。 |
| transcript.whisperx[582].start |
17671.657 |
| transcript.whisperx[582].end |
17696.158 |
| transcript.whisperx[582].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採納。〉主席,請問現在是第6條,對吧?對,對,現在第6條。對,那針對院版第6條的部分,最後在第5款之後需要加一點點的確定,前項所述之其他政府機關及醫療機構、學術研究機構、學校或法人所需之條件, |
| transcript.whisperx[583].start |
17697.159 |
| transcript.whisperx[583].end |
17697.88 |
| transcript.whisperx[583].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[584].start |
17723.396 |
| transcript.whisperx[584].end |
17723.796 |
| transcript.whisperx[584].text |
邱議瑩等25人擬具 |
| transcript.whisperx[585].start |
17745.751 |
| transcript.whisperx[585].end |
17771.42 |
| transcript.whisperx[585].text |
可以齁,那個行政單位,可以嗎?可以。那就照王振旭委員的修正動議通過。好,那那個王委員的第6條齁,上面是中央主管機關的委由其他政府機關,可是在下面是那個委託,那這個文字是不是要委由跟委託? |
| transcript.whisperx[586].start |
17771.94 |
| transcript.whisperx[586].end |
17775.122 |
| transcript.whisperx[586].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 規定規定規定規定規定規定規定 |
| transcript.whisperx[587].start |
17801.806 |
| transcript.whisperx[587].end |
17803.708 |
| transcript.whisperx[587].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[588].start |
17830.529 |
| transcript.whisperx[588].end |
17854.551 |
| transcript.whisperx[588].text |
所以都是委託的方式?所以上面那個委郵就改成委託,可以嗎?好,如果沒有其他的委任或委辦的需求的話,那委託應該是可以,如果可以符合的話,那就沒有意見。好,那上面那個就本來委郵現在改成委託,好,那委員還有其他意見嗎? |
| transcript.whisperx[589].start |
17857.082 |
| transcript.whisperx[589].end |
17858.704 |
| transcript.whisperx[589].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[590].start |
17881.534 |
| transcript.whisperx[590].end |
17882.095 |
| transcript.whisperx[590].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[591].start |
17896.572 |
| transcript.whisperx[591].end |
17918.286 |
| transcript.whisperx[591].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案 第10條跟第12條都在講的是產業促進的發展這原本就有兩個條例包括生技產業條例跟創新條例的部分所以我們是在院版裡面是沒有建議不予採納 |
| transcript.whisperx[592].start |
17921.018 |
| transcript.whisperx[592].end |
17949.079 |
| transcript.whisperx[592].text |
謝衣鳯委員第10條及第12條不予採納。接下來是第二章章名。第二章章名的部分的話我們定義的是再生醫療人體研究人體試驗及研究。然後那其實是跟所有委員的提案的版本的章名是一樣只是條次章的結次不一樣。然後建議是大家能夠支持院版。各位委員有沒有 |
| transcript.whisperx[593].start |
17950.58 |
| transcript.whisperx[593].end |
17952.563 |
| transcript.whisperx[593].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[594].start |
17960.87 |
| transcript.whisperx[594].end |
17985.096 |
| transcript.whisperx[594].text |
接下来第7條第7條的部分的話我們這邊是因為過去在去年度開始產生了一些對於人體試驗這一邊的一個疑問所以我們在第7條的部分的話就明定醫療機構在執行再生醫療前除了有第8條第一項的規定的例外情形之外應該進行並完成人體試驗 |
| transcript.whisperx[595].start |
17986.956 |
| transcript.whisperx[595].end |
18005.944 |
| transcript.whisperx[595].text |
各位委員有意見嗎?林月琴委員王振旭委員林月琴委員先我的是應該講第8條裏邊的第一項現在在講第7條我認為應該移到第7條來就是說應該把一般程序就放在第7條 |
| transcript.whisperx[596].start |
18006.864 |
| transcript.whisperx[596].end |
18007.305 |
| transcript.whisperx[596].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[597].start |
18031.274 |
| transcript.whisperx[597].end |
18031.674 |
| transcript.whisperx[597].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[598].start |
18047.003 |
| transcript.whisperx[598].end |
18048.706 |
| transcript.whisperx[598].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[599].start |
18062.085 |
| transcript.whisperx[599].end |
18086.466 |
| transcript.whisperx[599].text |
免完成人體試驗的例外情形我們就在第8條來做處理。第8條的第1項我們講的就是說危急的生命或者是嚴重失能國內沒有適當的藥品醫療器材或技術這樣子的概念的時候他才能夠做所謂的例外。第二個是我們的現在特管辦法已經在核准的再生技術的部分他也免進行人體試驗 |
| transcript.whisperx[600].start |
18088.948 |
| transcript.whisperx[600].end |
18106.645 |
| transcript.whisperx[600].text |
以這樣的概念所以所有的例外只有兩個情形一個是已經通過的一個是病情危急沒有適當方法的在第八條的是規定例外情形然後其中那個我們講的危急的這一塊的時候我們希望他限縮到個案 |
| transcript.whisperx[601].start |
18107.225 |
| transcript.whisperx[601].end |
18121.476 |
| transcript.whisperx[601].text |
所以我們對於這個第一款裡面他應該的條件甚至是案例的限制跟倫理的規範還有其他應遵循事項然後我們其實就會做嚴格的限制而且他是主案申請跟我們中央主管機關來做申請 |
| transcript.whisperx[602].start |
18122.857 |
| transcript.whisperx[602].end |
18131.7 |
| transcript.whisperx[602].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[603].start |
18151.365 |
| transcript.whisperx[603].end |
18153.147 |
| transcript.whisperx[603].text |
再生醫療法草案案。 |
| transcript.whisperx[604].start |
18167.179 |
| transcript.whisperx[604].end |
18168.04 |
| transcript.whisperx[604].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[605].start |
18183.595 |
| transcript.whisperx[605].end |
18206.725 |
| transcript.whisperx[605].text |
醫療機構執行再生醫療前,這部分要特別的跟大家做說明,如果你把他變成再生醫療的話,可能連自己本身都要做人體試驗,這個是我們在處理上把它改成再生技術,就能夠更確定第7條他需要適用的範圍,以上。好,陳昭之委員。 |
| transcript.whisperx[606].start |
18208.446 |
| transcript.whisperx[606].end |
18236.648 |
| transcript.whisperx[606].text |
謝謝主席我們對於這一次這個人體試驗入法非常的肯定謝謝衛福部然後有關這個恩慈療法部分這個內容我們也是支持的但是就是有關這個危及生命或嚴重失能疾病且尚無適當藥品我們希望能夠再增加一些說明那就是我們的第九條醫療機構為治療危及生命或嚴重失能這疾病且國內尚無適當實在藥品而執行再生技術得檢附下列文件當中央局管 |
| transcript.whisperx[607].start |
18237.268 |
| transcript.whisperx[607].end |
18238.549 |
| transcript.whisperx[607].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[608].start |
18266.48 |
| transcript.whisperx[608].end |
18268.562 |
| transcript.whisperx[608].text |
愈勤委員愈勤委員愈勤委員 |
| transcript.whisperx[609].start |
18292.063 |
| transcript.whisperx[609].end |
18293.745 |
| transcript.whisperx[609].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[610].start |
18310.6 |
| transcript.whisperx[610].end |
18311.2 |
| transcript.whisperx[610].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[611].start |
18341.02 |
| transcript.whisperx[611].end |
18342 |
| transcript.whisperx[611].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[612].start |
18362.635 |
| transcript.whisperx[612].end |
18384.387 |
| transcript.whisperx[612].text |
第七條,如果你們把醫療機構執行再生技術,把它改成再生技術,你們同意嗎?我是覺得王醫師的這個說法是有道理的,因為再生醫療它還是一個比較籠統的名詞嘛,它如果是執行再生技術,是不是就那個文字上是可以的?可以接受。 |
| transcript.whisperx[613].start |
18385.476 |
| transcript.whisperx[613].end |
18390.097 |
| transcript.whisperx[613].text |
醫療機構執行再生技術前除有第八條第一項規定情形外應進行並完成人體試驗。 |
| transcript.whisperx[614].start |
18408.499 |
| transcript.whisperx[614].end |
18436.598 |
| transcript.whisperx[614].text |
二）繼續審查委員羅廷瑋等21人擬具、「再生醫療發展法草案案案例8是否就這樣子的話就不需要就免進行或免完成人體試驗先確定這一點對因為一個是根本來不及像第一款的部分的話他是根本可能沒有時間做而且他是個案然後第二個的話是施行前我們已經通過的已經通過的我 |
| transcript.whisperx[615].start |
18437.605 |
| transcript.whisperx[615].end |
18438.006 |
| transcript.whisperx[615].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[616].start |
18448.717 |
| transcript.whisperx[616].end |
18476.019 |
| transcript.whisperx[616].text |
然後剩下要再做申請的部分就是等一下後面會講的他的依循的程序是第12條然後陳昭之委員在這邊講的第8條裡面的其實他剛剛講的事情其實都可以在我們的遵循的那個要要公告的辦法裡面去做處理可以嗎在立法說明立法說明裡面可以把那個所以這幾點那個市長您覺得都OK嗎就是第一個傳統治療無效是證明 |
| transcript.whisperx[617].start |
18476.94 |
| transcript.whisperx[617].end |
18477.601 |
| transcript.whisperx[617].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[618].start |
18491.817 |
| transcript.whisperx[618].end |
18492.317 |
| transcript.whisperx[618].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[619].start |
18507.392 |
| transcript.whisperx[619].end |
18508.033 |
| transcript.whisperx[619].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[620].start |
18527.512 |
| transcript.whisperx[620].end |
18528.573 |
| transcript.whisperx[620].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[621].start |
18556.411 |
| transcript.whisperx[621].end |
18556.812 |
| transcript.whisperx[621].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[622].start |
18573.96 |
| transcript.whisperx[622].end |
18575.041 |
| transcript.whisperx[622].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[623].start |
18596.474 |
| transcript.whisperx[623].end |
18597.035 |
| transcript.whisperx[623].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[624].start |
18622.432 |
| transcript.whisperx[624].end |
18622.992 |
| transcript.whisperx[624].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[625].start |
18638.872 |
| transcript.whisperx[625].end |
18660.618 |
| transcript.whisperx[625].text |
我思考的點比較不一樣就是說第八條第一項他明文講說免進行或免完成人體試驗免進行跟免完成人體試驗這是不一樣的那他是免進行也可以或是你沒有完成也可以那基本上這樣寫起來就是免進行了啦 |
| transcript.whisperx[626].start |
18661.831 |
| transcript.whisperx[626].end |
18676.824 |
| transcript.whisperx[626].text |
因為擇醫嘛,所以那這裡免進行或免完成其實就是等於免進行第一個,那這樣子完全都免,那連那個我們在講的這個叫第一期或是我們在講的是安全性測試都沒有 |
| transcript.whisperx[627].start |
18678.085 |
| transcript.whisperx[627].end |
18684.667 |
| transcript.whisperx[627].text |
我們要不要談到說至少要第一期的安全性測試做20到80個這個試驗這樣子我覺得大家討論否則的話免進行是連安全性測試試驗都沒有第一個第二個第二款裡面講本法實施行前我們特管辦法裡面已經核准的這一些都要讓他直接許可 |
| transcript.whisperx[628].start |
18705.131 |
| transcript.whisperx[628].end |
18709.272 |
| transcript.whisperx[628].text |
那會發生兩個問題第一個問題就是特管法我們要關門了那就是本法施行前你都已經許可我就讓你就地繼續許可可是從法律通過到施行中間空窗期很久欸不一定是馬上欸那這裡面再申請的或是補申請馬上送進來的怎麼辦 |
| transcript.whisperx[629].start |
18732.176 |
| transcript.whisperx[629].end |
18732.637 |
| transcript.whisperx[629].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[630].start |
18746.092 |
| transcript.whisperx[630].end |
18751.513 |
| transcript.whisperx[630].text |
再生醫療法草案案 案 同意過的,他技術肯定沒有之後的好,也就是說我們現在未來要新申請的門檻會比較高,但是未來要新申請的這一些再生醫療的技術 |
| transcript.whisperx[631].start |
18769.039 |
| transcript.whisperx[631].end |
18789.669 |
| transcript.whisperx[631].text |
應該會比過去申請的理論上更進化技術更好。那會跟農藥醫師一向說這個老的不好用的然後副作用大的都有許可結果新的副作用小的然後農藥殘留量低的然後對人體傷害低的反而沒有辦法再繼續開放 |
| transcript.whisperx[632].start |
18791.164 |
| transcript.whisperx[632].end |
18792.566 |
| transcript.whisperx[632].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[633].start |
18801.823 |
| transcript.whisperx[633].end |
18802.223 |
| transcript.whisperx[633].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[634].start |
18827.042 |
| transcript.whisperx[634].end |
18827.983 |
| transcript.whisperx[634].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[635].start |
18853.524 |
| transcript.whisperx[635].end |
18854.084 |
| transcript.whisperx[635].text |
王振旭委員 |
| transcript.whisperx[636].start |
18881.253 |
| transcript.whisperx[636].end |
18906.918 |
| transcript.whisperx[636].text |
謝謝主席。我剛剛針對十分委員所擔心的第一款就是危急生命或嚴重這部分到底要怎麼規範會最適當?第一項的文子。其實如果是針對第一款那部分我們現在是用恩慈的處置模式那個真的是要主案的來確認來做一些審議。 |
| transcript.whisperx[637].start |
18913.493 |
| transcript.whisperx[637].end |
18914.013 |
| transcript.whisperx[637].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[638].start |
18934.386 |
| transcript.whisperx[638].end |
18935.006 |
| transcript.whisperx[638].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[639].start |
18954.318 |
| transcript.whisperx[639].end |
18954.899 |
| transcript.whisperx[639].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[640].start |
18971.775 |
| transcript.whisperx[640].end |
18993.745 |
| transcript.whisperx[640].text |
所以部長所以就我們的法條的這個寫法是說是不用在國內進行可是他如果是在國外已經有進行的他有有一個有一個成效的話那要做恩賜把他引進來的話是可以的是這個意思對啊那你的寫法就不是這樣子了你的法律文字不是這樣子 |
| transcript.whisperx[641].start |
18994.71 |
| transcript.whisperx[641].end |
19014.885 |
| transcript.whisperx[641].text |
免進行括弧在國外經過什麼樣的這個官方的認定的什麼資格以後你就免進行我們的恩慈的寫法是怎麼寫他其實就是寫這樣因為我們在我要講的是說有時候制定起來比較粗糙 |
| transcript.whisperx[642].start |
19015.816 |
| transcript.whisperx[642].end |
19018.438 |
| transcript.whisperx[642].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〈三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[643].start |
19045.577 |
| transcript.whisperx[643].end |
19070.525 |
| transcript.whisperx[643].text |
國內找不到相關適當的藥品醫療器材或是醫療技術可以來所以他才會採用了一個國外的目前看起來好像可行的辦法來協助這個個案來做處理那如果是這樣的話文字上面條文的文字上面照你們原來的這樣但是在立法說明的部分是不是能夠把它加列進去可以我們來做修正 |
| transcript.whisperx[644].start |
19076.886 |
| transcript.whisperx[644].end |
19085.27 |
| transcript.whisperx[644].text |
國外要到官方還是什麼的?國外的確偽造的實驗數據很多的。他們如果沒有經過官方或是經過什麼他自己宣稱我已經完成了二期了或是完成一期了後來大家都知道很多這個虛偽不實的 |
| transcript.whisperx[645].start |
19107.17 |
| transcript.whisperx[645].end |
19107.89 |
| transcript.whisperx[645].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[646].start |
19134.284 |
| transcript.whisperx[646].end |
19134.845 |
| transcript.whisperx[646].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[647].start |
19155.945 |
| transcript.whisperx[647].end |
19157.767 |
| transcript.whisperx[647].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[648].start |
19168.144 |
| transcript.whisperx[648].end |
19197.239 |
| transcript.whisperx[648].text |
我跟大家報告今天講的是說因為我們要法治化所以恩恥療法是一個行政上的一個程序上的把關和一個一個一個辦法啦老實說那個法律位階跟這個不一樣那我現在思考的也不是說這個學術交流或是國際會議我是講說你要確如果我不曉得大家能不能在這裡先有一個共識這個共識就是至少要確定這個安全性 |
| transcript.whisperx[649].start |
19198.379 |
| transcript.whisperx[649].end |
19198.84 |
| transcript.whisperx[649].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[650].start |
19228.3 |
| transcript.whisperx[650].end |
19228.58 |
| transcript.whisperx[650].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[651].start |
19251.701 |
| transcript.whisperx[651].end |
19266.899 |
| transcript.whisperx[651].text |
那IRB倫理怎麼審查是一回事我們這裡講是說政府國家和立法者要求一定你做的不管多麼緊急的這個再生醫療都一定會有安全性試驗的基本上沒有問題這樣子 |
| transcript.whisperx[652].start |
19270.886 |
| transcript.whisperx[652].end |
19271.627 |
| transcript.whisperx[652].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[653].start |
19287.438 |
| transcript.whisperx[653].end |
19287.978 |
| transcript.whisperx[653].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[654].start |
19311.725 |
| transcript.whisperx[654].end |
19312.806 |
| transcript.whisperx[654].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[655].start |
19340.179 |
| transcript.whisperx[655].end |
19340.52 |
| transcript.whisperx[655].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[656].start |
19349.625 |
| transcript.whisperx[656].end |
19371.38 |
| transcript.whisperx[656].text |
道歉那我剛剛講第二款的問題你說三年一次審查那個不是我講的重點我講的重點是說大家有沒有想過這一款通過以後新技術而且更好的技術進來的門檻其實比過去的舊技術還更高你反而就是新的新的藥品不能進來舊的療效比較低的反而都一直繼續在那裡會不會有這種問題 |
| transcript.whisperx[657].start |
19372.543 |
| transcript.whisperx[657].end |
19373.265 |
| transcript.whisperx[657].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[658].start |
19386.66 |
| transcript.whisperx[658].end |
19408.332 |
| transcript.whisperx[658].text |
因為我們要用的全體必須要財債已經沒有現行沒有現行已經有這個局限沒有辦法了所以無適當的藥品和醫療醫材或醫療技術我們的申請有兩種一種就是個案的另外情形是第8條通案的申請的部分也就是那個林委員在講的新的 |
| transcript.whisperx[659].start |
19408.872 |
| transcript.whisperx[659].end |
19411.173 |
| transcript.whisperx[659].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[660].start |
19440.707 |
| transcript.whisperx[660].end |
19456.821 |
| transcript.whisperx[660].text |
我覺得你沒有聽或是我問的你可能不能我沒有講到讓你了解就是舊的我並不是反對他們繼續循環或是繼續許可就是舊的讓他就地許可我沒有但是我的質疑是說 |
| transcript.whisperx[661].start |
19459.093 |
| transcript.whisperx[661].end |
19459.674 |
| transcript.whisperx[661].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[662].start |
19476.184 |
| transcript.whisperx[662].end |
19477.025 |
| transcript.whisperx[662].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[663].start |
19505.768 |
| transcript.whisperx[663].end |
19506.25 |
| transcript.whisperx[663].text |
行政單位 |
| transcript.whisperx[664].start |
19516.9 |
| transcript.whisperx[664].end |
19537.855 |
| transcript.whisperx[664].text |
他不是複製啦對不起就是說他不會說因為有A所以你不能有B啦他其實是能夠持續的依照需要來做處理嘛那剛剛另外講的那個蘇委員講的那個有關於要不要進行或免除那一部分那個安全我想我們可以從立法的說明裡面去把它補強 |
| transcript.whisperx[665].start |
19540.277 |
| transcript.whisperx[665].end |
19555.464 |
| transcript.whisperx[665].text |
王醫師我可以請教你嗎因為我就有點不懂比如說我們現在特管法裡面許可了比如說某一種免疫細胞NK細胞好了大量的複製然後打回去治療肺癌比如說是這樣子好了 |
| transcript.whisperx[666].start |
19556.204 |
| transcript.whisperx[666].end |
19556.524 |
| transcript.whisperx[666].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[667].start |
19581.26 |
| transcript.whisperx[667].end |
19589.122 |
| transcript.whisperx[667].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審查委員羅廷瑋等21人審查委員羅廷瑋等21人審查委員羅廷瑋等21人審查委員羅廷瑋等21人審查委員羅廷瑋等21人審查委員羅廷瑋等21人審查委員羅廷瑋 |
| transcript.whisperx[668].start |
19610.947 |
| transcript.whisperx[668].end |
19611.568 |
| transcript.whisperx[668].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[669].start |
19630.672 |
| transcript.whisperx[669].end |
19631.453 |
| transcript.whisperx[669].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[670].start |
19653.954 |
| transcript.whisperx[670].end |
19682.984 |
| transcript.whisperx[670].text |
非常危急的狀態沒有藥可以治的沒有任何的治療可以使用的時候很危急的狀態但淑芬現在問的應該是第12條的狀況吧好那我在這邊是不是說可以照剛剛我們所講的這個修正文字通過大家看一下第7條我們第一項裡面的文字免進行或免完成人體試驗王醫師說在立法說明欄裡面說清楚但是大家怎麼寫所以這一條要先保養一下立法說明是不是你們明天一定要寫一下 |
| transcript.whisperx[671].start |
19684.326 |
| transcript.whisperx[671].end |
19684.666 |
| transcript.whisperx[671].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[672].start |
19713.973 |
| transcript.whisperx[672].end |
19715.414 |
| transcript.whisperx[672].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[673].start |
19744.605 |
| transcript.whisperx[673].end |
19744.625 |
| transcript.whisperx[673].text |
第8條 |
| transcript.whisperx[674].start |
19766.638 |
| transcript.whisperx[674].end |
19767.439 |
| transcript.whisperx[674].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[675].start |
19778.291 |
| transcript.whisperx[675].end |
19806.047 |
| transcript.whisperx[675].text |
第八條,那就照這個院版的通過,那說明的部分明天一定送上來。接下來第九條。第九條的部分的話,我們是將我們現行的人類胚胎及胚胎幹細胞研究倫理政策指引的行政規則提升到法律的位階,所以擬具了再生醫療涉及胚胎或胚胎幹細胞不得以下列方式來做處理。以上。好,委員。 |
| transcript.whisperx[676].start |
19807.816 |
| transcript.whisperx[676].end |
19819.085 |
| transcript.whisperx[676].text |
各位委員有意見嗎?沒見。沒見。那就第9條就照院版的通過。接下來第10條。 |
| transcript.whisperx[677].start |
19820.936 |
| transcript.whisperx[677].end |
19842.831 |
| transcript.whisperx[677].text |
第十條的部分的話是因為在我們的那個產生條件那邊是對產業的發展所以有特別有再生醫療法這邊的話是由我們中央主管機關或者是事業目的主管機關對於相關的研究發展給予獎勵或補助然後相關的程序的部分的話由我們中央主管機關會商中央目的事業主管機關定制 |
| transcript.whisperx[678].start |
19844.052 |
| transcript.whisperx[678].end |
19871.706 |
| transcript.whisperx[678].text |
則其他委員的部分的話其實也跟我們的版本很像然後那那個除了謝衣鳯委員這邊在講的是一定要編列所謂的獎金的部分然後我們覺得獎勵的方式給我們一些彈性空間其實搞不好更有對於整體產業的發展的鼓勵以上是好那第10條各位委員有沒有意見沒有那就照院板的通過接下來第三張張明同意 |
| transcript.whisperx[679].start |
19872.779 |
| transcript.whisperx[679].end |
19897.424 |
| transcript.whisperx[679].text |
同意好那就照院板通過接下來第11條11條的部分的話我們這邊就是強調非醫療機構不得執行再生醫療以杜絕現在其實我們怕的是醫美美容醫學這邊的亂象會再生所以我們就是直接就明定了後面的法則也連帶在非醫療機構這個地方有做加重的處罰以上好各位委員有沒有意見 |
| transcript.whisperx[680].start |
19902.211 |
| transcript.whisperx[680].end |
19926.425 |
| transcript.whisperx[680].text |
接下来第12條。第12條的部分的話也就是說我們在不管是要用再生醫療技術或者是特定的再生製劑的時候每一案都必須經過中央主管機關的一個同意必須要由我們中央主管機關跟我們申請核准之後向地方政府做一個登記才能夠做 |
| transcript.whisperx[681].start |
19927.145 |
| transcript.whisperx[681].end |
19927.885 |
| transcript.whisperx[681].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[682].start |
19944.753 |
| transcript.whisperx[682].end |
19945.853 |
| transcript.whisperx[682].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[683].start |
19961.72 |
| transcript.whisperx[683].end |
19983.484 |
| transcript.whisperx[683].text |
再生醫療法草案案件事項,主要還是以再生技術為主,所以我們就把技術跟指定的致敬的地方做了前後順序的調動,以上。好,各位委員有沒有意見?好,那第12條就照院版的通過。接下來第13條。 |
| transcript.whisperx[684].start |
19999.934 |
| transcript.whisperx[684].end |
20018.85 |
| transcript.whisperx[684].text |
邱議瑩委員、羅廷瑋委員、王振旭委員、楊瓊英委員的部分是不是說明一下?這個地方的部分的話就是我們已到第8條的第一項的第一款的部分來做一些些的處理了。已經在相關的文字跟條文裡面有做處理。是。 |
| transcript.whisperx[685].start |
20020.936 |
| transcript.whisperx[685].end |
20021.658 |
| transcript.whisperx[685].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[686].start |
20028.049 |
| transcript.whisperx[686].end |
20051.176 |
| transcript.whisperx[686].text |
第13條第13條的部分的話是針對執行再生醫療技術這邊的醫師他應該是該疾病相關領域的專科醫師這個資格有本就是中央主管機關公告相關的委員的文字內容的部分其實也跟院版其實是一致的希望委員能夠支持院版 |
| transcript.whisperx[687].start |
20052.208 |
| transcript.whisperx[687].end |
20053.069 |
| transcript.whisperx[687].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[688].start |
20069.005 |
| transcript.whisperx[688].end |
20071.066 |
| transcript.whisperx[688].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[689].start |
20097.662 |
| transcript.whisperx[689].end |
20100.887 |
| transcript.whisperx[689].text |
那第13條是不是照院版的通過?好。 |
| transcript.whisperx[690].start |
20102.15 |
| transcript.whisperx[690].end |
20103.351 |
| transcript.whisperx[690].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[691].start |
20129.352 |
| transcript.whisperx[691].end |
20129.952 |
| transcript.whisperx[691].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[692].start |
20151.383 |
| transcript.whisperx[692].end |
20155.385 |
| transcript.whisperx[692].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[693].start |
20179.654 |
| transcript.whisperx[693].end |
20181.636 |
| transcript.whisperx[693].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[694].start |
20201.698 |
| transcript.whisperx[694].end |
20202.438 |
| transcript.whisperx[694].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[695].start |
20220.046 |
| transcript.whisperx[695].end |
20221.467 |
| transcript.whisperx[695].text |
陳昭芝委員陳昭芝委員 |
| transcript.whisperx[696].start |
20241.644 |
| transcript.whisperx[696].end |
20244.965 |
| transcript.whisperx[696].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 |
| transcript.whisperx[697].start |
20271.395 |
| transcript.whisperx[697].end |
20273.496 |
| transcript.whisperx[697].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[698].start |
20301.251 |
| transcript.whisperx[698].end |
20302.512 |
| transcript.whisperx[698].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[699].start |
20318.726 |
| transcript.whisperx[699].end |
20321.167 |
| transcript.whisperx[699].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[700].start |
20341.148 |
| transcript.whisperx[700].end |
20346.469 |
| transcript.whisperx[700].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[701].start |
20367.284 |
| transcript.whisperx[701].end |
20368.145 |
| transcript.whisperx[701].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[702].start |
20384.942 |
| transcript.whisperx[702].end |
20386.183 |
| transcript.whisperx[702].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[703].start |
20417.04 |
| transcript.whisperx[703].end |
20431.67 |
| transcript.whisperx[703].text |
實驗室的查核的部分的話我們目前第一個是他要符合ISO然後或者是他是我們食藥署的那個所謂的分子檢驗認證的對象我覺得應該這個都太低太低層次了啦你們的那個規範是不是是在寫在那個製劑的那個範疇裡面啊 |
| transcript.whisperx[704].start |
20440.738 |
| transcript.whisperx[704].end |
20461.016 |
| transcript.whisperx[704].text |
我跟你講這個再生醫療再生醫療裡面其實最大的風險就是在這裡體外複製感染汙染汙染應該講汙染啦細胞實驗室或者是細胞儲存或者是細胞培養的那個藥廠的那個規範應該是是不是在製劑的那個規範裡頭還是說你們這邊要補充把那個整個規範把它補充 |
| transcript.whisperx[705].start |
20466.85 |
| transcript.whisperx[705].end |
20491.706 |
| transcript.whisperx[705].text |
這一個部分是這樣就我們現在再生醫療技術的部分的話在做細胞配置自備的時候是根據的是GDP也就是人體細胞組織優良操作規範那也不能講說這一個就是層次是比較低啦應該不是這樣他是因為GDP在處理的這種實驗室是要處理的 |
| transcript.whisperx[706].start |
20493.047 |
| transcript.whisperx[706].end |
20493.527 |
| transcript.whisperx[706].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[707].start |
20509.777 |
| transcript.whisperx[707].end |
20510.338 |
| transcript.whisperx[707].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[708].start |
20525.632 |
| transcript.whisperx[708].end |
20526.293 |
| transcript.whisperx[708].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[709].start |
20542.53 |
| transcript.whisperx[709].end |
20556.496 |
| transcript.whisperx[709].text |
則我們也不只是只有優良操作程序的規範,那我們有沒有可能應該要訂出一些基礎規範,衛福部自己訂也可以,你總是要規定那個環境它的標準要達到什麼程度吧。 |
| transcript.whisperx[710].start |
20558.598 |
| transcript.whisperx[710].end |
20559.618 |
| transcript.whisperx[710].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[711].start |
20575.683 |
| transcript.whisperx[711].end |
20576.584 |
| transcript.whisperx[711].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[712].start |
20596.082 |
| transcript.whisperx[712].end |
20599.365 |
| transcript.whisperx[712].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[713].start |
20621.407 |
| transcript.whisperx[713].end |
20622.309 |
| transcript.whisperx[713].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[714].start |
20630.031 |
| transcript.whisperx[714].end |
20630.371 |
| transcript.whisperx[714].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[715].start |
20656.602 |
| transcript.whisperx[715].end |
20658.283 |
| transcript.whisperx[715].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[716].start |
20678.965 |
| transcript.whisperx[716].end |
20705.203 |
| transcript.whisperx[716].text |
我執行業務提供病人使用而系販賣零售再生醫療致記者能因醫藥事法第15條第一項第一款申請為藥品販賣業者。意思就是說如果說在執行的過程裡面他本身是一個致記的話那這個是已經被確認過的東西在執行的時候呢就不需要再去申請藥商許可執照以上 |
| transcript.whisperx[717].start |
20707.751 |
| transcript.whisperx[717].end |
20716.157 |
| transcript.whisperx[717].text |
這個可能那個王委員有一點誤會啦我們現在醫療機構讓我們跟藥廠拿藥進藥然後經過診斷然後醫師開了處方阿給別人捏藥阿也從來不必說藥商的許可阿那個不叫販賣所以我想這個不必要寫啦 |
| transcript.whisperx[718].start |
20732.424 |
| transcript.whisperx[718].end |
20732.905 |
| transcript.whisperx[718].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[719].start |
20747.287 |
| transcript.whisperx[719].end |
20770.292 |
| transcript.whisperx[719].text |
這個傳統上就不是這樣認定,我們這樣一寫的話,可以造成混淆。現在其他就說,好,你再生醫療治劑的話,免那個藥商的許可執照。但是其他藥呢?醫院開藥給病人的話,是不是需要也要那個藥商許可證,因為那邊沒有寫。 |
| transcript.whisperx[720].start |
20771.092 |
| transcript.whisperx[720].end |
20772.093 |
| transcript.whisperx[720].text |
第14條就先保留。 |
| transcript.whisperx[721].start |
20787.025 |
| transcript.whisperx[721].end |
20788.427 |
| transcript.whisperx[721].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[722].start |
20802.646 |
| transcript.whisperx[722].end |
20822.146 |
| transcript.whisperx[722].text |
第15條的部分的話主要是在處理的是在做這樣子的一個再生醫療不管是我用技術或者是使用那個製劑的部分的話應該充分做說明這說明的部分的話包括了可能的效果或是不良反應費用跟救濟措施還有相關必要的 |
| transcript.whisperx[723].start |
20822.486 |
| transcript.whisperx[723].end |
20847.82 |
| transcript.whisperx[723].text |
一些事項。然後那在執行前的時候除了說明以外重點是同意同意的部分的話應該要有就是病人或者是法定代理人配偶親屬等相關關係人的同意簽據同意書可以才算數然後除了這個以外的話那個前項同意書的內容的部分由我們中央主管定之主要在針對的就是說明告知的這個部分 |
| transcript.whisperx[724].start |
20848.521 |
| transcript.whisperx[724].end |
20849.542 |
| transcript.whisperx[724].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[725].start |
20860.441 |
| transcript.whisperx[725].end |
20879.368 |
| transcript.whisperx[725].text |
第16條16條的部分的話是在講的是醫療機構在實在執行那個再生醫療的時候他必須做記錄這個記錄會比我們普通醫療法的7年要更長我們是在本法的草案裡面規定至少要保存15年而且到 |
| transcript.whisperx[726].start |
20880.168 |
| transcript.whisperx[726].end |
20880.668 |
| transcript.whisperx[726].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[727].start |
20903.704 |
| transcript.whisperx[727].end |
20930.862 |
| transcript.whisperx[727].text |
前向紀錄的內容他怎麼去使用執行的日期場所甚至程序還有一些嚴重不良事件的話其實都是我們要做一些規定在那個紀錄裡面的以上補充然後那個許多委員的版本裡面其實跟院版的精神其實都一致所以希望大家能夠支持院版以上好各位委員有沒有意見沒有吼那16條就照院版的通過 |
| transcript.whisperx[728].start |
20933.965 |
| transcript.whisperx[728].end |
20935.286 |
| transcript.whisperx[728].text |
第四章章明 |
| transcript.whisperx[729].start |
20944.762 |
| transcript.whisperx[729].end |
20947.102 |
| transcript.whisperx[729].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[730].start |
20971.527 |
| transcript.whisperx[730].end |
20971.967 |
| transcript.whisperx[730].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[731].start |
21001.747 |
| transcript.whisperx[731].end |
21002.948 |
| transcript.whisperx[731].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[732].start |
21023.775 |
| transcript.whisperx[732].end |
21025.416 |
| transcript.whisperx[732].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[733].start |
21043.666 |
| transcript.whisperx[733].end |
21044.727 |
| transcript.whisperx[733].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[734].start |
21072.961 |
| transcript.whisperx[734].end |
21073.441 |
| transcript.whisperx[734].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[735].start |
21094.758 |
| transcript.whisperx[735].end |
21095.278 |
| transcript.whisperx[735].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[736].start |
21111.718 |
| transcript.whisperx[736].end |
21112.298 |
| transcript.whisperx[736].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[737].start |
21130.673 |
| transcript.whisperx[737].end |
21131.474 |
| transcript.whisperx[737].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[738].start |
21146.247 |
| transcript.whisperx[738].end |
21146.767 |
| transcript.whisperx[738].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[739].start |
21165.18 |
| transcript.whisperx[739].end |
21165.64 |
| transcript.whisperx[739].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[740].start |
21195.08 |
| transcript.whisperx[740].end |
21196.18 |
| transcript.whisperx[740].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[741].start |
21220.149 |
| transcript.whisperx[741].end |
21221.59 |
| transcript.whisperx[741].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[742].start |
21248.701 |
| transcript.whisperx[742].end |
21277.6 |
| transcript.whisperx[742].text |
各位委員呃陳昭芝委員謝謝那個在這一條裡面我們是希望能夠還是回到一些倫理的考量因為國外就有發生過這個妹妹的出身就是為了捐捐贈血液期待來骨髓給姊姊的真實案例齁所以我們在這個就是第一第一項就是但顯有異於特定人口群或未能以其他對象取代者我們加了就是除胎兒無行為能力人外 |
| transcript.whisperx[743].start |
21281.567 |
| transcript.whisperx[743].end |
21304.794 |
| transcript.whisperx[743].text |
另有關書面同意的部分提供者為限制行為能力或受輔助宣告之人時應得其本人及法定代理人或輔助人書面同意第一項提供者為受監護宣告之人或無意思能力之成年人時以同意時具意思表示能力者為限其書面同意有效 |
| transcript.whisperx[744].start |
21305.868 |
| transcript.whisperx[744].end |
21334.144 |
| transcript.whisperx[744].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與特定人口群或未能以其他對象取代的竇點除胎兒、頓耗、無行為能力人外。」就是這兩群人要稍微要再排除。然後在書面同意的時候我們也訂了更仔細的規範。 |
| transcript.whisperx[745].start |
21336.135 |
| transcript.whisperx[745].end |
21336.856 |
| transcript.whisperx[745].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[746].start |
21351.915 |
| transcript.whisperx[746].end |
21353.356 |
| transcript.whisperx[746].text |
第三項對號第四項規定在生醫療組織跟細胞來源的提供 |
| transcript.whisperx[747].start |
21367.174 |
| transcript.whisperx[747].end |
21386.929 |
| transcript.whisperx[747].text |
則為胎兒、限制行為能力人、受輔助宣告之人、無行為能力人、受監護宣告之人或無意識能力的成年人取得的書面同意應經法院公正死身效力。」這個目的是在提高難度來降低如果有不法行為的可預期性來保護這些弱勢畢竟 |
| transcript.whisperx[748].start |
21388.51 |
| transcript.whisperx[748].end |
21388.95 |
| transcript.whisperx[748].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[749].start |
21409.417 |
| transcript.whisperx[749].end |
21433.771 |
| transcript.whisperx[749].text |
我覺得比較有疑慮的是第一項的最後就是嫌有益於特定人口群或未能與其他對象取代者這個裡面特定人口群嫌有益於誰這個特定人口群到底是要怎麼界定或者是未能與其他這個對象取代者到底是講什麼 |
| transcript.whisperx[750].start |
21434.571 |
| transcript.whisperx[750].end |
21435.412 |
| transcript.whisperx[750].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[751].start |
21454.926 |
| transcript.whisperx[751].end |
21455.826 |
| transcript.whisperx[751].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[752].start |
21477.952 |
| transcript.whisperx[752].end |
21479.073 |
| transcript.whisperx[752].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[753].start |
21502.894 |
| transcript.whisperx[753].end |
21531.26 |
| transcript.whisperx[753].text |
那他會不會有衍生的那個利益上的糾葛或是你除了要知情同意要簽同意書以外那需不需要告知說這個要不要取得細胞過程要不要補償那會不會衍生的利益或不當的細胞買賣那這個東西要怎麼我覺得在這裡面我們不能當作說不會發生那我們如果當作它會發生的時候我們要怎麼把它限制起來框定起來 |
| transcript.whisperx[754].start |
21535.425 |
| transcript.whisperx[754].end |
21537.874 |
| transcript.whisperx[754].text |
行政單位說明王委員 |
| transcript.whisperx[755].start |
21540.141 |
| transcript.whisperx[755].end |
21566.182 |
| transcript.whisperx[755].text |
謝謝趙委員我稍微再確認一下就是有關於胎兒的部分我們也知道事實上目前並沒有實際有胎兒的產品來提供臨床上執行的部分不過因為這是一部比較前瞻式的法案很多未來性我們透過好的醫療科技如果現在就把它限縮得太嚴格的話 |
| transcript.whisperx[756].start |
21567.583 |
| transcript.whisperx[756].end |
21590.439 |
| transcript.whisperx[756].text |
當然前提就是一定要有符合安全倫理規範的情形之下我們可不可以用不管是用立法說明的方式來解決剛剛不管是趙知委員或是蘇委員所提到的問題那字面上就先支持這個院板這邊的一些相關的文字說明以上 |
| transcript.whisperx[757].start |
21592.003 |
| transcript.whisperx[757].end |
21593.064 |
| transcript.whisperx[757].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[758].start |
21611.201 |
| transcript.whisperx[758].end |
21612.302 |
| transcript.whisperx[758].text |
因為我們一直沒有定義特定人口群和未能與其他對象取代者的定義。 |
| transcript.whisperx[759].start |
21630.065 |
| transcript.whisperx[759].end |
21631.166 |
| transcript.whisperx[759].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[760].start |
21649.441 |
| transcript.whisperx[760].end |
21649.781 |
| transcript.whisperx[760].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[761].start |
21670.814 |
| transcript.whisperx[761].end |
21673.335 |
| transcript.whisperx[761].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[762].start |
21701.531 |
| transcript.whisperx[762].end |
21728.696 |
| transcript.whisperx[762].text |
他是這一個九個月以下的幼兒的這一個兇腺的組織拿出來然後去治療其他的偏偏性無兇腺兒童病人的免疫重建所以第一個他是液體的那沒關係啦我不是在說這個我這樣說也不要說特定限定特定人口群啊只要治療疾病的通通都可以啊 |
| transcript.whisperx[763].start |
21729.736 |
| transcript.whisperx[763].end |
21730.117 |
| transcript.whisperx[763].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[764].start |
21739.161 |
| transcript.whisperx[764].end |
21759.753 |
| transcript.whisperx[764].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 案 條文要再看清楚一下。第一個就是說提供組織細胞的是以成年人為原則嘛。然後再有一個線說說除了這種特定的比方說這種先天性無兇性兒童病人的 |
| transcript.whisperx[765].start |
21760.593 |
| transcript.whisperx[765].end |
21761.393 |
| transcript.whisperx[765].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[766].start |
21779.159 |
| transcript.whisperx[766].end |
21782.64 |
| transcript.whisperx[766].text |
因為法律上又沒有這樣講說限縮在醫療所以你這個不是限縮條款搞不好有可能你是開更大的門的條款啊因為這邊是以成年人為限嘛對啊所以你不是限縮你有違憲但是你要開放例外可以用未成年的 |
| transcript.whisperx[767].start |
21798.084 |
| transcript.whisperx[767].end |
21798.344 |
| transcript.whisperx[767].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[768].start |
21816.196 |
| transcript.whisperx[768].end |
21843.269 |
| transcript.whisperx[768].text |
呃這個成年違憲這一條條款吧我們要讓未成年的東西也可以再被取用那我們希望是限定在醫療這個領域我的意思是這樣子是那如果是這樣子的話那是不是我們的條文就是說在那個有醫師能力的成年人違憲之後的話但有益於治療特定人口群或未能其他以其他的對象取代者不再實現 |
| transcript.whisperx[769].start |
21845.05 |
| transcript.whisperx[769].end |
21871.953 |
| transcript.whisperx[769].text |
我基本上是這樣子治療基本上是但是我們是不是可以暫時保留我們才能回去想一下這樣子是不是恰當胎兒跟無行為能力要先排除啊這我還繼續再說明一下啦胎兒的部分如果就是說他你這邊在排除的部分的話如果是 |
| transcript.whisperx[770].start |
21872.774 |
| transcript.whisperx[770].end |
21875.216 |
| transcript.whisperx[770].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[771].start |
21890.766 |
| transcript.whisperx[771].end |
21907.498 |
| transcript.whisperx[771].text |
所以如果胎兒不要去講不包括胎盤跟羊水的話那我們是可以同意就把胎兒排除掉胎兒不要去做為細胞的提供者 |
| transcript.whisperx[772].start |
21908.058 |
| transcript.whisperx[772].end |
21935.038 |
| transcript.whisperx[772].text |
但是羊水跟胎盤的話這個是要取這個羊水跟取胎盤的細胞的話這個是相當安全的一個procedure以目前來講在產前的檢查的部分其實都有所以不要把它也禁止掉啦我的意思是這樣那個無行為能力就是主要是小孩子 |
| transcript.whisperx[773].start |
21936.8 |
| transcript.whisperx[773].end |
21963.923 |
| transcript.whisperx[773].text |
除了7歲以下的小孩子都要無行為能力如果你把7歲小孩子通通排除掉就不能取他的胎兒的話那就我們剛剛舉的這一個就不能用了欸我們這裡是在提供者喔對啊就提供者啊提供者欸啊我就說這一張就看了嘛組織來源的也就是提供者是9歲以下的小孩子因為大9個月以下的小孩子因為大一點的話胸腺就沒有了就做萎縮了嘿 |
| transcript.whisperx[774].start |
21965.199 |
| transcript.whisperx[774].end |
21980.903 |
| transcript.whisperx[774].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:「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[775].start |
21995.482 |
| transcript.whisperx[775].end |
22018.836 |
| transcript.whisperx[775].text |
欸抱歉我問這個很奇怪的問題我自己也突然想到說這個東西是母親的還是胎兒還是嬰兒的還是胎兒的在法律上欸這個東西胎盤、脊帶、羊水我們在法律上的定義是可以去做處理但是以基因上面來看的話他是跟胎兒是一樣的基因啦所以連胎盤都是嗎? |
| transcript.whisperx[776].start |
22020.273 |
| transcript.whisperx[776].end |
22022.879 |
| transcript.whisperx[776].text |
對。所以連胎盤幾代?但是胎盤比較複雜因為胎盤有一面是媽媽的 |
| transcript.whisperx[777].start |
22028.675 |
| transcript.whisperx[777].end |
22029.635 |
| transcript.whisperx[777].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[778].start |
22057.808 |
| transcript.whisperx[778].end |
22058.949 |
| transcript.whisperx[778].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[779].start |
22076.835 |
| transcript.whisperx[779].end |
22104.953 |
| transcript.whisperx[779].text |
我剛還是沒有回答我齁因為從CRC的精神裏邊在講孩子最佳利益的時候應該要有一定的程序齁才能是晚輩的所以我剛還是沒有聽到你們回答是說我針對要增加所謂不是只有家長的意識這樣同意書就可以嗎應該不是這樣還要經過一定的程序所以我說是不是可行是取得的這些同意應該經法院公正使生效力 |
| transcript.whisperx[780].start |
22105.655 |
| transcript.whisperx[780].end |
22106.719 |
| transcript.whisperx[780].text |
對不起,剛剛這個沒有先釐清了。 |
| transcript.whisperx[781].start |
22110.308 |
| transcript.whisperx[781].end |
22133.818 |
| transcript.whisperx[781].text |
我們有跟法務部這邊也有溝通過啦我們是建議是這樣不要說如果要用公證來確保他有這一個同意是的效率的話那不要用法案公證因為法案公證的那個時間很長我跟各位報告一下齁我那個當初接那個契捐中心的董事長的時候後來換人 |
| transcript.whisperx[782].start |
22135.839 |
| transcript.whisperx[782].end |
22138.4 |
| transcript.whisperx[782].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[783].start |
22173.317 |
| transcript.whisperx[783].end |
22174.097 |
| transcript.whisperx[783].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[784].start |
22202.469 |
| transcript.whisperx[784].end |
22203.05 |
| transcript.whisperx[784].text |
第19條先保留。接下來第20條。 |
| transcript.whisperx[785].start |
22218.072 |
| transcript.whisperx[785].end |
22232.201 |
| transcript.whisperx[785].text |
第二十條的部分的話其實是在講告知就是那個取得同意應該告知的事項然後這裡面就包括了就是說我要取得的方式可能產生的副作用或者是說 |
| transcript.whisperx[786].start |
22233.502 |
| transcript.whisperx[786].end |
22234.203 |
| transcript.whisperx[786].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[787].start |
22256.343 |
| transcript.whisperx[787].end |
22256.904 |
| transcript.whisperx[787].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[788].start |
22272.105 |
| transcript.whisperx[788].end |
22273.405 |
| transcript.whisperx[788].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[789].start |
22301.894 |
| transcript.whisperx[789].end |
22329.796 |
| transcript.whisperx[789].text |
第1項的第4款就是剩餘組織細胞之後去處理那個或可能之使用範圍變成的是使用範圍把或可能的這個事情拿掉的時候因為在事前要去做一個說明的時候可能對於使用範圍的部分我們的文字才會用可能之使用範圍所以希望委員能夠支持我們的願板以上好各位委員有沒有意見王委員 |
| transcript.whisperx[790].start |
22330.532 |
| transcript.whisperx[790].end |
22353.448 |
| transcript.whisperx[790].text |
對,那剛剛司長所說明的就是或可能在第四款或可能是使用範圍相對是比較寬廣那當然它有好處不過也有擔心啦因為有時候會不會被因為這樣的形容詞之下導致在使用上會不夠明確所以如果說改成 |
| transcript.whisperx[791].start |
22357.61 |
| transcript.whisperx[791].end |
22382.104 |
| transcript.whisperx[791].text |
其餘組織細胞之後續處置與使用範圍讓這個處理的過程裡面是比較明確一點這是我們提出來做這個修正的主要的一個用意以上好還有沒有其他委員有意見沒有那行政單位剛剛王委員講的是 |
| transcript.whisperx[792].start |
22383.055 |
| transcript.whisperx[792].end |
22397.156 |
| transcript.whisperx[792].text |
我們是建議還是保留或可能因為在這裡的話可能有時候沒有辦法完全界定說這個還可以使用到什麼樣的一個程度 |
| transcript.whisperx[793].start |
22399.479 |
| transcript.whisperx[793].end |
22420.928 |
| transcript.whisperx[793].text |
比如說我們取了這一個組織然後我們使用了那還有剩餘的剩餘的也許這一次失敗那下一次可能會有一個這個組織要做另外的engineering的方法 |
| transcript.whisperx[794].start |
22421.588 |
| transcript.whisperx[794].end |
22429.254 |
| transcript.whisperx[794].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[795].start |
22451.309 |
| transcript.whisperx[795].end |
22454.071 |
| transcript.whisperx[795].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[796].start |
22481.032 |
| transcript.whisperx[796].end |
22483.013 |
| transcript.whisperx[796].text |
第二十條就照院版的通過就照委員王振旭等三人修正動議通過 |
| transcript.whisperx[797].start |
22507.685 |
| transcript.whisperx[797].end |
22509.528 |
| transcript.whisperx[797].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[798].start |
22525.615 |
| transcript.whisperx[798].end |
22553.294 |
| transcript.whisperx[798].text |
接下來第5張張明張明的部分的話院板這邊是監督與救濟然後有委員部分的版本是寫著是監督與預防因為我們後面的條文主要是以救濟為主所以我們才會在張明的部分以監督及救濟的部分希望委員們能夠支持院板以上各位委員有沒有意見沒有那就照院板通過接下來第21條 |
| transcript.whisperx[799].start |
22555.256 |
| transcript.whisperx[799].end |
22575.143 |
| transcript.whisperx[799].text |
二十一條的部分的話重點會在於是說對於廣告這邊的一個管理然後第一項的部分的話是針對就是說我們所謂的招募的廣告招募的廣告除了那個我們這邊在講我們會有那個所謂的組織庫保存庫這樣子的一個可以招 |
| transcript.whisperx[800].start |
22576.604 |
| transcript.whisperx[800].end |
22577.785 |
| transcript.whisperx[800].text |
再生醫療法草案．一）審查委員邱議瑩等21人擬具 |
| transcript.whisperx[801].start |
22602.617 |
| transcript.whisperx[801].end |
22603.398 |
| transcript.whisperx[801].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[802].start |
22622.113 |
| transcript.whisperx[802].end |
22623.213 |
| transcript.whisperx[802].text |
各位委員有沒有意見?王委員 |
| transcript.whisperx[803].start |
22655.398 |
| transcript.whisperx[803].end |
22676.731 |
| transcript.whisperx[803].text |
謝謝師長的說明其實這一部分在第二項有關於廣告醫師本身能不能廣告這個問題因為其實但是最近有被判一個違憲嘛所以我們是不希望又落入到那個困境裡面所以才說如果在這邊做一些調整的話再生醫療是廣告 |
| transcript.whisperx[804].start |
22677.991 |
| transcript.whisperx[804].end |
22701.172 |
| transcript.whisperx[804].text |
現由經核准執行再生醫療之醫療機構與經核准執行再生醫療技術之醫師為之。」避免說後面又有人去說為什麼我醫師都已經被判定說不能廣告是違憲那你現在又把這個限制住是有這個思考在裡面以上 |
| transcript.whisperx[805].start |
22704.173 |
| transcript.whisperx[805].end |
22731.05 |
| transcript.whisperx[805].text |
我補充說明的原因是因為在醫療法我們那個事先案我們在討論的是傳統醫療應該是說現在一般的現行的醫療它的風險相對也低那在這個情況下面的時候有大法官事先是說醫師也可以做廣告可是再生醫療我們會為什麼會特別創立一個再生醫療法就會希望這樣子的一個 |
| transcript.whisperx[806].start |
22732.01 |
| transcript.whisperx[806].end |
22756.077 |
| transcript.whisperx[806].text |
風險相對比較高而且新興的一個醫療在他的草創的過程當中其實是能夠形塑大家正確的行為那這樣子的一個狀況下面再加上執行再生醫療這邊幾乎都是以團隊為之所以我們在希望的是說以這樣子的一個管理下面的時候應該是由特許核准的醫療機構他來做所謂的廣告 |
| transcript.whisperx[807].start |
22758.638 |
| transcript.whisperx[807].end |
22759.118 |
| transcript.whisperx[807].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[808].start |
22782.093 |
| transcript.whisperx[808].end |
22796 |
| transcript.whisperx[808].text |
大家可以想象一下未來這個市場會是什麼樣子。第一個,再生醫療跟一般的傳統的醫療不一樣的地方是它要有一個細胞自備場所。 |
| transcript.whisperx[809].start |
22797.761 |
| transcript.whisperx[809].end |
22814.049 |
| transcript.whisperx[809].text |
當然如果你做的規模小那可以在自己的醫院裡面去做那也許是可以的但是我相信到後來這類的醫院治社有這個細胞智慧場所的可能會越來越少除了他的一個都做醫療的 |
| transcript.whisperx[810].start |
22815.55 |
| transcript.whisperx[810].end |
22816.351 |
| transcript.whisperx[810].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[811].start |
22834.21 |
| transcript.whisperx[811].end |
22835.191 |
| transcript.whisperx[811].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[812].start |
22853.198 |
| transcript.whisperx[812].end |
22853.818 |
| transcript.whisperx[812].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[813].start |
22872.566 |
| transcript.whisperx[813].end |
22892.74 |
| transcript.whisperx[813].text |
就是會這樣子,在臺灣這種情形非常可能所以我們是認為說這個法要開始的時候還是要謹慎一點可能這一個部分要限縮一點那這個因為跟那個憲法那個事先案的情況是不一樣我覺得我們是應該可以站得住腳 |
| transcript.whisperx[814].start |
22893.868 |
| transcript.whisperx[814].end |
22895.069 |
| transcript.whisperx[814].text |
陳少思委員陳少思委員 |
| transcript.whisperx[815].start |
22922.036 |
| transcript.whisperx[815].end |
22931.449 |
| transcript.whisperx[815].text |
我也是跟部長的意見一致但我也想說其實我是覺得本來應該要再更限縮比部長講的還要再更限縮 |
| transcript.whisperx[816].start |
22932.642 |
| transcript.whisperx[816].end |
22952.353 |
| transcript.whisperx[816].text |
就說大家可以想像一下這個再生醫療的廣告難道會是說我要解決關節炎然後讓你的皮膚這個修復會更好的嗎?絕對不是!這個廣告一定是要治療癌症啊!一定是以治療癌症讓大家不自知症的人覺得找到希望!他的功課的風雄就是去幾行的啦! |
| transcript.whisperx[817].start |
22952.973 |
| transcript.whisperx[817].end |
22972.26 |
| transcript.whisperx[817].text |
但我們知道這個治療癌症的第三期第四期的剛好剛好就是現在裡面我們在講說緊急的或是沒有有效的醫療方法的我們是排除了這個很多的限制直接就可以使用細胞治療法的也不用經過一期兩二期三期的 |
| transcript.whisperx[818].start |
22972.62 |
| transcript.whisperx[818].end |
22972.92 |
| transcript.whisperx[818].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[819].start |
23003.02 |
| transcript.whisperx[819].end |
23027.578 |
| transcript.whisperx[819].text |
這一些違憲是勉強啦第一個第二個那個醫療廣告內容絕對要審查通過才可以沒有經過審查通過這個一個療程我告訴大家我一直講一個療程都數百萬一次要上百萬然後要一到好數百萬上千萬不是有錢人才會這樣做沒有錢的請加蕩產借錢也一定會來救自己的親人 |
| transcript.whisperx[820].start |
23028.539 |
| transcript.whisperx[820].end |
23037.786 |
| transcript.whisperx[820].text |
所以在這種狀況裡面要讓大家要規範說廣告的內容要讓大家知道廣告的內容要讓大家知道說這種是一個非常實習的特別例外許可他不是正規程序完成什麼的讓大家都知道這個實驗的屬性吧 |
| transcript.whisperx[821].start |
23048.752 |
| transcript.whisperx[821].end |
23075.854 |
| transcript.whisperx[821].text |
不要以為這個就是細胞治療就是萬靈藥一千萬開下去就有效兩百萬開下去就有效你要讓大家知道這台八條例外條款裡面開下去沒保證有效存活率不知道一年不知道兩年我也不知道幾年總是要有規範啊我這也先做一個澄清啦因為我們現在要討論21條21條指的是招募廣告就是那個找那些要捐細胞組織的人 |
| transcript.whisperx[822].start |
23076.618 |
| transcript.whisperx[822].end |
23079.32 |
| transcript.whisperx[822].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[823].start |
23099.156 |
| transcript.whisperx[823].end |
23121.674 |
| transcript.whisperx[823].text |
為什麼會把那個與經核准執行再生醫療技術的醫師會加進來的主要擔心的就是說醫療法就通過已經被這樣認定那為什麼我還這個地方要另外限縮不過經過大家的說明我們也可以清楚了解這個的確如果未來這個問題不是問題的話我想這個願板是OK的 |
| transcript.whisperx[824].start |
23127.569 |
| transcript.whisperx[824].end |
23128.11 |
| transcript.whisperx[824].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[825].start |
23156.972 |
| transcript.whisperx[825].end |
23158.653 |
| transcript.whisperx[825].text |
再生醫療之廣告現今核准執行再生醫療 |
| transcript.whisperx[826].start |
23186.774 |
| transcript.whisperx[826].end |
23189.376 |
| transcript.whisperx[826].text |
第二十一條就照院板通過。 |
| transcript.whisperx[827].start |
23202.542 |
| transcript.whisperx[827].end |
23222.249 |
| transcript.whisperx[827].text |
二十二條的主要是在對於廣告相關的一些程序的部分我們做一些的管理包括他必須做預審這預審的部分的話我們會讓那個廣告的要刊登廣告的廣告的者他應該把他刊登的內容刊播的方式刊播的文件然後跟 |
| transcript.whisperx[828].start |
23223.149 |
| transcript.whisperx[828].end |
23223.889 |
| transcript.whisperx[828].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[829].start |
23238.815 |
| transcript.whisperx[829].end |
23241.716 |
| transcript.whisperx[829].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[830].start |
23265.64 |
| transcript.whisperx[830].end |
23266.04 |
| transcript.whisperx[830].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[831].start |
23281.431 |
| transcript.whisperx[831].end |
23310.034 |
| transcript.whisperx[831].text |
再生醫療法草案案案 第8條第1項第1款,也就是說為及的恩慈療法的再生技術是不得廣告的,因為我們很知道就是剛剛那個林淑芬委員在講的其實我們在這邊就直接寫在明文的法條裡面是第8條第1項第1款的再生技術不得廣告,其他應該應遵循的事項的部分的話我們大概都會由我們主管機關定之,然後希望委員能夠支持願板以上。好各位委員有見嗎? |
| transcript.whisperx[832].start |
23311.415 |
| transcript.whisperx[832].end |
23311.675 |
| transcript.whisperx[832].text |
三）繼續審查委員 |
| transcript.whisperx[833].start |
23340.597 |
| transcript.whisperx[833].end |
23342.119 |
| transcript.whisperx[833].text |
再生醫療發展法草案案。」案。 |
| transcript.whisperx[834].start |
23350.128 |
| transcript.whisperx[834].end |
23378.68 |
| transcript.whisperx[834].text |
欸我也想說齁你們第一項裡面那個不得救什麼什麼齁可不可以換一個方法寫我因為想到金管會齁投資買基金的時候都要有一個制式的官方要求的本基金什麼什麼然後那個風險要致富然後我所談的不一定是保證獲益什麼什麼的那或者是抽菸不是有個制式的乾脆我們衛福部應該建立一個制式的規範就直接講清楚 |
| transcript.whisperx[835].start |
23379.92 |
| transcript.whisperx[835].end |
23381.042 |
| transcript.whisperx[835].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[836].start |
23396.237 |
| transcript.whisperx[836].end |
23397.018 |
| transcript.whisperx[836].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[837].start |
23418.136 |
| transcript.whisperx[837].end |
23436.984 |
| transcript.whisperx[837].text |
我們立法說明欄可不可以我們要把我們在這裡獲得共識的這個旨意要清楚的寫到立法說明欄裡面要清楚的寫說我們在第一項裡面的應載名的這個文字是什麼樣的狀況 |
| transcript.whisperx[838].start |
23438.385 |
| transcript.whisperx[838].end |
23442.129 |
| transcript.whisperx[838].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[839].start |
23462.304 |
| transcript.whisperx[839].end |
23463.265 |
| transcript.whisperx[839].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[840].start |
23486.851 |
| transcript.whisperx[840].end |
23494.113 |
| transcript.whisperx[840].text |
第二十二條就照院版的通過那說明的部分明天是明天再一併送上來那我們是不是先休息一下因為已經兩個小時了先休息五分鐘 |
| transcript.whisperx[841].start |
23530.089 |
| transcript.whisperx[841].end |
23531.95 |
| transcript.whisperx[841].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[842].start |
24049.377 |
| transcript.whisperx[842].end |
24050.118 |
| transcript.whisperx[842].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[843].start |
24066.186 |
| transcript.whisperx[843].end |
24067.927 |
| transcript.whisperx[843].text |
二）繼續審查委員二）繼續審查委員二）繼續審查委員二）繼續審查委員 |
| transcript.whisperx[844].start |
24096.347 |
| transcript.whisperx[844].end |
24118.539 |
| transcript.whisperx[844].text |
獲禁禁止繼續刊播的廣告的部分的話每個委員的版本大概差不多然後那因為我們特別是強調未經核准或者是與核准事項不符的我們新增的這個部分然後那對於是傳播業者接受委託的這個6個月內的話要保存相關的一些資料以及後面的查核的部分然後第三項的部分的話 |
| transcript.whisperx[845].start |
24119.339 |
| transcript.whisperx[845].end |
24121.4 |
| transcript.whisperx[845].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[846].start |
24148.985 |
| transcript.whisperx[846].end |
24149.545 |
| transcript.whisperx[846].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[847].start |
24169.239 |
| transcript.whisperx[847].end |
24189.747 |
| transcript.whisperx[847].text |
新申請的第12條這樣子的一個再生技術他都必須在每一個年度終了後的6個月內像或者是我們特別通知他的期限內提出報告然後前項報告的內容的部分包括了案例效果不良事件以及其他經我們中央主管機關指定的事項然後我們 |
| transcript.whisperx[848].start |
24190.547 |
| transcript.whisperx[848].end |
24191.228 |
| transcript.whisperx[848].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[849].start |
24210.905 |
| transcript.whisperx[849].end |
24237.373 |
| transcript.whisperx[849].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 第24條。沒有齁,那就照院板通過。第二十五條。二十五條的部分的話指的是說我們醫療機構使用所謂指定的再生製劑或執行再生技術。如果有後面講的嚴重不良事件的時候應該通報中央主管機關。通報的期限方式。抱歉我剛才24條我有意見。 |
| transcript.whisperx[850].start |
24238.766 |
| transcript.whisperx[850].end |
24239.327 |
| transcript.whisperx[850].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[851].start |
24253.663 |
| transcript.whisperx[851].end |
24254.924 |
| transcript.whisperx[851].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[852].start |
24279.042 |
| transcript.whisperx[852].end |
24279.923 |
| transcript.whisperx[852].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[853].start |
24303.766 |
| transcript.whisperx[853].end |
24304.086 |
| transcript.whisperx[853].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[854].start |
24322.876 |
| transcript.whisperx[854].end |
24340.949 |
| transcript.whisperx[854].text |
就是法律上在治療前不確定治療以前他的這個療效但是呢在結束之後我們希望因為糧又不起啊這個做的人很多、夾子很多但是機率不一樣我們現在說的是機率不一樣那透過公開透明的資訊至少我們可以讓病人找一個 |
| transcript.whisperx[855].start |
24349.415 |
| transcript.whisperx[855].end |
24350.256 |
| transcript.whisperx[855].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[856].start |
24370.595 |
| transcript.whisperx[856].end |
24371.355 |
| transcript.whisperx[856].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[857].start |
24398.027 |
| transcript.whisperx[857].end |
24398.667 |
| transcript.whisperx[857].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[858].start |
24414.942 |
| transcript.whisperx[858].end |
24434.814 |
| transcript.whisperx[858].text |
請行政單位說明可不可以請委員看一下院版的第24條的第二項第二項裡面就在講前項報告的內容應包含案例數效果不良事件及其他中央主管機關指定的事項然後所以剛剛委員就叫的案例數效果跟不良事件你講這個講錯了前項報告是講這個再生技術者要跟你們報告的 |
| transcript.whisperx[859].start |
24441.118 |
| transcript.whisperx[859].end |
24442.519 |
| transcript.whisperx[859].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[860].start |
24466.269 |
| transcript.whisperx[860].end |
24487.457 |
| transcript.whisperx[860].text |
因為他們要跟你們結果報告,結果報告要包含案例數、效果、不良反應及其他中央主管機關指定的這個事情。這個事情為什麼我們不放心?因為現在就有特管法了。特管法也這樣子規定。特管法你現在這個條文都跟特管法幾乎都差不多一模一樣,就差在最後一項德跟因而已。 |
| transcript.whisperx[861].start |
24488.337 |
| transcript.whisperx[861].end |
24488.937 |
| transcript.whisperx[861].text |
二）繼續審查委員邱議瑩等25人擬具 |
| transcript.whisperx[862].start |
24513.576 |
| transcript.whisperx[862].end |
24520.853 |
| transcript.whisperx[862].text |
這部分的話那特官法相關的這一些數據的話那我們是重要簽辦當中那下個禮拜之前就公開 |
| transcript.whisperx[863].start |
24523.913 |
| transcript.whisperx[863].end |
24542.078 |
| transcript.whisperx[863].text |
邱議瑩委員我大概知道淑芬要的是什麼東西但是我可能要用一個病友的身份來跟淑芬委員報告一下如果依照特管法現在他們能夠公佈的數據特管法有做了幾項的治療 |
| transcript.whisperx[864].start |
24543.058 |
| transcript.whisperx[864].end |
24543.719 |
| transcript.whisperx[864].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[865].start |
24553.643 |
| transcript.whisperx[865].end |
24554.203 |
| transcript.whisperx[865].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[866].start |
24573.8 |
| transcript.whisperx[866].end |
24574.34 |
| transcript.whisperx[866].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[867].start |
24592.156 |
| transcript.whisperx[867].end |
24593.457 |
| transcript.whisperx[867].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[868].start |
24611.454 |
| transcript.whisperx[868].end |
24614.116 |
| transcript.whisperx[868].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[869].start |
24639.855 |
| transcript.whisperx[869].end |
24641.075 |
| transcript.whisperx[869].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[870].start |
24669.526 |
| transcript.whisperx[870].end |
24670.047 |
| transcript.whisperx[870].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[871].start |
24688.496 |
| transcript.whisperx[871].end |
24710.127 |
| transcript.whisperx[871].text |
但是我覺得就目前為止可能你們接受的案例效果不良事件我覺得反而不良事件是應該要被注意的因為這個其實就是會牽扯到失作的機構他們對於他們的細胞的提供跟他的技術的這個良率我覺得這個可能是衛福部要去做更精確的統計 |
| transcript.whisperx[872].start |
24712.076 |
| transcript.whisperx[872].end |
24713.197 |
| transcript.whisperx[872].text |
陳昭芝委員陳昭芝委員 |
| transcript.whisperx[873].start |
24729.048 |
| transcript.whisperx[873].end |
24729.529 |
| transcript.whisperx[873].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[874].start |
24746.972 |
| transcript.whisperx[874].end |
24746.992 |
| transcript.whisperx[874].text |
〔記者訪問〕 |
| transcript.whisperx[875].start |
24777.212 |
| transcript.whisperx[875].end |
24778.474 |
| transcript.whisperx[875].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[876].start |
24800.29 |
| transcript.whisperx[876].end |
24828.857 |
| transcript.whisperx[876].text |
我今天要講的是根據報導者的文章我也講過報導者文章訪問了一個本土生技公司的總經理他好奇他也做了很多私下接案還有執行許多地下化的細胞治療三年內賺了3億元但是他也講說為什麼要限制階段癌症這個治療其實他一直認為說其實在越早期治療搞不好效果越好 |
| transcript.whisperx[877].start |
24829.657 |
| transcript.whisperx[877].end |
24850.347 |
| transcript.whisperx[877].text |
但是他說前端要放寬就是說你放寬到第一期第二期搞不好是放寬的但是後端要收集數據公布療效他就是這樣子說不然像現在好的生技公司細胞跟不好生技公司的細胞的差別好的跟不好的公司的細胞的差別 |
| transcript.whisperx[878].start |
24851.648 |
| transcript.whisperx[878].end |
24857.012 |
| transcript.whisperx[878].text |
消費者無從知道業者的優劣競爭會不出來,所以他認為是說他自己主張要公佈療效,攤在陽光上讓大家都知道。所以今天在這裡就是說 |
| transcript.whisperx[879].start |
24867.719 |
| transcript.whisperx[879].end |
24868.199 |
| transcript.whisperx[879].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[880].start |
24888.747 |
| transcript.whisperx[880].end |
24912.782 |
| transcript.whisperx[880].text |
對,就是把他治療一次的或治療兩次的這種區隔出來或再一次以後就跑掉了,那就沒話說嘛,第一個。第二個就是說那你持續接受治療的現在還存活一年的有多少人?現在持續接受治療,持續治療然後治療一年的然後他存活率多少?治療這個存活率兩年的有多少? |
| transcript.whisperx[881].start |
24913.943 |
| transcript.whisperx[881].end |
24926.301 |
| transcript.whisperx[881].text |
我的意思是說,好了,我現在再回過頭回到本來我問你們的問題到底業者要跟你們報告什麼業者要跟你們報告什麼我們再來談論說你們要公開什麼 |
| transcript.whisperx[882].start |
24927.87 |
| transcript.whisperx[882].end |
24928.491 |
| transcript.whisperx[882].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[883].start |
24955.171 |
| transcript.whisperx[883].end |
24955.851 |
| transcript.whisperx[883].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[884].start |
24980.086 |
| transcript.whisperx[884].end |
24980.926 |
| transcript.whisperx[884].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[885].start |
24998.692 |
| transcript.whisperx[885].end |
24999.533 |
| transcript.whisperx[885].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[886].start |
25016.224 |
| transcript.whisperx[886].end |
25016.905 |
| transcript.whisperx[886].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[887].start |
25033.943 |
| transcript.whisperx[887].end |
25034.764 |
| transcript.whisperx[887].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[888].start |
25048.82 |
| transcript.whisperx[888].end |
25075.675 |
| transcript.whisperx[888].text |
自療的順序的這件事情搞不好就會產生所謂的生存活率的這個地方的改變然後也因為這樣我們目前只有就是收集的是他到底接受了哪些到底先後順序這邊我們是沒有辦法收集的然後再來的部分的話是回推到最終的所謂的算是收案結束的這件事情一個是這個病人沒有接受繼續的治療一個是他是死亡 |
| transcript.whisperx[889].start |
25076.135 |
| transcript.whisperx[889].end |
25077.396 |
| transcript.whisperx[889].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[890].start |
25095.302 |
| transcript.whisperx[890].end |
25095.662 |
| transcript.whisperx[890].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[891].start |
25113.51 |
| transcript.whisperx[891].end |
25114.09 |
| transcript.whisperx[891].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[892].start |
25134.44 |
| transcript.whisperx[892].end |
25134.94 |
| transcript.whisperx[892].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[893].start |
25165.724 |
| transcript.whisperx[893].end |
25179.69 |
| transcript.whisperx[893].text |
那我可不可以再請教一下廠商給醫院的這個有效的細胞你們用什麼這個程序誰去把關他說我這裡面有1100個NK細胞誰在把關誰確定食藥署這邊會幫忙做一個每一次每一個治療的在計劃開始的時候在開始的時候其實會有做製程的一個確認 |
| transcript.whisperx[894].start |
25194.062 |
| transcript.whisperx[894].end |
25195.023 |
| transcript.whisperx[894].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[895].start |
25223.024 |
| transcript.whisperx[895].end |
25246.456 |
| transcript.whisperx[895].text |
當然這個藥商或者是生技商他必須要取得食藥署的藥證那醫生選擇跟哪一家藥廠跟哪一家生技商合作這關乎自己醫生本身的信譽跟他的醫療所以醫生他一定會慎選跟他合作的廠商誰來把關醫生來把關如果他覺得這一家藥商出的細胞有問題 |
| transcript.whisperx[896].start |
25247.617 |
| transcript.whisperx[896].end |
25249.518 |
| transcript.whisperx[896].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[897].start |
25275.925 |
| transcript.whisperx[897].end |
25277.287 |
| transcript.whisperx[897].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[898].start |
25298.729 |
| transcript.whisperx[898].end |
25299.67 |
| transcript.whisperx[898].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[899].start |
25327.25 |
| transcript.whisperx[899].end |
25332.952 |
| transcript.whisperx[899].text |
三）繼續審查委員羅廷瑋等21人擬具:「再生醫療是相關的,因為合併治療、輔助治療這麼多,我覺得這太難去處理,但是到底要不要在嚴重不良反應才通報,這個也是一個點。第二個我要講說,你們到底對醫療機構叫他要給你報告的品質有哪些項目?第一個你是說你們合併治療、輔助治療的項目有哪些 |
| transcript.whisperx[900].start |
25352.879 |
| transcript.whisperx[900].end |
25381.314 |
| transcript.whisperx[900].text |
那你們收案的這個統計你們收的案的那個級別這個疾病的級別那你們收案結束的時候的統計資料是未積蓄或死亡或是達成療效打了幾劑那他現在的現況是怎麼樣大概聽起來就是這樣子啦對嗎那那對啦那我再問你說如果只是這樣子也沒關係啦那你未來要公佈的是不是全部都公佈 |
| transcript.whisperx[901].start |
25385.111 |
| transcript.whisperx[901].end |
25385.932 |
| transcript.whisperx[901].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[902].start |
25408.348 |
| transcript.whisperx[902].end |
25409.728 |
| transcript.whisperx[902].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[903].start |
25430.772 |
| transcript.whisperx[903].end |
25444.367 |
| transcript.whisperx[903].text |
我剛好是退款辦法的委員另外我也在醫院工作基本上剛剛村委員所擔心的問題我在這邊稍微做一個說明 |
| transcript.whisperx[904].start |
25445.359 |
| transcript.whisperx[904].end |
25473.292 |
| transcript.whisperx[904].text |
就是說當一個產品經過確認好以後他出廠出廠要用到這個個案之前他有一個check in list這個check in list是一開始就已經規範好的他一定要符合什麼樣的數目的標準他的出廠才算是有效的出廠如果沒有符合當初的規範那個出廠是要被重新處理的 |
| transcript.whisperx[905].start |
25473.892 |
| transcript.whisperx[905].end |
25475.233 |
| transcript.whisperx[905].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[906].start |
25492.947 |
| transcript.whisperx[906].end |
25520.778 |
| transcript.whisperx[906].text |
因為這些其實都是經過食藥署還有剛剛講的GDP是要被驗證的所以如果這個資料有錯誤或者是有任何欺騙的話他是應該要被處罰的這是目前我們所知道的執行情形那另外就是有關於這個結果的部分那依照這邊我們看到的就是當初在特管辦法裡面就有要求 |
| transcript.whisperx[907].start |
25521.698 |
| transcript.whisperx[907].end |
25522.879 |
| transcript.whisperx[907].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[908].start |
25537.526 |
| transcript.whisperx[908].end |
25538.526 |
| transcript.whisperx[908].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[909].start |
25556.471 |
| transcript.whisperx[909].end |
25557.292 |
| transcript.whisperx[909].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[910].start |
25574.793 |
| transcript.whisperx[910].end |
25575.333 |
| transcript.whisperx[910].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[911].start |
25593.899 |
| transcript.whisperx[911].end |
25597.18 |
| transcript.whisperx[911].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[912].start |
25625.073 |
| transcript.whisperx[912].end |
25645.408 |
| transcript.whisperx[912].text |
所以這個是可以等一下再麻煩部長或是市長這邊就說明就是說這一些的內容的公布的需要如何能夠細緻到不會對各自造型的影響之下可以讓民眾知道說曾經有過多少的這個治療經驗那他是什麼樣的癌別他是在哪一個階段治療 |
| transcript.whisperx[913].start |
25645.968 |
| transcript.whisperx[913].end |
25647.969 |
| transcript.whisperx[913].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[914].start |
25665.579 |
| transcript.whisperx[914].end |
25666.379 |
| transcript.whisperx[914].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[915].start |
25685.367 |
| transcript.whisperx[915].end |
25685.927 |
| transcript.whisperx[915].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[916].start |
25715.134 |
| transcript.whisperx[916].end |
25716.055 |
| transcript.whisperx[916].text |
陳昭芝委員陳昭芝委員 |
| transcript.whisperx[917].start |
25736.297 |
| transcript.whisperx[917].end |
25737.278 |
| transcript.whisperx[917].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[918].start |
25754.44 |
| transcript.whisperx[918].end |
25755.22 |
| transcript.whisperx[918].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[919].start |
25778.19 |
| transcript.whisperx[919].end |
25793.519 |
| transcript.whisperx[919].text |
這是一個高昂的費用帶著那個一線希望而且資訊是不對等情況下我們怎麼能夠保障大家的權益呢所以我提到倫理學那我個人認為不能依靠依靠依賴自律如果依賴我們也可以依賴全民的自律啊我們都不要法規了 |
| transcript.whisperx[920].start |
25794.159 |
| transcript.whisperx[920].end |
25794.479 |
| transcript.whisperx[920].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[921].start |
25820.151 |
| transcript.whisperx[921].end |
25820.731 |
| transcript.whisperx[921].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[922].start |
25839.042 |
| transcript.whisperx[922].end |
25839.703 |
| transcript.whisperx[922].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[923].start |
25862.475 |
| transcript.whisperx[923].end |
25862.995 |
| transcript.whisperx[923].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[924].start |
25891.161 |
| transcript.whisperx[924].end |
25891.641 |
| transcript.whisperx[924].text |
邱議瑩等25人擬具 |
| transcript.whisperx[925].start |
25910.738 |
| transcript.whisperx[925].end |
25911.979 |
| transcript.whisperx[925].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[926].start |
25939.119 |
| transcript.whisperx[926].end |
25939.5 |
| transcript.whisperx[926].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[927].start |
25961.099 |
| transcript.whisperx[927].end |
25987.39 |
| transcript.whisperx[927].text |
要多久有一個這樣的報告數字給立法院我覺得這個可能可以在提案說明頭去增加謝謝好淑芬委員抱歉我比較難以接受說就這樣子先通過因為呢我們也不能說這個剛開始施行不久這已經做了6年了6年裡面關於這個膝關節軟骨缺損的皮膚作者的凹洞的疤痕填補的修復的數據其實你們都有沒有療效都公佈出來了 |
| transcript.whisperx[928].start |
25988.59 |
| transcript.whisperx[928].end |
25990.331 |
| transcript.whisperx[928].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[929].start |
26003.715 |
| transcript.whisperx[929].end |
26006.796 |
| transcript.whisperx[929].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[930].start |
26032.545 |
| transcript.whisperx[930].end |
26059.844 |
| transcript.whisperx[930].text |
這個標準還是審議委員會通過的就公佈這一些啊那再來就是說你還要再補充說明這個裡面有什麼變化我就不要談及涉及個資再更精準的說明也可以啊但其實我也是主張說這裡面你即便是有效的因為是綜合輔助的合併治療輔助治療所以也讓大家知道說其實啊這個細胞治療它只是綜合治療的其中一種 |
| transcript.whisperx[931].start |
26060.524 |
| transcript.whisperx[931].end |
26062.045 |
| transcript.whisperx[931].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[932].start |
26089.358 |
| transcript.whisperx[932].end |
26090.539 |
| transcript.whisperx[932].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[933].start |
26109.855 |
| transcript.whisperx[933].end |
26110.856 |
| transcript.whisperx[933].text |
今天是第11屆立法院第一次第一天逐條審查。 |
| transcript.whisperx[934].start |
26131.543 |
| transcript.whisperx[934].end |
26148.027 |
| transcript.whisperx[934].text |
難道就不能夠讓我們再有多一點時間來思考嗎你言必稱說我們上屆審查過了上屆是上屆我們這一屆是這一屆這一屆是第一天第一次逐條審查我們為什麼不能夠再思考仔密一點讓我們回去好好想一下呢對那個我沒有等一下我覺得這個講話已經意氣了 |
| transcript.whisperx[935].start |
26156.792 |
| transcript.whisperx[935].end |
26157.212 |
| transcript.whisperx[935].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[936].start |
26176.264 |
| transcript.whisperx[936].end |
26187.671 |
| transcript.whisperx[936].text |
因為這個法條不是今天提出來,一個月前就已經詢答結束了。你要認真思考,你要看的時候,一個月前你就應該看法條了。好不好?第一個,第二個,我們大家都內行人在委員會審法案審這麼久了。經常委員都跟行政部門說,你提一個,這個照我們的意思,你提一個修正動議來看看,我們來參考你的修正。 |
| transcript.whisperx[937].start |
26202.259 |
| transcript.whisperx[937].end |
26202.579 |
| transcript.whisperx[937].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[938].start |
26218.15 |
| transcript.whisperx[938].end |
26222.795 |
| transcript.whisperx[938].text |
呃,這一條已經討論好幾輪了啦齁,那個趙姿委員也講過...不是,你現在要求我馬上長出文字,我為什麼沒有提對...好啦,好啦,這邊先聽我一下齁,因為剛剛也好幾位委員都講過兩輪了啦齁,那不然我們就這一條齁,第24條先保留啦,好不好? |
| transcript.whisperx[939].start |
26240.553 |
| transcript.whisperx[939].end |
26241.054 |
| transcript.whisperx[939].text |
第二十四條我們就先保留接下來第25條 |
| transcript.whisperx[940].start |
26254.022 |
| transcript.whisperx[940].end |
26254.662 |
| transcript.whisperx[940].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[941].start |
26282.399 |
| transcript.whisperx[941].end |
26298.776 |
| transcript.whisperx[941].text |
是在後面的條文裡面有去做一些描述所以建議謝衣鳯委員的不予參裁其他的希望大家支持院板以上。好那針對第25條大家有意見嗎?沒有齁那就按照院板的那謝衣鳯委員的就不予採納 |
| transcript.whisperx[942].start |
26302.027 |
| transcript.whisperx[942].end |
26302.287 |
| transcript.whisperx[942].text |
二）繼續審查委員 |
| transcript.whisperx[943].start |
26319.673 |
| transcript.whisperx[943].end |
26345.301 |
| transcript.whisperx[943].text |
第二項的部分的話其實就是針對就是他已經停止了這邊的話應該要說明理由然後再由像主管機關機關申請同意然後前兩項的一個停終止的部分的話會在我們的那個期限內他要檢據一些所謂的後續因為我們把他停止了然後停止之後就會有一些後續必須處理的事情包括他應該要對於他 |
| transcript.whisperx[944].start |
26348.142 |
| transcript.whisperx[944].end |
26373.619 |
| transcript.whisperx[944].text |
已經有的組織、細胞、甚至檢體、甚至執行紀錄的一個後續處理計畫書,經由中央主管機關核定以後再做後續的處理。然後我們針對的那個要停止或終止的部分的這些行為的部分的話,其實跟委員的版本裡面的內容的意思大概差不多,所以希望委員能夠支持願版。以上。 |
| transcript.whisperx[945].start |
26374.358 |
| transcript.whisperx[945].end |
26400.246 |
| transcript.whisperx[945].text |
第二十六條委員有意見嗎沒有那就照原版通過第二十七條二十七條的部分的話針對的就是說如果執行我們第八條第一項第二款就是現在的細胞治療或者是經由第十二條第一項的再生新申請的再生技術如果發生了需要救濟的事情的時候相關的範圍 |
| transcript.whisperx[946].start |
26401.286 |
| transcript.whisperx[946].end |
26403.226 |
| transcript.whisperx[946].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[947].start |
26427.352 |
| transcript.whisperx[947].end |
26449.169 |
| transcript.whisperx[947].text |
其他委員的版本裡面其實精神上面跟我們那個院裡面的版本其實是大致雷同的所以希望委員這邊能夠支持那個院版以上各位委員針對27條有意見嗎沒有那就照院版通過接下來是第6張張明 |
| transcript.whisperx[948].start |
26452.045 |
| transcript.whisperx[948].end |
26462.099 |
| transcript.whisperx[948].text |
第六章章名的部分是指罰則,罰則部分所有委員的版本都一致。委員有意見嗎?沒有,那就照院版通過。接下來第28條。 |
| transcript.whisperx[949].start |
26465.21 |
| transcript.whisperx[949].end |
26492.277 |
| transcript.whisperx[949].text |
二（二十八條的部分的話我們是針對就是說特別是強調我們分成兩大兩大應該主要是分成兩大項第一項是非醫療機構的處罰我們把它提升到就是說處罰兩百萬到兩千萬然後特別是針對違反第11條非醫療機構執行再生醫療還有就是說違反二十一條第二項就是非 |
| transcript.whisperx[950].start |
26494.358 |
| transcript.whisperx[950].end |
26517.836 |
| transcript.whisperx[950].text |
醫療機構為再生醫療廣告的部分,把它拉高了那個罰則,因為過去的醫療廣告的部分的話大概罰5萬到25萬啦,所以對醫療機構這一塊,非醫療機構這一塊我們希望就是拉高罰則,然後讓不當的廣告免得去誘導民眾,然後那對於醫療機構這一邊的話大概我們就是會處就是20萬到200萬這邊的罰則,然後我們可以看到 |
| transcript.whisperx[951].start |
26522.776 |
| transcript.whisperx[951].end |
26524.117 |
| transcript.whisperx[951].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[952].start |
26549.77 |
| transcript.whisperx[952].end |
26550.03 |
| transcript.whisperx[952].text |
三）繼續審查委員陳昭芝委員 |
| transcript.whisperx[953].start |
26568.806 |
| transcript.whisperx[953].end |
26569.867 |
| transcript.whisperx[953].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[954].start |
26589.385 |
| transcript.whisperx[954].end |
26606.214 |
| transcript.whisperx[954].text |
應該要酌情。」所以我希望能夠在立法說明的部分,中央主管級會應訂定廣告處理原則,酌審違反情節、累計違反次數,就累犯當然要加重啦,違法所得的利益或其他等因素為划緩額度之依據啦。 |
| transcript.whisperx[955].start |
26607.294 |
| transcript.whisperx[955].end |
26608.875 |
| transcript.whisperx[955].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[956].start |
26630.284 |
| transcript.whisperx[956].end |
26647.612 |
| transcript.whisperx[956].text |
再生醫療法草案 案 違反第9條規定以禁止行為進行涉及胚胎或胚胎幹細胞質再生醫療研究。院版的話事實上是放在第31條相對的事實上罰則是比較輕的處罰是5到50萬可是在這邊我覺得這件事情還蠻嚴重的因為為什麼因為 |
| transcript.whisperx[957].start |
26655.675 |
| transcript.whisperx[957].end |
26658.296 |
| transcript.whisperx[957].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[958].start |
26678.984 |
| transcript.whisperx[958].end |
26689.872 |
| transcript.whisperx[958].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:「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 |
| transcript.whisperx[959].start |
26706.914 |
| transcript.whisperx[959].end |
26724.47 |
| transcript.whisperx[959].text |
違規之情形得處6個月以上5年以下有期徒刑否則一直再犯的話你好像似乎對他一點辦法都沒有因為這是非醫療機構嘛如果他又再度的所以我這邊建議提出修正動議以上那請行政單位說明一下 |
| transcript.whisperx[960].start |
26742.286 |
| transcript.whisperx[960].end |
26744.19 |
| transcript.whisperx[960].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[961].start |
26746.847 |
| transcript.whisperx[961].end |
26773.764 |
| transcript.whisperx[961].text |
我們先針對就是說委員在講的第9條的部分那第9條的部分我們會列在5萬到50萬的部分的話是因為這個目前違反人體研究法的部分的法則就是執行沒有經過允許的他的在人體研究法裡面的法則是5萬到50萬啦然後都是由醫療機構來執行的部分所以我們才會在比例原則的部分是把它列在5萬到50萬 |
| transcript.whisperx[962].start |
26775.365 |
| transcript.whisperx[962].end |
26786.063 |
| transcript.whisperx[962].text |
然後那因為如果是說沿用就是我們的醫療法裡面如果針對就是說醫師如果執行的是 |
| transcript.whisperx[963].start |
26787.759 |
| transcript.whisperx[963].end |
26788.279 |
| transcript.whisperx[963].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[964].start |
26815.333 |
| transcript.whisperx[964].end |
26816.193 |
| transcript.whisperx[964].text |
二）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[965].start |
26833.2 |
| transcript.whisperx[965].end |
26833.58 |
| transcript.whisperx[965].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[966].start |
26862.14 |
| transcript.whisperx[966].end |
26864.103 |
| transcript.whisperx[966].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[967].start |
26882.816 |
| transcript.whisperx[967].end |
26905.728 |
| transcript.whisperx[967].text |
因為在行政法上面的話,比較少用這樣子所謂的壘犯那種概念。通常他用的是暗刺,可以暗刺連續處罰。你這本給我罰到了,下一次看到還是再繼續罰。抓到一次就罰一次就對了。 |
| transcript.whisperx[968].start |
26909.308 |
| transcript.whisperx[968].end |
26932.863 |
| transcript.whisperx[968].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 案次累計處罰的概念。」三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 案次累計處罰的概念。」三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 案次累計處罰的概念。」三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 案次累計處罰的概念。」三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 案次累計處罰的概 |
| transcript.whisperx[969].start |
26936.906 |
| transcript.whisperx[969].end |
26950.842 |
| transcript.whisperx[969].text |
不過那個這一次我們提出來28條的最後一項齁我們最後一項有一個齁就是說那個可以沒入齁沒入這一個執行再生醫療的設備及再生治劑啦 |
| transcript.whisperx[970].start |
26953.907 |
| transcript.whisperx[970].end |
26978.833 |
| transcript.whisperx[970].text |
所以就是說有這個第一項的也就是非醫療機構去從事從事這種再生醫療的行為的時候那可以把他的工具那跟他所有的這一這些字跡的話就把它沒入掉了那等於說他的生產工具我們就把它沒收了 |
| transcript.whisperx[971].start |
26980.924 |
| transcript.whisperx[971].end |
27004.763 |
| transcript.whisperx[971].text |
我補充一下剛剛醫師法的刑度的部分是6個月以上5年以下的有期徒刑密醫所以在刑度這部分的話本來我們就會串聯到醫師法的部分去做密醫的處理我剛剛還是提到行政法上面比較沒有所謂的累犯加重的這樣子的概念而是用按次連續處罰用這樣的方式 |
| transcript.whisperx[972].start |
27009.844 |
| transcript.whisperx[972].end |
27023.095 |
| transcript.whisperx[972].text |
那這個應該不用不一定不一定是要寫在寫在這個法條上面因為他本來就是可以這樣子按次連續處罰一按一按就處罰一次就一次那剛剛那個部分可以用在那個立法說明嘿嘿對在立法說明當中好可以嗎那這個第28條就照院版通過好不好 |
| transcript.whisperx[973].start |
27038.137 |
| transcript.whisperx[973].end |
27039.741 |
| transcript.whisperx[973].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[974].start |
27043.373 |
| transcript.whisperx[974].end |
27071.065 |
| transcript.whisperx[974].text |
第二十九條二十九條的違規的情形的部分的話是認為情節稍微比較輕一點所以我們的處罰是二十萬到兩百萬然後可以限期改善前面28條的是抓到一次反一次就沒有限期改善的這個空間因為覺得那個行為上面比較嚴重然後二十九條的部分的話除了限期二十萬到兩百萬罰金稍微低一點以外就是限期改善 |
| transcript.whisperx[975].start |
27071.425 |
| transcript.whisperx[975].end |
27072.626 |
| transcript.whisperx[975].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[976].start |
27099.074 |
| transcript.whisperx[976].end |
27099.494 |
| transcript.whisperx[976].text |
在修正動醫 |
| transcript.whisperx[977].start |
27153.012 |
| transcript.whisperx[977].end |
27161.561 |
| transcript.whisperx[977].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 、三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 、三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 、三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 、三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 、三）繼續審查委員羅廷瑋等21人擬具:「再生醫療發展法草案 、三）繼續審查委員羅� |
| transcript.whisperx[978].start |
27175.712 |
| transcript.whisperx[978].end |
27196.118 |
| transcript.whisperx[978].text |
剛我們這一條是保留耶就是第19條我們剛是保留所以如果要處理那個主席現在的那個修正動議的話那可能我們就就要連帶保留阿如果您不堅持的話我們就先通過好那就保留那我們就好保留那29條也有 |
| transcript.whisperx[979].start |
27207.355 |
| transcript.whisperx[979].end |
27226.622 |
| transcript.whisperx[979].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[980].start |
27232.099 |
| transcript.whisperx[980].end |
27236.02 |
| transcript.whisperx[980].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[981].start |
27261.425 |
| transcript.whisperx[981].end |
27272.349 |
| transcript.whisperx[981].text |
支持院版。」委員有沒有意見?沒有意見。委員沒有意見,我們就...好,沒意見。好,就按我們的行政院版本。好,通過。接下來第31條。 |
| transcript.whisperx[982].start |
27278.268 |
| transcript.whisperx[982].end |
27298.87 |
| transcript.whisperx[982].text |
三十一條的部分的話主要是針對就是情節相對上面也是比較輕微可是他沒有辦法有改善的部分所以我們就是是說儲新台幣5萬到50萬然後那在這個裡面的話其實就都 |
| transcript.whisperx[983].start |
27302.254 |
| transcript.whisperx[983].end |
27318.608 |
| transcript.whisperx[983].text |
以邱議瑩委員這邊的話其實跟我們在講的是第一款這邊的精神是相符合的所以是不是請委員能夠支持願版以上委員有沒有意見沒有就按照行政院版本通過 |
| transcript.whisperx[984].start |
27321.048 |
| transcript.whisperx[984].end |
27322.929 |
| transcript.whisperx[984].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[985].start |
27342.717 |
| transcript.whisperx[985].end |
27343.738 |
| transcript.whisperx[985].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[986].start |
27362.054 |
| transcript.whisperx[986].end |
27381.626 |
| transcript.whisperx[986].text |
三、三十三條的部分的話主要是針對的是處罰的主體啦。然後如果是法案的部分的話對於私人、私立的醫療機構就是處罰負責醫師。然後對於那個法人的部分的話其實就是處罰法人。然後那個照 |
| transcript.whisperx[987].start |
27383.807 |
| transcript.whisperx[987].end |
27388.409 |
| transcript.whisperx[987].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[988].start |
27412.097 |
| transcript.whisperx[988].end |
27414.598 |
| transcript.whisperx[988].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[989].start |
27435.549 |
| transcript.whisperx[989].end |
27455.654 |
| transcript.whisperx[989].text |
對我們醫療法而言所謂的私立醫療機構的負責人其實就是醫療法裏面在講的然後我們不會有委員版本裏面提出來的因為我們負責人在私立醫療機構就是負責醫師以上委員沒有意見我們就第33條造行政院版本通過 |
| transcript.whisperx[990].start |
27463.624 |
| transcript.whisperx[990].end |
27464.925 |
| transcript.whisperx[990].text |
在臺灣民眾黨這邊提案第33條在79頁 |
| transcript.whisperx[991].start |
27472.183 |
| transcript.whisperx[991].end |
27473.524 |
| transcript.whisperx[991].text |
二）繼續審查委員邱議瑩等25人擬具 |
| transcript.whisperx[992].start |
27495.034 |
| transcript.whisperx[992].end |
27496.915 |
| transcript.whisperx[992].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[993].start |
27520.023 |
| transcript.whisperx[993].end |
27523.744 |
| transcript.whisperx[993].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[994].start |
27546.189 |
| transcript.whisperx[994].end |
27571.334 |
| transcript.whisperx[994].text |
是中央主管現在在判斷所以我會期待是要你們有清楚的一些依據就剛剛有提到那廣告的處理的話可能是在地方其他大概都在中央在中央的話就比較那個不需要說另外再去訂那一個處罰的標準但是在地方的話有時候會怕各地方這一個不依然那我們希望這個再生醫療這個雙法都要嚴格啦 |
| transcript.whisperx[995].start |
27573.114 |
| transcript.whisperx[995].end |
27574.195 |
| transcript.whisperx[995].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[996].start |
27591.364 |
| transcript.whisperx[996].end |
27615.659 |
| transcript.whisperx[996].text |
此事我們是可以做的。但是那個所得利益的部分的話會有一點點麻煩啦,不容易啦,那個是不容易。那昭之委員同意再放在我們的立法說明。好,那我們就第33條造行政院版本通過。 |
| transcript.whisperx[997].start |
27618.217 |
| transcript.whisperx[997].end |
27631.184 |
| transcript.whisperx[997].text |
三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案 案 三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案 案 三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案 案 三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案 案 三）繼續審查委員羅廷瑋等21人擬具:「 |
| transcript.whisperx[998].start |
27650.915 |
| transcript.whisperx[998].end |
27651.636 |
| transcript.whisperx[998].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[999].start |
27671.963 |
| transcript.whisperx[999].end |
27690.47 |
| transcript.whisperx[999].text |
第16條的部分的話其實在推動的部分的話其實是都是一直在講的是發展法這部分然後所以相關的一個比如說在在檢討或政策的推動的部分因為我們在原本的法律裡面就有定所以我們會建議不予採納了 |
| transcript.whisperx[1000].start |
27692.263 |
| transcript.whisperx[1000].end |
27692.544 |
| transcript.whisperx[1000].text |
三）繼續審查委員謝衣鳯等19人擬具 |
| transcript.whisperx[1001].start |
27711.059 |
| transcript.whisperx[1001].end |
27712.019 |
| transcript.whisperx[1001].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1002].start |
27729.909 |
| transcript.whisperx[1002].end |
27757.945 |
| transcript.whisperx[1002].text |
沒有的話我們就依行政院版本好那接下來第35條三十五條部分的話是講施行日由行政院定之然後各位的版本其實也都一致希望支持院版委員有沒有意見沒有就按照行政院版本好那接下來就先休息五分鐘好休息結束繼續我們的審查再生醫療制藥條例的自給條例的草案那現在休息 |
| transcript.whisperx[1003].start |
27760.342 |
| transcript.whisperx[1003].end |
27761.143 |
| transcript.whisperx[1003].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1004].start |
27776.603 |
| transcript.whisperx[1004].end |
27793.108 |
| transcript.whisperx[1004].text |
三）繼續審查委員羅廷瑋等21人擬具:「再生醫療法草案案 判断权额 判断权额 判断权额 判断权额 判断权额 判断权额 判断权额 判断权额 |
| transcript.whisperx[1005].start |
28196.698 |
| transcript.whisperx[1005].end |
28213.059 |
| transcript.whisperx[1005].text |
現在進行討論事項第二案再生醫療制計條例草案之主條審查以行政院提供條次為準進行討論每條條文先請行政單位說明接著再請委員表示意見 |
| transcript.whisperx[1006].start |
28215.673 |
| transcript.whisperx[1006].end |
28231.293 |
| transcript.whisperx[1006].text |
法案名稱是再生醫療自治條例那大部分委員都跟我們的行政院提案是一致的那只有幾位委員有提到在法案名稱裡面還有管理 |
| transcript.whisperx[1007].start |
28232.034 |
| transcript.whisperx[1007].end |
28256.509 |
| transcript.whisperx[1007].text |
但是我們這個立法除了是對於再生醫療自己全生命週期的管理以外也希望一個好的立法能夠促進產業發展所以我們是敬請能夠支持行政院所提的法案名稱委員們有沒有意見沒有沒有我們就照行政院版本通過接下來第一條 |
| transcript.whisperx[1008].start |
28258.49 |
| transcript.whisperx[1008].end |
28258.991 |
| transcript.whisperx[1008].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1009].start |
28287.87 |
| transcript.whisperx[1009].end |
28291.912 |
| transcript.whisperx[1009].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[1010].start |
28320.863 |
| transcript.whisperx[1010].end |
28331.758 |
| transcript.whisperx[1010].text |
第三條是有關定義的部分就是我們提到再生醫療字跡他是指含有基因細胞或是他的衍生物供人體使用的字跡 |
| transcript.whisperx[1011].start |
28332.899 |
| transcript.whisperx[1011].end |
28358.237 |
| transcript.whisperx[1011].text |
那這個也大概是委員們所提的都跟我們是一致啦。那個那其中像劉建國委員他是有提到是說要把在前一項再生他在第二項裡面提前項再生醫療制計署要釋法第6條規定製藥品那因為我們在說明欄是有說了已經有提了所以是不是請就支持我們行政院的版本 |
| transcript.whisperx[1012].start |
28359.655 |
| transcript.whisperx[1012].end |
28379.87 |
| transcript.whisperx[1012].text |
告知委員請判決我剛好是意見一樣本來我也覺得這樣比較清楚沒有後續的爭議就是本例所稱再生醫療之一鬥典屬藥事法第6條之藥品所以署長你說這個寫在在說明欄有在說明欄但是加一句在這裡也不差不是很清楚嗎還需要再說明嗎有問題這樣可以嗎剛好我跟劉建國委員意見一樣謝謝 |
| transcript.whisperx[1013].start |
28384.113 |
| transcript.whisperx[1013].end |
28384.553 |
| transcript.whisperx[1013].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1014].start |
28409.779 |
| transcript.whisperx[1014].end |
28432.455 |
| transcript.whisperx[1014].text |
請問這邊是不是可以針對剛才他們兩位的,那文字上可不可以再做,另一邊再做確認。再一句話而已。我,我詢問一下齁,直接加在這裡跟放在立法說明的差別是什麼?就是說對你們來講。是一樣,是一樣,所以,如果要寫過來我們也可以修改。 |
| transcript.whisperx[1015].start |
28433.493 |
| transcript.whisperx[1015].end |
28435.295 |
| transcript.whisperx[1015].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1016].start |
28450.489 |
| transcript.whisperx[1016].end |
28478.351 |
| transcript.whisperx[1016].text |
第三條就是趙琉建國委員等三人修正動議通過。接下來第四條。第四條是有關再生醫療字跡的分類。分別就有基因治療字跡、細胞治療字跡、組織工程字跡、還有複合字跡這四大類。我們包括對於各項字跡它的說明也都有在上面入列。 |
| transcript.whisperx[1017].start |
28480.192 |
| transcript.whisperx[1017].end |
28495.579 |
| transcript.whisperx[1017].text |
請支持我們行政院的版本。委員除了劉建國委員跟謝衣鳯委員他們沒有把簽合就是他們沒有把我們的複合字跡放上去了。我想我們這樣子應該是更完整的。各位有沒有意見? |
| transcript.whisperx[1018].start |
28502.222 |
| transcript.whisperx[1018].end |
28505.385 |
| transcript.whisperx[1018].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〉 |
| transcript.whisperx[1019].start |
28530.246 |
| transcript.whisperx[1019].end |
28541.959 |
| transcript.whisperx[1019].text |
業者應聘用國內外大學院校以上醫藥或生命科學等相關科系畢業,並具有細胞學、衛生醫學或免疫學專門知識之專任人員駐場參與製造。 |
| transcript.whisperx[1020].start |
28546.644 |
| transcript.whisperx[1020].end |
28547.405 |
| transcript.whisperx[1020].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1021].start |
28566.476 |
| transcript.whisperx[1021].end |
28567.036 |
| transcript.whisperx[1021].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1022].start |
28591.909 |
| transcript.whisperx[1022].end |
28595.911 |
| transcript.whisperx[1022].text |
除了後面有規定要大學院校以上的醫藥或什麼相關畢業可是他畢業不見得他是在裡面當藥師 |
| transcript.whisperx[1023].start |
28615.019 |
| transcript.whisperx[1023].end |
28623.474 |
| transcript.whisperx[1023].text |
所以他才會希望特別再把這個應有專任藥師駐場監視及等等的這個文字入法以上我們的邱議瑩委員 |
| transcript.whisperx[1024].start |
28630.264 |
| transcript.whisperx[1024].end |
28651.259 |
| transcript.whisperx[1024].text |
我提一下我的意見就是說每一個藥廠他一定是有藥師我們在藥事法裡頭其實就有明文規定但是再生製劑他其實藥師能夠參與的角色並不太大所以這裡的寫法是寫說由專任藥師駐場監製我覺得監製這兩個字會有一點問題 |
| transcript.whisperx[1025].start |
28657.01 |
| transcript.whisperx[1025].end |
28673.995 |
| transcript.whisperx[1025].text |
所以我的建議其實就是你的藥廠本來就應該聘用藥師其實我不用在這裡多寫但是我在這裡寫的就劉建國委員寫的是駐場監製這件事情我覺得會有一點跟我們原來的想像是會有一點不太一樣的 |
| transcript.whisperx[1026].start |
28675.034 |
| transcript.whisperx[1026].end |
28689.049 |
| transcript.whisperx[1026].text |
跟委員報告對因為我們再生醫療自己他本來就是要評那這些藥廠他本來就要聘藥師住場監製所以這個是一定是要做的對所以本來就是有這樣的一個規定 |
| transcript.whisperx[1027].start |
28691.09 |
| transcript.whisperx[1027].end |
28691.97 |
| transcript.whisperx[1027].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1028].start |
28718.783 |
| transcript.whisperx[1028].end |
28719.224 |
| transcript.whisperx[1028].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1029].start |
28737.736 |
| transcript.whisperx[1029].end |
28760.485 |
| transcript.whisperx[1029].text |
第六條是有關不管是我們藥品的許可證或者是合與有付款的許可都必須是應該要向中央主管機關申請查驗登記那另外我們這裡第二項的部分也有提到如果我們合與前項有付款許可應先經再生醫療審議會之審議通過 |
| transcript.whisperx[1030].start |
28763.906 |
| transcript.whisperx[1030].end |
28790.013 |
| transcript.whisperx[1030].text |
那輸入第一項再生醫療字跡應由藥品許可證或有付款許可之所有人或其授權者為之那委員們的意見跟我們的都是方向都是一致的請支持我們行政院的版本各位有沒有意見支持行政院版本好那我們就第6條照行政院版本通過那接下來第7條好謝謝 |
| transcript.whisperx[1031].start |
28795.612 |
| transcript.whisperx[1031].end |
28811.068 |
| transcript.whisperx[1031].text |
第7條這邊主要是說有關經核准製造輸入之再生醫療製劑應經中央主管機關核准使得變更藥品許可證或有付款許可 |
| transcript.whisperx[1032].start |
28811.648 |
| transcript.whisperx[1032].end |
28831.962 |
| transcript.whisperx[1032].text |
及原查驗登記事項,那藥品許可證及有付款許可移轉時應辦理移轉登記,所以有變更或者是移轉,這個都要經由中央主管機關這邊核可,那委員們的提案跟我們的也是一致,那懇請支持行政院的版本。 |
| transcript.whisperx[1033].start |
28832.542 |
| transcript.whisperx[1033].end |
28861.117 |
| transcript.whisperx[1033].text |
其他委員有沒有意見?沒有。沒有就按照行政院版本通過。接下來第8條。好,第8條就是講那個有效期間。就是依照我們第6條第一項規定發給的藥品許可證,它有效期間是5年。期滿如果仍然需要繼續製造輸入的,因應有效期間屆滿3個月前至6個月之間,申請中央主管機關核准展延。 |
| transcript.whisperx[1034].start |
28862.177 |
| transcript.whisperx[1034].end |
28885.025 |
| transcript.whisperx[1034].text |
每次展演不得超過5年,要品許可證效期屆滿,沒有申請,或者是經否準展演者,那就喪失了這張許可證的效力,那就由中央主管機關來註銷。其他如果說有污損遺失,那續名理由也是必須要向中央主管機關這邊申請換花或補花。 |
| transcript.whisperx[1035].start |
28886.505 |
| transcript.whisperx[1035].end |
28887.066 |
| transcript.whisperx[1035].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1036].start |
28905.988 |
| transcript.whisperx[1036].end |
28928.964 |
| transcript.whisperx[1036].text |
那他申請的條件,要檢附的文件、資料、審查程序、核准基準、收費及其他相關事項,那中央主管機關都會定職。那委員們所提的跟我們的其實都是一致,所以也請能夠支持行政院的版本。委員們有沒有意見針對第8條?沒有,就按照行政院版本通過。接下來第9條。 |
| transcript.whisperx[1037].start |
28932.013 |
| transcript.whisperx[1037].end |
28935.715 |
| transcript.whisperx[1037].text |
第二期臨床試驗並經審查風險效益,它具有安全性及初步療效者。 |
| transcript.whisperx[1038].start |
28957.127 |
| transcript.whisperx[1038].end |
28972.073 |
| transcript.whisperx[1038].text |
則附加付款和與有效期間不超過5年的許可,其滿不得展延。那前向危及生命或是嚴重失能之疾病,得以申請查驗登記前向中央主管機關這邊申請認定。 |
| transcript.whisperx[1039].start |
28974.614 |
| transcript.whisperx[1039].end |
28974.774 |
| transcript.whisperx[1039].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1040].start |
28992.245 |
| transcript.whisperx[1040].end |
28992.565 |
| transcript.whisperx[1040].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1041].start |
29011.886 |
| transcript.whisperx[1041].end |
29013.068 |
| transcript.whisperx[1041].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[1042].start |
29031.539 |
| transcript.whisperx[1042].end |
29032.24 |
| transcript.whisperx[1042].text |
三）繼續審查委員邱議瑩等25人擬具 |
| transcript.whisperx[1043].start |
29051.479 |
| transcript.whisperx[1043].end |
29052.32 |
| transcript.whisperx[1043].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1044].start |
29075.751 |
| transcript.whisperx[1044].end |
29077.835 |
| transcript.whisperx[1044].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1045].start |
29087.225 |
| transcript.whisperx[1045].end |
29087.886 |
| transcript.whisperx[1045].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1046].start |
29108.754 |
| transcript.whisperx[1046].end |
29135.971 |
| transcript.whisperx[1046].text |
謝衣鳯等21人擬具 «再生醫療法草案案案案 中斷為恩治療法的寬限規定,所以院版的比較只有針對於危及生命或嚴重失能的疾病,是不是可以加我的修正動員國內尚無適當藥物或合適替代? |
| transcript.whisperx[1047].start |
29137.635 |
| transcript.whisperx[1047].end |
29163.53 |
| transcript.whisperx[1047].text |
療法者增加這些字眼。第二個要就教是在你這個必以核給就這個5年有效的那個條件的期限許可是不是可以先就這個就5年一次然後不得展延可是有沒有再重複核發所以我就說這邊如果沒有的話那當然就不用可是有的話我們會期待就是說必以核給一次違憲 |
| transcript.whisperx[1048].start |
29165.872 |
| transcript.whisperx[1048].end |
29190.194 |
| transcript.whisperx[1048].text |
再來就是再增加第二項中央主管機關對取得前項有條件期限許可的那個字跡得依風險程度公告使用該字跡的醫療機構範圍跟醫師資格。再增加第三項也就是未符合前項公告範圍的醫療機構或資格的醫師不得使用該再生醫療字跡。 |
| transcript.whisperx[1049].start |
29193.274 |
| transcript.whisperx[1049].end |
29220.535 |
| transcript.whisperx[1049].text |
跟委員報告,委員在這個整治危急生命或嚴重失能的疾病後面就是有提案是要多加且國內上午適當藥物或合適替代療法者但是現在有的一些藥物他也有可能對於這個病人他的治療效果是不好的所以我們的線說是在於危急生命或嚴重失能其實都是嚴重的疾病 |
| transcript.whisperx[1050].start |
29221.195 |
| transcript.whisperx[1050].end |
29221.635 |
| transcript.whisperx[1050].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1051].start |
29243.288 |
| transcript.whisperx[1051].end |
29263.07 |
| transcript.whisperx[1051].text |
所以請委員可以同意我們原來的那另外是說中央主管機關對於取得前項有條件期限許可的字跡因得醫風險程度公告這個這些醫師的資格就是醫療機構的範圍跟醫師資格這個在在我們再生醫療法那邊有規定 |
| transcript.whisperx[1052].start |
29263.67 |
| transcript.whisperx[1052].end |
29290.545 |
| transcript.whisperx[1052].text |
所以如果能夠就是用再生醫療法那邊的我們這裡不用再加這樣子的話看看市委員是不是覺得這樣適合那沒有全沒有符合前項公告的這些醫療機構或資格的醫生不得使用這個這個其實我們在再生醫療法那邊也是有是所以是不是請能夠用我們行政院的版本是那我也沒有其他意見你就第9條就按行政院版本通過那接下來第10條好謝謝 |
| transcript.whisperx[1053].start |
29299.859 |
| transcript.whisperx[1053].end |
29317.911 |
| transcript.whisperx[1053].text |
第10條就是針對付款的說明。就是我們在前條的第一項所定的付款應包括下列的四項。那第一項是執行療效驗證試驗並定期或於指定期限內繳交試驗報告。 |
| transcript.whisperx[1054].start |
29319.432 |
| transcript.whisperx[1054].end |
29319.912 |
| transcript.whisperx[1054].text |
二）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[1055].start |
29335.399 |
| transcript.whisperx[1055].end |
29335.599 |
| transcript.whisperx[1055].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1056].start |
29360.054 |
| transcript.whisperx[1056].end |
29361.515 |
| transcript.whisperx[1056].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[1057].start |
29387.982 |
| transcript.whisperx[1057].end |
29406.952 |
| transcript.whisperx[1057].text |
第11條有關提供者的合適性。第11條是說,再生醫療制劑是取自人體的組織細胞製造者,其製造或輸入業者應該要確保這個制劑來源提供者之合適性,使得製造或輸入。 |
| transcript.whisperx[1058].start |
29408.272 |
| transcript.whisperx[1058].end |
29408.873 |
| transcript.whisperx[1058].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1059].start |
29427.35 |
| transcript.whisperx[1059].end |
29428.471 |
| transcript.whisperx[1059].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1060].start |
29447.353 |
| transcript.whisperx[1060].end |
29474.437 |
| transcript.whisperx[1060].text |
可以依照另外還有台灣民眾黨這邊也有提案執行相關傳染病及其病原篩檢或測試沒有導入這些相關的沒有導入傳播還有擴散相關傳染病病原或疾病的風險那這些其實都是在我們之後會定的執辦法裡面都會詳細所以是不是請委員可以支持我們行政院的版本這個不能放在母法嗎 |
| transcript.whisperx[1061].start |
29475.077 |
| transcript.whisperx[1061].end |
29475.737 |
| transcript.whisperx[1061].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1062].start |
29502.347 |
| transcript.whisperx[1062].end |
29519.738 |
| transcript.whisperx[1062].text |
因為蘇委員這裡是附帶決議他以後我們定在我們以後第11條對第11條在執法規的時候放入那文字呢這就是 |
| transcript.whisperx[1063].start |
29523.561 |
| transcript.whisperx[1063].end |
29546.954 |
| transcript.whisperx[1063].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的文字。如果可以的話,我們就把這個附帶決議並就通過。就照行政院版本,但是有通過蘇巧惠委員的附帶決議。我們都會不會比較清楚,執行相關傳遞件。附帶決議。蘇委員所提的,我們可以,所以是不是就,那民眾黨提的這個呢? |
| transcript.whisperx[1064].start |
29549.813 |
| transcript.whisperx[1064].end |
29551.457 |
| transcript.whisperx[1064].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1065].start |
29558.404 |
| transcript.whisperx[1065].end |
29558.824 |
| transcript.whisperx[1065].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1066].start |
29584.83 |
| transcript.whisperx[1066].end |
29609.256 |
| transcript.whisperx[1066].text |
我這邊有修正綜藝是不是增列第三項也就是說因為取自體的細胞的話自行使用的藥劑所以應不涉及到第三人權益所以自得授權主管機關應該要有些寬鬆判定所以增列這第三項那請那個衛福部表示意見 |
| transcript.whisperx[1067].start |
29615.346 |
| transcript.whisperx[1067].end |
29642.961 |
| transcript.whisperx[1067].text |
包括委員我們也是會在執法規裡面詳細的去把它呈現出來所以是不是因為那我們在執法規那邊好那就按照行政院版本11條按照行政院版本通過好謝謝委員那剛剛蘇巧惠委員提的那個附帶決議我們就列入可以是謝謝好那就照樣通過好那接下來第12條 |
| transcript.whisperx[1068].start |
29646.95 |
| transcript.whisperx[1068].end |
29673.212 |
| transcript.whisperx[1068].text |
第12條主要是知情同意所以在這裡就是對於為供製造再生醫療製劑而以國內取得人體組織細胞的提供者以有意識能力之成年人為限但顯於有意於一特定人口群或未能與其他對象取代者不在此限那前項的組織細胞在取得之前也要獲得提供者的書面同意 |
| transcript.whisperx[1069].start |
29674.813 |
| transcript.whisperx[1069].end |
29691.02 |
| transcript.whisperx[1069].text |
第三項是前項書面同意提供者為胎兒是應得其母書面同意,若是限制行為能力人或是受輔助宣告人之人應得其本人以及法定代理人或輔助人。 |
| transcript.whisperx[1070].start |
29691.84 |
| transcript.whisperx[1070].end |
29696.945 |
| transcript.whisperx[1070].text |
再生醫療法草案案 案 等19人擬具:「再生醫療法草案 案 等19人擬具:「再生醫療法草案 案 等19人擬具:「再生醫療法草案 案 等19人擬具:「 |
| transcript.whisperx[1071].start |
29721.884 |
| transcript.whisperx[1071].end |
29735.94 |
| transcript.whisperx[1071].text |
陳昭芝委員發言。第12條剛剛我們之前相對應的《再生醫療法》是保留嗎?因為有關因為是對應的是同一件事。林月琴委員 |
| transcript.whisperx[1072].start |
29737.872 |
| transcript.whisperx[1072].end |
29764.987 |
| transcript.whisperx[1072].text |
那因為剛剛再生醫療法就期待事實上在第三項第四項的這些所謂談的這些所有人取得書面同意的話應該還是要有些公正所以我覺得這邊還是要比照以上好我們也會回去因為我們剛剛再生醫療法的這一條就保留了我想這一條好那就12條就先保留好那第12條就先保留 |
| transcript.whisperx[1073].start |
29765.785 |
| transcript.whisperx[1073].end |
29766.705 |
| transcript.whisperx[1073].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1074].start |
29789.514 |
| transcript.whisperx[1074].end |
29803.845 |
| transcript.whisperx[1074].text |
那所做成的再生醫療制劑一定的適應症還有適用對象那這些組織細胞取得的方式還有相關的包括可能會有的副作用病化症、化生力等等這些都一定要清楚的跟提供者來說明。 |
| transcript.whisperx[1075].start |
29805.166 |
| transcript.whisperx[1075].end |
29806.147 |
| transcript.whisperx[1075].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1076].start |
29826.176 |
| transcript.whisperx[1076].end |
29846.147 |
| transcript.whisperx[1076].text |
獲得這些的話,如果過程當中有發生了不良反應的相關的一些醫療照護補償及處理,還有可能衍生的利益跟歸屬,可能個人資料的保護等。所以這個我們相關的這個那委員所提的跟我們的應該都方向都一致,所以也建請能夠支持行政院的版本。 |
| transcript.whisperx[1077].start |
29847.383 |
| transcript.whisperx[1077].end |
29850.626 |
| transcript.whisperx[1077].text |
再生醫療自治的廣告就依照藥師法裡面藥品廣告的規定。 |
| transcript.whisperx[1078].start |
29871.827 |
| transcript.whisperx[1078].end |
29874.009 |
| transcript.whisperx[1078].text |
第15條是有關招募廣告的內容不得有誇大。 |
| transcript.whisperx[1079].start |
29891.163 |
| transcript.whisperx[1079].end |
29894.184 |
| transcript.whisperx[1079].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[1080].start |
29915.911 |
| transcript.whisperx[1080].end |
29917.012 |
| transcript.whisperx[1080].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[1081].start |
29937.975 |
| transcript.whisperx[1081].end |
29963.389 |
| transcript.whisperx[1081].text |
所以是不是我們就維持我們行政院的版本。好。林月琴委員因為這個涉及到比較龐大經濟利益而且可能存在危害健康的風險所以我認為是不應該委託民間團體來代為執行政府的公權利益所以政府應該執行審查因為這邊行政院版本有寫說或其委任委託的機構或法人 |
| transcript.whisperx[1082].start |
29963.889 |
| transcript.whisperx[1082].end |
29964.77 |
| transcript.whisperx[1082].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1083].start |
29981.579 |
| transcript.whisperx[1083].end |
29982.499 |
| transcript.whisperx[1083].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1084].start |
29996.445 |
| transcript.whisperx[1084].end |
30000.647 |
| transcript.whisperx[1084].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[1085].start |
30020.373 |
| transcript.whisperx[1085].end |
30046.129 |
| transcript.whisperx[1085].text |
第三項有,請委員是不是看一下第三項?第三項的部分是有限期改善。那第四項這個是未經核准的當然就馬上要把它停掉,沒有限期改善的問題。那與核准的事項不符,那這部分的話。也是例子,限期改善就是已經。已經廢止了那當然。就停止,好謝謝。 |
| transcript.whisperx[1086].start |
30048.612 |
| transcript.whisperx[1086].end |
30049.192 |
| transcript.whisperx[1086].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1087].start |
30065.444 |
| transcript.whisperx[1087].end |
30066.265 |
| transcript.whisperx[1087].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1088].start |
30094.262 |
| transcript.whisperx[1088].end |
30120.356 |
| transcript.whisperx[1088].text |
第16條主要是在規範相關的GMP跟GDP那這個藥商都必須要依照我們藥師法裡面的規定是藥師法第53條之一還有第57條的一個規定以上那因為在藥師法畢竟我們這個法是藥師法的特別法所以請大概委員的方向也跟我們是一致那是不是可以支持我們行政院的版本 |
| transcript.whisperx[1089].start |
30121.22 |
| transcript.whisperx[1089].end |
30123.282 |
| transcript.whisperx[1089].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[1090].start |
30130.711 |
| transcript.whisperx[1090].end |
30149.581 |
| transcript.whisperx[1090].text |
第17條談的是有關安全監視計劃所以經過核准製造輸入之再生醫療制計經中央主管機關得指定品項期間令藥品許可證或者是有付款許可之所有人依公告或核定之安全監視計劃監視其安全性 |
| transcript.whisperx[1091].start |
30152.082 |
| transcript.whisperx[1091].end |
30155.184 |
| transcript.whisperx[1091].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項案件事項案件事項案件事項案件事項案件事項案件事項案件事項 |
| transcript.whisperx[1092].start |
30181.081 |
| transcript.whisperx[1092].end |
30181.601 |
| transcript.whisperx[1092].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1093].start |
30198.915 |
| transcript.whisperx[1093].end |
30215.228 |
| transcript.whisperx[1093].text |
因為避免為了監視這個安全性資料造成個人隱私遭侵犯的問題所以是不是可以要再加入幾個字無法辨識當事人就相關安全監視資料與該許可證或有付款許可之所有人署長這樣可以嗎 |
| transcript.whisperx[1094].start |
30222.751 |
| transcript.whisperx[1094].end |
30249.936 |
| transcript.whisperx[1094].text |
因為我們還是對我們最主要是說這樣的病人在做一些安全監視的時候沒有比較希望能夠去掌握他的情況如果完全都去識別化有時候是有一些我們也要一樣要看病例啊一樣要知道是怎麼回事但是你是給許可證的持有人欸對但是現在給藥上的時候可不可以去那個無法辨識當事人之這個資料 |
| transcript.whisperx[1095].start |
30252.376 |
| transcript.whisperx[1095].end |
30252.876 |
| transcript.whisperx[1095].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1096].start |
30279.361 |
| transcript.whisperx[1096].end |
30280.802 |
| transcript.whisperx[1096].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1097].start |
30308.444 |
| transcript.whisperx[1097].end |
30309.104 |
| transcript.whisperx[1097].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1098].start |
30333.361 |
| transcript.whisperx[1098].end |
30357.852 |
| transcript.whisperx[1098].text |
因為這一個部分的話跟蘇巧惠委員的那個附帶決議是有關係的啦也就是說那目前大概有這樣子的風險的資料的時候是由醫療機構提供給這一個廠商嘛那廠商要把資料提供給衛福部 |
| transcript.whisperx[1099].start |
30359.133 |
| transcript.whisperx[1099].end |
30359.914 |
| transcript.whisperx[1099].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1100].start |
30380.586 |
| transcript.whisperx[1100].end |
30381.267 |
| transcript.whisperx[1100].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1101].start |
30396.606 |
| transcript.whisperx[1101].end |
30407.218 |
| transcript.whisperx[1101].text |
所以這裡可以加嗎?在這裡的話是可以但是必須要考慮到一個後果因為這些安全監視資料的話應該要報給那個主管機關 |
| transcript.whisperx[1102].start |
30413.098 |
| transcript.whisperx[1102].end |
30422.972 |
| transcript.whisperx[1102].text |
主管機關如果覺得說這一些有問題的有不良事件的必須要進一步去做調查的話因為沒有這些部長因為明天會再處理 |
| transcript.whisperx[1103].start |
30427.934 |
| transcript.whisperx[1103].end |
30428.495 |
| transcript.whisperx[1103].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1104].start |
30450.351 |
| transcript.whisperx[1104].end |
30462.67 |
| transcript.whisperx[1104].text |
我先跟委員報告我們的藥品安全監視管理辦法裡面有提到就是必須要依個人資料保護法跟相關的法規規定辦理對所以其實對於個人的資料都有一定的保護嗯 |
| transcript.whisperx[1105].start |
30465.64 |
| transcript.whisperx[1105].end |
30486.709 |
| transcript.whisperx[1105].text |
站在這裏啊,再生醫療這個,這個都是因為...那個是,變產是不能辨識的,對不對?他只是不能辨識當事人而已。對,不過我是建議說讓CLS回去看看現在的藥品是怎麼樣做。我們一支線的處理就好,是不是?好,那不然我們就17條先保留。好,17條。對不起,所以那個附帶決議可以一起帶進來嗎?這是相關內容,是。 |
| transcript.whisperx[1106].start |
30492.409 |
| transcript.whisperx[1106].end |
30510.578 |
| transcript.whisperx[1106].text |
其實剛剛部長講的內容跟附帶決議寫的是差不多是一樣包括那個署長寫的所以如果說陳委員同意的話那我們通過17條然後也通過這個附帶決議這樣其實是會比較更完整一點啦就是蘇巧慧這個翻頁翻頁翻頁17條 |
| transcript.whisperx[1107].start |
30518.644 |
| transcript.whisperx[1107].end |
30518.664 |
| transcript.whisperx[1107].text |
第18條 |
| transcript.whisperx[1108].start |
30546.842 |
| transcript.whisperx[1108].end |
30568.68 |
| transcript.whisperx[1108].text |
第18條是有關來源跟流向的資料。藥商跟醫療機構應保存再生醫療自己供應來源及流向資料。對於保留的資料的範圍保存方式與期限還有其他應該遵循的事項這個辦法就會由中央主管機關這邊來訂定。那這邊我們 |
| transcript.whisperx[1109].start |
30572.463 |
| transcript.whisperx[1109].end |
30579.754 |
| transcript.whisperx[1109].text |
我看委員們的方向跟我們也都是一致,那建請能夠支持我們行政院的版本。約情委員。 |
| transcript.whisperx[1110].start |
30583.574 |
| transcript.whisperx[1110].end |
30612.409 |
| transcript.whisperx[1110].text |
第三項因為在再生醫療法案的那個第16條也有規定那個期限是15年是不是這邊也一併處理因為我們現在各種治劑他的情況不同在國外他們一些管理單位有的可能會要求的像說5年有的10年有的甚至更長那像以現在這種基因治療的有的都是很小的小孩他搞不好就出生就治療了那那個一二十年對他們來講也都不算長 |
| transcript.whisperx[1111].start |
30613.109 |
| transcript.whisperx[1111].end |
30640.992 |
| transcript.whisperx[1111].text |
所以我們會針對字跡的種類的不同會有一些要求是所以會在你的在第二項的時候會特別去提那個視線嗎對好那第18條是不是照院板通過好通一好謝謝還有一個18條之一18條修正動議林月琴委員提的修正動議18條之一 |
| transcript.whisperx[1112].start |
30644.504 |
| transcript.whisperx[1112].end |
30670.435 |
| transcript.whisperx[1112].text |
十八條之一這裡是針對再生醫療製造販賣業者還有醫療機構應建立長期追蹤機制那這也是跟資料的保存這個保存的這是一致然後如果有發生一些不良反應的其實我們有相關的安全監視計畫 |
| transcript.whisperx[1113].start |
30672.736 |
| transcript.whisperx[1113].end |
30699.878 |
| transcript.whisperx[1113].text |
那這裡是應該就是說對於這一些相關的這一些事項應該還要有個委員會再來審議我們再生醫療自己安全監視及長期追蹤報告那也跟委員報告齁其實我們已經對於安全監視計畫就有一個小組一個諮議小組持續在做那這裡的齁其實就是在我們那個小組裡面我們會來執行是那是不是這種就不用另外再訂 |
| transcript.whisperx[1114].start |
30704.937 |
| transcript.whisperx[1114].end |
30706.242 |
| transcript.whisperx[1114].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1115].start |
30710.999 |
| transcript.whisperx[1115].end |
30736.65 |
| transcript.whisperx[1115].text |
對因為我們在18條那裡就針對相關的從資料的保存流向那更前面的又有安全監視所以這些其實應該能夠把這些這些部分給都會有涵蓋進去嗎對如果有不良反應也是都一定要跟我們通報的是所以包含我剛剛這第二項這邊特別去提到有這樣子的一個審議的那也會是在前面的審議 |
| transcript.whisperx[1116].start |
30740.563 |
| transcript.whisperx[1116].end |
30740.583 |
| transcript.whisperx[1116].text |
葉齊武 |
| transcript.whisperx[1117].start |
30766.189 |
| transcript.whisperx[1117].end |
30783.459 |
| transcript.whisperx[1117].text |
這一條大概是這樣子第一項的部分那這個我可能要我們要考慮一下因為再生醫療字跡那他用在病人的身上之後的話要去追蹤嘛這個是那個林委員你的你本意是這樣子嗎 |
| transcript.whisperx[1118].start |
30784.56 |
| transcript.whisperx[1118].end |
30802.963 |
| transcript.whisperx[1118].text |
但如果是這樣子的話是否是應該是在再生醫療法裡面的那一個追蹤因為再生醫療法是包括你使用的再生技術或者是使用再生醫療字跡那通過的字跡都必須要列入在追蹤嘛 |
| transcript.whisperx[1119].start |
30803.964 |
| transcript.whisperx[1119].end |
30829.215 |
| transcript.whisperx[1119].text |
這一個部分的話應該是在那個由醫療機構來追蹤然後要把資料給衛福部應該是這樣而不是去責成那個販賣業者或製造業者因為如果販賣業者跟製造業者的話那就會扯到我們剛剛那個那一條18條是不是 |
| transcript.whisperx[1120].start |
30830.555 |
| transcript.whisperx[1120].end |
30832.116 |
| transcript.whisperx[1120].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[1121].start |
30857.017 |
| transcript.whisperx[1121].end |
30857.737 |
| transcript.whisperx[1121].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1122].start |
30874.904 |
| transcript.whisperx[1122].end |
30875.784 |
| transcript.whisperx[1122].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1123].start |
30892.532 |
| transcript.whisperx[1123].end |
30892.892 |
| transcript.whisperx[1123].text |
再生醫療法草案案 |
| transcript.whisperx[1124].start |
30922.752 |
| transcript.whisperx[1124].end |
30923.833 |
| transcript.whisperx[1124].text |
〈再生醫療法草案案〉案〉 |
| transcript.whisperx[1125].start |
30953.113 |
| transcript.whisperx[1125].end |
30953.913 |
| transcript.whisperx[1125].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1126].start |
30966.781 |
| transcript.whisperx[1126].end |
30989.513 |
| transcript.whisperx[1126].text |
所以這樣是18條也要做保留然後18條之一建議一下好不好就是說剛剛部長提到的那個部分其實跟我們剛剛再生醫療法第24條在談的那個通報機制跟報告的那個機制是有相關那剛剛我們24條是保留嘛那如何把林月琴委員的這個概念跟這個 |
| transcript.whisperx[1127].start |
30990.333 |
| transcript.whisperx[1127].end |
31018.868 |
| transcript.whisperx[1127].text |
再生醫療法草案案 案 文字把他併到再生醫療法的第那個24條裡頭去讓剛剛幾個幾位委員要關心的就是我們在追蹤的那個部分能夠文字上更完備是不是也請衛福部今天晚上回去把它做一些做一些微調那我們就不增列第18條之一啊好就是我們把林委員的這個概念把它放到再生醫療法那反正我們明天還要再回來處理 |
| transcript.whisperx[1128].start |
31023.683 |
| transcript.whisperx[1128].end |
31025.524 |
| transcript.whisperx[1128].text |
再生醫療法草案 案 。 |
| transcript.whisperx[1129].start |
31054.193 |
| transcript.whisperx[1129].end |
31081.011 |
| transcript.whisperx[1129].text |
第19條是使用取得有付款許可之再生醫療之際發生不良反應致死亡障礙或嚴重疾病的依所附加之付款來進行相關的來辦理那如果是有藥品許可證的再生醫療之際就適用藥害救濟法之規定那委員們的提案跟我們是一致也請支持我們行政院的版本 |
| transcript.whisperx[1130].start |
31081.711 |
| transcript.whisperx[1130].end |
31084.652 |
| transcript.whisperx[1130].text |
第二十條開始是罰則所以如果有下列各款的情形那罰款是三萬以上兩百萬以下 |
| transcript.whisperx[1131].start |
31098.078 |
| transcript.whisperx[1131].end |
31100.019 |
| transcript.whisperx[1131].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[1132].start |
31118.349 |
| transcript.whisperx[1132].end |
31142.766 |
| transcript.whisperx[1132].text |
違反第15條第4項規定,就是刊播未經核准與核准事項不符以廢止核准或經令立即停止刊播之招募廣告。第三款是違反第15條第5項規定,未依規定期限保存資料或保存資料不全或規避、妨礙或拒絕提供資料。 |
| transcript.whisperx[1133].start |
31143.546 |
| transcript.whisperx[1133].end |
31162.228 |
| transcript.whisperx[1133].text |
第4款是違反第15條第6項鎖定辦法當中有關招募廣告刊播地點之規定所以最主要都是對於這些細胞組織提供者他的一個招募廣告相關的一個規定那我們的提案也跟我們的一致那請支持我們行政院的版本 |
| transcript.whisperx[1134].start |
31163.429 |
| transcript.whisperx[1134].end |
31165.051 |
| transcript.whisperx[1134].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[1135].start |
31188.573 |
| transcript.whisperx[1135].end |
31189.494 |
| transcript.whisperx[1135].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1136].start |
31211.557 |
| transcript.whisperx[1136].end |
31237.642 |
| transcript.whisperx[1136].text |
第二十一條也是有關罰則的部分那划款也是三萬到兩百萬那包括第一款衛醫第五條第二項規定聘用具相關學歷及專門知識之專任人員這個就有划然後違反第六條第一項規定沒有取得藥品許可證或有付款許可就製造或輸入的那第三款是違反第七條的規定 |
| transcript.whisperx[1137].start |
31239.042 |
| transcript.whisperx[1137].end |
31260.023 |
| transcript.whisperx[1137].text |
未經核准擅自變更藥品許可證,那對於有付款許可或者是原查驗登記事項,或者是說有擅自移轉,這些都有這一條的罰款。那第四款是違反第11條第1項的規定,為確保提供者合適性就擅自的製造或輸入再生醫療字跡。 |
| transcript.whisperx[1138].start |
31260.803 |
| transcript.whisperx[1138].end |
31285.117 |
| transcript.whisperx[1138].text |
第五款是違反第十二條第一項本文的規定那不是以有意識能力之成人人之組織細胞來製造再生醫療製劑那第六款是違反第十二條第二項規定沒有在取得組織細胞之前就先獲得提供者書面同意或者是沒有依同條第三項第五項有關同意權行使的一些規定來辦理 |
| transcript.whisperx[1139].start |
31286.458 |
| transcript.whisperx[1139].end |
31309.959 |
| transcript.whisperx[1139].text |
第七款是為依第13條第一項的規定,與取得同意之前就應該是要告知該項所列的事項。第八款是違反第13條第二項所定的辦法當中有關告知的方式或者是程序的這些規定。第九款是違反第14條第一項的規定,不是藥商就來招募這些提供細胞組織的這種廣告。 |
| transcript.whisperx[1140].start |
31312.121 |
| transcript.whisperx[1140].end |
31326.51 |
| transcript.whisperx[1140].text |
第10款是違反第17條第1項規定,藥品許可證或有付款許可之所有人未依公告或合併安全監視計劃來執行,或醫療機構沒有提供安全監視資料。第11款是違反依第17條第3項鎖定辦法中有關安全監視報告的內容,繳交期限或監視期間的規定。 |
| transcript.whisperx[1141].start |
31340.578 |
| transcript.whisperx[1141].end |
31361.861 |
| transcript.whisperx[1141].text |
第12款是違反第18條第一項的規定,沒有保存資料。那第13款是違反第18條第二項所定的辦法當中有關保存資料的範圍保存方式或保存期限。」所以這個那委員們跟我們的相關的版本都一致,那請能夠支持我們行政院的版本。 |
| transcript.whisperx[1142].start |
31362.441 |
| transcript.whisperx[1142].end |
31386.759 |
| transcript.whisperx[1142].text |
陳昭芝委員陳昭芝支持那剛剛因為蘇巧慧委員她提的附帶決議是只有第17條那這裡又提到再次提到那個安全監視資料本來我們是建議說再加上一個無法辨識當事人是安全監視不過如果那個17那個附帶決議是不是把這一條也放在裡面因為蘇委員她只提到第17條但是那個21條沒有提到 |
| transcript.whisperx[1143].start |
31388.416 |
| transcript.whisperx[1143].end |
31389.536 |
| transcript.whisperx[1143].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1144].start |
31412.761 |
| transcript.whisperx[1144].end |
31431.125 |
| transcript.whisperx[1144].text |
無法辨識當事人的資料。其實一致而已。一致而已。剛剛的決定是說條文通過嘛。附帶決議也通過嘛。對。現在附帶決議裡面是只有17條。沒有這一條。所以陳委員的意思是說。要不要。要不要。但是因為那個是舒喬二委員提的。 |
| transcript.whisperx[1145].start |
31431.565 |
| transcript.whisperx[1145].end |
31450.401 |
| transcript.whisperx[1145].text |
所以可能是要看...那就一致性...如果剛剛大家同意他17了那進來...就在...可能不能去改他...因為他不在了...所以是不是委員...你再提一個附帶決議...我們民眾黨版本上面就這樣子建議...我們用附帶決議來處理嘛...一致嘛...附帶決議... |
| transcript.whisperx[1146].start |
31452.322 |
| transcript.whisperx[1146].end |
31454.063 |
| transcript.whisperx[1146].text |
第二十一條就先保留 |
| transcript.whisperx[1147].start |
31467.199 |
| transcript.whisperx[1147].end |
31471.46 |
| transcript.whisperx[1147].text |
第二十二條是本條例有關再生醫療自治之管理事項主管機關的定期或不定期稽查就是說讓我們把稽查就明定在法裡面 |
| transcript.whisperx[1148].start |
31494.403 |
| transcript.whisperx[1148].end |
31495.144 |
| transcript.whisperx[1148].text |
三）繼續審查委員羅廷瑋等21人擬具 |
| transcript.whisperx[1149].start |
31509.974 |
| transcript.whisperx[1149].end |
31513.338 |
| transcript.whisperx[1149].text |
第二十三條本條例施行日期由行政院定之。委員有沒有意見? |
| transcript.whisperx[1150].start |
31527.285 |
| transcript.whisperx[1150].end |
31542.435 |
| transcript.whisperx[1150].text |
沒有意見好那就照院板通過那報告委員會做一下決議再生醫療法草案9案與再生醫療制計條例草案9案均審閉一輪本日會議到此結束明天早上9點繼續審查現在休息 |
| transcript.whisperx[1151].start |
31561.361 |
| transcript.whisperx[1151].end |
31562.643 |
| transcript.whisperx[1151].text |
三）繼續審查委員羅廷瑋等21人擬具 |