{"id":151016,"url":"https://ivod.ly.gov.tw/Play/Clip/1M/151016","video_url":"https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948ed3b659d75e352727533009c4a7c43105f8ba9b0039caa7a62978663c216c5fe85ea18f28b6918d91.mp4/playlist.m3u8","委員名稱":"劉建國","委員發言時間":"13:17:06 - 13:37:00","影片長度":"00:19:54","會議時間":"2024-04-10T09:00:00+08:00","會議名稱":"立法院第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議（事由：一、審查\n(一)委員邱議瑩等25人擬具「再生醫療法草案」案。\n(二)委員謝衣鳯等19人擬具「再生醫療發展法草案」案。\n(三)委員羅廷瑋等21人擬具「再生醫療法草案」案。\n二、審查\n(一)委員邱議瑩等25人擬具「再生醫療製劑條例草案」案。\n(二)委員謝衣鳯等18人擬具「再生醫療製劑管理條例草案」案。\n(三)委員羅廷瑋等21人擬具「再生醫療製劑管理條例草案」案。\n【一、二案採綜合詢答，本日會議僅詢答】\n【4月8日及10日二天一次會】）","meet":{"tmpMeeting":null,"title":"第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議","term":11,"type":"委員會","sessionPeriod":1,"sessionTimes":11,"committees":[26],"id":"委員會-11-1-26-11"},"date":"2024-04-10","duration":1194,"end_time":"2024-04-10T13:37:00+08:00","start_time":"2024-04-10T13:17:06+08:00","features":["ai-transcript","gazette"],"type":"Clip","gazette":{"lineno":1078,"blocks":[["劉委員建國：（13時17分）謝謝主席，有請部長跟食藥署署長。"],["主席：請薛部長、吳署長。"],["劉委員建國：再生醫療製劑我們等一下再討論，我先跟部長還有署長來討論食安的問題。"],["薛部長瑞元：委員好。"],["劉委員建國：部長，我想大家都記憶猶新，從3月18日寶林茶室的中毒案開始，還有3月28日的藏壽司、3月30日的漢來飯店、4月6日王品旗下的初瓦、嚮辣，還有昨天的八方雲集，應該不只這些啦！食安問題真的就像瘟疫一樣，我在這個地方也特別提過，不斷地在連環爆，尤其都在臺北市來爆發比較多，我想現在大家有個疑問，臺北市政府到底能不能去應付這個事情？這是第一個。","我會這樣講是有一個背景資料，我看到臺北市衛生局在3月24日稽查寶林茶室的時候，因為查無食餘，因此僅帶回砧板、菜刀、水果刀以及廚師手部的生物跡證共4項檢體。在3月28日藏壽師傳出食安問題的時候，臺北市衛生局同樣以查無食餘，然後也只採驗砧板、生食刀具及工作人員手部的生物跡證等。那臺北市衛生局陳局長他是這麼表達，「3月24日當天衛生局依據衛福部食藥署訂定的作業流程，先前往餐廳採集食餘，但現場沒有剩下同批食餘，所以僅採集環境及生物檢體」，陳局長又提到，「現行規定並沒有要求稽查人員在第一時間就要將所有食材扣走，也許未來可以與中央及專家學者討論，是否要修改處理方式，衛生局將會遵行」，這是他在記者會上講的。","我要簡單表達的是，臺北市政府衛生局把球丟回去給中央，說中央沒有規定，部長、署長，你怎麼說？"],["薛部長瑞元：其實在中央所訂的這一個處理要點，就是疑似食品中毒……"],["劉委員建國：處理什麼樣的要點？有一個正確名稱吧！"],["薛部長瑞元：「疑似食品中毒事件處理要點」裡面就有寫到，剛剛委員也提到了，他要去做食品檢體及環境檢體，包括這些砧板、刀具還有處理臺；食品的檢體就是食餘，另外一個叫做懷疑的食材。"],["劉委員建國：就是我簡報上提供的這一個，對不對？"],["薛部長瑞元：對。"],["劉委員建國：「疑似食品中毒事件處理要點」的第四條第一款，「食品檢體（食餘、嫌疑食品等）」。"],["薛部長瑞元：對。"],["劉委員建國：對嘛！有規定嘛！"],["薛部長瑞元：所以他們可能在取樣的時候，自己把解釋限縮了。當然這裡面會牽涉到一個，就是他認為是懷疑食品的話，他要帶走取樣的範圍有多大？臺北市衛生局的同仁可能在這個地方沒有辦法去做判斷，因為那個時候還沒有停業處分，所以它還在經營，你如果把東西都收光了，它就不用做了。"],["劉委員建國：我覺得部長你在幫他說話耶！你如果這麼說，你知道26日的時候有停業了嗎？"],["薛部長瑞元：當天停業。"],["劉委員建國：當天停業。"],["薛部長瑞元：對，當天停業。我們跟衛生局去的時候，當天就給它停業了，所以我們就統統帶回來。"],["劉委員建國：統統帶回來，總共帶回多少項檢體？"],["薛部長瑞元：35件。"],["劉委員建國：35件檢體。"],["薛部長瑞元：對。"],["劉委員建國：是因為停業，所以才會馬上，不是這樣吧！"],["薛部長瑞元：先採樣啦！應該是先採樣。"],["劉委員建國：對嘛！"],["薛部長瑞元：我的意思是說，基層的同仁有時候會對這一點有遲疑，我只是幫忙這些基層同仁講一下話。"],["劉委員建國：部長，你這樣不對，你在幫忙他們講話，好像我們在苛責他們的處理方式，不對吧！"],["薛部長瑞元：沒有，基層的……"],["劉委員建國：我們是把事情釐清嘛！"],["薛部長瑞元：對，這些基層的同仁也是辛苦啦！但是這個部分的話，他把自己的解釋限縮了，把懷疑食品的解釋限縮。"],["劉委員建國：你們這個要點什麼時候訂的？"],["薛部長瑞元：這個訂很久了。"],["吳署長秀梅：最新修訂是109年，我們在102年就訂了。"],["劉委員建國：102年11月28日就訂了，對不對？"],["薛部長瑞元：對。"],["劉委員建國：第四條的第一點沒有改嘛？"],["薛部長瑞元：應該沒有。"],["劉委員建國：都沒改過，所以109年的修正跟這個沒有關係。"],["薛部長瑞元：對。"],["劉委員建國：所以這個要點在102年11月28日就已經存在了，對不對？"],["薛部長瑞元：對。"],["劉委員建國：那內容也是如我們現在顯示出來的嘛？"],["吳署長秀梅：是。"],["劉委員建國：這個要點明確訂定縣市分工及請求中央支援的流程，還加入了疑似肉毒桿菌處理原則，還有醫療院所發生食品中毒的通報流程，也包含剛剛我特別提到的採檢食餘、嫌疑食品等，都在這個要點裡面，沒有錯嘛？對不對？"],["薛部長瑞元：對。"],["劉委員建國：好，今天部長你要去體諒基層第一線的同仁對整個要點的處理可能認知有所落差，這是另外一件事情，但是這個局長說他是依照你中央相關的規定……"],["薛部長瑞元：這樣講有點不太對。"],["劉委員建國：然後他還要要求未來可以與中央及專家學者來做討論是否要修改，那你要修改哪一條？你跟我講，現在局長說要跟你們修啊！"],["薛部長瑞元：沒有啦！這其實不是修的問題，而是這個SOP大家還要再做教育。"],["劉委員建國：這個要點已經囊括一切，當然法還是有些不周全之處，不過如果依照他們這幾次到現場去採集檢體的過程應該是足夠了，不是說不夠還必須要再……"],["薛部長瑞元：可以，已經可以執行了。"],["劉委員建國：對。好，我再給部長看一個資料，有議員去請求臺北市政府做相關的回復，他們叫索資啦！然後臺北市清楚地回復，「有關疑似食品中毒發生時食材抽驗作業流程說明如下：(一)衛生福利部食品藥物管理署『食品中毒採樣操作手冊』內容摘要……」，然後「(二)本局針對疑似食品中毒作業流程依照中央訂定之相關文件辦理，因本案稽查現場無同批食餘，爰採集廚師手部及環境檢體，爾後中央如修正『食品中毒採樣操作手冊』，本局將配合辦理」，又是你中央啊！"],["薛部長瑞元：這個是這樣子……"],["劉委員建國：不、不、不，好吧！部長你先答，我看你怎麼答。"],["薛部長瑞元：剛剛委員提到了，因為它會有食餘，還有另外一個叫做疑似食品，大家比較經常看到的是食餘的作業程序，比方說學校包桌，他做了這一桌，不管吃了幾道菜，每一道菜都要有一碟留存下來，有發生食中的時候，食物中毒的時候，就要把那一些拿回去做檢驗，這是比較例行的食物中毒的處理。","但是疑似食品這個部分，你把它限縮解釋就變成他都吃完了，就沒有了，會產生這個問題，但是事實上是可以不用那麼限縮解釋。老實說，你要拿就拿了，你要採樣多少，如果像我剛剛講的，它沒有勒令停業的話，你還是可以採啦！"],["劉委員建國：部長，我儘量讓你說清楚，但是我們在委員會要討論到很細的細節真的是有困難。"],["薛部長瑞元：對。"],["劉委員建國：現在臺北市政府答復議員，它是說依照中央的「食品中毒採樣操作手冊」，就是這一本，那我們針對食品中毒，到底是要依照「疑似食品中毒事件處理要點」，還是要依照這個手冊？"],["薛部長瑞元：應該主要依據的是疑似食品中毒那一個。"],["劉委員建國：主要是依據食品中毒的處理要點，對不對？"],["薛部長瑞元：對。手冊是更細節的部分，在採樣的部分。"],["劉委員建國：在更細節的採樣部分是依照這個手冊。"],["薛部長瑞元：對。"],["劉委員建國：不對吧！你食藥署現在還有這份資料嗎？你們有公告上網嗎？"],["薛部長瑞元：這已經廢止了，這一份已經廢止了。"],["劉委員建國：對嘛！所以部長不知道，署長要快一點跟他說，他還跟我說了半天。這個廢止了，為什麼臺北市政府還依照這個手冊在答復他們的市議員？"],["薛部長瑞元：我們不知道它怎麼會用這一個。"],["劉委員建國：你們這個手冊什麼時候廢止的？「食品中毒採樣操作手冊」！我的助理去查，你們曾經在112年3月8日公告廢止這本手冊附錄，是公告這個手冊的附錄哦！附錄就是後面第幾頁，你只有廢止「食品衛生檢驗項目暨抽樣數量表」，沒有查到你們什麼時候去廢止。現在署長你跟我講說這個已經廢止了，照理講通令各地方政府應該非常清楚啊！怎麼臺灣的首都還在依照你們廢止的手冊在處理整個食品中毒的流程？"],["薛部長瑞元：我們回去再查一下，看看什麼時候廢止的，廢止的時間。"],["劉委員建國：我覺得臺北市政府有其必要檢討的部分，但是衛福部這個地方也有問題哦！之前在網路上還可以查到這個手冊，我們適度地去提醒食藥署之後，這個手冊已經不見了，當時我們查到公告就只有針對那個附錄去公告廢止，所以我才會覺得很奇怪。但是衛福部之前叫衛生署的時候，這個「疑似食品中毒事件處理要點」在102年11月28日就訂出來了，然後縣市分工得非常清楚，在要點裡面都還括號應該做什麼事情、誰去做，怎麼臺北市政府到現在還會答復他們的議員是依照這個已經廢止的手冊在做處理？","在前段跟第二段我要向部長及署長表達的是，怎麼會這個樣子？難怪他們在參與的時候，會參與得「離離落落」嘛！難怪他們什麼事情到最後就是推給中央，那你們自己也造成這樣一個不應該發生的事情嘛！今天這個手冊已經公告廢止了，是不是可以明確地通告所有的縣市政府？"],["薛部長瑞元：好，這個我們再確認一下。"],["劉委員建國：我們就是要依據「疑似食品中毒事件處理要點」來做處理。好，署長請回，今天就處理，好不好？謝謝。","部長，再生醫療應該是我在這個委員會最早排入的，然後之前也在9樓擴大辦公聽會，那時候應該來了上百個醫事團體及相關協會的代表，我不曉得院版為什麼到現在還沒辦法進來，到底什麼時候才可以進來？"],["薛部長瑞元：我們目前排定的是4月19日。"],["劉委員建國：4月19日。"],["薛部長瑞元：政委會召開會議審查，因為內容有稍做修正，審查過後再來就是排院會，那院會的時間我就沒有辦法跟委員說明是哪一次的院會，但是我預計大概會在520之前送到立法院。"],["劉委員建國：因為召委已經排進來了，我起先以為行政院跟衛福部這邊都已經溝通好了。","你看這個是第10屆的行政院版本，在第九條第一款、第二款、第三款，尤其是第二款、第三款的授權，今天應該有很多委員有相對地對部長做出提醒，第二款跟第三款就是授權，當時引起民間團體很大的反彈，如醫改會、消基會、臺灣病友聯盟、台灣醫藥品法規學會及台灣受試者保護協會等等等都跳出來反對。","我也記得薛部長在4月21日，去年啦！不是今年，4月21日在第一次朝野黨團協商中，針對行政院的第九條第二款、第三款部長認為這個範圍過大、太過普遍了，有門檻放得太寬的疑慮，且不應該以風險低為由即可跳過完整的人體試驗；在4月21日的協商中，衛福部也針對第九條現場提出修正版本，僅保留恩慈療法的建議條文，當時是這樣，對不對？"],["薛部長瑞元：對。"],["劉委員建國：那個時候也獲得民間團體及醫界的肯定，這個記憶我再提醒一下。"],["薛部長瑞元：目前我們送到行政院的修正版本裡面，對於第九條做了一個大改，第一個就是在前面的這個情形的話，變成說所有的再生醫療都要做人體試驗，除了這一條所規定的情形之外是免完成人體試驗就可以來做，不會說什麼「免依再生醫療製劑條例之規定申請」，跟製劑條例無關，是免人體試驗、免完成人體試驗。","它本來是三款，現在剩下兩款，第一款就是原本的第一款，也就是恩慈療法，已經沒有辦法了，那讓他有這個機會；第二款的部分就是已經依現有的特管辦法執行中的案件，不必重複再做人體試驗。"],["劉委員建國：特管辦法已經有執行的。"],["薛部長瑞元：對，已經在執行中的，只有這兩種，其他我們都拿掉了，所以不會有什麼初步安全性跟初步療效，這個就把它拿掉，因為我們檢討的結果是無法執行。"],["劉委員建國：OK，但是你們在3月有舉辦再生醫療草案的說明會，部長，你看一下第八條第二款「先進國家完成人體試驗並已上市，或未上市但具安全性及初步療效」。"],["薛部長瑞元：對，當時在說明會裡面我們這個還保留，但是事後我們內部再做檢討，我們覺得這個無法執行啦！也就是說，如果按照這樣子在國外完成人體試驗而且已經上市了，你要進來的話用恩慈療法就可以了，因為國內還沒有做人體試驗，那你用第一款就可以處理。","再來，假設是還沒有上市但具安全性及初步療效，它看起來的意思有兩個可能，第一個就是說人體試驗有一個範圍，什麼樣的病人才可以進來，但是現在要把其他的病人、不符合原來人體試驗規劃範圍的也納進來，這樣子理論上是不可行，因為當時設計納入條件就把這個排除掉了，現在走到一半突然要把他納進來，應該是人體試驗那個Protocol要重新再去規劃、重新送審。","第二個情形是說，好，因為療效有比較好，比方說他本來預計做20個，現在做了10個，他覺得很好，那就要用第二款讓它加速上市，那這個也不對，因為當初在做的時候，納入條件越嚴格本來case就會少，如果case少的話當然可以快一點把它做完，因為case少。但是如果條件比較鬆的話case就會多，但是成功的機會就會變少；如果條件弄得嚴格的話可以快一點完成，但是成功機會就會比較高。會有這兩個情形，所以當初在設計人體試驗的時候就必須要考量好，有關這個主持人要怎麼樣做、納入的條件要多寬，這本來就要考量，不能做到一半才覺得不錯，還沒做完就要申請上市，我覺得這樣子不好，所以我們才把第二款拿掉。"],["劉委員建國：好，我聽部長說了很久，我聽得很仔細，我也聽懂了，所以你們現在把第八條第二款後面的「或未上市但具安全性及初步療效」……"],["薛部長瑞元：我們拿掉了。"],["劉委員建國：基本上你們已經拿掉了，對不對？"],["薛部長瑞元：對。"],["劉委員建國：但是我覺得很奇怪，為什麼3月的時候開說明會，這個東西顯示出來跟之前的第九條第二款是一樣的？為什麼是說明會開完之後回去才在檢討、才把它拿掉，而不是開說明會之前就把它拿掉？"],["薛部長瑞元：因為當時在處理的時候，文字的部分看起來沒有什麼問題，但是後來我們在檢討通過後要怎麼執行，就會發生這個問題，執行一定會出問題。"],["劉委員建國：好，我想這個法案一定要達到社會的共識，對不對？"],["薛部長瑞元：對。"],["劉委員建國：可能有些細節部長沒有這麼多時間看，但是相關的幕僚應該要看得清楚才對，請注意這個事情，好不好？"],["薛部長瑞元：好。"],["劉委員建國：我覺得也應該跟民間說明清楚，因為你們是開完說明會之後回去才拿掉。"],["薛部長瑞元：對，所以我們在送立法院之前可能還會對外界做一些宣導。"],["劉委員建國：好，謝謝部長，謝謝主席。"],["薛部長瑞元：謝謝。"],["主席：謝謝劉建國委員發言。","接下來請邱志偉委員、邱志偉委員、邱志偉委員不在。","本日會議詢答全部結束。委員邱鎮軍、林德福、邱志偉、羅廷瑋委員所提書面質詢列入紀錄，刊登公報。"],["委員邱鎮軍書面質詢：","近年來全球受疫情影響，凸顯生醫產業的重要性，也印證生技醫療在國家安全的重要戰略定位。","Q1：這次審查再生醫療法沒有院版提案，請問院版再生醫療法草案目前審查進度為何？預定何時送到立法院？","Q2：再生醫療法中最爭議的問題之一「治療昂貴且效果不明」，請問針對培養細胞或組織，其性質是否屬於藥事法第5條規定之「試驗用藥物」？又依藥事法第4條規定藥物係指藥品及醫療器材，則經培養之組織或細胞究為「藥品」或「醫療器材」？","Q3：針對醫師團體認為，再生製劑有別於一般藥品，大多是在醫院內由醫師直接用於病患，因此使用再生製劑，不該受到《藥品優良調劑作業準則》的限制；而藥師方則認為，執行再生醫療的過程，從製造端開始到施用於患者身上，都應遵循《藥品優良調劑作業準則》的框架，由藥師介入監督才合理。對此請問衛福部態度為何？","Q4：針對再生醫療法草案，可望開放異體細胞使用，不僅要留意細胞本身的安全性、提供者細胞的合適性、處理過程的污染問題及操作的複雜度，亦是風險評估的要點。有團體認為現階段實證研究不足，不宜貿然開放。請問衛福部態度為何？","Q5：針對上屆期院版「再生醫療製劑條例草案」第9條規定，為診治危及生命或嚴重失能之疾病，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，得附加附款，核予有效期間不超過五年之許可，期滿不得展延；然而「再生醫療法草案」第9條卻又規定，只要符合「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」、「經執行人體試驗結果，證實其安全性及初步療效」或「提供不含基因改造或轉殖之人類細胞及其衍生物之細胞治療」其中一種情形，就不用依再生醫療製劑條例規範，申請藥品許可證。對此有專家認為再生醫療法草案大幅鬆綁法規限制，對於醫院施行再生醫療技術的門檻與臨床試驗要求，明顯低於對再生醫療製劑的要求，問題很大。請問對此問題新版草案是否提出修正？","Q6：針對胎兒、限制行為能力及無行為能力者，只要得到法定代理人或監護人的書面同意，就能向醫院或細胞保存機構提供組織、細胞。外界憂心，倘若沒有限定細胞的使用方式，加上提供細胞還能從中獲得補助，請問未來立法是否具體規範父母能否提供上開對象之細胞，甚至用於販售？","Q7：針對上屆期院版再生醫療法草案，最高只罰款200萬元，沒有任何刑事責任，民眾可能花大錢當白老鼠，卻無法獲得應有的保障。請問目前立法方向，針對違反再生醫療雙法者，是否加入刑事責任？"],["委員林德福書面質詢：","問題一","根據衛福部去年統計，平均每天大約有6起「兒少遭性剝削」案件，且案件逾七成為運用「網路犯罪」！","近日媒體報導，性犯罪網站「創意私房」沒有被「封網」，依然可供民眾瀏覽。引發民眾質疑，為何「數發部」沒有動作？「數發部」說，只要收到「衛福部」發出的行政命令，就可配合「封網」。","社會都在關注本案後續發展，請衛福部要以最快速度處理，請問衛福部最新處理情形為何？","問題二","民眾生病，花大錢，希望找一線生機，但是網路搜尋「再生醫療」加「詐騙」，跳出來的案件卻層出不窮。","本席希望行政院版的再生醫療法草案，衛福部要做好把關，讓民眾就醫權益能夠獲得保障，不要花大錢當冤大頭。如果一旦「再生治療」上有疑慮，病人的權益如何保障？民眾能否申請救濟補償？","請衛福部說明未來的處理方式！","問題三","根據媒體報導，近期國內腸病毒疫情持續升溫，疾管署提醒，全國腸病毒就診人數較上禮拜增加，預估5月底達到疫情高降。","請問衛福部，「腸病毒71型」是否會在今年大流行？","請問衛福部，為何「腸病毒疫苗」沒有納入常規疫苗接種？是專家會議認為不需要？還是政府預算不足？","問題四","今天樓上「財政委員會」討論「所得稅法」相關扣除額，許多立委都關心「長照扣除額」並提案增加額度。","「外籍家庭看護工」一年薪資含加班費大約就要30萬，還不包含其他長照開銷！現行的12萬元的扣除額，恐不足因應物價膨脹、長照開銷等因素。","請問衛福部，是否「反對」提高「長照扣除額」？本席希望站在衛福部的立場，要替民眾爭取權益，提高長照扣除額，減少長照悲劇發生！"],["委員邱志偉書面質詢：","1.鑒於再生醫療之製劑成分特殊性及治療複雜性，風險管控有別於一般醫療行為，現行相關規範無法完全涵蓋或一體適用。惟另立專法亦可能有與其他法規產生競合或適用上疑義，如《再生醫療法》草案與《生技醫藥產業發展條例》針對「再生醫療」即有不同定義範圍。再者，「醫療機構」於《醫療法》中有較為詳盡之規範，而再生醫療屬新興生物醫學科技，使用不同之再生製劑或執行再生技術時，將有不同之風險等級，醫療機構應分級依其相當之資格與技術能力，並採較嚴謹之管控機制，始能確保病人接受再生醫療之品質、安全性及有效性。爰請衛福部於一個月內，全盤檢視相關法規範之定義及針對另立專法之必要性提出評估報告。","2.為兼顧醫療迫切需求之病人權益，食藥署受理再生醫療製劑查驗登記申請時，得考量病人生命之危急性及失能之嚴重度，經整體效益及風險評估，核予「附加附款且有效期間不超過五年之許可」，以即早提供多元治療之選擇。尋求細胞治療的病人，多數已相對虛弱或已有治療副作用或併發症等，於此情況下接受再生醫療之療法，若於治療過程中產生「不良反應」乃至於死亡（無論是治療過程中死亡或是療程結束後的死亡），通常難以釐清是疾病本身的進程或治療所致，導致難以舉證不良反應或根本無法舉證。而目前「有附款之許可」卻未有一致性通用的不良反應救濟規劃，爰請衛福部於一個月內，針對救濟程序如是否是用藥害救濟或醫療事故救濟制度提出評估報告。","3.再生醫療產品應應廣納醫學、藥學、法律倫理等專家學者共同組成公正且具有實質權限之審議委員會，就再生醫療產品全生命週期，包含上市前審查及上市後安全監控等各階段，共同監督管理，分別從法規、政策、科學研究及臨床醫療等面向，為民眾權益把關。爰請衛福部於一個月內，針對再生醫療審議會組成提出評估報告。"],["委員羅廷瑋書面質詢：","1.過去外界誤解「再生醫療法」，以為再生醫療不用人體試驗，但這是錯誤觀念，所有再生醫療若要常規化，都一定要經過人體試驗，僅有在幾個條件下，才可以不用等人體試驗完成。請問衛福部針對過去外界誤解「再生醫療法」，以為再生醫療不用人體試驗，這個錯誤觀念，還有報載四大爭議點、五大爭議點有無對外及與有異議學者溝通、解釋、說明？","2.請問自99年起迄今，向食藥署提出申請細胞治療產品臨床試驗：","(1)細胞治療共有幾件？基因治療共有幾件？","(2)目前已有幾件准予執行？","其中phaseⅠ共有幾件？","phaseⅠ/Ⅱ（一併二期）及phaseⅡ共有幾件？","phaseⅢ共有幾件？","完成三期臨床試驗者共有幾件？","核准細胞治療、基因治療許可證者各共有幾件？","3.承上，這些許可證：","（Ⅰ）各在什麼時候核准？","（Ⅱ）各完成幾期臨床試驗者分別有幾件？","（Ⅲ）國內外受試驗者人數共有多少人？","（Ⅳ）在那些醫院使用？有多少病患受益？","（Ⅴ）後續有無追蹤使用後之療效與安全性？是否符合宣稱之療效？又其不良反應如何？"],["主席：現在作以下決議：說明及詢答完畢。委員質詢未及答復或請補充資料者，請相關機關於兩週內以書面答復；委員另要求期限者，從其所定。「再生醫療法草案」等3案及「再生醫療製劑條例草案」等3案，另擇期繼續審查。","本次會議到此結束，現在散會，謝謝。","散會（13時37分）"]],"agenda":{"page_end":226,"meet_id":"委員會-11-1-26-11","speakers":["黃秀芳","邱議瑩","羅廷瑋","陳昭姿","林月琴","陳菁徽","王育敏","涂權吉","王正旭","蘇清泉","林淑芬","洪申翰","黃捷","賴士葆","陳瑩","黃國昌","洪孟楷","楊瓊瓔","蘇巧慧","陳冠廷","楊曜","劉建國","邱鎮軍","林德福","邱志偉"],"page_start":155,"meetingDate":["2024-04-10"],"gazette_id":"1132601","agenda_lcidc_ids":["1132601_00004"],"meet_name":"立法院第11屆第1會期社會福利及衛生環境委員會第11次全體委員會議紀錄","content":"一、審查(一)委員邱議瑩等25人擬具「再生醫療法草案」案、(二)委員謝衣鳯等19人擬具「再生\n醫療法草案」案、(三)委員羅廷瑋等21人擬具「再生醫療法草案」案；二、審查(一)委員邱議瑩\n等25人擬具「再生醫療製劑條例草案」案、(二)委員謝衣鳯等18人擬具「再生醫療製劑管理條例\n草案」案、( 三) 委員羅廷瑋等21 人擬具「再生醫療製劑管理條例草案」案【一、二案採綜合詢\n答，本日會議僅詢答】","agenda_id":"1132601_00003"}},"transcript":{"id":"151016","pyannote":{"name":"ronny","tool":"pyannote","data":{"url":"https://ivod.ly.gov.tw/Play/Clip/1M/151016","tool":"pyannote","id":"151016-pyannote"},"job_id":"U0RhfPZTGlVp4Zwz","queued_at":"2024-06-01 12:01:53","status":"done","log":[{"time":"2024-06-01 12:04:02","msg":"downloading https://ivod.ly.gov.tw/Play/Clip/1M/151016"},{"time":"2024-06-01 12:04:03","msg":"downloading https://ivod-lyvod.cdn.hinet.net/vod_1/_definst_/mp4:1MClips/871d5246fb87948ed3b659d75e352727533009c4a7c431059cf12f16b805e0f42920bcfc32d3c7235ea18f28b6918d91.mp4/playlist.m3u8"},{"time":"2024-06-01 12:04:34","msg":"converting mp4 to wav"},{"time":"2024-06-01 12:04:37","msg":"running pyannote"},{"time":"2024-06-01 12:04:52","msg":"status: 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\"end\": 1189.945, \"score\": 0.85}, {\"word\": \"長\"}, {\"word\": \"謝\"}, {\"word\": \"謝\"}, {\"word\": \"主\", \"start\": 1189.945, \"end\": 1190.065, \"score\": 0.942}, {\"word\": \"席\", \"start\": 1190.065, \"end\": 1190.245, \"score\": 0.883}, {\"word\": \"謝\"}, {\"word\": \"謝\"}, {\"word\": \"好\", \"start\": 1190.245, \"end\": 1190.385, \"score\": 0.857}, {\"word\": \"謝\"}, {\"word\": \"謝\"}, {\"word\": \"劉\"}, {\"word\": \"建\", \"start\": 1190.385, \"end\": 1191.786, \"score\": 0.975}, {\"word\": \"國\"}, {\"word\": \"委\", \"start\": 1191.786, \"end\": 1192.026, \"score\": 0.916}, {\"word\": \"員\"}, {\"word\": \"發\"}, {\"word\": \"言\", \"start\": 1192.026, \"end\": 1192.046, \"score\": 0.0}], \"language\": \"zh\"}","srt":"1\n00:00:06,836 --> 00:00:19,219\n謝主席。有請部長跟...請薛部長。跟食藥署署長。吳署長。那個再生醫療之際我們等一下討論齁。先跟部長還有署長來討論實案的問題。我想大家都記憶猶新嘛齁。從3月18這個保齡查釋的中毒案開始。\n\n2\n00:00:29,452 --> 00:00:57,737\n還有3月28日的長壽司、3月30日的汗奶飯店、世界烈化的文品旗下的粗瓦、響蠟還有昨天的八王雲集,應該不只這些啦。這個實案真的就像瘟疫一樣,我在這個地方也特別提過,不斷地在凌亂爆,尤其都在臺北市來爆發比較多。我想現在大家有一個疑問,臺北市政府到底能不能去應付這個事情,這是第一。\n\n3\n00:00:59,912 --> 00:01:18,223\n我會講這樣一個背景資料我看到臺北市這個衛生局在3月24號稽查保齡查試的時候因為查無實語也因此僅帶回砧板菜刀水果刀以及這個廚師手部的生物跡證共四項的檢體然後3月28號在長壽司也傳出這樣的審問題的時候臺北市衛生局同樣以查無實語\n\n4\n00:01:25,100 --> 00:01:31,815\n然後也制裁上砧板生死刀具還有工作人員首部的生物跡證等那\n\n5\n00:01:34,967 --> 00:02:02,174\n陳局長特別是衛生局的陳局長在3月24號當天他是這麼表達他是依照衛福部食藥署訂定的作為流程先前往餐廳採集食魚但現場沒有剩下同批食魚所以僅採集環境及生物前提陳局長又提到現行規定並沒有要求檢查人員在第一時間就要將所有的食材扣走\n\n6\n00:02:03,587 --> 00:02:27,065\n所有的食材扣走。」這是他記者會講的。然後也許未來可以與中央及專家去討論是我要修改處理方式,衛生局將會遵循。我要簡單表達就是說,台北市衛生局是把這個球丟回去給中央。所以中央沒有規定。那部長、署長你怎麼說?\n\n7\n00:02:28,853 --> 00:02:42,044\n呃這其實齁在中央所定的這一個處理要點齁就儀式食品中毒事件處理什麼樣的要點那個有一個正確名稱嗎儀式儀式食品中毒事件處理要點對裡面就有寫到齁剛剛\n\n8\n00:02:44,286 --> 00:03:03,388\n委員提到了他要去做食品的檢體跟環境檢體包括這些剛剛提到的砧板、刀具還有這些處理台食品的檢體就是食與另外一個叫做懷疑的食材\n\n9\n00:03:04,509 --> 00:03:22,285\n所以現在我提供這個嘛對不對?疑似食品中毒事件處理要點嘛齁在第4條的第1款裡面食品檢體括號食語還有嫌疑食品等嘛對嘛有規定嗎所以他可能自己在的時候是把他解釋線說了啦\n\n10\n00:03:24,581 --> 00:03:51,313\n當然這裡面會牽涉到一個就是說如果說他懷疑的食品的話那他要帶走取樣的範圍有多大那可能說那個臺北市衛生局的同仁這個地方他沒有辦法去做判斷因為他沒有在那個時候要被停業處分所以他還在經營嘛你如果把東西收起來他就要做了\n\n11\n00:03:53,964 --> 00:04:19,214\n我感覺不像你提供的。你如果這樣說,26號的時候,你知道26號的時候有停業了嗎?那當天停業。當天停業。我們跟衛生局去的時候,當天就給他停業了。所以我們就通通把他帶回來。通通把他帶回來。總共帶回來多少項的檢體?三十五件。三十五件檢體。是因為停業,所以才馬上,不是這樣吧?\n\n12\n00:04:20,600 --> 00:04:47,302\n先採樣啦。應該是先採樣啦。我的意思就是說基層的同仁有時候會對這一點就是會有遲疑啦。我只是說幫忙這些基層同仁去講一下話啦。拜託你還不對。你幫忙他們講話,還不會說你苛責他們的處理方式,不對吧?我們是把事情釐清嘛。對。這些基層的同仁也是辛苦啦。但是這個部分的話,他把自己的解釋先說了啦。\n\n13\n00:04:49,466 --> 00:04:52,648\n懷疑食品解釋的發現說⋯⋯你們這個什麼時候訂的?這很舊的最新修訂109我們102年就訂了1020的11月28號就訂了對不對?這個第4條的第一點沒有改嗎?\n\n14\n00:05:08,082 --> 00:05:21,219\n都沒改過嘛,所以英九的修正跟這個沒有關係嘛所以他在109年11月28日就已經存在了這個要點嘛對不對那內容也是如我們這樣顯示出來的嘛這個要點也明確定這個\n\n15\n00:05:22,761 --> 00:05:47,589\n整個縣市分工,請求中央的支援流程,還加入了什麼疑似漏土桿菌,處理原子,還有醫療院所發生食品中毒的通報流程,也包括剛剛我特別提到的採檢死予、嫌疑食品等都在這個要點裡面嘛,沒有錯嘛,對不對?那今天部長你要去體諒都基層的第一線的這些同仁可能對整個這個要點\n\n16\n00:05:49,233 --> 00:05:51,054\n邱議瑩等21人擬具〈再生醫療法草案案〉案。\n\n17\n00:06:08,052 --> 00:06:26,679\n這其實不是修的問題就是說這個SOP大家還要再做教育這個要點已經人看一切啦我當然還是有些不周全之處不過如果依照他們在這幾次到現場去採這個檢體的過程裡面應該是足夠了啦不是說\n\n18\n00:06:32,481 --> 00:07:01,281\n不夠還必須要再...已經可以執行了應該對嘛好那你看齁我再給部長看一個資料有議員啦齁去請求台北市政府做這個相關的一個回覆他們叫索資啦齁然後台北市得清楚的回覆是說有關疑似食品中毒發生在食材抽驗作業流程說明如下第一點依照衛生福利部食品藥管理署食品中毒採樣操作手冊\n\n19\n00:07:02,931 --> 00:07:27,317\n內容災藥然後第二點本局如果針對疑似食品食品中毒作為流程依照中央訂定之相關文件辦法因本案稽查現場無同批示與原採集廚師所布及環境檢體而後中央如修正食品中毒採樣操作所測本局將配合辦理又是你中央啊\n\n20\n00:07:28,865 --> 00:07:32,007\n邱議瑩等21人擬具:「再生醫療發展法草案案件事宜、儀式食品等事宜等事宜等事宜\n\n21\n00:07:48,436 --> 00:07:49,056\n邱議瑩等21人擬具:「再生醫療\n\n22\n00:08:11,998 --> 00:08:18,303\n邱議瑩等21人擬具:「再生醫療發展法草案案件事件事件事件事件事件事件事件事\n\n23\n00:08:34,651 --> 00:08:59,576\n我先讓你說清楚啦但是我們在這個委員會要討論到相關的很細的細節真的是有困難嘛現在這個是台北市政府打呼議員的他是說依照中央的食品中毒採樣操作手冊就這一本嘛就這本嘛好那我們針對食品中毒我們到底是要依照疑似食品中毒事件處理要點還是要依照這個手冊\n\n24\n00:09:04,688 --> 00:09:26,900\n這個應該主要依據的是那個疑似食品中毒的那一個啦。只要是要依據食品中毒的處理藥品那一個嘛,對不對?這是更細節的部分啦,在採樣的部分啦。這個更細節在採樣的部分依照這個手冊?對。不對吧?是啊。你是要首先知道還有這份資料嗎?你們有公告上網嗎?這已經廢紙了。這份是已經廢紙了。啊都對嘛。對,是廢紙的。\n\n25\n00:09:31,147 --> 00:09:37,390\n邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件\n\n26\n00:10:00,873 --> 00:10:18,700\n112年的3月8號公告廢紙這本手冊互錄是公告這個手冊的互錄喔,互錄就是後面第幾頁嘛齁然後食品衛生檢驗項目寄抽樣數量表你就廢紙那個數量表啊沒有查到你們什麼時候去廢紙那現在說你跟我講說這個已經廢紙了\n\n27\n00:10:20,543 --> 00:10:47,540\n他照理講通令各地方政府應該非常清楚怎麼台灣的首都還在依照你們廢紙的這個手冊在處理整個食品中毒的流程我們回去再查一下看看什麼時候廢紙的廢紙的時間我覺得特別是有其必要檢討的部分但是衛福部這個地方也有問題喔\n\n28\n00:10:50,070 --> 00:11:17,864\n之前在網路上還可以查到這個手冊我們有適度去提醒食藥署之後這個手冊已經不見了啦但是我們查到公告就只有針對那個賦錄去公告廢紙啦所以我才會覺得很奇怪嘛但是你們在我們應該還沒有衛生部之前叫衛生署的時候也把這個疑似食品中毒事件處理要點在102.11月28日就訂出來了然後縣市分工非常清楚連要點裡面都還括號\n\n29\n00:11:19,380 --> 00:11:47,058\n他應該做什麼事情啊誰去做嘛對不對啊怎麼台北市政府到現在還會答覆他們的議員是依照這個已經彙止的這個手冊在做處理所以在前段跟第二段我要跟部長跟所有人表達就是說怎麼會這個樣子不關他們參與的事參與得很離人不關什麼事情到最後就是推給中央嘛那我們自己也造成這個這樣的一個不應該發生的事情嘛\n\n30\n00:11:50,478 --> 00:12:09,129\n所以今天這個手冊已經公告會址了是不是可以明確的通告所有的各縣市政府嘛對不對我們就是要疑似這個食品中毒的事件處理要點來做處理嘛好請署長請回來今天就處理好不好謝謝署長這個再生醫療應該是\n\n31\n00:12:13,522 --> 00:12:35,294\n應該是我在這個委員會最早排入的啦。然後之前也透過擴大的公聽會在酒樓。那時候應該來了上百個醫師團體還有相關的協會的代表。我不曉得我們院辦為什麼到現在還沒幫我進來?到底什麼時候才可以進來?\n\n32\n00:12:36,810 --> 00:13:01,927\n我們目前排定的是4月19,政委會召開會議審查,因為內容有稍作修正。審查過後的話,就是排院會。院會的時間我就沒有辦法跟委員說明哪一次的院會。但是我預計大概會在520之前送到立法院。我是真的\n\n33\n00:13:02,898 --> 00:13:16,644\n因為招募已經排進來了,我起先以為是說跟行政院這邊跟衛福部這邊都已經溝通好了嘛對不對齁你看這個是第10屆的行政院的版本齁在第9條第一款、第二款、第三款\n\n34\n00:13:17,711 --> 00:13:34,098\n福利及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全\n\n35\n00:13:42,742 --> 00:14:07,345\n事由十一號在第一次的朝委這個黨團協商中有針對行政院的這個第九條第二款第三款也認為這部長的表達是這樣嘛也認為這個範圍過大嘛太過普遍了也是有門啦齁因為是有門檻放得太寬的這樣的一個疑慮啦且不應該以風險低為由即可跳過完整的這個人體試驗嘛在事由21號的協商中\n\n36\n00:14:08,145 --> 00:14:13,528\n醫療部也針對第9條現場提出修正版本僅保留恩慈療法的建議條文。當時是這樣嗎?對不對?那個時候也獲得民間團體和醫界的肯定嘛。這個記憶我再提醒一下。\n\n37\n00:14:25,482 --> 00:14:38,654\n目前我們送到行政院的這個修正的版本裡面對於第九條是做了一個大改第一個就是在前面前面的這個情形的話就是變成說\n\n38\n00:14:40,467 --> 00:15:06,038\n所有的再生醫療都要做人體試驗除了這一條所規定的情形之外是免完成這個人體試驗就可以來做那不會說是什麼免醫再生醫療自治條例的規定去申請什麼這跟這無關跟那個自治條例是無關是免人體試驗免完成人體試驗那它現在本來是三款現在剩下兩款\n\n39\n00:15:06,798 --> 00:15:26,471\n第一款的話就是這裡的第一款也就恩賜療法已經沒有辦法了讓他有這個機會第二款的部分就是已經依現有的這個特管辦法執行中的這些案件不必重複再做人體試驗\n\n40\n00:15:27,852 --> 00:15:54,706\n這款報告已經有執行了?對,對,對,已經在執行中了,只有這兩種,其他我們都拿掉了,所以不會有什麼初步安全性跟初步療效這個我們就把它拿掉,因為我們檢討的結果這個無法執行啦。OK,但是你們在3月有舉辦這個再生醫療這個草案的說明會,第8條裡面,部長你看一下,第8條裡面第二款,先進國家完成人體試驗必已上市或上市但具安全性及初步療效。\n\n41\n00:15:54,966 --> 00:16:14,104\n在當時說明會裡面我們這個還保留但是事後我們在內部再做檢討我們覺得這個無法執行也就是說如果按照這樣子已經上市在國外的話完成人體試驗而且已經上市你要進來的話你就可以用恩恥療法\n\n42\n00:16:15,165 --> 00:16:21,632\n草案案件事宜及衛生環境委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會\n\n43\n00:16:37,214 --> 00:16:48,578\n人理試驗有一個範圍什麼樣的病人才會進來但是你現在的話是要把其他的病人不符合你的原來的這一個人理試驗的規劃的範圍的也要把他納進來那這樣子\n\n44\n00:16:53,160 --> 00:17:10,122\n福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n\n45\n00:17:10,923 --> 00:17:34,338\n第二,因為他有療效比較好,比如說他本來預計做20個,現在做了10個,覺得他很好了,那你就要用這個第二款這種讓他加速上市。這個也不對,因為你當初在做的時候,你的條件,那個條件越嚴格的時候,那你本來case就會少。\n\n46\n00:17:35,540 --> 00:17:46,706\n草案案件事宜﹖一、審查),﹖一﹖二﹖二﹖一﹖二﹖二﹖二﹖一﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖\n\n47\n00:17:52,930 --> 00:18:13,378\n邱議瑩等21人擬具:「再生醫療發展法草案案件事宜及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11\n\n48\n00:18:15,990 --> 00:18:17,972\n草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n\n49\n00:18:37,768 --> 00:19:05,923\n我聽不斷說很久的我也聽得很誠實我也聽得有就對了所以你們現在的第8條的第二款這個後面或未上市但具安全性及初步療效基本上你們已經拿掉了對不對但是我就覺得很奇怪為什麼3月的時候開說明會這個東西顯示出來跟之前第9條的第二款是一樣的那為什麼是說明會開完之後回去才在檢討才把它拿掉為什麼不是開說明會之前就已經把它拿掉\n\n50\n00:19:06,643 --> 00:19:13,787\n因為當時在處理的時候在文字的部分看起來沒有什麼問題但是後來我們在檢討說這個通過要怎麼執行就會發生這個問題\n\n51\n00:19:19,240 --> 00:19:40,700\n對,就執行一定會出問題。我想這個環環已經一定要達到這個社會的共識嘛,對不對。所以可能有些細節,不曉得可能沒有這麼多時間看,但是相關的幕僚應該要看得清楚才對嘛。請注意這個事情啦。然後我覺得也應該跟民間說明清楚,因為你們是開完說明會之後回去才拿掉嘛。\n\n52\n00:19:42,281 --> 00:19:52,046\n所以我們在送立法院之前的話我們可能還會對外界做一些宣導OK好謝謝部長謝謝主席謝謝好謝謝劉建國委員發言\n\n","tsv":"start\tend\ttext\n6836\t19219\t謝主席。有請部長跟...請薛部長。跟食藥署署長。吳署長。那個再生醫療之際我們等一下討論齁。先跟部長還有署長來討論實案的問題。我想大家都記憶猶新嘛齁。從3月18這個保齡查釋的中毒案開始。\n29452\t57737\t還有3月28日的長壽司、3月30日的汗奶飯店、世界烈化的文品旗下的粗瓦、響蠟還有昨天的八王雲集,應該不只這些啦。這個實案真的就像瘟疫一樣,我在這個地方也特別提過,不斷地在凌亂爆,尤其都在臺北市來爆發比較多。我想現在大家有一個疑問,臺北市政府到底能不能去應付這個事情,這是第一。\n59912\t78223\t我會講這樣一個背景資料我看到臺北市這個衛生局在3月24號稽查保齡查試的時候因為查無實語也因此僅帶回砧板菜刀水果刀以及這個廚師手部的生物跡證共四項的檢體然後3月28號在長壽司也傳出這樣的審問題的時候臺北市衛生局同樣以查無實語\n85100\t91815\t然後也制裁上砧板生死刀具還有工作人員首部的生物跡證等那\n94967\t122174\t陳局長特別是衛生局的陳局長在3月24號當天他是這麼表達他是依照衛福部食藥署訂定的作為流程先前往餐廳採集食魚但現場沒有剩下同批食魚所以僅採集環境及生物前提陳局長又提到現行規定並沒有要求檢查人員在第一時間就要將所有的食材扣走\n123587\t147065\t所有的食材扣走。」這是他記者會講的。然後也許未來可以與中央及專家去討論是我要修改處理方式,衛生局將會遵循。我要簡單表達就是說,台北市衛生局是把這個球丟回去給中央。所以中央沒有規定。那部長、署長你怎麼說?\n148853\t162044\t呃這其實齁在中央所定的這一個處理要點齁就儀式食品中毒事件處理什麼樣的要點那個有一個正確名稱嗎儀式儀式食品中毒事件處理要點對裡面就有寫到齁剛剛\n164286\t183388\t委員提到了他要去做食品的檢體跟環境檢體包括這些剛剛提到的砧板、刀具還有這些處理台食品的檢體就是食與另外一個叫做懷疑的食材\n184509\t202285\t所以現在我提供這個嘛對不對?疑似食品中毒事件處理要點嘛齁在第4條的第1款裡面食品檢體括號食語還有嫌疑食品等嘛對嘛有規定嗎所以他可能自己在的時候是把他解釋線說了啦\n204581\t231313\t當然這裡面會牽涉到一個就是說如果說他懷疑的食品的話那他要帶走取樣的範圍有多大那可能說那個臺北市衛生局的同仁這個地方他沒有辦法去做判斷因為他沒有在那個時候要被停業處分所以他還在經營嘛你如果把東西收起來他就要做了\n233964\t259214\t我感覺不像你提供的。你如果這樣說,26號的時候,你知道26號的時候有停業了嗎?那當天停業。當天停業。我們跟衛生局去的時候,當天就給他停業了。所以我們就通通把他帶回來。通通把他帶回來。總共帶回來多少項的檢體?三十五件。三十五件檢體。是因為停業,所以才馬上,不是這樣吧?\n260600\t287302\t先採樣啦。應該是先採樣啦。我的意思就是說基層的同仁有時候會對這一點就是會有遲疑啦。我只是說幫忙這些基層同仁去講一下話啦。拜託你還不對。你幫忙他們講話,還不會說你苛責他們的處理方式,不對吧?我們是把事情釐清嘛。對。這些基層的同仁也是辛苦啦。但是這個部分的話,他把自己的解釋先說了啦。\n289466\t292648\t懷疑食品解釋的發現說⋯⋯你們這個什麼時候訂的?這很舊的最新修訂109我們102年就訂了1020的11月28號就訂了對不對?這個第4條的第一點沒有改嗎?\n308082\t321219\t都沒改過嘛,所以英九的修正跟這個沒有關係嘛所以他在109年11月28日就已經存在了這個要點嘛對不對那內容也是如我們這樣顯示出來的嘛這個要點也明確定這個\n322761\t347589\t整個縣市分工,請求中央的支援流程,還加入了什麼疑似漏土桿菌,處理原子,還有醫療院所發生食品中毒的通報流程,也包括剛剛我特別提到的採檢死予、嫌疑食品等都在這個要點裡面嘛,沒有錯嘛,對不對?那今天部長你要去體諒都基層的第一線的這些同仁可能對整個這個要點\n349233\t351054\t邱議瑩等21人擬具〈再生醫療法草案案〉案。\n368052\t386679\t這其實不是修的問題就是說這個SOP大家還要再做教育這個要點已經人看一切啦我當然還是有些不周全之處不過如果依照他們在這幾次到現場去採這個檢體的過程裡面應該是足夠了啦不是說\n392481\t421281\t不夠還必須要再...已經可以執行了應該 對嘛 好那你看齁我再給部長看一個資料有議員啦齁去請求台北市政府做這個相關的一個回覆他們叫索資啦齁然後台北市得清楚的回覆是說有關疑似食品中毒發生在食材抽驗作業流程說明如下第一點依照衛生福利部食品藥管理署食品中毒採樣操作手冊\n422931\t447317\t內容災藥然後第二點本局如果針對疑似食品食品中毒作為流程依照中央訂定之相關文件辦法因本案稽查現場無同批示與原採集廚師所布及環境檢體而後中央如修正食品中毒採樣操作所測本局將配合辦理又是你中央啊\n448865\t452007\t邱議瑩等21人擬具:「再生醫療發展法草案案件事宜、儀式食品等事宜等事宜等事宜\n468436\t469056\t邱議瑩等21人擬具:「再生醫療\n491998\t498303\t邱議瑩等21人擬具:「再生醫療發展法草案案件事件事件事件事件事件事件事件事\n514651\t539576\t我先讓你說清楚啦但是我們在這個委員會要討論到相關的很細的細節真的是有困難嘛現在這個是台北市政府打呼議員的他是說依照中央的食品中毒採樣操作手冊就這一本嘛就這本嘛好那我們針對食品中毒我們到底是要依照疑似食品中毒事件處理要點還是要依照這個手冊\n544688\t566900\t這個應該主要依據的是那個疑似食品中毒的那一個啦。只要是要依據食品中毒的處理藥品那一個嘛,對不對?這是更細節的部分啦,在採樣的部分啦。這個更細節在採樣的部分依照這個手冊?對。不對吧?是啊。你是要首先知道還有這份資料嗎?你們有公告上網嗎?這已經廢紙了。這份是已經廢紙了。啊都對嘛。對,是廢紙的。\n571147\t577390\t邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件\n600873\t618700\t112年的3月8號公告廢紙這本手冊互錄是公告這個手冊的互錄喔,互錄就是後面第幾頁嘛齁然後食品衛生檢驗項目寄抽樣數量表你就廢紙那個數量表啊沒有查到你們什麼時候去廢紙那現在說你跟我講說這個已經廢紙了\n620543\t647540\t他照理講通令各地方政府應該非常清楚怎麼台灣的首都還在依照你們廢紙的這個手冊在處理整個食品中毒的流程我們回去再查一下看看什麼時候廢紙的廢紙的時間我覺得特別是有其必要檢討的部分但是衛福部這個地方也有問題喔\n650070\t677864\t之前在網路上還可以查到這個手冊我們有適度去提醒食藥署之後這個手冊已經不見了啦但是我們查到公告就只有針對那個賦錄去公告廢紙啦所以我才會覺得很奇怪嘛但是你們在我們應該還沒有衛生部之前叫衛生署的時候也把這個疑似食品中毒事件處理要點在102.11月28日就訂出來了然後縣市分工非常清楚連要點裡面都還括號\n679380\t707058\t他應該做什麼事情啊誰去做嘛對不對啊怎麼台北市政府到現在還會答覆他們的議員是依照這個已經彙止的這個手冊在做處理所以在前段跟第二段我要跟部長跟所有人表達就是說怎麼會這個樣子不關他們參與的事參與得很離人不關什麼事情到最後就是推給中央嘛那我們自己也造成這個這樣的一個不應該發生的事情嘛\n710478\t729129\t所以今天這個手冊已經公告會址了是不是可以明確的通告所有的各縣市政府嘛對不對我們就是要疑似這個食品中毒的事件處理要點來做處理嘛好請署長請回來今天就處理好不好謝謝署長這個再生醫療應該是\n733522\t755294\t應該是我在這個委員會最早排入的啦。然後之前也透過擴大的公聽會在酒樓。那時候應該來了上百個醫師團體還有相關的協會的代表。我不曉得我們院辦為什麼到現在還沒幫我進來?到底什麼時候才可以進來?\n756810\t781927\t我們目前排定的是4月19,政委會召開會議審查,因為內容有稍作修正。審查過後的話,就是排院會。院會的時間我就沒有辦法跟委員說明哪一次的院會。但是我預計大概會在520之前送到立法院。我是真的\n782898\t796644\t因為招募已經排進來了,我起先以為是說跟行政院這邊跟衛福部這邊都已經溝通好了嘛對不對齁你看這個是第10屆的行政院的版本齁在第9條第一款、第二款、第三款\n797711\t814098\t福利及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全\n822742\t847345\t事由十一號在第一次的朝委這個黨團協商中有針對行政院的這個第九條第二款第三款也認為這部長的表達是這樣嘛也認為這個範圍過大嘛太過普遍了也是有門啦齁因為是有門檻放得太寬的這樣的一個疑慮啦且不應該以風險低為由即可跳過完整的這個人體試驗嘛在事由21號的協商中\n848145\t853528\t醫療部也針對第9條現場提出修正版本僅保留恩慈療法的建議條文。當時是這樣嗎?對不對?那個時候也獲得民間團體和醫界的肯定嘛。這個記憶我再提醒一下。\n865482\t878654\t目前我們送到行政院的這個修正的版本裡面對於第九條是做了一個大改第一個就是在前面前面的這個情形的話就是變成說\n880467\t906038\t所有的再生醫療都要做人體試驗除了這一條所規定的情形之外是免完成這個人體試驗就可以來做那不會說是什麼免醫再生醫療自治條例的規定去申請什麼這跟這無關跟那個自治條例是無關是免人體試驗免完成人體試驗那它現在本來是三款現在剩下兩款\n906798\t926471\t第一款的話就是這裡的第一款也就恩賜療法已經沒有辦法了讓他有這個機會第二款的部分就是已經依現有的這個特管辦法執行中的這些案件不必重複再做人體試驗\n927852\t954706\t這款報告已經有執行了?對,對,對,已經在執行中了,只有這兩種,其他我們都拿掉了,所以不會有什麼初步安全性跟初步療效這個我們就把它拿掉,因為我們檢討的結果這個無法執行啦。OK,但是你們在3月有舉辦這個再生醫療這個草案的說明會,第8條裡面,部長你看一下,第8條裡面第二款,先進國家完成人體試驗必已上市或上市但具安全性及初步療效。\n954966\t974104\t在當時說明會裡面我們這個還保留但是事後我們在內部再做檢討我們覺得這個無法執行也就是說如果按照這樣子已經上市在國外的話完成人體試驗而且已經上市你要進來的話你就可以用恩恥療法\n975165\t981632\t草案案件事宜及衛生環境委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會\n997214\t1008578\t人理試驗有一個範圍什麼樣的病人才會進來但是你現在的話是要把其他的病人不符合你的原來的這一個人理試驗的規劃的範圍的也要把他納進來那這樣子\n1013160\t1030122\t福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n1030923\t1054338\t第二,因為他有療效比較好,比如說他本來預計做20個,現在做了10個,覺得他很好了,那你就要用這個第二款這種讓他加速上市。這個也不對,因為你當初在做的時候,你的條件,那個條件越嚴格的時候,那你本來case就會少。\n1055540\t1066706\t草案案件事宜﹖一、審查), ﹖一﹖二﹖二﹖一﹖二﹖二﹖二﹖一﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖\n1072930\t1093378\t邱議瑩等21人擬具:「再生醫療發展法草案案件事宜及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11\n1095990\t1097972\t草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n1117768\t1145923\t我聽不斷說很久的我也聽得很誠實我也聽得有就對了所以你們現在的第8條的第二款這個後面或未上市但具安全性及初步療效基本上你們已經拿掉了對不對但是我就覺得很奇怪為什麼3月的時候開說明會這個東西顯示出來跟之前第9條的第二款是一樣的那為什麼是說明會開完之後回去才在檢討才把它拿掉為什麼不是開說明會之前就已經把它拿掉\n1146643\t1153787\t因為當時在處理的時候在文字的部分看起來沒有什麼問題但是後來我們在檢討說這個通過要怎麼執行就會發生這個問題\n1159240\t1180700\t對,就執行一定會出問題。我想這個環環已經一定要達到這個社會的共識嘛,對不對。所以可能有些細節,不曉得可能沒有這麼多時間看,但是相關的幕僚應該要看得清楚才對嘛。請注意這個事情啦。然後我覺得也應該跟民間說明清楚,因為你們是開完說明會之後回去才拿掉嘛。\n1182281\t1192046\t所以我們在送立法院之前的話我們可能還會對外界做一些宣導OK 好 謝謝部長 謝謝主席 謝謝好 謝謝劉建國委員發言\n","txt":"謝主席。有請部長跟...請薛部長。跟食藥署署長。吳署長。那個再生醫療之際我們等一下討論齁。先跟部長還有署長來討論實案的問題。我想大家都記憶猶新嘛齁。從3月18這個保齡查釋的中毒案開始。\n還有3月28日的長壽司、3月30日的汗奶飯店、世界烈化的文品旗下的粗瓦、響蠟還有昨天的八王雲集,應該不只這些啦。這個實案真的就像瘟疫一樣,我在這個地方也特別提過,不斷地在凌亂爆,尤其都在臺北市來爆發比較多。我想現在大家有一個疑問,臺北市政府到底能不能去應付這個事情,這是第一。\n我會講這樣一個背景資料我看到臺北市這個衛生局在3月24號稽查保齡查試的時候因為查無實語也因此僅帶回砧板菜刀水果刀以及這個廚師手部的生物跡證共四項的檢體然後3月28號在長壽司也傳出這樣的審問題的時候臺北市衛生局同樣以查無實語\n然後也制裁上砧板生死刀具還有工作人員首部的生物跡證等那\n陳局長特別是衛生局的陳局長在3月24號當天他是這麼表達他是依照衛福部食藥署訂定的作為流程先前往餐廳採集食魚但現場沒有剩下同批食魚所以僅採集環境及生物前提陳局長又提到現行規定並沒有要求檢查人員在第一時間就要將所有的食材扣走\n所有的食材扣走。」這是他記者會講的。然後也許未來可以與中央及專家去討論是我要修改處理方式,衛生局將會遵循。我要簡單表達就是說,台北市衛生局是把這個球丟回去給中央。所以中央沒有規定。那部長、署長你怎麼說?\n呃這其實齁在中央所定的這一個處理要點齁就儀式食品中毒事件處理什麼樣的要點那個有一個正確名稱嗎儀式儀式食品中毒事件處理要點對裡面就有寫到齁剛剛\n委員提到了他要去做食品的檢體跟環境檢體包括這些剛剛提到的砧板、刀具還有這些處理台食品的檢體就是食與另外一個叫做懷疑的食材\n所以現在我提供這個嘛對不對?疑似食品中毒事件處理要點嘛齁在第4條的第1款裡面食品檢體括號食語還有嫌疑食品等嘛對嘛有規定嗎所以他可能自己在的時候是把他解釋線說了啦\n當然這裡面會牽涉到一個就是說如果說他懷疑的食品的話那他要帶走取樣的範圍有多大那可能說那個臺北市衛生局的同仁這個地方他沒有辦法去做判斷因為他沒有在那個時候要被停業處分所以他還在經營嘛你如果把東西收起來他就要做了\n我感覺不像你提供的。你如果這樣說,26號的時候,你知道26號的時候有停業了嗎?那當天停業。當天停業。我們跟衛生局去的時候,當天就給他停業了。所以我們就通通把他帶回來。通通把他帶回來。總共帶回來多少項的檢體?三十五件。三十五件檢體。是因為停業,所以才馬上,不是這樣吧?\n先採樣啦。應該是先採樣啦。我的意思就是說基層的同仁有時候會對這一點就是會有遲疑啦。我只是說幫忙這些基層同仁去講一下話啦。拜託你還不對。你幫忙他們講話,還不會說你苛責他們的處理方式,不對吧?我們是把事情釐清嘛。對。這些基層的同仁也是辛苦啦。但是這個部分的話,他把自己的解釋先說了啦。\n懷疑食品解釋的發現說⋯⋯你們這個什麼時候訂的?這很舊的最新修訂109我們102年就訂了1020的11月28號就訂了對不對?這個第4條的第一點沒有改嗎?\n都沒改過嘛,所以英九的修正跟這個沒有關係嘛所以他在109年11月28日就已經存在了這個要點嘛對不對那內容也是如我們這樣顯示出來的嘛這個要點也明確定這個\n整個縣市分工,請求中央的支援流程,還加入了什麼疑似漏土桿菌,處理原子,還有醫療院所發生食品中毒的通報流程,也包括剛剛我特別提到的採檢死予、嫌疑食品等都在這個要點裡面嘛,沒有錯嘛,對不對?那今天部長你要去體諒都基層的第一線的這些同仁可能對整個這個要點\n邱議瑩等21人擬具〈再生醫療法草案案〉案。\n這其實不是修的問題就是說這個SOP大家還要再做教育這個要點已經人看一切啦我當然還是有些不周全之處不過如果依照他們在這幾次到現場去採這個檢體的過程裡面應該是足夠了啦不是說\n不夠還必須要再...已經可以執行了應該 對嘛 好那你看齁我再給部長看一個資料有議員啦齁去請求台北市政府做這個相關的一個回覆他們叫索資啦齁然後台北市得清楚的回覆是說有關疑似食品中毒發生在食材抽驗作業流程說明如下第一點依照衛生福利部食品藥管理署食品中毒採樣操作手冊\n內容災藥然後第二點本局如果針對疑似食品食品中毒作為流程依照中央訂定之相關文件辦法因本案稽查現場無同批示與原採集廚師所布及環境檢體而後中央如修正食品中毒採樣操作所測本局將配合辦理又是你中央啊\n邱議瑩等21人擬具:「再生醫療發展法草案案件事宜、儀式食品等事宜等事宜等事宜\n邱議瑩等21人擬具:「再生醫療\n邱議瑩等21人擬具:「再生醫療發展法草案案件事件事件事件事件事件事件事件事\n我先讓你說清楚啦但是我們在這個委員會要討論到相關的很細的細節真的是有困難嘛現在這個是台北市政府打呼議員的他是說依照中央的食品中毒採樣操作手冊就這一本嘛就這本嘛好那我們針對食品中毒我們到底是要依照疑似食品中毒事件處理要點還是要依照這個手冊\n這個應該主要依據的是那個疑似食品中毒的那一個啦。只要是要依據食品中毒的處理藥品那一個嘛,對不對?這是更細節的部分啦,在採樣的部分啦。這個更細節在採樣的部分依照這個手冊?對。不對吧?是啊。你是要首先知道還有這份資料嗎?你們有公告上網嗎?這已經廢紙了。這份是已經廢紙了。啊都對嘛。對,是廢紙的。\n邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件\n112年的3月8號公告廢紙這本手冊互錄是公告這個手冊的互錄喔,互錄就是後面第幾頁嘛齁然後食品衛生檢驗項目寄抽樣數量表你就廢紙那個數量表啊沒有查到你們什麼時候去廢紙那現在說你跟我講說這個已經廢紙了\n他照理講通令各地方政府應該非常清楚怎麼台灣的首都還在依照你們廢紙的這個手冊在處理整個食品中毒的流程我們回去再查一下看看什麼時候廢紙的廢紙的時間我覺得特別是有其必要檢討的部分但是衛福部這個地方也有問題喔\n之前在網路上還可以查到這個手冊我們有適度去提醒食藥署之後這個手冊已經不見了啦但是我們查到公告就只有針對那個賦錄去公告廢紙啦所以我才會覺得很奇怪嘛但是你們在我們應該還沒有衛生部之前叫衛生署的時候也把這個疑似食品中毒事件處理要點在102.11月28日就訂出來了然後縣市分工非常清楚連要點裡面都還括號\n他應該做什麼事情啊誰去做嘛對不對啊怎麼台北市政府到現在還會答覆他們的議員是依照這個已經彙止的這個手冊在做處理所以在前段跟第二段我要跟部長跟所有人表達就是說怎麼會這個樣子不關他們參與的事參與得很離人不關什麼事情到最後就是推給中央嘛那我們自己也造成這個這樣的一個不應該發生的事情嘛\n所以今天這個手冊已經公告會址了是不是可以明確的通告所有的各縣市政府嘛對不對我們就是要疑似這個食品中毒的事件處理要點來做處理嘛好請署長請回來今天就處理好不好謝謝署長這個再生醫療應該是\n應該是我在這個委員會最早排入的啦。然後之前也透過擴大的公聽會在酒樓。那時候應該來了上百個醫師團體還有相關的協會的代表。我不曉得我們院辦為什麼到現在還沒幫我進來?到底什麼時候才可以進來?\n我們目前排定的是4月19,政委會召開會議審查,因為內容有稍作修正。審查過後的話,就是排院會。院會的時間我就沒有辦法跟委員說明哪一次的院會。但是我預計大概會在520之前送到立法院。我是真的\n因為招募已經排進來了,我起先以為是說跟行政院這邊跟衛福部這邊都已經溝通好了嘛對不對齁你看這個是第10屆的行政院的版本齁在第9條第一款、第二款、第三款\n福利及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全\n事由十一號在第一次的朝委這個黨團協商中有針對行政院的這個第九條第二款第三款也認為這部長的表達是這樣嘛也認為這個範圍過大嘛太過普遍了也是有門啦齁因為是有門檻放得太寬的這樣的一個疑慮啦且不應該以風險低為由即可跳過完整的這個人體試驗嘛在事由21號的協商中\n醫療部也針對第9條現場提出修正版本僅保留恩慈療法的建議條文。當時是這樣嗎?對不對?那個時候也獲得民間團體和醫界的肯定嘛。這個記憶我再提醒一下。\n目前我們送到行政院的這個修正的版本裡面對於第九條是做了一個大改第一個就是在前面前面的這個情形的話就是變成說\n所有的再生醫療都要做人體試驗除了這一條所規定的情形之外是免完成這個人體試驗就可以來做那不會說是什麼免醫再生醫療自治條例的規定去申請什麼這跟這無關跟那個自治條例是無關是免人體試驗免完成人體試驗那它現在本來是三款現在剩下兩款\n第一款的話就是這裡的第一款也就恩賜療法已經沒有辦法了讓他有這個機會第二款的部分就是已經依現有的這個特管辦法執行中的這些案件不必重複再做人體試驗\n這款報告已經有執行了?對,對,對,已經在執行中了,只有這兩種,其他我們都拿掉了,所以不會有什麼初步安全性跟初步療效這個我們就把它拿掉,因為我們檢討的結果這個無法執行啦。OK,但是你們在3月有舉辦這個再生醫療這個草案的說明會,第8條裡面,部長你看一下,第8條裡面第二款,先進國家完成人體試驗必已上市或上市但具安全性及初步療效。\n在當時說明會裡面我們這個還保留但是事後我們在內部再做檢討我們覺得這個無法執行也就是說如果按照這樣子已經上市在國外的話完成人體試驗而且已經上市你要進來的話你就可以用恩恥療法\n草案案件事宜及衛生環境委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會\n人理試驗有一個範圍什麼樣的病人才會進來但是你現在的話是要把其他的病人不符合你的原來的這一個人理試驗的規劃的範圍的也要把他納進來那這樣子\n福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n第二,因為他有療效比較好,比如說他本來預計做20個,現在做了10個,覺得他很好了,那你就要用這個第二款這種讓他加速上市。這個也不對,因為你當初在做的時候,你的條件,那個條件越嚴格的時候,那你本來case就會少。\n草案案件事宜﹖一、審查), ﹖一﹖二﹖二﹖一﹖二﹖二﹖二﹖一﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖\n邱議瑩等21人擬具:「再生醫療發展法草案案件事宜及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11\n草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n我聽不斷說很久的我也聽得很誠實我也聽得有就對了所以你們現在的第8條的第二款這個後面或未上市但具安全性及初步療效基本上你們已經拿掉了對不對但是我就覺得很奇怪為什麼3月的時候開說明會這個東西顯示出來跟之前第9條的第二款是一樣的那為什麼是說明會開完之後回去才在檢討才把它拿掉為什麼不是開說明會之前就已經把它拿掉\n因為當時在處理的時候在文字的部分看起來沒有什麼問題但是後來我們在檢討說這個通過要怎麼執行就會發生這個問題\n對,就執行一定會出問題。我想這個環環已經一定要達到這個社會的共識嘛,對不對。所以可能有些細節,不曉得可能沒有這麼多時間看,但是相關的幕僚應該要看得清楚才對嘛。請注意這個事情啦。然後我覺得也應該跟民間說明清楚,因為你們是開完說明會之後回去才拿掉嘛。\n所以我們在送立法院之前的話我們可能還會對外界做一些宣導OK 好 謝謝部長 謝謝主席 謝謝好 謝謝劉建國委員發言\n","vtt":"WEBVTT\n\n00:06.836 --> 00:19.219\n謝主席。有請部長跟...請薛部長。跟食藥署署長。吳署長。那個再生醫療之際我們等一下討論齁。先跟部長還有署長來討論實案的問題。我想大家都記憶猶新嘛齁。從3月18這個保齡查釋的中毒案開始。\n\n00:29.452 --> 00:57.737\n還有3月28日的長壽司、3月30日的汗奶飯店、世界烈化的文品旗下的粗瓦、響蠟還有昨天的八王雲集,應該不只這些啦。這個實案真的就像瘟疫一樣,我在這個地方也特別提過,不斷地在凌亂爆,尤其都在臺北市來爆發比較多。我想現在大家有一個疑問,臺北市政府到底能不能去應付這個事情,這是第一。\n\n00:59.912 --> 01:18.223\n我會講這樣一個背景資料我看到臺北市這個衛生局在3月24號稽查保齡查試的時候因為查無實語也因此僅帶回砧板菜刀水果刀以及這個廚師手部的生物跡證共四項的檢體然後3月28號在長壽司也傳出這樣的審問題的時候臺北市衛生局同樣以查無實語\n\n01:25.100 --> 01:31.815\n然後也制裁上砧板生死刀具還有工作人員首部的生物跡證等那\n\n01:34.967 --> 02:02.174\n陳局長特別是衛生局的陳局長在3月24號當天他是這麼表達他是依照衛福部食藥署訂定的作為流程先前往餐廳採集食魚但現場沒有剩下同批食魚所以僅採集環境及生物前提陳局長又提到現行規定並沒有要求檢查人員在第一時間就要將所有的食材扣走\n\n02:03.587 --> 02:27.065\n所有的食材扣走。」這是他記者會講的。然後也許未來可以與中央及專家去討論是我要修改處理方式,衛生局將會遵循。我要簡單表達就是說,台北市衛生局是把這個球丟回去給中央。所以中央沒有規定。那部長、署長你怎麼說?\n\n02:28.853 --> 02:42.044\n呃這其實齁在中央所定的這一個處理要點齁就儀式食品中毒事件處理什麼樣的要點那個有一個正確名稱嗎儀式儀式食品中毒事件處理要點對裡面就有寫到齁剛剛\n\n02:44.286 --> 03:03.388\n委員提到了他要去做食品的檢體跟環境檢體包括這些剛剛提到的砧板、刀具還有這些處理台食品的檢體就是食與另外一個叫做懷疑的食材\n\n03:04.509 --> 03:22.285\n所以現在我提供這個嘛對不對?疑似食品中毒事件處理要點嘛齁在第4條的第1款裡面食品檢體括號食語還有嫌疑食品等嘛對嘛有規定嗎所以他可能自己在的時候是把他解釋線說了啦\n\n03:24.581 --> 03:51.313\n當然這裡面會牽涉到一個就是說如果說他懷疑的食品的話那他要帶走取樣的範圍有多大那可能說那個臺北市衛生局的同仁這個地方他沒有辦法去做判斷因為他沒有在那個時候要被停業處分所以他還在經營嘛你如果把東西收起來他就要做了\n\n03:53.964 --> 04:19.214\n我感覺不像你提供的。你如果這樣說,26號的時候,你知道26號的時候有停業了嗎?那當天停業。當天停業。我們跟衛生局去的時候,當天就給他停業了。所以我們就通通把他帶回來。通通把他帶回來。總共帶回來多少項的檢體?三十五件。三十五件檢體。是因為停業,所以才馬上,不是這樣吧?\n\n04:20.600 --> 04:47.302\n先採樣啦。應該是先採樣啦。我的意思就是說基層的同仁有時候會對這一點就是會有遲疑啦。我只是說幫忙這些基層同仁去講一下話啦。拜託你還不對。你幫忙他們講話,還不會說你苛責他們的處理方式,不對吧?我們是把事情釐清嘛。對。這些基層的同仁也是辛苦啦。但是這個部分的話,他把自己的解釋先說了啦。\n\n04:49.466 --> 04:52.648\n懷疑食品解釋的發現說⋯⋯你們這個什麼時候訂的?這很舊的最新修訂109我們102年就訂了1020的11月28號就訂了對不對?這個第4條的第一點沒有改嗎?\n\n05:08.082 --> 05:21.219\n都沒改過嘛,所以英九的修正跟這個沒有關係嘛所以他在109年11月28日就已經存在了這個要點嘛對不對那內容也是如我們這樣顯示出來的嘛這個要點也明確定這個\n\n05:22.761 --> 05:47.589\n整個縣市分工,請求中央的支援流程,還加入了什麼疑似漏土桿菌,處理原子,還有醫療院所發生食品中毒的通報流程,也包括剛剛我特別提到的採檢死予、嫌疑食品等都在這個要點裡面嘛,沒有錯嘛,對不對?那今天部長你要去體諒都基層的第一線的這些同仁可能對整個這個要點\n\n05:49.233 --> 05:51.054\n邱議瑩等21人擬具〈再生醫療法草案案〉案。\n\n06:08.052 --> 06:26.679\n這其實不是修的問題就是說這個SOP大家還要再做教育這個要點已經人看一切啦我當然還是有些不周全之處不過如果依照他們在這幾次到現場去採這個檢體的過程裡面應該是足夠了啦不是說\n\n06:32.481 --> 07:01.281\n不夠還必須要再...已經可以執行了應該對嘛好那你看齁我再給部長看一個資料有議員啦齁去請求台北市政府做這個相關的一個回覆他們叫索資啦齁然後台北市得清楚的回覆是說有關疑似食品中毒發生在食材抽驗作業流程說明如下第一點依照衛生福利部食品藥管理署食品中毒採樣操作手冊\n\n07:02.931 --> 07:27.317\n內容災藥然後第二點本局如果針對疑似食品食品中毒作為流程依照中央訂定之相關文件辦法因本案稽查現場無同批示與原採集廚師所布及環境檢體而後中央如修正食品中毒採樣操作所測本局將配合辦理又是你中央啊\n\n07:28.865 --> 07:32.007\n邱議瑩等21人擬具:「再生醫療發展法草案案件事宜、儀式食品等事宜等事宜等事宜\n\n07:48.436 --> 07:49.056\n邱議瑩等21人擬具:「再生醫療\n\n08:11.998 --> 08:18.303\n邱議瑩等21人擬具:「再生醫療發展法草案案件事件事件事件事件事件事件事件事\n\n08:34.651 --> 08:59.576\n我先讓你說清楚啦但是我們在這個委員會要討論到相關的很細的細節真的是有困難嘛現在這個是台北市政府打呼議員的他是說依照中央的食品中毒採樣操作手冊就這一本嘛就這本嘛好那我們針對食品中毒我們到底是要依照疑似食品中毒事件處理要點還是要依照這個手冊\n\n09:04.688 --> 09:26.900\n這個應該主要依據的是那個疑似食品中毒的那一個啦。只要是要依據食品中毒的處理藥品那一個嘛,對不對?這是更細節的部分啦,在採樣的部分啦。這個更細節在採樣的部分依照這個手冊?對。不對吧?是啊。你是要首先知道還有這份資料嗎?你們有公告上網嗎?這已經廢紙了。這份是已經廢紙了。啊都對嘛。對,是廢紙的。\n\n09:31.147 --> 09:37.390\n邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件\n\n10:00.873 --> 10:18.700\n112年的3月8號公告廢紙這本手冊互錄是公告這個手冊的互錄喔,互錄就是後面第幾頁嘛齁然後食品衛生檢驗項目寄抽樣數量表你就廢紙那個數量表啊沒有查到你們什麼時候去廢紙那現在說你跟我講說這個已經廢紙了\n\n10:20.543 --> 10:47.540\n他照理講通令各地方政府應該非常清楚怎麼台灣的首都還在依照你們廢紙的這個手冊在處理整個食品中毒的流程我們回去再查一下看看什麼時候廢紙的廢紙的時間我覺得特別是有其必要檢討的部分但是衛福部這個地方也有問題喔\n\n10:50.070 --> 11:17.864\n之前在網路上還可以查到這個手冊我們有適度去提醒食藥署之後這個手冊已經不見了啦但是我們查到公告就只有針對那個賦錄去公告廢紙啦所以我才會覺得很奇怪嘛但是你們在我們應該還沒有衛生部之前叫衛生署的時候也把這個疑似食品中毒事件處理要點在102.11月28日就訂出來了然後縣市分工非常清楚連要點裡面都還括號\n\n11:19.380 --> 11:47.058\n他應該做什麼事情啊誰去做嘛對不對啊怎麼台北市政府到現在還會答覆他們的議員是依照這個已經彙止的這個手冊在做處理所以在前段跟第二段我要跟部長跟所有人表達就是說怎麼會這個樣子不關他們參與的事參與得很離人不關什麼事情到最後就是推給中央嘛那我們自己也造成這個這樣的一個不應該發生的事情嘛\n\n11:50.478 --> 12:09.129\n所以今天這個手冊已經公告會址了是不是可以明確的通告所有的各縣市政府嘛對不對我們就是要疑似這個食品中毒的事件處理要點來做處理嘛好請署長請回來今天就處理好不好謝謝署長這個再生醫療應該是\n\n12:13.522 --> 12:35.294\n應該是我在這個委員會最早排入的啦。然後之前也透過擴大的公聽會在酒樓。那時候應該來了上百個醫師團體還有相關的協會的代表。我不曉得我們院辦為什麼到現在還沒幫我進來?到底什麼時候才可以進來?\n\n12:36.810 --> 13:01.927\n我們目前排定的是4月19,政委會召開會議審查,因為內容有稍作修正。審查過後的話,就是排院會。院會的時間我就沒有辦法跟委員說明哪一次的院會。但是我預計大概會在520之前送到立法院。我是真的\n\n13:02.898 --> 13:16.644\n因為招募已經排進來了,我起先以為是說跟行政院這邊跟衛福部這邊都已經溝通好了嘛對不對齁你看這個是第10屆的行政院的版本齁在第9條第一款、第二款、第三款\n\n13:17.711 --> 13:34.098\n福利及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全\n\n13:42.742 --> 14:07.345\n事由十一號在第一次的朝委這個黨團協商中有針對行政院的這個第九條第二款第三款也認為這部長的表達是這樣嘛也認為這個範圍過大嘛太過普遍了也是有門啦齁因為是有門檻放得太寬的這樣的一個疑慮啦且不應該以風險低為由即可跳過完整的這個人體試驗嘛在事由21號的協商中\n\n14:08.145 --> 14:13.528\n醫療部也針對第9條現場提出修正版本僅保留恩慈療法的建議條文。當時是這樣嗎?對不對?那個時候也獲得民間團體和醫界的肯定嘛。這個記憶我再提醒一下。\n\n14:25.482 --> 14:38.654\n目前我們送到行政院的這個修正的版本裡面對於第九條是做了一個大改第一個就是在前面前面的這個情形的話就是變成說\n\n14:40.467 --> 15:06.038\n所有的再生醫療都要做人體試驗除了這一條所規定的情形之外是免完成這個人體試驗就可以來做那不會說是什麼免醫再生醫療自治條例的規定去申請什麼這跟這無關跟那個自治條例是無關是免人體試驗免完成人體試驗那它現在本來是三款現在剩下兩款\n\n15:06.798 --> 15:26.471\n第一款的話就是這裡的第一款也就恩賜療法已經沒有辦法了讓他有這個機會第二款的部分就是已經依現有的這個特管辦法執行中的這些案件不必重複再做人體試驗\n\n15:27.852 --> 15:54.706\n這款報告已經有執行了?對,對,對,已經在執行中了,只有這兩種,其他我們都拿掉了,所以不會有什麼初步安全性跟初步療效這個我們就把它拿掉,因為我們檢討的結果這個無法執行啦。OK,但是你們在3月有舉辦這個再生醫療這個草案的說明會,第8條裡面,部長你看一下,第8條裡面第二款,先進國家完成人體試驗必已上市或上市但具安全性及初步療效。\n\n15:54.966 --> 16:14.104\n在當時說明會裡面我們這個還保留但是事後我們在內部再做檢討我們覺得這個無法執行也就是說如果按照這樣子已經上市在國外的話完成人體試驗而且已經上市你要進來的話你就可以用恩恥療法\n\n16:15.165 --> 16:21.632\n草案案件事宜及衛生環境委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會\n\n16:37.214 --> 16:48.578\n人理試驗有一個範圍什麼樣的病人才會進來但是你現在的話是要把其他的病人不符合你的原來的這一個人理試驗的規劃的範圍的也要把他納進來那這樣子\n\n16:53.160 --> 17:10.122\n福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會\n\n17:10.923 --> 17:34.338\n第二,因為他有療效比較好,比如說他本來預計做20個,現在做了10個,覺得他很好了,那你就要用這個第二款這種讓他加速上市。這個也不對,因為你當初在做的時候,你的條件,那個條件越嚴格的時候,那你本來case就會少。\n\n17:35.540 --> 17:46.706\n草案案件事宜﹖一、審查),﹖一﹖二﹖二﹖一﹖二﹖二﹖二﹖一﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖\n\n17:52.930 --> 18:13.378\n邱議瑩等21人擬具:「再生醫療發展法草案案件事宜及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11\n\n18:15.990 --> 18:17.972\n草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、\n\n18:37.768 --> 19:05.923\n我聽不斷說很久的我也聽得很誠實我也聽得有就對了所以你們現在的第8條的第二款這個後面或未上市但具安全性及初步療效基本上你們已經拿掉了對不對但是我就覺得很奇怪為什麼3月的時候開說明會這個東西顯示出來跟之前第9條的第二款是一樣的那為什麼是說明會開完之後回去才在檢討才把它拿掉為什麼不是開說明會之前就已經把它拿掉\n\n19:06.643 --> 19:13.787\n因為當時在處理的時候在文字的部分看起來沒有什麼問題但是後來我們在檢討說這個通過要怎麼執行就會發生這個問題\n\n19:19.240 --> 19:40.700\n對,就執行一定會出問題。我想這個環環已經一定要達到這個社會的共識嘛,對不對。所以可能有些細節,不曉得可能沒有這麼多時間看,但是相關的幕僚應該要看得清楚才對嘛。請注意這個事情啦。然後我覺得也應該跟民間說明清楚,因為你們是開完說明會之後回去才拿掉嘛。\n\n19:42.281 --> 19:52.046\n所以我們在送立法院之前的話我們可能還會對外界做一些宣導OK好謝謝部長謝謝主席謝謝好謝謝劉建國委員發言\n\n","segments":[{"start":6.836,"end":19.219,"text":"謝主席。有請部長跟...請薛部長。跟食藥署署長。吳署長。那個再生醫療之際我們等一下討論齁。先跟部長還有署長來討論實案的問題。我想大家都記憶猶新嘛齁。從3月18這個保齡查釋的中毒案開始。"},{"start":29.452,"end":57.737,"text":"還有3月28日的長壽司、3月30日的汗奶飯店、世界烈化的文品旗下的粗瓦、響蠟還有昨天的八王雲集,應該不只這些啦。這個實案真的就像瘟疫一樣,我在這個地方也特別提過,不斷地在凌亂爆,尤其都在臺北市來爆發比較多。我想現在大家有一個疑問,臺北市政府到底能不能去應付這個事情,這是第一。"},{"start":59.912,"end":78.223,"text":"我會講這樣一個背景資料我看到臺北市這個衛生局在3月24號稽查保齡查試的時候因為查無實語也因此僅帶回砧板菜刀水果刀以及這個廚師手部的生物跡證共四項的檢體然後3月28號在長壽司也傳出這樣的審問題的時候臺北市衛生局同樣以查無實語"},{"start":85.1,"end":91.815,"text":"然後也制裁上砧板生死刀具還有工作人員首部的生物跡證等那"},{"start":94.967,"end":122.174,"text":"陳局長特別是衛生局的陳局長在3月24號當天他是這麼表達他是依照衛福部食藥署訂定的作為流程先前往餐廳採集食魚但現場沒有剩下同批食魚所以僅採集環境及生物前提陳局長又提到現行規定並沒有要求檢查人員在第一時間就要將所有的食材扣走"},{"start":123.587,"end":147.065,"text":"所有的食材扣走。」這是他記者會講的。然後也許未來可以與中央及專家去討論是我要修改處理方式,衛生局將會遵循。我要簡單表達就是說,台北市衛生局是把這個球丟回去給中央。所以中央沒有規定。那部長、署長你怎麼說?"},{"start":148.853,"end":162.044,"text":"呃這其實齁在中央所定的這一個處理要點齁就儀式食品中毒事件處理什麼樣的要點那個有一個正確名稱嗎儀式儀式食品中毒事件處理要點對裡面就有寫到齁剛剛"},{"start":164.286,"end":183.388,"text":"委員提到了他要去做食品的檢體跟環境檢體包括這些剛剛提到的砧板、刀具還有這些處理台食品的檢體就是食與另外一個叫做懷疑的食材"},{"start":184.509,"end":202.285,"text":"所以現在我提供這個嘛對不對?疑似食品中毒事件處理要點嘛齁在第4條的第1款裡面食品檢體括號食語還有嫌疑食品等嘛對嘛有規定嗎所以他可能自己在的時候是把他解釋線說了啦"},{"start":204.581,"end":231.313,"text":"當然這裡面會牽涉到一個就是說如果說他懷疑的食品的話那他要帶走取樣的範圍有多大那可能說那個臺北市衛生局的同仁這個地方他沒有辦法去做判斷因為他沒有在那個時候要被停業處分所以他還在經營嘛你如果把東西收起來他就要做了"},{"start":233.964,"end":259.214,"text":"我感覺不像你提供的。你如果這樣說,26號的時候,你知道26號的時候有停業了嗎?那當天停業。當天停業。我們跟衛生局去的時候,當天就給他停業了。所以我們就通通把他帶回來。通通把他帶回來。總共帶回來多少項的檢體?三十五件。三十五件檢體。是因為停業,所以才馬上,不是這樣吧?"},{"start":260.6,"end":287.302,"text":"先採樣啦。應該是先採樣啦。我的意思就是說基層的同仁有時候會對這一點就是會有遲疑啦。我只是說幫忙這些基層同仁去講一下話啦。拜託你還不對。你幫忙他們講話,還不會說你苛責他們的處理方式,不對吧?我們是把事情釐清嘛。對。這些基層的同仁也是辛苦啦。但是這個部分的話,他把自己的解釋先說了啦。"},{"start":289.466,"end":292.648,"text":"懷疑食品解釋的發現說⋯⋯你們這個什麼時候訂的?這很舊的最新修訂109我們102年就訂了1020的11月28號就訂了對不對?這個第4條的第一點沒有改嗎?"},{"start":308.082,"end":321.219,"text":"都沒改過嘛,所以英九的修正跟這個沒有關係嘛所以他在109年11月28日就已經存在了這個要點嘛對不對那內容也是如我們這樣顯示出來的嘛這個要點也明確定這個"},{"start":322.761,"end":347.589,"text":"整個縣市分工,請求中央的支援流程,還加入了什麼疑似漏土桿菌,處理原子,還有醫療院所發生食品中毒的通報流程,也包括剛剛我特別提到的採檢死予、嫌疑食品等都在這個要點裡面嘛,沒有錯嘛,對不對?那今天部長你要去體諒都基層的第一線的這些同仁可能對整個這個要點"},{"start":349.233,"end":351.054,"text":"邱議瑩等21人擬具〈再生醫療法草案案〉案。"},{"start":368.052,"end":386.679,"text":"這其實不是修的問題就是說這個SOP大家還要再做教育這個要點已經人看一切啦我當然還是有些不周全之處不過如果依照他們在這幾次到現場去採這個檢體的過程裡面應該是足夠了啦不是說"},{"start":392.481,"end":421.281,"text":"不夠還必須要再...已經可以執行了應該 對嘛 好那你看齁我再給部長看一個資料有議員啦齁去請求台北市政府做這個相關的一個回覆他們叫索資啦齁然後台北市得清楚的回覆是說有關疑似食品中毒發生在食材抽驗作業流程說明如下第一點依照衛生福利部食品藥管理署食品中毒採樣操作手冊"},{"start":422.931,"end":447.317,"text":"內容災藥然後第二點本局如果針對疑似食品食品中毒作為流程依照中央訂定之相關文件辦法因本案稽查現場無同批示與原採集廚師所布及環境檢體而後中央如修正食品中毒採樣操作所測本局將配合辦理又是你中央啊"},{"start":448.865,"end":452.007,"text":"邱議瑩等21人擬具:「再生醫療發展法草案案件事宜、儀式食品等事宜等事宜等事宜"},{"start":468.436,"end":469.056,"text":"邱議瑩等21人擬具:「再生醫療"},{"start":491.998,"end":498.303,"text":"邱議瑩等21人擬具:「再生醫療發展法草案案件事件事件事件事件事件事件事件事"},{"start":514.651,"end":539.576,"text":"我先讓你說清楚啦但是我們在這個委員會要討論到相關的很細的細節真的是有困難嘛現在這個是台北市政府打呼議員的他是說依照中央的食品中毒採樣操作手冊就這一本嘛就這本嘛好那我們針對食品中毒我們到底是要依照疑似食品中毒事件處理要點還是要依照這個手冊"},{"start":544.688,"end":566.9,"text":"這個應該主要依據的是那個疑似食品中毒的那一個啦。只要是要依據食品中毒的處理藥品那一個嘛,對不對?這是更細節的部分啦,在採樣的部分啦。這個更細節在採樣的部分依照這個手冊?對。不對吧?是啊。你是要首先知道還有這份資料嗎?你們有公告上網嗎?這已經廢紙了。這份是已經廢紙了。啊都對嘛。對,是廢紙的。"},{"start":571.147,"end":577.39,"text":"邱議瑩等21人擬具:「再生醫療發展法草案案案件事件事件事件事件事件事件事件事件事件事件事件事件事件事件事件"},{"start":600.873,"end":618.7,"text":"112年的3月8號公告廢紙這本手冊互錄是公告這個手冊的互錄喔,互錄就是後面第幾頁嘛齁然後食品衛生檢驗項目寄抽樣數量表你就廢紙那個數量表啊沒有查到你們什麼時候去廢紙那現在說你跟我講說這個已經廢紙了"},{"start":620.543,"end":647.54,"text":"他照理講通令各地方政府應該非常清楚怎麼台灣的首都還在依照你們廢紙的這個手冊在處理整個食品中毒的流程我們回去再查一下看看什麼時候廢紙的廢紙的時間我覺得特別是有其必要檢討的部分但是衛福部這個地方也有問題喔"},{"start":650.07,"end":677.864,"text":"之前在網路上還可以查到這個手冊我們有適度去提醒食藥署之後這個手冊已經不見了啦但是我們查到公告就只有針對那個賦錄去公告廢紙啦所以我才會覺得很奇怪嘛但是你們在我們應該還沒有衛生部之前叫衛生署的時候也把這個疑似食品中毒事件處理要點在102.11月28日就訂出來了然後縣市分工非常清楚連要點裡面都還括號"},{"start":679.38,"end":707.058,"text":"他應該做什麼事情啊誰去做嘛對不對啊怎麼台北市政府到現在還會答覆他們的議員是依照這個已經彙止的這個手冊在做處理所以在前段跟第二段我要跟部長跟所有人表達就是說怎麼會這個樣子不關他們參與的事參與得很離人不關什麼事情到最後就是推給中央嘛那我們自己也造成這個這樣的一個不應該發生的事情嘛"},{"start":710.478,"end":729.129,"text":"所以今天這個手冊已經公告會址了是不是可以明確的通告所有的各縣市政府嘛對不對我們就是要疑似這個食品中毒的事件處理要點來做處理嘛好請署長請回來今天就處理好不好謝謝署長這個再生醫療應該是"},{"start":733.522,"end":755.294,"text":"應該是我在這個委員會最早排入的啦。然後之前也透過擴大的公聽會在酒樓。那時候應該來了上百個醫師團體還有相關的協會的代表。我不曉得我們院辦為什麼到現在還沒幫我進來?到底什麼時候才可以進來?"},{"start":756.81,"end":781.927,"text":"我們目前排定的是4月19,政委會召開會議審查,因為內容有稍作修正。審查過後的話,就是排院會。院會的時間我就沒有辦法跟委員說明哪一次的院會。但是我預計大概會在520之前送到立法院。我是真的"},{"start":782.898,"end":796.644,"text":"因為招募已經排進來了,我起先以為是說跟行政院這邊跟衛福部這邊都已經溝通好了嘛對不對齁你看這個是第10屆的行政院的版本齁在第9條第一款、第二款、第三款"},{"start":797.711,"end":814.098,"text":"福利及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全"},{"start":822.742,"end":847.345,"text":"事由十一號在第一次的朝委這個黨團協商中有針對行政院的這個第九條第二款第三款也認為這部長的表達是這樣嘛也認為這個範圍過大嘛太過普遍了也是有門啦齁因為是有門檻放得太寬的這樣的一個疑慮啦且不應該以風險低為由即可跳過完整的這個人體試驗嘛在事由21號的協商中"},{"start":848.145,"end":853.528,"text":"醫療部也針對第9條現場提出修正版本僅保留恩慈療法的建議條文。當時是這樣嗎?對不對?那個時候也獲得民間團體和醫界的肯定嘛。這個記憶我再提醒一下。"},{"start":865.482,"end":878.654,"text":"目前我們送到行政院的這個修正的版本裡面對於第九條是做了一個大改第一個就是在前面前面的這個情形的話就是變成說"},{"start":880.467,"end":906.038,"text":"所有的再生醫療都要做人體試驗除了這一條所規定的情形之外是免完成這個人體試驗就可以來做那不會說是什麼免醫再生醫療自治條例的規定去申請什麼這跟這無關跟那個自治條例是無關是免人體試驗免完成人體試驗那它現在本來是三款現在剩下兩款"},{"start":906.798,"end":926.471,"text":"第一款的話就是這裡的第一款也就恩賜療法已經沒有辦法了讓他有這個機會第二款的部分就是已經依現有的這個特管辦法執行中的這些案件不必重複再做人體試驗"},{"start":927.852,"end":954.706,"text":"這款報告已經有執行了?對,對,對,已經在執行中了,只有這兩種,其他我們都拿掉了,所以不會有什麼初步安全性跟初步療效這個我們就把它拿掉,因為我們檢討的結果這個無法執行啦。OK,但是你們在3月有舉辦這個再生醫療這個草案的說明會,第8條裡面,部長你看一下,第8條裡面第二款,先進國家完成人體試驗必已上市或上市但具安全性及初步療效。"},{"start":954.966,"end":974.104,"text":"在當時說明會裡面我們這個還保留但是事後我們在內部再做檢討我們覺得這個無法執行也就是說如果按照這樣子已經上市在國外的話完成人體試驗而且已經上市你要進來的話你就可以用恩恥療法"},{"start":975.165,"end":981.632,"text":"草案案件事宜及衛生環境委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會第12次全體委員會"},{"start":997.214,"end":1008.578,"text":"人理試驗有一個範圍什麼樣的病人才會進來但是你現在的話是要把其他的病人不符合你的原來的這一個人理試驗的規劃的範圍的也要把他納進來那這樣子"},{"start":1013.16,"end":1030.122,"text":"福利及衛生環境委員會第11屆第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會"},{"start":1030.923,"end":1054.338,"text":"第二,因為他有療效比較好,比如說他本來預計做20個,現在做了10個,覺得他很好了,那你就要用這個第二款這種讓他加速上市。這個也不對,因為你當初在做的時候,你的條件,那個條件越嚴格的時候,那你本來case就會少。"},{"start":1055.54,"end":1066.706,"text":"草案案件事宜﹖一、審查), ﹖一﹖二﹖二﹖一﹖二﹖二﹖二﹖一﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖二﹖"},{"start":1072.93,"end":1093.378,"text":"邱議瑩等21人擬具:「再生醫療發展法草案案件事宜及衛生環境委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11次全體委員會第11"},{"start":1095.99,"end":1097.972,"text":"草案：一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、審查一、"},{"start":1117.768,"end":1145.923,"text":"我聽不斷說很久的我也聽得很誠實我也聽得有就對了所以你們現在的第8條的第二款這個後面或未上市但具安全性及初步療效基本上你們已經拿掉了對不對但是我就覺得很奇怪為什麼3月的時候開說明會這個東西顯示出來跟之前第9條的第二款是一樣的那為什麼是說明會開完之後回去才在檢討才把它拿掉為什麼不是開說明會之前就已經把它拿掉"},{"start":1146.643,"end":1153.787,"text":"因為當時在處理的時候在文字的部分看起來沒有什麼問題但是後來我們在檢討說這個通過要怎麼執行就會發生這個問題"},{"start":1159.24,"end":1180.7,"text":"對,就執行一定會出問題。我想這個環環已經一定要達到這個社會的共識嘛,對不對。所以可能有些細節,不曉得可能沒有這麼多時間看,但是相關的幕僚應該要看得清楚才對嘛。請注意這個事情啦。然後我覺得也應該跟民間說明清楚,因為你們是開完說明會之後回去才拿掉嘛。"},{"start":1182.281,"end":1192.046,"text":"所以我們在送立法院之前的話我們可能還會對外界做一些宣導OK 好 謝謝部長 謝謝主席 謝謝好 謝謝劉建國委員發言"}]}}}}