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你比早知道了還懂得叫資訊處處長來今天新聞這麼大篇 食藥署沒人來"},{"start":75.593,"end":85.757,"text":"你現在是說在到立法院之前同時有四個委員會需要食藥署同時四個委員會需要食藥署 請問署長來哪一個委員會哪一個 署長在國安會所以你現在給我回答的是什麼問題我在問你食藥署署長有沒有來 副署長有沒有來你說立法院有四個委員會需要他們署長"},{"start":100.803,"end":104.464,"text":"我說署長在哪裡結果你說他不在立法院你說他不在立法院署長不在立法院我實在是不想對你動怒但是我想你今天在到立法院來之前你也受訪了"},{"start":118.772,"end":144.372,"text":"你還講說這個國光藥廠這些白老鼠這些實驗老鼠整個事件違反GMP要罰三到二萬就沒三到兩百萬問題是國光生技包庇這麼嚴重的污染事件有沒有違反GMP都是國光生技說了算嗎好他們今天發了新聞稿"},{"start":145.793,"end":150.415,"text":"國光 雙濟發的新聞稿 兩批 很大批在講動物福利然後 跟你衛福部 跟國人最關注的整個彈職場 彈職場在生產什麼疫苗 你給我講彈職場出事的這個工廠 在生產什麼疫苗 你給我回答"},{"start":171.44,"end":178.312,"text":"一般流感疫苗 破傷風疫苗那你在生產流感疫苗的"},{"start":180.567,"end":200.414,"text":"結果他們對於整個事情最後一段才提到他說他們內部調查確認上述實驗動物事件在作業程序上存在可進一步完善之處那相關部門依憑管系統啟動現場實地查核要求研發相關人員接受重新訓練"},{"start":201.994,"end":217.103,"text":"所以還有改善之處 人員要重新訓練沒有遵守實驗動物相關的SOP處理流程 他們會陷阱完成改善那本公司有嚴謹的設施區隔和管控措施並嚴格遵守相關規範 如果這樣 今天這個必責那些商品不是都AI合成的"},{"start":224.858,"end":233.163,"text":"他們說他們公司嚴格遵守相關規範研發實驗室和GMP管控的疫苗生產製造和品管檢驗場所在物理空間環境控制系統人員和物料動線以及所適用的管理規範上均各自獨立且完全區隔所以他認為有改善之處但是他們沒有問題他們沒有問題請問"},{"start":253.456,"end":258.662,"text":"這個接避者的所有的照片 都合成的你們現在才要說 今天你知道 看了報紙報導才知道"},{"start":266.865,"end":288.867,"text":"問題這麼嚴重關係到流感疫苗有沒有受到污染你們現在是整個部裡面神經斷掉你說現在要去查現在幾個月以後快一年啦你現在才要去查你能查到什麼你在這裡說要去調查去年事發到現在八個多月現在去查場能查什麼"},{"start":289.668,"end":314.067,"text":"老鼠的毛有嗎尿液有嗎你的實驗器材你的微量吸管菌質藥劑的試管震盪混合器你的檢測核酸DND濃度的精密儀器有沒有汙染你的製冰機恆溫水槽實驗袍有沒有暴露在汙染的實驗當中它的汙染有沒有造成實驗數據的"},{"start":316.229,"end":339.14,"text":"失真通通都沒辦法查了啦 重點是要查什麼不是你說你現在馬上去調查 最快速度跟大家報告可以解決現在是要完整的收集吹哨者的資料和說法而不是讓國光生氣 包庇 隻手遮天 欺上瞞下"},{"start":341.499,"end":351.446,"text":"不對 我這樣說 你也忙著聽你部署給你報告 你也不知道剛才休息十分鐘 你也不想去了解 現在就要臨時報佛教今天看到了根據媒體鋪路 我們現在看到的是你們需要署你們衛福部食品安全也靠吹哨者 藥品安全也要靠吹哨者"},{"start":367.995,"end":374.137,"text":"藥廠螺絲酸了 重點是這個藥廠這件事一夜之秋啊 見為知著啊整個藥廠的螺絲鬆了它不是單一事件 而且人家照片人員指證利率"},{"start":391.274,"end":401.105,"text":"你們在去年這個事情之後不要忘了國光發生了基隆市衛生局的通報事件"},{"start":402.374,"end":421.787,"text":"國光的流感疫苗這個外觀呈現黃色同批號回收18.3萬劑我問你你們這個事情已經過了這麼久了去年的10月到現在半年了請問這一批疫苗是哪一個廠製造的國光這一批出了問題的疫苗是哪一個廠製造的談是不是談紙廠"},{"start":432.605,"end":434.366,"text":"台中攤子是不是也是攤子廠是不是是啊 所以我說啊我說啊這個有氣螺絲掉滿地啊你們的螺絲也掉滿地"},{"start":449.403,"end":468.088,"text":"你們在出現這個疫苗變色的這個事件之後你們機關署初步判定非微生物污染認為是單一案例然後你們食藥署也是根據國光生技提交的調查報告"},{"start":470.493,"end":484.618,"text":"給專家審查然後認定是單一事件如今隨著今天的新聞披露內部的吹哨者才爆發出同樣這一個台中彈指廠國光生技實驗室爆發這麼嚴重的污染整個藥廠從研發到生產可能"},{"start":497.586,"end":521.174,"text":"整個螺絲都鬆動啊所以不是不是當初疫苗變色流感疫苗出問題單一事件當時你也說單一現在又說單一一個單一事件再加一個單一事件只要屬衛福部都是廠商說了算嗎看起來像是像是啊"},{"start":525.404,"end":528.466,"text":"補充你也說看看,現在是怎樣藥廠螺絲鬆了,掉滿地了主管機關衛福部都聽藥廠的報告然後就以單一事件結案了事然後一次又一次我們絕對不會只有聽藥廠的報告,它只是一個報告而已最重要我們會親自去查"},{"start":553.468,"end":557.171,"text":"會查核 你問我現在問你啦 今天你報到的事件 你要怎麼查核 經過各位要怎麼查核我們也去查核啦 你要去查什麼啦 老鼠的毛也掉不到找不到 有人也查不到"},{"start":569.34,"end":586.264,"text":"這個部分他照片呈現的部分是研發部門啦那當然研發部門也必須要保護他的研發部門都這麼隨便了你怎麼知道生產部門不隨便那生產部門的部分如果再有一個吹哨者吹出生產部門也是這樣俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐俐那我要你政府幹什麼"},{"start":599.909,"end":619.442,"text":"我們當然會全力按照一個最好的制度來所以我問你啊這次你要怎麼調查不要靠大家一起來努力靠大家是靠誰啊大家要靠你政府啦你政府要靠我們大家政府當然是擔任最大的一個責任我現在就問你這個事件你要怎麼查你說馬上去查現在去調查還能調查什麼我問你啊"},{"start":631.519,"end":641.865,"text":"我們當然是把所有整個實驗室的作業程序完全環境的一個紀錄那個紀錄 現在你就要調查啊 大家也做好給你看沒有啦 今天就隨便你查嘛啊就稍微曝光啊 人家就知道要曝光啊而且要訪談人家 人都知道啦來釐清我們報紙 媒體的報導的適合違反利用期 要司法的57條你光是認為立委很好呼嚨 連派一個主責機關的任何一個"},{"start":661.007,"end":669.592,"text":"高層來都沒有就知道你不在乎這個事情我們很在乎你在乎你告訴我食藥署派了誰來剛開始那個誰因為署長沒有來副署長沒有來署長在開國安的會議副署長在經濟委員會另外一個因為你今天派的是食品組的檢認記證來啦"},{"start":689.668,"end":697.712,"text":"我們另外一個副市長他本來回署裡面他現在已經在過來的路上你一個資訊案資訊的議題你就這樣資訊處處長趕快來年老公園院的就趕快來現在你業務主管的你核心的你最最最核心的業務主管的你連派個像樣的人都沒有業務單位通通都沒有"},{"start":717.702,"end":727.731,"text":"所以你也螺絲鬆了 算了 螺絲都不是鬆了 是掉滿地了國關藥廠的螺絲掉滿地 理事藥署衛福部的螺絲也掉滿地對不對 我現在再問你一次"},{"start":739.11,"end":744.254,"text":"我們在講說因為美國對等關稅的議題你上個禮拜來報告然後FDA食藥署裡面認為美國的輸入的藥品的許可證214張裡面在專利期限"},{"start":759.028,"end":780.534,"text":"替代性低的非買美國藥不可的有60個健保署說的數字當然不一樣健保署說美國進口的藥物一共有176個其中有72個在必要藥品清單包括抗腫瘤免疫相關藥物24項還有感染相關用藥及血液相關藥物各18項"},{"start":783.335,"end":787.998,"text":"這個東西我先跟你要資料請你們在三天內提供以上清單給我們辦公室我們來看看兩邊的數據兜不起來嘛那你把清單給我們然後再來就是說我上次只談到藥品醫材那現在問你說對於公費疫苗會不會受到美國關稅政策影響公費疫苗我國公費疫苗"},{"start":810.791,"end":835.2,"text":"製造廠在美國 距離上個禮拜來這裡你們的報告也已經過了一個禮拜了 你有沒有思考過這個議題我們最近一次疾管署採購的公費疫苗當中水痘疫苗 麻疹 篩腺炎 德國麻疹混合疫苗23架的肺炎鏈球菌多醣體疫苗的製造廠"},{"start":835.7,"end":857.436,"text":"都是美國廠採購合約都為美國莫沙東除此以外FDA合法的水痘和德國麻疹疫苗的藥證當中疫苗製造廠在美國的比例相當相當的高如果日後的關稅政策影響採購其他國家不是只有台灣要去搶喔"},{"start":859.045,"end":863.709,"text":"其他國家也一定會去講那個替代的藥廠選效但台灣市場小本來就沒有市場的這個這個市場的談判的能力在各國競爭之下你認不認為公費疫苗會不會有缺藥的問題"},{"start":880.743,"end":885.488,"text":"這個不是預算夠不夠有沒有被在野黨凍結喔這個是你有錢也沒有辦法在時間內完成採購買不到的問題台灣的公衛會受到相當相當的衝擊喔蛤 有沒有"},{"start":898.427,"end":907.332,"text":"包委員我想這個部份食藥機關使會做已經很早就會表示在議員這種狀況另外我們也也致力了疫苗產業委員會你不要在這裡關槍關掉再官宣一遍啦你告訴我你可不可以保證絕對不會受到衝擊"},{"start":920.817,"end":927.445,"text":"我現在問你一句話啦 麻疹疫苗 台灣自己有本土手在做這個疫苗嗎 有喔目前台灣沒有麻疹的疫苗是不是全部都有採購 越南有5.4萬例 雖然台灣都是還算是還可以"},{"start":939.6,"end":956.508,"text":"但是不要忘了 台灣到越南旅遊現在是旺季 人數大幅攀升台灣的麻疹疫苗有續創6年同期新高如果爆發全球大流行沒有台灣本土自製的麻疹疫苗 蛤 怎麼辦"},{"start":959.709,"end":968.678,"text":"跟委員報告因為我們目前國內的一個疫苗的麻疹疫苗的接種率大概都是至少95%以上所以整個全國的一個對呀小孩子都按照時間一定要啊所以我現在告訴你"},{"start":975.504,"end":994.437,"text":"採購的可能是OK下一次要漲價那你的預算怎麼辦你怎麼因應那有錢買不到的時候你怎麼因應各位媒體我們目前疫苗的採購政策大概主要還是跟多國來採購那我們都會採多年的一個合約來你告訴我現在就現在的這個多年合約多國採購現在美國製造的"},{"start":999.58,"end":1026.71,"text":"比例算多少那其他非美國製造當大家大幅去搶的時候他採購的時候遞延了送貨到貨的日子怎麼辦確實在短期之內應該沒有問題因為目前的採購合約那我再問你流感疫苗台灣的流感疫苗都叫做國光哩哩哩哩哩哩哩走台灣的流感疫苗國產的市占率多高其他都要外國採購"},{"start":1028.774,"end":1046.223,"text":"國光的疫苗本土自製的流感疫苗佔多少比例我們去年大概採購了將近700萬劑的疫苗那國光大概有將近500萬劑所以在流感疫苗這個部分我們自製的比例算是比較高的"},{"start":1046.983,"end":1063.316,"text":"有沒有原料上的這個風險 原料上 比如說自製的比例五百多萬高端是買回來分裝的台灣只有國光跟高端 而你沒有說的是高端是給外國買好做好回來分裝是啊你這個給外國買的人 大家也要買這沒有 這沒有"},{"start":1070.402,"end":1089.169,"text":"都沒有任何風險嗎有關目前流感疫苗的國產的一個部分就是像剛剛委員說的就是目前有國光跟高端那高端的疫苗目前其實只是在台灣分裝他們的原液是從韓國進來的對啊 我在問妳說原液 如果大家搶著要原液"},{"start":1089.889,"end":1090.269,"text":"國光跟高端各占多少萬劑?"},{"start":1104.906,"end":1131.678,"text":"以去年的一個採購的一個結果去年國光是採購將近500萬劑那因為高端的一個在評選的一個結果呢是屬於序位比較低的所以他們的劑量相對來講要少很多好那接下來就是希望你們對國光藥廠的把關要好一點那我今天為什麼要講這個因為下一波傳染病大流行來的時候呢"},{"start":1132.628,"end":1161.762,"text":"Who can help部長你現在講了大流行協定WHO的會員國大流行協定達成共識了而且在台灣時間這個月的16號就通過了爭議慶條文達成共識了5月召開的WHA就要正式通過而且簽署了但是呢我們都知道我們最友好的美國要退出WHO了"},{"start":1164.002,"end":1181.948,"text":"那這個東西美國退出WHO對我們在非WHOWHA會議上能表達的有限的狀況裡面大流行協定主要三個部分在取得共識是防疫議題"},{"start":1183.288,"end":1204.773,"text":"病毒株資訊分享 技術移轉我們沒有辦法參與談判 我們沒有辦法成為締約國我們在這種狀況裡面 照上次新冠疫情我們沒有辦法相互馬上得到資源的疫苗要不然病毒的資訊 也是有一點困難和障礙在這種狀況裡面 你們要怎麼因應啊 保定啊"},{"start":1211.75,"end":1227.656,"text":"失去了最重要的最有力的盟國美國的幫忙那我們要怎麼因應我想我們跟美國這些理念相近國家在醫藥上的合作是絕對持續不斷我現在問你說美國退出WHO之後他退出WHO以後對我們參加WHA的大會"},{"start":1237.501,"end":1244.626,"text":"對我們未來面對如果新興的大流行這個大流行病的這個衝擊我們會受到什麼影響"},{"start":1249.178,"end":1269.629,"text":"我想請委員放心 我們有COVID的經驗來看我們的政府 我們的人民 我們的防疫的成效是世界有名的而且我們來支援國際 為什麼那麼多國家國家問你不是這個 那當初都知道上次的經驗是因為我們有半導體產業拿去換啦"},{"start":1273.39,"end":1290.917,"text":"現在我們被迫要到美國設廠了我們連籌碼的重要性都遞減了我想委員要對我們台灣的防疫有信心我現在問你因應的方法是什麼不是只有精神上的信心你要提出具體的政策比如說你現在都講不出來你們都忘掉了比如說你們的CDMO"},{"start":1300.861,"end":1312.311,"text":"你知道你們的CDMO政策信心是要建立在具體的政府的作為政府面對下一波挑戰你最未雨綢繆"},{"start":1314.659,"end":1332.658,"text":"我們看得到你未雨綢繆當新冠突然來的時候全世界沒有發生過所以我們措手不及好努力去反應這個是可以的可是當有這樣子慘痛的經驗之後我們現在不能再像新冠那樣子"},{"start":1333.971,"end":1358.134,"text":"而且在新冠的時候同樣的在這個地方衛福部也做了一些報告你們提出來的報告當初是用半導體產業的優勢去換取這個疫苗那當初過了以後我們在講我們要發展台灣向國際爭取CDMO你知道什麼是CDMO吧"},{"start":1359.249,"end":1387.144,"text":"你那時候在這個委員會我還被踢出去這個委員會CDMO2021年專案報告題目叫做爭取COVID-19新冠肺炎國際疫苗代工策略目前我國各項疫苗政策方向疫苗準備情形及109年8月AZ疫苗研發團隊來台探尋代工疫苗評估過程當時你們衛福部就講"},{"start":1389.076,"end":1415.152,"text":"要發展台灣成為國際疫苗CDMO的夥伴CDMO當你們把新冠肺炎降階為第四類傳產以後你們指揮中心同時解編以後整個面對新興的大流行的這些病毒現在是怎樣CDMO現在是"},{"start":1419.64,"end":1428.609,"text":"這個叫政習人亡還是什麼的還是頭過心就過還是等下一波大傳染病大流行時的時候我們再來頭目在燒到底是要怎麼樣你們的CDMO在哪裡你叫我有信心我希望你給我們信心政府跟衛福部"},{"start":1438.559,"end":1447.325,"text":"都有針對新興的一個我現在問你CDMO你不要打高空你的CDMO現在是如何陸續在討論陸續在討論但是因為條件有相當多的差距陸續在討論所以我們不能說我現在講因為美國的保護主義心情美國的對等關稅"},{"start":1463.636,"end":1475.278,"text":"所以有沒有可能你即便你的CDMO可能的疫苗代工合作模式也會遇到障礙因為美國政府川普要連他們的藥廠都必須回去美國製造你CDMO連談都沒有談成然後如果當他們要求全部都搬回美國再一次如果發生這樣子像COVID-19這種疫情我們要怎麼自救"},{"start":1489.141,"end":1495.126,"text":"我們當然以最成全的方式來應變我十問你都虛答但是我十問你都答不出來你都沒在想耶你都沒在想耶我們全部的政府跟對付主的同仁日益企業在因應各種變化"},{"start":1510.031,"end":1518.905,"text":"五月就要到了失去美國這個這麼重要的夥伴他們退出WHO他們明年才會退出 今年還會參加今年還必須要繳費 我知道今年還必須 因為要提前一年告知"},{"start":1524.926,"end":1529.51,"text":"我們還會 還是跟美國的重要的關係我們要自立自強啦 我在講自立自強所以政府規劃當初說政府規劃主導成立新公司國發基金來投資招募民間生技廠商入股這個成立新版的生技條例委託代工CDMO你們還有租稅優惠條款"},{"start":1552.19,"end":1571.271,"text":"要跟莫德納談MRNA平台的技術移轉然後當初還講鎖定到台北地區一處現有的廠房然後莫德納在去年跟三星簽訂了CDMO合約在日本、澳洲同步設有辦公室"},{"start":1572.432,"end":1595.818,"text":"而且在香港、馬來西亞和新加坡增設子公司2022年到台灣合作所提到的未來開發重點請問當初你們講的是現在進行式還是已經成為過去式了不是進行式我們有成立一個國家疫苗產業合作標準對啦 進行式那進行到哪裡現在不是過去式吧當然是進行式啊"},{"start":1599.58,"end":1604.688,"text":"那美國政府要求藥廠回流本土製造有沒有衝擊我們會密切來評估"},{"start":1609.181,"end":1630.329,"text":"你藥品也沒有評估出來醫材然後現在告訴你公費疫苗公費疫苗你也沒有辦法好 新加坡已經成功的跟BNT建立疫苗生產基地越南也成為歐盟授權生產的重要基地因為美國大家都衝擊很大所以分散風險韓國"},{"start":1633.03,"end":1649.6,"text":"也透過美國他們在莫德納他們在做合作但是新加坡越南他們都跟歐盟在合作所以下一波疫情來之前你可以告訴我們說放心絕對沒有問題我們都CDMO也準備好了我們的衝擊也沒有問題如果你這樣講"},{"start":1657.405,"end":1662.711,"text":"講出具體的政策那我就相信但你今天在這裡什麼都講不出來你什麼都回答不出來"},{"start":1664.113,"end":1672.419,"text":"這是我們擔心的 不是精神上喊話就可以的我們買足夠的疫苗 經過專家的評估買足夠的疫苗 疫苗是動態的 持續動態的不是你現在精快買足夠就夠的 當重大的做到什麼 你在講什麼 我有說浪費公帑嗎不是空話 這個就是真的在做啊"},{"start":1689.591,"end":1697.713,"text":"我現在提醒你是 這是一個動態的狀態 動態的狀態因為你這一波的流感 光是你們的相關的疫苗 我剛剛講那些疫苗 小兒疫苗從美國採購的很多 很多 連預算都受到衝擊連預算都受到衝擊 這個預算是公務預算那你的公務預算如果短少了 怎麼辦"},{"start":1713.866,"end":1728.559,"text":"我們這是疫苗基金啦我們疫苗的基金我們會隨時來注意它的充分請委員放心也請國務院放心我很想對政府放心但是我對你邱太元就不放心啦不用對我放心對政府對衛福部要有信心謝謝"}]},"gazette":{"lineno":643,"blocks":[["林委員淑芬：（11時）是不是請邱部長？"],["邱部長泰源：委員好。"],["林委員淑芬：部長，今天在野黨委員質詢所謂的醫療資訊大平台的議題，所以你們派了資訊處處長來，工研院也派了法務長來，今天你最核心的業務，你們主管的國光藥廠出了這麼大的新聞，你說一大早就知道了，你通通都沒有派任何業務單位的人來，今天食藥署來列席的本來是一位簡任技正，你現在是當作立法院不會問這個問題，立法院立委對這個議題都不煩惱嗎？在野黨要問什麼你提早知道了，還懂得叫資訊處處長來，今天新聞這麼大篇食藥署沒有人來，你現在是說，在到立法院之前……"],["邱部長泰源：我們現在同時有四個委員會需要食藥署，那個……"],["林委員淑芬：同時四個委員會需要食藥署，請問署長去哪一個委員會？哪一個？"],["邱部長泰源：食藥署署長在國安會。"],["林委員淑芬：所以你現在回答我那個是什麼問題！我在問你食藥署署長有沒有來？副署長有沒有來？你說立法院有四個委員會需要署長；我說署長在哪裡？結果你說他不在立法院。"],["邱部長泰源：有一個署長在經濟委員會。"],["林委員淑芬：你說他不在立法院，現在你跟我說這個……"],["邱部長泰源：署長……"],["林委員淑芬：不要說這個啦！"],["邱部長泰源：署長不在立法院。"],["林委員淑芬：我實在是很不想對你動怒，但是我要講，你今天到立法院之前，你也受訪了，你還講說國光藥廠這些白老鼠、這些實驗老鼠，整個事件違反GMP要罰3到2萬，就沒……"],["邱部長泰源：3到200萬。"],["林委員淑芬：3到200萬，問題是國光生技包庇這麼嚴重的污染事件，連有沒有違反GMP都是國光生技說了算嗎？國光生技今天發了兩篇新聞稿，很大篇在說動物福利，然後跟衛福部、跟國人最關注的整個潭子廠。潭子廠在生產什麼疫苗，你跟我說？出事的這個工廠在生產什麼疫苗？你跟我回答。你不知道？"],["邱部長泰源：一般流感疫苗、破傷風疫苗。"],["林委員淑芬：好，流感疫苗，在生產流感疫苗的工廠，結果它們對於整個事情在新聞稿最後一段才提到說，他們內部調查確認上述實驗動物事件，在作業程序上存在可進一步完善之處，相關部門依品管系統啟動現場實地查核，並要求研發相關人員接受重新訓練，所以還有改善之處，人員要重新訓練，沒有遵守實驗動物相關SOP處理流程，他們會限期完成改善，本公司有嚴謹的設施區隔和管控措施，並嚴格遵守相關規範。如果是這樣，今天揭弊者的那些相片不就都是AI合成的。公司說嚴格遵守相關規範，研發實驗室和GMP管控的疫苗生產、製造、品管、檢驗場所，在物理空間、環境控制系統、人員和物料動線以及所適用的管理規範上，均各自獨立且完全區隔，所以它認為有改善之處，但是它們沒有問題。請問這個揭弊者所有的照片不就都是假的、都合成的。","你們現在才說看到報紙報導才知道，問題這麼嚴重，關係到流感疫苗有沒有受到污染，你們現在是整個部裡面神經斷掉，你說現在就要去查，現在……幾個月以後快一年了，你現在才要去查你能查到什麼，你在這裡說要去調查，去年事發到現在八個多月，現在去查廠能查什麼？老鼠的毛有嗎？尿液有嗎？它的實驗器材、它的微量吸管均質藥劑的試管振盪混合器、它的檢測核酸DNA濃度的精密儀器有沒有污染、它的製冰機、恆溫水槽、實驗袍有沒有暴露在污染的實驗當中、它的污染有沒有造成實驗數據的失真，通通都沒辦法查了啦！重點是要查什麼？現在不是你說馬上去調查，用最快速度跟大家報告可以解決，現在是要完整地蒐集吹哨者的資料和說法，而不是讓國光生技包庇、隻手遮天、欺上瞞下。","部長，我這樣說，你也忙著聽你的部屬跟你報告，你也不知道，剛才休息10分鐘你也不想去了解，現在才要臨時報佛腳。今天看到根據媒體披露，我們現在看的是食藥署、衛福部，食品安全也靠吹哨者、藥品安全也要靠吹哨者，藥廠螺絲鬆了，重點是藥廠這件事情一葉知秋、見微知著，整個藥廠的螺絲鬆了！它不是單一事件，而且人家照片人員指證歷歷，不要忘了國光發生基隆市衛生局的通報事件，國光的流感疫苗外觀呈現黃色，同批號回收18.3萬劑，我問你，你們這個事情已經過了這麼久了，去年的10月到現在半年了，請問這一批疫苗是哪一個廠製造的？國光這一批出了問題的疫苗，是哪一個廠製造的？是不是潭子廠？臺中潭子是不是？"],["邱部長泰源：是，潭子廠。"],["林委員淑芬：是啊！所以我說，這個藥廠螺絲掉滿地啊！你們的螺絲也掉滿地。你們在出現疫苗變色的事件之後，疾管署初步判定非微生物污染，認為是單一案例，然後食藥署也是根據國光生技提交的調查報告給專家審查，然後認定是單一事件。如今隨著今天的新聞披露，內部的吹哨者才爆發出同樣是臺中潭子廠國光生技實驗室，爆發這麼嚴重的污染，整個藥廠從研發到生產可能整個螺絲都鬆動了，所以不是當初疫苗變色、流感疫苗出問題的單一事件。當時你也說單一，現在又說單一，一個單一事件再加一個單一事件，食藥署、衛福部都是廠商說了算嗎？看起來像是啊！","部長，你也說說看，現在是怎樣？藥廠螺絲鬆了、掉滿地了，主管機關──衛福部都聽藥廠的報告，就以單一事件結案了事，然後一次又一次。"],["邱部長泰源：我們絕對不會只有聽藥廠的報告，它只是一個報告而已，最重要的是我們就會親自去查核，會查核……"],["林委員淑芬：我現在問你，就今天報導的事件你要怎麼查核？經過好幾個月了要怎麼查核？"],["邱部長泰源：我們會去查核。"],["林委員淑芬：你要去查什麼？老鼠的毛也調不到、找不到，污染也查不到啦！"],["邱部長泰源：查核的部分，第一個跟大家報告一下，照片呈現的這個部分是研發部門，那當然研發部門也必須要保持它的……"],["林委員淑芬：我現在說這是螺絲鬆了，研發部門都這麼隨便，你怎麼知道生產部門不隨便。"],["邱部長泰源：生產部門的部分……"],["林委員淑芬：如果再有一個吹哨者，吹出生產部門也是這樣「離離落落」……"],["邱部長泰源：當然我們一樣嚴加調查……"],["林委員淑芬：你現在是沒有政府了，都要靠吹哨者，你的食品安全靠吹哨者、你的藥品安全、疫苗安全也要靠吹哨者，那我要你政府幹什麼！"],["邱部長泰源：我們當然會全力按照最好的制度來努力，在這當中……"],["林委員淑芬：所以我問你，這次你要怎麼調查？"],["邱部長泰源：也要靠大家一起來努力。"],["林委員淑芬：靠大家是要靠誰？大家要靠你政府，你政府還要靠我們大家！"],["邱部長泰源：政府當然要承擔最大的責任，而且要負全責。"],["林委員淑芬：我現在問你這個事件要怎麼查，你說馬上去查，現在去調查還能調查什麼？我問你。"],["邱部長泰源：我們當然是把整個實驗室的作業程序、環境的紀錄……"],["林委員淑芬：現在你要調查了，大家當然做好給你看。"],["邱部長泰源：沒有，今天就馬上去查……"],["林委員淑芬：新聞就已經曝光，大家昨天就知道要曝光。"],["邱部長泰源：事件調查紀錄，而且要訪談人員，來釐清媒體的報導，是否違反藥事法第五十七條。"],["林委員淑芬：你認為立委很好糊弄，連派主責機關的高層來都沒有，就知道你不在乎這個事情。"],["邱部長泰源：我們很在乎。"],["林委員淑芬：你在乎，你告訴我剛開始食藥署派誰來？誰？署長沒有來、副署長沒有來。"],["邱部長泰源：因為署長在開國安會議，副署長在經濟委員會，另外因為……"],["林委員淑芬：你今天本來派的是食品組的簡任技正來。"],["邱部長泰源：另外一個副署長，他本來回署裡面，現在已經在過來的路上。"],["林委員淑芬：你一個資訊的議題，就趕快把資訊處處長叫來，工研院也趕快叫來，而現在最、最、最核心的業務主管單位，你連派個像樣的人來都沒有，業務單位通通都沒有，所以你螺絲鬆了，螺絲不是鬆了，是掉滿地！"],["邱部長泰源：我們有監管組，專門管理藥廠的監管組組長。"],["林委員淑芬：國光藥廠的螺絲掉滿地，你們食藥署、衛福部的螺絲也掉滿地，對不對？"],["邱部長泰源：我們會更加努力。"],["林委員淑芬：我現在再問你一個問題，因為美國對等關稅的議題，你上個禮拜來報告，然後FDA食藥署認為美國輸入藥品的214張許可證裡面，在專利期限替代性低的、非買美國藥不可的有60個，健保署說的數字當然不一樣，健保署說，美國進口的藥物一共有176個，其中有72個在必要藥品清單，包括抗腫瘤、免疫相關藥物24項，還有感染相關用藥及血液相關藥物各18項，請你們在3天之內，提供以上清單給我們辦公室，因為兩邊的數據兜不起來，你先把清單給我們。","再來，我上次只談到藥品、醫材，現在問你，對於公費疫苗會不會受到美國關稅政策影響？我國公費疫苗製造廠在美國，距離上個禮拜，你們來這裡報告，也已經過了一個禮拜，你有沒有思考過這個議題？我們最近一次疾管署採購的公費疫苗當中，水痘疫苗、麻疹、腮腺炎、德國麻疹、混合疫苗、23價肺炎鏈球菌多醣體疫苗的製造廠，都是美國廠，採購合約都為美國默沙東，除此以外，FDA核發的水痘和德國麻疹疫苗的藥證當中，疫苗製造廠在美國的比例相當、相當地高，如果日後的關稅政策影響採購，不是只有臺灣要去搶，其他國家也一定會去搶那個替代的藥廠選項，但臺灣市場小，本來就沒有市場談判的能力，在各國競爭之下，你認為公費疫苗會不會有缺藥的問題？這不是預算夠不夠、有沒有被在野黨凍結，這個是你有錢，也沒有辦法在時間內完成採購，買不到的問題，臺灣的公衛會受到相當、相當地衝擊，有沒有？"],["邱部長泰源：報告委員，這個部分疾管署很早就預言這種狀況……"],["林委員淑芬：你告訴我會不會有問題？會不會受衝擊？"],["邱部長泰源：另外我們也成立了疫苗產業委員會……"],["林委員淑芬：你不要在這裡官腔官調，再官宣一遍，你可不可以保證絕對不會受到衝擊？"],["邱部長泰源：我想請食藥署副署長來回答。"],["林委員淑芬：我現在問你一句話，麻疹疫苗臺灣自己有本土廠在做疫苗嗎？有嗎？"],["曾副署長淑慧：目前臺灣沒有麻疹的疫苗。"],["林委員淑芬：是不是全部都要採購？"],["曾副署長淑慧：是。"],["林委員淑芬：越南有5.4萬例，雖然臺灣算是還可以，但是不要忘了臺灣到越南旅遊，現在是旺季，人數大幅攀升，臺灣的麻疹疫苗也續創6年同期新高。如果爆發全球大流行，沒有臺灣本土自製的麻疹疫苗，怎麼辦？"],["曾副署長淑慧：跟委員報告，因為目前國內麻疹疫苗的接種率，大概至少95%以上，所以全國的免疫力……"],["林委員淑芬：小孩子都按照時間一定要啊！所以我現在告訴你，你現在採購的可能OK，下一次如果漲價，你的預算怎麼辦？你怎麼因應？有錢買不到的時候，你怎麼因應？"],["曾副署長淑慧：跟委員報告，目前疫苗的採購政策，主要還是跟多國採購，都會採多年的合約，我們會用分批……"],["林委員淑芬：你告訴我，就現在的多年合約、多國採購，現在美國製造的比例占多少？其他非美國製造，當大家大幅去搶的時候，採購如果遞延送貨、到貨的日子怎麼辦？"],["曾副署長淑慧：確實在短期之內應該沒有問題，因為目前的採購合約大概都……"],["林委員淑芬：那我再問你，臺灣的流感疫苗，剛剛說國光零零落落地做，臺灣的流感疫苗，國產的市占率多高？其他都要外國採購。"],["曾副署長淑慧：國光的疫苗在我們採購……"],["林委員淑芬：我現在問本土自製的流感疫苗占多少比例？"],["曾副署長淑慧：我們去年採購將近七百萬劑的疫苗，國光大概將近五百萬劑，所以在流感疫苗部分，我們自製的比例算是比較高的。"],["林委員淑芬：有沒有原料上的風險？比如說，自製的比例五百多萬，高端是買回來分裝的，臺灣只有國光跟高端，而你沒有說的是，高端是跟外國買做好的回來分裝，你跟外國買的大家也要買，這都沒有任何風險嗎？"],["曾副署長淑慧：有關流感疫苗國產的部分，像剛剛委員說的，目前有國光跟高端，高端的疫苗目前其實只是在臺灣分裝，他們的原液是從韓國進來的。"],["林委員淑芬：我的問題是，如果大家搶著要原液。"],["曾副署長淑慧：國光的疫苗是本土產的，從原料開始製作，到疫苗的生成。"],["林委員淑芬：國光跟高端各占多少萬劑？"],["曾副署長淑慧：以去年採購的結果，去年國光是採購將近五百萬劑，因為高端在評選的結果是屬於序位比較低的，所以他們的劑量相對來講要少很多。"],["林委員淑芬：好、好，接下來就是希望你們對國光藥廠的把關要好一點，我今天為什麼講這個？因為下一波傳染病大流行來的時候，who can help？部長，你現在講的大流行協定，WHO的會員國大流行協定達成共識了，而且在臺灣時間這個(4)月16號就通過爭議性條文達成共識，5月召開WHA就要正式通過而且簽署，但是我們最友好的美國要退出WHO，美國退出WHO，對我們非WHO成員，且在WHA會議上表達受限的狀況之下，大流行協定三個部分在取得共識，主要是防疫議題、病毒株資訊分享、技術移轉，我們沒有辦法參與談判，我們沒有辦法成為締約國，在這種狀況下，照上次新冠疫情，沒有辦法相互馬上得到支援的疫苗，取得藥物和病毒的資訊，也有一點困難和障礙。在這種狀況之下，你們要如何因應，部長？失去了最重要、最有利的盟國，美國的幫忙，我們要如何因應？"],["邱部長泰源：我們與美國等理念相近的國家在醫藥上的合作絕對是持續不斷，不是在WHA或WHO的問題而已。"],["林委員淑芬：我現在要問的是美國退出WHO之後對我們參加WHA大會、對我們未來面對新興大流行疾病的衝擊會受到什麼影響？"],["邱部長泰源：請委員放心，我們由COVID的經驗來看……"],["林委員淑芬：我要怎麼放心？COVID的經驗很慘啊！"],["邱部長泰源：我們的防疫成效是世界有名，而且我們還支援國際上那麼多的國家……"],["林委員淑芬：我現在問的不是這個，上次的經驗是因為我們有半導體產業去換啊！現在我們被迫要去美國設廠，連籌碼的重要性都遞減了。"],["邱部長泰源：委員要對我們臺灣的防疫有信心啊！"],["林委員淑芬：現在是問你因應的方法，不是只有精神上的信心，你要提出具體的政策，現在你們都講不出來、都忘掉了！譬如你們的CDMO？你知道你們的CDMO政策嗎？信心是要建立在具體的政府作為，政府面對下一波挑戰，你必須要未雨綢繆，而且我們看得到你正在未雨綢繆。當新冠突然來的時候，因為全世界都沒發生過，所以我們措手不及，必須努力去反應，這是可以的，但是當有這樣慘痛的經驗之後，現在我們不能再像面對新冠那樣子耶！而且在新冠疫情期間，同樣在這個地方，衛福部也做了一些報告，根據你們提出的報告，當初是用半導體產業的優勢換取疫苗，之後我們說要發展臺灣向國際爭取CDMO，你知道什麼是CDMO吧？那個時候你在這個委員會，而我還被踢出這個委員會耶！CDMO，2021年的專案報告，題目是爭取COVID 19新冠肺炎國際疫苗代工策略，目前我國各項疫苗政策方向、疫苗準備情形及109年8月AZ疫苗研發團隊來臺探詢代工疫苗評估過程。當時你們衛福部就說要發展臺灣成為國際疫苗CDMO的夥伴，蛤？CDMO，當你們把新冠肺炎降階為第四類傳產之後、你們的指揮中心同時解編之後，現在整個面對新興大流行的這些病毒是怎麼樣？現在CDMO是政息人亡或什麼的？或是「頭過身就過」？或是等下一波傳染病大流行的時候，我們再來「頭殼抱咧燒」？到底是要怎麼樣？你們的CDMO在哪裡？你叫我要有信心，但我希望你給我們信心！"],["邱部長泰源：政府及衛福部都有針對新興傳染病……"],["林委員淑芬：現在我是問你CDMO，你不要打高空啦！"],["邱部長泰源：關於這個，我們陸續在談……"],["林委員淑芬：關於CDMO，現在是怎麼樣？這個政策已經死了，是嗎？"],["邱部長泰源：陸續在討論，但是因為條件有相當多的差距……"],["林委員淑芬：陸續在討論喔！陸續在討論喔！"],["邱部長泰源：我們也不能在太差的條件下答應人家，一定要盡量的講價嘛！"],["林委員淑芬：美國的保護主義興起，面對美國的對等關稅，即便是你的CDMO、可能的疫苗代工合作模式也會遇到障礙，因為美國總統川普要求他們的藥廠也必須回去美國製造。現在你們的CDMO連談都沒有談成，當他們要求全部都搬回美國之後，一旦再次發生像COVID 19那樣的疫情，我們要怎麼自救？蛤？蛤？"],["邱部長泰源：我們當然以最周全的方式應變，但是……"],["林委員淑芬：我實問，你都虛答！我實問，你都答不出來！你都沒有在想耶！"],["邱部長泰源：我沒有虛答。"],["林委員淑芬：你都沒有在想耶！"],["邱部長泰源：我們衛福部全部的同仁日以繼夜在因應各種變化……"],["林委員淑芬：你叫他閉嘴，好嗎？","5月就要到了，失去美國這個如此重要的夥伴，他們退出WHO……"],["邱部長泰源：他們明年才會退出，今年還是會參加。"],["林委員淑芬：今年還必須要繳費，我知道，因為要提前一年告知，在未來也會……"],["邱部長泰源：我們與美國的重要官員還是會有互動。"],["林委員淑芬：我們要自立自強啦！"],["邱部長泰源：當然。"],["林委員淑芬：自立自強！當初說政府規劃主導成立新公司，由國發基金來投資，招募民間生技廠商入股，成立新版的生技條例委託代工CDMO，你們還有租稅優惠條款，要與莫德納談MRNA平台的技術移轉，甚至還說鎖定大臺北地區一處現有的廠房，結果莫德納去年與三星簽訂了CDMO合約，在日本及澳洲同步設有辦公室，而且在香港、馬來西亞及新加坡增設子公司。2022年到臺灣合作所提到的未來開發重點，請問，當初你們講的是現在進行式或是已經成為過去式了？"],["邱部長泰源：都是進行式，我們成立一個國家疫苗產業工作小組，也討論到這個主題。"],["林委員淑芬：既然是進行式，進行到哪裡了？現在不是過去式吧？不是過去式吧？"],["邱部長泰源：當然是進行式啊！"],["林委員淑芬：美國政府要求藥廠回流、本土製造，有沒有衝擊？"],["邱部長泰源：我們會密切評估。"],["林委員淑芬：你們針對藥品及醫材也沒有評估出來，現在對於公費疫苗也沒有辦法……"],["邱部長泰源：在川普關稅提出的第一天，我們全衛福部的各單位都已經對衝擊及因應……"],["林委員淑芬：新加坡已經成功地與BNT建立疫苗生產基地、越南也成為歐盟授權生產的重要基地，因為美國的關稅政策讓大家受到的衝擊都很大，所以要分散風險。除了韓國透過美國與莫德納合作之外，新加坡及越南都是與歐盟合作。因此，在下一波疫情來臨之前，如果你可以告訴我們，放心！絕對沒有問題！我們的CDMO也準備好了、我們面對衝擊也沒有問題！如果你能講出具體的政策，這樣我就會相信，但是你今天在這裡什麼都講不出來、什麼都回答不出來，這是我們擔心的！不是精神上喊話就可以了。"],["邱部長泰源：我們買足夠的疫苗，也經過專家的評估……"],["林委員淑芬：足夠的疫苗？"],["邱部長泰源：買足夠的藥物。"],["林委員淑芬：疫苗是動態的、持續動態的，不是你現在買足夠就夠了。"],["邱部長泰源：預期未來要如何多元化，我們都努力在做，這就是政策啊！為什麼說是空談呢？這是政策啊！"],["林委員淑芬：什麼？你在講什麼？我有說浪費公帑嗎？"],["邱部長泰源：沒有，我說這不是空話啊！就是真的在做啊！我們沒有講空話啊！"],["林委員淑芬：我現在是提醒你，這是一個動態的狀態。"],["邱部長泰源：當然是動態的狀態啊！"],["林委員淑芬：光是這一波流感的相關疫苗、剛剛我講的小兒疫苗，有很多很多是從美國採購的，連預算都受到衝擊、連預算都受到衝擊，這個預算是公務預算，如果你的公務預算短少了，怎麼辦？"],["邱部長泰源：這是屬於疫苗基金，我們會隨時注意它的充足，請委員放心、也請國人放心。"],["林委員淑芬：我很想對政府放心，但是我對你邱泰源就不放心啊！"],["邱部長泰源：不用對我放心，對政府、對衛福部要有信心，謝謝。"],["主席：謝謝林委員、謝謝部長。"],["主席（林委員淑芬代）：下一位請蘇清泉委員。"]],"agenda":{"page_end":370,"meet_id":"委員會-11-3-26-7","speakers":["蘇清泉","陳昭姿","林月琴","葛如鈞","劉建國","王育敏","邱鎮軍","廖偉翔","林淑芬","王正旭","黃秀芳","羅廷瑋","鍾佳濱","陳菁徽","盧縣一","李坤城","陳培瑜","張雅琳","莊瑞雄","楊曜","陳瑩","林楚茵","林德福"],"page_start":287,"meetingDate":["2025-04-23"],"gazette_id":"1144101","agenda_lcidc_ids":["1144101_00005"],"meet_name":"立法院第11屆第3會期社會福利及衛生環境委員會第7次全體委員會議紀錄","content":"邀請衛生福利部部長、財政部次長就「國家社會福利政策財源檢討及偏鄉兒童發展篩檢執行情\n形」進行專題報告，並備質詢","agenda_id":"1144101_00004"}}},"supported_relations":[],"relations":[]}