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您當前的位置:主頁 > 資訊 > IT數碼資訊 > 疫苗事件在做四事 食藥監局答疫苗事件:正在做4件事

疫苗事件在做四事 食藥監局答疫苗事件:正在做4件事

發布日期:2016-03-23 互聯網 slimet
疫苗事件在做四事 食藥監局答疫苗事件:正在做4件事
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導語

3月23日臨近中午,國家食品藥品監管總局主辦的分論壇上,副局長吳湞和來自輝瑞、美國FDA等嘉賓在臺上一起討論藥品審批。但聽眾更關心的是另一個、他一個小時的討論里都沒觸及話題――疫苗。

[名人名言 www.2009du.com]


騰訊財經訊(李偉 劉利平 羅飛)這可能是在2016年博鰲亞洲論壇上出現的第一次眾人搶話筒場面。


記 者們紛紛舉手 爭取提問機會


3月23日臨近中午,國家食品藥品監管總局主辦的分論壇上,副局長吳湞和來自輝瑞、美國FDA等嘉賓在臺上一起討論藥品審批。但聽眾更關心的是另一個、他一個小時的討論里都沒觸及話題――疫苗。


山東警方在稍早前破獲案值5.7億元非法疫苗案,這些疫苗被發現未經嚴格冷鏈存儲運輸銷往24個省市區。3月22日晚間,總理李克強做出批示。


“疫苗問題全球都是關注的,本來論壇沒有這個題目,但我知道繞不開,我知道多少,就答多少。”吳湞在回答騰訊財經詢問時坦承表示,疫苗在流通過程中確實存在問題,需要完善,目前食藥監總局和公安部、衛生部會認真處理好。


針對疫苗事件,吳湞表示,食藥監正在做四件事:


一、徹查案件,一定查清。20號晚上食藥監總局已經查出疫苗上游107人、下游193人,接下來聯合衛計委以及公安部對這些人員開展深入的查處;


二、嚴處違法違規甚至犯罪份子、涉及誰就處理誰,這里有個人也有單位、企業部門。


三、信息公開,這一年來食藥監總局信息公開已經有進步,幾乎每天都有公告。任何查實的事情,不管是報告還是處理決定,第一時間公布,前天晚上公布了9家企業。


四、補漏洞,出問題肯定因為有漏洞。疫苗流通總體規范,但這次要分析出問題在哪里,屬于規范的完善規范,屬于監管的完善監管,通過案子舉一反三。


國內人用疫苗分為兩種,一種是免費、強制使用,叫第一類疫苗;一種是收費、自愿使用,叫第二類疫苗。一類疫苗監管嚴格,個人無法倒賣。二類疫苗向市場開放,自由競爭。


形成地下銷售產業鏈的,正是第二類疫苗。


非法疫苗案件曝光是在3月19日。山東省食藥監局發布《關于龐某等非法經營疫苗案有關線索的通告》,梳理出非法疫苗案的大致脈絡。


3月20日,食藥監總局核實實有疫苗12種(無第一類疫苗,全部為第二類疫苗)、免疫球蛋白2種、治療性生物制品1種。


21日,食藥監總局、公安部、國家衛計委聯合發布通知,要求地方各級食品藥品監管、公安和衛生計生部門立即成立聯合工作組,切實落實落地查人責任,共同做好非法經營疫苗案件涉案產品處置和案件查辦工作。根據山東省公布的涉案嫌疑人員名單和協查線索,對涉及本地區的嫌疑人盡快核實身份,及時查明疫苗購銷情況。


“這次疫苗案件實際上是去年4月份立案,過去1年了,問題產品已經確認,核心問題實際上是無證經營,一段時間里脫離冷鏈、造成疫苗效力降低,安不安全?那是有害的,失效對人體是否有傷害,這是科學問題,不是官員幾句話能回答的問題,需要科學家來回答。”吳湞說。


世界衛生組織22日稱,疫苗應該正確儲存和管理,否則將失去效力或降低效力,但必須注意的是,不正確儲存或過期的疫苗幾乎不會引起毒性反應,因此在本事件中,疫苗安全風險非常低。


吳湞認為,大眾關注疫苗是對的,疫苗是非常特殊產品,是預防性制品,主要兒童注射;疫苗造成傷害不應該,流通和接種管理條例一直以來比較規范。他強調


徹查的含義,包括上游哪里來的、下游哪里去了;要查到底,然后做出評價,再采取補救措施。


根據國務院在2005年頒布了《疫苗流通和預防接種管理條例》,因預防接種異常反應造成受種者死亡、嚴重殘疾或者器官組織損傷的,應當給予一次性補償。預防接種異常反應具體補償辦法由省、自治區、直轄市人民政府制定。


疫苗問題暴露了哪些制度漏洞?北京大學教授、生命科學聯合中心主任饒毅道出了食藥監總局的尷尬處境:“疫苗事件食藥局責任重大,但資源和權利有限,他們也不能管衛計委、也不能管公安部門。這個事情總的處理,已經超出食藥監能handle(處理、掌控)的了。就一些重要的法規問題,食藥監也在完善。我說他們權利太小了,但(食藥監)領導們不能這么說,說了就好像向上要權利,他們現在是卡在中間了。不能把氣撒在食藥監頭上,現在的問題是要想實際可行的解決方案。”


22日,國務院總理李克強對非法經營疫苗系列案件作出批示,指出:疫苗安全事件引發社會高度關注,暴露出監管方面存在諸多漏洞。食藥監總局、衛生計生委、公安部要切實加強協同配合,徹查“問題疫苗”的流向和使用情況,及時回應社會關切,依法嚴厲打擊違法犯罪行為,對相關失職瀆職行為嚴肅問責,絕不姑息。同時,抓緊完善監管制度,落實疫苗生產、流通、接種等各環節監管責任,堵塞漏洞,保障人民群眾生命健康。


兩天后的3月25日,各有關省食品藥品監管局應將調查結果上報總局,由總局統一向社會公開,期望公眾的種種疑問能得到解決。



來源:騰訊財經 李偉 劉利平 羅飛


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