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解讀《普洱市貫徹落實改革完善仿制藥供應保障及使用政策實施方案》
索引號: 1001-/2019-0523001 公開目錄: 政策解讀 發布日期: 2019年05月15日
主題詞: 發布機構: 市政府辦公室 文    號: 普政辦發〔2019〕47號
 

一、文件出臺的背景

為貫徹落實《國務院辦公廳供應改革完善仿制藥供應保障及使用政策的意見》(國辦發〔2018〕20號)和《云南省人民政府辦公廳關于改革完善仿制藥供應保障及使用政策的實施意見》(云政辦發〔2019〕8號)精神,進一步深化醫藥衛生體制改革,促進仿制藥研發,提升仿制藥質量療效,提高仿制藥供應保障能力,推動我市醫藥產業快速發展,更好地滿足臨床用藥及公共衛生安全用藥需求,為我市打造世界一流的“健康生活目的地牌”,推進健康普洱建設創造條件,結合我市實際,制定《普洱市貫徹落實改革完善仿制藥供應保障及使用政策實施方案》。

二、貫徹落實改革完善仿制藥供應保障及使用政策的措施

(一)促進仿制藥研發生產:一是引導研發生產仿制藥。根據短缺藥品信息,以需求為導向,引導企業研發、注冊和生產仿制藥。鼓勵有條件的企業加快研發仿制臨床必需、療效確切、供應短缺的藥品。加強對研發過程的指導,避免同品種重復申報,降低研發風險。二是加強仿制藥技術攻關。支持開展國家鼓勵仿制藥品目錄內的重點化學藥品、生物藥品關鍵共性技術研究。發揮企業在仿制藥技術攻關中的主體作用和科研機構、高等院校、醫療機構的基礎支撐作用,健全產學研醫用協同創新體制,開展仿制藥技術協同攻關。鼓勵引進國際先進技術吸收消化再提高,增強核心競爭力,推動產業升級。三是完善藥品知識產權保護。落實藥品知識產權保護制度,引導企業樹立知識產權意識,大力實施專利質量提升工程,規范企業知識產權管理,圍繞藥品核心技術,培育高價值專利。在充分保護藥品創新的同時,防止知識產權濫用,促進仿制藥上市。建立完善藥品領域專利預警機制,降低仿制藥企業專利侵權風險。

(二)提升仿制藥質量療效:一是加快推進仿制藥質量和療效一致性評價工作。落實鼓勵政策,扶持市內藥品生產企業開展仿制藥質量和療效一致性評價工作,對臨床用量大、金額占比高、容易短缺且難以替代的藥品,設立“綠色通道”,優先給于支持。對通過仿制藥一致性評價的本市企業產品,給予適當獎勵。進一步釋放仿制藥一致性評價資源,支持具備條件的醫療機構、高等院校、科研機構和其他社會辦檢驗檢測機構參與一致性評價工作。提高醫療機構和醫務人員開展臨床試驗的積極性,將藥物臨床試驗的條件和能力納入三級醫院綜合績效考核指標。二是提高藥用原輔料和包裝材料質量。嚴格執行藥用原輔料和包裝材料質量標準,推動企業加強藥用原輔料和包裝材料研發,運用新材料、新工藝、新技術,提高質量水平,滿足制劑質量要求。強化檢查和抽檢,加強藥用原輔料和包裝材料質量監管。三是提高工藝制造水平。推動藥品生產企業優化產品結構、提高產品質量,大力提升制藥裝備和智能制造水平。推進藥品生產質量控制信息化建設,實現生產過程實時在線監控。四是加強藥品質量監管。督促藥品生產企業落實藥品安全主體責任,建立健全藥品質量管理體系。提升企業質量意識,夯實發展基礎。加大對仿制藥不良反應監測和質量抽查力度,依法查處并嚴厲打擊違法違規行為。

(三)完善仿制藥使用激勵機制:一是促進仿制藥替代使用。將通過質量和療效一致性評價的仿制藥納入與原研藥可相互替代藥品目錄,加強宣傳,推動仿制藥合理使用。醫療機構采購和使用仿制藥,應優先采購和使用質量和療效通過一致性評價的仿制藥。二是發揮基本醫療保險的激勵作用。醫保管理部門要按規定將符合條件的仿制藥向省級申請納入基本醫療保險報銷藥品目錄,滿足臨床用藥需求。合理制定醫保支付標準,對基本醫療保險藥品目錄中與原研藥質量和療效一致的仿制藥,按照原研藥相同標準支付,減輕參保人員醫藥費用負擔。

(四)其他支持政策:一是明確藥品專利實施強制許可路徑。加強藥品專利強制許可政策的宣傳,促進仿制藥生產企業、研發機構知曉藥品強制許可的條件和辦理程序。二是落實稅收優惠政策。仿制藥企業為開發新技術、新產品、新工藝產生的研發費用,按規定在企業所得稅前加計扣減;仿制藥企業經認定為高新技術企業的,減按15%的稅率征收企業所得稅。三是推進藥品價格改革。除特殊管理的藥品外,其他仿制藥實行市場調節價。做好藥品價格與醫保支付等政策的銜接。支持市內藥品生產企業生產的藥品,參與全省藥品招標采購。四是推動仿制藥產業國際化。發揮我市區位優勢和生物醫藥資源優勢,加強與周邊國家及國際組織的交流合作,加快藥品研發、注冊、生產、上市銷售的國際化步伐。吸引國內外優質企業在我市建立研發中心和生產基地,鼓勵我市制藥企業進行境外商標注冊及藥品國際注冊認證,進一步提升國際化經營能力。支持我市企業開展國際產能合作,建立國際合作研發平臺,提升我市仿制藥研發生產能力。積極為企業開展國際產能合作提高政策、金融、保險等綜合服務。

三、組織實施及相關要求

各級政府和各有關部門要加強領導,建立健全仿制藥供應保障及使用的工作機制,強化部門協同,落實工作責任,完善政策措施,優化發展環境,確保改革措施落地見效。做好政策解讀,提升人民群眾對國產仿制藥的信心。加強對醫務人員的宣傳教育,提高合理用藥水平,推動仿制藥替代使用。要及時回應社會關切,合理引導社會輿論和群眾預期,形成良好的改革氛圍。

 

 

原文鏈接:普洱市貫徹落實改革完善仿制藥供應保障及使用政策實施方案

 

 
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