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让百姓不再为短缺药着急
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Topic: 让百姓不再为短缺药着急 (Read 117 times)
MonkeyDLully
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让百姓不再为短缺药着急
June 30, 2017, 08:27:17 AM
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原标题:让百姓不再为短缺药着急
国家卫计委等9部门日前发布《关于改革完善短缺药品供应保障机制的实施意见》(以下简称《意见》),有关负责人就相关问题回答了本报记者的提问。
问:《意见》的主要创新点有哪些?
答:《意见》按照“分级应对、分类管理、会商联动、保障供应”的原则,借鉴国际有益做法和经验,主要有4个方面体制机制创新,概括起来为“1+1+1+6”。
“一个会商联动机制”,即国家和省两级建立9部门会商联动工作机制,评估短缺药品供应保障能力,研究完善重大政策制度,统筹解决短缺问题。“一个清单”,即建立国家、省两级短缺药品清单管理制度,实现动态管理。“一个平台”,即建设全国短缺药品多源信息采集和供应业务协同应用平台,在短缺药品研发注册、生产流通、采购使用等重点环节,逐步实现短缺药品信息监测全覆盖,根据短缺程度和范围,及时启动国家或省级跨部门应对机制,实现动态监测、精准及时应对。“六类精准措施”,即区分不同情况,通过实施定点生产、协调应急生产和进口、加强供需对接和协商调剂、完善短缺药品储备、打击违法违规行为、健全罕见病用药政策6类措施,把涉及短缺药品的各个环节信息打通、政策链条贯穿起来,综合施治、一揽子统筹考虑对策。
问:《意见》将给群众带来哪些实惠?
答:一是让医患双方不为无药可用所急、所困。建立健全开放的短缺药品供应保障体系,积极回应、妥善处理公众关心的药品短缺问题,理顺医药和患者用药需求的沟通渠道,切实保障有药可用。二是让企业不为利润和发展所忧。《意见》明确提出通过定点生产、优化药品采购机制、确定合理采购价格、推动理顺市场交易价格形成机制、支持企业技术改造升级、完善短缺药品储备等方式,给予企业合理利润,激发市场活力。三是让行业不为违法违规者所扰。《意见》注重在维护市场秩序上发力,明确了打击违法违规行为的多种措施;研究制定《短缺药品垄断性原料药价格行为指南》,建立失信经营者黑名单制度;严格执行药品采购诚信记录和市场清退制度等。
问:《意见》提出的短缺药品清单管理制度,具体实施思路是什么?
答:综合分析我国疾病谱变化、重点人群临床用药需求、突发事件应急保障需求、药品及其原料药生产审批等情况,合理界定临床必需药品短缺标准,建立国家、省两级短缺药品清单管理制度。根据短缺原因、短缺程度、影响范围等情况,及时启动国家或省级应对机制,定期公布相关信息。集成多源监测大数据信息,分步实现各部门短缺药品清单相关信息联动,畅通政府、医疗卫生机构、企业、社会组织等相关数据共建、共享、共用通道。组织开展清单内药品临床综合评价,不断优化清单,实现短缺药品清单动态管理。
问:短缺药品供应保障分类精准施策,具体包括哪些内容?
答:一是实施定点生产。综合临床必需、用量小或交易价格偏低、企业生产动力不足等因素,遴选定点生产品种,通过政府定价、价格谈判、市场撮合等多种方式确定统一采购价格,招标确定定点生产企业,直接挂网采购,保障区域合理供应。二是协调应急生产和进口。针对药品相关标准变化、认证改造等导致企业停产及临床需求突然增加等情况,协调有资质的企业应急生产或加快进口。三是加强供需对接、协商调剂。注重掌握药品生产流通企业和医疗卫生机构实际库存,推进临床需求侧与生产流通供给侧加强对接,及时协商调剂短缺药品,避免供需信息沟通不畅导致短缺。四是完善短缺药品储备。根据临床实际需求,筛选短缺药品储备品种(含原料药),合理确定储备数量,安排收储资金,保障药品储备及时到位、高效调剂调用。建立中央和地方两级常态短缺药品储备,中央医药储备以用量不确定的短缺药品为主,地方医药储备以用量确定的短缺药品为主。五是打击违法违规行为。加强对原料药货源、企业库存和市场交易行为等的跟踪监测,强化药品及原料药市场监管,依法查处哄抬价格和垄断等各类违法违规行为,加大处罚力度,维护市场秩序。六是健全罕见病用药政策。研究建立我国常见罕见病用药数据库,通过国家科技重大专项等国家研发项目支持企业和科研单位研发创新,将符合条件、临床急需罕见病用药列入优先研发清单,完善和落实罕见病用药优先审评审批政策。
《 人民日报 》( 2017年06月29日 09 版) (责编:袁勃)
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