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创新药准入应建立快速通道

来源: 南方日报网络版     时间: 2019年08月19日 03:00:53
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(  从)(2009年)(到)(现)(在)(,国)(家)(医)(保)(目)(录)(已)(有)(7年)(未)(变)(。由)(于)(在)(此)(期)(间)(研)(发)(上)(市)(的)(新)(药)(没)(有)(机)(会)(进)(入)(国)(家)(医)(保)(目)(录)(,创)(新)(药)(的)(销)(售)(空)(间)(受)(到)(极)(大)(的)(制)(约)(,这)(也)(挫)(伤)(了)(企)(业)(研)(发)(的)(积)(极)(性)(。两)(会)(期)(间)(,多)(位)(代)(表)(和)(委)(员)(提)(出)(应)(缩)(短)(国)(家)(医)(保)(目)(录)(调)(整)(周)(期)(,探)(索)(动)(态)(调)(整)(机)(制)(,建)(立)(创)(新)(药)(物)(进)(入)(医)(保)(目)(录)(快)(速)(通)(道)(。  近)(年)(来)(,我)(国)(新)(药)(自)(主)(研)(发)(实)(力)(不)(断)(增)(强)(,研)(发)(出)(一)(批)(高)(质)(量)(新)(药)(。国)(产)(创)(新)(药)(的)(上)(市)(,迫)(使)(进)(口)(药)(价)(格)(降)(低)(,减)(轻)(了)(医)(保)(基)(金)(压)(力)(。然)(而)(,由)(于)(新)(药)(获)(批)(后)(未)(能)(及)(时)(进)(入)(国)(家)(医)(保)(目)(录)(,衍)(生)(出)(一)(系)(列)(问)(题)(。  “对)(患)(者)(而)(言)(,创)(新)(药)(物)(往)(往)(是)(患)(者)(急)(用)(的)(,比)(如)(像)(肿)(瘤)(、糖)(尿)(病)(这)(样)(重)(大)(疾)(病)(的)(治)(疗)(新)(药)(,药)(价)(比)(较)(高)(,如)(果)(不)(能)(报)(销)(将)(使)(很)(多)(自)(费)(患)(者)(难)(以)(承)(受)(;对)(药)(企)(而)(言)(,进)(入)(医)(保)(意)(味)(着)(稳)(定)(的)(销)(量)(,持)(续)(的)(市)(场)(覆)(盖)(以)(及)(由)(此)(带)(来)(的)(利)(润)(增)(长)(,一)(个)(药)(品)(进)(不)(进)(入)(医)(保)(目)(录)(,销)(量)(可)(能)(相)(差)(10倍)(。”一)(位)(药)(企)(人)(士)(向)(记)(者)(表)(示)(,创)(新)(药)(不)(能)(进)(入)(国)(家)(医)(保)(目)(录)(,给)(患)(者)(带)(来)(沉)(重)(的)(经)(济)(压)(力)(,也)(给)(制)(药)(企)(业)(设)(立)(了)(难)(以)(逾)(越)(的)(关)(卡)(。  事)(实)(上)(,这)(也)(进)(一)(步)(导)(致)(药)(企)(不)(敢)(在)(新)(药)(研)(发)(上)(加)(大)(投)(入)(。有)(数)(据)(显)(示)(,2012年)(,我)(国)(医)(药)(产)(业)(的)(研)(发)(投)(入)(经)(费)(占)(总)(产)(值)(的)(比)(重)(仅)(为)(1.6%,而)(美)(国)(和)(英)(国)(分)(别)(达)(到)(23.63%和)(24.92%。目)(前)(中)(国)(制)(药)(企)(业)(绝)(大)(多)(数)(从)(事)(仿)(制)(药)(,研)(发)(创)(新)(药)(的)(企)(业)(凤)(毛)(麟)(角)(。  全)(国)(人)(大)(代)(表)(、扬)(子)(江)(药)(业)(集)(团)(董)(事)(长)(徐)(镜)(人)(表)(示)(,当)(今)(世)(界)(,谁)(走)(好)(了)(科)(技)(创)(新)(这)(步)(先)(手)(棋)(,谁)(就)(能)(占)(领)(先)(机)(、赢)(得)(优)(势)(。但)(目)(前)(从)(创)(新)(能)(力)(上)(分)(析)(,国)(内)(制)(药)(企)(业)(与)(我)(们)(的)(期)(盼)(还)(存)(在)(一)(定)(差)(距)(,与)(国)(际)(制)(药)(巨)(头)(还)(存)(在)(相)(当)(大)(的)(差)(距)(,建)(议)(国)(家)(将)(创)(新)(药)(物)(尽)(快)(纳)(入)(医)(保)(体)(系)(。  “一)(方)(面)(,在)(全)(国)(大)(部)(分)(地)(区)(,普)(通)(民)(众)(想)(要)(以)(较)(低)(的)(价)(格)(享)(受)(到)(新)(药)(依)(然)(很)(困)(难)(;另)(一)(方)(面)(,临)(床)(使)(用)(制)(约)(明)(显)(,销)(售)(不)(能)(上)(量)(。由)(于)(很)(难)(短)(时)(间)(内)(收)(回)(研)(发)(成)(本)(,大)(多)(数)(企)(业)(不)(敢)(在)(新)(药)(研)(发)(上)(加)(大)(投)(入)(,挫)(伤)(了)(企)(业)(科)(技)(创)(新)(积)(极)(性)(。”全)(国)(人)(大)(代)(表)(、泰)(州)(市)(委)(常)(委)(、泰)(州)(医)(药)(高)(新)(技)(术)(产)(业)(开)(发)(区)(党)(工)(委)(书)(记)(陆)(春)(云)(表)(示)(,从)(国)(际)(上)(看)(,在)(法)(国)(、美)(国)(、日)(本)(,新)(药)(从)(上)(市)(到)(获)(得)(最)(终)(报)(销)(许)(可)(的)(时)(间)(是)(半)(年)(至)(一)(年)(,德)(国)(、英)(国)(则)(只)(要)(一)(个)(月)(。但)(是)(,我)(国)(目)(前)(还)(未)(出)(台)(相)(关)(的)(政)(策)(机)(制)(。为)(加)(快)(我)(国)(自)(主)(创)(新)(药)(物)(产)(业)(化)(、市)(场)(化)(,不)(断)(增)(强)(企)(业)(创)(新)(意)(识)(,亟)(需)(加)(大)(对)(创)(新)(药)(物)(的)(政)(策)(支)(持)(,特)(别)(是)(国)(家)(医)(保)(方)(面)(的)(政)(策)(扶)(持)(。  全)(国)(人)(大)(代)(表)(、贝)(达)(药)(业)(股)(份)(有)(限)(公)(司)(董)(事)(长)(兼)(首)(席)(执)(行)(官)(丁)(列)(明)(建)(议)(,改)(革)(医)(保)(药)(品)(目)(录)(遴)(选)(机)(制)(,打)(破)(目)(前)(僵)(化)(的)(周)(期)(性)(调)(整)(。对)(于)(创)(新)(药)(,尤)(其)(是)(临)(床)(急)(需)(而)(之)(前)(缺)(乏)(和)(打)(破)(进)(口)(品)(种)(垄)(断)(的)(产)(品)(,一)(旦)(临)(床)(获)(批)(上)(市)(,应)(尽)(快)(组)(织)(专)(家)(进)(行)(药)(物)(经)(济)(学)(评)(估)(,在)(上)(市)(一)(年)(内)((完)(成)(上)(市)(后)(安)(全)(性)(观)(察)()尽)(快)(纳)(入)(医)(保)(报)(销)(范)(围)(。这)(个)(过)(程)(可)(以)(和)(国)(家)(的)(价)(格)(谈)(判)(联)(动)(,以)(避)(免)(招)(标)(进)(院)(等)(各)(种)(地)(方)(性)(政)(策)(的)(干)(扰)(,确)(保)(新)(药)(纳)(入)(目)(录)(后)(能)(尽)(快)(实)(施)(。  陆)(春)(云)(也)(建)(议)(,应)(将)(创)(新)(药)(品)(优)(先)(纳)(入)(国)(家)(医)(保)(目)(录)(。明)(确)(创)(新)(药)(物)(进)(入)(医)(保)(目)(录)(的)(评)(价)(标)(准)(和)(条)(件)(,将)(国)(家)(“重)(大)(新)(药)(创)(制)(”专)(项)(成)(果)(直)(接)(纳)(入)(医)(保)(目)(录)(。对)(已)(上)(市)(的)(创)(新)(药)(物)(,尤)(其)(是)(解)(决)(重)(大)(疾)(病)(或)(填)(补)(市)(场)(空)(白)(、价)(格)(合)(理)(的)(创)(新)(药)(物)(,应)(该)(优)(先)(纳)(入)(医)(保)(目)(录)(。对)(于)(创)(新)(药)(已)(经)(获)(得)(价)(格)(批)(准)(的)(,国)(家)(应)(明)(确)(鼓)(励)(尽)(早)(进)(入)(临)(床)(使)(用)(,通)(过)(竞)(争)(性)(的)(谈)(判)(机)(制)(,上)(市)(一)(年)(后)((完)(成)(上)(市)(后)(临)(床)(试)(验)()即)(可)(经)(评)(估)(进)(入)(报)(销)(目)(录)(。通)(过)(快)(速)(通)(道)(进)(入)(医)(保)(目)(录)(的)(品)(种)(,不)(再)(经)(过)(药)(品)(集)(中)(招)(标)(采)(购)(和)(医)(院)(二)(次)(议)(价)(环)(节)(。尚)(未)(能)(进)(入)(医)(保)(目)(录)(的)(新)(药)(,建)(议)(在)(招)(标)(采)(购)(环)(节)(设)(立)(针)(对)(创)(新)(药)(的)(鼓)(励)(机)(制)(。  此)(外)(,陆)(春)(云)(还)(建)(议)(,应)(规)(范)(医)(保)(药)(品)(目)(录)(更)(新)(调)(整)(周)(期)(。现)(有)(的)(国)(家)(医)(保)(目)(录)(更)(新)(周)(期)(已)(经)(不)(能)(适)(应)(当)(前)(新)(药)(研)(发)(上)(市)(速)(度)(和)(民)(众)(对)(治)(疗)(效)(果)(的)(需)(求)(。缩)(短)(药)(品)(招)(标)(周)(期)(对)(药)(品)(采)(购)(周)(期)(内)(新)(上)(市)(的)(创)(新)(药)(品)(,建)(立)(增)(补)(或)(备)(案)(采)(购)(的)(绿)(色)(通)(道)(。更)(新)(周)(期)(缩)(短)(至)(每)(两)(年)(一)(调)(整)(、一)(年)(一)(增)(补)(,并)(严)(格)(执)(行)(。完)(善)(医)(保)(药)(品)(目)(录)(遴)(选)(的)(科)(学)(评)(价)(机)(制)(,并)(与)(国)(家)(新)(药)(审)(批)(制)(度)(衔)(接)(。  作)(者)(:李)(唐)(宁)(
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