辽宁省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见

Country-interest evidence · pilot

Trade inferences use UN Comtrade, with China as reporter. Country connections indicate potential trade relevance, not measured harm, firm-level exposure or legal applicability. Inward measures concern exporters to China; competition with Chinese exports in third markets is not assessed.

Inspect implementing jurisdictions and partner evidence · 43 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 68,184,646

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 618,891,566

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 358,810,322

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 590,678,951

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 6,021,604

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 46,580,181

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 181,300,594

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,358,551,546

Cuba: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 2,366,120

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 31,321,155

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 6,734,171,707

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 549,005,874

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 441,744,613

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 154,379,223

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 2,310,444,459

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,166,113,342

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 111,570,202

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 375,926,467

Croatia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 6,690,794

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 86,744,660

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 2,503,424

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 22,172,944

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 750,566,329

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 21,854,855

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,835,757,872

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 866,692,641

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 141,837,898

Lithuania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,277,721

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 9,412,622

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 305,319,120

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 30,963,788

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 17,019,606

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 31,617,816

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,415,686

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 62,461,850

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 16,552,563

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,291,085,679

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 7,882,552

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 205,461,971

Uruguay: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 1,601,931

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 3,532,200,082

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70441 · recorded trade USD 106,623,326

Implementing jurisdiction: China · intervention 70441

Assessment states

Trade-based partners recorded

Measures

Tax relief

Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · Keyword screen (unreviewed)

Implemented by China (subnational) · affects 42 partners (inferred from trade data, 2017 trade): Germany, United States, France, Italy, Switzerland, Sweden …

落实现行税收优惠政策，仿制药企业为开发新技术、新产品、新工艺发生的研发费用，符合条件的按照有关规定在企业所得税税前加计扣除。

Supports production in a place, so favours that place by rule.

Same central policy, other provinces

国务院办公厅关于改革完善仿制药供应保障及使用政策的意见 · 国办发〔2018〕20号 · 2018-03-21 · answered in 6 provinces held · trace it ↗

Province	First document citing it	Dated	Lag
Liaoning	this document	2018-06-11	82 d
Fujian	福建省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见	2018-08-02	134 d
Jilin	吉林省人民政府公报	2018-09-12	175 d
Guangdong	广东省人民政府办公厅关于印发广东省改革完善仿制药供应保障及使用政策实施方案的通知	2018-10-30	223 d
Anhui	安徽省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见	2018-11-21	245 d
Chongqing	重庆市人民政府办公厅关于印发重庆市改革完善仿制药供应保障及使用政策实施方案的通知	2018-11-27	251 d

Held documents only: these are counts of what we have collected, not of what each province issued.

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各市人民政府，省政府各厅委、各直属机构：为贯彻落实《国务院办公厅关于改革完善仿制药供应保障及使用政策的意见》（国办发〔2018〕20号）精神，促进仿制药研发，提升仿制药质量疗效，提高药品供应保障能力，推动医药产业供给侧结构性改革，更好地满足临床用药及公共卫生安全需求，建设健康辽宁，经省政府同意，现提出如下实施意见。一、促进仿制药研发（一）加强仿制药供求对接。建立跨部门的药品生产和使用信息共享机制，强化药品供应保障及使用信息监测，及时掌握和发布药品供求情况，引导企业研发、注册和生产。以需求为导向，鼓励仿制临床必需、疗效确切、供应短缺的药品，鼓励仿制重大传染病防治和罕见病治疗所需药品、处置突发公共卫生事件所需药品、儿童使用药品以及专利到期前一年尚没有提出注册申请的药品。积极推动国家鼓励仿制的药品目录和中国新上市药品目录集内药品落地，省卫生计生委、省食品药品监管局联合建立国家鼓励仿制的药品和中国新上市药品清单动态发布制度，引导产需供求对接。（责任单位：省卫生计生委、省食品药品监管局）（二）加强仿制药技术攻关。将鼓励仿制的药品目录内的重点化学药品、生物药品关键共性技术研究列入省级相关科技计划，并积极争取国家支持。健全产学研医用协同创新机制，建立仿制药技术攻关联盟，发挥企业的主导作用和医院、科研机构、高等院校的基础支撑作用，加强药用原辅料、包装材料和制剂研发联动，促进药品研发链和产业链有机衔接。积极引进国际先进技术，进行消化吸收再提高。（牵头部门：省科技厅，配合部门：省教育厅）（三）完善药品知识产权保护。按照鼓励新药创制和鼓励仿制药研发并重的原则，平衡药品专利权人与社会公众的利益。培育医药领域知识产权优势企业，着力强化医药企业创新主体地位，推动企业贯彻《企业知识产权管理规范》，促进企业利用已有资源开展创新，提高企业发明创造、保护自主知识产权的能力和水平。认真贯彻执行专利创造资助政策，对代理机构加强培训，引导专利质量不断提升。调处仿制药专利侵权案时，在充分保护药品创新的同时，平衡好人民健康权与药品知识产权，防止药品领域专利滥用，破坏市场公平竞争。（责任单位：省知识产权局）二、提升仿制药质量疗效（一）加快推进仿制药质量和疗效一致性评价工作。开展临床试验第三方评估，探索建立区域伦理委员会，支持具备条件的医疗机构、高等院校、科研机构和社会办检验检测机构参与一致性评价工作。各相关部门要细化落实措施，形成政策合力，进一步释放仿制药一致性评价资源，加快推进一致性评价工作。采取有效措施，提高医疗机构和医务人员开展临床试验的积极性。对临床使用量大、金额占比高的品种，有关部门要加快工作进度；对临床必需、价格低廉的品种，各有关部门要采取针对性措施，省卫生计生委要通过市场撮合、邀请招标、价格联动等更加灵活的措施，不断完善采购、使用政策，推动提升质量疗效和临床供应水平。（牵头部门：省食品药品监管局，配合部门：省工业和信息化委、省科技厅、省人力资源社会保障厅、省卫生计生委、省物价局）（二）提高药用原辅料和包装材料质量。推动企业等加强药用原辅料和包装材料研发，运用新材料、新工艺、新技术，提高质量水平。通过提高自我创新能力、积极引进国外先进技术等措施，推动技术升级，突破提纯、质量控制等关键技术，淘汰落后技术和产能，改变部分药用原辅料和包装材料依赖进口的局面，满足制剂质量需求。加强对药用原辅料和包装材料的生产监管，各级食品药品监管部门要做好日常监管，依法公布对生产厂家的检查和抽验信息。（责任单位：省科技厅，省食品药品监管局）（三）提高工艺制造水平。鼓励仿制药生产企业开展技术改造，提升加工制造水平，支持有条件的企业开展智能制造，对于符合条件的项目，积极争取国家支持。大力提升制药装备和智能制造水平，提高关键设备的研究制造能力和设备性能，推广应用新技术，优化和改进工艺生产管理，强化全面质量控制，提升关键工艺过程控制水平，推动解决制约产品质量的瓶颈问题。推进无菌药品生产企业按照药品GMP的相关规定实施生产过程在线监控。（责任单位：省工业和信息化委、省科技厅、省食品药品监管局）（四）加强药品质量监管。加快建立覆盖仿制药全生命周期的质量管理和质量追溯制度。加强对药物研发、生产、流通及使用环节的监督检查，加强不良反应监测和质量抽查，严肃查处数据造假、偷工减料、掺杂使假等违法违规行为，强化责任追究，检查和处罚结果向社会公开。（责任单位：省食品药品监管局）三、完善支持政策（一）及时纳入采购目录。省卫生计生委、省政府采购中心要进一步完善按药品通用名编制采购目录、分类采购、药品价格和种类动态调整的工作机制，促进与原研药质量和疗效一致的仿制药和原研药平等竞争。对于新批准上市的仿制药，对应的通用名药品已在药品采购目录中的，省政府采购中心应及时编制公立医疗卫生机构药品采购编码；对应的通用名药品未在药品采购目录中的，自批准上市之日起，省卫生计生委要会同相关部门按季度论证，及时将其纳入辽宁省药品分类采购清单；国家实施专利强制许可的药品，要无条件纳入辽宁省药品集中采购清单。省政府采购中心应及时启动采购程序，原则上通过按季度动态调整的方式实行直接挂网采购，并在药品集中采购平台进行明显标注，便于医务人员和患者选择使用。（牵头部门：省卫生计生委，配合部门：省政府采购中心）（二）促进仿制药替代使用。各级公立医疗卫生机构要将与原研药质量和疗效一致的仿制药纳入与原研药可相互替代药品目录，便于医务人员和患者选择使用。对于同品种药品通过仿制药质量和疗效一致性评价的生产企业达到3家以上的，在药品集中采购等方面不再选用未通过仿制药质量和疗效一致性评价的药品。其他未通过仿制药质量和疗效一致性评价的药品，已在辽宁省药品集中采购平台挂网采购的，原则上暂停挂网采购资格。未在辽宁省药品集中采购平台挂网采购的，按规定暂不纳入辽宁省药品集中采购范围。（牵头部门：省卫生计生委，配合部门：省政府采购中心）国家基本药物和公立医院在门诊中使用的属于医保目录中按照高值药品规定进行管理的药品（主要是肿瘤靶向治疗药物），不纳入公立医院药占比计算范畴。各级医疗卫生机构在2018年底前，可临时增加采购使用通过仿制药质量和疗效一致性评价的药品。卫生计生等部门要加强药事管理，加大对临床用药的监管力度。严格落实按药品通用名开具处方的要求，除特殊情形外，处方上不得出现商品名。落实处方点评制度，加强医疗卫生机构药品合理使用情况考核，对不合理用药的处方医生进行公示，并建立约谈制度。加强药学和药事队伍建设。合理设置药事服务收费项目，按规定可在诊查费中提取一定比例用于体现药事服务价值。探索建立医院总药师管理制度，强化药师在处方审核和药品调配中的作用。在按规定向艾滋病、结核病患者提供药物时，要优先采购使用仿制药。（责任单位：省卫生计生委）（三）发挥基本医疗保险的激励作用。按照国家部署制定医保药品支付标准，与原研药质量和疗效一致的仿制药、原研药按相同标准支付。根据国家药品目录调整工作安排，做好基本医疗保险药品目录动态调整工作，及时将符合条件的药品纳入目录。基本医疗保险药品目录按照通用名管理，对目录中的药品不得按商品名或生产厂家进行限定，及时更新药品编码库等医保信息系统，确保批准上市的仿制药同等纳入医保支付范围。通过医保支付激励约束机制，鼓励医疗机构使用仿制药。（责任单位：省人力资源社会保障厅）（四）落实税收优惠政策和价格政策。落实现行税收优惠政策，仿制药企业为开发新技术、新产品、新工艺发生的研发费用，符合条件的按照有关规定在企业所得税税前加计扣除。仿制药企业经认定为高新技术企业的，减按15%的税率征收企业所得税。（责任单位：省国税局、省地税局）完善主要由市场形成药品价格的机制，做好药品采购、医保支付等改革政策的衔接。加强药品价格监测预警，依法严厉打击原料药价格垄断等违法违规行为。（责任单位：省卫生计生委、省人力资源社会保障厅、省物价局）坚持药品分类采购，突出药品临床价值，充分考虑药品成本，形成有升有降、科学合理的药品集中采购价格形成机制，调动企业提高药品质量的积极性。通过仿制药质量和疗效一致性评价的药品，已在辽宁省药品集中采购平台挂网采购的，可按原价格继续供应。如需进行价格调整，价格下调的，可依据生产企业申请及时受理；价格上调的，可依据生产企业申请，通过年度动态调整的方式，按照辽宁省有关规定由生产企业与医疗卫生机构重新议定价格。国产同类品种的采购价，不得高于通过仿制药质量和疗效一致性评价药品的采购价。（牵头部门：省卫生计生委，配合部门：省政府采购中心）（五）推动仿制药产业国际和区域合作。结合推进“一带一路”建设重大倡议，加强与相关国际组织和国家的交流，加快药品研发、注册、上市销售的国际化步伐。支持企业开展国际和区域产能合作，共同建立研发平台。积极引进先进管理经验和关键工艺技术，鼓励境内外企业在辽宁建立研发中心和生产基地。（责任单位：省科技厅）（六）做好宣传引导。卫生计生、食品药品监管、人力资源社会保障等部门要做好政策宣传解读，普及药品知识和相关信息，提升人民群众对国产仿制药的信心。开展“合理用药·全民健康素养提升行动”，加强对医务人员和患者的宣传、教育和倡导，改变不合理用药习惯，提高合理用药水平，推动仿制药替代使用。及时回应社会关切，合理引导社会舆论和群众预期，形成良好改革氛围。（责任单位：省卫生计生委、省人力资源社会保障厅、省食品药品监管局）辽宁省人民政府办公厅 2018年6月11日