澳大利亚药品可及性政策介绍及对我国的启示  

Introduction to Australia’s drug accessibility policy and its implications for China

作　　者：邓斌 赵瑛 DENG Bin;ZHAO Ying(Dept.of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Mater Research Institute,University of Queensland,Brisbane 4102,Australia;Medical Engineering Center,University of Queensland,Brisbane 4067,Australia)

机构地区：[1]华中科技大学同济医学院附属协和医院药学部,武汉430022 [2]澳大利亚昆士兰大学Mater医学研究中心,澳大利亚布里斯班4102 [3]澳大利亚昆士兰大学医学工程中心,澳大利亚布里斯班4067

出　　处：《中国药房》2025年第7期779-783,共5页China Pharmacy

基　　金：国家留学基金项目(No.202306160046,No.202206165011);国家自然科学基金青年项目(No.82104317);湖北省自然科学基金面上项目(No.2022CFB254)。

摘　　要：目的 总结澳大利亚在提高药品可及性方面采取的有效措施及实践经验,旨在为我国药品可及性政策的持续优化与稳步推进提供参考。方法 通过检索澳大利亚联邦政府官方网站及相关文献,介绍澳大利亚在药品福利计划(PBS)政策、药品注册与PBS准入、药品定价与采购政策、仿制药价格竞争与披露、孤儿药注册审批中的实践经验,总结澳大利亚联邦政府在提高药品可及性和控制药品费用支出方面的有效措施。结果与结论 澳大利亚卫生系统良好的管理协作机制、灵活的药品价格谈判体系和全面的药品可及性政策支持体系,长期维持着药品可及性、患者负担和政府补贴之间的良好平衡,有力地保障了澳大利亚药品的可及性。建议我国在药品可及性方面加强政策协调与部门合作,优化新药注册与加速审批路径,完善价格管理和谈判机制,构建全面的药品可及性支持体系。OBJECTIVE To summarize the effective measures and implementation effects of Australia in improving drug accessibility,and provide reference for the optimization and promotion of drug accessibility policies in China.METHODS By searching the official website of the Australian Federal Government and relevant literature,this study introduced Australia’s practical experiences in the Pharmaceutical Benefits Scheme(PBS),drug registration and PBS access,drug pricing and procurement policies,generic drug price competition and disclosure,and orphan drug registration and approval policies.It summarized the effective measures taken by the federal government to improve drug accessibility and control drug expenditure.RESULTS&CONCLUSIONS The good management collaboration mechanism,flexible drug price negotiation system,and comprehensive drug accessibility policy support system of the Australian health system have maintained a good balance between drug accessibility,patient burden,and government subsidies in the long run,effectively ensuring the accessibility of Australian drugs.It is recommended that our country strengthen policy coordination and departmental cooperation in terms of drug accessibility,optimize the registration and accelerated approval process for new drugs,improve the price management and negotiation mechanism,and establish a comprehensive drug accessibility support system.

关 键 词：药品可及性 药品福利计划 药品价格谈判 仿制药政策 孤儿药政策 澳大利亚 启示 

分 类 号：R95[医药卫生—药学]