澳大利亚药品可及性政策介绍及对我国的启示 <sup>Δ</sup>

邓斌; 赵瑛

doi:10.6039/j.issn.1001-0408.2025.07.02

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澳大利亚药品可及性政策介绍及对我国的启示 ^Δ

药事管理 | 更新时间：2025-04-09

- 澳大利亚药品可及性政策介绍及对我国的启示 ^Δ
- Introduction to Australia’s drug accessibility policy and its implications for China
- 中国药房 2025年36卷第7期页码：779-783
- 作者机构：
  
  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
- 作者简介：
  
  副主任药师，博士。研究方向：内分泌药理、药事管理。电话：027-85726192。E-mail：dengbin@hust.edu.cn
  副主任药师，硕士。研究方向：神经药理、药事管理。电话：027-85726062。E-mail：23zhaoying@163.com
- 基金信息：
  
  国家留学基金项目(202306160046;202206165011);国家自然科学基金青年项目(82104317);湖北省自然科学基金面上项目(2022CFB254)
- DOI：10.6039/j.issn.1001-0408.2025.07.02
  中图分类号： R95
- 收稿日期：2024-10-29，
  
  修回日期：2025-02-21，
  
  录用日期：2025-02-21，
  
  纸质出版日期：2025-04-15
- 稿件说明：
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邓斌,赵瑛.澳大利亚药品可及性政策介绍及对我国的启示 ^Δ[J].中国药房,2025,36(07):779-783.

DENG Bin,ZHAO Ying.Introduction to Australia’s drug accessibility policy and its implications for China[J].ZHONGGUO YAOFANG,2025,36(07):779-783.
邓斌,赵瑛.澳大利亚药品可及性政策介绍及对我国的启示 ^Δ[J].中国药房,2025,36(07):779-783. DOI： 10.6039/j.issn.1001-0408.2025.07.02.

DENG Bin,ZHAO Ying.Introduction to Australia’s drug accessibility policy and its implications for China[J].ZHONGGUO YAOFANG,2025,36(07):779-783. DOI： 10.6039/j.issn.1001-0408.2025.07.02.

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。

Abstract

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

Keywords

references

Australian Government Department of Health and Aged Care . Pharmaceutical Benefits Scheme （PBS） expenditure & prescriptions report （1 July 2022 to 30 June 2023 ） [EB/OL ] . [ 2024-08-12 ] . https：//www.PBS.gov.au/statistics/expenditure-prescriptions/2022-2023/PBS-Expenditure-prescriptions-report-2022-23 https://www.PBS.gov.au/statistics/expenditure-prescriptions/2022-2023/PBS-Expenditure-prescriptions-report-2022-23 .

Pharmaceutical Benefits Scheme . PBS News [EB/OL ] . [ 2024-08-12 ] . https：//www.pbs.gov.au/info/news/2024/05/pbs-website-update-1-may-2024 https://www.pbs.gov.au/info/news/2024/05/pbs-website-update-1-may-2024 .

Pharmaceutical Benefits Scheme . PBS website update [EB/OL ] . [ 2025-02-01 ] . https：//www.pbs.gov.au/info/news/2025/02/pbs-website-update-1-february-2025 https://www.pbs.gov.au/info/news/2025/02/pbs-website-update-1-february-2025 .

李大双，颜建周，邵蓉 . 澳大利亚PBS药品上市后再审查制度介绍及对我国的启示 [J ] . 中国药房， 2023 ， 34 （ 15 ）： 1793 - 1797 .

Australian Therapeutics and Goods Administration . Australian prescription medicines registration process [EB/OL ] . [ 2024-08-12 ] . https：//www.tga.gov.au/prescription-medicines-registration-process https://www.tga.gov.au/prescription-medicines-registration-process .

YOFFE A ， LIU J ， SMITH G ， et al . Regulatory reform outcomes and accelerated regulatory pathways for new prescription medicines in Australia [J ] . Ther Innov Regul Sci ， 2023 ， 57 （ 2 ）： 271 - 286 .

VITRY A I ， THAI L ， ROUGHEAD E E . Pharmaceutical prices in the 21st century [M ] . Cham ： Springer International Publishing ， 2015 ： 1 - 23 .

STEWART D J ， BRADFORD J P ， SEHDEV S ， et al . New anticancer drugs：reliably assessing “value” while addres- sing high prices [J ] . Curr Oncol ， 2024 ， 31 （ 5 ）： 2453 - 2480 .

杨姿锐，陶田甜，蒋蓉，等 . 澳大利亚医保药品价格协议研究及对我国的启示 [J ] . 中国卫生经济， 2020 ， 39 （ 6 ）： 93 - 96 .

MANSFIELD S J . Generic drug prices and policy in Australia：room for improvement? a comparative analysis with England [J ] . Aust Health Rev ， 2014 ， 38 （ 1 ）： 6 - 15 .

PBS . First new brand price reductions [EB/OL ] . [ 2024-10-01 ] . https：//www.pbs.gov.au/info/industry/pricing/pbs-items/first-new-brand-price-reductions https://www.pbs.gov.au/info/industry/pricing/pbs-items/first-new-brand-price-reductions .

Australian Government Department of Health and Aged Care . What is price disclosure [EB/OL ] . [ 2024-01-09 ] . https：//www.pbs.gov.au/info/industry/pricing/price-disclosure-spd#_what_is_price https://www.pbs.gov.au/info/industry/pricing/price-disclosure-spd#_what_is_price .

Generic and Biosimilar Medicines Association . Price disclosure [EB/OL ] . [ 2024-10-26 ] . https：//gbma.com.au/price-disclosure/ https://gbma.com.au/price-disclosure/ .

LEE J ， PANAGIOTELIS A ， CAIRNS R ， et al . An analysis of the trends in the usage of Pharmaceutical Benefits Scheme-subsidised cancer drugs in Australia from 2012 to 2022 [J ] . J Cancer Res Clin Oncol ， 2024 ， 150 （ 8 ）： 375 .

JONES AM ， SERRA-SASTRE V ， KIM H . The impact of generic entry of pharmaceuticals in Australia [J ] . Value Health Reg Issues ， 2024 ， 43 ： 101008 .

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RUSECKAITE R ， MUDUNNA C ， CARUSO M ， et al . Current state of rare disease registries and databases in Australia：a scoping review [J ] . Orphanet J Rare Dis ， 2023 ， 18 （ 1 ）： 216 .

Australian Government Department of Health and Aged Care . About the life saving drugs program [EB/OL ] . [ 2024-09-02 ] . https：//www.health.gov.au/our-work/life-saving-drugs-program/about-the-lsdp https://www.health.gov.au/our-work/life-saving-drugs-program/about-the-lsdp .

Maven Marketing . List of pharmacies and chemists in Australia [EB/OL ] .[ 2024-08-22 ] . http：//www.mavenmarketing.com.au/list-of-pharmacies-in-australia http://www.mavenmarketing.com.au/list-of-pharmacies-in-australia .

Australian Government Department of Health and Aged Care . Community pharmacy programs under the eighth community pharmacy agreement [EB/OL ] . [ 2024-08-22 ] . https：//www.health.gov.au/resources/collections/eighth-community-pharmacy-agreement-fact-sheets https://www.health.gov.au/resources/collections/eighth-community-pharmacy-agreement-fact-sheets .

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澳大利亚药品可及性政策介绍及对我国的启示 Δ

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

DOI：10.6039/j.issn.1001-0408.2025.07.02

摘要

Abstract

关键词

Keywords

references

澳大利亚药品可及性政策介绍及对我国的启示 ^Δ