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改善药品可及性:中国 2009-2020 年十年药物改革的经验教训。

Improving access to medicines: lessons from 10 years of drug reforms in China, 2009-2020.

机构信息

Department of Health Economics, Fudan University School of Public Health, Shanghai, China.

The Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, North Carolina, USA.

出版信息

BMJ Glob Health. 2022 Nov;7(11). doi: 10.1136/bmjgh-2022-009916.

Abstract

China initiated its healthcare reform in 2009 to provide accessible and affordable healthcare to all. We summarised China's drug reforms between 2009 and 2020 using the WHO framework. China has initiated comprehensive drug policies to address different issues, including: (1) issuing or amending major regulations with changes in institutional settings; (2) implementing the marketing authorisation holder system and bioequivalence assessment to improve the quality of drugs; (3) leveraging accelerated market approval and insurance listing to encourage needs-driven innovation and improve the access to new drugs; (4) introducing compulsory licensing to address major public health threats when needed; (5) scaling up the National Essential Medicine Policy and introducing pharmacoeconomic evaluation in National Reimbursable Drug List to promote rational use of medicine and evidence-based selection; (6) applying differentiated pricing strategies and scaling up zero mark-up policies to form a new financing mechanism; (7) adapting bulk procurement and placing strict regulations on the supply chain management to ensure supply and reduce the cost; (8) empowering pharmacists to improve the rational use of medicine; and (9) using procurement and supply chain digital platforms to inform decision and improve efficiency. China's drug reform has adopted a phased and systemic approach that mobilises multiple policy levers including governance, regulation and financing. Despite the progress, emerging challenges in implementation, coordination and capacity need to be addressed. Cross-cutting lessons from China's drug reforms include aligning the drug reform with the overall health reforms, adapting a systemic approach that mobilised policy levers and stakeholders and informing policy decision by conducting pilot studies.

摘要

中国于 2009 年启动了医疗改革,旨在为全民提供可负担和可及的医疗服务。我们使用世界卫生组织(WHO)的框架,总结了中国 2009 年至 2020 年期间的药品改革。中国已经启动了全面的药品政策,以解决各种问题,包括:(1)在体制改革的背景下,颁布或修订主要法规;(2)实施药品上市许可持有人制度和生物等效性评估,以提高药品质量;(3)利用加速市场审批和保险上市,鼓励以需求为导向的创新,提高新药的可及性;(4)在必要时引入强制许可,以应对重大公共卫生威胁;(5)扩大国家基本药物政策,在国家医保药品目录中引入药物经济学评价,以促进合理用药和循证选择;(6)采用差异化定价策略,扩大零加成政策,形成新的筹资机制;(7)适应批量采购,并严格规范供应链管理,以确保供应和降低成本;(8)授权药剂师提高合理用药水平;(9)利用采购和供应链数字平台提供决策信息,提高效率。中国的药品改革采取了分阶段和系统的方法,调动了治理、监管和融资等多个政策杠杆。尽管取得了进展,但在实施、协调和能力方面仍存在新的挑战。中国药品改革的跨领域经验教训包括:将药品改革与整体卫生改革相协调,采用系统的方法,调动政策杠杆和利益相关者,并通过试点研究为政策决策提供信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5cd/9639057/079c96aee278/bmjgh-2022-009916f01.jpg

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