[1]石 瑛,丛鹂萱,谢春艳,等.欧洲创新药品管理准入协议应用现状及启示[J].卫生经济研究,2023,40(3):64-67.
　SHI Ying,CONG Lixuan,XIE Chunyan,et al.Application and Enlightenment of the Access Agreement for Innovative Drugs in European[J].Journal Press of Health Economics Research,2023,40(3):64-67.
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欧洲创新药品管理准入协议应用现状及启示
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卫生经济研究[ISSN:1004-7778/CN:33-1056/F]

卷:
40
期数:
2023年3期
页码:
64-67
栏目:
他山之石
出版日期:
2023-03-01

文章信息/Info

Title:
Application and Enlightenment of the Access Agreement for Innovative Drugs in European
作者:
石 瑛1; 丛鹂萱1; 谢春艳1; 王美凤1; 王海银1
1.上海市卫生和健康发展研究中心（上海市医学科学技术情报研究所），上海 200032
Author(s):
SHI Ying;  CONG Lixuan;  XIE Chunyan;  WANG Meifeng;  WANG Haiyin
Shanghai Health Development Research Center(Shanghai Municipal Institute of Medical Science and Technology Information), Shanghai 200032, China
关键词:
欧洲; 创新药品; 管理准入协议
Keywords:
Europe;  innovative drugs;  access agreement
分类号:
R95
文献标志码:
A
摘要:
医疗技术的提高带来了创新药品的蓬勃发展，加快创新药品医保准入支付对提高患者可及性具有重要意义。本文研究了欧洲28个国家的创新药品管理准入协议，介绍其背景、内容、覆盖面、配套法律、有效期、特点，为我国建立健全创新药品医保准入支付制度提供借鉴。
Abstract:
The improvement of medical technology has brought about the vigorous development of innovative drugs. The access to medical insurance payment for innovative drugs is of great significance to improve the accessibility of patients. This paper studies the access agreements of innovative drugs in 28 European countries, introduces its background, content, coverage, supporting laws, validity period and characteristics, and provides reference to establishing the payment system of medical insurance access for innovative drugs in China.

参考文献/References:

[[1] The World Bank.Albania-Health System Improvement Project[R].Washington DC:Bank T W,2015.
[2] Savedoff W D,Gottret P.Governing Mandatory Health Insurance: Learning from Experience[M].Washington DC:The World Bank,2008.
[3] 安顺.欧盟医保模式在比较中创新[J].中国医疗保险, 2009(4):3.
[4] 陈晓棠.俄罗斯强制医疗保险制度构建的法律依据和实践经验[J].医学与法学，2019，11（6）：5.
[5] 蔡华伟.部分国家医疗状况概览[J].中国医疗保险，2012（4）：25.
[6] 石文伟.中英两国医疗模式比较[J].医学与哲学（A），2012，33（12）：2.
[7] 谢戎彬.塞尔维亚医疗改革新举措（综述）[EB／OL].http://www.people.com.cn/GB/channel2/18/20000809/179050.html.
[8] 尤川梅，姚岚.斯洛文尼亚卫生体制改革概况[J].中国社会医学杂志，2009，26（5）：289-290.
[9] 赵世超，王欣，卢颖，等.苏东地区国家卫生改革综述[J].中国卫生事业管理，2013，30（9）：648-651.
[10] 周淼.克罗地亚卫生筹资改革[J].国外医学（卫生经济分册），2008（3）:107-111.
[11] Croatian Health Insurance Fund.Health Insurance in the Republic of Croatia [EB/OL].https://hzzo.hr/en/national-contact-point-ncp/health-insurance-republic-croatia.
[12] 毛燕娜，王小万.中东欧转型国家卫生筹资改革经验与启示[J].国外医学（卫生经济分册），2012（2）：49-54.
[13] The Council of the European Communities. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products[J]. Official Journal of the European Communities, 1993:1-21.ducts for human and veterinary use and establishing aEuropean Agency for the Evaluation of Medicinal Products, OJ L 214, 24.8.1993, p.1规范格式
[14] European Medicines Agency and European Commission. Procedures for marketing authorization[EB/OL]. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-6/vol6a_chap1_en.pdf.
[15] European Medicines Agency. Guideline on the Chemistry of Active Substances. Committee for Medicinal Products for Human Use (CHMP) [EB/OL]. (2016-10-15).https://www.docin.com/p-1938796217.html.
[16] EXPH,Barry M M.EXPH Innovative payment models for high-cost innovative medicines[M].2018.
[17] Bouvy J C,Claudine S, Sarah G. Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe [J].Frontiers in Pharmacology,2018,9:280.
[18] 汤静琪，张晓.澳大利亚高值药物管理准入政策及对我国的启示[J].中国新药杂志，2021（12）：1073-1078.
[19] Carlson J J,Gries K S,Yeung K,et al. Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers[J].Applied Health Economics and Health Policy,2014,12(3):567-568.
[20] Carlson J J,Sullivan S D,Garrison L P,et al.Linking payment to health outcomes:A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers[J].Health Policy,2010, 96(3):179-190.
[21] Andrea Navarria , Valentina Drago，Lucia Gozzo，et al. Do the Current Performance-Based Schemes in Italy Really Work? "Success Fee": A Novel Measure for Cost-Containment of Drug Expenditure[J]. Value in health,2015,18:131-136.

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更新日期/Last Update: 2023-03-01