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我国罕用药可及性现状及其市场准入制度分析

丁锦希, 刘维婧, 李伟, 刘阳阳, 白庚亮

丁锦希, 刘维婧, 李伟, 刘阳阳, 白庚亮. 我国罕用药可及性现状及其市场准入制度分析[J]. 中国药科大学学报, 2014, 45(1): 111-117. DOI: 10.11665/j.issn.1000-5048.20140121
引用本文: 丁锦希, 刘维婧, 李伟, 刘阳阳, 白庚亮. 我国罕用药可及性现状及其市场准入制度分析[J]. 中国药科大学学报, 2014, 45(1): 111-117. DOI: 10.11665/j.issn.1000-5048.20140121
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DING Jinxi, LIU Weijing, LI Wei, LIU Yangyang, BAI Gengliang. Analysis of orphan drug accessibility and marketing authorization system in China[J]. Journal of China Pharmaceutical University, 2014, 45(1): 111-117. DOI: 10.11665/j.issn.1000-5048.20140121
Citation: DING Jinxi, LIU Weijing, LI Wei, LIU Yangyang, BAI Gengliang. Analysis of orphan drug accessibility and marketing authorization system in China[J]. Journal of China Pharmaceutical University, 2014, 45(1): 111-117. DOI: 10.11665/j.issn.1000-5048.20140121
shu

我国罕用药可及性现状及其市场准入制度分析

  • 中国药科大学国际医药商学院

基金项目: 国家社会科学基金资助项目(No.13BFX120)

Analysis of orphan drug accessibility and marketing authorization system in China

摘要

    摘要
  • 摘要: 根据我国罕见药市场可及性现状，构建罕用药评价指标体系，为我国建立完善准入制度提供参考依据。研究表明，我国罕用药市场准入制度尚未完善，罕用药的可获得性、可供应性和可负担性指标均不及发达国家或地区，严重影响罕见病患者用药，阻碍罕用药产业发展。建议借鉴其他国家或地区的经验，完善我国罕用药市场准入制度，以期激励我国罕用药研发创新，提高罕见病患者的治疗水平。
    Abstract: According to the status-quo of orphan drug access in China, this paper constructedan index evaluation system so as to provide referable foundationfor establishing and improving orphan drug authorization system. Study results indicated that the less-improved orphan drug marketing authorization system, poorer orphan drug availability, supply capacity and affordability compared with developed countries and regions severely affected patients′ timely medication and hindered orphan drug industry development. With reference to foreign countries, it is urgent to improve orphan drugs marketing authorization system for the purpose of encouraging orphan drug R&D and improving the health benefits of patients.
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    • 参考文献(28)
  • [1] U.S.Food and Drug Administration(FDA).Rare diseases take spotlight in annual event[EB/OL].(2011-02-24)[2012-12-22].http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm244408.htm.
    [2] Gong SW,Zhang M.Thinking on the definitions of rare disease and orphan drugs in China[J].Chin J New Drugs(中国新药杂志),2006(15):1 225-1 229.
    [3] Tao Y.The current situation of orphan drug regulation in the United States[J].Chin Pharm J(中国药学杂志),2001,36(9):634-636.
    [4] Jiang H.Review and reference on the USA drug market access system[J].Guangxi Soc Sci(广西社会科学),2013(2):89-93.
    [5] Zhu JP.Exploration of ancient Chinese on the relation of geographical environment tohuman diseases[J].China J Tradit Chin Med Pharm(中华中医药杂志),2011,26(12):2 791-2 794.
    [6] Xin ZJ,Wang ZS,Chen ZJ.Studying the status of orphan drugs in China and its countermeasures[J].Chin Health Serv Manage(中国卫生事业管理),2011(5):349-351.
    [7] Li HT.Analys is on the accessibility of drugs in China[J].Chin Health Serv Manage(中国卫生事业管理),2009(9):612-614.
    [8] Ding JX, Li XT, Zhao Y. The unify operation pattern of drug reimbursement list under the policy of new medical reform-based on the empirical analyses of the drug reimbursement list of new cooperative medical system[J].Chin Pharm Aff(中国药事),2011,25(10):962-968.
    [9] Liu LQ.Research on strategies of essential medicines availability in community health service facilities(促进社区卫生服务机构基本药物可获得性策略研究)[D].Wuhan:Huazhong University of Science and Technology,2009.
    [10] U.S.Food and drug administration.search orphan drug designations and approvals[EB/OL].(2012-12-02)[2013-01-03].http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm.
    [11] List of medicinal products for rare diseases in Europe [EB/OL].(2013-10-01)[2013-12-20].http://www.orpha.net/orphancome/cahriers/docs/GB/list_of_orphan_drugs_in_europe.pdf.
    [12] Ministry of Health,Labour and Welfare.Rare disease medicine formulated product catalogue[EB/OL].[2008-09-05](2013-01-03).http://www.mhlw.go.jp/english/index.html.
    [13] Korea food and drug administration[EB/OL].[2012-08-30](2012-12-29).http://www.mfds.go.kr/index.do.
    [14] China Food and Drug Administration. State Food and Drug Administration issued ″special approval of new drug registration regulations″[EB/OL].[2009-01-09](2013-01-01).http://www.sda.gov.cn/WS01/CL0051/35168.html.
    [15] Gao S.Do not let a rare disease ″rare″ drug[N].Health News(健康报),2010-06-19(5).
    [16] Gong SW. Management strategies of improving orphan drugs access in China(促进我国罕见病患者药品可及性的管理策略研究)[D].Wuhan:Huazhong University of Science and Technology,2008.
    [17] Sun GJ.Discussion about market concentration ratio of pharmaceutical industry in China[J].Chin Pharm(中国药房),2004,15(4):588-590.
    [18] Rare Disease Relief Public Fund.China rare disease network[EB/OL].(2010-01-01)[2012-12-26].http://www.chinararedisease.cn/5-7.html.
    [19] Global concern on the orphan drug development[N].China High-Tech Industry Health(中国高新技术产业导报).2002-07-03(5).
    [20] Zhang L.Orphan drug development prospect analysis[N].Med Econ News(医药经济报),2002-06-24(2).
    [21] Gong SW,Xu Y,Zhang L.Study on evaluation indicator system of drug accessibility[J].Chin Health Econ(中国卫生经济),2011,30(5):72-74.
    [22] Zhang RW,Hu SL.A comparative study of international price for pharmaceuticals medicine price[J].Chin Health Econ(中国卫生经济),2001,20(2): 26-28.
    [23] Ding JX,Sun XD,Ji N,et al.Availability evaluation and safeguard legal system research for orphan drugs in US and China[J].Chin Pharm J(中国药学杂志),2011(14):1 129-1 132.
    [24] Yang L,Hu SL,Gong YC.International experience of pharmacoeconomic evaluation in health decision-making[J].Chin Pharm(中国药房),2004(6):347-351.
    [25] Hu JJ,Luo AQ,Xu P,et al.Analysis of international medical insurance status orphan drugs[R]. 2012年中国药学会药事管理专业委员会年会论文集(上册).Beijing:2012-08-11.
    [26] Lin YH,Wu XM.Design of orphan drug industrial policy[J].Modern Management Sci(现代管理科学),2012(5):9-11.
    [27] Li MY.Provide the necessary protection for rare diseases medical[N].People′s Political Consultative Daily(人民政协报),2010-03-10:(D02).
    [28] Zhong X.Rare diseases is likely into health insurance directory next year[J].China Health Insurance(中国医疗保险),2012(8):71.
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  • 刊出日期:  2014-02-24

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