目的 药品是保障人民生命健康的重要物资,具有区别于一般商品的特殊属性。药品安全事关社会稳定和国家安全,药品治理水平是国家治理体系和治理能力现代化的重要方面,本文对构建国家药品治理体系进行研究。方法 笔者通过研究国内外药品治理领域研究成果,概述了国家药品治理体系的内涵和特点,梳理了在药品治理方面表现优秀的主流国家和新兴国家的治理经验,结合我国药品治理发展现状,提出目前存在的问题。构建国家药品治理体系框架模型,并分析各构成要素以及要素相互关系。结果 通过分析发现,我国药品治理体系存在管理职能碎片化、社会参与度较低、监管效能不高等问题。结论 下阶段我国应构建统一权威高效的国家药品治理体系,加强监管制度顶层设计,引入多元参与的社会共治模式,发挥学会协会桥梁作用以及保险机制在药品治理中的作用。
Abstract
OBJECTIVE Drug is an important goods and materials for safeguarding people's life and health, and has special attributes different from general commodities. Drug safety concerns social stability and national security. Drug governance level is an important aspect of modernization of national governance system and capacity. This paper studies the construction of national drug governance system. METHODS By researching the domestic and foreign research achievements in the field of drug governance, this article summarizes the connotation and characteristics of national governance in the field of medicine,and the governance experience of mainstream countries and emerging countries with excellent performance in drug governance. Combining with the current situation of China, the author proposes some problems. Constructing the framework model of national drug governance system, and analyzing the constituent elements and their mutuality of the national governance system in the pharmaceutical field. RESULTS The author proposes that China′s drug governance system has the problems of fragmentation of management functions, low social participation and low regulatory efficiency. CONCLUSION Some suggestions of next stage are put forward for the modernization of China's national governance system and governance capacity in the pharmaceutical field. Through the research, China should build a unified, authoritative and efficient national drug governance system, strengthen the top-level design of the regulatory system, introduce a multi-participatory social governance model, and give play to the role of association and insurance mechanism in drug governance.
关键词
药品 /
治理体系 /
治理能力
{{custom_keyword}} /
Key words
pharmaceutical /
national governance system /
governance capacity
{{custom_keyword}} /
中图分类号：
R951
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] YING S N. To accelerate the development of the rule of law and modernize the country′s governance system and capacity for governance [J]. China Legal Sci(中国法学), 2014,(6):40-56.
[2] JAMES N. Rosenau.Governance without Government(没有政府的治理)[M]. Nanchang: Jiangxi People′s Publishing House,2001:10-12.
[3] YU K P. Good Governance(治理与善治)[M]. Beijing: Soc Sci Literature Publishing House,2000:329-330.
[4] GERRY S, HUA X F. Governance as a theory: five arguments [J]. Int Soc Sci J(Chin Ed)(国际社会社会科学杂志 中文版), 1999,55(1):19-30.
[5] Overview of the development of China′s pharmaceutical industry in 2017 [EB/OL]. [2018-06-20]. http://www.chyxx.com/industry/201703/504995.html.
[6] Jacobzone, S. (2000), “Pharmaceutical Policies in OECD Countries: Reconciling Social and Industrial Goals”, OECD Labour Market and Social Policy Occasional Papers, No. 40, OECD Publishing, Paris[EB/OL]. [2018-06-20]. http://dx.doi.org/10.1787/323807375536.
[7] HU Y L, MU L. Beyond the linear regulatory system to build a national drug safety governance system [J]. China Food Drug Admin Magazine(中国食品药品监管), 2017,8(1):41-45.
[8] LIU L. The difficulties and management of the construction of drug safety society in China [J]. Probe(探索), 2017,(6):160-165.
[9] SHEN W X, LIU C. On the connotation, significance and mechanism of social governance of drug safety in China [J]. Law Science Magazine(法学杂志), 2017, 38(11):47-56.
[10] WANG X, ZHEN C. The history of American drug regulation and its enlightenment to China [J]. Chin J New Drugs(中国新药杂志), 2016, 25(8):849-854.
[11] ZHANG R M, WANG H N, DANG H X, et al. New steps by the FDA to tighten drug safety regulations [J]. Chin Pharm J(中国药学杂志), 2015, 50(10):913-915.
[12] EISENBERG R S. The role of the FDA in innovation policy[J]. Mich Telecomm. & Tech L. Rev, 2006,13(1):345.
[13] PISANO D J, MANTUS D. FDA Regulatory Affairs[M]. Boca Raton:CRC Press, 2014:14-19.
[14] COLLIER J. Book: Regulating medicines in europe: competition, expertise and public health[J]. Bmj Clin Res, 2001, 322(7295):1187-1187.
[15] LIU C X. Overview of the scientific development of international drug regulation [J]. Drug Eval Res(药物评价研究), 2017, 40(8):1029-1043.
[16] SONG X. A brief analysis of the development history and current situation of Brazilian life science industry [J]. J Latin Am Stud(拉丁美洲研究), 2011,33(1):57-64,80.
[17] SONG X D. Legal system: protection of drug production and pricing in Mexico [N]. Pharmaceutical economics(医药经济报), 2004-08-09(006).
[18] LIU L. The difficulties and management of the construction of drug safety society in China[J]. Probe(探索), 2017,(6):160-165.
[19] ZHENG J F. The basic structure and level of national governance system[J]. Chongqing Soc Sci(重庆社会科学杂志), 2014,(4):18-25.
[20] ZHANG W X. Modernization of the rule of law and state governance [J]. China Legal Sci(中国法学), 2014,(4):5-27.
[21] NIU R, LIU Y, XIANG Y F, et al. Comparative study of international experience and domestic practice in drug price negotiation [J]. Chin J Health Policy(中国卫生政策研究), 2017, 10(6):25-32.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
PDF(1249 KB)
