药品安全突发事件应急处理机制研究
On Emergency Regulations in the Wake of Medicine-Security Accidents
【摘要】 在利益驱使的当今社会,由于医疗机构的一些不法行为,药品生产企业的违规操作行为,医药监管部门的监管力度不够,导致了药品突发公共事件时有发生。本文通过药品安全突发事件应急处理机制的研究浅谈我国药品行政监管体系的完善。本文共五部分,第一部分,首先对药品安全突发事件进行释义,并阐述其类别,然后阐述药品安全突发事件应急处理机制的含义和特征。第二部分,主要研究药品安全突发事件应急处理机制的价值,突出表现在四个方面:第一,保障公民权利方面。生命健康权是人作为人最基本的权利,在药品安全突发事件中最先受到侵害,因此药品安全突发事件应急处理机制在保障公民权利方面主要通过保障公民生命健康权来得以体现。第二,维护社会秩序方面。药品安全突发事件应急处理机制的建立,离不开一系列的相关法律制度,完善的药品法律制度是建设和谐社会的基础,也是维护社会秩序的必要条件。第三,建设服务型政府方面。从社会服务承诺制、政务公开制和行政效能方面阐述药品安全突发事件应急处理机制对建设服务型政府的价值。第四,人权保护国际化趋势方面。首先阐述人权保护的国际化现状,然后通过对刑事被害人、刑事犯罪嫌疑人和被告人以及社会公众人权的保护阐述我国人权保护的国际化趋势。第三部分研究药品安全突发事件应急处理机制的责任主体。第一,药监部门。以责任政府理念为切入点,阐述药监部门要贯彻责任政府理念,把公众利益放在至高无上的地位,对药品安全突发事件做出及时处理,以及将科学监管作为工作的指导方针。第二,药品生产企业。以企业的社会责任为切入点,阐述药品生产企业在经营中要贯彻“以人为本”理念,依法履行义务。第三,医疗机构。以医疗机构的社会责任为切入点,阐述医疗机构在药品安全突发事件应急处理机制中的重要作用,从而得出,医疗机构必须明确工作职责。第四部分,主要研究美国、英国两国的药品安全突发事件应急处理机制,并分析其优势所在。第五部分,主要研究我国现行药品行政监管体系的框架及完善。首先分析我国现行药品行政监管体系的主要缺陷:第一,监控控制体系薄弱:第二,药监部门公信力下降;第三,监管部门的职能定位不准确;第四,相应制度设计不合理。然后在借鉴国外优势的基础上,总结出完善的方向:第一,强化权力监督机制;第二,建立全程监管体系;第三,明晰监管职能定位:第四,完善相关法律制度。本文通过药品安全突发事件应急处理机制的责任主体,研究得出目前我国药品安全突发事件应急处理机制存在的问题。在借鉴国外药品安全突发事件应急处理机制的先进模式的基础上,分析我国药品行政监管体系的缺陷,以企启迪我国药品行政监管体系的完善。
【Abstract】 In the benefits-driven society, because of medical institutions' unlawful behaviors, pharmaceutical production enterprises' acts of illegal operations and medicine regulatory authorities' inadequate supervision, the emergency drug-security accident occur from time to time. This article is on our state administration supervision over drugs by the emergency regulations of drugs-security accidents.This article consisting of five parts. The first part interpret emergency drug-security accident and then expound the meanings and characteristics of emergency regulations of drugs-security accidents. The second part mainly research on the value of the emergency regulations of drugs-security accidents. It performances in four aspects outstandingly. Firstly, the protection of civil rights. The rights to life and health is the most basic rights, and is to be infringed in the emergency drug-security accident in advance, so the emergency regulations of drugs-security accidents is mainly to protect citizens' rights to life and health in the protection of civil rights. Secondly, the maintenance of social order. To establish the emergency regulations of drugs-security accidents, cannot be separated from a series of related legal system, sound drug legal system is the foundation of the building of harmonies society, and also the necessary conditions of the maintenance of social order. Thirdly, the building of service-oriental government. To expound the value of the emergency regulations of drugs-security accidents to the building of service-oriental government by social service commitment system、chief public system and administrative efficiency. Fourthly, internationalization of human rights protection. First to expound the actuality of the human rights protection, then the trends of our human rights by protecting the human rights of criminal victims、criminal suspects and defendants、also the publics. The third part study the main responsibility of the emergency regulations of drugs-security accidents. Firstly, drug supervision department.To the concept of the responsible government as the breakthrough point, expounding the drug supervision department ought to implement the concept of responsible government, and put the interest of public on the supremacy, and treat with the emergency drug-security accident immediately, also hold the scientific supervision as work guidelines. Secondly, drug production enterprise. To corporate social responsibility as the breakthrough point, expounding the drug production enterprise ought to implement the concept of people-oriental, fulfill its obligation legally. Thirdly, medical institutions . To medical institutions social responsibility as the breakthrough point, expounding its importance in the emergency regulations of drugs-security accidents, so as to arrive at it must clear its responsibility. The fourth part mainly study the emergency regulations of drugs-security accidents in America and Great Britain and its advantage. The fifth part mainly research on frame and perfection of our existing administrative supervision over drugs. Above all, analyzing the main defects of the frame and perfection of our existing administrative supervision over drugs: firstly, weak monitoring and control system; secondly, declining of the credibility of the drugs supervision department; thirdly, inaccurate position functions of supervision department; fourthly, unreasonable design of corresponding system. Then to sum up the way of perfection on the basic of advantages abroad: firstly, strength the power supervision mechanism; secondly, setting up the whole regulatory system; thirdly, clarity the position of regulatory function; fourthly, perfecting relevant legal system.This article research out the problems of our emergency regulations of drugs-security accidents by its body's responsibility. On the basic of the advanced mode of emergency regulations of drugs-security accidents abroad, analyzing our defects of administrative supervision over drugs, and make a proposal to perfect our administrative supervision over drugs.

【关键词】 药品安全突发事件; 药品安全突发事件应急处理机制; 药品行政监管体系
  药品安全突发事件应急处理机制研究

中文摘要 9-11
ABSTRACT 11-12
导论 13-15
一、药品安全突发事件应急处理机制释义 15-23
    (一) 药品安全突发事件的概念及类别 15-19
        1. 药品安全突发事件的概念 15-17
        2. 药品安全突发事件的类别 17-19
    (二) 药品安全突发事件应急处理机制的含义及特征 19-23
        1. 药品安全突发事件应急处理机制的含义 19-21
        2. 药品安全突发事件应急处理机制的特征 21-23
二、药品安全突发事件应急处理机制的价值 23-34
    (一) 药品安全突发事件应急处理机制在保障公民权利方面的价值 23-25
        1. 生命健康权是公民权利的核心 23-24
        2. 药品安全突发事件应急处理机制如何保障公民权利 24-25
    (二) 药品安全突发事件应急处理机制在维护社会秩序方面的价值 25-27
        1. 建设和谐社会是维护社会秩序的根本 25-26
        2. 药品安全突发事件应急处理机制如何维护社会秩序 26-27
    (三) 药品安全突发事件应急处理机制在建设服务型政府方面的价值 27-30
        1. 公共服务是服务型政府的使命 27-29
        2. 药品安全突发事件应急处理机制如何体现服务型政府建设 29-30
    (四) 药品安全突发事件应急处理机制体现我国人权保护的国际化趋势 30-34
        1. 人权保护的国际化现状 30-31
        2. 我国药品安全突发事件应急处理机制如何体现人权保护的国际化 31-34
三、药品安全突发事件应急处理机制的责任主体 34-42
    (一) 药监部门在药品安全突发事件应急处理机制中的职责 34-36
        1. 将公众利益放在至高无上的位置 34-35
        2. 对药品安全突发事件及时做出处理 35
        3. 以科学的监管理论为工作指导方针 35-36
    (二) 药品生产企业在药品安全突发事件应急处理机制中的义务 36-39
        1. 建立健全质量管理体系 37-38
        2. 建立健全药品召回制度 38-39
    (三) 医疗机构在药品安全突发事件应急处理机制中的职能 39-42
        1. 明确社会职能角色 39-40
        2. 完善应急管理措施 40-42
四、美国、英国的药品安全突发事件应急处理机制及优势 42-48
    (一) 美国药品安全突发事件应急处理机制及优势 42-45
        1. 美国药品安全突发事件应急处理机制 42-44
        2. 美国药品安全突发事件应急处理机制优势 44-45
    (二) 英国药品安全突发事件应急处理机制及优势 45-48
        1. 英国药品安全突发事件应急处理机制 45-46
        2. 英国药品安全突发事件应急处理机制优势 46-48
五、我国现行药品行政监管体系及完善 48-57
    (一) 我国现行药品行政监管体系的框架及缺陷 49-53
        1. 我国现行药品行政监管体系的框架 49-50
        2. 我国现行药品行政监管体系的缺陷 50-53
    (二) 我国现行药品行政监管体系的完善 53-57
        1. 强化权力监督机制 53-54
        2. 建立全程监管体系 54
        3. 明晰监管职能定位 54-55
        4. 完善相关法律制度 55-57
结语 57-58
参考文献 58-66
谢辞 66-67
学位论文评阅及答辩情况表 67