多中心治理视角下药品安全问题的研究——以安溪县为例.pdf

摘要 I 摘要 药品安全关系人民群众的身体健康和生命安全，与人民群众的利益息息相 关。我国从开始药品安全治理以来，长期处于政府完全主导的形式之下，这种 完全依赖政府监管来解决药品安全的模式开始随着经济社会的发展暴露出越来 越多的弊端。近几年来频发的药品安全事件，使群众对药品安全的关注程度日 益增加；而关于食品药品监管体制的不断变革，也使人民群众更加关心食品药 品安全情况。 本文从我国药品安全现状和治理情况出发，对安溪县药品安全存在的问题 进行剖析，认为主要存在行政执法不力、企业责任意识不强、公民的维权意识 不高这三个方面的问题，而后对影响药品安全治理的因素进行分析，认为在信 息技术的迅猛发展和全球性政府改革浪潮不断涌起的今天，药品安全治理需要 与时俱进。 本文引入多中心治理理论，倡导一种新的治理模式即以政府监管为主导， 发动和鼓励企业及社会力量共同参与治理，改变了以往单一的政府监管模式， 采用文献研究、案例分析、比较研究等方法，分析了多中心治理我国药品安全 的必要性和可行性，借鉴国外的先进经验，进一步分析多中心治理我国药品安 全的对策，确立了治理的基本原则和目标，提出了通过完善药品监管的政府职 责、提高企业责任意识、重视和强化社会力量、培养公众参与意识这几个措施 来完善我国的药品安全治理。 关键词：多中心治理 药品安全 监管 万方数据 Abstract III Abstract Drug safety is closely related to people’s interests of life safety and health. Long as it has been dominated completely by the government since drug safety governance started, increasing disadvantages has appeared from this pattern of drug safety governance, which fully depends on government administration, with the development of economic society. Incidents of drug safety in recent years have caused a rising mass concern on it. Moreover, China’s unceasing reform on regulatory administration system of food and drug has contributed to increasing awareness on status quo of drug regulatory administration as well. Existing problems of drug safety regulatory administration in An’xi County were analyzed in this paper, basing on China’s present drug safety and its regulatory administration. Three aspects including incomplete ineffective enforcement of executive law, weak sense of responsibility in enterprises, and low citizen consciousness of rights safeguarding, were concluded as major issues in presence. The factors influencing China’s drug safety regulatory administration were further studied, and it was proposed that the regulatory administration on drug safety should advance with time when information technology developed rapidly and global government reform proceeded consistently. A new pattern of governance was brought up in this paper, w