论药品监管中行政裁量的内部控制

【作者】 肖燕；

【导师】 潘伟杰；

【作者基本信息】 复旦大学 ， 法律， 2011， 硕士

【摘要】 随着药品安全事故频发,监管部门的行政效能也受到前所未有的考验。现阶段,亟待解决的是如何在现有的法制框架下,加强行政裁量的内部控制,提高行政监管效能,降低药品安全隐患。在现代法治背景下,行政自律是当下解决行政效能的最有效、便捷的途径之一,尤其在关乎民生的药品安全监管领域。药品监管行政自由裁量权是指药品监管部门在法定权限内就行为条件、行为程序、事实认定、法律适用、做出行为与否和做出何种行为方面作合理选择的权力。目前,关于药品监管中行政裁量内部控制的制度依据,主要在行政程序和裁量基准两方面。基本上涉及的是行政处罚领域,实际的控制效率也是相当有限。行政裁量无处不在,行政行为的所有环节都存在程度不等的判断和选择。从药品监管中的腐败案件和假药现象等,我们可以发现,行政许可、行政检查等环节的裁量权的恣意和滥用也将带来严重的后果和深远的影响。因此,不仅是现有基准制度和程序制度理念需要结合形势的发展不断的完善和扩展,其他有效的控制途径也亟待不断的研究和探索。笔者试从行政伦理、行政内部约束机制、内部控制的外部约束三方面完善药品监管中行政裁量内部控制体系。更多还原

【Abstract】 With drug safety accidents, the administrative efficiency of regulators have also been faced unprecedented challenges. At this stage, to the regulators what should be solved is how to strengthen the internal control of the administrative discretion, improve the administrative efficiency, and reduce drug safety risks under the existing legal framework.In the context of the modern rule of law, administrative self-regulation is the most effective and convenient way to improve administrative efficiency, especially in the field of livelihood-related drug safety. Drug regulation discretion is the power to make rational choice of drug regulation authorities, about the conditions, procedures, fact finding, legal application, make act or not, what kind of act to make within the statutory authority. Currently, the system basis on the internal control of administrative discretion in the drug regulation, concentrated in the administrative procedures and discretion standard. Mainly applied to the field of administrative penalty and the actual efficiency are quite limited.Administrative discretion is everywhere. There is varying degrees of judgments and choices in all aspects of administrative acts. From the corruption cases and the phenomenon of counterfeit medicines, we can find that the abuse and arbitrary of administrative discretion during the licensing, inspection and other aspects will also bring serious consequences and far-reaching impact. It is not just the existing systems of basis and procedures require improvement and development, other effective means also need to research and discover.Try to perfect the drug regulatory system of internal control of administrative discretion from three aspects, including the construction of administrative ethics, the administrative internal restraint mechanism, and the external constraints of internal control.更多还原