疫苗安全监管问题研究

发布时间：2018-04-30 16:07

本文选题：疫苗安全 + 监管体系　；参考：《安徽大学》2017年硕士论文

【摘要】：疫苗的质量安全关系到个人的福祉、政府的形象和社会的稳定,随着一系列疫苗安全事件的出现,暴露出我国疫苗安全监管工作中存在的漏洞。完善疫苗安全监管制度对保障疫苗安全显得尤为的重要。文章主要分为四个部分,第一部分对疫苗安全监管制度进行了基本的介绍。通过对疫苗安全监管的概念、疫苗监管的主要环节的介绍,指出了疫苗安全监管包括两方面,其一是行政机关包括法律、法规授权的组织,运用行政权对疫苗生产的各个阶段进行长期、有效的疫苗质量监督管理。其二是对监督者自身进行监督管理,防止滋生腐败。其三是阐述了我国疫苗安全监管的现状,并运用规制理论分析了疫苗安全监管的理论基础,指出了疫苗安全监管的必要性和合法性。第二部分通过分析指出了我国疫苗安全监管中存在的问题,文章从监管体系、监管范围、监管方式和监管程序四个方面进行了阐释。首先,监管体系中存在的问题主要有监管职能不清晰,购销体系监管不到位,储存运输管理体系不健全。第二,针对监管范围中存在的问题,笔者从研发、审批、生产、流通和接种的各个环节进行了具体的分析。第三,文章通过分析传统疫苗安全监管的方式,指出了行政立法、行政许可、行政检查和行政处罚中存在的弊端。最后,对疫苗安全监管程序中存在的问题进行了介绍,主要从两个方面展开,其一是政府采购疫苗程序,其二是疫苗安全信息公开制度。第三部分文章对国外的疫苗监管法律制度进行了研究,希望能够从国外的监管模式中得到有益的启示,建立适合我国国情的疫苗安全监管制度。通过总结归纳,我们可以发现国外十分注重对疫苗安全监管的行政指导,通过行政指导来对疫苗生产企业加以规范。此外,政府十分注重对疫苗监管领域的立法,以期通过立法的手段,提高对疫苗各个环节的监管能力。其次,政府的财政支持力度大,完善相关配套基础设施的建设,包括实验室的建设和疫苗数据库的建设。再次,政府十分注重疫苗信息的跟踪检查,对疫苗的全过程实行监管。同时,注重加强各个部门疫苗信息的合作,注重疫苗资源的合理配置。最后,注重疫苗相关各种制度的建设,包括信息公开制度,疫苗损害赔偿制度,预防接种不良反应报告制度等。第四部分针对第三部分提出的疫苗安全监管中存在的问题,笔者提出了完善我国疫苗安全监管的具体措施。主要从以下四个方面展开,第一,加强疫苗监管组织、监测体系的建设,完善疫苗安全监管体系。第二,在疫苗的各个环节合理界定疫苗安全监管的范围。第三,在完善传统疫苗安全监管方法的同时,引入新的疫苗安全监管方法。在规范行政立法、行政许可、行政处罚和行政检查的同时,建立起信息规制、信用规制和行政指导的监管手段。第四,健全疫苗安全监管的程序,包括政府的疫苗采购程序和疫苗安全信息公开制度。最后,文章对提出的观点进行了总结,指出只有通过健全疫苗安全监管的法制、监管体系、监管范围和监管方式,才能保障疫苗的安全、有效。
[Abstract]:The quality and safety of the vaccine is related to the well-being of the individual, the image of the government and the stability of the society. With the emergence of a series of vaccine safety incidents, the loopholes in the safety supervision of the vaccine in China are exposed. It is particularly important to improve the safety supervision system of the vaccine. The article is divided into four parts, the first part The basic introduction of the vaccine safety supervision system is made. Through the introduction of the concept of vaccine safety supervision and the main link of vaccine supervision, it is pointed out that the vaccine safety supervision includes two aspects, one is that the administrative organs include the law, the organization authorized by the laws and regulations, and the use of administrative power for the long-term and effective vaccine of the vaccine production. Quality supervision and management. The second is to supervise and manage the supervisors themselves to prevent corruption. Thirdly, the present situation of vaccine safety supervision in China is expounded, and the theoretical basis of vaccine safety supervision is analyzed with the theory of regulation, and the necessity and legitimacy of the vaccine safety supervision are pointed out. The second part points out the vaccine of our country through analysis. The problems existing in the safety supervision are explained in four aspects: the supervision system, the scope of supervision, the mode of supervision and the supervision procedure. First, the main problems in the supervision system are unclear supervision function, lack of supervision of the purchase and marketing system, and the imperfect storage and transportation management system. Second. A specific analysis was made from the aspects of R & D, approval, production, circulation and inoculation. Third, the article pointed out the drawbacks of the administrative legislation, administrative license, administrative inspection and administrative punishment through the analysis of the traditional vaccine safety regulation. Finally, the problems in the vaccine safety supervision procedure were introduced, mainly from the problems. Two aspects, one is the government purchasing the vaccine program, the other is the vaccine safety information disclosure system. The third part of the article makes a study on the legal system of foreign vaccine supervision, hoping to get useful inspiration from the foreign regulatory model and establish a vaccine safety supervision system suitable for our country. We can find that foreign countries pay great attention to the administration guidance of vaccine safety supervision and regulate vaccine production enterprises through administrative guidance. In addition, the government pays great attention to the legislation in the field of vaccine supervision so as to improve the supervision ability of every link of the vaccine through legislative means. Secondly, the government's financial support is great and perfect. The construction of the supporting infrastructure, including the construction of the laboratory and the construction of the vaccine database. Again, the government pays great attention to the tracking and inspection of the vaccine information and the supervision of the whole process of the vaccine. At the same time, we should pay more attention to the cooperation of the vaccine information in various departments and pay attention to the rational allocation of vaccine resources. Finally, pay attention to the various systems related to the vaccine. Construction, including information disclosure system, vaccine damage compensation system, prevention of adverse reaction reporting system. The fourth part of the third part of the vaccine safety supervision of the existing problems, the author put forward to improve the specific measures of vaccine safety supervision in China, mainly from the next four aspects, the first, strengthen the vaccine regulatory organization The construction of the monitoring system and the improvement of the vaccine safety supervision system. Second, the scope of the safety supervision of the vaccine is rationally defined in every link of the vaccine. Third, while improving the traditional vaccine safety supervision and supervision methods, the new method of vaccine safety supervision is introduced. It is established at the same time, while standardizing administrative legislation, administrative license, administrative punishment and administrative inspection. Information regulation, credit regulation and administrative guidance supervision means. Fourth, improve the procedures of vaccine safety supervision, including the government's vaccine procurement procedures and the system for the disclosure of vaccine safety information. Finally, the article summarizes the views put forward, and points out that the legal system, supervision system, regulatory scope and supervision are only through the sound supervision of the vaccine security. In order to ensure the safety and effectiveness of the vaccine.

【学位授予单位】：安徽大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D922.16;R186

【参考文献】