KoGuan School of Law, China Institute for Smart Court, Shanghai Jiao Tong University, Shanghai 200030, China.
Int J Environ Res Public Health. 2023 Feb 16;20(4):3450. doi: 10.3390/ijerph20043450.
Recent vaccine scandals have overshadowed China's accomplishments in public health, triggering discussions on the causes of vaccine incidents. This study aims to review the development of China's vaccine administration, find out the causes of recurring vaccine incidents in the past decades, and propose a new governance approach to vaccine administration in the context of a public resource trading system. We collect and analyze relevant legal frameworks and data from legislative materials, government documents, press releases, and reports from the World Health Organization. In essence, it is the combination of the lagging legal system and the absence of information technology infrastructure in the process of vaccine administration reform that has led to the recurrence of vaccine incidents. Though the vaccine incidents occurred concentratedly in phases of production and lot release, and circulation, it is necessary to examine the whole life cycle of vaccine administration. The enactment of the Vaccine Administration Law outlines a supervision framework, which utilizes the Whole Process Electronic Traceability System and Whole Life-cycle Quality Management System to achieve the interconnection of all aspects of vaccine administration. The reform of China's vaccine administration is essentially a balance between efficiency and safety, which also represents the interaction between marketization and administrative supervision.
近期的疫苗丑闻给中国的公共卫生成就蒙上了阴影，引发了对疫苗事件原因的讨论。本研究旨在回顾中国疫苗管理的发展历程，找出过去几十年疫苗事件反复发生的原因，并在公共资源交易体系背景下提出疫苗管理的新治理方法。我们收集并分析了立法材料、政府文件、新闻稿和世界卫生组织报告中的相关法律框架和数据。从本质上讲，疫苗管理改革过程中滞后的法律体系和缺乏信息技术基础设施导致了疫苗事件的反复发生。虽然疫苗事件集中发生在生产和批次放行以及流通阶段，但有必要对疫苗管理的整个生命周期进行审查。《疫苗管理法》的颁布勾勒出一个监督框架，利用全过程电子追溯系统和全生命周期质量管理体系实现疫苗管理各个方面的互联。中国疫苗管理的改革本质上是在效率和安全之间取得平衡，这也代表了市场化和行政监督之间的互动。
