平衡监管和市场:疫苗安全的挑战和对策

Balance Regulation and Market: Ideology and Approach of Drug Safety Governance in China——A Case Study of Changsheng Vaccine Incident

药品安全监管的根本使命,是实现公众健康、国家安全和产业利益多方共赢。本文以长生疫苗案件为焦点个案,分析我国疫苗供应和监管体系存在的四大深层次挑战,即疫苗生产充分竞争与接种环节过度行政化的矛盾,监管体制纵横割裂与疫苗产业链条连续性的矛盾,疾控机构公益属性与营利动机的矛盾,政策议题高度敏感与社会共治严重缺失的矛盾。疫苗问题不仅仅是利益驱动,也不能完全归咎于监管缺失。行政逻辑吸纳市场机制的内在扭曲使疫苗安全长期维持在大事不出、小事常有的低水平均衡状态,直至利益链条被偶发事件打破。必须继续坚持"四个最严"原则,以"放管服"改革为抓手,超越线性监管模式,增强监管机构能力和自主性,让疾控回归公益并引导企业落实主体责任,全面提升新时代疫苗安全治理水平。

The essential mission of pharmaceutical regulation is to achieve muhiple policy goals including public health, national security and business interest. Based on Changsheng vaccine incident in 2018, an empirical analysis of vaccine supply and regulation system in China is conducted. Four structural challenges are highlighted in this article, including the adequate competition and excessive administrative control within various stages of vaccine industry, the fragmented regulation and full life circle risk of vaccine supply chain, the public welfare status and profit motivation of CDC, and the sensitive policy agenda and weak social governance. Intentional violation and weak regulatory capacity cannot explain the whole picture, while a low equilibrium is obtained due to the tensions between market and administration mechanism until incidence breaks out. Modern governance paradigm rather than linear regulation model needs to be introduced to enhance both capacity and autonomy of regulatory agency, and corporate responsibility and the returning of public welfare of CDC are critical as well.