指导性文件是如何制定和演进的?——对新冠肺炎七版诊疗方案的跟踪研究

How is the Guidance Document Introduced and Further Evolved?—A Longitudinal Study of Seven Versions of the Diagnosis and Treatment Protocol for COVID-19

【问题】指导性文件的内容如何动态演进?指导性文件的法律性质为何?指导性文件的形成程序为何?【方法】聚焦国务院卫生行政部门颁布的七版新冠肺炎诊疗方案,梳理新冠肺炎诊疗方案文本的变迁。利用官方网站、新闻媒体的报道,关注新冠肺炎诊疗过程中的经验证据,分析指导性文件的动态演进、法律效果和审议程序。【发现】指导性文件的动态演进,是实验主义治理和反思性法的体现。指导性文件内容的变迁,受中央层面统一领导、政策考量、专家学科倾向的影响,并有赖于诊疗经验的不断积累。【结论】诊疗方案不具有法律规范的外观,但具有实践层面的拘束效果。指导性文件制定过程中,应完善专家咨询程序,汲取专业人士的专业知识,听取患者、普通公众、专业团体等利益相关方的意见。

Motivation:How guidance documents evolve,what are their legal effects,and what are the rule-making procedures for them?Methodology:Case study of the“Diagnostic and Treatment Protocol of COVID-19”issued by National Health Commission.It relied on a survey of the evolution of the Protocol documents andobservations of empirical material from official websites and mass media.Empirical data was used to analyzethe documents evolution,deliberation procedures,and the binding effectsof the Protocol.Findings:The evolution of guidance is a reflection of experimental governance and reflexive law.The contents of a guidance document depend on unified leadership,policy considerations,the academic inclination of experts,and the accumulation of diagnostic experience.Conclusion:The protocol has no legal validity,but it has practical,binding effects.During the rulemaking process of guidance documents,expert consultation should be made part of procedural rules.This should introduce professional expertise into the process as well as the voices of stakeholders,including patients,citizens and professional groups.