新体系下危害药品安全犯罪中药品监督管理部门出具认定意见的认定规则探析

Analysis of the Rules for the Identification Opinion Issued by Drug Regulatory Departments on Crimes Against Drug Safety under the New System

认定意见是药品监督管理部门对危害药品安全犯罪所涉药品作出的专业性判断。最高人民法院、最高人民检察院新修订的《关于办理危害药品安全刑事案件适用法律若干问题的解释》增加了药品监督管理部门出具认定意见的情形,凸显了药品监督管理部门认定意见的重要证据地位。然而,目前认定意见的出具流程、认定标准与规则存在制度性缺位,势必影响认定意见的专业性和科学性。鉴于此,应构建由始至终的启动与内控程序机制,构建以药品实质功效为主线,围绕药品外观特征、功能特征、实质特征,结合违法行为领域、行为人类型,按照从外到内的审查顺序等综合认定的认定规则。

The identification opinion is the professional judgment made by drug regulatory departments on the drugs involved in the crime of endangering drug safety.The Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Endangering Drug Safety newly revised by the Supreme People's Court and the Supreme People's Procuratorate has added the situation that drug regulatory departments would issue the identification opinions,highlighting the important evidentiary status of the identification opinions of drug regulatory departments.However,at present,there is an institutional vacancy in the issuance process,identification standards and rules of identification opinions,which is bound to affect the professionalism and scientificity of identification opinions.In view of this,an initial and internal control procedure mechanism from beginning to end should be built,and an identification rule should be set,taking substantive efficacy of drugs as the main line,revolving around the appearance characteristics,functional characteristics and substantive characteristics of drugs,combining the field of illegal acts and the type of actors,and reviewing from outside to inside.