药品行政执法适用免责条款的要件构建

Construction of Essential Elements for the Application of Exemption Clauses in Drug Administrative Enforcement

与新修订《药品管理法》配套的《药品管理法实施条例》尚未出台,药品经营企业、医疗机构对修订《药品管理法实施条例》具有构建免责条款的诉求。新修订《行政处罚法》确立了轻微不罚、初次不罚、无错不罚制度。修订《药品管理法实施条例》,应当落实免责条款,既要回应相对人的诉求,也要与新修订《药品管理法》、新修订《行政处罚法》相衔接,明确依法予以免责的适用要件,包括适用主体、主观过错、具体情形以及危害后果4个方面,以解决药品行政执法免责情形认定难的问题。

The Regulations for Implementation of the Drug Administration Law that complements the newly revised Drug Administration Law has not yet been issued.Pharmaceutical companies and medical institutions demand that an exemption clause be built in the revision of the Regulations for Implementation of the Drug Administration Law.The newly revised Administrative Punishment Law establishes a system of impunity for minor offences,first offences,and no-intent offence.Revision of the Regulations for Implementation of the Drug Administration Law should include an exemption clauses,not only to respond to the demands of the counterpart,but also to be in line with the new Drug Administration Law and Administrative Punishment Law.The revision should clarify the applicable requirements for exemption from liability,including the applicable subject,subjective fault,specific circumstances,and elimination of harmful consequences,so as to solve the difficulty in determining when exemption applies in drug administrative enforcement.