论解释性规则的法治化——以药品监管为例证

On the Rule-of-law Interpretative Rules——Take drug regulation as an example

药品监管部门制定解释性规则,是其固有权限所在。解释性规则包括抽象解释和具体应用解释。药品监管部门颁布的解释性规则不是正式的法律渊源,不具有法律规范效力,但对行政机关有直接拘束效果,对行政相对人有间接拘束效果。解释性规则对法院不具有法律规范意义上的约束力,但在药品行政诉讼案例中,更多体现了司法对解释性规则的尊重和援引。应考虑文义解释、体系解释、目的解释等方法,完善解释性规则的制定程序,并确保解释性规则内容的合法性。

The drug regulatory authorities possess their inherent duty to formulate interpretative rules that include abstract interpretation and specific application interpretation. The interpretative rules issued by drug regulatory authorities are not originated from formal legal sources, without legal normative effect, but they have direct effect on binding administrative organs and indirect one on administrative counterparts. The interpretative rules have no restraint on the court in the sense of legal norms, but in drug administrative litigation cases, the judicial respect and citation of interpretative rules are more reflected. We should consider the methods of literal interpretation, system interpretation and purpose interpretation to improve the procedure of formulating interpretative rules and ensure the legitimacy of the content of interpretative rules.