医药合规法治模式的全球发展及我国构建  

A Study on the Global Development of Legal Mode of Pharmaceutical Compliance and the Construction of Legal Mode of Pharmaceutical Compliance in China

作　　者：赵赤 ZHAO Chi

机构地区：[1]常州大学史良法学院 [2]常州大学合规研究中心

出　　处：《中国政法大学学报》2024年第1期217-237,共21页Journal Of CUPL

摘　　要：基于医药合规法治发展的全球视野研究可知,我国确立并构建医药合规法治模式,需要重点把握好如下几个方面:一是指导观念方面,高度重视医药合规在企业合规整体格局中的突出地位。二是合规法律方面,努力构建医药反腐的双轨立法模式,同时着重形成关于医药合规的类型化、精细化的权威指引,尤其是司法指引。三是合规内涵方面,着力形成以理性监管医药行业经济互动以及提升医疗质量为中心的医药合规规范格局。四是合规执法方面,尽快出台有利于保障医药行业高质量发展的“安全港规则”,同时确立并加强以“穿透式监管”为主要特点的现代医药行业监管模式。五是基础研究方面,大力加强关于医药腐败的犯罪学实证研究以及关于医药反腐与医药合规的全球视野研究。While promoting the development of Chinese medicine anti-corruption preventive laws,it is necessary to investigate and study the foreign medicine anti-corruption laws and practice from a global perspective.Since the beginning of this century,the development and improvement of the legal practice of pharmaceutical compliance in the international community has been reflected firstly in the deepening of basic research on pharmaceutical anti-corruption,the condensation of anti-corruption policies and the development of legal practice;and secondly also manifested in clarifying the basic elements of pharmaceutical compliance,forming the system framework of pharmaceutical compliance,focusing on the focal system of pharmaceutical compliance,and constructing the typed,refined and legalized judicial guidance of pharmaceutical compliance.To establish and realize the legalization operation and preventive expansion of China's medicine anti-corruption,China urgently needs to build the legal mode of medicine compliance in the following aspects.Firstly,in terms of guiding ideology,we should attach great importance to the prominent position of pharmaceutical compliance in the overall pattern of corporate compliance.Secondly,in terms of compliance laws,we should establish the policy guidance and strategic guidance for pharmaceutical compliance,and then strives to build a dual-track legislative model of pharmaceutical anti-corruption,and after that focuses on forming typed,refined and legalized authoritative guidance,especially judicial guidance,on pharmaceutical compliance.Thirdly,in terms of compliance connotation,efforts should be made to form a pharmaceutical compliance standard pattern centered on rational supervision of the interaction between the pharmaceutical industry and improvement of medical quality.Fourthly,in terms of compliance and law enforcement,the"safe harbor rules"conducive to the high-quality development of the pharmaceutical industry should be introduced as soon as possible,and the modern pharmaceutical industr

关 键 词：医药合规 全球考察 立法模式 合规指引 我国完善 

分 类 号：D922.16[政治法律—宪法学与行政法学]