摘要
In China,the regulatory framework for medical device procurement and sales,particularly concerning anti commercial bribery,relies heavily on punitive mechanisms applied after violations occur.Consequently,there is an urgent need to establish a scientific risk regulation framework as a complementary approach.Effective risk-oriented regulatory models require precise identification of risk areas in commercial bribery.Focusing on several major procurement scenarios such as centralized bulk-buying,tendering and bidding processes,in-hospital procurement,and online purchasing,this article analyzes the structural factors contributing to these risks,represented by the absence of certification mechanisms,lack of transparency in information disclosure,and inadequate checks and balances.Based on official risk assessment results,this study applies the theory of power and responsibility to propose a preventive regulatory framework that combines industry self-discipline and administrative oversight.By combining these approaches,the framework aims to develop regulatory measures that can effectively reduce commercial bribery risks and prevent illegal and non-compliant conduct.
当前我国医疗器械购销领域的反商业贿赂监管主要依赖于事后处罚机制,亟需建立一种科学的风险监管机制作为补充。以风险为导向的监管模式的前提是准确界定商业贿赂风险领域。本文聚焦集中带量采购、招标投标、院内采购及线上采购等主要风险情景,剖析这些风险背后缺乏认证机制、信息公开、权力制衡的结构性原因。运用以上风险评估的结果,依据权力责任理论探寻行业协会自治与行政监管相结合的预防性监管体制,以达到控制商业贿赂风险、预防违法违规行为的监管目标。
