药品广告规制：准则、监管与责任

Drug advertising regulation:guidelines,regulations and responsibilities

药品广告规制对于保障消费者的生命健康,维护药品市场公平竞争秩序,促进药品产业持续健康发展具有重要意义。《广告法》《药品管理法》《药品管理法实施条例》《药品广告审查办法》《药品广告审查发布标准》等法律、法规、规章构成我国的药品广告规制法律体系。我国应当从消极性和积极性规范入手,完善药品广告内容和形式的准则。进一步健全药品广告审监分离的监管体制,明确药品监管部门和市场监管部门的职权,建立协调沟通机制,以及通过药品监管部门协助和行业自律监管,加强市场监管部门的规制能力。针对违法药品广告,应当建立专门的惩罚性赔偿制度,加大行政罚款额度及增加资格罚的适用情形以及完善行刑衔接机制。

Drug advertising regulation is of great significance for protecting consumers′life and health,maintaining fair competition order in the drug market,and promoting the sustainable and healthy development of the drug industry.Advertising Law,Drug Administration Law,Drug Management Law Implementation Regulations,Pharmaceutical Advertising Approval Measures,Drug Advertising Approval and Release Standards and other laws,regulations and rules constitute drug advertising regulatory legal system in China.China should start with the norms of passiveness and enthusiasm,and improve the guidelines for the content and form of drug advertisements.China needs to further improve the regulatory system for the separation of drug advertisements from approval and supervision,clarify the functions and powers of drug regulatory authorities and market supervision departments,establish coordination and communication mechanism,and strengthen the regulatory capacity of market supervision departments through the assistance of drug regulatory authorities and industry self-regulation.In response to illegal drug advertisements,China should establish special punitive damages system,increase the amount of administrative fines and increase the application of qualification penalties,and improve the administrative and criminal connection mechanisms.