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作 者:徐璐 杜庆鹏[1] 朱炯[1] 白玉萍[1] Xu Lu;Du Qingpeng;Zhu Jiong;Bai Yuping(National Institutes for Food and Drug Control, Beijing 100050, China)
机构地区:[1]中国食品药品检定研究院
出 处:《中国药事》2019年第7期737-740,共4页Chinese Pharmaceutical Affairs
摘 要:目的:基于《中华人民共和国广告法》《中华人民共和国专利法》《药品广告审查发布标准》等法律法规的相关规定,对专利药品广告进行解析,为药品广告中专利内容的规范宣传、消费者购买药品的注意事项以及监管部门对药品广告的监管提供参考和建议。方法:对药品广告中专利宣传的情形进行分类总结,结合具体案例和相关法规的规定,深入分析药品专利、广告内容和药品的适应证/功能主治之间的联系。结果与结论:医药企业应当遵循相关法律法规的要求,正确宣传药品广告,审批部门应当严谨审批,同时做好对企业和广告申请人的培训,监管部门应当对药品广告中专利的内容进行严格监管,以保证药品广告中的专利宣传的准确性,消费者应当在了解药品适应证/功能主治的基础上,理性地看待药品广告中的专利宣传内容,避免被不当宣传误导。Objective: To analyze advertisements of the patent drugs according to the relevant provisions of "Advertisement Law of the People’s Republic of China","Patent Law of the People’s Republic of China" and "Standards for Examination and Publication of Drug Advertisements" in order to provide references and suggestions for the standardization of publicity of patent contents in drug advertisements, precautions for consumers in purchasing drugs, and the supervision of drug advertisements by regulatory departments. Methods:The patent publicity in drug advertisements was classified and summarized. The relationship between drug patents,drug advertisements and the indications of the drug in conjunction with specific cases and relevant regulations was analyzed in detail. Results and Conclusion: Pharmaceutical enterprises should follow the requirements of relevant laws and regulations and correctly publicize the drug advertisements. Approval departments should examine and approve scrupulously, and organize training for pharmaceutical enterprises and advertising applicants. Regulatory departments should supervise and manage the patent contents in drug advertisements strictly to ensure the accuracy of the patent publicity in drug advertisements. Consumers should take drug advertisements rationally on the basis of understanding the indications/functions of drugs, so as to avoid being misled by improper publicity.
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