药品广告监管制度研究

发布时间：2018-09-11 16:10

【摘要】：药品广告在推动健康信息传播、普及公众健康知识、促进我国医药行业快速发展等方面发挥了重要作用,已成为药品企业拓展市场的重要手段。凭借广告,一些药品企业在众多竞争对手中脱颖而出,取得了骄人的市场业绩。由于受药品广告巨大经济利益的驱使,我国药品广告违法现象十分严重,违法药品广告数量长期居高不下,给消费者带来了严重的危害。如何有效治理违法药品广告已成为社会关注的热点,国务院2012年发布的《国家药品安全“十二五”规划》也专门提到要严厉打击发布违法药品广告行为。要有效治理违法药品广告,就必须加强监管制度的创新建设,因此,本文尝试对我国药品广告监管制度的创新进行探索性研究。首先,本文在介绍药品和药品广告基本概念及其特性的基础上,按四个不同的历史时期对我国的药品广告发展概况及其作用进行了总结和分析,并推测了我国药品广告的未来发展趋势。同时,本文从两个方面阐述了药品广告的意义和作用,即药品广告推动了医药行业发展并有利于推动健康信息的传播。研究指出,药品广告市场将越来越大,竞争也日趋激烈,未来药品广告的形式和内容将更加隐蔽,因此加强对药品广告的监管十分重要。其次,本文对我国药品广告存在的问题与危害做了深入的分析,指出我国药品广告违法现象日趋严重,表现形式多种多样,常见的有:资格违法;对禁止发布广告的药品做广告;对药品功能疗效做不恰当宣传;利用公众人物、患者和专业机构的名义进行宣传;使用软文的形式进行宣传等。研究指出,违法药品广告对社会造成了严重危害,主要体现在7个方面:影响人类健康;加重消费者负担;影响行业公平竞争;影响药品企业创新力;对生态环境造成污染;影响政府公信力;引发道德风险。第三,本文利用利益政策学的基本理论和观点,分析了我国药品广告相关主体即政府监管者、消费者、药品企业、广告经营者和媒体的利益,指出药品广告作为一类特殊的广告,不仅攸关人类的身体健康和生活质量,也与政府部门、消费者、药品企业、媒体及广告经营者的利益密切相关。研究发现,违法药品广告各相关主体之间存在着错综复杂的利益关系,正是这种利益关系才导致违法药品广告的屡禁不止。因此,如何通过制约和平衡各方利益,设计合理的药品广告监管制度显得尤为重要。第四,本文将全国31个省、自治区和直辖市药监局的门户网站作为研究样本,从药品广告信息查阅途径、公告更新周期、公告内容详尽度、监管栏目所含信息量、公众举报投诉平台建设情况5个方面,对这些省、自治区和直辖市药监局的药品广告政府监管行为及监管工具应用情况做了深入的调查和对比研究。研究发现,我国药监部门在药品广告监管中存在诸多问题:一是各省、自治区和直辖市对违法药品广告监管的重视程度不一;二是各省、自治区和直辖市查阅违法药品广告信息的复杂程度普遍较高;三是各省违法药品广告公告信息多数更新不及时;四是各省、自治区和直辖市违法药品广告公告内容详尽程度不一;五是设有违法药品广告监管专栏的省份少,有设专栏的,其所含的信息量也不够丰富;六是违法药品广告公众举报投诉平台建立不完善、不科学。第五,笔者先后走访了哈药集团三精制药股份有限公司、福建省工商局、福建省药监局、海峡都市报、宁德电视台和合众广告有限公司等单位和部门,与药品广告的相关的市场监管者、药品生产者、媒体发布者、广告经营者进行深度访谈。结果显示,大部分受访者认为,目前药品广告已经成为严重的社会问题,其深层次的原因是制度问题,而制度背后隐藏更深的是各种利益问题;他们一致认为只有从制度层面进行创新,才有可能从根源上解决我国违法药品广告数量长期居高不下的现状。访谈为药品广告监管制度的创新设计提供了翔实的第一手素材。第六,通过向福州市五区八县(市)的回春、惠好、康利达、融佳等13家药店,以及福建医科大学附属协和医院、福建省肿瘤医院等7家医院的消费者发放2200份调查问卷,从定量分析角度了解消费者对药品广告的认知度情况,进一步佐证了访谈结论。研究表明,当前普遍存在违法药品广告泛滥、消费者受骗程度严重、维权意识薄弱、社会监督不力等严峻问题。第七,本文总结了我国药品广告监管制度5个阶段的历史沿革,分析了我国药品广告的监管体制和法律体系,归纳了我国药品广告监管制度的特点;同时介绍了美国、澳大利亚、法国、德国、英国、日本和新加坡等国家的药品广告监管制度的基本情况。研究认为,鉴往知来,洋为中用,吸收我国药品广告监管制度以往成功经验以及借鉴国外药品广告监管制度之精华,对创新设计我国药品广告监管制度有着重要的现实意义。最后,本文以制约和平衡药品广告各方利益、实现共同利益最大化为目标,根据我国药品广告监管制度的实际,从制定一部专门的《药品广告法》、归口一个部门监管、合并成一个“药品广告监测中心”、搭建一个全国统一的“药品广告信息发布平台”、设立一部全国统一的“违法药品广告举报电话”、创办一档全国性《用药健康》栏目、修订完善药品广告相关法律体系、营造一个良好的社会文化环境等8个方面,对我国药品广告监管制度进行了创新设计,提出了我国政府对药品广告监管在体制机制改革、法律法规建设、政府职能再造、监管工具创新等方面的具体内容和要求,凸显了研究这一课题的理论与现实意义。
[Abstract]:Drug advertising has played an important role in promoting health information dissemination, popularizing public health knowledge and promoting the rapid development of the pharmaceutical industry in China. It has become an important means for pharmaceutical enterprises to expand their markets. Driven by enormous economic benefits, the illegal phenomenon of drug advertisement in China is very serious, and the number of illegal drug advertisements has been high for a long time, which has brought serious harm to consumers. To crack down on the publication of illegal drug advertisements, we must strengthen the innovation and construction of supervision system to effectively control illegal drug advertisements. Therefore, this paper attempts to explore the innovation of drug advertisement supervision system in China. This paper summarizes and analyzes the general situation and function of drug advertisement in different historical periods, and speculates the future development trend of drug advertisement in China. Meanwhile, this paper expounds the significance and function of drug advertisement from two aspects, that is, drug advertisement promotes the development of pharmaceutical industry and promotes the dissemination of health information. It is pointed out that the drug advertisement market will become bigger and bigger, and the competition will become more and more fierce. The form and content of drug advertisement will be more concealed in the future. Therefore, it is very important to strengthen the supervision of drug advertisement. There are various forms of publicity, such as: illegal qualifications; advertisement of drugs prohibited from advertising; inappropriate publicity of the efficacy of drugs; publicity in the name of public figures, patients and professional institutions; and publicity in the form of soft text. Now there are seven aspects: affecting human health; increasing the burden on consumers; affecting fair competition in the industry; affecting the innovation of pharmaceutical enterprises; polluting the ecological environment; affecting the credibility of the government; causing moral hazards. The interests of consumers, pharmaceutical enterprises, advertisers and media point out that as a special kind of advertising, drug advertising is not only related to human health and quality of life, but also closely related to the interests of government departments, consumers, pharmaceutical enterprises, media and advertising operators. It is the intricate interest relationship that leads to the repeated prohibition of illegal drug advertising. Therefore, it is particularly important to design a reasonable drug advertising supervision system by restricting and balancing the interests of all parties. Fourthly, this paper takes the portals of 31 provinces, autonomous regions and municipalities directly under the Central Government as the research samples. From five aspects of access to drug advertisement information, update cycle of announcement, detailed content of announcement, information content of supervision column and construction of public complaint platform, the government supervision behavior and application of supervision tools of drug advertisement in these provinces, autonomous regions and municipalities directly under the Central Government were investigated and compared. Nowadays, there are many problems in the supervision of drug advertisement in China's drug regulatory departments: first, the importance of the supervision of illegal drug advertisement varies among provinces, autonomous regions and municipalities directly under the Central Government; second, the complexity of accessing the information of illegal drug advertisement is generally high among provinces, autonomous regions and municipalities directly under the Central Government; third, most of the information of illegal drug advertisement in each province is not updated. Fourthly, the content of illegal drug advertisement announcements in different provinces, autonomous regions and municipalities directly under the Central Government is not detailed; Fifthly, there are few provinces with illegal drug advertisement supervision columns, and the information contained in them is not rich enough; Sixthly, the public complaint platform for illegal drug advertisement is not perfect and scientific. Fifthly, the author has visited them successively. In-depth interviews with market regulators, drug producers, media publishers and advertisers related to drug advertisements were conducted among the units and departments of Harbin Pharmaceutical Group Sanjing Pharmaceutical Co., Ltd., Fujian Industry and Commerce Bureau, Fujian Pharmaceutical Regulatory Bureau, Taiwan Metropolitan Daily, Ningde Television Station and United Advertising Co., Ltd. They believe that the current drug advertising has become a serious social problem, the deep-seated reason is the system problem, and the system behind the hidden is a variety of interests; they agree that only from the system level of innovation, it is possible to solve the root causes of the long-standing high number of illegal drug advertising in China. Sixthly, 2 200 questionnaires were distributed to consumers of 13 pharmacies, including Huihao, Kanglida, Rongjia, Fujian Medical University Affiliated Union Medical College Hospital, Fujian Cancer Hospital and other 7 hospitals from quantitative analysis angle. The research shows that there are many serious problems in the current drug advertisement, such as the prevalence of illegal drug advertisements, the severity of consumers'deception, the weak awareness of safeguarding rights, and the weak social supervision. This paper analyzes the regulatory system and legal system of drug advertisement in China, summarizes the characteristics of drug advertisement regulatory system in China, and introduces the basic situation of drug advertisement regulatory system in the United States, Australia, France, Germany, Britain, Japan and Singapore. The successful experience of the regulatory system in the past and the essence of the foreign drug advertising regulatory system are of great practical significance to the innovative design of China's drug advertising regulatory system. A special Drug Advertising Law will be enacted to centralize the supervision of a department and merge it into a "Drug Advertising Monitoring Center". A nationwide unified "Drug Advertising Information Publishing Platform" will be set up. A nationwide unified "Drug Advertising Reporting Telephone" will be set up. A nationwide column on "Drug Health" will be set up to revise and improve the scope of drugs. In eight aspects, such as informing the relevant legal system and creating a good social and cultural environment, we innovatively designed the drug advertising supervision system in China, and put forward the specific contents and requirements of the government's drug advertising supervision in the aspects of institutional mechanism reform, law and regulation construction, government function reengineering and supervision tool innovation, which highlighted the research. The theoretical and practical significance of this topic.
【学位授予单位】：沈阳药科大学
【学位级别】：博士
【学位授予年份】：2012
【分类号】：D922.16;D922.294

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