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KMID : 1142220230180010053
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.53 ~ p.61
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A Study on the Analysis of Related Laws and Regulations for the Improvement of Drug Advertising Review Act
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Park Jee-Woo
Jung Hyun-Sil
Hwang Min-Hyeok
Go Jeong-Min
Guilherme Gago
Cheong Jae-Hoon
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Abstract
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The contents of deliberation on pharmaceutical advertising are included in Article 68-2 (Advertising Review) of the Pharmaceutical Affairs Act, which was newly established in 2007, and the Regulation on Safety of Pharmaceuticals, etc. (Ordinance of the Prime Minister) enacted in 2013. Since the laws and regulations related to pharmaceutical advertising were enacted or newly established, no changes have been made to the law except for “media or means for advertising drugs, etc.” in 2018. In this study, we will examine and analyze legislation related to pharmaceutical advertising, i.e., the Act and the Ordinance on pharmaceutical advertising, find the problems of the application of the laws and propose improvements in the current social environment. To this end, we investigated and analyzed the laws concerning pharmaceutical advertising and advertising review, guidelines for pharmaceutical advertising, and related documents. We compared and analyzed the Ordinance according to the sections of the Act. And then, we found the cases of application of this Act. Compared with the time of enactment of the law, the social convention, culture, and advertising circumstances have changed significantly, and in particular, advertising technology and methods have developed to the point of a major change. We checked the gap between the laws and the reality and the ambiguity of the application of the laws. For example, “Article 78, Paragraph 3 of the Regulations on the Safety of Drugs, etc. subparagraph (b) of Appended Table 7 states, “Only the product name, manufacturer name, efficacy and effect can be displayed when advertising outdoors.” However, at this point in time, with the development of technology and methods, it is being advertised in the form of video in outdoor advertising. So this subparagraph is anachronistic. Thus, we identified the contents of laws and regulations that were not suitable for the current situation and suggested the direction for revision in accordance with the purpose of the law. We need to continuously observe drug advertising-related laws to reflect changes in the scientific and social environment, focusing on whether they meet the purpose of legislation.
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KEYWORD
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Over-the-counter drugs, Drug advertisement, Review of drug advertisement, Pharmaceutical Affairs Act, Drug safety regulations, Misuse and abuse of drugs
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