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標題: | 論藥品廣告之管制-以藥事法之廣告規範為中心 Regulation of Drug Advertising: Focusing on Pharmaceutical Affairs Act |
作者: | Chi Chen 陳麒 |
指導教授: | 李建良(Chien-Liang Lee) |
關鍵字: | 藥品,廣告,管制,事前審查,監督,競合,軟法, drug,advertisement,regulation,pre-vetting,monitor,overlapping rules,soft law, |
出版年 : | 2018 |
學位: | 碩士 |
摘要: | 藥品帶有副作用,應避免過度商業化,故藥品廣告之管制與一般商品有別。本文擬從藥品廣告管制之觀點,檢討現行藥事法之廣告規範妥適性,並排除醫療器材廣告之討論。
所謂藥品廣告,指任何促進藥品之處方、供應、銷售或消費之行為,如推銷與置入性行銷。但藥品標示及其他不具行銷性質之行為並非藥品廣告。 藥事法之廣告規範集中於母法第7章及施行細則第44至第47條,以下檢討廣告規範。首先,規範以用藥安全為管制目的。其次,依循實務解釋,多數藥品廣告行為並不適用廣告規範,而適用規範的廣告行為中卻有部分難以契合事前審查制度。第三,藥事法之廣告主規範之實務解釋有違憲疑義,應為合憲性解釋為「所有營業地址均持有合法登記執照之藥商」始能為廣告主。第四,藥事法之廣告內容規範包含施行細則,立法上有違反法律保留之疑義,其中關於記載事項之規定未區分廣告對象為專業人士或一般民眾,更有違憲爭議。第五,藥事法之廣告審查與監督規範可區分為事前審查與事後監督規範。前者中之審查標準應以藥事法明確授權為宜,內容上亦應統一。後者立法上呈現雙重監督模式,屬疊床架屋之規定,而衛生主管機關之管制權限也欠缺彈性。另就後者與公平交易法間之規範競合問題,實務之作法則有待改進。 藥品廣告應區分為資訊完整與資訊簡略、藥商名義與第三人名義之廣告。僅「藥商名義之完整廣告」,及部分的「第三人名義之完整廣告」適用藥事法之廣告規範。其他廣告則應另循管制規範如「IRPMA市場行銷規範」。現行廣告規範之管制目的應擴大為「合理用藥」,規範架構上則應著重資訊來源、資訊呈現與資訊即時性之確保。 Given that drug causes side effects, there is limit on drug commercialization, and hence regulations of drug advertisement is set apart from that of other products. The purpose of this thesis is to review whether advertisement regulations of Pharmaceutical Affairs Act (PAA) are appropriate from the perspective of drug advertisement control. The regulations of medical device advertisement are not included in the discussion. “Drug advertisement” refers to any form of activity designed to promote the prescription, supply, sale or consumption of drugs. But the labelling and behavior without promotional purposes are not covered. Advertisement regulations of PAA (hereinafter “the Ad Regulations”) are mainly stipulated in Chapter 7 of the Pharmaceutical Affairs Act (hereinafter “the PAA”) and Article 44 to Article 47 of the Enforcement Rule of Pharmaceutical Affairs Act (hereinafter “the ERPAA”). This thesis discusses the appropriateness of the Ad Regulations in five parts. First, medication safety can be considered the regulatory purpose of the Ad Regulations. Second, in accordance with judicial opinions, the Ad Regulations are not applicable to most of the drug advertisement; for those applicable, they may not be compatible with pre-release system stipulated in the Ad Regulations. Third, there is constitutional doubt in judicial explanation about the Ad Regulations regulating advertiser qualification. To make constitutional interpretation, only “pharmaceutical firms holding lawful business license with regard to all operating location” can publish drug advertisement. Fourth, the ERPAA rules included in the Ad Regulations which prescribe advertisement content are doubted to breach principle of legal reservation; among the above ERPAA rules, the recordation provisions are further considered unconstitutional due to their failure to take different treatment between the professionals and the general public as target audience. Fifth, the Ad Regulations which prescribe advertising monitoring consist of pre-vetting regulations (PVR) and post-vetting regulations (POVR). The rule for vetting criteria in PVR should be amended to gain clearer authorization from the PAA, and to ensure the unity of content and form. There are also problems in POVR. For one thing, the legislation allows dual monitoring which is duplication and waste, but gives the competent authority to take enforcement actions with little flexibility. For another, the overlapping condition between the PAA and the Fair Trade Act is not properly dealt with by the respective authorities. This thesis argues that drug advertisement can be devided into two categories: the advertisement containing full or brief information, and the advertisement published by a pharmaceutical firm or the third party. The Ad Regulations only apply to the advertisement containing full information and published by a pharmaceutical firm, as well as part of that containing full information and published by the third party. Conversely, drug advertisement other than the above should comply with other regulations such as IRPMA code of practice. Regarding the revision of the Ad Regulations, the regulatory purpose should be expanded to “rational drug use”, and three points can be considered: Where is the advertising information from (info source), how is the information presented, and finally whether the information can reflect the latest info source. |
URI: | http://tdr.lib.ntu.edu.tw/handle/123456789/1139 |
DOI: | 10.6342/NTU201802438 |
全文授權: | 同意授權(全球公開) |
顯示於系所單位: | 法律學系 |
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ntu-107-1.pdf | 2.42 MB | Adobe PDF | 檢視/開啟 |
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