一般商品醫療效能廣告管制之研究

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Title:	一般商品醫療效能廣告管制之研究
Authors:	戴玉宜;Tai, Yu-I
Contributors:	法律與政府研究所
Keywords:	醫療效能;廣告;管制;不實或引人錯誤;藥事法;公平交易法
Date:	2022-07-25
Issue Date:	2022-10-04 11:16:33 (UTC+8)
Publisher:	國立中央大學
Abstract:	2020年COVID-19肆虐，消費者購買習慣開始轉變為線上購物，隨著使用網際網路之人數、時間及用量增加，醫療效能廣告爭議與日俱增。由於現今商品多樣化且複雜化，商品屬性區隔逐漸模糊，許多商品尚難一望即知是否係藥事法等特別法規或公平交易法之適用？是否會有規範上競合或衝突的問題？衛生福利部與公平交易委員會在執法上該如何協調與分工？均為值得探討之議題。有鑒於一般商品廣告內容涉及醫療效能之問題層出不窮，本文從藥事法第69條、醫療器材管理法第46條及公平交易法第21條切入進行法規檢視，藉由對法規立法目的、規範要件、規範主體及管制方式併予觀察，進行法規比較，並就衛生福利部與公平交易委員會協調分工及案例分析，據以找出現今市面宣稱療效的商品廣告氾濫之問題，並探討如何有效提升醫療效能廣告之管制。本文發現衛生相關法規要件定義模糊，事業難以遵循，且有易使事業規避藥物廣告事前審查之問題；又未對薦證者訂定妥適的規定，難以對有影響力者產生規範；二機關在判定管轄權之分歧，造成相互推諉之困境，均是造成醫療效能廣告之管制成效不佳之原因。最後，本文建議在規範面，衛生相關法規應調整法規要件之定義，制定例示詞句之處理原則；對影響力者訂定相關規範提升執法效能。在執行面，建議設立醫療效能廣告檢舉案件查詢系統，以解決二機關有重覆處理案件之問題；成立協調處理小組或中心，提升執法成效；在長期，可考慮統一廣告權責機關以解決管轄權爭議及突破機關間相互推諉之困境。 ;With the outbreak of COVID-19 in 2020, consumers′ purchasing behavior has been shifting to online shopping. The controversy of advertisement involving medical efficacy is increasing with popularity and coverage of the Internet. Due to the diversification and complexity of commodities nowadays, the attribute and category of commodities is getting blurred, and it is difficult to know whether commodities are subject to specific regulations such as the Pharmaceutical Affairs Act (PAA), the Medical Device Act (MDA) or the Fair Trade Act (FTA). Whether there will be normative concurrence or conflict? How should the Ministry of Health and Welfare (MOHW) coordinate with the Fair Trade Commission (FTC) to the enforcement? These issues are necessary to be discussed further. According to the endless cases emerging in the content of advertisement that related to medical efficacy, this study starts from reviewing rules including Article 69 of the PAA, Article 46 of the MDA and Article 21 of the FTA. This study comprehensively compares rules that mentioned above with the legislations, normative subjects and enforcement, and analyzes the coordination and cases between the MOHW and the FTC, so as to find out the proliferation of advertisements involving medical efficacy nowadays, and address on how to regulate such advertisements more effectively. The findings of this study are as follows: the definitions and elements of health-related rules are not clear; it’s difficult to comply the regulations for enterprises but easily escape the reviewing process of medicament advertisement; without making appropriate rules for endorsers to regulate the influencers, The recognition of jurisdiction between the agencies are not consistent, so that the phenomenon of mutual buck-passing leads to the ineffectiveness of enforcement on medical efficacy advertisements. Finally, the suggestions of this study are as follows: regulators should modify the definitions and elements of the health-related rules and regulations; making guidelines for illustrative examples and establishing relevant norms for influencersto enhance the enforcement. In terms of implementation, to set up an inquiry platform for reporting medical efficacy advertisement to avoid the MOHW and the FTC handling duplicate cases; to establish a coordination handling group or center to improve the effectiveness of enforcement; to assign a specific agency for the authority of handling advertisement to avoid the phenomenon of controversy and mutual buck-passing between these two agencies.
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