醫藥行銷師(MR)專業制度法制化與藥事法之修法探討

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Title:	醫藥行銷師(MR)專業制度法制化與藥事法之修法探討 Study on the Legalized Profession System of Medical Representative (MR) and Amendment of the Pharmaceutical Affairs Act
Authors:	高孟熙
Contributors:	法律學系碩士在職專班
Keywords:	藥事法第33條行銷專業醫藥行銷師(MR) 醫藥行銷醫療法制 Article 33 of the Pharmaceutical Affairs Act Marketing professional Medical Representative (MR) Medical marketing Medical regulation
Date:	2022
Issue Date:	2023-02-24 14:34:52 (UTC+8)
Abstract:	社會及經濟結構之變動與發展，造成國民權利之伸張及構成之細緻化及複雜度提高，連動到相關法律及規範之對應修正。近年社會上一連串之食安風暴、偽藥事件，都形成民眾之重大疑慮，而政府也透過新訂法規或辦法、修訂或增訂相關條文來防範不法情事發生。藥品是人維持其生理機能或解決、改善身體患疾時無法完全避免使用之重要物品。不僅台灣政府，各國也都按其醫療法制特性，設置相關特別法以規範之，範圍涵括研發、輸入、製造、銷售、智慧財產、專利，甚至於專門執業人員之資格條件皆有所規範，顯見藥事對國民影響深遠及對社會秩序穩定之重要。現行藥事法第33條中對於藥品行銷人員有「推銷員」名稱、業務限制及資格登錄等相關規定，但衡量社會發展、需求，並參照醫藥先進國對於醫藥行銷制度之專業化、人員資格條件之限制，藥事法中所稱「推銷員」顯欠缺專業尊重，並容易引發誤會，極需名稱之修正；而醫藥行銷師專業制度之內容，兼具科學性、學術及醫學倫理，影響社會公益，因此對於人員之資格有其規定限制之必要。修正後第33條為「藥商僱用之醫藥行銷師，應由該業者向當地之直轄市、縣 (市) 衛生主管機關登記後，方准執行藥品行銷業務。前項所稱醫藥行銷師，以向藥局、藥商、衛生醫療機構、醫學研究機構及經衛生主管機關准予登記為兼售藥物者行銷其受僱藥商所製售或經銷之藥物為限，並不得有沿途推銷、設攤出售或擅將藥物拆封、改裝或非法廣告之行為。前項醫藥行銷師資格，由中央衛生主管機關定之。」 The changes and developments of social and economic structures cause the increases in the complexity and sensitivity of the demand of the civil right. Therefore, the related laws and regulations need to be revised. Recent events of food safety crises and counterfeit drugs raise serious concerns of the public and the government tries to prevent these issues through revising current regulations or initiating new regulations. Medicines are crucial for humankind when suffering from diseases or unbalanced health conditions. The governments around the world, including Taiwan, set special legislations on the research and development, imports, manufacturing, sales, intellectual property, patents and the qualifications of professionals, according to local specialty. Current Article 33 of Pharmaceutical Affairs names the medical marketing workforces as “sales person” and regulates their business contents and qualifications for registration. However, the term “sales person” is lack of professional credential and needs to be modified. Since medical marketing requires professional knowledge in medical science and affects social welfare, the regulations on the medical marketing professionals are necessary.
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