頁籤選單縮合
題 名 | 論網路DTC廣告之法律規範--以藥物DTC廣告對隱私權保障及產品責任影響為例=The Regulation of Internet Direct-to-Consumer Advertising--An Empirical Research of Drugs DTC Ad Effect on the Protection of Privacy and Product Liability |
---|---|
作 者 | 陳汝吟; | 書刊名 | 玄奘法律學報 |
卷 期 | 2 2004.12[民93.12] |
頁 次 | 頁281-331 |
分類號 | 497.468 |
關鍵詞 | 網路廣告; DTC廣告; 直效行銷; 侵權行為; 藥事法; 消費者保護; 處方藥物; 專業中介人原則; 產品責任; Internet advertising; Direct-to-consumer advertising; Direct marketing; Tort; Pharmaceutical affairs law; Consumer protection; Prescription drugs; The learned intermediary rule; Product liability; |
語 文 | 中文(Chinese) |
中文摘要 | 傳統上,病患關於治療主要乃尋求醫師之專業建議並由醫師作成決定,包括開列藥物;而病患專業醫療資訊來源亦僅有醫師,故在進一步以藥物類別區分一處方藥與非處方藥,可發現其說明對象不同,內容標準有異。原則上,就製藥者言,若是處方藥物,則其對「醫師」負「使用之適當資訊」的說明義務,若係非處方藥物,則要求其對「消費者」負「使用之適當指示」義務。然而,現在有許多病人透過網路接受來自藥物製造者之訊息與建議,自主性因此強化,則我們必須重新思考,若此有處方藥物之訊息錯誤,造成使用者損害,責任究應如何由醫師、藥物製造者,甚至是使用者來擔負的問題。在製造事業以DTC廣告直接對消費者灌輸訊息之情形下,即使仍存在著專業的中介者,但製造事業應否亦負有直接警告病患用藥風險與併發症等訊,息之法律上義務,必須更進一步討論。 我國網路DTC藥物廣告,得適用之重要規範即是藥事法第六十七條的規定,須由醫師處方或經中央衛生主管機關公告指定之藥物,其廣告以登載於學術性醫療刊物為限。只是在網路上廣告之型態千變萬化,真若依藥事法所謂藥物廣告之定義,凡利用傳播方法宣傳醫療效能達到招徠銷售為目的之行為均屬之者,不僅如何落實令人擔心,進一步已有消費者因信賴廣告服用藥物遭受損害時,民法第一百八十四條第二項、第一百九十一條之一與消費者保護法第七條應為如何適用問題遂是錯綜複雜。 本文以為藥事法第六十七條係民法第一百八十四條第二項所謂保護他人之法律。蓋不論依藥事法第六十七條之立法目的,或自網際網路形形色色為宣傳醫療效能以達招徠銷售為目的之行為觀之,應認為於該廣告致消費者受其吸引購買並服用藥品造成損害,有民法第一百八十四條第二項規定之適用,並認為DTC廣告於此無適用「專業中介人原則」。而第一百九十一條之一的商品製造人責任規定,因係採推定過失之中間責任,在廣告等表示缺陷之情形,以有說明義務為前提,若標的是處方用藥,加上藥事法第六十七條規定反推,而認無所謂說明義務,故不適用一百九十一條之一,消保法第七條亦是,其判斷與第一百八十四條第二項有別。因此,民法第一百八十四條第二項規定之獨立請求權基礎便顯出其價值所在,而解釋現行藥事法第六十七條為保護他人之法律亦有其階段重要性。惟若未來思量開放處方藥物之廣告,則令廣告主負擔直接對消費者之充實的資訊揭露義務等配套規範'須一併修訂,方使民事侵權責任無適用上欠缺,並保障消費者權益。 |
英文摘要 | Direct-to-consumer advertising is one of the most significant recent developments in the marketing of prescription drugs. The rise of DTC ad also raises new problems. DTC ad undermines the traditional legal rules governing transmission of information to patients. Current regulations require drug manufacturers to provide information and warnings directed at the prescribing physician, who in turn must warn the patient under common law tort doctrine. A drug manufacturer is generally not liable for failing to directly warn the consumer of potential adverse consequences of prescribed drugs. This “learned intermediary” rule follows from the assumption that the prescribing physician is best able to proper1y communicate the relevant risks to the patient and most able to understand a complex warning when deciding whether the stated risks outweigh the benefits for a particular patient. But, when drug manufacturers advertise directly to consumers, they have no duty under current regulations to provide a warning tailored to the consumer, and bypass the intermediary assumed by the traditional legal duties. This artic1e examines current tort doctrine and regulation relevant to DTC prescription drug ad and draws three conclusions. These current regulations are inadequate to cope with the issues raised by DTC ad. Specifically, they present no uniform framework for realistic depictions of a drug’s benefits and dangers to a lay audience. |
本系統中英文摘要資訊取自各篇刊載內容。