台灣公共衛生規制之法政策研究：以電子煙為例

A Study on Legal Policy of Public Health Regulations in Taiwan: Taking Electronic Cigarettes for Example

系所名稱：醫療暨生物科技法律研究所 學位別：碩士 畢業學年：106年 指導教授：李崇僖 電子煙近年來開始普及並逐漸取代傳統紙菸，但世界各國對於電子煙之使用情況與安全健康風險仍未有詳細的數據資料或調查報告佐證，電子煙是否可能造成更多的社會問題、其又應如何加以定性及管理監控，如今成為全球公共衛生的新興議題。 台灣目前之電子煙管制政策將其定性為藥物，並採取全面禁止之管制模式。此一模式的極限，在於〈藥事法〉規範偏重於製造端和進口端，但對於電子煙的吸食/使用者、入境旅客攜帶、甚至轉贈流通等行行為則均缺乏明文規範，似乎有違一開始管制電子煙以避免民眾健康受侵害的法政策目的；有待進一步釐清與檢討。本論文利用文獻分析法、歷史結構途徑分析法以及法政策分析法，針對美國、澳大利亞、歐盟及德國、大韓民國等先進國家以及台灣之菸草產業歷史、吸菸文化、菸害訴訟歷史、立法例及判決的演進過程為基礎，探討各國菸草產業的歷史背景、社會文化、發展狀況，以及既有的國家組織結構主導下的如何影響主管機關之選定、變遷與相關管制政策，並以此為參考與比較之依據，探討台灣的歷史法律背景以及國家組織結構之下，電子煙應該遵循何種管制模式以及如何選定主管機關。 本論文藉由探討目前台灣以藥物為定性之管制模式（藥物模式），與將電子煙定性為菸品之管制模式（菸品模式）相比較，並參酌美國及德國判決實務、大韓民國管制單位變遷史以及世界衛生組織菸草控制框架公約（FCTC）對於未禁止銷售電子煙的締約方所提出之建議管制方案清單，嘗試尋繹台灣電子煙管制模式（雙軌併行制）的改進建議。

In recent years, an increasing number of smokers have begun to use Electronic Cigarettes to replace traditional cigarettes; nevertheless, due to the limited amount of studies available, regulatory organizations worldwide lack sufficient data and report regarding the long-term health risks and users’ trends of using Electronic Cigarettes. The hotly debated issue of Electronic Cigarettes have drawn discussions among international public health governances on whether Electronic Cigarettes could result in more social problems and how they should be regulated as well as classified.Currently, Taiwan classifies Electronic Cigarettes as “drugs” under the Pharmaceutical Affairs Act, prohibiting their use altogether. The limitation of this regulatory model is that the Pharmaceutical Affairs Law focuses on regulating manufacturers and importers. However, the law has no explicit regulations on Electronic Cigarettes users, visitors entering Taiwan with Electronic Cigarettes, and the circulation of Electronic Cigarettes as commodities or gifts in Taiwan. Given these grey areas, Taiwan’s current regulatory model requires further clarifications and revisions.Using Document Analysis, Historical-Structural Approach, and Legal Policy Analysis as research methods, this thesis explores the evolution of Tobacco industry history, smoking culture, tobacco litigation and legislation history in Taiwan and compared it with those of other countries, including the United States, Australia, European Union, Germany, and the Republic of Korea. Furthermore, it explores each country’s tobacco industry, including their respective historical context, social culture, developmental situation, how they decide the choice of their regulatory body and form related policies under their governance structure. Based on analyzing the aforementioned data and comparing it with Taiwan’s historical legal context as well as national governance structure, the thesis explores what regulatory model Electronic Cigarettes should be regulated under and how appropriate regulatory body should be appointed. This thesis provides suggestions to improve Taiwan’s current regulations towards parallel regulatory model on Electronic Cigarettes through the following analysis: the comparison of Taiwan’s current regulatory model (drug model) with that of classifying it as “Tobacco Products” regulated under the Tobacco Hazards Prevention Act (tobacco model), the lessons drawn from relevant laws and legal cases in Germany and the United States, the development of governance in the Republic of Korea, as well as the lists of Specific Regulatory Options proposed by the WHO’s Framework Convention on Tobacco Control (FCTC) for conferences of the parties that do not prohibit the sales of Electronic Cigarettes.