論預防原則於風險管制措施之適用及法律上界線 ─ 以電子菸之管制措施為例

The Application and Boundary of Precautionary Principle in Risk Regulation ─ Regulating Electronic Cigarette as an Example

陳佳琦(Chia-chi Chen)

指導教授 ： 羅昌發

國立臺灣大學/法律學院/法律學研究所/碩士(2016年)

https://doi.org/10.6342/NTU201610191

摘要

有鑑於科技商品化而生的新型態產品，時常在未及制定相應的安全性驗證與適當規範的情況下，進入人民的日常生活中；此外，由於科技的日新月異，自其衍伸而出的新型態產品，更經常超越決策者的想像，使得關於此類產品的安全性與可能危害的判定倍顯艱難。是以，應如何劃定公權力行使的界線，同時亦平衡人民可能因而遭受的危害，實屬一大挑戰。
本文針對前述問題，擬透過「風險」的視角進行檢討與分析，亦即，跳脫該項產品是否確實有危害的辯證，直接針對其存有風險的狀態，討論決策者是否以及應如何介入管制。而在風險與其因應的相關討論中，本文選擇以經常在環境風險的因應中被提及的「預防原則」為主軸，藉由分析預防原則的概念意涵與歸納其過往的適用情況，嘗試將預防原則進一步抽象化，並適用於科技商品化所衍伸之新型態產品的管制議題中，作為驗證決策者對於此類產品所採取之舉措是否適當的檢證依據。此外，為能更清楚的闡述與演繹本文所關懷的管制議題，以下將舉電子菸為例，自其所衍伸的風險情狀與產品屬性等面向著手進行分析；復回應預防原則適用於電子菸之管制措施時可能產生的爭議；並依循本文針對預防原則所歸納出之前提要件與適用上之法律界限進行討論。
申言之，有鑑於電子菸對於使用者及非使用者可能產生的健康影響，與其對於菸害防制措施之實行與延續的可能影響，均有待科學證據進一步核實或排除，而屬於存有科學上不確定性之風險情狀；並且，自電子菸衍伸之風險若確實實現，其所生損害亦具有重大性。電子菸所衍伸之風險情狀當符合本文針對預防原則所歸納之適用前提，亦即「風險情狀存在科學上不確定性」與「風險實現所生損害具有重大性」兩者，應有適用預防原則之空間。而在其適用上之法律界限的討論上，亦即關於比例原則的檢驗，本文認為各國目前對於電子菸的管制內涵，雖在規範分類與管制密度上各有不同，惟大抵仍在預防原則之適用範圍內，而得以藉由預防原則之適用加以正當化。惟全面禁止電子菸之措施，因係對於具有科學上不確定性之風險情狀，透過全面而永久的禁絕措施予以因應，應難以通過比例原則的必要性審查，而無法透過預防原則之適用予以正當化。

關鍵字

預防原則 ； 比例原則 ； 風險 ； 風險管制 ； 新風險產品 ； 電子菸/煙 ； 菸害防制 ； 世界衛生組織菸草控制框架公約

並列摘要

Since the products derived from commercialization of scientific research achievement are usually devoted into our daily life without corresponding mechanism for safety evaluation and appropriate regulation, it is quite a challenge for decision makers to strike a balance between the harmful effect possibly undertaken by people and the boundary of the right to regulate. In addition, the continued evolution of cutting-edge science and technology applied in the above products, which often transcend the imagination of decision makers, would also make the evaluation of safety and possible harm much harder than ever.
This article intends to elaborate and analyze the above issue from the aspect of “risk” instead of the debate of the existence of real harm. In other words, the author would focus on the present circumstance, which involved the factor of risk and discuss whether or how to regulate the risk posed by the above products. And “precautionary principle” which has been frequently mentioned in the field of environmental risk and the corresponding regulation would be the main approach of this article when dealing with the issue of risk. To apply precautionary principle in the issue of regulating above products and invoke it as a criterion to determine whether the measures adopted by the decision maker are appropriate, this article would also be devoted to the abstraction of precautionary principle by analyzing its essential meaning and generalizing the experiences of past applications. Additionally, in order to elaborate and demonstrate the core of this article in a more precise way, the author would take the regulation of electronic cigarette (hereinafter “e-cigarette”) as an example. To apply the precautionary principle in the regulation of e-cigarette, the following manuscript would be started from the characterization of e-cigarette and the risk derived from it; then consequently respond to the controversy over the application; and discuss the detailed application by the prerequisite and legal boundary addressed by the author in this article.
Further speaking, since both the health effect derived from e-cigarette on the user and non-user and the possible influence on the implementation and continuity of tobacco control measures have not yet been confirmed or eliminated by scientific evidence, the risk derived from e- cigarette could be characterized as “the risk with scientific uncertainty”. And the damages caused by the realization of the risk derived from e-cigarette would also be substantial. Hence, the risk derived from e-cigarette indeed fit in with the prerequisite of applying precautionary principle generalized by this article, which are “the risk with scientific uncertainty” and “the damages caused by the realization of risk are substantial”. With regard to the legal boundary of its application which is the scrutiny of the principle of proportionality, the author is of the view that most of the measures adopted by individual countries are within the legal boundary of applying precautionary principle and could be justified by the application of precautionary principle, even though the category and intensity of the regulation are diverse. However, “the total ban approach” which advocate the completely elimination of the risk with scientific uncertainty is not pass the examination of the necessity test included in the principle of proportionality and could not be justified by the application of precautionary principle.

並列關鍵字

precautionary principle ； principle of proportionality ； risk ； risk regulation ； products with new-developed risk ； electronic cigarette ； tobacco control ； WHO Framework Convention on Tobacco Control (FCTC)

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