再論新興菸品管制

吳全峰(中央研究院法律學研究所副研究員、澄社社員)

國民健康是透過公私部門、社區、與個人共同推動的複雜議題,亦為權利義務衝突之變因。也因國民健康與在地價值、社會決定因素等密切相關,公衛法不應僅是單純移植外國立法例,亦需重視規範與社會之密切鏈結。

以新興菸品(如電子煙或加熱菸品)興起對菸害防制之衝擊為例,各國均在尋求適當管制模式(視為菸品、視為藥品、或直接禁止)以避免健康風險,台灣亦嘗試將其納入菸害防制法修正。但反對管制者屢以美國市場開放,施壓政府採寬鬆管制;問題是,美國管制模式有其社會因素,亦有相應配套,其政策邏輯是否適合全盤套用,不無疑問。

首先,美國新興菸品管制並非自始便採寬鬆模式,實係不得已之選擇。美國食品藥物管理署(FDA)在電子煙甫上市時,便嘗試將其視為藥品並嚴格管制,但因法令設計疏失造成法院挑戰,從而出現管制空窗(包括產品內容無規範、公共場所禁菸與菸品廣告禁止規定不適用電子煙等),學者多認為該空窗期影響國民健康甚鉅。而台灣仍有機會在修法時完整檢視新興菸品之影響,是否適合以存在過管制空窗之美國作為開放案例,不無疑問。

其次,為彌補管制空窗之影響,美國新修正法律規範回溯要求二○○七年二月十五日後生產之新興菸品、或改變傳統菸品性質之產品,均視為新興菸品並受較嚴格管制,但該回溯條款在台灣修法討論中卻被忽略。

第三,美國要求新興菸品需經上市審查、證明健康風險未較傳統菸品嚴重後始得上市;且即令健康風險可被接受,審查委員會仍可因該產品上市對菸害防制之可能負面影響,予以否決。但在反對管制之論述中,多僅見開放呼籲而未見市場許可機制之討論。尤其美國新興菸品上市審查係由FDA主導,台灣菸害防制主管機關卻為國健署(非食藥署),是否有足夠資源建構類似制度;若否,應如何因應,亦應充分討論。

總言之,風險未明之新興菸品與國民健康密切相關,自不宜貿然開放,並應深慮如何發展適當管制規範;且在規範建構時,雖可參考各國立法例,但亦應仔細檢視各國立法例發展時之社會經濟文化背景,始可依據我國國情(包括菸害防制架構、健康風險容忍程度等)適當調整。

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