由藥品類緣物問題談我國藥品、食品及健康食品之管制

Abstract

關於藥品的定義，我國與美國對於藥品的管制都是以「成分」為標的，即使其最終產品是以化妝品或膳食補充品販售，不論其產品的名義或型態，只要該成分具有藥品的功效，都不脫離藥品規範所管轄的範圍。藥品類緣物即與原廠藥有緣源的類似物，其化學結構的主要部份與原廠藥相同，但外圍分支部份則有部份不同，因此對於人體產生的作用與原廠藥類似。俗稱的保健食品，其功效訴求類似於健康食品，雖以食品名義販售，卻仍標榜對於人體的組織功能有特殊的功效來吸引消費者。為搏得消費者的好感，這類產品多強調以天然食品為原料或是從中草藥材所提煉。為了強化產品的功效，部分業者甚至添加了不為人知的神祕配方─藥品類緣物，使得食品與藥品之間的界線更加模糊。檢調單位大幅取締後，於刑事訴訟過程也產生了諸多法律爭議。本文藉由司法實務判決的實證研究，發現不少法院見解對於犯罪主觀構成要件的成立被限制於藥品類緣物解構的時間之後，可能造成「犯罪安全期」的存在，因此於本文提出參考的解決方法，也對於藥事法藥品的定義做進一步的解析，並提出修法建議。筆者認為，製造商之主觀故意取決於是否知悉系爭成分具有藥品功效，製造商應無動機將不明的異物添加至其產品之內，徒增加其原料與生產成本。只要將藥品類緣物解構時間點的限制移除，司法實務工作者對於主觀故意的證明方法就可解脫不必要的錮桎，將犯罪者繩之以法。

Any given substances containing an ingredient exerting a pharmaceutical effect on human organism are considered pharmaceuticals that must be regulated by the drug provisions. Producing similar effects as an approved drug, a drug analogue falls under the definition of pharmaceuticals even though it is a synthetically created structure derivative of a parent chemical compound by replacing some elements with alternatives. Compared with drug analogues, health food is monitored by the authorities with distinctive provisions. Health food with drug analogue additives should be regulated as a type of drug rather than a type of food; however, some health food manufactures conceal such additives to avoid the drug provisions. The improper marketing of health food with drug analogue additives has led to false perceptions within the consumers that it is nature, safe, and legal. This study qualitatively researches the court decisions on drug analogue additives and finds the controversial disputes. Some courts set the same ruling that the subjective intention of the manufacture defendant sustains only after the accused drug analogue has been deconstructed. Such ruling likely triggers so-called “a grace period” in favor of defendants who claim unawareness of drug analogues. In reality, it is not reasonable for the manufacture to pay extra costs to add something unidentified and useless. In order to promptly suppress the illegal food additives, legislative amendments recommended in the conclusion of this study are to modify the definition of ‘drug’, and the courts are recommended to dismiss when the drug analogue’s chemical structure was deconstructed in judging the subjective intention to overcome the concern about “the grace period” of crime.