論藥品、健康食品、食品之管制

On the Regulation of Drug, Dietary Supplement,and Food

系所名稱：法律研究所
學位別：碩士
畢業學年：91年
指導教授：葉俊榮
藥事法、健康食品管理法、食品衛生管理法將「藥品/健康食品/食品」洋洋灑灑分成近十種，並施以各種管制。但管制目的多半並未達成：規矩的藥品販售者想打廣告會受到重重限制，但不肖之徒的宣傳無日無之。民眾的健康知識並沒有因大量管制而提升；假藥依然充斥市面。健康食品銷售方式與購買方式也沒有受到許可管制太多影響。規定藥師才能開藥局，但又容許借牌開藥房。法律與實務之間存在無法跨越的鴻溝。本文運用管制理論分析這些問題。不但引入經濟學、社會學、心理學等等實證科學的方法論；也綜合運用各種法律手段。給定「市場、管制文化、社會規範、架構」對本議題的影響，運用管制理論分析「如何運用『法律』達到最可欲之境」。
本文主張，中藥思想深深影響台灣的管制文化，不容忽視。中藥思想的核心觀念是：藥品、健康食品、食品本質相同，只是對人體影響大小不同。也因此，不能用本質區分藥品/健康食品/食品；必須用「管制模式」分類藥品/健康食品/食品。本文進一步提出三種管制模式：「管制模式一」包含毒劇、管制、處方藥品。本文並大膽主張「以罰鍰及其他機制全面取代商品責任」、「許可業務委外審查、開放競爭」等管制措施。「管制模式二」囊括指示藥品、成藥與食品添加物；本文主張指示藥品與成藥無區分必要。「管制模式三」容納健康食品與食品；本文主張兩者亦無區分必要。最後，本文主張網路與全球化將會影響管制模式，但基因科技不會。

The regulatory problems of drug, dietary supplement, and food were almost left untouched by academic discussions. For example, the FDA in Taiwan spent much money planning and executing the permit system of dietary supplement, from which the consumers seemed not to benefit. The government strived against a variety of advertisements, claiming medical effects for instance; nevertheless, these prohibitions were wrong as far as science and culture are concerned. Besides, lacking information from the advertisements will reduce consumers’ welfare. Regulatory Theory, the analytical tool used in this thesis, not only integrates the empirical perspectives of Economic Analysis of Law, Law and Society, and Behavioral Law, but also interconnects the studies of Administrative Law, Constitutional Law, Civil Law, Insurance Law, to name a few. There are five forces affecting regulation: Law, Social Norm, Market, Architecture, and Culture. In the most part of the thesis, I take Social Norm, Market, Architecture, and Culture as given, and discuss how to use law to accomplish desirable aims. In the last part, I set free Architecture, which is indeed changing, and discuss its impact on my models.This thesis argues that Chinese herbal culture is pervasive in Taiwan. Just because the regulators neglected the culture and regulated everything according to the western medical paradigm, regulatory failures ensued. By taking the herbal culture into consideration, this thesis argues that there is no intrinsic difference among drug, dietary supplement, and food; the effects on human bodies are different— some are mild and some are wild—only in degree. Thus, it is impossible to classify drug/dietary supplement/food by nature; the only way is to classify by how drug/dietary supplement/food are regulated. Each subset of drug/dietary supplement/food has its own distinctive regulatory model. This thesis designs three regulatory models. The first model, replacing product liability system with fine system, contains prescription drug. The second model includes both food additive and over-the-counter drug, divided into two subcategories under current law, but in my opinion needless. The third contains dietary supplement and food (including genetically modified food)— but in my view there is no need to distinguish dietary supplement from food.In addition, this thesis argues that all kinds of restrictions toward advertisements should be lifted. All we need is a clause against false advertisements, and in order to enforce, mandate the broadcasters to register the information of advertisers.This thesis also discusses the potential impacts of biotechnology, the internet, and globalization on the regulatory models. I propose that biotechnology will not undermine the models; rather, it will underpin them. However, the internet and globalization will probably make my models obsolete some day. Then, we are obliged to use Regulatory Theory to reform these models again.