藥品試驗資料專屬權制度之研究－以美國藥品上市法制為中心

Abstract

資料專屬權制度是新藥上市相關法規體系中的一環，惟此一制度從問世至今一直存在有許多相關的爭議，包含其對於開發藥廠及學名藥廠之不同競爭利益的影響，其和專利制度間的競合關係，以及在TRIPS協定正式生效後，伴隨此一制度而生之國際公共衛生議題等，都曾引起相當廣泛的討論。而這些爭議的核心，大抵而言，係源自於三種各不相同，但卻應盡力保持平衡的基本社會需求：「藥品之安全性及有效性」、「人民對於藥品有充分之近用機會」，以及「新藥暨相關技術之持續研發與進步」。 這三種不同的社會需求背後，其實也具體而微地反映了開發藥廠、學名藥廠，以及人民和政府間相互的利益拉扯。而資料專屬權此一制度之良窳，誠然是牽繫著開發藥廠、學名藥廠，以及人民和政府，甚至是國際間已開發國家和其他不同發展程度之國家間彼此不同之利益的重要環節。而晚近隨著美國在生物藥領域建立起了類似學名藥之簡易上市程序的「生物相似途徑」，以及相應的「生物藥資料專屬權制度」後，讓資料專屬權再一次成為了製藥產業中備受矚目的焦點，並將成為我國在未來國際談判時必須面對的重要課題。 爰此，本文以為資料專屬權不論在理論及實務的面向上，均有相當之討論空間與實益，故而希望能透過文獻分析、實證研究，以及法律經濟分析等不同的研究方法，來對上述議題做深入而多元之探討。更為重要的是，本文期望能透過學術與實務之相關研究結果，建立一套思考的脈絡與分析的基礎，進一步來檢視台灣目前的現制是否有可資增益的空間與方向，以及未來面對外交談判時所應把握的基本立場。透過這樣的思考與討論，期能提出相關之具體建議，俾利我國製藥產業之發展與人民的福祉。

Pharmaceutical data exclusivity is part of new drug approval system, which has been full of controversy since it was created. For example, the effect related to this mechanism between research-based pharmacies and generic pharmacies, its competitive relationship with patent system, and the international issues about public health caused by it after the approval of TRIPS agreement are all important issues in both academic and practical regions. Generally speaking, all the controversy above can be attributed to three different but needed to be balanced basic social demands: the safety and efficacy of the drugs, the sufficient availability for people to use the drugs, the constant development and progression of new drugs. These three different social demands can subtly reflect the twist of variant benefit among research-based pharmacies, generic pharmacies, the people, the government, or even countries with variant developmental extent, and the pharmaceutical data exclusivity is indeed a key factor of their interaction which may cause significant effect. In addition, along with the appearance of new “biosimilar approach” and the related data protection designation for biologics in America, once again, data exclusivity has become a hot issue of pharmaceutical region, and will be an important diplomatic issue that we have to confront. For reasons that I have stated above, I think there are still great space and value to have more researches related to pharmaceutical data exclusivity in both academic and practical regions. To be more specific, In order to deal with these issues, the research approaches including document analysis, practical research, and economic analysis of law will be used, expecting to have more thorough and plentiful discussion to this topic. Consequently, I hope I can build a route of thinking and an analytic basis, trying to better the present system in Taiwan, and to form the foundation that we can stand during the diplomatic negotiation. By doing so, it is anticipated that this article can really benefit our pharmaceutical industry and nationals.