產品標準在現今社會中扮演非常重要的角色，但也容易造成許多技術性貿易障礙。醫藥產品由於攸關人類身體的健康及安全，因此相較於其他行業，各國對藥品皆設有許多嚴格的產品標準及技術法規，對藥品的國際貿易產生嚴重的技術性貿易障礙。PIC/S制定共通的GMP標準，並且旨在降低醫藥產品在國際貿易及流通上所面臨的非關稅貿易障礙。台灣藥物食品檢驗局於2007年公告實施PIC/S GMP，預計於2013年開始全面實施。本研究關注的核心議題，主要將以WTO對技術性貿易障礙的主要規範原則，分析探討PIC/S降低醫藥產品技術性貿易障礙的功能。另外，台灣製藥業由於缺乏關鍵技術、藥廠家數眾多、生產規模小，惡性競爭十分激烈，未來實施PIC/S GMP後，對我國製藥業的衝擊不容小覷，因此本研究另一項主要議題是PIC/S GMP對我國製藥業及藥品貿易之可能影響。 / Product standards play an important role in modern societies. However, they also raise many concerns about technical barriers to trade, particularly for pharmaceutical products which must comply with numerous stringent product standards, such as GMP standards. Therefore, PIC/S aims at reducing the technical barriers to pharmaceutical trade by providing a common GMP standard, which the Bureau of Food and Drug Analysis of Taiwan declared to introduce PIC/S GMP in 2007, and to fully enforce in 2013. This study will examine how PIC/S decreases technical barriers to trade for pharmaceutical products with principals in the WTO TBT Agreement. In addition, since Taiwan pharmaceutical industry has low competitiveness for a long time, how PIC/S GMP will affect the pharmaceutical industry and international trade of Taiwan is another main issue of this study.

近年來，由於消費者對於產品安全的重視程度與日俱增，各式各樣的私營標準開始蓬勃發展。這些私營標準雖不具備法律強制力，其所導致的市場排擠效應仍使生產者不得不積極使其產品取得各項私營標準的認證，引發私營標準是否具有實質上強制力並進而影響國際間自由貿易之疑慮。隨著開發中國家自2005年開始於SPS委員會中提出全球良好農業慣例標準對國際自由貿易之負面影響，私營標準之相關法律議題於WTO場域中益發重要，實有研究討論之必要。鑒於私營標準種類、數量之眾，本論文以於WTO下被具體指謫之全球良好農業慣例標準為例，探討全球良好農業慣例標準是否有落入WTO法規範管轄範疇之可能，並透過涉及私營標準議題之食品衛生檢驗與動植物檢疫措施協定、技術性貿易障礙協定與關稅及貿易總協定相關條文的解釋與分析，討論全球良好農業慣例標準與該些規範之關連性及適法性，既而於WTO下甚至WTO以外之國際場域，探究尋求相關貿易衝擊因應之道的可行性，希冀能為私營標準對國際自由貿易體系所帶來的影響及其與WTO之關係進行審視並作出建議。 / In recent years, all kinds of private standards have started to develop prosperously because consumers consider product safety more and more important. Although these private standards are not mandatory, the crowding out effect of markets causing by these standards still makes producers have to achieve relevant certification as far as possible. This situation causes anxiety about the possibility that private standards are de facto mandatory and create trade barriers. While developing countries have stated that GlobalGAP Standard makes bad influence on international trade in the SPS Committees since 2005, the legal issues about private standards become more and more important under WTO regime and need to be studied and discussed. In view of the fact that there are too many kinds of private standards, the thesis takes GlobalGAP Standard for example to discuss whether private standards shall be subject to the rules of WTO Agreements. In order to conduct careful examining and come up with suggestions of the influence on international trade which caused by private standards and the relationship between private standards and WTO, it is necessary to research into the connection between GlobalGAP Standard and WTO rules and the legality of this standard through explaining and analyzing relevant rules which involves the issue of private standards under the SPS Agreement, TBT Agreement, and GATT and to discuss the feasibility of finding the solution to relevant trade impact under WTO regime or other international fields.