國際醫藥法規協和組織作為技術性貿易障礙協定下之國際標準組織之適格性分析

TBT協定之規範目的在於確保各國輸出品之品質、保護人類、動植物之生命或健康或環境、防止詐欺行為等目的，確保會員之技術性法規、標準以及符合性評估程序，不致對國際貿易造成不必要之障礙。為促進國際貿易之順暢，調和各國分歧的技術規章或標準有其必要性，TBT協定第2.4條要求會員應以相關國際標準作為其技術性措施之依據，以避免造成不必要之國際貿易障礙，但條文中並未明確定義何謂國際標準。特別是牽涉到人類健康、安全的醫藥產品，因其特殊性，此類產品與其製程向來受到各國政府高度管制，各國在藥品跨國輸入時，所面臨的技術性法規往往不一致，因此便有呼籲發起調和國際間規範落差之國際倡議，國際醫藥法規協合組織的成立便受到重視。我國衛生福利部食品藥物管理署於2014年12月22日公告一份「國際醫藥法規協合組織（ICH）規範採認清單」，為與國際藥品審查標準接軌，我國爰引ICH之指導原則制定出此份規範採認清單。假若其他WTO會員國對於我國的藥品制度產生合法性爭議時，我國衛生福利部基於ICH所制定的指導原則，是否符合TBT協定下第2.4條的國際標準，更進一步言之，ICH所通過的指導原則是否符合TBT協定下第2.4條的國際標準。本文將從TBT協定相關條文、TBT委員會相關決議、爭端解決機構所通過的小組及上訴機構報告、ICH官方資料等進行研究，分析TBT協定第2.4條下之國際標準之構成要件，以及ICH指導原則與TBT協定下的國際標準之合致性。若未來我國面臨此類議題時，希冀能提供相關建議及參考。

關鍵字

技術性貿易障礙協定；國際標準；國際標準組織；國際醫藥法規協合組織；國際醫藥法規協和會議

並列摘要

The purpose of the Agreement on Technical Barriers to Trade is to ensure the quality of its exports, or for the protection of human, animal or plant life or health, of the environment, of for the prevention of deceptive practices and to ensure that technical regulations and standards and procedures of assessment of conformity do not create unnecessary obstacles to international trade. In order to facilitate the conduct of international trade, Articles 2.4 of TBT agreement require WTO members shall use relevant international standard, or the relevant part of them, as a basis for the technical regulations. However, the term "international standard" is not defined under the TBT Agreement.Because the particularity of pharmaceutical products for human use, such products and its process has always been highly regulated by the governments. On account of the divergence in technical requirements of new medicinal products from country to country. The urgent need to rationalise and harmonise regulation was impelled by concerns. Thus, the authorities of various countries discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived. The establishment of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use has received considerable critical attention. To be more actively involved in ICH’s harmonisation work, our government has developed the specification checklist according to the ICH guidelines in recent years. If one day the member of WTO requested the establishment of a panel, considering the legitimacy of our government’s regulation.Whether our government regulations, according to the ICH guideline, are inconsistent with Article 2.4 of the TBT Agreement. Furthermore, whether the alleged ICH guidelines was indeed a "relevant international standard" within the meaning of Article 2.4. This essay tries to analysis the elements constitutes a "international standard" for the purposes of Article 2.4 and whether the ICH guidelines are consistent with Article 2.4 of the TBT Agreement, based on the relevant article wording, decision made by TBT committee, DSB decisions , Official report from ICH and so on. Finally, this essay offer suggestions for future directions.