我國「克流感」專利強制授權處分係援引TRIPS協定第三十一條(b)項及「杜哈宣言」第五條(c)項，會員在國家緊急情況下所為專利強制授權規定。唯TRIPS協定第三十一條(b)項之立法範圍橫跨了GATT第XX條(b)項公共衛生例外規定與GATT第XXI條(b)項國家安全例外規定，其授與會員行政裁量權以認定國家緊急情況，而在立法架構下未為規定檢驗原則。本文檢驗TRIPS協定第三十一條(b)項在適用上若是依循WTO一般公共衛生例外規定，則必須符合其立法架構，即應符合其客觀「必要性」、科學證據、科學標準、一致性、等同等客觀標準之檢驗流程，故所需之標準較高，在運用有時效性之措施時可能會緩不濟急。若是依循國家安全例外條款之檢驗途徑，雖然評估標準較為有彈性，相形之下適用範圍較寬廣、面貌多樣化、也較為主觀，但在實證上亦需符合WTO下「例外從嚴解釋」原則與客觀上「理性國家」標準，會員可在客觀有限的範圍內彈性適用，而不得肆無忌憚無限上綱式地援引。然而，針對尚未發生的傳染病恐慌事件，應依此病毒本身的特性，例如傳染途徑、死亡率高低及所造成衝擊之大小等因素，來決定其處理步調。除了客觀上需參考國際組織（如WHO）之公告建議外，本文建議有必要另外在國內建立一套適用機制，經由國會及元首宣布進入「國家緊急情況」，再由行政院衛生署向智慧財產局申請「特許實施」，以避免GATT第XXI(b)之濫用。

The compulsory licensing of "Tamiflu" in Taiwan in Nov. 2005 is originated from the regulation of other use without the authorization of patent right holder under national emergency of TRIPS Agreement Art.31 (b) and "Doha Declaration" para.5 (c). The scope of TRIPS Agreement Art.31 (b) contains both public health and national security concerns. Public health concern is addressed by GATTΧΧ (b), and national security exception is regulated in GATTΧΧΙ. Both these provisions provide mechanisms respectively to deal with such issues, and to prevent trade distortion. It's from "Doha Declaration" para.5 (c) that clearly grants members the right to determine what constitutes a national emergency or other circumstances of extreme urgency, and it being understood that public health crises represent a national emergency or other circumstances of extreme urgency. However, the criteria to apply Art.31 (b) of TRIPS Agreement still remains uncertain. The article would like to examine the mechanism of Art.31 (b). If followed public health exception under WTO law, including GATTΧΧ (b), SPS Agreement, and TBT Agreement, the objective standards thus required are high, and might be time-consuming to serve in a critical situation. On the other hand, the mechanism to apply national security exception seems to be flexible and subjective. Nevertheless, two principles of "strict explanation of exception rules" and a "rational state" standard are developed to supplement the application of GATTΧΧΙ. The article suggests that the mechanism to apply Art.31 (b) of TRIPS Agreement to address public health emergency shall follow the principles in the case of national security exception.