Abstract
英文摘要 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.