Study On The Issues Of TRIPs Waivers In The Context Of Public Health Crisis

With the outbreak of the COVID-19 at the end of 2019,South Africa,India and other countries submitted a TRIPS waiver proposal to the TRIPS Council with the aim of initiating the waiver procedure under Article 9 of the WTO Agreement to waive members from their obligations regarding the protection of copyright,industrial designs,patents,undisclosed information under the TRIPS Agreement until the majority of the world’s population has developed immunity So that countries can get timely access to medical products and improve their ability to respond to the pandemic.The TRIPS waiver proposal has been extremely controversial.WTO members engaged in a heated discussion about the function of TRIPS waiver in response to public health crises.Opponents of the TRIPS waiver proposal believe that the pandemic does not require a TRIPS waiver because IPRs are not an impediment to the prevention and control of the pandemic,and even if IPRs did impede,existing TRIPS flexibilities would be sufficient to deal with it.While proponents cite cases and practices in the pandemic to demonstrate that IPRs besides patents have hindered the control of the pandemic,and suggest that TRIPS flexibilities are helpless in the face of the pandemic.The TRIPS waiver is the effective way to address the public health crisis.In the discussion of the function of TRIPS waivers,the primary issue is to clarify what the TRIPS waiver is.The TRIPS Agreement does not explain or clarify the TRIPS waiver.Article 25 of GATT 1947 and Article 9 of the WTO Agreement are the arrangements for the waiver system under the WTO legal system.The waiver clause is different from the exception clause in that the former is more of an exante legal arrangement to prevent the review of illegality under a change of circumstances,while the latter is an ex post facto exemption that can be directly invoked.According to the TRIPS waiver proposal and related provisions,the TRIPS waiver should be temporary,exceptional,and specific.Given the global public health crisis such as the COVID-19,the flexibility of the TRIPS waiver is stronger than the TRIPS flexibilities,and it can solve the problems of TRIPS flexibilities in practice,such as low effectiveness due to cumbersome and lengthy implementation procedures.Therefore,TRIPS waiver is effective in addressing public health crises.According to previous waiver practices under the GATT and WTO,waivers were often applied in the area of trade,but there is little practice in the area of intellectual property.There are also many problems with the review and approval of a waiver application,such as the lack of an interpretative provision on “exceptional circumstances” makes the review of a waiver application a mere formality.In addition,the way in which decision-making is conducted under the WTO Agreement can lead to difficulties in the adoption of a waiver application.TRIPS waiver also exists under the WTO legal system and follow the relevant legal provisions,and TRIPS waiver proposals are also subject to special case review rules and consensus decision-making mechanisms.At present,the TRIPS waiver proposal is still pending after the review period.Apart from the hindrance of WTO decision-making mechanism,the great disagreement among WTO members on TRIPS waiver and the resistance of different stakeholders are also important reasons for this dilemma.TRIPS waiver proposal hits a rough patch causing reflection for the international community.At a time of global public health crisis,the IP protection regime centered on the TRIPS Agreement has not been weakened.Moreover,the derivative function of TRIPS waiver in response to public health crisis cannot be ignored.From existing practices,TRIPS waiver can create soft pressure on IP holders to engage in voluntary licensing or price reductions.The dilemma of the TRIPS waiver has reinforced the international community’s understanding that there is never a single,once-and-for-all solution to a public health crisis.It determines that TRIPS waiver may bring some utility to solving public health crises,but it will never be the only path to crisis resolution.Due to the situation,the international community should revisit and further optimize the implementation procedures of TRIPS flexibilities with the aim of solving the public health crisis,so that they can function to the maximum extent.