Potential Impact of Provisions of Intellectual Property Rights Related to the Pharmaceutical Sector in the Comprehensive and Progressive Agreement for Trans-Pacific Partnership on Access to Medicines, in the Context of the COVID-19 Pandemic

Abstract

With the aim of strengthening the economic integration to liberalize trade and investment among members, 12 countries in the Pacific Rim including Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam came together under a FTA called Trans-Pacific Partnership Agreement (TPP). After the withdrawal of the United States based on the consideration that the agreement would adversely affect the its economy and independence, the remaining 11 countries came up with a new FTA, now renamed as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). In terms of IPRs, among various provisions, CPTPP incorporated a few controversial articles intensively related to the pharmaceutical sector including patentability, patent term extension, test data exclusivity and patent linkage. These provisions promote a higher level of protection for IPRs compared to the TRIPs agreement; therefore, raise strong arguments regarding their potential consequences on public health. Although the first three provisions, namely patentability, patent term extension and test data exclusivity, were suspended in the transition from TPP to CPTPP, their possible impact on access to medicines has not withered yet based on the fact that the negotiation of these suspended articles can be reopened to welcome the United States back and attract new members to the game. The thesis will focus on analyzing the aforementioned IPRs introduced in CPTPP, both the suspended and remaining ones, in relation to access to medicines in member states, especially in developing countries. A comparison between these provisions and corresponding provisions under TRIPs, references to other TRIPs-Plus FTAs and arguments surrounding their justifications will be incorporated. The evaluation of potential impact of such IPRs on widespread access to affordable medicines will be elaborated through various examples and studies including those in countries which are not members of CPTPP but have already introduced such TRIPs-Plus provisions into their domestic laws. Especially, such provisions also raise strong concerns in the context of the COVID-19 pandemic when governments are putting their priorities on developing safe and effective vaccines and treatment medicines used against the disease. Therefore, the question of whether such provisions would create obstacles to member states in utilizing flexibilities set out under TRIPs such as compulsory licensing, and prevent them from timely and proper access to pharmaceutical products used for COVID-19 will also be discussed. At the end, this thesis comes up with several suggestions regarding possible actions for the countries to consider in order to minimize the potential impact of such provisions, while considering the scenario of a re-opening of negotiation and lift of the suspension of these provisions.

Keywords: CPTPP, Free Trade Agreements (FTAs), Access to Medicines (A2M), COVID-19 Pandemic, Patentable Subject Matter, Patent Term Extension, Test Data Exclusivity, Patent Linkage