Navigating Trips Flexbilities: Applicability and Gaps in Mainland Tanzania

Abstract: Anchored within the framework of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the article looks at how Tanzania, as a least developed country (LDC) and Member of the World Trade Organization, navigates its international intellectual property obligations while safeguarding public health, technological development, and access to essential medicines. It analyses key TRIPS flexibilities, including compulsory licensing, parallel importation, transitional periods for LDCs, and exceptions and limitations to patent rights. It assesses the extent to which these mechanisms have been incorporated into the Patents (Registration) Act. Special attention is given to the public health dimension, especially in light of the Doha Declaration on the TRIPS Agreement and Public Health, which affirms Members’ rights to protect public health and promote access to medicines.

It argues that while Tanzania has formally integrated several TRIPS flexibilities into its legal framework, significant gaps remain in operationalization and institutional capacity. Challenges include limited technical expertise in patent examination, regulatory fragmentation, weak coordination, limited use of compulsory licensing mechanisms, and external pressures arising from bilateral and regional trade arrangements that may narrow policy space. Furthermore, the study highlights practical obstacles such as insufficient awareness among policymakers and judicial actors, constrained local pharmaceutical production capacity, and limited engagement with technology transfer mechanisms envisaged under Article 66.2 of TRIPS. Through doctrinal analysis, the article concludes that the effectiveness of TRIPS flexibilities in Mainland Tanzania depends not merely on legislative incorporation but on strategic implementation, institutional strengthening, and coherent alignment between trade policy and public health priorities.

It recommends enhanced capacity-building, clearer procedural regulations for compulsory licensing, improved inter-agency coordination, and stronger use of LDC transition periods to maximize policy space. Ultimately,Tanzania’s experience illustrates both the protective potential and structural limitations of TRIPS flexibilities within the broader context of global intellectual property governance and development policy.

Keywords: TRIPS Agreement, TRIPS Flexibilities, Public Health, Patent Law and Mainland Tanzania