Reconstructing Indonesia’s Pharmaceutical Patent Governance: TRIPS Flexibilities, Essential Medicines Access, and Social Justice

Abstract

Patent protection in the pharmaceutical sector may constrain equitable access to essential medicines. Indonesia reflects this tension: although its regime incorporates TRIPS flexibilities, implementation remains institutionally fragmented. This study examines how patent governance, institutional capacity, and health-system integration affect compulsory licensing (CL) and government use (GU) in Indonesia, using Thailand and India as comparative cases. The study employs doctrinal legal research using statutory, conceptual, case, and comparative approaches, supported by policy-document analysis. Primary legal materials include the TRIPS Agreement, Doha Declaration, Indonesia’s Patent Law No. 13 of 2016 as amended by Law No. 65 of 2024, Presidential Regulations No. 76 of 2012 and No. 77 of 2020, Section 51 of the Thai Patent Act, Sections 83–84 of the Indian Patents Act, and Bayer Corporation v. Natco Pharma Ltd. Secondary materials include peer-reviewed literature and authoritative WTO, WHO, WIPO, and UN documents. The findings show that Indonesia’s main gap is not the absence of CL or GU authority, but the lack of an integrated pathway connecting access-problem identification, intervention selection, decision-making, implementation, and medicine procurement. Comparative evidence from Thailand and India identifies institutional conditions that remain unavailable or insufficiently integrated in Indonesia, particularly coordinated authority, evidentiary procedures, pharmaceutical capacity, procurement linkages, and accountability. The study is limited by its doctrinal and documentary basis and absence of patient-level or primary institutional evidence. Its scientific contribution is a governance-oriented reconstruction framework linking TRIPS flexibilities, institutional coordination, and the right to health in Indonesia. Strengthening procedural guidelines, interinstitutional coordination, and pharmaceutical capacity is necessary.

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