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Compulsory Licensing: A Comparative Study On Its Impact On Global Health Equity And Pharmaceutical Innovation




Aindri Saha, Christ University, Pune, Lavasa

Ms. Stuti Sowmya, Christ University, Pune, Lavasa


ABSTRACT


Persistent disparities in access to essential medicines remain a significant global health challenge, especially in low- and middle-income countries (LMICs). A central issue is the tension between enforcing pharmaceutical patents—which aim to incentivize innovation—and upholding the universal human right to health. This research critically examines the role of compulsory licensing (CL) within the broader context of international intellectual property (IP) law and public health policy. Through a comparative legal analysis of jurisdictions including India, Brazil, South Africa, and Germany, the study explores how different legal systems interpret and implement CL and the broader implications of such divergence for global health equity. The paper begins by outlining the legal and conceptual foundations of IP rights in the pharmaceutical sector, focusing on the TRIPS Agreement under the World Trade Organization (WTO) and its interpretation through the Doha Declaration. It then defines key terms such as generic drugs, patent pools, and voluntary licensing, situating CL within a broader toolkit for promoting medicine accessibility. The comparative section reveals that while countries like India and Brazil have invoked compulsory licensing as a public health safeguard, developed economies often maintain stricter patent enforcement regimes, limiting the use of such flexibilities through trade pressures or political lobbying. The paper further assesses the impact of compulsory licensing on drug affordability, availability, and health outcomes, using case studies such as India’s issuance of a license for Nexavar, Thailand’s response to the HIV/AIDS crisis, and the stalled efforts around COVID-19 vaccines. While CL can dramatically reduce costs and enhance treatment coverage, it often faces resistance from pharmaceutical corporations, who argue that it undermines innovation and commercial viability. This research evaluates such claims, ultimately finding that compulsory licensing does not necessarily hinder innovation— especially when combined with mechanisms like tiered pricing, public- private R&D partnerships, and advance market commitments. In its final sections, the paper addresses the ethical, economic, and political dimensions of the global IP regime, advocating for a more equitable, transparent, and cooperative approach. It also explores the emerging role of AI in drug discovery, raising new questions about future IP enforcement and access paradigms. This research concludes with a call to action for reforming TRIPS flexibilities, strengthening international institutions, and embedding compulsory licensing within trade and public health policy as a legitimate, routine mechanism. By repositioning access to medicines as a moral imperative rather than a market transaction, the paper envisions a future where innovation and equity coexist in a truly global public health framework.



Indian Journal of Law and Legal Research

Abbreviation: IJLLR

ISSN: 2582-8878

Website: www.ijllr.com

Accessibility: Open Access

License: Creative Commons 4.0

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All research articles published in The Indian Journal of Law and Legal Research are fully open access. i.e. immediately freely available to read, download and share. Articles are published under the terms of a Creative Commons license which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

 

Disclaimer:

The opinions expressed in this publication are those of the authors. They do not purport to reflect the opinions or views of the IJLLR or its members. The designations employed in this publication and the presentation of material therein do not imply the expression of any opinion whatsoever on the part of the IJLLR.

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