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Compulsory Licensing And Global Health Equity: “A Comparative Analysis Of Patient Regulation, Access To Essential Medicines And The Future Of Pharmaceutical Innovation”




Aindri Saha, Christ University, Pune, Lavasa Campus


ABSTRACT


The persistent inequities in access to essential medicines continue to pose a serious challenge to global public health, particularly in low- and middle- income countries (LMICs). Central to this challenge is the tension between pharmaceutical patent enforcement—designed to incentivize innovation— and the universal human right to health. This research critically explores the role of compulsory licensing (CL) within the broader framework 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 paper examines how legal systems vary in their interpretation and implementation of CL, and the broader implications of such divergence for global health equity.


The study begins by outlining the legal and conceptual foundations of intellectual property 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.



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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