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Research Paper Volume 8 Issue 1 1598 - 1614 February 28, 2025

Access to Essential Medicines: Challenges and Solutions within Article 31bis of the TRIPs Agreement

Lead author · Corresponding
K. Ankita Rao
Research Assistant DPIIT-IPR Chair at Maharashtra National Law University, Mumbai, India
View PDF Full text DOIhttps://doij.org/10.10000/IJLMH.118984
Abstract

In this era where health crises are increasingly prominent throughout the world, Article 31bis of the TRIPs Agreement emerges as a beacon of hope for equitable access to essential pharmaceuticals especially for under developed and developing countries. This article examines in detail, Article 31bis of the TRIPs Agreement which facilitates the export of pharmaceutical products from countries having manufacturing capacities to those lacking such capability, particularly in the context of public health emergencies such as COVID-19 pandemic. The article also focusses on the shortcomings of the provision which is further illustrated by Bolivia’s challenges in importing vaccines during the pandemic. The article discusses the ambiguity and flexibility that is inherent in Article 31bis, which may lead to inconsistencies and disputed among member states regarding its interpretation and application. In order to address these issues, the article proposes several solutions including encouragement of Regional Trade Agreements (RTAs) and the development of scientific infrastructure in developing nations. Further, the article calls for a reconsideration of data exclusivity regulations to better align with the goals of expanding access to essential medicines. Finally, the article emphasizes on the need for international cooperation and adaptability in order to enhance the effectiveness of Article 31bis, thereby ensuring equitable access to vital medicines while balancing the rights of holders of intellectual property.

Type
Research Paper
Information
International Journal of Law Management and Humanities, Volume 8, Issue 1, Page 1598 - 1614
DOI: https://doij.org/10.10000/IJLMH.118984
Creative Commons
CC BY-NC 4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution–NonCommercial 4.0 International (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/), which permits remixing, adapting, and building upon the work for non-commercial use, provided the original work is properly cited.
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Copyright © IJLMH 2026
Disclaimer
The views and opinions expressed in this manuscript are those of the author(s) alone and do not reflect the views, policies, or position of the Journal.

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