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Pharmaceutical Patent Wars and Access to Medicines: Striking a Delicate Balance


Author(s): GYANENDRA SINGH, VIR NARAYAN

Received: December 02, 2024; Accepted: December 04, 2024; Published: December 10, 2024

*Corresponding author: Dr. Gyanendra Singh, M. Pharm, PhD (IITBHU) School of Legal Studies, Vikrant University, Gwalior, Madhya Pradesh, India; Email: gyanileo@gmail.com

Citation: Singh G (2024) Pharmaceutical Patent Wars and Access to Medicines: Striking a Delicate Balance. J Med and Pharm Sci Vol.1 No.1.

Copyright: ©2024 Singh G. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

The conflict between pharmaceutical patent protection and equitable access to medications represents one of the most significant global health challenges in contemporary society. Patents, which confer exclusive rights to inventors for their innovations, are fundamental in incentivizing research and development (R&D). However, this system often creates barriers for millions of patients, particularly in low- and middle-income countries (LMICs), who are unable to afford life-saving treatments. The ethical and economic dilemmas surrounding this issue demand urgent attention and balanced solutions.

Pharmaceutical patents confer exclusivity for duration of 20 years, enabling companies to recover the substantial investments necessitated by the development and commercialization of novel pharmaceutical agents. These expenditures, typically ranging from $1 billion to $2.6 billion per pharmaceutical compound, render patents essential for promoting innovation. Yet, the exclusivity afforded by patents enables corporations to establish prohibitively high prices, thereby limiting accessibility. For instance, the gene therapy Zolgensma, priced at over $2 million per dose, exemplifies the disparity between innovation and affordability. Similarly, the persistently high cost of insulin despite its discovery over a century ago underscores the necessity to reevaluate the current patent system.

India’s 2012 decision to issue a compulsory license for Bayer’s cancer drug Nexavar represents a significant instance of prioritizing public health concerns over corporate financial interests. Bayer had established the drug’s price at $5,000 per month, rendering it inaccessible to the majority of Indian patients. In contrast, the generic version manufactured by Natco Pharma was priced at $150. While this action was lauded as a positive outcome for patients, it also generated discourse regarding its potential implications for pharmaceutical innovation and foreign investment.

The COVID-19 pandemic elucidated the global ramifications of stringent patent protections. India and South Africa proposed a temporary waiver under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to facilitate expanded vaccine production in LMICs. Despite garnering widespread support, this proposal encountered opposition from high-income countries and pharmaceutical corporations, which contended that such waivers might impede future innovation. The limited licensing agreements proffered by entities such as Pfizer and Moderna proved insufficient to address the magnitude of the crisis, thereby exposing the inadequacies of the extant system.

From an ethical perspective, the pharmaceutical patent system presents a fundamental dilemma: should innovation be prioritized at the potential cost of human lives? Economically, it raises concerns regarding sustainability. Critics posit that in the absence of robust patent protections, pharmaceutical companies may lack sufficient incentives to invest in costly and high-risk research and development. Conversely, the inaccessibility of affordable medicines exacerbates global health inequities, particularly in LMICs where healthcare systems are already under considerable strain.

Balancing these opposing objectives necessitates new solutions. Tiered pricing, in which medicines are priced based on a country’s socioeconomic level, is a potential strategy to make medicines more accessible while maintaining profitability. Initiatives such as the Medicines Patent Pool, which licenses patents to generic producers, show the value of collaborative frameworks. Governments should take a more active role by strengthening patent rules to avoid evergreening, which occurs when modest changes to current pharmaceuticals prolong patent protection.

A global framework that harmonizes intellectual property rights with public health needs is essential. The TRIPS waiver debate underscores the urgency of international solidarity in addressing global health crises. Governments, pharmaceutical companies, and international organizations must work together to ensure that the benefits of innovation are equitably shared.

The health is not a commodity but a fundamental human right. By rethinking the pharmaceutical patent system, we can move closer to a future where life-saving medicines are accessible to all, without stifling the drive for groundbreaking discoveries.