Role Of Reverse Engineering And Compulsory License In Access To Life Saving Medicines

Abstract

Reverse engineering, which involves studying existing products to identify their design and production methods, has become an important practice in advancing public health. It has been used by pharmaceutical manufacturers, government agencies, and civil society to increase the availability of essential medicines, adapt medical technologies, and respond quickly to shortages at the times of emergency. Notable examples include the production of generic medicines, the replication of ventilator components during the COVID-19 pandemic, and efforts to provide alternatives when patented drugs such as oseltamivir (Tamiflu) were in limited supply.

This research paper explores the technical, legal, and ethical aspects of reverse engineering within the public health framework. It highlights three key case studies -Tamiflu, emergency ventilator part production, and generic antiretroviral drugs to illustrate how reverse engineering can both support access and raise concerns regarding safety, legality, and innovation.

This paper further evaluates policy instruments such as technology transfer initiatives, compulsory license provisions, and the role of regulatory safeguards in ensuring that reverse-engineering products meet safety and quality standards. Using doctrinal legal analysis alongside insights from supply chain practices, the study suggests that reverse engineering, when combined with transparent technology transfer and strong regulatory oversight, can act as a practical complement to intellectual property rights. This approach not only strengthens public access to life-saving medicines and devices but also balances the need for innovation incentives with ethical responsibility and patient safety.