The accessibility and affordability of essential medicine continues to be a major challenge in developing countries. As of 2023, the World Health Organisation (WHO) reports that there is significant variation in access to generic drugs across different countries in the world. Intellectual property rights work as a necessary incentive to drive innovation for new drugs in the pharmaceutical industry, as companies are motivated by recouping research and development costs as a result of exclusive rights to produce and sell their product. The challenge, however, is that in strengthening intellectual property rights for the pharmaceutical industry, there is a cost in social welfare regarding availability, accessibility and affordability of essential medicine, particularly in developing countries.

The study seeks to evaluate how the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a protocol that increased the intellectual property protections on the availability of essential drugs to developing countries, influences the balance between incentives for introducing new medicines and giving access to generic drugs to developing countries. A comprehensive understanding of the factors that affect the availability, accessibility and affordability of generic drugs will be gathered through a literature review, quantitative analysis of data from pharmaceutical firms and qualitative interviews with stakeholders. This examination will showcase the impact on access to healthcare, health system strengthening, health equity as well as innovation and diffusion.

By identifying barriers to access and potential solutions to improving access to generic drugs, this study has the potential to shape the formulation of policies and implementation of practices aimed at enhancing health outcomes for millions of people. Specifically, the study could provide recommendations on regulatory frameworks that can ensure the quality, safety and efficacy of generic drugs in developing countries. An understanding of how driving innovation can be achieved could contribute to efforts aimed at ensuring universal access to essential medicines and improving health outcomes in developing countries.