Ethical and Legal Reflections on First-in-Class Drugs Exploring Biomaterials and Compulsory Licensing

Abstract

Access to life-saving medications for advanced stages of chronic diseases remains limited due to issues of affordability, availability, and accessibility. First-in-class (FIC) drugs, often central to treatment in such conditions, present a unique set of ethical and policy challenges. This study investigates the ethical dilemmas surrounding FIC drugs, including (1) high costs associated with new FICs, (2) limited accessibility, (3) monopolistic practices impacting equity, (4) tension between commercial interests and states obligations to uphold the right to health, and (5) increasing concerns regarding their availability. Using a medico-legal research framework, this study systematically explores how compulsory licensing (CL) could serve as a policy tool to address these dilemmas. A detailed literature review of the discovery, development, and regulatory approval of FICs, drawing from sources such as PubMed and the U.S. FDA was conducted. FICs are then categorized into two groups: (1) First generation FICs and (2) Second generation FICs, which are typically tested in targeted populations with well-defined phenotypes and genotypes, mimicked on in vitro systems exploring advanced biomaterial based technologies often allowing for faster and less costly approvals. However, the absence of a regulatory or ethical distinction between these two types has contributed to persistent inequities. A case analysis of India’s first CL issued for sorafenib illustrates how policy responses can be shaped by real-world therapeutic effectiveness and alternatives such as lenvatinib. The findings support the argument that a nuanced classification of FICs, alongside experience-based compulsory licensing policies, may enhance the ethical distribution and health parity  of innovative medicines. The study concludes that CL remains a vital mechanism for promoting the right to health, but its effectiveness depends on national policy contexts and recognition of the diverse nature of FIC innovation.