FairChain: A Trusted and Transparent Blockchain-Based Ecosystem for Drug Development for Nagoya Protocol Implementation

Abstract

The coronavirus pandemic has spread globally, affecting over 700 million people and resulting in over 7 million deaths. In response, global pharmaceutical companies and disease control centers have urgently sought effective treatments and vaccines. However, the rise of counterfeit drugs has become a significant concern amid this urgency. To standardize the legal provision and usage of genetic resources, the United Nations Development Program (UNDP) introduced the Nagoya Protocol. Despite advancements in drug research, the production process remains tedious, complex and vulnerable to fraud. <i>FairChain</i> addresses this pressing challenge by creating a transparent ecosystem that builds trust among all stakeholders throughout the Drug Development Life Cycle (DDLC) by using decentralized, immutable, and transparent blockchain technology. This makes <i>FairChain</i> the first digital health tool to implement the principles of the UNDP&rsquo;s Nagoya Protocol among all stakeholders throughout all DDLC stages, starting with sample collection, to discovery and development, to preclinical research, to clinical development, to regulator review, and ending with post-market monitoring. Therefore, <i>FairChain</i> allows pharmaceutical companies to document the entire drug production process, landowners to monitor bio-samples from their land, doctors to share clinical research, and regulatory agencies such as the Food and Drug Authority to oversee samples and authorize production. <i>FairChain</i> should enhance transparency, foster trust and efficiency, and ensure a fair and traceable DDLC. To date, no blockchain-based framework has addressed the integration of traceability, auditability, and Nagoya Protocol compliance within a unified system architecture. This paper introduces <i>FairChain</i>, a system that formalizes these requirements in a modular, policy-aligned, and verifiable digital trust infrastructure.