TRADEMARK INFRINGEMENT AND REGULATORY FRAGILITY AS STRUCTURAL HEALTH DETERMINANTS IN THE GAMBIA: A LEGAL EPIDEMIOLOGY AND HEALTH SYSTEMS ANALYSIS

The proliferation of counterfeit and substandard medicines constitutes a major public health crisis in low- and middle-income countries, with The Gambia exemplifying regulatory fragility. This article contends that trademark infringement, often treated as a commercial issue, is a structural determinant of health, generating pathogenic legal exposures that intensify disease burden and inequity. A convergent mixed-methods design, grounded in legal epidemiology and health systems analysis, underpins the study. Quantitatively, it examines national data (2013–2023) on customs seizures, adverse drug reactions, and health facility records. Qualitatively, it integrates 32 semi-structured interviews with regulators, healthcare providers, and legal experts, alongside analysis of national and international policy frameworks. A literature synthesis situates The Gambia within the global counterfeit medicines burden, underscoring West Africa’s vulnerability due to porous borders, fragmented institutions, and the limited utility of mobile authentication in resource-constrained settings. Findings reveal profound systemic weaknesses: legal ambiguities, overlapping mandates, chronic underfunding of enforcement agencies, and limited public access to verified pharmaceutical data. Thematic analysis highlights policy incoherence and accountability gaps, while regression modelling demonstrates a significant link between weak trademark enforcement and counterfeit drug proliferation. The 2022 acute kidney injury outbreak from contaminated syrups illustrates these failures. The study concludes that combatting counterfeit medicines requires reframing trademark protection as a public health imperative. It recommends integrated legal-regulatory reform, multisectoral governance, capacity-building for enforcement bodies, and consumer empowerment through accessible verification tools. Embedding legal determinants into pharmaceutical policy offers a novel pathway to strengthening health security and restoring public trust in The Gambia and comparable contexts.