Pharmacovigilance and bioethics: the importance of a neglected relationship

This study examines the critical, yet often neglected, link between bioethics and pharmacovigilance-disciplines that collectively aim to ground drug therapies in robust evidence and respect for patient rights. Despite their shared mission, scholarly dialogue between these fields remains sparse. This gap is bridged by tracing their historical foundations and addressing key ethical challenges in pharmacovigilance through the lens of four core bioethical principles: autonomy, beneficence, non-maleficence, and justice. For each principle, pivotal questions and illustrative examples are outlined, offering guidance on embedding ethical reasoning into pharmacovigilance practice. It is argued that while regulations, standard operating procedures, and digital tools are indispensable, they cannot alone resolve the ethical dilemmas posed by rapid scientific innovation, resource constraints, and global inequities, and they may reduce safety professionals to mere task executors. Consequently, it is imperative that alongside technical and regulatory progress, pharmacovigilance fosters the study and application of ethical principles in every aspect of its operation. This transformation will recast it from a purely technical function into an equitable guardian of public health, ensuring sound decision-making, promoting public trust, and delivering maximal benefit while upholding human dignity worldwide.