The therapeutic potential of psychedelics: the European regulatory perspective

Introduction

Drummond and colleagues open by situating their commentary within the large societal and economic burden of mental disorders in the European Union, noting that more than one in six people are affected and that associated costs exceed 4% of EU gross domestic product. They describe a renewed international research interest in psychedelic compounds as potential treatments for conditions such as treatment-resistant depression, addictive disorders, post-traumatic stress disorder, and psychological distress at the end of life. The paper narrows its focus to classic psychedelics — agents that act primarily as 5-HT2A receptor agonists, including mescaline, N,N-dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and psilocybin — and explicitly excludes atypical psychedelics (for example, MDMA and ketamine), noting that some atypical agents already have medicinal approvals in the EU. The authors set out to identify the main scientific, methodological, safety, and regulatory challenges that must be addressed for psychedelics to become safe and effective therapeutic options in Europe and to describe how European regulatory mechanisms might support developers and stakeholders in overcoming these challenges.