Belgium

Belgium's current psychedelic policy environment is best understood as a medicines-control framework, not a reform framework. The operative legal base remains the 1921 drug law as implemented through the 2017 Royal Decree, which FAMHP continues to update through consolidated annexes. As of the March 2026 update, named classical psychedelics remain in the national psychotropics system, and the official sources reviewed do not show a national move towards decriminalisation or non-medical legal access. # #

The modern Belgian evidence base began earlier with ketamine than with psilocybin. A Belgian phase II trial recorded in EudraCT in 2016, sponsored by UZ Leuven, set out to replicate the efficacy of intravenous ketamine in a Belgian sample and identify biomarkers of response and relapse in major depression and bipolar depression. The trial was completed, and Belgian follow-on work included a 2021 pilot randomised analysis reporting heart-rate findings after a single ketamine infusion. # #

Belgium then became part of the multinational esketamine development programme. Belgian sites participated in key Janssen studies including TRANSFORM-3, and broader long-term or comparative esketamine studies such as SUSTAIN-3 and ESCAPE-TRD. Belgium's first routine psychiatric access route around a psychedelic-adjacent medicine therefore came through mainstream antidepressant development, authorisation and reimbursement rather than through psychedelic-policy reform. # # # #

The classical psychedelic restart appears later and remains small. A 2024 protocol paper described the CHU Brugmann psilocybin-assisted therapy trial for severe alcohol use disorder in Brussels, and public registry material now shows a hospital-based psilocybin programme in treatment-resistant depression at Ghent University Hospital. This is a meaningful step for Belgium, but it still looks like a cautious hospital-based restart rather than a mature national platform. # # #

The clearest regional starting point is Brussels. It combines national regulation and payment architecture with hospital research: FAMHP and RIZIV/INAMI sit there, and CHU Brugmann hosts the country's best-documented psilocybin alcohol-use-disorder programme. Brussels also appears in multinational esketamine development through Belgian trial-site participation. # # # #

Belgium's live ecosystem is no longer only a Brussels story. Ghent has emerged through the PSIHOS-D programme at Ghent University Hospital and a linked UGent implementation project. Leuven remains important through KU Leuven and UZ Leuven's ketamine work in depression and severe brain injury, while Liege's contribution is strongest in consciousness science and neurocritical research rather than psychiatric psilocybin therapy. # # # # #

The relevant actors are FAMHP for medicines and controlled substances, RIZIV/INAMI for reimbursement, CHU Brugmann and Universite libre de Bruxelles for psilocybin addiction research, Ghent University Hospital for treatment-resistant depression feasibility work, KU Leuven and UZ Leuven for ketamine research, and the University of Liege and Coma Science Group for disorders-of-consciousness work. # # # # # #

The ecosystem signal is therefore strongest where regulation, university hospitals and translational neuroscience intersect. Belgium does not yet present as a broad commercial psychedelic-care market; it presents as a compact, methodical, hospital-based research environment with one reimbursed esketamine route and a small but credible classic-psychedelic revival. # # # # # #

Over the next 12-24 months, the most plausible changes in Belgium are evidentiary rather than legislative. The visible psilocybin studies in Brussels and Ghent, alongside ketamine work in Leuven and Liege, are the likeliest sources of near-term change. If Belgian sites publish feasibility, safety or implementation data, Belgium's profile will rise mainly as an investigator-led hospital research node rather than as a first-mover access jurisdiction. # # # # # # #

Regulatory liberalisation looks unlikely over the same period. The official material reviewed shows a standard narcotics/psychotropics control model, continued FAMHP annex maintenance, and no obvious move towards general psilocybin or MDMA treatment pathways outside trials. The more realistic regulatory developments are incremental: additional trial approvals, controlled-substance handling refinements, and better-defined hospital practice around authorised esketamine and off-label ketamine. # # # #

Reimbursement is also unlikely to broaden quickly beyond current esketamine rules. Any future Belgian reimbursement for a classical psychedelic would still have to follow evidence generation, marketing authorisation or a special-access logic, and then a payer decision through RIZIV/INAMI. Belgium is likely to become more interesting scientifically before it becomes materially more permissive for patient access. # #