Belgium

Last updated 18 August 2026

Psychedelic Therapy Legal Landscape

Esketamine (Spravato)

Reimbursed (hospital)

Reimbursed since June 2021 under INAMI/RIZIV Chapter IV: hospital-administered, per-patient prior authorization by the insurer’s advising physician, for moderate-to-severe depression after at least two failed antidepressants.

Ketamine Therapy

Hospital-only

Effectively no private clinic market — off-label IV ketamine exists inside hospital psychiatry under prescriber responsibility (typically resistant depression or acute severe suicidal distress).

Psilocybin

Trials only — two recruiting

Trial-only under the FAMHP annexes — but two hospital studies are recruiting: Ghent for treatment-resistant depression (NCT06378229) and CHU Brugmann, Brussels, for severe alcohol use disorder (NCT06160232).

MDMA

Trials only

No Belgian MDMA trial is recruiting and no compassionate-use programme is open.

Medical Cannabis

Cannabinoid medicines only

Sativex is the only marketed cannabis-based medicine since 2015 (MS spasticity; neurologist prescription, hospital pharmacy); raw cannabis and magistral preparations may not be dispensed. Recreational: illegal, with lowest prosecution priority for adult possession of up to 3 g / 1 plant (2005 directive) — de facto tolerance, no clubs.

Clinical Trials

Open route

18 studies tracked, 4 active — a hospital-led ecosystem: Brussels, Ghent, Leuven, Liège. Participation is free; screening is strict; never pay for “trial access”.

Frequently asked questions — Belgium

Is ketamine therapy legal in Belgium?
Hospital-only. Effectively no private clinic market — off-label IV ketamine exists inside hospital psychiatry under prescriber responsibility (typically resistant depression or acute severe suicidal distress).
Is psilocybin legal in Belgium?
Trials only — two recruiting. Trial-only under the FAMHP annexes — but two hospital studies are recruiting: Ghent for treatment-resistant depression (NCT06378229) and CHU Brugmann, Brussels, for severe alcohol use disorder (NCT06160232).
Is MDMA therapy legal in Belgium?
Trials only. No Belgian MDMA trial is recruiting and no compassionate-use programme is open.
Can I join a psychedelic clinical trial in Belgium?
18 studies tracked, 4 active — a hospital-led ecosystem: Brussels, Ghent, Leuven, Liège. Participation is free; screening is strict; never pay for "trial access".