Psilocybin for depression in Belgium: compassionate use plan unveiled

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By Spliff NewsroomPublished 2 November 2026 at 16:38·3 min read

Belgium has announced a compassionate use programme for psilocybin in treatment-resistant depression, led by psychiatrist Daniel Souery, pending regulatory approval. The plan follows Germany's lead, while a Swedish trial reports remission in 53% of participants six weeks after one dose.

The Belgian plan was reported by Dolce Vita Magazine. It covers psilocybin, under the code PEX010, for patients whose depression has not responded to other treatments. Psychiatrist Daniel Souery would lead it.

Belgium waits for regulatory approval

The programme still needs a green light from the AFMPS, the Belgian federal medicines agency, and from an ethics committee. That approval is not yet confirmed. The framework rests on article 106 of a 2006 royal decree, according to the same report.

Souery already uses esketamine with his patients. He considers true psychedelics more powerful and longer lasting, the magazine reports.

Germany, Czechia and Italy move too

Germany approved a comparable programme in July 2025, with the same PEX010 supplied to sites in Mannheim and Berlin. The Czech Republic has allowed psilocybin treatment for severe depression since 1 January 2026.

Italy has had a legal basis for compassionate use since September 2017, through a ministerial decree. Yet no patient is registered for psilocybin under it, and the reason is unclear.

• Italy’s AIFA has authorised a first clinical trial in Chieti.
• It involves 68 patients with treatment-resistant depression.
• In February 2026, a 63-year-old woman became the first Italian patient to receive psilocybin.

Italian doctors also ran at least 60 trials with psychedelic substances between 1927 and 1966, per the same source.

Swedish trial reports fast remission

A randomised, double-blind trial by the Karolinska Institutet tested a single 25 mg dose of psilocybin. As Ganjapreneur summarises it, symptoms eased within 48 hours. The study enrolled 35 adults aged 20 to 65 with moderate to severe depression.

Six weeks later, 53% of the psilocybin group were in remission, against 6% on placebo. Researcher Hampus Yngwe said the substance could offer a rapid, clinically meaningful improvement and serve as an alternative when quick symptom relief matters.

Limits of the Swedish findings

Participants could often tell whether they had received psilocybin or placebo because of distinctive side effects. That weakens the blinding. One year on, the two groups showed no statistical difference.

Ce que ça change pour toi

For now, these developments concern medical settings, not shops. A Belgian programme would be supervised by doctors, and it has not started. It could, however, signal a wider European debate on how psychedelic-based treatments are evaluated.

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What happens next

The Belgian programme must wait for the AFMPS and ethics committee. The Chieti trial in Italy is expected to continue and produce results.