This video takes you inside the event through interviews with key participants, who discuss the opportunities and challenges of bringing psychedelic treatments to patients across Europe. It also highlights recent developments in several countries, showcasing the diverse regulatory pathways, research initiatives, and advocacy efforts that are shaping the future of psychedelic medicine.
At present, with the exception of ketamine and EMA-approved esketamine, access to psychedelic-assisted therapies in Europe is largely limited to clinical trials. Early access (also known as compassionate use or expanded access) offers an alternative pathway for patients with serious conditions who are unable to participate in clinical trials but may still benefit from promising investigational treatments. As the documentary shows, several European countries are now developing different regulatory models to make such access possible.
At the European level, compassionate use is enabled under Article 83 of Regulation (EC) No 726/2004, which allows Member States to establish early access programmes for promising investigational medicines outside clinical trials. However, the implementation of these programmes remains the responsibility of individual countries, resulting in very different access pathways across Europe.
Germany is developing one of the first pathways for compassionate access to psychedelic-assisted therapies within the European Union. Under the existing EU compassionate use framework, treatment outside clinical trials is possible in exceptional cases, although access currently remains limited to a small number of authorised institutions. The German model demonstrates how existing European legislation can be used to provide patients with early access to promising treatments before full regulatory approval.
Switzerland, although not a member of the European Union, has operated one of the world’s longest-running limited medical use programmes for psychedelic-assisted therapy. For more than twelve years, authorised psychiatrists have been able to obtain case-by-case exemptions from the Federal Office of Public Health to treat patients with substances such as LSD and psilocybin. The Swiss experience offers valuable real-world evidence on how carefully regulated psychedelic treatments can be integrated into clinical practice while broader regulatory reforms continue to develop.
The Czech Republic has become one of the first European countries to establish a legal pathway for psilocybin-assisted therapy. Since January 2026, specially trained psychiatrists have been allowed to administer psilocybin in authorised healthcare settings under strict medical supervision. Rather than a compassionate access programme, the reform creates a regulated framework for medical access to psilocybin-assisted treatment.
Norway has become the first country to introduce nationwide public reimbursement for intravenous ketamine treatment for treatment-resistant depression. Since 2025, eligible patients have been able to access ketamine therapy through the public healthcare system, making Norway a global leader in equitable access to this evidence-based treatment.
Beyond comparing access pathways in Germany and Switzerland, the video offers a comprehensive overview of the rapidly evolving European psychedelic landscape. It introduces the European Forum of National Psychedelic Societies and explores how patients can currently access psychedelic treatments across Europe. Viewers will hear from experts working to expand compassionate access in Belgium and Spain, overcome the legacy of criminalisation in Poland, strengthen psychedelic research in Greece and develop new access pathways in Austria, and expand ketamine-assisted therapy in Estonia. The video also highlights the urgent need for psychedelic treatments for people affected by war and trauma in Ukraine and concludes with a discussion of advocacy efforts at the European Union level, demonstrating how collaboration across countries is shaping the future of psychedelic medicine in Europe.
As momentum grows across Europe, collaboration between science, healthcare, policymakers, patients and civil society will be essential to ensure that innovative treatments become accessible, equitable and grounded in the best available evidence. The Psychedelic Access and Research European Alliance (PAREA) was created to foster exactly this collaboration, bringing together stakeholders from across Europe to accelerate the development of safe, evidence-based pathways to psychedelic-assisted therapies.
Interviews: Péter Sárosi and István Gábor Takács
Video: István Gábor Takács
