PAREA marks 3 years with policy wins, EU traction, and new research milestones

 

Dear First name / Readers,

 

Soon after the Czech President signed into law the bill enabling the medical use of psilocybin, Germany announced the approval of compassionate use of psilocybin for people living with treatment-resistant depression. Just days later, Norway became the first country to reimburse nationwide the off-label use of generic ketamine for treatment-resistant depression. Together, these steps illustrate the rapid momentum building across Europe in expanding access to innovative mental health treatments.

 

In this issue, you’ll also find an update on our recent engagement with the European Parliament: PAREA calls for stronger action on mental health innovation, urging MEPs to back a European mental health moonshot, a strategy, an innovation hub, and a care capacity initiative.

 

Looking ahead, we invite you to join us on 4 November in Brussels (and online) for our hybrid event on the future of mental health innovation. We’ll launch a new policy paper, spotlight regulatory sandboxes, and discuss how Europe can close the psychiatric innovation gap and responsibly integrate novel psychedelic therapies. Read more below and register here.

 

With best wishes,

Tadeusz Hawrot

 

PAREA NEWS

Join us on 4 November 2025 in Brussels (and online) for PAREA’s hybrid event on the future of mental health innovation. We’ll launch a new policy paper, spotlight regulatory sandboxes, and explore how Europe can close the psychiatric innovation gap and responsibly integrate novel psychedelic therapies. 

In early September, PAREA met with Members of the European Parliament to discuss files that will shape EU mental health policy in the years ahead. With the Parliament drafting a mental health report and planning a related public hearing, and with committees preparing priorities for the next EU R&I budget (€175 billion for 2028–2034), PAREA is calling for: a European mental health moonshot, an EU Mental Health Strategy, a European mental health innovation hub, and a European mental health care capacity initiative.

A new paper by the European Medicines Agency (EMA) and the broader European regulatory network has been published in ACS Pharmacology & Translational Science. Among the co-authors is PAREA’s Project Officer, Francisca Silva. The article builds on insights from the EMA’s 2024 Multi-Stakeholder Workshop on Psychedelics and the development of the psychedelics section in the revised EMA guideline for depression, which comes into force later this month.

PAREA contributed to the European Commission’s consultation on the EU4Health 2026 Work Programme, highlighting the need for a strategic, well-funded mental health agenda. We called for a European Mental Health Strategy, regulatory innovation, multidisciplinary training, and an EU-wide Innovation Hub. Addressing the burden–innovation gap, PAREA stresses mental health must be an EU priority.

In September, PAREA’s Tadeusz Hawrot attended a seminar on Ukraine’s National Drug Policy in Salzburg, which highlighted unprecedented steps towards enabling psychedelic research in the country. With Ukraine now joining the UN Commission on Narcotic Drugs and advancing the rescheduling bill for six psychedelics, momentum is growing for science-based drug policy and medical access to psychedelics for individuals with PTSD who do not respond to other treatments.

In July, PAREA took part in the 2025 Academy of Management (AOM) Annual Meeting in Copenhagen. Our Founder joined a panel titled “Expanding Horizons for Psychedelic-Assisted Therapy & Management Scholarship: European Perspectives,” discussing how institutional dynamics in Europe are shaping the future of psychedelic therapy. 
Learn more here.

PAREA’s Tadeusz Hawrot co-authored a new paper on Switzerland’s limited medical use programme for psychedelics, active since 2014. The study reviews its history, legal framework, patient outcomes, and comparisons with Canada and Australia. These insights offer timely lessons for countries like Germany and Czechia expanding access beyond clinical trials.

Komfolk podcast features PAREA’s Tadeusz Hawrot in a conversation on storytelling, stigma, and psychedelic therapy. The interview took place in Lviv, Ukraine, and it highlights the urgent need for new treatments and collaboration. The discussion underscores how effective communication can advance advocacy, policy, and care infrastructure for mental health.

In July, PAREA received a €50,000 grant from the Entheon Foundation to support its work advancing psychedelic mental health treatments in Europe. The unrestricted funding comes at a crucial time, as EU-level support for health NGOs faces increasing uncertainty. The grant will strengthen PAREA’s core efforts in EU advocacy, funding mobilisation, and capacity-building, helping embed psychedelic innovation into European health systems and policies, and expanding education for clinicians, patients, and national societies.

The Finnish Association for Psychedelic Studies (Psyty) and Irish Doctors for Psychedelic Assisted Therapy (IDPAT) have joined the PAREA Community Supporters network! 
Psyty is a volunteer-run, multidisciplinary association promoting scientific research and public education on psychedelics. 
A leading advocate for clinician and policymaker engagement in Ireland, IDPAT promotes access to psychedelic-assisted therapies and research. This autumn, we’ll join them at the IMBAS Psychedelic Research Conference in Dublin.

NEWS FROM OUR PARTNERS

THE LATEST FROM EUROPE 

Germany has become the first EU country to approve compassionate use of psilocybin therapy for people living with treatment-resistant depression. Approved by the Federal Institute for Drugs and Medical Devices, the therapy will be offered by two clinics under strict clinical supervision. This marks a significant shift toward broader access to psychedelic treatments in Europe. 

In August, Norway became the first European country to reimburse nation-wide off-label ketamine for people affected by treatment-resistant depression. The decision follows national clinical protocols and requires psychotherapy alongside treatment, offering a model for how countries can integrate medicines with psychedelic properties into structured, publicly reimbursed mental health care pathways.  

The Dutch Medicines Evaluation Board will host a Pipeline Meeting on 5 November 2025, focusing on psychedelic drug development. Companies can present their pipelines and discuss key regulatory challenges with Dutch medicines regulators (CBG MEB) and the Central Committee on Research Involving Human Subjects (CCMO). 

The EU is funding INTEGRATE, a €4.3M doctoral training network under Horizon Europe to advance psychedelic science. Sixteen PhD students will study mechanisms of action of psychedelics, clinical standards, as well as regulatory, ethical, and societal challenges. PAREA will be involved in the project as an associated partner, contributing to a work package identifying ethical, legal and societal challenges and opportunities for applying psychedelic therapy by hosting a PhD student for a secondment.

Mental health inequalities are widening across Europe, according to a new Eurofound report. Suicide has overtaken traffic accidents as the top cause of death among 15–29 year-olds, accounting for 18.9% of deaths in 2021. The report highlights deep inequalities, barriers to care, and urgent needs for prevention and quality support.

Upcoming Events of Interest

Psychedelic Therapy: From Evidence to Equity symposium, October 1, Lisbon

LAPsyCONF, October 8-10, Buenos Aires

Brain Innovation Days, October 15-16, Brussels

ALPS Conference, October 24-25, Geneva

IMBAS Conference, October 31-November 1, Dublin

NEXUS Meeting, November 12, Fitchburg, WI

5th Annual UW Madison Psychedelic Symposium, November 13-14, Madison, WI

HoloMind Psychedelic Therapy & Integration Conference, November 15-16, Warsaw

Psychedelic Lived Experiences Summit, November 21-23, online

PSYCH Symposium, December 4, London

 

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