Dear First name / Readers,

 

Mental health innovation in Europe is finally moving up the agenda, and PAREA has been at the centre of the conversation.

 

Together with Members of the European Parliament Action Group on Psychedelics in Healthcare, we have called on European Commission President Ursula von der Leyen to launch a European Mental Health Moonshot – a mission-driven initiative to make mental health a strategic pillar of Europe’s competitiveness, growth, and social policy. The call was covered by POLITICO, which highlighted our argument that mental health deserves the same policy priority as critical infrastructure such as energy, semiconductors, or AI.

 

In parallel, we released a new policy paper, From Lagging to Leading: A Policy Toolkit for Mental Health Innovation “Made in Europe.” It sets out practical proposals for how the EU can accelerate mental health innovation through a European mental health innovation hub, a coordinated care capacity initiative, and regulatory sandboxes to safely pilot psychedelics.

 

PAREA representatives also met with EU Research Commissioner Ekaterina Zaharieva to discuss the moonshot initiative, the need for EU-supported multinational clinical trials with psychedelics, and greater investment in mental health R&I.

 

In other developments, we are pleased to welcome the Women’s Brain Foundation as a new full member of PAREA, reinforcing our shared goal of ensuring that sex and gender differences are systematically addressed in mental health and brain research.

 

Finally, this issue also features an update on PsyPal – the first EU-funded clinical trial of psychedelic therapy – which is now recruiting participants in Copenhagen, Groningen, Lisbon, and Prague. The study explores psilocybin-assisted therapy for psychological distress in people with chronic and life-limiting conditions.

 

More details and study contacts below.

 

With best wishes,

Tadeusz Hawrot

 

PAREA NEWS

On November 4th in Brussels, PAREA launched its new policy paper, From Lagging to Leading: A Policy Toolkit for Mental Health Innovation “Made in Europe”. Psychedelic therapies as a test of Europe’s innovation capacity, calling on the European institutions to launch a European Mental Health Moonshot – a bold, mission-driven initiative to make mental health a driver of Europe’s competitiveness, innovation, and social agenda.

🎬 Watch the recording. 

Later in the week, we met with Commissioner Ekaterina Zaharieva, who leads the EU’s research and innovation portfolio, to present our recommendations and discuss how the Commission can advance evidence generation and innovation frameworks in this area, particularly through large-scale multinational trials. A note from the meeting can be found here, along with the slides presented by PAREA.

PAREA is pleased to welcome the Women’s Brain Foundation as a new full member. Their membership helps put greater focus on ensuring that sex and gender differences are systematically recognised and addressed across mental health and psychedelic research, policy, and clinical innovation in Europe.

This new initiative aims to strengthen Europe’s competitiveness in biotechnology - a field increasingly recognised as strategic for Europe’s economic sovereignty, innovation leadership, and resilience. The consultation invited stakeholders to identify barriers in the EU’s regulatory and investment environment and propose actions to unlock the next wave of biotech innovation.

On World Mental Health Day, PAREA called for mental health to be recognised as a defining pillar of Europe’s strategic priorities in the years ahead. We submitted feedback to the European Commission’s consultation on the EU’s next long-term budget, urging a strategic EU response: modernised regulation, real-world testing, and infrastructure for next-generation mental health treatments.

This year, PAREA celebrated World Mental Health Day in Buenos Aires at LaPsyConf 2025, an international conference reimagining the future of mental health, longevity, and well-being. Founder Tadeusz Hawrot opened the event with his keynote, “Global trends, European lessons: the case for psychedelic therapies in mental health,” offering a global perspective on how regulation, health data, and economics are shaping the next era of mental healthcare. Drawing on his experience with the WHO and the European Union, he helped frame the discussion for a Latin American audience exploring new approaches to mental healthcare.

On October 31 and November 1, PAREA participated in the IMBAS Psychedelic Research Conference at Trinity College Dublin, the second edition of Ireland's leading event on psychedelic science. Representing PAREA, Francisca Silva delivered a presentation offering a high-level overview of the European trajectory from development to delivery of psychedelic therapies in healthcare. The talk highlighted the importance of collaboration, communication, and multi-stakeholder engagement in shaping a responsible and effective ecosystem for novel mental health treatments.

WHO released a new guideline on balanced controlled-medicines policies. PAREA contributed expert input through the External Review Group, and a significant share of our recommendations made it into the final version. The group included major global health and drug-policy institutions. The guideline strengthens global standards for safe, accessible controlled-medicine use.

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Spain’s Council of Ministers has approved a Royal Decree regulating the medical use of standardised cannabis preparations. These formulations may be prescribed by specialists for patients with conditions such as chronic pain, multiple sclerosis–related spasticity, refractory epilepsy, and chemotherapy-induced nausea. Preparation and dispensing will take place only in hospital pharmacies under strict supervision by the Spanish Agency of Medicines and Medical Devices. 

Debate over how the EU should define “unmet medical need” is intensifying as institutions move closer to finalising the pharmaceutical reform package. At the European Health Forum Gastein, EMA’s Steffen Thirstrup suggested redefining “unmet medical need” as “unmet therapeutic need” to better reflect patient realities. PAREA welcomes this broader approach, emphasising in its Unmet Medical Needs policy paper that definitions must account for chronic, high-burden conditions such as mental health and substance use disorders, areas where treatment gaps remain vast despite enormous societal cost. 

Eurostat’s latest data show that 4.1 % of all deaths in the EU in 2022 were due to mental and behavioural disorders. Dementia is included, being the largest cause of deaths. The analysis also found that alcohol and drug-related disorders remain major contributors, while 2023 data show over 318 000 psychiatric care beds across the EU. The findings highlight both Europe’s ageing population and persistent mental-health system pressures.

The European Investment Bank and European Investment Fund have joined forces with major institutional investors to create a €5 billion Scaleup Europe Fund. The fund will support late-stage European tech and deeptech firms struggling to grow within EU capital markets. A private manager will oversee operations, with first investments expected in 2026. The initiative aims to close Europe’s chronic “scale-up gap.”

The latest Global Burden of Disease study shows a striking surge in mental health conditions worldwide: since 1990, anxiety disorders have increased by 63% and depression by 26%. These findings highlight mental health as one of the fastest-growing global health challenges. Yet, WHO data reveal that mental health still receives only around 2% of national health budgets. Without stronger investment and policy action, the treatment gap will continue to widen.

Upcoming Events of Interest

Psychedelic Lived Experiences Summit, November 21-23, online

Virtual Global Launch of the WHO Guidance on Policy & Strategic Actions to Protect & Promote Mental Health, November 25, online

PSYCH Symposium, December 4, London

Brain Awareness Week, March 16-22

EPA's 34th European Congress of Psychiatry, March 28-31, Prague

Interdisciplinary Conference on Psychedelic Research 2026, June 4-6, Haarlem

 

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