🔗 Past EU Insights

 

Dear First name / Readers,

 

The past few weeks mark continued progress across both EU and international policy spaces, with several important developments ahead: our upcoming EU Health Policy Platform webinar on the PsyPal project (13 April), focused on psychological distress in palliative care, and our European Parliament event on Ukraine (6 May), addressing research, access, and war-related mental health needs.

 

At the global level, PAREA participated in the UN Commission on Narcotic Drugs meeting in Vienna, where discussions increasingly point toward the need for a more enabling framework for scientific research. Building on this, we are working with partners and supportive member states to help advance international policy change, including exploring a potential UN resolution on the importance of research on controlled substances, including psychedelics.

 

At the same time, we are reflecting on where the field is heading. In a new article, I outline a shift from a focus on “psychedelics” toward experiential mental health treatments, emphasising the role of context, meaning, and therapeutic support in care, and pointing to a broader evolution in how mental health care is understood and delivered.

 

Tadeusz Hawrot

 

PAREA NEWS

Join an upcoming webinar on the PsyPal project, which is investigating psychedelic therapy to address psychological distress needs in palliative care, including in neurological conditions. We are co-organising this online session with the European Commission’s EU Health Policy Platform on 13 April 2026 from 14:00 to 15:30 CEST. People living with progressive, life-limiting conditions often face severe psychological and existential distress, yet many health systems lack effective ways to address these needs. This webinar will explore palliative care gaps, emerging scientific evidence, ethical considerations in trials, and the regulatory landscape for psychedelic therapies in Europe.

Join us on 6 May, 14:30 to 16:30, at the European Parliament and online for a policy discussion on psychedelic therapies and war-related mental health needs in Ukraine. Co-organised by PAREA, UPRA and hosted by MEP Vytenis Andriukaitis, the event will explore MDMA-assisted therapy for PTSD, recent policy developments, and pathways from research to care. Speakers include Director of the State Expert Center of the Ministry of Health of Ukraine Edem Adamanov, Chair of the Committee on Public Health, Medical Care and Health Insurance at the Verkhovna Rada of Ukraine Mykhailo Radutskyi, Past President of the European Psychiatric Association Prof. Geert Dom, and Prof. Eric Vermetten.

PAREA Founder Tadeusz Hawrot will speak on Friday, April 10 at the SPACE symposium “Psychedelics in the Clinic: From Science to Experience” in Porto. His talk will focus on PAREA’s shift toward the experiential dimension of psychedelic treatments and what this means for policy and care. SPACE, a Portuguese scientific association founded in 2021, has been a PAREA Community Supporter since the early days and works to advance research and knowledge on the therapeutic use of psychedelics.

PAREA Founder Tadeusz Hawrot shares a new reflection on how the field is evolving and how this is shaping PAREA’s direction. He outlines a shift from a focus on psychedelics toward experiential treatments, where meaning, context, and therapeutic support are central to care. The rationale is corroborated by evidence linking adverse childhood experiences to treatment-resistant depression, reinforcing the need for trauma-informed approaches. It raises key questions about agency, delivery, and how mental health systems can move beyond purely pharmacological models.

PAREA participated in the 34th European Psychiatric Association Congress in Prague, focused on improving mental health care. At our stand, we engaged clinicians on the role of psychedelic therapies and represented the EU-funded PsyPal project on psilocybin therapy in palliative care, alongside PAREA Chair Professor David Nutt. We are grateful to our Member, the EPA, for the opportunity to participate in this meaningful exchange.

From 9 to 13 March, PAREA participated in the 69th session of the UN Commission on Narcotic Drugs in Vienna, where global stakeholders convened to discuss drug policy. Founder Tadeusz Hawrot joined the MAPS delegation and engaged with policymakers on research and access to controlled substances. Discussions also explored potential UN support for expanding research, including psychedelics. Side events highlighted European developments, including Ukraine’s reform efforts and new Czech legislation on medical psilocybin access.

On March 6, PAREA Project Officer Francisca Silva contributed to a hybrid event in Chieti, Italy, organised by the Luca Coscioni Association together with partner universities, titled Psychedelics: scientific research, clinical reality, therapeutic uses and regulatory implications. The discussion addressed psychedelic research and therapeutic potential, as well as access to psychedelic therapies and emerging regulatory frameworks, featuring Italian and international experts and bringing together academic and policy perspectives on these treatments.

On March 20, the Public Health Centre of Ukraine and UPRA, in partnership with PAREA, hosted a webinar on legal and regulatory frameworks for psychedelic therapies in Europe. The discussion focused on how to enable research and clinical use within existing legal boundaries. Experts João Taborda da Gama, Marion Haberkamp, and Pavel Pachta shared insights on European regulatory pathways, international conventions, and the evolving policy landscape. The session included live Ukrainian interpretation and a Q & A discussion.

We are expanding the PAREA Community Supporters network with two new organisations contributing distinct perspectives to the field.

Hystelica, founded in 2022 by Dr Grace Blest Hopley, focuses on advancing psychedelic science for women. Its work spans research, advocacy, and education, with a clear emphasis on integrating female biology into psychedelic medicine. Through collaborations with academic institutions, Hystelica supports studies on how psychedelic substances interact with women’s health, helping address long-standing gaps in research.

 

The Barcelona Computational Foundation (BCOM) joins with a strong focus on interdisciplinary science. BCOM is a nonprofit research foundation working at the intersection of neuroscience, philosophy, physics, and artificial intelligence. Its research advances areas such as computational neuropsychiatry and neurosynthetic AI, with the goal of better understanding cognition, mental health, and how computational approaches can support healthier biological, hybrid, and synthetic systems and societies.

NEWS FROM OUR PARTNERS

On March 30, PsyPal published a new guidance paper on the standardisation and implementation of psychedelic therapies across Europe. The paper, co-authored by PAREA’s Tadeusz Hawrot and Francisca Silva, maps the current landscape and provides practical steps for researchers, clinicians, regulators, and policymakers to build and sustain multi-stakeholder coalitions.

On February 13, 2026, Spain’s Parliament hosted its first conference on psychedelic-assisted psychotherapies. Organized by the Inawe Foundation and the Spanish Society of Psychedelic Medicine, both PAREA Community Supporters, the event examined evidence, regulatory pathways, regulation, and emerging clinical models. Clinicians, researchers, and policymakers discussed responsible regulation, patient safety, and the role these therapies could play within Spain’s public health system, marking a significant institutional step in Spain’s evolving mental health policy debate.

This newly published analytical paper, co-authored by the Ukrainian Psychedelic Research Association, presents a conceptual framework for standardising psychedelic-assisted therapy (PAT) in Ukraine as a professional field within mental health care. The key focus of the work is on describing professional roles (clinical, educational, research, and support) and the system of competencies required to perform functional duties within these roles.

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On 24 February, the European Parliament’s Committee on Public Health held a public hearing on brain health and neurological diseases. Featuring contributions from our Members the European Brain Council (EBC) and the European Federation of Neurological Associations (EFNA), the discussion focused on strengthening prevention, improving early diagnosis, and accelerating research and innovation to address the growing burden of neurological diseases across Europe.

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THE LATEST FROM EUROPE 

Bretisilocin has entered the EMA’s PRIME scheme for major depressive disorder, marking a key step for psychedelic therapies in Europe. PRIME supports medicines addressing unmet needs through early regulatory engagement and potential accelerated review. Psychiatry has had limited presence in the program, making this inclusion notable. The compound, now owned by AbbVie, is in Phase 2 trials. While not approved, this signals growing regulatory openness and could shape Europe’s role in the development and regulation of psychedelic treatments.

On February 17, Compass Pathways released topline data from its second Phase 3 trial, COMP006, in treatment resistant depression. In 581 participants, two 25 mg doses showed a -3.8 point MADRS difference versus 1 mg at Week 6, with 39 percent achieving a ≥25 percent reduction.Safety findings were consistent with prior trials. Compass plans to complete its NDA filing with the FDA in Q4 2026.

The EU’s upcoming Biotech Act is currently under development, aiming to strengthen Europe’s position as a global hub for biotechnology, clinical research, and health innovation. The initiative focuses on improving the clinical trials environment, accelerating development timelines, and introducing new tools—such as regulatory sandboxes—to better support emerging and complex therapies. PAREA is actively engaging in this process and is preparing targeted amendments to ensure that mental health is adequately reflected as a strategic priority. While the Act signals a strong political commitment to competitiveness and innovation, key questions remain around whether it will go far enough in addressing structural barriers—especially for complex and emerging treatment approaches.

 

We have prepared a detailed analysis for Pro subscribers, outlining what the Biotech Act means in practice, where gaps remain, and how it could shape the future of mental health innovation in Europe.

The European Commission has released the Horizon Europe 2026–2027 Work Programme, allocating €14 billion to research and innovation. Within Cluster 1: Health, upcoming calls focus on prevention, mental health, non-communicable diseases, and strengthening health systems. The programme supports development of new technologies, improved care delivery, and more equitable and sustainable public health systems. These opportunities are relevant for stakeholders advancing drug-related research, health innovation, and system-level responses across Europe.

Upcoming Events of Interest 

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