🔗 Past EU Insights

Dear First name / Readers,

 

This edition of our newsletter comes at a time of real momentum for mental health and psychedelic research across Europe. From regulatory progress in Ukraine to high-level policy advocacy within the EU, PAREA continues to help shape the conversations that matter.

 

In a breakthrough moment, the Ukrainian Ministry of Health has published draft proposals to enable national psychedelic research—an initiative to which PAREA has proudly contributed. This marks a bold and hopeful step for a country navigating the mental health consequences of war and trauma, and offers inspiration to the wider region on how evidence-based reform can take shape even under immense pressure.

 

Looking ahead, ensuring access to future psychedelic treatments will be a central challenge once they begin to receive regulatory approval. A new report on reimbursement pathways in Europe, to which PAREA contributed, lays out key policy, pricing, and infrastructure considerations that must be addressed now to avoid delays in patient access once these therapies reach the market.

 

We’re also proud to highlight a new review by PAREA’s Francisca Silva, published by the European Medicines Agency, examining the regulatory landscape for psychedelic trials in depression. This work offers valuable insight into how thoughtful trial design and early dialogue with regulators can pave the way for safe, effective, and responsible therapeutic innovation.

 

Finally, we continue to advocate for systemic change through our call for a dedicated Mental Health Mission and Innovation Hub in the EU’s next research programme (FP10).

 

It’s time mental health was treated not just as a health priority, but as a central pillar of European research and innovation policy.

 

 

PAREA NEWS

A new report, “Reimbursement Pathways for Psychedelic Therapies Across Europe”—funded by Norrsken Mind and co-authored by Martin Gisby and Floris Wolswijk—dives deep into one of the most pressing questions in psychedelic policy today: how do we ensure equitable, timely access to novel psychedelic treatments?

 

The report examines how European healthcare systems currently fund innovative mental health treatments and identifies key barriers—including stringent HTA evidence requirements, high upfront costs, and infrastructure limitations—that could slow the adoption of psychedelic therapies. In a detailed analysis, the report outlines actionable recommendations such as early payer engagement, innovative pricing models, and targeted cost-effectiveness analyses to overcome these obstacles.

 

PAREA collaborated in shaping the report. In the “Critical Observations from Collaborators” section, we share our reflections on what psychedelic and mental health advocacy can learn from earlier public health campaigns—particularly the HIV/AIDS treatment movement. Just as clinical advocacy played a key role in expanding access then, we believe that bringing together informed researchers, practitioners, and patient groups—as PAREA aims to do—can be a powerful force in accelerating access in the psychedelic field today.

 

You can read PAREA’s full contribution here and find the news release about the report here.

In a promising development on March 18, the Ukrainian Ministry of Health released two draft documents proposing legislative changes that would open the door to national scientific research on psychedelic therapies.

 

The documents, which will be open for public consultation for 30 days, comprise:

1. A proposal to reschedule substances such as psilocybin, psilocin (including containing mushrooms), LSD, DMT, 5-MeO-DMT, MDMA, and ibogaine, to allow their use in research. ;

2. A draft by-law outlining the regulatory framework for conducting research with scheduled substances.

 

While there is still a long road ahead, these proposals represent an important step forward for Ukraine in advancing access to psychedelic mental health treatments, in a country deeply affected by war and trauma.

 

PAREA has actively contributed to these efforts through the facilitation of meetings between the Ministry of Health and international experts, as well as through ongoing collaboration with the Ukrainian psychedelic community. We’d like to extend special recognition to the Ukrainian Psychedelic Research Association (UPRA) for their critical role and continued leadership in this work.

 

Read more about this breakthrough and PAREA’s engagement in a new guest post by our founder Tadeusz Hawrot for Drug Science: “Ukraine Opens the Door to Psychedelic Research: A First Legal Framework Emerges”.

We’re proud to announce that PAREA is an official partner of THE REAL Summit, a bold, global initiative redefining how mental health is valued in the world of investment and innovation.

 

Following a sold-out debut in 2024 at Deutsche Bank HQ in New York and THE REAL Mental Health Day in Davos during the 2025 World Economic Forum, the movement now heads to London—bringing together family offices, philanthropists, policymakers, and industry leaders to mobilise capital and collaboration. The goal? To channel $10 billion into mental health by 2030.

 

As part of this growing ecosystem, PAREA will continue to advocate for neuroscience, psychiatric innovation, and equitable access to brain health solutions—ensuring they are seen not just as medical imperatives, but as social and economic priorities.

PAREA has issued a news release calling for the next EU research and innovation framework programme (FP10) to include a dedicated Mission for Mental Health and a Mental Health Innovation Hub. A mission-driven approach would ensure long-term funding and coordination for mental health research, while the hub would create a central structure to translate scientific advancements into real-world solutions. Given the scale of the mental health crisis in Europe, these measures are essential to prioritising research and fostering innovation in this critical area.

 

More broadly, discussions on FP10’s structure and budget are gaining momentum. The Warsaw Declaration, signed by EU research ministers, calls for FP10 to remain a standalone programme with a strengthened budget. The declaration also urges the Commission to preserve the independence and expand the roles of the European Research Council (ERC) and the European Innovation Council (EIC)—both of which play key roles in supporting frontier research and breakthrough innovation. Ensuring adequate investment in FP10 will be essential to tackling major societal challenges, including mental health.

The European Medicines Agency (EMA) has published a paper titled “A review of psychedelics trials completed in depression, informed by European regulatory perspectives”. Authored by PAREA’s Project Officer Francisca Silva during her time at EMA, the paper is now available in Neuroscience Applied.

 

The review analyses completed clinical trials involving psilocybin, LSD, DMT, and ayahuasca for depression, highlighting key regulatory considerations such as trial design, blinding, support frameworks, and safety assessments. It also reflects on how these studies align with updated EMA guidance on developing treatments for depression.

 

The paper underscores that while challenges remain, many can be addressed through thoughtful study design and early regulatory engagement—signalling growing support for the evidence-based development of psychedelic therapies in Europe.

In a powerful Personal View “Drug development in psychiatry: 50 years of failure and how to resuscitate it” published in The Lancet Psychiatry, PAREA Chair Prof. David Nutt critically examines why drug development in psychiatry has stagnated over the past 50 years—despite vast advances in neuroscience and a growing global burden of mental illness. Unlike fields such as oncology or cardiology, psychiatric medicine still relies on drug classes discovered by chance in the 1950s, with few genuinely novel treatments emerging since.

 

Prof. Nutt outlines a series of interlinked barriers—from flawed preclinical models and regulatory hurdles to underinvestment, stigma, and a lack of financial incentives for innovation. Importantly, he also proposes concrete solutions: embracing real-world evidence, reforming approval pathways, extending data exclusivity for novel psychiatric drugs, and reviving shelved compounds with potential through public–private collaboration.

 

This call to action aligns closely with PAREA’s position paper on unmet medical needs which highlights the urgent need for innovation, investment, and smarter policy to address the treatment gap in mental and neurological disorders. 

In late February, PAREA had the honor of participating in the second edition of the Psychedelics as Medicine conference in Reykjavík, Iceland, where our Founder and Executive Director took part in the panel "Laws, Liberties & Psychedelics – The Future of Policy & Reform", contributing to a powerful dialogue on the evolving landscape of psychedelic policy.

 

Organised by the Eden Foundation—a non-profit supporting researchers and medical professionals in psychedelic science—the conference brought together a strong lineup of thought leaders and researchers, alongside a brilliant range of community-building activities that encouraged connection with one another and with the Icelandic landscape.

 

Running alongside the conference was Nordic Day—a gathering of psychedelic associations from across the region—which culminated in the signing of the Nordic Psychedelic Initiative. This agreement represents a shared commitment to responsible policy, grounded in scientific evidence, cultural wisdom, and core values of sustainability, equity, and well-being.

 

PAREA is proud to stand alongside our Nordic peers in championing thoughtful, collaborative progress in this important field.

PAREA supports the EU4Health Civil Society Alliance (CSA) in raising concerns over two critical developments impacting civil society organisations (CSOs) in the EU health space.

 

Firstly, PAREA was a co-signatory of the Alliance’s Joint Statement responding to new restrictions, introduced under EU LIFE grants, on CSOs’ ability to engage in policy and advocacy, that could set an alarming precedent across sectors. Limiting public funding for advocacy work threatens the democratic role of civil society in representing citizens, contributing expertise, and ensuring inclusive policy processes.

 

Secondly, there remains a concerning lack of information on the 2025 EU4Health work programme and operating grants. Three months into the year, no timeline has been provided for their release or retroactive implementation, creating significant uncertainty for CSOs. Continued delays risk undermining the work of health CSOs by shortening implementation periods and limiting impact. These and broader concerns over reduced health spending within EU budgets were further echoed by multiple stakeholders during an event organised by the EU4Health CSA at the European Parliament on March 26, hosted by MEPs Tilly Metz (Greens), Stine Bosse (Renew), Vytenis Andriukaitis (S&D) and András Tivadar Kulja (EPP).

 

PAREA stands with its fellow CSOs in calling on the European Commission to uphold civic space and secure a sustainable, supportive funding environment for meaningful civil society engagement in EU policymaking.

As of our Board Meeting in February, we are delighted to have Emma Christersson as the new PAREA Board Vice-Chair. As Co-Managing Director of Norrsken Mind, Emma brings a wealth of experience from the psychedelic research and nonprofit sector. Her leadership and commitment to bridging science, clinical research, and policy to improve mental health care will be invaluable in advancing our collective mission. 

 

We are also pleased to welcome MAPS Italia as a new Community Supporter! Founded in 2024, MAPS Italia is dedicated to fostering informed dialogue on psychedelic therapies through research, education, and advocacy. Their work includes building a collaborative network, supporting Italy-specific research, and promoting public and professional awareness around the therapeutic potential of psychedelics.

 

THE LATEST FROM EUROPE

The public portal of the Clinical Trials Information System (CTIS) now includes an interactive clinical trial map. Designed to improve access to information, the tool allows patients and healthcare professionals to easily identify ongoing clinical trials in their region and by medical condition.

 

The map is built on real-time data from CTIS and supports features such as lay-language search, autocorrect suggestions, and direct access to investigator contact details for trial participation enquiries. The initial version is available in English, with additional EU languages planned in future updates.

 

While authorisation and oversight of clinical trials remains under the responsibility of Member States, the CTIS platform is maintained by the European Medicines Agency (EMA) and forms part of the implementation of the Clinical Trials Regulation and the Accelerating Clinical Trials in the EU (ACT EU) workplan for 2025–2026.

 

March 25 marked the launch of new WHO guidance aiming to strengthen mental health policies globally. The updated framework offers practical strategies to help countries reform their mental health policies and systems in order to address critical gaps in mental health services.

 

It emphasises key aspects, such as the need for holistic, person-centred care, addressing social determinants of mental health, integrating prevention and population-wide promotion of mental health, alignment with international human rights standards and meaningful participation of people with lived experience in shaping policy and services. The guidance identifies five urgent policy priorities: leadership and governance, service organisation, workforce development, person-centred interventions, and addressing structural determinants of mental health.

The European Health Data Space (EHDS) regulation has officially been published in the Official Journal of the European Union, setting the stage for its phased implementation. The regulation aims to create a unified framework for the secure exchange and use of health data across Europe, improving patient care and enabling better research and innovation in health.

 

The rollout will happen in stages. From March 2029, patient summaries, e-prescriptions, and other priority data will be available for exchange across EU countries. At the same time, rules governing the secondary use of health data—allowing researchers and policymakers to access anonymised data—will take effect for most categories. By 2031, additional types of health data, such as medical imaging and laboratory results, will also be included.

 

The European Commission has a tight timeline ahead, with over 20 implementing acts to be delivered in the next four years to guide member states in establishing governance structures and technical specifications. While some countries have already started preparations, concerns remain about whether all EU nations will be ready on time. Experts are urging member states to act now to ensure a smooth implementation.

 

For a deeper analysis of what this means for health innovation, including implications for psychedelic research, a detailed breakdown is available for Pro subscribers.

The European Commission has proposed new legislation aimed at improving access to essential medicines, including those that are often unavailable in multiple EU countries. Importantly, the Critical Medicines Act  introduces joint procurement mechanisms for medicines that are currently inaccessible in at least three member states due to market limitations.

 

This approach is designed to enhance the availability of critical treatments by allowing EU countries to pool their purchasing power, making it easier to secure important medicines. While initially focused on rare-disease drugs and novel antimicrobials, the new framework could apply more broadly to innovative medicines that struggle to reach all EU markets.

 

Health Commissioner Olivér Várhelyi emphasized that the new rules would allow the EU to respond faster to market disruptions, ensuring patients have access to essential treatments. The pharmaceutical industry, historically has been resistant to joint procurement, has become more open to this model for drugs treating smaller patient populations.

 

The proposal could significantly impact access to mental health treatments, as many innovative psychiatric and neurological therapies face availability gaps across Europe.

Read more from EURACTIVE: EXCLUSIVE: The Critical Medicines Act that aims to bring control of pharma back to Europe

A new study published in The Lancet Global Health highlights a sharp rise in the demand for palliative care, with nearly 74 million people in need in 2021—a 74% increase since 1990. While population growth accounted for about half of this rise, the remainder was driven by an increase in serious health conditions requiring palliative care, including cancer, cardiovascular diseases, dementia, and HIV/AIDS.

 

The study reveals significant disparities between regions. Low- and middle-income countries (LMICs) bear the greatest burden, accounting for 80% of global palliative care needs, with an 83% increase over the past three decades. In contrast, high-income countries saw a 46% rise.

 

The researchers call for urgent action to expand palliative care access globally and emphasize the need for improved prevention and treatment strategies to reduce suffering. Addressing this growing demand will require integrating palliative care into health systems worldwide. Psychedelic research is increasingly exploring the role of psychedelic  therapies in palliative care, and the EU-funded PsyPal project is investigating how these treatments could improve end-of-life care.

 

🔗 Read the full study in The Lancet Global Health

 

RESEARCH ANNOUNCEMENT

A new research study, in collaboration between Imperial College London, the University of Exeter, and the University of California San Francisco, is exploring the therapeutic potential of psychedelics across transdiagnostic dimensions of mental health. Specifically, the study will examine how different psychosocial aspects of psychedelic use in ceremonial (group) settings may contribute to well-being.

 

Participants will be asked to complete a series of short online surveys, composed of standardised questionnaires that align with the retreats’ preparation and integration phases, at the following three time points:

If you are interested in participating or would like to learn more, please follow this link or contact Siân Lavis at sml211@exeter.ac.uk.

 

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