🔗 Past EU Insights

Dear First name / Readers,

 

So much has been happening across the field lately - it feels like the pace keeps picking up. In this edition, we reflect on a rich array of developments over the past couple of months for PAREA and our partners, from the release of our 2024 Impact Report to our involvement in an educational course on MDMA-assisted therapy for PTSD for Ukrainian mental health professionals in Lviv, as well as preparations for the European Academy of Neurology Congress in Helsinki.

 

You’ll also find updates on Portugal’s new clinical guidelines for psychedelics, a major EU funding opportunity under Horizon Europe 2025, and one of the strongest economic arguments yet for investing in mental health.

 

Thanks, as always, for reading and for being part of this growing community. We hope this issue gives you a helpful sense of where things are heading - and how we're continuing to push for thoughtful, well-supported change across Europe

 

With best wishes,

 

PAREA NEWS

We’re proud to share our 2024 Impact Report, capturing a landmark year for psychedelic science and for PAREA’s growing role in shaping the field in Europe!

 

In 2024, we contributed to major milestones, including the launch of the EU-funded PsyPal trial, the EMA’s first Multi-Stakeholder Workshop on Psychedelics, and our invitation to join the WHO external review group on controlled medicines policy.

 

We also became a legally registered nonprofit, expanded our Board, led high-level EU policy engagement, and coordinated efforts like the MEP Action Group, EU elections campaign, and mental health pledges.

 

Through events, podcasts, media, and community initiatives, we continued to foster dialogue across science, policy, and patient advocacy - particularly through partnerships supporting mental health in Ukraine.

 

Explore the highlights on our website or read the full report here.

PAREA will be present at this year’s European Academy of Neurology (EAN) Congress, taking place 21–24 June in Helsinki, Finland!

 

You’ll find us in the Neurohood—a dedicated space for innovation and exchange—where we’ll host a staffed booth to engage with the neurology community and share our work at the intersection of brain health and psychedelic science.

 

We’ll also host a session at the Scientific Theatre where we’ll speak about PsyPal, the EU-funded project investigating the use of psilocybin-assisted therapy to address existential distress in patients with amyotrophic lateral sclerosis (ALS), multiple sclerosis, atypical Parkinson’s disease, and chronic obstructive pulmonary disease (COPD).

 

We look forward to meeting researchers, clinicians, and fellow advocates and sparking new ideas, conversations, and collaborations! You can register to attend the EAN Congress here.

From April 28 to May 4, a landmark educational event on psychedelic therapy took place in Lviv, Ukraine, organised by the Multidisciplinary Association for Psychedelic Studies (MAPS) in partnership with the Ukrainian Psychedelic Research Association (UPRA). PAREA Founder & Executive Tadeusz Hawrot joined as an invited observer.

 

Part of MAPS’ International Therapist Education (ITE) Program, the event brought together 55 Ukrainian mental health professionals for a weeklong immersive training on the fundamentals of psychedelic-assisted therapy, with a focus on MDMA-assisted therapy for PTSD. It covered key areas such as building therapeutic alliance, conducting preparation and integration sessions, and working with complex challenges including transference, suicidal ideation, and deep trauma.

 

The training was led by experienced MAPS educators and supported by Ukrainian teaching assistants, themselves alumni of earlier ITE cohorts. Live interpretation was provided throughout the event, and all core materials were translated into Ukrainian.

 

Against the backdrop of ongoing conflict, the initiative represents a significant step in expanding clinical capacity in regions experiencing widespread trauma. 

Notably, this also occurred as the Ukrainian Ministry of Health considers the rescheduling and regulation of clinical research with psychedelic substances — a historic shift in policy that could pave the way for Ukraine to emerge as a regional leader in innovative trauma care.

On May 12, PAREA attended the official launch of Portugal’s Multidisciplinary Recommendations on the Clinical Use of Psychedelic Substances—an initiative led by the Champalimaud Foundation, with support from leading national professional societies.

 

The launch event in Lisbon brought together a remarkable coalition of stakeholders, including Presidents of the

These recommendations are a milestone—not only for Portugal, but as an example of how cross-disciplinary collaboration can shape the future of psychedelic care. As highlighted in a recent BrainFutures white paper, the successful integration of psychedelic therapies into real-world health systems will depend greatly on the readiness of healthcare professionals and their confidence in delivering these treatments.

 

As PAREA continues to support dialogue across medical, research, and civil society actors, we recognise the value of lived experience and traditional knowledge alongside emerging clinical models. It is through shared standards, respectful collaboration, and care-centred practice that these therapies can meaningfully serve those who need them.

For now, the recommendations are available only in Portuguese, with an English version forthcoming as part of a scientific publication.

In April, PAREA Project Officer Francisca Silva took part in Breaking Convention - one of Europe’s largest and most diverse conferences on psychedelic research.

 

Held in Exeter, the gathering brought together a broad range of voices, from scientific researchers and practitioners to artists and cultural thinkers, reflecting the richness and interdisciplinarity of the psychedelic field.

 

In her presentation, Francisca explored recent regulatory and research developments shaping the future of psychedelic therapies in Europe. She spotlighted key updates from the European Medicines Agency (EMA) - including the newly published review of depression trials and considerations for the clinical investigation of psychedelics for depression, as outlined in the revised EMA depression guideline - and introduced the EU-funded PsyPal trial.

 

We’d like to express our gratitude to everyone involved in Breaking Convention for creating a meaningful space for cross-disciplinary dialogue and reconnection with the wider psychedelic community.

As part of the EU-funded PsyPal project, PAREA Founder and Executive Director, Tadeusz Hawrot, participated in a two-day Design Thinking Workshop hosted by IESE Business School in Barcelona. 

 

The workshop brought together cross-sector stakeholders to explore how psychedelic therapies could be responsibly integrated into palliative care in Europe.

 

Conversations were dynamic and forward-looking, covering a range of critical topics, including engagement with regulators and policymakers, involvement of patients and families, optimising care delivery, improving clinical trials, and aligning innovation with real-world needs. Tadeusz led the Policy discussion table, where participants tackled regulatory, access, and governance questions, working toward actionable solutions to accelerate safe, ethical, and patient-centred innovation. 

 

Key ideas and initiatives are now set to be further developed within the PsyPal project and beyond.

 

PAREA submitted feedback to the European Commission’s upcoming multidisciplinary life sciences strategy, calling for mental health innovation to be recognised as a strategic priority.

 

The Commission’s consultation highlights persistent barriers to innovation across Europe—including weak research translation, insufficient incentives, and limited funding. These are particularly acute in mental health, where progress has stalled: just five psychiatric treatments have been approved in the EU over the past five years, compared to over 120 in oncology.

PAREA’s response outlines four key recommendations:

 

With targeted action towards mental health innovation, the EU can turn the tide—strengthening its life sciences sector while advancing care for millions.

PAREA joined 35 organisations in signing a joint open letter from the EU4Health Civil Society Alliance to Commission President Ursula von der Leyen, urging the European Commission to ensure stable and timely funding for health civil society organisations.

 

With no 2025 Work Plan announced and delays mounting, there is growing concern that key EU health priorities will be disrupted and that essential public health organisations may face operational uncertainty.

 

PAREA stands with its fellow signatories in calling for the immediate adoption of the 2025 EU4Health Work Plan and the approval of full-year operational funding for CSOs with existing partnership agreements.

 

We’d like to extend a warm welcome to Reconnect Foundation, our newest Community Supporter!

 

Based in Switzerland, Reconnect Foundation is a non-profit organisation dedicated to deepening humanity’s relationship with nature through consciousness research, equitable mental health access, and support for Indigenous-led ecological stewardship.

Through its affiliation with the University of Zurich’s Center of Excellence for Transformative Therapies, Reconnect Foundation helps bridge science, tradition, and sustainable healing.

 

NEWS FROM OUR PARTNERS

PAREA is proud to support the Global Psychedelic Survey 2025 (GPS 2025)—the world’s largest study on real-world psychedelic use, led by the University of Michigan and over 20 partner organisations.

 

The survey, available in 18 languages, closes tomorrow, May 16. This is your final chance to contribute to a groundbreaking effort to reduce stigma, inform evidence-based policy, and elevate the voices of those with lived experience.

 

Open to adults aged 21+, it takes just 20–30 minutes to complete and is entirely anonymous. Take the survey here.

 

THE LATEST FROM EUROPE

 

The newly released Horizon Europe 2025 Work Programme brings encouraging news for the psychedelic science field, with fresh funding opportunities that could pave the way for a second EU-funded psychedelic research project. Notably, the call “Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders” includes a €6–8 million budget to support clinical studies focused on evaluating safety, efficacy, and mechanisms of action for innovative treatments—explicitly welcoming approaches that integrate psychotherapy.

 

This builds on momentum from the PsyPal project, the EU’s first psychedelic research initiative in palliative care, and marks a chance to further establish psychedelics within EU-funded health research. Additionally, the new European Partnership for Brain Health—co-funded by the Commission and Member States with a combined budget approaching €650 million—aims to improve diagnosis and treatment of brain conditions, while supporting networking and training across disciplines.

 

Together, these developments open up significant opportunities to advance psychedelic research in Europe—both through large-scale clinical studies and by embedding this work more firmly within the broader brain health research and policy landscape.

A new evidence brief from WHO/Europe makes a clear case for scaling up mental health services within primary health care systems, positioning primary care as both a gateway and a foundation for more inclusive, trusted mental health support.

 

The report underscores that between one third and one half of all patients in primary care settings present with mental health complaints, highlighting the central role of general practitioners, nurses, and community clinics in addressing mental health needs. Strengthening this entry point is essential not only for early intervention and continuity of care, but also for building public trust in health systems—particularly when services are available “close to home.”

 

Despite over 125 million people living with a mental health condition in the WHO European Region, only a fraction currently receive the care they need. The report identifies key barriers, including a shortage of trained professionals, under-resourced facilities, and persistent stigma that discourages help-seeking.

 

To address these challenges, WHO outlines four core recommendations:

Mounting instability at the U.S. Food and Drug Administration is prompting some drug developers to reconsider their regulatory strategies — and the European Medicines Agency (EMA) may increasingly benefit. With over 2,500 FDA staff departures reported, a group of biotech leaders in the U.S. has raised alarms about talent loss and its implications for regulatory timelines. In one striking example, a California-based biotech told U.S. senators it is now engaging with the EMA earlier than planned, filing an investigational medical product dossier in Europe to ensure trial continuity and preserve development timelines — effectively “offshoring” clinical investment.

 

While the EMA has said it’s too early to see a spike in regulatory engagement, the trend is worth watching. European regulators are often seen as more open to patient input in trial design and less constrained by the Inflation Reduction Act’s pricing timeline — factors already nudging some developers toward Europe. Psychedelic medicine developers, many of whom have long prioritised FDA pathways, may now find new incentives to engage earlier with EU regulators, particularly if timelines tighten in the U.S. or clinical infrastructure shifts.

 

Though the EMA reiterates its commitment to ongoing FDA collaboration, the current moment may present an opportunity for Europe to position itself more prominently in global drug development — including in emerging fields like psychedelic therapies.

As political attacks on U.S. universities escalate, European leaders are making a strategic play to position the EU as a global sanctuary for science. European Commission President Ursula von der Leyen and French President Emmanuel Macron unveiled Choose Europe for Science, a €500 million initiative aimed at attracting top international researchers between 2025 and 2027. Macron also pledged €100 million from France’s 2030 programme to bolster national efforts.

 

Speaking at the Sorbonne, von der Leyen criticised moves to defund academic research and restrict visas in the U.S., calling them a “gigantic miscalculation.” Macron warned that one of the world’s largest democracies is undermining the very foundations of open inquiry. Both leaders framed science as essential to democracy and economic strength — and made it clear that Europe intends to step in where others are pulling back.

 

The new initiative will be backed by proposals to codify academic freedom in EU law and ease the path from lab to market through a European Innovation Act and Startup and Scaleup Strategy. With researchers facing growing constraints in the U.S., Europe is positioning itself not just as an alternative — but as a refuge for the scientific values now under siege.

A new report from the McKinsey Health Institute offers one of the most compelling economic arguments to date for scaling up global mental health care. According to Investing in the future: How better mental health benefits everyone, improved mental health access and innovation could unlock a staggering $4.4 trillion in GDP by 2050. The gains would come from enabling 60 million more people to participate in the workforce, enhancing productivity through better health, and reducing the direct and indirect costs of mental illness. For every $1 invested, the global economy could see a return of $5–6.

 

Beyond the economic headline lies a more sobering truth: mental health conditions now account for more years lived with disability than cardiovascular disease, diabetes, cancer and chronic respiratory diseases combined. Yet despite this overwhelming burden, investment in mental health systems and innovation remains marginal. The report urges a rebalancing of health priorities, reframing mental health not as a siloed concern, but as core to human functioning and interwoven with non-communicable diseases (NCDs) more broadly. Depression alone triples the risk of cardiovascular disease.

 

What makes this report particularly striking is how forcefully it argues that improving mental health is not just about averting deaths of despair — it’s about helping people reclaim years of full, healthy life. With scalable interventions already in hand, and transformative tools on the horizon, the moment to act is now. Europe, where NCDs account for 90% of all deaths and mental illness is the leading cause of morbidity, has both a moral and economic imperative to lead.

On 19 March 2025, Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), addressed the European Parliament’s SANT committee, highlighting how public-private partnerships can accelerate health innovation in Europe.

 

IHI is a large-scale EU partnership that brings together the public and private sectors to fund collaborative health research and support the development of cutting-edge solutions across disease areas.

 

Blomberg emphasised that IHI’s model—uniting academia, industry, SMEs, hospitals, and civil society—is crucial for tackling complex challenges, from health data infrastructure to novel therapies. He stressed the importance of trust, legitimacy, and joint effort across all sectors.

Only 46 percent of centrally approved innovative medicines from 2020 to 2023 were available to patients in Europe as of January 2025, according to EFPIA’s latest W.A.I.T. Indicator — a slight decline from previous years. Access to orphan drugs improved modestly, while cancer drug availability fell. Just 29 percent of medicines were fully reimbursed, down from 42 percent in 2019, with restricted access now affecting 17 percent of products.

 

A companion report points to fragmented regulatory timelines, duplicative evidence requirements, and delays in market access assessments as key contributors. Infrastructure gaps and limited diagnostic capacity further block patient uptake even after reimbursement. EFPIA is calling for faster, more coordinated EU and national processes, new pricing models, and greater transparency from industry. It has pledged to file in all EU countries within two years of authorisation. Fixing access, the group argues, requires joint action to reduce red tape and better reward innovation.

The Joint Research Centre of the European Commission has published a new report “Decoding Depression: Exploring the Environome Across Life Course” exploring the complex, multifactorial nature of depression and its growing impact on individuals and societies across Europe.

 

The report highlights the need for transdisciplinary, evidence-based policy responses, addressing not only acute episodes of illness but also promoting mental well-being, prevention, and early intervention throughout all stages of life. Importantly, it calls for enhanced access to evidence-based treatments and recovery-focused interventions as part of a comprehensive approach to managing depression.

 

In reflecting on the future of treatment innovation, the report notes that new research is expanding the therapeutic landscape — including advances in neuroimaging, neuromodulation, and the exploration of alternative therapeutic settings aimed at facilitating recovery in treatment-resistant depression. Notably, these references include recent meta-analyses assessing the efficacy and safety of psychedelic therapies in mental health care.

A new report “When Less is More: How Reducing Alcohol Consumption Benefits Society” by the Alcohol & Society network explores evolving alcohol policy approaches across Europe, emphasising a shift from individual responsibility narratives towards broader public health and societal frameworks.

 

The report highlights increasing recognition of alcohol consumption as a major driver of preventable harm — including its role in mental health disorders, social inequalities, and the burden on healthcare systems. It also outlines how evidence-based policy measures — such as minimum pricing, marketing restrictions, and health warnings — can be effective in reducing consumption at the population level.

 

Importantly, the report situates alcohol within the wider conversation on substance use policy and health promotion in Europe — a space where mental health advocacy, including that of psychedelic research and treatment innovation, is becoming increasingly relevant. As substance policies evolve, the integration of harm reduction, prevention, and access to evidence-based treatment remains essential.

The Polish Presidency of the Council of the EU is leading efforts to strengthen the protection of young people’s mental health online. In newly drafted Council Conclusions, EU Member States are encouraged to push digital platforms to take greater responsibility for how their design choices impact mental health.

 

The draft calls on digital technology developers to build safety, transparency, user well-being, and content diversity directly into the design of online platforms, helping to create a healthier digital environment for children and adolescents. Further recommendations include exploring preventive policies, such as improved age verification processes to protect young users from addictive design practices, manipulative online content, gambling elements in games, and aggressive personalization techniques. The conclusions also promote school-level rules to help limit digital use and uphold children’s right to disconnect.

 

These discussions come in the broader context of growing EU focus on the mental health impact of social media, with upcoming guidelines under the Digital Services Act expected soon. The draft conclusions are set for adoption at the EPSCO Council meeting on June 20.

 

WHAT WE ARE READING