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

 

Dear First name / Readers,

 

We marked our third birthday this month at the European Academy of Neurology Congress, surrounded by clinicians, researchers, and advocates - all helping shape the future of care. Building dialogue with healthcare professionals has always been central to PAREA’s work, and the congress offered a timely moment to reflect on just how far the field has come. 

 

We are also delighted to welcome a new colleague to our growing team. Nico Gusac will support our communications efforts. 

 

One of the recent highlights was the launch of our new policy paper, “Leading, not Lagging: Putting Mental Health at the Core of Europe’s Innovation and Competitiveness Agenda". It sets out a bold vision for how Europe can lead in this space and has already received strong positive reactions from across EU institutions. We were honoured to be invited to discuss our proposals later this year in a one-on-one meeting with European Commissioner Ekaterina Zaharieva, who is responsible for startups, research, and innovation. The paper was also covered by POLITICO. 

 

There’s also growing momentum across Europe and beyond. In the Czech Republic, authorities are preparing a national pathway for the medical use of psilocybin. Following the bill’s introduction in Parliament, the Senate approved it yesterday, bringing it one step closer to reality. It now awaits the President’s signature. Globally, New Zealand’s Ministry of Health recently approved its first non-trial prescribing of psilocybin, and Australia is exploring insurance and reimbursement frameworks - clear signs that psychedelic care models are gaining traction.

 

Another major milestone: a new European research network focused on psychedelics has been approved under the EU-funded COST programme. The initiative brings together researchers from 22 countries to collaborate on future large-scale trials, data sharing, and clinical implementation. I'm honoured to be among the participants and look forward to contributing to this ambitious platform.

 

And back in Brussels, the Council of the EU reached a deal on the pharmaceutical package. PAREA has prepared a detailed analysis for pro subscribers - essential reading as the new modular incentives system will be particularly relevant for developers of innovative treatments. Beyond that, other key files are gaining momentum too, including the EU’s Life Sciences Strategy and the planned Biotech Act.

 

In short, the policy landscape is shifting and the opportunities to shape it are multiplying.

 

With best wishes,

Tadeusz Hawrot

 

PAREA NEWS

To mark European Mental Health Week, PAREA released a new policy paper - “Leading, not Lagging: Putting Mental Health at the Core of Europe’s Innovation and Competitiveness Agenda” - urging the EU to treat mental health  as a central pillar of its innovation and competitiveness agenda. The paper sets out five concrete proposals, including a “moonshot” mission for mental health, a long-term European Mental Health Strategy, and the creation of a dedicated innovation hub.

 

The paper highlights stark figures: mental health conditions now account for more years lived in poor health than cancer, cardiovascular disease, diabetes, and respiratory illnesses combined. Yet psychiatry continues to receive the lowest share of commercial clinical trials in the EU - just 2%, according to the EFPIA/ IQVIA data chart included on page 2.

 

PAREA argues that Europe has a unique opportunity to lead. As other regions face regulatory and political headwinds, the EU can position itself as a trusted base for mental health innovation. The proposed framework aims to reverse years of underinvestment and bring the field onto equal footing with other major health priorities like oncology.

The World Health Organization (WHO) has issued a rapid communication on its forthcoming guideline on controlled medicines, designed to support national policies that strike a balance between access and safety.

 

PAREA was honoured to be invited to join the External Review Group for this new guideline. Our contribution was developed with a multidisciplinary focus group of legal, clinical, and research experts, and underscored the importance of ensuring access to controlled substances for scientific research and for addressing serious unmet medical needs. Our participation in this process reflects a growing global recognition of the medical potential of psychedelics and the need to support the development of these treatments.

 

The rapid communication serves as an interim step, with the full guideline revision expected to be released later this year.

A new European research network focused on psychedelics has been approved for funding under the COST (European Cooperation in Science and Technology) programme.

 

Titled “Psychedelic Renaissance: Turn On, Tune In and Drop In”, the initiative brings together researchers from 22 countries across Europe to build a collaborative platform for psychedelic research. The network aims to lay the foundation for future large-scale projects, multicentre clinical trials, open-access data sharing, and advanced big data analysis—with the ultimate goal of supporting the implementation of psychedelic therapies in mental health care.

 

COST is an EU-funded programme that enables multidisciplinary research collaboration through over 300 networks across science and technology. 

 

In 2023, PAREA was honoured to speak at a COST meeting in Brussels on “Advancing mental health research through networking and collaboration in Europe.”

 

Congratulations to all involved in securing this important new funding stream. PAREA’s Founder Tadeusz Hawrot is pleased to be among the participants and looks forward to contributing to this ambitious effort to strengthen Europe’s psychedelic research landscape.

PAREA submitted evidence to the Commission’s call on the upcoming EU Biotech Act, praising its aim to drive safe, sustainable biotech innovation while urging mental health as a top priority. 

 

With mental health conditions affecting over 143 million Europeans yet lacking new treatments, our submission recommends: targeted regulatory support for early-stage firms; new public–private funding with a dedicated EU Mental Health Innovation Fund; expanded pan-EU trial capacity via the Brain Health Partnership; and improved data and real-world evidence platforms. 

 

Europe now has a policy window to lead mental-health innovation and strengthen resilience. Read the full submission here.

PAREA was present at Psychedelic Science 2025 in Denver, Colorado.

 

In the Policy Track, Founder Tadeusz Hawrot and Project Officer Francisca Silva presented on “Progress in the European Union: Lessons from Multi-Stakeholder Processes”, highlighting regulatory developments, the role of coalition-building, and the integration of projects like the PsyPal trial, which exemplify multidisciplinary, patient-centered approaches in the EU.

 

 

Tadeusz also chaired a Studies Track session on “The Potential for Psychedelic-Assisted Therapy in Conflict-Affected Populations: Ukraine and the Balkans”, spotlighting early clinical efforts and the complexities of delivering trauma care amid ongoing conflict. During wars, everyone is at war - not just military, but the society at large that carry the burden. Both in Balkans and in Ukraine, millions have been exposed to ongoing trauma. Ukraine continues to fight but also in Balkans, it’s hard to talk about post-conflict time. The war can be declared over but the psychological suffering continues, especially if people’s hidden injuries are not taken care of.

 

During the session, participants including Oksana Gryshchenko, Elise Wilson, and Galyna Pidpruzhnykova discussed the recently implemented structured training programs for group ketamine-assisted psychotherapy in Ukraine, offering a practical pathway for training therapists and delivering care in a cost-effective, community-based setting. The panelists also outlined the collaborative model being developed, led by PAREA and the Ukrainian ecosystem, including the Ukrainian Psychedelic Research Association.

 

 

Beyond the sessions, the conference offered a welcome opportunity to connect with PAREA team members in person and re-connect with international partners advancing psychedelic research and policy.

Just days after presenting in Denver, the PAREA team travelled to Helsinki to participate in the European Academy of Neurology (EAN) Congress, a major event that also marked PAREA’s three-year anniversary.

 

Our presence in the Neurohood exhibition area sparked rich dialogue with clinicians, researchers, and patient advocates—many of whom were seeing, for the first time, the full scope of neurology-related psychedelic trials visualised in a striking bull’s eye graphic, courtesy of Psychedelic Alpha.

 

As part of the EAN’s Scientific Theatre, we presented the PsyPal trial—the first EU-funded clinical trial of psilocybin-assisted therapy, targeting four life-limiting conditions, including three neurological diagnoses: amyotrophic lateral sclerosis, multiple sclerosis, and atypical Parkinson’s.

We were especially pleased to connect in person with key figures shaping brain health policy and advocacy in Europe and beyond, including:

The EAN Congress provided an important platform to expand awareness about psychedelic science within the neurology community, reaffirming the importance of collaboration across disciplines and sectors. Celebrating three years of PAREA amid such vibrant scientific exchange was a perfect reminder of why we do this work—and how far the conversation has come. 

Earlier in June, PAREA’s Founder Tadeusz Hawrot participated in the REAL Summit London, a dynamic gathering of changemakers, investors, and innovators committed to transforming global mental health. Hosted by the REAL Mental Health Foundation, the event spotlighted urgent challenges in mental health care—most notably, the persistent stigma that continues to prevent millions from seeking help.

 

Tadeusz joined a panel exploring the emerging role of psychedelics in mental health innovation, sharing insights on policy, access, and the importance of responsible development frameworks in Europe. He spoke alongside leading figures in the field, including David Nutt, Tais Poda, Tom McDonald, and Henrik Jungaberle, in a conversation that reflected the growing momentum behind psychedelic therapies as part of a broader mental health ecosystem.

 

We’re also proud to share that Tadeusz has joined the REAL Mental Health Foundation as an Ambassador, joining a movement dedicated to changing the way the world approaches mental health. The Foundation, led by Shawn Lesser, is mobilising a powerful vision: to support the mental health of 10 million men and secure $10 billion of investment in the field by 2030.

We are delighted to welcome Nico Gusac as our new Communications Officer!

 

Nico brings a multidisciplinary academic background to our team, with a BA in Economics and Global and International Studies from Bard College, NY and currently completing a Master’s in Medical Anthropology and Global Health in Tarragona, Spain, where her research explores the intersection of mental health, culture, and ethics.

Convinced that individual health is inseparable from the wellbeing of our communities and environments, Nico is committed to exploring not only the biomedical aspects of mental health, but also its cultural, relational, and systemic dimensions. 

 

At PAREA, Nico will support our communications efforts. Her expertise, passion, and dedication to creating supportive frameworks for integration will strengthen our mission to advance mental health and psychedelic research across Europe.

 

NEWS FROM OUR PARTNERS

In a landmark initiative, the European College of Neuropsychopharmacology (ECNP)—a PAREA member—is leading a global effort to develop a Precision Psychiatry Roadmap (PPR). Published in Molecular Psychiatry, the call to action urges a shift from symptom-based diagnostics to a dynamic, biology-informed framework.The authors critique tools like DSM and ICD for lacking biological precision, proposing instead the use of biomarkers, behavioral data, and digital phenotyping—similar to Alzheimer’s ATN model.

 

The roadmap unfolds in three phases: global alignment on principles and data (with ECNP coordinating efforts), validation of biomarkers and stratified trials, and integration into clinical practice, backed by regulators.This neuroscience-based approach aims to improve diagnosis, treatment targeting, and psychiatric R&D. ECNP’s leadership, including its 2024–2025 New Frontiers meetings, underscores its central role in advancing the field.

 

A companion podcast episode featuring ECNP experts is available here.

GAMIAN-Europe - a member organisation of PAREA - has launched two new important mental health initiatives.

 

The Mental Health & Cancer Hub is a new digital platform, released on European Week Against Cancer 2025, to support people navigating the emotional toll of cancer, released on European Week. Mental health issues like depression, anxiety, and trauma are common among patients, carers, and families, yet psycho-oncological support remains uneven and under-resourced across Europe.

 

The Hub aims to close this gap by offering country-specific directories of mental health services, regularly updated resources in over 20 European countries, and curated content including personal stories, expert advice, and the latest research. Whether you're seeking professional help, peer support, or a better understanding of the emotional impact of cancer, the Hub is designed to meet diverse needs—including those of carers and loved ones. 

 

As part of European Mental Health Week 2025, GAMIAN-Europe also launched its Mental Health Dashboard, a new digital tool offering a detailed, data-driven view of the mental health landscape across the EU. The platform brings together key indicators such as the prevalence of mental health conditions, public stigma levels, and national policies on investment, services, and workforce capacity.

 

Designed for advocates, researchers, and policymakers, the Dashboard supports rights-based, evidence-informed decision-making. It provides essential insights to help shape mental health reforms and keep mental health high on the European agenda. With plans to expand and update regularly, the Dashboard is not just a snapshot of current trends but a long-term platform to support research, advocacy, and policy development.

On February 26, 2025, during the Psychedelics as Medicine conference in Reykjavik, Iceland, representatives from all Nordic psychedelic associations signed the Manifesto for the Nordic Psychedelic Network Initiative, a formal commitment to ethical, sustainable, and collaborative development of psychedelic science and medicine in the region.The gathering emphasized shared values of integrity, ecological responsibility, and cross-border cooperation in shaping a more holistic future.

PAREA celebrates this milestone and invites you to learn more in our latest guest article by Cecilie Byholt Endresen, President of the Norwegian Association for Psychedelic Science and co-founder of the Nordic Psychedelic Network Initiative: “A New Era for Psychedelic Science in the Nordic Region”.

Upcoming events

On behalf of the Swedish Network for Psychedelic Science (NPV), PAREA invites you to the Borealis Psychedelic Science Summit, a two-day scientific conference taking place in Stockholm on September 26–27, 2025.

 

Designed to advance meaningful discourse on psychedelic science and therapy, the summit will feature in-depth presentations, interactive workshops, and opportunities for professional exchange. It aims to be the leading European forum for researchers, clinicians, policymakers, and practitioners committed to the rigorous development of the field. Speakers will include internationally recognized experts, with the full lineup to be announced soon.

 

Date: September 26–27, 2025
Location: Stockholm, Sweden
Tickets and Information

The third edition of Finland’s interdisciplinary conference on psychedelics is on the horizon — Psykedeelit 2025: Challenging Psychedelics will take place on October 2–4, 2025, in Turku, Finland. This year’s theme invites researchers from across disciplines to engage with a range of challenges in the field — from methodological and ethical considerations in clinical trials, to debates about the appropriation of Indigenous knowledge and the influence of personal experience in psychedelic research.

 

Date: October 2-4, 2025
Location: Turku, Finland
Tickets and Information

THE LATEST FROM EUROPE (AND BEYOND)

 

The EU’s long-awaited pharmaceutical reform is now moving into trilogue negotiations, with the European Commission, Parliament, and Council aligning around a reworked system of drug market exclusivity. After months of debate, Member States backed a proposal, led by Poland, that preserves 8 years of data protection but shifts to a more flexible model of market exclusivity, modulated based on public health objectives.

 

As shown in the visual above, the current system offers 11 years of combined protection, with 2 years of market exclusivity fixed. Under the new proposals, that second phase becomes conditional. Medicines could gain back some or all of that time if they address unmet medical needs, add new indications, or include comparative trials across EU countries. The Parliament’s proposal even includes rewards for conducting R&D within Europe.

 

Although the final shape is still up for negotiation, all three institutions appear to agree on the general direction: a modular incentives system that rewards public health value, while retaining industry incentives to innovate. This could be particularly relevant for complex, research-intensive therapies, such as those requiring combined treatment approaches or multi-country trials.

 

A comprehensive breakdown of the Pharma Package—covering timelines, stakeholder positions, and the potential impact on future EU health innovation—is available exclusively for our Pro subscribers. To access this and other in-depth analyses, consider supporting us and becoming a Pro newsletter subscriber.

The European Commission has unveiled a comprehensive new strategy aimed at transforming Europe into a global powerhouse for startups and scaleups. Presented as the "EU Startup and Scaleup Strategy," the initiative sets ambitious goals to create a more innovation-friendly environment, improve access to financing, accelerate market uptake, attract and retain talent, and enhance infrastructure.

 

The strategy identifies persistent barriers - including regulatory fragmentation, limited venture capital, complex procurement processes, and talent shortages - that hinder European startups. To overcome these challenges, the Commission proposes a series of targeted measures, including: innovation-friendly regulation, better financing, accelerated market uptake, talent attraction and retention, and access to infrastructure.

The European Commission launched its long-awaited Life Sciences Strategy earlier this week, outlining plans to make the EU “the world’s most attractive place for life sciences by 2030.” The strategy confirms a strong focus on boosting investment, supporting regulatory innovation, and accelerating clinical research.

 

Key among the proposals is the Commission’s plan to transform the environment for clinical research in Europe. It proposes to monitor the Clinical Trials Regulation, establish clinical trial networks and regional centers to promote multi-country studies, as well as provide funding.

 

It also introduces a new network of European Centres of Excellence in advanced therapies, a dedicated life sciences coordination group, and a research and innovation data assembly to streamline data interpretation and access. The Commission will also introduce a new matchmaking programme to connect life science start-ups with investors, and channel €170 million in Horizon Europe funding into research at the intersection of health and climate.

 

The pharmaceutical and biotech industries see the strategy as an opportunity for the EU to restore its global leadership in the field and regain ground lost to the U.S. and China.

 

The strategy is backed by €10 billion in estimated funding from existing programmes. For Pro subscribers, PAREA’s detailed analysis explores what this new direction means for mental health innovation and emerging fields such as psychedelic research.

A new modelling study in The Lancet Psychiatry reveals that common mental disorders in Europe carry a massive—but often overlooked—cost to physical healthcare systems. Looking at data from 32 countries, researchers estimated that €55.3 billion in hospital inpatient and emergency care each year is linked not to mental health treatment directly, but to the physical health consequences of four mental disorders.

Here’s how the estimated annual costs break down:

Altogether, these costs account for nearly 2% of total healthcare spending and highlight how failing to integrate mental and physical care leads to serious downstream costs. Even a modest reduction—just 1%—in this excess hospital use could save around €188 million a year across Europe.

European Commission President Ursula von der Leyen has confirmed that the EU’s next research framework programme (FP10) will remain a standalone initiative, though closely linked to the upcoming European Competitiveness Fund. Speaking at the Competitiveness Council, she emphasized preserving FP10’s identity while aligning it with broader EU goals in innovation, industry, and resilience. “We want this success story to continue,” she said, noting Horizon Europe’s role in Nobel Prize-winning research.

 

The clarification follows concerns over potential programme mergers. Though FP10 won’t be absorbed, its close connection to the new fund raises questions about its future autonomy.

Research advocates continue to urge protection for blue-sky science and long-term stability. PAREA’s recent paper, Leading, not lagging, also calls for a moonshot mission on mental health within FP10. A formal proposal for the Competitiveness Fund is expected in July.

A new report from the Partnership for Health System Sustainability and Resilience calls on the EU to treat health not as a cost, but as a long-term investment in resilience, equity, and prosperity. Investing in Health: Pathways to a Thriving European Union argues that strategic health spending can improve well-being, boost public trust, and fuel inclusive economic growth.

 

The report highlights chronic underinvestment in areas like public health, primary care, mental health, and research, and urges a shift from reactive to proactive funding. Health should be seen as a driver of democratic stability and value creation amid ageing populations and climate pressures.

 

Key recommendations include launching a European Health Investment Platform, integrating health into broader EU initiatives, and treating mental health and prevention as essential infrastructure. With the next EU budget under negotiation, the report reinforces calls for a bold, coordinated health strategy to secure Europe's future.

Thirty-one countries in the WHO European Region have committed to embedding mental health considerations across all areas of policymaking - including education, employment, housing, and healthcare. Announced by WHO Europe, this broad approach aims to address the needs of the 17% of the region’s population living with mental health conditions, translating into millions affected.

 

The initiative represents a significant policy shift, recognising mental health as a collective societal responsibility, not solely a healthcare issue. By systematically incorporating mental health into diverse policy frameworks, countries aim to reduce stigma, enhance social inclusion, and strengthen preventive measures. The commitment follows rising evidence that mental well-being is crucial to overall health, economic productivity, and community resilience. Ultimately, this move could improve access to services and provide more cohesive support systems for individuals experiencing mental health challenges, promoting a more inclusive and resilient society.

On June 30th, the EU4Health Civil Society Alliance launched Health4Europe, a strategic blueprint for the next EU Health Programme. Its goal is to ensure that health remains a top political and financial priority in the upcoming Multiannual Financial Framework (MFF), and to further strengthen the European Health Union. As a member of the Alliance, PAREA fully endorses this proposal. 

Medibank, Australia’s biggest private health insurer, has committed AUD 10 million (~EUR 6 million) to fund patient access to MDMA-assisted PTSD therapy and an ANU-led health economics study—part of a broader AUD 50 million, five-year mental-health investment. 

 

Although MDMA and psilocybin were rescheduled for medical use in 2023, fewer than 100 Australians have been treated because of cost and access barriers. As the first major effort to expand access, this pilot offers valuable lessons for Europe—where mental illness is driving early retirement and soaring insurance costs.

The Czech Parliament has passed a significant law allowing psilocybin therapy for mental health conditions like depression, anxiety, and addiction. The Senate approved the legislation yesterday, clearing the final legislative hurdle. Once signed by the President, the law will enable qualified psychiatrists to administer psilocybin in accredited clinical settings under professional supervision. With this step, Czechia is set to join countries like Switzerland, Canada, Australia, and now also New Zealand, in leading the way on the medical use of psychedelics.

 

At PAREA, we applaud this responsible and evidence-based approach, which offers a model for safe, regulated integration of psychedelic therapies in clinical practice. This move not only advances mental health treatment but also re-establishes the Czech Republic’s legacy as a leader in psychedelic research.

The EU Drugs Agency (EUDA) has released its annual European Drug Report, focusing on emerging trends in the European drug market. It includes a chapter on the growing interest in psychedelics for therapeutic use, noting that research on substances like psilocybin, MDMA, DMT, and LSD for conditions such as PTSD and treatment-resistant depression is advancing rapidly. The report also highlights new funding developments and the rise of unregulated psychedelic practices, including wellness retreats involving substances like ayahuasca and psilocybin. 

 

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