Dear First name / Readers,

 

With the year drawing to a close, this is a moment to reflect on the areas where sustained policy work translated into concrete outcomes.

 

Over the past twelve months, our work reached both European and global policy tables. PAREA contributed directly to the updated WHO guideline on balanced national policies for controlled medicines, helping shape language that safeguards medical access while maintaining safety. At EU level, we also fed into the EMA’s updated depression guidelines, where a substantial share of our feedback was reflected in the final text. These are not symbolic or bureaucratic processes, they define how treatments are evaluated, prescribed, and accessed in practice.

 

Early in the year, we strengthened political engagement through the launch of the MEP Action Group on Psychedelic Therapies, and contributed to high-level discussions at Davos, where mental and brain health featured more prominently than in previous years.

 

Our work in Ukraine continued alongside this, supporting regulatory steps towards evidence-based psychedelic research in a country facing extraordinary mental health needs.

 

Throughout the year, we published two major policy papers, including our call for a European Mental Health Moonshot. We also deepened dialogue with clinicians and researchers, including through our presence at the European Academy of Neurology Congress.

 

This year also saw significant progress in research funding. Following our continuous engagement with EU institutions, the Horizon Europe 2025 Work Programme allocated €50 million for calls aimed at advancing innovative interventions for mental, behavioral, and neurodevelopmental disorders. The scope includes clinical studies that combine pharmacological approaches with psychotherapy. This creates new opportunities to build on earlier projects, such as PsyPal, the first EU-funded initiative exploring psychedelic therapies in palliative care. There has been strong interest in this call from European researchers working on psychedelic therapies. Looking ahead to 2026, we will get a clearer picture of which projects, including those involving psychedelic research, the EU decides to fund. 

 

Beyond Brussels, the wider landscape has continued to shift. Developments in Germany, Czechia, and Norway point to new approaches to access, compassionate use, and reimbursement, still uneven, but no longer isolated. 

 

At EU level, the year closed with two major files finally coming together: the revised pharmaceutical legislation and the Biotech Act.

 

We knew from the outset that influencing these files would be difficult, especially as a small organisation. Over the past two years, PAREA has participated in numerous consultations, published four policy papers, met with the EU Research Commissioner, more than 20 MEPs, and representatives from close to 10 member states. Our core arguments - particularly around unmet needs and incentives, appeared repeatedly in POLITICO coverage.

 

Mental health innovation has not yet been explicitly recognised as an area needing additional EU-level support. While this is disappointing, it is not surprising. We are realistic about what can be achieved in a short time and are prepared for a multi-year engagement. At the same time, the strong emphasis on regulatory sandboxes in both the pharma legislation and the Biotech Act is encouraging, and we are actively exploring how this tool could be applied to psychedelic therapies.

 

Europe is clearly trying to bring innovation and clinical trials back after two decades of losing ground in the life sciences. Under the new rules, market protection incentives could become among the most attractive globally. For companies addressing unmet medical needs, running trials in Europe, conducting comparative studies, and filing early in the EU, protection may reach up to 11 years - potentially 12 with the new Biotech Act's supplementary protection certificate.

 

For psychedelic developers, and for mental health more broadly, Europe deserves a closer look. The case for sustained, system-level innovation is stronger than ever and PAREA will continue to push for it in the years ahead.

 

Wishing you all the best for the final stretch of the year, and some well-earned rest as 2025 comes to a close.

 

Tadeusz Hawrot

 

PAREA NEWS

On 4 December, Francisca Silva, Project Officer at PAREA, took part in this year’s PSYCH Symposium in London, co-organised with Drug Science. The event continues to serve as a go-to platform for researchers, clinicians, corporate, and industry stakeholders in the psychedelic space. Francisca participated in the panel titled “How to Integrate Psychedelic Therapies in Our Healthcare Systems” alongside Henrik and Andrea Jungaberle (MIND Foundation), Liliana Galindo (University of Cambridge), and Jeff Smith MP (Labour Party; All Party Parliamentary Group on Drug Reform). The discussion focused on equity and accessibility in public healthcare, political momentum, and the role of national initiatives like Germany’s compassionate use programme.

On 10 December, the fifth Headway Mental Health Index report was launched at a roundtable event at the European Parliament, attended by PAREA Project Officer, Francisca Silva. Hosted by MEP Tomáš Zdechovský under the title “Headway – A New Roadmap in Brain Health: Focus Mental Health; Care, Cohesion, and Growth”, the event showcased new data on the growing prevalence of mental health conditions in the EU and UK, and on the socio-economic impact of informal caregiving, estimated at €214 billion annually. The event called for viewing mental health not as a cost, but as a long-term investment in Europe’s wellbeing and productivity.

On December 13th, PAREA Founder and Executive Director, Tadeusz Hawrot, joined Victoria Costa Paz for a new episode of Eywa Academy, titled “The path to accessible and scalable mental health for all.” The conversation focused on how socioeconomic factors influence mental health outcomes, the need for scalable and accessible psychedelic therapies, and the importance of inclusive policy design. As Tadeusz noted: “We need to make sure that psychedelics are not another privilege for the few, but reach the communities that need them the most.”

PAREA is a co-signatory of a joint call by 38 health and patient organisations urging EU Member States to safeguard funding for health and civil society in Europe. The statement highlights the essential role of civil society in EU health policy and the increasing risks faced by organisations when sustainable funding is withdrawn. Ahead of the upcoming EU4Health Steering Group and European Council meetings (18–19 December), the call urges Member States to reinstate operating grants in the 2026 EU4Health Work Programme and to secure a strong, ring-fenced health budget in the next Multiannual Financial Framework (2028–2034).

PAREA contributed to The European Correspondent’s feature article titled “Europe’s Psychedelic Renaissance” by Jessica Mariana Masucci. The piece explores recent policy and regulatory developments across Europe and includes insights from PAREA’s founder, Tadeusz Hawrot. The contribution focused on two core priorities: first, the need to co-create standards of care with individuals who have lived experience, and second, the importance of addressing the social and structural conditions that drive poor mental health. 

Just days after PAREA called for a mission driven mental health moonshot in Europe, the US has announced its own mental health moonshot. The Advanced Research Projects Agency for Health, ARPA-H, announced a $100 million mental health moonshot called EVIDENT. It aims to speed up next generation treatments and to develop more objective ways of measuring outcomes in behavioural health. For Europe, this is a timely benchmark. With debates underway on the next long term EU budget, the successor to Horizon Europe, and new competitiveness tools, this US step shows mental health innovation is becoming a strategic priority globally.

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NEWS FROM OUR PARTNERS

The Independent Psychedelic Evidence Assessment Working Group (IPEA-WG) has been launched at the Faculdade de Medicina da Universidade de Lisboa, with support from Norrsken Mind. This multidisciplinary group brings together scientists, philosophers and health experts to provide rigorous, independent guidance on the evaluation of psychedelic therapies. Their mission is to deliver expert guidance ensuring psychedelic therapies are assessed with the highest standards of scientific rigor and multidisciplinary perspectives.

Many people with severe depression do not find relief from conventional treatments and are in urgent need of innovative alternatives. Germany’s new Compassionate Use programme now offers, for the first time in the EU, a legal and regulated pathway for eligible patients to receive psilocybin therapy outside of clinical trials. However, access remains limited, as the treatment is not currently covered by public health insurance. To help bridge this gap, our partners at the MIND Foundation have launched a fundraising initiative to support patients who cannot afford the therapy.

A new report launched by PAREA’s member GAMIAN-Europe highlights persistent gaps in access to mental health care across Europe. While services exist, many people face long waiting times, fragmented support, and poor coordination—especially those with complex or multiple needs. The report calls for person-centred, integrated, and recovery-focused care, with lived experience at the centre of service design.
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THE LATEST FROM EUROPE 

A new article in European Neuropsychopharmacology maps out the key regulatory and clinical hurdles for bringing psychedelic therapies into European healthcare. The authors underline that Health Technology Assessment (HTA) will be the decisive barrier. Additionally, the article underscores that most European guidelines treat psychotherapy combined with pharmacotherapy as the gold-standard approach for severe depression. This raises important questions about how future psychedelic-assisted treatments will be assessed for added therapeutic value.

EU institutions have reached a political agreement on the revision of pharmaceutical legislation — the first full overhaul in more than 20 years. The deal covers regulatory protection periods, new access obligations for companies, and the introduction of regulatory sandboxes. The final package will shape how Europe supports innovation, access, and evidence generation, including in mental health and emerging treatment areas.
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The EU has adopted its long-awaited Biotech Act, introducing speedier clinical trial approvals, financial support for industry, and an extra year of patent protection for biotech therapies via a supplementary protection certificate (SPC), with the condition that they are made in Europe. The legislation aims to strengthen Europe’s biotech competitiveness and keep investment onshore, building on earlier proposals to streamline approvals and improve incentives for high-risk innovation.

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The EU’s proposed European Competitiveness Fund is taking shape as a core pillar of the next long-term budget. But at €410 billion over seven years, it falls far short of the scale recommended by Mario Draghi to reverse Europe’s industrial decline. For health, biotech, and research-driven innovation, what matters now is not just the headline number, but how the fund is governed, prioritised, and linked to Horizon Europe.

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REMESOS – Resilient and Mentally Healthy Societies, an EU-funded initiative to strengthen mental health across Europe was launched. The project works along two pillars: i) measuring mental health at population level and ii) strengthening community support through Guided Functional Peer Support. Expected outputs include practical tools, good-practice exchange, and policy guidance to reduce inequalities and prevent deterioration in mental health. A multi-country consortium is involved, coordinated by EuroHealthNet.

Eurostat reports that the EU spent €403.1 billion on research and development in 2024, a 3.2% increase from the previous year. R&D intensity rose in 18 Member States, with the highest levels recorded in Belgium, Sweden and Austria. The business sector accounted for 66% of all R&D expenditure, followed by higher education and government.
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Healthcare spending across the EU reached 10% of GDP in 2023, according to new Eurostat data. While this reflects sustained investment following the pandemic, the figures also highlight persistent differences between member states and rising pressure on health systems. As costs continue to grow, questions around efficiency, workforce capacity, and how spending translates into better outcomes are becoming harder to ignore.

The European Commission has released the final Horizon Europe work programmes for 2026–2027, setting out around €41 billion in research and innovation funding. The new calls are described as less prescriptive and broader in scope, with a stronger emphasis on flexible, challenge-oriented topics rather than narrow, highly specified projects. This closing phase of Horizon Europe will help set the tone for the design of FP10.

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Upcoming Events of Interest

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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