Dear First name / Readers,

 

We have some encouraging news to share on the European Biotech Act, which has become one of PAREA’s main policy priorities this year. Some 20 amendments PAREA has been advocating for — aimed at better recognising mental health innovation and creating a more supportive environment for complex treatments such as psychedelics — have made it into the first draft of the European Parliament’s position. See also here a POLITICO coverage discussing PAREA’s work in this context. That text has now moved into negotiations, so there is still a long way to go, but it is an encouraging step. In parallel, we have been engaging directly with Member States and have had fruitful exchanges with a good number of national representatives on how the Act could better support mental health research and innovation. We will continue this work in the months ahead, including at our 17 November European Parliament event on mental health innovation and the Biotech Act.

 

This week, our attention also turns again to Ukraine. On 23 September, together with the Ukrainian Psychedelic Research Association and with the official support of the Public Health Centre of Ukraine's Ministry of Health, we are hosting a webinar on how ketamine is already being integrated into public healthcare systems in countries such as Norway, the UK, and France — and what Ukraine can learn from these experiences.

 

There are encouraging developments on the research side too. In France, the ERPPAD Phase 3 trial has begun dosing participants, evaluating psilocybin for relapse prevention in people living with alcohol use disorder and depressive symptoms. This is important not only because of the indication, where unmet need remains enormous, but also because Europe still has very few large, late-stage psychedelic trials capable of generating evidence that could ultimately support regulatory approval. A fully European Phase 3 study is therefore worth paying attention to.

 

It is also good to see psychedelic research becoming more firmly embedded in mainstream European scientific education. Our Founding Member ECNP has launched a free 12-lecture course on psychedelic research, bringing together leading European researchers and covering everything from neurobiology and clinical protocols to safety and future directions in mental healthcare.

 

And just as we were about to send this newsletter, we learned that the final texts of the new EU pharmaceutical legislation have now been published: the Regulation, which includes the new references to mental health, and the accompanying Directive. This is especially significant for PAREA: the legislation explicitly recognises mental health within unmet medical needs and states that promising medicines for serious mental health conditions should benefit from enhanced scientific support and be considered for compassionate use. These references were absent from earlier drafts and reflect an issue PAREA has been tirelessly advocating for since our 2023 position paper on mental health and unmet medical needs. For us, this is both a major policy win and a milestone, one that could help create a more supportive regulatory environment for mental health innovation, including novel psychedelic treatments.

 

With best wishes,

Tadeusz Hawrot

 

PAREA NEWS

Join us on 17 November, from 15:00 to 17:00 CET, at the European Parliament for a policy discussion on mental health innovation in the European Biotech Act. The event is co-organised by PAREA, Global Alliance of Mental Illness Advocacy Networks – GAMIAN-Europe, and the European College of Neuropsychopharmacology (ECNP), and hosted by MEP Romana Jerković on behalf of the MEP Action Group on Psychedelics in Healthcare. It will explore Europe's innovation gap in psychiatry and PAREA’s policy recommendations for the Biotech Act. Speakers include ECNP’s President, Professor Andreas Reif, Vice-President of GAMIAN-Europe, Matthew Paris, and Founder and Executive Director of PAREA, Tadeusz Hawrot.

 

Join us online on 23 September, 18:00-19:30 CEST / 19:00–20:30 EET, for a webinar exploring how European countries are integrating ketamine treatment for mental health conditions into public healthcare systems — and what these experiences can teach us about expanding access to ketamine-assisted therapy in Ukraine and beyond. Co-organised by PAREA and the Ukrainian Psychedelic Research Association, the event is officially supported by the Public Health Centre of Ukraine’s Ministry of Health. Speakers include Lowan Stewart, Medical Director of Axonklinikken, on Norway’s implementation of ketamine therapy in reimbursed healthcare; David Erritzoe, Director of the Centre for Psychedelic Research at Imperial College London, on progress towards integration into the UK’s National Health Service; and Professor Fabrice Jollant of Paris-Saclay University, on compassionate access to ketamine for suicidal crises in France. Opening remarks will be delivered by Iryna Ivanchuk, Department Head at the Public Health Centre.

 

Last May, PAREA brought together leaders from 25 countries, representing around 30 national psychedelic organisations, for a meeting in Brussels focused on advancing access to psychedelic therapies across Europe. The gathering followed a meeting at the European Parliament on access to psychedelics in Ukraine. Our friends at Drugreporter joined us to document the gathering and interview participants. The resulting videos offer a unique snapshot of the initiatives, experiences and perspectives shaping psychedelic access across Europe. 

 

In September, the PAREA team was in Lisbon for the PSY-NET Clinical Working Group (WG3) meeting and the symposium “Keeping the psychedelic promise: From bench to bedside”, organised by the Champalimaud Foundation. PSY-NET is an EU COST Action-funded platform working to strengthen coordination in psychedelic research across Europe. This marked PAREA’s second in-person participation in a PSY-NET meeting, following the Non-Clinical Working Group (WG2) meeting in Barcelona in July, where Francisca Silva was invited to present.

 

Professor David Nutt, PAREA Board Chair and psychiatrist, joins WIRED to answer the internet's burning questions about psychedelic therapy. Do magic mushrooms combat depression? How does ketamine therapy work? Can psychedelics really help with PTSD, addiction, or even cluster headaches? What happened during Bryan Johnson's 5-MeO-DMT livestream? Answers to these and many more await in Psychedelic Therapy Support.

 

PAREA’s Francisca Silva joined podcast host Yoshi for the Interdisciplinary Conference on Psychedelic Research (ICPR) 2026 podcast, recorded during the conference in June. The conversation addressed PAREA’s work within the psychedelic ecosystem and recent developments in access to psychedelic therapies across Europe. It offered an opportunity to reflect on how the psychedelic space has evolved since the last ICPR in 2024. A big thank you to Yoshi and to the OPEN Foundation for the invitation and for continuing to bring the psychedelic community together.

 

PAREA has joined 187 organisations across Europe in calling on the European Commission to reinstate meaningful, adequate, and sustainable operating grants for health civil society organisations under the 2026 EU4Health Work Programme and beyond. Predictable funding is essential for independent organisations to contribute expertise, represent communities, and participate meaningfully in long-term policymaking—particularly as the EU prepares its next Multiannual Financial Framework.

 

We’re pleased to welcome six new organisations to our Community Supporters network: Rights Reporter Foundation, ACER Integration, International Jungian Psychedelic Association (IJPA), Global Psychedelic Society (GPS), the Hungarian Psychedelic Association, and SÄPT, the Swiss Society for Psychedelic-assisted Therapy. Together, they bring expertise in community building, psychedelic research, professional education, and safe and ethical therapeutic practice, strengthening connections and collaboration across the psychedelic field in Europe and beyond.

 

NEWS FROM OUR PARTNERS

One of PAREA's Founding Members, the European College of Neuropsychopharmacology (ECNP), is launching a free 12-lecture course on psychedelic research: "Psychedelic Research: Science, Therapy and Future Directions in Mental Health," covering the neurobiological mechanisms, clinical protocols, safety considerations, and future directions of psychedelics in mental healthcare. It convenes many of the leading European researchers working in this area, including PAREA Board Chair Professor David Nutt (Imperial College London). This represents precisely the kind of progress the field requires: mainstream scientific and clinical institutions helping to build the knowledge base around what these therapies are, how they work, their associated risks, and the questions that still need to be addressed. Enroll for free on the ECNP Knowledge Hub.

 

PsyPal, the first EU-funded clinical trial investigating psychedelic therapy, is currently recruiting patients in Denmark, Czechia, Portugal and the Netherlands. The study is exploring whether psilocybin therapy can support the management of depressive symptoms in people with life-limiting conditions — namely, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), and atypical Parkinsonism or advanced Parkinson’s disease.

Following a recent amendment, each participating site can now recruit participants with a broader range of conditions, expanding opportunities to take part in the trial. As a proud partner of PsyPal, PAREA is calling on our network of clinical and patient-facing organisations to help spread the word.

 

A recent article in the MAPS Bulletin covered the participation of PAREA’s Tadeusz Hawrot in an MAPS international delegation at the 69th session of the UN Commission on Narcotic Drugs in Vienna in March. Over a week of sessions and 166 side events, delegates tackled human rights, harm reduction, the Czech Republic's new legal framework for medical psilocybin, and the environmental toll of the War on Drugs. PAREA opened talks with the CND Secretariat on a potential resolution to strengthen international support for scientific research into controlled substances, including psychedelics.

 

PAREA’s member Pain Alliance Europe's "Chronic Pain, Mental Health and Self-Management Survey 2025" gathered insights from 1,220 participants across 22 countries via an online survey conducted from May to November 2025, aiming to better understand the lived experiences of people with chronic pain, with a particular focus on mental health, self-management, and access to care. The results reveal the scale of unmet needs: 84% experience pain daily, 97% report at least one mental health complaint, and 70% had no diagnosed mental health condition before their pain began. Yet integrated care remains rare — 57% never have access to multidisciplinary teams, 39% say their healthcare provider never asks about mental health, and general practitioners, not pain specialists, carry primary responsibility for 45% of cases. The report calls for urgent integration of mental health into chronic pain care pathways across Europe. Read the full findings on the Pain Alliance Europe website.

 

THE LATEST FROM EUROPE & BEYOND

A new Phase 3 clinical trial has commenced in Europe to assess psilocybin for relapse prevention in people with severe alcohol use disorder and depressive symptoms after detoxification. The ERPPAD trial, sponsored by the Centre Hospitalier Universitaire de Nîmes, will compare two high doses of psilocybin with two low doses, administered three weeks apart to assess whether high-dose psilocybin therapy is more effective in preventing relapse over six months.The study plans to enrol 172 participants and marks the first academically led Phase 3 study of its kind in Europe, although it is being conducted solely in France.

 

The US federal agency, the Substance Abuse and Mental Health Services Administration (SAMHSA), has released a highly useful and comprehensive technical assistance paper on current research, regulatory, and policy considerations regarding psychedelics as medicine. Although written for the US context, the document is highly relevant for European healthcare policymakers, payers, regulators, service planners, and providers. The paper offers a useful framework for thinking through what health systems may need to consider as psychedelic therapies move closer to possible approval, including safety, oversight, workforce, reimbursement, and implementation requirements. While formal approvals in Europe may still take time, several countries are already introducing early access pathways or regulated access models, making these questions relevant now, not only in the future.

 

On 14 September, the US Food and Drug Administration held its first public hearing on the future therapeutic use of psychedelic drugs, bringing together researchers, clinicians, drug developers and veterans. Rather than focusing on specific applications or legalisation, the hearing examined how psychedelic medicines could be administered, monitored and studied if approved. For Europe, the discussion reflects an increasingly familiar challenge: approval alone does not guarantee patient access. As countries including the Czech Republic, Germany, Switzerland and France develop different pathways for psychedelic treatments, questions around infrastructure, trained professionals, supply and delivery remain central. The US debate offers another important reference point as Europe works to build sustainable pathways from regulatory approval to real-world access.

 

Australia’s regulated access model for psychedelic-assisted therapy is beginning to generate meaningful real-world experience. Since July 2023, the Therapeutic Goods Administration has allowed specifically authorised psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression under the Authorised Prescriber scheme. According to the latest update, more than 400 patients have now received treatment in Australia, supported by over 50 trained psychiatrists and associated clinics. New Zealand is also beginning to move in a similar direction, with a small number of clinicians approved to prescribe psilocybin and MDMA under strict conditions.

 

The EMA has opened a voluntary form for academic institutions and not-for-profit organisations to share information about medicinal products and therapies they are developing. The form will remain open to collect data on an ongoing basis and offer an opportunity for enhanced regulatory engagement. Separately, on 21 September, EMA and the European Commission held a joint workshop examining the implementation of regulatory sandboxes under the revised pharmaceutical legislation. PAREA is closely monitoring the development of sandboxes and other initiatives relevant to innovative mental health interventions, including psychedelic therapies.

 

Germany has passed a major health reform package aimed at stabilising statutory health insurance finances, including significant new pressure on medicine prices. The reform comes as Germany faces a projected health insurance deficit of around €19 billion next year, while medicine costs have almost doubled since 2013. The move adds to the growing tension between affordability, access, and Europe’s competitiveness in pharmaceutical innovation. Industry has warned that stronger price pressure could affect investment and launches in Germany, while the government argues that cost control is needed to keep healthcare affordable. The debate is also being watched closely by the US, where officials have accused European countries of underpaying for innovative medicines.

 

A new Rare Barometer survey by EURORDIS highlights the significant mental health burden faced by people living with rare diseases and their families. Based on responses from nearly 10,000 participants across 45 European countries, the survey finds that 7 in 10 people living with rare diseases and their families report poor mental health, including symptoms of depression, anxiety, loneliness, or suicidal thoughts. The findings underline the need to better integrate mental health into rare disease care and policy and highlight existing barriers to accessing professional psychological support.

 

Spain is proposing a new EU-level early access or “early procurement” mechanism for innovative medicines, designed to bridge the period between European marketing authorisation and completion of national pricing and reimbursement procedures. The idea, promoted by Spanish Secretary of State for Health Javier Padilla, argues that earlier market access may be more valuable for some companies than additional years of exclusivity granted later — as is currently being discussed in the Biotech Act — especially as biomedical innovation accelerates and new treatments may face competition well before patent expiry. The proposal has already received positive feedback from some Member States and is expected to be brought to the EU Council in the coming weeks. Industry, however, has raised concerns.

 

Upcoming Events with PAREA's Participation

TAIP is the first international scientific conference on psychedelic-assisted therapy in Estonia, open to mental health professionals, clinicians, researchers, students, healthcare professionals, policymakers, and anyone interested in the field. Europe is facing a mental health crisis that calls for new treatment approaches, and TAIP creates a space for science-based discussion on this rapidly evolving field. PAREA founder Tadeusz Hawrot will be speaking, alongside talks, panel discussions, and networking opportunities.

PAREA Executive Director Tadeusz Hawrot has been invited to attend this high-level conference at University College Cork, held as part of Ireland’s Presidency of the Council of the EU. The event will bring together ministers, senior officials, and experts to discuss the latest research and share expertise in mental health policy, with a particular focus on learning from previous crises and building systemic mental health resilience in communities.

PAREA will be at the 1st KAP International Association Summit (16–18 October, Barcelona), part of Clínica Synaptica's nine-day Complete KAP Experience on Ketamine-Assisted Psychotherapy. Communications Officer Nico Gusac will present PAREA's work building European pathways for psychedelic-assisted care, covering the Mental Health Moonshot, regulatory advocacy, and European coordination. The Summit is accredited by the Catalan Council for Continuing Education of Health Professions. Scholarships are available to apply for, and PAREA community members can use code PAREAKAP2026 for 15% off the Standard 3-Day Pass.

On October 22–23, PAREA will join THE REAL Summits New York, the global event series uniting family offices, VCs, policymakers, insurers, academics, NGOs and innovators working to move $10 billion into mental health by 2030. PAREA founder Tadeusz Hawrot, an advisor to THE REAL, will moderate "Psychedelic Medicine in 2026: Access, Adoption & Scale," exploring how psychedelics are moving from the margins into mainstream research, clinical development and investment — covering pipeline developments, evolving U.S. policy, and what it takes to bring treatments to patients safely at scale. Four surprise guests will join the session.

Upcoming Events of Interest 

Psychedelic Society Belgium's 4th Symposium, "When Healing Is Not a Shortcut: Integrity in Psychedelic Therapy," takes place October 9–10 in Brussels. Over one and a half days, researchers, therapists, clinicians, policymakers, artists, and people with lived experience explore how to build a psychedelic field rooted in integrity, humility, and care — balancing optimism and innovation with critical reflection and harm reduction.

ALPS Foundation, a PAREA Community Supporter, holds its 6th Conference on 9–10 October in Aarau, Switzerland — now the country's largest event on evidence-based psychedelic science, convened with the Universities of Basel, Zurich, Geneva, Fribourg, and Geneva University Hospitals (HUG). Around 16 speakers include Prof. Dr. Eric Vermetten, Dr. Sandeep Nayak, and Dr. Max Wolff. A pre-conference Workshop Day (8 October) offers four language tracks with up to 14 education credits.

SCALE arrives at a pivotal moment for mental health care: research is advancing and psychedelic-assisted therapies are gaining regulatory recognition, but the real challenge now is turning evidence into access. It brings together scientists, clinicians, policymakers, insurers, investors, and philanthropists to tackle regulatory pathways, resilience and trauma, global psychiatric trends, and reimbursement — moving mental health innovation from evidence to real-world impact.

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