Dear First name / Readers,

 

As 2026 gets underway, momentum around mental health innovation and psychedelic research at EU level continues to build and PAREA’s work is increasingly being recognised at the highest political levels.

 

The year opened with a formal reply from Commission President Ursula von der Leyen to PAREA and members of the European Parliament letter, explicitly linking mental health innovation to the EU’s competitiveness and research agenda and confirming that key priorities remain open for influence.

 

At the same time, PAREA was invited to participate in a high-level mental health conference in Nicosia under the Cyprus Presidency of the Council of the EU as well as to a closed-door, invitation-only roundtable with one of the European Parliament’s main political groups. The roundtable was organised by the negotiating team shaping the forthcoming European Competitiveness Fund, expected to exceed €400 billion. Alongside other invited organisations - the European Cancer Organisation, the European Pain Federation, and the European Patients Forum, PAREA contributed to discussions on how health, research, and innovation priorities should be reflected in the Fund’s design.

 

This edition also looks ahead, with two important save the date moments: an upcoming European Parliament event on psychedelic research and access in Ukraine, and a public EU Health Policy Platform webinar on palliative care and the EU-funded PsyPal trial.

 

Together, these developments signal a strong start to the year and a widening policy space for responsible mental health innovation in Europe.

 

Tadeusz Hawrot

 

PAREA NEWS

European Commission President Ursula von der Leyen has responded to a joint letter from PAREA and Members of the European Parliament Action Group on Psychedelics in Healthcare, led by MEP Tilly Metz. The letter spoke about the importance of mental health innovation and called for the European moonshot on mental health. While the reply does not commit to specific new proposals, it explicitly links mental health innovation to ongoing negotiations on the EU competitiveness R&I funds, confirming that these priorities are still being shaped and that the window for influence remains open. The exchange has also drawn media attention, with POLITICO Europe covering the letter and the Commission’s response on several occasions, feeding into the broader policy discussion around mental health and EU competitiveness.

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On 6 May, 1:00–3:00 pm, PAREA will organise an event at the European Parliament on psychedelic research and access in Ukraine, together with the MEP Action Group on Psychedelics in Healthcare and the Ukrainian Psychedelic Research Association. Hosted by MEP Vytenis Andriukaitis, the meeting will focus on how Ukraine is building a legal, evidence-based framework for research and future clinical use in response to urgent war-related mental health needs.

A high-level EU conference on mental health and inclusiveness took place in Nicosia in January under the Cyprus Presidency of the Council of the EU. The event brought together national health ministries, EU institutions, and WHO Europe, with limited civil society participation. PAREA was invited to join the conference, reflecting growing recognition of the need for more coordinated, whole-of-society approaches to mental health across Europe.

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PAREA participated in a closed-door roundtable at the European Parliament on the health dimension of the upcoming EU Competitiveness Fund, organised by Renew Europe MEPs. Alongside the European Patients’ Forum, the European Cancer Organisation, and the European Pain Federation, we underlined the importance of safeguarding dedicated funding for health and ensuring continued support for research. PAREA emphasised that innovation in mental health is not only essential for human and societal wellbeing, but also a strategic investment in Europe’s long-term competitiveness and resilience.

The 34th edition of the European Psychiatric Association (EPA) Congress will take place in Prague, Czech Republic, from 28–31 March. Under the theme “Mental Health: Improving Care and Expanding Horizons”, the Congress will provide a key platform to advance clinical knowledge and explore novel mental health care approaches across Europe. PAREA will be present with a dedicated stand in the exhibition hall, where we look forward to engaging directly with the psychiatric community on the potential and current status of psychedelic therapies. We are grateful to our member, the EPA, for this opportunity for meaningful exchange.

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PAREA has submitted a response to the European Commission’s public consultation on the forthcoming European Research Area (ERA) Act. Our input highlights mental health as a strategic research and innovation priority for Europe, calling for stronger coordination of funding, reduced fragmentation, protection of scientific freedom, and better translation of research into practice. We emphasised the need for a mission-oriented approach, improved research infrastructures, and regulatory sandboxes as tools to strengthen Europe’s competitiveness.

NEWS FROM OUR PARTNERS

Ukraine’s Ministry of Health has updated its methodology for developing evidence-based medical standards, formally expanding the list of recognised international sources for clinical guidelines. For the first time, a dedicated mental health and psychiatry section has been added, including leading professional bodies from Europe, North America, and Australasia. This strengthens the use of internationally recognised psychiatric guidance in future standard-setting work in Ukraine. The involvement of the Ukrainian Psychedelic Research Association was instrumental in making this happen.

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Funded under the prestigious EU Marie Skłodowska-Curie Actions, INTEGRATE is a doctoral network offering 16 fully funded PhD positions aimed at developing forward-looking, interdisciplinary expertise in psychedelic research, addressing fundamental questions in the field. The projects span nine countries and cover several disciplines, including neuroscience, neurobiology, psychiatry, psychology, anthropology, pharmacology, law, and ethics. The programme features strong cross-sector and inter-institutional components through collaborations and international secondments, including with PAREA. The application deadline is 11 February. 

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Please save the date for an upcoming public webinar on psychological distress in palliative care and the EU-funded PsyPal project, provisionally scheduled for 13th April, 2pm CEST. The session will explore unmet psychological and existential needs in palliative care and present PsyPal as a case study of EU-funded clinical research responding to these gaps.

Alongside the policy and research discussion, the PsyPal trial - the first EU-funded clinical study of psychedelic therapy - is actively recruiting participants across four sites in Copenhagen, Groningen, Lisbon, and Prague. The study focuses on people living with chronic and life-limiting neurological and respiratory conditions.

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In 2025, Norrsken Mind awarded EUR 1.1 million across eight psychedelic research and non profit initiatives, including direct support for PAREA’s work on early and responsible access to psychedelic therapies in the EU. The grant enables PAREA to explore regulatory sandboxes within EU pharmaceutical legislation, helping generate real world evidence, inform regulatory pathways, and support healthcare system readiness for future implementation.

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THE LATEST FROM EUROPE 

A new report warns that proposed changes to US drug pricing could have knock-on effects for European patients. Industry surveys suggest companies may delay or skip EU launches, rebalance prices upwards in Europe, or cut global R&D spending in response. 

 

The report found that two thirds of mid-sized biotechs that responded to the survey said they were considering withdrawing from or delaying product launches in some EU countries in the short term if the U.S. adopts MFN pricing. That figure rose to 82 percent when companies looked five to ten years ahead. That’s because launching in EU countries at lower prices than the U.S. “will automatically lead to lower prices in the U.S. as well,” the report said.

 

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Momentum is growing behind proposals for an EU-wide company status that would allow firms, including innovative and research-driven companies, to operate under a single legal framework across member states. Backed by the Commission and several governments, the idea aims to reduce fragmentation, cut administrative costs, and make it easier for innovative companies to scale across Europe. Details are still under discussion, but the initiative signals a push to make the single market work better for growth-focused sectors.

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