Dear First name / Readers,

 

Europe’s debate on health innovation is becoming more urgent. The proposed Biotech Act is now one of the main files through which the EU is trying to respond to a much wider competitiveness problem: fewer clinical trials, slower regulatory and reimbursement pathways, as well as fewer launches of innovative medicines (one year on from the announcement of the US most favoured nation drug pricing policy, the number of new launches in Europe has fallen by 35%). A recent US issue brief makes the imbalance stark: across OECD markets, the US accounted for 79.87% of revenues for innovative drug products launched between 2020 and 2025, far ahead of any other OECD country. Industry argues that this level of concentration is unsustainable if Europe wants faster access to new treatments and stronger investment at home. Governments, however, are facing very real budget constraints. As one Belgian health official recently put it, health is not the only public spending priority, and the only thing Belgium spends more money on than health is pensions. That tension is now at the heart of Europe’s life sciences agenda.

 

For PAREA, the Biotech Act is a major opportunity to make sure that mental health innovation is part of this conversation from the start. Over the past 15 years, the US FDA approved 62 treatments across eight psychiatric conditions, while only 23 received EMA approval. Less than 10% became meaningfully available to patients across Europe. If Europe is serious about becoming a stronger place to develop, test, and deliver new treatments, this cannot be limited to oncology, rare diseases, or advanced therapies alone. Mental health remains one of Europe’s largest areas of unmet need, yet it continues to suffer from underinvestment, fragmented research infrastructure, and regulatory models that are not always suited to complex interventions. This year, one of our key EU policy priorities is therefore to engage with the Biotech Act and related competitiveness files to ensure that mental health innovation – including psychedelic therapies - is recognised as a strategic innovation area for Europe.

 

Tadeusz Hawrot

 

PAREA NEWS

PAREA is delighted to be attending the 12th European Academy of Neurology (EAN) Congress in Geneva, where our Founder, Tadeusz, and Project Officer, Francisca, are representing the organisation with a booth in the Neurohood. Building on last year's successful participation in Helsinki, we are engaging with neurologists and researchers about the emerging role of psychedelic therapies in neurology. We are also presenting the PsyPal clinical trial, which is investigating psilocybin therapy for psychological and existential distress in people with life-limiting neurological conditions - chronic obstructive pulmonary disorder, amyotrophic lateral sclerosis, multiple sclerosis, and atypical Parkinsonism or advanced Parkinson's disease. Although psychedelic research has primarily focused on psychiatry, interest in neurology is growing. Early studies are exploring applications in neurodegenerative diseases, chronic pain, and rehabilitation after stroke or traumatic brain injury. For PAREA, engaging directly with healthcare professionals remains essential to advancing awareness and supporting later evidence-based access to innovative treatments.

 

PAREA has submitted formal feedback to the European Commission’s consultation on the upcoming European Biotech Act, calling for mental health to be recognised as a strategic area and innovation opportunity.

 

The Biotech Act aims to make Europe a more attractive place to develop and launch innovative therapies by accelerating clinical trials, simplifying regulatory processes, strengthening biotech investment, and introducing new tools such as regulatory sandboxes. In its submission, PAREA argues that these tools must also work for complex mental health innovations, including treatments that combine pharmacological and non-pharmacological elements and do not fit traditional product-development models.

 

PAREA responds to consultation on EU4Health 2027 Work Programme

PAREA has submitted its response to the European Commission’s consultation on the EU4Health 2027 Work Programme, the EU’s flagship health funding instrument. We call for the strengthening of health systems’ capacity to address non-communicable diseases, with mental health recognised as a core priority, reflecting its impact on public health, productivity, and social cohesion. Our recommendations include stronger support for workforce development, implementation infrastructure, outcome measurement, access to care, and the translation of mental health innovation into routine practice.

 

PAREA founder Tadeusz Hawrot chaired a panel at the REAL Mental Health Foundation Summit in London, bringing together Natasha Müller from Kokoro, Neel Lakhani, VP of Innovation at the Clinton Health Access Initiative, and David Erritzoe from Imperial College London, to tackle a pressing question: given limited biotech industry interest in bringing novel mental health treatments to Europe, how can responsible access pathways be built now — through public systems, philanthropy, and new models of care — rather than simply waiting for industry-led approvals?

 

On Thursday, June 4th, our founder Tadeusz Hawrot took part in a panel at ICPR26 — the Interdisciplinary Conference on Psychedelic Research — alongside Metten Somers, Tonnie Prinsen-Reinders, and Wietse Rypkema. The discussion used a recent Dutch disciplinary ruling on psilocybin treatment as a springboard to explore the ethical, legal, and regulatory boundaries of professional responsibility in psychedelic therapy, and how professional standards must evolve in response to emerging clinical evidence and growing societal demand.

 

The Psychedelic Lived Experiences Initiative joins the PAREA Community Supporters network with a focus on elevating patient and participant voices in psychedelic care.

 

Built on the conviction that lived experience is genuine expertise, the initiative works to integrate firsthand perspectives into research, treatment design, and policy. Its efforts include advocacy, peer-led community building, and the first-ever Psychedelic Lived Experiences Summit, which brings patients, caregivers, and clinicians into direct dialogue. Through this work, it aims to make psychedelic care more human-centered, accountable, and grounded in the real-world experiences of those it serves.

 

NEWS FROM OUR PARTNERS

PsyPal, the EU-funded clinical trial investigating psilocybin therapy for psychological distress in individuals living with life-limiting illnesses, has expanded its inclusion criteria across its sites in Czechia, Denmark, the Netherlands and Portugal. The study will now be able to enrol a wider range of conditions in each country. Eligible conditions are amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), atypical Parkinsonism and advanced Parkinson's disease, and chronic obstructive pulmonary disorder (COPD). Visit the PsyPal website for details on which conditions are being included at each participating centre.

 

A new piece was published by Drug Science revisiting Ukraine's proposed rescheduling of classic psychedelics for scientific and educational purposes, first announced by the Ministry of Health in 2025. While formal approval has yet to materialise, delayed by regulatory complexity and lingering political hesitancy, momentum continues to build. Key developments include a new national drug strategy explicitly referencing novel PTSD treatments, an active institutional roundtable in Kyiv, and MAPS-supported therapist training with government backing.

 

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A detailed analysis by Dr Mourad Wahba for Drug Science examines the Czech Republic's newly published clinical guidelines for psilocybin-assisted therapy, which accompany legislation permitting its use under specialist supervision. The guidelines cover patient eligibility, team structure, training requirements, treatment protocols, and adverse event management. Wahba argues they represent a practical and flexible model for early-phase implementation, and considers how the framework could inform a comparable programme within the NHS.

 

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A new guidance paper published in European Psychiatry by the European Psychiatric Association outlines the current state of precision medicine in mental health and its implications for clinical practice and policy. The paper reviews advances in genomics, neuroimaging, AI, and digital technologies across the full clinical pathway, while identifying key barriers to implementation including limited biomarker validation, equity concerns, and regulatory gaps. It proposes strategic recommendations to support responsible and equitable integration of precision approaches into European mental health care.

 

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THE LATEST FROM EUROPE 

The WHO Regional Office for Europe and the European Commission have launched a new €11 million initiative under the EU4Health programme aimed at strengthening mental health systems across the EU, Iceland, and Norway. The project will support countries through policy dialogues, workforce training, data monitoring, and tailored capacity-building to advance a more comprehensive approach to mental health. Key areas include prevention, well-being promotion, adverse childhood experiences, and improving implementation of existing mental health policies.

 

France and Germany have issued a joint declaration calling for major EU action to strengthen Europe’s pharmaceutical industry, warning that the EU risks losing competitiveness to countries such as China and India amid growing geopolitical pressures. The declaration supports faster clinical trial approvals, stronger coordination on market access, increased support for European manufacturing, and implementation of initiatives including the Biotech Act and Critical Medicines Act. Notably, the two countries also call for a more harmonised and potentially binding European benefit assessment system for medicines, marking a significant shift in a debate that has long divided member states.

 

Recent developments from medicines’ regulators highlight Europe's growing capacity to integrate real-world evidence (RWE) in regulatory decision-making and evaluate innovative medicines using coordinated HTA processes. The first Joint Clinical Assessment (JCA) under the EU HTA Regulation has been published for a new oncology medicine, marking the start of a new system for jointly assessing the clinical value of innovative medicines across Europe. The framework is expected to reduce duplication of work between Member States and support more consistent evidence assessments for pricing and reimbursement decisions. In parallel, the European Medicines Agency (EMA) published its fourth progress report on the use of RWE, showing continued growth in the use of healthcare data to support regulatory decision-making.

 

A new European pilot project, FAST-EU, is testing whether multinational clinical trials can be authorised more quickly and consistently across Europe. Launched in early 2026, the pilot aims to complete coordinated approvals within 70 days, while maintaining safety and data quality standards. Early results are promising: the first completed procedures met or came close to the 70-day target, suggesting that faster, coordinated authorisation may be feasible across participating countries. This is relevant for Europe’s wider effort to strengthen clinical research, attract innovative trials, and improve patient access to new treatments.

 

The EU has officially launched the Scaleup Europe Fund, a new initiative intended to mobilise up to €5 billion for Europe’s deeptech scaleups, including medical innovation. The fund is designed to help promising European companies grow without having to rely on larger US or foreign investors, addressing one of Europe’s long-standing weaknesses: the lack of late-stage capital for companies ready to scale. The fund manager described the approach as “ultra-fast” and focused on backing Europe’s most competitive scaleups.

 

WHO Europe has published a new policy framework on Managed Entry Agreements (MEAs), developed through its Access to Novel Medicines Platform. MEAs are agreements between health technology developers and payers that can support access to innovative medicines while managing uncertainty around their clinical performance, real-world effectiveness, or budget impact.

 

The framework sets out voluntary principles to help countries design and implement MEAs more consistently, including when to use simpler financial agreements and when more complex outcome-based agreements may be appropriate. It also includes an uncertainty scale, flow chart, and checklist to guide decision-making. The framework is especially relevant as Europe faces growing pressure to enable access to high-cost and complex therapies while protecting health system sustainability.

 

In Europe, obtaining regulatory approval from the European Medicines Agency (EMA) is only one step toward patient access. New medicines must also undergo health technology assessment (HTA), which evaluates their added clinical value and informs national reimbursement and pricing decisions.

A new interview with Niklas Hedberg, Co-Chair of the EU Member State Coordination Group on HTA, provides insights into the implementation of the EU’s new HTA Regulation and the first Joint Clinical Assessments (JCAs) now underway. The discussion explores how the new system aims to reduce duplication across member states, improve consistency in evidence assessment, and ultimately support faster access to innovative medicines across Europe.

 

Upcoming Events with PAREA Participation

On 11–12 July, PAREA Project Officer Francisca Silva will be in Barcelona for a meeting organised by the preclinical working group of the EU COST Action-funded PSY-NET, held as a satellite event to the Federation of European Neuroscience Societies (FENS) Forum 2026. The meeting, titled "Crushing the Barriers in Psychedelic Science," addresses the need for knowledge sharing and coordination among scientists in preclinical and translational psychedelic research to strengthen the methodological rigour and translational validity of data across the field. Francisca will deliver a presentation and participate in a panel discussion on the regulatory aspects of translational psychedelic research within the European medicines regulatory framework.

 

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

Upcoming Events of Interest 

WAF2026 takes place September 9–13 in Girona, Spain. Unlike a typical academic conference, this is an Indigenous-led gathering centred on relationship, dialogue, music, art, and culture, bringing together practitioners, knowledge holders, and community leaders from across the field. Ayahuasca sits at the heart of some of the most pressing questions in psychedelic policy and practice, making this a gathering close to PAREA's work. PAREA is a community partner. Use code WAF2026 for a 10% discount on tickets at ayahuasca2026.com/tickets.

 

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