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Psychedelic Access and Research European Alliance

PAREA

Psychedelic Access and Research European Alliance (PAREA) is a non-profit, membership-led, multistakeholder and multidisciplinary partnership.

Lobbying Activity

Meeting with Yvan Verougstraete (Member of the European Parliament, Shadow rapporteur) and European Chemical Industry Council and

27 Jan 2026 · European Competitiveness Fund

Meeting with Ekaterina Zaharieva (Commissioner) and

6 Nov 2025 · Mental health research

Meeting with Aurelijus Veryga (Member of the European Parliament)

2 Sept 2025 · Developments in mental health policy

Response to Biotech Act

6 Jun 2025

PAREA welcomes the Commissions ambition to strengthen the European biotech ecosystem. The Biotech Act can play a crucial role in unlocking innovation in areas that combine high public health need with persistent underinvestment - notably mental health. Mental health is not just another disease area. It is a foundational layer that cuts across all aspects of human life and societal functioning. It shapes our ability to work, learn, connect, and care for ourselves and others. Mental health conditions now cause more years of poor health than cardiovascular disease, cancer, diabetes, and chronic respiratory illness combined. They are becoming the leading cause of disability-related early retirement in many countries. Depression accounts for up to 50% of chronic sick leave across the EU. In Germany, the number of sick days taken due to mental health issues has doubled over the past decade, while in France, mental illness has become the number one health insurance expense. Most pharmacological psychiatric treatments are still based on mechanisms discovered over 50 years ago. Over 143 million people in the WHO European Region live with some form of mental health condition and only 6.9% receive optimal, effective treatment, with the single biggest barrier being that many do not recognise or believe they need help. In the past five years, only five new psychiatric medicines were approved in the EU, compared to over 120 in oncology. Psychiatry also ranks last in the share of commercial clinical trials conducted in Europe. As the Heitors report recently stated: A clear example is mental health, which has not been addressed by the pharmaceutical industry at the same level as many other diseases. This challenge is not simply scientific, it is structural. Mental health is widely recognised as a space where conventional market incentives have failed to stimulate adequate innovation. This has been echoed in the April 2024 Letta Report, which identified mental health - along with antimicrobial resistance and neurodegenerative diseases - as a top priority for urgent, cross-border public investment. The EU must ensure that biotech policy does not just follow capital, but helps direct it toward societal needs, and most notably toward mental health. The Biotech Act should therefore enable a new generation of mental health innovation to flourish, including treatments with novel mechanisms of action, such as psychedelic therapy. Much of the activity in this space is being led by early-stage biotech firms and academic spinouts. These developers face significant barriers, including limited access to capital, regulatory uncertainty, and infrastructure gaps. The Biotech Act can address these challenges by: Ensuring early-stage biotech developers working in high-need, low-return areas such as mental health can benefit from targeted support mechanisms. Expanding access to early scientific advice, regulatory flexibility, and PRIME-like pathways to include mental health biotechnologies by default. Encouraging publicprivate co-investment models and supporting EU-level instruments such as a dedicated Mental Health Innovation Fund. Facilitating clinical trial capacity, infrastructure, and cross-border collaboration for mental health and brain-related conditions, including through the forthcoming Brain Health Partnership. Promoting data access and real-world evidence platforms to accelerate uptake and scale. Europe has a chance to lead in mental health innovation, not only because the need is urgent, but because for the first time in decades, transformative solutions, such as psychedelic therapies, are within reach. Europe has the policy window to act. In contrast to growing uncertainty in the US, Europe is positioning itself as a stable, values-based environment for science. If the EU seizes this opportunity, the Biotech Act could become a model for how innovation policy can serve both competitiveness and societal resilience.
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Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

5 Jun 2025 · Badania nad terapiami z wykorzystaniem substancji psychodelicznych

Response to EU Life sciences strategy

11 Apr 2025

Mental Health Innovation in the EU Life Sciences Strategy Europe stands at a critical juncture in health innovation. Half of us will experience a mental illness in our lifetime. The World Economic Forum warns that poor mental health is a looming global economic emergency. Yet our ability to address this growing burden remains dangerously limited. Despite the crisis, innovation in mental health has stagnated for decades. In the past 5 years, only 5 new psychiatry medicines have been approved in the EU, compared to about 120 in oncology. Most mood disorders medications still rely on mechanisms discovered by chance in the 1950s. Meanwhile, pharmaceutical investment has drifted away from this field. As one R&D head explained when a major company exited depression research, the gaps in understanding are simply too large for any one company. The EU Life Sciences Strategy offers a chance to change course. The Commissions call for evidence rightly flags poor translation of research, lack of incentives, and financing hurdles as barriers to innovation all especially true in mental health. We urge the EU to go further: make mental health innovation a strategic priority where Europe aims to lead globally, not just catch up. If Europe seizes this moment investing in mental health research and solutions it can set the pace internationally. The payoff would be a healthier, more productive society and a competitive edge in a field of growing importance. The EU Life Science Strategy should focus on four key areas: 1. Strengthen incentives and financing by i) introducing targeted incentives (e.g. special regulatory designations, innovation prizes, extended market exclusivity) to stimulate the pipeline, much as orphan drug incentives did for rare diseases. ii) Increase dedicated funding for mental health innovation through Horizon Europe and InvestEU. 2. Launch an Europe-wide Mental Health Innovation Mission (building on the upcoming European Brain Health Partnership) to align efforts across countries and sectors. This mission should set bold goals (e.g. cutting suicide rates, new treatments for treatment-resistant depression) and coordinate public-private collaboration to achieve them. A mission approach will break silos and ensure that research, clinical trials and implementation feed into each other across Europe, rather than fragmented pilots. 3. Support the startups and SMEs driving breakthroughs with better access to capital and expertise. Most novel mental health ventures today are led by small companies, but they face major funding and regulatory barriers. The strategy should create a more nurturing ecosystem through measures such as dedicated EU grants, an investment fund for mental health innovation, and streamlined regulatory advice and fee waivers for developers of high-priority mental health treatments. 4. Ensure health systems are ready to adopt innovation. This means updating regulatory and reimbursement frameworks so that novel mental health treatments are evaluated and approved efficiently, and then integrated into care. The EMA should proactively support new kinds of therapies (e.g. combination psychotherapy-drug treatments) with flexible guidelines. At the same time, Member States should invest in training clinicians and infrastructure to deliver emerging treatments. Building public trust and reducing stigma through education will be critical so that new options are embraced by patients and professionals. By acting on these priorities, the EU can transform mental health from a neglected problem into a showcase of European leadership. We urge the Commission to make mental health a strategic pillar of the Life Sciences Strategy a bold commitment that will address a pressing health crisis and position Europe as the worlds leader in mental health innovation.
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Meeting with Kasia Jurczak (Head of Unit Research and Innovation)

5 Feb 2025 · Presentation of the Psychedelic Access and Research European Alliance (PAREA), and exchanges on research policies and funding needs in the field of psychedelic substances to treat mental disorders

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

11 Nov 2024 · mental health innovation

Meeting with Tomislav Sokol (Member of the European Parliament) and American Chamber of Commerce in Belgium

23 Oct 2024 · Health policy

Meeting with Sunčana Glavak (Member of the European Parliament)

22 Oct 2024 · Psychedelic therapies and mental health innovation

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

18 Oct 2024 · przygotowanie Europy do bezpiecznego i odpowiedzialnego wdrażania terapii psychodelicznych w europejskich systemach opieki zdrowotnej.

Meeting with Tilly Metz (Member of the European Parliament)

12 Sept 2024 · mental health

Meeting with Friedrich Pürner (Member of the European Parliament)

11 Sept 2024 · psychedelic assisted therapies

Response to A comprehensive approach to mental health

13 Feb 2023

PAREA applauds the new EU mental health initiative and, in particular, its objectives of support and improving access to treatment and care of mental health problems, focusing on evidence-based innovative, promising and personalised approaches and interventions, effective treatments and high-quality care. Mental ill-health represents the area of unmet needs par excellence and the WEF Global Risks Report 2023 identified severe mental health deterioration as one of the key risks in the years to come. Psychedelic-assisted therapies (PATs) are emerging as a potent new class of treatments for mental, neurological and substance use disorders, as shown by the rapidly growing, rigorous, and compelling body of research. In conjunction with proper psychosocial support, they hold the potential to provide safe, rapid acting, and robust clinical improvements with durable effects. While no treatment is without risks, psychedelic compounds are non-toxic and non-habit forming, and research shows that PATs have good physiological and psychological safety profiles when delivered in controlled and supportive settings. Unlike current treatments that mostly address symptoms, these therapies help to confront the root causes of mental health problems or addictions. In doing so, they demonstrate a unique ability to restore a sense of purpose and connection. This, coupled with increased neuroplasticity, provides a deep foundation for those affected by mental illnesses to embark on a healing process. A crucial aspect of PAT is that improvements are often seen across the board: e.g., someone treated for PTSD may also drink less, have a healthier relationship with food, and feel less depressed. Moreover, research indicates that PAT can improve capacities for coping and making meaning, increase empathy, and foster a sense of social and environmental connectedness. As such, PAT could help fill the current gap in preventative mental healthcare. First psychedelic novel treatments will likely be approved by the FDA in 2024. Soon after, the EU may follow, and millions of Europeans may be eligible to undergo PAT. This is an unparalleled opportunity which also calls for bold but thoughtful measures. We need to develop the infrastructure for the highest quality safe, affordable, and equitable access to PATs so that they can benefit the greatest number of people. This will include establishing good standards of practice, training of specialised therapists, credentialing and licencing, safe and ethical use monitoring, protocols to support people with challenging experiences, engagement of communities and peer support networks, and developing ethical guidelines and data standards. To address these issues proactively, the US administration is establishing an inter-agency Federal task force. We urgently need to formulate a similar initiative in Europe to address numerous policy and regulatory considerations related to the future roll-out of PATs. The EU initiative on a comprehensive approach to mental health is perfectly placed to host such efforts. It can drive the efforts to develop European guidelines that the EU Member States could choose to follow as they put in place frameworks and structures to accommodate the medical use of psychedelics. Such central coordination will have a clear EU added value and will create an effective and efficient mechanism to advance the field, as opposed to having EU countries preparing individually and duplicating efforts. Science is revealing that psychedelic substances can be powerful tools with considerable potential for alleviating human suffering. Through cooperative and EU-led stakeholder engagement, a short window of opportunity opens for the creation of a therapeutic framework that can facilitate safe, ethical, accessible and equitable access to PAT. We must act now we owe it to over 100 mil. EU citizens affected by mental health conditions and substance use disorders who are often in desperate need for better treatments.
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Meeting with Sara Cerdas (Member of the European Parliament)

17 Dec 2022 · Terapia assistida por agentes psicadélicos

Meeting with Frédérique Ries (Member of the European Parliament)

30 Nov 2022 · Advancements in the developement of psychedelic therapies

Meeting with Sara Cerdas (Member of the European Parliament)

13 Oct 2022 · Terapia assistida por agentes psicadélicos

Meeting with Sara Cerdas (Member of the European Parliament)

13 Oct 2022 · Fármacos psicadélicos

Meeting with Alex Agius Saliba (Member of the European Parliament)

1 Sept 2022 · psychedelic access for mental health patients

Meeting with Cyrus Engerer (Member of the European Parliament)

31 Aug 2022 · Mental Health

Meeting with Tilly Metz (Member of the European Parliament)

11 Jul 2022 · Health

Response to A New European Innovation Agenda

10 May 2022

When it comes to health, nowhere a need for more R&I is starker than with mental, neurological and substance use disorders. In this context, the psychedelic-assisted therapy has shown promise for a range of indications, including: 1 depression (Carhart-Harris et al., 2016; Davis et al., 2020), 2 end-of-life anxiety (Griffiths et al., 2016), 3 addiction (Johnson et al., 2014) and 4 OCD (Moreno et al., 2006). Indirect evidence also supports its potential for treating eating disorders (Renelli et al., 2020; Spriggs et al., 2020) and chronic pain (Whelan and Johnson, 2018). 4 separate systematic reviews have been published in 2021 highlighting the potential of psychedelics for those conditions and more: end of life care, brain injury, neurodegenerative disorders, mood disorders, smoking cessation and addiction. The renaissance of research into the neuroscience and therapeutic applications of psychedelics-assisted therapy represents one of the most promising and important initiatives in brain science and neuropsychopharmacology in recent times. This is why the FDA granted ‘breakthrough therapy’ status to two independent multi-site DB-RCTs, aiming to bring psilocybin therapy to marketing authorisation for depression, while related work is currently underway across Europe. The third breakthrough designation went to study PTSD with MDMA. In May 2021, Nature Medicine published the results of the most advanced trial of psychedelic therapy to date. In this Phase 3 trial of MDMA-assisted therapy for PTSD, 88% of participants who received MDMA in conjunction with trauma-focused therapy experienced a clinically significant reduction in symptoms; 67% of participants no longer met criteria for a PTSD diagnosis. The US NIH awarded a grant for a multisite trial to study psilocybin for tobacco addiction and the Australian Government’s Medical Research Future Fund announced the $15 m. grant for clinical trials with psychedelics for major depression with alcohol use, anorexia nervosa, PTSD and anxiety disorders. Top tier US universities like NY University, Johns Hopkins and the University of California established centres dedicated to the study of psychedelic compounds and many more or are in the process of doing so. In Europe, there only exists the Centre for Psychedelic Research at Imperial College London. Accelerating innovation in this field will only be achievable through the legal rescheduling of psychedelics. In 2020, the EU and its MS said in the CND-Resolution 63/3 that ”From a medical care perspective, it is particularly difficult to accept that people continue to suffer because of no or inadequate availability, or the lack of affordability of internationally controlled substances for medical purposes in reliable pharmaceutical quality.” The EU needs to address the regulatory, financial and cultural barriers which weigh on scientific research into the use of psychedelics for medicinal purposes. We encourage the EU to lead international efforts to reschedule certain psychedelic compounds taking into account the most recent scientific developments. Now, psychedelic compounds are classified as Schedule I drugs — “ with no currently accepted medical use and high potential for abuse”. PAREA calls on the EU to embark on more research activity and to stimulate innovation with regard to the use of psychedelics for medicinal purposes. More innovative ways of bringing these novel medicines should be employed. Psychedelic clinical research could benefit significantly from the RWE approach, given that the existing data so far supports several psychedelic compounds as: i) a proven, safe substance; ii) addressing an urgent and unmet healthcare need. This makes compounds like psilocybin, LSD and MDMA strong candidates for RWD drug development. Additionally, given that the costs of an RWD trial are significantly lower than those of RCT’s, it could help smaller drug development European companies with advancing their own trials.
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Meeting with Sara Cerdas (Member of the European Parliament)

10 May 2022 · Uso de substâncias psicaldélicas