February, 2025

Dear First name / Readers,

 

It’s been an exciting and productive start to the year for PAREA. This week, we officially launched the MEP Action Group on Psychedelic Therapies, an important step in strengthening political engagement at the EU level. I want to extend my gratitude to the MEPs who have already joined us: Alex Agius Saliba (Malta, S&D), Tilly Metz (Luxembourg, Greens/EFA), Tomislav Sokol (Croatia, EPP), Romana Jerković (Croatia, S&D), and Vytenis Andriukaitis (Lithuania, S&D). The launch coincided with the start of the PsychedeliCare European Citizens’ Initiative, marking a major moment for psychedelic grassroot advocacy in Europe.

 

In January, I had the opportunity to attend the Davos annual meetings during the World Economic Forum, where mental health and brain health were firmly on the agenda. PAREA participated in discussions that highlighted the importance of innovation and investment in mental health, including psychedelic therapies, as part of broader societal transformation efforts.

 

Lastly, we are grateful to PAREA member Norrsken Mind for including PAREA among their latest grantees. With Norrsken  continued support, we are better positioned to contribute to advancing psychedelic science and policy in Europe.

 

 

 

PAREA NEWS

Yesterday, February 6, we partnered with PsychedeliCare at the European Parliament to co-launch their European Citizen’s Initiative and our re-established MEP Action Group on Psychedelics in Healthcare, focused on driving policy change towards evidence-based mental health innovation.

 

With impactful opening and closing by host MEP Tilly Metz (Greens/EFA) and co-host MEP Tomislav Sokol (EPP), there were presentations covering the background and latest research on psychedelic therapies, and an impactful testimonial by a patient having undergone LSD therapy after being diagnosed with cancer. PAREA was well represented, with our Treasurer Frédéric Destrebecq as moderator and team member Francisca Silva presenting on unmet medical needs in mental health and the PsyPal project.

 

In addition to re-launching PAREA’s MEP Action Group on Psychedelics in Healthcare, the event marked the beginning of PsychedeliCare’s year-long campaign to collect one million signatures to bring their calls for advancing psychedelic therapies to the European Commission. These include the development of standards of care for psychedelic therapies in Europe, the enhancement of EU-funded research on the therapeutic application of psychedelics, and the adoption of pragmatic positions on the global scheduling of these substances. 

 

You can add your signature to the PsychedeliCare Initiative here. Together, we will continue to generate awareness and build momentum for innovative and science-based mental health approaches in the EU.

During the week of February 3rd in Brussels, we held several policy meetings to further the conversation on psychedelic research and innovation. 

 

At the European Commission, we engaged with the Director General for Research, who oversees the €100 billion Horizon Europe programme, already supporting psychedelic research. We met with the Unit Combatting Disease team, including Head of Unit Kasia Jurczak, Deputy Head Petra Goyens, and colleagues Alessandra Martini, Tim Raemaekers, and Nika Merkus. The discussions highlighted the Commission’s openness to better understanding the therapeutic potential of psychedelics. We explored how Europe compares to the U.S. in this field and examined how public funding could accelerate the adoption of psychedelic-assisted therapies in the EU.

 

In the European Parliament, we had productive meetings with Polish MEPs Bogdan Zdrojewski and Dariusz Joński, who expressed genuine interest in supporting psychedelic research.

PAREA participated in key discussions on mental health innovation at this year’s Davos gathering, where global leaders in business, policy, and advocacy addressed urgent global challenges. Mental health took center stage as a critical issue, with growing recognition of its impact on economic and social stability.

 

As part of Mental Health Day at the Davos Social Innovation House, PAREA’s Founder, Tadeusz Hawrot, spoke during the Brain Capital & Human Flourishing: Connecting Brain Health, Psychedelics, Purpose, and Economic Prosperity panel, emphasizing how innovations—including psychedelic therapies—can transform mental health care and create value across industries. He also participated in the Psychedelics and Technodelics for Brain Optimization panel at the unDavos Summit, highlighting the need for responsible use and proper integration of psychedelic experiences.

 

Davos 2025 underscored that mental and brain health must be prioritized at the same level as cancer or pandemics. As AI-driven transformations reshape economies, addressing mental health challenges is more urgent than ever.

 

Read the full article on PAREA’s website here and watch one of the panel’s recordings here. 

On January 14, PAREA Founder and Executive Director Tadeusz Hawrot was in Tallin to attend the inaugural meeting of the SA TAIP (Foundation for Therapeutic Advancement and Innovation with Psychedelics in Estonia) on the theme of “Psychedelic-Assisted Therapy in Estonia and Europe”. Coinciding with the day of the PsychedeliCare launch, this marked a notable date for advancing these innovative mental health treatments across Europe.

 

In Estonia, the use of psychedelics in scientific research is allowed, and clinics using ketamine to treat certain cases of depression, with and without psychological support and psychotherapy, already exist. Estonian psychiatrists support the potential of psychedelic therapies to address difficult to treat conditions, such as alcohol use disorders co-occurring with PTSD and depression, and emphasise the need for promoting rational and evidence-based discussions about psychedelics.

 

By hosting this seminal seminar in Tallin, TAIP is taking meaningful steps to advance the conversation on psychedelic-assisted therapies in Estonia. Their other initiatives include the establishment of integration circles to support individuals who have independently sought psychedelic treatments and plans to fund future clinical research. PAREA takes pride in having Estonia represented within its network and looks forward to supporting their progress in this area.

January 2025 also saw exciting updates on PAREA's evolving community, with the International Center for Ethnobotanical Education, Research and Service (ICEERS) transitioning to full membership status after years of valued involvement as an Observer, and the welcoming of three new Community Supporters: Heal Ukraine Trauma (HUT), Centre for Evidence-Based Drug Policy (CEBDP), and Psilocybin Access Rights (PAR).

 

We extend our appreciation for the important work conducted by these organisations and look forward to meaningful collaborations in the year ahead.

NEWS FROM OUR PARTNERS

In their latest funding cycle, Norrsken Mind announced the award of 1.2 million euro to eight different research projects and non-profit initiatives in the psychedelics field in Europe. PAREA is honored to be among this list of grantees.

 

Other recipients include two clinical trials of psilocybin-assisted therapy for anorexia nervosa and depression, led by Lund University and the University of Copenhagen respectively, two studies of psychotherapeutic data from two Swedish trials of psilocybin for depression, and a report on reimbursement for psychedelic therapies led by Blossom. Alongside PAREA, non-profit initiatives receiving support include the Psychedelic Participant Advocacy Network (PsyPan) and Drug Science. You may find more details on all the funded projects here.

 

With over EUR 2.2 million allocated to impactful psychedelic projects since 2023, Norrsken Mind’s grant program is playing a crucial role in driving progress in the European psychedelics space. We are deeply grateful for Norrsken Mind’s continued support of our work, and for their invaluable contributions to advancing psychedelic science and regulation in Europe.

ADEPT (Advanced Education in Psychedelic Therapy) is the OPEN Foundation’s newly established therapist training programme, now accepting applications for its first cohort starting in May 2025. 

 

Spanning two years of hybrid learning and training by global leading experts, ADEPT is designed to equip licensed mental health professionals with the core knowledge and competencies needed to become skilled and responsible psychedelic therapists—grounded in ethics, science, care, and integrity. The programme is officially registered in the Central Register for Short Vocational Education (CRKBO) in the Netherlands, ensuring the highest quality criteria for professional education. 

 

ADEPT works towards establishing standards for therapist training that support the responsible and safe integration of psychedelic therapies in mental health care.

 

The European Psychiatric Association (EPA), a member of PAREA, has published a policy paper titled "Use of psychedelic treatments in psychiatric clinical practice". This paper reflects the growing recognition of psychedelics' potential as a transformative therapeutic tool in psychiatric care.

 

The policy paper looks into the emerging evidence supporting the therapeutic use of psychedelics for various mental health conditions. It also provides recommendations for their safe and effective integration into clinical practice, emphasizing the need for rigorous regulatory frameworks, standardized protocols, and robust training for professionals in this field.

 

PAREA is pleased to see the EPA taking a proactive stance on this important topic, furthering evidence-based discussions on the role psychedelics can play in addressing the mental health crisis. This initiative aligns with our shared commitment to advancing innovation in mental health care across Europe.

 

The publication of this policy paper marks a significant step toward fostering responsible research and practice in the field of psychedelic-assisted care. We look forward to supporting and collaborating with EPA in its ongoing efforts to guide the future of mental health treatments.

The European Brain Council (EBC) has released its final Joint Statement “Towards an EU Coordination Plan for the Brain” in the context of the official launch of its EU Health Policy Platform Thematic Network by the same title.

 

This document, endorsed by several partner organisations including PAREA, outlines the need and vision for EU coordinated action on brain health, and was shaped by insights gathered from two webinars and a public consultation with stakeholders across the brain health community.

 

The Joint Statement highlights the growing burden of brain conditions - both neurological and mental - as well as the broader importance of brain health in sustaining healthy societies and economies. It identifies challenges posed, namely, by insufficient or fragmented policy and research efforts and limited resources, and calls for enhanced multidisciplinary coordination embedded in policies and for the leveraging of existing initiatives in the area, such as the European Partnership for Brain Health.

THE LATEST FROM EUROPE

 

A leaked draft of the 2025 health research section of Horizon Europe outlines major funding prospects for psychedelic research, confirming an important shift in European health R&I priorities. With a budget of €803 million for health research, the EU is opening doors to further explore solutions to major health challenges including innovative mental health interventions.

 

Following the success of PsyPal, the first EU-funded clinical trial in psychedelics, the European scientific community is well-positioned to apply for a new call under the draft programme: Advancing innovative interventions for mental, behavioural, and neurodevelopmental disorders. The call aims to support clinical studies focusing on new therapeutic interventions, blending both pharmaceutical and non-pharmaceutical options. The funding is expected to range from €6-8 million, with a key emphasis on addressing the limited efficacy and high relapse rates seen with many current mental health treatments.

 

Additionally, the draft reveals that approximately €150 million will be allocated to the European Partnership for Brain Health over the next three years. PAREA played a role in shaping the partnership’s Strategic Research and Innovation Agenda through providing feedback via public consultations in 2024. The partnership aims to streamline funding across EU Member States, with a focus on fulfilling unmet medical needs in brain health—creating another critical avenue for psychedelic research support.

 

With proposals opening in May, the coming months could be a turning point for European psychedelic research.

The Commission has introduced a Biotech and Biomanufacturing Hub aimed at supporting innovative companies and scaling up biotechnological solutions to address societal challenges. The Hub will act as a collaborative platform, fostering cooperation among startups, SMEs, academia, industry leaders, and public bodies to accelerate the development and commercialization of new treatments and health innovations.

 

Key areas of focus for the Hub include:

The Hub also seeks to improve market access pathways for biotech products by addressing regulatory hurdles and creating a more innovation-friendly environment. These measures are expected to support the development of novel therapies and enable faster scaling of breakthroughs into real-world applications.

 

For biotech companies exploring innovative therapies, such as those working in the mental health space including psychedelic therapies, this initiative could provide much-needed infrastructure and resources to support growth and regulatory progress.

As of January 12, 2025, the European Union has begun implementing new rules on Health Technology Assessment (HTA)—a process that evaluates the medical, social, economic, and ethical aspects of new medicines and medical devices to inform pricing and reimbursement decisions across Member States.

 

The new EU HTA framework pertains to the clinical aspects of HTA, i.e. the relative clinical effectiveness and safety of new technologies compared with existing ones, introducing joint assessments of this data to avoid duplicated workload and streamline the procedure.

 

Joint assessments are carried out by an HTA coordination group and sub-groups composed of the national HTA bodies on a single EU-level file. The procedure is triggered once the marketing authorisation for a new product is validated by the European Medicines Agency and must be completed within 30 days. The new framework also emphasises the involvement of patients and clinicians in the HTA process.

 

The roll-out of the new rules will begin with assessments of cancer medicines and advanced therapy medicinal products (ATMPs). By 2026, the framework will extend to high-risk medical devices, followed by orphan medicines by 2028, and cover all medicinal products by 2030.

The European Medicines Agency (EMA) announced that the Clinical Trials Regulation (CTR) has become fully applicable, marking a significant milestone in harmonizing and streamlining clinical trial processes across the EU. The regulation replaces the previous directive, aiming to simplify trial submissions through a single online system—the Clinical Trials Information System (CTIS)—and enhance transparency and collaboration among EU Member States.

 

This regulatory change is designed to reduce administrative burdens, accelerate timelines, and improve safety oversight, ultimately making Europe a more competitive hub for clinical research. Importantly, the CTR supports the conduct of large, multi-country trials and ensures that clinical data is readily accessible for the public and researchers.

 

Read the full EMA announcement here.

The European Parliament has officially confirmed the establishment of a new standing committee for public health, known as SANT. This development marks a significant shift, separating public health matters from the broader Environment, Public Health, and Food Safety (ENVI) Committee.

 

The SANT committee will oversee key areas such as public health policy, pharmaceuticals and medical devices, health crisis preparedness, mental health, patient rights, and health aspects of bioterrorism. It will also collaborate with agencies such as the European Medicines Agency and the European Centre for Disease Prevention and Control.

 

The decision to create SANT reflects the growing importance of public health in the EU policy agenda, especially in the wake of lessons learned from the COVID-19 pandemic. By dedicating a standalone committee to health, the Parliament aims to ensure more focused and effective policymaking in this critical area.

 

With SANT in place, the EU is poised to take a more proactive approach to addressing public health challenges, prioritizing innovation, mental health, and crisis preparedness.

European Commissioner for Startups, Research, and Innovation, Ekaterina Zaharieva, has unveiled plans for a European Innovation Act. This ambitious initiative aims to position the EU as a global leader in innovation, ensuring breakthroughs in science and technology directly address societal needs and benefit citizens.

 

The Act, as described by Zaharieva, will focus on accelerating research-to-market transitions, fostering collaboration between the public and private sectors, and addressing systemic barriers to innovation. Emphasis will be placed on strategic fields such as health, climate, and digital technologies.

 

While the details remain under discussion, Zaharieva’s plans suggest a significant reshaping of the EU’s innovation landscape, potentially including the establishment of new funding mechanisms and support structures.

 

More updates on the Act’s development are expected soon, as the Commission moves forward with its legislative agenda.

 

Pro subscribers can access a detailed analysis of Zaharieva’s plans for the European Innovation Act, including its implications for health, life sciences, and innovation funding across Europe.

The first Europe-wide platform trial on depression treatments will utilise study designs from the Innovative Medicines Initiative EU-PEARL project. Traditional clinical trials for depression are resource-intensive and often inefficient, as approximately half of patients fail to fully respond to existing antidepressants. The innovative platform trial approach aims to address these challenges.

 

Developed under the EU-PEARL initiative, platform trials use a shared master protocol to test multiple treatments simultaneously, allowing ineffective treatments to be dropped and new therapies to be added without restarting the trial process. This approach is faster, less resource-heavy, and less burdensome for participants.

 

With funding from the Wellcome Trust, the trial will launch in six European countries—Germany, Spain, the Netherlands, Italy, Denmark, and the UK. Initially, two drugs and a shared placebo arm will be tested, with plans to expand the treatment pool over time. Patient enrolment is scheduled to begin in 2026.

 

This innovative trial design not only accelerates the delivery of robust results but also improves participant experiences and streamlines ethical and regulatory approvals, paving the way for more effective and patient-centric depression therapies.

The Commission’s Competitive Compass draft document sets the stage for a raft of measures to boost the EU's competitiveness, with significant implications for health and biotechnology. Central to these plans is the forthcoming Biotech Act, which promises a “forward-looking regulatory framework” to address longstanding challenges in Europe’s clinical trials environment.

 

While the Clinical Trials Regulation introduced in January 2022 was designed to streamline multi-country medical studies through a single application process, industry stakeholders have expressed dissatisfaction, citing persistent regulatory fragmentation. Each country’s individual approval is still required, making the EU less competitive compared to the U.S. and China. The Biotech Act aims to tackle these barriers and foster a more attractive landscape for investment and innovation in clinical trials.

 

Europe’s Apply AI Strategy is also part of the blueprint, focusing on advancing industrial uses of artificial intelligence in sectors like pharmaceuticals and improving public health services. Furthermore, the draft emphasizes the transformative potential of quantum technologies in health, such as revolutionizing drug discovery and scanning methods. To maintain a leading position globally, the EU plans to roll out a Quantum Strategy and Quantum Act.

 

Start-ups and small businesses in life sciences could also benefit from better funding opportunities under a proposed TechEU program within the European Investment Bank Group, designed to support innovation and scale-up efforts.

 

The Biotech Act and broader Competitiveness Compass outline a comprehensive strategy to not only boost Europe’s standing in clinical research but also ensure health innovation aligns with societal needs and economic resilience.

The Portuguese Psychologist Association (“Ordem dos Psicólogos Portugueses” - OPP) has released a 35-page document outlining key definitions, scientific evidence and initial recommendations on the therapeutic use of psychedelics.

 

The document provides information and professional guidance on the current landscape of psychedelics for mental health in Portugal, geared towards psychologists. This release follows a 2023 resolution from the College of Psychiatry of the Portuguese Medical Association, which recognised growing activity in this area - including the off-label use of ketamine for treatment-resistant major depression - and noted a need for experienced professionals capable of providing psychotherapeutic support before and after psychedelic interventions.

 

In addition to useful background on psychedelic-assisted therapy, the OPP document offers a few recommendations for working with individuals who are considering undergoing these treatments or experiencing psychological difficulties after a psychedelic experience. Importantly, it highlights the need for enhanced education and training of psychologists, equipping them with the knowledge to provide evidence-based support and empower patients to make well-informed decisions. The document also stresses the importance of multidisciplinary collaboration among health professionals and bioethics experts to ensure the safe and effective development of psychedelic therapies.

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