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The EU’s Plan for a €6.5M Study of Psychedelics To Treat Mental Disorders

At the recent launch of PsyPal, the first EU-funded clinical research project focused on psychedelic-assisted mental health treatments, MEPs were informed…



At the recent launch of PsyPal, the first EU-funded clinical research project focused on psychedelic-assisted mental health treatments, MEPs were informed about the innovative strides being made in the field. The project, supported by a €6.5 million grant from Horizon Europe, seeks to explore the therapeutic benefits of psilocybin, particularly for patients in palliative care suffering from severe neurological and respiratory conditions.

Greens MEP Tilly Metz highlighted the growing realization within the scientific community that psychedelics could not only revolutionize mental health care but also provide new approaches to neurological diseases. PsyPal will specifically investigate how psilocybin-assisted therapy could alleviate anxiety and depression in patients with chronic obstructive pulmonary disorder, multiple sclerosis, amyotrophic lateral sclerosis, and atypical Parkinson’s disease. The project will involve 19 organizations across nine European countries and aims to recruit around 100 patients at four clinical sites.

The event, hosted by MEP Cyrus Engerer, also focused on future regulatory challenges and opportunities. “As we move forward, we’ll need to develop a regulatory framework that balances accessibility with safety,” Metz stated, emphasizing the importance of creating supportive guidelines for the production, distribution, and administration of psilocybin.

S&D MEP Radka Maxová discussed the necessity of establishing a regulated environment that ensures safe and clear contexts for psilocybin use, along with proper training for healthcare professionals. Echoing her sentiments, EPP’s Tomislav Sokol stressed the need for increased health funding in the upcoming EU budget to strengthen common European health policies, particularly for brain disorders.

Sara Cerdas, also from the S&D group, compared the slow pace of innovation in mental health treatments to the challenges faced in developing new antibiotics. She referenced her own report, which called on the European Commission to prioritize mental health in Horizon Europe and future frameworks.

Despite significant potential shown in managing mental health disorders like PTSD, depression, and anorexia, the use of psychedelic drugs remains largely illegal in Europe, and none were approved for psychological conditions by the European Medicines Agency (EMA) in 2022 or 2023. However, the global perspective is gradually shifting, with countries like Australia regulating the medical use of psychedelics and the US expected to approve MDMA-assisted therapy for PTSD.

The PsyPal trial is set to begin dosing patients in January 2025 and will continue for two years. “Psychopharmacology has been relatively stagnant, and the increase in studies and funding brings hope,” said principal investigator Robert Schoevers.

Schoevers also highlighted the unique nature of psychedelic therapies, which require more infrastructure and trained professionals compared to traditional treatments, potentially discouraging investment from big pharma. Yet, interest from the pharmaceutical industry is growing, albeit cautiously.

Tadeusz Hawrot, founder of the Psychedelic Access and Research European Alliance (PAREA), noted the support from the European Commission for using psychedelics to meet unmet medical needs. He also mentioned the potential for collaborative projects through the Innovative Health Initiative, although engagement from large pharmaceutical groups in Europe has been limited.

The launch of a new partnership on brain health by the Commission next year could open more doors for funding and research, aligning with efforts to harmonize regulations and standardize testing frameworks across the EU. As the PsyPal project progresses, its results will be crucial in shaping future policies and practices in the treatment of mental health, potentially leading to more evidence-based and innovative therapies.

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