MEPs were informed on Tuesday, during the launch of PsyPal, the inaugural EU-funded clinical research project exploring psychedelic-assisted mental health treatments, that despite the growing awareness of mental health issues, there hasn’t been a translation of this awareness into innovative treatments.
Tilly Metz, a Greens MEP, highlighted the potential of psychedelics to revolutionize mental health care and possibly address other ailments such as neurological diseases. With a focus on patients with chronic obstructive pulmonary disease, multiple sclerosis, amyotrophic lateral sclerosis, and atypical Parkinson’s disease, the €6.5 million Horizon Europe project will specifically investigate the use of psilocybin-assisted therapy to alleviate anxiety and depression in patients receiving palliative care.
Nineteen organizations from nine European countries are collaborating on this project, which plans to recruit around 100 patients across four clinical sites in Europe. Hosted by MEP Cyrus Engerer, the event was organized under the auspices of the Brain Health & Neurological Conditions MEP Interest Group and the MEP Action Group for the Medical Use of Psychedelics, with MEPs expressing their anticipation for future regulatory roles beyond the current study.
Metz emphasized the importance of evidence-based studies like PsyPal for legislative work, stressing the need for a supportive regulatory environment. This sentiment was echoed by S&D MEP Radka Maxová, who emphasized the necessity of establishing guidelines for the safe production, distribution, and administration of psilocybin, along with proper training standards for healthcare professionals.
Tomislav Sokol from the EPP stressed the importance of securing more funding for health research in the upcoming EU budget, particularly for brain disorders, while Sara Cerdas from the S&D group likened the stagnation in mental health treatments to the challenges faced in developing new antibiotics. She advocated for the creation of a mental health mission in Horizon Europe and the next framework program.
Despite the potential of psychedelic drugs in treating mental health disorders, their use remains largely illegal across Europe. They are classified as Schedule 1 drugs with no recognized medical use by the United Nations. However, research indicates their efficacy in managing conditions such as post-traumatic stress disorder, anorexia, and depression. Notably, Australia became the first country to regulate the medical use of psychedelics, with MDMA-assisted therapy for PTSD expected to gain approval in the US.
The European Medicines Agency (EMA) has not approved any new treatments for psychological conditions in recent years. The PsyPal research team aims to commence patient dosing in January 2025, with the trial spanning two years. Principal investigator Robert Schoevers expressed optimism about the increasing interest and funding in psychopharmacology, with the EMA planning a workshop in Amsterdam to discuss the future regulatory framework.
One of the challenges for regulators is the departure from traditional treatments, as psychedelic therapies require a combination of medication and psychotherapy. Additionally, the labor-intensive nature of these therapies, along with the need for specialized healthcare professionals, poses hurdles for industry investment.
While there is interest from large pharmaceutical associations in researching the medical applications of psychedelics, there’s a hesitancy to engage in collaborative projects. However, initiatives like the Innovative Health Initiative offer potential avenues for research funding.
Charlotte Marchandise, executive director of the European Public Health Association, emphasized the importance of projects like PsyPal in addressing the lack of research in mental health treatments. She called for increased funding, harmonized regulations, and standardized testing frameworks across the EU to facilitate innovation and ensure widespread access to effective treatments.
