There are decades where nothing happens; and there are weeks where decades happen. At the risk of sounding dramatic, European psychedelic therapy may have just lived through one of those times.
In early May, a series of key events at the European Parliament between patients, policymakers and regulators underscored the increasingly established nature of the psychedelic therapy industry across the bloc. Today, what was once considered a fringe idea is increasingly accepted by the mainstream medical establishment as a treatment worth taking seriously, backed by a growing body of evidence.
On 6 May, the Psychedelic Access and Research European Alliance (PAREA), alongside the MEP Action Group on Psychedelics in Healthcare and the Ukrainian Psychedelic Research Association (UPRA), organised an event into the use of psychedelic therapies for war-related traumas.
The event focused on its application within a Ukrainian war context, due to an increasing need for medical solutions to veteran and civilian war-related conditions like trauma, anxiety and more: research shows that nearly half (45.9%) of Ukrainian soldiers suffer from PTSD. The event also acknowledged the rapid growth of clinical research on psychedelics across Europe, and the urgent need for the continent to address this emerging field of medicine. The day ultimately finished with calls for Ukrainian institutions to accelerate the development of a safe, ethical and rigorous framework for controlled access to psychedelic-assisted care with European support.
The following day, PAREA organised the first ever European Forum of National Psychedelic Societies in Brussels, gathering organisations and policymakers from 25 countries to discuss how to establish safe and equitable access to psychedelic therapies.
Slow and steady
Both of these key events highlight just how far psychedelics have come in being perceived as a legitimate medicine in the European Union. For almost a decade, Switzerland was an outlier after pioneering special access to psychedelic-assisted therapy in 2014, using MDMA and LSD for post-traumatic stress disorder and treatment-resistant depression (later adding psilocybin in 2021). Czechia is also advancing psychedelic access and research, offering since the start of this year widespread access to psilocybin for depression and other mental health disorders.
Recent years have also seen successful pushes to expand access to psychedelic therapy across the continent. Horizon Europe’s project PsyPal is funding multi-site clinical trials in Czechia, Denmark, the Netherlands and Portugal into psychedelic-assisted palliative care for distressed patients with Chronic Obstructive Pulmonary Disorder (COPD), Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS, also known as MND), and advanced Parkinson’s disease. Just last year, Germany took a cautious step forward with a compassionate care access for treatment resistant depression in 2025, enabling licensed psychiatrists to identify patients that would benefit from such treatment.
European hesitancy
While these advances are noteworthy, Europe-wide access has not happened yet. Europe-wide campaigns like PsychedeliCare, which attempted to gather a million signatures in support of psychedelic medicine in one year, shed some light on the challenges of this mission. While they featured frequently in national media, their mission ultimately failed, raising just over 17,000 signatures. In their self-impact report, PsychedeliCare acknowledged how pre-existing stigma around psychedelics, social media content bans as well as reticence from politicians to publicly support psychedelic regulation (despite private endorsements) meant their campaign struggled to reach its goal.
Another key challenge to expand access is a very logistical one: how would psychedelics be regulated within a multi-nation structure like the EU, where individual nations often prefer to conduct their own analysis of medicines?
Psychedelic therapy approval would have to come from the European Medicines Agency (EMA), the bloc’s primary medicines regulatory authority. To date, the only psychedelic medicine they’ve given marketing authorisation for is esketamine (commercialised as Spravato) for treatment-resistant depression.
An EMA workshop held in 2024 with patients, professionals, academia and industry interested in furthering access to psychedelics for mental health conditions highlighted some key concerns that need to be addressed. In it, EMA regulators underscored the importance of demonstrating psychedelic therapies’ “positive benefit-risk balance” – a crucial piece of evidence that determines whether medications receive marketing approval or not. This is primarily determined by producing high-quality clinical data that demonstrates psychedelics’ clear, repeatable and standardised efficacy results.
Challenge after challenge
Another challenge when it comes to psychedelic therapies is the multidisciplinary nature: unlike most standalone medications or treatments, psychedelics are often used in psychedelic-assisted care, which combines the drug itself with psychotherapy or other forms of psychological support. This requires designing clinical trials that bring together the pharmaceutical development of the drug, the medical practice around it, and the development of complementary psychotherapy treatments, which gets complicated.
The EMA regulators also noted the challenges around designing “robust clinical trials” similar to those that other medicines go through. The psychoactive nature of psychedelics means that there are issues with functional unblinding – when patients can guess whether they are receiving a treatment vs a placebo based on the effects of the drug. This awareness can create expectancy effects and bias in clinical trials that need to be addressed, and the report does suggest a few options including using remote, blinded independent raters and administering different doses.
Yet another issue pertains to “set and setting”: if psychotherapy is integrated into the treatment, clinical trials will have to account for added bias of the therapy. This also creates issues for standardisation. Some other challenges that regulators noted include issues with selection bias, where only enthusiasts will want to participate; establishing the relationship between dose and effect; understanding the long term effects; and the subjectivity of patient experience.
Despite recent wins, there is still a long road ahead before psychedelic-assisted therapies become widely accessible across Europe. Regulators will need to grapple with questions that most conventional medicines and treatments rarely pose, from how to account for functional unblinding to how to assess profoundly subjective experiences within traditional clinical trial frameworks. Since January 2025, the EU Health Technology Assessment Regulation has been looking to harmonise clinical assessments conducted on medicines to avoid duplication and delays in access; these efforts are likely to accelerate a European “acceptance” of medications, no matter where the clinical data is collected.
Nonetheless, last month’s events show that debates on psychedelic treatments have made their way into the heart of Brussels, and the conversation has shifted from whether these therapies deserve consideration to how they can be evaluated and implemented safely. Millions of Europeans living with conditions for which current treatments fall short – from PTSD to MS – stand to benefit.
