Psychedelics: The pathway to implementation in the European healthcare systems
This much-needed review (2025) examines the challenges of integrating psychedelic therapies into European healthcare systems, highlighting that beyond obtaining regulatory approval, these treatments must also pass health technology assessments in individual countries, a process complicated by the lack of studies comparing psychedelics to existing treatments and the difficulty of evaluating therapies that combine drugs with psychotherapy.
Substances such as psilocybin, LSD, DMT and MDMA have shown promising effects across a range of psychiatric disorders, particularly major depressive disorder (MDD), treatment-resistant depression (TRD), anxiety disorders and substance use disorders. The authors of the review explain that, unlike conventional antidepressants, these substances often produce rapid and sometimes sustained improvements after only one or two administrations when combined with structured psychological support. This combination of pharmacological effects and therapeutic context is commonly referred to as psychedelic-assisted therapy.
Despite this emerging evidence base, the authors emphasise that translating psychedelic therapies into routine clinical practice in Europe is not straightforward. Approval by the European Medicines Agency (EMA) is only the first step. Even after regulatory approval, new treatments must pass Health Technology Assessment (HTA) processes in individual European countries. HTA bodies do not only assess whether a treatment works and is safe, but whether it provides meaningful additional benefit compared with existing treatments and whether it represents good value for public healthcare systems.
“ The integration of psychedelic therapies into European healthcare is a nuanced process that involves not only obtaining European Medicines Agency (EMA) approval but also successfully navigating Health Technology Assessment (HTA) evaluations across member states. After EMA approval, which focuses on the safety, efficacy, and quality of the therapeutic, HTA agencies assess these therapies for their “added therapeutic value,” considering factors like cost-effectiveness, clinical outcomes, and overall societal impact. Each country's HTA, including the UK’s National Institute for Health and Care Excellence (NICE), Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), and France’s Haute Autorité de Santé (HAS), plays a pivotal role in determining reimbursement and access to these treatments.
An added challenge is that HTA bodies in Europe often require active comparator studies rather than just placebo controls to establish a treatment’s advantage over existing standard of care – a particular hurdle for psychedelic-assisted therapies, where controlled trials against active comparators are almost completely lacking. Furthermore, psychedelics are typically integrated with psychotherapy, adding complexity to HTA evaluations, as few frameworks currently assess the value of combination therapies within healthcare systems.
Creating a standardized HTA approach or a unified European guideline for such novel treatments could promote equitable access across countries, helping to overcome the discrepancies in market access and patient reach across Europe.”
Gründer, G., Mertens, L. J., Spangemacher, M., Meyer-Lindenberg, A., & Jungaberle, H. (2026). Psychedelics: The pathway to implementation in the European healthcare systems. European Neuropsychopharmacology, 102, 41-48. Access paper
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