Germany is navigating the complex landscape of integrating psychedelic-assisted therapy (PAT) into its healthcare system, balancing promising therapeutic potential with stringent regulatory frameworks and significant training gaps. While substances like MDMA and psilocybin have shown substantial long-term alleviation of symptoms in patients suffering from psychopathologies such as PTSD, TRD, major depressive disorder (MDD), end of life anxiety, obsessive–compulsive disorder (OCD), substance use disorders (SUD), psychotic conditions, and more, Germany's path to adoption is fraught with challenges.
Economic Burden and Unmet Needs
The economic and human costs of PTSD and depression in Germany underscore the urgent need for more effective interventions. Trauma-related healthcare costs range from 524.5 million to 3.3 billion euros annually, while depression adds another 1 to 5.2 billion euros. Current pharmaceutical treatments, such as serotonin-reuptake inhibitors (SSRI), offer limited efficacy and fail to fully address the needs of individuals with PTSD, depression, or their comorbidities. PTSD patients typically suffer for about 6 years, with a 50–100% likelihood of comorbid conditions such as major depressive disorder (MDD), panic disorder, and substance use disorder (SUD). Per-patient costs were 43,000 EUR, three times higher than for those without PTSD, driven by increased healthcare utilization, impaired work capacity and reduced quality of life.
Regulatory Landscape and Gatekeeper Institutes
The European Medicines Agency (EMA) grants marketing authorization for new medicines across the EU. In Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees clinical trial approval and safety considerations. The Federal Joint Committee (GBA) negotiates costs to be reimbursed by federal insurers for new medications. The Institute for Quality and Efficiency in Health Care (IQWiG) compares new therapies with standard treatments, such as cognitive-behavioral therapy (CBT) and SSRIs. However, the IQWiG may face challenges in evaluating new therapies if there are insufficient comparisons with standard therapies in the published literature, in such cases the absence of direct head-to-head data can lead the IQWiG to conclude that a therapy's benefit cannot be adequately assessed, potentially overlooking its actual therapeutic value.
EMA's Evolving Opinion on Psychedelics
The EMA aims to create a supportive regulatory framework to facilitate psychedelic medicine as a novel form of therapy and on March 16, 2023, acknowledged the potential of PAT for various mental health conditions. However, concerns were raised at that time regarding the challenges developers may encounter in meeting the rigorous scientific and regulatory standards required for marketing authorization of these products. The EMA has identified scientific, legal, and implementation obstacles in approving psychedelics, including maintaining double-blind conditions, determining optimal doses, ensuring long-term efficacy, integrating psychotherapy, and managing potential adverse effects. To close the identified data gaps, the EU recently awarded a €6.5 million grant for the PsyPal trial, a clinical study involving 19 partners from nine European countries.
Accessibility and Barriers
There are currently very few legal avenues for patients to access not-approved psychedelics in Germany. According to the Narcotics Act in Germany, psychedelics including LSD, MDMA, mescaline and psilocybin are classified as "not marketable", meaning that they cannot be used for therapeutic purposes by law. Therapeutic supervision of psychedelic substance consumption for medications such as Psilocybin or DMT constitutes a legal gray area according to the German Narcotics Act, for example, in cases in which patients independently obtain and consume the substances while the consumption is only accompanied therapeutically afterwards as integration therapy.
Current Therapy Infrastructure
First-line pharmaceutical treatments for PTSD and depression primarily consist of SSRIs and SNRIs, which have shown limited efficacy compared to psychotherapy. Outpatient psychotherapy has been demonstrated to result in significant reductions in work disability days, hospitalization days, and inpatient costs. However, there are issues in Germany with access to therapy services which will also affect the availability of PAT if and when it is approved. Bottlenecks in access to insured psychotherapy, scarcity of licenses, and prolonged waiting periods present formidable challenges for patients.
Training Programs and Ethical Framework
Emerging research continues to underscore the therapeutic potential of PAT, leading to a notable shift in acceptance among healthcare professionals. The training required to master the facilitation of psychedelic-assisted therapies is still in its infancy and remains difficult to quantify due to several factors. Economic and time constraints pose significant challenges to delivering comprehensive training, and there is substantial variability in both practitioners' expertise and the interpersonal complexities inherent to mental health disorders. We propose a novel PAT training program adapted to the German condition, called Bildung und Nutzung von Traumähnlichen-zuständen (BuNT) which loosely translates as Training and Kaleidoscope Dream-like States, akin to those in emergency medicine, with certification administered by local physicians' chambers (Ärztekammer) or external bodies.
Ketamine: Germany's First Approved Psychedelic
Ketamine, an NMDA receptor antagonist, has demonstrated efficacy in reducing symptoms across various mental health conditions. Esketamine, the S-enantiomer of ketamine, has been widely approved for the treatment of major depression and TRD. Administered as a nasal spray (Spravato®), in combination with an SSRI, esketamine produces rapid reductions in depressive symptoms and suicidal ideation, with continued improvement over the course of a month, outperforming traditional antidepressant therapies. However, access to ketamine therapy is largely restricted to specialized clinics capable of administering it intravenously. The off-label use of ketamine in the treatment of mental health conditions, particularly TRD, anxiety disorders, and PTSD, has shown promise, but its widespread clinical use is hindered by practical barriers.
A Path Forward
Germany's journey toward integrating PAT requires addressing regulatory hurdles, expanding access to therapy services, and establishing robust training programs for practitioners. By leveraging existing frameworks, such as the German certificate for emergency medicine, and adapting international models, Germany can create a comprehensive and ethical approach to psychedelic-assisted therapy, ultimately improving mental healthcare outcomes for its citizens.
