Framework Conditions for Psychedelic-Assisted Therapy in the German Healthcare System
Considerations on Access, Regulation, and Training in Psychedelic-Assisted Therapy
An approach that engages people
Psychedelic therapy is no longer a fringe topic. Clinical studies on MDMA and psilocybin show promising results, media attention is growing and, in Germany, many are asking: How do we move from research to regulated care?
If Germany wants to introduce psychedelic-assisted therapies, it needs more than just good studies. It requires clear pathways of access for patients, rules for financing, and professionals trained in handling altered states of consciousness.
A specialist article published in 2024 and a poster presented at Psychedelic Science 2025 propose focusing on three key areas: access, regulation, and training. Examining these three aspects clearly shows where the German healthcare system already offers solutions and where gaps still exist.
What do policymakers, institutions, and professionals need to build today to ensure psychedelic treatments don’t fall into a void tomorrow?
Three Central Challenges
Looking at the German healthcare system, three central challenges emerge concerning psychedelic-assisted therapy.
The first concerns access. Under what conditions should people be able to receive psychedelic medications, both before and after broad approval? A key term to mention here is the so-called Compassionate Use Programs.
The second challenge concerns the institutions in Germany that decide on the approval, evaluation, and reimbursement of new therapies. Ultimately, they determine whether a treatment becomes part of routine care or remains stuck in individual pilot projects.
The third challenge is training. Who should accompany psychedelic states, what competencies are required, and what could a continuing education program look like that goes beyond individual training weekends?
These three questions now structure many professional discussions on the integration of psychedelic-assisted therapy. They will be addressed sequentially below.
Compassionate Use: When Therapy Can’t Wait
Simply put, Compassionate Use means: Seriously ill individuals can receive a medication that is not yet regularly approved if no other viable treatment option exists.
A legal framework for this already exists in Germany. Crucial factors include, for example, whether it is a severe or life-threatening illness, whether effective standard therapies are available, what data from clinical studies exist, and whether approval procedures are underway.
In practice, this framework can be represented as a decision tree. Step by step, it is checked whether the conditions for Compassionate Use are met. This is particularly relevant in the context of psychedelic medications, as international approvals and German reality might diverge in terms of timing.
How theory can transition into practice is demonstrated by initial projects that utilize the existing framework to implement psychedelic treatments in clearly defined settings within Compassionate Use programs. Conceptual considerations, as described in the specialist article, provide a blueprint for this, while the poster condenses them into an easily understandable decision pathway.
Who Actually Decides on New Therapies?
Before a new therapy reaches routine care, several levels must interact.
At the European level, the focus is initially on the efficacy and safety of a new active substance. In Germany, a federal authority reviews clinical studies and approval applications. After that, the question arises whether statutory health insurance funds will cover the treatment and under what conditions. Here, further committees come into play that evaluate the medical benefit and cost-effectiveness.
For psychedelic or psycholytic therapy, this means: Even if a substance is well-supported scientifically, it does not automatically mean it will enter routine care. Decisions are needed on how it is classified, evaluated, and financed.
Presented graphically, it becomes clear how many checkpoints exist along this path. This helps correct typical misunderstandings. The crucial question is not just whether a substance works, but also whether the system is prepared to integrate it.
Who is allowed to accompany psychedelic states?
Another central question is: Who is adequately prepared to accompany individuals in psychedelic sessions?
Here, professional recommendations build upon existing models, such as the Rochester Model of Core Competencies from North America. This model describes key competencies that should be present after specialized further training. At its core, it aims to define the skills that therapists should possess after specialized further training.
These include, among other things, a clear therapeutic stance, knowledge of risks, integration, and aftercare, sensitivity to cultural and biographical factors, and the professional handling of extraordinary states of consciousness. Additionally, fundamentals of pharmacology and neurobiology of psychedelic substances, as well as legal and ethical aspects, are included.
For Germany, it is evident: There are already initial training programs, but hardly any common standards or binding ethical guidelines. For a broader introduction of psychedelic or psycholytic therapy, a clearly described competency profile would be an important step. The present recommendations point precisely in this direction.
A 100-hour Model for Germany
Based on this, a continuing education model of approximately 100 hours is proposed, which is oriented towards existing additional medical specializations. It is named BuNT, stands for “Bildung und Nutzung von traumähnlichen Zuständen” (Education and Utilization of Dream-like States), and adapts content from the Rochester Model for the German context.
Bild 5: Struktur des BuNT-Weiterbildungsmodells mit insgesamt 100 Stunden in sieben Modulen.The structure is divided into seven modules, each approximately 15 hours long. It covers general psychotherapeutic fundamentals, questions of ethics and cultural sensitivity, preparation and screening, integration and harm reduction, therapy in altered states of consciousness, managing challenging experiences, and a practical day with clinical application and community relevance.
The idea behind it is clear: Defined theoretical content on research, effects, and risks, complemented by practical experience in accompanying altered states of consciousness under supervision, and formal recognition demonstrating that specific competencies have indeed been acquired. BuNT sees itself as a starting point for future specialization in psychedelic-assisted therapy. It does not replace existing specialized further training but rather complements it with a clearly defined module.
Why This is Relevant Now
The described works connect three levels that are often discussed separately: Scientific evidence, regulatory pathways, and the practical question of who accompanies people in these processes.
This is relevant for public debate because it shifts the focus away from whether psychedelic therapies will arrive, towards how they should be designed: with clear rules, defined competencies, and access oriented towards the needs of patients.
The next steps will take place simultaneously in many areas: in regulatory authorities, clinics, continuing education courses, and in politics. Specialist articles and posters provide a proposal on how these steps can be considered together.
Those who wish to delve deeper will find detailed background information on the expert recommendations and the proposed continuing education model in the specialist article.
Academic article on this topic: Expert Recommendations for Germany’s Integration of Psychedelic Assisted Therapy
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