Germany Becomes First European Country to Approve Compassionate Use of Psilocybin

Germany has become the first European Union nation to permit the use of psilocybin for therapeutic purposes outside of a clinical trial. The newly-approved compassionate use program will allow selected patients suffering from severe depression to receive psilocybin therapy. 

While the number of people able to use these treatments will be limited and strictly controlled, this news is a welcome step forward for those hoping to remove regulatory barriers and improve access for patients in need.

Compassionate Psilocybin Access: A First in the European Union

This approval was granted under Germany’s “compassionate use” framework and marks the first time psilocybin will be prescribed using this framework in the European Union. 

The selection process and therapy delivery will be overseen by the Federal Institute for Drugs and Medical Devices (BfArM), and will allow selected patients suffering from treatment-resistant depression (TRD) to receive psilocybin therapy. The therapy will be given at two clinics: the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin.

Depression is one of the most common mental health disorders in Germany. Numerous established treatment options do exist, like traditional SSRI antidepressant drugs, but approximately 20 to 30 percent of individuals do not respond sufficiently to these interventions and are thus classified as “treatment-resistant”. 

These patients have often exhausted treatment options and are in desperate need of alternatives.

Expanded access programs like these allow the use of as yet unapproved drugs in patients suffering from serious illnesses. However, space will be very limited with some serious restrictions and conditions for patient selection. Each case must be carefully examined in terms of a risk-benefit assessment. 

The program will be conducted by Dr. Gerhard Gründer of the Central Institute of Mental Health.

“This is a landmark moment for the field of psychedelic medicine in the European Union. Treatment-resistant depression affects up to 30% of individuals diagnosed with major depressive disorder and remains one of the most difficult psychiatric conditions to treat. Psilocybin has demonstrated significant promise as a novel therapeutic option, and this approval marks an important step toward expanding access for those in urgent need,” said Dr. Gründer in a statement announcing the news.

The program mirrors similar models in Canada and Switzerland, where early access pathways were established to give patients with severe, otherwise untreatable conditions access to psychedelic therapies. Germany is the first EU member state to formally integrate such compassionate access into federal regulatory frameworks.

What Is a Compassionate Use Program?

Compassionate Use Programs are special access mechanisms that allow patients with serious or life-threatening conditions to try investigational treatments before these therapies have received full regulatory approval. These programs are typically reserved for those who have exhausted all conventional treatment options.

Germany now joins a small but growing list of countries using similar limited access models to deliver psychedelic medicine treatments. 

In Switzerland, physicians have been allowed to apply for case-by-case exemptions to use psilocybin, MDMA, and LSD since 2014. In 2024 alone, Swiss regulators granted nearly 700 exemptions, with psilocybin making up nearly half.

Canada’s Special Access Program (SAP) has granted access to psychedelics like psilocybin for patients facing terminal illness, major depression, and other severe conditions. Australia and New Zealand have also launched limited frameworks allowing authorized psychiatrists to prescribe psychedelics like psilocybin and MDMA ahead of formal drug approvals.

These programs may seem like small changes in regulatory access, but for people suffering and desperate for options, the government finally allowing access to a plant medicine can seem like a life-saving lifeline. 

The words of a Canadian patient, granted special access in 2021, highlights the human story behind the regulations. Nathan Kruljac and other patients had to take the Canadian government to court before finally being given access by the Minister of Health:

“​​I have been in agony for 15 years. This decision by the Minister to acknowledge my trauma and pain and allow me compassionate access to psilocybin may be the turning point in my life; it may not. The choice is mine and shouldn’t fall to a decision made by an administrative department of our government. The Minister has accepted that my 15 years of experience and suffering was enough and I hope that it will open doors to help other people with their trauma…” 

Increased Access is Good, But More is Needed 

Germany’s Compassionate Use Program is a meaningful step forward, but experts caution that its reach will remain very limited. These programs are temporary, apply only in exceptional cases, and operate under strict regulatory oversight.

Prof. Gründer, head of the German program, gives his view on the realities of need versus access: 

“Experience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,” he continues, “a Compassionate Use Program cannot replace approval. We must therefore continue to work on bringing psychedelics such as psilocybin into standard care for the treatment of mental illness.”

“Experience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,” explains Prof. Gründer. 

While far from a comprehensive solution, early access initiatives can still make a difference for patients in need. 

“Although limited, this initiative can offer relief to German patients who have not benefited from conventional treatments,” said Tadeusz Hawrot in a statement when we reached out for his comment on the news. Hawrot is the founder of PAREA, a European advocacy group for psychedelic medicine access.

“With several hundred clinical trials involving psychedelic compounds currently ongoing worldwide, approvals for broader clinical use are expected within the next few years. However, compassionate use programs offer a critical interim step, making these treatments accessible to patients who cannot wait.”

It may not be enough. People will still need increased access to these treatments. But small regulatory baby steps like these are part of the slow movement forward.

Natural Psilocybin Being Used for Government Early Access Programs

Compassionate use programs offer more than just increased access for patients, they provide unique opportunities for companies developing psychedelic medicines. 

Access programs like these need supplies of psychedelic drugs for the therapies they’re now making legally available. Problem is the medicines aren’t yet legal, and thus are not available in ready and safe supply. 

So they turn to psychedelic medicine companies currently working on tomorrow’s mushroom medicines to supply these programs. One such company, Filament Health, is actively participating in these early access pathways. The Canadian company is supplying its natural psilocybin drug candidate to access programs in Canada and now Germany.

We spoke to Filament Health CEO Ben Lightburn after the news that his company would be supplying the German access program. We asked him why Filament seems to be supporting compassionate access, more than others in the industry – and why this is important?

“Filament is supporting compassionate access more than others in the industry because we’re currently the only drug developer supplying consistent doses of GMP, pharmaceutical-grade psilocybin. Therefore, we feel that we have a responsibility to support compassionate use programs. We believe in the importance of access to psilocybin and recognize our unique position as a source of it.”

And why aren’t other companies as involved in these access programs? 

“Typically drug development companies will treat compassionate use programs with caution or even skepticism. In the majority of cases, the calculation will be that the risks outweigh the benefits towards the goal of getting a new drug approved.”

Filament has also been generous with its mushroom supply, initially providing the Canadian access programs with their proprietary natural psilocybin compound free of charge. After supplying hundreds of patients, they now charge the government a fee to cover their costs. 

They will also begin supplying the German program for free before adding a modest fee. Is this being done out of the goodness of their hearts? Partially. But it’s also good for business.

“Another reason we support these programs is to build relationships with the providers around the world who will eventually be the ones prescribing our drugs when they are approved. In a similar vein, we also gain insight into the workings of different regulatory agencies.

“And, patients that are eligible for these programs are in dire need having tried and failed multiple other treatments, and are very often quite literally out of options.”

Doing good while doing good business. If only all our commercial dealings could be so.

Germany’s compassionate use program is a small but necessary step toward meeting the urgent needs of patients who haven’t found relief through conventional treatments. While access remains limited, it helps move the process forward — one case, one country, one business deal, and one patient at a time.