Germany Approves EU's First Psilocybin Access Program
The country's drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM), has given the green light for two medical facilities to offer psilocybin to adults with treatment-resistant depression.
Depression is one of the most common mental illnesses in Germany, affecting around 5.3 million people. Up to a third of cases are considered to be "treatment-resistant', meaning the individual hasn't responded adequately to conventional treatments.
In recent years, scientific research has pointed to psilocybin—the active ingredient found in certain types of mushrooms—as a promising treatment for this type of depression, along with other psychiatric conditions.
While no drugs containing psilocybin are currently authorized for use in Germany or the EU, the Expanded Access Program enables the use of as-yet-unapproved drugs in patients suffering from serious or life-threatening illnesses.
Under the direction of Professor Gerhard Gründer, head of the department of molecular neuroimaging at the Central Institute of Mental Health (CIMH), individual patients in Mannheim and Berlin will be able to receive the drug in justified exceptional cases.
Prof Gründer, who successfully made the application, said in a statement: 'In selected individual cases, the therapeutic use of psilocybin as part of a Compassionate Use Program can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision.'
Very few such programs for psilocybin have been established worldwide, with Germany's model expected to be similar to those operating in Switzerland and Canada.
While Switzerland is a European neighbour of Germany, it is not a member of the EU, and regulations allowing the legal use of psilocybin, MDMA, and LSD in certain cases were introduced in 2014.
Demand Expected To Exceed Supply
A botanical psilocybin drug candidate known as PEX010, will be provided by Canadian company Filament Health, which also supplies the vast majority of psilocybin prescribed under Canada's Special Access Program.
The drug will be administered to patients at the CIMH in Mannheim and the OVID Clinic in Berlin, on an inpatient basis only, and in combination with psychotherapy, to help patients 'release rigid thought patterns, promote new insights, perspectives, and behaviors, and improve depressive symptoms'.
Announcing the news in a press release, Benjamin Lightburn, co-founder and chief executive officer at Filament Health, commented: 'The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament's position as the world's leading supplier of GMP-quality psychedelic drug candidates.
'We're incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It's a validation of Filament's ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most.'
However, while an 'enormously important step', compassionate access programs are not thought to be a suitable substitute for the wider regulatory approval, and demand is expected to 'far exceed supply'.
'Experience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,' continues Gründer
'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.'
Legitimizing Psychedelic Medicine
Elsewhere in Europe, the Czech Republic has also taken steps to legalize the therapeutic use of psilocybin.
On 30th May, the lower house of the country's parliament passed an amendment to allow the use of psilocybin in psychiatric hospitals and clinics from 2026. If passed in the senate, this would make the Czech Republic the first EU country to legally regulate the treatment for medical use.
Meanwhile, the UK has recently seen a potentially significant policy shift, with the government backing a proposal put forward by the Advisory Council on the Misuse of Drugs to remove the requirement for research licences when studying Schedule 1 drugs such as psilocybin and MDMA.
Josh Hardman, founder and editor of media and consultancy firm, Psychedelic Alpha, said over email that while Germany's program may be limited in scope, it could be significant for 'legitimizing' psychedelic medicine and influencing wider regulatory change across Europe.
'While the program might only reach up to around 50 patients in its first year, the significance of the German regulator's decision should not be lost on people,' says Hardman.
'The country now joins Switzerland in allowing certain European patients to access psilocybin when they have exhausted other options. What's more, the imprimatur of Swiss engineering and German efficiency and process focus could add to psychedelic medicine's legitimacy both in Europe and beyond.'
He adds: 'I have spoken with the architects of this compassionate use program and am encouraged to hear that they are keen to collect and share data from the project. Such real-world data and learnings would be very useful for the field. If those experiences are broadly positive, other EU member states might consider joining.'
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