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Germany has become the first EU country to introduce a compassionate access program for the use of psilocybin in treatment-resistant depression.<\/p>\n
The Washington Post via Getty Images<\/p>\n
Germany has become the first country in the European Union to allow access to a psychedelic for a limited number of patients under strict conditions.<\/p>\n
The country\u2019s 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.<\/p>\n
Depression is one of the most common mental illnesses in Germany, affecting around 5.3 million people. <\/a>Up to a third of cases are considered to be “treatment-resistant\u201d, meaning the individual hasn\u2019t responded adequately to conventional treatments.<\/p>\n In recent years, scientific research<\/a> has pointed to psilocybin\u2014the active ingredient found in certain types of mushrooms\u2014as a promising treatment for this type of depression, along with other psychiatric conditions. <\/p>\n 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. <\/p>\n Under the direction of Professor Gerhard Gr\u00fcnder, 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. <\/p>\n Prof Gr\u00fcnder, who successfully made the application, said in a statement: \u201cIn 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.\u201d<\/p>\n Very few such programs for psilocybin have been established worldwide, with Germany\u2019s model expected to be similar to those operating in Switzerland and Canada.<\/p>\n 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.<\/p>\n Demand Expected To Exceed Supply<\/p>\n 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\u2019s Special Access Program.<\/p>\n 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 \u201crelease rigid thought patterns, promote new insights, perspectives, and behaviors, and improve depressive symptoms\u201d. <\/p>\n Announcing the news in a press release, Benjamin Lightburn, co-founder and chief executive officer at Filament Health, commented: \u201cThe approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament\u2019s position as the world\u2019s leading supplier of GMP-quality psychedelic drug candidates. <\/p>\n \u201cWe\u2019re incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It\u2019s a validation of Filament\u2019s ongoing efforts to make safe, standardized psychedelic medicines<\/a> available to those who need them most.\u201d<\/p>\n However, while an \u201cenormously important step\u201d, compassionate access programs are not thought to be a suitable substitute for the wider regulatory approval, and demand is expected to \u201cfar exceed supply\u201d.<\/p>\n \u201cExperience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,\u201d continues Gr\u00fcnder <\/p>\n \u201cA 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.\u201d<\/p>\n Legitimizing Psychedelic Medicine<\/p>\n Elsewhere in Europe, the Czech Republic has also taken steps to legalize the therapeutic use of psilocybin. <\/p>\n On 30th May, the lower house of the country\u2019s parliament passed an amendment <\/a>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.<\/p>\n