Germany’s medicine regulator will allow certain patients with treatment-resistant depression to try psilocybin therapy, a major shift as psychedelics inch closer to mainstream medicine.
It is the first time in the European Union that psilocybin – the hallucinogenic compound in magic mushrooms – will be made available through a compassionate use scheme, in which patients with serious or life-threatening illnesses can get access to drugs that have not yet been approved.
In Germany, psilocybin will only be prescribed in “justified exceptional cases,” according to the Central Institute of Mental Health (CIMH), which asked regulators to greenlight the programme.
“This is an enormously important step that expands our scope for action,” Dr Gerhard Gründer, head of CIMH’s molecular neuroimaging department, said in a statement.
In some cases, psilocybin therapy “can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision,” Gründer added.
Depression is a common mental health problem, but approximately 20 per cent to 30 per cent of people with depression do not respond well to standard treatments, CIMH said.
Studies have shown that psilocybin could be a promising alternative for these patients. The drug is thought to foster connections between different regions of the brain, helping people let go of excessive self-focus and rumination, according to scientists from the United Kingdom and United States.
But sceptics have warned that studies on psychedelic drugs can be hard to replicate.
Growing interest in psychedelics
The decision from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) reflects growing interest in psychedelic therapies, including psilocybin and MDMA, as a treatment for mental health issues such as depression, anxiety, addiction, and post-traumatic stress disorder (PTSD).
Earlier this month, the Czech Republic legalised the medical use of psilocybin for conditions such as depression.
Meanwhile, the first EU-funded trial on psychedelic medicines launched last year to test whether psilocybin can alleviate anxiety and depression among patients with progressive diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).
Other clinical trials are also underway in Europe, including in Germany, though full approval for psilocybin is not expected in Germany for several years.
In the meantime, the Psychedelic Access And Research European Alliance (PAREA), a nonprofit advocacy group, said compassionate use programmes can complement clinical trials by offering real-world data on these treatments and ensuring they are available for “patients who cannot wait” for full approval.
CIMH expects that many patients will be interested in Germany’s limited access scheme.
“Experience from Switzerland shows that demand far exceeds the available supply,” Gründer said.
“We must therefore continue to work on bringing psychedelics such as psilocybin into standard care for the treatment of mental illness,” he added.
