Much like the United States, Europe is currently figuring out how to incorporate psychedelic therapy into its healthcare landscape most effectively. A lobby group representing developers and professionals within the industry advocates for including seasoned practitioners as integral members of a “multidisciplinary advisory body.” They would serve as a guiding authority, offering essential insights to regulators and healthcare practitioners regarding optimal practices as the field expands and changes. This effort comes from the European Psychedelic Access Research and European Alliance (PAREA), as reported by Politico, as per a briefing document slated for submission to the European Medicines Agency (EMA).
It basically says that those with actual experience with psychedelics should have influence. In both legal cannabis and psychedelics space, there is often a feeling that those with an actual relationship with the substance, rather than simply a desire to profit from it, makes for better business.
Europe still needs to legalize any psychedelic treatments. However, as Australia and parts of the United States are already offering psychedelic therapy, many lawmakers in Europe want to be prepared to hit the ground running. Having such an advisory board (with people who have experience with these substances) will make psychedelic treatment easier to implement.
In July, Australia became the first country in the world to authorize psilocybin and MDMA use through a doctor’s prescription to treat mental health conditions like post-traumatic stress disorder (PTSD) and depression. Both were legalized for therapeutic use.
In 2019, Denver, Colorado, became the first U.S. city to decriminalize psilocybin. Cities such as Oakland, Santa Cruz, and Washington D.C. have followed suit. In 2020, Oregon both decriminalized it and legalized supervised therapeutic use, with Colorado passing a similar law in 2022.
Psilocybin remains illegal under federal law.
Ketamine, which is technically a (legal) dissociative anesthetic with hallucinogenic properties, is FDA-approved for treatment-resistant depression in the U.S. under as “esketamine,” the S enantiomer of ketamine, as that’s how Johnson & Johnson could patent and sell it under the brand name Spravato. Often, doctors prescribe an off-label actual ketamine nasal spray that one can have made in a compound pharmacy.
A study by the American Medical Association, published late last month, found growing evidence that psilocybin, the mind-altering ingredient in magic mushrooms, is a potentially effective treatment for those suffering from depression. Psilocybin is also being tested to treat people with anorexia.
MDMA is currently being studied with successful results for its capacity to treat PTSD, among other mental health conditions.
Such substances would be under review of the proposed multidisciplinary advisory body. Before an upcoming EMA workshop on psychedelic treatments, PAREA urged the regulator to provide centralized leadership for the practical and clinical aspects of these therapies, including their delivery methods.
Unlike conventional pills, such as SSRI antidepressants, psychedelics require a comprehensive regimen of pre- and post-care, as well as support during the experience itself. PAREA wants to ensure that this care is uniformly standardized, drawing upon consensus from a diverse group of stakeholders.
In psychedelic spaces, this pre- and post-care is known as integration, or the belief that one needs more than the drug itself. Integration typically involves therapy before the trip and afterwards, helping one take what they learned and “integrate” it into everyday life. One may also need more than one session or return for boosters, as with ketamine IV therapy and other psychedelic therapies. Even within recreational psychedelic spaces, many people use a “trip sitter,” or at least one trusted person to abstain and look after them.
An EU advisory body “would benefit from the collective knowledge of various stakeholders, including the EMA, [the European Monitoring Centre for Drugs and Drug Addiction], national competent authorities, professional organizations, health care professionals and managers, psychedelic organizations, patients’ organizations, drug developers, and the wider community,” the briefing states.
PAREA told POLITICO these professional organizations could include the Open Foundation and the Beckley Academy in the Netherlands and the Mind Foundation in Germany. These groups train therapists in psychedelics using the latest research from institutions like Imperial College London and Johns Hopkins University. Some programs include experiential learning (getting high) on substances like psilocybin or ketamine. The Beckley group teaches people to “navigate non-ordinary states to better serve your clients,” and also runs psilocybin retreats.
“The importance of ensuring that the therapeutic model adopted is evidence-based and in the best interest of the patients cannot be overstated,” the lobby group’s briefing states.
PAREA also advocates for the EMA to ensure consistent delivery strategies throughout Europe. “Centralized coordination would offer an efficient mechanism to propel the field forward, rather than individual EU countries initiating their own work groups,” it states.
Meanwhile, setting the stage for future generations, psychedelic knowledge and industry are now being taken seriously in academia. Last month, the University of California, Berkeley’s Center for the Science of Psychedelics launched a free online course titled “Psychedelics and the Mind.” The new class is another expansion (and win) for the Center, launched three years ago. The course will be available for free.
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