With Europe embarking on psychedelic reform and the potential legalization of therapeutic psychedelics, a lobby group comprised of industry players and developers says regulators should leverage knowledge from experienced psychedelic users to inform their decisions. In a document sent to the European Medicines Agency (EMA), the Psychedelic Access Research and European Alliance (PAREA) said the regional bloc needs a standard voice of authority for therapeutic psychedelic use, which includes experienced psychedelic users.
The lobby group called for authorities to create a multidisciplinary advisory body to provide professionals and regulators with guidance on best practices for psychedelic-assisted therapies amid the ongoing surge of psychedelic research. Several studies and clinical trials involving psychedelics such as LSD, MDMA and psilocybin (magic mushrooms) have revealed that psychedelics have the potential to offer sustained relief against several mental-health conditions with minimal adverse side effects.
For instance, psilocybin and ecstasy pills have shown positive results against conditions such as post-traumatic stress disorder (PTSD) and hard-to-treat depression, which don’t always respond to conventional mental health-treatments, including talk therapy and antidepressants. Scientists are also researching the potential of psilocybin, the main hallucinogenic agent in magic mushrooms, in the treatment of the eating disorder anorexia.
Although European regulators are just considering the possibility of therapeutic psychedelics, regulators in Australia and some parts of the United States have already legalized the prescription of psychedelic-based treatments to treat specific mental-health disorders. With some regulators calling for faster regulatory action on psychedelics in the European Union, PAREA asked the drug regulator to push for centralized leadership on the clinical and practical use of psychedelic-assisted therapies.
Psychedelics are expected to revolutionize the psychiatric industry over the next few decades, thanks to their therapeutic potential against typically hard-to-treat mental disorders such as PTSD and treatment-resistant depression. However, unlike traditional mental-health treatments, psychedelic-assisted therapy requires plenty of preparation, pre- and postcare, and guidance during the psychedelic trip. The lobby group wants regulators to ensure all this complementary care is standardized and has approval from multiple relevant groups.
According to PAREA’s briefing document to the European Medicine Agency, an advisory body would benefit from using knowledge from a wide variety of stakeholders. This includes psychedelic organizations, national competent authorities, physicians, drug developers, patient organizations and professional organizations such as Germany’s Mind Foundation the Netherlands’ Beckley Academy and the Open Foundation. Such groups use up-to-date research from institutions such as Johns Hopkins University in the U.S. and the Imperial College London to provide much-needed training to psychedelic therapists.
As efforts to bring about psychedelic policy reform ramp up around the world, industry actors such as Seelos Therapeutics Inc. (NASDAQ: SEEL) could see their operating environment become increasingly supportive when compared to the current regulatory climate.
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