[ad_1]
The agency regulating all things related to psychedelic-assisted therapy (PAT), Health Canada released a notice to stakeholders on risk-management measures for clinical trials, a seemingly supporting move towards future government-supported access.
As stated, the purpose of notice 22-111811-471 is to outline Health Canada’s expectations regarding the implementation of risk-management measures by clinical trial sponsors and reflect on the “best practices emerging in the literature” of PAT in a context where there are no established clinical practice guidelines set yet.
The note states that any proposed clinical trial should detail which of the derisk considerations it will use within the Clinical Trial Application (CTA), as well as be conducted in accordance with Good Clinical Practices (GCP.)
The document has four sections. The first, titled “Risk-management measures for CTAs involving psychedelic-assisted psychotherapy,” discusses current trials considering that most involve psilocybin and MDMA, and what each substance requires to ensure participants’ safety.
The second, “Expectations regarding therapists and clinical setting”, goes through therapy training and licensing and several protocols including before, during and after treatment sessions, setting, and contingency plans for potentially serious adverse events.
The third section deals with informed consent, which should be “clearly articulated” in the forms given to participants considering the possible psychological and physical benefits and risks associated with the substance that will be used in the clinical trial.
And the fourth, “Good manufacturing practices (GMP)”, requires that an attestation be provided in the CTA confirming that the psychedelic drug to be used was manufactured according to GMP (high quality) standards.
The final paragraphs refer to Health Canada’s compliance and enforcement as related to provisions of the FDA and associated regulations such as the Canadian Controlled Drugs and Substances Act (CDSA) and how sponsors willing to submit a CTA should best approach that possibility.
Quebec Is The First Province To Cover Costs Of Psilocybin-Assisted Therapy
Two Quebec-based doctors have successfully were paid by the Canadian province after completing psilocybin-assisted psychotherapy treatment for a mental health patient with Health Canada-granted access.
See also: Alberta Becomes First Canadian Province To Regulate Psychedelics-Assisted Therapy
The case is the first in which the government’s healthcare system covers for a psychedelic-assisted treatment and a sign that ongoing efforts to remove legal barriers to access are slowly yet steadily thriving.
Two doctors successfully billed for and were paid by the province of Quebec after completing psilocybin-assisted psychotherapy treatment for a patient with legal access pic.twitter.com/8CdYI10i9D
On the other hand, this November, the Canadian non-profit advocate organization TheraPsil joined patients and healthcare professionals in Ottawa to demand for increased, more compassionate access to psilocybin after requesting a meeting with federal health ministers Jean-Yves Duclos and Carolyn Bennett.
Though a formal meeting with the health ministers was denied, once in Ottawa the delegation spoke with the press, interested people and other government representatives to raise awareness on psilocybin’s medical benefits as well as educate and recommend a clean regulatory approach for medical access to the psychedelic.
Furthermore, some months ago TheraPsil worked on a landmark lawsuit against the Canadian government and health minister regarding patients’ access to psilocybin which, as a Schedule III substance, can only be accessed by Canadians through certain legal pathways, which are proving to be insufficient and inadequate to the needs of patients.
Psilocybin Dispensaries, A Legality Issue
Magic Mush is the third magic mushroom dispensary opening in Ottawa after Health Canada’s opening of legal pathways for psilocybin use.
Located in Centretown, the new shop opened its doors on Nov. 1 and operates similarly to cannabis dispensaries in the city, offering a variety of dried mushrooms, microdose capsules, gummies and chocolate bars containing announced amounts of psilocybin.
The two other psilocybin dispensaries in Ottawa are called Golden Teacher and Shroomyz have been open since May 2022. Furthermore, this is not the only Canadian province where these shops have appeared: Vancouver and Toronto have their own psilocybin dispensaries working.
Magic Mush’s owner acknowledged that “technically what we’re doing is still illegal.” He further said it was a risk willing to take since he believes that what he is doing will help more people get access to magic mushrooms’ benefits by assisting customers with their specific needs, a difference as to, for instance, buying these products online.
Neuroscience professor at Carleton University and former researcher and policy analyst at the Canadian Center for Substance Use and Addiction Zachary Patterson sees parallels between these new psilocybin dispensaries and cannabis dispensaries’ status before October 2018.
Patterson believes psilocybin sales could pose some risks, as “there’s much less stigma around psilocybin use than there is around cannabis use just because it’s less prevalent and less talked about and less known.”
Jennifer Tobe, lawyer and advisory board member of Canada’s Psychedelic Association added: “We have psilocybin, mushroom dispensaries popping up all over the place. That is certainly an activist effort towards pushing towards legalization and demand and pecuniary interests. Police are treating it as low priority in terms of enforcement, as they did with many of the cannabis shops prior to medical legalization.”
Nonetheless, all psilocybin product providers are required to have a license as well as follow GMP compliance.
Photo by Jason Hafso on Unsplash
[ad_2]
Image and article originally from www.benzinga.com. Read the original article here.