What Does TheraPsil's Victory Mean?
By now, I am sure you've heard that TheraPsil, the Canadian non-profit advocating on behalf of palliative patients for compassionate use of psilocybin for end of life anxiety, has achieved a significant milestone.
Four palliative patients have had their applications for the exemption granted by Health Canada and will be able to consume psilocybin legally.
Troy Farah, in a piece for DoubleBlind, offers a succint back story:
“This exemption is the fruit of nearly a decade of psilocybin advocacy from Bruce Tobin, a psychotherapist from British Columbia with more than 35 years of experience. Around 2010, Tobin was approached by a patient who was dying and had tried everything—medication, therapy and expensive residential treatment programs—but nothing had helped her overcome her fear of death…
“I discovered I could apply for a so-called Section 56(1) exemption that would excuse me from the provisions of the Canadian Controlled Drugs and Substances Act, allowing me to legally use psilocybin in cases where it was ‘necessary for a medical purpose,” Tobin explained to me in a 2019 interview for WIRED.”
And Ben Adlin for Marijuana Moment provides insight into the exemption process:
“Health Canada is committed to carefully and thoroughly reviewing each request for an exemption under the Controlled Drugs and Substances Act, on a case-by-case basis, taking into account all relevant considerations, including evidence of potential benefits and risks or harms to the health and safety of Canadians,” a government spokesperson told Marijuana Moment in an email.”
And as Farah notes in DoubleBlind:
“But there’s an interesting parallel here: Section 56 is the same segment of Canada’s drug laws that allowed for an exemption of medical marijuana back in 1999. By mid-2002, less than 700 people had been enrolled in the medical cannabis program, but it didn’t take long for pot to become a huge industry in Canada.”
Medical Marijuana was also the starting line for the cannabis industry in America. In 1996 California voters passed proposition 215, aka The Compassionate Use Act of 1996. Much like TheraPsil's approach, California activists were advocating on behalf of HIV patients who found symptomatic relief with marijuana.
This timeline is sobering, considering the amount of investment, strategizing, and hype in the current psychedelic landscape.
I am pretty naive about the history of the marijuana industry, especially as far back as 1996 and 1999. Still, I bet that there were no publicly listed marijuana companies ready at the gate upon these exemptions.
On the other hand, Section 56 exemptions are a subset of the many policy initiatives underway, including Oregon's IP 34, DecriminalizeNature Oakland and DC, Denver Psilocybin Initiative, and Hawaii's Clarity Project.
Does this momentum imply that the timeline of psychedelic policy change will be quicker than the 20+ years of cannabis?
I am assuming it does.
A few days before the anticipated announcement, I wondered about some of the specifics if the exemptions were approved:
Yesterday, I reached out to TheraPsil's' Communications Director Holly Bennett to get some insight into these and other questions and try to understand what this means for future patients, a nascent industry chomping at the bit, and broader issues of legal access.
*** Holly's responses are indented, and bolding I added for emphasis***
I asked about the sourcing of psilocybin, specifically curious if any emerging companies are racing to supply these patients. In answering, she shed light on a topic that a few readers have pointed about the Special Access Programme:
“Part of the inclusion criteria for patients to be supported by TheraPsil (as laid out on our website) is that patients must have already secured their own supply of psilocybin mushrooms. Some patients have chosen to grow their own. The companies you are referring to are unable to supply patients with psilocybin as psilocybin is inaccessible through the Food and Drug Regulations (FDR) or the Special Access Programme (SAP), because psilocybin is a schedule J drug. Only by removing psilocybin from schedule J and through changes to the SAP, would these companies be allowed to supply exempt patients access to their psilocybin.”
Next, I was curious to understand how companies might leverage section 56 exemption since I saw it touted as a legalization route in pitch decks. Would we see the companies building clinical infrastructure host these palliative patients?
Where would the four palliative patients (and future exemptions) administer the psilocybin?
“The pre-and post-integration sessions, along with the medicine session will be facilitated in a location chosen by the patient - most often their home. To be clear: the companies that have donated money to our organization have no influence on our operations, motivations or advocacy work. The donations we have received have and always will be ‘no strings attached’.”
Since we've recently looked into the Bureaucratic Burden on Psychedelic Science, I wondered, in the case of Section 56 Exemption, is all the red-tape upfront, that is in the application?
Will Health Canada require specific documentation to be collected from the administration, preparation, and integration? Will the compassionate use patients, their providers, or TheraPsil be required to submit medical records to Health Canada to document good practice, Adverse Events, or other data?
“This is still hard to say, to remind everyone, there are not yet clear regulations regarding psilocybin in Canada. This means that each patient application is handled on a case by case basis. Some patients may need more or less documentation than others, so at this stage working with Health Canada and the Office of Controlled substances is essential. From what was disclosed regarding the applications there is some basic record keeping that must be done by the doctor and patent as is standard for many controlled medicines.”
How many applications does Therapsil expect to submit?
“We are receiving more inquiries from palliative patients who are requesting our support everyday and we look forward to helping as many patients as possible with their application. Now that there has been a precedent set, we are confident that future applications will not take over 100 days to process and that this will be an easy and swift process for patients.”
Where do we go from here? Is there a potential path to legalized compassionate use program beyond individual exemptions?
Right now, the government has no incentive to change policy regarding access to psilocybin as there have only been (that we know of) 4 individuals who have applied for the section 56 exemption, and received it. The section 56 process therefore has been proven to work and is a suitable system, for the time being. However, we would like to work towards a ‘doctor-as-gatekeeper’ system where the choice to use psilocybin for a medical purpose is a decision made between the patient and the patients doctor, and the patient has access to either access GMC certified psilocybin, or is legally allowed to grow their own. As such, we need to demonstrate that there are more patients out there who want access to psilocybin therapy - so many that processing these requests through the section 56 exemption process would no longer make sense, and there would be a need to create policy change and proper regulations. Furthermore, we need to educate the government and the general public that healthcare practitioners should have access to psilocybin for professional training purpose, as it is well-agreed upon in the medical psychedelic community that for a psychedelic therapist to be properly trained in psychedelic therapy, they need to have their own personal experience with the substances themselves. There is a lot of work to be done!
Coincidentally, MindMed just announced that Dr. Peter Gasser has joined their advisory board (see below). Gasser’s experience in Switzerland, as one of a few psychiatrists, authorized to use Schedule 1 substance in private practice under Compassionate Use exemption might be the model for the ‘doctor-as-gatekeeper’ system.
Additionally, as we mentioned on Wednesday the other notable effort in Canada, spearheaded by Decriminalize Nature Canada, is a petition to the House of Commons to decriminalize entheogenic plant medicines.
Might increase attention to compassionate use combined with heightened activism lead to rescheduling in Canada? I suppose we’ll find out.
Thanks again to Holly Bennet for taking the time to answer my questions and to the whole TheraPsil team for their work!
News and Headlines
Guided ketamine trip therapy clinic opening in NYC this month
“Psychedelically-enhanced therapy clinic, Field Trip Health, has already begun consulting patients for its new Manhattan location and is set to begin administering medically-supervised ketamine doses as treatment for mental conditions as soon as next week.”
MindMed Adds Psychedelic Assisted Therapy Expert Dr. Peter Gasser As Clinical Advisor For Project Lucy
“Dr. Gasser has pioneered the legal, medical use of psychedelics through clinical research and compassionate access in Switzerland. Dr Gasser has served as the President of the Swiss Medical Society for Psycholytic Therapy since 1997. Through compassionate access in Switzerland, Dr Gasser holds several individual treatment permissions to treat patients with MDMA and LSD.”
Thanks for reading, and have a great weekend!
Zach
Excellent review of some of the questions related to the new S.56 exemptions!