On January 5, 2022 with a reversal of a “2013 Health Canada policy that prevented “a letter of authorization for a new drug that is or that contains a restricted drug” the floodgates opened for psychedelic drug development companies with Health Canada’s Special Access Program (SAP) which will allow physicians to “request patient access to illegal psychoactive substances, like MDMA and psilocybin, for psychedelic-assisted therapy”.
What is the Special Access Program (SAP) exactly? Can anyone just ask their doctor to get them a script to trip on shrooms? Not exactly. The Special Access Program allows doctors and healthcare practitioners to request emergency access to restricted drugs on behalf of patients with serious or life-threatening conditions, “when other therapies have failed, are unsuitable, or are unavailable in Canada and when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient.”
But how this is actually going to be rolled out and what will it look like in real time? Canadian healthcare providers have relied on Health Canada’s Special Access Program for several years. Requests are decided on a case-by-case basis and do not always get approved. When a drug is not yet available for sale the doctor must submit a request to Health Canada and wait for a decision. Once or if approved, the manufacturer is cleared to dispense the drug to the licensed health care professional to administer to their patient. In the case of psychedelics, “health care providers can only access drugs from a dealer licensed under the Controlled Drugs and Substances Act (CDSA)”. The manufacturer will have to be licensed to manufacture the psychedelic.
“In other words, the SAP doesn’t give carte blanche to all psychedelics from any source.”
However, the SAP amendment does not require that the psychedelic be dispensed in a therapy setting.
Before this change a patient seeking access to psilocybin therapy had to apply for a Subsection 56(1) exemption from Health Canada, a lengthy process, which took months for a response, while suffering with severe or life threatening conditions.
Now that this change has gone into effect, who are the companies that have jumped on the psychedelic bandwagon and have requested access on behalf of patients or plan to take advantage of this change in policy?
There are two types of companies that will take advantage of the change in policy: those that operate clinics with healthcare practitioners and those that are in a position to manufacture psychedelics for use in the SAP. “Companies that want to manufacture or import restricted drugs like psilocybin and MDMA for use by patients in the SAP must possess a dealer’s licence issued by Health Canada.”
On December 22, 2021 Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI), a psychedelic focused mental healthcare company, praised Health Canada for the change in policy. Numinus has a research arm, Numinus Bioscience, which “holds a dealer’s licence for a wide variety of psychedelic compounds including psilocybin and MDMA”. Numinus also has clinic locations, for psychedelic therapy, in former MAPS clinical trial sites in Vancouver and Montreal.
“Amending the SAP and righting a historical wrong based on stigma highlights Canada’s Commitment to making psychedelic-assisted therapies a possibility for the many Canadians who struggle with mental wellness,” said Payton Nyquvest, Founder and CEO, Numinus. “While we believe this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic medicine. I am proud of our team who have had a longstanding role in advocating for this reform.”
The big news and recent news has us looking across the pond to the Netherlands where a certain species of truffles are sold legally. On January 28, 2022, Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) , an Ontario based company whose business revolves around the production, growth, and sale of a premium brand of magic truffles congratulated their partner, CCrest Lab, in a press release,“for being approved by Health Canada to supply Psilocybin to the new Special Access Program that would allow patients with conditions that are not treatable by other medication to get access to Psilocybin”.
“Red Light Holland has successfully imported their psilocybin truffles from the Netherlands to CCrest Laboratories twice where they were tested. Red Light Holland and CCrest Laboratories have continuously demonstrated their strong commitment to the highest regulatory compliance standards.”
“Red Light Holland hopes to continue to provide CCrest Laboratories with a source of their naturally occurring Psilocybin truffles, that would then be made available free of charge for patients who are eligible under the Special Access Program based on compassionate need.”
Mydecine Innovations Group (NEO: MYCO) (OTCMKTS: MYCOF) launched The Special Access Support and Supply Program (SASSP) serving physicians, clinics, and hospitals throughout Canada.
SASSP is a package of goods and services including:
- cGMP certified pharmaceutical grade psilocybin and MDMA
- Health Canada Schedule 1 Drugs and Substances Dealer’s License
- API is manufactured and shipped from Alberta, Canada
- Investigative brochures and therapy manuals
- Ongoing advising services from world-class team of scientists and doctors experienced in treating mental health and addiction disorders
- Training on best-in-class psychedelic-assisted psychotherapy protocols
- Support services to reinforce safe and effective administration of medicine-based treatments
- Personalized patient support through the Mindleap digital health platform
Psygen, a privately held psychedelic company based in Calgary, will build a psychedelic “supply chain”. Their subsidiary, Psygen Labs, received its dealer’s licence, issued by Health Canada on January 17, 2022.
“A subsidiary of Psygen Industries, Psygen Labs is now authorized to manufacture, sell, import, export, and work with controlled substances including LSD, MDMA, psilocybin, psilocin, DMT, 2C-B, and mescaline. Psygen is also capable of manufacturing unscheduled substances including but not limited to 5-MeO-DMT and ibogaine.”
“Psygen also provided Health Canada with consent to be identified on a public list as a licensed dealer able to provide GMP psilocybin for use in patients through Canada’s special access program (the “SAP“).”
Last, but certainly not least, we circle back to Field Trip Health (CNSX: FTRP) (OTCMKTS: FTRPF). Field Trip has already made a name for themselves in the legal ketamine market. On January 6, 2022 Field Trip announced that it “will begin making applications for Canadians in need to access psilocybin-assisted and MDMA-assisted therapy through Health Canada’s Special Access Program (SAP)”. Although the folks at Field Trip do feel there is a long road ahead.
“We still have a huge amount of work to do because these medicines could really, really revolutionize the entire mental health-care field,” said Dr. Michael Verbora, who works as a medical director at the Field Trip Health therapy center in Toronto.”
Ronan Levy, co-founder of Field Trip Health, said most applications except for the most severe will probably be rejected. He is hoping that Health Canada’s criteria for approval of psychedelics will expand in the future.
Who then will benefit from these applications, if most will probably be rejected? How is Health Canada defining life-threatening?
Dr. DJ Cook, Head of Neurosurgery at Queen’s University and Chief Medical Officer at Dimensions Healing had this to say, “I think individuals in a palliative state who are experiencing death anxiety, for instance, and where there is reasonable literature supporting the use of psychedelics to treat anxiety, have a clear case.” “But again, the threshold and the requirements of proof are unknown.”
“I believe that, over time, we’re going to see ’emergency’ classified as people who’ve had consistent drug overdoses, for example, and we’re going to see this expand and morph.”
“Without a concrete list of conditions, we can assume Health Canada will follow the data. And studies on psychedelic use in end-of-life care, Alzheimer’s care, and treatments for people grappling with post-traumatic stress do make compelling arguments.”
Since the beginning of 2020 over 20 psychedelics companies have been listed on the Canadian stock exchanges.
“With a growing body of research, shifting demographics and a general openness to evaluate non-conventional ways to deal with existing challenges, the public has become more receptive to psychedelics for medical and therapeutic purposes.”
“It is anticipated that access to drugs and treatments that incorporate psychedelics may increase through the recent Amendments to the SAP as well as s. 56 Exemptions continuing to be granted by the Minister of Health.”
I would hope with continued interest from large venture capital psychedelic medicine companies Health Canada will soften their stance on decriminalization or legalization of restricted drugs.
Author: Sherri Margolin (Dark Matters)