Two psychedelic industry insiders reflect on the progress and flaws within Health Canada's recent amendment to the Special Access Program.
Last month, Health Canada’s new Special Access Program (SAP) amendment went into effect, allowing physicians to request access to psilocybin, MDMA, DMT, LSD, and other psychedelic treatments not officially approved for sale in the country. The amendment, which reversed a 2013 policy prohibiting special access to restricted drugs, signifies a positive change in the healthcare industry’s perception of psychedelics.
But while medical professionals and psychedelic advocates responded with enthusiasm, the news also ignited a few misconceptions around program eligibility and psychedelic legality.
“This [amendment] shows that Health Canada is aware of the promise of psychedelic therapy and committed to understanding more through further research,” says Dr. DJ Cook, Head of Neurosurgery at Queen’s University and Chief Medical Officer at Dimensions Healing. “But it won't be an assured means of acquiring these medicines for therapy — there will be a threshold to gain approval.
To better understand, we dug deeper into how the program will work, who will benefit, and whether there’s potential for full legalization.
How Does the Special Access Program Work?
For several years, Canadian health care providers have relied on Health Canada’s SAP to access otherwise unavailable drugs for “serious or life-threatening conditions” — particularly when traditional paths fail to yield positive outcomes. For example, the SAP might grant access to a not-yet-approved chemotherapy drug for a patient with a rare tumor or a new antiviral for a patient with long-standing, treatment-resistant HIV.
However, requests are decided on a case-by-case basis and don’t automatically guarantee access. When a healthcare professional determines a patient may benefit from a drug that’s not yet available for sale, they must submit a request to Health Canada and wait for a decision. If approved, the manufacturer is cleared to supply the drug to the licensed health care professional to distribute to their patient.|
When it comes to psychedelics, health care providers can only access drugs from a dealer licensed under the Controlled Drugs and Substances Act (CDSA). In other words, the SAP doesn’t give carte blanche to all psychedelics from any source.
However, the SAP amendment also doesn’t require psychedelics to be dispensed in a therapy setting — which Dr. Cook says could be an oversight. “There is a key aspect to the environment and setting in which these therapies are undertaken,” he says. “Having therapists and retreat centers and therapeutic settings where patients can [take psychedelics] in a way that respects the cultural and ceremonial aspects of the therapies is critical.”
Kelsey Ramsden, co-founder and CEO of MINDCURE, agrees that integration is essential. “I think people are a bit misguided about this idea that psychedelics without psychotherapy will get the same kind of result,” she says. “Having psychotherapy paired with these drugs allows people to integrate what they learn.”
Of course, patients can choose to seek psychological therapy alongside the medication on their own, and health care professionals may even encourage psychotherapy or include it within their care plan. But, currently, it’s not required.
Who Will Likely Benefit Most from the SAP?
We still don’t know how Health Canada defines “life-threatening” regarding mental health conditions or how many failed conventional treatments are necessary before a patient can access a psychedelic drug. And we likely won’t know more until there have been a significant number of cases authorized or denied. But experts have some ideas about which conditions may be more likely to get approval.
“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,” Dr. Cook says. Additionally, he notes patients with treatment-resistant PTSD and those with a high potential for suicidality also have a strong case. “But again, the threshold and the requirements of proof are unknown.”
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.
Kelsey also believes the conditions that fall into the “serious or life-threatening” category will shift as clinical research evolves and the SAP fields more cases. “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.”
Will Psychedelics Follow the Same Path to Legalization as Cannabis?
One of the biggest questions amidst the amendment’s rollout is whether psychedelics are on the same course to legalization as cannabis. However, it appears, at least in this stage, that Health Canada is treating these drugs more like a controlled medicine and less like a recreational substance.
“What we're talking about with respect to psychedelic medicine is very different than cannabis,” Kelsey says. “Comparing the two is like comparing a Ferrari to Toyota Tercel. Both will get you places, but one is very powerful and requires a lot of experience to handle properly. Who do you want to put behind the wheel of something that performs this way?”
Dr. Cook echoes this sentiment and says the pathway to legalization for psychedelics should more closely resemble pharmaceutical development than cannabis. “I hope that there is a more metered and regulated approach to accessing the therapies,” he says.
But even with its limitations and ambiguous thresholds for accessibility, the new amendment is an exciting step in a progressive direction. It’s also a clear signal that regulators are interested in seeing psychedelics advance. And as new data moves science forward, patients' first-hand accounts will likely sway culture toward normalization and acceptance.
“The more we have individuals who can speak to the transformative effects of psychedelics for mental health care, the better we all will be,” Kelsey says. “It's a testament to the forward-thinking nature of our healthcare system. And for that, I'm grateful.”