Health Canada’s SAP Amendments: A Game-Changer For Psychedelic Medicine In Canada?

  • Industry leaders offer their views
  • We explain how/why this could be a catalyst in Canada for the normalization of psychedelic medicine



Canada’s federal government has rightfully been credited with taking a more progressive approach to drug laws than the governments of other major nations around the world.

However, 50 years after psychedelic drugs were (erroneously) heavily criminalized, drugs such as psilocybin, LSD, and DMT remain as “Schedule III” controlled substances in Canada.

This is despite the fact that clinical research (and formal clinical trials) has now established that psychedelic medicine has the potential to revolutionize mental health care and that (administered in clinical settings) psychedelic drugs are safe.

This is despite a rapidly-worsening global Mental Health Crisis, with 2+ billion people currently suffering from treatable (but generally untreated) mental health disorders.

While Canada has largely corrected its irrational drug laws with respect to the legalization of cannabis, the same cannot be said with respect to psychedelic drug laws and access to psychedelic medicine, in particular.

However, beginning in 2020, Health Canada initiated baby-steps in opening up access to (specifically) psilocybin-based therapies for terminally ill patients. This came in the form of medical “exemptions” granted through its Special Access Program (SAP).

Compassionate relief.

In 2021, Health Canada began to slightly increase access to these exemptions, beyond exclusively reserving them for terminally ill patients.

Health Canada broadens SAP access in 2022

As of January 5, 2022, Health Canada has enacted formal amendments to the SAP with the potential to significantly increase access to (in particular) psychedelics-based therapies.

On the one hand, Health Canada has explicitly stated that these amendments will allow practitioners to request “emergency access” to “restricted drugs, which include psychedelic drugs”.

On the other hand, Health Canada has been equally explicit that the regulatory amendments “do not signal any intent towards the decriminalization or legalization of restricted drugs, and they are not intended to create large-scale access to restricted drugs”.

Not a backdoor to legalization. But, rather, increased access to what is still classified as an “emergency” program. Sadly, there is no shortage of mental health emergencies in Canada (and around the world), due both to a rapidly worsening Mental Health Crisis and conventional therapies that are grossly inadequate to deal with these mental health conditions.

This is some middle road, between the extremely restricted SAP access prior to 2022 and “large-scale access” to these next-generation medicines for mental health. The question is: what exactly will this middle road look like in Canada?

Industry leaders share their thoughts

Psychedelic Stock Watch has already asked someone who has a particularly informed perspective on psychedelic medicine and drug policy in Canada.

Payton Nyquvest, Founder and Chief Executive Officer for Numinus Wellness (CAN:NUMI / US:NUMIF) shared his thoughts in a recent Q&A. Numinus is one of the leading providers of psychedelics-based therapies to Canadian patients. When we posed this question to Nyquvest, this is how he saw these dynamics playing out.
 
“What we do know is this is a crucial step that recognizes the research and benefits of psychedelic-assisted therapy. And while full regulated medical access may not be part of this announcement, with no limit to SAP requests, we hope this can start to provide lasting change for the many people in Canada in need.”  

However, the psychedelic drug industry is growing rapidly and with such important news, Psychedelic Stock Watch has reached out to other industry leaders in the Canadian psychedelic drug industry for additional perspectives on this development.

Ronan Levy is Co-Founder and Executive Chairman of Field Trip Health (US:FTRP / CAN:FTRP), and another one of the “thought leaders” in the psychedelic drug industry. Field Trip is also a leader in Canada in psychedelics-based mental health therapy. This is how Levy views the recent Health Canada amendments.
 
“We've long believed that legalized access to psychedelic-assisted therapies using psilocybin and MDMA would happen much sooner than people would ever have guessed. It's why, despite many questioning raised eyebrows, we started building Field Trip almost three years ago in Canada. Deep down we knew that Health Canada, like it did with medical cannabis, would be demonstrate leadership in this regard.

While these amendments to the SAP do not yet achieve our hope of generalized medical access to these therapies, it is a big step closer and makes it only a matter of time before we see a more comprehensive access program.”

Why does Levy see it as “only a matter of time” until Health Canada provides “comprehensive access” to psychedelic medicine? This September 2020 article from the Ottawa Citizen provides a stark answer to that question.
 
The Mental Health Crisis now “affects nearly everyone” in Canada – and that was more than 15 months ago. In contrast, as of today, less than 8% of Canadians have actually contracted Covid itself, with most of those infections very mild.

Kelsey Ramsden is the Co-Founder and CEO of Mind Cure Health (CAN:MCUR / US:MCURF), another Canadian-based psychedelics company. MINDCURE has a strategic investment in Atma Journey Centers, Canada’s first private sector provider of psychedelics-based mental health therapy. MINDCURE is also preparing to commercialize its iSTRYM digital therapeutics platform, which will be used in some of the Canadian clinics providing psychedelics-assisted therapies.

As a two-time Female Entrepreneur of the Year in Canada, we asked Ramsden how she saw these amendments impacting the overall development of the psychedelic drug industry.
 
"I believe that the changes to the SAP will make little to no difference to the market for psychedelic drugs, provided that the access remains truly “emergency” driven. The real test will be in how Health Canada defines emergency. The potential good that comes with this change is, indeed, access to life-changing care for those provided access under the SAP.

I applaud Health Canada for committing to upholding a rigorous review process for these applications, so as to avoid the potential risk of a slide toward recreation — similar to what we saw in the cannabis industry, which resulted in a lack of funding for true drug research. Psychedelics can only truly transform outcomes and generate widespread access based on evidence-backed clinical research advancing."

Cautious optimism for the industry.

A potential game-changer for psychedelic medicine

Definitely a step in the right direction in terms of drug policy in Canada, but is it a game-changer for the psychedelic drug industry?

Arguably, yes. If not immediately, then certainly from a longer-term perspective.

Canada’s drug laws with respect to psychedelics remain irrational and an obstruction to drug research – as well as treatment. Not as absurd as U.S. drug scheduling, but certainly in need of being updated to reflect the scientific and medical realities of the 21st century.

The recent Health Canada amendments to the SAP will not provide large-scale access to psychedelic medicine. Health Canada has been up-front about this.

But what happens if Health Canada receives a deluge of SAP applications for “emergency” exemptions for psychedelics-based therapy? In particular, what happens if a large percentage of those applications are for psilocybin-assisted therapy?

A 2021 poll reported that 80% of Canadians would like to see access to psilocybin-based medicine legalized today. So, for the majority of Canadians, the new amendments to the SAP already don’t go nearly as far as they would like.

If Health Canada should receive large numbers of applications for psilocybin-based therapies, it has two choices.
 
a)  It can provide a high ratio of approvals (since psilocybin has a strong safety profile and there is no shortage of patients with genuinely urgent needs).
b)  It can provide a low ratio of approvals and look like an obstructionist bureaucracy that is blatantly defying the will of the people.

With (a), Health Canada gets credit for relaxing SAP guidelines, but ends up doing what it did not intend to do: provide a backdoor to legalizing this form of therapy.

With (b), Health Canada not only gets no credit for the SAP amendments, it looks to the People like a bona fide villain.

It’s obvious which optics would be more appealing to Canada’s current minority government. With “nearly everyone” now experiencing at least some strain to their mental health, Canadians will be watching Health Canada closely on how it handles these applications.

As Health Canada acknowledges, SAP is not a practical framework for adopting psychedelic medicine on any sort of large scale.

If these SAP amendments do result in large numbers of approvals for psilocybin-based therapies (along with other psychedelics?), it would be hard not to see that scenario as leading to near-term legalization of at least some psychedelic-based medicine in Canada – as predicted by Ronan Levy.

A point of no return on the road to normalizing access to psychedelic medicine.

With cannabis, Canada’s federal government took a much more proactive approach to drug normalization. Despite the warnings of skeptics, cannabis legalization in Canada (and legalization at the state level in the U.S.) has produced only positive societal benefits.

Canada’s same Liberal government has been considerably more tentative when it comes to normalizing psychedelic drug laws.

These Health Canada amendments to the SAP might provide exactly the sort of political pressure that could serve as a catalyst for further drug reform in Canada.

For investors in psychedelic stocks, this news couldn’t come at a better time. Recent market weakness has taken many of these stocks to new lows. Great value for new investors, but a concern to existing shareholders.

Health Canada’s amendments to its Special Access Program are, at the least, a mildly positive event for the industry, and mental health care in Canada, in general. But these changes might represent much more.

We may look back at these amendments in hindsight as the “game-changer” that put Canada’s federal government on a direct path to the normalization of psychedelic drug laws.




DISCLOSURE: The writer holds shares in Numinus Wellness and Mind Cure Health.
 
Thumbnail Photo Credit: N/A by N/A is licensed under N/A N/A
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