what canada’s special access program means for patients and doctors

the special access program that launched last week, allowing canadians to potentially access restricted drugs on a case-by-case basis, is a reworking of past policy, rather than something new.the program was amended in 2013, under former health minister rona ambrose, after she learned health canada had approved an application to allow 21 patients with long-term addictions access to prescription heroin. the patients had previously been involved in a clinical trial comparing hydromorphone to diacetylmorphine, heroin’s active ingredient.last week, the newly amended sap went into effect. the 2013 changes were reversed and physicians can now once again request patient access to restricted drugs and psychedelic treatments like psilocybin- and mdma-assisted therapy, as well as lysergic acid diethylamide (lsd) and n, n-dimethyltryptamine (dmt).the government also emphasized that the “regulatory amendments will not create large-scale access to restricted drugs.” nor do they “signal an intent towards the decriminalization or legalization of restricted drugs.” the sap is considered only when conventional therapies have failed, or are unsuitable or unavailable.as the government notes throughout the official communication, the sap is for emergency treatment only. patients who want to use the program will need to find doctors who are not only willing to complete the paperwork and application process but are also qualified to administer psychedelic therapies.so what do the changes really mean for canadians?“this whole program is going to be quite limited initially, and probably for its duration,” says dr. michael mcdonnell, an assistant professor in the department of emergency medicine at queen’s university and the chief medical officer for diamond therapeutics, a toronto-based psychedelic pharmaceutical company.he adds, though, that the amendment is “a really good first step forward” in spurring further research and generating more data regarding these therapies and their possible applications.“i would say there are probably very few doctors initially that are going to really use the program. but i think over time, as we get some comfort with this, and as we just keep getting more and more data, i think we’re going to see that expand to some degree,” he says.“this is the very, very beginning, and definitely not the end.”

mdma and psilocybin leading the charge

although the sap potentially opens up access to substances beyond mdma and psilocybin, the research backing their medical applications is robust. it’s unlikely that health canada would approve a medication for use unless there’s evidence to support it at the level of a phase two clinical trial.in 2017, the u.s. food and drug administration granted a breakthrough therapy designation for mdma-assisted psychotherapy for the treatment of post-traumatic stress disorder (ptsd). the designation can speed up the drug development and review process.california-based multidisciplinary association for psychedelic studies (maps) has been at the front of mdma research. in a phase 3 trial, maps found that mdma-assisted therapy is “highly efficacious in individuals with severe ptsd, and treatment is safe and well-tolerated, even in those with comorbidities,” or the presence of one or more medical conditions at the same time.maps notes that of approximately 1,700 human subjects administered with mdma, there has been only one serious adverse reaction.it’s this type of research that has mdma on a “drug development pathway,” says dr. evan wood, a professor of medicine at the university of british columbia and the chief medical officer for numinus, a vancouver-based mental health and wellness company.“mdma is going to be like a prescription drug and there’s little question in my mind about that,” he says.

dr. wood also stresses the importance of assessing psychedelic substances individually. mdma is much different than psilocybin, he notes. a naturally occurring psychedelic, psilocybin is produced by more than 200 species of fungi and has been used for thousands of years as a natural medicine by indigenous communities.like mdma, psilocybin has been granted a breakthrough designation by the fda. twice, in fact. in 2019, it was given the designation for its potential in treating major depressive disorder, as well as treatment-resistant depression. but the similarities mostly stop there.dr. wood says he sees one pathway for synthetic drugs like mdma, but natural psychedelics need to be looked at from a different vantage point.“for health canada or any other federal government, to put blinders on, and only look at psilocybin from the perspective of a future prescription drug is naive, because it is a naturally occurring molecule and limiting its use to a pharmaceutical paradigm doesn’t make a great deal of sense,” he says.“i think there has to be more [changes] coming as it relates to psilocybin because it’s simply not ethical to keep it illegal, and only available for a very small number of people,” he adds.dr. wood also notes that for some individuals with certain mental or physical conditions, psychedelics may not be well tolerated. he underscores the need for thoughtful implementation of any therapies that relate to these substances.“these are incredibly powerful experiences for people and with that potential to create a powerful experience is the potential, if it’s done without thoughtfulness, for someone to have a negative outcome, and we all want to avoid that. so that’s where the implementation science and the work in front of everyone that’s involved in this area, is to really be thinking about best outcomes and not having a situation where somebody is potentially harmed.”

urgent need for doctor training

therapsil, a b.c.-based non-profit founded in 2019, is one of the organizations working to address that problem.the organization has helped nearly 50 patients secure section 56 exemptions to the controlled drugs and substances act over the past two years, allowing patients to legally access psilocybin-assisted psychotherapy.to meet the demand of canadians interested in pursuing these types of therapies, therapsil launched a historic psilocybin-therapy training program last march. nineteen health care professionals, ranging from registered nurses to palliative care physicians, emergency medicine doctors, clinical psychologists and more, were granted section 56 exemptions to participate in the program.

since then, an additional 120 health care professionals have applied for exemptions and are enrolled in the organization’s training program, but not a single one has received an exemption.“we’ve got 120 doctors and therapists and nurses who are just begging and pleading the minister to grant their exemptions so that they can start treating their patients,” spencer hawkswell, therapsil’s ceo tells the growthop. some of those health care professionals have been waiting nearly a year for a response. this is part of the reason the sap amendments don’t go far enough, hawkswell says.“[psilocybin] is not just a drug you give to a patient. this is a drug therapy. we need trained health care practitioners to be there holding space and providing therapy for these patients. and the sap does not allow for that. it does not support health care practitioners.”in the meantime, the organization plans to continue to support canadians as they apply for section 56 exemptions.“we’ve still got a huge problem around training and we’ve still got a huge problem around access for patients,” hawkswell says.there are also unanswered questions about what constitutes an emergency. hawkswell says that about 90 per cent of the patients that contact therapsil are dealing with conditions like chronic pain, cluster headaches, anxiety, depression and suicidal ideation. it’s not clear which of those conditions, if any, will meet the government’s criteria.ultimately, what the organization wants to see are regulations that allow access to psilocybin for medical purposes.“i can’t stress enough that the sap is not a full solution, it’s a stopgap measure,” hawkswell says. “we’ve been yelling in the streets for the last few years that this is too little too late. but it truly is. so as happy as some of us are, we need more. and medical regulations are that answer.”

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