TheraPsil’s White Paper: Accessing Psilocybin Through Canada’s Special Access Program

Published on: January 26th 2022

Disclaimer: This white paper does not constitute medical or legal advice. This is merely TheraPsil’s interpretation of the recent changes to the Special Access Program based on the available literature and our experience, as of the date of posting.

Summary

Licensed healthcare professionals who are authorized to prescribe in their respective provinces (i.e. Medical Doctors or Nurse Practitioners), can now apply for a safe supply of psilocybin on behalf of their patients with serious or life-threatening illnesses. The psilocybin must be manufactured or imported by a Health Canada approved licensed dealer, through Canada's Special Access Program (SAP).

Health Canada has indicated - by recently responding to many patient's section 56 exemption applications - that patients should first attempt access to psilocybin through an SAP request form submitted by their healthcare professional.

SAP request forms are processed on a case-by-case basis and place discretion of access to a medicine at the governmental level. Discretion of which Licensed Dealers can sell or provide their psilocybin products to patients is decided on a case-by-case basis by Health Canada or the Minister of Health.

While the changes to the SAP represent a small and positive step for some patients who are in critical need of psilocybin for medical purposes, we feel that the SAP does not meet the needs of most patients and their healthcare providers.

Canada still urgently needs regulatory change. TheraPsil continues to advocate for our proposed ‘Access to Psilocybin for Medical Purposes Regulations’ so that patients can access regulated medical psilocybin and psilocybin-assisted psychotherapy through direct consultation with their healthcare provider, rather than the government, like most other medical treatment options.

What is the Special Access Program (SAP)?

“Health Canada’s Special Access Program for drugs (SAP) enables drugs that are not marketed in Canada to be requested by practitioners for the treatment, diagnosis, or prevention of serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.” (source )

This program allows licensed healthcare professionals who are authorized to prescribe in their respective provinces (i.e Medical Doctors or Nurse Practitioners) to request a drug that is not available for sale in Canada, on behalf of their patient. An example of how the SAP has been used in the past, was to allow access to Trikafta, a Cystic Fibrosis treatment drug, for some critically-ill patients, prior to this drug being approved in Canada in Summer 2021. This allowed some critically-ill patients, access to a drug that treats the causes of cystic fibrosis in up to 90% of Canadians. (source). More commonly the Special Access Program is used to help practitioners gain access to cancer and HIV treatment drugs that are not yet available in Canada.

The SAP is for serious and critical or ‘emergency treatment’ use only and is not intended for broad access to drugs.

How is the SAP different from section 56 exemptions?

Section 56 exemptions allow patients to legally use, possess, transport and destroy a certain amount of psilocybin for medical use under certain circumstances and guidelines (i.e for use in psilocybin-assisted psychotherapy). It essentially decriminalizes a small amount of psilocybin for a patient so that they can legally pursue psilocybin-assisted psychotherapy. Patients with section 56 exemptions must procure their own psilocybin from unregulated sources. As of the date of publishing this White Paper, 55 patients, supported by TheraPsil have received section 56 exemptions.

Until January 25th 2022, when TheraPsil-supported patients were contacted by Health Canada regarding their favour for SAP requests, applying for a section 56 exemption was the most common route (outside of clinical trials) for patients to legally use and possess psilocybin for medical purposes.

In contrast, the SAP will now allow a patient’s doctor to request, on behalf of their patient, access to a safe supply of a specifically requested psilocybin product from an approved drug manufacturer (“Licensed Dealer”). In addition, certain healthcare professionals now fall under a class exemption so they may possess, transport and administer psilocybin, approved and obtained via the SAP, to a patient. Patients who are treated with psilocybin through the SAP are not allowed to be in possession of psilocybin or self-administer. (source)

The SAP is for emergency use in patients only, and at the time of publishing this White Paper, TheraPsil is still in the process of testing this program. We are working to scale this process and provide education to physicians so they can support the thousands of patients who have reached out to us.

Further down in this White Paper you can view a comprehensive comparison chart outlining some key differences between access through the SAP, section 56 exemptions and what access would look like through our proposed ‘Access to Psilocybin for Medical Purposes Regulations’.

What changes were made to the SAP related to psilocybin access?

On January 5th 2022, Health Canada announced changes to the SAP through an announcement in the Canada Gazette. The full announcement can be read here.

These changes repeal a 2013 amendment to part C of the Food and Drug regulations which made certain drugs, listed in the schedule to Part J of the of the Food and Drug Regulations (“restricted drugs”), inaccessible through the SAP.

Therefore the changes to the SAP “restore the possibility for practitioners to request access to restricted drugs through the Special Access Program. In practice, this means that practitioners will, on behalf of patients with serious or life-threatening conditions, be able to request restricted drugs through the Special Access Program in instances where other therapies have failed, are unsuitable, or are not available in Canada.” (source).

Psilocybin is an example of a restricted drug that is now able to be requested through the SAP.

What does this change mean for patients?

Patients who meet certain criteria, may now request that their physicians fill out and submit the 8 page SAP request form on their behalf. Physicians complete mandatory reporting requirements and accept liability for the treatment outcomes. These patients may be granted access to regulated psilocybin products, manufactured or imported by Health Canada approved license dealers.

In short, it means some patients may be able to access a safe supply of psilocybin through a request made by their doctor. This may include synthetic or natural psilocybin but likely does not include whole psilocybin containing mushrooms (i.e fruiting bodies).

Again, it is important to note that the SAP was not designed for access to psychedelics, nor is it designed for broad access to novel drugs. It is for ‘emergency use’ only.

The SAP may be very beneficial for patients facing critical life-threatening illness who need urgent access to psilocybin, however the SAP is not expected to help the majority of patients in medical need who require medical psilocybin or psilocybin-assisted psychotherapy.

What are the eligibility requirements patients must meet for their doctor’s to request psilocybin products through the SAP?

Health Canada states that the “request must be for treating a patient with a serious or life-threatening condition where conventional treatments:

have failed
are unsuitable or
are not available in Canada” (source)

We are unsure of all the conditions and circumstances that Health Canada deems to be ‘serious’ or ‘life-threatening'. We do know however that ‘Intractable depression’ along with ‘terminal cancer’ are considered serious enough, as outlined by Health Canada. (source)

In addition, we know that as part of their decision making process, the individual(s) processing SAP request forms will review the following information requested on the form (among other information requested):

“Relevant clinical information on the patient’s current condition, medical history and comorbidities. What specifically about this drug (e.g. mechanism of action, drug class, dosage form) makes it the best choice for your patient(s)?
All treatments tried and/or failed, including details on dosage, duration and clinical response. For treatment options that have been ruled out on clinical grounds, please specify and explain.
Recent and relevant data, references, and/or resources in your possession with respect to the use, safety, and efficacy of the drug. The supporting evidence must be directly relevant to the medical emergency specified, be from credible medical/scientific information sources. For citations, please include author(s), title, journal, volume, issue, date, and page information.” (source)

Page 23 of this Guidance Document provides ample details on the factors that the SAP takes into consideration before issuing a letter of authorization or letter of denial to requesting practitioners.

As exemplified by the above, it is clear that a substantial amount of clinical rationale is required by a physician who is requesting psilocybin on behalf of their patient.

What does this mean for healthcare providers?

Prescribing Healthcare Professionals who are caring for patients with life-threatening or serious medical conditions, who agree that medical psilocybin is a suitable treatment option and who are willing to support their patient, can now request access to psilocybin on behalf of their patient when all other treatment options have failed or are unsuitable.

Healthcare providers themselves will be unable to request psilocybin for experiential training or other purposes through the SAP. The SAP is reserved only for emergency use when needed by patients.

Healthcare providers must understand that the SAP request form is 8 pages long and may take up to 2 hours to complete. In addition there are mandatory reporting requirements the practitioner must meet, by completing a ‘follow up form’, following each administration of the requested drug, which can be expected to take up to 1 hour to complete.

Healthcare professionals can request drugs for immediate use (Form A), or fill out a future use request form (Form B), in anticipation of an emergency in the future.

Healthcare professionals must understand that “In deciding to request a drug through the SAP, the practitioner assumes the liability and responsibility for the use of that drug.” (source)

In addition, some healthcare professionals who meet certain criteria now fall under a ‘class exemption’ which allows them to possess and transport the requested drug (if approved) and administer it to their patients. Healthcare professionals who do not fall under the class exemption will need an individual section 56 exemption in order to administer psilocybin for their patients. (source).

How does a patient apply for access through the SAP?

A patient cannot apply for drugs through the SAP. Their health care professional must apply on behalf of them. The request form for a specific patient (“Form A”) is available here. The future use request form (“Form B”) is available here.

Do patients still need section 56 exemptions?

As communicated in emails received by patients on January 25th 2022, Health Canada is encouraging patients to use the SAP (through requests submitted by their doctors) instead of applying for section 56 exemptions, stating that the SAP and clinical trials are the primary routes to access.

Only after an attempt to access psilocybin through the SAP been denied, or deemed unsuitable for that patient, will patients be considered by Health Canada for a section 56 exemption.

Patients who need support in accessing medical psilocybin are encouraged to contact TheraPsil, here.

Although we are currently unable to predict the most suitable pathways for access for each individual patient, we will continue to work diligently to support patients who need compassionate access, either by supporting their physicians with the SAP process, or by supporting them to apply directly for a section 56 exemption.

Is TheraPsil still advocating for their ‘Access to Psilocybin for Medical Purposes Regulations’ (the APMPR)?

YES. While the SAP may solve two important problems not addressed by section 56 exemptions - safe supply, and long wait times, it is very clearly a ‘special’ access program that will likely not help the majority of patients in medical need of psilocybin or psilocybin-assisted psychotherapy. Furthermore, now that the SAP is considered a primary access route, above section 56 exemptions, patients and their healthcare providers face an even more administratively cumbersome process in order to request access.

Because the SAP request forms are processed by bureaucrats working in the SAP office, the discretion of an individual's access to medicine is determined on a case-by-case basis at the governmental level. The Minister of Health also has full discretion to decide which manufacturers and products may be approved through the SAP.

TheraPsil’s proposed APMPR would place the discretion of access to this medicine and treatment option where it belongs: with a patient's healthcare provider, like the majority of other healthcare decisions. A patient would be able to consult with and be approved for this treatment option by their healthcare provider, without bureaucratic or governmental interference.

Regulations would allow quick and predictable access to safe, regulated sources of psilocybin without the onerous section 56 or SAP application processes.

In addition, regulations would allow healthcare providers the ability to access psilocybin for experiential training purposes, which is not currently possible through the SAP and has had limited success through the section 56 exemption process.

To learn more about the Access to Psilocybin for Medical Purposes Regulations that we have proposed, please click here.

Some perceived pros and cons of accessing psilocybin and psilocybin-assisted psychotherapy through the SAP

Some Pros of Access through SAP

Safe supply: Patients who meet the criteria and who are granted access through the SAP will have access to regulated psilocybin products, manufactured or imported by Health Canada approved licensed dealers. These patients will not have to procure their medicine from the illicit and unregulated market, which is currently required by patients who hold section 56 exemptions.
Standard service time and process for requests: SAP requests can be expected to be processed within 1-2 business days (source). Additionally, there is a clear process for what can happen after a request is made:
- Authorization: the request is approved
- Application is deemed incomplete and more information is requested from the healthcare professional
- Cancellation of request if the manufacturer is unable to provide access to the drug through SAP
- Application is withdrawn by the health care professional
- Denial: the request is denied because the information does not meet SAP criteria (source).

In contrast, there is no standard service times for section 56 exemption applications to be processed. Some patients have waited up to 300 days for their applications to be approved, while some patients have been approved in less than 48 hours.

Some Cons of Access through SAP

Limited access: The SAP is not intended for broad access. It is for emergency use only. Patients who do not meet the SAP criteria, who do not have enough clinical rationale to support their request and/or do not have a doctor willing to complete and submit their request form still do not have legal access to medical psilocybin or psilocybin-assisted psychotherapy unless they have a section 56 exemption, or are enrolled in a clinical trial.
Government as gate-keeper: The SAP places a bureaucrat, an individual working in the Special Access Program office, as the decision maker for access to a patient’s medicine. It is a bureaucrat who reviews the clinical rationale for access and determines whether or not access to psilocybin is justified.
Cumbersome for healthcare professionals: A healthcare professional requesting access to psilocybin through the SAP for a patient can expect to take up to 2 hours completing the request form, plus up to an additional hour to meet existing regulatory requirements required / mandatory reporting. Although the section 56 application process is also onerous, although in comparison, TheraPsil’s established section 56 application process time requirement for prescribers is not as immense.
Limited patient involvement: SAP request forms are completed and submitted by a healthcare professional. If they are approved, the psilocybin is shipped to a specific location (pharmacy, doctors office, blood bank, etc) (source) where a healthcare professional is in possession. Patients are not involved in the process of applying for their medicine nor are they ever in possession of it. This is particularly challenging for patients who require psilocybin for pain management (i.e cluster headaches) and who may need to self-administer psilocybin in sub-hallucinogenic doses on irregular schedules to prevent or abort cluster attacks.
No access for training: Healthcare professionals who are being trained on how to safely and effectively facilitate psilocybin-assisted psychotherapy for patients do not have access to psilocybin for experiential training purposes through the SAP. The SAP is for ‘emergency use’, for patients only.

Some things we don’t know yet:

Cost: "The manufacturer determines the cost of the drug. In some cases, drugs released through SAP are free.
If there’s a charge, hospitals, public or private insurers or, in some cases, patients or their families will cover the cost."(source).
Real world eligibility: We do not know which patients are genuinely eligible for access through the SAP. We do not know what Health Canada considers emergency use, or the amount of supporting information on the patient’s previous treatment options, condition and/or literature and research on the drug being requested that are required to satisfy the SAP’s requirements for approval. This will become clearer with time as applications are submitted, approved, and are requested to be updated with more information or denied.

Comparison Chart

This chart compares the SAP, section 56 and our Proposed Regulations head-to-head on a number of factors.

View Chart

What is TheraPsil doing as a result of this change?

TheraPsil is working to educate healthcare professionals on the SAP and how to support their patients.

If a patient’s own doctor successfully submits and is approved for access to psilocybin through the SAP, that doctor is encouraged to contact TheraPsil for support as it relates to the therapeutic aspects of psilocybin-assisted psychotherapy. TheraPsil can refer patients to TheraPsil-trained healthcare professionals who can facilitate psilocybin-assisted psychotherapy.

If a patient is denied access via the SAP, TheraPsil will support that patient in applying for a section 56 exemption.

TheraPsil continues to advocate for regulatory change so that all Canadians in medical need can access regulated psilocybin, and legal psilocybin-assisted psychotherapy through consultation with their healthcare professional, not through exemptions or request forms processed at the governmental level.

What is TheraPsil’s overall opinion regarding the changes to the Special Access Program?

While we agree that changes to the SAP indicate a willingness by Health Canada to acknowledge the medical potential of psilocybin and other psychedelics, overall we feel that the SAP does not meet the needs of patients and healthcare professionals.

Accessing medical psilocybin and psilocybin-assisted psychotherapy should be a decision made between a patient and their prescribing physician. This is not a decision that should be made individually at the governmental level requiring individual approvals patient-by-patient and doctor-by-doctor.

Calls to action

If you believe that access to psilocybin for medical purposes, and psilocybin-assisted psychotherapy should be a decision made between a patient and their healthcare provider, not a decision made by a politician or bureaucrat, we invite you to advocate with us.

Write, call or tweet your Member of Parliament and Health Minister Jean-Yves Duclos.

We’ve made it supremely easy to contact your Member of Parliament (cc’ing Minister Jean-Yves Duclos) through our advocacy tool, powered by NewMode. It takes less than 30 seconds to email your MP and demand regulations for medical psilocybin and psilocybin-assisted psychotherapy in Canada.

Advocate with us today. Your voice matters. Your voice makes a difference.

Please also consider donating to TheraPsil. We are a small non-profit working to make big changes. Every dollar you donate enables us to continue and accelerate our work. Please consider supporting us here.

(February 2023 Update) SAP after 1 Year: What we know now

In 2022, Canada's Special Access Program (SAP) was amended to allow licensed, prescribing healthcare professionals to apply for a safe supply of psilocybin on behalf of their patients with serious or life-threatening illnesses. While this was a step forward in recognizing the medical potential of psilocybin and other psychedelics, the limitations of the program, predicted in this white paper in January 2022, have become apparent over the past year.

One major issue with the SAP is the standard service time, which was expected to be 1-2 business days but has proven to be much longer. For example, Kristine Porter, a patient experiencing suicidal ideation and treatment-resistant depression, had to resort to legal action to force the government to render a decision on her SAP application. It took less than 48 hours for her application to be approved once legal action was taken, demonstrating the need for faster response times. Patients should not have to resort to legal action just to get a response from Health Canada.

Another issue is finding willing prescribers, especially in smaller Canadian communities. Patients are only considered for s. 56 applications (which allow access to non-approved drugs for serious or life-threatening conditions) after their SAP application has been denied. If a patient cannot find a physician to support their SAP application, they may have no option but to explore underground sources. Janis Hughes, a TheraPsil-supported patient, was denied access through a s. 56 and couldn't find a prescriber to support her with a SAP application, leading her to undergo an underground psilocybin journey without Health Canada approval. Additionally, physicians without experience in writing SAP applications may struggle with the onerous process.

Bureaucratic gatekeeping is another issue, as patients' applications may be denied because they haven't tried other forms of therapy such as ECT. Patients must wait for the approval of a government bureaucrat, which creates unnecessary steps that can harm patients. Furthermore, healthcare practitioners such as Dr. Valorie Masuda have been turned away from accessing psilocybin for their patients through SAP because they are "treating too many people". Dr. Masuda has been told she should apply for a clinical trial instead.

The emergency use criteria for SAP also restricts access for patients and healthcare practitioners. “Emergency use” excludes many patients suffering from serious conditions. For example, patients with cluster headaches may experience suicidal ideation due to their chronic pain. Should their condition not then qualify as an emergency? Additionally, there is no space for healthcare practitioners to use psilocybin as part of their psychedelic-assisted psychotherapy training.

While safe supply of psilocybin is a positive development, some patients may prefer to take whole, dried mushrooms instead of a naturally or synthetically derived psilocybin product. Patients may find that GMP psilocybin is much shorter acting and lacks many of the traits essential to a mushroom "trip", which can only occur by using whole, fruiting body mushrooms.

As of January 27th, 2023, SAP received 76 requests involving 95 patients, of which only 57 applications involving 72 patients were authorized access to psilocybin. While Health Canada may point out that some patients are getting access, this is a small fraction of the over 1100 patients who have applied for support from TheraPsil.

In summary, Health Canada's SAP falls short in providing adequate access to psilocybin for patients and healthcare professionals. Improvements are needed in response times, finding willing prescribers, bureaucratic gatekeeping, emergency use criteria, and allowing for whole mushrooms.

Patients should not have to be special to access their medicine.