HEALTH CANADA
APPLICATIONS

Working with Health Canada is currently the primary path to which patients are able to access legal psychedelic-assisted therapy in Canada.

ATMA Journey Centers was the first private therapy company in Canada to conduct legal psychedelic-assisted therapy using psilocybin under a Health Canada Section 56 Exemption, and we continue to work with clients to assist in facilitating approvals.

While psychedelic-assisted therapy continues to gain mainstream acceptance and a large body of evidence-based research and science continues to grow, psychedelics continue to be a restricted or prohibited category of substances in many jurisdictions, including Canada. A small number of medicines are currently legal in Canada to be used in a therapeutic and medically supervised setting such as ketamine and ibogaine.

However, most of the other psychedelics that are showing extraordinary potential as healing and transformative medicine such as psilocybin, MDMA and LSD are currently banned from any use in Canada.  The exciting news is that Health Canada has recently begun approving individual applications for Canadians which provide legal access to some of these important medicines. 

Building on our success of having conducted the first private therapy in Canada using psilocybin, we continue to work diligently to increase access to psychedelic medicine options for Canadians.

There are currently two methods in which patients have the potential to access this life-changing therapy in a legal and sanctioned way, both involving Health Canada.

SECTION 56 EXEMPTION

The Controlled Drugs and Substances Act is the primary legislation in Canada that “prohibits activities related to controlled substances and precursor chemicals.”  Because psychedelics are predominantly categorized as Schedule 3 drugs in Canada, they are considered prohibited substances.

However, the CDSA also allows for certain exemptions to be made by the Health Minister:

56 (1) The Minister may, on any terms and conditions that the Minister considers necessary, exempt from the application of all or any of the provisions of this Act or the regulations any person or class of persons or any controlled substance or precursor or any class of either of them if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.

This exemption is the method by which legal psychedelic-assisted therapy was able to happen starting in 2020, with a small number of patients being granted a Section 56 Exemption by Health Canada.  The initial exemptions were granted on compassionate grounds, as the applicants were all facing terminal illnesses and were palliative care patients.  However, it appears the grounds on which applications are being considered is broadening — which is likely to open the door to exemptions for patients suffering from debilitating (but not palliative) mental and emotional health conditions that traditional therapy and medication has been unsuccessful in treating.

Exemptions under Section 56 of the CSSA have become the primary gateway through which legally sanctioned psychedelic therapy has become possible in Canada.  We expect this gate to open wider in 2021 and beyond, and we are actively working with clients to submit applications to Health Canada to receive these exemptions.  If you’d like to begin the application process, please click here.

SPECIAL ACCESS PROGRAM

The Special Access Program (SAP) offered by Health Canada allows health care professionals to request access to non-marketed drugs to treat patients with serious or life-threatening conditions that are not yet approved for wider usage in Canada.  According to the Health Canada website, “access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable.”

Unfortunately, in 2013 the government passed an amendment to the Food and Drug Regulations (which affects what drugs or medicines may be considered under the SAP) that explicitly excluded restricted drugs such as psychedelics like psilocybin and MDMA. As a result, the only way to access these substances was through a costly and time-consuming process involving clinical trials.

The story doesn’t end here however, as Health Canada is actively considering amending the legislation again so that restricted drugs will again be eligible to be considered in the Special Access Program. 

According to Health Canada:

“Health Canada is proposing to reverse the remaining regulatory changes made in 2013, which would remove the current prohibition on access to restricted drugs through the SAP.”

A public consultation process is currently underway, and it is widely anticipated that the government will follow through and allow restricted drugs back into consideration.

Practically speaking, this means that health professionals would be able to apply to Health Canada in order to access psychedelics on behalf of a specific patient for therapeutic purposes, and the eligible treatment would likely apply to a wide range of psychiatric and mental health conditions beyond just palliative or end-of-life situations.

The time frame in which the government consultation process may take, and how long it might be until health professionals can actively apply to the SAP regarding psychedelic substances is unknown.  However, at ATMA we are eagerly anticipating the government to move swiftly through this process, given the pressing and urgent need of alternative treatment options for mental, emotional and existential challenges.

Please be sure to join our updates list (using the subscribe box at the bottom of this page) to stay informed as we monitor and actively work to bring greater and wider access to psychedelic-assisted therapy in Canada and beyond.

Curious about the potential benefits of psychedelic-assisted therapy?

If you have never experienced psychedelics, either in recreational or therapeutic settings, it may seem foreign and non-traditional. Here is a breakdown of what it can be like to experience.

Psychedelic therapy is a completely different protocol than traditional medicine. Typically, a medicine is taken to solve a problem in our body. We take a pill when we have a headache, and we don’t feel what it’s doing as – we just hope the headache goes away.

Psychedelics, in contrast, open up our psyche to understand the root cause of the issue or show us how to reach the goal we are seeking to identify. For example; PTSD is linked to trauma in our past. Often we can block the trauma, or we fixate on the trauma. Either way we are not able to get past the core issue that is holding us back from mental health.

Often times, the traumatizing event or memory is so painful that our protective self makes it impossible for our conscious mind to acknowledge it. In an effort to protect us, our inner self keeps that painful trauma hidden – but even though we consciously cannot acknowledge it, the trauma remains buried in our subconscious, creating a variety of problems and challenges. This is why traditional approaches such as talk therapy have limited effect on trauma-based conditions and challenges.

When we enter into the psychedelic state, it can often allow us to discover a new perspective on the trauma, and help reframe the “story” that we have created in our minds about the trauma. Our protective self is gently relaxed, allowing us to see these otherwise hidden challenges so that we can finally acknowledge and process them. It allows us to dive into our own limitations, and be able to find a new way to view the issue, so that we are able to look forward to a positive future, rather than be fixated on the past.

Therapeutic use of psychedelics is contrasted with recreational psychedelic use by the various protocols and intentions that are involved when undertaking psychedelic-assisted therapy.

Many people currently and in the past have used psychedelics for the recreational properties that they provide. Euphoria, visual distortions, and a sense of oneness with all living beings can be a beautiful experience. However, when they are utilized without conscious planning or thought around optimizing the experience and maximizing safety, the possibility of experiencing a negative “trip” increases.

Utilizing psychedelic medicines in an appropriate therapeutic setting involves a number of measures and protections. These include:

  • counselling and discussion prior to the medicine session to assist in setting expectations as well as intentions for the therapy;
  • a safe and comfortable environment in which to undertake the medicine, while being supported by an experienced facilitator (therapist, counsellor, etc.);
  • access to appropriate tools and aids in maximizing the experience (such as an eye mask, curated music designed specifically for psychedelic therapy sessions, etc.)
  • using medicines that are clean and pure in their chemistry ( i.e. safe source);
  • follow up support that can include psychological counselling and therapy, allowing the patient to further explore and process what may come up during or after the medicine session.
When undertaken in an appropriate setting with an experienced facilitation team, clients can fully tap into the healing properties of the medicines, knowing they won’t be endangered in any way, and that the support is right there if they need it. Even more importantly, the work of the medicine provides that inner spotlight showing us where the issues are, and allows us to see how we can make changes towards healing.

Bringing professional therapeutic guides into the process at all stages – for pre-session intake counselling, during the psychedelic journey, and for post therapy discussions – the work of the medicine can be amplified in ways that the psychedelic alone cannot.

At ATMA, we have great respect for the traditional work of psychedelic use that goes back thousands of years. The synergy of combining it with current research and appropriate and well designed protocols has shown remarkable results for PTSD, depression, anxiety, and other ailments in the range of 70-90 %. These results are proving to last for months or years after only one or two sessions. As the body of research grows, we continue to see that psychedelic-assisted therapy appears to offer the extraordinary potential of healing that cannot be ignored.
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