Minister of Health expands access to psilocybin to Canadians via the Special Access Program.

Minister of Health expands access to psilocybin to Canadians via the Special Access Program.

Recent news of Health Canada’s decision to amend its rules to further increase the accessibility of its Special Access Program (SAP) may leave you wondering: what are the changes, what do they mean, and what is the SAP anyways? 

The Special Access Program is a Health Canada initiative which seeks to provide medical professionals treating patients with serious or life-threatening conditions access to non-market drugs when standard therapies have been unsuccessful, unavailable, or are unsuitable for the patient’s needs. This authorizes a manufacturer to sell drugs that are otherwise unavailable for sale or distribution in Canada—permission is typically only granted in the most extreme cases. 

Patients wishing to explore non-standard medical treatments must access SAP through a health care professional. While this is generally a licensed physician, any health care professional who is (1) entitled under the laws of a given province or territory to treat patients with an unapproved prescription drug, (2) practices in said province or territory, and (3) has prescribing privileges in the respective province or territory is able to apply for access to non-market drugs under the SAP. However, the program also requires that the healthcare practitioner’s decision to provide the drug is supported by credible evidence in relevant medical literature provided by the manufacturer or via peer-reviewed studies. 

For those interested in using psilocybin-assisted treatments, recent events have held great promise. The non-profit advocacy group Therapsil has helped around 50 patients get an exemption to use psilocybin for anxiety and depression on compassionate grounds - permissions previously reserved for end-of-life care or those with terminal illnesses - since August 2020. The recent release of research constituting the largest ever randomized controlled trial from the Institute of Psychiatry, Psychology, & Neuroscience at King’s College London clearly indicating the safety and feasibility of psilocybin for effectively treating a variety of mental health issues (notably Treatment Resistant Depression and Post-Traumatic Stress Disorder); now followed by the most significant news this January, the Minister of Health’s Order in Council changes to the Controlled Drugs and Substances Act could signal the final step in the start of a mental health care revolution in Canada. 

While the notice of changes to the regulations issued in the Canada Gazette published on January 5th marks their coming into force, some background may be required on the issue of SAP to better understand what these regulations mean. In 2013, regulatory amendments to the Food and Drug Regulations meant that controlled substances designated restricted drugs became one of the only substances unable to be requested through the SAP; substances listed as restricted drugs are generally not considered to have approved medical uses, however, the announcement notes the science and clinical research has yielded promising therapeutic results since the changes were made over 9 years ago—as a result of this, the only way a patient could access restricted drugs for treatment was through participation in a clinical trial, often meaning patients without the ability to participate in clinical trials for any number of reasons had to forego this opportunity to improve their health. In addressing this, the stated objective of the newest regulatory amendments is to restore the ability of practitioners to request access to restricted drugs through the SAP - while the amendments deal with a variety of substances (for example, removes cocaine from the category of restricted drug such that it is regulated as a narcotic under the Narcotic Control Regulations).

Of particular interest is the changes that now allow Health Canada discretion to authorize restricted drugs under the SAP in relation to accessing psilocybin. After Health Canada published a Notice of Intent in December 2020, they began a sixty-day consultation period to gather feedback from stakeholders and the general public on the nascent desire to restore potential access to restricted drugs through the SAP; Health Canada noted that of the 392 unique responses, only 2% were opposed to the proposed regulatory amendments, also noting 80% of respondents associated the proposed reforms with increased access to psychedelic restricted drugs (i.e. psilocybin, MDMA, LSD, or DMT) for the treatment of mental health disorders, with some personal accounts mentioning the relative ineffectiveness and negative side-effects of existing treatment options. While they note that the outcomes of the consultation “suggested there is strong public interest in the use of psychedelic restricted drugs for therapeutic purposes. The regulatory proposal was commonly misinterpreted to mean that there would be guaranteed access to psychedelic restricted drugs through the Special Access Program” - the Regulatory Impact Analysis Statement makes clear that while many respondents supported the reforms, they are not meant to grant access to restricted drugs beyond the Program’s scope and do not signal “large scale” access to restricted drugs, or an intent towards the decriminalization or legalization of restricted drugs broadly, noting that access will continue to be granted on a case-by-case basis. 

Ultimately, while this news may appear to be of limited scope, this represents another step forward in the progression of psychedelics as a viable support for mental health therapies, and the Government should be commended on following the science and supporting those patients for whom traditional therapies have failed.