On January 5, 2022, Health Canada announced that effective immediately, certain regulatory amendments are being put into place which will permit the possibility for practitioners who are allowed to prescribe drugs to request access to restricted drugs through Health Canada’s Special Access Program (SAP).
Health Canada’s Special Access Program will allow these qualified healthcare practitioners to request access to restricted drugs on a case-by-case basis. Therefore, the door to medical access to psychedelics like psilocybin and MDMA has now been opened.
Activities such as sale, possession, production, etc. of substances such as psilocybin are prohibited unless authorized under Part J of the Food and Drug Regulations. Psilocybin is currently being studied for its potential to treat various conditions such as anxiety, depression, obsessive compulsive disorder and problematic drug use.
Healthcare practitioners may request emergency access to restricted drugs (e.g. psychedelics, psilocybin, MDMA) on behalf of patients with serious or life-threatening conditions, “when other therapies have failed, are unsuitable, or are unavailable in Canada and when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient.”
Historically, medical access to psychedelics such as psilocybin for therapeutic purposes has been extremely restricted. Patients had to apply for a Section 56 Exemption from the federal government and wait for months to know if/when access was possible. Patients suffering from severe or life-threatening conditions, unfortunately, do not have the luxury of time, and therefore waiting months or even years for a medical exemption has not been ideal.
The Special Access Program was created by the federal government to grant access to new medications before they are formally approved for use. Given the growing body of evidence for psychedelic-assisted therapy and the therapeutic benefits of psilocybin, it’s about time that the government makes this change.
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Under the Special Access Program, Health Canada will need to provide their response to any healthcare practitioner making a request within 48 hours. This will ensure timely approval for eligible Canadians who have not been able to find effective cures or treatments to their health conditions using other widely available options.
Health Canada maintains that these types of regulatory amendments are not intended to promote or encourage the early use of unapproved drugs, or to circumvent the well-established clinical trial or drug review and approval processes. Clinical trials are the best way to advance research into unapproved drugs. However, for those who don’t have the time to wait for a clinical trial or drug approval process, this change is welcomed and provides great relief to patients suffering severe or life-threatening conditions.