After much anticipation in the industry, the regulatory amendments restoring access to restricted drugs under Health Canada’s Special Access Program (the “SAP”) finally came into force. The Regulations Amending Certain Regulations Relating to Restricted Drugs (the “Amendments”) were published on January 5, 2022 and came into force on the same day, generating much excitement in the healthcare space.
The Amendments allow physicians to request access to restricted drugs, such as psychedelics, through the SAP for eligible patients, e.g. as part of their psychotherapy. According to Health Canada, requests to the SAP “will be assessed on a case-by-case basis” for a “serious or life-threatening condition when conventional treatments have failed, are unsuitable or unavailable.” Thus, there is no guarantee that all requests made through the SAP will be approved, since the SAP can be used for emergency treatment only. Moreover, existing requirements under the SAP are not affected by the Amendments.
In 2013, following regulatory changes made to the provisions in Part C of the Food and Drug Regulations (the “provisions”), clinical trials were technically the only way by which a restricted drug could be authorized for the treatment of patients. Seeing an increased interest in the scientific community and a certain advancement in the science pertaining to the efficacy and safety of some restricted drugs, Health Canada also granted exemptions on a case-by-case basis under Section 56 of the Controlled Drugs and Substances Act, allowing a few individuals to obtain restricted drugs for medical purposes over the last few years. Despite the foregoing, it remained extremely difficult for physicians (and their patients) to use restricted drugs as a treatment.
The Amendments repeal the provisions that prohibited the sale or importation of a restricted drug by a manufacturer for the purposes of the SAP.
It is worth noting that access through the SAP which, as mentioned above, is not directly affected by the Amendments, is subject to tight conditions. Generally, the SAP is designed to allow the importation of drugs that are not available in Canada, but can be imported from a foreign country. It can of course provide special authorization for any unapproved medication, but the goal of the SAP is not to allow large scale distribution of unapproved drugs or, in the case at hand, restricted drugs.
Moreover, as clearly outlined in the current version of SAP request form published by Health Canada, the SAP still requires “relevant clinical information on the patient’s current condition, medical history and co-morbidities. What specifically about this drug (e.g. mechanism of action, drug class, dosage form) makes it the best choice for your patient(s)?” as well as documented evidence regarding the failure of other treatment options that have been ruled out on clinical grounds. The requesting physician must “provide recent and relevant data, references, and/or resources in [his/her] 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.” In light of the above, requesting access to restricted drugs is not easy. Health Canada will still require clinical evidence and, although the science is advancing at a rapid pace, it could be challenging to satisfy the SAP conditions for psychedelics.
Finally, the only persons that can request access under the SAP are practitioners, i.e. professionals with prescribing privileges entitled to treat patients with an unapproved prescription drug. This rules out the possibility of any therapist who is not a prescriber using the SAP to provide access to psychedelic-assisted psychotherapy.
All that being said, the availability of restricted drugs through the SAP certainly offers a new avenue of access. While many conditions still apply, the new (or restored) approach is generally better geared towards addressing patients with unique conditions and needs.
It should also be noted that Health Canada does not consider the Amendments as an intent to decriminalize or legalize restricted drugs. For now, it remains to be seen if psilocybin, MDMA, DMT and other psychedelics will be legalized in Canada.
The Fasken Life Sciences team is monitoring the situation closely and will keep you apprised of any future developments concerning the SAP.
 Health Canada - “Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program): SOR/2021-271”.
 Food and Drug Regulations, CRC, c. 870.
 Health Canada, Special Access Program, Form A – Patient specific request – C08.010(1).