On Wednesday, Health Canada brought into force new regulations surrounding controlled substances under the Special Access Program, allowing Canadian physicians a mechanism to request medical access to restricted drugs for patients, including psychedelics such as psilocybin and MDMA.
The agency outlined its revised position in a series of amendments entitled ‘Regulations Amending Certain Regulations Relating to Restricted Drugs’ published in the Canada Gazette — an official Government of Canada publication.
According to the impact analysis statement, “The objective of the regulatory amendments is to 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.”
Since August of 2020, Canadians have been able to request access to psilocybin through Section 56 exemptions to the Controlled Drugs and Substances Act. While effective in providing therapy to a handful of patients, this avenue to access has been inconsistent, with lengthy wait times and a legal process not specifically designed for patient care. Advocates of the SAP hope that it will offer a substantially quicker turnaround time for those in need.
While far from a complete overhaul of the existing framework, the current revisions do acknowledge both the scientific progress surrounding psychedelics and other controlled substances, and the prevailing interest in psychedelic therapy on the part of the public and healthcare providers.
The process of revising the special access program began in December of 2020, when Health Canada published a Letter of Intent (LOI), beginning a consultation and comment period in which the public was allowed to provide feedback on the proposed amendments concerning controlled substance access.
According to the agency, input was received from 392 unique respondents. Of these, the vast majority were individual members of the public, and 25 represented organizations including psychedelic and mental health advocacy associations, medical and pharmacy groups, legal firms, and licensed or prospective controlled substance manufacturers.
Notably, “Over 80 percent of all respondents associated Health Canada’s proposal with increasing access to psychedelic restricted drugs (e.g. MDMA, psilocybin, LSD, DMT), often for the treatment of various conditions, most notably mental health disorders.” Opposition to the proposed amendments made up only 2 percent of all respondents.
It is important to note that while potentially expeditious for individual patients and caregivers, the amendments are not intended to provide an avenue to widespread access. Much like the Section 56 Exemptions to the CDSA, applications for the SAP will be assessed on a case-by-case basis.
