I have taken a strong interest in Psychedelics and Psilocybin Law in Canada, particularly since Health Canada announced a consultation conducted in December 2020 proposing to enable allow patients access to “restricted drugs” – including MDMA, Psilocybin and LSD – through the Special Access Program that allows Canadians to access products that show promise in treating medical conditions but do not yet have a Drug Identification Number.
Much needs to be considered by both the government Below is my letter to Health Canada, which has been slightly edited.
If you need any assistance with psilocybin / psychedelics legal matters, do not hesitate to reach out to me at 647-371-0032.
February 10, 2021
To Whom it May Concern at Health Canada,
I want to thank you for the opportunity to submit my comments.
I am a lawyer with a focus on cannabis and regulated substances matters and I am also the President of Alan Aldous Inc., the world’s first public relations agency for the regulated psychedelics sector.
I want to share with you my submission, which reflects my personal views.
Canada is at an important moment in history.
As you know, doctors and patients are saying that the use of certain illicit psychoactive substances can provide tremendous therapeutic relief to the degree that traditional pharmaceutical medicines sometimes cannot provide.
In addition to this anecdotal evidence, clinical evidence is coming out every day now demonstrating that certain substances that are considered restricted drugs under the Food and Drug Regulations may actually provide relief.
I won’t touch upon that evidence because I am sure it is more than voluminous in respect of this consultation.
Health Canada over the past year has approved more than a dozen section 56 Controlled Drugs and Substances Act applications for patients and practitioners to use psilocybin for therapeutic purposes.
The section 56 application process is arduous and requires that physicians, patients and lawyers collaborate for an application.
Health Canada has proposed to remove the prohibition on restricted drugs as defined under the FDRs from being accessed by patients through the Special Access Program, enabling drugs like psilocybin and MDMA to be accessed by potentially patients through the SAP program. This proposal does not guarantee access or supply, nor does it establish the standards with which Health Canada will assess SAP applications, but it demonstrates a marked improvement over the s. 56 process.
Due to the overwhelming anecdotal evidence as well as emerging clinical evidence demonstrating potentially significant treatment of medical conditions, I call on the government to go one step further and move psilocybin from the Part J “restricted drugs” list to Part G of the Food and Drug Regulations, ie on the list of “controlled drugs.”
This would permit companies to obtain Drug Establishment Licences for the production, fabrication and distribution of commercially-processed psilocybin subject to issuance of Drug Identification Numbers.
Canada can look to how it treats another psychedelic, ketamine, in how it should regulate psilocybin. Similar to psilocybin, ketamine is controlled under the Controlled Drugs and Substances Act. It is listed as a narcotic under the Narcotic Control Regulations and is regulated in many of the ways psilocybin could be regulated under Part G of the FDRs, with legal production by companies under DELs and the regulatory colleges of healthcare practitioners regulating the administration of the substance by its members to the public.
In moving psilocybin to Part G of the Food and Drug Regulations, the government could still meet the obligations under the 1971 Convention while establishing additional safeguards such as only permitting possession and consumption [in the presence of] the authorizing healthcare practitioner, and only permitting Drug Establishment Licences to be issued to companies that have active Dealers Licences under the CDSA with respect to psilocybin in good standing and a track record of upholding public safety.
If therapeutic psilocybin access is authorized solely under the SAP, Health Canada will become a gatekeeper to access coming in between patients and their healthcare practitioners. Federal resources will be unduly tied up and overwhelmed with a deluge of applications.
Lastly, the government should consider establishing an independent scientific advisory board that meets every year to make recommendations to the federal government as to which otherwise prohibited substances should be considered for placement on the Food and Drug Regulations’ Part G list, enabling more wide-spread access [to promising psychedelics] by Canadians with medical conditions subject to issuance of drug identification numbers.