Background
Health Canada announced a proposed intent to revise the Special Access Program (the SAP) on December 12, 2020. The proposal includes a suggestion to amend Part C of the Food and Drug Regulations (the FDR), reversing a 2013 amendment to Part C of the FDR that excluded restricted drugs (i.e. controlled substances scheduled to Part J of the FDR) from the SAP. Psilocybin and psilocin, each found in certain species of fungi, exemplified by Psilocybe cubensis, are restricted drugs. The proposed amendment to Part C of the FDR would allow healthcare practitioners (HCPs) to apply for access to extracted or synthetic psilocybin (or psilocin), or dried fruiting bodies (which would contain both psilocybin and psilocin), on behalf of their patients for serious or life-threatening conditions when conventional therapies have failed, are unsuitable or unavailable.
We would like to preface our open letter to Health Canada in response to the invitation for public consultation with the following:
While TheraPsil supports proposed changes to allow access to psilocybin, psilocin and other restricted drugs through the SAP, we believe much more work is needed before Canadians with a medical need have true regulated access to psilocybin as a support for psychotherapy or for other therapeutic applications.
TheraPsil is acutely aware that the proposed amendment to Part C of the FDR is an improvement to the scope of the SAP, and while positive, it does not fully address the broader need for federal regulations that provide nation-wide access to psilocybin and psilocin from a regulated source, for use in support of psychotherapy or for other therapeutic purposes endorsed by an HCP in a medical document.
As TheraPsil continues to advocate for improved access to psilocybin and psilocin, we will never lose sight of the objective: a regulatory framework that provides safe, regulated, and equitable access to psilocybin and psilocin, facilitating psilocybin-assisted psychotherapy for patients and other therapeutic purposes. It is critical that this regulatory framework also includes safe, regulated, and equitable access to psilocybin and psilocin for training HCPs in psilocybin-assisted psychotherapy.
The letter below is strictly in response to the intent to revise the SAP program, and TheraPsil will continue to work towards broader regulatory changes for safe, regulated and equitable access to psilocybin and psilocin through our advocacy.
Open Letter to Health Canada Re: Amendments to the SAP
To: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca
Dear Health Canada,
TheraPsil would like to congratulate Health Canada for its proposed intent to support an amendment to Part C of the Food and Drug Regulations (the FDR) to broaden the Special Access Program (the SAP) to include restricted drugs listed in the schedule to Part J of the FDR. All restricted drugs are controlled substances scheduled to the Controlled Drugs and Substances Act (the CDSA). Restricted drugs include psilocybin and psilocin. The proposed amendment to part C of the FDR would make psilocybin and psilocin available to patients through the Special Access Program.
As you know, TheraPsil is a non-profit patient advocacy group dedicated to facilitating legal access psilocybin-assisted psychotherapy for Canadians in medical need.
Since the first four subsection 56(1) exemptions were approved by Minister Hajdu and issued by Health Canada on August 4th 2020, TheraPsil has supported successful exemption applications for an additional 20 patients for medical purposes and 19 healthcare practitioners (HCPs) for training purposes. Many more applications for exemptions are in the queue. To date, the exemptions that TheraPsil has successfully supported and seen through to issue allow patients to possess dried fruiting bodies of species of mushrooms that include psilocybin. The exemptions protect these individuals from criminal liability under the CDSA. We applaud Minister Hajdu, the Office of Controlled Substances and all of Health Canada for taking the brave and compassionate step of approving exemptions to possess and consume psilocybin on a case by case basis for patients in medical need.
One problem that faces patients and HCPs holding exemptions, is the absence of a regulated source of dried fruiting bodies including psilocybin or other forms of psilocybin. While the exemptions allow patients and HCPs to possess and consume psilocybin, patients do not have a regulated supply of this medicine.
However, many private companies in Canada hold a dealer’s license under Part J of the FDR to deal with psilocybin and psilocin, including to cultivate, synthesize, extract or import psilocybin and psilocin. TheraPsil has interacted with many of these companies and there is clear willingness and competency to provide dried fruiting bodies or synthetic psilocybin for use by exemption holders – both patients and HCPs.
Therefore, TheraPsil supports Health Canada’s proposal to amend Part C of the FDR to allow access to restricted drugs through the SAP, and specifically by repealing subsections C.08.010(3) and C.08.011.1(2), which each read as follows: “The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001”. This expanded SAP will allow practitioners, on behalf of patients with a serious or life-threatening condition, to request access to restricted drugs, such as psilocybin, through the SAP.
It is our hope that through amendments to part C of the FDR that broaden the SAP to include restricted drugs, that patients and HCPs will be able to directly access synthetic psilocybin manufactured in accordance with good manufacturing practices (GMP) standards, dried fruiting bodies cultivated in accordance with standards similar to good production practices (GPP) defined in the Cannabis Regulations, or other classes of psilocybin products manufactured in accordance with standards similar to GPP. We feel that patients and HCPs should be free to choose between dried fruiting bodies, synthetic psilocybin, and psilocybin products in other forms, depending on the preference of the patient and advice of the HCP. In the event that part C of the FDR is amended to broaden the SAP to include restricted drugs, we are hopeful that Health Canada will manage access to psilocybin and psilocin in a manner that supports choices by patients and HCPs in the class and form of psilocybin or psilocin, and in a manner that is consistent with cooperating with industry to provide a regulated source of psilocybin and psilocin. We believe this is a crucial step in helping individuals suffering from end of life distress, and other appropriate conditions, where psilocybin could be beneficial, obtain a legal and safe supply of their medicine from a Health Canada approved licensed dealer.
We believe that effective access is not complete until patients and HCPs can not only pursue psilocybin-supported psychotherapy and other therapeutic applications of psilocybin without legal repercussions but also be permitted to access the medicine itself in a safe, regulated and equitable manner. Amendments to part C of the FDR, broadening the SAP to include restricted drugs, is a significant step toward making this possible and our team deeply supports Health Canada’s proposed amendment to Part C of the FDR.
Warm regards,
Spencer Hawkswell, CEO of TheraPsil, on behalf of TheraPsil; in consultation with David Wood, PhD, Partner at Borden Ladner Gervais LLP
Show Your Support
If you also support the changes to the SAP to make psilocybin accessible, please consider voicing your support via email at hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca. Please feel free to use our letter as a place to start/template.
Public Consultation is open until February 10th, 2021. You can read the full proposal here.
