In a historic move, Health Canada announces plans to restore access to restricted drugs—including psychedelics such as MDMA and psilocybin—through the Special Access Program.

Today, Health Canada opened a 60-day public consultation on its intention to restore potential access to restricted drugs through the Special Access Program (SAP). The Program allows healthcare professionals to request drugs that are not available for sale in Canada in cases where a patient has a serious or life-threatening condition. The purpose is to afford Canadians access to emerging, potentially life-saving medications prior to their formal approval and routine provision.

In 2013, an amendment to the Food and Drug Regulations (section C.08.010) saw restricted drugs—including psychedelics like MDMA and Psilocybin—explicitly excluded from the SAP. Under this amendment, clinical trials were the only route through which patients could access these drugs.

 Now, Health Canada is looking to reverse the 2013 amendment:

“Health Canada is proposing to reverse the remaining regulatory changes made in 2013, which would remove the current prohibition on access to restricted drugs through the SAP”

“More specifically, Health Canada proposes to repeal subsections C.08.010 (3) and C.08.011.1 (2) in Part C of the FDR, which prohibit the issuance of letters of authorization to a manufacturer for any drug that is or that contains a restricted drug.”

Canada Gazette, Part I, Volume 154, Number 50: GOVERNMENT NOTICES. December 12, 2020

Once the subsection is repealed, restricted drugs will be treated in the same manner as all other controlled substances when considered under the SAP, that is: practitioners can request these drugs for patients with serious or life-threatening conditions where other therapies have failed, aren’t suitable, or aren’t available in Canada.

Restricted Drugs: The Controlled Drugs and Substances Act (CDSA) delineates a number of categories of controlled substances. Restricted drugs are those described in Part J of the Food and Drug Regulations (FDR), described as having no approved medical uses, i.e., they may only be used for research or scientific purposes including clinical trials.

This reversal does not guarantee that restricted drugs will be approved via a SAP application, but rather that they will be treated in the same manner as all other controlled substances.

Access to Psilocybin-Assisted Therapy via Section 56 Exemptions

Interpretation of ‘serious’ conditions, and the point at which other therapies are deemed to have ‘failed’ or to not be ‘suitable,’ may become points of contestation. However, it is worth noting that TheraPsil successfully obtained a Section 56 exemption for Mona Streleaff who, unlike such exemptions prior, was not terminally ill. Rather, she struggled with life-long trauma, and was permitted access to psilocybin-assisted therapy in an effort to resolve this. This suggests that her condition was serious enough to achieve a Section 56 exemption, which—although a distinct regulatory channel—may hint at Health Canada’s future stance on such matters.

This week we also learned that 17 Canadian healthcare professionals have been granted Section 56 exemptions, again thanks to TheraPsil’s campaigning. This allows the practitioners to possess and use psilocybin for training purposes.

It is clear, then, that Patty Hajdu’s Health Canada is acting progressively when it comes to case-by-case Section 56 exemption requests. Now, it appears the department is seeking to apply a similar case-by-case method of appraisal to the Special Access Program.

Implications for Psychedelics

This amendment would allow psychedelics including psilocybin and MDMA to be considered for access via the SAP, as they fall under the banner of ‘restricted drugs’. Interestingly, the Government notice specifically references the potential of certain restricted drugs currently at Phase II and III in the clinical trial process:

“Since these regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance. Certain restricted drugs are now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials.”

Canada Gazette, Part I, Volume 154, Number 50: GOVERNMENT NOTICES. December 12, 2020

This bodes well for psilocybin-assisted therapy, which is currently undergoing Phase II trials by COMPASS Pathways and the Usona Institute for treatment-resistant depression and major depressive disorder, respectively. MAPS’ Phase III trial of MDMA-assisted psychotherapy, meanwhile, is most likely the psychedelic therapy clinical trial nearest to completion.

Numinus has already publicly commended the intended amendment, and earlier this month announced plans for an MDMA-assisted psychotherapy for PTSD trial in collaboration with MAPS.

This progressive move by Health Canada is the latest in a series of apparent acknowledgments of the growing body of research and clinical trial data on the efficacy of psychedelic-assisted therapy. There are now 60 days of public comment on the proposed change. To share comments, you can email hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca. You can also visit the Government of Canada’s public consultation page here.