April.11.2019

Dear Mr. Costen

On behalf of the Multidiciplinary Association for Psychedelic Studies Canada (“MAPS Canada”), the British Columbia Centre on Substance Use, and the Canadian Drug Policy Coalition, we write to request that Health Canada (and other relevant agencies) consider implementing an amendment to the Food and Drug Regulations (C.R.C., c. 870, “FDR”). Specifically, we request the removal of Section C.08.010 (1.1) of the FDR:

The Minister shall not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.

This section, which as we understand was introduced in October 2013 (SOR/2013-172), prohibits substances listed in the Schedule to Part J (i.e. “Restricted Drugs”) from being the subject of an authorization by Health Canada under the Special Access Program (“SAP”). We also believe that the basis for this amendment to the FDR in 2013 was a political one and not based on medical or scientific evidence. Specifically, the exclusion of these substances was a political response to the approval by Health Canada of several SAP applications by the doctors at the Crosstown Clinic in Vancouver for access to injectable diacetlymorphine treatment for patients exiting the SALOME research study. Under the current federal government, access to diacetylmorphine under the SAP was restored, but restrictions on the remainder of substances listed continued.

As you are aware, there is currently much interest and renewed clinical research into the potential medical benefits of several controlled psychedelic drugs [e.g. MDMA and psilocybin].

This research picks up a promising line of scientific inquiry from the 1950s through the early 1970s (during which time Canada was a global leader in field of psychedelic medicine), which was abandoned due to political concerns about uncontrolled non-medical street use of these substances by young people at the time. Consequently, many of the psychedelic substances scheduled in the Controlled Drugs and Substances Act (and in the Convention on Psychotropic Substances of 1971) were hurriedly classified as having limited or no medical value, and were strictly scheduled without taking into account the substantial medical evidence of possible therapeutic efficacy available even at that time.

Academic research is currently exploring psychedelic-assisted psychotherapy for a wide variety of mental health conditions, and the evidence base for allowing compassionate access to these substances through SAP is rapidly accumulating. In the United States, the Food and Drug Administration has granted “breakthrough therapy” status to at least two of these medications, MDMA and psilocybin, based on recent Phase II clinical trial data, thereby reducing regulatory hurdles to researchers. In addition, the US Expanded Access program allows patients in immediate need to gain rapid access to any investigational medical product for treatment outside of FDA-approved drug development trials when no comparable alternative therapy or research options are available. This process is based on approving a specific diagnosis and individuals do not need separate applications as we do in Canada. Therefore, accessing urgently needed medications is significantly less arduous in the USA. We hope that while Phase III clinical trials get underway—to determine more conclusively whether safety and therapeutic efficacy warrant regulatory approval of these substances for medical use in Canada (see Appendix A)—there would be a mechanism for more rapid compassionate access to these medications for Canadian patients who are suffering and seeking options from their health care providers.

MAPS Canada and the BC Centre on Substance Use, through the sponsorship of MAPS USA, are beginning a Phase III Clinical Trial examining the effectiveness of MDMA-assisted psychotherapy for PTSD. However, with only two sites in Canada, this trial will be limited to a few dozen experimental subjects, while many thousands more Canadians suffering from treatment-refractory PTSD (including Canadian Forces veterans and first responders, such as police officers and firefighters) continue to experience the debilitating and life-threatening symptoms. Phase II clinical trial results suggest not only that MDMA can be administered safely, but that for a majority of patients it can also provide rapid and sustained clinical outcomes that exceed currently best available treatments. Access to MDMA for use as an adjunct to psychotherapy through SAP would potentially allow for this innovative and highly efficacious treatment to be made available to a broader range of patients based on compassionate grounds. Our MDMA-assisted psychotherapy treatments are provided by trained and licensed professionals in closely supervised clinical settings and MDMA is never available for take-home use, therefore there is little to no risk of diversion.

Likewise, psilocybin-assisted psychotherapy has shown considerable promise in treating anxiety and depression for patients facing a life-threatening illness such as cancer, and in treating people struggling with substance use disorders such as alcohol and tobacco addictions. While more research in certainly necessary, the safety profile of psilocybin—when administered by trained clinicians in a controlled setting—makes it an ideal compound to provide compassionate access to through the SAP.

The regulations underpinning SAP, as set out in Health Canada’s website, make it clear that the program is designed for innovative treatment options for patients who have exhausted currently available treatment options and yet continue to suffer. With these principles in mind, and the ever-growing research already showing favorable efficacy and safety data for various psychedelic therapies, allowing the inclusion of psychedelics for consideration under the SAP regime aligns with the core mission of the program itself: increasing access to life changing medicines for Canadians.

Additionally, as there remain a number of barriers in place to receiving access to controlled substances for medical purposes—in addition to the SAP evaluation and approval process—we suggest that a blanket restriction on consideration of restricted drugs for SAP approval is both redundant and unnecessary.

On behalf of MAPS Canada, the BC Centre on Substance Use, and the Canadian Drug Policy Coalition, we strongly urge you to recommend the amendment to the FDR removing the above referenced section that prevents availability of psychedelic substances on special access / compassionate grounds for Canadians who are suffering from debilitating mental illnesses like PTSD.

Sincerely,