November 20, 2020 Patty Hajdu Honourable Minister of Health Health Canada Email: [email protected] Dear Minister Hajdu, On behalf of the Numinus Wellness Clinical Advisory Board*, please find enclosed a briefing note and appendices making recommendations for the revision of Health Canada’s Special Access Programme. We would appreciate the opportunity to have a follow up call with relevant Health Canada staff to review these recommendations if this would be of assistance. Sincerely, ____________________________ ____________________________ Evan Wood, MD, PhD, FRCPC Devon Christie, MD, CCFP, RTC Chief Medical Officer Medical Director *Gabor Maté, M.D.,C.M, Author & Retired Physician, Pam Kryskow, M.D., CCFP, Physician & Clinical Instructor, UBC, Zach Walsh, PhD, Professor, Psychology, UBC, Kate Browning RN, Administrator & Instructor, Holistic Health, Langara College, Dr. Jason Marr, BScH, COC, ND, Founder & Director of Evoke Integrative Medicine Ltd. cc: Pierre Sabourin, Assistant Deputy Minister Health Products and Food Branch, Health Canada Email: [email protected] Eric Costen, Associate Assistant Deputy Minister Controlled Substances and Cannabis Branch, Health Canada Email: [email protected] numinus.ca [email protected] TITLE: Revising Health Canada’s Special Access Program to Allow Pre-Approval Access to MDMA and Psilocybin PREPARED FOR: Patty Hajdu, Honourable Minister of Health DATE: November 20, 2020 ISSUE: There is a large and growing burden of mental illness affecting Canadians. In some cases, this is severe and can be life threatening for a range of reasons (e.g. opioid overdose, suicide). Existing treatments for severe mental illness are often ineffective and associated with unwanted side effects meaning new treatment modalities are urgently needed. A substantial body of research, including the completion of a growing number of randomized clinical trials, has demonstrated that psychedelic-assisted psychotherapy using psilocybin, MDMA and other substances is emerging as a novel approach for the treatment of a host of mental illnesses including treatment-resistant depression, post-traumatic stress disorder, substance-use disorder, and severe anxiety associated with a terminal diagnosis (see Appendix 2). These treatment modalities remain under investigation and are presently illegal in Canada, which presents a serious ethical concern, given that although phase III clinical trials are ongoing, including in Canada, patients who may benefit from pre-approval access through Health Canada’s Special Access Programme are precluded from doing so as a result of current regulatory restrictions. This includes patients who have volunteered for, and graduated from, clinical trials in Canada and who may benefit from further treatment - and is not dissimilar to a volunteer to a cancer chemotherapy trial being unable to access ongoing investigational medication despite apparent clinical benefit once the trial is completed. BACKGROUND: Historically, pre-approval access for medications in the drug development pipeline was possible through Canada’s Special Access Programme. As summarized in a 2013 Canada Gazette (Vol. 147, No 22, October 2013), however, “The Government is concerned that the Special Access Programme (SAP) could be used to give individuals access to heroin, unauthorized products containing cocaine (benzoylmethylecgonine) and “restricted drugs” (defined in Part J of the FDR). Accordingly, amendments to the FDR and the Narcotic Control Regulations (NCR), with consequential amendments to the New Classes of Practitioners Regulations (NCPR), are needed to prevent access to these substances through the programme.” While government regulations have been revised to enable legal access to heroin for medical purposes, access to psychedelic medications through the SAP remains not possible. Importantly, the psychedelic substances being considered in research trials were unrelated to the focus on diacetylmorphine (heroin) which was the rationale for the change in 2013 whereas the removal of psychedelic medicines from the Special Access Programme could be viewed as totally unrelated (and inappropriate given existing research). Specifically, when the change to the Special Access Programme was made in 2013, decades of clinical research into psychedelic substances had been completed and there were already a large number of clinical trials demonstrating the safety and likely benefits of psychedelic-assisted psychotherapy (Appendix 2). Additionally, in certain Indigenous cultures (e.g. Mazatec people of Mexico), psychedelic substances, such as psilocybin mushrooms, have been used in traditional medicine contexts for centuries and used recreationally without documented concerns (1). Lastly, there is growing recognition of stigma and racial discrimination as underpinning drug policies in North America (i.e. laws not based on clinical or public health evidence) and revisiting access to psychedelic assisted psychotherapy is therefore timely. Since the above mental health conditions are often life threatening and existing treatments have major limitations in terms of success rates and side effects, Canadian citizens suffering with these conditions and who have exhausted conventional treatments would benefit from strategies that enable access to psychedelic-assisted psychotherapy prior to full approval by Health Canada while these drugs remain in clinical trials. Recent approval of Section-56 exemptions for Canadians suffering with anxiety associated with terminal diagnoses to lawfully access psilocybin represents a positive step forward for Canadians who wish to access potentially life saving therapy; however, Section-56 exemptions do not account for two very important considerations regarding safety: 1. Access to a safe supply of psilocybin (including natural sources) that does not involve obtaining the drug from the unregulated illicit market 2. Parameters delineating the context in which the drug will be administered, which is critical for psychedelic substances due to drug interactions and other concerns (Appendix 1) In the above context, clinical scientists have developed a knowledge base and best practices regarding methodologies for safe and effective delivery of psychedelic-assisted psychotherapy. Importantly, psychedelic-assisted psychotherapy is distinct in many ways and requires special attention to the context of delivery for safety and efficacy. Specifically, psychedelic medicines can not be considered in the same way as many pharmaceutical drugs, since effective treatment combines the psychedelic drug experience with a carefully established psychotherapeutic protocol involving: 1. Qualified mental health providers 2. Screening parameters for appropriate candidates for treatment including ensuring patients are not using other substances including medications that may lead to negative drug interactions 3. Psychological preparation sessions prior to psychedelic-assisted psychotherapy 4. Special considerations for the psychedelic-assisted session including the physical setting while under the influence of the medication 5. Psychological integration sessions and follow up in the weeks following the psychedelic- assisted psychotherapy session 6. Often, consideration for multiple psychedelic sessions (e.g. a month apart) as research (see appendix 3) has demonstrated that repeated sessions are often more effective than single sessions Currently, the two drugs in development that show promise when combined with psychotherapy for the aforementioned mental health conditions are psilocybin and MDMA, both of which are restricted under the Food and Drug Act Schedule J and therefore may not be accessed through the Special Access Programme. Given that both MDMA and psilocybin are already currently being developed for clinical trials, and are therefore accessible, and that there is a high burden of illness affecting Canadians for the aforementioned conditions, the Special Access Programme represents the most appropriate route for access that would ensure safe supply of the drug and, with additional parameters being set (Appendix 1), to appropriate clinical settings where the drug- assisted psychotherapy protocols could safely take place. RECOMMENDATION: We recommend that the Health Canada Special Access Programme be revised so as to allow for consideration of applications for access to MDMA- and psilocybin- assisted psychotherapies via the Special Access Programme mechanism. We also recommend that the Special Access Programme further develop a process for approving SAP requests that considers the following elements to ensure safety: - Description of how the medication will be obtained (allowing for both synthetic and natural forms of psilocybin given Indigenous traditional practices) and safely stored prior to clinical use - Description of the psychotherapy modality (e.g. motivational enhancement), including a brief description of the preparatory psychotherapy and post psychedelic psychotherapy integration, as well as the necessary training and credentials of who will be providing the psychotherapy - Description of an appropriate location where the psychedelic-assisted psychotherapy will be safely provided with consideration given to ensuring patient safety while under the influence of the medication A draft proposed Special Access Programme considerations template (Appendix 1), a summary of published literature (Appendix 2), and PDFs of relevant literature (Appendix 3) are attached for your interest. Given the known