Toth v. Canada (Health and Addictions)

Toth v. Canada (Health and Addictions)
Court (s) Database
Federal Court Decisions
Date
2023-09-25
Neutral citation
2023 FC 1283
File numbers
T-1424-22
Decision Content
Date: 20230925
Docket: T-1424-22
Citation: 2023 FC 1283
Ottawa, Ontario, September 25, 2023
PRESENT: Madam Justice Pallotta
BETWEEN:
JEFF TOTH, ADELE PHILLIPS, ALEX DOLEY, ALLISON PRINSEN, ANTHONY DI VIRGILIO, BARBARA FEHLAU, BARBARA GRIFFIN, CHRISTINE DENNSTEDT, DALE TRIMBLE, DANIELLE SCHROEDER, DANUSIA KANACHOWSKI, DAPHNE LOBB, GRAHAM BERGSTRA, GREGORY COHEN, HILLARY MCBRIDE, JENNA FLETCHER, JILL KOEHLER, JOHN GYRA, JONATHAN WIESER, KEYANNA EHSANI, KYLE GREENWAY, LAURIE SCHULZ, LISA FREDE, MYRNA MARTIN, RICHARD TATOMIR, SALLYJANE BODNAR, SARAH HOFFMAN, STACY SMITH, VALENTINA CHICHINIOVA, VANATHY PARANTHAMAN, AAMIR SUBHAN, AMANDA GRINTER, ANNE-MARIE ARMOUR, BETH TROTTER, BRODIN ANDERSON, BRYCE KOCH, CLAIRE WEISS, DAYNA MYLES, DOROTHY GAMBLE, ELINOR BAZAR, ELIZABETH BLEAKLEY, GORDON REID, JANE HARRISON, JANIE BROWN, JEAN-FRANÇOIS STEPHAN, JENNIFER NAGEL, JULIA MACARTHUR, KATHLEEN HERBINSON, KERRY CHUTTER, LORRAINE REIMER, MARILYN CHOTEM, MICHAEL SHEPPARD, NATHAN TORTI, NIKHITA SINGHAL, PARVEEN SIHOTA, RAJVEER SOOS, RICHARD MINERS, SCOTT KOURI, SHAUNA SUTHERLAND, STEPHANIE MARCHAL, STEVEN GRIFFITH-COCHRANE, TAMARA SMITH, TRACY LOWE, TRINA WOODS, YASSIE PIRANI, DANA SIMARD, MICHAEL SIMARD, ANNE KWASNIK-KRAWCZYK, GRANT HUTCHINSON, JULIEN THIBAULT LÉVESQUE, SUSAN MCAFEE, LARA ELLISON, ELANA ANGUS, AND THERAPSIL
Applicants
and
Minister of Mental Health and Addictions and Associate Minister of Health
Respondent
JUDGMENT AND REASONS
I. Introduction [1] This application for judicial review relates to 96 decisions made by a delegate of the Minister of Mental Health and Addictions and Associate Minister of Health (Minister), refusing requests for an exemption under subsection 56(1) (Section 56 Exemption) of the Controlled Drugs and Substances Act, SC 1996, c 19 [CDSA].
[2] Generally, an application for judicial review challenges only one administrative decision: Federal Courts Rules, SOR/98-106, Rule 302. The applicants were permitted to challenge more than one decision by an order of this Court dated September 14, 2022.
[3] For the reasons below, this application for judicial review is dismissed.
II. Background [4] All 96 challenged decisions relate to Section 56 Exemption requests made by healthcare practitioners, with varied qualifications (HCPs). They include doctors, psychologists, nurses, social workers, counsellors and other regulated healthcare professionals. The HCPs want the exemption for the same reason, namely, to possess and consume raw psilocybin mushrooms in the course of their own professional training for psilocybin-assisted psychotherapy.
[5] Psilocybin-assisted psychotherapy is a form of psychotherapy that includes a medicinal session, during which the patient consumes a therapeutic dose of psilocybin under the supervision of a qualified practitioner. The therapy can help patients who are suffering from certain types of depression, distress associated with life-threatening or terminal illness, and other conditions.
[6] The HCPs’ requests for a Section 56 Exemption stated that, for optimal results, qualified practitioners should have experience with the psychedelic medicines that will be used to treat their patients. The goal of training with psilocybin is to improve HCPs’ understanding of psilocybin therapy so they may better help their patients. While undergoing training, the HCPs would likely consume five grams of raw psilocybin mushrooms for three exposures over a six-month period, and they would supply the mushrooms themselves, from a “trusted source” they did not identify.
[7] Psilocybin is a hallucinogen and a controlled substance under the CDSA. The CDSA prohibits possession of psilocybin, except as authorized under the regulations: CDSA s 4. However, the CDSA allows the Minister to authorize an exemption from the prohibitions, if the Minister is of the opinion that the exemption is necessary for a medical or scientific purpose or otherwise in the public interest: CDSA s 56.
[8] There are 82 applicants in this application for judicial review. 73 applicants are HCPs whose Section 56 Exemption refusals are under challenge (Exemption Applicants). The other 23 decisions under challenge are Section 56 Exemption refusals for HCPs who are not parties to this proceeding.
[9] The applicant TheraPsil describes itself as a non-profit patient advocacy organization dedicated to helping Canadians in medical need access legal psilocybin-assisted psychotherapy. One of the aims of the organization is to connect prospective patients—people who wish to be assessed for and receive psilocybin-assisted psychotherapy—with qualified practitioners. To this end, TheraPsil maintains a roster of practitioners whose names can be provided to prospective patients.
[10] TheraPsil offers a psilocybin-assisted psychotherapy training program in order to “develop a pool of trained healthcare practitioners whom they can confidently include on their roster of practitioners able to support treatment”. TheraPsil’s training program includes an experiential training module, which requires the trainees to consume psilocybin mushrooms. The HCPs are in TheraPsil’s training program and require a Section 56 Exemption to participate in the experiential training module. TheraPsil coordinated the Section 56 Exemption requests on the HCPs’ behalf, and retained counsel to provide submissions to the Minister in respect of those requests.
[11] The remaining 8 applicants in this proceeding are individuals who contacted TheraPsil because they want to be assessed for and receive psilocybin-assisted psychotherapy (Patient Applicants). TheraPsil placed the Patient Applicants on a waitlist; it states it was forced to do so due to a shortage of properly qualified and trained practitioners in Canada. Affidavits from the Patient Applicants (as well as five other waitlisted patients) were submitted to the Minister to support the HCPs’ Section 56 Exemption requests.
[12] There is no evidence that any of the Patient Applicants have requested their own Section 56 Exemptions to access psilocybin for the purpose of receiving psilocybin-assisted psychotherapy.
[13] The applicants rely on a common set of materials. TheraPsil’s counsel made representations on behalf of all applicants in this proceeding.
III. Minister’s Decisions and Overview of Parties’ Positions [14] The Minister refused all 96 Section 56 Exemption requests in June 2022, for identical reasons. The Minister determined that a Section 56 Exemption was not necessary for a medical or scientific purpose or otherwise in the public interest, as there was an alternative option available under the Food and Drug Regulations, CRC, c 870 [FDR], namely, authorization to obtain a controlled drug for the purposes of a clinical trial.
[15] The decisions note TheraPsil’s opinion that this regulatory option is unsuitable and would not protect HCPs’ best interests, and pursuing a clinical trial to allow practitioners to gain experience with psilocybin for training purposes would be unethical, interfere with training objectives, and cause delay. The Minister’s view was that Health Canada had recently authorized a clinical trial for healthcare professionals to use psilocybin for training purposes, and while a clinical trial might not be available to all healthcare professionals, the authorization demonstrated that a clinical trial was a feasible regulatory option that may be available to HCPs. A clinical trial would protect the best interests of the participants, ensure that the psilocybin complies with good manufacturing practices (GMP) and is administered in accordance with ethical, medical and scientific standards, and would address prohibitions under the FDR as well as under the CDSA, unlike a Section 56 Exemption. The decisions recommend that the HCPs reconsider their position that clinical trials are unsuitable to achieve their purposes, and develop an appropriate clinical trial design that would allow a better understanding of the various effects of psilocybin on humans. The decisions provide information on clinical trials and funding opportunities supporting clinical trials involving psilocybin.
[16] The Minister noted in her decisions that 19 practitioner exemptions were approved in late 2020, but since then, Health Canada had engaged with a number of stakeholder groups in order to emphasize the importance of building evidence about the safety and efficacy of psilocybin through clinical trials. The decisions refer to Health Canada’s efforts in this regard and its efforts to reduce barriers to clinical research with psilocybin, including by holding information sessions, meeting with interested researchers, and supporting clinical trial sponsors. Health Canada addressed meeting requests in an expedited manner. The decisions state that as a result of these actions, the number of clinical trial applications for psilocybin grew significantly. Prior to 2021, Health Canada had authorized only one clinical trial involving psilocybin. As of May 2022, Health Canada had authorized 10 additional trials to evaluate the use of psilocybin in the treatment of mental health and substance use disorders, and collect valuable evidence on psilocybin’s effectiveness in different populations and under different conditions. The decisions refer to “multiple conversations” with TheraPsil over the prior two years, conveying the message that Section 56 Exemptions are granted on an exceptional basis when other legal regulatory options are not available.
[17] The decisions state Health Canada was not aware of any peer-reviewed clinical evidence demonstrating that healthcare professionals need to take a psychedelic drug in order to appreciate what the patient experiences, and none of the evidence TheraPsil had provided was based on findings of peer-reviewed clinical evidence. The Minister found that while TheraPsil’s training program requires personal experience with psilocybin, other therapists have been able to offer psilocybin-assisted psychotherapy without personal experience consuming psilocybin. The Minister also found there were potential health and safety risks associated with obtaining and consuming illegally sourced psilocybin as opposed to accessing psilocybin through the clinical trial pathway.
[18] The applicants submit the Minister’s decisions are unreasonable. The applicants state the Minister: failed to grapple with central arguments and evidence, including evidence from Health Canada’s own Office of Clinical Trials (OCT) that a clinical trial for TheraPsil’s training program is not feasible; gave unintelligible or non-transparent reasons for her decisions; failed to address or meaningfully grapple with substantive arguments; failed to account for evidence about the benefits of experiential training or misapprehended the evidence; departed from the 19 previous decisions approving practitioner exemptions without justifying the departure; and did not address arguments about the impact a refusal would have on the HCPs’ and patients’ rights under section 7 of the Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11 [Charter].
[19] The applicants state there are hundreds of patients on TheraPsil’s waitlist for psilocybin-assisted psychotherapy, and a shortage of experientially trained practitioners in Canada. While the Minister approved 19 psilocybin exemption requests made by TheraPsil-affiliated practitioners in 2020, the applicants allege that more Section 56 Exemptions are needed to address the shortage of providers and serve patients’ needs. The applicants contend the Minister’s refusals prevent the HCPs from becoming fully trained.
[20] The applicants submit that, collectively, they have standing to bring this application for judicial review in respect of all 96 decisions. Each of the 73 Exemption Applicants has standing to challenge their own decisions. In addition, the applicants state TheraPsil and the Patient Applicants are directly affected by all 96 decisions—TheraPsil because it requested the Section 56 Exemptions on the HCPs’ behalf and it cannot run the experiential training module of its program unless the practitioners being trained are granted Section 56 Exemptions, and the Patient Applicants because a delay and denial of the HCPs’ training delays and denies their assessment and treatment.
[21] The applicants ask this Court to set aside all 96 decisions, and direct the Minister to grant exemptions to the HCPs that would permit them to possess and consume psilocybin for experiential training in psilocybin-assisted psychotherapy.
[22] The Minister does not contest the Exemption Applicants’ standing, or TheraPsil’s standing to challenge all 96 decisions. However, the Minister submits the Patient Applicants do not have standing, and asks for an order removing them as applicants to this proceeding.
[23] Also, the Minister submits that the Minister of Health, the sole respondent named in the notice of application, is not the proper respondent. The Minister asks for an order amending the style of cause to substitute the Minister of Mental Health and Addictions and Associate Minister of Health as respondent.
[24] The Minister submits the applicants have not shown the decisions in question are unreasonable, and this application for judicial review should be dismissed. Section 56 of the CDSA confers broad discretion to grant or refuse an exemption and the applicants have not established any errors that warrant interference with the decisions. The Minister states she considered the medical evidence, made supported findings about whether the evidence demonstrated that experiential training is required for administering psilocybin-assisted therapy to patients, and the Court on judicial review should not reweigh the evidence or decide scientific debates. The decisions refusing the exemption requests addressed the risks to HCPs, the previous 19 practitioner exemptions, the need for clinical trial evidence, and the feasibility of a clinical trial with HCPs. The Minister states she came to a reasonable conclusion, the decisions do not limit Charter protections, and in any event the decisions reflect a proportionate balancing of any Charter values at play.
IV. Issues [25] I would frame the issues on this application as follows:
Preliminary Issue: Who are the proper parties to this application?
Main Issue 1: What is the appropriate standard of review?
Main Issue 2: Are the Minister’s decisions unreasonable?
Main Issue 3: If the Minister’s decisions are unreasonable, what is the appropriate remedy?
V. Analysis A. Preliminary Issue: Who are the proper parties to this application? [26] As noted above, the Minister raises two questions for determination regarding the proper parties to this proceeding.
(1) Patient Applicants [27] First, the Minister submits the Patient Applicants are not proper applicants. They do not have private interest standing or public interest standing, and they should be removed as applicants to this proceeding.
[28] The Minister submits the Patient Applicants do not have private interest standing because they are not directly affected by the matter in respect of which relief is sought: Federal Courts Act, RSC 1985, c F-7, ss 18.1(1) [FC Act]. A party has a direct interest under subsection 18.1(1) of the FC Act when their legal rights are affected, legal obligations are imposed upon them, or they are prejudicially affected in some direct way: Forest Ethics Advocacy Association v Canada (National Energy Board), 2013 FCA 236 at para 20 [Forest Ethics]. The Minister states the evidentiary record does not establish the Patient Applicants have a direct interest in challenging the 96 decisions. At best, their connection to the decisions is speculative and remote. The Patient Applicants are effectively “strangers to the Court”.
[29] The Minister states that the notice of application alleges the Patient Applicants have conditions that are treatable by psilocybin-assisted psychotherapy, that they have been unable to find anyone to treat them due to a lack of trained practitioners, and that the Minister’s refusals delay or deny healthcare practitioner training, which in turn delays or denies treatment and violates the Patient Applicants’ section 7 Charter rights. However, a notice of application is not evidence, and the Minister submits the evidence does not establish the Patient Applicants are directly affected by the 96 decisions. There is no evidence that any Patient Applicant is a patient of an HCP who was denied a Section 56 Exemption, or that they have been prescribed psilocybin-assisted psychotherapy by a healthcare practitioner, have access to psilocybin, or applied for their own Section 56 Exemption. The Patient Applicants’ affidavits submitted in support of the HCPs’ requests for a Section 56 Exemption indicate that these individuals believe they would benefit from psilocybin-assisted psychotherapy based on their personal research. Moreover, the Minister submits there is no evidence that any Patient Applicant needs to undergo therapy with an experientially trained practitioner. Experiential training is a practitioner qualification that TheraPsil has imposed.
[30] The Minister submits the Patient Applicants also lack public interest standing. There is no automatic right to public interest standing—it is a matter within the Court’s discretion. In determining whether to grant public interest standing, the Court must consider whether: (1) there is a serious justiciable issue raised; (2) the public interest litigant has a real stake or a genuine interest in the issue raised; and (3) in all the circumstances, the public interest litigant’s involvement is a reasonable and effective way to bring the issue before the Court: Canada (Attorney General) v Downtown Eastside Sex Workers United Against Violence Society, 2012 SCC 45 at para 2. The Minister argues none of these considerations favours granting public interest standing to the Patient Applicants in the circumstances of this case.
[31] While the application raises a serious justiciable issue, the Minister states the Patient Applicants’ participation does not raise or add a serious justiciable issue beyond those raised by the other applicants, and the Patient Applicants’ participation in the application is frivolous. In addition, the Minister states there is no evidence the Patient Applicants have a real stake in the outcome. The fact that they gave evidence to support the HCPs’ Section 56 Exemption requests does not give the Patient Applicants a stake or genuine interest in this proceeding. The Patient Applicants will not be bound by the Court’s decision on this application or entitled to anything because of it—the decision will not give them access to psilocybin or a right to undergo psilocybin-assisted therapy. Lastly, the Minister argues the Patient Applicants have not demonstrated their presence is a reasonable and effective way to bring issues before the Court. Generally, parties with standing as of right are the preferred applicants, and the Minister contends the directly affected litigants are able to challenge the decisions effectively. Public interest standing will be denied if directly affected parties have brought a matter forward: Canadian Council of Churches v Canada (Minister of Employment and Immigration), [1992] 1 SCR 236 at 255-256.
[32] The applicants submit the Patient Applicants are directly affected by the Minister’s decisions because the delay and denial of HCP training delays and denies their assessment and treatment. The Patient Applicants are individuals who had approached TheraPsil for assistance in being assessed for psilocybin-assisted psychotherapy, and if suitable, to be supported in gaining access to psilocybin and connected to practitioners who can provide the treatment. TheraPsil was unable to assist the Patient Applicants due to the scarcity of trained healthcare professionals, which has forced TheraPsil to implement an intake protocol and restrict its assistance to those individuals with the most urgent or life-threatening needs. According to the applicants, the Minister’s argument that Patient Applicants have not been prescribed psilocybin-assisted psychotherapy misses the point. Due to the shortage of trained practitioners, the Patient Applicants cannot even be assessed for psilocybin-assisted psychotherapy. Furthermore, two of the Patient Applicants stated in their affidavits that their attending healthcare practitioners supported their efforts to pursue psilocybin-assisted therapy. The applicants contend this is the best evidence that can be expected in the circumstances.
[33] The applicants state there are over 800 people on TheraPsil’s waitlist. The Charter argument made to the Minister was that patient access to psilocybin does not equate to patient access to psilocybin-assisted psychotherapy. Patients in need who are granted Section 56 Exemptions themselves, or granted access to psilocybin via Special Access Program (SAP) requests made under the FDR, do not have access to psilocybin-assisted psychotherapy unless there are enough trained practitioners in Canada to assess, support, and treat them. The applicants state that the Patient Applicants’ affidavits speak to their unsuccessful efforts to access psilocybin-assisted therapy. They turned to TheraPsil because they were unable to find healthcare practitioners to assess, support, and treat them.
[34] The applicants submit the lack of trained practitioners prevents patient access to health care, the Minister’s refusals are the greatest barrier to being assessed, supported, and treated with psilocybin-assisted therapy, and denying standing to the Patient Applicants would insulate the Minister’s decisions from a Charter challenge.
[35] I agree with the Minister that the Patient Applicants do not have private interest standing.
[36] The Patient Applicants are prospective patients—individuals who approached TheraPsil for assistance in being assessed for psilocybin-assisted therapy, and if they are found to be suitable, to benefit from TheraPsil’s assistance in gaining access to psilocybin and being connected to practitioners who could provide the treatment. Their affidavits (as well as the affidavits of the five other waitlisted patients who are not parties to this proceeding) make the same main points. Each affiant describes their medical condition, and states:
the treatments they have tried have not worked; they believe, based on research they are aware of, that psilocybin-assisted psychotherapy will likely have a positive impact on their health; they contacted TheraPsil requesting assistance to be assessed for psilocybin-assisted psychotherapy, and if suitable, to be supported in efforts to gain legal access to psilocybin and be connected to practitioners who could provide treatment; TheraPsil informed them that it could not assist, because it lacked capacity to help the large number of people seeking similar assistance and support; TheraPsil informed them that it lacked capacity due to the scarcity of trained healthcare professionals, it had been forced to adopt patient inclusion criteria, and they did not meet the criteria (e.g. facing a life-threatening cancer diagnosis); they were unable to find any other person or organization in Canada to assist.
[37] As the Minister correctly notes, there is no evidence that the Patient Applicants are patients of HCPs who were denied a Section 56 Exemption. There is no basis to conclude that the Minister’s decisions prevent the Patient Applicants from being assessed as candidates for psilocybin-assisted psychotherapy, and I do not accept the applicants’ contention that the Patient Applicants cannot be expected to provide evidence that they are suitable candidates for psilocybin-assisted psychotherapy. TheraPsil’s position is that experiential training is required for practitioners to administer a form of psilocybin-assisted psychotherapy that is optimally safe and effective. The evidence does not establish that experiential training is required to assess patient suitability for the treatment. Furthermore, even if the Patient Applicants are suitable candidates for psilocybin-assisted psychotherapy, the evidence does not establish that any of them requires treatment by an experientially trained practitioner.
[38] The Section 56 Exemption refusals do not affect the Patient Applicants’ legal rights, impose legal obligations upon them, or prejudicially affect them in a direct way: Forest Ethics at para 20. The connection between the Patient Applicants and the decisions under challenge is an indirect connection, through TheraPsil, and it only arises because of the training model TheraPsil chose to adopt. TheraPsil placed the Patient Applicants on a waitlist in accordance with an intake protocol it implemented, to ration access to practitioners it has admitted to its roster. If an HCP successfully completes TheraPsil’s training program, TheraPsil may add the HCP to the roster and give their name to waitlisted patients who may, after assessment, be considered suitable candidates for psilocybin-assisted psychotherapy and choose to undergo treatment with the HCP.
[39] The Patient Applicants are in the same position as other individuals TheraPsil placed on a waitlist for the same reason—in this sense, they are essentially representative applicants. However, TheraPsil’s decision to place individuals on a waitlist does not give rise to private interest standing to challenge the decisions under review. In my view, the Patient Applicants’ connection to the decisions is too remote to support private interest standing. The connection is even more remote for the 23 decisions issued to HCPs who chose not to challenge the Minister’s decision to deny their Section 56 Exemption requests.
[40] I also find that the considerations for granting public interest standing do not favour granting such standing to the Patient Applicants in the circumstances of this case.
[41] I agree with the Minister that the Patient Applicants’ participation does not raise a serious justiciable issue. The Patient Applicants do not bring a different perspective from other applicants on the central issue before the Court—that is, whether the Minister committed a reviewable error in refusing Section 56 Exemptions so HCPs can complete TheraPsil’s experiential training module. The Patient Applicants do not present distinct arguments or a helpful perspective on the reasonableness of the Minister’s decisions or the question of whether HCPs should be experientially trained. From the record, it appears that the Patient Applicants’ knowledge in this regard is what they learned from TheraPsil.
[42] For similar reasons, I am not satisfied the Patient Applicants have a real stake or genuine interest in the issues raised in this proceeding. The affidavits that were submitted to support the HCPs’ Section 56 Exemption requests indicate the Patient Applicants want treatment; they do not express a need for an experientially trained practitioner to provide it. Many of the affidavits describe the affiants’ unsuccessful efforts to find a person or organization to assist them, including: inquiries through their attending healthcare practitioners; searches for other healthcare practitioners; contacting private clinics or centres within or outside Canada, or organizations that support patients who want to be assessed for and receive psilocybin-assisted psychotherapy; joining clinical trials; and requesting access to psilocybin through the SAP. The Patient Applicants have been pursuing different avenues to access psilocybin-assisted psychotherapy, and TheraPsil is one of the avenues they pursued without success. Apart from being one avenue that may lead to psilocybin-assisted psychotherapy, the applicants have not adequately explained how the Patient Applicants have a stake or genuine interest in the central issue of experiential training for HCPs.
[43] The 73 Exemption Applicants who are directly affected by decisions refusing their exemption requests are able to effectively challenge the decisions, particularly with TheraPsil’s support. In all the circumstances, I am not satisfied the Patient Applicants’ participation as applicants is a reasonable and effective way to bring issues before the Court.
[44] I note that while the Minister does not contest TheraPsil’s standing, I have reservations about TheraPsil’s standing to challenge at least the 23 decisions for HCPs who are not parties to this proceeding. Those 23 HCPs chose not to challenge the Minister’s refusals, despite TheraPsil’s support. However, it is unnecessary to say more on this point. In view of my decision to dismiss this application, questions about TheraPsil’s standing make no difference to the result.
(2) Proper Respondent [45] The second question raised by the Minister relates to the proper respondent. The Minister states that the Minister of Health is not the proper respondent to this application, and asks that the style of cause be amended to substitute the Minister of Mental Health and Addictions and Associate Minister of Health. Order-in-Council 2022-0549, which was effective May 26, 2022, transferred the powers, duties, and functions under the CDSA from the Minister of Health to the Minister of Mental Health and Addictions and Associate Minister of Health. The decisions challenged in this application post-date this change.
[46] I agree that the responsible decision maker is the Minister of Mental Health and Addictions and Associate Minister of Health, and the style of cause will be amended accordingly.
B. Main Issue 1: Standard of Review [47] According to the Supreme Court of Canada’s (SCC) decision in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 [Vavilov], the presumptive standard of review is reasonableness. The reasonableness standard is a deferential but robust form of review. In applying the reasonableness standard, the Court must ask if the decision under review bears the hallmarks of reasonableness—justification, transparency and intelligibility—and whether it is justified in relation to the relevant factual and legal constraints that bear on the decision: Vavilov at para 99. The robust form of reasonableness review described in Vavilov recognizes that what is reasonable in a given situation will always depend on the constraints imposed by the legal and factual context of the particular decision under review: Vavilov at paras 90, 105. The contextual constraints dictate the limits and contours of the space in which the decision maker may act and the type of solutions it may adopt: Ibid. The party challenging the decision bears the onus of demonstrating that it is unreasonable: Vavilov at para 100.
[48] The applicants submit the reasonableness standard of review applies to the Court’s review of the Minister’s decisions, with one exception. The applicants submit that when this Court is reviewing the Minister’s approach to Charter issues, it should adopt a correctness standard of review for part of the analysis. The Minister disagrees, and submits the standard of review for all issues on this application, including Charter review, is reasonableness.
[49] Both parties addressed the standard for Charter review at some length, and I intend to address this question below in the context of the parties’ Charter arguments. In this section I will simply state that in my view, the standard of review for all issues raised in this case, including Charter review, should be reasonableness; however, the result on this application does not turn on the standard of review.
C. Main Issue 2: Are the Minister’s decisions unreasonable? [50] The applicants identify five problem areas with the Minister’s decisions, and allege that each presents a sufficient basis to overturn the decisions. The applicants allege the Minister: (1) failed to meaningfully grapple with three central arguments that a clinical trial is unsuitable to achieve the goals of practitioner training; (2) did not account for OCT evidence that a clinical trial for TheraPsil’s training program would not be possible; (3) made unclear statements about experiential training, rendering the decisions unintelligible and non-transparent, and demonstrating a fundamental misapprehension of the evidence and failure to account for relevant evidence; (4) relied on an unreasonable conclusion that Section 56 Exemptions would create unacceptable risks, and that a clinical trial would reduce the risks; and (5) failed to balance the infringement of HCPs’ and patients’ section 7 Charter rights with statutory objectives, or even acknowledge the Charter arguments.
[51] The Minister submits subsection 56(1) of the CDSA confers broad discretion, and significant leeway in the exercise of her discretion: Canada (Attorney General) v PHS Community Services Society, 2011 SCC 44 at para 112 [PHS]. The Minister states there is no right to an exemption; she may refuse an exemption based on her opinion, as long as the decision is reasonable and reflects a proportionate balancing of Charter rights and values with statutory objectives. With respect to the decisions at issue, the Minister states she formed the opinion that a Section 56 Exemption was not “necessary for a medical or scientific purpose or otherwise in the public interest” given the option of a clinical trial. She did not accept that the HCPs need to consume psilocybin in order to provide psilocybin-assisted psychotherapy to patients in a safe and effective manner.
[52] The Minister states the applicants disagree with her findings and seek to reargue scientific and medical issues related to psilocybin-assisted psychotherapy, such as the risks associated with psilocybin acquisition and use, ethical considerations regarding clinical trials, and whether experiential training is necessary and improves patient outcomes. In reviewing a decision under subsection 56(1) of the CDSA, it is not the Court’s role to settle or determine scientific and medical debates: Vavilov at para 125.
[53] The Minister states she was not required to provide formal reasons, and in any event, the reasons were as comprehensive as required in the circumstances. Administrative reasons need not be perfect, address every argument, or make an explicit finding on each constituent element leading to the conclusion: Vavilov at paras 91-92 and paras 127-128.
(1) Did the Minister fail to meaningfully grapple with central arguments about the unsuitability of a clinical trial? [54] The applicants state the Minister did not meaningfully grapple with three central arguments that a clinical trial is unsuitable to achieve the goals of practitioner training: a clinical trial is not available in a timely manner and would cause delay; the effects of psilocybin in healthy human subjects are already known and it would be unethical to conduct a clinical trial for therapist training without a specific research question; a clinical trial is not compatible with training objectives and many elements of clinical trial design could interfere with participants’ training objectives. The applicants contend the Minister merely summarized these arguments and stated a peremptory conclusion, which is inadequate: Vavilov at para 102; Paul v Canada (Attorney General), 2022 FC 1157 at paras 32-34. The applicants state that while there are a number of paragraphs in the decision related to clinical trials, they do not actually address the HCPs’ central arguments. For example, the Minister’s recommendation that TheraPsil reconsider its position on a clinical trial is simply a statement of disagreement, and her statement that Health Canada addressed meeting requests in a timely manner does not address the concerns with delay. Similarly, the Minister’s remarks about Health Canada’s efforts to encourage clinical trials and the benefits of clinical trials studying the efficacy of psilocybin-assisted psychotherapy for patients were not responsive to the arguments related to clinical trials involving practitioners, and the remarks are irrelevant. Reasons must be justified, not merely justifiable, and the failure to grapple with central arguments constitutes a reviewable error: Vavilov at paras 86, 128.
[55] The Minister states that while the decisions do not explicitly articulate a response to each of the HCPs’ three arguments, the decisions address them. The arguments that a clinical trial would be unethical and interfere with training objectives are addressed by the finding that TheraPsil’s experiential training requirement is a choice, and not a necessity. The Minister noted that providers can be trained in psychedelic-assisted psychotherapy without consuming psilocybin themselves, and thus the HCPs had not shown that experiential training is necessary. In any event, TheraPsil could apply for a clinical trial, which would allow access to psilocybin for training purposes through a legal avenue. The Minister states the decision adequately explained this regulatory pathway, and also explained developments in the pathway since the 19 exemptions were previously granted to practitioners—this met any “justificatory burden” to explain a departure from past practice: Vavilov at para 131. While the applicants prefer to avoid the clinical trial process and instead obtain exemptions, the Minister states she reasonably determined that Section 56 Exemptions are not necessary for a medical or scientific purpose, or otherwise in the public interest.
[56] I find the applicants have not established a reviewable error based on a failure to address the three arguments about suitability of a clinical trial. The Minister adequately addressed the arguments.
[57] As noted above, the Minister was tasked with deciding whether a Section 56 Exemption, that would allow HCPs to possess and consume psilocybin as part of their training with TheraPsil, was necessary for a medical or scientific purpose or otherwise in the public interest. The Minister found that an exemption was not necessary because the HCPs have an option under the FDR—namely, to participate in a clinical trial. The Minister explained that Health Canada’s recent authorization of a clinical trial for healthcare professionals’ use of psilocybin for training purposes demonstrated that a clinical trial is a feasible regulatory option.
[58] The HCPs’ arguments that a clinical trial would not be timely, ethical, or compatible with training objectives assume that experiential training is necessary. The evidence did not establish that experiential training is necessary. The HCPs’ arguments were fully addressed by the Minister’s findings that there is no peer-reviewed clinical evidence demonstrating that HCPs need to take a psychedelic drug in order to appreciate what the patient experiences, and while TheraPsil’s training program requires trainees to consume psilocybin, it is not required for therapists to offer psilocybin-assisted psychotherapy.
[59] The Minister’s findings were open to her, and supported by the record. TheraPsil does not regulate or license healthcare professionals. The doctors, psychologists, nurses, social workers, counsellors, and other regulated healthcare professionals who applied for exemptions are licensed by their respective regulatory bodies. The extent of each HCP’s involvement in administering psilocybin-assisted psychotherapy to patients would be limited by their qualifications, and the healthcare services they are licensed to provide. For example, a physician who was granted one of the prior Section 56 Exemptions and completed TheraPsil’s training program states in her affidavit, “Because I am not a trained t