Adapting the Safe Consumption Site Model for Patient-Procured MDMA

Adapting the Safe Consumption Site Model for Patient-Procured MDMA

Shannon Dames¹; Crosbie Watler²; Kerrie Miller³; Robert W.E. Laurie⁴; Vivian W.L. Tsang⁵; Raimey Olthuis⁶; Pearl Allard⁷; Elena Argento⁸: Pam Kryskow⁹

ABSTRACT

Increasing demand for access to psychedelic therapy within Western medicine has given rise to a concerning trend in Canada, where individuals are increasingly resorting to self-medication with psychedelic substances or turning to unregulated psychedelic-assisted therapy. Concurrently, there is growing interest in honoring Indigenous ways of knowing and healing, including the traditional use of psychoactive substances. This article highlights the challenges facing those seeking alternative treatments, particularly persons with treatment-resistant conditions. The risks associated with unregulated practices are defined, including the prevalence of tainted drug supplies and the lack of protective measures, which pose significant threats to vulnerable populations. In a landscape where regulated care remains out of reach for many, the criminalized market catering to treatment-resistant individuals continues to expand. Healthcare providers, motivated by an ethical commitment to culturally inclusive care and enhancing access to promising therapeutic solutions, increasingly find themselves navigating the underground terrain. Informed by established safe consumption sites designed to mitigate overdose risks, this article presents an adapted harm reduction approach tailored for psychedelics, with a focus on supporting safe MDMA consumption. This innovative approach offers support to persons who have self-procured psychedelic substances for mental health indications, or for those who feel these medicines might offer benefits beyond the treatment of a defined mental disorder. This model incorporates the essential safety standards for those exploring alternative mental health treatments, laying the scientific and legal groundwork for a comprehensive harm reduction and wellness strategy.

Keywords: MDMA; Psychedelic; Harm Reduction; Mental Health Crises; Safe Consumption; Drug Testing

Author(s) Affiliations:

1. RN MPH EdD [Resilience], Roots to Thrive Society for Psychedelic Therapy (RTT), Vancouver Island University (VIU); [email protected].
2. MD FRCPC [Psychiatrist], RTT, VIU, University of British Columbia (UBC)
3. RN PATGC, RTT
4. Barrister and Solicitor, Ad Lucem Law Corporation
5. MPH MD [UBC psychiatry resident; VIU PaT Postdoctoral Research], RTT
6. PhD [Medical Sciences], VIU
7. RN, VIU
8. PhD [UBC PaT Postdoctoral Research], RTT
9. MD [PaT expert], RTT, VIU, UBC

Contributors: Todd Haspect (Registered Therapist); Wes Taylor (Program Development); Renae Wheatley (Registered Therapist and Law Enforcement)

Author Contact: [email protected]

Cite: Dames, Shannon et al (2023). Adapting the Safe Consumption Site Model for Patient-Procured MDMA. Canadian Health Policy, OCT 2023. https://doi.org/10.54194/MMCN2584 | canadianhealthpolicy.com.

Disclosure: No conflicts declared by authors.

Open Access: Not sponsored.

Status: Peer reviewed. Submitted: 23 AUG 2023. Published: 26 OCT 2023.

Preface

We acknowledge and are grateful to Indigenous cultures for their historic relationship with psychedelic medicines in ceremonial settings. Modern psychedelic-assisted therapy (PaT) protocols have much to learn from these deeply rooted traditions. We also recognize contemporary underground practitioners who, despite the ‘war on drugs,’ risk their careers and personal freedom to provide care and share knowledge in the underground psychedelic-assisted therapy environment, contributing to the resurgence of psychedelics in Western medicine. In these times of overlapping crises and a mental health epidemic, we aim to embrace Elder Geraldine Manson’s call, “Naut sa mawt,” to walk together, with one mind and one Spirit.

Introduction

Western medicine is faced with an escalating demand for access to psychedelic substances. A rapidly growing number of Canadians are turning to psychedelic substances for self-medication or engaging in unregulated psychedelic-assisted therapy (PaT) (Yockey et al., 2020). Increasingly, people are turning to PaT as a last resort for debilitating conditions including treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). With limited access to licensed providers and safe medical spaces, many are turning to the unregulated underground, where they encounter highly variable practices, training, and safety (Gorman & Grady, 2021).  A further concern is a tainted drug supply, where 11% of the 18,616 samples (9500 MDMA samples) tested by the BC Centre on Substance Use were contaminated with other substances (BCCSU, 2023). This lack of protective measures exposes vulnerable populations to potential risks and questionable practices, leaving them without adequate safeguards.

While access to regulated care is available for exceptional cases, unregulated care continues to expand, and an increasing portion of those deemed ‘treatment resistant’ to publicly available treatment options are circumventing the law to access novel treatment options. This criminalized market caters to those who are unable to access PaT through legitimate channels. As a result of arduous and often unviable routes to regulated care pathways, an increasing number of healthcare providers feel compelled to navigate the underground environment. Their motivation is driven by surging demand, also by a profound ethical duty to facilitate access to promising therapeutic solutions.

Consistent with the creation of safe consumption sites to mitigate overdose risks, an adapted approach for psychedelics could provide a viable harm reduction solution. This approach incorporates the medical supervision and therapeutic support necessary for safe and effective use of psychedelic agents. The following analysis forms the scientific and legal foundation towards developing a harm reduction and wellness promotion strategy for the psychedelic landscape.

“Harm reduction refers to policies, programmes and practices that aim to minimise the negative health, social and legal impacts associated with drug use, drug policies and drug laws. Harm reduction is grounded in justice and human rights. It focuses on positive change and on working with people without judgment, coercion, discrimination, or requiring that people stop using drugs as a precondition of support.” (Harm Reduction International, 2023)

Fundamental Rights to Mental Health Care

Canadians seeking mental health treatment have fundamental rights under Section 7 of the Canadian Charter of Rights and Freedoms, whereby everyone has the right to life, liberty, and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice (1982). In the case of R vs. Parker (2000), the Court found that because Parker used cannabis medically to control seizures, the criminalization of cannabis infringed upon his section 7 rights since it “force[d] Parker to choose between commission of a crime to obtain effective medical treatment and inadequate treatment” (para 107). Those with invisible illnesses, such as mental health disorders, should have the same right to challenge the validity of drug prohibitions which infringe upon their section 7 rights through deprivation of access to effective treatments for their illnesses by means of a criminal sanction. These rights are fundamental for safeguarding the well-being and preserving the dignity of individuals contending with mental health challenges, regardless of the source of the substance patients choose for self-medication. At its core, this initiative is committed to delivering both medical and therapeutic oversight to individuals who independently acquire psychedelic substances for their own consumption. The primary aim is twofold: to prevent injuries related to unsafe settings and unsupervised treatment environments, and to mitigate risks associated with a contaminated drug supply. To ensure the best possible mental health care for all Canadians, we advocate for three key pillars:

• A Safe Drug Supply: It is crucial that mental health patients have access to a safe drug supply. This would require that substances used for treatment purposes are regulated and screened through reliable drug testing services.
• Regulated Medical Supervision: Proper medical supervision is a requirement for all mental health treatments. Qualified healthcare professionals should oversee and manage care, providing guidance and personalized treatment plans to address unique care needs.
• Comprehensive Therapeutic Support: A comprehensive therapeutic approach incorporates all the pillars necessary for optimal health and recovery. There should be access to various evidence-based therapeutic options adapted to patient-specific needs. This would increase potential for recovery and enhance overall well-being.

In advocating for these elements, we hope to raise awareness of the need to uphold the rights of those seeking mental health treatment. Providing a safe drug supply, regulated medical supervision, and comprehensive therapeutic support could significantly improve mental health care across Canada, supporting access for vulnerable patients who are poorly responsive to mainstream therapies. Together, we can work towards building a more compassionate, accessible, and supportive mental health care system that respects the rights and dignity of all Canadians.

Consideration of Indigenous Rights

Prior to being criminalized by settlers, numerous psychedelic substances have been used medicinally by Indigenous peoples for centuries (George et al., 2020; Pilecki et al., 2021). In Canada, recognizing and collaborating with Indigenous communities ensures their inclusion and active participation in mental health care. The constitutional rights of Indigenous peoples in Canada is recognized and affirmed by Section 35 of the Constitution Act, 1982, which includes the right to preserve traditional cultural practices (R. v. Van der Peet, 1996). This is consistent with the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), respecting the right of Indigenous Peoples to their traditional medicines and health practices (United Nations General Assembly, 2007).

The United Nations Declaration of the Rights of Indigenous Peoples (UNDRIP)

While the primary focus of this article is not centered on access pathways aligned with the rights of Indigenous Peoples, the presented framework offers a potential avenue that could intersect with legally established cultivation and procurement routes for First Nations communities. UNDRIP, adopted by the United Nations General Assembly in 2007, delineates both the individual and collective rights of Indigenous peoples on a global scale. These encompass various aspects, including culture, identity, religion, language, health, and education. Moreover, UNDRIP underscores the rights of Indigenous communities to preserve their traditions, customs, and the establishment of their own educational, media, and judicial institutions.

At the federal level in Canada, UNDRIP was given legislative recognition through the United Nations Declaration on the Rights of the Indigenous Peoples Act (2021). The primary objective of the federal act is to ensure that the laws of Canada are in harmony with UNDRIP. It requires the Canadian government to:

1. Take measures to ensure that federal laws are consistent with UNDRIP.
2. Prepare and implement an action plan to achieve the declaration’s objectives.
3. Submit annual reports to Parliament on progress toward these goals.

Before the federal government’s adoption of Bill C-15, the province of British Columbia (BC) took the pioneering step of implementing UNDRIP at the provincial level. In 2019, BC introduced the Declaration on the Rights of Indigenous Peoples Act (DRIPA) (2019). This provincial legislation recognizes and affirms the application of UNDRIP in BC. DRIPA’s provisions are similar to the federal act in terms of mandating action plans and ensuring that provincial laws are consistent with UNDRIP. It underscores the importance of consultation and collaboration with Indigenous communities in the province.

The adoption of UNDRIP into Canadian federal and provincial law reflects a commitment to rectify past injustices and promote a future built on mutual respect and partnership. The incorporation of UNDRIP principles in both federal and provincial legal landscapes reinforces the principle that the rights of Indigenous peoples are integral to Canada’s legal and moral fabric. The journey towards the full realization of Indigenous rights remains a work in progress. While legislative recognitions are important first steps, meaningful reconciliation and recognition of rights necessitates effective and sustained implementation, genuine consultations, and continuous collaboration with Indigenous communities.

The federal and provincial Acts reflect Canada’s commitment to the principles laid out in UNDRIP, also serving as a precedent for other jurisdictions navigating similar challenges, including access to psychedelic medicine. By expanding access to traditional psychedelic medicines, we actively support the process of decolonization and seek to integrate Western and Indigenous knowledge systems within regulatory frameworks. This comprehensive and inclusive approach respects Indigenous sovereignty, while benefiting the well-being of all Canadians.

Indigenous communities continue to be impacted by the legacy of residential schools, colonization, and racism, disrupting the healing traditions, which are integral to their cultural heritage. The trauma experienced by Indigenous peoples stems from the direct harm caused by colonization and the government systems that hold it in place. Beyond mere acknowledgement, we need tangible steps towards reconciliation, potentially reducing the negative impacts of multi-generational trauma.

The Royal Proclamation of 1763 forms the constitutional foundation for Indigenous treaties and legal rights. Section 35 of the Constitution Act, 1982 reinforces these principles, safeguarding Indigenous and treaty rights, in line with UNDRIP. These include the right to pre-colonization practices related to farming, gathering, foraging, and seed propagation, underscoring the significance of sacred medicines (including psychedelic substances) in the context of Indigenous rights and access to traditional healing practices.

A Focus on 3,4-Methylenedioxymethamphetamine (MDMA)

Early in the new year, small-scale possession of MDMA was granted a temporary exemption under the Controlled Drugs and Substances Act (CDSA) (1996) in the Province of BC. This reduces the risk of criminalization when providing harm reduction services. Further, pilot data could help us understand the potential benefits of applying these principles to a broader range of psychedelic substances, towards developing a model that could be expanded to other psychedelic substances, should decriminalization broaden.

Hendy (2021) speaks to the importance of distinguishing MDMA from ecstasy defining the structures, processes, and safeguards that make MDMA safe and clinically significant in the treatment of PTSD. The results of research studies demonstrating safety and efficacy assume the presence of structured processes, including screening, environmental and competency requirements, baseline predictability, and consistent safeguards to mitigate potential harms. Although MDMA and ecstasy share the same chemical makeup, the crucial distinction lies in the presence of a structured therapeutic process in MDMA-assisted therapy, which is absent in recreational ecstasy use.

Prior to gaining popularity in the unregulated market as ‘ecstasy’, MDMA was developed by Merck in 1912, combining elements of mescaline and amphetamine (Stolaroff, 2004). During the 1970s and early 1980s, MDMA was not a controlled substance, offering a legal therapeutic alternative to recently criminalized psychedelics, notably LSD and psilocybin (Hendy, 2021). Prior to MDMA’s criminalization in 1985, an estimated 4000 psychiatrists and psychologists administered MDMA to an estimated 500,000 patients in the context of psychotherapy (Mithoefer, Grob, & Brewerton, 2018; Shulgin & Shlugin, 1991; Passie, 2018). Over this interval, MDMA gained recognition for fostering trust, facilitating communication, enhancing self-understanding, self-confidence, and self-acceptance (Greer & Tolbert, 1986; Stolaroff, 2004; Wolfson, 1986). In 1986, soon after the DEA classified MDMA as a controlled substance, the newly launched MAPS organization initiated a Drug Master File MDMA with the FDA, beginning the development of a clinical program centered on MDMA-assisted therapy for PTSD (Hendy, 2021).

MDMA has become readily accessible in the unregulated drug market in Canada, prompting policymakers in BC to decriminalize small quantities. This move aims to combat the adulterated drug crisis, destigmatize drug possession, and facilitate greater acceptance and accessibility of drug testing. Advocates and politicians contend that decriminalizing drug use shifts the focus from criminalization to health and harm reduction, addressing the crisis from a more compassionate perspective (CBC, 2023).

Overview of Psychedelic-assisted Therapy

From ancient times, indigenous peoples have cultivated sacred and therapeutic relationships with various plants and fungal medicines. It is from these origins that the ‘Western’ world was first introduced to psychedelics in the 20th century. PaT combines psychedelic medicine, various psychotherapy elements, somatic energy work, psychiatry, and other therapeutic practices. PaT uses psychedelic substances as a catalyst to enhance the therapeutic process, deepening self-exploration, and facilitating healing. It involves oral or parenteral administration of psychedelics with the guidance of trained providers in a supportive and therapeutic setting, with prior preparation/planning sessions, and subsequent integration sessions.

The choice of psychedelic substance varies depending on the therapeutic goals and the specific approach being used. In North America, substances most utilized for PaT include ketamine, psilocybin, and MDMA. These substances are known to induce altered states of consciousness characterized by heightened introspection, emotional openness, and expanded awareness. Mounting evidence, including phase three trials of MDMA for PTSD treatment, demonstrates safety and efficacy (Mitchell et al, 2023).

Preparation for PaT typically involves 1-4 sessions with the therapist, and includes initiating an ongoing informed consent process, discussing concerns or fears, establishing boundaries and agreements for the session, cultivating a strong therapeutic alliance, intention setting, and managing expectations.

During a PaT session, the individual takes a carefully measured dose of the psychedelic substance. The therapy session is conducted in a controlled environment, frequently including a carefully curated musical playlist, with trained PaT providers present to provide guidance, support, and ensure the individual’s safety throughout the experience. The provider may engage in techniques such as talk therapy, somatic approaches, or mindfulness practices to promote emotional breakthroughs, enhance introspection, foster insights, and facilitate a sense of connectedness and meaning making.

Following a PaT session, typically 1-6 integration sessions are provided to help patients continue to make meaning of their experience and to integrate insights and apply new perspectives to their daily life.

The potential mechanisms of action of psychedelics in therapy are complex and not fully understood. They are thought to work by modulating brain activity, particularly in areas associated with emotion, cognition, and sense of self (Hipolito et al., 2023). Psychedelics may promote neuroplasticity, enhance the formation of new neural connections, and facilitate a loosening of rigid patterns of thinking and behavior, all of which can create opportunities for profound and transformative change (Hipolito et al., 2023). In this non-ordinary state of consciousness, a person’s psychological defenses are softened, enabling access to repressed emotions and memories that may remain outside of one’s conscious awareness (Inserra, 2019; Grob et al., 2011). This can create opportunities to heal past traumas that are so often suppressed and at the root of their mental health condition(s).

The therapeutic benefits often result from the combination of the drug’s effects and the supportive therapeutic context. Given the state of vulnerability of the patients, and the non-ordinary mechanism of therapy, emerging research around the therapeutic use of psychedelics establishes the importance of set and setting during consumption for optimal mental health and safety outcomes (Aday et al., 2021; Johnson et al., 2008). Therefore, it is important that a specialized and accountable approach is used, facilitated by trained professionals in a multidisciplinary team environment.

From “Psychedelic-assisted Therapy” to “Safe Psychedelic Consumption”

In Canada, Section 56.1 exemptions (elaborated on further down) are granted on a case-by-case basis to sanction either an individual or a group of people for a very specific purpose and substances with clearly defined parameters. These exemptions are necessary for the legal consumption of unregulated substances. Our objective is to promote safe consumption by adopting a comprehensive public health approach that includes harm reduction, drug testing, medical supervision, and continuity of care. This approach addresses the increasing number of Canadians resorting to self-medicating with psychedelic substances and the growing number of healthcare providers operating outside regulated environments to assist individuals now considered ‘treatment resistant’ to publicly provided care. While the regulated system cannot sanction unregulated psychedelic consumption, through Section 56.1 exemptions, they can sanction access to harm reduction and medical supervision.

Economic and Societal Considerations

The resurgence of psychedelic use in Western medicine has shown promise in clinical trials for treating major mental health conditions, potentially expanding psychiatric treatment options. Research has not definitively linked long-term self-administered psychedelic use to adverse mental health consequences (Hendricks et al., 2015; Johansen and Krebs, 2015; dos Santos et al., 2018; Studerus et al., 2011). While we provide some economic and societal considerations, impact studies are lagging, necessitating further investigation (Marseille, Bertozzi, & Khan, 2022).

On the economic front, recent analyses of previous studies have shown significant benefits associated with the use of psilocybin in depression treatment, even when factoring in the initially high pharmaceutical costs (McCrone et al., 2023). Furthermore, in a cost-benefit analysis of MDMA-assisted therapy in the United States, providing access to MDMA-assisted therapy for 25-75% of individuals with acute and chronic PTSD over a 10-year period could potentially prevent between 43,000-106,000 deaths, contribute an additional 3.3-8.2 million years of life, and result in savings of 109-266 billion dollars for the healthcare system (Avancena, Kahn, & Marseille, 2022). In the case of MDMA, the current price from a pharmaceutical company in Canada stands at $500 per dose, whereas the underground market offers the same substance for $30 or less (Pharmala Webinar, October 4, 2023). Notably, unregulated drug prices are often considerably lower than their regulated counterparts, especially when they are newly introduced to the market. Consequently, individuals who cannot afford the $500 cost (plus clinical support expenses) will likely turn to underground sources for more affordable options. This underscores the persistence of equity issues even when these treatments become accessible at a cost, emphasizing the ongoing need for a harm reduction approach.

On the societal front, well supported, psychedelic substance use could yield substantial societal benefits by addressing fundamental human needs for meaning, connectedness, and purpose, often overlooked in Western individualistic cultures (Maslow, 1969; Frankl, 1946/1985). Empirical evidence supports the notion that psychedelics have the capacity to enhance well-being while fostering fresh perspectives, offering valuable resources for tackling societal issues (Elsey, 2017). Further, there is evidence that psychedelic use reduces criminal behavior (Jones & Nock, 2022). While further research is required, these findings suggest that a harm reduction model might yield both economic and social advantages, better addressing critical societal needs.

The Canadian Context

An Intersecting Mental Health and Overdose Crisis

More than half of all Canadians will experience mental health issues by the age of 40 and mental illness is the leading cause of disability in Canada (MHCC, 2022a). Since the COVID-19 pandemic, Canadians experiencing moderate to severe depression has increased 600% (MHCC, 2022b). A Statistics Canada survey completed in 2021 found that approximately 8% of Canadians met criteria for PTSD diagnosis – 6% of men, and 10% of women (Statistics Canada, 2022a). PTSD has a high rate of comorbidity with other mental health challenges, especially alcohol and other substance use disorders, and major depressive disorder (Van Ameringen, Mancini, Patterson, & Boyle, 2008).

This mental health crisis is concurrent with an ongoing toxic unregulated drug crisis in BC. First declared a public health emergency in 2016, deaths from poisoned drugs have continued to rise (BC Gov News, 2023). In June 2023, we witnessed a devastating toll on human lives, with 184 (averaging 6.1 deaths per day) fatalities caused by the toxic unregulated drug supply. The ongoing epidemic has claimed over 1,200 lives in the first half of 2023, and is now the leading cause of death for those aged 10-59 in BC (CBC, 2023).

These grim statistics serve as a stark reminder of the dire consequences resulting from unsupervised self-medication practices. While these numbers represent the most extreme outcomes, it is crucial to recognize that there are numerous other physical and psychological risks associated with unsupervised and unregulated drug consumption. Addressing this crisis through harm reduction services, such as supervised consumption sites, is essential to prevent further loss of life and protect individuals from the broader range of adverse effects that can arise from self-medication without proper oversight.

Interestingly, adopting the safe consumption model for regulated psychedelic use support could potentially contribute to a decrease in problematic substance use in various domains. Based on a cross-sectional online survey of 1639 adults who had consumed psychedelics, they found substantial reductions in alcohol use (43.8%), antidepressant use (42.5%), and cocaine use (42.4%). These reductions were linked to factors such as increased self-connection (73%), a heightened connection with nature (55%), and decreased anxiety or depression (59.4%) (Boehnke et al., 2023).

Traditional Mental Health Treatments are Failing Many

The term “treatment-resistant” is commonly used to describe individuals who do not respond adequately to standard or commonly used treatments, including medications and evidence-based psychotherapies. Research has shown that the prevalence of treatment resistance varies across mental health conditions, ranging from 20% to 60% (Howes, Thase, & Pillinger, 2022).

Studies have raised questions about the efficacy of standard treatments used to treat mental illnesses. A study conducted by Kirsch in 2014 found the differences between antidepressants and placebo to be minimal, and any slight improvement observed may have been influenced by participants becoming aware of their treatment, which compromised the blinding process. A study by Cipriani et al. in 2018 compared the efficacy of 21 antidepressants and found that all were moderately more effective than a placebo for major depression, however, these findings were later challenged by Munkholm, Paludan-Müller, and Boesen in 2019, who highlighted methodological limitations and argued that the clinical relevance of the differences between antidepressants and placebo was minimal.

Like antidepressants, concerns have been raised about the efficacy of traditional psychotherapy, with some questioning bias and weak control measures that may lead to an overestimation of positive results. A recent second-order meta-analysis by Leichsenring, Steinert, Rabung, and Ioannidis (2022) revealed comparatively small effect sizes across various mental disorders, suggesting limited overall efficacy.

Despite the widespread prescription of antidepressants, mental health-related disability rates in Canada have been on the rise, particularly among women and Indigenous populations (Statistics Canada, 2022b; Employment and Social Development Canada, 2022). This situation places a disproportionate burden on society and carries a significant financial cost, estimated at $51 billion annually for Canada (CAMH, 2023).

A Growing Body of Evidence on MDMA as a medicine

MDMA has demonstrated the ability to diminish fear, improve prosocial effects, and foster feelings of interpersonal closeness (Curry et al., 2019; Hysek et al., 2014). It effectively mitigates the avoidance and hyperarousal symptoms commonly associated with PTSD, which can hinder the therapeutic process, all the while leaving other cognitive functions unimpaired (Mithoefer et al., 2021). Neurologically, those with PTSD experience increased activity in the amygdala and decreased prefrontal functioning. In contrast, MDMA decreases activity in the amygdala and increases blood-flow to prefrontal regions. This neurobiological state creates a fertile ground for therapeutic work by decreasing fear and enhancing a person’s capacity for communication and self-compassion (Young et al., 2017).

In 2017, 3,4-methylenedioxymethamphetamine (MDMA) was granted breakthrough therapy status in the treatment of PTSD by the Federal Drug Administration (FDA) in the United States (FDA, 2017). This was in response to pooled data of six phase 2 clinical trials by the Multidisciplinary Association of Psychedelic Studies (MAPS), and a comparative analysis with sertraline and paroxetine, the two oral medications approved by the FDA for treatment of PTSD (Fedducia et al., 2020). The first double-blind randomized clinical trial showed safety and high efficacy compared to placebo, even with individuals with comorbidities, and no serious adverse events during treatment (Mitchell et al, 2020). In a multi-site phase 3 clinical trial published earlier this year, 86.5% of participants treated with MDMA-AT achieved a clinically meaningful benefit, with 71.2% of participants no longer meeting criteria for PTSD at the conclusion of the study (Mitchell et al, 2023). Twelve-month follow-up of phase 2 trials shows MDMA assisted therapy to be a durable treatment for PTSD (Jermone et al., 2020). Long-term follow-up of phase 3 RCT participants is on-going, with ninety-seven clinical trials of MDMA registered in the United States at the time of writing (www.clinicaltrials.gov).

A recent review of the literature (Rush et al., 2022) showed compelling evidence to support the use of MDMA in the treatment of PTSD, including severe and chronic PTSD, and moderate evidence to support its use in the treatment of depressive disorders (Rush et al., 2022; Smith et al., 2022). There is emerging evidence indicating it may be helpful in treating alcohol use disorder (Nicolas et al., 2022; Sessa et al., 2021), social anxiety in autistic adults (Danforth et al., 2016), anxiety related to terminal illnesses (Wolfson et al., 2020), and eating disorders (Brewerton et al., 2022).

A potential concern is that most PAT studies (including MDMA) have included a small number of participants. The most recent systematic review of MDMA found the certainty of evidence to be low, and moderate to low (Kisely, Conner, Somogyi, & Siskind, 2023) and another recent review found inconsistencies with defining and reporting adverse events, which could be leading to under-reporting of AEs (Breeksma et al., 2022). Researchers have also pointed to the need to better understand how to optimize the ‘therapy’ portion of PAT, and which factors are the most impactful, as there is significant variability practiced within MDMA research protocols (McNamee, Devenot, & Buisson, 2023).

With the first double-blind randomized control trial being published only two years ago (Mitchell et al., 2023), research into MDMA is still in its infancy. There are challenges in researching this novel treatment including strict regulations due its status as a controlled substance, insufficient public funding, and the difficulty in truly blinding participants to a psychedelic substance (Hall & Humphreys, 2022). Media reports portraying psychedelics as the next ‘magic bullet’ have led to considerable hype and large-scale private investment. In this climate, it is imperative that data and best practices guide public policy (Phelps, Shah, & Lieberman, 2022).

While randomized control trials are considered the ‘gold standard’ in research, they only represent one way of knowing and are best suited for reductionist queries. In a time when recognizing Indigenous ways of knowing is a national priority, and in a field that is actively navigating challenges around cultural expropriation and trying to discern how to steward these medicines in a good way, we must create space for diverse voices and ways of knowing. To this end, we suggest a ‘multi-eyed approach’, informed by cultural safety frameworks, as proposed by culturally inclusive leaders in the field (Nawt sa mawt Centre for Psychedelic Research, 2023).

A Growing Acceptance of Criminalized Psychedelic Substances

A significant portion of Canadians are engaging in unregulated psychedelic use and are rarely discussed with their regulated healthcare providers (Glynos et al., 2023), signaling a growing divide between regulated and unregulated care pathways. Simultaneously, there is a rising acceptance of crossing legal boundaries to obtain psychedelic substances for health and wellness benefits (Yockey et. al., 2020).

In an anonymous survey involving 2,384 Canadians, 34% had used psychedelics to self-treat a health condition, only 4% had used psychedelics with a therapist, and 4% in a clinical setting. Although 45% were aware of substance testing services, only 42% had used them (Glynos et al., 2023). In a Canadian survey of 2045 respondents performed in 2022, psilocybin, LSD, and MDMA were found to be the most consumed psychedelic substances and over 75% has used them in the last year; of those, 53% procured substances from a friend, 15% procured them from a street dealer or black market, and nearly half ordered them online (Lake & Lucas, 2023).

A survey conducted between 2002-2019, involving over 1 million individuals aged 12 and above in the United States, reveals a decline in psychedelic use among those under 18, but a steady increase among those over 18. This shift is suggested to be linked to a change in risk perception and the anticipation of positive effects (Livne et al., 2022). Furthermore, a recent random telephone survey focused on psilocybin-assisted therapy, involving over a thousand Canadian adults in 2021, found that 82% of respondents either support or somewhat support government approval of psychedelic medicines (PAC, 2021). Another Canadian study, now in the publication process, including approximately 1,000 first responders, found over 80% reported at least mild psychological impairment, and over 20% reported severe or extreme levels of impairment. Over 60% of participants reported using psychedelics to support their mental health, and over 40% had a strong desire to use psychedelics in the future (Brodie et al., 2023). These findings suggest a change in attitudes towards the use of psychedelic medicines among adults, where personal beliefs and mental health needs appear to be increasingly prioritized over strict adherence to existing laws.

The growing acceptance of these substances for therapeutic purposes raises concerns about the potential dangers associated with unregulated use. This underscores the need for accessing through secure channels to guarantee safety and effectiveness. Procuring unregulated drug supplies carries significant risks concerning purity and dosage accuracy, potentially leading to adverse reactions, psychological distress, or even life-threatening situations. When regulated access is not feasible, as is the case for many, the next public health priority is to ensure drug testing is accessible and convenient. Beyond the substance alone, there are other factors within the care pathway that shape the overall experience, often determining whether the treatment is perceived as harmful or helpful (Haijen et al., 2018; Lee et al., 2023). Given the growing acceptance of self-procuring unregulated psychedelic substances, there should be a parallel effort to ensure individuals using these substances for mental health purposes are well-informed about the factors that support safety and efficacy.

Political Context

It is important to reflect on the status of other commonly used substances in Canada, including tobacco and alcohol. Research has found that psychedelics are extremely low risk in comparison to alcohol and other controlled substances, causing much less harm to users than mainstream legal substances (Nutt et al., 2010; van Amsterdam & van den Brink, 2010; Bonomo et al., 2019; Morgan et al., 2010). Despite significant health morbidity caused by tobacco and alcohol, they remain legal, while certain psychedelic substances are illegal. This discrepancy highlights the lack of scientific evidence presented in the 1970’s ‘War on Drugs’ when these substances were removed from medical use. It demonstrates that the legality of substances is not solely based on current scientific evidence and public health risk assessments (Smith, 2021). In 2018, the Canadian federal government legalized cannabis, after years of sustained pressure by consumers, health care professionals, civil liberty advocates, Supreme Court challenges and many others seeking safe access to the therapeutic benefits of cannabis through a regulated and quality-controlled system, similar to the one that governs the production and sale of alcohol.

In 2023, Health Canada started offering limited access to MDMA through the Special Access Program (SAP).  In addition, the Province of BC temporarily decriminalized possession of MDMA (and numerous other substances) for personal use; the exemption runs from January 31, 2023, until January 31, 2026. This enables people to possess and consume MDMA without fear of prosecution; however, procurement remains illegal, and poisoned drug supply remains a significant risk. Finally, in February of this year, the Special Joint Committee on Medical Assisted in Dying (MAiD), issued recommendations around accessing MAiD for mental distress, specifically encouraging removing barriers to promising novel treatments such as psilocybin therapy (Garneau & Martin, 2023).

Despite advances, there is still a large gap between public demand and legal avenues for safely using psychedelic medicines. The growing divide is leading more people to procure substances in the unregulated market, and to seek out unregulated providers that are willing, and perhaps even feel ethically compelled, to provide therapeutic support (Livne et al., 2022).

Legal Access Options for Psychedelic Substances

Amid the increasing acceptance of psychedelic substances, the reduced fear of legal repercussions, and extremely limited regulated access, the availability of MDMA and other psychedelic substances through illegal channels has become widespread. A simple internet search yields numerous websites that offer to send these substances by mail (Third Wave, 2023). Additionally, individuals can acquire them through word-of-mouth contacts or by seeking out areas known for street sales (Daily Hive, 2023). It is important to note that purchasing these substances from illegitimate sources or legitimate storefronts for recreational use remains illegal in most jurisdictions, emphasizing the need for responsible and legal access options.

Section 56 Exemptions

Section 56.1 Exemptions can be granted for individuals, groups at specific addresses, or for specific substances, all subject to specific conditions. Presently, there are exemptions for safe injection sites at government-sanctioned locations and, specifically for MDMA, a Section 56.1 exemption in place for personal use throughout the entire province of BC, covering small amounts.

To operate legally, safe injection sites require a Section 56.1 Exemption to the CDSA, from Health Canada. Canada began using this exemption in 2003 to sanction safe consumption sites, an important step in acknowledging the importance of providing professional medical care and harm reduction services. In 2008, the Minister of Health chose not to renew an exemption for an operational injection site, leading to a Supreme Court of Canada (SCC) trial, which determined that it was illegal to withhold the exemption, based on a violation of rights to liberty of the staff and the right to life and security of the users (Canada (Attorney General) v. PHS Community Services Society, 2011).

Individuals can apply for a Section 56.1 Exemption, through their primary care provider. This pathway provides a government-approved framework that promotes health and reduces risks associated with certain substances. However, Health Canada has granted only a limited number of these exemptions, choosing rather to redirect applicants to the SAP.

Under Section 56 exemptions, controlled substances can be used outside the regular legal framework for specific medical or scientific purposes, striking a balance between addressing health needs and mitigating risks related to these substances. Nevertheless, the scarcity of granted exemptions suggests that the process might not have been as accessible or widely applicable as hoped.

Finally, all people within the province of BC are covered under a Section 56.1 Exemption that allows for the possession of small amounts of MDMA and several other substances. The primary goal with all Section 56.1 Exemptions is to reduce stigma, encourage access to services and support, and promote safer practices. It acknowledges the complexities of substance use and aims to address these challenges with a focus on public health.

Providers operating within a harm reduction framework without government sanctioning should be aware that evidence of intentional and recurring misconduct may lead to legal prosecution and licensure complications (Pilecki, 2021; Smith & Tracy, 2021) . To safeguard the well-being of both patients and professionals we strongly advise potential providers to seek legal counsel, obtain appropriate liability coverage, and consult with their respective licensure boards. These precautions are vital for upholding professional standards, promoting safety, and maintaining the ethical integrity of their practice.

Special Access Program

As an alternative to Section 56 Exemption access, applicants are now being directed to the SAP, requiring healthcare practitioners to request access to drugs not readily available on the market, particularly for patients with serious or life-threatening conditions. At the time of this analysis, there have been 25 approved MDMA SAP requests, with 15 of them completed (Pharmala Webinar, October 4, 2023)

The current process presents significant equity challenges. Access to the program requires a primary care provider (PCP) to apply on behalf of the patient. SAP applications are significantly time consuming, and physicians receive no compensation for this time (personal communication, Dr Pam Kryskow). SAP requests often involve multiple rejections and reapplications, and there is a lack of clear and/or consistently applied rationale for the same (personal communication, Dr. Val Masuda & Dr. Pam Kryskow). A recent Angus Reid poll found that nearly 60% (or over three million) British Columbians find it difficult to access a doctor or have no access at all (Angus Reid, 2022). This limits access to PaT to those with privileged circumstances and resources (Carhart-Harris et al., 2021; Nutt et al., 2020).

Clinical Trials

Clinical trials can provide access to psychedelics, but only for a select few. Barriers to participation in trials have been extensively discussed in the literature, highlighting the following issues:

1. Limited availability and stringent eligibility criteria. Clinical trial eligibility often excludes those with severe mental health conditions (Griffiths et al., 2016; Ross et al., 2016), or comorbidities, both of which account for many Canadians deemed ‘treatment resistant’ to legally available options (Johnson et al., 2014; Davis et al., 2020; Mithoefer et al., 2011).
2. Cost – Geographic limitations. Research centers conducting these trials are often located in specific regions, creating barriers for individuals who do not reside nearby (Carhart-Harris et al., 2018). Participants may incur expenses related to travel, accommodation, and medical assessments, which can be prohibitive for individuals with limited financial resources (Bogenschutz et al., 2015). There are also huge costs associated with running a clinical trial which makes it difficult for most PaT clinics and centers, many of which are run as non-profits, to be able to provide access.
3. Lengthy screening processes (Wolff et al., 2019) and high demand for participation (MacLean et al., 2011).
4. Racial and ethnic minorities are underrepresented in clinical trials, which, despite a diverse population, are still composed of more than 90% white participants (Ma et al., 2021).
5. Pharmaceutical companies recoup the high costs of drug development through patents and the exclusive right to sales. Psychedelics in their natural form cannot be patented and are of limited interest to pharmaceutical companies, and not-for-profit organizations can rarely afford the high costs associated with clinical trials. Phase 2 studies can cost between $7.0 million to $19.6 million, while Phase 3 studies range from $11.5 million to $52.9 million (Sertkaya et al., 2016). A study of 59 clinical trials revealed a median cost of $19 million per study (Moore et al., 2018). In Canada, industry-sponsored trials had an average drug cost of 89,680 Canadian dollars per participant (Tran, Akpinar, & Jacobs, 2016). These exorbitant costs make clinical trials an impractical solution for mental health treatment.

These challenges contribute to the reality that many Canadians are seeking alternative, unregulated pathways to access psychedelic substances that are more accessible and inclusive.

Legal Landscape of MDMA

MDMA is categorized under Section 19 of Schedule 1 of the Controlled Drugs and Substances Act (CDSA) in Canada. Schedule 1 substances, as defined by Health Canada, are considered highly addictive and are associated with severe penalties. Notably, MDMA is placed within this strict classification, despite studies indicating the absence of neurotoxicity and enduring neurocognitive impairments when used in isolation, and when compared to other stimulants, particularly cocaine, amphetamine, and methamphetamine, MDMA exhibits a notably low potential for addiction (Sessa, Higbed, & Nutt, 2019).

Based on MDMA receiving breakthrough therapy designation for treatment of PTSD in the United States (FDA, 2017), becoming available by prescription in Australia (ADF, 2023), and the release of phase 3 clinical trial results and related media reports about it’s effectiveness, there is a global interest and recognition of its therapeutic potential (Mithoefer et al., 2021).

Considering the legal landscape, including the recent allowance for personal possession of MDMA in the province of BC, it is important to note that there are no inherent legal obstacles preventing the medical supervision of MDMA consumption for the purpose of reducing risks and promoting wellness. Activities including trafficking, importing/exporting, production, and possession for the purpose of trafficking MDMA would be beyond the province-wide exemption concerning the possession of small amounts of MDMA for personal use. However, it’s crucial to emphasize that any therapeutic use of MDMA must comply with established legal and regulatory procedures (Government of Canada, 2023b). Medical supervision within a regulated healthcare setting is essential to ensure patient safety and legal adherence, but there is very limited official guidance for practitioners providing such therapy.

By approaching psychedelic consumption responsibly and compassionately, we can highlight the potential benefits of MDMA use for therapeutic purposes while staying within the bounds of the law. This approach involves engaging qualified healthcare professionals who are well-versed in harm reduction principles and experienced in providing appropriate medical supervision during the therapeutic process.

An Adapted Safe Consumption Site Model

Safe consumption sites were established as a public health approach to addiction, reducing harms related to a toxic drug supply and unsafe substance use practices. They are sanctioned under a Section 56 Exemption umbrella, enabling possession and use of controlled substances within specific locations. Participants typically visit these sites without prior notice, often seeking assistance related to various aspects of addiction. Supervised consumption sites for the use of opioids are associated with decreased mortality rates (Kennedy, Karamouzian, & Kerr, 2017). There is no evidence to suggest that consumption sites contribute to an increase in drug use.

At Insite, Canada’s first, and oldest supervised consumption site, there have been 4.6 million visits for safe consumption since 2003, including over 11,000 overdoses reversed, over 71,000 referrals to service providers for access to healthcare and social supports, and there have been no reported overdose deaths (VCH, 2023). Supervised consumption sites are known to rebuild trust between regulatory services and marginalized populations, ultimately reconnecting citizens to safe care and, in some cases, saving lives.

From Opioids to Psychedelics

Historically, supervised consumption centers were primarily established to serve individuals with known opioid use. However, it’s crucial to clarify that the harm reduction approach advocated in this article exclusively pertains to psychedelic medicines, which, in contrast to common substances found at consumption sites such as opioids and stimulants, are not considered addictive. Argento et al. (2022) discovered that psychedelic use is linked to reduced daily opioid consumption among individuals who use criminalized drugs in Canada. Receptor pharmacology also suggests that the repeated use of psychedelics in close succession results in diminishing physiological effects, contributing to their non-addictive characteristics (Nichols, 2016). Nevertheless, the possibility of product contamination with opioids or concurrent use by patients still exists. This underscores the critical need for medical supervision when it comes to psychedelic use. This supervision should encompass on-site testing before consumption and the presence of well-trained medical staff equipped to respond to unforeseen events.

Legal Rationale for Safer Consumption

The right to medical care, enshrined in the Universal Declaration of Human Rights by the United Nations General Assembly in 1948, encompasses proper clinical supervision during therapeutic sessions. Extending this right to responsible users of psychedelic substances upholds principles of fairness and universal human rights, ensuring that individuals can access the therapeutic benefits of psychedelic consumption, in a safe and supportive environment, when conventional treatments prove ineffective. Recognizing the potential value of self-initiated PaT promotes patient choice and access to effective therapeutic options within a responsible and supervised framework.

The following are key considerations that support the legal rationale for implementing a harm reduction approach to ensure access to medical supervision for psychedelic consumption:

1. Inaccessibility of Clinical Care: Currently, the illegal status of MDMA renders clinical care for medically supported PaT unavailable for most within the existing medical system. Ethical and legal concerns often deter responsible therapists from providing this care (Zeifman & Wagner, 2019).
2. Need for Medical Exemption: A medical exemption for MDMA is necessary to grant individuals access to the medical supervision they are rightfully entitled to and protect responsible practitioners from legal exposure (Anderson & Liknaitzky, 2020). This exemption would create a regulated framework for safe and controlled therapeutic use.
3. Limitations of Health Canada’s Special Access Program (SAP): While the SAP exists for accessing MDMA, only one was granted in the first 6 months of 2023 (Pharmala, 2023), and as noted earlier, only 15 have been completed at the time of this writing (Pharmala Webinar, October 4, 2023). SAP applications require highly motivated physicians who are willing to volunteer hours of their time to complete applications and follow through with requests for further information and/or denials and re-applications. Currently there is a high frequency of rejections and a substantive lack of consistent rationale for rejection. These delays can result in clinical exacerbation of conditions (Dell’Osso et al., 2013).
4. Precedent Using Canadian Charter of Rights and Freedoms: Providing regulated medical supervision for the consumption of psychedelic substances in the current prohibitive environment is supported by Section 7 of the Canadian Charter of Rights and Freedoms, which guarantees the right to “life, liberty, and security of person” for all individuals. This argument draws parallels to landmark cannabis cases in Canadian courts, such as R v. Parker (2000 CanLII 5762), R v. Smith (2015, SCC 34 CanLII, 2 SCR 602), and Allard v. Canada (2016, FC 236 CanLII, 3 FCR 303). In these cases, the courts determined that the absolute prohibition of cannabis under the CDSA limited the liberty of medical users by denying them reasonable medical choices and forced them to choose between inadequate legal treatments and potentially more effective but illegal options (CDSA, SC 1996, c 19).
5. Extending Legal Reasoning to Psychedelic Consumption Support: Building upon these legal precedents, it can be argued that psychedelic medicines, such as MDMA, represent reasonable medical choices and potentially more effective treatments for individuals experiencing end-of-life distress and other conditions when other options have failed. The legal reasoning applied to cannabis can be extended to support the case for psychedelic substances, as both involve individuals seeking access to alternative treatments to alleviate their suffering.

The restriction on psychedelic medicines, despite their growing utilization in self-treating mental health conditions, curtails medical users’ freedom and denies them potentially superior options. This predicament compels individuals to decide between inadequate legal treatments and potentially beneficial but illegal alternatives, putting their well-being at risk and infringing upon their personal security. Drawing on principles applied in cannabis cases, it becomes reasonable to create a harm reduction pathway that facilitates medical supervision and safe access to these substances.

Scientific Rationale for Safer Consumption

Safety Profile

Psychedelics, including MDMA, are widely acknowledged for their relatively low physiological safety risk, even at high doses, with limited evidence of associated toxicity (Schlag et al., 2022). Clinical trials involving MDMA have consistently demonstrated its overall safety and tolerability among the majority of participants during MDMA-assisted therapy sessions (Mithoefer et al., 2021; Mitchell et al., 2021, 2023). Adverse effects typically linked to MDMA use are mild and temporary, encompassing increased heart rate, blood pressure, body temperature, and potential short-term impacts on mood and cognition (Bedi et al., 2010). Furthermore, regardless of whether used within a clinical context or not, the incidence of morbidity and mortality associated with MDMA is relatively low, even when compared to alcohol and tobacco (Nutt, 2009), underscoring its relative safety (Sessa, Higbed, & Nutt, 2019).

While MDMA has a favorable safety profile in and out of regulated contexts, responsible use should still be emphasized, favoring use in controlled settings under the guidance of trained professionals that can provide adequate medical supervision and therapeutic support. Individual responses to psychedelics can vary, with pre-existing medical conditions, mental health status, and environmental factors all impacting safety and the overall experience.

Psychological and Environmental Safety

In a survey of 2000 people examining the factors associated with distressing experiences using psychedelics, the greatest risks of harm came from a negative mindset, a lack of preparation, environmental challenges, and a lack of psychological support (Simonsson et al., 2023). In the same study, the most distressing experiences were associated with lack of preparation, negative mindset, lack of psychological support, a challenging social and physical environment, and inappropriate dosing. In a regulated care environment adhering to best practices for PaT, all these risk factors would be addressed to mitigate harm and distress. Considering the points mentioned above, unregulated access to psychedelic substances may be deemed appropriate under specific circumstances and certain criteria, including:

• Enduring and Debilitating Suffering: Patients must be experiencing severe and persistent suffering that significantly impacts their quality of life, and conventional treatments have proven ineffective in providing relief.
• Substantial Scientific Evidence: There should be compelling scientific evidence supporting the use of psychedelics, such as MDMA, as a potential treatment for the patient’s specific condition, demonstrating significant therapeutic benefits.
• Exhaustion of Conventional Treatments: Patients should have explored and exhausted all available conventional treatment options without achieving satisfactory results, making PaT a viable alternative with hopeful potential for symptom alleviation and overall well-being improvement.
• Limited Access to Regulated Pathways: In cases where patients face financial limitations or lack access to regulated pathways for PaT, unregulated access may be considered as a last resort to ensure they can access potential therapeutic benefits.
• Informed Decision-Making: Patients opting for psychedelic consumption should make informed decisions based on thorough research, considering the available evidence, potential risks, and benefits associated with such treatments.
• Aligned intentions and agreements: No matter how substances are procured, it’s important that there are clear intentions and agreements (i.e. terms of service, role clarity, etc.). When unclear, patients should be encouraged to seek guidance from the care team, ensuring their safety and well-being throughout the process.

Applying Harm Reduction Principles to Safer Psychedelic Consumption

The harm reduction approach for psychedelic consumption seeks to optimize therapeutic outcomes while minimizing potential risks for individuals who opt for psychedelic use. To achieve this, we align with core principles of harm reduction as outlined by the National Harm Reduction Coalition (2023). This framework guides our efforts, as we:

Accept the existence of both legal and illegal drug use in society and aim to reduce associated harm rather than ignoring or condemning it. Rather than downplaying or ignoring the real dangers associated with illicit drug use, seek ways to minimize harm and promote safety.

Recognize drug use as a multifaceted spectrum of behaviors and understand that some methods of use are safer than others. Acknowledge that social inequalities such as poverty, racism, and past trauma can impact both vulnerability to and capacity for addressing drug-related harm.

Prioritize the quality of life and well-being of individuals and communities as the ultimate goals of interventions and policies, without necessarily mandating total abstinence. Provide non-judgmental and non-coercive services and resources to people who use drugs and their communities to help them reduce harm.

Ensure that those served have a meaningful say in the development of programs and policies that serve them and take a lead in harm reduction efforts by sharing information and supporting each other based on their unique circumstances.

Building from the above framework, translated into programming action, a safe consumption site for psychedelic substances involves:

Meeting people where they are at: Harm reduction recognizes that individuals may already be engaging with psychedelic substances outside of therapeutic settings. By offering support and guidance within the context of a therapeutic relationship, harm reduction aims to minimize potential risks and maximize therapeutic benefits for those who choose to use psychedelics (Belser et al., 2017). Providing access, or at least not punishing those who find access on their own, aligns with harm reduction principles. ‘Underground’ PaT, which occurs due to the lack of legal channels, poses significant risks to patients regarding dosage, substance purity, safety, and the quality of practitioners. Legal availability of PaT conducted by qualified professionals can reduce these risks and ensure the well-being of patients (Schenberg, 2018).

Supportive environments and education: Engaging in psychedelic experiences without proper guidance can pose risks to individuals’ physical and psychological well-being. The harm reduction approach seeks to mitigate these risks by providing a supportive environment where therapists can offer education, safety guidelines, and harm reduction strategies. This can include discussions on testing, dosage, preparation, set and setting, and integration practices (Carhart-Harris & Goodwin, 2017).

Providing access to experience integration support: Harm reduction acknowledges that the use of psychedelics can be meaningful and potentially transformative for individuals. By incorporating the person’s own substance use into the therapeutic process, therapists can help patients explore and integrate their experiences into their overall well-being and personal growth (Belser et al., 2017).

Cultivating trust and therapeutic alliance: The harm reduction approach builds trust and fosters a strong therapeutic alliance between the therapist and the patient. By acknowledging and respecting an individual’s autonomy and choices, therapists work to create a non-judgmental space where patients feel safe to share their experiences openly and honestly (Belser et al., 2017). Therapeutic alliance has been shown to be one of the most salient factors in the effectiveness of therapy (Wampold, 2015).

Promoting accessibility and equity: Acknowledging the possibility that individuals may already have access to psychedelic substances, the harm reduction approach enhances accessibility to therapeutic benefits. It recognizes that conventional models of PaT, often reliant on investigational drugs or limited availability, can create barriers for certain populations. In response, harm reduction endeavors to offer support and guidance to a wider range of individuals who can potentially benefit from consuming psychedelic substances in a safe set and setting (Winkelman & Sessa, 2020). By adopting this inclusive strategy, harm reduction aims to ensure that therapeutic advantages are attainable to those in need, fostering a more equitable and accessible approach to PaT.

By integrating harm reduction principles, we will optimize outcomes and minimize the risk of harm. To ensure safe and effective practice in this evolving field, legislation and protocols must align with research and be embedded within proper ethical and legal frameworks. This would include ongoing research that informs the development of principles that serve as safeguards and professional standards (Garcia-Romeu et al., 2019; Hysek et al., 2014).

Safer Consumption Practices

In implementing the harm reduction approach for psychedelic substances, several aspects of care are important:

1. Screening and Assessment: Thorough intake protocols play a vital role in PaT, determining the balance between benefits and risks while prioritizing patient safety and well-being (Gasser et al., 2014; Carhart-Harris et al., 2018). These include assessment and evaluation of physical and mental health, allowing for the identification of contraindications and risk factors that may influence treatment outcomes.
2. Preparation and Education: Practitioners provide comprehensive education and preparation to patients, explaining the effects, potential risks, and benefits of consuming psychedelic substances. This helps patients develop realistic expectations, understand the process, and make informed decisions.
3. Safe (Mind)Set and Setting: Creating an appropriate mental / emotional focus and attitude and setting is crucial for ensuring a safe and supportive environment during the psychedelic experience. Practitioners carefully design the physical space, paying attention to factors such as lighting, comfort, and privacy. They also work with patients to cultivate a mindset conducive to therapeutic exploration and provide emotional support.
4. Dosage and Administration: Practitioners work with patients to determine appropriate dosage of MDMA based on available safety data and the individual’s needs and characteristics. They carefully advise on the administration of the substance, considering factors such as purity, potency, and method of ingestion, to ensure consistency and minimize potential risks.
5. Monitoring and Support: Throughout the session, practitioners closely monitor the patient’s physical and psychological well-being. They offer emotional support, guidance, and reassurance, helping patients navigate any challenging or potentially distressing experiences that may arise during the therapy.
6. Integration and Aftercare: Integration refers to the necessary psychological support following a psychedelic session to help patients process and make sense of their experiences and incorporate them into their daily life. This may include follow-up sessions, therapeutic discussions, and guidance on incorporating insights gained from the psychedelic experience into personal growth and well-being.

By implementing these aspects of care within the harm reduction approach, practitioners aim to ensure the safety, well-being, and therapeutic effectiveness of psychedelic consumption for individuals (Garcia-Romeu et al., 2019; Winkelman & Sessa, 2020). It’s important to note that the field of PaT and harm reduction is still evolving, and ongoing research is crucial to refine and improve these practices. Professional guidelines, training programs, and interdisciplinary collaborations are essential in providing a framework for safe and effective implementation of the harm reduction approach for psychedelic substances (Garcia-Romeu et al., 2019; Winkelman & Sessa, 2020).

MDMA Consumption Support

In this article, we propose that MDMA is a substance that could benefit from an adapted, medically supervised safe consumption model approach. The pharmacodynamic and pharmacokinetic properties of MDMA and other psychedelics are vastly different from that of opioids. MDMA, even in incredibly high doses, does not cause hypoxia or respiratory depression; however, in rare circumstances, it has been known to have cardiotoxic impacts (Kaye, Darke, & Durlou, 2009), and while no cases of serotonin syndrome have been reported in research trials of MDMA alone, there are reported cases when combined with other substances (Makunts et al, 2021). To this end, it is important that trained medical staff as well as medical supplies are required to review concurrent medication, screen properly for safety risks, and respond to signs of cardiotoxicity and respond accordingly.

For the medical supplies and training on site, depending on the substance being supported, a minimum number of adequately trained staff, with the necessary advanced practice skills should be required on site, mirroring safety standards in the regulatory environment. For example, in the case of MDMA consumption, medical staff with basic life support (BLS) and/or advanced cardiovascular life support (ACLS) training. ACLS supplies onsite include oxygen, bag valve mask, airways, resuscitation medications and AED.

Because the consumption site is for people with mental health conditions that are generally not imminently life threatening, a safe consumption site for MDMA consumption would de facto be operating as a supportive therapeutic environment where patients would be supported indoors in comfortable rooms with medical supervision and therapeutic support. Furthermore, they could be seen on an appointment basis, making it more feasible on a staffing front, and mitigating risks of loitering in the surrounding area.

Moving beyond a model centered on ‘survival’ toward an approach that promotes ‘thriving’, there are research-informed protocols that provide an MDMA support pathway that could be mirrored in a safe consumption model. In this way, translating knowledge from research to practice, we can reduce harm and promote wellness. To elaborate further, in randomized control studies there is proven safety and efficacy data when administering MDMA through a specific protocol for those suffering from acute PTSD symptoms compared with an inactive placebo, even in those with comorbidities (Mitchell et al., 2021, Mitchell et al., 2023), and even after 12 months post treatment (Jermone et al., 2020).

Whether MDMA is self-procured or prescribed, a similar protocolized process could be applied through a harm reduction approach, ensuring adequate medical supervision and therapeutic support, mirroring the process used in clinical research trials. Given the lack of data on the effects of ‘underground’ MDMA-assisted therapy (in unregulated environments with unregulated MDMA), an additional benefit to providing a regulated pathway for those self-procuring MDMA is the opportunity to capture real world data, enabling a better understanding of how clinical research results are translating in ‘real world’ settings.

Medical Supervision

When the harm reduction approach is operationalized through an adapted safe consumption site model, healthcare providers focus on education about risks and benefits, implementing safe supply or drug-testing measures, and ensuring qualified healthcare supervision. Such a harm reduction and wellness approach enable safe consumption within a regulated environment, respecting individuals’ autonomy and rights. It also acknowledges Indigenous communities’ autonomy to engage in medicine-assisted ceremonies without discrimination. Furthermore, it supports the well-being of healthcare providers by enabling them to practice in a regulated care setting, reducing personal safety and security risks.

Scope of Practice

In the realm of PaT, it is crucial for practitioners to adhere to their trained and credentialed scope of practice, even within an unregulated environment. The inclusion of team members with appropriate credentials becomes essential for ensuring safety and risk reduction. Here we examine the roles in PaT and their respective considerations:

• Therapists: Traditionally trained therapists should not engage in PaT without a team member who can provide medical monitoring and guidance surrounding administration of therapeutic substances.
• Registered Nurses: Nurses with adequate mental health training and experience can contribute to PaT by conducting medical assessments, monitoring patients, and they can provide the necessary safety guidance required for patients to safely self-administer medications. They bring expertise in both physical touch and an ability to ‘hold space’ in the presence of challenging events and emotions being experienced by the patient, which holds significance in the PaT context (Denis-Lalonde & Estefan, 2020; Penn et al., 2021).
• Medical Doctors: Although physicians possess the necessary license to fulfill all PaT roles, they may lack training and experience in the specific therapeutic approach suited to PaT. Given the duration of PaT sessions, it may not be financially viable to rely solely on physicians. Their involvement is best focused on medical oversight, screening, prescribing, and referrals for complex cases.
• Somatic Energy Therapists: Professionals trained and credentialed in working with the physical body and energy field play a crucial role in PaT. Given the non-ordinary states of consciousness involved, their expertise in somatic approaches becomes imperative for addressing the entirety of the human experience.

The inclusion of multidisciplinary team members ensures that the diverse needs of patients in PaT are effectively addressed, promoting comprehensive care and optimal outcomes.

Licensing Considerations for Medical Supervision

Agreeing to provide therapeutic supervision for individuals using self-procured substances necessitates a careful examination of both ethical and legal implications. In British Columbia, in the case of MDMA, the possession of MDMA for personal use is currently not subject to legal penalties. However, due to the absence of well-defined regulatory guidelines and the temporary nature of this exemption, healthcare providers find themselves operating in a legal gray area. Even if providers are not involved in the procurement or administration of psychedelics acquired illegally, the harm reduction approach may still carry legal and licensure risks if there is evidence of premeditated and recurring behavior (Pilecki, 2021; Smith & Tracy, 2021). In this section, we explore licensing considerations specifically for providers affiliated with professional oversight bodies. It is important to note, however, that not all allied health professionals are overseen by such bodies. Consequently, within the context of regulated healthcare, those lacking oversight by a professional body may need to seek supervision from a qualified professional who is subject to such oversight.

For registered therapists in BC, adherence to standards of practice and the code of ethical conduct is crucial. Considerations specific to therapists include:

1. Competence: Therapists should limit their practice to areas where they have gained proficiency through education, training, or experience (BCACC Code of Ethical Conduct, Section 2-7). It is essential for therapists to evaluate their competence through quality improvement and mentorship pathways as the field continues to evolve.
2. Boundaries: Therapists should establish and maintain appropriate professional boundaries (BCACC Code of Ethical Conduct, Section 2-1). When considering the supervision of psychedelic consumption with a patient-procured substance, therapists must assess the ethical implications and potential risks associated with crossing professional boundaries.
3. Non-Discrimination: Therapists should provide care without discrimination and ensure equitable access to services (BCACC Code of Ethical Conduct, Section 2-9). While PaT may hold potential benefits, therapists must consider the access barriers faced by individuals who do not have the resources or connections to legally access this form of therapy. Providing therapeutic supervision to those who have self-procured psychedelic substances may be seen as addressing the needs of a vulnerable and marginalized population.

For physicians, when considering the provision of medical supervision for psychedelic consumption with substances that are patient-procured, physicians in British Columbia should refer to the relevant practice standards and code of ethics. The following components from the Canadian Medical Association (CMA) Code of Ethics (2018) and the College of Physicians and Surgeons of British Columbia (CPSBC) standards and guidelines are particularly relevant:

CMA Code of Ethics (2018):

1. Article 1 – Primacy of Patient Welfare (providing medical supervision as a harm reduction approach): Physicians should consider the well-being of the patient and act to benefit the patient, promoting their good and preventing or minimizing harm.
2. Article 2 – Patient Autonomy (If deemed a competent adult, holding persons able to make medical decisions): Physicians should respect the autonomy of the patient and involve them in decision-making regarding their health.
3. Article 3 – Informed Consent: Physicians should provide information to enable patients to make informed decisions about their care, including material risks and benefits of treatment or intervention.
4. Article 8 – Resource Allocation (Addressing access barriers for those without the connections and resources to access the SAP process or clinical trials): Physicians should promote equitable access to healthcare resources and stewardship of resources.

CPSBC Standards and Guidelines:

1. Access to Care Without Discrimination (Considering equity related to those self-procuring psychedelic substances for the purpose of alleviating suffering, and for whom legal options are infeasible to access or have failed): Physicians should provide care without discrimination, ensuring equitable access to services for all patients.
2. Professionalism: Physicians should adhere to ethical standards, maintaining professional boundaries, and respecting the rights and dignity of patients.
3. Scope of Practice (Ensuring physicians have obtained credible education to justify competency in PaT supervision): Physicians should practice within their authorized scope, ensuring they have the necessary knowledge, skills, and competence to provide appropriate care.
4. Respectful and Culturally Safe Care (Indigenous Sovereignty – enabling use of traditional plant medicines): Physicians should provide care that is respectful, culturally safe, and sensitive to the needs and values of diverse patient populations.

Registered nurses (RN)/registered psychiatric nurses (RPN). For RN/RPNs in BC, adherence to the standards set by the British Columbia College of Nurses and Midwives (BCCNM) is essential. When considering the provision of medical supervision for PaT with patient-procured substances, nurses should carefully assess their formal training and related competence, ensure they are practicing within their authorized scope, and maintain ethical standards and professional boundaries. It is important for nurses to prioritize patient well-being, respect patient autonomy, and collaborate with other healthcare professionals to ensure the best possible care for their patients. The following standards are particularly relevant when considering the provision of medical supervision for PaT with patient-procured substances:

1. Professional Responsibility and Accountability: Nurses have a professional responsibility to provide safe, competent, and ethical care. This includes adhering to legal and regulatory requirements related to the practice of nursing (BCCNM, 2023d).
2. Ethical Practice: Nurses are expected to uphold ethical principles in their practice (BCCNM, 2023b). This includes promoting the well-being of patients, respecting patient autonomy, maintaining professional boundaries, and ensuring non-discrimination in the provision of care (CNA, 2017).
3. Scope of Practice: Nurses must practice within their authorized scope and area of competence. This means that nurses should only provide care and interventions for which they have the necessary knowledge, skills, and competence (BCCNM, 2023c; BCCNM, 2023d).
4. Collaborative Practice: Nurses should collaborate with patients, families, and other healthcare professionals to provide safe and effective care. This includes communicating effectively, seeking consultation when necessary, and ensuring appropriate referrals to other healthcare providers (BCCNM, 2023a).

It is essential for other healthcare providers to familiarize themselves with their respective licensing board’s ethical requirements and carefully consider how colleagues and local law enforcement may perceive the advertising of services related to psychedelic consumption. Early engagement with local law enforcement and seeking guidance from a criminal defense attorney can provide valuable insights and ensure compliance with applicable laws and regulations.

Evidence-Informed Best Practice, Risks and Benefits

Being well-informed about the scientific evidence regarding psychedelics is crucial for therapists when discussing these substances with patients. This knowledge allows therapists to avoid making exaggerated or unrealistic claims, especially considering mainstream media portrayals of psychedelics as miracle cures or ‘groundbreaking’ treatments. By having a solid understanding of the scientific literature, therapists can provide scientifically accurate information which will include clear explanation of potentially negative side effects, ensuring discussions are evidence-based, and managing patients’ expectations appropriately (Pilecki et al., 2021).

Practice Supervision and Interdisciplinary Teams

PaT providers must work in multidisciplinary teams and should actively engage in clinical supervision and interdisciplinary consultation groups (Barrett et al., 2021). This collaborative approach is essential for maintaining the quality of care, enhancing professional competence, and mitigating potential risks. These collaborative practices contribute to ongoing professional development, the sharing of best practices, and the ethical delivery of care.

Clinical supervision is a fundamental practice in the field of psychotherapy and counseling, ensuring the continuous growth and accountability of therapists (APA, 2020; CCPA, 2018). This process involves mentorship and oversight by experienced therapists, offering invaluable guidance, support, and a dedicated space for critical self-reflection on clinical practice (Milne, 2007). Supervision plays a pivotal role in ongoing professional development and serves as a mechanism to uphold ethical guidelines and best practices in therapy (Bernard & Goodyear, 2018). For practitioners engaged in PaT, supervision is particularly crucial, given the added complexities of clients navigating non-ordinary states of consciousness. Engaging in supervision empowers PaT providers to receive constructive feedback, gain fresh perspectives, and effectively navigate the challenges and ethical dilemmas that may emerge during their work (Yalom & Leszcz, 2005). This supervisory process can occur through direct observation and recording of sessions, which can be later reviewed for training and development purposes (Holloway & Neufeldt, 2019).

Access to interdisciplinary consultation enhances the therapeutic process by incorporating expertise from various fields, including energy medicine, psychiatry, psychology, neuroscience, nursing, and social work. This diverse collaboration enables providers to consider both medical and psychological aspects, promoting holistic care and improving the safety and effectiveness of PaT. Multidisciplinary consultation serves as a platform for therapists to discuss complex cases, seek treatment advice, and prioritize patient well-being. Furthermore, it facilitates knowledge exchange, experience sharing, and staying up to date with the latest research in PaT. For instance, Vancouver Island University’s Psychedelic-assisted Therapy Graduate Certificate (PATGC) program offers ongoing consultation groups for its graduates. In a landscape where practitioners often lack comprehensive guidance and infrastructure, these collaborative efforts become vital to ensure safety standards are consistent in the advancement of the field. By actively engaging in therapy supervision and seeking multidisciplinary consultation, therapists demonstrate their commitment to continuous learning, professional growth, and providing the highest standard of care to their patients.

Never Work Alone

In the context of psychedelic consumption, it is crucial to have at least two trained providers involved in the process. Having two practitioners present helps create a system of checks and balances that offers protection to all parties involved. It provides additional oversight and accountability, reducing the risk of potential ethical transgressions and ensuring the well-being of both the patients and the therapists themselves. It can provide a third-party witness in situations where allegations of unethical behavior arise or when concerns regarding professional conduct emerge and can contribute to a more productive resolution process. Having two practitioners present also helps to establish a professional boundary, maintain appropriate therapeutic relationships, and minimize the likelihood of boundary violations. It also allows for ongoing collaboration and consultation within the PaT team. Practitioners can share insights, perspectives, and knowledge, enhancing the quality of care and decision-making. This collaboration helps ensure that therapeutic interventions are well-informed, evidence-based, and considerate of the diverse needs of patients.

Composition and Dosage of Substances

Providers must take measures to mitigate the risk of contaminated substances, which has become a growing problem in Canada. Studies have highlighted the need for accurate identification of adulterants, such as fentanyl. Testing purity and potency are imperative to protect patients from accidentally overdosing or consuming a contaminated supply (Carhart-Harris et al., 2018; Johnson et al., 2014; Palamar et al., 2020). Medical supervision includes assurance that substances are free from toxic additives such as fentanyl and various stimulants and are taken at appropriate dosages. It ensures that providers can indirectly support safe procurement and ingestion without directly handling or procuring the substances themselves (Winstock et al., 2019).

Many point-of-care drug checking devices are readily accessible and can accurately detect if fentanyl is present (Green et al., 2020). These services could be provided on-site or distributed for take-home use. However, research suggests that drug checking conducted in a laboratory by qualified staff is the most effective way to reduce medical risks associated with the use of drugs that may be adulterated or contaminated with harmful substances (Measham, 2019). This highlights the importance of relying on professional drug checking services for accurate and reliable information (Measham, 2019).

Access to Testing Services

A study by Barratt et al. (2019) examined the efficacy of on-site drug checking services in identifying harmful adulterants in MDMA. They found that such services could play a crucial role in harm reduction by providing real-time information on the composition of criminalized substances. These services often employ techniques like reagent testing, spectrometry, or chromatography to detect adulterants, contaminants, and can identify incorrect dosages. Drug testing facilities typically utilize Fourier Transform Infrared Spectroscopy (FTIR) as a reliable and accurate option for identifying the composition of substances. This technique can help detect the presence of contaminants, adulterants, or toxic compounds. These facilities may also use fentanyl test strips, which can quickly indicate its presence in a substance.

Drug testing centres that offer free access to highly sensitive drug testing services are available in most major cities. For those in remote locations, in Canada, there is a national mailing service that is free of charge, which allows small samples of substances to be sent by mail. Results are returned via email (Get Your Drugs Tested, 2023; Substance Drug Testing, 2023).

Those providing PaT to individuals who have self-procured psychedelic substances can offer on-site FTIR testing services to verify the composition and purity of the substances, or if not feasible, should require patients to provide documentation demonstrating the substance has been adequately tested by a reputable testing service.

Mitigating Liability Related to a Safer Consumption Approach

Understanding the risks associated with potential criminal charges is crucial for individuals who choose not to adhere to a government-sanctioned pathway. Research on underground PaT has shed light on the dangers of operating outside legal channels, emphasizing the importance of providers working within established frameworks (Khey & Campbell, 2017).

The legal process typically involves law enforcement submitting criminal charges, which may be open to interpretation by the arresting officer. The Crown then evaluates these charges for approval, considering factors like the likelihood of conviction and public interest before the case proceeds to court.

Violating drug laws, such as the CDSA and the Food and Drug Act/Regulations (FDA/FDR), can expose medical professionals to charges related to drug laws or regulations, potentially leading to legal consequences such as fines, imprisonment, or other penalties. It is crucial for individuals to be fully aware of these potential consequences when engaging in activities outside sanctioned pathways.

These potential legal liabilities may include charges related to:

• Procuring, possessing, or trafficking criminalized substances (elaborated on below)
• Conspiracy (elaborated on below)
• Criminal Negligence causing bodily harm.

Furthermore, medical professionals providing supervision and therapy support to individuals who are self-procuring and self-administering substances without proper authorization or exemptions could potentially face legal liabilities. These potential legal liabilities include:

• Professional misconduct: Medical professionals who knowingly assist or enable patients in engaging in illegal activities, such as self-procuring and self-administering MDMA without authorization, may be subject to charges of professional misconduct. This could involve violations of professional ethics or regulations governing their practice.
• Licensing and regulatory violations: Medical professionals are typically bound by licensing requirements and regulatory frameworks. Engaging in activities that contravene these requirements, such as providing medical supervision for unauthorized use of MDMA, may result in disciplinary actions, suspension, or revocation of licenses.
• Civil liabilities: If a patient experiences adverse health effects or causes harm to others while under the influence of self-administered MDMA with the support of medical professionals, there may be civil liabilities for both the individuals involved and the medical professionals who provided supervision and support. This could lead to civil lawsuits seeking compensation for damage or injuries caused. In such cases, a liability waiver may help limit liability, but legal consequences may still arise.

Given these potential legal risks, it is crucial for medical professionals to exercise extreme caution and strictly adhere to legal and ethical guidelines when considering providing PaT with patients who are self-procuring and self-administering substances without proper authorization. Seeking legal advice and understanding the implications of their actions can help safeguard medical professionals from potential legal liabilities and protect the well-being of their patients.

Procuring, Possessing, and/or Trafficking Charges

The illegal status of access to psychedelics is at odds with the ethical responsibility of medical professionals to reduce the risk of patient harm. Procuring, possessing, and/or trafficking criminalized substances in Canada can result in various charges under the CDSA. Here is a brief overview of these charges:

• Possession: Under the CDSA, possession refers to having control or custody of a controlled substance. Possession means possession within the meaning of subsection 4(3) of the Criminal Code. Possession charges can apply if an individual has criminalized psychedelic substances in their possession, whether it be physically on their person or in their control, such as in their home or vehicle.
• Possession for the purpose of trafficking: Under the CDSA possession for the purpose of trafficking is contrary to Section 5(2) of the CDSA. The severity of the charges may depend on factors such as the quantity of substances and the individual’s intent (e.g., personal use or possession with the intent to distribute). Penalties for possession offenses can include fines, imprisonment, or both.
• Procuring: Procuring refers to obtaining or acquiring controlled substances, which can include activities like buying, acquiring, or obtaining them through various means. Procuring charges can apply to individuals involved in the process of obtaining criminalized psychedelic substances, even if they are not the ultimate end-user. Penalties for procuring offenses can also include fines, imprisonment, or a combination of both, depending on the circumstances.
• Trafficking: Under Section 5(1) of the CDSA in Canada, trafficking is defined as the “selling, administering, giving, transferring, transporting, sending or delivering the substance, or offering to do anything mentioned.” Therefore, any actions that involve the intentional transfer or movement of psychedelic substances to others, whether through physical exchange or other means of delivery, can potentially lead to a trafficking charge. The severity of the charges may depend on factors such as the quantity of substances involved, the individual’s role in the operation, and their previous criminal history. Penalties for trafficking offenses can include fines, imprisonment, or a combination of both.

It is essential to refrain from facilitating procurement and/or possession of unregulated psychedelic substances to uphold the requirements of the regulated care environment, maintain professional boundaries, and avoid potential legal ramifications (Barrett et al., 2021). Instead, healthcare providers can play a valuable role by sharing information, directing patients to appropriate authorities for guidance, and referring patients to organizations that promote safe supply (Carhart-Harris et al., 2018), enabling healthcare providers to fulfill their responsibilities while prioritizing patient safety and well-being.

Conspiracy Charges: Counseling and Encouraging Use

Under Section 21 of the Criminal Code of Canada, the principle of party liability establishes the accountability of individuals involved in the commission of a criminal offense, regardless of whether they directly committed it. Party liability can be attributed through three main avenues:

• Actual Commission: If an individual physically carries out the criminal act, they can be considered a party to the offense.
• Aiding and Abetting: Individuals who assist the offender in any manner, facilitating the commission of the offense, can also be held accountable.
• Abetting: Encouraging or instigating another person to commit the offense can make one a party to the crime.

According to Section 21(1) of the Criminal Code, anyone who aids, abets, or takes actions to assist or encourage another person in committing an offense can be deemed a party to that offense. Aiding and abetting involve actions that help the perpetrator, while abetting includes activities like encouraging, instigating, promoting, or procuring the commission of the crime. It’s essential for individuals to be aware of these legal implications, as being a party to an offense can lead to criminal charges and consequences under Canadian law.

Moreover, Section 22(1) of the Criminal Code outlines the concept of shared criminal intention, stating that if two or more individuals collaborate to pursue an unlawful purpose and assist each other in doing so, all those involved are considered parties to any offenses committed during the pursuit of that purpose. It doesn’t matter if only one of them actually carries out the offense; everyone who knew or should have known that the offense would likely result from their collective actions is held accountable for it.

In addition, Section 22(2) specifies that anyone who counsels another person to be a party to an offense becomes a party to every offense committed by the person they counseled if it was known or should have been known that those offenses were likely to be committed. The term “counsel” encompasses those who procure, solicit, or incite, as defined in Section 22(3) of the Criminal Code. This means that individuals who encourage or incite others to commit offenses are equally responsible for those offenses.

These provisions emphasize the importance of being cautious and mindful of one’s actions, as collaboration in criminal activities or counseling others to engage in unlawful acts can lead to shared responsibility for the resulting offenses under Canadian law. Therefore, it is essential for healthcare providers to be fully aware of their legal responsibilities and ensure that they do not engage in activities that could be construed as aiding, abetting, or counseling the possession or use of illegal substances (Tobin, 2016).

Respecting Autonomy of Individuals to Make their own Decisions

Respecting autonomy and allowing patients to make their own decisions is a crucial aspect of therapy, as outlined in both the BCACC Code of Ethical Conduct and the CNA Code of Ethics for Registered Nurses. This promotes self-efficacy and self-responsibility, and ultimately affirms a person’s right to be informed and make autonomous decisions. It is important to convey understanding and respect for the patient’s decision while not endorsing illegal behavior. Consistency in communication is essential.

Section 7 of the Canadian Charter of Rights and Freedoms ensures personal autonomy in healthcare decisions and safeguards individuals from overly restrictive regulatory schemes. This right has been upheld in court cases like R. v. Parker (2000), R. v. Smith (2015), and Allard v. Canada (2016), which recognized the infringement on personal liberty and security caused by criminal prohibitions, leading to the approval of growing medical cannabis as an alternative to government-approved sources. Drawing parallels from these cases, individuals seeking PaT for treatment-resistant psychological conditions may also argue for a constitutional exemption to the Criminal Code provisions regarding psychedelics. To make their case, they would need to demonstrate the reasonableness of PaT as a valid medical choice within the framework of Section 7 of the Charter.

Clear Roles and Boundaries

To ensure compliance with legal requirements and minimize potential issues, it is essential to establish clear boundaries:

– The healthcare provider must refrain from supplying or administering psychedelic substances.

-The healthcare provider must not facilitate the ingestion of such substances.

– The patient should sign a statement acknowledging these boundaries and their commitment to adhere to them (e.g., terms of service).

– Including a waiver of liability in cases where the service is not adequately insured is advisable.

– Informed consent from the patient is imperative.

Understanding legal precedents is crucial when considering potential challenges. In Canada, the Canadian Charter of Rights and Freedoms, particularly Section 7, guarantees personal autonomy in healthcare decisions and protects individuals from overly restrictive regulatory schemes.

Similar to nurses offering medical oversight at safe consumption sites, supervised psychedelic experiences could also reduce the risk of adverse effects. Maintaining the healthcare provider’s role in guiding a psychedelic session would respect the patient’s autonomy, while remaining ethically and professionally sound.  As with other substances, patients and practitioners engaged in PaT would be safe from prosecution if possessing a psychedelic substance for therapy purposes.

A Concluding Call to Action

With increasing access to psychedelic substances, a growing body of positive research, and with many remaining ‘treatment resistant’ to mainstream treatments, Canadians will increasingly turn to unregulated care pathways. This speaks to the urgent need for a public health strategy that prioritizes patient wellness and harm reduction. Decriminalization and access to safe supply are important first steps. Next, is the need for standardized best-practices care protocols, with training programmes that build competence working in this unique landscape.

Sharing our experience, successes and challenges could inform policy, also providing a bridge for healthcare providers transitioning from underground to regulated care settings.  It is imperative that we support equitable access, with client-friendly and evidence-based policies and protocols.

At this time of unprecedented mental unwellness, we should support novel treatments with demonstrated positive outcomes.  All publicly funded treatments should demonstrate tangible efficacy and efficiency, justifying the resources allocated. With our mainstream therapy modalities–pharmacology and individual talk therapy–failing so many, we need to respect the person’s agency and their right to choose.

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