Psychedelic Medicines 2024 Comparisons

In Canada, psychedelic substances are regulated under three primary laws: the Cannabis Act, the Controlled Drugs and Substances Act (CDSA), and the Food and Drugs Act (FDA). While cannabis is fully legal for adult use, other psychedelics like psilocybin, LSD, DMT, and MDMA remain illegal under the CDSA, except in specific cases where exemptions are granted under Section 56 of the CDSA or through Health Canada’s Special Access Program (SAP). These programmes allow for limited, compassionate access to psychedelics for medical or scientific purposes, particularly for patients with serious or life-threatening conditions. However, the process is highly restrictive, with most applicants facing significant hurdles, including time-consuming applications and frequent rejections, limiting broader access to these substances. Additionally, British Columbia has decriminalised small-scale possession of MDMA and other substances as part of a harm reduction initiative.

In Canada, several regulatory bodies are responsible for enforcing the laws governing medical psychedelics:

• Health Canada: This federal agency oversees the enforcement of the CDSA and the Food and FDA. Health Canada manages the SAP, which provides compassionate access to restricted substances like psilocybin and MDMA for medical use in serious or life-threatening conditions. Health Canada also grants Section 56 exemptions for medical or scientific purposes, allowing controlled use of otherwise illegal substances.
• Provincial health authorities: These bodies ensure that medical professionals comply with provincial health regulations, particularly regarding patient care and prescription practices. They work in conjunction with Health Canada to ensure that psychedelic therapies, when permitted, meet medical and ethical standards.
• Law enforcement agencies: Local and federal law enforcement, such as the Royal Canadian Mounted Police (RCMP) and municipal/provincial police, are responsible for ensuring compliance with federal and provincial drug laws. Their scope includes investigating illegal activities such as unauthorised sale or distribution of psychedelics and enforcing regulations around medical exemptions and legal dispensaries.
• Canada Border Services Agency (CBSA): CBSA regulates the import and export of controlled substances under the CDSA. They ensure that psychedelic substances crossing Canadian borders comply with legal exemptions and permits, including those for scientific or medical research.

Each of these bodies plays a role in ensuring that the medical use of psychedelics is carefully regulated, balancing access to therapies with public safety and legal compliance.

Currently, Canada does not have a formal self-regulatory authority specifically governing the psychedelic medicine industry or psychedelic trials. However, several organisations play influential roles in shaping standards and practices for the emerging psychedelic field:

• Multidisciplinary Association for Psychedelic Studies Canada (MAPS Canada): Although not a regulatory body, MAPS is a prominent non-profit organisation involved in funding and conducting psychedelic research, particularly for MDMA-assisted therapy. MAPS Canada works closely with regulators like Health Canada to ensure compliance with research standards and advocates for the integration of psychedelics into medical practices.
• Psychedelic Association of Canada (PAC): The PAC acts as a hub for professionals, researchers, and advocates in the psychedelic space. It promotes ethical practices, harm reduction, and public education. While the PAC has no direct regulatory authority, it influences the self-regulation of the industry by promoting responsible use and working to develop industry standards.
• TheraPsil: Another non-profit organisation, TheraPsil focuses on advocating for access to psilocybin-assisted therapy, primarily for patients in palliative care. While not a regulator, TheraPsil helps guide healthcare professionals and patients in navigating the complex legal landscape surrounding psychedelic therapy through training and advocacy.

• Roots to Thrive: Canada’s first multidisciplinary, non-profit healthcare practice offering evidence-informed, multi-week group therapy programmes, including ketamine-assisted therapy. Guided by principles of trauma-informed practice, anti-racism, health promotion, and holistic care, Roots to Thrive tackles the root causes of illness and reduces stigma while fostering interconnectedness and spiritual health.

These organisations help foster best practices and ethical frameworks within the psychedelic medicine industry, advocating for safe and effective use of psychedelics, but they operate within the larger framework of Canadian law, without formal regulatory power.

In Canada, the market for psychedelic substances is still emerging and operates largely in a grey area, with legal access limited to clinical trials, compassionate use through Health Canada’s SAP, and exemptions under Section 56 of the CDSA. There is no fully legalised market for psychedelics like there is for cannabis, but certain activities indicate a growing interest in both medical and underground markets.

• Medical market: Legally, the medical market is focused on clinical trials and highly regulated programs like the SAP. Patients with serious or life-threatening conditions can apply through their healthcare provider for limited access to psychedelics such as psilocybin or MDMA for therapeutic purposes. However, the process is cumbersome, and access is restricted, limiting the size of the formal medical market.
• Underground and illegal market: Despite the legal restrictions, there has been a rapid growth of illegal psychedelic dispensaries, particularly in cities like Vancouver and Toronto. These stores openly sell products like psilocybin in the form of mushrooms, edibles, and other formulations, often packaged in sleek, consumer-friendly ways. While these dispensaries operate illegally, local law enforcement in some areas has taken a relatively hands-off approach, allowing the market to expand despite the legal risks.
• Psychedelic retreats and clinics: Though not a widespread market yet, Canada is seeing a rise in clinics and retreats offering ketamine-assisted therapy, which is legal for medical use. These clinics are often part of the broader mental health treatment sector and reflect growing consumer demand for psychedelic-based therapies. As other psychedelics like psilocybin and MDMA move through clinical trials, there is potential for this segment of the market to expand significantly.

Overall, while the legal psychedelic market is still in its infancy and restricted to tightly controlled medical uses, an underground market is flourishing in parallel. This dual-market dynamic suggests increasing demand for psychedelic therapies and products, with the potential for significant growth if further legal reforms are enacted.

Market participants in the psychedelic industry in Canada face several notable challenges, primarily due to the complex and evolving legal landscape. Here are the key legal risks and challenges companies should consider:

• Regulatory uncertainty: The legal status of most psychedelics, such as psilocybin, LSD, and MDMA, remains highly restricted under the CDSA. Access is typically only granted through Health Canada’s SAP or Section 56 exemptions for medical or scientific purposes. Companies attempting to engage in clinical research, production, or distribution must navigate a complex and often slow regulatory approval process. The lack of clear pathways for broader commercialisation makes long-term planning difficult.
• Enforcement risk: While certain cities (like Vancouver) have seen lenient enforcement regarding illegal psychedelic dispensaries, these operations remain fully illegal under federal law. Participants in the underground market risk raids, asset seizures, fines, and criminal charges. Law enforcement’s inconsistent approach across jurisdictions further complicates matters, creating unpredictability in how laws will be enforced.
• Compliance with Health Canada: For companies involved in clinical trials or legal psychedelic therapies, strict adherence to Health Canada’s regulations is critical. This includes obtaining appropriate licenses, maintaining high standards of safety, and following protocols for drug production, distribution, and patient treatment. Non-compliance can result in the suspension of trials, fines, and other penalties, as well as reputational damage.
• Limited access to capital and banking services: Due to the legal uncertainty surrounding psychedelics, many financial institutions are hesitant to work with companies in this sector. This limits access to banking services, loans, and investment capital. Similar challenges were faced by the cannabis industry in its early stages, where companies struggled to secure funding from traditional financial institutions.
• Intellectual property and patents: Since many psychedelic substances, especially in their natural forms (eg, psilocybin mushrooms), cannot be patented, companies face challenges in securing intellectual property protection. This limits their ability to create competitive advantages through proprietary formulations or therapies. Companies investing heavily in research and development may struggle to recoup their costs without strong IP protections.
• Public and market perception: Psychedelics are still heavily stigmatised in some sectors of society, and companies entering this market face reputational risks. Public opinion can influence regulatory decisions and consumer demand, making it important for companies to engage in educational and advocacy efforts to promote the therapeutic benefits of psychedelics and counter negative stereotypes.
• Ethical and legal responsibility in treatment settings: Clinics offering legal psychedelic therapies (such as ketamine) must navigate ethical challenges, including ensuring proper screening of patients, providing adequate supervision, and mitigating risks of adverse reactions. Failure to uphold high standards of care could lead to legal liabilities, including malpractice claims.

In conclusion, companies in the psychedelic industry must be aware of the legal risks involved, from navigating complex regulatory frameworks to managing reputational and financial challenges. Careful planning, compliance, and legal counsel are essential for operating safely and successfully in this emerging sector.

Cross-jurisdictional issues are common in the emerging psychedelic industry due to the varying legal frameworks across different regions. Some of the key challenges include:

• Inconsistent legal status of psychedelics: In Canada, psychedelics like psilocybin and MDMA are illegal under the CDSA, except under specific exemptions for medical or research purposes. Meanwhile, in other countries, particularly in parts of the USA such as Oregon and Colorado, psychedelics are legal or decriminalised for medical or therapeutic use. This creates complications for companies operating across borders, as substances legal in one jurisdiction may be strictly prohibited in another.
• Cross-border research and clinical trials: Companies conducting research on psychedelics often face challenges when collaborating internationally. Different countries have varying requirements for the approval of clinical trials and the transportation of controlled substances. Canadian companies seeking to participate in global research initiatives must navigate these regulatory differences, which can cause delays or restrict collaboration.
• Import and export of psychedelic substances: The transportation of psychedelic substances across borders is strictly regulated, and in many cases, prohibited without specific permits. Even for research purposes, companies face complex import/export regulations, both in Canada and in other countries. Non-compliance can result in significant legal consequences, including fines, seizures, and criminal charges.
• Banking and financial services: Due to the different legal statuses of psychedelics in various jurisdictions, many financial institutions are reluctant to provide services to companies operating in this space. For example, a company in Canada may struggle to access banking or investment services if its operations involve jurisdictions where psychedelics are still heavily restricted, such as in the USA. This can limit cross-border growth and investment opportunities.
• Intellectual property and patent protection: The legal protections for psychedelic-related intellectual property vary widely across jurisdictions. Some countries do not allow the patenting of natural psychedelic compounds, while others offer more robust protections. This creates difficulties for companies trying to safeguard their innovations across borders, especially when operating in multiple countries with different IP laws.
• Varying enforcement approaches: Even within Canada, enforcement of psychedelic laws differs by city and province, and this is amplified internationally. For instance, while some Canadian cities like Vancouver are lenient toward illegal psilocybin dispensaries, other jurisdictions strictly enforce prohibition. Companies operating in multiple jurisdictions must be prepared for differing levels of enforcement and the associated legal risks.
• Ethical and medical standards: The standards for conducting psychedelic-assisted therapy vary widely across regions. For example, what is considered appropriate medical supervision in one country may differ in another. Companies offering psychedelic treatments across borders must ensure compliance with local medical, ethical, and regulatory standards, which can add complexity to their operations.

These cross-jurisdictional issues require companies to maintain a clear understanding of the legal landscape in each country or region where they operate, ensuring compliance with local regulations while managing the risks associated with operating in a highly fragmented and evolving industry.

Access to psychedelic medicines in Canada is influenced by the laws and progress of psychedelic regulations in other jurisdictions, particularly in the United States and other countries that are advancing in this space. Here are a few key ways this cross-border influence occurs:

• Clinical research and trials: Much of the research on psychedelics, especially MDMA and psilocybin, is being conducted internationally, notably in the USA through organisations like MAPS. Canada often looks to global clinical trial data and research outcomes to inform its own regulatory decisions. If another country demonstrates significant therapeutic benefits through studies or trials, it may encourage Health Canada to consider expanding access through its SAP or Section 56 exemptions.
• Regulatory precedents: Progress made in jurisdictions like Oregon, where psilocybin is now legal for therapeutic use, and Colorado, which is launching its medical psychedelics programme, can set important precedents for Canada. These developments abroad can build momentum for legal reforms domestically, especially if positive outcomes are observed. For example, as more US states decriminalise or regulate psychedelics, there may be increasing pressure on Canadian lawmakers to follow suit.
• Market and industry development: The success of legal markets in other countries, such as the legal psilocybin program in Oregon, can influence the economic and regulatory landscape in Canada. If other jurisdictions establish robust, regulated psychedelic markets, Canadian companies and advocates may push for similar changes to tap into international demand, fostering a more competitive and open market at home.
• Import of best practices: As other countries advance in legalising and regulating psychedelic therapies, Canada may adopt best practices from those jurisdictions. For instance, frameworks around the safe administration of psychedelics, such as training requirements for therapists or protocols for clinics, can be modelled on international successes and help shape Canadian regulations.
• Cross-border collaboration: Canadian researchers and companies often collaborate with international partners, particularly in countries with more advanced psychedelic regulations. These collaborations may drive innovation and influence Canadian policies by demonstrating the safety and efficacy of psychedelic therapies through international data. Access to international clinical trials or studies can also provide Canadian patients with early opportunities to benefit from psychedelic therapies under compassionate use frameworks.

In conclusion, while Canadian psychedelic laws remain restrictive, progress in other jurisdictions – particularly in the USA and Europe – can have a significant impact on regulatory discussions, research, and eventual access to psychedelic medicines in Canada.

In Canada, access to medical psychedelics is primarily governed by the CDSA, the FDA, and Health Canada’s regulatory frameworks. Several key legal elements impact access to medical psychedelics:

• Prohibition under the CDSA: Most psychedelics, including psilocybin, LSD, DMT, and MDMA, are classified as illegal under the CDSA. This prohibits their possession, production, and distribution unless authorised under specific exemptions. Medical access is limited to Health Canada’s SAP and Section 56 exemptions, which allow the use of controlled substances for patients with serious or life-threatening conditions and for scientific research.
• SAP: The SAP allows healthcare practitioners to request access to otherwise unavailable drugs, including psychedelics, for compassionate reasons. However, the process is slow, restrictive, and only available in exceptional circumstances. The limited nature of SAP approvals means that access remains tightly controlled and available to a small number of patients.
• Section 56 exemptions: These exemptions allow individuals, groups, or researchers to legally use psychedelics for medical or scientific purposes. While Health Canada has granted some exemptions for clinical trials and individual therapies, they are issued sparingly, and the process can be bureaucratic and time-consuming.
• Clinical trials: Access to psychedelics is also possible through participation in clinical trials. However, these trials are limited in scope and availability, making this pathway inaccessible to the broader population. Approval for new trials requires extensive regulatory compliance, further slowing the expansion of access.

Likelihood of Change

The likelihood of these legal elements changing is moderate, driven by a combination of scientific advancements, public pressure, and developments in other jurisdictions, especially in the USA.

• Growing advocacy and research: Increasing advocacy from organisations like MAPS and TheraPsil, combined with promising results from clinical trials on psychedelics’ therapeutic benefits, may push regulators to reconsider the current legal restrictions. With MDMA and psilocybin showing positive outcomes in treating PTSD and depression, the regulatory environment is becoming more favourable for expanded access.
• International influence: The progress of psychedelic regulation in places like Oregon and Colorado has set a precedent that may influence Canadian policymakers. As other countries and US states demonstrate the safe therapeutic use of psychedelics, there will be more pressure on Canada to align with international developments.
• Public and medical interest: Public opinion is slowly shifting in favour of therapeutic psychedelics, and the medical community’s growing interest in these treatments may spur regulatory change. However, given the cautious approach of Canadian regulators, any expansion in access will likely be incremental and tied to strict medical supervision.

Regulatory Agenda

The topic of medical psychedelics is increasingly gaining attention among Canadian regulators. While full legalisation or widespread medical access is not yet on the immediate agenda, the following developments suggest it is moving up the list of priorities:

• Senate report on veterans’ psychedelic therapy: In 2023, the Canadian Senate published a report advocating for more research into psychedelic-assisted therapies for veterans suffering from PTSD. This marks the first significant government recognition of the therapeutic potential of psychedelics.
• Increased research approvals: Health Canada is approving more clinical trials for psychedelics and granting some Section 56 exemptions, indicating a shift toward recognising the medical potential of these substances.
• Public pressure: Advocacy groups and public demand for alternative treatments are putting pressure on regulators to reconsider the restrictive frameworks. The increasing awareness and success of psychedelic treatments in the USA are likely to push this issue further into the regulatory spotlight.

In conclusion, while the current legal elements still impose significant barriers to access, there is growing momentum toward change. Regulators are becoming more open to the therapeutic potential of psychedelics, but any broad changes will likely be gradual, focusing first on controlled medical use and expanded research opportunities.

In Canada, any initial legislative route to expanding access to medical psychedelics is likely to follow a cautious, incremental approach, similar to the pathway taken with cannabis legalisation. Here is a potential outline of what that legislative route might look like:

SAP and Section 56 Exemptions

The first step in legislative reform would likely involve broadening the existing frameworks under the SAP and Section 56 exemptions. This could include:

• simplifying the application process for healthcare providers and patients to request psychedelic treatments through the SAP for a wider range of medical conditions, not just life-threatening ones;
• expanding Section 56 exemptions to include more patients and research initiatives, particularly for mental health disorders like PTSD, depression, and anxiety, which would allow for a greater number of individuals to legally use psychedelics in clinical settings; and
• encouraging more clinical trials through government incentives or streamlined approval processes to gather additional data on the therapeutic benefits of psychedelics.

Creation of a Medical Psychedelic Framework

As the data from clinical trials and exemptions accumulate, the next step would likely involve creating a formalised medical framework for psychedelics, similar to the early medical cannabis system:

• Medical psychedelic programme: This could allow registered patients to access certain psychedelics under medical supervision for specified conditions. Access might initially be limited to substances like psilocybin and MDMA, which have shown strong therapeutic potential in studies.
• Licensed clinics and therapists: Legislation would likely establish a system of licensed clinics or healthcare providers qualified to administer psychedelics, similar to how ketamine clinics currently operate. Strict training and certification requirements would ensure safe administration.
• Tightly controlled supply chain: Initially, the production and distribution of psychedelics would be heavily regulated, with licensed producers supplying approved clinics. This would mirror Canada’s approach to medical cannabis, ensuring quality control and safety.

Harm Reduction and Decriminalisation Measures

In parallel to the medical framework, Canada might also take steps toward decriminalisation and harm reduction. This would involve:

• Decriminalising small possession: Similar to British Columbia’s decriminalisation of small amounts of MDMA and other substances, Canada could expand this to include psilocybin and other psychedelics. This would focus on reducing criminal penalties for personal use while still regulating the sale and distribution.
• Harm reduction initiatives: Public health campaigns and harm reduction strategies would likely be implemented to educate the public on safe usage and reduce the stigma around psychedelics.

Controlled Expansion of Legal Access

Over time, with growing evidence of safety and efficacy, the legal framework could expand access to psychedelics:

• Additional conditions: The list of conditions for which psychedelics can be prescribed would likely grow, expanding beyond PTSD and treatment-resistant depression to include anxiety disorders, end-of-life care, and addiction treatment.
• Commercial availability for medical use: Licensed pharmacies or dispensaries may eventually be permitted to sell psychedelics directly to patients with prescriptions, further expanding access and aligning with the growing demand for alternative mental health treatments.

Possible Integration with Indigenous Rights and Traditional Use

Any legislative route in Canada is likely to include consideration for the rights of Indigenous communities, especially regarding traditional use of psychedelics in ceremonial and healing contexts. Legislative frameworks could integrate UNDRIP principles, allowing for regulated access to psychedelics for Indigenous practices and recognising the historical use of these substances.

Timeline and Challenges

• Gradual reform: Given the cautious nature of Canadian drug policy reform, this process is likely to unfold gradually, with medical access frameworks developed first, followed by broader decriminalisation and harm reduction initiatives.
• Regulatory and public scrutiny: Any legislative route will involve extensive public consultation and scrutiny from regulators to ensure that safety, medical ethics, and societal impact are considered at every stage.

In conclusion, the initial legislative route in Canada would likely involve expanding access through existing frameworks like SAP and Section 56, followed by the creation of a regulated medical programme and eventual decriminalisation. This phased approach would allow regulators to balance public safety with growing demand for psychedelic therapies.

The likelihood of a regulated, recreational (“adult-use”) psychedelic market emerging in Canada is currently low in the short term but possible in the long term, particularly if the therapeutic use of psychedelics gains widespread acceptance and successful regulatory frameworks are established. Here is an analysis of what such a market could look like and the factors that could influence its development:

Likelihood of an Adult-Use Market

• Current regulatory landscape: At present, psychedelics like psilocybin, MDMA, and LSD are classified as controlled substances under the CDSA. The legal focus is currently on medical and research-based use, with access limited to Health Canada’s SAP, Section 56 exemptions, and clinical trials. These frameworks are highly restrictive and show no immediate signs of shifting toward recreational use.
• Comparison to cannabis legalisation: Canada’s approach to cannabis legalisation could serve as a precedent for psychedelics. Cannabis was legalised first for medical use, and after years of public debate, court rulings, and changes in public opinion, the adult-use market was established in 2018. If similar patterns hold, a recreational psychedelic market could eventually emerge, though likely after several years of strict medical use and careful research-based regulation.
• Public opinion and advocacy: Public awareness and acceptance of psychedelics are growing, particularly due to the increasing recognition of their therapeutic potential. However, public opinion on psychedelics for recreational use is less developed than it was for cannabis. Advocacy groups are currently focused on medical access, with little push for outright recreational legalisation. Significant public education and cultural shifts would be required before the idea of recreational psychedelics gains widespread support.
• Government reluctance: Canadian regulators are generally cautious when it comes to drug policy reform. Health Canada is still focused on ensuring safe and controlled access to psychedelics for therapeutic purposes. Given the stigma and safety concerns associated with recreational psychedelics, it is unlikely that a regulated adult-use market will be prioritised in the near future. In the long term, if therapeutic programmes are successful and the substances are proven safe under controlled conditions, the government may reconsider its stance.

What a Regulated Adult-Use Market Might Look Like

If Canada were to establish a regulated recreational psychedelic market, it would likely follow a framework similar to cannabis, with strict controls and gradual roll-outs. Here is what such a market might entail:

• Strict regulation and licensing: The government would likely impose strict licensing requirements for production, distribution, and sale, similar to the cannabis industry. Licensed producers would be responsible for cultivating and manufacturing psychedelics, while retail outlets would need government approval to operate. Regulations around quality control, dosing, and packaging would be implemented to ensure consumer safety.
• Controlled access and age restrictions: A recreational market would likely have strict age restrictions, possibly mirroring the minimum age for cannabis consumption (18 or 19, depending on the province). There would also be limits on the quantity of psychedelics an individual could purchase or possess at any given time, along with education programmes focused on responsible use.
• Licensed psychedelic dispensaries: Similar to cannabis, specialised dispensaries would likely be established to sell psychedelics in a regulated environment. These dispensaries would be responsible for ensuring that customers are informed about the effects and risks of psychedelics and that products are sold in a safe, controlled manner.
• Zoning and public consumption laws: The government would likely impose zoning laws to regulate where psychedelics could be sold, as well as restrictions on where they could be consumed. Public consumption might be prohibited, with a focus on private, controlled settings to minimise public health and safety risks.
• Product forms and limitations: Initially, only certain psychedelic substances like psilocybin might be legalised for recreational use. The market would likely focus on lower-potency products, such as dried mushrooms or low-dose formulations, with tighter controls on more potent substances like LSD or MDMA. Microdosing might also be promoted as a safer, more socially acceptable form of recreational use.
• Taxation and government revenue: Similar to the cannabis market, a regulated psychedelic market would generate government revenue through taxes on sales and licenses. These funds could be allocated to public health initiatives, harm reduction programmes, and further research into the safe use of psychedelics.
• Integration of harm reduction programmes: Any recreational framework would likely include strong harm reduction measures. This might involve mandatory education for consumers, training for dispensary staff, and partnerships with healthcare providers to mitigate risks associated with misuse. Safe consumption spaces, similar to safe injection sites, could also be introduced for those using psychedelics in public settings.

Barriers to an Adult-Use Market

• Public health concerns: Psychedelics can have strong psychoactive effects, and there are concerns about their use outside of medical supervision. Unlike cannabis, psychedelics are less understood by the public, and the risks of adverse reactions (such as “bad trips” or psychological harm) are significant concerns for regulators.
• Lack of precedent: While the therapeutic potential of psychedelics is being researched, there is little global precedent for a fully regulated adult-use psychedelic market. Without examples of successful recreational frameworks elsewhere, Canada may be reluctant to lead the way.
• Stigma and perception: The stigma around psychedelics, often associated with the counterculture of the 1960s, still exists. Overcoming this stigma will take time and education, especially given the more serious psychoactive effects of psychedelics compared to cannabis.

Conclusion

In the short to medium term, the likelihood of a regulated adult-use psychedelic market in Canada remains low. The current focus is on expanding medical access and researching the therapeutic potential of psychedelics. However, if these medical frameworks prove successful and public perception shifts, a recreational market could develop over time. Any such market would likely be tightly regulated, mirroring the gradual approach Canada took with cannabis legalisation, with an emphasis on public safety, responsible use, and harm reduction.