Highlights
- Cannabis use for medical purposes bypassed the traditional drug policy protocols before the introduction of the Cannabis Act through successive court decisions suspending it from the Canadian Substance Drugs Act (CSDA).
- Psychedelics, such as psilocybin and MDMA, are following Health Canada’s standard protocols for clinical trial phases.
- Full legalization of psychedelics for recreational use remains doubtful. The Federal government has already restored the Special Access Program (SAP) without further indications of direct political action.
What’s all the hype about?
Recently, the Minister of Health provided exemptions to patients nearing end of life to access psilocybin and amended legislation governing the Special Access Program (SAP). This program allows health care providers access to non-market drugs for patients including psychedelics. Speculation has begun about the future market for psychedelics in Canada and the hype has drawn parallels to cannabis legalisation. What becomes lost in this hypothetical scenario are the nuances of the political environment, administrative powers and the series of court cases that led to full legalisation of cannabis. The purpose of this article is to examine what drove cannabis legalisation and how the same outcome may not be possible for psychedelics.
Summary of Relevant CSDA
The introduction of the Cannabis Act into law by the 42nd Parliament resulted from a series of court cases forcing the federal government to implement, then restructure, policies outlining medical patient access to cannabis and production within the Controlled Substances and Drugs Act (CSDA). Each case presented the argument that the continued prohibition of cannabis for medical purposes violated section 7 of the Canadian Charter of Rights and Freedoms (the Charter). This section declares: “Everyone has the right to life and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice.”
Health Canada uses the CSDA to govern the definition, sale, import/export, possession, production and exemptions of all controlled substances. Section 4(1) of the CSDA states: “Except as authorized under the regulations, no person shall possess a substance included in Schedule I, II or III.” Schedule I covers opioids and derivative substances including heroin, morphine as well as MDMA. Schedule II did include cannabis prior to the introduction of the Cannabis Act. The CSDA still contains synthetic cannabinoids while psychedelics such as DMT, LSD and psilocybin are covered by Schedule III.
Clinical trials, and exemptions for substances are possible under the CSDA if the Minister of Health allows it for scientific and medical purposes as outlined in Section 56(1) with these decisions made public in writing. The Governor in Council also has the power to add or delete substances from the schedules (I to IV and IX) if deemed necessary in the public interest under section 60.
Cannabis Exemption through Judicial Decisions: A Primer
Successive provincial and Supreme Court of Canada decisions exempted cannabis from Schedule II of the CSDA for medical use. The landmark case R. v. Parker decided upon in 2000 by the Ontario Court of Appeal was the first of many cases exempting cannabis for medical purposes. Mr. Parker was convicted in 1997 for possession but successfully argued he grew and used cannabis to alleviate symptoms from epilepsy. The government was given twelve months to find a solution to the unconstitutional nature of CSDA section 4(1) preventing possession of cannabis for medical purposes. The decisions also found that Mr. Parker’s section 7 Charter rights had been violated.
The government responded by enacting the Marijuana Medical Access Regulations (MMAR) on July 21, 2001. The MMAR allowed for individuals too ill to produce their own cannabis to identify a dependent producer who could grow cannabis on their behalf, but no payments were allowed between the user and the producer, and the producer was restricted to growing cannabis for a single user. The regulations were challenged as being too restrictive.
Hitzig v. Canadain 2003 was filed with the Court of Appeal of Ontario which heard a challenge that the restrictions of the MMAR possessions and production of cannabis violated section 7 Charter rights to liberty and security. The government policy did not permit a legal avenue to access cannabis for medical purposes without breaking the law and the surrogate producers were prevented from tapping into economies of scale due to being unable to work with other producers. These observations were further examined in 2008 by the Federal Court of Canada.
In Sfetkopoulos v. Canada subsection 41(b.1) of the MMAR was found to contrive the fundamental justice of section 7 of the Charter as the Minister of Health could not refuse an individual access to more than one production licence. It also forced individuals requiring cannabis for medical purposes to turn to the illicit market which was deemed inconsistent with the rule of law and the principles of fundamental justice.
The MMAR was found unconstitutional in 2011 by the Ontario Superior Court through the decisions of R v. Mernagh. The sections within the CSDA prohibiting possession and production were deemed constitutionally invalid and suspended for three months to allow the federal government to adjust their regulatory regime. The government then introduced the new Marihuana for Medical Purposes Regulations (MMPR) in 2014 which permitted doctors to prescribe cannabis. Patients could also purchase from a licensed producer but were not permitted to grow their own plants.
Turning Points for Cannabis
In 2015 a case fixated on the vulnerability of cannabis producers was presented in R. v. Smith in the Supreme Court of Canada. Mr. Smith was charged with possession of THC for the purpose of trafficking. This was contrary to section 5(2), and possession of cannabis under section 4(1), of the CSDA. The government’s regulatory framework only provided exemption for possession of dried marihuana. This case opened the capacity for medically exempt individuals to access more than just dried marijuana. It acknowledged that the production and possession of marijuana oils, extracts, or other medically active compounds were unjustly prohibited. It was found the charge violated section 7 of the Charter.
The case of Allard v. Canada in 2016 by the Supreme Court of Canada found that the MMPR violated section 7 of the Charter of fundamental justice and again struck down section 4 of the CSDA. The Justices stated in their summary position the MMPR invalid and provided a resolution: “…to suspend the operation of the declaration of invalidity to permit Canada to enact a new or parallel medical marihuana regime. As this regime was created by regulation, the legislative process is simpler than the requirement for Parliament to pass a new law.” The government was provided six months to outline new policy.
The Allard decision resulted in the government creating the Access to Cannabis for Medical Purposes Regulation (ACMPR) in August 2016 which reintroduced personal cultivation as found in the original MMAR. The ACMPR would be replaced by the passage of Bill C-45 Cannabis Act which outlined regulations for the production, sale, import and export of cannabis. This removed it from Schedule II of the CSDA allowing for recreational and medical use. The bill received Roya Assent on June 21, 2015.
Political and Policy Environment
The political context is important when comparing potential regulations for psychedelics to those that were implemented for cannabis. During the successive court cases on the access of cannabis for medical purposes the governing federal political party maintained anti-drug use stance. Under these circumstances the courts drove the change forcing the government to react to the successive cancelling of cannabis from Schedule II of the CSDA.
A change of the governing political party in 2015 resulted in a majority of parliamentary seats for the Liberal Party of Canada who specifically ran on a pro-legalisation platform. The new government could have unilaterally struck cannabis from the CSDA for medical purposes without bringing it before Parliament, but a political decision was made to have a public debate in the House of Commons on the full legalization for medical and recreational use.
How Psychedelic Process Differs
The progression of psychedelics into medical use are currently following the standard testing process as set out by the Health Products and Food Branch (HPFB) of Health Canada. The HPFB are the national authority which regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians. Through a four-phase process a drug is determined to have potential therapeutic value that outweighs the risks associated adverse effects and toxicity. Once these have been determined a new drug submission can be made to the HPFB.
The government has not declared any interest in psychedelic legalisation through the Minister of Health’s Mandate Letter released December 2021. Instead, in 2022 Health Canada restored the ability for health care professionals to request a patient’s access to any non-market drug not available if the conventional ones have failed, are unsuitable or unavailable in Canada through the Special Access Program (SAP). Clinical trials have been underway to determine therapeutic value for a very limited set of medical conditions.
Some Current Clinical Trials of Psychedelics in Canada
The median time to bring a drug from pre-market to market via clinical trials in Canada is 11.8 years according to Lexchin in a 2019 study. The Health Canada database of clinical trials indicates there are two psylocibin studies for the treatment of depression and seven studies for MDMA examining PTSD and anorexia. Recently, a single Phase I clinical trial in July 2018 examined treatment resistant depression in adults and completed September 2021 by Compass Pathfinder Limited. Another Phase 2 study with the same goal by the Brain and Cognitive Discovery Foundation, is pending since the application in July 2021.
The other psychedelic undergoing clinical trials was MDMA. All seven of the trials are being conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS). The most recent of these began has been in 2021 to explore the use of MDMA for PTSD while the most advanced is an ongoing phase 3 started April 2019 again for PTSD. Setbacks have emerged among the MAPS group as the Minister of Health halted MDMA trials to review possible inappropriate administration of the therapy.
Concluding Thoughts
The nuances leading to cannabis legalisation progressed over two decades not because the federal governing party at the time did not have the power to remove the drug from CSDA. Instead, legalization was a journey that require successive judicial decisions to pressure the creation of regulatory regimes over access to cannabis for medical purposes. At present there have been several clinical trials for psilocybin and MDMA. Once these trials have been completed the government will further decide if psychedelics provide any benefits for depression (psylocibin), PTSD or anorexia/binge eating (MDMA) then regulate their use as they do for all other medicines.
Ministerial exemptions for psychedelic continue to be granted on a case-by-case basis through the resting authority found within the CSDA or health care provider requests through the Special Access Program but such exemptions produce zero indication psychedelics will be systematically legalized for recreational purposes. There has been no discussion within ministerial mandates or government political platform about legalisation of psychedelics by the current federal government. Given all this evidence, the psychedelic legalisation is doubtful in the near future unless an umbrella decriminalization for substances covered by the CSDA occurs or a successful Supreme Court case alters the regulatory landscape.
Ramsgate Policy Group continues to keep the pulse on health care policy. Reach out if anything in this article rouses interest among your little grey cells.