Making Waves – A Psychedelic Update 

As discussed here and here, the psychedelic renaissance has spurred a renewed interest in the potential therapeutic benefits of substances such as psilocybin, LSD and tryptamines.  As the evidence of clinical efficacy builds, countries are now grappling with how to legalize the substances for medical treatment, yet still restrict illicit use of the drugs.  In this article, we will summarize how Canada, the United States (US) and the European Union (EU) are regulating such drugs and are allowing them to be used in clinical trials. In addition, we will provide a brief overview of recent developments in Australia where medicines containing MDMA or psilocybin can be legally prescribed for limited purposes.

Canada

Currently, there are no licensed commercial therapeutic products containing psilocybin in Canada.[1] Products for experimental use or special access have been permitted on a limited basis. Psychedelic drugs are governed by the Controlled Drugs and Substances Act (CDSA), which generally prohibits their use.  Exemptions can be granted by Health Canada for uses that are necessary for medical or scientific purposes or otherwise in the public interest.

As the use of psychedelics have shown significant promise for treating many different mental health disorders, Health Canada has granted exemptions for research and clinical application of such compounds. For example:

• Researchers have been given an exemption (and a federal grant) to study whether psilocybin’s psychedelic effects are required for it to have antidepressant effects; and
• a Canadian university is researching the benefits and drawbacks of micro-dosing psilocybin.[2]
• The UHN Psychedelic Psychotherapy Research Group is examining the feasibility, safety, and efficacy of Psilocybin-Assisted Existential, Attachment and Relational (PEARL) therapy for end-of-life distress in patients with advanced cancer.[3]

Canada’s willingness to support more research in this area is also evident with the Canadian Institutes of Health Research’s new funding opportunity which will support phase I or II clinical trials.  In particular, the new funding opportunities will include projects regarding psilocybin-assisted psychotherapy for treatment of substance use dependence or disorders, major depressive disorder or treatment resistance depression, and end-of-life psychological distress in patients with advanced stage cancer.[4]

Health Canada has also instigated a Special Access Program, accessible through a Subsection 56(1) exemption in the CDSA, wherein certain individuals may be able to access psilocybin. This program provides health care practitioners with access to drugs that have shown promise in clinical trials or been approved in other countries but have not yet been authorized for sale in Canada.  The program allows access to the drugs for the treatment of serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.[5] Health Canada noted that emerging scientific evidence supports therapeutic uses for psilocybin and MDMA in the treatment of PTSD and treatment-resistant depression in their reasoning.  Accordingly, the use of psilocybin has been authorized through the SAP.[6]

While the future legality of psychedelics remains unresolved, some advocacy groups have made submissions to Health Canada based on the argument that a general prohibition against psilocybin possession violates Canadians’ Section 7 Charter rights to life, liberty, and security of the person, and that Subsection 56(1) exemptions may not constitute sufficient access.[7]   These challenges have not been decided in court to date, and the likelihood of success is not clear.

United States

In the 1980s, the US Drug Enforcement Agency (DEA) classified MDMA and psilocybin as Schedule I substances, defined as substances and chemicals with no currently accepted medical use and a high potential for abuse. A Schedule I classification makes it especially difficult to conduct research on the substance(s) in question and requires DEA approval.

Despite these hurdles, there is ongoing research on the use of psychedelics for the treatment of mental health disorders.

Between 2017-2019, MDMA and psilocybin obtained Breakthrough Therapy designation by the Food and Drug Administration (FDA) for treatment of PTSD, drug-resistant depression and major depressive disorder. This designation expedites the development and review of drugs intended to treat serious conditions where preliminary clinical evidence indicates that the drug may have a meaningful advantage over current therapies.[8]

The Multidisciplinary Association for Psychedelic Studies (MAPS) has recently completed two Phase III clinical trials of MDMA-assisted therapy. The studies compared the efficacy of MDMA-assisted therapy compared to placebo in treating individuals with severe and moderate PTSD.[9] MAPS is currently planning for Phase II clinical trials to evaluate MDMA-assisted therapies for similar conditions such as substance use disorders and eating disorders.[10]

The Multidisciplinary Association for Psychedelic Studies (MAPS) also received expanded access by the FDA for MDMA-assisted therapy. This allows patients to receive treatment not yet approved by the FDA, outside of a clinical trial, so long as the patient meets certain criteria.[11]

Europe

European member states classify drugs according to three UN conventions. The 1971 United Nations Convention on Psychotropic Substances, lists psychedelics as a Schedule I substance, defined as presenting a high risk of abuse with very little to no therapeutic value, and a serious threat to public health. This classification limits the use of these substances to medical and scientific purposes.[12]

As of February 2023, the European Medicines Agency (EMA) reported that there are numerous ongoing clinical trials in the EU for treatment of various central nervous system conditions. Specifically, there are 11 ongoing clinical trials with psilocybin, 4 ongoing trials with MDMA, and 1 ongoing trial with LSD.[13] For example:

• The Central Institute of Mental Health in Germany is conducting a phase II clinical trial on the efficacy and safety of psilocybin for treatment of treatment-resistant major depression.[14]
• In Norway, with support from the South-Eastern Regional Health Authority, they are conducting Phase II clinical trials to evaluate the effect of MDMA-assisted psychotherapy for major depressive disorder.[15]

While aware of the potential benefits of psychedelics for treatment of mental health disorders, Canada, the US and the EU are delving into the field with caution and in their own regulatory ways.

Australia

Earlier this year, the Australian Therapeutic Goods Administration (TGA) recognized MDMA and psilocybin containing products as medicines. As of July 1, 2023, authorized psychiatrists were allowed to register to prescribe MDMA containing medicine for the treatment of PTSD, and psilocybin containing medicine for the treatment of treatment-resistant depression to certain patients. Strict rules have been established to ensure patient safety. For example, MDMA can only be prescribed for PTSD, and psilocybin can only be prescribed for treatment-resistant depression. Furthermore, only certain psychiatrists, registered under Australian law, with permission from the human research ethics committee and authorization from the TGA can provide these prescriptions. Lastly, patients must take the medication while in a health setting supervised by their psychiatrist; they will not have access to MDMA or psilocybin outside the facility.[16] It will be interesting to see whether Canada, the US or the EU follow suit in providing a similar, limited authorization.

Intellectual Property and Psychedelics

Like most pharmaceutical research, protection of such innovations will be an important aspect for how the field develops, and its clear that companies are taking their innovations seriously.  A worldwide search for patents which recite the word “psilocybin” in the claims between the years 2000 and 2019 shows 127 separate patents.  The number of patents reciting the word “psilocybin” in the claims since 2019 has more than doubled to 258, supporting the fact that the psychedelic revolution is in full swing.  From new synthetic derivatives to new methods of extraction and new formulations, there are many different ways to protect inventions in the psychedelic space.  While the basic tenets of patent law apply to all inventions in that an invention must be new, non-obvious and useful, there are important issues in the psychedelic field of which innovators should be aware, and which we will review in a future article.

[1] https://www.canada.ca/en/health-canada/services/substance-use/controlled-illegal-drugs/magic-mushrooms.html

[2] https://www.utm.utoronto.ca/psychedelics/research-program-background

[3] https://www.uhn.ca/MentalHealth/Research/Psychedelic-Psychotherapy-Research/Pages/Research.aspx

[4] https://cihr-irsc.gc.ca/e/52880.html

[5] https://www.canada.ca/en/health-canada/services/substance-use/controlled-illegal-drugs/magic-mushrooms.html

[6] https://www.gazette.gc.ca/rp-pr/p2/2022/2022-01-05/html/sor-dors271-eng.html

[7] https://www.rightslawyer.ca/docs/hcp-reps.pdf

[8] https://maps.org/news/media/press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd-agrees-on-special-protocol-assessment-for-phase-3-trials/  https://www.scientificamerican.com/article/a-strategy-for-rescheduling-psilocybin/

[9] https://psychedelichealth.co.uk/2022/11/21/maps-completes-phase-3-trial-of-mdma-assisted-therapy-for-ptsd/

[10] https://psychedelichealth.co.uk/2023/01/05/maps-confirms-successful-phase-3-trial-of-mdma-for-ptsd/

[11] https://maps.org/mdma/ptsd/expanded-access/

[12] https://www.emcdda.europa.eu/publications/topic-overviews/classification-of-controlled-drugs/html_en

[13] https://www.ema.europa.eu/en/documents/other/ema-reply-letter-members-european-parliament-mr-agius-saliba-ms-ries-mr-duda-mr-biedron-ms-cerdas-ms_en.pdf

[14] https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003984-24/DE

[15] https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000805-26/NO#summary

[16] https://www.tga.gov.au/news/blog/understanding-changes-mdma-and-psilocybin-access