The world is watching as Canada holds centre stage as one of the first developed countries to develop federal legislation for the legalization of both medical and recreational cannabis, which is targeted to be unveiled by July 2018.
This will end nearly a century of the prohibition of recreational cannabis. Canada already has federal approval for the use of medical cannabis under Access to Cannabis for Medical Purposes Regulations (ACMPR). Along with legalization, Canada has the potential to be the global leader in medical cannabis research. In addition to the regulatory landscape, Canada has other advantages that have created the ideal environment for conducting medical cannabis research.
Top five reasons for conducting cannabis research in Canada:
- Unlike many other countries, cannabis is considered a Schedule II drug in Canada, and is currently accessible for medical purposes, in many cases making the investigation of its clinical use easier from a regulatory approval perspective. In the US for example, cannabis is considered a Schedule I drug (falling within the same schedule as drugs such as heroin), making access for research purposes very difficult. Furthermore, research in Canada is not limited in terms of the type of plant that can be used in clinical research, whereas in the US for example, it must be obtained from a single approved supplier, the quality of which has recently come into question.
- Canadian licensed cannabis producers are held to high standards of production by Health Canada, many of which have implemented production practices similar to those in the pharmaceutical industry. This allows for some of the safest and highest quality cannabis products being available for testing in clinical trials. Much of the previous research that has been conducted has investigated the effects of smoked cannabis or cannabis infused edible products, and evidence pertaining to the pharmacokinetic profile, safety, and tolerability of controlled doses of physiologically active components of the cannabis plant is not accurately demonstrated in those studies. The use of high-quality products with consistent and known concentrations of key components will allow some of these current knowledge gaps to be filled.
- Cannabis is becoming more widely accepted by physicians and patients in Canada, resulting in an increased willingness to participate in clinical research. Medical Cannabis has been accessible in Canada since 2001, and since 2014 it has been available for purchase through Health Canada licensed producers, under the order of a physician. This has resulted in an increased understanding of the potential medical benefits of this drug amongst Canadians, and a slow but growing adoption of its use in regular clinical practice. This has created an environment in which many physicians, researchers, institutions, and patients are ready and willing to be involved in research so that they can contribute to the body of evidence needed to validate its medical use.
- Canada is recognized as a leader in research and an ideal location for conducting clinical trials. Canada has many well-established research organizations and academic research-focused hospitals and institutions with which recognized research scientists and professionals are affiliated. Many of these centres are becoming familiar with cannabis research and are developing validated methods for measuring its active ingredients and their metabolites, in the plant as well as in vivo, as well as establishing the most appropriate study designs for measuring these products’ safety and efficacy. Canada also has a highly diverse ethnic demographic population which makes for an ideal population to conduct research studies.
- Legalization alone will create the urgent need for more research to answer questions such as the impact of cannabis use on driving, and risks associated with the use of cannabis in younger and more vulnerable populations. In addition to this, it will create the need for the use of cannabis for medical purposes to be further validated so that there will remain a clear differentiation between medical and recreational products, and physicians can continue to become more confident in prescribing cannabis-based medicines in their practices.
Although cannabis is legally accessible for medical purposes in Canada, it is not currently recognized by Health Canada as an “approved” medication. Amongst the reasons for this state of affairs is the fact that it has not yet undergone the rigours of clinical trials that other prescription drugs on the market have. As a result, cannabis products have generally not been assigned a Drug Identification Number (DIN), which have typically been made accessible to patients through traditional pharmacies or been made eligible for insurance coverage through many public or private insurers. All stakeholders recognize that formal, robust, and well-controlled clinical trials are needed to validate cannabis-based medicines which will eventually contribute to their formal regulatory approval and an increase in accessibility.
There are a few key reasons that have likely contributed to the lack of clinical trial conduct thus far, including:
- Lack of funding. Clinical trials are extremely costly to conduct. Prior to the commercialization of the cannabis industry, there was a lack of public funding made available for cannabis research. It is likely that now both private and public funding will contribute to the advancement of clinical research in this field.
- Medical cannabis already approved for use. Because government regulations allowed licensed companies to produce and sell medical cannabis without first requiring scientific validation, many organizations have not demonstrated motivation to invest in clinical trials. This landscape may change when regulations allow access to cannabis for recreational purposes.
- Lack of clear guidance for research prioritization. Cannabis is currently prescribed for a wide range of indications, many of which are supported by extensive anecdotal evidence. Without clear guidance on where further research should be prioritized, it is challenging for organizations to determine the most appropriate areas and initiatives in which to invest.
Some companies in Canada have committed to investing significant funds into the advancement of clinical research. MedReleaf, one of Canada’s first and largest Licensed Producers, is one of the few companies that has demonstrated its strong commitment to clinical research. They are taking advantage of Canada’s legal and regulatory landscape, and contributing to the development and validation of innovative cannabis based therapies.
MedReleaf has received approval from Health Canada to conduct their first clinical trial which is now underway, and expected to be completed in the spring of 2017. The study looks at the pharmacokinetics of a capsule product which is currently being prescribed to patients by a number of physicians across Canada.
Products on today’s market currently do not have any information available with regards to pharmacokinetic profiles, which makes it challenging for healthcare providers to understand and educate patients on their optimal use (i.e. dosing regimen). The results of this trial are expected to begin to fill some of the gaps and provide this much-needed information to patients and healthcare providers responsible for their care.
Research in this field has only begun to scratch the surface in terms of understanding the medical potential of this plant. Medical cannabis plants contain more than 100 different chemical compounds, many of which are known to be associated with a range of different physiological effects. More research is needed to better understand how these compounds work, both on their own and in synergy with the entourage of other compounds. Unlike pharmaceutical drugs that typically target only one medical condition, medical cannabis has been shown to benefit a wide variety of medical conditions and symptoms. Therefore, clinical research investigating the indication-specific efficacy of cannabis in larger patient populations is needed to validate its use in various therapeutic areas.
It is an exciting time for research in the evolving cannabis industry and Canada is leading the way for the rest of the world to follow with both medical and recreational legalization. The door is wide open for much needed clinical research on cannabinoid based medicine with companies such as MedReleaf leading the way. The best medical care is based on evidence and there is currently not enough conclusive or substantial evidence supporting the utility of cannabis for many of the conditions for which it is currently prescribed. This lack of evidence is an invitation to researchers, scientists, physicians, health care providers, licensed cannabis producers, government agencies and most importantly, patients to be part of shaping the future of this industry and leading the way for validating the use of cannabis as a medicine.
References: 1. A Framework for the Legalization and Regulation of Cannabis in Canada: http:// healthycanadians.gc.ca/task-force-marijuana-groupe-etude/framework-cadre/ alt/framework-cadre-eng.pdf 2. ACMPR Regulations: http://laws.justice. gc.ca/PDF/SOR-2016-230.pdf 3. Article in “The Cannabist: http://www. thecannabist.co/2017/03/31/medicalmarijuana-ptsd-study-johns-hopkinsmaps/76491/
Sabrina Ramkellawan has 15+ years of experience conducting phase I-IV clinical trials for pharmaceutical and biotech companies. She is currently involved in a number of medical cannabis clinical trials and speaking engagements on this topic. She is a Clinical Research Consultant, Vice President of the Clinical Research Association of Canada, and the Co-Founder of the Canadian Institute for Medical Advancement.