With Canada’s legalization of cannabis now here, it’s important for the clinical research community to stay informed on what legalization will mean for cannabis regulations in clinical drug trials. With terms like decriminalization and phytocannabinoids coming up in everyday conversation, it may appear that legalization will further complicate the pre-existing clinical trial regulations but – spoiler alert: developing treatments that use cannabis will be easier than ever before.
As only the 2nd country in the world to have done so, Canada decriminalized recreational cannabis on October 17, 2018, with the implementation of the Cannabis Act. New regulations surrounding the use of cannabis in clinical trials went into play on this day. Previously, the use of cannabis for clinical research was regulated by the Access to Cannabis for Medical Purposes Regulations (ACMPR). These regulations, while tried, tested, and true, made using cannabis in clinical trials a less-than-streamlined process. However, the ACMPR has been repealed since the October 17th decriminalization, and all references to cannabis in the Narcotic Control Regulations (NCR) will be removed.
So, what exactly will The Cannabis Act cover? The Act will pertain to industrial hemp, organic and synthetic phytocannabinoids, as well as test kits and drugs containing cannabis. Cannabis Regulations, under the Cannabis Act, will become the authority for what was previously regulated under both the ACMPR and the NCR with the exclusion of industrial hemp, which will fall under the new Industrial Hemp Regulations.
All that said, using cannabis in clinical trials should be a more streamlined, accessible process, and with organizations like the DeGroote Centre for Medicinal Cannabis Research focused on among other things conducting cutting-edge research, a more robust one as well. Currently, the use of cannabis in drug trials requires a subsection 56(1) exemption per controlled substance. That’s aton of paperwork for drug developers working within the medical cannabis sphere. Through the Cannabis Regulations, researchers will be able to apply for a single Research License that will extend to more than one form of cannabis. The Research License will allow holders to possess, produce, deliver, send, and transport cannabis for research purposes. Research License holders will also be able to apply for an import and/or export license through Health Canada. Research License applications are also open now, since October 17th.
Cannabis and its derivatives already have a substantial hold in medicine. Products that will fall under the Cannabis Regulations are currently being used in the treatment of clinical anxiety, cancer treatment, pain management, and the list goes on. The numbers associated with these substances are high – the Cannabidiol (CBD) industry, for example, is set to reach 2.1billion USD by 2020. Clinical trials that fall into the Cannabis Regulations arena could also have an unprecedented audience in communities outside of the traditional clinical trials arena. Millennials and members of Generation Z show the highest rates of clinical anxiety against all other age groups. These demographics also hold the monopoly over social platforms and are already, understandably, invested in treatments using cannabis. Canadian clinical cannabis trials seem to be poised for significant growth. The pre-existing industry, in combination with Canada’s new, easy-to-use approach to cannabis in clinical trials will undoubtedly have a global impact.
Is your clinical trial ready to get onboard?