Our mission at Zentrela is to educate cannabis consumers on the best products to deliver the experience they are seeking. We were very pleased with the proposed changes to the Cannabis and Food and Drug Regulations concerning interventional research on non-therapeutic effects of cannabis because they represent an opportunity to get more objective data into the hands of cannabis consumers.
The way the regulations are currently written, certain types of research, such as studies conducted under the ‘observational study’ framework which we at Zentrela currently use, are permitted. This means we can study the effects of cannabis but only with significant limitations – for example, we cannot supply or even specify which products the participants use during one of our research sessions. Rather, participants must themselves supply legally purchased products that they normally might use and consume them according to their preferred method and dosage. This limits us to studying only products currently available from legal cannabis suppliers.
Under current regulations, any study where the researchers supplied the product would be considered ‘interventional’ studies and would require a ‘Clinical Trial Application’ to be filed and approved. However, this process is extremely complex due to rules around the specification of the product involved. Almost all cannabis products currently on the market do not meet the production standards required for an ‘investigational product’ to be used in a clinical trial. They are produced by licensed producers under the ‘GPP’ standard. Products that can be used in a clinical trial must be produced under a different standard, the ‘GMP’ standard. GMP isn’t legally required to operate a cannabis company in Canada, and not many producers are GMP certified. It would be a considerable additional expense to become GMP certified only for the purposes of studying product effects. This ‘catch 22’ makes it difficult and expensive for researchers to study the actual effects from products that millions of Canadians consume every day.
Health Canada has recognized that these rules significantly limit legitimate research that would enable the development of educational material that would assist consumers with making informed decisions about cannabis consumption, safety and the risks of using cannabis. Changing these rules would also enable cannabis producers to engage in research and development of new products taking into account product effects (both positive and negative) before the products are released to consumers – surely a change that would benefit both consumers and producers. Health Canada is proposing to remove the requirement for a ‘Clinical Trial Application’ for most research on the non-therapeutic effects of cannabis products. Therapeutic effects (for example effects relating to the diagnosis, treatment, mitigation, or prevention of a disease or its symptoms) would still require a Clinical Trial to be conducted. The non-therapeutic research would still require researchers to possess a cannabis research license and special conditions would be attached to protect the health and safety of research participants.
These changes are in complete alignment with market needs already identified by Zentrela. We know that both producers and consumers want more information about the non-therapeutic effects of cannabis. We applaud these proposed changes and hope they can be enacted soon in order to benefit both cannabis consumers and cannabis producers.
