Health Canada announced today in a group call with all Licensed Producers that the regulatory agency are immediately issuing a section 56 exemption under the Controlled Drugs and Substances Act (CDSA), which will allow licensed producers to produce and sell "cannabis oil and fresh marijuana buds and leaves in addition to dried marijuana".
The announcement has been expected since the recent Supreme Court ruling that patients have the right to use medical marijuana in all its forms, not simply the 'dried bud' form previously allowed under the MMPR, although the announcement today has caught many by surprise. It was expected the regulator would be waiting some time before such an announcement. Fresh marijuana leaves and buds will allow those who wish to, for example, juice their marijuana.
Currently, those allowed to possess marijuana under the MMPR are limited to 150 grams in total. The new rules state that the quantity of fresh marijuana buds or leaves or oil is stated 'in equivalency terms to one gram of dried marihuana' and lists various labeling requirements, including preventing Licensed Producers from selling any cannabis oil over 30mg per mL of THC. The section 56 exemption explanation defines 'cannabis' as including its preparations and derivatives, including cannabis resin; cannabidiol (CBD), cannabinol (CBN) and tetrahydrocannabinol (THC).
Producers must list in mg, the delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) that the oil in the container can yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol and cannabidiolic acid into cannabidiol. Cannabis oils are not allowed to contain any added flavor or scent. If sold in capsule form, the maximum yield quantity cannot exceed 10 mg of THC.
"I think this will be very beneficial for patients, especially for those parents of children being treated as well as for the elderly, who do not want to smoke. It will hopefully will help improve uptake by physicians and make it more acceptable to prescribe, but it will also require more education for physicians to understand how this works." ~Dr. Danial Schecter
Many questions are still left unanswered, like how doctors will be instructed by the various national and provincial colleges of physicians on dosage and titration, as well as exactly what forms of derivatives will and wont be allowed.
Dr. Danial Schecter, of Toronto's Cannabinoid Medical Clinic, says he is very happy to see these changes beginning to be implemented, and looks forward to having more dosage possibilities available, especially for the non-traditional patients.
"I think this is a phenomenal move," says Schecter. "I'm very happy that the regulations by Health Canada have finally caught up with the legislation from the Supreme Court of Canada. I think this will be very beneficial for patients, especially for those parents of children being treated as well as for the elderly, who do not want to smoke. It will hopefully will help improve uptake by physicians and make it more acceptable to prescribe, but it will also require more education for physicians to understand how this works."
Many producers have been working on developing processes to manufacture various oils and cannabis derivatives with the expectation of this change in the regulations. Adam Miron of the Hydropothecary, a recently-approved producer in Quebec, says his company has been working on the process behind the scenes for some time, and is excited to begin offering products for sale as soon as they are able.
"We're excited by the news, although we're not surprised by it, based on the Supreme Court ruling," said Miron in an interview with Lift. "Our plan is to be one of the first to market. What we are looking to do is cartridge-based for vaporization, and we will also do oil for sale for people who wish to cook with it. We hope to be one of the first to offer these products. We've already been working on processes and techniques, and we already have two staff members dedicated to these processes. As soon as we get that license, we are ready to start producing oil".
CanniMed released an announcement today echoing the sentiment, stating they have been working on the research and development into oils and 'alternate preparations' for some time and are excited to begin selling products as soon as possible.
“We support the new regulations as being a very reasonable way to approach the safe and effective development of oils and alternate preparations of cannabis,” said Brent Zettl, President and CEO of CanniMed Ltd. “Patient request for products have been significant and we are pleased that Health Canada has recognized the need to modify the Marihuana for Medical Purposes Regulations (MMPR).”
A second conference call between Health Canada and all 19 currently-licensed producers is expected tomorrow to help guide producers through the application process, and to answer the numerous questions producers likely will have.
More information on when Licensed Producers will be coming soon. Stay tuned to Lift for all your MMPR news. More info from Health Canada here. This article has been extensively updated throughout the day as new information about this historic change comes in.