OTTAWA, July 8, 2015 /CNW/ - The purpose of this statement is to provide clarity and guidance regarding access to marijuana for medical purposes, further to the June 11, 2015, Supreme Court of Canada decision R v. Smith.
Marijuana is not an approved drug or medicine in Canada and has not gone through the necessary rigorous scientific trials for efficacy or safety. Canadian courts have required reasonable access to a legal source of marijuana for medical purposes when authorized by a physician. The Government of Canada's position is that this must be done in a controlled fashion to protect public health and safety.
To this end, Health Canada implemented the Marihuana for Medical Purposes Regulations (MMPR) in 2013, setting out strict controls over the production and sale of marijuana. The MMPR include stringent requirements with which licensed producers must demonstrate compliance, including quality control standards, record keeping of all activities and inventories, and physical security measures to protect against potential diversion. The MMPR also require key personnel, along with directors and officers in the case of a corporation, to hold a security clearance granted under the regulations. In particular, the MMPR provide for rigorous oversight to reduce public health, safety, and security risks.
As a result of the Supreme Court of Canada decision, individuals authorized to possess marijuana under the MMPR and those falling under the terms of a court injunction (for example, Allard injunction) may now possess marijuana derivatives for their own use. In order to eliminate uncertainty around a legal source of supply of marijuana, Health Canada has taken the immediate step of issuing a section 56 exemption under the Controlled Drugs and Substances Act (CDSA), allowing licensed producers to produce and sell cannabis oil and fresh marijuana buds and leaves in addition to dried marijuana (plant material that can be used to propagate marijuana will not be permitted to be sold by licensed producers to clients). The role of healthcare practitioners in authorizing marijuana for medical purposes does not change.
Licensed producers must continue to comply with all provisions of the MMPR or the Department may take enforcement action.
The Section 56 exemption under the CDSA enables licensed producers to provide a legal source of cannabis oil and fresh marijuana buds and leaves. This exemption, effective immediately, sets out the strict terms and conditions with which licensed producers must comply. These build on the regulatory requirements set out in the MMPR:
All marijuana must be shipped in child resistant packaging
- Licensed producers must ship any fresh, and dried marijuana, and/or cannabis oil in a safe and secure manner, with child-resistant packaging.
Labeling requirements: health warning messages
- Licensed producers must include the following warning clearly and prominently displayed on the label: "This product has not been authorized for sale under the Food and Drugs Act. It has not been assessed for safety or efficacy to treat or prevent any disease or symptom."
- Licensed producers must ensure that the container carries the following warning "KEEP OUT OF REACH OF CHILDREN"
Labeling requirements: amounts
- Licensed producers must not sell or provide any cannabis oil that will exceed 30mg per mL of delta-9-tetrahydrocannabinol (THC).
- Licensed producers must ensure that the label specifies amounts (in milligrams) of its content of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
- Licensed producers must ensure that the quantity of the fresh marihuana buds or leaves or cannabis oil is also stated in equivalency terms to one gram of dried marihuana and the information is included on the label, and information regarding the conversion method be on their websites.
Prohibited from making therapeutic claims
- Licensed producers must not make therapeutic claims in relation to marijuana unless they have otherwise received market approval under the Food and Drugs Act.
Record keeping requirements for all activities involving fresh marijuana buds and leaves and cannabis oil
- Licensed producers must continue to comply with the maintenance of records for all transactions including fresh marijuana buds and leaves and cannabis oil, which will allow for traceability of marijuana from cultivation to product, including sales and destruction records.
Adverse reaction reporting
- Licensed producers must notify Health Canada of any adverse reactions related to fresh marijuana buds and leaves or cannabis oil of which they become aware. Healthcare professionals and the public will also be able to submit adverse reactions.
Licensed producers must follow all other applicable acts and regulations.
Health Canada will continue to conduct routine inspections of licensed producers of marijuana for medical purposes, verifying their ongoing compliance with the regulations as well as with the terms and conditions in the section 56 exemption.
Find out more information regarding how to lawfully access marijuana when authorized by a physician.
Health Canada will closely monitor these changes and will make further changes as needed to continue to protect the health and safety of Canadians.
Further Information on the MMPR:
Compassion Clubs and Dispensaries are Illegal
Licensed producers must continue to comply with all provisions of the MMPR or the Department may take enforcement action. Health Canada does not license organizations such as "compassion clubs" or "dispensaries". They are illegal.
On the Marihuana for Medical Purposes Regulations
The Marihuana for Medical Purposes Regulations (MMPR) came into force in June 2013. The regulations create conditions for a commercial industry that is responsible for the production and distribution of marijuana for medical purposes. They also provide Canadians, with physician support, access to quality controlled marijuana grown under secure and sanitary conditions. The MMPR include stringent requirements with which licensed producers must demonstrate compliance, including quality control standards, record keeping of all activities and inventories, and physical security measures to protect against potential diversion.
Under the MMPR, there are 25 Licensed Producers (LPs) covering all regions of the country. Prices are reasonable, supply is meeting demand and the Department has been vigilant in overseeing compliance. The latest information also suggests that average authorizations supported by physicians have gone from almost 18g/day under the previous Program to a current average of 4g/day of dried marijuana.
Since implementation, Health Canada has issued five recalls related to the safety of regulated products as a direct result of these strong oversight controls.
Risks of Marijuana Use
There continues to be little to no scientific evidence of safety or efficacy for marijuana for medical purposes including how marijuana interacts with other substances or how it affects the body when consumed in forms other than dried. As such, Health Canada is also concerned about the risks associated with consuming marijuana, particularly the impacts on the developing brain and unintentional ingestion and overdose amongst children with marijuana products. Youth are especially susceptible to the negative effects of marijuana use, including harmful effects on mental functioning and mental health including addiction, psychosis, and schizophrenia. All fresh or dried marijuana or cannabis oil should be kept in a secure container and out of the reach of children.
Clinical Trials and Research on Marijuana-Derived Drugs
Marijuana is not an approved drug or medicine in Canada.
Health Canada does not endorse the use of marijuana and to date, Health Canada has not received any application for approval of a drug or medicine made from dried marijuana. Doctors and scientists, independent of Health Canada, pursue research to develop clinical trials to determine the benefits of potential medical treatments. Health Canada encourages clinical research to support the development of safe, effective and high quality drugs for Canadians. Health Canada does not conduct or fund clinical trials. As the regulatory authority, the department must approve or reject product applications and must, therefore, be free of even the appearance of conflict of interest in its decision-making. This is true not just in the case of marijuana, but for all substances.
Clinical trials are administered in accordance with national and international ethical, medical, and scientific standards. They are meant to gather information on clinical risks and benefits, such as proper dosage and the potential interactions with other medications. The role of Health Canada in reviewing a clinical trial application includes assessing whether these standards and protocols are in place.
Health Canada carefully considers every application for a clinical trial that is submitted. To date, the department has not rejected any clinical trial around marijuana for medical purposes. Since 2001, Health Canada has approved six clinical trials in Canada with respect to dried marijuana. Health Canada's online Clinical Trials Database is updated on a regular basis.
Find out information regarding approved clinical trials.
In addition, there are two drugs using the active ingredients found in marijuana that have been approved through Health Canada's drug regulatory approval process:
Sativex – a liquid extract of marijuana plants used in the treatment of certain symptoms associated with multiple sclerosis and certain kinds of pain; and
Cesamet – a capsule containing a synthetic version of THC, used in the management of nausea and vomiting associated with cancer chemotherapy.
Section 56 Exemptions:
Section 56 Class Exemption for Individuals Authorized to Possess or to Produce Marihuana for Medical Purposes by virtue of an interim injunction
Section 56 Class Exemption for clients and responsible persons Under the Marihuana for Medical Purposes Regulations to Conduct Activities with Cannabis
Section 56 Class Exemption to Authorize Health Care Practitioners to Conduct Activities with Cannabis
Section 56 Class Exemption to Authorize the Conduct of Activities with Cannabis in Hospitals
Section 56 Class Exemption for Licensed Producers Under the Marihuana for Medical Purposes Regulations to Conduct Activities with Cannabis
SOURCE Health Canada
For further information: Media Inquiries: Health Canada, (613) 957-2983; Public Inquiries: (613) 957-2991, 1-866 225-0709