Chapter 13 - Regulating Therapeutic Use of Cannabis 

Marihuana medical access regulations

 

As stated above, there are two parts to the Marihuana Medical Access Regulations (MMAR): part 1, authorization to possess, and part 2, licence to produce. One of the objectives of the regulations is to provide a compassionate framework to allow  access to marijuana for medical purposes.

 

The regulations establish a compassionate framework to allow the use of marijuana by people who are suffering from serious illnesses, where conventional treatments are inappropriate or are not providing adequate relief of the symptoms related to the medical condition or its treatment, and where the use of marijuana is expected to have some medical benefit that outweighs the risk of its use.[1][24]

 

As will be reviewed in detail, the MMAR are intended to provide access to marijuana in special circumstances only: in the case of serious medical conditions where conventional treatment may not provide adequate symptomatic relief. Health Canada explains that this limitation is due to “the health risks associated with the smoked form in particular, and due to the lack of evidence supporting the claimed health benefits.”[2][25]  

Significantly, the application of the MMAR is limited to “Cannabis (marihuana)” as referred to in sub-item 1(2) of Schedule II of the CDSA. Thus, the regulations do not provide access to other cannabis-related products.

The key provisions of the MMAR are as follows.

 

Authorization to possess

Three distinct categories have been established in relation to authorization to possess dried marijuana, each with its own application requirements. In each case, the application is to be submitted by the patient, whose declaration must include information identifying the applicant and indicating that:

 

vv     The applicant is aware that no notice of compliance has been issued under the Food and Drugs Act concerning the safety and effectiveness of marijuana as a drug and that the applicant understands the significance of that fact; and

vv     The applicant has discussed the risks of using marijuana with a medical practitioner and consents to using it for the recommended medical purpose.

 

Category 1

vv     Eligibility: Applicants who suffer from a symptom associated with a medical condition for which the prognosis is death within 12 months.

v     Conditions: A medical practitioner must provide a medical declaration indicating, among other things:

··               The applicant’s medical condition and the symptom that is associated with that condition or its treatment;

··               The applicant suffers from a terminal illness;

·               All conventional treatments for the symptom have been tried or considered;

··               The recommended use of marijuana would mitigate the symptom;

··               The benefits from the applicant’s recommended use of marijuana would outweigh any risks associated with that use;

··               The medical practitioner is aware that no notice of compliance has been issued under the Food and Drug Regulations concerning the safety and effectiveness of marijuana as a drug;  

··               The applicant’s recommended daily dosage and period of use.

 

Category 2

vv     Eligibility: Applicants who suffer from specific symptoms associated with some serious medical conditions, specially:  

··               Multiple sclerosis: severe pain and/or persistent muscle spasms;

··               Spinal cord injury: severe pain and/or persistent muscle spasms;

··               Spinal cord disease: severe pain and/or persistent muscle spasms;

··               Cancer: severe pain, cachexia, anorexia, weight loss, and/or severe nausea;

··               AIDS/HIV infection: severe pain, cachexia, anorexia, weight loss, and/or severe nausea;

··               Severe forms of arthritis: severe pain; and

··               Epilepsy: seizures.[3][26]

 

 

 

 

 

Source: Application for Authorization to Possess Dried Marihuana, Category 2 – Medical Specialist Form

 

v     Conditions: Applicants must provide a declaration from a medical specialist to support their application, indicating, among other things:

··               The applicant’s medical condition and the symptom that is associated with that condition or its treatment;

··               The specialist practises in an area of medicine that is relevant to the treatment of the applicant’s medical condition;

·               All conventional treatments for the symptoms have been tried or considered and were found to be medically inappropriate for reasons outlined in the Regulations;

··               The recommended use of marijuana would mitigate the symptom;

··               The benefits from the applicant’s recommended use of marijuana would outweigh any risks associated with that use, including risks associated with long-term use of marijuana;

·               The medical specialist is aware that no notice of compliance has been issued under the Food and Drug Regulations concerning the safety and effectiveness of marijuana as a drug; and

··               The applicant’s recommended daily dosage and period of use.

 

Category 3

vv     Eligibility: Applicants who have symptoms associated with a medical condition, other than those described in Categories 1 and 2.

vv      Conditions: Declarations from two medical specialists must accompany the application. The first declaration must indicate all information required  under Category 2; all conventional treatments that have been tried or considered for the symptom; and the reasons, from those outlined in the Regulations, why the medical specialist considers that those treatments are medically inappropriate.

· 

 

Source: Application for Authorization to Possess Dried Marihuana, Category 3 – First Medical Specialist Form

 

 

 

v     The second declaration must indicate that, among other thingss:  the specialist has reviewed the applicant’s medical file and the reasons why the conventional treatments are considered to be medically inappropriate; the specialist has discussed the applicant’s case with the first specialist and agrees that the recommended use of marijuana would mitigate the symptom, and the benefits of the applicant’s recommended use of marijuana would outweigh any risks associated with that use, including the risks associated with long-term use of marijuana; and the second specialist is aware that no notice of compliance has been issued under the Food and Drug Regulations concerning the safety and effectiveness of marijuana as a drug.

· 

Dosage

The medical practitioner or specialist sets the daily dosage. If the recommended daily dosage is more than 5 grams per day, the medical practitioner or specialist must indicate that he or she has considered the risks associated with an elevated daily dosage of marijuana, including risks with respect to the effect on the applicant’s cardio-vascular, pulmonary and immune systems and psychomotor performance, as well as the potential for drug dependency; and that in his or her medical opinion, the benefits of the applicant’s use of marijuana according to the recommended daily dosage would outweigh the risks associated with that dosage, including risks associated with the long-term use of marijuana.

 

Maximum quantity possessed

The authorization to possess specifies the amount that may be possessed at any given time is a 30-day treatment supply. As explained above, the medical practitioner or specialist sets the daily dosage used to determine the 30-day treatment supply.

 

Duration

Generally, authorizations to possess are valid for one year and may be renewed.

 

Licence to produce

There are currently two possible legal sources for holders of an authorization to possess: they can grow their own supply or they can designate someone else to grow it for them. Health Canada has stated that, in the future, they should also be able to obtain it from a licensed supplier.

Only holders of an authorization to possess (personal-use production licence) or someone who has been designated as their representative (designated-person production licence) are eligible to hold a licence to produce. A designated person cannot be remunerated for their activities.

Conditions for obtaining a licence to produce include the following:

 

vv     A person cannot be the holder of more than one licence to produce;

vv     One site may be used for the production of marijuana under a maximum of three separate licences;

vv     The holder of a licence to produce must maintain measures necessary to ensure the security of the product;

vv     The production of marijuana outdoors is not permitted if the production site is adjacent to a school, public playground, day care facility or other public place frequented mainly by persons under 18 years of age;

v     A person is ineligible for a designated-person production licence, who has been found guilty of a designated drug offence in the previous 10 years.

 

The licence specifies the maximum number of plants that may be cultivated. The licence also deals with the maximum quantity of dried marijuana that may be kept in storage and, in the case of a designated representative, the transportation of marijuana. The maximum amount of marijuana that may be cultivated and stored at any time depends on the daily dosage that has been set by the medical practitioner or specialist, and whether plants are grown indoors or outside. The regulations also deal with inspection powers and record-keeping requirements.

 

Other provisions

There are also provisions dealing with matters such as: measures to ensure the security of the marijuana in the possession of an authorized person; the revocation of licences; the showing of documents to police officers; the referral to police of complaints received by inspectors; and the disclosure of information about a medical practitioner to provincial licensing authorities of medicine. Of note is a transitional provision extending section 56 exemptions for an extra six months after the date of their expiry.

Health Canada has established an ongoing review process to monitor the effectiveness and application of the MMAR and provide advice on future measures related to the manufacture, distribution and sale of marijuana for medical purposes. This process involves a series of activities intended to collect information and seek input on various aspects of the MMAR. A 15-member committee representing a number of different stakeholder groups is currently being established, with a its first meeting planned in October 2002.