spring 2013

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The lowdown on marijuana for medical purposes

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A national poll recently conducted for the Canadian Medical Association found that 85 per cent of Canadians believe that medical marijuana should go through the same rigorous testing and approval as other medicines.

By NLMA Staff

A national poll recently conducted for the Canadian Medical Association found that 85 per cent of Canadians believe that medical marijuana should go through the same rigorous testing and approval as other medicines.

The online survey of 1,000 Canadians was conducted during the week of February 24 by Ipsos Reid on Health Canada’s proposed Marihuana for Medical Purposes Regulations (MMPR). It found that a majority of Canadians (79 per cent) agree that Health Canada, as the body that approves prescription medicines for safety and efficacy, should maintain its current role in authorizing the use of medical marijuana for patients. An overwhelming majority of Canadians (92 per cent) also thought it important that Health Canada not remove itself from its oversight role until such guidelines become available for physicians.

Under the current Marihuana Medical Access Program (MMAP), people can apply to Health Canada for authorization to possess marijuana for medical purposes and can be licensed to grow their own or designate someone else to grow it for them.

The MMAP requires a person to have the support of a medical practitioner when applying for authorization to possess marijuana to alleviate symptoms associated with multiple sclerosis, spinal cord injury or disease, cancer, HIV/AIDS, severe forms of arthritis, epilepsy and chronic pain. People who have debilitating symptoms caused by other medical conditions can apply to obtain an authorization to possess marijuana, if a specialist confirms the diagnosis and that conventional treatments have failed or are inappropriate.

The newly proposed Marihuana for Medical Purposes Regulations, which are expected to come into force in spring 2013, will change the way Canadians access marijuana for medical purposes. The most significant change is the removal of Health Canada from the approval process, making it a transaction between the patient, the practitioner and a licensed marijuana producer.

Section 125 of the regulatory proposal will reduce the content of the authorization form, from its current two-page format to a brief document requiring little more than the information that is required for a standard medical prescription. Patients will then be able to purchase the marijuana from an authorized vendor. The industry will set its own prices and sell a variety of strains that will be subject to security requirements and inspections.

Section 124 of the proposed regulations authorizes health care practitioners to “sell, provide or administer dried marijuana.” This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that “Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party.”

Both the MMAP and the MMPR will operate concurrently until the new MMPR regulations are fully implemented by March 31, 2014. All authorizations to possess and licenses to produce issued under the old MMAP program will then expire.

In the past decade, Health Canada’s Marihuana Medical Access Program has grown exponentially, from under 500 authorized persons in 2002 to over 26,000 today.

Interestingly, Health Canada states on its website that “Marihuana (marijuana, cannabis) is not an approved therapeutic substance in Canada and no marihuana product has been issued a notice of compliance by Health Canada authorizing sale in Canada.” Health Canada’s Information for Health Professionals document also contains a disclaimer stating that the information “should not be construed as expressing conclusions from Health Canada about the appropriate use of marihuana for medical purposes.”

According to the Food and Drugs Act (FDA), all drugs requiring a health professional’s authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs. However, because of its unique legal position, Health Canada has exempted medical marijuana from the applications of the Act and its regulations.

One of the reasons why Health Canada and the Federal Government continue to permit physicians to prescribe medical marijuana is because they are constrained by the decisions of Canadian courts. Federal courts have consistently sided with patients’ rights to relieve symptoms of terminal disease or certain chronic conditions, despite the limited data on the drug. However, the Courts have not addressed the ethical position in which physicians are placed as a result of becoming the gatekeeper for access to a medication without full knowledge of its effectiveness, proper dosage, or short and long-term side effects.

When Federal Health Minister Leona Aglukkaq introduced the MMPR last December, she issued a 75-day comment period to allow stakeholders to provide input into the proposed changes. The CMA submitted its brief in February outlining concerns that Health Canada was abdicating its duty in the authorization process. It argued that physicians should not be put in the position of gatekeepers for a proposed medical intervention that has not undergone an established regulatory review process as required for all other prescription medicines.

The CMA recommends that physicians not prescribe marijuana for medical purposes due to the failure of governments and manufacturers to provide adequate information regarding quality, effectiveness and safety. However, the CMA accepts that physicians who feel qualified to recommend medical marijuana to their patients are able to do so in accordance with Health Canada’s regulations.

It is important to note that physicians are not legally obligated to prescribe, recommend, or assist patients to obtain treatments that they believe, on sound medical grounds, to be clinically inappropriate. Physicians who wish to authorize the use of marijuana for patients in their practices should first consult relevant CMPA and CPSNL policy and use the CMPA “Release from Liability” form to ensure appropriate medico-legal protection.



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