Which medical conditions qualify for treatment with cannabis products? What other rules and restrictions govern medical use of cannabis (eg, dosage limits)?
The regulation of medical cannabis falls under the exclusive jurisdiction of the federal Cannabis Act and the Cannabis Regulations made under it.
Medical conditions that may qualify for treatment with cannabis products include:
- attention deficit disorder and attention deficit hyperactivity disorder;
- Alzheimer’s disease;
- back and neck problems;
- brain injury;
- chronic nausea;
- chronic pain;
- Crohn’s disease;
- eating disorders;
- gastrointestinal disorders;
- hepatitis C;
- HIV and AIDS;
- irritable bowel syndrome;
- kidney failure and dialysis;
- multiple sclerosis;
- muscle spasms;
- muscular dystrophy;
- Parkinson’s disease;
- post-traumatic stress disorder;
- severe arthritis;
- sexual dysfunction;
- sleep disorders; and
- spinal cord injury and disease.
There are no restrictions on the daily cannabis amount that a physician may prescribe; however, there is a possession limit equal to the lesser of 150 grams of dried cannabis (or its equivalent in fresh cannabis or oils) or 30 times the daily amount of cannabis authorised.
The federal Cannabis Regulations also introduced a cannabis drug licence that authorises the licence holder to manufacture and sell a drug (as defined in the Food and Drugs Act) that contains cannabis.
What licensing requirements apply for physicians seeking to prescribe cannabis products to patients?
The regulation of medical cannabis falls under the exclusive jurisdiction of the federal Cannabis Act and the Cannabis Regulations made under it. Accordingly Ontario’s cannabis legislation defers to the federal regime for medical cannabis.
There are no special licensing requirements that must be satisfied for physicians to prescribe medical cannabis products to patients. However, physicians should be aware of the policies or guidelines promulgated by their provincial self-governing regulatory bodies (eg, in Ontario, the College of Physicians and Surgeons of Ontario) before prescribing medical cannabis.
What licensing requirements apply for pharmacies seeking to dispense cannabis products?
The federal Cannabis Regulations govern the sale of cannabis by holders of a cannabis drug licence and Sections 170 to 182 apply specifically to pharmacists.
In Ontario, pharmacies may obtain a retail licence under the Cannabis Licence Act 2018 to sell cannabis as a recreational product. However, if a pharmacy wants to dispense medical cannabis, a federal sale licence must be obtained under the federal Cannabis Act. Pharmacists that are federally licensed to sell medical cannabis can dispense it on registration of a medical document obtained from an applicable healthcare provider.
How are cannabis products covered by health insurers (both public and private)? Are there any rules or restrictions in this regard?
Ontario’s insurance companies are beginning to make changes to their policies by offering coverage for medical cannabis. However, coverage is restricted at this time, with only a small range of conditions being included in policies, such as:
- cancer with severe or refractory pain;
- nausea and vomiting due to cancer treatment;
- multiple sclerosis with neuropathic pain or spasticity;
- rheumatoid arthritis with pain that has not responded to standard therapy;
- HIV and AIDS with anorexia or neuropathic pain; and
- patients requiring palliative care.
Insurers are expected to conduct periodic reviews of evolving clinical evidence supporting the use of medical cannabis for various conditions.
Insurers will likely require claimants to be registered with Health Canada in accordance with the requirements of the federal Cannabis Regulations as they relate to access to cannabis for medical purposes.
What opportunities are available for cannabis businesses to cooperate with healthcare providers, pharmaceutical companies and research institutes in the development of new medical cannabis products? Are there any notable regulatory considerations in this regard?
The regulation of medical cannabis is under the exclusive jurisdiction of the federal government, pursuant to the Cannabis Act and the Cannabis Regulations.
They provide three classes of licence that form the foundation of a licensing framework that will permit the development and commercialisation of new medical cannabis products.
The three licence classes are:
- cannabis drug licences;
- research licences; and
- analytical testing licences.
The holder of a cannabis drug licence is authorised to manufacture and sell a pharmaceutical drug that contains cannabis. The prerequisite for applying for a cannabis drug licence is that the company must already hold a drug establishment licence under the Food and Drug Regulations. Obtaining both licences would permit the possession, production or manufacturing, distribution and sale of cannabis pharmaceuticals.
Although research and development activities can be conducted under other licence classes, holders of research or analytical testing licences are ideally positioned to operate in the healthcare industry for the purposes of developing new medical cannabis products to be commercialised by holders of cannabis drug licences or cultivate or process licences as well.