Drug Regulation and Formulary System in Canada
Canadians do not have universally funded Pharmacare. They do, however, in most provinces, have income-adjusted access to a formulary of approximately 4000 medications. Health Canada’s federal drug regulation system works similarly to the FDA in the USA and EMEA in Europe. Manufacturers bring drugs for approval based primarily on efficacy while demonstrating acceptable safety. Promising medications for serious conditions where there is a high need for better therapies are sometimes granted Notice of Compliance with Conditions (NoCC) where additional evidence must be gathered to confirm initial impressions of efficacy and safety. This is an important distinction from full Notice of Compliance (NoC) as NoCC medications frequently do not turn out to be safe and effective.
Once cleared by Health Canada with NoC, medications are usually submitted to the Common Drug Review at CADTH (Canadian Agency for Drugs and Technology in Health) for recommendations regarding funding through public formularies in the provinces and territories. This requires an additional and more rigorous standard of evidence based on societal value, systematic review of the evidence with economic analysis of cost-effectiveness, and burden of illness.
The recommendations from the expert advisory committees based on the above review, are then considered by the individual provinces/territories and a formulary designation made. In Ontario, this is managed by the Ontario Public Drug Benefit Program. This program covers, seniors 65 years and older, children and youth 25 years and younger, those on disability or social assistance, and those with extreme drug expenditures relative to household income.
Drug Product Database online query (canada.ca)
The Drug Review and Approval Process in Canada
CADTH. Reimbursement Reviews. 2020.
CMPA. Medication Safety. 2021.