Many of us have had a relative, friend, or coworker who gets their medications from Canada. For many of us, this sparks a stream of questions: “Are Canadian medications legit? How are medications approved in Canada? Is it legal to buy prescription medications from Canada?” You may be surprised to discover that Canada and the United States (U.S.) are very similar in their drug approval process; some may even say they are near identical.
Similarities between the U.S. and Canadian drug approval process
Both Health Canada and the U.S. Food and Drug Administration (FDA) have processes which drug companies must follow in order to get medications approved. Both processes have three phases of clinical trials as well as a post-marketing phase.1 Even though the processes are so similar for prescription medication approval, it is still illegal to import drugs or devices into the U.S. for personal use.3 The FDA’s reasoning behind this is that they cannot ensure “safety and effectiveness” of the medications being imported. Many of you may then be asking, “What if it’s a medication like Lisinopril that is already approved in the U.S.?” This is a gray area and even the FDA is vague on the topic saying these are “circumstances in which the FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs.”4
Why are Canadian medications so much cheaper?
The Patented Medicine Prices Review Board (PMPRB) “protects and informs Canadians by ensuring that the prices of patented medicines sold in Canada are not excessive and by reporting on pharmaceutical trends.” Furthermore, Canada has a law that states the price of a new medication, first of its kind, cannot exceed the median price for the rest of the world.2 As discussed above, the Canadian drug approval process is just as rigorous as the U.S., therefore if you decide to purchase from a Canadian pharmacy, one way to verify that it is legit is to look for the pharmacy license number to be shown on the website.2 Unfortunately, the United States is the only industrialized country that doesn’t utilize price controls for pharmaceuticals resulting in astronomical drug prices. The U.S. federal government reported that in 2012, around 5 million Americans had purchased drugs outside the U.S.
Over-the-Counter (OTC) Medications
Along with cheaper prescription medications, Canada also has cheaper over-the-counter (OTC) medications, too. However, unlike prescription medications, it is legal to buy OTC medications from Canada.5 To determine whether the product is legit, look for the product label to contain an 8-digit Drug Identification Number (DIN), which means it has met Canadian standards for safety, quality, and effectiveness.5
“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices;”3 therefore the safest option is to obey the FDA regulations.
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- “Comparison: Canada and United States.” National Institute of Allergy and Infectious Diseases, U.S. Department of Health and Human Services, 8 Feb. 2018, https://clinregs.niaid.nih.gov/country/canada/united-states#_top.
- Kirschner, Chanie. “Why Are Pharmaceuticals Cheaper in Canada?” MNN – Mother Nature Network, Mother Nature Network, 5 June 2017, https://www.mnn.com/health/fitness-well-being/questions/why-are-pharmaceuticals-cheaper-in-canada
- Office of Regulatory Affairs. “Import Basics – Personal Importation.” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, 3 Aug. 2018, https://www.fda.gov/forindustry/importprogram/importbasics/ucm432661.htm
- Osterweil, Neil. “Buying or Importing Prescription Drugs: Laws and Regulations.” WebMD, WebMD, www.webmd.com/healthy-aging/features/letter-and-spirit-of-drug-import-laws.
- Canada, Health. “Regulation of Non-Prescription Drugs.” ca, Innovation, Science and Economic Development Canada, 21 Feb. 2018, https://www.canada.ca/en/health-canada/services/self-care-regulation-non-prescription-drugs.html