Drugs manufactured in Canada combined with drugs imported into Canada from the U.S. are not enough to meet the needs of the Canadian market, let alone the demands of the U.S. mail-order market.

A review of Canadian government pharmaceutical production and trade data reveals that American pharmaceutical exports to Canada, combined with Canadian pharmaceutical production, provides less than the required amount of drugs to meet the needs of the Canadian drug market alone. Canada has to rely on imports from countries other than the U.S. to meet its own pharmaceutical supply needs. American advocates of importing prescription drugs from Canada via mail order often claim that these products are “FDA approved” drugs either manufactured in the U.S. and re-imported from Canada or manufactured in Canada. Drugs imported into the U.S. by mail are more likely to be drugs manufactured for the Canadian market and diverted from Canadian pharmacy shelves or drugs manufactured for other foreign markets.

Internet mail order drug sellers circumvent the safeguards that protect Canada’s drug supply. Health Canada ensures the safety of Canada’s drug supply system by setting high standards for domestic pharmaceutical production; by establishing mutual recognition agreements for pharmaceutical good manufacturing practices with 18 other countries; and by requiring import establishment licenses for approved wholesalers. According to a Health Canada enforcement directive “foreign suppliers, which have commercial sales organizations in Canada, are using Canada’s personal use exemption for commercial purposes" and "to evade the submission review process for individual products, and/or the Establishment License requirements for importers. This has ramifications related to safety because large quantities of products, which have not been reviewed for safety and/or efficacy, and which are of unknown quality, can enter the country and be distributed. The lack of an importer also means no person is responsible for meeting GMP requirements such as appropriate record retention or recall mechanisms". Importation schemes that circumvent the Canadian and American laws and regulations that safeguard the drug supply chain and also those laws that ensure the safe prescribing and dispensing of prescription put consumers and patients in both countries at unnecessary risk.