Study says Canadians wait far longer than U.S. and European patients for new drugs
A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
Canadians are waiting significantly longer than patients in peer countries to access new prescription medicines, according to a major comparative study released this month. Canadian patients waited an average of more than 90 weeks longer than Americans and 65 weeks longer than Europeans to gain access to new drugs approved between 2019 and 2025.
The study, Timely Access to New Pharmaceuticals in Canada, found that of the 194 drugs approved both in Canada and the United States between 2019/20 and 2024/25, the FDA granted approval an average of 636 days earlier, with a median of 371 days, than Health Canada for drugs subject to standard review. Of the 174 drugs approved in both the EU and Canada between 2019/20 and 2024/25, the EU granted approval earlier by an average of 459 days, with a median of 211 days, than Canada for drugs subject to standard review.
The report examined 196 new drugs approved by Health Canada over the six-year period and compared their approval timelines with those of the U.S. Food and Drug Administration and the European Medicines Agency. Of the drugs approved in Canada, nearly all had already been approved in the U.S., and almost 90 percent had been approved in Europe, often years earlier.
The most striking finding was not just the length of the delay, but where it occurred. While Health Canada’s review process was found to be somewhat slower than the FDA’s and faster than the EMA’s, the dominant factor was late submission. On average, drugs were submitted to U.S. regulators 586 days earlier than to Health Canada, while European submissions preceded Canadian ones by 501 days.
The study said the majority of this delay is in the submission of new drugs for approval in Canada, citing market attractiveness including price controls and formulary requirements, rules on drug pricing, regulatory and administrative burdens, and public and private insurance policies. The study suggests several factors may be discouraging earlier submissions to Health Canada, including Canada’s smaller market size, federal price controls, reimbursement uncertainty, and weaker intellectual property protections compared to other jurisdictions.
The researchers also identified 145 drugs approved in the U.S. or Europe between 2019 and 2025 that were not approved in Canada at all during the study period. In most cases, those drugs were never submitted to Health Canada. Antineoplastic and immunomodulating agents accounted for the largest share of drugs approved abroad but unavailable in Canada.
The study also found that priority medicines did not escape the pattern. For priority drugs, FDA approvals occurred an average of 659 days earlier than Health Canada approvals, while EMA approvals preceded Canadian ones by 640 days.
The report concludes that incremental gains in review efficiency relative to Europe are outweighed by late submissions and duplicative regulatory requirements. It renews calls for Canada to consider mutual recognition agreements with the U.S. and EU, allowing approvals by the FDA or EMA to serve as sufficient grounds for market access in Canada, while preserving Health Canada’s authority over post-market surveillance and safety warnings.