By Mata Press Service

Canadians are waiting significantly longer than patients in peer countries to access new prescription medicines, according to a major comparative study released this month, raising fresh concerns about how federal drug approval policies are shaping health outcomes.

The study, Timely Access to New Pharmaceuticals in Canada, released by the Fraser Institute, finds that 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 delays apply to medicines already deemed safe and effective by regulators in the United States and European Union, including treatments for cancer, autoimmune diseases, cardiovascular conditions, and rare disorders.

The report examined 196 new drugs approved by Health Canada over the six-year period and compared their approval timelines with those of the US 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. Pharmaceutical companies typically filed applications in Canada hundreds of days after submitting the same drugs in the U.S. or EU, pushing Canadian access further down the line

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, according to the study’s analysis of submission and approval dates.

By the time approvals were finalized, the cumulative delay left Canadian patients waiting close to two years longer in many cases.

Kristina Acri, a senior fellow at the Fraser Institute and lead author of the study, said the findings point to structural issues in Canada’s pharmaceutical policy framework rather than isolated administrative bottlenecks. “In some cases, pharmaceutical companies will wait up to a year after a drug has been approved in the U.S. or Europe before submitting that same drug for approval in Canada,” Acri said in the institute’s news release.

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. Together, those conditions may reduce the commercial incentive for manufacturers to prioritize Canada when launching new therapies.

The impact is not limited to delays alone. 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, meaning Canadian patients had no access regardless of medical need.

Many of the missing therapies fall into high-impact categories such as oncology and immunology. Antineoplastic and immunomodulating agents accounted for the largest share of drugs approved abroad but unavailable in Canada, underscoring the potential clinical consequences of delayed or absent access for patients with serious and life-threatening conditions

The study also found that priority medicines did not escape the pattern. Drugs given expedited or conditional review status in Canada still reached U.S. and European patients far sooner. 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

While Health Canada has made incremental gains in review efficiency relative to Europe, the report concludes that these improvements are outweighed by late submissions and duplicative regulatory requirements. Canada independently reassesses drugs already vetted by trusted regulators using similar scientific standards, a process the authors argue adds time without meaningfully improving safety outcomes

The Fraser Institute study 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. Such agreements, the authors argue, could accelerate access without compromising patient safety.

Beyond patient outcomes, the report warns of broader system-level costs. Delayed access to newer medicines has been linked in prior research to higher hospitalization rates, lower treatment adherence, and increased long-term health-care spending. The study cites evidence showing that newer “vintage” drugs are associated with longer life expectancy, fewer adverse effects, and improved quality of life.

Canada’s aging population and rising burden of chronic disease only heighten the stakes, the authors argue. As demand for advanced therapies grows, delays in access risk widening health disparities between Canadian patients and those in comparable high-income countries.

“Innovative medicines can have a profound impact on health and wellbeing,” Acri said. “Unfortunately, Canadians are often denied these benefits for months, if not years, waiting for government to approve drugs already available elsewhere” .

The findings arrive amid ongoing federal debates over drug pricing reforms and pharmacare expansion, adding pressure on policymakers to balance cost containment with timely access. The study cautions that without changes to regulatory and market conditions, Canada may continue to fall behind its peers in introducing new treatments, regardless of downstream coverage decisions.

By the Numbers

90+ weeks
Average delay for Canadian patients compared with the United States for access to new medicines approved between 2019 and 2025.

65+ weeks
Average delay compared with Europe for the same drugs and period.

194 drugs
Approved in both Canada and the U.S.; U.S. approval came 636 days earlier on average.

174 drugs
Approved in both Canada and the EU; EU approval came 459 days earlier on average.

586 days
Average gap between U.S. and Canadian submission dates, showing drugs are filed far later in Canada.

501 days
Average gap between EU and Canadian submission dates.

145 drugs
Approved in the U.S. and/or EU between 2019 and 2025 that were not approved in Canada at all during the study period.