Access to new medicines in Canada, Europe, and the United States: Study finds less availability and longer waits for Canadian patients

TORONTO, April 11, 2024 (GLOBE NEWSWIRE) -- A recent study published by the Canadian Health Policy Institute examined the availability and wait times for access to new drugs, accounting for product launches, marketing authorizations, and insurance coverage under publicly funded drug plans in Canada, Europe, and the United States.

Data showed that Canada was a low priority market for new drug launches. The number of new drug applications submitted in Canada was only 54% of the number launched in the United States, and 62% of those launched in the European Union.

Health Canada subsequently approved fewer new drugs compared to the European Medicines Agency and the US Food and Drug Administration. Only 69% of the new drugs authorized for marketing in the United States were also approved in Canada. Of the drugs authorized for marketing in the EU, 78% were also approved in Canada.

On average, Canada’s public drug plans covered only 12% of the new medicines covered by US Medicare part D drug plans, and 14% of the new drugs covered by European public drug plans.

In total, publicly insured Canadians waited an average of 4 years to access new drugs, from the first date that a new drug application was launched in any of the 3 markets, to the date the drug was positively listed on the formulary of a public drug plan. This was 2.5 years longer than Americans insured under Medicare, and 2.2 years longer than publicly insured Europeans.

The study recommends 4 policy options to address the lack of access to new medicines in Canada:

  • Health Canada should automatically and immediately recognize new drug approvals occurring first in either the EMA or the FDA. Regulatory harmonization could have potentially made an additional 171 new drugs available to Canadians and could have reduced the overall wait by 2 months.
  • Canada should adopt the German model and allow immediate interim insurance coverage for new medicines following marketing authorization, with permanent insurance coverage pending the outcome of post-market price and reimbursement negotiations. This could have reduced wait times by more than 2 years.
  • The federal government should end its price control regime. Research has shown that price regulation is a significant disincentive in company decisions about prioritizing markets for new drug launches.
  • Patent term restoration should compensate pharmaceutical companies for regulatory approval delays, and subsequent delays caused by HTA, price and reimbursement negotiations.

The study is available free of charge at

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