Canada’s drug approval delays outpace even moon missions
Astronaut Jeremy Hansen’s historic flight around the moon aboard NASA’s Artemis II mission this spring marked a defining moment for Canada: the first Canadian to undertake such a journey. The mission itself spanned just 10 days, yet its preparation required nearly a decade of rigorous training and collaboration. In stark contrast, the journey from scientific discovery to making a new medication available to Canadian patients often takes even longer, sometimes twice as long or more, before it reaches pharmacy shelves. The prolonged timeline between breakthrough research and patient access stems from a system prioritizing caution over speed.
After extensive pre-clinical testing, drugs progress through three phases of clinical trials, each demanding greater scrutiny and higher costs. By the time a drug submission reaches Health Canada for approval, developers have already committed over a decade and up to $3.6 billion CAD in resources, with no assurance the drug will be listed for public use. Health Canada’s own approval process averages 300 days, a duration comparable to other regulatory bodies. However, the true delay occurs post-approval. Manufacturers establish initial pricing based on global standards, only to face steep reductions through cost-value assessments that frequently push prices to unsustainable levels.
An independent panel then negotiates with individual provinces, each of which must independently decide whether to cover the drug, sometimes reopening negotiations or rejecting coverage entirely. The result? Canada consistently ranks last in the G7 for timely access to new medicines, with only 18 per cent of globally available medicines reaching public plans, compared with the OECD average of 28 per cent. For patients, these delays translate into prolonged reliance on outdated or less effective treatments, or no treatment at all. Some Canadians travel abroad for care, a phenomenon known as medical tourism. Each month a drug remains under review represents another month of unmet medical needs.
The system’s inefficiencies do not stem from negligence but from a complex bureaucracy where caution consistently outweighs practical urgency. Canada’s scientific achievements, including the discovery of stem cells in 1961, advancements in mRNA vaccine technology, and the development of the world’s first Ebola vaccine in 2014, demonstrate the country’s capacity for innovation. What remains lacking is the corresponding urgency to ensure patients benefit from these advancements. The upcoming July 22 premiers’ meeting in Charlottetown presents an opportunity to address these systemic barriers. Provinces could advocate for federal action to streamline drug reviews, update pricing frameworks, and guarantee consistent access across the country.
