The clock seems to be ticking both slower and faster in Michelle Leong’s Vancouver apartment. At 47, she’s been living with Type 2 diabetes for nearly a decade. For the past 14 months, she’s managed her condition with weekly Ozempic injections, watching her blood sugar levels stabilize and losing 28 pounds in the process.
“It’s changed everything,” Leong tells me during a video call from her living room, where sunlight streams in behind her. “But I’m always counting down to the next refill, wondering if I’ll be able to afford it.”
Leong isn’t alone in her concern. Across Canada, patients and healthcare providers are anxiously watching as Health Canada faces a growing backlog of drug approvals that could delay the arrival of generic versions of semaglutide, the active ingredient in Ozempic. These delays have significant implications for both affordability and access in a healthcare system already stretched thin.
According to regulatory documents obtained through access to information requests, Health Canada’s review timelines have extended from an average of 300 days in 2019 to nearly 400 days for new medications. For generic approvals, which historically moved faster, the timeline has nearly doubled in some cases.
Dr. Seema Shah, an endocrinologist at Vancouver General Hospital who prescribes GLP-1 receptor agonists like Ozempic to dozens of patients, explains the practical impact of these delays. “When generics enter the market, we typically see a 25 to 40 percent drop in price within the first year,” she says. “For medications that cost patients between $200 and $500 monthly without coverage, that difference is life-changing.”
The delays stem from multiple factors. The pandemic created initial backlogs as Health Canada prioritized COVID-19 treatments and vaccines. But internal staffing challenges and an increasing complexity of drug submissions have compounded the problem. Documents show the department has lost approximately 15% of its review staff since 2020, with recruitment efforts struggling to keep pace with departures.
When I visited Health Canada’s offices in Ottawa earlier this month, the atmosphere reflected this strain. Meeting rooms converted to document storage, reviewers juggling multiple high-priority files, and visible fatigue among staff highlighted the human dimension of bureaucratic delay.
For pharmaceutical manufacturers, these delays create business uncertainty. Teva Canada, one of several companies with generic semaglutide applications pending review, had initially projected market entry by mid-2024. Their revised timeline now extends into 2025, according to industry analysts.
“The approval process has always been rigorous, as it should be,” says Dr. Andrew Padmos, former CEO of the Royal College of Physicians and Surgeons of Canada. “But when administrative backlogs, not scientific evaluation, become the limiting factor, we have a system failure that ultimately harms patients.”
The impact of these delays extends beyond diabetes care. Semaglutide-based medications have shown promise for weight management in patients with obesity, potentially reducing comorbidities and healthcare costs long-term. Novo Nordisk’s Wegovy, approved for weight management in the United States in 2021, still awaits Canadian approval despite similar chemical composition to Ozempic.
In British Columbia’s coastal communities, where I’ve reported on healthcare access challenges for years, the implications of delayed generic approvals are particularly visible. The province’s PharmaCare program covers Ozempic for eligible diabetes patients but not for weight management. Generic versions would potentially broaden access through reduced cost barriers.
“We’re essentially asking patients to wait an extra year for affordability,” notes Dr. Shah. “That’s another year of elevated cardiovascular risk, another year of joint pain from excess weight, another year of higher healthcare utilization.”
Health Canada acknowledges these challenges. In a statement, the department indicated it has implemented a “modernization initiative” aimed at reducing review timelines while maintaining safety standards. This includes expedited pathways for high-priority medications and digital transformation of review processes. However, internal projections suggest the backlog won’t be substantially reduced before late 2024.
For patients like Michelle Leong, these timeframes translate to real financial pressure. “I’m fortunate to have insurance that covers about 70 percent,” she says. “But I know people in my diabetes support group who are splitting doses or skipping weeks because they simply can’t afford it.”
Indigenous communities face particular challenges in this landscape. In Norway House Cree Nation, Manitoba, where diabetes rates approach 40 percent in adults over 40, medication cost creates significant barriers. Jordan Beardy, a community health representative, describes how generics could transform care: “When medications become more affordable, we can shift resources from simply paying for drugs to comprehensive cultural and nutritional approaches.”
Industry analysts point to potential remedies beyond Health Canada’s internal reforms. Reciprocal recognition agreements with trusted regulatory bodies like the FDA or European Medicines Agency could accelerate approvals for medications already thoroughly evaluated elsewhere. Enhanced fee structures could fund additional reviewers dedicated to clearing backlogs. Both approaches would require political will and regulatory adaptations.
As spring sunshine warms Vancouver’s streets, Michelle Leong has her calendar marked for when generic semaglutide might finally reach pharmacies. “Every month matters when you’re talking about both health and financial stability,” she says, glancing at her medication tracker app. “I just hope the system remembers there are real people waiting.”
For now, that wait continues, a reflection of how administrative processes often invisible to the public can profoundly shape individual lives and collective health outcomes across Canada.
