Recent data reveal a troubling trend: Health Canada is taking longer to assess generic and biosimilar drug submissions, delaying the arrival of cost-saving prescription medications on the market, and increasing costs for Canadian taxpayers and patients. As the federal government prepares to unveil its budget on November 4, it is vital that it address these delays through strategic investments in Health Canada’s resources and staffing.

Both the number and complexity of drug submissions received by Health Canada have been increasing for many years but resources for its drug review programs have remained largely static and chronically underfunded. In contrast, regulators in other countries have seen similar submission trends and made the strategic hiring investments needed to meet increased demands and maintain predictable business operations.

The issue is pressing. Today, there are more than 500 generic submissions under review at Health Canada, and the volume continues to rise. Between 2016 and 2023, the number of generic submissions filed grew by 43 percent. More than 100 generic drug submissions are now in backlog, with many more submissions poised to join them. At this rate, without added review resources, it will take Health Canada years to clear the backlog, while patients continue to pay more for their medicines. 

These delays have tangible consequences. In Canada, generic medicines are dispensed to fill nearly 80 percent of all prescriptions yet account for less than 23 percent of the $49-billion Canadians spend annually on prescription drugs and can provide up to 90 percent savings off the price of their brand-name equivalents. Biosimilar medicines now fill about 13 percent of all biologic drug prescriptions in Canada, and usage is growing. All provincial and federal drug programs have adopted transition policies to maximize the savings from biosimilars. 

Each day of delayed drug competition can result in millions of dollars in extra costs for the health-care system that federal and provincial drug plans, businesses who provide drug benefit programs for their employees, and individual Canadian patients who pay for medicines out of pocket cannot afford. At the same time, drug plans are being denied the financial headroom provided by the use of generics and biosimilars to fund new treatments for patients.

These delays also hurt the federal government’s bottom line as it increases costs for the four federally-funded public drug programs – Canadian Armed Forces, Correctional Services Canada, Non-Insured Health Benefits for First Nations and Inuit, and Veterans Affairs Canada. It also increases costs for the federal government through its funding of the Public Service Health Care Plan for federal government employees and their families, which provides drug coverage for about 1.7 million Canadians.

Investing in Health Canada’s review capacity isn’t just about resolving current backlog issues; it’s a strategic move to restore Health Canada’s reputation as a world-class regulator and ensure Canada remains aligned with international standards. Other countries can approve similar drugs in half the time. Harmonizing standards and approval timelines could improve efficiency, reduce delays, attract more investments in domestic generic drug manufacturing, and ensure Canadians timely access to affordable medicines. 

The upcoming budget is an opportunity to prioritize timely access to cost-saving medicines for Canadians and properly fund a core business service provided by the federal government – 75 percent of the cost of which is recovered through user fees paid by industry. Health Minister Marjorie Michel has publicly recognized the importance of streamlining processes and enhancing collaboration with the European Medicines Agency and other regulatory peers without compromising safety standards. While these are important initiatives, they do not address the root cause of the issue – a significant double-digit shortage of review staff to handle current and future workloads.

Ultimately, faster generic and biosimilar drug approvals will translate into significant savings for taxpayers, employers and patients, fostering a competitive environment that better supports domestic manufacturing and investment. The current government’s commitment to cutting red tape and speeding up drug approvals should be backed by concrete investments in Health Canada drug review staff.

Delays in reviewing generic and biosimilar medicines threaten to keep cost-savings medicines out of Canadians’ hands longer than necessary. By directing resources to strengthen Health Canada’s capacity in the upcoming budget, the federal government can ensure that generic medicines reach the market faster, controlling costs, promoting competition, made-in-Canada production, and safeguarding public health. It is time for decisive action; Canadians deserve no less.

Jim Keon is President of the Canadian Generic Pharmaceutical Association (CGPA) and its Biosimilars Canada division