This article originally appeared in National Newswatch.
By Nigel Rawson and John Adams, November 21, 2025
Once again, Canada’s many layers of bureaucratic gatekeeping are blocking Canadian patients from accessing an innovative new drug.
Earlier this fall, the pan-Canadian Pharmaceutical Alliance (pCPA) announced its negotiations on behalf of Canadian government drug plans had ended with the makers of Carvykti—which clinical studies have shown is an important new treatment for relapsed or refractory multiple myeloma, the second most common blood cancer in Canada. Canada’s two agencies that assess new drug cost-effectiveness—Quebec’s Institut national d’excellence en santé et services sociaux (INESSS) and Canada’s Drug Agency (CDA)—had recommended government drug plans reimburse Carvykti.
The termination of negotiations means Carvykti is unlikely to be covered by Canadian public drug plans. Canadians with multiple myeloma will be treated with older, less effective medicines, while patients in the United States, Belgium, France, Italy, Portugal, Spain, and Japan have Carvykti access.
This is a glaring example of Canada’s failure to deliver on appropriate drug use: the proper prescribing of safe medicines to provide the greatest possible health benefits. Instead, patients are left depending on older, cheaper, less effective, and less precise drugs because state-of-the-art medications are delayed or unavailable in Canada. Medicines for cancer and rare diseases are particularly affected, despite widespread unmet health-care needs.
CDA has launched its pan-Canadian Strategy for Advancing the Appropriate Use of Prescription Medicines. As a component of the federal Pharmacare Act, Health Canada funded the strategy’s development. Its proposals include increasing awareness and understanding of appropriate use; implementing a promising practices program; connecting people to existing appropriate use resources; promoting collection, access, and use of relevant data; and sharing lessons learned.
There are multiple reasons why inappropriate medication use occurs. Poor diagnosing and prescribing by physicians may stem from inadequate doctor-patient communication due to confusing jargon, time and billing constraints, and poor health literacy. Patients may not take medications as prescribed. However, the inability to access up-to-date therapies is yet another cause—one that focuses on health-care system shortcomings rather than doctors and patients.
But the CDA’s strategy focuses on the overuse and underuse of medications. It’s a limited perspective. Moreover, there’s no mention of what baseline will be used or how any change prompted by the strategy will be evaluated. Without these measures, it’s impossible to see how success can be determined.
The strategy also doesn’t state who will assess its impact or whether it is cost-effective—a bizarre omission because CDA’s original purpose is assessing the cost-effectiveness of new drugs for government plans. If CDA is to assess its own work, we are unlikely to have a genuinely independent measure of success or failure, especially since CDA is sheltered from public oversight through traditional accountability mechanisms like freedom of information requests, whistleblowing, Auditor General of Canada reviews, and ombudsman or integrity commissioner investigations.
Health Canada, CDA/INESSS, and the pharmaceutical alliance are three of five gatekeepers that drug developers must satisfy to get their medicines covered by government plans. The 14 federal, provincial, and territorial government drug plans collectively form another layer—independently deciding whether to reimburse drugs, and sometimes declining to do so despite medicines having cleared the previous hurdles. There’s also the Patented Medicine Prices Review Board which assesses whether list prices are “excessive.”
These gatekeepers have a deterrent effect on where drug developers place Canada on their priority lists for new launches. They often choose other countries with less onerous processes before Canada. About a third of new drugs are not launched here at all.
Even when developers bring new medicines to Canada, these gatekeepers cause substantial time delay: three to four years is common, and government drug plan listings frequently vary by jurisdiction. This means Canadians face delayed or blocked access, and publicly funded coverage depends on where patients live.
It’s time for the federation to assess how it can do better. Recently, Enbridge president and CEO Greg Ebel outlined five steps Ottawa and provincial governments should take to improve Canada’s infrastructure environment: smarter, simpler regulations; shorter, predictable timelines; rewards, not punishments, for progress; and coherent policy to attract beneficial new opportunities.
In a similar way, our federal and provincial governments should reform the world’s most burdensome and complicated system of new drug regulation, assessment, and coverage—whose effects are to delay and too often deny patient access to innovative medicines and better health outcomes.
Nigel Rawson and John Adams are senior fellows at the Macdonald-Laurier Institute.
