In recent years, many critics have raised alarms that new prescription drugs are not being introduced into Canada. They generally compare Health Canada to the U.S. Food and Drug Administration (FDA), which approves more new drugs annually than any other drug regulator. Like all regulators, the large majority of drugs that the FDA approves are not any better than existing medicines.
The right wing Fraser Institute recently ran a commentary arguing that between 2006 and 2014, 80 per cent of the drugs submitted to the U.S. Food and Drug Administration (FDA) were also submitted to Health Canada. But, according to them, by 2020 that number had dropped to 40 per cent. Two of the main types of drugs that critics claim are missing are for rare diseases and for cancer.
In its brief to the House of Commons about changes in how the federal Patented Medicine Prices Review Board defines an “excessive” price of a new drug, the Coalition Priorité Cancer au Québec issued a warning. If the changes went ahead, “drug manufacturers will no longer invest in Canada, as is already the case in many countries and jurisdictions where they do not intend to launch new medicines.”
The Canadian Organization for Rare Disorders (CORD) prominently claims that “only 60 per cent of treatments for rare disorders [orphan drugs] make it into Canada”.
Is the situation as bad as they claim? And, even more importantly, are the drugs that are not making it into Canada important therapeutic advances? From 2011 to 2023, the FDA approved 542 new drugs. Seventeen of the drugs that were initially approved were later discontinued, the manufacturers submitted applications for 11 drugs to Health Canada but withdrew the applications before a decision was made and four drugs were still being reviewed by Health Canada as of late 2025. That leaves 510 drugs that could potentially have been approved in Canada.
A total of 376 (that is 73.7 per cent) were approved by Health Canada and 134 (26.3 per cent) were never submitted. Out of 51 FDA-approved drugs, (two more were discontinued), Health Canada approved 36 (70.6 per cent), contrary to the Fraser Institute’s shocking claim of only 40 per cent. . The authors of that piece also didn’t bother to point out that more drugs were likely to be approved in Canada after the agency finishes collecting data.
During the 2011 to 2023 period, the FDA approved 273 new orphan drugs—of which Health Canada approved 197 (72.2 per cent) for the same conditions, not the 60 per cent claimed by CORD.
The FDA approved 136 new drugs for cancer and Health Canada approved 121 (89.0 per cent) of these. The changes to how the PMPRB functions went into effect on January 1, 2026, although court challenges struck down two of the three proposed changes. It’s too early to be sure how the change will affect the introduction of new cancer drugs, but out of the 49 cancer drugs that the FDA approved from 2020 to 2023, when policymakers were hotly debating the changes, Health Canada approved 79.6 per cent of them.
What about the additional therapeutic value of drugs that aren’t available to Canadians? There are two organizations, one in France and one in Germany, along with a French journal that evaluate the therapeutic value of new drugs versus older drugs that treat the same condition. They then rate the new drugs as either major, moderate or minor advances.
These organizations have evaluated 47 of the 134 drugs that were not sold in Canada. Four were major advances, seven were moderate advances, and 36 were minor advances. There were relatively few evaluations for drugs for rare diseases—three were major advances, two were moderate advances and 18 minor advances, but that leaves 53 without evaluations. Finally, one of the 16 cancer drugs not marketed in Canada was a moderate advance and five were minor advances.
The overall take away from all these numbers is that at least 70 per cent of all drugs approved by the FDA end up being sold in Canada and for cancer drugs that figure is even higher. When therapeutic evaluations are available, the large majority of all missing drugs were only a minor therapeutic advance, but such evaluations were frequently unavailable.
Some drugs that are major advances are not being sold in Canada, but we don’t know how many. Health Canada is no help in this regard. It only looks at whether drugs perform either better than placebos or as at least as well as drugs already on the market. It doesn’t make a decision whether a new drug is better than existing ones.
Canada’s Drug Agency (CDA), the body that recommends to the provinces and territories (except Quebec) whether they should fund new drugs, does make comparisons between old and new drugs, but only for drugs that are already on the Canadian market. CDA should expand its mandate to also evaluate drugs sold in the U.S. or the European Union but not in Canada. At the same time, the federal government needs to develop a plan to get faster public coverage at affordable prices for those drugs that are major therapeutic advances.
Some critics may be overblowing some of the numbers about Canada’s drug approval deficit compared with the United States, but that doesn’t mean there is no work to be done. Both Health Canada and the CDA should be adopting best practices from elsewhere in the world in order to ensure Canadians have continually improving access to major advances in treatment in one of our great sources of national pride—our public health care system.
