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The Human Toll: Exploring the Patient Impact of Regulatory Delays for Medications in Canada

Timely access to medications is an essential contributor to health and well-being, with the majority of adults in developed countries reporting that they take at least one prescription drug. Efforts to increase access have largely focused on a narrow list of essential medicines, but for patients with rare conditions and life-threatening illnesses, access to innovative drugs that may still be in the later stages of clinical trials has the chance to improve quality of life and, in some cases, save lives. With its status in the top 25 countries worldwide in terms of GDP per capita, Canada should be able to provide its citizens with access to the latest innovative medications, but unacceptable regulatory delays have stood in the way of this.

The Human Toll: Exploring the Patient Impact of Regulatory Delays for Medications in Canada

Why timely approval matters


A report from the Montreal Economic Institute noted that 73% of increases in life expectancy in recent decades for a sample of 30 countries could be attributed to new pharmaceuticals. The report also noted that the largest declines in premature mortality rate were seen for the types of cancer that had the most pharmaceutical innovation.


Health Canada’s review process takes, on average, nearly a year once a drug is submitted for review. A priority process exists for certain types of potentially lifesaving medications; these drugs move to the front of the queue, but the regulatory body often misses its identified target of reviewing these drugs within 180 days of submission. A 2022 study concluded that delays in review for one particular type of oncology drugs—those that treat non-small cell lung cancer—affected 6,400 patients across Canada, who lost up to 1,740 person-years of life, with quality of life impacts valued at $112 million.


Aside from delays in regulatory approval, delays in listing of drugs on the provinces’ public formularies also pose a barrier to access. The time from approval to listing averages two years in Canada—double the OECD average—according to a January 2024 report from the Conference Board of Canada. This report also noted that approvals for rare disorder medications can take up to six years longer in Canada than in the U.S. or Europe—and that 1 in 12 Canadians lives with a rare disorder—according to the Canadian Organization for Rare Disorders.



Reducing time to market for high-impact medications


The implementation of a “rolling review” process for medicines and vaccines during the COVID-19 pandemic has shown that such a process—in which manufacturers submit incomplete applications and update them as more information becomes available—can effectively expedite approval while effectively protecting patient safety.


The recent creation of a temporary access process for medications with promising early results means drugs can be submitted for review sooner rather than waiting until all three phases of clinical trials are complete. This is a positive step that will potentially give millions of patients quicker access to medications that can alter the course of their treatment. In addition, Canada might consider partnerships with selected foreign regulatory authorities to fast-track review or grant provisional approval for medications that have already undergone a thorough review process in a partner country (or, in the case of simultaneous review, process harmonization). This could especially help expedite the process in the case of drugs whose manufacturers submit their products for sequential review rather than to multiple markets at once, since the U.S. and the EU are likely to come before the smaller Canadian market.



Upholding a high standard of patient safety


Getting drugs to market faster has the potential to impact both patients’ quality of life—as they not only have more time with loved ones, but are able to take part in the economy thanks to better health—and the cost of their treatment—if medications can slow down the progress of their disease and reduce the need for costly emergent or hospital-based care down the line. This is why Canada’s regulatory bodies cannot ignore the cost of delayed access.


Any new initiatives adopted should be subject to thorough review so patient safety remains paramount. For example, policymakers should analyze whether faster approvals are associated with more frequent adverse events or post-marketing safety revisions. The cost of these outcomes can be evaluated in comparison with the opportunity cost of keeping patients waiting for medications they need as the approval process drags on.


In addition to monitoring the cost-benefit balance of bringing drugs to market faster, policymakers should look for ways to speed time to market with no downside. For example, this might include investing in staff and in the pipeline of professionals with the technical skills needed to perform reviews of new drugs. It might also include improving coordination and reducing bureaucratic red tape to accelerate the timeline for addition of drugs to provincial formularies. By the time medications reach this point in the approval process, their safety and efficacy has already been proven. Prompt listing of these drugs on public plans (which cover one-third of Canada’s population) can help reduce the disparities in quality of care between Canadians who have private insurance and those that rely on public options.

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