Marjorie Michel, Canada’s Health Minister, is taking significant steps to streamline the country’s drug approval process, which currently ranks among the slowest in developed nations. In the past, Health Canada has come under fire for its extensive review times. On top of that, the agency has an extraordinarily high rate of applications rejected. So far, about three-quarters of the time, Health Canada has asked for more information, but 90% of applications do go on to eventually getting approved.
In July, Michel threw down the gauntlet with a massive investment of $1.3 billion in research funding to develop and promote the province’s pharmaceutical industry. This funding is part of a broader effort to enhance drug approval processes, a goal that aligns with Prime Minister Mark Carney’s commitment to improving efficiency and reducing bureaucratic red tape in Canada’s health system.
Michel is working hand-in-hand with her provincial counterparts to tackle the issue. She further pointed out that Health Canada timelines are frequently longer than those of European regulatory agencies, pointing to the need for urgent reforms. “Where I can push is, yeah, we cannot take eight months to let them know,” she stated, emphasizing the urgency of improving communication with applicants.
Health Canada has been meeting a lot of criticism for its poor response times. Applicants are annoyed by the long lag time before they are notified of a paperwork or other error. Today, applicants wait an average of eight months for the department to inform them of these issues. Michel hopes to cut this timeframe down dramatically, knowing how critical fast feedback is for pharmaceutical companies.
And if work does need to be done, then that person needs to know that as early as possible,” she reiterated. Michel’s comments highlight her interest in reassuring applicants that they will be updated during the course of review.
The Canadian Generic Pharmaceutical Association, which represents most of the manufacturers of relatively low-cost generic drugs, has long supported efforts to speed up approvals. The association is adamant that the industry would be better served by a more efficient system. It would support patients’ ability to get faster access to medications.
As a next step to make the process more efficient, Michel is looking to improve coordination with regulators in other countries. “Because if a drug is approved somewhere, we trust that [they] have the same regulations than we have or quite the same, well, maybe it can speed up the process,” she explained. The substance behind this approach is an attempt to harness international best practices in drug regulation and approval.
Even with these attempts to shorten timelines, Michel is deeply committed to safety. She understands that speeding up approvals can’t be done by cutting corners on robust safety reviews. “Safety cannot be compromised in the drug approval process,” she reiterated.
Toronto, Ontario—Canada is trying to improve its drug approval processes. Under Michel’s visionary leadership and with his steadfast, proactive efforts, new therapies will hopefully find their way to patients much quicker than before. Her efforts encourage collaboration between federal, provincial and territorial governments. By moving in concert with international benchmarks, they would set themselves on the path to a more agile, accountable healthcare system.
