A scientist at work in CCRM’s Centre for Advanced Therapeutic Cell Technologies. Photo credit: CCRM
“Regulatory approval does not translate to dollars for a company, nor does it lead to patients being treated. Without reimbursement, all of the efforts of translation and development are lost.”
My former colleague, Mark Curtis, wrote these words back when he blogged for Signals and worked as a business development analyst for CCRM. At the time, he was reflecting on a significant obstacle facing regenerative medicine: getting innovative therapies to patients after they receive regulatory approval. A quick search of topics we have covered on Signals shows that reimbursement has remained a recurring theme for well over a decade. In that time, how much has actually changed?
In May 2026, Bettina Hamelin, President & CEO of Innovative Medicines Canada, wrote “The Cost of Red Tape: Why Canadians Have Slow and Limited Access to New Medicines.” Hamelin says that Canadians now experience the longest wait among G7 countries to obtain new and innovative medicines, a gap she believes will continue to widen as global companies prioritize markets with more predictable pricing and reimbursement environments.
Hamelin goes on to explain that how prices are determined in Canada often undermines “the financial case for bringing new medicines to Canada.” Following Health Canada approval, most medicines undergo health technology assessment and separate price negotiations before provinces decide whether to publicly fund them, creating multiple sequential steps between approval and patient access. While rigorous review is essential, the process is so laborious that “even scientifically promising therapies can become commercially unsustainable to launch here.”
The consequences of these policy and pricing challenges extend well beyond industry investment decisions. They can affect whether patients are able to benefit from emerging treatments in a timely manner.
This delay plays out in ways that hurt Canadian patients. Kelly Grant recently wrote in The Globe and Mail that “there is a 2 ½-year gap, on average, between when new medications are approved by the U.S. Food and Drug Administration [FDA] and when they’re publicly funded in at least one Canadian province.”
Grant was writing about Evan Armit, a 22-year-old with metastatic melanoma, who died in 2025 while the tumour-infiltrating lymphocyte (TIL) therapy that might have been an option for him was still undergoing regulatory review in Canada. The FDA approved Iovance Biotherapeutics’ Lifileucel, to treat metastatic melanoma, in 2024. Health Canada’s authorization came after he passed away.
TIL therapy is a cellular immunotherapy that harnesses a patient’s own immune cells to seek out and destroy cancer. It illustrates both the promise and problem of advanced therapies. It is highly personalized, complex to manufacture and potentially transformative for individuals with advanced cancers, which are characteristics that make existing reimbursement and health system pathways difficult to navigate. Laszlo Radvanyi, President and Scientific Director of the Ontario Institute for Cancer Research (OICR), and the founding Chief Scientific Officer of Lion Biotechnologies before it became Iovance Biotherapeutics, says that TIL therapy “is truly a life-saving therapy, and it will help make metastatic melanoma a survivable disease.” (Read the full interview with Dr. Radvanyi on OICR’s website.)
But breakthrough science alone isn’t enough if proven treatments aren’t available to people like Evan.
Jon Draper, Vice President, Research & Training with the Stem Cell Network, argues that our system is the bottleneck and “delivery systems are the defining challenge for regenerative medicine today.”
Dr. Draper says that we are looking at a global coordination problem. Other countries are also trying to adapt to the regulatory and reimbursement issues posed by very expensive cell and gene therapies that are more complicated to produce and distribute, particularly if you reside in less densely populated regions and low- and middle-income countries.
As I wrote in 2022, one reason the industry continues to face coverage hurdles is that payer landscapes vary considerably across countries. Health care systems differ in how funding decisions are made, the evidence required to demonstrate value, and the organizations responsible for reimbursement.
For example, a country with a predominantly publicly funded health care system, such as Canada, faces different reimbursement considerations than the United States, where payment decisions are made across a fragmented mix of public and private insurers. As well, traditional reimbursement pathways were designed around chronic therapies with ongoing costs, making it difficult to evaluate and fund one-time treatments with high upfront costs, like cell and gene therapies, whose benefits may extend over decades or could be “one and done.”
There will be no one-size-fits-all solution.
Four years on, progress has been slower than many anticipated. While reimbursement frameworks have evolved and payers have gained experience with advanced therapies, many of the fundamental challenges identified in 2022 remain. You can read “Unpacking talent and reimbursement issues at Advanced Therapies Week 2022” on Signal’s website. It mentions payment models that were emerging at that time, such as treatment milestones and subscription-based plans. Canada has made relatively limited use of managed access agreements and conditional or time-limited reimbursement arrangements compared with some other jurisdictions.
In Canada and around the world, we have an expanding number of transformative cell and gene therapies; now we need to build health systems that can deliver them to patients.
The Stem Cell Network is spearheading a “Made-in-Canada designation and prioritized pathway for advanced therapeutics” that would integrate all the steps into a predictable process, encompassing the regulatory review, health technology assessment and reimbursement model. Efforts like this suggest that workable solutions are beginning to emerge, with collaboration from regulators, payers, industry, clinicians, patients and governments. Success will ultimately be measured by whether patients can access effective advanced therapies in a timely, equitable and sustainable way.
Stacey Johnson
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