The urgency felt when facing a cancer diagnosis is real, and a measured approach to treatment is clinically sound. However, questions are being raised regarding the length of time it takes for new medications to be approved in Canada, and particularly in Québec, by bureaucratic authorities.
Studies indicate that years of life are lost due to these delays in Canada and Québec(1, 2). The process begins with Santé Canada’s initial approval, based on extensive clinical trials, which can take months, or even over a year. This is followed by an evaluation of the therapeutic value, considering a drug’s effectiveness compared to existing treatments, its efficacy-to-side-effect ratio, and its cost per quality-adjusted life year (QALY).
Rising Drug Costs
This evaluation is complex, requiring not only scientific judgment but also social, ethical, and moral considerations regarding the impact of the disease. The increasing cost of innovative medications adds to the challenge, driven by stricter regulatory requirements, the complexity of producing biological products, and reduced patent profitability due to lengthy approval times.
Governments are facing rising drug budgets, especially in oncology due to a growing patient population and high treatment costs. While budgetary concerns are valid, they do not explain the prolonged decision-making processes that restrict access to potentially life-saving medications.
A Complex System
The process is complicated by the multiplication of evaluation and decision-making bodies. It is becoming increasingly difficult to ensure adequate funding and access to multiple antineoplastic agents for the many patients who are waiting for these therapies. The process includes review by the Canadian Agency for Drugs and Technologies in Health, and uniquely in Québec, by the Institut national pour l’excellence en santé et services sociaux (INESSS).
If a positive recommendation is made, the Pan-Canadian Pharmaceutical Alliance negotiates discounted pricing. Each province then has the opportunity to further negotiate. These steps can take months, or even years. As an example, only 20% of cancer drugs presented for funding in Québec in 2025 were reimbursed.
Québec’s Restrictions
Québec previously had measures in place to expedite access to medications upon Santé Canada approval, but these have been significantly curtailed in recent years, coinciding with budget constraints for hospital medications. This combination of restrictions is making oncological practice more difficult and hindering the adoption of innovation.
As one observer noted, “It is proof that an innovation is not necessary when it is too difficult to establish.” It is possible that delaying access to new medications is a consequence of these budgetary pressures, masked by delays in report production and ministerial decisions.
Frequently Asked Questions
What is the role of Santé Canada in the drug approval process?
Santé Canada is responsible for the initial approval of medications, based on large-scale clinical trials. This process can take months, or even over a year.
What is the QALY and why is it important?
QALY stands for quality-adjusted life year. It is a measure used to assess the value of a medication, considering both its effectiveness and its impact on a patient’s quality of life.
Does Québec have a unique process for drug approval compared to other provinces?
Yes, Québec has the INESSS (Institut national pour l’excellence en santé et services sociaux) conduct a similar evaluation to the Canadian Agency for Drugs and Technologies in Health, a step that no other province takes.
Considering the complexities and potential consequences of these delays, what changes could be made to expedite access to potentially life-saving cancer treatments for patients in Canada and Québec?
