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Deeming Doesn't Deliver: Reliance on foreign regulators targets the wrong stage of Canadian drug access

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  • Eisenkraft Klein, Daniel
  • Kesselheim, Aaron S.

Abstract

Canada's federal government recently proposed allowing Health Canada to deem certain drug submission requirements met based on foreign regulatory decisions. Proponents frame this as a solution to delayed drug access. Yet the major contributors to delayed access to new drugs in Canada are manufacturers' late submissions and prolonged public reimbursement processes—not regulatory review times. This Policy Comment argues that the proposal targets the wrong stage of the access pipeline. We propose feasible alternatives — earlier filing incentives, enforceable reimbursement clocks, and a pan-Canadian listing default — that would meaningfully accelerate patient access to new therapies in Canada.

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  • Eisenkraft Klein, Daniel & Kesselheim, Aaron S., 2026. "Deeming Doesn't Deliver: Reliance on foreign regulators targets the wrong stage of Canadian drug access," Health Policy, Elsevier, vol. 170(C).
    • Handle: RePEc:eee:hepoli:v:170:y:2026:i:c:s0168851026000746
    DOI: 10.1016/j.healthpol.2026.105637
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