Deeming Doesn’t Deliver: Reliance on Foreign Regulators Targets the Wrong Stage of Canadian Drug Access

Eisenkraft Klein D, Kesselheim AS - Health Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence

Summary:

The authors argue that Health Canada’s proposal to deem certain drug submission requirements met based on foreign regulatory decisions targets the wrong stage of Canada’s drug access pipeline. The primary drivers of delayed access are manufacturers’ late submissions and prolonged public reimbursement processes, not regulatory review times. More impactful reforms would include incentives for earlier manufacturer filings, enforceable timelines for reimbursement negotiations, and a pan-Canadian listing default to meaningfully accelerate patient access to new therapies.

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