Eisenkraft Klein D, Kesselheim AS - Health Policy
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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Eisenkraft Klein D, Kesselheim AS - Clinical Pharmacology & Therapeutics
Daval CJR, Kesselheim AS - STAT
Cai CL, Bucha S, Kesselheim AS, Rome BN - Journal of General Internal Medicine