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Published on: December 11, 2016
Deeming Doesn't Deliver: Reliance on foreign regulators targets the wrong stage of Canadian drug access
Daniel Eisenkraft Klein1, Aaron S Kesselheim1
1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
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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