Patented Medicine Prices Review Board invites comments on proposed policy amendments

Overview

Food and Drug Law
Food and Drug Regulatory Law The Canadian Patented Medicine Prices Review Board (PMPRB) regulates the prices of many drugs in Canada. Recently, the PMPRB proposed changes to its policies and procedures, and interested parties are invited to submit comments on the proposed changes.

The first change the PMPRB is proposing is to the application of the “Reasonable Relationship” test, by which an acceptable price for a new patented drug is established by comparison to the Canadian price of “comparable” drugs with the same chemical entity and indication and dosage regimen as the new drug. Currently, the PMPRB considers “the lowest publicly available price” of the comparable drugs, as determined from publicly available industry sources. Under the new proposal, in cases where the new drug and the comparable drugs are owned by the same entity, PMPRB will instead use the non-excessive National Average Transaction Price of the comparable drugs to determine the acceptable price for a new patented drug.

The second proposed change is a new requirement that the “list price” of a new patented drug (as calculated from publicly available industry sources) falls below the Maximum Average Potential Price determined by the PMPRB. This change is intended to address the growing disparity between the publicly available “list price” and the National Average Transaction Price, caused in part by “proliferation of non-transparent pricing and market segmentation pricing strategies.”

Interested parties are invited to submit comments to the PMPRB until January 15, 2016.

The proposals may be found on the PMPRB website here.

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