International report - PMPRB seeks more efficient use of its resources 06 Jun 12
Fasken Martineau DuMoulin LLP - Canada
The Patented Medicine Prices Review Board (PMPRB) has sought stakeholder comments on proposed changes to its Compendium of Policies, Guidelines and Procedures related to thresholds for opening an investigation and offsetting de minimis excess revenues.
With respect to thresholds for opening an investigation, the PMPRB has proposed to eliminate the 5% investigation trigger at the national level for existing drug products. The present criterion for commencing an investigation for existing drug products when the national average transaction price exceeds the non-excessive average price by 5% will trigger a high number of investigations with cumulative excess revenues that are less than C$50,000. It is believed that the avoidance of investigations involving amounts of excess revenue less than C$50,000 will result in a more efficient use of the PMPRB's resources.
To offset de minimis excess revenues (ie, an amount that does not trigger the investigation criteria), the PMPRB proposes that the three-year period that is allowed at present to offset such revenues through a voluntary compliance undertaking be replaced by a requirement to offset in a timely manner. Investigations are not triggered for drug products with a de minimis excess revenue balance. In the absence of a voluntary compliance undertaking, the only existing option is to proceed to a public hearing, which has led to delays in collecting de minimis excess revenues. It is the PMPRB's belief that it would be more efficient if patentees were required to offset excess revenues less than the de minimis amount in a timely manner.
The deadline for providing feedback on the proposed changes was 14th May 2012.
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