Incremental Reforms to Compendium of Policies, Guidelines and Procedures
Result of this Notice and Comment initiative
On December 4, 2015, the Patented Medicine Prices Review Board announced the start of a Notice and Comment initiative to seek stakeholder feedback on two proposed amendments to the Compendium of Policies, Guidelines and Procedures (Guidelines): the “Reasonable Relationship Test (Schedule 4)” and the “List Price Relative to Maximum Average Potential Price (MAPP) Verification (section C.11).”
Following a thorough review of stakeholder comments and further analysis by Board Staff, the Board concluded the “Reasonable Relationship Test” proposal raised issues that are larger than the narrow set of line extensions the proposal was intended to address and, as such, decided against implementing the amendment. It is the Board’s view that these larger issues should be addressed within the context of a broader framework modernization initiative.
The Board decided in favour of the “List Price Relative to MAPP Verification” amendment, which will be implemented effective September 1, 2016 with minor modifications from the original proposal.
The prices found in the Association québécoise des pharmaciens propriétaires; IMS Health; McKesson Canada; Ontario Drug Benefit Programs; PPS Pharma; and the Régie de l’assurance maladie du Québec for a new patented drug product shall not exceed the MAPP established by the appropriate introductory price test(s). A price from these sources found to exceed the MAPP would trigger an investigation by Board Staff, who would, as a first step, confirm with patentees whether the list price in question is a price at which ex-factory sales are being made to one or more customers in any market in Canada. If it is found that such sales have taken place, an investigation would proceed in accordance with the Guidelines.
A detailed review of both amendments, as originally proposed, and the finalized text of the “List Price Relative to MAPP Verification” amendment are available.
Public comments received