Results of the Notice and Comment Period on Incremental Reforms to the Compendium of Policies, Guidelines and Procedures
On December 4, 2015, the PMPRB 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: the “Reasonable Relationship Test (Schedule 4)” and the “List Price Relative to Maximum Average Potential Price (MAPP) Verification (Section C.11).” Since issues raised were larger than the narrow set of line extensions the proposal was intended to address, the PMPRB decided against implementing the amendment. 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. A detailed review of both amendments, as originally proposed, is available on the PMPRB website. The finalized text of the “List Price Relative to MAPP Verification” amendment will be made available online in September.
2017 HDAP Meeting Schedule
The following table provides the submission deadlines for the HDAP meetings in 2017:
|HDAP Meeting Date||Filing Deadlines|
|Product Monograph (1)||Submission (2)|
|February 27, 2017||November 14, 2016||December 8, 2016|
|May 29, 2017||January 19, 2017||February 16, 2017|
|September 18, 2017||May 25, 2017||June 22, 2017|
|December 4, 2017||July 27, 2017||August 24, 2017|
(1) One (1) copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada) and the proposed level of therapeutic improvement.
(2) One (1) electronic copy of patentee submission.
For more information, please click on the following link.
Rethinking the Guidelines: Public and Stakeholder Comments Invited
Stakeholders and members of the public are invited to submit feedback in response to the Guidelines Modernization Discussion Paper and the series of questions it puts forward as part of the first phase of a major consultation that will ultimately modernize and simplify the regulatory framework around patented drug pricing in Canada. Written comments and feedback must be submitted to the PMPRB by October 24, 2016. All comments will be considered public and will be published on the PMPRB website. Comments and feedback may be submitted by e-mail, letter mail or fax to:
Patented Medicine Prices Review Board
(Rethinking the Guidelines)
Box L40, 333 Laurier Avenue West, Suite 1400
Ottawa, Ontario K1P 1C1
Other news include:
- Federal Court Dismisses Challenge to Constitutionality of PMPRB
- New Expression of Interest Process for Potential Outside Counsel to Board Staff
- Voluntary Compliance Undertakings
- Summary of the Board’s May 2016 Meeting
For more information, please consult the July 2016 PMPRB NEWSletter found here.