Consultations
The Patented Medicine Prices Review Board (PMPRB) is committed to listening to the voices and views of Canadians, and to including them in decision making. Effective and meaningful stakeholder involvement is essential to enable the PMPRB to fulfil its mandate, deliver programs, launch new initiatives, and build public trust.
As outlined in the Consultation Policy, the PMPRB strives to regularly engage industry and other stakeholders through a variety of channels. Dialogue leads to more creative solutions, more effective policies, and better decision making. The PMPRB undertakes the following types of consultations:
Notice and Comment initiatives
From time to time the PMPRB invites comment from the public on changes to its Guidelines, employing a Notice and Comment process.
| Notice and Comment Initiatives | Status |
|---|---|
| On the change to the definition of Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions | Closed |
| On the change to the definition of Gap medicines and the timeline for compliance | Closed |
| Incremental reforms to Compendium of Policies, Guidelines and Procedures (December 2015) | Closed |
| Consumer Price Index (CPI) initiative (October 2013) | Closed |
| Regulatory Burden Reduction: CPI and filing requirements (May 2013) | Closed |
| Compendium of Policies, Guidelines and Procedures (April 2012) | Closed |
| Proposed Rules of Practice and Procedure for Hearings (June 2011) | Closed |
| Proposed Voluntary Compliance Undertaking approval: Faslodex (June 2010) | Closed |
| Proposed Advance Ruling Certificate: Viread (2004) | Closed |
Major Consultations
When the PMPRB is considering changes to its Guidelines, Regulations or policies that it expects could have a major impact, the PMPRB may, in addition to the Notice and Comment process, host public, face-to-face consultations across Canada to ensure all stakeholders have the opportunity to provide informed, detailed responses in-person to Board Staff. These consultations are based on a detailed analysis of the issues at hand provided to participants in advance of the consultation.
| Major Consultations | Status |
|---|---|
| Consultation on the Guideline Monitoring and Evaluation Plan | Closed |
| PMPRB Draft Guidelines Consultation | Closed |
| Amendments to the Patented Medicines Regulations - Questions and Answers | Closed |
| PMPRB Guidelines Scoping Paper - High Level Overview of Potential New Framework (Canada Gazette, Part I) | Closed |
PMPRB Guidelines Modernization: Rethinking the Guidelines
|
Closed |
PMPRB Guidelines Modernization: Rethinking the Guidelines, Phase 1 (October 2016)
|
Closed |
| Closed |
Working Groups
When a potential avenue for improving the PMPRB’s Guidelines, Regulations or policies is identified, Board Staff will periodically convene a working group to address the issue. A working group is a group of experts representing key stakeholders with the goal of reporting conclusions and recommendations on technical or complex issues.
| Working Groups | Status |
|---|---|
| Steering Committee on Modernization of Price Review Process Guidelines | Closed |
| DIP Methodology Technical Working Group (January 2010) | Closed |
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