The Patented Medicine Prices Review Board (PMPRB) has released its April 2016 NEWSletter. Some recent changes include:
Public Consultation on PMPRB Framework Modernization
In December 2015, the PMPRB released its 2015-2018 Strategic Plan, the culmination of a year-long strategic planning process that identified a new vision, a revised mission statement, and four strategic objectives. One of these objectives, Framework Modernization, includes a commitment by the PMPRB to examine changes to its regulatory framework to ensure that it continues to fulfill its mandate of protecting consumers from excessively priced patented medicines in the face of recent and significant changes in its operating environment. As a first step, the PMPRB will publish PMPRB Guidelines Modernization: Discussion Paper for spring 2016. The Discussion Paper seeks public and stakeholder feedback on a range of questions relating to potential Guideline reform and its release will be followed by a number of events that will provide further opportunity for public participation including:
- Cross-country face to face meetings with interested members of the public and key stakeholders
- Public policy hearing
- Multi-stakeholder round table
Update: Notice and Comment on Incremental Changes to the Guidelines
On December 4, 2015, a Notice and Comment initiative was announced on two proposed amendments to the Compendium of Policies, Guidelines and Procedures. The PMPRB received written submissions from 12 stakeholders and is currently analyzing the feedback. The PMPRB will develop options for the Board to consider at its next meeting in May 2016. Next steps in this process will be announced in June 2016 following the Board’s meeting.
Information Sessions Available: PMPRB Price Regulation Framework
Patentees may request one-on-one introductory information sessions on the PMPRB price regulation framework. These sessions are facilitated by the Regulatory Affairs and Outreach branch and can be conducted in person at the PMPRB offices in Ottawa or remotely using webinar technology.
Voluntary Compliance Undertakings
A Voluntary Compliance Undertaking (VCU) is a written undertaking by a patentee to adjust its price to conform to the Board’s Guidelines. In the first quarter of 2016, four (4) VCUs were accepted by the PMPRB Chair.
Other news include:
- Form 2 Filing Requirements for New Patented Medicines
- Updates on Hearings
- NPDUIS Update: Engagement Activities
- New and Upcoming Publications
- Summary of the Board’s February 2016 Meeting
For more information, please consult the April 2016 PMPRB NEWSletter found here.