The PMPRB has released its March 2018 NEWSletter. This is the first NEWSletter posted by the PMPRB in several months.

While the details of the framework to modernize the PMPRB Guidelines remain to be worked out through consultation, its basic structure can be described as a risk-based approach to pricing review that is broken down into five main parts:

• Interim international price reference test;
• Screening;
• High priority drugs;
• Medium and low priority drugs; and
• Re-benching

In this edition of the NEWSletter, Douglas Clark, Executive Director of the PMPRB, stated the following: […]”As for what lies ahead in 2018, while we will continue to provide analytical support to our Health Canada colleagues as they push to finalize the regulatory amendments, our focus will be consulting with our stakeholders on the details of the risk-based regulatory framework described in our December scoping paper. Building on the dialogue which took place in at our annual outreach session with patentees in January, we intend to publish a draft set of proposed new Guidelines for comment in the spring and strike technical working groups on discrete components of that framework through the summer and early fall, with a view to finalizing the document by December. We recognize that this is an aggressive timetable given the very technical nature of the subject matter and that success will depend on constructive engagement with all of our stakeholders. While some may disagree with aspects of these changes or their underlying policy rational, we are hopeful that stakeholders of all stripes will recognize that it is in everyone’s interests to work towards the best, most technically sound document that time allows.” […]

Stakeholders will have to stay tuned to the PMPRB’s website and NEWSletter for more information on next steps concerning the consultation process on Guideline reform.

Other news include:

• 2018 CPI-Based Price-Adjustment Factors for Patented Drug Products

The following table provides the CPI-Based Price-Adjustment factors for 2018. These factors were based on the actual rate of CPI inflation of 2.0% in 2014, 1.1% in 2015 and 1.4% in 2016.

The year-over-year price increase cap for the 12-month period ending December 2018 is 2.1% (=1.5 x Actual Inflation in 2016).

•  Message from the Chairperson on the 30th anniversary of the PMPRB
• Federal Court of Appeal reiterates constitutional validity of the PMPRB
• 2016 PMPRB Annual Report
• PMPRB Hearing Panel issues decision in Soliris Case
• PMPRB bids farewell to Elaine McGillivray
• NPDUIS update: Engagement activities
• New and upcoming publications
• Voluntary Compliance Undertakings
• Summary of the Board’s September 2017 and January 2018 meetings

For more information, please consult the March 2018 PMPRB NEWSletter found here.