09

Aug2019

HEALTH CANADA AMENDMENTS TO PMPRB REGULATIONS

PMPRB and Health Canada held two technical briefings on the soon-to-be published final amendments to the Patented Medicines Regulations (PMR) on August 9th, 2019. This coincided with the pre-release of the final regulatory text and an updated Regulatory Impact Analysis Statement (RIAS). Publication in Canada Gazette II is expected August ... Read More

18

Jun2019

PMPRB Announces New Board Vice-Chairperson

Effective June 14, 2019, Mélanie Bourassa Forcier is Vice-Chairperson of the Patented Medicine Prices Review Board (PMPRB)    Professor Bourassa Forcier is an Associate Professor in the Faculty of Law at the Université de Sherbrooke, and directs the Law and Health Policy, and Law and Life Sciences programs. ... Read More

14

Jun2019

Forthcoming Revised PMPRB Guidelines

Mark down June 26th, 2019 in your calendars. It is now widely expected the patented medicines price regulations will be in Canada Gazette Part II (CGII), volume 151 No.13, which will be released on June 26th. Draft PMPRB Guidelines for consultation will likely be published immediately following CGII publication. Comments earlier this week from Federal Health Minister Petitpas-Taylor, appeared to confirm these expectations. When asked in an interview surrounding when changes to the ... Read More

27

Aug2018

PMPRB 2017 Annual Report Released

PMPRB published its 2017 annual report this week, recalling an eventful year (complete with proposed amendments to its overarching regulations, poised to fundamentally change its future mandate & operations) and looking forward in 2018 to working constructively with stakeholders to finalize its Guidelines modernization initiative, underway since 2016. PMPRB 2017 Annual ... Read More

11

May2018

PMPRB’s May 2018 NEWSletter Updates Guideline Reform Timelines

PMPRB has released its May 2018 NEWSletter which includes anticipated updates on PMPRB’s timelines for its Guidelines modernization initiative: June 2018: PMPRB to release more specific guidance on how the PMPRB foresees operationalizing regulatory changes PMPRB to form a multi-stakeholder Working Group to gather input on key technical aspects of ... Read More

08

Mar2018

PMPRB March 2018 NEWSletter Released

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 ... Read More

07

Feb2018

PMPRB Form 3 (R&D) Due Date Reminder

This is a reminder to patentees of their filing requirements respecting revenues and development expenditures. These filing requirements are contained in section 5 of the Patented Medicines Regulations. All patentees must submit their Form 3 information for 2017 by March 1, 2018. Form 3, the template created by the PMPRB to ... Read More

11

Dec2017

PMPRB Releases Guidelines Scoping Paper with Overview of Potential New Framework

Following the December 2, 2017 publication of proposed amendments to the Patented Medicines Regulations in Canada Gazette Part I, and the corresponding publication of the Regulatory Impact Assessment Statement, PMPRB has published a Guidelines Scoping Paper providing “…an outline of the PMPRB’s preliminary thoughts on how best to operationalize ... Read More

04

Dec2017

PDCI Webinar: Proposed Amendments to Patented Medicines Regulations – What Patentees Need to Know

Join us for a webinar on Dec 06, 2017 at 2:00 PM EST. Register now! Join PDCI’s Founder and Principal Consultant, Neil Palmer on this industry only webinar as he discusses the proposed amendments to the Patented Medicines Regulations as published in Canada Gazette Part 1 on December 2, 2017. What ... Read More

01

Dec2017

Proposed Amendments to Patented Medicines Regulations Announced

Proposed regulatory text of amendments to the Patented Medicines Regulations is published by the Governor-in-Council in Canada Gazette Part I (CG1) on December 2, 2017.  Interested persons may submit comments on the proposed regulations within 75 days of publication in CG1 (by ... Read More