25

Apr2022
On April 14, 2022, Health Canada announced that the government will:  Proceed only with the proposed amendments to the Regulations pertaining to schedule of reference countries (the PMPRB11 replacing the PMPRB7).   Not proceed with new excessive price factors (cost effectiveness, market size, GDP) nor the reporting of third-party ... Read More

04

Apr2022
On March 31, 2022, PMPRB published its 2020 Annual Report on its website. Key statistics reinforce concerns about Canada’s continued attractiveness for new medicine investment and launch since drug pricing reform began in 2017. Statistical Highlights201820192020Total # of Patented Medicines for Human Use Reported ... Read More

25

Mar2022
On September 29, 2021, the Attorney General of Canada applied for leave to appeal to the Supreme Court of Canada concerning the Federal Court of Appeal’s (FCA) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). On March 24, 2022, the Supreme Court of Canada ... Read More

22

Feb2022
On February 18, 2022, the Quebec Court of Appeal ruled that two of the three major proposed changes to the PMPRB price regulations are unconstitutional: As more information becomes available, PDCI will share further insights and implications for ... Read More

14

Feb2022
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. The Annual Form 3 filing to the PMPRB is due on March 1, 2022. As ... Read More

17

Dec2021
On October 28th, 2021, PMPRB provided their first update to the Notice & Comment that was issued on July 15, 2021. The primary takeaway is PMPRB will be providing patentees two reporting periods for compliance, a change from PMPRB's earlier position expecting one reporting period for ... Read More

29

Jun2021
This morning, June 29th, 2021, Health Canada announced an additional 6-month delay in implementation of the Patented Medicines Regulations and Final PMPRB Guidelines.  The changes will now come into force on January 1, 2022. The reasons cited by Health Canada for the delay are the ongoing COVID-19 pandemic and need ... Read More

14

Jun2021
Information regarding the PMPRB guidelines and the upcoming webinar can be found here. Registration is required to attend the webinar and can be completed here. Online Filing Tool & Transition Measures for Grandfathered and Gap MedicinesDate: Tuesday June 15th, 2021Time: 1:30-3:30pm For inquiries on ... Read More

06

May2021
The PMPRB is developing a Guideline Monitoring and Evaluation Plan (GMEP) that will analyze trends in the pharmaceutical market before and after the implementation of the new framework to assess whether it is working as intended, and to inform the need for any future adjustments. The PMPRB ... Read More

19

Apr2021
The PMPRB has announced it has revisited it’s March 17, 2021 decision regarding timelines for compliance for Grandfathered and Gap medicines.  The Board has reset the maximum list price (MLP) compliance timeline for these drugs to 2 PMPRB reporting periods, rather than their amended 1 reporting period timeline. MLP compliance for ... Read More