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
25
Mar2022
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
29
Mar2021
The PMPRB has published the long awaited 2019 Annual Report. The following are some of the high-level takeaways:
Sales of patented medicines in Canada reached $17.2 billion in 2019, a moderate increase of 3.5% from the ... Read More
18
Mar2021
On January 15, 2021, PMPRB invited stakeholders to comment on two key amendments to the final guidelines that were originally to come into affect for January 1, 2021 but were delayed to July 1, 2021. PMPRB received 48 submissions in response to the definition of Gap Medicines and ... Read More