22

Feb2022

Quebec Court Strikes 2 of 3 PMPRB Changes

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

Reminder: Form 3 filing is due to the PMPRB On March 1, 2022

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

PMPRB Proposed Amendments to the July 1, 2021 Guidelines

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

Patented Medicines Regulations/PMPRB Guidelines Further Delayed Until January 1, 2022

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

Save the Date! PMPRB has Released Upcoming Webinar on June 15th

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

PMPRB Announces the Guideline Monitoring and Evaluation Plan (GMEP) Consultation

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

Breaking News: 2 Reporting Periods for PMPRB MLP Compliance for Grandfathered and Gap Medicines

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

Patented Medicine Prices Review Board (PMPRB) 2019 Annual Report Published

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

PMPRB February 15th Consultation – Decision made for Gap Medicines and Timelines for Compliance

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

19

Feb2021

PDCI Launches Sharing Page for Submissions to the PMPRB Proposed Amendments to the New Guidelines

On December 29, 2020, the coming into force date for the amended PMPRB regulations and guidelines were further delayed to July 1, 2021.  The PMPRB has invited stakeholders to comment on two critical amendments to the regulations with responses due by February 15th. Specifically, the PMPRB proposes ... Read More