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
News & Events
25
Apr2022
11
Apr2022
The Canadian Agency for Drugs and Technologies in Health (CADTH) has published Issue 28 of its Pharmaceutical Reviews Update. Below PDCI has summarized the updates and clarifications, and provided implications for manufacturers. CADTH’s update also includes two consultations open until April 14, one concerning a streamlined drug class ... Read More
04
Apr2022
PMPRB 2020 Annual Report Shows Almost 30% Decrease in New Patented Medicines Reported Since 2018
/ PMPRB, What's New
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
Supreme Court Dismisses Attorney General’s Application for Leave to Appeal FCA decision in PMPRB Alexion Soliris Matter
/ News, PMPRB, What's New
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
23
Feb2022
PDCI releases new issue of PDCI Market Access INSIGHTS, featuring research and opinion on the evolving state of private health insurance in Canada.
Volume 2, Issue 2
AnalyticsOur analytics article features ... 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
31
Jan2022
The Ontario Ministry of Health has recently updated the Ontario Guidelines for Drug Submission and Evaluation (Guidelines). In an effort to reduce complexity and simplify their policy document, specific guidelines aiming to address individual product types are now available on the Ontario Ministry of Health website.... Read More
14
Jan2022
Join us on January 25, 2022 for insights and guidance on the potential impact of delayed PMPRB Pricing Regulations and Guidelines.
Health Canada’s announcement on December 23, 2021 delayed the coming into force date for the Patented Medicines Regulations by a further ... Read More
31
Dec2021
As 2021 comes to an end, PDCI is reflecting on the year we've had in Canadian market access. PDCI's 2021 Year in Review highlights important milestones that occurred in 2021 and looks forward at Trends to Watch in 2022.
Click here for the PDF version... Read More