20

Jun2020

New Draft PMPRB Guidelines: A High Level Summary

As PDCI announced earlier today, the PMPRB has issued the second draft of the PMPRB Guidelines to support the implementation of Patented Medicines Regulations (Regulations) changes coming unto force on January 1, 2021.  This draft is now available for a 30-day Notice and Comment Period.  Written feedback ... Read More

19

Jun2020

Now Released: PMPRB New Draft Guidelines

The Patented Medicine Prices Review Board (PMPRB) has just released its second set of Draft Guidelines under the recently amended Patented Medicines Regulations (“Regulations”).  This launches a 30-day consultation period for stakeholders to provide written comments on the new Draft Guidelines.  Stay ... Read More

10

Jun2020

Amendment to the Patented Medicines Regulations Published in Canada Gazette II

As expected, amendments to the Patented Medicines Regulations (“Regulations”) were published in Canada Gazette II this morning.  The amendments officially change the coming into force date of the new amending Regulation to January 1, 2021.  These Regulations were originally published in Canada Gazette II on August 21, 2020 with an ... Read More

01

Jun2020

PMPRB Guidelines and Regulations Update

PMPRB Guidelines and Regulations Update As first disclosed by PDCI last week, the PMPRB Board Chair officially confirmed that the amended Patented Medicines Regulations (“Regulations”) will now come into force on January 1, 2021.  These Regulations were published in Canada Gazette II in August 2019 with ... Read More

29

May2020

Delay of Implementation of PMPRB Amended Regulations to January 1, 2021

PDCI Market Access understands from multiple sources that Health Canada is reaching out to stakeholder groups today to confirm the delay of the implementation of the PMPRB amended Regulations to January 1, 2021. Official publication of the delay in Canada Gazette to follow (likely in CG2 on June ... Read More

19

Mar2020

PMPRB Has Now Published Submissions Received as Part of its Draft Guidelines Consultation

The full list of submissions can be found here under the Submissions tab at the bottom of the page. Background: On November 21, 2019, the PMPRB published its draft Guidelines and launched a public consultation as a step towards implementing the recently amended Patented Medicines Regulations. The PMPRB ... Read More

10

Mar2020

PMPRB Cancellation of March 18th Policy Forum

PMPRB Cancellation of March 18th Policy Forum The Patented Medicines Prices Review Board (PMPRB) has announced the cancellation of its Policy Forum expected to be held on March 18th, 2020 amid the evolving COVID-19 situation. In order to provide stakeholders with an opportunity to convey information that may ... Read More

25

Feb2020

Sharing Responses to the Patented Medicine Prices Review Board (PMPRB) Draft Guidelines Consultation

On November 21, 2019, the PMPRB published its draft Guidelines and launched a public consultation as a step towards implementing the recently amended Patented Medicines Regulations. Since then, the PMPRB has engaged with stakeholders to obtain feedback on its proposed pricing Guidelines. The consultation period closed on February 14, ... Read More

13

Feb2020

PDCI Analysis Estimates Impact of PMPRB Draft Guidelines to be up to $41.8 Billion

Following the publication of the PMPRB Draft Guidelines on Nov 21, 2019, PDCI undertook an analysis to critically assess the impact of the PMPRB regulatory changes published in August 2019, as proposed to be implemented in the Draft Guidelines. Top-Line Summary The PMPRB regulatory changes and Draft ... Read More

14

Jan2020

PMPRB and “Zero-dollar” Sales

W. Neil Palmer In its December 2019 NEWSletter[1], the Patented Medicine Prices Review Board (PMPRB) is “reminding” patentees that they are required under the Patent Act (the Act) and the Patented Medicines Regulations (the Regulations) to file all zero-dollar sales, referring specifically to free goods. This “reminder” is troubling ... Read More