25

Feb2020
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
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
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

06

Jan2020
Recently, the deadline for providing written submissions on the PMPRB’s proposed new Guidelines was extended until January 31, 2020. As part of the ongoing consultation process, the PMPRB has reserved three days in January for bilateral meetings with individual patentees: January 8, 9, and 10, 2020. Meetings will be scheduled on ... Read More

26

Nov2019
REGISTRATION IS OPEN! Learn how the new PMPRB amendments and guidelines will affect your pharmaceutical pricing, negotiations and reimbursement Join PDCI Market Access Inc., Canada’s leading pricing and reimbursement consultancy, for industry-only sessions on the pricing guidelines, led by senior members ... Read More

21

Nov2019
Pricing changes for Canada’s patented medicines are on their way and stakeholders are anticipating the release of the updated guidelines. How will the guidelines be operationalized? How will the new pharmacoeconomic factors be implemented? In an effort to answer these questions, PDCI has attempted to reverse-engineer the proposed Pharmacoeconomic Value ... Read More

22

Oct2019
PDCI presented a case study on the proposed amendments to the PMPRB regulations in Canada at the 2019 CAPT Conference held by the Canadian Association for Population Therapeutics. The objective of this policy analysis was to estimate the impact of the proposed PMPRB amendments on orphan drug prices. Review our poster ... Read More

27

Aug2019
PDCI and 3Sixty Public Affairs invites its industry clients, partners and colleagues to participate in a webinar on September 4, 2019 between 2:00pm to 3:00pm. This important session will cover the PMPRB price regulatory amendments and share insights on their implications for pharmaceutical market access. The session will provide an overview of ... Read More

19

Aug2019
The PMPRB has announced the 2020 meeting dates to the Human Drug Advisory Panel (HDAP)’s , releasing a total of four (4) dates, as per previous years. This corrected version of TargetPharma makes a distinction between the deadline for submitting the Product Monograph and the deadline for the Patentee's submission.... Read More

09

Aug2019
PMPRB and Health Canada held two technical briefings on the soon-to-be published final amendments to the Patented Medicines Regulations (PMR) on August 9th, 2019. This coincided with the pre-release of the final regulatory text and an updated Regulatory Impact Analysis Statement (RIAS). Publication in Canada Gazette II is expected August ... Read More