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
06
May2021
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
19
Feb2021
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
15
Jan2021
On January 13th 2021, as a consequence of the new PMPRB coming-into-force date, PMPRB has invited stakeholders to comment on two proposed amendments to the New Guidelines. The two amendments pertain to (A) the Definition of Gap Medicines and (B) Compliance Timelines with Maximum List ... Read More
15
Jan2021
The PMPRB has released a list of potential sources for prices in the PMPRB 11 basket of reference countries. A non-exhaustive list of examples of potential foreign sources can be found here.
Starting July 1, 2021, the Patented Medicines Regulations will require patentees to ... Read More
06
Jan2021
The delay in the implementation of the new Patented Medicines Regulations to July 1, 2021 means that patentees can take 2021 price increases on medicines under PMPRB jurisdiction.
PMPRB has released the 2021 CPI-Based Price-Adjustment Factors for Patented Drug ... Read More
29
Dec2020
Health Canada has announced that the implementation of the Patented Medicines Regulations and Final PMPRB Guidelines has been delayed for 6 months to July 1, 2021. Health Canada stated that the primary reason for the delay are the challenges posed by COVID-19 for all stakeholders. Additionally, Health Canada stated ... Read More
08
Dec2020
Today the PMPRB hosted a webinar for their new online filing tool which will be available to all patentees as of January 1st, 2021. The webinar revealed a new Form 4 (which will provide PMPRB with the National Market size estimation for new medicines) along with a walk through of the ... Read More