On February 16, 2024, the Minister of Health tabled the 2022 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The 2022 Annual Report provides an overview of the PMPRB’s mandate, structure and price review...more
On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...more
The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative for generic drugs, effective October 1, 2023. This agreement, which...more
On September 1, 2022, a Panel of the Patented Medicine Prices Review Board (PMPRB) issued a decision that the price of Horizon Pharma’s PROCYSBI (cysteamine delayed release capsules) was and is excessive under sections 83 and...more
On October 6, 2022, the Patented Medicine Prices Review Board (PMPRB) released its revised draft Guidelines to give effect to the July 1, 2022 amendments to the Patented Medicines Regulations. Submissions are due by December...more
The amended PMPRB regulations came into force on July 1, 2022, and at that time an interim approach to pricing was proposed. The interim approach proposed a “status quo” to pricing until Guidelines could be established...more
In September 2017, the Patented Medicine Prices Review Board (PMPRB) decided that Alexion’s SOLIRIS (eculizumab) was sold at an excessive price. In doing so, the Board departed from the Guidelines, in finding the appropriate...more
As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more
On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more
On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more
The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more
On January 11, 2022, the Patented Medicine Prices Review Board (PMPRB) released a report entitled Expensive Drugs for Rare Diseases: Canadian Trends and International Comparisons, 2011-2020 as part of the National...more
Update: On October 28, 2021, the PMPRB provided an update on this consultation, announcing that patentees will have at least two reporting periods to comply with any forthcoming changes to either the current Guidelines or the...more
The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more
Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...more
Update: The decision has been appealed. On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more
On October 27, 2020, the Patented Medicine Prices Review Board (PMPRB) released the National Drug Prescription Utilization System’s (NDPUIS) analytic study of the Canadian oncology market for 2010 to 2019. The study is...more
Update: On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final Guidelines. See also the PMPRB’s November 20, 2020 webinar slides here....more
UPDATE: See our article here highlighting changes relative to the June 2020 draft Guidelines. This morning, the PMPRB released the final Guidelines operationalizing the amended Patented Medicines Regulations (Amended...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in October...more
UPDATE: On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed. As...more
Update: See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final...more
Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021. Further to our June 1, 2020 update,...more
Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more
On April 2, 2020, the Patented Medicine Prices Review Board (PMPRB) published a message from the Chairperson regarding the results of its consultation on the draft Guidelines operationalizing the amended Patented Medicines...more