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
7/5/2022
/ Amended Regulation ,
Canada ,
Comment Period ,
Drug Pricing ,
New Regulations ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Comment ,
Reporting Requirements
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
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
12/23/2020
/ Amended Regulation ,
Canada ,
Constitutional Challenges ,
Drug Pricing ,
Health Canada ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Rebates ,
Reporting Requirements
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
6/12/2020
/ Amended Regulation ,
Canada ,
Drug Pricing ,
Health Canada ,
New Amendments ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reporting Requirements
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 August 21st, the long-awaited amendments to the Patented Medicines Regulations were published in Part II of the Canada Gazette. We have prepared an unofficial consolidated version of the Regulations incorporating the...more
8/25/2019
/ Amended Regulation ,
Canada ,
Confidential Information ,
Drug Pricing ,
Exemptions ,
IP License ,
Licensees ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Rebates ,
Reporting Requirements ,
Third-Party
On August 9, 2019, Health Canada announced the final amendments to the Patented Medicines Regulations (see news release here and RIAS here). These amendments represent the first substantive revision to the Regulations since...more
8/12/2019
/ Amended Regulation ,
Canada ,
Drug Pricing ,
Exemptions ,
Final Rules ,
Health Canada ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Rebates ,
Reporting Requirements
On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more
12/5/2017
/ Canada ,
Consultation Periods ,
Drug Pricing ,
Health Canada ,
Life Sciences ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Proposed Regulation ,
Reporting Requirements ,
Third-Party
The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more