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 reference countries, and modify reporting requirements for particular categories of drugs (see our articles here and here regarding the amendments). The coming into force of the provisions relating to confidential third party rebates was previously delayed after those provisions were declared invalid by the Federal Court and found to be unconstitutional by the Quebec Superior Court. Appeals are pending in both cases.
The Patented Medicine Prices Review Board (PMPRB) Guidelines, which are intended to operationalize the amendments, are now similarly scheduled to take effect January 1, 2022. Innovative Medicines Canada and a number of pharmaceutical companies have commenced an application for judicial review in relation to the Guidelines.
The amendments to the Patent Act flowing from the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (sections 45-58) that extend the PMPRB’s jurisdiction to encompass Certificates of Supplementary Protection will come into force on June 30, 2021, along with consequential amendments to the Patented Medicines Regulations and Patented Medicines Price Review Board Rules of Practice and Procedure.
On July 7, 2021, the amendments modifying the coming into force date of the amended Patented Medicines Regulations were published in Part II of the Canada Gazette, as the Regulations amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 3. The Regulatory Impact Analysis Statement that accompanies the Regulations indicates, “[t]his delay provides industry with additional time to prepare for and comply with the changes introduced in the Amending Regulations”. We have prepared an unofficial consolidated version of the Patented Medicines Regulations incorporating the amendments to date.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.