Tag Archives: PMPRB

PMPRB

Health Canada announced this afternoon, “…Health Canada will be moving forward with the implementation of the new basket of comparator countries and reduced reporting requirements for those medicines at lowest risk of excessive pricing. These [Amendments to the Patented Medicines Regulations] will come-into-force on July 1, 2022. The Government will not proceed with the Amendments related to the new price regulatory factors, nor with the requirements to file information net of all price adjustments.” Continue reading PMPRB

Consultations

Two consultations were announced today:

  • the Patented Medicine Prices Review Board announced a  consultation on updated guidance relating to Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions, all arising from the six month extension to the coming-into-force of the new Regulations.
  • The government announced a consultation on the copyright framework relating to artificial intelligence and the Internet of Things, including data mining, authorship and ownership of works created by AI, infringement and liability regarding AI, and repair and interoperability issues related to technological protection measures.

Gazette Amendments

Several IP related amendments have been published in the Canada Gazette:

PMPRB

Various amendments relating to the Patented Medicines Prices Review Board are to come into force on June 30, 2021 including amendments to sections 79 to 103 of the Patent Act. In addition there are some changes being made for consistency with the Patent Act and to encompass CSPs. This is in addition to the amended Patented Medicines Regulations expanding reporting requirements are scheduled to come into force July 1, 2021 after being delayed several times. Continue reading PMPRB

PMPRB

Proposed “Regulations Amending the Patented Medicines Regulations” have been published in the Canada Gazette for a 75 day consultation. According to the Regulatory Impact Analysis Statement, “This proposal would amend the Patented Medicines Regulations (“Regulations”) so that the PMPRB’s regulatory framework includes new price regulatory factors and patentee price information reporting requirements that will help the PMPRB to protect Canadian consumers from excessive prices.”

Continue reading PMPRB