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.
See Orders in Council:
- 2021-0467 – Rules amending the PATENTED MEDICINE PRICES REVIEW BOARD RULES OF PRACTICE AND PROCEDURE in order to ensure that their wording is consistent with that of their enabling legislation (the Patent Act).
- 2021-0466 – Regulations amending the PATENTED MEDICINES REGULATIONS AND the Regulations Amending the PATENTED MEDICINES REGULATIONS (ADDITIONAL FACTORS AND INFORMATION REPORTING REQUIREMENTS) in order to require that holders of Certificates of Supplementary Protection’s report information to the Patented Medicine Prices Review Board on the same terms and conditions as would be reported by patentees.
- 2021-0465 – Order fixing June 30, 2021 as the day on which sections 45 to 58 of the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act, chapter 6 of the Statutes of Canada, 2017, COME INTO FORCE in order to amend certain sections of the PATENT ACT to extend the jurisdiction of the Patented Medicine Prices Review Board to include medicines that are protected by a Certificate of Supplementary Protection.
Update Jun 9, 2021: These have now been published in the Canada Gazette.
- Regulations Amending the Patented Medicines Regulations and the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements)
- Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure
- Order Fixing June 30, 2021 as the Day on Which Sections 45 to 58 of that Act Come into Force