Changes to Patented Medicines Prices Review Board’s regulatory framework come into force June 30

Certificates of supplementary protection meant to compensate for time spent researching

Changes to Patented Medicines Prices Review Board’s regulatory framework come into force June 30

Amendments concerning the Patented Medicines Prices Review Board, including changes aiming for consistency with the Patent Act, RSC 1985, c P-4, and the inclusion of certificates of supplementary protection, will come into force on June 30.

These changes, which have been published in the Canada Gazette and which include amendments to s. 79 to 103 of the Patent Act, will be made to the Patented Medicines Regulations. They will expand reporting requirements and are set to come into force on July 1 after being delayed several times.

The stated aims of the Regulations Amending the Patented Medicines Regulations and the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) are to offer the Patented Medicines Prices Review Board a coherent regulatory framework through obliging those holding supplementary protection certificates to report information to the board on the same terms and conditions applicable to patentees, to ensure that that board receives the information it requires, and to safeguard Canadian consumers from excessive prices for medicines protected by a supplementary protection certificate.

The federal government introduced the amendments as a result of changes made to the Patent Act, which expanded the jurisdiction of the board to include medicines protected by certificates of supplementary protection.

Certificates of supplementary protection -- a new patent-like protection implemented due to the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act -- are intended to offer an additional period of sui generis protection for eligible pharmaceutical products, partly to compensate for the time spent researching and applying for marketing authorization.

The Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure provide technical amendments seeking to harmonize the language of the rules with the wording in the Patent Act, following changes to the legislation made by the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act.

For instance, the amendments will replace “patented medicine” with “patented or protected medicine” in s. 6(1)(b), s. 14(2)(b), s. 15(3)(a) and s. 15(3)(b), and will replace “patentee” with “rights holder” in s. 1. The one-for-one rule and the small business lens are inapplicable to such changes.

The order fixing June 30, 2021 as the day on which s. 45 to s. 58 of the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act come into force aims to modify the patented medicines section of the Patent Act to extend the jurisdiction of the board to include medicines safeguarded by the certificate of supplementary protection.

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