On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017.
These amended regulations herald a significant change to the landscape and environment in Canada for pharmaceutical companies, with long lasting impact to innovators in terms of exclusivity and drug product life-cycle management.
We reported (here) on the drafts of:
PMNOC Regulations amendments
There are no differences between the text of the draft and the final regulations.
When in force, the amended regulations will immediately apply to all submissions for which a notice of allegation is served on or after the effective date of the regulations (September 21, 2017). Any notice of allegation served before that date will be governed by the current regulations.
The amendments to the regulations are accompanied by a regulatory impact analysis statement (“RIAS”) outlining the background and objectives and describing the changes. The objectives are stated to include:
According to the “precis” published with the Order in Council promulgating the amended regulations, the regulations were amended to:
Key specific amendments in the new scheme include:
As noted in our earlier newsletter, the CSP Regulations will allow for protection to take effect at the end of the term of the relevant patent which will be calculated by subtracting five years from the period beginning on the filing date of the application for the patent and ending on the day on which the authorization for sale is issued, for a maximum of two years.
The final regulations have two amendments, discussed below, over the prior draft regulations (discussed previously here).
Key provisions of the CSP Regulations, as finalized, include:
It is anticipated that Health Canada will update its guidance documents in light of the PMNOC Regulations amendments, and release new guidance documents relating to the CSP Regulations. We also understand that the Federal Court is working to settle guidelines that will apply to actions covered by the PMNOC Regulations amendments. We will keep you up-to-date on any such guidance documents through our regular Rx IP Updates.