Compulsory licences under Canada's Access to Medicines Regime
A compulsory licence granted under Canada's Access to Medicines Regime carries with it certain conditions. Apart from the conditions listed below, importing countries and pharmaceutical companies must also comply with the Regime's anti-diversionary measures and determine the royalty payment due to the patent holder.
Before a drug or medical device that has been authorized for export may be exported, the licence holder must establish a website that contains complete and up-to-date information about the drug or medical device the company has had licensed under the Regime. The information must include
For further information regarding the information that must be made available on the website, see Section 7 of Use of Patented Products for International Humanitarian Purposes Regulations
A compulsory licence is valid for two years. A licence may be renewed for a subsequent two-year period if the full amount of the product specified in the licence has not been shipped. No subsequent renewals are permitted, but the licence holder may apply for a new compulsory licence if all required conditions are met.
A compulsory licence ceases to be valid on the earliest of
For information regarding the termination of a compulsory licence by a patent holder, see Good Faith Clause. For information regarding the termination of a compulsory licence by the Federal Court of Canada, see Termination of an Authorization by the Court.
Report a problem or mistake on this page
- Date modified: