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
- the name of the licensed product, as set out in Schedule 1, and, if applicable, the strength, dosage form and route of administration;
- its distinguishing characteristics;
- the identity of the importing country;
- the amount to be manufactured and sold for export;
- information identifying every known party who will be handling the product while it is in transit from Canada to the importing country; and
- the export tracking number and number of the bill of lading for each shipment.
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
- the period specified in the compulsory licence;
- the day on which the Commissioner of Patents receives notice from the Minister of Health that the product has ceased to meet the requirement of the Food and Drugs Act and its associated Regulations;
- the day on which the last of the authorized amount has been shipped; or
- 30 days after the day on which the product has been removed from Schedule 1 to the Patent Act or the importing country has been removed from Schedule 2, Schedule 3 or Schedule 4.
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.
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