Terms and conditions of a compulsory licence under Canada's Access to Medicines Regime

If an application for a compulsory licence is successful, the pharmaceutical company must ensure that it meets all the terms and conditions of the licence. The terms and conditions are outlined below, with links to more detailed information:

  • Comply with the Conditions of Compulsory Licences and Anti-diversionary Measures.
  • Before the first manufacturing run of the drug or medical device, and 15 days before the export of subsequent lots of the product, notify Health Canada. Health Canada may inspect the shipment before export.
  • Within 15 days before each shipment, provide a notice to the patent holder, the importing country and the purchasing contact (for example, a non-governmental organization), specifying the quantity to be shipped and every known party that will be handling the product while in transit. The notification must be made via certified or registered mail.
  • Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed, whichever is later, submit a statement to the patent holder and the Commissioner of Patents of the monetary value and number of units sold. The statement must be accompanied by a copy of the sales agreement.
  • Determine and pay a royalty fee to the patent holder.
  • Comply with pre-export inspections that may be performed to verify that the anti-diversionary features are included on all products and labels.

For an illustration of the terms and conditions, see the process map for meeting the terms and conditions.

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