Declaring monetary value and units sold under Canada's Access to Medicines Regime

Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed, whichever is later, the pharmaceutical company must complete and submit to the patent holder and the Commissioner of Patents a "Solemn or Statutory Declaration Under Paragraph 21.16(1)(b) of the Patent Act". The declaration should contain information on

• the total monetary value of the agreement; and
• the number of units of the drug or medical device sold to the importing country.

The declaration must be accompanied by a copy of the supply agreement made between the pharmaceutical company and the importing country or other purchasing entity (for example, non-governmental organization). The declaration and the copy of the agreement must be provided before any of the product is exported.