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Found 10 records similar to WTO-member countries eligible to import under Canada's Access to Medicines Regime
It presents WTO-Member Countries and Non-WTO Member Countries Eligible to Import Under the Regime.
It presents the list Least-Developed Countries Eligible to Import Under the Regime.
In August 2003, negotiations among World Trade Organization (WTO) members resulted in a landmark decision to waive two licensing provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that appeared to prevent the export of generic drugs and medical devices to developing countries faced with public health problems.
Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in Canada's Access to Medicines Regime. Under the Regime, eligible countries can import less expensive, generic versions of patented products manufactured in Canada.
To participate in the Regime, an eligible importing country must declare that it has insufficient or no pharmaceutical manufacturing capacity in relation to the specific product it is requesting. It is up to each country to determine for itself the level of its manufacturing capacity.
To participate in the Regime, a pharmaceutical company must enter into a sales agreement with an eligible importing country for the purchase of a specified amount of an eligible product listed on Schedule 1. A pharmaceutical company must also submit an application for authorization to Canada's Commissioner of Patents. Once the authorization or compulsory licence is issued, there are additional terms and conditions that the company must meet and maintain.
Within 30 days of the end of the two-year period of the original compulsory licence, a pharmaceutical company may apply to have it renewed. A renewal will only be granted if the full shipment of the original authorization has not yet been shipped. Only one renewal is allowed for each original application for a total of four years for each compulsory licence.
Instructions for complying with the Requirements of Canada's Access to Medicines Regime specify how to notify the World Trade Organization or the Government of Canada, and how to request the addition of a particular drug or medical device to the list of eligible products.
The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).
The patent holder may seek an order from the Federal Court of Canada to terminate a compulsory licence, if the patent holder can establish that any information in the application by the licence holder is inaccurate or that the licence holder has failed