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The Government of Canada regards non-governmental organizations (NGOs) as valuable resources and actively consulted with them when designing Canada's Access to Medicines Regime.
Canada's Access to Medicines Regime is intended to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other diseases.
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.
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.
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.
Canada's Access to Medicines Regime provides a way for the world's developing and least-developed countries to import high-quality drugs and medical devices at a lower cost to treat the diseases that bring suffering to their citizens.
Canada's Access to Medicines Regime provides a framework within which eligible countries can import less expensive generic versions of patented drugs and medical devices.
A pharmaceutical company that holds a compulsory licence under Canada's Access to Medicines Regime is required to pay royalties to the patent holder. The company must make payments within a prescribed amount of time and in accordance with a prescribed formula.
Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.