Open Government Portal

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.

It presents the list Least-Developed Countries Eligible to Import Under the Regime.

It presents WTO-Member Countries and Non-WTO Member Countries Eligible to Import Under the Regime.

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.

Below are some of the unique features of Canada's Access to Medicines Regime, many of which resulted from negotiations between the Government of Canada, the private sector and various non-governmental organizations.

It presents WTO-Member Countries Eligible to Import Under the Regime

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 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.

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.

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company that is preparing to submit an application for a compulsory licence under Canada's Access to Medicines Regime.