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. Every product destined for export will first be reviewed and authorized by Health Canada to ensure that it meets the same safety, effectiveness and quality requirements as products that are sold in Canada.
The drugs and medical devices available for export to countries in need are listed on Schedule 1 to Canada's Patent Act. Schedule 1 can be amended to ensure that it continues to meet the public health needs of developing countries. Schedule 1 was initially composed of products on the World Health Organization's Model List of Essential Medicines that are patented in Canada but it was expanded at the request of interested stakeholders to include additional products.
Countries eligible to participate in the Regime include members of the WTO and least-developed or developing countries that are not members of the WTO. The eligible countries have been organized into three categories and included on Schedule 2, Schedule 3 and Schedule 4 to Canada's Patent Act.
The requirements for countries participating in the Regime have been kept to a minimum. To participate, a country must notify the appropriate authority of its intention to import in accordance with the WTO decision and enter into an agreement with a Canadian pharmaceutical company.