Introduction to the Canada's Access to Medicines Regime
The Government of Canada is committed to improving access to drugs and medical devices that are needed to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other diseases. 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. All products exported under the Regime must meet the same rigorous requirements for safety, effectiveness and quality as those authorized for the Canadian market.
The Regime is based on a World Trade Organization decision that allows WTO countries, such as Canada, to authorize someone other than the patent holder to manufacture a lower cost version of a patented drug or medical device for export to developing countries that do not have the capacity to manufacture such products. Canada is one of the first countries to implement this decision, which means that generic medicines can now be exported from Canada to eligible countries that cannot produce them.
To use the Regime, eligible countries must make an arrangement with pharmaceutical companies based in Canada. Non-governmental organizations can help countries to obtain and distribute drugs and medical devices through the Regime and can also obtain and distribute generic drugs on their own. Eligible countries may be able to obtain funding to support their purchase of medicines, although not directly through Canada's Access to Medicines Regime.
The legislation upon which the Regime is based lists the pharmaceutical products eligible for export. These include drugs to treat HIV/AIDS, malaria, tuberculosis and other diseases. There are also measures in place for adding to the list of eligible products.
Canada's Access to Medicines Regime complements other humanitarian efforts by the Government of Canada to assist least-developed and developing countries in responding to public health problems. For more detailed information, see Background. Countries and companies interested in finding out how they can participate in the Regime should follow the links to their sections of the information package, as provided here and in the menu on the left-hand side of each page.
Note: Under Canada's Food and Drugs Act and its associated Regulations, drugs are all pharmaceutical products, including prescription and non-prescription pharmaceuticals, and disinfectants and sanitizers with disinfectant claims, and biologics, including vaccines and biotechnology products, radiopharmaceuticals and genetic therapies. See Schedule 1 for a list of drugs and medical devices that have been authorized for export under Canada's Access to Medicines Regime.
Active pharmaceutical ingredients (API) are typically not regulated as drugs under the Food and Drugs Act and therefore, are not subject to Health Canada's regulatory review.
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