Introduction
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.
Given that active pharmaceutical ingredients are not typically considered drugs or medical devices under the
Food and Drugs Act and its associated Regulations, these cannot be the subject of an authorization
by the Commissioner of Patents.
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