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Found 10 records similar to Introduction to the 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.
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.
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.
The legislation establishing Canada's Access to Medicines Regime contains a "Good Faith Clause" that provides patent holders with the right to challenge a compulsory licence in the Federal Court of Canada. A challenge can be mounted if the patent holder believes the licence is being used for predominantly commercial rather than humanitarian purposes.
Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.
It presents the list Least-Developed Countries Eligible to Import Under the Regime.
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.
Instructions for complying with the Requirements of Canada's Access to Medicines Regime specify how to notify the World Trade Organization or the Government of Canada, and how to request the addition of a particular drug or medical device to the list of eligible products.
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.
Governments can override patent rights when necessary. In such instances, the government authorizes a third party to use the patented invention without the patent holder's permission. This authorization comes in the form of a compulsory licence.