Features of Canada's Access to Medicines Regime

The World Trade Organization (WTO) decision of August 2003 established the basic framework for a compulsory licence for export regime. Within that framework, each WTO member decides for itself how it will implement the decision domestically. 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:

• Although the WTO decision was an agreement amongst WTO member countries, the Regime is available to most non-WTO countries as well.
• All drugs and medical devices exported under the Regime must meet the same safety, effectiveness and quality requirements as those produced for the Canadian market.
• Health Canada will review products intended for export under the Regime using the same process as products for the Canadian market. A special stream has been created for Regime products so that review of them will not be delayed.
• Once a compulsory licence is issued under the Regime, and if a claim for remission is made, Health Canada will remit to the manufacturer the fees normally associated with the regulatory review process.
• Drugs and medical devices eligible for export under the Regime are primarily from the World Health Organization's Model List of Essential Medicines, but provisions are in place for products to be added to the list.
• Products exported under the Regime must have special markings, colouring and labelling, as applicable, to distinguish them from the patented versions sold in Canada. This will assist in preventing the products from being diverted into markets other than those for which they are authorized.
• To ensure that the Regime is used in good faith, patent holders may challenge a compulsory licence in court if the cost of the generic product is more than 25 percent of the cost of its equivalent patented version in Canada.
• Non-governmental organizations can act as purchasers of licensed pharmaceutical products with the permission of the importing country's government.
• Other measures are in place to ensure that the Regime is as transparent as possible.