Canada's Access to Medicines Regime background

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. The August 2003 decision allows WTO member countries with pharmaceutical manufacturing capacity to issue licences for the manufacture and export of generic versions of patented drugs and medical devices to developing countries without the capacity to manufacture the products themselves. Although all WTO member countries are eligible to import under the 2003 decision, 23 developed countries have voluntarily announced that they will not use the system to import, while a number of others have announced separately that they would only use the system for emergencies or situations of extreme urgency.

In September 2003, Canada became the first WTO member to announce its intention to implement the WTO decision. In May 2004, the Government of Canada passed An Act to amend the Patent Act and the Food and Drugs Act--The Jean Chrétien Pledge to Africa. The Act, along with a supporting set of regulations, establishes the legal framework for Canada's Access to Medicines Regime. The Regime came into force on May 14, 2005. Representatives of Canada's generic and brand name drug companies, and various non-governmental organizations were consulted during the development of the legislation and regulations. The Regime balances Canada's trade and intellectual property obligations with the humanitarian objective of the WTO decision.

The Regime is a result of the co-operation of Industry Canada, Health Canada, the Canadian International Development Agency, the Canadian Intellectual Property Office, International Trade Canada and Foreign Affairs Canada. It requires the good will of pharmaceutical companies to participate in the Regime to fulfill the humanitarian objective of alleviating public health problems in developing nations. The goal is to facilitate timely access to generic versions of patented drugs and medical devices, especially those needed by least-developed or developing countries to fight HIV/AIDS, malaria, tuberculosis and other diseases.

In late 2005, WTO members agreed to amend the TRIPS Agreement to formally adopt the 2003 WTO decision. The amendment will become part of the TRIPS Agreement when two-thirds of the WTO's members have ratified it, with the deadline for ratification set for December 1, 2007.

For more information about the Regime, see Features of the Regime.