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On 30 August 2003, negotiations among World Trade Organization (WTO) Members resulted in a landmark decision (the "Decision") waiving two compulsory licensing provisions (Articles 31 [f] and [h]) of the WTO Agreement on Trade-Related Intellectual Property Rights (the 'TRIPS Agreement"), which were thought to be a barrier to effective responses to public health problems. In doing so, WTO members with pharmaceutical manufacturing capacity could establish compulsory licensing regimes authorizing persons, other than the patent holder, to manufacture a lower-cost version of a patented pharmaceutical product for export to an eligible importing Member. Consequently, developing and least-developed countries with insufficient or no manufacturing capacities for pharmaceutical products could benefit from greater access to needed medicines.
In September 2003, Canada became the first WTO member and G-8 country to announce its intention to implement the Decision domestically. Implementation of the Decision was accomplished on 14 May 2004 with the passage of An Act to amend the Patent Act and the Food and Drugs Act- The Jean Chrétien Pledge to Africa (JCPA) (S.C.2004, c.23). This provided a coming into force of the legislation upon adoption of regulatory provisions. The regulations were adopted on 14 May 2005 and are referred to as the Use of Patented Products for International Humanitarian Purposes Regulations (S.O.R./2005-141 ). This legislative framework, which amended both the Canadian Patent Act ana the Food and Drugs Act, was introduced to ensure timely access to affordable versions of patented pharmaceutical products urgently needed by least-developed or developing countries to fight HIV/AIDS, malaria, tuberculosis and other epidemics. Although not required by the Decision, Canada introduced changes to the Food and Drugs Act ana its regulations to ensure that pharmaceutical products exported under the JCPA regime meet Canadian standards for safety, quality and efficacy.
The following is a summary of the process to be followed by importing countries and pharmaceutical manufacturers who wish to avail themselves of Canada's JCPA regime. A chart outlining the major required steps is also found at the end of this article.
Eligible importers
Although the Decision is an agreement between WTO Member Countries, Canada has, for humanitarian reasons, opted to implement it in a manner that enables both WTO and non-WTO Member Countries to import urgently needed pharmaceutical products (drugs and medical devices) under...