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Muhammad Zaheer Abbas, ‘Revisiting Canada’s Access to Medicines Regime in Response to COVID-19: A Review of the Legislation and its Underlying Objectives’ (2022) 34(2) Intellectual Property Journal 147-180. https://eprints.qut.edu.au/226445/

ABSTRACT: The current COVID-19 pandemic has highlighted the significance of the export-oriented compulsory licensing mechanism for countries lacking domestic manufacturing capacity. Article 31bis, the first amendment to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), is aimed at giving effect to the WTO General Council Decision 2003, which waived the domestic market requirement of compulsory licensing. In 2005, Canada became the first country to amend its patent laws to provide for Canada’s Access to Medicines Regime (CAMR) as enabling legislation to implement the WTO General Council Decision 2003. Canada clearly described its regime as a humanitarian initiative aimed at helping developing countries that lack sufficient drug and/or vaccine manufacturing capacity of their own and rely upon imports to address their public health problems. The legislation was compromised, however, by the conflicting desire to protect the corporate interests of patent-holding corporations. The CAMR system is thus incapable of delivering on its promises because of the unnecessarily added extra layers of complication, restrictions, and regulatory requirements to the requirements of Article 31bis, which is itself too onerous to invoke for resource-poor countries. This research paper also evaluates Canada’s efforts to reform CAMR and suggests an overhaul of the export-oriented compulsory licensing mechanism to provide a functional and expeditious one-licence solution that is workable for importing countries and acceptable to generic drug companies.

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