The Fourth Ministerial Conference of the World Trade Organization (WTO) in 2001 issued the Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration). The Declaration is significant for establishing legal certainty on the freedom of countries to determine the grounds for granting a compulsory license, what may constitute a national emergency or other circumstances of extreme urgency, and the applicable regime for exhaustion of intellectual property (IP) rights. The Declaration determined that a public health crisis is a circumstance amounting to a national emergency. It also shifted the burden of proving otherwise to the country disputing the various determinations made by another state. The adoption of the Protocol Amending the TRIPS Agreement in 2005 follows a provisional arrangement under the Decision of the General Council on the Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (the August 2003 Decision).
The scepticism regarding the utility and functionality of the August 2003 Decision and the implementation of the Decision were put to test when Rwanda officially notified the TRIPS Council that it will import drugs from Canada under the system (IP/N/9/RWA/1). There are no notifications yet under paragraph 1(b) of the August 2003 Decision, which requires that countries notify their intention to use the system as importing countries. However, Rwanda has directly notified that it expects to import a specific pharmaceutical product from a generic manufacturer in Canada under paragraph 2(a) of the August 2003 Decision. This is because the requirement under paragraph 1(b) does not apply to Least-Developed Countries (LDCs). Canada has also notified the TRIPS Council that it has authorized the manufacture and export of the pharmaceutical product concerned to meet Rwanda’s needs (IP/N/10/CAN/1).
This article provides a detailed analysis of the Rwanda-Canada use of the system created under the August 2003 Decision for the import/export of pharmaceutical products manufactured under compulsory license. It will describe the various procedures that the importing country, the generic pharmaceutical company and the exporting country have to go through, identifying lessons from the experience. The precedent that may be established by this case is critical to the continued utility and functionality of the system under the August 2003 Decision.