In 2003, the WTO General Council decided to provide an additional legal pathway for WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector to access medicines. Two years later, in 2005, WTO Members unanimously agreed to give this mechanism, often referred to as the "Paragraph 6 System", a permanent legal status when they adopted the Protocol Amending the TRIPS Agreement. The implementation and use of the additional pro-public health flexibilities provided by the System is optional, not mandatory. To take advantage of them, as of July 2015, 51 WTO Members have adopted specific implementing measures with a variable degree of detail and complexity which incorporate the Paragraph 6 System in their respective legal frameworks and provide the basis for them to act either as exporter or as importers, or as both. This represents almost a third of the WTO Membership, and the predominant bulk of existing pharmaceutical exporters. Given that, unlike other flexibilities in the TRIPS Agreement, the Paragraph 6 System was devised as a new mechanism without previous domestic experience to draw upon, there seems to be an exceptional need for an in-depth discussion of how it has been implemented at country level to which this paper attempts to respond. There is, indeed, often limited knowledge in the policy and procurement communities about the wide range of specific measures that have been introduced in many major exporters of medicines and the importance of this information both from a practical point of view, to facilitate exports of needed medicines, and from a policy point of view, to understand the implementation of this novel tool for access to medicines. To contribute to a better understanding of how the System has been implemented in practice, this paper surveys domestic measures that WTO Members have put in place. By doing so, it can inform the broader dialogue about access to medicines and provide practical information for procurement programmes. It can also put a valuable source of information and inspiration at the disposal of those Members who are yet in the process of considering whether and how best to implement the Paragraph 6 System in their domestic legal framework. While the survey illustrates that a robust framework supportive of the export of generic medicines to meet public health needs has been put in place by a significant number of WTO Members, there is an obvious need to move a step forward and engage in a substantive review of the System, including if and how better, more frequent use could be made of it. To conclude, the paper therefore offers some elements for reflection regarding the way forward in order to support the functioning of the Paragraph 6 System.


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  • Published online: 31 Jul 2015
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