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Implementation of the WTO General Council Decision on Paragraph 6 of the DOHA Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 016
(2004; 49 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentIntroduction
View the documentCircumstances in which the Decision may be used
View the documentCompulsory licence in the importing country
View the documentCompulsory licence in the exporting country
View the documentAnti-diversion measures
View the documentSuspension of the system
View the documentConclusions
View the documentAnnex 1: WTO Decision of 30 August 2003 (WT/L/540)
View the documentAnnex 2: Summary of context and steps required to use the system
 

Conclusions

The WTO General Council Decision allows Member countries to grant compulsory licences for the export of pharmaceutical products without the restriction established by Article 31 (f) of the TRIPS Agreement, and permits the importing country not to provide compensation to the patent owner where a compulsory licence is granted. The Decision may be also applied on the basis of government non-commercial use, an avenue that in many instances may be quicker, simpler and more effective than the granting of a compulsory licence.

In addition to the steps and procedures stipulated by the Decision, legislative changes are likely to be necessary in both the exporting and importing countries in order to implement the Decision. The conditions under which a compulsory licence can be obtained will influence the speed and cost of making the system operative. Recourse to non-commercial government use may be the most appropriate way in many cases, as the requirement of Article 31 (b) may be waived. A summary of some of the issues to be considered and the steps to be taken to make the system operational are included in Annex 2.

Finally, countries willing to use the Decision should ensure that legal obstacles are not erected through data exclusivity obligations, the “linkage” between product patents and drug registration, or through other regulations.

 

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