(2004; 49 pages)
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.