TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES
Model notifications for the use of the Paragraph 6 system
The following model notifications are provided for illustrative purposes only, as an aid to technical assistance, and are prepared without prejudice to °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ members’ rights and obligations under the °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ agreements. As illustrative guides to what is to be notified, they do not have any legal or procedural status.
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Model 3: Exporting Member's Notification
Reference for this notification
See paragraph 2(c) of the 2003 Decision (°ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ document WT/L/540 and Corr.1).
Notes to Model 3
This is the exporting member’s notification of the grant of a compulsory licence for export, including the conditions attached to it, as required under the Paragraph 6 System.
Who needs to make an exporting member’s notification?
Any member that exports under the Paragraph 6 System must make this notification for every compulsory licence that it issues under the System prior to export. A notification is not required to export pharmaceutical products under the regional mechanism (see paragraph 6 of the 2003 Decision — °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ document WT/L/540 and Corr.1). If the medicines to be exported form part of production under a compulsory licence that is issued predominantly for the supply of the domestic market, then there is no need to use the Paragraph 6 System at all, and consequently no notification is needed.
Can the exporting member attach a copy of the compulsory licence(s) instead?
Yes, as long as all the information listed in the model notification is included in the attachment. Other information, such as the patent number(s), can also be included.
Must the licensee set up its own website?
No. The licensee may post the required information on its own website or, with the assistance of the °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ Secretariat, on the page of the °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ website dedicated to the Paragraph 6 System.