TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES
Model notifications for the use of the Paragraph 6 system
The following model notification is provided for illustrapative purposes only, as an aid to technical assistance, and is prepared without prejudice to °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ members’ rights and obligations under the °ÄÃÅÁùºÏ²Ê¹ÙÍø×ÊÁÏ agreements. As an illustrative guide to what needs to be notified, it does 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 Annex to the amended TRIPS Agreement.
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 3 of Article 31bis of the amended TRIPS Agreement). If the medicines to be exported form part of production under a compulsory licence that is issued predominantly for 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.