TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES

Notifications by exporting WTO members

Countries have to notify the WTO when they export pharmaceutical products manufactured under compulsory licences under the “paragraph 6” system.

For members who have accepted the amendment to the TRIPS Agreement that entered into force on 23 January 2017, these requirements are set out in the Annex to the amended TRIPS Agreement. For members that are yet to accept the amendment, the same requirements apply under the 2003 waiver decision.

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Information from the government notified to the WTO  

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The government in the exporting country has to provide information on the conditions attached to the compulsory licence, the name and address of the licensee, the product(s) involved, the quantity or quantities to be produced under the licence, the designated importing country or countries, and the duration of the licence. This is specified in Paragraph 2(c) of both the 2003 decision and 2005 annex to the TRIPS Agreement. This is specified in Paragraph 2(c) of the Annex to the amended TRIPS Agreement / the 2003 waiver decision.

These notifications have to be made available publicly by the WTO Secretariat through a dedicated page on the WTO website.

  

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Information to be posted by the licensee on its website  

The notification from the government also has to show the website address where the licensee is required to post the following information:

  • The quantities being supplied to each destination as referred to in subparagraph 2(b)(i) of the Annex to the amended TRIPS Agreement / the 2003 waiver decision. This subparagraph says that a compulsory licence issued by an exporting member under the Decision has to contain the condition that only the amount necessary to meet the needs of the eligible importing member(s) may be manufactured under the licence and that all the products manufactured have to be exported to the member(s) which has notified its needs to the TRIPS Council.
  • The distinguishing features of the product(s) referred to in subparagraph 2(b)(ii) of the Annex to the amended TRIPS Agreement / the 2003 waiver decision. This subparagraph says that products produced under the compulsory licence have to be clearly identified as being produced under the system through specific labelling or marketing; and that suppliers should distinguish the products through special packaging, special colouring or special shaping of the products or combinations of these — provided that these distinguishing characteristics are feasible and do not have a significant impact on price.