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TRIPS: TRIPS AND PUBLIC HEALTH ‘PARAGRAPH 6’ SYSTEM

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.

The requirement is set out in the August 2003 decision and subsequently repeated in the Annex to the TRIPS Agreement provided for in the 2005 Protocol amending the agreement. (“Paragraph 6” refers to the provision of the Doha Declaration on the TRIPS Agreement and Public Health that is implemented by the 2003 decision and 2005 protocol.)

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Information from the government notified to the WTO   back to top

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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.

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

Information to be posted by the licensee on its website   back to top

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 both the 2003 decision and the 2005 annex to the TRIPS Agreement. This subparagraph says that a compulsory licence issued by an exporting member under the Decision has 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 both the 2003 decision and the 2005 annex to the TRIPS Agreement. 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.