TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES
Notifications by importing WTO members
Countries wanting to import under the “paragraph 6” system have to notify the WTO in two ways. They have to announce once that they intend to make use of the system, and then they have to supply information each time they use it.
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.
Eligibility: Paragraph 1(b)
If a country wants to be an “eligible importing member” under the “Paragraph 6” system it has to notify the TRIPS Council that it intends to use the system as an importer — unless it is a least-developed country, in which case no such notification is needed. The relevant provision is Paragraph 1(b) of the Annex to the amended TRIPS Agreement / the 2003 waiver decision.
The provision clarifies that members may notify at any time and may state that they will use the system in whole or in a limited way, for example only in a national emergency or other circumstances of extreme urgency.
Some members are excluded from using the system as importers (footnote 3 to the Annex to the amended TRIPS Agreement / the 2003 waiver decision), and some others have said that if they use the system it would only be in national emergencies or other extremely urgent circumstances (see the 2003 and 2005 statements read out by the General Council chairs when the Council adopted the 2003 waiver decision and the 2005 protocol).
The status of notifications made under paragraph 1(b) will be kept up to date in a TRIPS document accessible from this page.
No notifications have been made so far.
Details to be notified each time: Paragraph 2(a)
When an eligible importing country wants to import it has to notify certain details to the TRIPS Council each time. These details are:
(i) the names and expected quantities of the product(s) needed;
(ii) confirmation that the eligible importing member in question — other than a least developed country member — has established that it has insufficient or no manufacturing capacity in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Appendix to the Annex of the amended TRIPS Agreement / the Annex to the 2003 waiver decision; and
(iii) where a pharmaceutical product is patented in the member’s territory, confirmation that it has granted or intends to grant a compulsory licence in accordance with Article 31 of the TRIPS Agreement and the provisions of the Annex to the amended TRIPS Agreement / the 2003 waiver decision.
The relevant provisions are in Paragraph 2(a) 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.