TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES
Guide to Notifications
Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health recognized that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement, as the Agreement then stood.
> TRIPS and public health
- Countries with insufficient or no manufacturing capacities are naturally reliant on imports from foreign suppliers.
- When medicines are produced under a compulsory licence in another country, the TRIPS Agreement in effect limited the proportion that could be exported.
- TRIPS therefore posed a potential barrier if a country lacked its own production capacity and wished to import medicines from another country where a patent was in force and where a compulsory licence was needed for production.
Paragraph 6 system
The “Paragraph 6 system” is often used to refer to the system set up by the WTO to address this problem by creating a new form of compulsory licence specifically for the export of medicines (see further background information). The use of this special compulsory licence requires formal notification to the WTO. There are three types of notification:
1. importing member’s one-off general notification of intention to use the Paragraph 6 system (not required for least-developed country members);
2. importing member’s specific notification of the details of the needed pharmaceutical products and other details required under the Paragraph 6 system;
3. exporting member’s notification of grant of a compulsory licence for export and conditions attached to it.
Notifications can be signed by any authorized government official. They are made for transparency purposes, and do not need to be approved by a WTO body in order for a member to use the system.
Notifications are sent to the WTO Council for TRIPS through the WTO Secretariat. They can be sent by post (see models for postal address) or fax to +41 22 739 5790, with a copy by email to firstname.lastname@example.org with a copy to email@example.com. The WTO Secretariat will circulate the notification to other members of the Council for TRIPS and the Chairperson will bring it to the attention at the next meeting. The notifications will be circulated as formal WTO documents in series IP/N/8, 9 or 10 and will also be made available publicly by the WTO Secretariat here.
The following model notifications are provided for illustrative purposes only as an aid to technical assistance, and are prepared without prejudice to WTO members’ rights and obligations under the WTO agreements. As illustrative guides only to what is to be notified, they do not have any legal or procedural status.
Since the entry into force of the TRIPS Amendment in January 2017, members that have accepted the amendment operate on the basis of the amended TRIPS Agreement. For these members, the following model notifications are available:
Other members who have yet to accept the Protocol Amending the TRIPS Agreement continue to operate on the basis of the waiver decision of 2003. In case of intention to use the system, these members may wish to use the following model notifications:
Web links for further background
Background on TRIPS and health www.wto.org/tripshealth
Text of the amended TRIPS Agreement: Article 31bis
Text of the amended TRIPS Agreement: Annex and Appendix
Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health (Document WT/L/540 and Corr.1)
Minutes of General Council meetings in WT/GC/M/82
Protocol Amending the TRIPS Agreement (Document WT/L/641)
Minutes of General Council meetings in WT/GC/M/100
Accepting the TRIPS amendment
Dedicated webpage for notifications