Minutes - TRIPS Council - View details of the intervention/statement

Ambassador Al-Otaibi (Kingdom of Saudi-Arabia)
9.1 Protocol Amending the TRIPS Agreement
213. The Paragraph 6 System exists today as a pending amendment allowing generic medicines to be made under "compulsory licences" exclusively for export to countries that cannot produce the medicines themselves. The system deals with a problem identified in Paragraph 6 of the 2001 Doha Declaration on the TRIPS Agreement and Public Health by removing a limit in the TRIPS Agreement's Article 31(f) and allowing nations to export under a compulsory licence to countries needing the medicines. 214. In the 20 years of TRIPS implementation and 19 years of our national industrial property law, only one compulsory license has been issued in order to allow access to medicines. 215. At that time, Brazil had the benefit of the fact that the medicine was not protected by patents in another WTO Member, allowing the international supply without the need to resort to the Paragraph 6 System. With the growing protection of IP throughout the globe, situations where a high-cost life-saving medicine is not protected by patents in manufacturing countries will grow scarce. In this context, the formal ratification and entry into force of the Paragraph 6 System becomes more urgent in order to grant to all countries the assurances that the TRIPS Agreement would not prevent Members from taking measures to protect public health. 216. Brazil urges all Members to expedite the implementation process of the Protocol. We are ready to share our experience with the acceptance of the Protocol with other Members.
The Council took note of the statements made.
9.1. The Chairman recalled that, at its last meeting, the Council had been informed by his predecessor about the Director-General's renewed efforts that he had undertaken earlier this year in order to secure the entry into force of the TRIPS amendment by MC10.

9.2. As outlined by the Director-General in his statement at the General Council in February, entry into force of the amendment would give this new compulsory licensing mechanism the same status as all other public health-related flexibilities under the TRIPS Agreement. It would provide a permanent legal pathway that strengthens the System's future potential to facilitate export of medicines that was needed by patients in developing countries. And it would respond to widespread calls within the UN, including from the UN Economic and Social Council and the UN General Assembly, to complete the process of acceptance.

9.3. These earlier initiatives by the Director-General had triggered significant interest in many WTO Members who were yet to accept the TRIPS amendment. Other Members who had already accepted the TRIPS Protocol had also confirmed their availability to assist and share their experience with Members concerned.

9.4. Reportedly, considerable progress had been made in domestic acceptance procedures in some of the Members concerned. This said, since the last meeting in February, only Brunei Darussalam had formally deposited its instrument of acceptance.1

9.5. In his capacity as the Chair of the Council, he therefore had taken the initiative to suggest, in a communication that had been circulated by the WTO Secretariat in a fax dated 26 May 2015, that the issue of cooperation to facilitate domestic procedures to accept the TRIPS Protocol and thus ultimately to support the entry into force of the TRIPS amendment be raised under the agenda item on technical cooperation. At this stage, he still hoped that this goal could be achieved in time for MC10 later this year. For this to happen, it was necessary that another 26 Members submit their respective instruments of acceptance to the WTO.

9.6. His initiative built on past work in this Council that had recognized the need for technical assistance concerning the acceptance process and had also provided support to Members in this area. In his communication, he had proposed that Members concerned come prepared to this meeting to share information about any potential needs for further assistance and experience sharing and to inform the Council about the steps taken in order to complete their domestic acceptance procedures since the letter of the Director-General in February.

9.7. The representatives of Chile; India; the European Union; Bangladesh on behalf the LDC Group; Australia; Brazil; the Republic of Seychelles; Chinese Taipei; Pakistan and Rwanda took the floor.

9.8. The Council took note of the statements made.

IP/C/M/79, IP/C/M/79/Add.1