Ambassador Al-Otaibi (Kingdom of Saudi-Arabia) and Ambassador Alfredo Suescum (Panama)

World Trade Organization

7 REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

87. We have engaged in dialogue with a number of Members about this matter following the Director General's introduction of this issue in the General Council in February and following Ambassador Al-Otaibi's communication to Members as Chair of this Council in May. 88. Our feedback has been very much about practical matters concerning the instrument of acceptance of the Protocol Amending the TRIPS Agreement. The key message that comes up in many conversations is this: there is concern that before accepting the Protocol, the assumption has often been that it is necessary to introduce domestic implementing legislation, in other words to implement this new TRIPS flexibility before accepting the amendment. Without questioning or analysing individual Members' constitutional arrangements, the wide experience among the membership is that this is not the case. Indeed, as a rough estimate, almost fifty members have lodged their acceptances without having first passed any legislation implementing the System. Why is this? It is because this is a new flexibility, not a new obligation. It is an optional measure for WTO Members to use if they wish, so as to advance their public health interests. 89. The Protocol as such, and the amendment of the Agreement, create no obligation to implement this flexibility in domestic law, just as is the current situation under the interim waiver, which applies at the moment – that situation has not obliged Members to avail themselves of the waiver. It would remain entirely a matter of choice for individual Members to implement or not to implement, even when the waiver is converted into a permanent amendment of the TRIPS Agreement. From that point of view it is important to understand, that it is a flexibility – it is an additional flexibility, and not a mandatory standard. 90. In that sense the TRIPS amendment is different in character from the Agreement itself, which does require positive implementation in domestic law. Therefore if a Member does accept the Protocol, it does not assume any legal obligation to have in place or to put in place implementing legislation. Effectively, the step of accepting the Protocol means that a Member is confirming its agreement that other Members are entitled to use the System of special compulsory licences for trade in pharmaceuticals if they so wish. Of course, it is an important step to accept the Protocol, but essentially because it will mainly give other Members legal certainty and confidence to use the System. If they do choose to use the new flexibility to obtain affordable medicines, their access to medicines by these means will thus be on a legal parity with any other health-related flexibility in the TRIPS Agreement. Therefore, it is clear that many Members - in fact the overwhelming majority of acceptances of the Protocol from a wide range of legal, economic, geographic backgrounds - have accepted the Protocol without first putting implementing legislation in place. I have mentioned this at length, because this is a recurrent issue that does come up in a more informal dialogue with Members. We hope that this clarifies at least one practical obstacle to acceptance of the Protocol. 91. The other constraint that has been mentioned has been simply the process of getting an instrument of acceptance signed and lodged. From that point of view, we would draw Members' attention to what is available on the website – a resource providing background on how to accept the Protocol and including a Model Instrument of Acceptance, as well as a map depicting the range of acceptances and other details that you have seen earlier. And just to clarify – the Model Instrument of Acceptance is a very simple document. It refers to the Protocol Amending the TRIPS Agreement, it refers to the process of acceptance in general terms, and it has in effect one very brief operational paragraph stating that the signatory (who does have to be a sufficiently senior figure in the administration) hereby formally declares that the Member concerned accepts the Protocol and expresses consent to be bound by it. That is the full operative paragraph, it is nothing more than that. Being bound by it is effectively saying: other Members may wish to avail themselves of this option, rather than binding any Member to make use of it itself, or to implement it. 92. We have had very constructive conversations with a wide spectrum of delegations on this matter. The Director General has flagged that this would be a highly desirable outcome in the context of the Nairobi Ministerial, for a whole host of reasons, of course, and we look forward to working with Members, with interested delegations, in a practical way to help them take this process forward.

The Council took note of the statements made.

7.1. The Chairman recalled that paragraph 8 of the waiver Decision provided that the Council for TRIPS shall review annually the functioning of the system set out in the Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council. Furthermore, the paragraph provided that this review shall be deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement.

7.2. He said that the records of the Council's earlier reviews continued to provide a unique and valuable resource for understanding this important measure. This included the records of the reviews in 2010 and 2011 when the Council had held a more structured debate on the basis of lists of topics for the discussion that had been agreed in advance. These earlier records and lists of topics might also inform discussions at the present review. If Members felt that any questions posed at earlier reviews regarding the Paragraph 6 System itself or possible alternatives to it were not adequately addressed at those reviews, they should feel free to revert to any such questions.

7.3. The Secretariat had prepared a draft cover note for the Council's report modelled on previous years' reports (circulated as JOB/IP/13). He suggested that the Council take up the preparation of its report to the General Council after it had exhausted its discussion. The cover note of the report contained a list of Members that had notified their acceptance of the Protocol Amending the TRIPS Agreement (WT/L/641). The following Members had deposited their instruments of acceptance since the Council's last meeting in June: Moldova on 7 July, Kenya on 21 July, Saint Kitts and Nevis on 27 July, Sri Lanka on 9 September, Lao People's Democratic Republic on 29 September, and Iceland on 12 October.

7.4. The Chairman further recalled that the Protocol had been originally open for acceptance by Members until 1 December 2007. Upon proposals by the Council for TRIPS, the General Council had four times extended this period for further two-year periods. At present, the period ran until 31 December 2015. The TRIPS amendment would enter into force once two thirds of the membership had accepted it. For this to happen, another 21 instruments of acceptance needed to be deposited with the Director-General. He strongly encouraged those Members, especially developing country Members, who were yet to complete their domestic procedures to do as soon as possible. If needed, the Secretariat could assist Members concerned regarding the steps that were required in order to accept the Protocol.

7.5. The representative of the WTO Secretariat took the floor.

7.6. The Chairman noted that the vast majority of Members that had already deposited their instrument of acceptance had done so before adopting implementing legislation, if at all, which was not required by the amendment.

7.7. He reported that, at the informal meeting on 14 October 2015, some delegations had reiterated the proposal that a workshop open to all stakeholders be jointly organized by the WTO, WHO and WIPO as part of their trilateral cooperation. While other delegations had indicated their readiness, in principle, to consider such a proposal, they had asked for more information regarding the issues to be covered by such a workshop. He encouraged the proponents to explore the proposal in their direct contacts with other delegations.

7.8. The representatives of Canada, India, Australia, Cuba, Chinese Taipei, Egypt, Brazil, Indonesia, Thailand, Chile, the European Union, New Zealand, Ecuador, Switzerland, Japan, the United States, Bangladesh on behalf of the LDC Group, South Africa, and Uganda took the floor.

7.9. The Council took note of the statements made.

7.10. Turning to the draft cover note for the Council's report (circulated as JOB/IP/13), the Chairman said that, in accordance with the way that the Council had prepared its reports in the previous years, the part of the minutes of the meeting that reflected the discussions held under this agenda item might be attached to the cover note. He also suggested that the report be updated in order to take account of the instruments of acceptance that had been deposited since the circulation of the initial draft report.

7.11. He said that the Protocol had originally been open for acceptance by Members until 1 December 2007. At present, the period ended on 31 December 2015. Given the proximity of this date, the Council might wish to consider again submitting a proposal to the General Council for a decision to extend the period for the acceptance of the Protocol. For this purpose, a draft decision that could be submitted to the General Council for adoption had been included in Annex 2 to the draft report. As the draft proposal for a decision by the General Council did not yet contain a new deadline for the extended period for acceptances, he suggested that the Council propose to extend the period by a further two years until 31 December 2017.

7.12. In conclusion, the Chairman proposed that the Council agree on forwarding to the General Council the proposal for a decision to extend the period of acceptance by Members of the Protocol Amending the TRIPS Agreement until 31 December 2017. The last paragraph of the draft decision by the General Council contained in Annex 2 to the draft report should be complemented by inserting this date. He also proposed that the Council agree on the cover note to the report contained in JOB/IP/13, with the update concerning the instruments of acceptance that had been deposited by Sri Lanka, Lao People's Democratic Republic, and Iceland since the circulation of the draft cover note, and also that the Council minutes containing the record of the discussion be attached to it.

7.13. The Council so agreed.

IP/C/M/80, IP/C/M/80/Add.1