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Council for Trade-Related Aspects of Intellectual Property Rights - Annual review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health - Report to the General Council
日期:2015/11/09
作者:Council for Trade-Related Aspects of Intellectual Property Rights
文件編號:IP/C/72
附件下載:IPC72.doc
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ANNUAL REVIEW OF THE DECISION ON THE implementation
of paragraph 6 of the doha declaration on
the trips agreement and public health

Report to the General Council

 

1.  Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 30 August 2003 (the "2003 Decision") provides 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.  This review is deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement.

2.  The Council for TRIPS undertook the eleventh annual review in October 2014. The General Council took note of the report of the Council for TRIPS (IP/C/69) at its meeting on 10-11 December 2014 (WT/GC/M/155, paragraph 11.15). The present report covers the period since October 2014.

3.  At its meeting of 15-16 October 2015, the Council undertook the twelfth annual review. Annex 1 and Appendix 1 to this report record the review and the statements made by delegations. The paragraphs below set out factual information regarding the implementation and use of the 2003 Decision and the acceptance of the Protocol Amending the TRIPS Agreement.

1  Information on implementation and use of the System established under the Decision

4.  Since the last annual review, New Zealand and Australia have notified legislation implementing the System into domestic law to the Council for TRIPS.[1] An overview of all notified implementing laws and regulations, including hyperlinks to the legal texts, is available on a dedicated page on the WTO website at http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm.

5.  During the period covered by the present report, no notifications by importing or exporting Members pursuant to paragraphs 1(b), 2(a) and 2(c) of the 2003 Decision have been made to the Council for TRIPS. As foreseen in the 2003 Decision, the Secretariat regularly updates a page on the WTO website dedicated to this Decision, notably to ensure the public availability of notifications made pursuant to it (http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm).

6.  A trilateral study on "Promoting Access to Medical Technologies and Innovation – Intersections Between Public Health, Intellectual Property and Trade", launched by the WHO, WIPO and WTO Secretariats in February 2013, offers explanatory background material on the implementation and use of the System.[2] In addition, a set of model notifications has been provided for illustrative purposes on the WTO's webpage dedicated to public health in order to further facilitate the use of the System.[3]

2  Decision on the Amendment to the TRIPS Agreement

7.  As called for in paragraph 11 of the 2003 Decision, the General Council adopted a Protocol Amending the TRIPS Agreement, by a Decision of 6 December 2005 (WT/L/641). The Protocol is open for acceptance by Members until 31 December 2015 or such later date as may be decided by the Ministerial Conference (WT/L/899). In accordance with Article X:3 of the WTO Agreement, the Protocol will enter into force upon acceptance by two thirds of the WTO Members.

8.  In February 2015, Director-General Azevêdo addressed letters to all WTO Members, encouraging those who were yet to accept the Protocol to urgently complete their domestic procedures so that the TRIPS amendment could enter into force by the 10th Ministerial Conference, and asking other WTO Members to provide practical advice and assistance based on their own experience with the process of acceptance. He emphasized that securing the entry into force of the TRIPS amendment was not only a priority for the WTO, but represented a concrete contribution that WTO Members could make to global efforts to strengthen the legal framework for access to medicines. Permanently incorporating the Paragraph 6 System into the TRIPS Agreement would thus respond to the many calls for its timely implementation and entry into force that emanated from the multilateral system, including from the UN General Assembly, ECOSOC, the WHO and UNAIDS.

9.  On 20 February 2015, Director-General Azevêdo updated the General Council on the status of acceptances and called upon Members that were yet to accept the TRIPS amendment to complete their domestic procedures. He recalled that the entry into force of the Paragraph 6 System provided the necessary legal certainty that would strengthen the future potential to facilitate exports of much-needed medicines.[4] At the same meeting, the General Council also agreed to the circulation of an Aide Mémoire as a formal WTO document that set out the expected benefits of the Paragraph 6 System and provided a model instrument of acceptance.[5]

10.  Based on an initiative taken by the Chair of the Council for TRIPS, H.E. Ambassador Al-Otaibi from Saudi Arabia, the Council, at its meeting on 9-10 June 2015, had a constructive discussion under the agenda item on "Technical Cooperation" of possible ways and means to enhance cooperation among Members with a view to facilitating the completion of domestic acceptance procedures.[6] This initiative built on the Council's past work that had recognized the need for technical assistance concerning the acceptance process and as part of which support had already been provided to Members.

11.  As of 15 October 2015, the following Members have notified their acceptance:

·         United States, 17 December 2005, WT/Let/506;

·         Switzerland, 13 September 2006, WT/Let/547;

·         El Salvador,  19 September 2006, WT/Let/548;

·         Republic of Korea, 24 January 2007, WT/Let/558;

·         Norway, 5 February 2007, WT/Let/563;

·         India, 26 March 2007, WT/Let/572;

·         Philippines, 30 March 2007, WT/Let/573;

·         Israel, 10 August 2007, WT/Let/582;

·         Japan, 31 August 2007, WT/Let/592;

·         Australia, 12 September 2007, WT/Let/593;

·         Singapore, 28 September 2007, WT/Let/594;

·         Hong Kong, China, 27 November 2007, WT/Let/606;

·         China, People's Republic of, 28 November 2007, WT/Let/607;

·         European Communities[7], 30 November 2007, WT/Let/608;

·         Mauritius, 16 April 2008, WT/Let/619;

·         Egypt, 18 April 2008, WT/Let/617;

·         Mexico, 23 May 2008, WT/Let/620;

·         Jordan, 6 August 2008,WT/Let/630;

·         Brazil, 13 November 2008, WT/Let/636;

·         Morocco, 2 December 2008, WT/Let/638;

·         Albania, 28 January 2009, WT/Let/639;

·         Macao, China, 16 June 2009, WT/Let/645;

·         Canada, 16 June 2009, WT/Let/646;

·         Bahrain, Kingdom of, 4 August 2009, WT/Let/652;

·         Colombia, 7 August 2009, WT/Let/650;

·         Zambia, 10 August 2009, WT/Let/651;

·         Nicaragua, 25 January 2010, WT/Let/663;

·         Pakistan, 8 February 2010, WT/Let/664;

·         Former Yugoslav Republic of Macedonia, 16 March 2010, WT/Let/671;

·         Uganda, 12 July 2010, WT/Let/678;

·         Mongolia, 17 September 2010, WT/Let/684;

·         Croatia, 6 December 2010, WT/Let/747;

·         Senegal, 18 January 2011, WT/Let/753;

·         Bangladesh, 15 March 2011, WT/Let/758;

·         Argentina, 20 October 2011, WT/Let/830;

·         Indonesia, 20 October 2011, WT/Let/831;

·         New Zealand, 21 October 2011, WT/Let/832;

·         Cambodia, 1 November 2011,WT/Let/833;

·         Panama, 24 November 2011, WT/Let/837;

·         Costa Rica, 8 December 2011; WT/Let/838;

·         Rwanda, 12 December 2011, WT/Let/839;

·         Honduras, 16 December 2011, WT/Let/843;

·         Togo, 13 March 2012, WT/Let/848;

·         Saudi Arabia, Kingdom of, 29 May 2012, WT/Let/855;

·         Chinese Taipei, 31 July 2012, WT/Let/870;

·         Dominican Republic, 23 May 2013, WT/Let/884;

·         Chile, 26 July 2013, WT/Let/888;

·         Montenegro, 9 September 2013, WT/Let/893;

·         Trinidad and Tobago, 19 September 2013, WT/Let/894;

·         Central African Republic, 13 January 2014, WT/Let/920;

·         Turkey, 14 May 2014, WT/Let/949;

·         Botswana, 18 June 2014, WT/Let/953;

·         Uruguay, 31 July 2014, WT/Let/984;

·         Brunei Darussalam, 10 April 2015, WT/Let/1037;

·         Moldova, 7 July 2015, WT/Let/1048;

·         Kenya, 21 July 2015, WT/Let/1052;

·         Saint Kitts and Nevis, 27 July 2015, WT/Let/1055;

·         Sri Lanka, 9 September 2015, WT/Let/1080;

·         Lao People's Democratic Republic, 29 September 2015, WT/Let/1084; and

·         Iceland, 12 October 2015, WT/Let/1088.

12.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage which is regularly updated by the WTO Secretariat.[8]

13.  Given the present status of acceptances, and the indications that a number of Members are actively pursuing their respective domestic procedures in order to accept the Protocol, the Council for TRIPS submits the attached proposal to the General Council for a decision to extend the period for acceptances of the Protocol. A draft of such a proposal for consideration by the Council is contained in Annex 2 of this document.


ANNEX 1

 

        Excerpt from the Minutes of the Council's meeting of 15-16 October 2015

(to be circulated as IP/C/M/80)

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

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.

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.

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.

4.  The Chairman further recalled that the Protocol had been originally open for acceptance by Members until 1 December 2007. Upon proposals by the TRIPS Council, 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.

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

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.  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.

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.

9.  The Council took note of the statements made.

10.  Turning to the draft cover note for the Council's report (circulated as JOB/IP/139), 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.

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.

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.

13.  The Council so agreed.

 

_______________

 

 


ANNEX 2

 

 

 

WT/L/..

 

 

(15-0000)

Page: ../..

 

 

amendment of the TRIPS agreement – fifth extension of the period for the acceptance by Members of the protocol amending

the trips agreement

Draft Decision of [date]

 

            The General Council,

 

            Conducting the functions of the Ministerial Conference in the interval between meetings pursuant to paragraph 2 of Article IV of the Marrakesh Agreement establishing the World Trade Organization (the "WTO Agreement");

 

            Having regard to paragraph 2 of the Decision of the General Council of 6 December 2005 on the Amendment of the TRIPS Agreement (the "TRIPS Amendment Decision") and paragraph 3 of the Protocol Amending the TRIPS Agreement (the "Protocol")[9], which provide that the Protocol shall be open for acceptance by Members until 1 December 2007 or such later date as may be decided by the Ministerial Conference;

 

            Recalling that the General Council, by its decision of 26 November 2013 (the "2013 Extension Decision")[10], extended the period for acceptances of the Protocol by Members for the fourth time until 31 December 2015 or such later date as may be decided by the Ministerial Conference;

 

            Recalling also that, pursuant to paragraph 3 of the TRIPS Amendment Decision and paragraph 4 of the Protocol, the Protocol shall take effect and enter into force in accordance with the provisions of paragraph 3 of Article X of the WTO Agreement;

 

            Noting that acceptance of the Protocol by two thirds of the Members in accordance with paragraph 3 of Article X of the WTO Agreement is taking longer than initially foreseen;

 

            Having considered the proposal to further extend the period for acceptances of the Protocol submitted by the Council for TRIPS (IP/C/70);

 

            Decides as follows:

 

        The period for acceptances by Members of the Protocol Amending the TRIPS Agreement referred to in paragraph 2 of the TRIPS Amendment Decision and paragraph 3 of the Protocol, and extended by the 2013 Extension Decision, shall be further extended until 31 December 2017 or such later date as may be decided by the Ministerial Conference.

 

 

Appendix 1

Excerpt from the Addendum to the Minutes, containing the statements made during the Council's meeting held on 15-16 October 2015

(to be circulated as IP/C/M/80/Add.1)

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

7.1  Secretariat

 

1.  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.

2.  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 to so as to advance their public health interests.

3.  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 has not obliged Members to avail themselves of that 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.

4.  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 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.

5.  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 that map 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 has in effect one very brief operational paragraph stating that the signatory (who does have to be a sufficiently senior 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 implement it.

6.  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, interested delegations in a practical way to help them take this process forward.

7.2  Canada

 

7.  I am happy to take the floor on behalf of Canada on this major issue. Canada would like to urge all Members having not done it as yet to deposit their instruments of acceptance. We consider the Protocol on access to medicines which Canada has been the first country to implement. As a major tool permitting access to medicines for developing and LDCs.

7.3  India

 

8.  India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System as established under the 2003 Decision and the 2005 Protocol Amending the TRIPS Agreement.

9.  India notified its acceptance of the Protocol in March 2007. We would like to congratulate Members who have deposited their Instrument of Acceptance of the Protocol since the last TRIPS meeting held in June 2015. However, in spite of the fourth extension of the period of acceptance until 31 December 2015, only 60 Members including the EU have accepted the Protocol so far. The fact that it is still a long way to go for it to enter into force and that acceptance by two thirds of the membership is required is not a positive signal.

10.  While we reiterate the concern that the Paragraph 6 System was only used once so far and the System is too complex and administratively unwieldy for further use, we have always been of the view that the Doha Declaration on the TRIPS Agreement and Public Health constituted a major landmark in the short history of the WTO, because it recognised the primacy of public health needs and the preparedness of the Organization to take up the problems faced by the poor and developing countries.

11.  Along with several other Members, India has worked relentlessly on the Doha Declaration and the Decision. The Decision established the framework for special compulsory licences which is an additional flexibility aimed at enabling exports of medicines to WTO Members with insufficient or no manufacturing capacity in the pharmaceutical sector.

12.  The TRIPS Council has been reviewing the Paragraph 6 mechanism for the last several years. Our delegation feels that the review mechanism has become ritualistic in nature and it will not serve any purpose if we go on repeating the similar questions and get similar replies. The implementation of the Paragraph 6 mechanism involves several stakeholders and our discussions would not be effective if we restrict the discussion to this level.

13.  At the TRIPS Council meeting in October 2014, we have also proposed a multi-stakeholder symposium. I proposed it again during yesterday's informal meeting, and the membership accepted in principle and asked me to provide more information on this suggestion. I am providing more information now.

14.  Discussion in the symposium with relevant stakeholders including international organisations, public health experts, industry experts, civil society organisations and WTO Members would be extremely useful to explore the issue in depth. The symposium could discuss the implementation of the Paragraph 6 System so far, the challenges and opportunities involved as well as ways of improving the System to make it effective and meaningful. In this regard India proposes that a technical symposium be held in March 2016 under the trilateral cooperation of WHO, WIPO and WTO. The symposium could be aimed to increase our understanding of the System, the challenges in its implementation so far and suggestions on the way forward. It would be an experience sharing and exploratory basis with various views on the System being discussed and debated. We request that the Council for TRIPS agree to hold this technical symposium and direct the Secretariat to draw the broad contours of the symposium based on the suggestions of various Members.

15.  It is also requested that the Chair continues to hold informal consultations with interested Members in this regard in the coming months.

16.  With regard to the proposal for the extension of the period for acceptance of the Protocol for a further period of two years up to 31 of December 2017, we support the proposal. I conclude by encouraging Members who are yet to accept the Protocol Amending the TRIPS Agreement to accept the Protocol and notify their acceptance on a priority basis.

7.4  Australia

 

17.  May I begin by thanking the Secretariat for what was a very clear explanation of a simple process for acceptance. Certainly Australia's experience bears out the simplicity of the process, but also, as the Secretariat noted, the fact that there is no need for implementation necessarily attached to the acceptance. In our case there was an eight year gap between our acceptance in 2007 and our implementing, domestic implementation arrangements, which we notified this year and which are referred to in my intervention under item 2. 

18.  Australia adds its voice in support of desiring to see the TRIPS Protocol enter into force. We believe that this outcome will reinforce the WTO's potential to deliver practical, development-orientated outcomes. And like Canada and India before us, we commend Members from every region and at every stage of development that have already accepted this Instrument. In particular, we welcome recent acceptances this year of the Protocol by Members in the Asia-Pacific, including Brunei Darussalam, and as the Chair has mentioned, most recently: Lao PDR and Sri Lanka.

19.  Australia is very encouraged by interventions that have been made at the TRIPS Council earlier this year that indicated that other Members are preparing to take this important step and we look forward to seeing the number of 21 that was mentioned reduce further.

20.  Now mindful that a number of Members are actively pursuing acceptance and noting what the Chair has referred to as the proposal that has been informally discussed for an extension of the period of time for acceptance, Australia adds its voice in support of an extension period and we are flexible about the time-period of this extension.

7.5  Cuba

 

21.  Cuba would wish to support in full the proposal presented by the delegation of India regarding the organization of the technical symposium next year under trilateral cooperation. We hope Members will be able to support this proposal. In this regard we encourage all to show a constructive spirit. All delegations should see this technical workshop as an excellent opportunity to discuss the implementation of the System. This would furthermore help Members that have not as yet accepted the Protocol.

7.6  Chinese Taipei

 

22.  We wish to thank the Secretariat for their excellent work regarding the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. My delegation attaches great importance to the Paragraph 6 System, particularly in the view of the 2003 Decision and the 2005 Protocol.

23.  We have ratified the Protocol on 31 July 2012. We also wish to congratulate Sri Lanka and the other seven Members which have accepted the TRIPS amendment this year. We welcome the efforts of the Secretariat in order to obtain more acceptances of the amendment. In this regard we wish to call the delegates' attention to the TRIPS webpage, where Members will be able to find the link taking them to a manual on notifications as contemplated by Paragraph 6 which we also consider very useful.

24.  Many developing countries and many LDCs suffer from public health problems. We wish to highlight that this Agreement does not prevent Members and should not prevent them from taking measures protect public health, particularly in terms of facilitating access to medicines for all. We encourage Members to notify their acceptance of the amendment in order to allow it to come into force.

7.7  Egypt

 

25.  We would like first to associate ourselves with India and Cuba. Many questions spring to mind, including the administrative and regulatory complexity of the System, lack of appreciation of business methods in supplying markets and associated overhead costs, as well as constraining requirements.

26.  These questions need to be addressed. Egypt strongly supports the proposal to organize a workshop to address these questions and others of relevance, and include in this workshop participants from all stakeholders. Therefore we urge those Members that seem to be reluctant to join consensus on the convening of this workshop with the participation of all stakeholders to reconsider their position in view of the direct relevance for access to medicines and ultimately for human rights involved in this problem.

7.8  Brazil

 

27.  We welcome the information about the acceptance of the Protocol by Moldova, Kenya, Saint Kitts and Nevis, Sri Lanka, Lao PDR and Iceland. We congratulate these countries and urge those that have not yet accepted it, to take the necessary measures to do so at an early stage. As mentioned, taking these steps is even more urgent when we consider that the overwhelming majority of Members that are still to accept the Protocol are comprised by developing countries, potentially beneficiaries of this instrument.

28.  We thank the Director of the IP Division for his detailed explanation on the details for the acceptance of the Protocol. We hope the efforts of the Secretariat led by the Director General bear the expected fruit soon, so that we reach the 21 needed instruments of acceptance soon. Thus, the beneficiaries of this mechanism can start enjoying the flexibilities of the System.

29.  On the proposal for a multi-stakeholder technical symposium on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, we would like to thank the delegation of India for this timely initiative. We believe it is a timely initiative for one simple reason, namely: that the Paragraph 6 has not been used in practice except on one occasion. We believe that this would suffice to make it necessary or at least timely, to bring other stakeholders to discuss the reasons for this, well, lack of knowledge about the benefits of the System. Yesterday during our informal meeting, we heard some delegations requesting something on paper. I don’t know if all of us have a document that was prepared by India, but I believe, regardless of the details that can be discussed further during the time till we prepare the conference, that the contours of this multi-stakeholder event would benefit those countries that need more information in order to consider the possibility of using the System. So we fully support the initiative and we hope we can agree to hold it on a date that is foreseen here in this document.

7.9  Indonesia

 

30.  First of all we would like to thank the Secretariat for the presentation on the notification of the Paragraph 6 System.  Access to medicines still remains a problem for most developing countries and LDCs. A WHO report said that with growing recent numbers of trade in medicines, developing countries and LDCs only contribute to 70% of all imports and 6% of all exports. The situation will affect the health profile of the population which will subsequently hamper the productivity of their people which is significant for their development. Therefore, the unanimously adopted 2005 General Council Decision to amend the TRIPS Agreement to give legal certainty to the implementation of the Paragraph 6 System was a great breakthrough to help developing countries and LDCs obtain greater access to affordable medicines when needed. We would like to congratulate Brunei, Lao PDR, Sri Lanka, Moldova, Kenya, Iceland and other Members that have accepted the Protocol this year. Yet, we still need more Members to submit their instruments of acceptance before this noble objective can be implemented. In this light, while calling on Members to expedite their ratification process, Indonesia would like to lend its support for the extension of the period of acceptance by the Members of the Protocol Amending the TRIPS Agreement. On this opportunity, we would also like to support the proposal of India that a technical symposium be held on the Paragraph 6 System of the Doha Declaration on the TRIPS Agreement and Public Health.

7.10  Thailand

 

31.  Regarding Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Thailand is currently accelerating the internal process for accepting the Protocol Amending the TRIPS Agreement and aims to accept the Protocol, possibly by the tenth Ministerial Conference.

7.11  Chile

 

32.  Our delegation has been attentive to the efforts of the Director General and those undertaken by delegations regarding the Paragraph 6 System. As we see it, it is very important to extend the period for acceptance as proposed in Job/IP/13. We would also like to voice our concern that this very important amendment has not yet received a sufficient number of ratifications so as to enter into force. Given the potential of this measure to save thousands of lives on a daily basis, we would like to extend our appeal to all the remaining countries to ratify this draft amendment and thank all those who have taken this initiative. Finally, we would like to thank India for their proposal. We see the proposed symposium as an important element, and it could make it possible for those countries that have not been able to ratify so far to avail themselves of the necessary information so that they can ratify very swiftly.

7.12  European Union

 

33.  The European Union agrees with DG Azevêdo that the entry into force of the Protocol will be an important signal that will ensure a legally secure, predictable, effective and sustainable solution for those countries wishing to use the TRIPS flexibilities to get affordable medicines. Therefore, the European Commission will continue to encourage and assist the remaining WTO Members to accept the Protocol so that it can enter into force, if possible by the time of the next Ministerial Conference, if not, as soon as possible thereafter. Commissioner Malmström herself has included this in her briefing and each time she is meeting with countries concerned she is stressing the importance of this, as was requested by DG Azevêdo. On the idea of a symposium, and noting that there are different positions held here, we wonder whether it would not be possible to have a more Member-driven approach and to have the kind of events in the margins of this Council that have been taking place for a number of years regarding issues that we consider very valuable like the debate on IP and innovation. If the intention is to provide information and assistance to the countries who need it in this process, we believe it is perfectly possible to do it as a Member-driven approach and have these informative sessions organized in the margins of a TRIPS Council meeting.

7.13  New Zealand

 

34.  Since the last annual review, New Zealand has notified its legislation implementing the system established under this Decision. We would like to congratulate Members who have accepted the Amendment this year. As others have mentioned, we would like to encourage Members who have not completed domestic procedures to take the relevant steps to deposit instruments to accept the Amendment before MC10 given the humanitarian objectives of the Amendment and the development dimension as well. We hope that the TRIPS Amendment can enter into force at the tenth Ministerial Conference; that would be a highly-desirable outcome.

7.14  Ecuador

 

35.  We would like to thank those delegations who have accepted the Protocol and also add our voice to the request made by India to have this technical symposium or workshop. This ought to make it possible for countries to be more knowledgeable regarding a number of items and ratify the Protocol so that it could come into force.

7.15  Switzerland

 

36.  We would first like to congratulate Brunei Darussalam, Iceland, Kenya, Lao PDR, Moldova, Sri Lanka, and St. Kitts and Nevis for notifying the WTO of their acceptance of the Protocol Amending the TRIPS Agreement.

37.  Switzerland seizes the opportunity to encourage Members who have not yet notified their acceptance to undertake the necessary steps and proceed so that the required acceptance by two thirds of WTO Members may be met and that the Protocol can enter into force. The Paragraph 6 system is a significant mechanism. Its goal is to put those WTO Members on a level playing field with the other WTO Members that do not have manufacturing capacity in the pharmaceutical sector. It enables those Members to make use of the flexibility offered by Article 31 TRIPS, thereby filling the shortfall of this article.

38.  As the Director General stressed in his letter to the WTO Members last February, acceptance of the Protocol is a concrete contribution that WTO Members can make to global efforts to strengthen the legal framework for access to medicines. We would also like to remind that the procedure of acceptance of the Protocol is straightforward, as was just explained by the Secretariat. The WTO Secretariat's website provides helpful information on the procedure in general and the few formalities that apply.

39.  My delegation thus calls on all those WTO Members who have not yet done so, to proceed with their acceptance of the Protocol without further delay.

40.  As for the proposal for a multi-stakeholder symposium, taken up by a number of delegations, in order to discuss the workability of the Paragraph 6 mechanism and associating therefore a broad range of WTO external stakeholders, we consider this premature. We have not heard from potential beneficiary Members whether at all they face specific obstacles, and if so, which ones, when wishing to make use of the Paragraph 6 mechanism. Before having heard about such concerns and problems from beneficiary WTO Members, we see neither the need nor the merits of considering including external stakeholders to the Council’s discussion. Experience sharing should in the first place be deepened in this Council.

7.16  Japan

 

41.  Firstly, this delegation would like to reiterate that Japan attaches great importance to the issue of access to medicines, which needs to be discussed in a broader context, taking into account not only the Paragraph 6 System but also various other relevant measures and factors, such as procurement and tariffs to name a few. Japan supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol Amending the TRIPS Agreement. At the same time, however, we would like to recall that the very objective of the System is merely, but importantly, to enable those WTO Members that have either insufficient or no pharmaceutical manufacturing capacity to make use of compulsory licenses as a policy tool under the TRIPS Agreement, just like other WTO Members with pharmaceutical manufacturing capacity, for the purpose of promoting access to medicines. Compulsory licenses are, whether granted under the Paragraph 6 System or not, just one of the potential policy tools that can be utilized for this purpose and therefore, the Paragraph 6 System should not be considered as the only solution, but rather as just an option we could consider.

42.  Secondly, the delegation of Japan would like to congratulate Republic of Moldova, Kenya, Saint Kitts and Nevis, Sri Lanka, Lao People’s Democratic Republic and Iceland for depositing their instruments of acceptance of the Protocol most recently. To our disappointment, however, the list of Members has not yet reached the necessary number for the Protocol to enter into force and we are looking into the fifth extension of the deadline for the acceptance of the Protocol. We would like to call upon all Members that have not yet done so to deposit their instruments of acceptance of the Protocol as soon as possible and urge such Members to inform the Council their intended timeline for doing so, just like the distinguished delegate of Thailand did so earlier in this meeting.

43.  Lastly, with respect to the proposal at yesterday's informal meeting on holding a multi-stakeholder technical symposium on this subject, we are open to consider the proposal provided its objective is made clear in written form. At the same time, this delegation believes that we should take full advantage of this annual review to fully understand and identify challenges that Members might be facing in utilizing the Paragraph 6 System.

7.17  United States of America

 

44.  Thank you for this update regarding the status of notifications of acceptance of the 2005 Protocol Amending the TRIPS Agreement. Since the last annual review, New Zealand and Australia have notified legislation implementing the System. The United States strongly supports the Paragraph 6 System as established under the 2003 waiver decision, the 2005 Protocol, and the 2013 General Council decision to extend the deadline to 31 December 2015 for acceptance of the Amendment.

45.  The United States congratulates those Members identified by the Chairman -- Brunei Darussalam, Moldova, Kenya, and Saint Kitts and Nevis, Sri Lanka, Lao PDR, and Iceland – which formally accepted the Amendment since the last review. We welcome and encourage the Secretariat's efforts with respect to depositing instruments of acceptance of the Amendment as well and encourage other Members to notify their acceptance of the Amendment so that it can enter into force.

46.  With respect to the present status of acceptances, and the indications that a number of Members, including the delegation of Thailand, which so indicated today, are actively pursuing domestic efforts in order to accept the Amendment, the United States supports the draft TRIPS Council proposal to the General Council for a decision to extend the period for acceptances of the Protocol.

47.  We would also encourage those delegations that have expressed criticism of the Paragraph 6 System under this agenda item to consider further the impact of their interventions on our shared efforts to encourage Members to accept this important Amendment. We urge caution regarding suggestions that its use indicates flaws in the System. We do not share this view. We also think Members should take full advantage of meetings of this Council. If Members have information to share that is relevant to acceptances of the Amendment, it should be presented at our meetings, including the presently, and not held for some future date at some future event.  The time is now to deliver on a decade-old promise on public health.

48.  As we have explained, there are multiple avenues available for promoting access to medicines. The Paragraph 6 System is important, but it is not alone. Appropriate mechanisms for transparency, procedural and due process protections, and opportunities for public engagement are important in the context of health care systems. Measures, including those that are discriminatory, non-transparent or otherwise trade-restrictive, have the potential to hinder access to pharmaceuticals and medical devices, and potentially result in reduced access to healthcare due to higher healthcare costs.

49.  We continue to believe that the access to medicines issue is multidimensional. Making life‑saving medicine available requires transparency and a commitment to address measures that unduly delay patients from getting the treatments they need. For example, we continue to have a great interest in hearing from other delegations regarding their efforts related to trade to facilitate such access. For instance, what measures have been taken by those Members identified in the 2012 staff working paper entitled, "More Trade for Better Health? International Trade and Tariffs on Health Products" as maintaining the highest tariffs, bound and applied, on medicines, medical inputs and medical devices? We recall the Uruguay Round pharmaceutical zero-for-zero agreement including the United States and other WTO Members. Are other WTO Members preparing to do the same?

50.  Finally, while we are not in a position to accept the proposal due to a lack of information on this suggestion, we support the suggestion made by the EU. We also confirm our support for the proposal to extend the period of acceptance of the amendment for another two years.

7.18  Bangladesh, on behalf of the LDC Group

51.  I am taking the floor on behalf of the LDC Group. The Paragraph 6 mechanism is a unique mechanism to serve the cause of public health and the LDCs are grateful to the Members of the WTO for the Decisions taken in this regard. Bangladesh, as LDC coordinator had reminded and encouraged the LDC Members concerned to notify their acceptance. However to find out the causes for non-ratification, we may hold formal or informal exchanges of ideas and experiences so that we can understand their causes for delay and we can help the countries if they need any technical support or any support for understanding and ratifying this amendment.

7.19  South Africa

52.  South Africa is a signatory to the TRIPS Agreement and one of the countries that played an active role in ensuring that the TRIPS Agreement accommodates issues on public health. Hence South Africa would like to reaffirm its commitment to improve access to essential medicines in developing countries and preserving the spirit and principles contained in the TRIPS Agreement and the Doha Declaration. In this regard, South Africa is currently taking all the necessary steps in terms of its constitutional requirements to implement the Paragraph 6 System into its domestic legislative framework. South Africa will continue to participate in discussions that aim to improve the efficiency of the Paragraph 6 System.

53.  Furthermore, South Africa supports all endeavors aimed at promoting and fostering a better understanding of the challenges associated with the effective utilization of the Paragraph 6 System, including through a dedicated workshop, as proposed by India and other delegations, and wider stakeholder consultation to this end. This delegation wishes to further express its support for the extension of the period for acceptance of the Protocol Amending the TRIPS Agreement for a further two years.

7.20  India

54.  I apologise for taking the floor once again. I would like to restrict my comments to the proposal on the technical workshop or symposium. Firstly we would like to thank the delegations who have supported the idea of a technical workshop based on the information provided, but we are quite dismayed that a few delegations have opposed the idea of a workshop. The intention of India proposing this technical workshop was simple, we are aware of the working of the Paragraph 6 System. This item that has been discussed in the Council for TRIPS and Members have aired their views on its practical application and its working. The trilateral study too has discussed it and we felt that it is now time to discuss it in a larger setting with multiple stakeholders, including representatives from industry, civil society, from international organizations involved in these issues, from public health experts on an exploratory informal basis without any bearing on any decisions. The proposal was just that – to take it forward in terms of a trilateral co-operation symposium with WHO, WIPO and WTO which is done every year on different issues. It would, in our opinion, increase Members' understanding on these issues without prejudice to the views that each Member has. A number of delegations have opposed this and we would like to address the concerns that they have raised and urge them to reconsider.

55.  Firstly I would like to respond to the EU suggestion that it should be a Member-driven approach and could be held in the margins of the Council and could be based on an information-sharing basis where it is Member-driven. We do not necessarily disagree with this view, the timing of the technical symposium is immaterial, it could be when the next TRIPS Council is meeting or in the margins of the Council, but what is important is that a larger stakeholder involvement of different interests and different ideas including industry, civil society and experts would help to break this impasse we have seen for the past decade. It has been discussed in the TRIPS Council but it is not just an information-sharing exercise, it would be a sharing of experiences, sharing of challenges and sharing of different viewpoints. While we agree with the EU on holding it in the margins of the Council, we urge that this multi stakeholder technical symposium is important to get more views and understanding for all Members on this point.

56.  The second opposition from Switzerland of being premature, we fail to understand when it would become mature, because the Paragraph 6 mechanism entered into force in 2003. Since then, we have been debating it in the TRIPS Council incessantly, we feel it has become ritualistic and we feel that it is the right mature time, as many delegations including Brazil have mentioned. Switzerland may find that it is premature. This opinion could be stated in the workshop, that it is premature to discuss it, but that should not be a bar to discuss it with other experts.

57.  We thank Japan for making the point that they are open to consider if the objective is clear. I think we have made our objective very clear in the last meeting last year, and again at this meeting about the workshop being to tackle Paragraph 6 and to see the challenges and problems being faced in the context of Paragraph 6. Of course Japan has different views on a broader context in which this has to work, and it is free to air that during the symposium. There is no bar against Members bringing their opinions, to even suggest speakers; we don't have a list of speakers ourselves. I think that merely because there is a plethora of other ways to handle this doesn't bar a technical symposium on Paragraph 6, so I believe we have addressed to our limited ability Japan's objection.

58.  The US has basically stated that we have different views on how Paragraph 6 should work and there are multiple avenues to promote access to medicines. Nobody is making the point that holding this technical symposium would change that view. The US could continue to have that view and could place that particular view on the agenda of the symposium, but it would be important to discuss that symposium so that we understand better how Paragraph 6 could work. The US also mentioned that they need more information; we fail to understand what other information we could provide. There are topics on the Council agenda for which we have no papers, but we are discussing them without any information. We should be more in a flexible mode of accepting. What we have proposed basically is that Members could come with various suggestions on the agenda, on the speakers, on the formats. The Chair could consult in informal mode how it could go, so it is Member-driven. I would urge Members who are opposing it to reconsider because this is purely a symposium on a technical basis, on an informal basis, which would not influence any decision in the TRIPS Council.

7.21  Uganda

59.  You recall that Uganda submitted its instrument of acceptance in 2010, so I would like to encourage others to do so as well. With regard to the proposal by India, we welcome the suggestion for a multi-stakeholder workshop to better understand, inter alia, why the System is not working well and what the concerns of Members are so as to be able to utilize this instrument. A technical symposium could offer us all an opportunity to find ways for the effective operationalization of this instrument. We have noted the different views expressed by Members, but we think that Members should not be afraid of an information and experience-sharing session, except of course if the instrument was never meant to be precise, effective and operational like is the case for so many S&D proposals currently under review in the CTDSS.

__________



[1] WTO Documents IP/N/1/NZL/P/5 and IP/N/1/AUS/P/11 and 12.

[4] See minutes of the General Council meeting of 23 February 2015, WT/GC/M/156, para.3.5.

[5] Document WT/GC/W/696 of 20 February 2015.

[6] See minutes of the TRIPS Council meeting of 9-10 June 2015, IP/C/M/79, paras.9.1 to 9.8 and IP/C/M/79/Add.1.

[7] The text of the instrument of acceptance reads as follows:

 

"THE PRESIDENT OF THE COUNCIL OF THE EUROPEAN UNION,

 

HAVING regard to the Treaty establishing the European Community, and in particular Article 133(5) in conjunction with the first sentence of the first subparagraph of Article 300(2) and the second subparagraph of Article 300(3) thereof,

 

NOTIFIES by these presents the acceptance, by the European Community, of the Protocol amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at Geneva on 6 December 2005,

 

CONFIRMS, in accordance with Article 300(7) of the Treaty establishing the European Community, that the Protocol will be binding on the Member States of the European Union.

 

The Secretary-General/High Representative                The President of the Council

                                                               of the European Union"

[8] http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm. Revisions of document IP/C/W/490 will no longer be circulated.

[9] WT/L/641.

[10] WT/L/899.