Actas - Consejo de los ADPIC - Ver detalles de la intervención/declaración

Ambassador Mero (United Republic of Tanzania)
1 THE PROTOCOL AMENDING THE TRIPS AGREEMENT – STATUS UPDATE
7. I want to say, at the very outset, that I fully agree with the Director-General for the metaphor he used to describe this epoch-making event of the TRIPS Agreement entering into force. It is truly an historic measure that has been taken, the first ever amendment to the WTO Agreements that enters into force. We have proved that trade policies can truly complement other vital public policy goals and that, at the WTO, we can negotiate smart solutions for real problems affecting our lives. I also thank the Director-General and all officials at the WTO who made continuous efforts towards reaching the required number of ratifications. Let me take this opportunity to make a few observations. 8. First, we have recently seen tremendous advancements, including fundamental innovation in all sectors of science and technology, including in ICT and medicine. Unfortunately, not all countries of the world share and enjoy this benefit in the same way. On the one hand, some are enjoying all the advantages of scientific progress, and on the other, for many countries the existing digital divide continues to widen and we are having ever enlarging gaps between basic requirements and real availability of treatments and medicines required to treat communicable and non-communicable diseases. 9. Our Ministers were very right in making a judgement call under paragraph 6 of the Doha Declaration regarding the real difficulties of WTO Members with insufficient or no manufacturing in the pharmaceutical sector in making effective use of compulsory licensing under the TRIPS Agreement. Their kind concern prompted today's momentous decision of the Members, and for that, we congratulate all of them. 10. Secondly, after food, medication for the cure of diseases is a primary need for people living in developed, developing and least developing countries. Health is a precondition for an outcome, and indicator of all dimensions of sustainable development, and it demands, we believe, persistent attention. The right to the enjoyment of the highest attainable standard of physical and mental health was first articulated in the Preamble of the WHO constitution of 1948, the right to health is also enshrined in the Article 25 of the Universal Declaration of Human Rights on 1948 and Article 12 of the International Covenant on Economic, Social and Economic Rights and in the Human Rights Council Resolution entitled "Right of Everyone to the Enjoyment of the highest attainable standard of physical and mental health". Now the WTO TRIPS Agreement with its new Article 31bis ranks alongside these important international instruments to ensure health and happiness for all. 11. Let us recall that this provision was already in place through the temporary Waiver, and was only used once, between Rwanda and Canada, to which the Canadian Ambassador made reference. However, our experience from that case proves that we have to work on the process further, to make it more effective, and requiring effort, since we now have the legal certainty, we have to find ways which can best suit everybody's requirement. For national governments this can actually be a very effective procurement tool. We also call upon all developed countries and multinational companies to extend all possible assistance expeditiously when any such notification for compulsory licensing is made by any developing country or any LDC, and request them to remove any potential administrative or procedural barrier. In future, we may discuss under the auspices of the TRIPS Council in any form, the possible problems and prospects of this System, so that countries are encouraged to use this important provision. You are probably aware, that, with the help of TRIPS flexibilities for LDCs, Bangladesh has invested heavily in the pharmaceutical sector, and is almost self-sufficient as regards the supply of medicines for its 160million people. It even exports medicines to more than 70 countries of the world. Bangladesh would be very happy to extend its production capacity in the aid of any future requirement by any developing country or any LDC. 12. Thirdly, although the private sector is the principle holder of patents, and the burden of access to medicines and treatment is increasing every day, strong political commitment is now needed to address the challenges of financing, creating and enabling the environment at all levels for the success of this System. When global leaders adopted the Sustainable Development Goals including SDG3, to "ensure healthy lives and promote well-being for all at all ages" they pronounced a commitment that no-one would be left behind, that no goal can be achieved unless it is achieved for all. We at the WTO expect no less than this vision and goal. 13. To conclude, we would like to place on record our profound appreciation again to all Members and Observers in this Organization, in relevant UN organizations, all the academics, NGOs and activists who have written, campaigned and raised awareness in support of this idea. We are profoundly grateful and humbled by the generosity and concern. Bangladesh aligns itself with the statement made by Benin as LDC Coordinator.
The Council took note of the statements made.
1. The Chairman provided a status report on the Protocol Amending the TRIPS Agreement.

2. He recalled that he had updated delegations on the status of acceptances at the Council's last meeting in November. At that meeting, he had noted that fifteen instruments of acceptance had been deposited in 2016 and only five more instruments of acceptance were needed to trigger the entry into force of the Protocol. He referred delegations to the record in paragraph 28 of the cover part of the minutes of the Council's meeting held on 8-9 November 2016 that had been circulated in document IP/C/M/83.

3. The Chairman also said that he had briefed the General Council at its meeting on 7 8 December 2016 that two more instrument had been deposited with the WTO Director-General after the Council for TRIPS meeting in early November. Accordingly, he had informed the delegations that only three more acceptances were needed to reach the two-thirds threshold that was required for the Protocol to enter into force.

4. He noted that there has been considerable momentum up to the entry into force of the TRIPS Amendment over the last two years. In 2015 and 2016 alone, 27 Members had formally accepted the Protocol.

5. The Chairman welcomed the fact that this momentum was continuing in 2017. Since mid January, Nigeria, Burkina Faso, Liechtenstein, the United Arab Emirates and Viet Nam had all deposited instruments of acceptance. The updated list of WTO Members who had deposited instruments of acceptance was available on the WTO dedicated webpage. 1

6. He recalled that, in accordance with paragraph 3 of Article X of the WTO Agreement, as referred to in paragraph 4 of the Protocol Amending the TRIPS Agreement, the Protocol shall enter into force upon acceptance by two thirds of the Members. It was his understanding that, with the deposit of the last three acceptances by Liechtenstein, the United Arab Emirates and Viet Nam on 23 January 2017, the condition set out in paragraph 4 of the Protocol had been met and that therefore the amendment to the TRIPS Agreement had entered into force on 23 January 2017.

7. The Chairman thanked all delegations that had contributed to making the amendment happen through their hard work and support. The entry into force of the TRIPS amendment was a milestone in the WTO's comparatively short history. It was the first ever amendment to a multilateral agreement administered by the WTO, with its roots in the Doha Declaration on the TRIPS Agreement and Public Health, that had been unanimously adopted by WTO Members in 2001. In response to a concrete proposal by the African Group, the amendment provided a secure legal pathway to access affordable medicines and put this new procurement tool on par with other TRIPS flexibilities directly relevant to public health. He emphasized that this was clearly a major contribution by the WTO membership to wider multilateral efforts to deliver on public health and the Sustainable Development Goals.

8. He said that the continuing string of acceptances that had been deposited over the last two years, as well the amendment's recent entry into force demonstrated Member's firm commitment to this additional flexibility that was now a permanent part of the TRIPS Agreement. Equally, this commitment was confirmed by the significant increase of implementing legislation in countries that were major exporters of pharmaceuticals and that was now estimated to cover about 80% of the current global medicines export capacities.

9. The Chairman noted that these important developments seemed to support demands from Members to look into how to make this new procurement tool work effectively so that it delivered concrete results in practice. At the Council's last meeting in November, a number of issues that could be usefully considered for that matter had been brought to Members' attention, both under the agenda item on technical cooperation and also as part of the annual review of the Paragraph 6 System. The Council's report on the annual review that had been circulated in document IP/C/W/76, as well as Annex II to the WTO Secretariat's annual report on its technical cooperation activities that had been circulated in document IP/C/W/618, provided useful information resources in that regard.

10. He then referred to Members that had not yet accepted the TRIPS amendment. Paragraph 3 of Article X of the WTO Agreement, as referred to in the Protocol, provided that the amendment would enter into force for each Member concerned when it had accepted the Protocol. In the meantime, the 2003 waiver Decision would continue to apply to them.

11. He clarified that the entry into force of the amendment did not mean that no further action was needed by Members that had not yet accepted the amendment. Rather, these Members were also expected to take action that would enable them to deposit their instruments of acceptance with the WTO in due course. The deadline to do so currently was end 2017. Therefore, he called upon these Members to undertake the necessary steps as soon as possible.

12. The Director-General took the floor and made the following statement:

This year starts in Geneva with a positive note. This is a historic session of the TRIPS Council. It marks the entry into force of the TRIPS amendment – and we should reflect on what a striking development this outcome represents. We received acceptances of the amendment from five Members last week: Burkina Faso, Nigeria, Liechtenstein, the United Arab Emirates and Viet Nam. Those acceptances took us over the threshold for entry into force. So thank you to those Members, and to all the others who have previously completed their notification.



This is the very first amendment to WTO multilateral law, the first to be agreed among all Members, and the first to come into force. It is significant that this first amendment is not about pursuing trade opportunities or market access for their own sake. Rather, its aim is to enhance access to medicines by the most vulnerable countries and overturn a situation in which the poorest could face the biggest hurdles in accessing essential drugs. As such it is in keeping with Sustainable Development Goal 3, on public health. And it is in keeping with the spirit of the WTO's founding agreements – to ensure that trade complements other essential public policy goals. It also marks a very concrete and definitive action taken under the mandate set by ministers in the Doha Declaration on the TRIPS Agreement and Public Health.



We should recall that the initiative to turn this into a formal provision of the TRIPS Agreement was taken by the African Group of WTO Members. Many have referred to it, quite rightly, as the "African Amendment". Today therefore marks a significant achievement for the Group. Moreover, I think it is a reminder of what the WTO community can do when it works together to deliver practical solutions. In this sense it is fitting that today the TRIPS Council is chaired by a respected African Head of Delegation, my good friend, Ambassador Modest Mero of Tanzania. I understand that this will be your last meeting as Chair, Ambassador Mero, before you leave us for your new posting in New York. So let me say thank you, once again, for your work in delivering entry into force. Indeed, Tanzania’s acceptance of the amendment last year was part of the final burst of momentum among the Membership that brought about this result today.



Members will know that the month of January is thought to be named after the Roman deity Janus, who is depicted with two faces – one looking to the future and one to the past. On occasions like this I think that we should try to do the same. Looking back to the moment that the General Council unanimously agreed the TRIPS amendment in 2005, I think we have to acknowledge that this journey took a lot longer than we expected it to take – and a lot longer than it should have taken. Over the years there was continuing encouragement from the international community to push ahead with entry into force. We saw this most recently, from the UN General Assembly in their Political Declaration on HIV and AIDS. However, the rate of acceptances was persistently slow.



Two years ago, the question returned to the General Council, and at that point I think we decided, collectively, to put new energy behind entry into force. Since then, we have seen a dramatic rise in engagement. Almost 40% of all the instruments of acceptance have come over these last two years.



The Secretariat has been busy. I personally have been busy. Your Chairs have been busy – all working to encourage Members to take this step. But of course it is the Members who have taken the decisive action. This impressive show of support is testament to Members' renewed interest in the system, their desire to see it work for the benefit of all, and their willingness to deliver on commitments made to each other. So now, let's look ahead. Entry into force consolidates compulsory licences for exports of generic medicines as an integral part of the TRIPS Agreement. It is now on a par with all other flexibilities for health under the Agreement.



This provides a firm foundation for Members to make use of this mechanism, where needed, to serve their public health needs. We have heard concerns expressed, even in this Council, that Members may be reluctant to use this mechanism for fear of repercussions. The system is now unambiguously part of international law. It is a negotiated solution that has been expressly welcomed and supported by governments around the world.



Policy debate may continue about the optimal use of compulsory licensing for access to medicines but there is no ambiguity about the status of this system. It is a legitimate measure with wide support and encouragement for its use when the situation on the ground so requires. So, if this is to be a practical tool for access to medicines, we should look beyond the legal text. Like other public health flexibilities, its impact will depend on how it is used in practice. The new Article 31bis is another tool which can be used for procurement, and it is one that has to be taken up positively if its potential is to be realized. There is considerable scope for pooling demand and coordinating use of the system, to build economies of scale and to service regional needs in an efficient way. And we need to understand first, for what medicines, second, for what patient cohorts, and third, for what practical supply scenarios it is most useful. This is particularly true given that we now have a widening range of alternative avenues for procurement of affordable medicines.



Therefore our collective tasks, looking ahead, are firstly to step up practical support for those Members and groups of Members who wish to make use of the system. And secondly to focus our attention on how to implement the system, and on how to identify the actual procurement scenarios for which the system is the optimal solution. So in marking this most significant milestone, I would like to echo the Chairman. This is not the time to take our rest – the remainder of journey lies ahead. We must continue working together to fulfil the potential of this mechanism – and others – to ensure access to medicines for those in greatest need, and to help deliver the Sustainable Development Goals.

13. The representatives of Canada, Benin on behalf of the LDC Group, Bangladesh, the European Union, Australia, Republic of Korea, Kenya, Morocco on behalf of the African Group, South Africa, Brazil, Botswana, Switzerland, China, Chile, Tanzania, Singapore on behalf of the ASEAN Group, Peru, India, Chinese Taipei, Argentina, Norway, and Japan. The representative from UNCTAD also took the floor.

14. The Council took note of the statements made.

IP/C/M/84, IP/C/M/84/Add.1