Ambassador Mero (United Republic of Tanzania)

European Union

1 THE PROTOCOL AMENDING THE TRIPS AGREEMENT – STATUS UPDATE

14. The European Union welcomes the entry into force of the Amendment of the TRIPS Agreement. We all agree that it is essential to secure access to medicines for those in need, wherever they are. This development is important not only because it formalises better access to medicines, but it is equally important because it demonstrates that the WTO is capable of responding in an adequate way to essential needs beyond trade policy. This shows that when there is the real necessity to change the rules at the WTO, to defend the fundamental interests of developing countries, it can, and will be done. 15. We delivered our part early on, our instrument of acceptance was deposited with the WTO Director-General on 30 November 2007, that is almost 10 years ago. In the WTO, the EU has stressed its political commitment to ensuring that domestic implementation of the 2003 Waiver, and the Amendment to the TRIPS by Members is facilitated in that the right conditions are in place for its operation and efficient application. We would like to thank in particular the WTO Secretariat and the Director-General for its work on that matter. 16. The current innovation model, based on patents, has delivered consistent progress in global public health, continuously leading to important new and improved treatments, as well as much extended life expectancy, both in developed and developing countries. Medicines are created not by public authorities, but by the pharmaceutical industry. As all industries, its needs an adequate return on investments to finance innovation. The challenges are how to use all levers available to public authorities to promote affordable access to medicines without affecting negatively the R&D by the pharmaceutical industry, and therefore the availability of new and innovative medicines. Let us also recall that evidence shows that, indeed, there are many different significant causes of lack of access to medicines, which renders it misleading to attribute a problem merely to or even principally IPR aspects. In fact, IPR issues seem to play a minor role in the problem, but a disproportionately large role in the debate. This has also been echoed in a join report from the WHO, WTO and WIPO stating that the lack of access to medical technologies is rarely due to a single isolated factor. Additionally, it should be mentioned that currently most medicines on the WHO list of essential medicines, that is 98.6%, are available in a generic format, either because they were never protected by a patent or because protection has expired. Still these medicines do not reach all in need, in fact many countries apply tariffs, taxes and substantial mark-ups to medicines and lack an efficient procurement and health care system, with the result that medicines are not available to the population or at least not at an affordable price. 17. However, the EU has never shied away from serious and constructive debate in the IPR context. From the outset, the EU has been at the forefront of debates on TRIPS and access to medicines. In the WTO, the EU has played an active role, with the aim of bringing together the almost irreconcilable positions of the opposing sides, including on the latest LDC Waiver. We have also consistently supported the use, when necessary and justified, of the flexibilities provided in the TRIPS Agreement and the Doha Declaration by developing countries in the objective of ensuring effective access to medicines for their populations. 18. The TRIPS Agreement provides for a number of flexibilities that can be used to take into account public health needs. In particular the TRIPS Agreement provides for the possibility under certain conditions of issuing a compulsory licence for domestic production and consumption of medicines. Sometimes the mere possibility of using compulsory licences has led to companies granting voluntary licences and price reductions in situations where such an approach was justifiable by systemic public health needs. However, the original TRIPS Agreement left one issue unresolved; specifically by stating that compulsory licences could only be issued to satisfy domestic consumption, it left out countries with no manufacturing capacity for pharmaceuticals. These countries could not credibly make the argument of granting a compulsory licence and produce locally generic medicines. Paragraph 6 of the Doha Declaration instructed the TRIPS Council to find an expeditious solution to this problem. 19. The Decision of 2005 to transform the 2003 Waiver Decision into a permanent Amendment of the TRIPS Agreement was that solution. The Amendment to the TRIPS Agreement allows any WTO Member to export pharmaceutical products made under a compulsory licence for the purpose of supplying developing countries with insufficient manufacturing capacities. It does ensure a legally secure, predictable, effective and sustainable solution for those countries which want to use the system to get affordable medicines they need. We therefore see 23 January 2017 as an important milestone for the WTO, and a successful proof that, when there is the real need to change rules to defend the interests of developing countries, it can, and will be done.

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