H.E. Ambassador Xolelwa Mlumbi-Peter

Switzerland

1 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19

247.   Switzerland would like to thank you, Chair, for the consultations you held to build consensus on your oral report to the General Council. Introduction 248.   In the view of Switzerland, the proposed TRIPS Waiver would not facilitate global access to COVID-19 vaccines. On the contrary, we consider suspending large parts of the TRIPS Agreement would be counterproductive. It would undermine the efforts currently ongoing, to scale up manufacturing to achieve such global access. 249.   We have set out our main arguments, explaining our view in past meetings, including in those of 19 January and 4 February 2021. We ask the Secretariat to include our statements from those two meetings in the present minutes. Scale up manufacturing 250.   Roughly 12 months after the world entered the pandemic, in record time, the first few vaccines have been developed and tested for their efficacy and safe use. Scaling up their manufacturing is the most important challenge now, as they are not available in sufficient quantities, yet. This comes not unexpected, as alleged by the delegation of India. It was hardly avoidable. Never before have such novel and highly complex biotech vaccines had to be made available to the whole of the world population in such a short time. This is a pioneering challenge. Progress is made, but we stand only at the beginning of this process. 251.   The partnerships engaged in this manufacturing scale-up are built also on the TRIPS Agreement. By enabling licensing agreements, patents and other IPRs help to build bridges between the various stakeholders and connect these partnerships, offering safe passages for knowhow and technology transfer, thereby accelerating the manufacturing scale up. 252.   If we were to suspend large parts of the TRIPS Agreement now, we would also suspend the bridges between these partnerships. The collaborations mentioned would be thrown into legal uncertainty, slowed down in their efforts and risk to stop functioning properly. Precious time would be lost and harm done to the fight against this pandemic, costing lives. 253.   Negative impacts might be felt also on the international initiatives underway, such as ACT-A and COVAX, in which WHO, specialized organizations and the private sector are partnering up for making vaccines available for low and middle income countries. 254.   Last week, the WHO listed a first COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by SK Bio of South Korea and the Serum Institute of India, under licensing agreements from the vaccine innovator Astra Zeneca. With WHO's emergency use listing obtained, the joint UN-led COVAX initiative can now start to deliver vaccines to recipient countries. 255.   In a recent interview in the newspaper The Guardian, Adar Poonawalla, the CEO of the Serum Institute of India was asked, whether the reason for the roll out having been slow was because of the developers who hold the patents on the vaccines having licensed too few manufacturers to make the vaccines. His answer was plain and simple: No – He said: "There are enough manufacturers, but the scale up simply takes times." Mid and long term consequences of the TRIPS Waiver 256.   Fighting this pandemic successfully is a marathon. We are on the way, but nowhere near crossing the finish line. There is worrying news about mutations of the virus and new variants, potentially more contagious or dangerous. Existing vaccines might have to be adapted, and new ones to be developed to fight this pandemic successfully. This requires keeping all stakeholders engaged and build on the existing innovation regulatory framework, of which the TRIPS Agreement is a key component. 257.   Accordingly, the incentive to continue research and development, also during the pandemic, must be preserved in order for innovative activity to be able to contribute to the fight against COVID19; Suspending the TRIPS Agreement at this critical stage would have serious consequences, for the fight against this pandemic and for world pandemic preparedness in the future. 258.   Switzerland reiterates its openness to discuss with WTO Members how we can ensure a global, equitable and timely access to COVID-19 vaccines, treatments and diagnostics within the multilateral legal framework. Responding to India 259.   Just to note that India posed a number of questions including in relation to the statement of my own delegation from this morning. We will come back with answers to these questions at our next meeting, to do justice to them. 260.   One question posed by India I would like to answer right away, however: India asked "on what side Switzerland really stands…": 261.   It goes without saying, that Switzerland stands on the side of all those who want this pandemic to end as soon as possible, to prevent further loss of lives and to end the social and economic misery caused by this pandemic. Switzerland's position in the Council's discussion on the Waiver Proposal is to be seen and understood exactly on this background. Switzerland' statement at the informal meeting held on 4 February 2021 262.   I refer to the statements made by this delegation in the discussion under this ad hoc agenda item in the TRIPS Council's past five formal and informal meetings. Thus, I will not repeat our wellknown position on the proposed Waiver request at length. Indeed, our position has not changed. 263.   We do not support the Waiver Proposal because we firmly believe that it would not help us to achieve the goal of expeditious global access, that goal we all share. Much more, we are convinced that it would undermine the efforts currently under way to reach this objective. It is thus not a matter of prioritizing IP protection over expeditious and equitable global access to COVID-19 therapeutics, but simply a matter of the supposed solution not solving the problem. 264.   My delegation would like to focus on the following arguments raised by proponents in documents IP/C/W/672, 673 and 674. Proponents argue that public research and also public funding have been key in the R&D of COVID-19 vaccines and other therapeutics. Accordingly, pharmaceutical companies would not deserve any patent rights on the resulting therapeutics. 265.   My delegation agrees that cooperation between universities, public research institutions and pharmaceutical R&D companies have been instrumental in successfully developing an innovative vaccine or therapeutics in the current pandemic. We can now start to mass produce safe, quality and effective vaccines or therapeutic products to administer to patients and work towards immunity against COVID-19, mainly thanks to close collaboration and partnership between a wide range of stakeholders from the public and the private sectors. 266.   Public universities, which deliver basic research, often lack the capacity and the finances to turn their basic scientific results into applied research and most often to develop them into tested, safe, effective, approved and marketable products. For this reason, they enter partnerships with other stakeholders, including those from the private sector, each contributing his or her particular expertise to this joint venture. And it is IPRs and thus the TRIPS Agreement which are a key prerequisite for these stakeholders being able and willing to do so. 267.   Accordingly, IP rights and the TRIPS Agreement are not solely a privilege for R&D pharmaceutical companies to recoup the investment for their contribution to the resulting innovative COVID-19 vaccines or therapeutics, but are similarly used by public sector institutions engaged in such partnerships. 268.   Governments that are funding such partnerships can, by fixing contractual arrangements about resulting novel vaccines or therapeutics, set the relevant terms and conditions about the ownership of respective IP right or determine other factors, like those concerning the affordable pricing or the distribution of these products. 269.   By suspending large parts of the TRIPS Agreement - and thus the linchpin of the international IP system - we would deprive these partnerships of a key basis for their collaboration. Proponents also claim that the TRIPS Agreement and IP rights are a barrier to global access. We have not been presented with convincing evidence of this actually being the case in this pandemic. 270.   Shortages in supply and issues in manufacturing processes were to be expected at the initial stage of mass production of vaccines, only very recently market approved in the first few countries. 271.   Vaccines in general, and in particular novel vaccines from biotechnology, are highly complex products and bringing them from the laboratory to the process of mass manufacturing is a highly complex task, which is fault-prone, incurs huge responsibility and thus represents an enormous challenge. 272.   This applies not just for their mass production, but also for their storage, international and domestic distributions, which includes the dispensing of these products to patients. Therefore, the collaboration of many stakeholders is needed for these production and delivery chains to work. The IP system builds essential bridges between various stakeholders, rather than constituting a barrier to access. 273.   By waiving obligations under the TRIPS Agreement, we would suspend these bridges and this at a crucial juncture where numerous stakeholders are working together towards achieving global access. It is important to note that intellectual property protection is essential because it also allows the patent holder of the concerned health technology to guarantee for the quality and safety of its products. 274.   Due to high quality requirements and patient safety, it must be thoroughly examined on a case-by-case basis, whether a licensee is at all capable of producing the respective product at the required quality standards, within a reasonable period and at an acceptable price. Furthermore, the licensee must have the necessary infrastructure to produce as well as to distribute the product. 275.   Another argument mentioned by the proponents to which we would like to revert is the following: The TRIPS Agreement and IPRs would be barriers to the transfer of technology, sharing of know-how, and undisclosed information. Again, my delegation believes that this claim stands in stark contrast and contradiction to what we have experienced in reality, including in this pandemic. 276.   In order to allow newly discovered innovations to be turn into marketable products, transfer of technology is crucial. Transfer of technology is not only crucial, but highly complex and requires a large number of specialized skills. This transfer of know-how takes place through partnerships between the originator companies and the generic manufacturers. 277.   Waiving international obligations concerning intellectual property rights without securing the necessary technology transfer is like letting the well run dry: the required health technologies will hardly be able to get reproduced in a timely manner. Moreover, future incentives into the research and development of health technologies will be deterred. 278.   It is exactly because the TRIPS Agreement and the IP system enable sharing of technology, know-how and trade secrets in a legally safe environment, that research and manufacturing partnerships are entered into and that such transfer and sharing actually happen. 279.   Parties do so only if they feel safe and comfortable and if they can rely on a trustworthy national and international regulatory framework. Against this background, our delegation believes that suspending large parts of the TRIPS Agreement would not facilitate technology transfer and sharing of know-how. If now, in the midst of this tragic pandemic, the WTO should suspend a key component of the international regulatory framework – and moreover – its very own regulatory framework, we would do harm and no good. 280.   Finally, my delegation would like to respond to the question raised in document IP/C/W/674 specifically addressed to Switzerland. Switzerland fully acknowledges that compulsory licenses are a flexibility that the TRIPS Agreement provides in its Article 31 for Members' use, as also confirmed in the separate Doha Declaration on the TRIPS Agreement and Public Health. 281.   Under this Article, a compulsory license can be issued promptly and in the case of an emergency, like the COVID-19 pandemic, even without prior negotiations with the right holder. This being said, Switzerland is of the view that in most situations where there is a prompt need for access to an innovation, voluntary licensing agreements, e.g. through contractual licensing, are a more expeditious and more efficient approach to access and manufacture an invention still under patent protection. 282.   Transfer of technology and know-how are regularly an important part of such licensing agreements. They are key components of actual and effective access to an innovation – and of the partnership entered into through such agreements. Switzerland takes this view not only in the WTO, but it shares it consistently with its partners at the multilateral level as well as the bilateral level. 283.   To sum up: Switzerland remains open to discuss with all WTO Members how we can ensure a global and fast access to COVID-19 vaccines, treatments and diagnostics. This is indeed an enormous challenge, and we should address it in a holistic and sustainable manner, and within the rules-based multilateral trading system. 284.   On the process, Switzerland remains open for discussions on how to best address the actual challenges that would be identified. This could be considered in a short, factual status report to the General Council to be held in March. Switzerland is ready to engage in the process leading us to such a report. Switzerland' statement at the informal meeting held on 19 January 2021 285.   There is positive news since we first started discussing under this ad hoc agenda item in the Council – there are now a number of vaccines in the manufacturing and rollout stage and a few more in the pipeline. Dozens of countries, both developed and developing, have launched mass vaccination programmes. 286.   Only a couple of months ago, we would not have thought such quick progress possible as concerns new vaccines. Of course, this is only the beginning of overcoming the pandemic. The challenges ahead are enormous: to scale up manufacturing with a view to expeditiously respond to global needs, the logistics of distribution and safe and efficient administration. 287.   Still, that we are at this point now, having tools available to combat the pandemic effectively, roughly one year after its breakout, is the result of unprecedented efforts and collaboration of many stakeholders involved: governments, international organisations, universities, scientists, research institutions, both public and private, public-private partnerships and the private sector. They are joining forces to address this global public health crisis. 288.   IPRs and thus the TRIPS Agreement help build bridges between these stakeholders, help establish, organize and manage these partnerships. What is true for the research and development of the vaccines, is true for the tasks of scaling up manufacturing, distributing and administering the vaccines over the next few months and throughout 2021. 289.   An example of such a partnership is the licensing agreement between Oxford University, the pharmaceutical company AstraZeneca (AZ) and the Indian generic manufacturer Serum Institute of India (SII). The SII produces the AstraZeneca vaccine in India. According to SII, millions of doses have already been stockpiled, and are ready for distribution to vaccination centres in India. 290.   These are welcome news, and only one example of many that I could cite here from the past few weeks. Since these vaccines have only recently been approved for market entry and only in some Members, scaling up production will take time, naturally. As of today, we are still far from the goal that I understand we all share: fastest possible and equitable access to the new, safe and effective vaccines at global scale. We will only reach this goal through continued joint efforts and committed collaboration of all the stakeholders already engaged in this undertaking. 291.   During the collective race towards this goal, we must not suspend these rules. Suspending large parts of the TRIPS Agreement would result in considerable legal uncertainty, disrupt existing partnerships and hamper the establishment of new ones. The bridges between the stakeholders I mentioned IPRs help to build, would be jeopardized. A safe regulatory framework has and will help them guide their collaboration. It will make it predictable and accountable. 292.   The TRIPS Agreement underpins licensing agreements such as the one mentioned between Oxford University, AZ and the Serum Institute of India. It supports technology and know-how transfer. We need confidence in down-stream financing and delivery capacity for rollout of products, including in low and middle income countries). 293.   I mentioned that the arrival of new vaccines against the novel coronavirus is positive news. There is also worrying news since we last met. News about the novel coronavirus mutating and building new variants, potentially more dangerous and contagious. This shows that the fight against COVID-19 is not a one-time effort. Rather, it is an ongoing challenge for months and years to come. And there will be future pandemics. 294.   Therefore, we must ensure a safe, reliable, rule-based environment that encourages - today and in the future - the research and development of new vaccines and medicines, adapting existing ones to respond to mutations of viruses and develop innovative therapeutic products and diagnostics against them. The TRIPS Agreement is a key component of such a reliable regulatory environment. Our focus now is COVID-19, we must collectively mobilize and join forces in the fight against this pandemic. While doing this, we must keep in mind that our actions today will have an important impact on medical innovation tomorrow, including on our preparedness for a next pandemic. 295.   In sum: The concern of fast and equitable access to those new vaccines and medicines for all is one my delegation fully shares with the proponents of the TRIPS Waiver request. Yet, my delegation has not been convinced and does not believe that suspending large parts of the TRIPS Agreement will help us meet this goal. On the contrary, we think it would prevent us from doing so. It is essential that we take into account all relevant factors that determine access, and continue to address the challenges that we are facing in a holistic and sustainable manner, and within the rules-based multilateral trading system. It is a global pandemic and there is no alternative to overcoming it together. 296.   We thank the proponents for their three submissions with answers to questions raised in the Council's past discussion and questions of their own posed to other Members. We received these submissions late last Friday and are still examining them. As already stated, Switzerland is open to discuss concrete challenges related to IP with regard to access to health technologies relevant to COVID-19. We will come back on questions posed at our next meeting.

1. The Chair said that the "Proposal for A Waiver from Certain Provisions of The TRIPS Agreement for the Prevention, Containment and Treatment of Covid-19" had been circulated in document IP/C/W/669 by India and South Africa on 2 October 2020 and had since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt and – most recently – the African Group and the LDC Group.
2. At the Council's last formal meeting on 10 December 2020, the Council had agreed to provide a 'Status Report on the consideration by the TRIPS Council of the waiver proposal' to the General Council meeting of 16-17 December 2020. That Status Report provided a factual overview of the waiver discussions in this Council and highlighted Members' common goal of providing access to high-quality, safe, efficacious and affordable vaccines and medicines for all. It reported that Members had exchanged views, had provided information and sought clarifications, but had not been able to reach consensus. It concluded that,
"[T]herefore, the TRIPS Council will continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement."
3. Since then, the Council had continued its consideration of the waiver request at informal open-ended meetings on 19 January and 4 February 2021, including on the basis of three new submissions circulated by the co-sponsors on 15 January 2021, and which bear the document numbers IP/C/W/672, IP/C/W/673 and IP/C/W/674.
4. She said that, after the informal open-ended meeting on 19 January, she had held consultations with a number of delegations on 27 January 2021 to encourage more solution-oriented discussions and to explore in concrete terms whether a possible landing zone could exist – in terms of concrete elements and outcomes – and to hear views on our report to the General Council. In preparation of that meeting, she had requested delegations consider three questions, namely (1) which elements of the Waiver were critical to deliver a multilateral solution on the common objective of ensuring swift, timely, affordable and equitable access to the vaccines and therapeutics to combat the COVID19 pandemic, (2) whether the discussion had provided clarifications about core elements of the TRIPS Agreement in relation to public health and how these can be captured to establish a common understanding; and (3) what were delegations' views on the timing and format of deliberations towards a report to the GC as communicated by the TRIPS Council in December 2020.
5. While delegations' responses to these questions did not indicate any significant shifts in positions, a number of delegations signalled openness to hearing concrete evidence of any IP-related challenges that would be related to or arising from the TRIPS Agreement, and to seek consensual, proportionate and commensurate solutions to any such problems where necessary. The co-sponsors also indicated that they were ready to consider the contours, the scope and the time frame of the waiver proposal, and indicated that they would once again reach out to delegations individually for further discussions.
6. At the informal open-ended meeting on 4 February 2021, Members had continued their consideration of the waiver request. She said that, from the discussions at these meetings, it seemed that there remained differences in Members' approaches to the waiver proposal. A number of delegations had indicated a need for more evidence-based discussions in the TRIPS Council to understand the issues underlying the waiver request, as well as clarifying the impact and operation of the waiver in practise. The co-sponsors had made numerous interventions – and circulated a number of new documents – in response to questions and concerns raised by delegations and had indicated that they would wish to advance to text-based negotiations.
7. She said that, as regards the question about the Council's report to the General Council, most delegations indicated a preference for a factual report that would once again reflect the state of play of discussions among Members, following the same lines as the status report delivered in December 2020.
8. As foreshadowed at the informal open-ended meeting on 4 February, she had circulated draft language for such a report on 9 February, with an invitation for Members to comment on this language by 12 February 2021. On the basis of the comments that were received by the deadline, she had held further consultations on 16 February, and circulated a revised draft status report in document JOB/IP/42 on 17 February, which she hoped could be adopted today. The item had also been placed on the agenda of the General Council meeting scheduled for 1 March. This concluded the summary of the Council's activities since its last formal meeting.
9. Turning to the revised language for the oral status report to the General Council which had been circulated in document JOB/IP/42 on 17 February 2021, she noted that the African Group and the LDC Group had now been listed as co-sponsors of the waiver proposal, and she suggested that this be also reflected in the first paragraph of the status report for the purposes of accuracy. She therefore proposed the Council agree that she would deliver an oral status report to the General Council as follows:
At the meeting of the TRIPS Council on 15-16 October 2020, India and South Africa introduced document IP/C/W/669, requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19, which had been circulated on 2 October 2020 and has since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group and the LDC Group. The Council continued its discussions under that agenda item at informal meetings on 20 November and 3 December, as well as at its resumed meeting on 10 December 2020. Following the status report to the General Council on 16-17 December 2020, the Council continued its consideration of the waiver request at informal meetings on 19 January and 4 February 2021, and at its formal meeting on 23 February 2021.
At those meetings, delegations highlighted the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through documents IP/C/W/670, IP/C/W/671, IP/C/W/672, IP/C/W/673 and IP/C/W/674, on the waiver request but could not reach consensus, including on whether it is appropriate to move to text-based negotiations. Delegations indicated a need for further discussions on the waiver request and views exchanged by delegations.
This means that the TRIPS Council has not yet completed its consideration of the waiver request. The TRIPS Council will therefore continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.
10. The Council so agreed.
11. The Chair thanked all delegations, particularly those involved in the consultations, for the constructive spirit in which they had engaged in the discussions on this report. As regards the TRIPS Council's next steps in this regard, this item would now be on the agenda of the next regular meeting, scheduled for 10-11 March 2021. After that, the next regular meeting of the TRIPS Council was scheduled for 8-9 June 2021. She said delegations might wish to consider how to organize the Council's consideration of this issue going forward, would be invited to also share their views in this regard, so that the Secretariat and the Chair could make any appropriate arrangements.
12. In her view, the single most important priority of the global community was to stop the COVID19 pandemic, halt its rapid transmission, reduce the risks of variants and reverse the trend of consequential global distress. This goal is only achievable when everyone, everywhere can access the health technologies they need for COVID-19 detection, prevention, treatment and response. This was a goal that Members of the WTO have consistently repeated in their statements. Now more than ever, international cooperation and solidarity were vital to restore global health security, now and in future.
13. The business community is calling for a coordinated approach to vaccine access in view of the risks to the global economy inherent in an uncoordinated approach. The WTO's four DDGs have also issued a statement calling for heightened international cooperation, including ensuring the global availability of vaccines. Importantly, that the war against the pandemic can only be won when universal coverage in vaccination is achieved. The new WTO DG had stated that for the global economy to return to sustained growth, the global community would need to get a tight grip on the pandemic by intensifying cooperation to make equitable and affordable access to vaccines, therapeutics, and diagnostics a key plank of the recovery.
14. In the informal meeting of 4 February 2021, many Members had recognized the challenge arising from limited manufacturing capacity of vaccines and the inability of existing manufacturers to meet global demand. She urged Members to engage in a candid and good-faith discussion on what is required to scale up global production in these unprecedented times of a public health crisis. She expressed her hope that Members would engage in a solution-oriented process that will provide an effective solution to boosting productive capacity for products that are essential to deal with COVID-19 across the world. The WTO membership should demonstrate its commitment to the overarching goals of universal and equitable access to COVID-19 medical products not only in words, but through action. She also reminded Members of the heightened public interest and concern in this regard.
15. The Chair invited Members to take the floor.
16. The representatives of Chile; Tanzania; South Africa; Egypt; Colombia; Chad; Pakistan; Bangladesh; Mozambique; India; Indonesia; El Salvador; Venezuela; Sri Lanka; Namibia; Nepal; Nigeria; China; the European Union; the United States; Norway; Switzerland; Mali; Singapore; Canada; the United Kingdom; Australia; Japan; and the Holy See took the floor.
17. The Chair said that it seemed from delegations' statements that there was still no consensus on this waiver request at this point. She noted that the proponents had made further efforts to address a number of questions on the functioning and the impact of the requested waiver, which delegations have raised in the last meetings and in a recent submission. In light of this, she encouraged delegations to continue to engage with each other, and to seek common ground in regard to the subject matter of the waiver request, including in relation to scope and substance – as indicated by proponents in order to achieve the common objective shared by all.
18. She emphasized that the detailed exchanges and discussions that Members had had in the context of the waiver proposal were extremely useful and valuable. While Members were still discussing the waiver proposal before them, it was her impression that these discussions had highlighted a number of shared understandings with respect to TRIPS flexibilities which Members might wish to reflect on and explore further. COVID-19 may not be the only pandemic. Therefore, the TRIPS Council might wish to highlight and communicate such shared understandings on the role of IP in the context of a pandemic, as these could provide valuable elements and could help prepare for future pandemics.
19. She said that she herself, and the Secretariat, were always available to help facilitate any path forward that Members might wish to explore in this regard

IP/C/M/97, IP/C/M/97/Add.1