H.E. Ambassador Dagfinn Sørli (Norway)

Switzerland

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

130.   Thank you, Chair, for consulting with Members the draft for your oral status report on the Council's discussion on this item to next week's meeting of the General Council. We fully support your status report. 131.   On the Waiver request, worldwide, the COVID-19 pandemic continues to have far-reaching negative impact on public health, the economic and social well-being. We are particularly concerned about the worrying news from India about the impact of the 2nd wave. The pictures we see and the loss of lives suffered are devastating. The Swiss Government has offered its support to India for its efforts to address this public health crisis. 132.   While the fight against the pandemic must be fought on many fronts, clearly, scaling up manufacturing of COVID-19 vaccines to achieve global access as efficiently and effectively as possible must be a priority. Switzerland supports all initiatives and measures, which truly help enable, in a practical manner, to scale-up manufacturing and to advance global access. 133.   Among practical and hands on initiatives, I cite COVAX first, the international initiative under the leadership of WHO, bringing together Member states, international organizations and other public and private stakeholders as partners to work together towards the goal of global access to COVID19 vaccines. The Swiss Government, in addition to its substantial financial contributions of last year, approved last Wednesday, a further 300 Million CHF to support the Access to COVID-19 Tools Accelerator initiative. 134.   Vaccine supply chains are international. This is evidenced by the example of the BioNTech/Pfizer vaccine, which contains more than 280 ingredients and components, sourced from 19 countries. Other novel vaccines, such as those from Moderna or Johnson & Johnson are similarly complex. The WTO and its Members have a key role to play in addressing the challenges to scale-up manufacturing. 135.   Members can contribute to making increased production and global access happen faster and better with appropriate national policies. For example by way of implementing trade facilitating measures and by avoiding trade-restrictive measures such as export restrictions, tariffs or other administrative measures which come in the way of a smoothly functioning transnational supply chain. 136.   The Trade and Health Initiative initiated by the Ottawa Group addresses these factors and promotes transparency in trade-related measures. Generating more information and data along the value chains, in cooperation with the private sector and relevant international organizations, is equally important to better understand the complexity of global value chains for medical goods, including vaccines, and foster efficient and coherent trade policy making. 137.   To achieve scaling up of manufacturing in a quick, safe, and effective manner, cooperative and collaborative approaches are in our view most promising. We therefore thank the DG for her engagement and organization of the COVID-19 Vaccine Equity Event on 14 April. Switzerland follows with interest the initiative of the DG to engage the WTO helpfully as a facilitator in bringing together vaccines developers with manufacturers that are qualified for the production of the new COVID-19 vaccines or that can meaningfully contribute to its scale-up. 138.   We encourage those delegations who have knowledge about such qualified manufacturing capacity lying idle in their country or region, to come forward with this information, in a substantiated manner, so that it can be fed into this initiative and the further process. For this cooperation, and for the partnerships mentioned, to have a reliable and stable international regulatory framework to build on is an enormous asset. This reliable basis is all the more important in times of crisis, as in a pandemic like COVID-19, where we face manifold new challenges and grapple to keep up with new and serious developments to adapt our strategies against the virus almost every day. The TRIPS Agreement builds such a stable, reliable international regulatory framework. 139.   It has been recalled many times in our discussion that the TRIPS Agreement also provides the necessary balance, means and remedies to allow the use of protected content and or product if needed in individual cases. Such legal guidance is needed - and particularly useful - in crises such as this pandemic, in which time is of essence. WTO Members have introduced these rules in the TRIPS Agreement also - and in fact, in part specifically - to take into account public health emergencies. 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. Under this article, a compulsory license can be issued promptly and in the case of an emergency, like the COVID-19 pandemic, without prior negotiations with the right holder. 140.   We have heard from some delegations that Members may face difficulties in making use of these flexibilities. As others, my delegation is open to discuss difficulties that Members have encountered in practical instances when actually wanting to make use of these TRIPS flexibilities. In reaction to our question in relation to the impact of a TRIPS waiver on existing manufacturing partnerships, South Africa, at our last informal meeting, answered that it expects no impact and that these collaborations CAN continue; and that, anyway, the proposed TRIPS waiver is proposed for a time-limited duration. 141.   However, this response does not allay our concerns. Switzerland is not home to a COVID-19 vaccine developer. However, a number of Swiss pharmaceutical companies are contractual manufacturers and suppliers to foreign vaccines developers. Suspending TRIPS risks throwing into uncertainty also these partnerships. 142.   Further, we fail to understand how the effects of a TRIPS waiver could be time limited. In particular, how could inventions made and used during a TRIPS waiver still claim IP protection after the waiver has ended? Technology and proprietary information, once disclosed and shared, can no longer re-enter the status of being "un-disclosed" or "un-shared". Once made public, without IPR coverage, they fall into the public domain. Accordingly, the proposed waiver would have effects and affect the innovation landscape and pandemic preparedness for many years after its effective duration. 143.   The global community, the private sector and we as WTO Members must now step up efforts to scale-up global manufacturing of COVID-19 vaccines and to ensure equitable, timely and affordable access. In these efforts, my delegation considers the TRIPS Agreement as part of the solution - and thus, as one tool of a broader toolbox helping us to win the battle against this pandemic.

The Council took note of the statements made and agreed to revert to the matter at its 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, the African Group, the LDC Group, the Maldives, Fiji and Namibia. He said the purpose of this formal meeting was threefold: first, to report on his activities since he had taken office; second, to adopt the status report to the General Council; and third, to continue consideration of the waiver proposal on the record.
2. The Chair said that, since his election at the end of the TRIPS Council meeting on 11 March, he had held a number of consultations with delegations in different formats to encourage more solutionoriented discussions and to explore in concrete terms whether a possible landing zone could exist.
3. On 24 March 2021 he had held group consultations with around 24 delegations on the waiver request and other topics where he solicited delegations' views on how to move discussions forward and find a common approach to this topic. Delegations' responses in these consultations had reiterated known positions and showed some frustration with the repetitive nature of exchanges in the recent open-ended meetings. A number of delegations had indicated a willingness to try a format of smaller consultations to address outstanding issues.
4. Following up on these indications, the Chair had held two small group consultations with 14 delegations on 12 and 13 April to permit discussing individual aspects of the waiver proposal in a smaller setting. The first session focused on "examples of IP-related challenges, including in using TRIPS flexibilities", while the second session intended to address the "operation of the proposed waiver". These discussions clearly showed delegations' agreement that production and distribution of COVID-19-related medical products, including vaccines, are facing serious challenges and that rapid scaling-up of production and ensuring safe supply of all countries is essential. Delegations also shared the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all.
5. However, delegations continued to differ on the fundamental question whether, and to what extent, intellectual property protection represents barriers or challenges to the achievement of our common objective, which could not be overcome by using the existing flexibilities. Co-sponsors were of the clear opinion that such challenges do exist and can only be effectively addressed by waiving certain TRIPS obligations. Other delegations remained unconvinced about the necessity of a waiver at the international level, with some arguing that a waiver might be counterproductive in relation to ongoing collaborative efforts.
6. He said that, in his intervention at the Director General's event "COVID-19 and Vaccine Equity: What can the WTO contribute?" on 14 April, which had been circulated to all delegations, he shared that assessment and indicated that these in his opinion, remained the key questions. In her summary of that event, the Director General also called on WTO Members to advance work in the TRIPS Council "on the waiver proposal and on incentives for research and innovation" and expressed her hope that the ideas and the open dialogue heard at the event will move us closer to agreement.
7. He said that Members had continued their consideration of the waiver request at an informal open-ended meeting on 22 April 2021. At that meeting, many exchanges had reiterated known positions regarding the role of voluntary licensing in scaling up production of vaccines, and the application of existing TRIPS flexibilities in domestic situations of vaccine shortages in the pandemic. However, the co-sponsors had also indicated that they were working on an updated waiver proposal, and that they had initiated bilateral discussions in this regard. A number of delegations also requested the Secretariat to compile data on existing and future voluntary license agreements, and on the projected and actual production of vaccine doses produced by such arrangements over time.
8. Other delegations had acknowledged the co-sponsors' responses to questions circulated in recent documents but felt that questions posed subsequently – particularly with respect to the operation of a potential waiver – remained unanswered. While these delegations had reiterated that cooperation and voluntary licensing were key to ensuring the technology transfer needed for scaling up production, they said it was equally clear that governments do play a role in facilitating such cooperation, and that the use of TRIPS flexibilities such as compulsory licensing was the sovereign right of all WTO Members. Some had considered whether there might be value in a confirmation by the TRIPS Council how these flexibilities apply in a pandemic, and in stepping up technical support for Members to use them, including by reinforcing cooperation with other international organizations on domestic implementation legislation of flexibilities. Overall, it was his impression that although significant differences remain, there was willingness on all sides to find a constructive consensual approach to these questions.
9. The Chair said that, as also foreshadowed at that informal open-ended meeting on 22 April, he had circulated draft language for an oral status report to the General Council, with an invitation to Members to comment on this language by 26 April 2021. Having received no textual comments in this regard, this draft status report had been circulated in document JOB/IP/44 on 27 April 2021, which he hoped delegations would be able to adopt at the present meeting. He informed Members that the item had also been placed on the agenda of the General Council meeting scheduled for 56 May 2021 in the usual fashion. This concluded his summary of the Council's activities since our last formal meeting.
10. Turning to the language for the oral status report to the General Council which had been circulated in document JOB/IP/44 on 27 April 2021, he said that Fiji and Namibia had recently been added as co-sponsors of the waiver proposal, and suggested that this be also reflected in the first paragraph of the status report for the purposes of accuracy.
11. He proposed the Council agree that he 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 Maldives, Fiji and Namibia. 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. Following the status report to the General Council on 3-4 March 2021, the Council continued its consideration of the waiver request at its formal meeting on 1011 March 2021, at an informal meeting on 22 April and at its formal meeting on 30 April 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. In April 2021, the co-sponsors indicated that they were considering an update of their proposal and were in the process of consulting with Members. 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.
12. The Council so agreed.
13. The Chair thanked all delegations for their support in this regard. He gave the floor to the Secretariat to react to the requests for data collection and compilation that were raised at the last informal meeting.
14. A representative of the Secretariat took the floor.
15. The Chair invited delegations to take the floor to continue their consideration of this request and the associated issues, and to share their views on how the work of the Council should be organized on this matter going forward.
16. The representatives of South Africa, Egypt, Bolivia, India, Maldives, Tanzania on behalf of the African Group, Chad on behalf of LDC Group, Pakistan, Zimbabwe, Bangladesh, Nepal, Saudi Arabia, Tunisia, Nigeria, Sri Lanka, Namibia, Fiji, China, Vanuatu, Switzerland, Paraguay, European Union, Uruguay, United Kingdom, Indonesia, Chinese Taipei, Cameroon, Singapore, New Zealand, Japan, Australia, the United States, and Angola took the floor.
17. In summing up, the Chair said that he had heard some well-known views and positions repeated also at this meeting so that the assessment of the state of play reflected in the oral status report to the General Council was indeed correct. At the same time, he also saw reason for some careful optimism, first and foremost as a result of the co-sponsors' announcement that they are considering revisions to the waiver proposal, and that they were currently consulting with other Members on the basis of such revisions. He noted the co-sponsors' request for time to continue such consultations to reflect on what they heard, and to develop a revised proposal on that basis, which – as they indicated – might be circulated in the second half of May. He said he would stay in close contact with the delegations concerned, consult them on the progress of their efforts, and would try to find a suitable timing for such a meeting, which would be communicated to all Members as it becomes clearer.
18. He noted and commended delegations on their expressed willingness to engage directly with each other - and encouraged constructive engagement on all sides in these engagements.
19. The Council took note of the statements made and agreed to revert to the matter at its next meeting.

IP/C/M/99, IP/C/M/99/Add.1