Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Dagfinn Sørli (Norway)
13; 14 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19; DRAFT GENERAL COUNCIL DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH IN THE CIRCUMSTANCES OF A PANDEMIC

330.   My delegation will address agenda items 13 and 14 together in our statement. My delegation would like to first thank you, Chair, for your interim report to the General Council last week concerning the status of our work. The informal consultation meetings have been helpful and instructive to deepen our understanding of the proposals we have in front of us. One year after the submission of the Waiver Proposal, it is important to take a close look at the developments on the ground and the state of play of our collective fight against the pandemic. This is a prerequisite for the Council to be in a position to do meaningful work and take well-informed decisions on possible measures to help us reach our shared objective: ensuring global, equitable and timely access to vaccines and medicines against COVID-19. 331.   The recent statement by the Director-General of the World Health Organization, Dr Tedros Adhanom Ghebreyesus, has been cited by other delegations. But the information is key in our context. With 7 billion doses produced so far and with global vaccine production now at nearly 1.5 billion doses per month, there are sufficient vaccines from a supply perspective to achieve the global vaccination targets. The true challenge we need to address is the equitable distribution of those doses. But this is not a matter of intellectual property rights nor could it be solved by suspending them. The special advisor of the WHO DG recently informed that 40% of people were already fully vaccinated in most countries in the Americas, Asia and Europe, while the Western Pacific was close to that. A survey in one of the recent editions of The Economist concluded that good progress has been made in most regions of the world as concerns vaccination rates. The exception, however, is subSaharan Africa, where serious problems of vaccine supply and rollout of vaccines persist in many countries. 332.   The COVAX Global Vaccine Facility was established in April 2020 to ensure equitable access to COVID-19 vaccines for low- and middle-income countries. It is also supposed to be a key source of vaccine doses for African countries. A number of factors have prevented the COVAX Facility so far from meeting this expectation. Export restrictions in COVAX partner countries in relation to COVID19 vaccines, therapeutics or ancillaries for vaccination were a key factor for this. We therefore welcome the announcement of India that it will resume exports of COVID-19 vaccines this month. COVAX has entered delivery contracts with the Serum Institute of India for hundreds of millions of COVID-19 vaccine doses, produced under licence from Astra Zeneca, that have been earmarked also for Africa since last spring. 333.   Dose-sharing to COVAX from as many countries as possible should also make an important contribution, so that COVAX and the international community can fulfil their promises visàvis Africa. There are lessons to be learned for future pandemics. The WTO has an important role to promote equitable access, by facilitating trade, ensuring regulatory coherence, fostering the resilience of essential medical goods supply chains, avoiding export restrictions and dismantling prohibitive tariffs. Reference is made in this context to the "Walker process", and also to the "Trade and Health Initiative" launched by the Ottawa Group, putting forward pragmatic proposals that could make their way into a multilateral outcome at MC12. 334.   Reliable facts and figures are key for our discussion to be meaningful, like the ones we have learned about in today's presentation by the WTO Secretariat. We thank the WTO Secretariat also for publishing on 8 October 2021 two important papers with highly relevant information: one on tariffs on vaccines inputs, indicating that tariffs on critical products to manufacture vaccines remain high, especially in some developing countries; the other one being an update on bottlenecks in critical COVID-19 products to combat the pandemic. The 11page paper does not mention IPRs in its list of trade-related bottlenecks. 335.   We need to match our answer to the problem we wish to solve. The most pressing problem is how to ensure equitable access to the vaccines produced and available. But this is not a TRIPS or an IP question. Accordingly, suspending the TRIPS Agreement is not the answer. Over the last 12 months, we have seen much evidence that demonstrates that TRIPS and the international IP system are working as enablers and are not a barrier in this pandemic. I refer to the more than 320 COVID19 vaccine manufacturing partnerships that have been established since the outbreak of the pandemic. Global monthly manufacturing capacity, starting from zero less than a year ago, stands now at 1.5 billion doses per month, and is growing. 336.   In the field of new and effective therapeutics against COVID-19, we are still mainly in the stage of research and development. One recent breakthrough was announced recently with a product called "molnupiravir". To respond to the urgent and potentially vast demand for an effective COVID19 therapeutic in this pandemic, its US developer has entered into voluntary licensing agreements with eight Indian biogeneric companies, even before the positive trial results were officially confirmed or approved. 337.   Concerning the mid-term goal to foster regional production capacity of vaccines in developing countries, we note important developments and progress over the past few months. Last spring, the COVID-19 vaccine developer Johnson & Johnson announced a manufacturing partnership with South Africa's Aspen Pharmacare. In July, Pfizer, another mRNA vaccine developer, announced a partnership with South Africa's Biovac, and in September, Moderna announced an investment in an mRNA vaccine facility in Africa for the production of up to 500 million doses a year. With that, all emergency use listed approved mRNA COVID-19 vaccine developers have now made commitments to manufacturing in Africa. For all these developments, TRIPS and IP have worked as enablers. We must make sure that we are not undermining the basis of this progress. 338.   Let me now turn to the proposals that the TRIPS Council is examining to consider whether they could contribute to reaching our shared objective of ensuring global, equitable and timely access to vaccines and medicines against COVID-19. In our recent work done in the informal consultation format on the Waiver Proposal, Members posed many questions about its implementation in order to better understand whether such a waiver would be an effective measure for the WTO to take. Its proponents in one of their communications say the following: "The proposal for a waiver on certain IP provisions offers an expedited, open and automatic global solution that allows for uninterrupted collaboration in development and scale up of production and supply and that collectively addresses the global challenge facing all countries." 339.   Notwithstanding the intense work we have undertaken so far, my delegation grapples with understanding how a TRIPS waiver could be an effective or expeditious measure to help us fight this pandemic. How could a TRIPS waiver be global, considering that each of the 164 WTO Members would decide individually whether or not, and if yes, to what extent, it would make use of and thus implement the proposed waiver? How could it be automatic, considering that each WTO Member intending to make use of the waiver would first have to go through national implementation to suspend or abrogate respective national IP laws and regulations, with different national procedures and timelines applicable in each Member? 340.   LDCs excepted, of course, for whom a waiver would not change anything in their situation under the TRIPS Agreement at all, due to the applicable transitional periods. But for the remainder of the WTO membership, an untransparent and disparate regulatory environment risks to be the result at the global level, and this for years to come. How could such an environment of legal uncertainty allow for uninterrupted collaboration among the more than 300 international partnerships currently engaged in the development, production and delivery of COVID-19 vaccines and therapeutics? 341.   Finally, how could such a waiver have an immediate impact? In one of our earlier statements, my delegation made reference to one of the new mRNA COVID-19 vaccines containing 280 ingredients that the developer is sourcing from 19 countries across the world. In spite of its wellestablished network of partners, it took this vaccine developer almost a year, after the development of the vaccine, to build up the necessary supply chains and get a safe and approved mass production process going. Without the cooperation and the voluntary sharing of technology and knowhow from the vaccine developer, a biogenerics producer located in one WTO Member wishing to develop and manufacture a copy of this vaccine under a TRIPS waiver would take even longer to reach that stage. 342.   We welcomed the most recent informal consultation, where Members examined the requirements for the use of compulsory licences contained in Articles 31 and 31bis of the TRIPS Agreement. In this respect, in its communication IP/C/W/681, the European Union proposes confirmations and clarifications for the use of these flexibilities in a pandemic. 343.   In our statement today, we have referred to facts and figures which demonstrate that TRIPS and the international IP system have been part of the solution in view of reaching global access. This said, we agree that every system, including the international IP system, needs to dispose of remedies if, in a specific case, an emergency or other situation requires an exception from the rule. My delegation therefore fully acknowledges that Members may use compulsory licences as a TRIPS flexibility. A key rational for having this policy tool in international law and implemented at the national level is to induce stakeholders to come to voluntary agreements. 344.   Some Members have indicated that they have difficulties in implementing these TRIPS provisions or in making use of this policy tool effectively. In order to address these concerns and difficulties, we see merit in providing, where needed, additional clarity on, and where possible, facilitating the use of these TRIPS provisions in the circumstances of a pandemic. This would assist Members in implementing these flexibilities at the national level in a more effective manner and, if required, in making efficient use of them. Switzerland is ready to continue constructively the Council's work on the proposals before us and identify points of convergence with a view to reaching a mutually acceptable outcome. Finally, my delegation asks the Secretariat to add our delegation's statement from the informal Council meeting of 14 September to the minutes of today's formal meeting. Switzerland's statement from informal meeting of 14 September 2021 345.   A number of delegations have recalled that the global COVID-19 pandemic has caused millions of deaths and devastating social and economic harm. We agree. While the world still faces immense challenges in fighting the pandemic, we should, however, also look at the progress that has been made. Had it not been for the innovators, the researchers and developers who rushed to find an effective antidote against the deadly virus, we would see millions more victims and would be still today helpless against this virus. Without the tested and trusted international IP regime and WTO TRIPS Agreement, these innovators, investors, researchers and developers would not have been prepared, ready on the starting blocks, to start the race for finding an effective vaccine against the new coronavirus. 346.   We concur with other delegations. As we resume the Council's discussion, it is worthwhile to look back to where we come from, where we stand today and to look ahead at what scientists and analytics have to say on supply and access to COVID-19 vaccines and medicines. 347.   The WHO declared this coronavirus a pandemic in March 2020. At this time, not a single vaccine or therapeutic against the new virus was at disposal. Scientists, researchers and developers came up with the first effective vaccines in a record time of less than nine months, their safety and efficacy tested for marketing approval early this year. Since then, we have seen a massive growth in the global manufacturing capacity of COVID-19 vaccines. 348.   According to Airfinity, a science information and analytics company, by September 2021 7.5 billion doses of COVID-19 vaccines had been produced. Production capacity has increased from 0 to 1.5 billion doses per month. 12 billion vaccine doses will thus be produced by the end of this year and more than 20 billion doses by mid-2022, with a vaccine surplus expected in the course of 2022. 349.   More than 320 manufacturing partnerships work currently around the globe on this scaling up of production. Recent examples of such manufacturing partnerships are: a. Pfizer and BioNTech with Eurofarma Laboratorios in Brazil; b. Johnson & Johnson with Aspen Pharmacare in South Africa; c. Pfizer and BioNTech with Biovac, in South Africa; d. Novavax with the Serum Institute of India; and e. The Russian Research Institute of Epidemiology and Microbiology with the Indian pharmaceutical company Panacea Biotec. 350.   The developments we have seen over the last nine months show that manufacturing networks are being developed, technology and know-how transfer is taking place, and production is effectively scaling up. IP rights, the international IP framework and the TRIPS Agreement have worked as facilitators and enablers for these achievements. 351.   Waiving large parts of the TRIPS Agreement would therefore be counterproductive. It would disrupt the technology and know-how transfer now happening in the international collaborations and manufacturing partnerships like the ones I just referred to. Also, it would send a negative signal to innovative vaccine and therapeutic researchers and developers, and risks to discourage them in continuing their research to respond swiftly to mutations and variants of the virus, and develop solutions for the next public health emergency. 352.   Having said this, access to these manufactured vaccines and medicines has been and still is unequal and insufficient in many countries. There are many reasons for this and they vary from country to country. WHO experts recently mentioned the following reasons: export bans, bilateral deals and vaccine diplomacy instead of prioritizing the COVAX mechanism, production challenges (as far as safety, quality and efficiency are concerned), delays in vaccine regulatory approval, vaccine hesitancy, absence of vaccination campaigns and logistical deficiencies hindering the administration of received vaccines promptly - resulting in vaccine waste, etc. 353.   The reasons for unequal access must be urgently addressed to defeat the COVID-19 pandemic and lessons learned for future pandemics as this must be avoided next time. The WTO has an important role to play in this: by facilitating trade, ensuring regulatory coherence, fostering the resilience of essential medical goods supply chains, avoiding export restrictions and dismantling prohibitive tariffs. The "Trade and Health Initiative" launched by the Ottawa Group has put forward pragmatic proposals to address these concerns and we are currently discussing in the "Walker process" what deliverables we could achieve at MC12. 354.   Increasing and diversifying global, local and regional vaccine manufacturing capacity, and building up relevant expertise in low- and middle-income countries (LMICs) to produce vaccines is one avenue that needs to be further explored and promoted to be better prepared for a future pandemic. The World Health Organization's announcement of the establishment of the first mRNA vaccine manufacturing hub in South Africa is welcome news in that respect. 355.   Making regional vaccine manufacturing capacity in LMICs happen will require close international collaboration. Technology and know-how transfer will again be a prerequisite to achieve this goal within a meaningful time period and in a sustainable manner. The TRIPS Agreement and WTO's overall regulatory framework will thus play an important supportive role for this venture to succeed. 356.   On process, my delegation is ready to continue work on technical issues, which started before summer. While we have already discussed a number of topics, Members had pointed out that they wished to conclude discussions on undisclosed information and regulatory data, and on technology transfer. We are also awaiting answers still to the many questions that my own and other delegations have posed on the issue of implementation of the proposed waiver. 357.   Concerning the proposal of the European Union on clarifications on the TRIPS flexibilities contained in Article 31 and 31bis of the TRIPS Agreement, we again hear from certain Members that they consider Article 31bis to be ineffective, complicated and difficult to use in the situation of a pandemic, starting with the notification requirements, but also in relation to labelling or packaging. It could therefore be useful for us to look at these issues and hear what these problems are and see whether there is room for further clarifications to make Members feel more confident to use these flexibilities. 358.   As we have signalled a number of times, Switzerland remains committed to look into concerns that Members have raised in relation to TRIPS and the challenges that the pandemic represents, and to discuss possible solutions. 359.   As concerns the appropriate format for the Council's discussions, we leave this in your able hands, Chair. Whatever the format may be, we reiterate that Members' proposals need to be discussed on an equal footing and that it is important that Members have sufficient time to prepare appropriately, for the Council's discussion to be substantive and useful.

78. 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 at the request of India and South Africa on 2 October 2020. It had since been co- sponsored by the delegations of the Plurinational State of Bolivia; Kenya; Eswatini; Mozambique; Pakistan; the Bolivarian Republic of Venezuela; Mongolia; Zimbabwe; Egypt; the African Group; the LDC Group; the Maldives; Fiji; Namibia; Vanuatu; Indonesia and Jordan. A revised proposal had been circulated by the co-sponsors on 21 May 2021 in document , which had since been co-sponsored by the delegation of Malaysia.
79. He recalled that, since the formal meeting of the TRIPS Council on 8-9 June 2021, there had been an intensive schedule of dedicated meetings to discuss this and related proposals in various formats. This involved a series of small-group consultations with delegations and group coordinators, five informal open-ended meetings for the purposes of transparency and inclusiveness, and two additional formal meetings of the Council to adopt successive status reports to the General Council. In its most recent oral status report to the General Council on 4 October, Members had concluded that: "[…] the TRIPS Council has not yet completed its consideration of the revised waiver request. The TRIPS Council will therefore continue its consideration of the revised waiver request, including through small-group consultations and informal open-ended meetings, and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement. In addition, the TRIPS Council will also continue in the same manner its consideration of the other related proposals by Members".
80. At the informal open-ended meeting of the Council on 14 September 2021, delegations had expressed their willingness to continue discussing specific aspects of the proposals in small-group meetings. He had therefore suggested to hold one small-group meeting in each of the next two weeks, and then reunite for an informal open-ended meeting of the TRIPS Council for the sake of openness, transparency, and inclusiveness, and to provide an opportunity to take stock and discuss how to advance further in light of that experience.
81. The Chair informed the Council that the two small-group consultations were held on 23 and 29 September. At the first meeting, which was dedicated to discussing 'scope' and 'implementation', delegations had engaged constructively in the questions underlying the waiver proposal and discussed the practical differences between TRIPS flexibilities and the waiver approach at the national level. On that occasion he had also heard delegations expressing their willingness to explore areas of common interest. One particular aspect of the discussion had touched on the existing TRIPS flexibilities and the concern voiced by the co-sponsors of the revised waiver proposal, that the use of such flexibilities was cumbersome. Thus, the second small-group consultation had aimed to examine one of the TRIPS flexibilities cited in the discussions, namely the requirements for using compulsory licensing in Articles 31, 31bis and the Annex of the TRIPS Agreement; and to relate any assessment of the practical impact of these requirements to the two proposals before the Council. Delegations had detailed exchanges on individual sub-paragraphs of Article 31 and 31bis of the TRIPS Agreement, and their impact on the practical use of compulsory licensing. In general, deliberations had taken place in a constructive atmosphere and it seemed that some of these detailed discussions could be pursued further. Some delegations had also voiced their frustration with the lack of progress, while a number of delegations had urged Members to focus on practical areas where consensus could be feasible in the short term.
82. At the informal open-ended meeting of 4 October 2021, the co-sponsors of the revised waiver proposal had once again indicated their flexibility towards considering the proposal by the European Union as a complementary approach, but they had emphasized that, in their view, a TRIPS waiver was a central and necessary element in the WTO's response to the pandemic. They had urged Members to end the binary view of the two proposals as alternatives.
83. Other Members, while welcoming the increased engagement in the small-group consultations, had remained unconvinced that a waiver would be an appropriate or effective tool to scale up production or ensure equitable distribution of vaccine doses around the world. These delegations had highlighted the broader Trade and Health initiative as the right tool to address the supply chain bottlenecks that the pandemic response was facing. Some had urged convergence on the basis of the proposal by the European Union aimed at clarifying, or improving the functioning of, existing TRIPS flexibilities.
84. While it had been clear that discussions had not bridged the persisting disagreement on the fundamental approaches underlying the different proposals, he noted that all delegations remained willing to continue discussion on the proposals in the various meeting formats.
85. The Chair stressed the importance of bilateral engagement between delegations in order to explore common ground and find possible landing zones, which Members could agree upon to conclude these discussions in the TRIPS Council. He said the world was expecting the Council to find a resolution of these discussions soon, and this could only happen if delegations could find agreement amongst themselves. He encouraged delegations to intensify their bilateral contacts and indicated his availability to facilitate engagement in a smaller group, keeping in mind that any outcomes from engagement between individual Members regarding the conclusion of the discussions should feed back into the Council and through it into the broader MC12 discussions. He sincerely hoped that engagement between delegations could still lead to something the Council could agree on, be that in the shape of a recommendation of the TRIPS Council as foreseen under Article IX:3 of the Marrakesh Agreement, or be it through some other consensus decision representing a conclusion of this process.
86. The representatives of the United Kingdom; South Africa; Pakistan; Bangladesh; the Plurinational State of Bolivia; Chile; Cuba; Nigeria, the Bolivarian Republic of Venezuela; Egypt; Indonesia; the Kingdom of Saudi Arabia; India; the European Union; Korea; Singapore; Türkiye; Japan; China; Switzerland; Norway; New Zealand; the United States; Namibia; Colombia; Australia; Brazil; and Mozambique took the floor.
87. The Chair said that, with respect to the suggestion to move the current TRIPS discussion into the process on trade and health issues Ambassador Walker was facilitating under the aegis of the Chair of the General Council at this time, it seemed clear to him that any conclusions on how different WTO disciplines should respond to the pandemic would all have to be part of the MC12 outcome document, and that IP was clearly expected to be part of that, in some form or other. Considering the attention and bandwidth that the Council's discussion had occupied over the last year, he was not concerned that the waiver request would somehow be forgotten in any prospective MC12 ministerial declaration.
88. In terms of procedure, he said it was for Members to decide whether they would want to terminate the waiver discussions in the TRIPS Council at that time to continue them in Ambassador Walker's process together with the equally complex trade-related considerations discussed there, or whether they would prefer to continue focused efforts to find a consensus conclusion on the IP-related discussions in the TRIPS context, which could then be introduced into an overall MC12 outcome document, together with any outcome resulting from Ambassador Walker's process.
89. While procedural considerations should not stand in the way if consensus among Members emerges, the Chair recalled that it was the TRIPS Council's obligation to come up with a recommendation, so that the procedure foreseen under the waiver provisions of the Marrakech Agreement could be properly concluded.
90. In light of the discussion, it seemed that the Council was not yet ready to agree on a recommendation, but that there remained a willingness to continue discussions and exploring possible common ground. The Chair proposed to keep the agenda item open, and thus permit delegations to further explore common ground and possible compromise solutions to this discussion. If there emerged an indication that Members were in a position to reach consensus, he would reconvene the Council to see whether an agreement could be reached on how to conclude these discussions before the Ministerial Conference, in a timely manner.
91. The Council took note of the statements made and agreed to keep the agenda item open.
92. During the reconvened meeting on 18 November, the Chair recalled that, as discussed at an informal open-ended meeting on 15 November, he had circulated draft language for an oral status report to the General Council on the same day in document JOB/IP/53, with an invitation to Members to comment by 16 November 2021. An agenda item for this status report had also been placed on the agenda of the General Council meeting scheduled for 22-23 November in the usual fashion. Since no comments had been received on the draft language, delegations had been informed on 17 November that the Chair would propose the text as circulated for adoption on 18 November. The language for the oral status report to the General Council which had been circulated in document JOB/IP/53 read as follows:
"At the meeting of the TRIPS Council on 15-16 October 2020, India and South Africa introduced document , 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, the Plurinational State of Bolivia; Bolivarian Republic of Venezuela; Mongolia; Zimbabwe; Egypt; the African Group; the LDC Group; the Maldives; Fiji; Namibia; Vanuatu; Indonesia and Jordan.
Since the introduction of the document, discussions took place in various formal and informal TRIPS Council meetings. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through documents , , , and , on the waiver request.
On 21 May 2021 the co-sponsors issued a revised proposal which was circulated in document . The revised waiver request was presented at an informal open-ended meeting of the Council on 31 May, and introduced at its formal meeting on 8-9 June 2021. It has since been co-sponsored by Malaysia. On 29 September 2021, the co-sponsors circulated a summary of their interventions in document .
Since the last oral status report delivered on 7 October 2021, discussions continued in small-group consultations, at a formal meeting of 13-14 October, at informal open-ended meetings on 5 and 15 November, and at an informal and resumed formal meeting on 18 November 2021.
In the course of discussions on the revised waiver proposal, delegations held focused discussions on the topics of 'scope', both from the perspective of products and of IP rights, on 'duration', 'implementation' and on protection of undisclosed information. Delegations engaged positively and their detailed substantive exchanges helped clarify various aspects and nuances of positions. While delegations remain committed to the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all, disagreement persists on the fundamental question of whether a waiver is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID-19 related products.
In addition, a proposal for a draft General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, issued by the European Union and circulated in document , has also been discussed in meetings since its circulation on 21 June 2021. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information. Disagreement persists on the fundamental question of whether this proposal is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID-19 related products.
This means that the TRIPS Council has not yet completed its consideration of the revised waiver request. The TRIPS Council will therefore continue its consideration of the revised waiver request, including through small-group consultations and informal open-ended meetings, and report back to the 12th Ministerial Conference as stipulated in Article IX:3 of the Marrakesh Agreement.
In addition, the TRIPS Council will also continue in the same manner its consideration of the other related proposals by Members."
93. The Chair proposed that the Council formally adopt the status report as a factual reflection of discussions on the TRIPS Waiver request.
94. The Council so agreed.
95. The Chair thanked delegations for their cooperation. He would deliver this report to the General Council, on 22-23 November, as agreed.
96. The representatives of India; the European Union; South Africa; Indonesia; Switzerland; the United Kingdom; and the United States took the floor.
97. The Chair said that, in line with the report that had been adopted, it was therefore understood that the agenda items 13 and 14 on the Council's agenda continued to remain open in order to permit more time for bilateral engagement, with a view to resuming – at short notice if necessary – the meeting, when there were indications that Members might be ready to reach an agreement.
98. For the next resumption of the Council's meeting, meeting room facilities were available for a formal resumption for Monday, 29 November 2021. This did not exclude the possibility of an earlier resumption at short notice should the circumstances require this.
99. The Chair encouraged delegations to remain seriously engaged, flexible and focused on an outcome, which remained within reach. The role of IP in the context of the pandemic had become the centre of attention in the run-up to this Ministerial Conference and a pragmatic and tangible outcome of these discussions would be a strong and positive signal to the Ministerial Conference and the global community as a whole. He would reach out to delegations to ensure that every opportunity to find possible landing zones ahead of MC12 would be used.
100. The Council took note of the statements made.
101. At the reconvened meeting on 29 November, the Chair suggested to take up agenda items 13 and 14 together, as most delegations were making one single statement covering both agenda items. He recalled that at the resumed meeting on 18 November, the Council had adopted an oral status report to the General Council, which he had delivered on 22 November 2021. This report had concluded that "the TRIPS Council will therefore continue its consideration of the revised waiver request, including through small-group consultations and informal open-ended meetings, and report back to the 12th Ministerial Conference as stipulated in Article IX:3 of the Marrakesh Agreement. In addition, the TRIPS Council will also continue in the same manner its consideration of the other related proposals by Members."
102. Since then, the Chair had held consultations with individual and groups of delegations, as well as a small-group consultation on 25 November. He had also circulated a draft report to the Ministerial Conference in document JOB/IP/54. However, in light of the indefinite postponement of the 12th Ministerial Conference, announced on 26 November 2021, the draft report was no longer proposed for adoption.
103. At the informal meeting that had preceded the this reconvened formal meeting, delegations had exchanged views on whether and how they wished to approach work on these items. He had shared his view that, although the much-awaited ministerial engagement on the important question of the role of IP in the pandemic had now been delayed, the Council could not afford to lose the momentum that had been gathering in the discussions among delegations during the previous week. From delegations' interventions in that meeting it was his sense that there was unanimous support for keeping the momentum of the discussions and continuing to engage on these matters, to try and harvest any outcome that may still be possible under the changed circumstances.
104. The representatives of South Africa; the European Union; India; the United Kingdom; Vanuatu; Indonesia; Chad, on behalf of the LDC Group; the Plurinational State of Bolivia; Pakistan; Brazil; Maldives; Switzerland; and Tanzania, on behalf of the African Group, took the floor.
105. The Chair said that he would consult with delegations to help facilitate continued engagement, and with a view to finding consensus on a substantive solution. He suggested that the agenda items remain open, with a view to resuming the meeting, at short notice, if necessary, when there are indications that Members might be closer to agreement on how to conclude these items. He noted that the next options for reconvening the Council's meeting were 10 and 16 December.
106. The Council so agreed.
107. The Chair thanked delegations for their engagement on this complex and highly politicized issue. He knew that all delegations shared the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all, and all were working hard to narrow their differences on how this common goal could be achieved. He said he had heard the shared view that IP should not be a barrier to access to medicines, and that governments should be able to permit manufacturers that were able and ready to produce COVID-19 vaccines to start producing without worrying about a patent.
108. While the Chair regretted that the Council had not been able to reach consensus on a substantive recommendation to the 12th Ministerial Conference the previous week, he remained convinced that a pragmatic compromise solution was within reach, if the political will could be mustered. Although the Council must now continue its work without the political input from ministers, he recalled that a practical, tangible WTO response to the pandemic was needed, now more than ever. As the pandemic continued to challenge the world's sense of stability, it was important that the WTO reached agreement on meaningful responses to these challenges. He urged delegations to remain fully engaged with a sense of urgency, and with the objective to find a pragmatic consensus-based outcome. This is not the moment to let up, but rather – to quote Lord Tennyson – "to strive, to seek, to find, and not to yield."
109. At the reconvened meeting on 16 December, the Chair suggested to once again take up agenda items 13 and 14 together, as most delegations were making one single statement covering both agenda items. He reported that he had held consultations with a group of co-sponsors, and with a group of 'non-proponents', respectively, on 8 and 14 December. These separate meetings had not indicated any further engagement between these groups at delegation level since mid-November, nor had they revealed any movement in positions. The co-sponsors had re-iterated their calls for the urgent commencement of text-based negotiations on the basis of the revised waiver proposal document , while other delegations had seen no promise in any textual engagement as long as fundamental disagreements persisted on the merits of different approaches.
110. The Chair also indicated he had kept in touch with the Director General and DDG Gonzales with regard to their political contacts with Members. He invited delegations to share their views on recent developments and on next steps the Council should take in these matters.
111. The representatives of Argentina; South Africa; Mozambique; the European Union; Colombia; Pakistan; Brazil; Australia; Tanzania, on behalf of the African Group; the Plurinational State of Bolivia; Nigeria; China; the United States; New Zealand; Norway; Switzerland; Indonesia; India; and the United Kingdom took the floor.
112. The Chair said that what he had heard confirmed the impression he had gathered in the consultations with the two groups he had described earlier. On the one hand, there was the co- sponsors' insistence that textual engagement should be commenced based on the entirety of their proposal. On the other hand, there remained significant scepticism and outright opposition vis- à-vis the waiver approach among a number of delegations, who were therefore reluctant to engage on the basis of a text with whose underlying premise they disagree.
113. He recalled that, during the first small-group consultations in June, the text of the revised waiver had, in fact, been put on the screen with a view to discussing it – but the differences described above, and a certain lack of trust among delegations, meant that serious line-by-line engagement on that text had simply not been possible among delegations. Despite this, delegations had managed to have quite a number of meetings on substance and on additional proposals – and this was reflected in the reports to the General Council.
114. During the summer, the Chair said, it had been very much hoped that bilateral engagements among delegations would overcome these obstacles and lead to a situation where constructive engagement in the Council could be based on a pragmatic focus on common ground, but despite some encouraging signs along the way, this had ultimately not been the case. It was his impression, that these obstacles unfortunately still remained in place, and he was not able to detect any convergence towards a common ground for textual engagement that was any more promising than what had been attempted earlier in the year. To be precise, he said, he did not mean agreement on a text, but on a basis for engagement.
115. He said that, in the last few weeks leading up to the planned ministerial conference, it had been clear that Members were preparing for engagement at the political level at the conference. While it had been rightly pointed that the waiver was not formally part of the designated outcome of MC12 and could be addressed at the level of the TRIPS Council and the General Council, it had been clear to everybody, given the timing, that Members wanted those issues to be discussed at the conference. This was also reflected in the draft report that the Council was ready to adopt at the meeting on 29 November. In light of the postponement of MC12, Members had instead expressed their willingness and intention to intensify their engagement with each other. The TRIPS Council therefore had decided to stay in session, meaning that the Council could be reconvened at short notice.
116. The Chair said that, in the Heads of Delegations meeting held on 2 December he had shared with Members his personal assessment that another type of engagement was needed between members than what had been witnessed for some time. His first suggestion had been that delegations should focus more on what united them than on what divided them, referring also to the common objectives shared by Members.
117. His second suggestion had been that political engagement and input was needed to be able to change the current dynamic, input that had been anticipated from the ministerial conference. He had therefore urged members, in particular those who have taken a leading role in the discussions on these matters, to engage with each other, across the aisle, with a sense of urgency, not only here in Geneva, but also, and most importantly, at the political level. He was therefore encouraged by what he had heard from some members regarding such political engagement taking place now.
118. Against this background, the Chair believed that the best course of action for the immediate future was to let the on-going high-level engagement continue and mature. If a common approach to the discussions on these items could be developed among these Members, he said, this could hopefully contribute to unlocking the situation in the Council and allow all Members to take a step forward towards developing a consensus outcome. He had also taken note of Members underlining the need for transparency and inclusiveness, while welcoming engagement among a few Members. He said that it went without saying that any achievement among a small group of Members would have to be brought to the larger membership. He reiterated his belief that a practical, tangible WTO response to the pandemic is needed, now more than ever. If members focus on that, he also believed it was within reach.
119. In light of this, the Chair proposed that the Council once again keep the agenda items open, with a view to resuming the meeting – at short notice, if necessary – when there are indications that Members might be closer to a common understanding on how to proceed towards a possible landing zone and ultimately a consensus-based solution. In the meantime, he would remain in touch with delegations to keep abreast of any developments and would make practical arrangements to be able to resume whenever there were any new developments or a need to inform Members of the current state of play.
120. The Council so agreed.
121. At the reconvened meeting on 22 February 2022, the Chair suggested to once again take up agenda items 13 and 14 together, as had been the case in past meetings. The Chair recalled that, as indicated in his communication dated 11 February 2022, he had circulated draft language for an oral status report to the General Council in document JOB/IP/55 on 16 February 2022, with an invitation to Members to comment by 18 February 2022. An agenda item for this status report had also been placed on the agenda of the General Council meeting scheduled for 23-24 February in the usual fashion. Since no comments had been received on the draft language, delegations had been informed that the Chair would propose the text as circulated for adoption on 22 February 2022. The language for the oral status report to the General Council which had been circulated in document JOB/IP/55 read as follows:
At the meeting of the TRIPS Council on 15-16 October 2020, India and South Africa introduced document , 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, the LDC Group, the Maldives, Fiji, Namibia, Vanuatu, Indonesia and Jordan.
Since the introduction of the document, discussions took place in various formal and informal TRIPS Council meetings. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through documents , , , and , on the waiver request.
On 21 May 2021 the co-sponsors issued a revised proposal which was circulated in document . The revised waiver request was presented at an informal open-ended meeting of the Council on 31 May, and introduced at its formal meeting on 8-9 June 2021. It has since been co-sponsored by Malaysia and Argentina. On 29 September 2021, the co-sponsors circulated a summary of their interventions in document .
Status reports on the considerations by the TRIPS Council on the revised "Proposal for a Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19" were delivered to the General Council on 34 March, 5-6 May, 27 July, 7 October and, most recently, on 22 November 2021.
In the course of discussions on the revised waiver proposal, delegations held focused discussions on the topics of 'scope', both from the perspective of products and of IP rights, on 'duration', 'implementation' and on protection of undisclosed information. Delegations engaged positively and their detailed substantive exchanges helped clarify various aspects and nuances of positions. While delegations remain committed to the common goal of providing timely and secure access to high quality, safe, efficacious and affordable vaccines and medicines for all, disagreement persists on the fundamental question of whether a waiver is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID related products.
In addition, a proposal for a draft General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, issued by the European Union and circulated in document , has also been discussed in meetings since its circulation on 21 June 2021. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information. Disagreement persists on the fundamental question of whether this proposal is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID-related products.
This means that the TRIPS Council has not yet completed its consideration of the revised waiver request. The TRIPS Council will therefore continue its consideration of the revised waiver request, and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.
In addition, the TRIPS Council will also continue in the same manner its consideration of the other related proposals by Members.
122. The Chair proposed that the Council formally adopt the status report as a factual reflection of discussions on the TRIPS Waiver request.
123. The Council so agreed.
124. The Chair thanked delegations for their cooperation and said he would deliver this report to the General Council, on 23-24 February, as agreed. He recalled that, given the upcoming opportunities for delegations to place formal statements on the record at the General Council and at the next formal meeting of the TRIPS Council on 9-10 March, he was not intending to open the floor under this agenda item, and he thanked delegations for their cooperation in this regard.
125. The Secretariat briefly announced that a Secretariat Briefing on the TRIPS Council intended for new delegations would be held on 1 March 2022.
126. At the reconvened meeting of 18 November, the report to the General Council was adopted and the Chair said that, it was therefore understood that the agenda items 13 and 14 on the Council's agenda continued to remain open in order to permit more time for bilateral engagement, with a view to resuming – at short notice if necessary – the meeting, when there were indications that Members might be ready to reach an agreement. [see paragraphs 93-99]
127. At the reconvened meeting of 29 November, the Chair proposed to take agenda items 13 and 14 together, as delegations had been making a single statement. [see paragraphs 100-107]
128. At the reconvened meeting of 16 December, the Chair proposed to take agenda items 13 and 14 together, as delegations had been making a single statement. [see paragraphs 108-119]
IP/C/M/103, IP/C/M/103/Add.1, IP/C/M/103/Rev.1