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

H.E. Ambassador Xolelwa Mlumbi-Peter
European Union
12 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19
374.   There is no doubt that all WTO Members agree on the objective in this global fight against the COVID pandemic: to rapidly develop and manufacture safe and effective therapeutics and vaccines and to distribute them equitably across the world as soon as possible. Achieving the objective of equitable access to vaccines is a top priority of the EU. We believe that the main global mechanism to achieve such equitable access is the COVAX Facility. The Facility has received a major financial boost following the G7 meeting. 375.   These new pledges bring us closer to achieving COVAX's target to deliver 1.3 billion doses for 92 low and middle-income countries by the end of 2021. Team Europe is one of the lead contributors to COVAX with over EUR 2.2 billion, including EUR 900 million pledged by Germany. It is clear that this is only the start and that we will need to mobilise additional support as we move forward. We need to encourage the industry to step up and make their vaccines available and affordable to COVAX to create conditions for a timely global rollout. 376.   Recently two versions of the AstraZeneca/Oxford COVID-19 vaccine have been given WHO Emergency Use Listing. This announcement means that two versions of the AstraZeneca/Oxford vaccine, produced by AstraZeneca-SK Bioscience and the Serum Institute of India , are now available for global rollout through the COVAX Facility. This is crucial for the functioning of COVAX's distribution mechanism and we hope to see more vaccines approved for emergency use soon. However, we see clearly that having a vaccine developed and reserved is not enough. The actual delivery of vaccines will depend on a number of factors which include timely regulatory approvals, country readiness and logistics. The one major challenge we are facing now is to ensure rapid production of COVID-19 vaccines while maintaining the supply of all other medicines and vaccines. 377.   The fact that we cannot meet the demand for COVID-19 vaccines is not a surprise – we are dealing with an unprecedented situation of exploding global demand on the one hand, and a complex manufacturing process of biological products, on the other hand. There is no silver bullet. In order to resolve the supply issues we need a much closer, more integrated and more strategic publicprivate cooperation with the industry in order to facilitate the transfer of the required knowhow and technology. Intellectual property is a key factor in providing a framework that enables this cooperation. 378.   In the EU, we have set-up a Task Force for Industrial Scale-up of COVID-19 vaccines to detect and help respond to issues regarding the supply of vaccines in real time. In order to ramp up production in the EU, the EU will, amongst others, work closely with manufacturers to help monitoring supply chains and addressing identified production bottlenecks. As already indicated in the General Council: the EU is ready to engage with the WTO partners to find similar solutions globally and to facilitate the collaboration with the pharmaceutical industry in order to scale up the manufacturing capacity for COVID-19 vaccines worldwide. 379.   We should focus our efforts on the necessary cooperation with pharmaceutical companies with the relevant know-how on COVID-19 vaccines production. The objective should be to ensure they enter into licence agreements with companies around the world that have the necessary production capacities and could export the vaccines to any low and middle-income country without production capacity. The EU, working together with the other WTO Members and under the leadership of the Director-General, Dr Ngozi Okonjo-Iweala, is ready to facilitate a dialogue between the vaccine developers and companies with the production facilities that are ready to step in to help out with the production of vaccines and their delivery to the countries in need. 380.   The scale up of production capacity is already happening, as developers of vaccines are entering into manufacturing agreements with producers, and are expanding global production by transferring their technology to licensees. We see this being done by AstraZeneca or Johnson & Johnson. In the EU we have examples of companies such as Sanofi that will provide help in manufacturing of vaccines to both Johnson & Johnson and Pfizer/BioNtech. We hope to see these collaborations grow and intensify so that we use the available and adequate manufacturing capacity to the maximum extent. 381.   While we see the main solution to this crisis in the intensified collaboration with the pharmaceutical industry, should the voluntary solutions not be available, we consider that the TRIPS Agreement and the principles of the Doha Declaration can play a role in addressing this crisis. They reflect a careful balance between protecting intellectual property on one hand, which is a crucial incentive to innovation, and promoting widespread access to medicines and health care, on the other hand. 382.   The flexibilities offered by the TRIPS Agreement are absolutely legitimate tools for Members in need as many are in the midst of this pandemic. This includes fast track compulsory licences for export to countries without manufacturing capacity. We have noted carefully the difficulties conveyed by some Members with regard to the implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. Administrative burdens should not stand in the way of manufacturing and delivering vaccines to where they are needed. 383.   We need to use measures that both respond to our current needs, as well as preserve the incentives to innovate and invest in health-related research. It is not only about preparedness for future pandemics, the challenges posed by COVID-19 variants show very clearly that constant innovation and investment are key for dealing with the current crisis. 384.   The EU is committed to an open and comprehensive dialogue with all WTO Members and the Director General of the WTO to explore how the multilateral rules-based trading system can best support universal and equitable access to COVID-19 vaccines and treatments as we seek to provide for a robust, rapid and universal response to the pandemic. We are ready to continue this discussion, also in additional meetings that may be scheduled by the Chair, whether in formal or informal format.
52. The Chair recalled 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 by India and South Africa on 2 October 2020. It had since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, the Plurinational State of Bolivia, the Bolivarian Republic of Venezuela, Mongolia, Zimbabwe, Egypt and, most recently, by the African Group and the LDC Group.
53. At its previous meeting in February 2021, the Council had agreed to once again provide a "Status Report on the consideration by the TRIPS Council of the waiver proposal" to the General Council meeting of 1-2 March 2021. That Status Report had provided a factual overview of the waiver discussions in the Council and highlighted Members' common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all. It had reported that Members had exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through new documents, but had not been able to reach consensus, including on whether it was appropriate to move to text-based negotiations. Delegations had indicated a need for further discussions on the waiver request and views exchanged by delegations. The report had concluded that "[t]he 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."
54. The co-sponsors had signalled their openness to discuss the scope and duration of the waiver, as well as other questions delegations might have, in the context of text-based negotiations. Other delegations had emphasised a need for more discussions and were not ready to move towards textbased discussions. Members had also recognized the challenge arising from limited manufacturing capacity of vaccines and the inability of existing manufacturers to meet global demand. Members needed to engage in a candid and good-faith and evidence-based discussion on what was required to scale up global production in these unprecedented times of a public health crisis. She encouraged Members to engage in a result-oriented process that would contribute to an effective solution to boosting productive capacity for products that were essential to deal with COVID19 across the world. Swift action was required urgently to help scale up COVID-19 vaccine production and distribution. The Council needed to shift gears and move towards a solution-oriented discussion. The world was in desperate need for solutions. She urged delegations to work together and engage with this purpose in mind.
55. At the General Council meeting of 1 March 2021, the Director-General had said we need to do things differently. She had said "it cannot be business as usual. We have to change our approach from debate and rounds of questions to delivering results". She noted that she was not sensationalizing when she reminded delegations that it was a literally a life and death issue. People were dying at that very moment. She urged delegations to demonstrate their commitment to the overarching goals of universal and equitable access to COVID-19 medical products, not only in words, but through action. She wanted to remind Members of the heightened public interest and concern in this regard, that the world was watching, and that the Council should not fail.
56. There were a number of declarations and letters from civil society regarding the WTO's role in the COVID-19 pandemic, which had been made available on the WTO COVID-19 website under the section "Business/Society response". The previous day, she had received a letter from 'Global Nurses United', which would also be made available on that COVID-19 webpage.
57. She encouraged delegations to also address two issues in their interventions:
a. First, the practical question on how the Council should organize the consideration of this matter going forward. The next regular meeting of the TRIPS Council was scheduled for 89 June 2021. She encouraged delegations to share their views on how to consider the matter in the meantime, so that the Secretariat and the Chair can make any appropriate arrangements so that the Council can move swiftly to a balanced outcome and a landing zone on this urgent matter. The Secretariat had identified dates for possible additional meetings, which the incoming chair could use, depending on delegations' views; and
b. Secondly, whether and how to capture a number of shared understandings with respect to TRIPS flexibilities that had been highlighted. While Members were still discussing the waiver request, Members might wish to capture and communicate such shared understandings on the role of IP in the context of a pandemic, which could provide valuable elements for the broader understanding of the TRIPS Agreement; and might also provide positive guidance to prepare for future pandemics.
58. The representatives of India; Maldives; Zimbabwe; Qatar; Pakistan; Egypt; Nepal; Bangladesh; Vanuatu; Cuba; South Africa; Brazil; Ukraine; China; Nigeria; Mozambique; Jamaica; Tanzania, on behalf of the African Group; Chile; El Salvador; Cameroon, on behalf of the ACP Group; Colombia; New Zealand; Mongolia; Namibia; Canada; the United Kingdom; Switzerland; Japan; the European Union; Chinese Taipei; Indonesia; Singapore; Australia; the United States of America; and the World Health Organization took the floor.
59. The Council took note of the statements made and agreed to revert to the matter at its next meeting.
IP/C/M/98, IP/C/M/98/Add.1