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

H.E. Ambassador Xolelwa Mlumbi-Peter
European Union
15 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19
1024.   The European Union fully shares concerns expressed by various Members about pandemic caused by COVID-19 and its devastating impact on people's health and wellbeing as well as on economic prosperity. 1025.   Safe and effective diagnostics, treatments and vaccines are crucial in the fight against COVID19. In a global pandemic only broad and equitable access to vaccines across the globe will ensure that the public health crisis can be tackled effectively, including in developing countries that have no production capacities or more limited financial resources. 1026.   We need to find solutions for everyone, whether in the developed or developing countries, because it is a challenge we face together and because no one is safe until everyone is safe. The European Union stands committed to work with all Members on this global challenge. 1027.   Researchers and pharmaceutical industry, supported by public funding, have put extraordinary efforts into the development of future treatments and vaccines against COVID-19. A well-functioning intellectual property rights system is crucial to ensure that these efforts are adequately incentivised and rewarded. 1028.   There is no indication that IPRs issues have been a genuine barrier in relation to COVID19related medicines and technologies. While we agree that maintaining continued supply of such medicines and technologies is a difficult task we all face, non-efficient and underfunded healthcare and procurement systems, spike in demand and lack of manufacturing capacity or materials are much more likely to have an impact on the access to those medicines and technologies. 1029.   A well-functioning IPRs system, including its wide range of exceptions and flexibilities, is part of the solution rather than an obstacle. It is our view that we should concentrate on the key current challenges: a. rapidly developing safe and effective treatment or vaccine against COVID-19; b. increasing manufacturing capacity; c. keeping global supply chains open; and d. ensuring broad and equitable global distribution of treatments and vaccines once they become available. 1030.   We would like to present in more detail how the European Union tackles these challenges. 1031.   The absolute priority and a major challenge at the moment is the rapid development and rolling out of safe and effective treatments and vaccines against COVID-19. Vaccine development is a complex and lengthy process, which normally takes around ten years. The public funding and support is contributing significantly to the development of the future vaccines, potentially within a timeframe between 12 and 18 months. However, it is the researchers and the industry with their know-how, previous and current investment that will be delivering these new vaccines, including the running of clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of a successful vaccine. This work must be incentivised and adequately rewarded and the IPRs system is one the main economic incentives. 1032.   We note that public financing of research and development of the innovative treatments and vaccines can be subject to certain conditions. For example, the European Commission has published a Manifesto for EU COVID-19 research to encourage recipients of EU funding to make research results accessible to all. Recent Horizon 2020 COVID-19 calls have also included a temporary obligation to license results on a non-exclusive basis and at fair and reasonable conditions. 1033.   Once the treatment or the vaccine is available, the manufacturing of these treatments and vaccines at such an unprecedented scale and within an unprecedented timeline is likely to be the most problematic issue to be tackled. We should collaborate and assist the pharmaceutical sector in ramping up the manufacturing capacity. To tackle current and future supply side shortages, the European Commission signed and continues discussing further pre-purchase agreements that incentivise and enable the pharmaceutical sector to build and prepare large-scale production facilities once effective treatments and vaccines become available. 1034.   Being aware of the importance of the global supply chains in the pharmaceutical sector, the EU is discussing with some WTO partners a possible WTO 'trade and health' initiative with the aim to facilitate global access to affordable healthcare products, including for vulnerable countries without appropriate manufacturing capacities. The goal is to make supply chains more resilient and diversified and to support efforts to build strategic reserves of critical equipment. This initiative would cover issues such as establishing a scheme of global cooperation in times of health crisis in order to remove unnecessary barriers to trade, abolishing tariffs on pharmaceutical and medical goods, enhanced transparency and trade facilitating measures. 1035.   Finally, global collaboration is the only way to overcome a global pandemic. At present, international efforts are being made to ensure equitable distribution of affordable vaccines, in particular to the most vulnerable populations. To enable broad and equitable global distribution of treatments and vaccines, the EU has taken a leading role in the Global Coronavirus Response where so far nearly EUR 16 billion have been pledged for universal access to tests, treatments and vaccines against COVID-19 for the global recovery. 1036.   In collaboration with the WHO, the European Commission is actively supporting the Access to COVID-19 Tools Accelerator (ACT-A) and its vaccine pillar – the COVAX Facility. In September, the European Commission announced that it would fully participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere, for everyone who needs them. As part of a Team Europe effort, the Commission contributes EUR 400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response. 1037.   The EU considers that on the basis of the global innovation system, with the necessary IP tools such as patent pools and procurement arrangements as the COVAX Facility in place, existing and new treatments, and ultimately vaccines, can be made available and effectively deployed rapidly across the globe. 1038.   The TRIPS Agreement together with the principles endorsed in the Doha Declaration, is fit for purpose and allows for the necessary flexibilities in relation to IPRs protection, including in the case of a health emergency, such as the COVID-19 pandemic. 1039.   If all voluntary solutions failed and IP became a barrier to treatments or vaccines against COVID-19, mechanisms to overcome it are already available. The EU has consistently supported the use, where necessary and justified, of the flexibilities provided under the TRIPS Agreement and the Doha Declaration with the objective of ensuring effective access to medicines. 1040.   In particular, the TRIPS Agreement provides for the possibility, under certain conditions, of issuing a compulsory licence for local consumption of medicines and provides for fast-track procedures in health emergencies. The TRIPS Council Secretariat has, regularly and consistently, offered its services to any WTO Member that sees itself in the need of getting help to manage the process of Article 31bis. This was confirmed in the presentation we saw the previous day. 1041.   This system is accompanied by other inbuilt TRIPS flexibilities, applying to the various IP rights. In addition, we note that the least developed countries are exempt from the application of the TRIPS Agreement and, in particular, its pharmaceutical-related provisions. 1042.   Public health in light of the pandemic is a clear and undisputed priority. No effort must be spared to obtain safe, effective and affordable treatments, vaccines, tests and medical devices necessary to fight this pandemic and to ensure that these products are equitably distributed on a global scale. However, all these efforts must be geared towards addressing genuine challenges in this pandemic with appropriate solutions.
84. The Chair said that this item had been put on the agenda at the request of India and South Africa; and a communication had been circulated. She invited India and South Africa to introduce their proposal.
85. The representatives of India and South Africa took the floor.
86. The Chair invited Members to take the floor.
87. The representatives of Kenya; Nigeria; Bangladesh; Sri Lanka; Pakistan; the Bolivarian Republic of Venezuela; Nepal; Philippines; Nicaragua; Chile; Turkey; Egypt; Indonesia; Argentina; Chad, on behalf of the LDC Group; China; Thailand; Tunisia; Tanzania, on behalf of the African Group; Ecuador; Senegal; Costa Rica; Mauritius; Colombia; El Salvador; Mali; Jamaica; the European Union; the United States of America; Switzerland; Japan; Norway; the United Kingdom; Brazil; Mozambique; Canada; Australia; Honduras; the Holy See; the World Health Organization (WHO) and the United Nations Programme on HIV/AIDS (UNAIDS) took the floor.
88. The Chair invited the Secretariat to share procedural requirements.
89. The representative of the Secretariat took the floor.
90. The representative of the United States of America took the floor.
91. The Chair noted that the proposal had been submitted to the Council on 2 October 2020. Thus, the 90-day time-period would expire on 31 December 2020. For practical purposes, this would mean that the last opportunity for the Council to adopt the report envisaged by Article IX:3 (b) of the Marrakech Agreement, was before the end-year-break in December. In order to facilitate reconvening the Council to consider a report in this regard, she proposed to keep the agenda item open. She encouraged Members to further consult on the proposal and explore possibilities to bridge the gap.
92. The Council took note of the statements made and agreed to keep the agenda item open.
93. At the Council for TRIPS' reconvened formal meeting of 10 December 2020, the Chair reported that, on 20 November and on 3 December, she had convened the Council in informal open-ended mode to take stock of developments since the suspension in October, and to continue the consideration of the agenda item in informal mode. At these meetings delegations had highlighted their common goal of providing access to high-quality, safe, efficacious and affordable vaccines and medicines for all. Delegations had also exchanged views, sought clarifications and provided information on the operation, implementation and impact of the requested waiver during these meetings.
94. The Chair said she also held consultations in the time-period between 26 November and 1 December, in order to seek delegations' views on (a) what kind of report the TRIPS Council could likely agree on at today's meeting, and (b) how substantive engagement could be further facilitated, given the importance of meaningful and focused discussions on the substance of the proposal. In these consultations she had detected an emerging agreement that the TRIPS Council should provide a communication to the General Council that would be neutral and factual, and reflect the state of play of discussions and the absence of consensus on the waiver proposal in the TRIPS Council at this time. Delegations had also seen a need to continue discussions on the matter within the TRIPS Council.
95. On the basis of these consultations, and after discussions in the informal open-ended meeting on 3 December, an agenda item for a status report on the consideration of the waiver request was put on the proposed agenda of the next General Council meeting scheduled for 1617 December. During the informal meeting of 3 December, the Chair had circulated draft language for such an oral status report with an invitation to Members to comment on this language by 7 December. On the basis of the comments that were received by the deadline, she had held further consultations on 8 and 9 December, and had circulated a revised draft status report.
96. In light of these informal meetings and consultations, she 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, Pakistan, Mozambique, and Bolivia. The Council continued its discussions under that agenda item at its resumed meeting on 10 December 2020.
At those meetings, and at informal meetings on 20 November and 3 December, delegations highlighted the common goal of providing access to high-quality, safe, efficacious and affordable vaccines and medicines for all. Delegations exchanged views, sought clarifications and provided information on the waiver request but could not reach consensus. 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 and may not be able to do so within the 90 days stipulated in Article IX:3 of the Marrakesh Agreement. Therefore, 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.
97. The Council so agreed.
98. 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, she noted that the next regular meeting is scheduled for 1011 March 2021. In order to allow for further consideration of the waiver request in the more immediate future, she proposed that the Council reserve 19 January and 4 February 2021 for meetings of the Council that could be dedicated to the discussion of the waiver request. The next regular meeting – with the usual complete agenda – would remain scheduled for 10-11 March.
99. The Council so agreed.
100. The representatives of Malaysia, Canada, Chile, Bolivia, Sri Lanka, Chad, Norway, Turkey, Singapore, Viet Nam, Eswatini, Egypt, Indonesia, the European Union, Japan, China, the United Kingdom, Oman, Mauritius, Bolivarian Republic of Venezuela, Ukraine, the United States of America, Ecuador, the Republic of Korea, El Salvador, New Zealand, Mozambique, Brazil, Jamaica, India, Pakistan, Switzerland, Israel, Colombia, Bangladesh, Tanzania, on behalf of the African Group, Botswana, South Africa, Nepal and Vanuatu took the floor.
IP/C/M/96, IP/C/M/96/Add.1