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
1268.   We would like to thank you and all the delegations for the constructive engagement on the status report which we fully support. In the present statement, the European Union would like to make further contributions to the discussion but also, for the record, recall some of the points made during the informal meeting the previous week. 1269.   Universal and equitable access to safe and effective diagnostics, treatments and vaccines is crucial in the fight against COVID-19. Achieving this objective is a priority of the EU and this is why the EU is leading the Coronavirus Global Response for universal access to affordable COVID-19 vaccination, treatment and testing. Nearly EUR 16 billion have been pledged so far for universal access to tests, treatments, medical devices and vaccines against COVID-19 and for the global recovery. 1270.   The EU is the main contributor to the COVAX Facility – the international initiative to ensure global access to vaccines for COVID-19. It brings together governments, the WHO, UNICEF, manufacturers, private sector, civil society and philanthropy and is the best way to ensure that highincome countries finance the vaccines and their deployment for low- and middle-income countries. Here the key issue is to address the remaining global financing needs as underlined in the recent G20 Riyadh Leaders Declaration. 1271.   The challenges that we face are enormous. The manufacturing at huge scale, the distribution of vaccines, their storage and even their administering will test our financial capacity, our logistical skills and perhaps, most of all, our global collaboration and solidarity in the face of this crisis. 1272.   We believe that the intellectual property system, with its checks and balances, does not stand in the way of these efforts. Indeed, it is part of the solution to the challenge of universal and equitable access to vaccines and COVID-19 treatments. 1273.   We have already seen it with the development of vaccines – unprecedented work and collaboration among governments, pharmaceutical innovators, foundations and researchers have taken place. We are looking at vaccines being approved within 12 months where normally it takes ten years. According to the industry sources, some 1100 potential treatments and vaccines are in development. Much of this rapid response, like for example the vaccines based on mRNA technology, builds on knowledge and research capacity developed over many years with the support of intellectual property incentives. We would not be where we are now without the years of this research. 1274.   What is most needed now, beyond developing vaccines, is the ramping up of manufacturing of vaccines and the best way of achieving that is by disseminating the technology and know-how of those who developed the vaccines through licensing arrangements. Manufacturing cannot take place without the required technology and know-how. In addition, we need these vaccines to be produced in a manner that ensures their efficacy and safety. Intellectual property is a key factor in providing a framework that enables these arrangements. Developers of vaccines can enter into manufacturing agreements, transfer technology and expand production with their licensees. Our main concern is that suspending the relevant IP rights will not enhance such collaboration and manufacturing but, to the contrary, will slow it down or even block it, to the detriment of all. 1275.   Many pharmaceutical companies have committed publicly and are already working closely with governments to ensure that the vaccines will be available and affordable to all who need them. We also see agreements on expanding manufacturing capacity, we understand that e.g. AstraZeneca entered into agreements with companies in various countries to support the manufacturing, procurement and distribution of vaccines. It also entered into a technology transfer agreement with Serum Institute of India to supply doses for low and middle-income countries. We also understand that Johnson & Johnson entered into manufacturing service agreements for large-scale manufacturing for its vaccines. And there are other examples, also as regards collaboration to increase manufacturing of promising COVID-19 therapeutics. 1276.   We would like to thank the delegations of South Africa and India for the information provided in the course of the consultations and for document IP/C/W/670 from South Africa which we have carefully studied. It presents the patent landscape of various anti-viral and other medicines. We are grateful to South Africa for explanations given during our last session as to the fact that this information was collected for monitoring purposes and the intention was not to infer that the existence of these patents amounts to barriers to access. We will be of course interested to hear more as the monitoring progresses. We note also the examples of shortages in supply that occurred at the early stages of the pandemic. We understand that these were resolved rather quickly but are of course open to hear more. 1277.   Without doubt, making sure that there is a continued supply of medicines and technologies related to COVID-19 is a difficult task. However, fragile and underfunded healthcare and procurement systems, spikes in demand and lack of manufacturing capacity are much more likely to have an impact on the access to those medicines and technologies than intellectual property. 1278.   Having said that, in case intellectual property should become an issue in the context of this access, the international intellectual property system already provides solutions. Patent or any other intellectual property protection, such as the protection of test and clinical trial data, is not absolute. Intellectual property is a system of checks and balances. The TRIPS Agreement provides for the necessary flexibilities such as a possibility to grant compulsory licences – these have been used in the past in the context of pharmaceutical products in various countries. 1279.   The system includes solutions provided specifically for emergencies such as this pandemic. And these can be used, especially if the companies do not heed the calls for manufacturing at scale including with the use of adequate licensing. This includes fast-track procedures where no negotiations with the patent holder are required and the possibility of granting licences for export to countries with no or insufficient manufacturing capacity. Only simple notifications are required to put the latter one into effect. It is also possible to dispatch notifications with regard to many products at the same time. 1280.   During our discussions, problems with domestic implementation of the flexibilities have been raised by a number of delegations. We are ready to discuss ways of facilitating the use of these flexibilities. Technical assistance can and should be provided to Members that experience difficulties with the implementation and the use of these flexibilities. 1281.   We continue to have questions on the rationale and the potential benefit of the waiver proposed by India and South Africa when compared to the approach based on licensing arrangements combined with the flexibilities under the TRIPS Agreement. Our main concern is the impact this waiver could have on the ongoing private-public partnerships and well as the global effort undertaken through the COVAX Facility. 1282.   In that regard, and in order to facilitate a consensual, constructive and evidence-based discussion, we fully support the approach presented in the document IP/C/W/671 submitted by the delegations of Australia, Canada, Chile and Mexico and the questions put forward in this document as highly pertinent for our discussion. 1283.   In addition to the questions posed by these delegations, in the spirit of open discussion and to foster further exchanges, while appreciating comments already provided, we would like to invite the proponents to: a. explain in more detail how concretely the waiver could operate with regard to the vaccine production, including the transfer of the required technology and know-how; and b. how it would affect the existing licensing mechanisms and the COVAX Facility more generally, what would the domestic implementation of the waiver entail and why would it be easier to carry out than introducing fast-track procedures for compulsory licensing on the basis of the existing system?, how the "temporary" nature of the waiver would work, with regards to unregistered rights as copyright and with regard to patents and designs - should they not be granted if in application stage? If they are already granted, does the waiver mean that they cannot be enforced? When the application of the waiver is over, how do the owners recuperate their rights? 1284.   The EU believes that the important and complex issues brought up in the context of the ongoing discussion merit further reflection and significant consideration to determine the exact nature of challenges faced by Members in addressing COVID-19. It is important to emphasise that intellectual property rights are but a part of a broader response to COVID-19 which includes also significant investments made by the EU in the COVAX Facility as well as the work undertaken by the EU to safeguard global supply chains. 1285.   Trade policy can support the vaccine delivery by keeping markets open to essential healthcare products, avoiding export restrictions and adopting trade facilitation measures. A global crisis requires global cooperation. This is the spirit in which the EU and other like-minded WTO partners have submitted a proposal to the WTO on the so-called "Trade and Health Initiative" under which all WTO Members would jointly agree on a number of actions in response to the current crisis and undertake commitments that would contribute to an effective response to any future crisis. 1286.   The EU is committed to an open and comprehensive dialogue with all WTO Members to explore how the multilateral rules-based trading system can best support universal and equitable access to COVID-19 vaccines and treatments. All possible tools should be explored to leverage this system to provide for as robust response as possible.
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