H.E. Ambassador Xolelwa Mlumbi-Peter (South Africa)

United States of America

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

1043.   The United States is committed to working with international partners in identifying practical ways both to increase access to safe, effective, affordable and lifesaving medicines around the world and to support policies that drive the development of new medicines. 1044.   Intellectual property encourages innovation, incentivizes research and development, and can facilitate manufacturing and distribution, thus helping to expand access to medicines around the world. These core features of intellectual property are necessary for the global community to find and develop treatments and cures for this deadly pandemic and to support economic recovery. 1045.   IP plays a key role in facilitating access to today's medicines and enables investments in R&D that leads to tomorrow's cures. IP promotes collaboration that is essential for the rapid development of new treatments and cures, particularly during crises like COVID-19. 1046.   We have the shared objective of helping to ensure the swift delivery of potential COVID-19 therapeutics and vaccines around the globe. We believe that facilitating incentives for innovation and competition to develop, test, and produce safe and effective therapeutics and vaccines for the COVID-19 response, including by respecting intellectual property rights, and supporting industryled collaboration and voluntary knowledge sharing, will best achieve our shared objective. 1047.   As we have stated in past discussions, IP is an important piece, but ultimately only one piece of addressing the issue of access to any potential therapy. We believe that IP has not been an obstacle in addressing the pandemic but rather has motivated global efforts to find treatments and cures. Limits to manufacturing capacities and supply chain issues, for example, are of much greater concern, especially for vaccines, given the need to provide access to the entire global population. We also must be concerned about the pandemic creating the opportunity for the increase of counterfeit COVID-19 pharmaceuticals, which are in and of themselves a threat to health and safety. In fact, the perspective that IP is a barrier to access to medicines is often voiced by governments that have significant barriers like taxes and tariffs in places that affect access. 1048.   Where intellectual property rights exist, they can be licensed to companies around the world to scale up manufacturing. But if the time needed to get the required regulatory approvals is too long, and other barriers make the cost of products too high, the raw materials or labour needed are unavailable, or the market is flooded with counterfeit goods, then safe and effective access to needed treatments and equipment would be affected. 1049.   The United States does not support the waiver proposal of India and South Africa. Weakening IP protection and enforcement would be counterproductive to our global fight against COVID through the creation of needed medical technologies and would not address the current, main challenges to access concerning manufacturing and raw material resources.

The Council so agreed.

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