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

H.E. Ambassador Xolelwa Mlumbi-Peter
15 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19
863.   We thank South Africa for its detailed and comprehensive statement. We also thank UNAIDS, UNITAID, MSF, other academics, researchers as well as numerous civil society organisations who have expressed widespread support for our proposal. 864.   Let me also take this opportunity to thank the Secretariat for its report on the TRIPS Agreement and COVID-19. We believe that it is not merely coincidental that this report came out the day before, more than six months into the COVID-19 pandemic. At least our proposal could generate enough interest for action now. However, in our view, the measures listed in the report are not sufficient for an effective COVID-19 response, which necessitates the need for our waiver proposal. 865.   At the outset we would like to emphasize that this proposal is, particularly important to cater for those who have insufficient or no manufacturing capacities in the health products required to combat the COVID crisis. In the past few months, India has supplied medical products and equipment needed in fighting the pandemic to more than 150 countries and resisted the attempts to corner the supplies by a few countries. We would like to remind the Members that in a global pandemic where every country is affected, we need a global solution. And our waiver proposal represents an open and expedited global solution to allow uninterrupted collaboration in development, production and supply of health products and technologies required for an effective COVID-19 response. 866.   South Africa has very clearly explained the purpose and objective of our proposal. In this regard, we want to highlight following points: 867.   First, there can be no denying the fact that the development of and equitable access to the tools – such as diagnostics, therapeutics, treatments, vaccines etc.– required to fight the COVID19 pandemic are limited by IP barriers. It is quite evident from an array of lawsuits filed by private companies in different parts of the world for IP infringement on COVID-19 products. In the past few months, we have also seen that IPRs do come in the way of scaling up production of test kit reagents, ventilator valves, N95 respirators, therapeutics, fluorescent proteins and other technologies used in development of vaccines etc. 868.   Second, governments across the globe are supporting development of new health technologies, in particular vaccines by pouring billions of USD of public funds into research and development. The EU tracker of pledged resources for access to tests, treatments and vaccines stands at EUR 16 billion. Therefore, the often-repeated argument that monopoly rights are needed to allow the inventors to recoup their investment does not seem to apply in case of development of health products and technologies required for handling the ongoing COVID-19 crisis. 869.   Third, we have heard from some Members in the previous meetings that voluntary licenses are the most appropriate solution to scale up manufacturing in response to COVID-19. However, the fact remains that not a single IP holder has shown willingness to commit to the COVID-19 Technology Access Pool (C-TAP) and the ACT-Accelerator voluntary initiatives launched under the aegis of WHO. In fact, the representative from WHO in the Council admitted in response to a question that no pharmaceutical company has committed to sharing its IP and technologies in the C-TAP pool since its launch more than five months ago. Given the refusal by pharmaceutical industry to routinely offer nonexclusive licenses with worldwide coverage to facilitate global access, clearly the solution to ending the pandemic does not lie in voluntary licenses. 870.   Fourth, with regard to existing flexibilities under the TRIPS Agreement, the same are not adequate to address the fast-changing landscape of COVID-19. Of particular concern for countries with insufficient or no manufacturing capacity is Article 31bis, which is limited to pharmaceutical products, and was not designed to address challenges arising from pandemics of this scale and magnitude. Medical devices like ventilators, dialysis machines etc. that are crucial for combating the ongoing pandemic, may not be covered under the scope of Article 31bis. There is a reason why the Special Compulsory Licensing system has been used only once. Requirements under this System that exporters and importers have to comply with, are extremely onerous and time-consuming, thereby rendering it of no practical utility towards handling the ongoing pandemic. 871.   Fifth, we have included four sections of TRIPS Agreement namely patents, copyrights, industrial designs and undisclosed information or trade secrets, in our proposal. This is because the health products and technologies like test kits, masks, medicines, vaccines, components of ventilators like valves, control mechanisms and the algorithms and CAD files used in their manufacturing are protected by these four types of IPRs. This ensures that our waiver proposal does not suggest a waiver from all TRIPS obligations, but only from these specific sections and that too only to the extent the same are essential for effective handling of the COVID-19 crisis. 872.   Sixth, it may be noted that the waivers granted to LDC Members with respect to obligations in Article 70.8 and 70.9 and their rights under Article 66.1 of the TRIPS Agreement are in no way impacted by this proposal. 873.   Lastly, we want to clarify that the time period of 'X' years does not signify that we are seeking a waiver for an indefinite duration. The actual waiver duration will be negotiated and be limited to a period that this Council finds necessary to effectively handle the COVID crisis. Furthermore, the waiver will be reviewed annually by the General Council in accordance with the provisions of Article IX (4) of the WTO Agreement. We are flexible with regard to the scope and duration of the waiver. We look forward to constructively engage with Members having any questions or concerns regarding our proposal. 874.   We believe that now is the time for WTO as an organization to rise up to the collective call for defeating the pandemic. It will not succeed in its efforts in rebuilding the COVID affected economies unless it acts now to first save those lives that are going to build these economies. It's time for Members to take collective responsibility and put people's lives before anything else. History will not judge us kindly if we do not act immediately to save large scale loss of human life and health and allow global dysfunction to prevail over global cooperation. We hope that Members will support our proposal that will ensure that vaccines and treatments become truly global public goods.
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