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

South Africa

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

852.   I have the honour to introduce this proposal on behalf of the delegations of Eswatini, India, Kenya and South Africa. 853.   The COVID-19 pandemic is a clarion call for us to answer to the better angels of our nature. High-minded language on solidarity and global public goods, however, has not been matched by tangible steps to share know-how and intellectual property rights to facilitate deep technology transfer in the COVID-19 response. Business as usual approaches will not bring back the countless lives that were lost, neither will it ensure that IP barriers to the prevention, containment and treatment of COVID-19 will be addressed effectively. 854.   We have seen this before. At the height of the HIV crisis, prices set for ARVs to treat HIV were simply too high and out of reach for many developing countries. As death rates due to aids plunged in rich countries, infected people across the developing world were left to die. 855.   Our leaders vowed that is would never happen again, the Doha Declaration on TRIPS and Public Health reaffirmed flexibilities to accommodate access to medicines. Even in light of this political undertaking and its translation into the Paragraph 6 System, prices of many life-saving diagnostics, therapeutics, vaccines and other medical products remain out of reach of most governments and its people. 856.   In 2004 the highly pathogenic avian influenza H5N1 re-emerged, developed countries had priority access, while affected developing countries did not. Within five years another pandemic flu (H1N1) emerged and once again rich countries placed large pre-orders of a vaccine buying almost all doses that could possibly be produced. Many countries promised to donate vaccines, most of them reneged and moved to secure their own supplies. With COVID-19 history is repeating itself. 857.   Several months into this pandemic there are no meaningful global policy solutions to ensure access. Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines and/or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19. 858.   All WTO Members are struggling to contain the spread of the pandemic and provide health care services to those affected. Many developed, developing and least developed countries have declared a national emergency with the aim to curb the growing outbreak, and as advised by the WHO implemented social distancing measures with significant consequences for society and the economy. Notably, developing countries and least developed countries are especially disproportionately affected. 859.   An effective response to COVID-19 pandemic requires rapid access to affordable medical products including diagnostic kits, medical masks, other personal protective equipment and ventilators, as well as vaccines and medicines for the prevention and treatment of patients in dire need. Shortages of these products has put the lives of health and other essential workers at risk and led to many avoidable deaths. It is also threatening to prolong the COVID-19 pandemic. The longer the current global crisis persist, the greater the socio-economic fallout, making it imperative and urgent to collaborate internationally to rapidly contain the outbreak. As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there are significant concerns, how these will be made available promptly, in sufficient quantities and at affordable price to meet global demand. Critical shortages in medical products have also put at grave risk patients suffering from other communicable and non-communicable diseases. The rapid scaling up of manufacturing globally is an obvious crucial solution to address the timely availability and affordability of medical products to all countries in need. The emerging second wave of the disease underscores the importance to finding global solutions that ensure equitable access. 860.   There are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients. It is also reported that some WTO Members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses, as evidenced by the updated Secretariat report on national measures taken by WTO Members. Beyond patents, other intellectual property rights may also pose a barrier, with limited options to overcome those barriers. In addition, many countries especially developing countries may face institutional and legal difficulties when using flexibilities available in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). A particular concern for countries with insufficient or no manufacturing capacity are the requirements of Article 31bis and consequently the cumbersome and lengthy process for the import and export of pharmaceutical products. 861.   Internationally, there is an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19 can be put in place on a real time basis. Our joint proposal requests a waiver to be granted to all WTO Members so that they do not have to implement, apply or enforce certain obligations related to COVID-19 products and technologies under Section 1 (copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement. Let me stress that the proposed waiver would be applicable only to COVID-19. The waiver is limited and does not suggest a waiver from all possible TRIPS obligations, nor does it suggest a waiver beyond what is needed for COVID-19 prevention, containment and treatment. 862.   The waiver should continue until widespread vaccination is in place globally, and the majority of the world's population has developed immunity. Hence, we propose an initial duration of [X] years from the date of the adoption of the waiver.

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