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

H.E. Ambassador Dr Lansana GBERIE
389.   We would like to underscore the need to intensify discussions so as to ensure that all Members decide on the extension of the waiver agreement on vaccines to therapeutics and diagnostics, as indicated in paragraph 8 of the 17 June Decision. 390.   The COVID-19 pandemic remains a crisis with infections on the rise. According to an ACT-A report, without adequate emphasis on testing, treating and vaccines, the global population would lose its significant progress in its fight against the disease. In addition, the report stressed that oral antivirals can prevent hospitalization and save the lives of patients with the most likelihood of developing severe illness. The report clearly identified the main barrier hindering the introduction of oral antivirals and attributed it to limited access to the products required and the fact that the landscape of treatments and costs is ever changing. Currently, the majority of the known supply deals – to the tune of 76% – are concentrated in high-income countries. 391.   Reports show that manufacturing of diagnostics and therapeutics is still predominantly concentrated in specific regions. There is a need to overcome this challenge by diversifying manufacturing activities by facilitating local production. Without comprehensive and adequate access to therapeutics and diagnostics in developing countries, the test to treat initiative as currently applied by some Members would be unavailable to developing countries. It is pertinent to note that in terms of therapeutics options for COVID-19, most of the products are either unavailable or unaffordable for developing countries. 392.   The World Health Organization has clearly indicated that there have been significant shortages of recommended therapeutics, which are not easily accessible to developing countries as a result of high costs. The IMF projects that as a result of the pandemic, cumulative global output losses amount to almost USD 13.8 trillion through 2024 and therefore advises that the best defence against the pandemic will be to shift from a singular focus on vaccines to equipping each country with a comprehensive COVID-19 toolkit with vaccines, tests and treatments. The WHO has also expressed disappointment on the existence of inequitable access to COVID-19 treatments, particularly in those countries which need these treatments to save the lives of their citizens. 393.   Regarding therapeutics, there is evidence that intellectual property has posed a barrier to access to COVID-19 therapeutics. For Paxlovid, containing the nirmatrelvir compound as recommended by WHO for patients with non-severe illness at the highest risk of hospitalization, research shows that patent protection has been sought worldwide by the proprietor Pfizer, particularly in developing countries. Therefore, if these patent applications are granted, it will hinder generic manufacturing or supply of the compound in the countries where patents are granted. For the patented Paxlovid, access challenges exist as a result of the high cost. The cost per treatment ranges between USD 200-500 in some developing countries, whereas the cost of its generic counterpart is only USD 73. The voluntary licence agreement with Medicines Patent Pool (MPP) signed by Pfizer excludes some developing countries. These same access challenges were also identified for WHO-recommended therapeutics, namely molnupiravir. 394.   Finally, the 17 June Decision has been negotiated and it can apply mutatis mutandis to therapeutics and diagnostics. We recommend the extension of the 17 June Decision to therapeutics and diagnostics by Members. We would continue to engage constructively in future negotiations.
The Council so agreed.
61. The Chair recalled that under paragraph 8 of the Ministerial Decision on the TRIPS Agreement, adopted on 17 June 2022, Members had agreed to make a decision within six months from adoption, on whether to extend this Decision to cover the production and supply of COVID-19 diagnostics and therapeutics. Since the last formal meeting of the Council in July, Members had held two dedicated informal open-ended meetings on this issue - on 19 September and on 3 October 2022. At the first meeting, Members had shared their views on which key issues would need to be discussed to enable Members to take a decision by the prescribed deadline in December.
62. A number of Members had expressed their readiness to move ahead with an extension of the Decision to therapeutics and diagnostics. Other Members had called for an evidence- and fact-based analysis to identify supply side constraints and any IP-related barriers to access to individual therapeutics and diagnostics. A number of delegations had raised the question of the scope of an extension of the Decision, including possibilities for a definition of 'therapeutics and diagnostics'. Some delegations also indicated the need for a list of individual products to be covered. After the meeting, a number of Members had informally shared their questions and analysis in writing with all Members.
63. The Chair said that, based on this discussion, he had set out a schedule of dedicated meetings until December in order to map out the path forward, which he had circulated on 21 September 2022.
64. The second dedicated informal open-ended meeting on the issue had taken place on 3 October 2022. At that meeting, a number of delegations had provided responses to questions circulated after the previous meeting. Detailed interventions had given examples of product definitions from national legislation, and had shared information on the licensing and supply situation of certain therapeutic products used to treat COVID-19. Other delegations had requested evidence on concrete IP-related barriers and indicated that their internal information-gathering and consultation exercises were still on-going. Many delegations had argued that the differences in use, production and distribution between vaccines on the one hand, and therapeutics and diagnostics on the other, meant that a solution for these products also needed to be different from that for vaccines. He said that he had once again invited delegations to share these detailed statements in writing and he hoped this would be the case soon.
65. Most Members who had taken the floor had also emphasized again that the negotiation process on this question should continue in an open, transparent, and inclusive manner, and that all Members needed to be heard on the development of any outcome.
66. The Chair said that he had reported on these meetings to the General Council on 25 July and on 6 October. As mentioned in his last report, while heartened by the engagement and the efforts that delegations had clearly made – to formulate questions and to provide detailed responses – it was his sense that Members would need to focus on concrete outcomes of our discussion very soon, in order to meet the approaching December deadline. He therefore encouraged delegations to start considering which concrete form their respective proposed outcome decision should take – and ideally propose concrete text, so that other delegations could take a view on this basis.
67. The representatives of South Africa; Maldives; Kenya, on behalf of the ACP Group; Malaysia; Bangladesh, on behalf of the LDC Group; Colombia; Indonesia; Sri Lanka; Egypt; Argentina; Bolivia, Plurinational State of; Brazil; China; Uruguay; Peru; Singapore; Switzerland; Chinese Taipei; the United States of America; Mexico; the European Union; Japan; Canada; Korea, Republic of; India; the United Kingdom; Nigeria; and the World Health Organization (WHO) took the floor.
68. The Chair thanked Members for a rich discussion, and for their serious engagement on this matter. He said he was very much aware that the time until 17 December 2022 was short – and that, in order to take a meaningful decision by that deadline, Members would have to focus on concrete steps very soon. Judging from the interventions at the informal open-ended meetings and today, there were currently a wide range of views held by Members in this regard. In his view, they included at least the following positions:
a. those who wished to extend the current decision "as is" to therapeutics and diagnostics without any additional language or definition;
b. those who wished to see concrete evidence of IP barriers before considering an extension to therapeutics and diagnostics; and finally
c. those who were looking to include a definition, or to agree a concrete list of products to be covered by an extension of the TRIPS Decision to therapeutics and diagnostics.
69. In view of the deadline for a decision in December, he said he would suggest the following approach. As the Council's next open-ended informal meeting dedicated to this issue was just over two weeks away – scheduled for 2 November 2022 – he urged delegations to use the time until that meeting to engage bilaterally and to address concerns and information queries, as these would otherwise take up too much time in the open-ended meetings.
70. He also requested that, by the time of the next meeting on 2 November, all delegations that had a view on what the Council should decide, should make concrete textual proposals for such a Council decision in writing. As he had indicated before, such textual proposals for a decision should be circulated in writing before that meeting, so that these could be a basis for discussion at the meeting. These could be position papers, outlines, detailed drafts, or fully formulated decisions but it was his sense that such concrete textual options were necessary to focus the discussions ahead of the December deadline. He also indicated that, if the discussions did not concretize on concrete textual options at the next meeting, he would consider a more intense consultative process to drive this process forward.
71. Given that this was the last formal meeting planned for this year, he suggested to keep this agenda item open with a view to resuming in formal mode before 17 December in order to take a decision as prescribed by paragraph 8 of the Ministerial Decision.
72. The Council so agreed.
73. At a resumed meeting of the Council on 15 December 2022, the Chair recalled that the Council had kept discussions under this item open at its meeting on 12-13 October 2022. Since then, the Council had held informal meetings on this matter on 2 and 22 November, and on 6 and 15 December, including directly preceding the current formal meeting. In these meetings, Members agreed that the Council should report the state of play of discussions under this item to the General Council by the expiry of the deadline specified in paragraph 8 of the Ministerial Decision.
74. Against that background, he had circulated a draft report for a factual and neutral reflection of the state of play, as well as for a forward-looking element, on 7 December 2022 in document with an invitation for Members to provide comments. The item had also been placed on the agenda of the General Council meeting scheduled for 19-20 December in the usual fashion.
75. He said that, having received comments on the draft, he had held consultations with a group of interested Members on 12 and 14 December, and the matter had been further discussed in an openended informal meeting of the Council on 15 December, immediately preceding this formal session.
76. Although these discussions had been inconclusive, he still believed that the amended language of his proposed draft report circulated in was the best chance of reaching consensus. He said he would refrain from reading out the entire text at this meeting, and simply propose that the Council adopt the draft report as circulated in document .
77. The representatives of South Africa; Sri Lanka; Switzerland; the United Kingdom; the United States of America; and the European Union took the floor.
78. Resuming in formal mode later on the same day, the Chair said it was his impression that there was no consensus on adopting a report to the General Council under this agenda item, and that he would therefore report to the General Council under his own responsibility next week.
79. The representatives of Sri Lanka; South Africa; Switzerland; the United Kingdom; Tanzania; Singapore; and Egypt took the floor.
80. The Chair said he would suspend the agenda item one more time, and that he would call a meeting the following day, if Members would be able to find an agreed solution that could then be adopted by all Members.
81. At a resumed meeting of the Council on 16 December 2022 the Chair proposed that the following text – also displayed on the screen in the room – be adopted as the Council's report to the General Council:
"In view of paragraph 8 of the Ministerial Decision on the TRIPS Agreement adopted on 17 June 2022 providing that
[n]o later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics
the TRIPS Council recommends that the General Council extend the deadline."
82. The Council so agreed.
83. The representative of Switzerland took the floor.
IP/C/M/106, IP/C/M/106/Add.1