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

H.E. Ambassador Dr Lansana GBERIE

359.   Japan appreciates the efforts made by the Chair and the Secretariat to continuously provide us with opportunities to discuss this important matter. Intellectual property rights and the TRIPS Agreement play a crucial role in the development of COVID-19 vaccines, diagnostics, and therapeutics. According to the Ministerial Decision on the TRIPS Agreement at MC12, Members will decide by December on an extension to cover the production and supply of COVID-19 diagnostics and therapeutics. In the consideration of the extension, Japan believes that this discussion should be conducted based on evidence and facts. 360.   We would like to draw your attention to one of the important points, that diagnostics and therapeutics are different from vaccines in their nature, distribution patterns, usage and so on. Therefore, the extension of the Decision to diagnostics and therapeutics should be considered in light of these facts. Japan appreciates the submission of the room document RD/IP/49 at the last TRIPS Council meeting in July for its discussion of this issue. We have studied the arguments presented in the document and shared our analyses on the arguments in the informal meetings held twice after the last regular Council meeting. Japan constructively participates in this discussion with Members. 361.   In this context, Japan also appreciates the feedback/explanations from the proponent countries in response to questions raised by Members in the last informal meeting. Japan would like to share with TRIPS Members the factual information we have collected so far: EFPIA (European Federation of Pharmaceutical Industries and Associations) published a report titled "Factsheet on Covid-19 Therapeutics" on 29 September. Based on Airfinity's data, this report indicates the following: a. The production of therapeutics presently exceeds demand; b. Many voluntary licensing agreements have been in place for therapeutics; and c. Many pharmaceutical companies offer therapeutics at tiered pricing. 362.   PhRMA (Pharmaceutical Research and Manufacturers of America) also published a report on 29 September. Based on Airfinity's data, this report indicates that the quantity of therapeutics produced currently exceeds demand not only in high-income countries, but also in low-income and middle-income countries. We should collect and assess these facts reflecting the current situation or reality. 363.   We would like to first discuss therapeutics and then diagnostics. At the last informal meeting, as a response to the question on how intellectual property has been the barrier to access, we listened to statements from Members insisting that high prices for products create the barrier to access in developing countries. As indicated by the EFPIA's report, tiered pricing is used in developing countries to ensure affordability. In some cases, inexpensive generics are available on the market through voluntary licensing. It has been publicly announced that Pfizer's Paxlovid would be offered to low-income and middle-income countries at a non-profit price in cooperation with UNICEF and the Global Fund, in addition to the sublicences via MPP, Medicines Patent Pool. This month, a Japanese pharmaceutical company also signed a licence agreement with MPP for the purpose of offering its COVID-19 therapeutic drug, ensitrelvir, widely to lower middle-income countries with no royalties. 364.   In response to the question of how intellectual property is or has been the barrier to access, we also heard statements from Members saying that generics are more affordable and accessible than expensive original drugs. 365.   However, without IP protection, there would be less hope for the development of new therapeutics for future pandemics, which requires considerable investment and effort. And if new therapeutics are not developed, there would be no generics either. In fact, it is intellectual property that incentivizes the development of new therapeutics, facilitates access to generics, and enables tiered pricing. 366.   The room document RD/IP/49 argues in the paragraph on therapeutics that the number of patent applications is increasing. This means that many inventions are being produced to combat COVID-19. This is evidence that innovation is promoted by intellectual property in the field of treatment, and that there is a virtuous cycle of therapeutics development. Another fact is that some patents of therapeutics efficacious for COVID-19 have already expired. Given these facts, and especially regarding the therapeutics we mentioned above, it can be concluded that patents will not cause price increases or access limitations in developing countries. 367.   We welcome any additional evidence and analyses showing that IP is or has been a barrier to access. At the last informal meeting, it was pointed out that some countries could not take advantage of sublicences via MPP due to the World Health Organization's strict prequalification requirement. However, our understanding is that the requirement aims to achieve our common goal of delivering high-quality and safe therapeutic products to patients. 368.   Now we are going to discuss diagnostics. At the informal meeting, it was pointed out that patent monopolies were a significant barrier to promoting equitable access. However, as mentioned in the room document RD/IP/49, the foundational patents for the main diagnostic methods have already expired. Therefore, we recognize that not only certain manufacturers with such foundational patents, but also other manufacturers can produce COVID-19 diagnostics. In fact, the ACT-A report was mentioned at the last meeting, and the report indicates the following: a. More than 1,500 new diagnostics for COVID-19 have been commercially available; b. Many of the diagnostics are from companies new to the IVD (in-vitro diagnostic) market; and c. Diagnostics are actually produced locally in several developing countries in Africa and South America. 369.   The report points out that the existing challenges to expanding local production of diagnostics include: a. Difficulties in recruiting sufficiently skilled personnel; b. Unpredictable demand; c. Difficulties being cost competitive with other manufacturers during the start-up period; d. Regulatory issues in individual countries, among others. 370.   If there is any specific evidence or analyses which support the argument that patent rights are barriers to access to diagnostics and therapeutics, and expansion of local production of diagnostics and therapeutics, we would like to have them for our review and analysis. Japan continues to constructively participate in this discussion.

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