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

H.E. Ambassador Dr Lansana GBERIE

241.   We thank you for the schedule of meetings to engage on this important issue. The World Health Organization has been abundantly clear about the need to deal with the COVID-19 pandemic comprehensively. Dr Ghebreysus, Director-General of the WHO, has said, "Vaccines alone will not end the pandemic." "Many countries need diagnostics, lifesaving therapeutics — including oxygen and support for vaccine rollout". 242.   The COVID-19 pandemic is ongoing. Health experts have warned that while Omicron subvariants BA.4/5 have dominated in Europe over the summer, newer Omicron subvariants are gaining ground. WHO data released last Wednesday showed that cases in the European Union reached 1.5 million last week, up 8% from the prior week while hospitalization rates in Europe have increased significantly over the past few weeks. It is reasonably foreseeable that this trend will be replicated in other regions heading into the winter months.6 243.   As we witnessed in the initial waves of the pandemic, the interconnectedness of the global economy rendered the spread and mutation of new variants inevitable. Let us learn from the lessons of the past few years and develop a comprehensive response to the pandemic as health experts have urged. 244.   The Ministerial mandate in paragraph 8 of the WTO Decision on the TRIPS Agreement is a matter of utmost priority. The 17 December deadline is fast approaching and necessitates that we act decisively on this important item that affects people's lives. The Decision reached at MC12 demonstrated what we can achieve as the Membership when we work together and adopt a solutionoriented approach to issues that affect humanity. The said Decision was a step in the right direction, but we must conclude our unfinished business. 245.   The waiver proponents have provided sufficient evidence in the documents that have been submitted before on the intellectual property barriers applicable to therapeutics and diagnostics, including concerns regarding accessibility and affordability. Therefore, we urge all Members to move beyond circular Q&A sessions and expeditiously proceed with the decision entailed in paragraph 8. 246.   As we stated in the General Council last week, the paragraph 8 mandate is clear: the task before us is to decide within 6 months on the extension of the WTO Ministerial Decision on the TRIPS Agreement to cover therapeutics and diagnostics. It is not an agreement to renegotiate the text. 247.   Some delegations have expressed concern about therapeutics with multiple uses and have thus called for the products covered by the decision to be limited. However, the WTO Ministerial Decision contains safeguards to ensure that products produced and supplied under the authorization are for COVID-19. This is reflected, for instance, in paragraph 1 which provides that authorizations under the Decision may only be granted, "to the extent necessary to address the COVID-19 pandemic". My friend Sherif spent many hours in the green room negotiating those wordings. 248.   In addition, the treatment options to be availed to patients depend on many factors, such as the disease severity, the availability of drugs, routes of administration (only intravenous for remdesivir and the monoclonal antibodies), and duration of treatment, among others. Some of these treatments can be used in combination (i.e. as for severe or critical COVID-19) while others are to be used as alternatives. The evolution of the virus and patterns of vaccination affect the efficacy of therapeutics thus raising the importance of adapting the treatments to local contexts. We caution against an approach that ties the hands of health authorities on the ground and therefore defeats the very purpose of the waiver Decision. 249.   At the TRIPS Council meeting of 19 September, a number of questions were posed to the cosponsors and we thank delegations for these questions. They are, however, similar to the questions that have been repeatedly asked and answered since October 2020. We suggest that delegations go back to the submissions that we have already made. However, as we did at the informal meeting on 3 October and in the spirit of constructive engagement, we offer some reflections on some of the most pertinent of these recent questions. So I have selected some of them and will read them out and give some responses. Two of them read as follows: a. In which countries and for which products have the prices been prohibitively high so that they have posed a barrier to access? b. Do these prices reflect the lower prices that many pharmaceutical companies offer via their tiered pricing systems? 250.   In response we would posit the following: equitable access means that therapeutics and tests are available and affordable for all who need them at the same time everywhere. Currently, many therapeutics and diagnostics, which are widely available in high-income countries (HICs) are not so in low- and middle-income countries (LMICs). Developing countries are kept waiting for donations or for companies' decisions on whether: a. to enter into a voluntary licence and the conditionalities that companies impose on their voluntary actions, e.g. geographic limitation; b. to donate some products to countries or populations of the company's choice; c. to lower the price to a level and for countries of the company's choice. 251.   Clearly this is not a sound public health policy to leave LMICs subject to the largesse of companies' decisions. 252.   There are two important issues related to access to COVID-19 therapeutics and diagnostics: a. supply in terms of the quantity of the product available for LMICs to procure; and b. the price. Like vaccines, pharmaceutical companies prefer to supply the high-income market where they can sell for higher prices and maximize their profit than in LMICs where profit will be less. 253.   That is why access to therapeutics and diagnostics is repeating the inequitable situation seen in vaccines. For example, as of April 2022, 66% of Merck's anti-viral medicine (Molnupiravir) was sold in high-income countries. 254.   Other medicines such as monoclonal antibodies are not available in many LMICs. When available, the price is prohibitive. For example, Roche's price of a 600 mg dose of tocilizumab is USD 646. The main patent on tocilizumab expired in 2017, yet several secondary patents remain on the medicine in a number of LMICs that cause uncertainties about the potential of production of biosimilars. Shortages of tocilizumab have been observed in many countries that have already started using it for COVID-19 treatment. It has been documented by Médicins Sans Frontières that during the second wave, in one developing country7, the distributor ran out of the medicine and not a single vial was available in that country for critical patients. 255.   WHO recommended the monoclonal antibodies (mAbs) casirivimab and imdevimab for people at high risk of developing serious COVID-19 diseases and defined these groups as: a) older age b) have immunodeficiency or chronic disease or c) are unvaccinated.8 The medicine is the subject of patent applications filed in at least 11 LMICs. 256.   These medicines are examples where the producing companies dictate supply, allocation, and price. Supply is not adequate, and the prices are too high in LMICs. Since the real cost of R&D and manufacturing are not known due to a total lack of transparency, it is difficult to assess the prices offered except in terms of countries' affordability to purchase. In the case of repurposed drugs it is particularly difficult to justify monopoly prices as an incentive for research and development. Many LMICs would not consider the current prices of most COVID-19 therapeutics and diagnostics to be affordable. 257.   Turning to the next question, it is more of a statement than a question: there are many therapeutics for which patent rights do not exist, or which are royalty-free. In response, we would posit that there are medicines such as dexamethasone that have been produced by generic companies in several countries. Generic competition of this medicine has led to lower prices and wider availability. This is precisely the situation that we would like to create for newer therapeutics and hence extending the WTO Decision of June to therapeutics would be helpful in this regard. There are not many royalty-free therapeutics for COVID-19 and, as we pointed out before, treatments that are suitable for patients differ and are based on a number of factors. 258.   Patent barriers affect accessibility and affordability. For example, tocilizumab, which was mentioned before, is strongly recommended for treating patients with severe and critical COVID-19. It is a biological medicine manufactured by a Swiss-headquartered company.9 Tocilizumab is in fact a repurposed drug, having been used for inter alia rheumatoid arthritis since it was first marketed. Its main patents expired in 2017. However, subsequent patent applications for other features have been filed leading to the extension of tocilizumab's patent thicket up until 2028 for some jurisdictions in the world.10 These are known as "evergreening" patents. Although Roche voluntarily said that it would not enforce its patents in some developing countries and least developed countries, it leaves out key manufacturing countries.11 In South Africa, for example, despite an expert panel finding that tocilizumab reduced deaths, the recommendation was for the medicine to not be used because it is "not affordable at the current offered price". The life-saving therapy is largely out of reach for African populations at a cost of around 2,000 dollars per patient.12 The cost to manufacture tocilizumab is estimated to be as low as 40 dollars per dose of 400 mg.13 Further, the demand for tocilizumab far outstrips its limited supply, jeopardising the treatment not only of COVID-19 patients but also those who use the drug for the other indications available.14 259.   Two further questions state as follows: first, there are some COVID-19 therapeutics available to developing countries at low prices through voluntary licences including via the Medicines Patent Pool (MPP), or tiered pricing. Considering these facts, patent rights are unlikely to be the cause of rising prices or restricted access to therapeutics in developing countries. 260.   The second one reads as follows: we need comprehensive information about existing collaborations and in particular voluntary licences. For instance, are there countries that would have been interested in applying for a sublicence for molnupiravir and Paxlovid but were not able to do so because they fall outside the scope of the MPP licence agreements? Which companies from those countries, that are eligible for applying for a sublicence, have been rejected in WHO's prequalification phase? Have applications been turned down for other reasons? And in which cases has it been possible for low- and middle-income countries to conclude voluntary licensing agreements? 261.   In response we would say the following: there are only two anti-viral products that have been recently licensed to the MPP, molnupiravir produced by Merck and a combination drug produced by Pfizer. One generic equivalent of molnupiravir received WHO prequalification approval and several more versions of both medicines are awaiting approval. However, these licences have limitations, for example, as to the geographical scope. Although the licences allow for manufacturing worldwide, they limit where the licensees can supply these products. 262.   The licences exclude most of Latin America and many Asian countries from benefiting from these arrangements directly. The extension of the June Decision would streamline the process for compulsory licensing to allow excluded countries to access lifesaving treatments at affordable prices. 263.   Outside the MPP, bilateral voluntary licences between producing companies and generic companies lack transparency and have several conditionalities on supplies and geographic allocation. For example, a bilateral licensing agreement for remdesivir excluded nearly half of the world's population from benefitting from price-lowering generic competition.15 264.   Other medicines, especially monoclonal antibodies, colloquially knows as mAbs, such as baricitinib, are not available due to exclusive rights held by the originator.16 The originator holds patents in more than 50 developing countries, e.g. Latin America, Asia and Africa, which are hit hard by the pandemic. 265.   Problems with access to mAbs are not limited to LMICs. For example, the drug bebtelovimab is recommended for immunosuppressed patients with COVID-19. It is not available in Europe because the company that holds the IP rights refuses to register and market the product for patients in Europe.17 This is discussed extensively in an open letter by Michel Goldman, President of the Institute for Interdisciplinary Innovation in Healthcare, Université libre de Bruxelles, Belgium. This open letter dated is 5 August 2022.18 266.   Many of these details that we provided today are available in our written submissions document IP/C/W/670-674. We urge delegations to consult these submissions.

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

6 https://www.reuters.com/world/europe/covid-wave-looms-europe-booster-campaign-makes-slow-start-2022-10-06/

7 https://msfaccess.org/tocilizumab-second-drug-ever-recommended-who-covid-19-will-remain-unaffordable-and-inaccessible

8 https://www.who.int/docs/default-source/coronaviruse/poster_casirivimab-and-imdevimab.pdf

9 https://app.magicapp.org/#/guideline/nBkO1E

10 See IP/C/W/670

11 In countries where there is no such waiver of patent implementation, it is reported that Roche has kept the price of this therapeutic very high in most countries, ranging from 410 dollars in Australia, 646 dollars in India to 3,625 dollars in the USA per dose of 600 mg for COVID-19.

12 https://www.twn.my/title2/intellectual_property/info.service/2021/ip211011.htm.

13 https://reliefweb.int/report/world/tocilizumab-second-drug-ever-recommended-who-covid-19-will-remain-unaffordable-and.

14 https://msfaccess.org/tocilizumab-second-drug-ever-recommended-who-covid-19-will-remain-unaffordable-and-inaccessible

15 https://www.msf.org/governments-must-support-proposal-waive-coronavirus-covid-19-patents

16 https://msfaccess.org/latin-america-how-patents-and-licensing-hinder-access-covid-19-treatments

17 https://www.thepharmaletter.com/article/weak-demand-leads-lilly-to-withdraw-covid-antibody-in-europe

18 https://www.ft.com/content/36b1d91d-6b0c-453e-b4a0-37f3d21912e4?accessToken=zwAAAYO8xn4ikc82sdkdawxFPtO0oDfz0hkS5A.MEUCIQDif6JgTk6nWXumorWb6HvIjWbna_iFasMLcQMwq_rIEwIgDVwZ4rJXBB83PJmoEHCKHgq24j0N44Z4MQg4F3X_v1A&sharetype=gift&token=d2901bba-041a-456c-b04a-32a6acdc3b13