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TWN Info Service
on Health Issues (Oct22/0) This is an expanded version of the article first written by D. Ravi Kanth in SUNS #9667 dated 14 October 2022 The prospects for reaching an agreement at the World Trade Organization on extending the MC12 TRIPS decision to cover the production and supply of COVID-19 diagnostics and therapeutics by the deadline of 17 December seems increasingly unlikely due to the same old “stonewalling” tactics adopted by the major developed countries since 2020, said people familiar with the discussions. At a regular meeting of the WTO’s TRIPS Council on 12 October, the differences in positions echoed by major industrialized countries like the United States, the European Union, Japan, Canada, Korea, and the United Kingdom, as well as Singapore, on the one side, and a large majority of developing and least-developed countries, on the other, surfaced all over again and strangely enough, almost on the same lines when 65 countries called for a comprehensive TRIPS waiver back in 2020. As per paragraph 8 of the Ministerial Decision on the TRIPS Agreement adopted at the WTO’s 12th ministerial conference (MC12) on 17 June, WTO members are mandated to decide “on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics” no later than six months from the date of the Decision. That deadline expires on 17 December. Yet, during the TRIPS Council meeting on 12 October, major industrialized countries such as Switzerland, the European Union, the United States, Japan, Canada, the United Kingdom, and Korea, as well as Singapore, insisted that they need concrete evidence that intellectual property (IP) constitutes a barrier to access to diagnostics and therapeutics, even before considering the extension of the TRIPS Decision, said people familiar with the discussions. In what seems like the repeat of events that preceded the June TRIPS Decision, the industrialized countries had made the same argument, when India and South Africa on 2 October 2020 had presented their proposal for a waiver to suspend several provisions of the TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information for combating the COVID-19 pandemic. Earlier, India expressed concerns about the apparent hesitancy with which the TRIPS Council has approached the issue. India said despite submitting a room document (RD/IP/49), which was circulated on 6 July, on how to conduct negotiations within the stipulated time period of six months, “we are surprised to see this hesitation from the institution.” (See SUNS #9612 dated 8 July 2022). Ramping up “production for therapeutics and diagnostics have been thoroughly discussed in various formats on several occasions for the past two years,” India said. The revised TRIPS waiver proposal by 65 co-sponsoring countries sought to suspend several provisions in the TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information for combating the COVID-19 pandemic, by scaling-up the production of diagnostics, therapeutics, and vaccines. Prior to that revised proposal, the 65 countries, in three separate documents, had answered all the questions raised by the industrialized countries on the need for the TRIPS waiver. India emphasized that “for the matter of evidence-based discussions, proponents have already submitted numerous documents while giving the proposal in IP/C/W/669/Rev.1, which was followed by 3-4 very elaborated documents.” India urged members “who are asking for new evidence to please go through those documents and also go through the documents released by WHO, which has well recognized therapeutics and diagnostics as integral components of a comprehensive “prevent, test and treat” strategy to combat the pandemic.” With COVID-19 continuing to persist across countries in varying levels of intensity, India said that the pandemic “still remains a public health emergency of international concern” requiring that testing and treatment are essential aspects of controlling and managing COVID-19. It is against this backdrop that India had said that “in order to follow test and treatment model, we need to make therapeutics and diagnostics not only available but also affordable and accessible.” Under international pressure, particularly from US Congress members, including Senators Bernie Sanders and Ms Elizabeth Warren, as well as several international leaders, Nobel Laureates, and more than 150 civil society groups, the US had agreed in May 2021 to engage in the negotiations. Later, under rather controversial circumstances, the WTO Director-General constituted a group of four countries – the US, the EU, India, and South Africa – to negotiate a deal that finally translated into the June decision on the TRIPS Agreement, a person said. Although the 17 June TRIPS Decision was sub-optimal and failed to address the concerns raised by the developing countries, they agreed to the final outcome. The industrialized countries seem to be repeating what many developing countries regard as “stonewalling” tactics, which they had adopted earlier, by demanding concrete evidence to prove that IP is not a barrier in terms of access to diagnostics and therapeutics, the person said. In sharp contrast, at the TRIPS Council meeting on 12 October, a large majority of developing countries, including the original proponents of the TRIPS waiver proposal such as India and South Africa, along with Kenya on behalf of the ACP (African, Caribbean, and Pacific) group, Indonesia, Colombia, Sri Lanka, Egypt, Bolivia, Argentina, Brazil, and Bangladesh on behalf of the least-developed countries (LDCs) apparently demanded a blanket approach for the mandated extension of the TRIPS decision to cover diagnostics and therapeutics. India said “while the MC 12 Decision is far from being a perfect one, as it comes too late and offers too little, nonetheless, we regard it as a step in the right direction” adding that it laid to rest the debate on whether IP is a barrier to equitable and affordable access. “All members agree that to combat the COVID 19 virus and its ever-mutating strains, a comprehensive strategy must be adopted. Apart from preventive measures, test and treat strategies continue to be relevant and important to save lives, as people continue to contract the virus and fall sick and also die in some cases despite several doses of vaccinations”, India said, adding that testing is also “essential to identify new variants to start building vaccines and therapeutics that can prevent or treat infection and to better understand the scale of infection allowing for expeditious action to be taken to break the chain of transmission and contain the spread further”. India referred to the 12th meeting of the International Health Regulations Emergency Committee of the WHO which met in July 2022 and stressed that for COVID-19, “access to timely and accurate testing, with linkage to clinical care and therapeutics, needs to be maintained” and recommended that “local production … related to … therapeutics and diagnostics should be encouraged and supported as increased production capacity can contribute to global equitable access to therapeutics”. India called on WTO Members to optimally use the meetings planned and to “avoid getting into circular discussions, and the need for providing endless evidence”. It stressed that “it’s unfortunate that questions posed by some non-proponents seeking evidence to prove lack of access to therapeutics and diagnostics appear to be both insincere and insensitive given that over 6.5 million lives have been lost amidst the acute shortages of masks, ventilators, PPE kits, therapeutics, vaccines, diagnostics etc, that we all have faced a global catastrophe that no one can deny”. India emphasised that “substantive and protracted discussions have been undertaken on this issue since the introduction of this proposal in October 2020 and several documents containing comprehensive information and analysis have already been provided by the proponents”. South Africa responding to certain delegations that have expressed concern about therapeutics with multiple uses and for the products covered by the Decision to be limited. argued that “the WTO Ministerial Decision contains safeguards to ensure that products produced and supplied under the authorization are for COVID-19. This is reflected in paragraph 1 which provides that authorizations under the Decision may only be granted “to the extent necessary to address the COVID-19 pandemic”. In addition, South Africa said “the treatment options to be availed to patients depend on many factors such as the disease severity, the availability of drugs, routes of administration, duration of treatment among others. Some 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”, it said. South Africa further stated that while therapeutics and diagnostics were available in developed countries, this is not the case developing countries that have “kept waiting” for donations or for companies’ decisions on availability and affordability. It add that “this is not a sound public health policy”, and “That is why, access to therapeutics and diagnostics is repeating the inequality situation seen in vaccines”. South Africa gave several examples of the challenge of access in developing countries. For example, as of April 2022, 66% of Merck’ anti-viral medicine (molnupiravir) was sold in developed countries, it said. Other medicines such as monoclonal antibodies are not available in many developing countries. When available, the price is prohibitive. For example, Roche’s price of 600 mg dose of tocilizumab is USD646. The main patent on tocilizumab expired in 2017, yet several secondary patents remain on the medicine in a number of developing countries, 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, South Africa said, adding that it has been documented by MSF that during the second wave, in one developing country, the distributor ran out of the medicine and not a single vial was available in the country for critical patients. South Africa also related its own experience on access i.e. 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 USD2,000 per patient. The cost to manufacture tocilizumab is estimated to be as low as USD40 per dose of 400 mg. With respect to two anti-viral products that have been recently licensed to the Medicines Patent Pool (MPP), molnupiravir produced by Merck and nirmatrelvir + ritonavir produced by Pfizer, South Africa said that the licenses have geographical limitations in terms of which countries can be supplied. The licenses exclude most of Latin America and many Asian countries from benefiting from these agreements directly. “The extension of the June (TRIPS) Decision would streamline the process for compulsory licensing to allow excluded countries to access lifesaving treatments at affordable prices”, South Africa emphasized. Outside the MPP, bilateral voluntary licenses between producing companies and generic companies lack transparency and contain several conditionalities on supplies and geographic allocation, South Africa pointed out. For example, a bilateral licensing agreement for remdesivir, excluded nearly half of the world’s population from benefitting from price-lowering generic competition. Other medicines such as baricitinib are not available due to exclusive rights held by the originator company. The originator holds patents in more than 50 developing countries including in Latin America, Asia and Africa, which are hit hard by the pandemic, South Africa explained. These medicines are examples where the producing companies dictate supply, allocation, and price and as a result supply is not adequate, and the prices are too high for developing countries, South Africa emphasized. It also expressed concerns with respect to price transparency, and that in the case of repurposed drugs it is particularly difficult to justify monopoly prices as an R&D incentive. Indonesia also stressed that therapeutics and diagnostics are inseparable parts of the countermeasures devised in the WHO’s four-pillar strategy and have been proven to be effective in the prevention, containment, and treatment of COVID-19. Indonesia referred to a recent statement by the World Health Organization’s Director-General that it is simply not acceptable that innovative treatments that can save lives are not reaching those that need them, while manufacturers are posting record high profits. In fact, for both testing and therapeutics, the ACT-Accelerator report notes with concern the challenge that manufacturing is highly concentrated and the need for diversified production in particular local production, Indonesia added. Indonesia strongly reminded the TRIPS Council that to be bogged down by providing evidence in a circular manner is to repeat the same mistake we have done, where it took us 18 months to reach a Decision that is partial, conditioned, and narrow in scope to respond to the COVID-19. “Are we going to follow the same old pattern or are we going to become an organization that is relevant and responsive in addressing this global issue?”, Indonesia asked The developing and least developed countries emphasized that the TRIPS Decision must be implemented without any further change, either in terms of definition or language, said trade officials, who asked not to be quoted. China supported the demand for implementing the TRIPS Decision but suggested that it is holding domestic consultations. Several other countries including the US, Mexico and Chinese Taipei among others sought flexibility on grounds that they are engaged in domestic consultations and are eliciting information on issues concerning COVID-19 diagnostics and therapeutics. WHO INTERVENES IN TRIPS DISCUSSION A WHO representative also intervened as an observer during the debate at the TRIPS Council on the extension of the TRIPS Decision to cover the production and supply of COVID-19 diagnostics and therapeutics. WHO seems to have suggested the need to ensure coherence in the response to address public health concerns. WHO argued that “not only vaccines are important, the “test and treat” strategy is vital for the COIVD-19 response. Countries are facing challenges to access affordable diagnostics” adding that for therapeutics “there are few voluntary licenses from key technology holders to scale up manufacturing and respond to the needs in countries”. According to WHO “unfortunately, the scope of the licenses is not sufficient, it excludes many countries”, emphasizing the urgent need to provide these technologies to developing countries. TRIPS COUNCIL CHAIR’S REMARKS The TRIPS Council Chair, Ambassador Gberie of Sierra Leone, informed Members that he would hold the next informal TRIPS Council meeting on 2 November. Until then, he asked WTO Members to engage bilaterally. Additional rounds of informal meetings have been planned for 16 November, 6 December, with the possibility of a meeting on 15 December, two days before the deadline in the TRIPS Decision regarding diagnostics and therapeutics. The Chair informed the TRIPS Council that the discussion under the agenda item of the Council will remain open in order to resume in formal mode before 17 December in order to take a decision as prescribed by the Decision. In conclusion, the prospects for agreeing on the extension of the TRIPS Decision to cover the production and supply of COVID-19 diagnostics and therapeutics by 17 December seem somewhat remote due to the apparent lack of urgency attached to the issue, said a developing country official, who asked not to be quoted. +
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