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Info Service on Health Issues (Jun23/05) Washington DC, 19 Jun (D. Ravi Kanth) — The new chair of the World Trade Organization’s TRIPS Council has said there has been little progress on extending the Ministerial Decision on the TRIPS Agreement reached at the WTO’s 12th ministerial conference (MC12) last June to COVID-19 diagnostics and therapeutics due to continued divergent views among members, raising serious doubts about the credibility of the MC12 decisions, SUNS has learned. At a formal meeting of the WTO’s TRIPS Council on 14 June, India apparently expressed sharp concern that some countries have forced “protracted and circular discussions that will not make possible an outcome (on paragraph eight of the Ministerial Decision) at MC13.” As per paragraph eight of the MC12 Ministerial Decision on the TRIPS Agreement, members are mandated to decide on extending the Ministerial Decision on vaccines to COVID-19 diagnostics and therapeutics within six months, namely by end-December 2022. “No later than six months from the date of this Decision (reached on 17 June 2022), Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics,” according to paragraph eight of the Ministerial Decision. The new chair of the TRIPS Council, Ambassador Pimchanok Pitfield of Thailand, informed members that her consultations failed to yield any progress due to entrenched differences. Although she did not name the countries and the positions adopted by them, it is clear that a small group of industrialized countries such as Switzerland, and the United Kingdom among others, where “Big Pharma” is headquartered, has seemingly adopted obdurate positions that were inimical to an early decision, said people, who asked not to be quoted. Despite repeated attempts by a large majority of developing and least-developed countries, including China, for an expeditious solution on paragraph eight, the prospects for any early breakthrough remain few and far between, said several TRIPS negotiators. While the United States allegedly continues to hold hostage any decision on grounds that its International Trade Commission (ITC) has been tasked to come up with a report on paragraph eight by 17 October, the European Union said it is fully engaged in the consultations but remains somewhat sceptical, said negotiators, who asked not to be quoted. In her first formal meeting as the new chair of the TRIPS Council, Ambassador Pitfield apparently indicated that her “consultations did not bear any fruit in terms of bridging differences on how to address the issue of therapeutics and diagnostics.” However, she said that she remains committed to do everything possible to advance the discussion in the run-up to the WTO’s 13th Ministerial Conference (MC13), to be held in Abu Dhabi in February 2024. Ambassador Pitfield apparently indicated that she will develop, along with the Secretariat, a draft program that will be circulated for comments. The chair said that she would take into consideration Members’ preferences for a balanced composition of stakeholders from diverse geographical and organizational backgrounds. She suggested that a wide variety of views persisted in her recent consultations on paragraph eight. Apparently, members will only be able to engage in substantive discussions after they have completed their domestic consultation processes. Meanwhile, the chair urged members to continue consultations based on the proposals submitted by Chinese Taipei, as well as Mexico and Switzerland, respectively. MAJORITY SEEKS EXPEDITIOUS DECISION The views expressed by a large majority of developing and least-developed countries appear to have reinforced the popular perception about the developments in the WTO and how they are invariably “held hostage” to the positions of some powerful members, said TRIPS negotiators, who asked not to be quoted. Otherwise, it is difficult to explain how the demand for a comprehensive TRIPS waiver, first raised in October 2020, has been successfully scuttled and even the “minimalistic” outcome of MC12 is now being stonewalled, said TRIPS negotiators, who preferred not to be quoted. At the meeting on 14 June, South Africa reminded members about “the massive unmet global health needs for COVID-19 therapeutics and diagnostics.” South Africa highlighted how demand for diagnostics and therapeutics has been artificially suppressed for various reasons, including: * un-affordability of many patented tools for low- and middle-income countries; * budget constraints in many of these countries; * opacity in supply agreements; * competing health priorities and knowledge gaps regarding the available health technologies; and * the value of testing and therapeutics. In this environment, said South Africa, “low- and middle-income countries cannot rely on the goodwill of corporations.” South Africa and India spearheaded the global campaign for the TRIPS waiver back in October 2020. The two countries participated in the so-called “quadrilateral” talks involving the US, the EU, India, and South Africa conducted by the WTO’s Director-General Ms Ngozi Okonjo-Iweala. At the formal TRIPS Council meeting, India expressed consternation that despite engaging in bilateral consultations with several delegations for trying to break some new ground, the response has been anything but constructive, said trade negotiators, who asked not to be quoted. Without naming these countries, it lamented that some members entered into “protracted and circular discussions that will not make possible an outcome at MC13.” However, both South Africa and India supported the holding of thematic sessions, emphasizing that such sessions “would have to feature a diverse representation, both geographically and in terms of the diversity of voices and opinions, with the presence of relevant organizations and representatives of civil society.” GUIDELINES FOR THEMATIC SESSIONS The two countries also stressed that members’ participation must be ensured in the drafting of the agenda including the topics which need to be addressed, as well as in suggesting potential speakers. The two coordinators of the group of 65 proponents of the original TRIPS waiver insisted that the thematic events “should not in any way supplant the informal and formal meetings of the TRIPS Council to discuss the mandated issues at hand.” Further, discussions and negotiations must remain exclusively under the remit of members, South Africa and India emphasized. Many developing countries including Djibouti (on behalf of the LDC Group), Bangladesh, Indonesia, Nepal, El Salvador, Peru, Tanzania (on behalf of the African Group), Thailand, and Cambodia among others endorsed the position laid out by South Africa and India. In a somewhat nuanced statement, China noted that notwithstanding the World Health Organization’s decision of 5 May that “the COVID-19 pandemic no longer constitutes a Public Health Emergency of International Concern (PHEIC),” it must be noted that the announcement only means a transition in the level of management of COVID-19, from emergency mode to a level same as other similar infectious diseases. China said “COVID-19 still poses a threat to global health,” adding that “we are witnessing a standstill [in] the discussion on this topic.” It called on members “to continue promoting consultations and make decisions in accordance with the MC12 mandate.” Noting the wide range of COVID-19 diagnostics and therapeutics and the complex status of related intellectual property rights, at an informal meeting held on 25 April, China had said that it “proposed to hold a thematic session on this issue, engaging representatives from government agencies, academic institutions, enterprises and international organizations to share relevant information and experience.” At an informal TRIPS Council meeting on 8 June, China had said many members expressed support (which is highly appreciated). China said it hopes “the thematic session could serve as a platform for thorough information exchanging and sharing, so as to contribute to follow-up consultation of this issue.” At the formal TRIPS Council meeting, Brazil drove home the message that as developing countries continue to grapple with the numerous challenges brought about by the pandemic, the need for crucial therapeutics and diagnostics to fight infectious diseases has never been more pressing. Access to these tools, according to Brazil, is just part of the solution. It is key that developing countries also have the scientific knowledge and technological capacity to address the challenges posed by pandemics, Brazil noted. OPPONENTS OF PARAGRAPH EIGHT Meanwhile, major industrialized countries continued to hold sceptical positions on extending the MC12 Ministerial Decision on vaccines to COVID-19 diagnostics and therapeutics, said people familiar with the discussions. Switzerland, which opposed the extension on grounds that there is no need for such a decision, reiterated its position at the meeting. Apparently, Switzerland, Japan, the EU, and the US claimed that in the current context, it is unnecessary and could be counterproductive to the common goal of ensuring timely, affordable, and equitable access to COVID- 19 medical products and preparing for future pandemics. The US lent support to the Chinese proposal of a thematic session. Washington reported on the current status of the investigation launched by the US ITC into COVID-19 diagnostics and therapeutics, mentioning the public hearings held over the past few months, which are publicly available on the ITC website. The EU supported the initiative to convene a thematic session to advance the discussion that has been characterized as difficult. Brussels apparently noted that “one element that adds complexity to this issue is the lack of clear definition of what products are considered therapeutics and diagnostics, contrary to the situation of COVID-19 vaccines.” The EU also cited multiple factors that affect the accessibility and affordability of these products, such as variable financing, licensing, procurement mechanisms, and regulatory procedures. It spoke about the adequacy of supply of COVID-19 therapeutics and diagnostics, the effect of mechanisms run by the Medicines Patent Pool (MPP), UNICEF, or the Global Fund to Fight AIDS, Tuberculosis and Malaria on access to these products, and more generally, the assessment of various factors that contribute to the accessibility and affordability of COVID-19 therapeutics and diagnostics in low- and middle-income countries. Japan spoke about the need to prepare for future pandemics, while the United Kingdom said it also considered that realities are very different when it comes to vaccines, and therapeutics and diagnostics, both in terms of supply and demand dynamics and the scope of products. In conclusion, a decision on paragraph eight of the MC12 Ministerial Decision on the TRIPS Agreement may not materialize by MC13, said people, who asked not to be quoted. +
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