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Info Service on Health Issues (Jun23/04) Washington DC, 13 Jun (D. Ravi Kanth) — Colombia along with a large majority of developing and least- developed countries at the World Trade Organization apparently “upped the ante” for expeditiously extending the Ministerial Decision on the TRIPS Agreement reached at the WTO’s twelfth ministerial conference (MC12) last June to COVID-19 diagnostics and therapeutics, said people familiar with the discussions. At an informal TRIPS Council meeting on 8 June, the number of countries that sought an early decision on paragraph eight of the MC12 Ministerial Decision on the TRIPS Agreement has apparently substantially grown, said people who took part in the meeting. Along with the 65 members, led by South Africa and India, who had originally called for a TRIPS waiver in October 2020, several other countries including Colombia have come upfront and issued a powerful message at the informal TRIPS Council meeting on 8 June, said people, who asked not to be identified. COLOMBIA’S NEW TRADE ENVOY At the TRIPS Council meeting, Colombia’s new trade envoy, Ambassador Mauricio Bustamante, reiterated “the extension of the waiver to the production and supply of diagnostic means and treatments against COVID-19.” He urged members to start thinking about future pandemics, in line with the discussions that are taking place in other fora. Ambassador Bustamante called for intensifying efforts to “establish a “trigger” mechanism that allows the waiver to be used in future pandemics, without having to start negotiating everything from scratch in the midst of a crisis.” He suggested “allowing this to be an instrument that can be used by default in the face of a new health crisis that gives rise to a new declaration of a pandemic by the WHO, so that valuable time is not lost in circumstances that require speed and urgency.” Commenting on an associated issue concerning the use of voluntary licenses for future pandemics instead of a waiver, as suggested by the opponents, the new Colombian trade envoy said somewhat firmly that from Colombia’s perspective, “voluntary licenses may be valuable in some specific cases, but they are not a definitive global answer and they do not serve all of us equally.” The Colombian trade envoy said, “The experience of the pandemic showed us that in crisis situations, this was not the ideal path.” He spoke about the very difficult negotiations that Colombia faced, due “to high prices, in asymmetrical conditions, and in competition with its partners and neighbours.” In this context, he said, “It is only reasonable that the locally produced alternative should be part of our current public policy conversations.” “Even despite possible inefficiencies, it is clear that in certain situations a minimum of autonomy is required to solve acute social and public health problems such as the one that occurred in the case of COVID-19,” the Colombian trade envoy said. While expressing appreciation for the document issued by Switzerland and Mexico on enhancing the use of voluntary licenses, he said, “Indeed, voluntary licenses have not been a good public policy option for Colombia to prepare for crises like the one we are experiencing.” Indeed, voluntary licensing is affected by several problems, the envoy added. They include: (1) lack of information, as only four out of 138 voluntary licenses (VLs) were used; (2) VLs include very restrictive clauses for the export of the manufactured products, which makes them unfeasible for countries with small or medium markets; (3) even the VLs issued through the Medicines Patent Pool failed to be a solution for Colombia; (4) even existing voluntary licensing, even those considered successful, do not appear to have had a significant effect on the price of [the] necessary medical product; and (5) voluntary licensing entails high legal uncertainty, derived from the multiple claims and counterclaims for patents that are being filed in various countries. More importantly, “the terms of negotiation with the licensee are inherently asymmetrical, not transparent, and have very modest effects on price so that even in the best of cases, the voluntary licensing alternative presents significant problems as a policy option,” Colombia said. Little wonder that “Voluntary licensing for the production of certain goods is fraught with limitations and difficulties,” the Colombian trade envoy said, adding that is why it supported the waiver on vaccines and now supports the simple extension of the waiver to therapeutics and diagnostics, as well as the existence of a “trigger” mechanism that facilitates discussions in the future. It appears that Colombia’s new trade envoy, who is apparently a medical professional, has issued a powerful statement against the delay in extending the MC12 Ministerial Decision on the TRIPS Agreement to COVID-19 diagnostics and therapeutics, said people familiar with the discussions. Under paragraph eight of the MC12 Ministerial Decision on the TRIPS Agreement (WT/MIN(22)/30), WTO members are required to extend the decision on COVID-19 vaccines to COVID-19 diagnostics and therapeutics. But due to the continued stumbling blocks created by some of the leading industrialized countries representing “Big Pharma”, the chances of an early decision look somewhat bleak, at least until end-October, when the US is expected to announce a decision based on its International Trade Commission’s (ITC) investigations. Against this backdrop, South Africa, India, and many developing countries flagged the issue as their central concern at the informal TRIPS Council meeting. Several proponents in the coalition of developing countries that have been vigorously pushing for a decision based on paragraph eight, beginning with South Africa and India, and including Colombia and other countries drove home a strong message emphasizing the importance of COVID-19 diagnostics and therapeutics as critical tools to fight the pandemic. The proponents apparently argued that the presence of COVID-19 in several countries is a cause for concern and excluding these vital tools will undermine the effectiveness of the decision that aims for timely and affordable access to effective vaccines against the ongoing COVID-19 pandemic, said people, who asked not to be quoted. The 65 proponents repeatedly highlighted the importance of diagnostics and therapeutics, that will result in a holistic approach to enable the developing countries to address those IP (intellectual property) barriers that prevent the expansion and diversification of production and increase accessibility to crucial life-saving COVID-19 tools. Earlier, the proponents said, “The current outcome (MC12 Ministerial Decision on the TRIPS Agreement) represents a narrow conditioned Decision due to demands of some WTO Members, requiring significant compromises on the part of the co-sponsors that had hoped for greater solidarity among WTO Members during a public health emergency and consequently a more comprehensive waiver decision as envisaged in the original TRIPS waiver proposal that would support ramping up of production and expanding supply options.” Privately, several countries maintained that the WTO’s credibility has been tainted because of the capture of the decision-making process by a handful of countries representing the interests of “Big Pharma”, said people who preferred not to be identified. OPPOSITION TO PARAGRAPH EIGHT At the informal TRIPS Council meeting, Switzerland continued to oppose any decision on paragraph eight on the grounds that there is no material evidence to suggest that intellectual property rights remain a barrier, a stand that was also shared by the United Kingdom. The European Union said that it is ready to engage with the proponents to finalize the decision, while the US apparently provided a report on its ongoing ITC investigations, said people, who preferred not to be quoted. TRIPS CHAIR’S STATEMENT The chair of the TRIPS Council, Ambassador Pimchanok Pitfield of Thailand, indicated her continued engagement with members in different groups/configurations. The chair apparently reported that things have not moved at all as regards paragraph eight in the last three months. She reiterated her intention to keep working to find ways to bridge the existing differences. Ambassador Pitfield spoke about her meetings with delegations in the last two months. She said her report clearly indicates that substantive engagement on this issue will be more constructive once members have completed their respective domestic consultation processes. Ambassador Pitfield sought to know from members whether there was an appetite to take stock of relevant developments with outside stakeholders, such as international organizations, civil society, and academia, particularly on how to go about addressing paragraph eight of the MC12 Ministerial Decision on the TRIPS Agreement. She said that delegations were generally supportive of this idea with a view to gathering inputs and sharing experiences. The chair, who is expected to convene a regular TRIPS Council meeting on 14 June, is expected to come up with a clear report on the way forward on several issues such as pandemic preparedness and on TRIPS non-violation and situation complaints, two issues that were discussed at the informal meeting on 8 June. As per the MC12 Ministerial Decision on TRIPS non-violation and situation complaints (WT/MIN(22)/26), trade ministers “took note of the work done by the Council for Trade-Related Aspects of Intellectual Property Rights pursuant to the General Council Decision of 10 December 2019 on “TRIPS Non-Violation and Situation Complaints” (WT/L/1080), and direct it to continue its examination of the scope and modalities for complaints of the types provided for under subparagraphs 1(b) and 1( c) of Article XXIII of GATT 1994 and make recommendations to the 13th Ministerial Conference. It is agreed that, in the meantime, Members will not initiate such complaints under the TRIPS Agreement.” Trade ministers also issued a rather long declaration (WT/MIN(22)/31) on the WTO’s response to the COVID-19 pandemic and preparedness for future pandemics. Some of the important elements of the declaration are:
Ambassador Pitfield seems to have suggested that if members want a thematic session, it could be potentially organized to address other relevant issues. She noted that members already have a way to discuss the extension of the MC12 Ministerial Decision on the TRIPS Agreement, but also have a mandate to examine and have a broader exchange of IP-related experiences on COVID-19 to better prepare for future pandemics. +
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