|
||
|
TWN
Info Service on Health Issues (Nov24/03) Geneva, 23 November (K M Gopakumar and Nithin Ramakrishnan) – The slow progress at the 12th round of negotiations forced the International Negotiation Body on the Pandemic Agreement (INB) to postpone its earlier plan to hold the Special Session of the World Health Assembly (WHA) in December 2024 to adopt the new instrument. The 77th WHA decision (WHA 77. 20) mandated continued negotiations till the 78th WHA in May 2025. However, it also provided for the convening of a Special Session to adopt the pandemic instrument in December 2024 if the negotiations could be concluded earlier. The decision states: “… to extend the mandate of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response to finish its work as soon as possible, and submit its outcome for consideration by the Seventy-eighth World Health Assembly in 2025, or earlier by a special session of the World Health Assembly if possible, in 2024 with only one agenda item dedicated to this outcome”. The INB decision was taken on 11 November after a stock-taking session on the 8th. AFP quotes co-chair Anne-Claire Amprou at a press conference on 11th November as follows: “Today member states agreed we need to conclude the agreement as soon as possible, and continue negotiations into 2025, with the goal of concluding the agreement by the next World Health Assembly scheduled in May. We are moving in the right direction ,..” The interim report of the INB12 adopted on 15 November reads: “Under agenda item 3 and regarding the determination of a process for the convening of a special session of the Health Assembly by the end of 2024, Member States acknowledged that additional time was required as there was insufficient progress and no convergence on convening such a Special Session. The overwhelming majority of Member States recognised the progress made and expressed heightened commitment and urgency to the finalisation, as soon as possible, of the work of the INB. In that regard, the INB will continue its work with the aim of fulfilling its mandate by the Seventy-eighth World Health Assembly in May 2025, in line with Decision WHA77(20). The INB agreed to resume its 12th meeting from 2 – 6 December 2024”. However, according to some delegates, efforts are still on to have an early conclusion of the negotiations to facilitate a Special Session of WHA immediately after the 156th Session of the WHA Executive Board, which would take place 3-11 February 2025. The progress in the upcoming round of negotiation (2-6 December) will determine the fate of such an effort. After the completion of the 9 days of negotiations during INB12, the chasm is clearly visible in the following critical areas. Consensus in these areas is critical for an early conclusion of the negotiations. Article 4: Prevention and Surveillance Article 4 of the negotiating text deals with the prevention and surveillance provisions. It imposes an obligation on Parties to place surveillance in 10 areas. These 10 areas are: prevention of the emergence and re-emergence of infectious diseases; coordinated multi-sectoral surveillance and risk assessment; early detection and control measures including at the community level; water, sanitation and hygiene; routine immunization; infection prevention and control; prevention of infectious disease transmission between animals and humans, including zoonotic disease spill-over; vector-borne disease surveillance and prevention; laboratory biological risk management; prevention of antimicrobial resistance. Further, Paragraph 3 of Article 4 proposes an annex detailing the prevention measures, taking into consideration a one health approach. The Bureau proposed a new Paragraph 4, which contains the non-exhaustive list of provisions of the proposed Annex, which reads: “The Annex referred to in paragraph 3 shall contain provisions regarding, inter alia, the following: (a) specific measures and operational dimensions that Parties shall consider including in their comprehensive multisectoral national pandemic prevention and surveillance plans, programs and/or actions, as appropriate, pursuant to sub-paragraphs 2 (a) through (j) of this article; (b) cooperation to implement the provisions of this article, in particular through technical assistance, capacity building, technology transfer and financing, and in support of global, regional and national initiatives aimed at preventing public health emergencies of international concern including pandemic emergencies, with particular consideration given to the specific needs and special circumstances of developing country parties; and (c) technical support to the Parties, as appropriate and upon request, in implementing the provisions of this article to be facilitated by WHO, in coordination with relevant intergovernmental organizations and stakeholders”. During the first week of INB12 most of the developing countries opposed this proposal to have an annex under Paragraph 3. The Africa Group and many other developing countries asked the Bureau and the European Union, which is the proponent of the instrument on “prevention”, to provide the detailed elements of the Annex. Instead of answering the query, most EU Member States stressed the importance of prevention measures in the pandemic instrument. However, the EU circulated a new document, which provides the template of the Annex. Paragraph 1 of the templates states: “Pursuant to Article 4, the Parties commit to develop, implement and periodically review policies, strategies, and measures in line with the One Health approach to progressively strengthen pandemic prevention and coordinated multisectoral surveillance, taking into account national capacities and national and regional circumstances, as well as obligations under the International Health Regulations”. Paragraph 2 seeks to impose obligations to cooperate especially “in support of relevant global, regional and national initiatives aimed at preventing pandemic emergencies, in particular those that improve surveillance, early warning and risk assessment; promote evidence-based actions, risk communication and community engagement; and identify and address settings and activities presenting a risk of emergence and re-emergence of pathogens with pandemic potential”. Paragraph 3 is a holder for the 10 areas of surveillance mentioned in Article 4. Paragraph 4 proposes obligations on the implementation of the Annex, including the following: “… take into account recommendations, guidelines and standards developed and adopted by WHO and other relevant intergovernmental organisations or bodies, including the Quadripartite organizations, in the development of relevant national and, where applicable, regional policies, strategies and measures to prevent pandemic emergencies”. TWN learnt that during the discussion on Article 4 on 14 November the Africa Group, China, India and Russia opposed the proposal to highlight the text in yellow and sought clarity on elements. [Highlighting the text in the negotiating draft with yellow indicates an initial convergence amongst the Member States, although there is no consensus.] Article 11: Transfer of Technology and Know-How Article 11 on Transfer of Technology and know-how is another provision which is highly contentious, even though a considerable part of the text is in green highlight, indicating initial agreement. All critical elements that ensure certainty or predictability of access to technologies for developing countries are pending without any form of convergence. Developed countries are not agreeing to the provision referring to the transfer of technology without the phrase “voluntary and mutually agreed terms” (VMAT), especially in clauses that call for mechanisms to actively share technology and know-how, such as Paragraph 5. The INB Bureau devised an ingenious definition for “transfer of technology” to avoid the phrase VMAT in such provisions, although it is not clear how this would resolve divergences between developed and developing countries. It just shifted the application of VMAT from one paragraph to another paragraph. As anticipated, the definition has not generated convergence. It reads as follows: “Transfer of Technology refers to a [consensual/voluntary and] collaborative process where technology required to manufacture a product is transferred successfully on mutually agreed terms. This understanding is without prejudice to and does not affect the measures that Parties may take in accordance with their domestic or national legislation, provided that these measures comply with their international obligations on intellectual property”. Paragraph 3 of Article 11 on time-bound measures for access to technology during pandemic emergencies, is also pending convergence. The new Bureau’s proposal is as follows: “3. ALT. the Parties shall support, as appropriate, time-bound measures by WHO [and other organizations] to accelerate or scale up the manufacturing of pandemic-related health products, to the extent necessary to increase the availability, accessibility and affordability of pandemic-related health products during pandemic emergencies”. Also, a clause to prevent pressure that discourages the use of TRIPS Flexibilities has not generated convergence in Paragraph 4: “… The Parties respect the use of these flexibilities that is consistent with the TRIPS Agreement [and shall not exercise any direct or indirect pressure [to that effect] [to discourage the use of such flexibilities]”. Article 12: Pathogen Access and Benefit Sharing (PABS) During INB12, two and a half days were spent on negotiations on Article 12 mainly focusing on benefit-sharing formulas and traceability. When the discussion resumed on Article 12 on 12 November exchanges on Paragraph 7 were based on the following new textual proposal from the Bureau: “Each participating manufacturer shall make available to WHO, pursuant to legally binding contracts signed with WHO, rapid access to 20% of their real-time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency, with flexibility, provided that a threshold of at least 10% of the mentioned production is made available to WHO free of charge and the remaining percentage to fulfil 20% commitment at affordable price or reserved for WHO”. This proposal can pave way for the decoupling of access to pathogens from the benefit sharing arising from uses thereof. The obligation to share benefits applies to those participating manufacturers who enter into a contract with WHO to share the benefits. This implies that the obligation to share benefits is not a pre-condition for accessing benefits. Further, the obligation on the manufacturers is to donate only 10 % of the real-time production, and another 10 % of these manufacturers have the choice of selling at an affordable price or reserving to sell to WHO at market price. This effectively means that the PABS system offers 10% of the pandemic-related products as benefit sharing. The discussion did not lead to any consensus. The second issue is related to the traceability. Paragraph 4 of the Bureau’s text states: “The PABS Instrument shall address the scope, feasibility and practicality of traceability, recognizing the distinctive practices in the use of PABS materials and of sequence information”. This does not guarantee the inclusion of traceability in the PABS system. Generally speaking, traceability refers to the methods or tools to deploy to trace the movements of pathogens or sequence information to facilitate compliance with the terms and conditions of the access agreement. Further, traceability could prevent the use of pathogens or sequence information for illegal activities such as bioterrorism. User registration, data access agreements and digital tagging of data are some of the common traceability tools. Developed countries especially the EU oppose traceability for sequence information within the PABS system. The discussion during the formal and informal meetings did not result in any agreement to resolve the issue. The text currently states as follows: “The development of a safe, accountable and transparent PABS System shall address the scope [and practicality] of traceability, taking into account the differences in the use of PABS Materials and Sequence Information”. Article 13 and 13bis: Supply Chain, Logistics, Procurement and Distribution Article 13 addresses issues relating to supply chain and logistics maintenance to ensure the supply of pandemic-related health products across countries and vulnerable populations. Article 13bis addresses procurement and distribution in particular pandemic-related products. Even though this text is mostly cleaned and greened, a couple of key issues are still contested. First, in Article 13, it is highly debated which word should be used to describe vulnerable populations, that receive pandemic-related health products – whether it should be “vulnerable persons” or “vulnerable people”. Developed countries, like Germany and the United States, want to stick to “persons” referring to vulnerability on an individual basis, while developing countries want to use both “persons” and “peoples” referring to vulnerability at the community level, consistent with public health rationale. Secondly, both in Article 13 and 13bis, there is a proposal for addressing liabilities arising from the injury caused by novel vaccines. This is highly contested, as developed countries see this clause as critical for the functioning of international supply chain networks to ensure vaccine supply, and developing countries consider this proposal an intrusion into national policy space and unprincipled, as the demand is to create a no-fault compensation mechanism to shift the burden from the private sector to governments. The clause can degenerate from being a compensation mechanism for victims to an impunity mechanism for Big Pharma. The contested paragraphs are as follows: Article 13.6: “[The GSCL Network may consider developing recommendations, for the consideration of the Conference of the Parties, [for a possible no-fault compensation mechanism] [multilateral mechanism for liability risk management] for novel pandemic vaccines allocated through the GSCL Network, with particular regard for persons in humanitarian settings.]” Article 13bis.8 ALT: “The Partis shall request WHO, working in full collaboration with relevant entities and multilateral organizations, as appropriate, to develop recommendations for, and support when needed, policies for managing liability related to novel pandemic vaccines during pandemic emergencies.” Article 20: Finance The discussion on finance is again stuck on two issues. First, there is a division about whether to create a financial mechanism or designate the Coordinating Financial Mechanism under the International Health Regulations (IHR) as a common mechanism for both instruments. Some of the Member States would like to maintain independence from IHR and proposed creating a new financial mechanism under the pandemic instrument. The apprehension among Member States who are opposing the creation of new financial mechanism under the pandemic instrument is the potential fragmentation of finance. The second issue is the proposal to provide a mandate to the Conference of Parties to the pandemic agreement to create a new fund. Paragraph 4 states: “The Conference of the Parties shall take appropriate measures to give effect to this Article, including the possibility of exploring, additional financial resources to support the implementation of this Agreement [through new or existing funds]”. Developed countries consistently take a position against the creation of a new fund to implement the pandemic agreement or IHR. Article 21: Governance The division on governance is related to the mechanisms to be in place for the monitoring of the implementation of the pandemic instrument. One proposal is to make use of the Implementation Committee to be established under the IHR for implementation monitoring as well as support. However, the Member States supporting the adoption of a pandemic instruments under Article 19 of the WHO Constitution, which includes the Africa Group, would not like to designate the IHR implementation Committee. They say that such a decision allows the IHR Implementation Committee, which would consist of all IHR members (196 Members), to undermine the independence of the pandemic instrument (which may not have the same parties depending on the legal nature to be finally decided). Another issue is Paragraph 6 of Article 21 dealing with financial regulation that states: “The Conference of the Parties shall apply the Financial Regulations and Rules of the World Health Organization. At each ordinary session, it shall adopt a budget for the financial period until the next ordinary session. The costs of the meetings of the Conference of the Parties and of any subsidiary bodies it may establish shall be borne by the States Parties and States not parties to this Agreement participating therein as observers, in accordance with the United Nations scale of assessment adjusted appropriately”. This proposal clearly shows that the implementation of the pandemic instrument will have its own budget and not be linked to the WHO regulatory budget. This again raises concerns about the fragmentation of financial resources. Trump’s cloud on INB The election of Donald Trump as US President has created speculation around the US walking out of the WHO and the INB process. This speculation around Trump’s approach to WHO is now effectively used by certain negotiators to push for quick conclusions of the pandemic instrument negotiations prior to Trump’s inauguration in January 2025. This push bears the danger of compromising on critical issues to facilitate equitable access and a transparent negotiating process. According to an observer, INB negotiations always used one reason or other to hasten negotiations which has resulted in the marginalization of the equity elements.+
|
||
