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Info Service on Health Issues (May24/07) WHO: Developing countries disagree with the indemnity proposals on vaccines and therapeutics Geneva 9 May (TWN) – Many developing countries disagree with the proposals to establish indemnity and no-fault compensation for pandemic-related vaccines and therapeutics during the resumed ninth session of the Intergovernmental Negotiating Body (INB) on the pandemic instrument. The resumed ninth session of the INB is taking place from 29 April to 10 May at the WHO Headquarters in Geneva in a hybrid mode. Proposals on compensation and liability management are referenced in Article 13 and 13bis of the draft negotiating text. Article 13.6 Article 13.6 of the draft negotiating text for the resumed session states: “A multilateral system for managing vaccine and therapeutic-related compensation and liability during pandemics shall be considered”. Article 13 deals with the supply chain and logistics and propose to establish a Global Supply Chain and Logistics Network (the Network) with the mandate of procuring and distributing pandemic-related health products under the equitable allocation plan as well as donations from countries. However, the proposed compensation and liability management clause is not clear from the paragraph as to who is to consider the establishment of such a multilateral system: whether it the Network or the Conference of Parties of the pandemic instrument that will consider the setting up of such a multilateral system. Further, the scope of the proposed mechanism is now covering not only vaccines but also therapeutics. As shown below the initial proposal was confined to vaccines and the new proposal is to cover therapeutics too. Another issue is on the source of financing for the compensation. The proposal is silent on this financing. Until the current resumed INB session the proposal under Article 13.6 was under a separate article and merged with Article 13 in the current negotiating text. The negotiating text considered during the 9th session proposed a no-fault compensation system at the global, regional and national level under Article 15. Article 15 .2 of the earlier text stated: “The Parties, within the framework of the Conference of the Parties, in collaboration with relevant entities and multilateral organizations, as appropriate, shall develop recommendations for the establishment and implementation of national, regional and/or global no-fault compensation mechanisms and strategies for managing liability during pandemic emergencies, including with regard to individuals that are in a humanitarian setting or vulnerable situations”. The INB Working Group discussions on 6 and 7 May have resulted in altering Article 13.6 as follows: “The GSCL Network [may consider developing] [shall develop DEL] recommendations, for the consideration of the Conference of the Parties, for a multilateral mechanism for [compensation and] liability risk management for novel pandemic vaccines [allocated through the GSCL Network], with particular regard for individuals in humanitarian settings. DEL]. (Brackets indicate differing options with “DEL” indicating deletion of the option concerned.) Various developing countries opposed the text. India proposed the deletion of the whole paragraph.
Article 13bis.6 Paragraph 6 of Article 13 bis of the draft negotiation text for the resumed 9th INB session reads: “Each Party shall endeavour to ensure that, in contracts for the supply or purchase of novel pandemic vaccines, buyer/recipient indemnity clauses, if any, are exceptionally provided and are time-bound”. It makes it an obligation to endeavour to ensure that liability indemnity clauses are provided for novel pandemic vaccines but can be interpreted as a nudge to make such indemnity clauses exceptional and time bound. Article 15.1 of the draft negotiating text considered during the 9th session had a broad scope. It stated as follows: “Each Party shall consider developing, as necessary and in accordance with applicable law, national strategies for managing liability in its territory related to pandemic vaccines and shall make such strategies publicly available. Strategies may include, inter alia, legal and administrative frameworks; no-fault compensation mechanisms, potentially funded by private sector contributions; policies and other approaches for the negotiation of procurement and/or donation agreements”. Here the scope of indemnity covers all pandemic vaccines. After the Working Group discussions, the proposed text is now modified as follows: [Each Party shall consider developing and making publicly available, as necessary and in accordance with applicable law, national strategies for managing liability, including indemnification clauses that are time-bound, in its territory related to novel pandemic vaccines.] However, the current text does not enjoy support and is thus entirely bracketed. Reason for the disagreement The COVID-19 Vaccines Global Access (COVAX) facility had introduced no-fault compensation for the COVID-19 vaccines. A UNICEF person involved in the COVAX vaccine procurement told TWN that UNICEF does not have a compensation or liability limiting mechanism for distributing the vaccine. This was followed during COVID-19 primarily due to the insistence of pharmaceutical companies like Pfizer that imposed additional conditions on the COVAX facility for the supply of the vaccines. A developing country delegate sitting through the negotiations to obtain Pfizer’s vaccine described the experience as highly humiliating. According to a report of the Bureau of Investigative Journalism “Pfizer has been accused of “bullying” Latin American governments in Covid vaccine negotiations and has asked some countries to put up sovereign assets, such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases”. TWN learned that India expressed its inability to accept the proposals on compensation and indemnity in the context of pandemic vaccines citing its national law. Further India also stated that manufacturers cannot run away from liability. The Working Group is to discuss the issue again on 9 May afternoon. Hectic negotiating schedule for 9 May Hectic negotiations are scheduled to iron out a deal on the pandemic instrument. The schedule circulated last night (8 May) shows 4 working group meetings till 5.30 pm on various articles and the drafting group will meet from 6 pm till late night on the pathogen access and benefit sharing instrument. The meeting schedule is as follows. 09:00 - 12:30: Working Group on Articles 9-10-11 and Working Group on Articles 32-35, 21-31, preamble, articles 1-3; 14:00 - 17:30: Working Group on articles 4-5-6-7, 17-18-19-20 and Working Group on Articles 13, 13bis, 14; 18:00 – till late: Working Group on Article 12.
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