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Info Service on Health Issues (May24/15) WHO: Rich countries refuse to share vaccines, medicines & diagnostics for health emergencies Geneva, 25 May (Sangeeta Shashikant) – Developed countries rejected proposals to meaningfully share vaccines, medicines, and diagnostics to prevent health emergencies, during discussions on the Pathogen Access and Benefit-Sharing (PABS System). This stance has not gone down well with developing countries, which had hoped for concrete deliverables on equity to deal with health emergencies in the WHO negotiations on a pandemic agreement. Rich countries’ persistent refusal to commit to provide certainty of access during health emergencies brought negotiations on the PABS system to an abrupt halt. Cautious optimism on concluding the Pandemic Agreement, turned into pessimism, according to sources involved in the negotiations. Some observers view this as a major setback for WHO. Ministers of Health will meet in Geneva for the 77th World Health Assembly (WHA) starting on Monday, 27 May 2024. There was an expectation that international solidarity would prevail to deliver a Pandemic Agreement that operationalizes equity. However, after weeks of long days and late nights, as rich countries continue to create obstacles to achieving equitable outcomes, hopes for a meaningful Pandemic Agreement by the WHA have been dashed. Refusal to Commit to Access during Public Health Emergencies of International Concern and Pandemics A key point of contention between developed and developing countries is the certainty of some supply of vaccines, therapeutics and diagnostics being available to affected developing countries during a public health emergency of international concern (PHEIC) and pandemics. For more than a year the Africa Group and the Group for Equity have called for at least 20% of real-time production to be made available to WHO for supply to countries with public health risk and need during a PHEIC as well as a pandemic. This proposal has faced persistent objection from developed countries. On Thursday (23 May), the Co-Chairs of the Intergovernmental Negotiating Body presented text in an attempt to bridge the divide between developed and developing countries. The text separated the demand for access during a PHEIC from access during pandemics. The Co-Chairs’ text proposed provision by manufacturers to WHO of 3%-10% of production of vaccines, therapeutics, and diagnostics needed during a PHEIC, on a free-of-charge basis or at not-for-profit prices. For a pandemic emergency, a manufacturer would provide between 5%-20% of production needed for pandemic response, on a free-of-charge basis or at not-for-profit prices, “recognizing that flexibility is important in negotiating in the above referenced range with all manufacturers”. These ranges would then become the basis of contractual negotiations between WHO and a manufacturer that intends to use the PABS system. If the starting point of a range is low, manufacturers are likely to agree to only provide a small percentage (lower end of the range) of production to WHO for distribution to affected countries. . According to various sources involved in the negotiations, the Co-Chairs’ text was very much influenced by the positions of developed countries especially the United States (US) which refused to specify minimum percentages for access. Namibia on behalf of the Africa Group and Egypt argued that the range proposed by the Co-chairs is too low and inadequate. It instead proposed a range of 10-15% for PHEIC. In support of its proposal, Namibia pointed to the repeated challenges of timely and affordable access during PHEIC, e.g. during outbreaks of Ebola and monkeypox. It argued that in June 2023, Gavi, the Vaccine Alliance had reported that despite promises made by wealthy countries, African nations are yet to receive any monkeypox vaccines. Many rich countries secured millions of doses and 20 million doses even expired without sharing them with other nations. Rich countries stockpiled vaccines, but developing countries that had a need for it had no access. Namibia on behalf of the Africa Group and Egypt further called for “at least 20%” for supply during pandemic emergencies. It argued that such an emergency was a rare occurrence; the next pandemic may happen after decades, but meanwhile many companies and developed countries will have benefitted from the use of the PABS system. So, it is not unreasonable to call for this minimum. The US and other developed countries argued that every PHEIC is different, that the issue needs further discussion and called for the matter of supply during PHEIC to be parked in future work on the development of the PABS system, a common negotiation tactic used to sideline the issue. For supply during a pandemic emergency, led by the US, the developed countries insisted on text that states “up to 20%”. However, for developing countries, the positions of developed countries were not acceptable. Several countries related their experience in suffering from inequitable access during a PHEIC. There was also concern that “up to 20%” also meant that a manufacturer will have the option to contribute 0%. China supported the call for greater access, arguing in favour of a “reasonable minimum percentage”, that is not lower than the PIP Framework range of 5-20%. Namibia also argued that if the range is 3-10% as proposed by the Co-Chairs and manufacturers agree to only provide 5% of production, this will limit the flexibility WHO will have to deal with a PHEIC, hence Namibia proposed a higher range for PHEIC. This will provide WHO more flexibility in terms of access to supplies for distribution to developing countries in need. In response to the US intervention that if the contribution of a manufacturer is too high, it will disincentivise a manufacturer from participating in the PABS System, Malaysia pointed to the need to encourage providers of biological materials and sequences, by ensuring reasonable benefit sharing.
Rich Countries Question Supplies for WHO Stockpiles According to sources, there was also significant discussion on advance release of the contribution to WHO, as developed nations questioned the proposal of the Central African Republic. On previous occasions the Central African Republic had proposed: “The Director-General (DG) of WHO may initiate advance release of these pandemic-related products to developing countries before PHEIC, to prevent outbreaks becoming PHEIC, in cases where concerned countries lack equitable access and/or for WHO stockpiles. Manufacturers shall comply with the DG’s request for advance release”. The Central African Republic sought to reintroduce the text as an element of the PABS system, leading the US and the European Union (EU) to question the viability of the proposal. A representative from the International Coordinating Group on Vaccine Provision (ICG) based in WHO clarified its role, including in projecting vaccine needs which does facilitate shaping of market and consequently production of vaccines, stressing the need for availability of vaccines throughout the year for the biggest impact, as well as flexibility. The representative also confirmed the central role of WHO in the ICG. [Note: The International Coordinating Group (ICG) on Vaccine Provision was established in 1997, following major outbreaks of meningitis in Africa, as a mechanism to manage and coordinate the provision of emergency vaccine supplies to countries during major outbreaks. WHO is the Secretariat of the ICG , and also focuses on vaccine stockpile management, preparedness and response to disease outbreaks.] Notably, a publication by Medecins Sans frontieres (MSF) on “ensuring access to new treatments for ebola virus disease” noted that due to price barriers and lack of supply there is little chance of a WHO stockpile, highlighting the importance of the Central African Republic’s proposal. It is learnt that South Africa also supported this demand and questioned its deletion from the Co-Chairs’ text. Voluntary Contracts According to sources, PABS discussions went further downhill when the United Kingdom (UK) insisted on introducing “voluntary” in the text. The insertion suggests that access to pathogen biological material and sequence information is not subject to the recipient (e.g. manufacturer) signing a legally binding contract that outlines terms of access as well as benefit sharing. Instead, the UK insisted on voluntary benefit sharing contracts. Other developed countries also supported the insertion. This move riled up developing countries, said a delegate. The access and benefit sharing system set up under the Convention on Biological Diversity (CBD) and the Nagoya Protocol on Access and Benefit Sharing does effectively mean linking access to biological materials and sequence information to fair and equitable benefit sharing, through legally binding contracts. Insistence by developed countries on benefit sharing contracts that are voluntarily signed by some manufacturers is inconsistent with the essence of the CBD and the Nagoya Protocol. Hence developing countries argued that the sharing of biological materials and sequence information should then also be voluntary, sources said, questioning the double standards shown by the developed countries after agreeing to treat access and benefit sharing on an equal footing. Indonesia inserted text suggesting that access to biological materials and sequence information should be based on prior informed consent and mutually agreed terms. Discussion on voluntary contracts as well as refusal by developed countries to converge and agree to provide meaningful benefit sharing, essentially ended the PABS discussions early and abruptly.
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