Special: Pandemic Agreement Round-up as INB 11 Concludes
Here's what happened and what didn't.
Dear Friend of Global Health Conversations,
On Friday afternoon, INB 11 concluded, rounding up the 11th session of negotiations on the Pandemic Accord in this process that begun in 2022 following the 2021 WHA proposal that followed the COVID-19 pandemic. Never again: This is the sentiment that initiated this historic process. This fortnight is a special edition of the GHC newsletter.
Fast forward to the end of the current session of negotiations on Friday afternoon. WHO DG, Dr Tedros Adhanom Ghebreyesus gave a closing speech. He talked about the progress made over the fortnight, acknowledging that the sentiment from the delegates and the Bureau was that despite valuable progress being made, it was less progress than had been hoped for at this stage. Further, he mentioned his absence at the start of the negotiations as he was in Sudan and Chad. Movingly, he highlighted the plight of the Sudanese people in this conflict, the outsized effect of conflicts on women and children, describing violence against women as ‘very very serious’; the low media coverage of the situation and finally, solemnly urged delegates to use their influence to mobilise support. This following the call to action (video) two weeks prior.
But first - some background. The COVID-19 pandemic revealed significant gaps in global infrastructure for pandemic prevention, preparedness and response. Global supply chains and systems to ensure access to appropriate medical countermeasures in the event of a pandemic or a PHEIC; and stirking inequities in access; even for buyers offering above market rate for MCMs. A situation that should not be repeated. In May 2024, IHR amendments were agreed. But the Pandemic Accord is still pending finalisation. This special edition details the progress made therein.
Finally, I briefly address the fear and propaganda in certain media at the end of the breakdown. I would never dignify or amplify any of it by sharing it here, but I tend to read everything. While there is space for disagreement, always; I have to say that some media has veered so far from fact as to have virtually no relation to it. Worryingly so. Most readers of this publication are likely not connected to that grapevine. But some are. I have deliberately stuck to pure fact below about what discussions have taken place. The agreement has very little to do with forcing anyone to receive vaccinations that they are ideologically opposed to. And everything to do with assuring sufficient R&D, ensuring supply chains and assuring access to vital medical countermeasures such as medical oxygen, therapeutics, diagnostics and vaccines for those who need them, globally. Here is a recent version of the Agreement from this week.
For further background, I discussed The Pandemic Accord & PABS in this end of May deep-dive edition of Global Health Conversations.
And until next week,
Stay warm,
Christiana
INB 11 Updates: 9–20 September 2024
Key discussions during INB 11 negotiations on the Pandemic Agreement focused largely on Articles 4, 5, 9, 10, 12, 13, 13bis, and 14. Outside of the primary meetings, there were informal sessions and discussions; as well as non-papers developed by different delegates on specific subject areas based on proposals.
I have distilled my notes from the fortnight below in brief by Article. The way it works is that the parts left in white are not agreed. The parts in yellow are agreed in principle but have not reached consensus. The parts in green are fully accepted by all parties. Again, please find the agreement here.
Article 12: Pathogen Access and Benefit Sharing (PABS)
Discussions focused on traceability and accountability within the system and potential overlaps, alongside monetary and non-monetary contributions; wherein, despite significant compromises, consensus was ultimately not reached.
Initially proposed for inclusion early in the year by the Africa group, PABS is an essential part of the Agreement and over the past months, it may be the area that has drawn the most energy in negotiations. At the end of the fortnight, some important and fundamental areas of Article 12 are in green. While there are still areas of contention within the text, progress was made this fortnight.
‘…including the consideration of a traceability mechanism.’
Many delegates, including the Equity Group strongly supported the inclusion of a traceability mechanism to ensure transparency in tracking biological samples. It was argued that without it, some countries may opt out of the Pandemic Access and Benefit Sharing (PABS) system. While more delegates were in favour of this language than not; there were strong concerns opposing this and proposed compromises in language. Ultimately, no agreement was reached on this point.
There were other points of contention within PABS with proposed rewordings. Nevertheless, good progress was made. And there is a good foundation to build on for the upcoming informals and INB 12 or beyond.
Articles 4 & 5: Pandemic prevention & surveillance and One Health approach for Pandemic Prevention, Preparedness and Response
The One-Health instrument, as it was originally proposed within Article 5 was moved for consideration to Article 4 which focusses on prevention - reworking the instrument into an integrated one-health approach embedded within existing prevention for pandemics and PHEICs as part of disease surveillance. Disagreement in this area was not focussed on whether or not a one-health approach is beneficial, but rather on some of the legally binding elements of the proposal.
Experts and member states emphasized the need for clarity in the functional definition of One Health and operationalization, as well as the role of communities, and support for countries to improve surveillance and prevention. It was highlighted by some delegates, that many aspects of disease prevention and surveillance are not currently encapsulated in a legally binding agreement - such as those relating to water and sanitation.
As such, many of these are yet unagreed, with parts agreed in principle and marked for further discussion. Especially on operationalizing One Health, including through a separate instrument on prevention.
Article 10: Sustainable and geographically diversified local production
Agreed ad referendum. Basically everything agreed and in green but one or two terms remain in white, pending further discussion
Article 11: Technology transfer
The major debate centred around the level of commitment and nature of technology transfer: the word “voluntary” and the legal wording around who technology will be transferred to - institutions, producers, manufacturers, be they publicly funded institutions and considerations around those, partially public funded or otherwise.
In my opinion, there will be much further discussion, if not omissions / additions, before this article is agreed.
Article 13 & 13bis: Supply chain & Logistics and Procurement & Distribution
Remains pending discussion on ‘unhindered’ (or the alternative proposed this fortnight by a delegation - ‘unimpeded’) and emergency trade measures.
Access to Pandemic Health Products
Several delegates including the Africa group emphasized the need for the inclusion of ‘unhindered’ as an adjective for ‘access’ to medical products during pandemics to ensure equitable distribution. Other parties opposed this definitive wording, proposing alternatives. Ultimately, no consensus was agreed on this inclusion. The rest of paragraph 2 was agreed.
Equity and Liability Provisions
Discussions on Article 13bis focused on vaccine equity and liability during pandemics. A no-fault compensation mechanism was proposed to ensure vaccine supply, but several delegations opposed it. Some citing experiences from the COVID-19 pandemic that still looms large. The debate reflected broader concerns about balancing equity and financial mechanisms for pandemic response; particularly in ways that could both ensure access and be feasible for manufacturers and industry.
Article 9: R&D
References to ‘open science’ were not agreed and garnered further discussion into the second week. The participation of ‘relevant’ stakeholders and issues around public-funded research remained contested and were not agreed at the end of the session. Nevertheless, significant progress was made towards a resolution:
Licensing & Sub-licensing and Public-Private Partnerships
There was broad support for maintaining public-private partnerships, but opinions differed on licensing provisions. The terms ‘voluntary and mutually agreed,’ were proposed and most parties were firmly in support of voluntary licensing in some way. It was also proposed to include the term PHEIC in the relevant portion of the text.
Transparency in Clinical Trials
There was strong support for clinical trial transparency and the appropriate language gained consensus after refinements of the text. This area will be revisited.
Comparator Products in Clinical Trials
Notable disagreement arose over the inclusion of ‘comparator’ products. One delegation strongly objected, deeming the term wholly inappropriate; while others supported its inclusion for evaluating pandemic treatments. Others called for greater inclusivity on the whole for including the term ‘communities’ with regard to clinical trial inclusion. Generally, however, movements towards greater inclusivity in clinical trials and appropriate representation were not agreed. WHO Experts were consulted and this area will be revisited before finalisation. It is important to remember that this Agreement stands as a legally binding international document; and as such, great consideration is taken by all parties to ensure that what is agreed to is feasible.
Article 14:
Focus on WHO processes for EUL and pre-qualification. Regulatory decisions, what should be published and included in dossiers to or from regulators - or excluded - within a reliance mechanism under the agreement. It was a particularly interesting and spirited discussion. A great deal of goodwill from all. On the whole, it was accepted that the outlined forms of information sharing are important to a reliance system and could be included in some way; but the wording was ultimately not concluded.
Next Steps:
The Bureau outlined the intersessional work planned. Informal discussions with Member States aimed at building consensus on important issues will continue through October. Member States reiterated their dedication to reaching a robust pandemic agreement promptly. Incredible work was done by all, including the Bureau. Holding informal sessions, weekend meetings, lunch discussions, evening ones and producing non-papers in-between. It is fair to say that member states put in an incredible effort to persuade, negotiate and work towards the shared goal of reaching agreement for the benefit of the global community and global health. That said, all countries have varied situations. And if you have seen media reporting from those who have been advocating strongly against a Pandemic Accord, particularly those who seek to frame it as an effort by WHO to gain ‘control of liberties’; I can make the reassurance that the Articles and instruments contained within the Agreement are being discussed by member states - countries. All member states have shown their complete commitment to their populations and national interests; for the benefit of populations and with populations in mind. And all greened paragraphs become so through unanimous agreement. I feel that this agreement signifies hope and a more prepared world in the case of a future pandemic.
Global Health Conversations Podcast Past Episodes Relevant to this Issue 🎧
Episode 23: Mpox Update 18/08/2024
On August 14, 2024, WHO DG Dr Tedros Adhanom Ghebreyesus declared the Mpox outbreak a PHEIC, the second such declaration in two years. The Africa CDC declared Mpox a Public Health Emergency of Continental Security a day earlier.
Episode 22: Project 2025’s Impact on Healthcare, Women's Health and Regulation
We explore and discuss Project 2025's proposed policies, which could dramatically impact health, women’s health and safety. The plan includes lifetime caps on Medicaid, reducing coverage for millions, and increased out-of-pocket costs for Medicare recipients. It threatens reproductive rights and seeks to curtail the CDC's public health role, potentially weakening responses to health crises. Basically, an anti-epidemic preparedness vision and plan.
Episode 19: Drug Licensing and the Pandemic Accord
In this episode, we look at Colombia's recent move in issuing its first compulsory license. The country challenged ViiV Healthcare's monopoly on their patented drug, dolutegravir, an HIV therapeutic, in an attempt to open doors for affordable generic versions and thus improve accessibility & affordability.
Episode 9: How Medical Countermeasures are vital to Pandemic Preparedness within the context of Disease X
Focus on R&D. Medical countermeasures refer to the measures and products aimed at addressing the medical needs arising from infectious disease outbreaks. The COVID-19 pandemic underscored deficiencies and requirements in ensuring a swift, efficient, and equitable response to global infectious disease outbreaks, pandemics or diseases with pandemic potential; including the potential emergence of "Disease X."
Episode 13: Non Disease Related Causes of Death: Gender-Based-Violence, a public health issue
‘These are the ways in which women disproportionately die prematurely because of being women’. Throughout this episode, you will hear me use this phrase as I walk through the ways that gender based violence impacts the right to long and healthy life; as well as the real life stories of survivors told in their own words. Fortunate to have lived but with life long scars - physical and emotional.