EXCLUSIVE: WHO Medical Countermeasures Platform Takes Route from New York to Geneva [UNGA-PPR Text]
EXCLUSIVE: WHO Medical Countermeasures Platform Takes Route from New York to Geneva [UNGA-PPR Text]
Newsletter Edition #191 [News Flash]
Hi,
We understand that often policy-making happens in the context of inadequate information, even we do not have all the answers. But taking decisions where there is helpful evidence at hand is usually good use of history.
Devising a medical countermeasures platform for future health emergencies is a case in point.
It appears there is greater convergence between New York and Geneva processes on the discussions around Pandemic Preparedness and Response, than initially expected. While some diplomats worry that certain issues may be working at cross-purposes to Geneva negotiations, we will have to wait to see how these discussions will evolve.
Write to us with your thoughts. Thank you for reading.
If you find our work valuable, support us! Accountability journalism is tough and expensive. Help us in raising important questions and bringing closed door negotiations to light in a timely manner. Readers paying for our work helps us meet our costs.
We will likely not have a reported edition next week. I will be at a week-long course in global health law at the University of Geneva. We are making every effort to improve our understanding and our work to offer true value to our readers.
Until later!
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. STORY OF THE WEEK
WHO Medical Countermeasures Platform Takes Route from New York to Geneva [UNGA-PPR Text]
The Medical Countermeasures Platform that is being discussed by WHO and partners, has emerged clearly in the draft text of the Political Declaration on Pandemic Prevention, Preparedness and Response, for the United Nations General Assembly High-level Meeting in September 2023.
In the latest version of the text, dated June 20th, seen by Geneva Health Files, there have been several references to the medical countermeasures platform. Of course, this should not be surprising given that the idea for such a platform has steadily moved this year through WHO, the G7, the G20, the Johannesburg processes and now in New York.
The concern among countries continues to be the implications of having discussions on this, outside of the on-going negotiations at the Intergovernmental Negotiating Body and at the Working Group on the amendments to the International Health Regulations. Both of these two-track negotiations are discussions matters of ensuring access to medical countermeasures, research and development, supply chain and other issues that are also ostensibly being discussed in a proposed MCMs platform. (The UNGA-PPR text acknowledges both these processes.)
As we reported earlier, critics say that the platform as proposed now has several shortcomings including on matters of representation, inadequate consultations with countries, not effectively dealing with concerns on intellectual property, issues of vulnerability among groups among others.
The question is whether the discussions on this, in the context of the UNGA-PPR text, will address these concerns or will the New York process set the agenda for Geneva without tackling these pertinent issues.
This story looks at the references made to the MCMs platform in the current UNGA-PPR text, and the implications for negotiations in Geneva.
UNGA-PPR TEXT ON MCMs [June 20th Version]
The latest version of the draft text on the UNGA-PPR declaration has substantial amount of new language over the previous one expanding on the idea for a medical countermeasures platform, on technology transfers, on waivers among other aspects related to equitable access to medical products. (There is also new text on One Health and AMR.)
We are unable to share all the names of countries and their specific positions given the sensitivity around these discussions, but indicate the most prominent ones with respect to text around the countermeasures platform – the focus of this story. (The EU, Japan, the U.S., Bangladesh, among others)
PREAMBULAR PARAS
Some preambular paras have text on the reasons for inequities in vaccination rates ranging from export restrictions to diverse factors that affect access; there are also references to low confidence, demand and uptake, suggested by developed countries.
There is also text suggested by some developing countries acknowledging the role of intellectual property barriers for the production and distribution of medical products in low- and middle-income countries, that exacerbated inequities.
REFERENCES TO THE COUNTERMEASURES PLATFORM
Below we cite some language suggested by countries on the MCMs platform:
THE EU
“PP8bis. Acknowledge the importance of adequately funded multilateral response mechanisms for equitable effective pandemic response, particularly equitable delivery of and access to medical countermeasures, and in this regard stressing the urgency for the international community to establish, as soon as possible, a mechanism for a coordinated and powerful response in the event of future pandemics, focusing on the relevant functions, drawing on lessons learnt from and welcoming the efforts of the Access to COVID-19 Tools (ACT) Accelerator, including its COVAX Facility, and other initiatives, to speed up the development, production, manufacturing and equitable access to COVID-19 vaccines, therapeutics, diagnostics and essential supplies, to ensure that no one is left behind, while also welcoming the important work of the COVID-19 Vaccine Delivery Partnership (COVDP) to support vaccination in humanitarian settings, stressing that a countermeasures platform is crucial to foster equity and should be an integral part of a World Health Organization convention, agreement or other international instrument on pandemic prevention, preparedness and response; (Based on A/RES/76/257) [EU ADD]”
[Emphasis ours]
JAPAN
“PP12Bis. Recognizing the need to develop and strengthen a sustainable, equitable, effective, and efficient end-to-end medical countermeasures (MCMs) ecosystem from research and development, manufacturing, stockpiling, distribution to actual administration based on lessons from the Covid-19 pandemic, including the ACT-A Independent Evaluation and other relevant evaluations; (New language based on Final Report of BUILDING CONSENSUS FOR AN EQUITABLE AND SUSTAINABLE MEDICAL COUNTERMEASURES PLATFORM FOR THE NEXT PANDEMIC, Senior-Level Technical Meeting, Johannesburg, South Africa February 23rd-24th, 2023) [JPN ADD]”
BANGLADESH
“PP17bis. Acknowledge that present and future pandemics pose unprecedented challenges to humanity and to science, given the urgent need within 100 days of recognition of a pandemic pathogen, to develop safe and effective vaccines, while enabling equitable access to vaccines and other biologic countermeasures; and acknowledge the important role played by the scientific community, and the role of the private and public sector, in research and development of innovative medicines and their critical role in our common objective to protect present and future generations from pandemics. Commit to facilitate a One Health approach to discovery of new tools and other results to be gained through research and development, and sustainable and predictable financing during inter-pandemic periods, as well as ready-releasable surge financing to respond immediately to new outbreaks; (Based on A/RES/74/2, PP53) [BGD ADD]”
JAPAN
“PP17bis. Recognize that, delivery should be an integral part of efforts towards the formulation of an end-to-end MCM ecosystem encompassing the entire value chain from research and development to manufacturing and delivery, and that the planning of delivery should include everything from stockpiling to vaccination campaigns, telemedicine, and ensuring logistics for last-mile delivery services while considering compliance with the country's regulations ; (New language based on Final Report of BUILDING CONSENSUS FOR AN EQUITABLE AND SUSTAINABLE MEDICAL COUNTERMEASURES PLATFORM FOR THE NEXT PANDEMIC,Senior-Level Technical Meeting, Johannesburg, South Africa February 23rd-24th, 2023) [JPN ADD]”
OPERATIONAL PARAS
The new additions of text to the operational paras on equity go into substantial detail on the speed with medical products such as diagnostics, vaccine sand therapeutics should be made available, while referring variously to “an interim adaptable, agile, sustainable, inclusive, equitable, effective, efficient and accountable” multistakeholder coordination effort.
Countries such as Bangladesh and Africa Group have also suggested language that links issues of transparency, R&D, pricing around medical products emphasising affordability in LMICs and LDCs.
There is also emphasis on local and regional production in LMICs albeit “voluntary technology transfer on mutually agreed terms, cooperation with, support to and the development of voluntary patent pools and other voluntary initiatives, such as the World Health Organization COVID-19 Technology Access Pool and the Medicines Patent Pool, and promoting generic competition in line with the World Health Organization road map for access to medicines, vaccines and other health products, 2019–2023” as suggested by the U.S. [OP2alt]
Specifically, on the MCMs Platform:
NORWAY
“OP2bis. Further ensure an adaptable, agile, sustainable, inclusive, equitable, effective, efficient and accountable multi-stakeholder coordination mechanism for pandemic-related medical countermeasures, to be adapted as relevant following discussions of the Intergovernmental Negotiating Body and the Working Group on Amendments to the International Health Regulations, which is agile and ready when pandemic emergencies hit and have limited essential operational coordination capacity in inter-pandemic periods, and call on the WHO to host such a mechanism; [NOR ADD]”
THE EU
“OP2bis. Stress that a countermeasures platform is crucial to foster equity and should be anchored in the pandemic agreement, and [call for the swift]/[welcome the] introduction of an interim coordination mechanism for medical countermeasures which further builds on the ACT-A partnership model and its resources to cover other pandemic threats beyond COVID and is agile, inclusive, and accountable in delivering the core relevant functions in both interpandemic and pandemic periods, with a scalable model based on lean and equally impactful operational arrangements which build on existing bodies and networks, and is in particular inclusive of LMICs, and that the interim mechanism will support and feed into the negotiations of a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (“WHO CA+”) which will be the legal underpinning for a permanent medical countermeasures platform, and will be adjusted to the outcomes of such negotiations; [EU ADD]”
JAPAN
“OP2bis. Call upon all stakeholders including Member States to cooperate to develop and strengthen an end-to-end global MCM ecosystem, guided by key principles including equity, inclusivity, efficiency, affordability, quality, accountability, agility and speed and in line with the ongoing discussions on the WHO CA+, addressing issues relating to manufacturing and delivery including through related existing initiatives such as MCM Delivery Partnership for Equitable Access (MCDP), taking into account the lessons learnt from ACT-A and its COVAX including the COVID-19 Vaccine Delivery Partnership (CoVDP); (New language) [JPN ADD]”
BANGLADESH
Bangladesh calls for a WHO-led coordination effort:
“OP11bis. Support a sustainable, and accountable multi-stakeholder coordination mechanism for medical countermeasures with limited operational coordination capacity in inter-pandemic periods that can be rapidly scaled for pandemic emergencies, guided by principles of equity, inclusivity, and quality and promoting country led decision making, led by the World Health Organization to leverage existing expertise and complement the global health architecture; (New language, Based on WHA A76/10, Strengthening WHO preparedness for and response to health emergencies: Strengthening the global architecture for health emergency) [BGD ADD]”
On waivers:
“OP13bis. Address the need for removing trade barriers, strengthening global and regional supply chains, and facilitating the movement of medical and public health goods, especially during pandemics and health emergencies among and within countries, including through appropriate waivers; [BGD ADD]”
“OP14bis. Reiterate the urgent need to foster innovation and to strengthen research and development of safe, effective, quality-assured and affordable medical countermeasures (MCMs). Commit to enhancing equitable access to MCM, including by ensuring that products are developed and distributed with an equity lens, with the end user in mind, and with characteristics, including affordability, acceptability, and ease of administration that facilitate their uptake and delivery; (Based on the 2023 G7 Hiroshima Communique) [BGD ADD]”
WILL THE PLATFORM RESULT IN A “TRANSFORMATIVE R&D AND MANUFACTURING ECOSYSTEM”?
Critics say that using approaches in enshrined in the ACT-A will not go far enough – if these same principles also dominate a new countermeasures platform.
They call for a “common good approach” instead of market-based approaches and recommend “a new end-to-end value proposition that prioritizes equity from the R&D stage and one that strengthens capacity to control outbreaks when and where they occur.” Regional hubs such as the WHO mRNA tech transfer program in South Africa is suggested as a model.
In a recent opinion piece in Devex on the MCMs platform, Fighting epidemics takes equitable medical countermeasures, Els Torreele, Joanne Liu, Michel Kazatchkine argue:
“While the transitional nature of this platform is being emphasized by its protagonists, who acknowledge the need to align with the future outcomes of the INB and IHR negotiations, there’s a risk that interim arrangements become the de-facto longer-term reality. Moreover, initial design choices typically weigh heavily in the contours of any future platform, leaving little room for transformative change.
…..Despite what some proclaim, ACT-A did not deliver on its ambitions and has fundamental design flaws that go beyond the lack of relevant representation. It is therefore surprising to see that WHO and partners are now rushing to set up another platform, with more or less the same stakeholders and largely following the same overall ideas.
These same ideas are: accelerating availability and equitable access of products that will be developed by the current R&D ecosystem, primarily focusing on improving supply lines, scaling up manufacturing capacity, and market shaping. These do not address the fundamental inequities in access to the means of innovation; i.e.: knowledge, including intellectual property, technological capacity, and affordable finance.
A new platform that is largely based on the same premises is unlikely to give different results. As we have argued before, to be effective, any future platform for MCMs must be rooted in equity from research to bedside —“end-to-end”—, have the freedom to operate to adapt existing technologies to emerging health threats to build local and regional resilience, and focus on tackling outbreaks when and where they occur as opposed to wait until there’s a pandemic to get activated.
…As political negotiations between WHO member states look for common ground on important issues related to access to knowledge and technologies, benefit sharing, and appropriate incentives and finance to ensure equity for future MCM development and availability, it is critical to uphold the ambition for a truly transformative R&D and manufacturing ecosystem. Essential design principles must be built into the newly created platform. And by no means should a rapidly established interim structure become the default fall-back position.”
Both the amendments to the IHR and the negotiations for a Pandemic Accord have text from WHO member states on R&D, transparency, procurement, supply chain, among others. It is unclear at this point, how such a platform will sit with potentially binding obligations on some of these issues.
Take one example - the industry has been a partner within the ACT-A (and a proposed MCMs platform), but is now opposed to issues such as rules of access to pathogens and benefit-sharing. The question for countries is how they will reconcile “partners” and binding obligations on key matters?
IMPLICATIONS FOR GENEVA
Sources familiar with the dynamics say, that WHO is keen on getting legitimacy for this initiative by getting the platform endorsed in New York first. (UNGA-PPR comes up in September 2023, and negotiations in Geneva are scheduled to finish by May 2024)
However, once a political declaration endorses such a mechanism, technical experts in Geneva, will have to work within this agreed UNGA-PPR text on MCMs in the current global health negotiations, diplomats in Geneva caution.
Recall that WHO member states have raised concerns on the platform, including most recently at the INB drafting group held last week (12th-16th June) in Geneva. Countries are at pains to arrive at a range of legally-binding rules to ensure equitable access for future emergencies.
Sources at WHO told us that Emergencies Chief Mike Ryan is now leading the discussions on the MCMs platform. (See Ryan’s comments at a side event during the World Health Assembly in May last month underscoring the importance of engaging with member states with respect to the MCMs platform.)
The MCMs platform is steadily becoming a reality whether or not countries fully understand its implications at this point in the wider global health negotiations.
This is reminiscent of the TRIPS waiver discussions last year in the run up to the WTO ministerial, when a few key countries engaged at the political level, leaving technical experts to do what was possible in a matter of weeks resulting in a huge compromise.
Fifa Rahman, CSO Representative for the Medical Countermeasures Prototype Working Group, who has been involved in the discussions around the platform, told us:
“We have a number of red lines on the MCM. Explicit working groups on vulnerability, gender, and equity is necessary. Secondly - IP and tech transfer affects access to countermeasures so intimately - the squeamishness around this in the MCM must be sorted and Member States too have to demand this. Thirdly one of the ACT-A failures was about poor co-creation and intellectual partnership with LMICs. We’d like to see this remedied through an MCP advisory group. The fact is countries haven’t been adequately engaged in co-creating the proposed model. We insulted their intelligence during COVID and we are teetering dangerously closely to doing it again.”
Also see:
Proposal for a Global Health Threats Council has Geneva debating: The Geneva Observer
From us on MCMs and the UNGA-PPR discussions:
A New Medical Countermeasures Platform for Equitable Access: Implications for On-Going Negotiations
UNGA's PPPR Zero Draft Defers to WHO
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"The definition of insanity is doing the same thing over and over and expecting. different results."
Many LMICs are not ensuthiastic about the MCM platform but northern countries are super ensuthiastic and pushing hard everywhere. After all, maintaining the current system enables pharma to maximise profit and rich countries to hoard doses to vaccinate/treat their citizens first rather than sharing doses with people of similar risk (e.g. health workers) in LMICs.