Pandemic Treaty Opponents Have Bought Time Till a Special Session of WHA in Nov, Supporters Manage to Keep Pressure On

Newsletter Edition #59 [The Weekly Primer]

May 25, 2021

Hi,

We are in The Big Week in Geneva - a World Health Assembly that is being seen as one of the most decisive ever.

Our quick update from the on-going World Health Assembly: pandemic treaty talks will now have more time to evolve including discussions within a open-ended working group that will assess the need for an international instrument.

We try and live-tweet key events as they unfold. If you are on twitter, follow @filesgeneva or my personal-is-political handle @pretpat.

Last week we reported that the push back on the speed towards a pandemic treaty shows that multilateralism is alive and well. We are hardcore realists, but it is important to take note of any signs of egalitarian decision-making in global health at a time when inequities find mention in every speechwriter’s text.

Sharing our exclusive story from last week: Spanner in the works for a pandemic treaty: The U.S., Brazil & Russia Converge to Oppose EU plans at WHO, Discussions Continue. Sign up to read!

We also have other updates from you from a fast-moving scene in Geneva including the revised TRIPS waiver proposal and how it is being received.

Finally, may we request you to spread the word around for us: we are open for our first summer internship - an opportunity for those interested, to work with a contemporary, small newsroom to get a glimpse into critical global health reporting and an exciting initiative in media entrepreneurship in the making.

Until Friday!

Best,

Priti

Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva

I. POLICY UPDATES

Pandemic Treaty Talks: Special Session in November to Assess The Need for International Instrument

Opponents to the Pandemic Treaty talks have made early gains on deferring commitments to launch negotiations immediately. After several rounds of wrangling on the decision-text into early hours of Saturday last week, WHO member states have now reached consensus.

It is now proposed that the discussions for “an international instrument” will formally be addressed at a special session of the World Health Assembly in November 2021, where countries will decide on the need to establish an inter-governmental process to draft and negotiate a potential treaty (or other international instruments).

The suggested decision text with a operational paragraph now reads:

“to request the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies to prioritize the assessment of the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response and to provide a report to be considered at the special session of the Health Assembly referred to in paragraph OP1.2 of this decision.”

The open-ended working group established through the WHO Strengthening resolution (OP1), will assess the process towards a relevant international instrument and present a report at the intended special session, sources said. “The working group set up under this preparedness resolution now has an additional mandate to examine the benefits of a treaty,” a diplomatic source told Geneva Health Files.

Geneva-based sources who witnessed the discussions told us, that the agreed decision-text on the pandemic treaty has to an extent addressed concerns of the opponents while preserving the interests of the supporters of the treaty to maintain “urgency and political momentum”. Countries in the midst of the response to COVID-19 will now have more time. It is debatable whether this additional time is sufficient.

The draft decision is now proposed by Albania, Australia, Azerbaijan, Canada, Chile, Costa Rica, Dominican Republic, Egypt, Fiji, Georgia, Iceland, Indonesia, Kenya, Montenegro, Norway, Paraguay, Philippines, Qatar, Republic of Korea, Republic of Moldova, Rwanda, Senegal, South Africa, Sudan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay and Member States of the European Union.

The agreed-text hard won by the opponents, was submitted to the WHO secretariat at the beginning of the Assembly on May 24th. It was published on the WHO website a few hours ago when this story went to print.

The decision-text also asks the DG WHO to:

“to convene a special session of the World Health Assembly in November 2021, and to include on the agenda of the special session only one item dedicated to considering the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response with a view towards the establishment of an intergovernmental process to draft and negotiate such convention, agreement or other international instrument on pandemic preparedness and response, taking into account the report of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies referred to in paragraph OP1.1”

It is understood that the US was not comfortable to any references on the mention of “legally-binding instruments.” Any international obligation has to be ratified by the legislature, as a result it is possible that the US likely remain only a signatory without ratification for any such treaty, sources said.

It is also understood that some EU member states were of the view that any potential treaty should have a mandate approved by the World Health Assembly. They were keen on anchoring the discussions towards a potential treaty within the governance mechanisms of WHO to send a strong signal on the political commitment of member states to work on ways to prevent the next pandemic. “It did not make sense to locate these discussions outside of the WHO,” a source said.

In the event, the decision text on the Pandemic Treaty and the Resolution on Strengthening WHO Preparedness and Response to Health Emergencies are adopted at this on-going Assembly, the Working Group will meet ahead of September 2021 according to sources. Countries believe that the adoption of these decisions look very likely at this Assembly.

It will then mean, that a report will be submitted to the Special Session in November assessing the benefits of developing a WHO convention, agreement or other international instrument. As per current discussions, countries will then decide at the special session on whether an intergovernmental process to draft and negotiate an international instrument is necessary. (Countries debated at length on the nature of an international instrument, sources said.)

Supporters of the treaty fought back on a proposal to have a “high-level ministerial meeting” and pushed instead the need for discussions around an international instrument. Despite the additional headroom that opponents to the treaty have won, this is being perceived as a major success by the proponents for a treaty.

The negotiated text also requests the Executive Board to determine the conduct of such Special Session of the World Health Assembly in accordance with the Rules of Procedure, during 29 November 2021 to 1 December 2021 at WHO headquarters.

Later today, it is expected that South Africa on behalf of the proponents of the treaty will make a joint statement at the Assembly during the discussion on emergencies, sources told us. (“74th World Health Assembly Item 17 Public health emergencies: preparedness and response Joint Statement on the way towards a WHO convention, agreement or other international instrument on pandemic preparedness and response”)

The momentum towards a pandemic treaty has also been contributed by the slew of review reports including by the IOAC, the IHR Review Committee and the IPPPR. “The threshold for a legally binding treaty has been set high by these various reports. It will be difficult for member states to settle for anything less,” a delegate from a developed country said.

Image Credit: Photo by Todd Trapani from Pexels

ACT Accelerator: “a new pillar in the international system”

In his remarks at the opening of the 74th World Health Assembly, DG Tedros said, “We are already building on lessons from the WHO-hosted ACT Accelerator which will need to be a pillar of the new international system.” Yet another clear admission that this multistakeholder model for pandemic policy response is here to stay.

On the need for a Pandemic Treaty he said:

“The proposed Framework Convention on Pandemic Preparedness and Response can support international solidarity and sharing data, information and resources.
We cannot build a safer world from the top down; we must build from the ground up. Preparing for, preventing, detecting and responding rapidly to epidemics doesn’t start in the world’s corridors of power. It starts in the streets of deprivation and overcrowding where people live without enough food, access to health workers, clean water and electricity.
The ACT Accelerator, the pilot Universal Health and Preparedness Review programme, and plans for the WHO Hub for Pandemic and Epidemic Intelligence in Berlin, the WHO Academy, and the WHO BioHub in Switzerland are examples of the platforms needed to fill gaps.”
DG Tedros at WHA 74

But as we have noted earlier, many member states have seen these discussions for a treaty as very much a “top-down” process forged among a small group of actors, let alone from “the streets of deprivation”.

The push for a Pandemic Treaty continues

Experts continue to add their weight to the on-going discussions on the pandemic treaty, although some member states have expressed reservations towards such negotiations. In this recent paper, global health governance experts elucidate on the link between the International Health Regulations and the proposed treaty: “In our view, the principal aim of a pandemic treaty should be to go beyond, rather than merely facilitate the application of IHR.”

Meanwhile, industry is also keenly watching and tracking these discussions. A recent statement from IFPMA said,

“The pandemic has underscored the importance of sharing of pathogens and their genetic sequence, for instance, through platforms such as GISAID[2]. The unprecedented speed in developing new vaccines and medical countermeasures against COVID-19 has only been possible due to the sequence of SARS-CoV-2 being made available in an extremely fast fashion and to everyone who wished to perform research and to track the evolution of viral variants. Only through timely and comprehensive pathogen sharing can we ensure that vaccines and medicines are well-matched to circulating strains or variants, have the highest possible effectiveness, and are rapidly manufactured and supplied. “As we have learned from COVID-19, pathogens know no borders. To fight infectious diseases we need to ensure cooperation and universal commitment to an open-source data and pathogen sharing system. The evolution of the virus is a stark reminder that continued innovation is key. Biopharmaceutical companies are working on booster shots to tackle the threat of emerging variants”, said Thomas Cueni.
COVID-19 has focused minds on being ready for the next pandemic. Industry has been engaged in pandemic preparedness, particularly for influenza and antimicrobial resistance, and therefore appreciates the complexities of making sure that discussions on pandemic preparedness reflect the need to cover this ground and further incentivise and harness medical innovation to ensure we are better equipped to fight future pandemics.”
IFPMA

In this context the industry had also urged “governments to guarantee unhindered access to pathogens (e.g. samples and sequences) of any COVID-19 variants to support the development of new vaccine and treatments.”

Diabetes Resolution Promoting Insulin Access Gathers Support at World Health Assembly: Health Policy Watch

Reducing the burden of noncommunicable diseases through strengthening prevention and control of diabetes: WHA A74/A/CONF./5

Three companies — Novo Nordisk, Sanofi, and Eli Lilly — control more than 90% of the global insulin market – a monopoly that leads to unaffordable prices for diabetics in many countries – including even some in high-income countries. The remaining share of the global insulin market is split among approximately seven other insulin manufacturers.
MSF has said that insulin often is not available in public health facilities or private pharmacies in many of the 70 countries worldwide, in which the organisation is active.
To make matters worse, in April 2020, at the peak of the first wave of the COVID-19 pandemic, several countries in Europe also banned the export of insulin fearing that lockdowns would lead to increased insulin demand and shortages, and also possibly disrupting supply chains in other areas.
Health Policy Watch

TRIPS Waiver revised proposal:

The revised text submitted by co-sponsors of the TRIPS Waiver proposal was published by Knowledge Ecology International, late last week. (See original proposal here.)

It essentially spells out specifics categories of products for which the waiver could potentially be applicable on including “health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.” It also suggests that a waiver should be in force for a duration of three years, the WTO General Council governing on its extension or termination.

In an explanation on the rationale, co-sponsors say:

“The preambular text has been revised to reflect the concern of continuous mutations and the emergence of new variants and consequently the many unknowns with respect to SARS-COV-2 and its variants and the global need for access as well as the importance of diversifying production and supply…
The operative paragraph (1) has been revised to add specificity to the decision text following concern that the original decision text was too broad. Hence the revised text addresses this concern by focusing the text on "health products and technologies" as the prevention, treatment or containment of COVID-19 involves a range of products and technologies and intellectual property issues may arise with respect to the products and technologies, their materials or components, as well as their methods and means of manufacture…
…The revised text also adds a paragraph on the proposed duration. The international community is dealing with a novel pathogen, with many uncertainties. For instance, investigation is still underway for effective therapeutics, and there are still many unknowns with respect to vaccines which will have a bearing on the scale manufacturing and supply that will be needed to control the pandemic such as the duration of immunity conferred, effectiveness of vaccines against new variants, and the effect of vaccines on children. In addition, the duration has to be practical for manufacturing to be feasible and viable. These complexities suggest the need for a practical and flexible duration. Hence it is proposed that the General Council assesses the existence of the exceptional circumstances justifying the waiver after a minimum period to determine the date of termination. The proposed language is based on Article IX (4) of the WTO Agreement…”

Some critics feel that the revised text is not conducive to quick negotiations and continues to be broad. Also see this related blog on why Peter Ungphakorn is of the view: “Voting in the WTO? It won’t happen”.

Also see: Commission set to propose alternatives to COVID vaccine IP waiver

WHO and Switzerland launch global BioHub for pathogen storage, sharing and analysis: WHO press statement

Worryingly this announcement from WHO has no word on how countries sharing pathogen information will have access to “benefits”. See excerpts:
“Currently, most pathogen sharing is done bilaterally between countries and on an ad hoc basis, which can be slow, and leave some countries without access to the benefits and tools. The BioHub will enable Member States to share biological materials with and via the BioHub under pre-agreed conditions, including biosafety, biosecurity, and other applicable regulations. This will ensure timeliness and predictability in response activities…
…In parallel, WHO will broaden its BioHub System for the use of biological materials by qualified entities – such as manufacturers – for the development of medical by-products for fair allocation to countries. WHO is currently running a pilot phase, using SARS-COV-2 and its variants, to test the feasibility and operational arrangements for sharing such materials with the facilities of the BioHub System.”
WHO

NEWS:

How the Covid pandemic ends: Scientists look to the past to see the future: Stat News
“…How did those pandemics end? The viruses didn’t go away; a descendent of the Spanish flu virus, the modern H1N1, circulates to this day, as does H3N2. Humans didn’t develop herd immunity to them, either. That’s a phenomenon by which a pathogen stops spreading because so many people are protected against it, because they’ve already been infected or vaccinated.
Instead, the viruses that caused these pandemics underwent a transition. Or more to the point, we did. Our immune systems learned enough about them to fend off the deadliest manifestations of infection, at least most of the time. Humans and viruses reached an immunological détente. Instead of causing tsunamis of devastating illness, over time the viruses came to trigger small surges of milder illness. Pandemic flu became seasonal flu.
The viruses became endemic.”
Stat News
What Happens When the Vaccine Factory of the World Can’t Deliver? New York Times
Worth a read.
“Afghanistan, Bangladesh, the Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Mozambique, Myanmar, Nigeria, Pakistan and Uganda were to receive the largest allocations of Indian-made Covax vaccines during the first half of 2021. Who knows now when vaccines will come to those countries.
Why has the production of vaccines become so heavily concentrated in India? Two reasons, historically: the country’s technical capacity and comparatively low overhead manufacturing costs. But those advantages have now been overtaken by starker realities. The world’s vaccine supply chain needs to be rethought.
First, we need to develop a way to map global vaccine-manufacturing capacity rigorously, routinely and transparently.”
New York Times
This Is the Wrong Way to Distribute Badly Needed Vaccines: New York Times
A problematic point of view on how vaccines should be distributed. Also, blaming WHO alone for the failure of COVAX is unfair and unhelpful.
The WHO Assembly Has a New Pandemic Treaty Proposal. India Should Be Wary: The Wire
An opinion on why India must oppose a pandemic treaty.
“…Perceived deficiencies in the existing response to COVID-19 pandemic don’t exist in the absence of law – but due to its poor implementation. According to the IOAC and IRC reports, they aren’t implemented properly because of structural problems and lack of resources, at both the member-states and the WHO levels. The IPPPR report also identifies social and economic inequities both within and between nation states as the principal aggravating factors for COVID-19. As a result, the obligations specified in the IHR haven’t been executed properly.
….In fact, adopting interpretative texts, rules, guidelines or amendments to IHR 2005, under Article 21 of the WHO Constitution, can all help make the application of the aforementioned provisions more certain. Such adoptions can also alter the regulations’ voluntary nature by articulating the “differentiated but shared responsibilities” of high-, middle- and low-income states during a public health emergency.
Another advantage is that an instrument based on IHR 2005 can enter into force faster, and can be binding through Article 21….”
The Wire
Drug Industry Money Quietly Backs Media Voices Against Sharing Vaccine Patents: The Intercept
“Across newspapers, online outlets, and broadcast media, prominent experts and organizations backed by the pharmaceutical industry are weighing in against the global push to temporarily waive enforcement of certain patent and intellectual property rights on vaccines and other pandemic-fighting technologies..”
The Intercept
The Fall of the House of Gates? The Nation
“Even as the pandemic took off, the Gates Foundation’s media presence and political influence seemed to far outstrip its actual philanthropy. As of today’s writing, the Gates Foundation reports only $1.75 billion in charitable grants for the pandemic.”
The Nation
India and Pfizer at Impasse Over COVID Vaccine Indemnity Demand: Reuters
AstraZeneca chief says ‘vaccine has a future’ after setbacks: Financial Times
What next for a COVID-19 intellectual property waiver? The Lancet
Can the European Union’s plans for the WTO withstand reality? Borderlex
The EU at the WTO. A good overview of the trade policy issues and how these must be read together.
How Much Vaccine Will Be Produced This Year? Global Trade Alert
How Humanity Gave Itself an Extra Life: The New York Times Magazine
“Between 1920 and 2020, the average human life span doubled. How did we do it? Science mattered — but so did activism.”

FROM THE JOURNALS/REPORTS

The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic: LSE Legal Studies Working Paper (forthcoming, 2021)
What Norway Should Ask Of The Pharmaceutical Industry In The Covid-19 Pandemic - Centre for Development and the Environment, University of Oslo
Authors suggest:
“We call on Norway to conduct a public review of CEPI, COVAX and EU contracts for Covid-19 tools to assess whether the terms of the contracts adequately take into account public subsidies for R&D and corporate risk reduction (through APAs).
With the WHO, establish a global price and access policy observatory that publishes pricing information on Covid19 tools and companies’ access policies…”
….Make disbursements of Norwegian funding to CEPI, GAVI, COVAX and ACTA conditional on supported companies’ transparency about scientific data, R&D and manufacturing costs, and access policies..”

IV. THE WEEK IN TWEETS

Sanjoy Bhattacharya, Head at WHO Collaborating Centre for Global Health Histories raises a relevant question:

Geneva Health Files