A pandemic treaty: reforming global health security; TRIPS Waiver update at WTO

Newsletter Edition #24

Hi,

After what seems like a long time, politics is uplifting democratic spirits everywhere.

This wave of optimism from Washington D.C. swept through W.H.O virtual board meeting, when the U.S. renewed its commitment to global health in the gentle glow of camaraderie. This is a shot in the arm for scientific collaboration and diplomacy in these challenging times. It also sets the stage for a contest on who will ultimately shape WHO in the post-pandemic world.

We bring you two different analyses this week to make sure you keep up with the important events unfolding in the Geneva Global Health Scene.

The first story is our reading of an action-filled, on-going, WHO Executive Board meeting - a veritable montage showcasing geopolitics and an emerging, yet defining agenda on global health security.

The second is a quick story on the TRIPS waiver talks at WTO this week. We hope to feature these issues every once in a while under our new section, The Trade & Health Update.

We hope you enjoy reading both.

See you next week.

Best,

Priti

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

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1. Story of the week

A PANDEMIC TREATY? OPENING THE DOOR TO THE REFORM OF GLOBAL HEALTH SECURITY

Health security and sustainable financing concern member states at WHO Board

For months experts and critics have been exhorting WHO and its member states to use the organization’s constitutional mandate specifically its treaty-making powers to deftly address the urgency of the pandemic.

Mostly critics want WHO to use its constitutional powers to quell the pandemic and to address the difficult issue of access to medicines, for example, given the glaring inequities in the access to vaccines during the current pandemic.

However, given the inexorable emphasis on global health security, it was perhaps not so surprising when DG Tedros Adhanom Ghebreyesus casually put the idea of a pandemic treaty to member states during the proceedings of the Executive Board meeting this week. And yet, it was surprising to even traditional WHO watchers.

Image credit: Photo by Iva Muškić from Pexels

He asked member states to work on a resolution to be tabled at the May 2021 World Health Assembly to find ways of working towards a pandemic treaty which he said is a “very good idea”. He said that such a treaty could give a political dimension to the International Health Regulations (2005). If such a treaty becomes a reality, it will only be second to the Framework Convention on Tobacco Control (FCTC) which was negotiated by member states in 2003.

The DG also revealed that this proposal was first suggested by Charles Michel, President of the European Council, the institution which sets the political direction for EU member states. Given the overall importance of the EU in the response to the pandemic, this nudge from the European Council is perhaps not unexpected. But what remains to be seen, is what this will mean for other member states for WHO.

Undoubtedly, this is a significant moment in the pandemic as the world witnesses financial shortfalls in funding the response on the back of a rapidly mutating virus which makes devising counter-measures challenging. However, it appears that by asking member states to negotiate a binding treaty on health security, the DG might have put the ball in the court of the countries, many of whom have not followed the recommendations of the IHR during COVID-19.

Nevertheless, it assumes importance in the context of a slew of reviews by several committees looking at the response to the pandemic including the Review Committee on the Functioning of the IHR (2005) and the Independent Panel on Pandemic Response and Preparedness. (Both these committees are expected to submit their reviews to World Health Assembly in May 2021, in addition to the work of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme.)

In the on-going reform discussions at WHO, member states have coalesced around the need for changes in the implementation of the IHR, improving on the oversight, funding and governance of WHO’s emergencies work, sharing of pathogen samples, among other areas. Already there is an emerging view within the IHR Review Committee, for example, that improving upon implementation of existing IHR provisions will be sufficient instead of changing the design of the IHR, the Executive Board was informed this week.

So, is a treaty at this point really necessary, other than to coerce member states to fall in line with binding commitments? Or will this exercise prove to be an opportunity to think more boldly about the reforms in global health governance?

IS A PANDEMIC TREATY NECESSARY?

To understand the potential of such an idea, we spoke with global health law expert, Gian Luca Burci, also Adjunct Professor of International Law at the Graduate Institute of International and Development Studies in Geneva. Burci is also a former legal counsel for WHO. He believes that COVID-19 needs more than a well-resourced WHO and an effective implementation of the IHR.

“WHO and IHR are, in principle, tools to avoid a pandemic, especially one of this magnitude.  If they fail, we need on top of them other policy and legal instruments to drive and sustain a multilateral response while coordinating and regulating a range of fields beyond health in order to avoid the messy uncoordinated situation that prevailed during the first wave as well as the current depressing spectacle of vaccine nationalism. These fields range from trade to investments, financing, transportation, migration etc. These are complex issues, that in my view, go beyond WHO's mandate and the scope of the IHR.” He also points out that IHR “disappeared from WHO's own narrative” for months after the DG declared the emergency at the end of January 2020.

Notwithstanding what kind of an appetite, already-burdened and financially-strapped member states will have for the long and arduous route to treaty-making, there are risks that this process will be too difficult politically, might result in a weak outcome, or worse,  may even fail altogether.

The other question to raise is, does WHO have the mandate and the resources to host such a negotiation? Experts suggest that improving response to pandemics in the future should be routed in a political framework in the wider UN system, or an inter-institutional arrangement.

So, what are the options?

“It would be tragic, if all we get out of this crisis, is tinkering with the IHR and giving some more money to WHO. There is a clear need for more ambitious and holistic measures,” Burci says.

He points to the Global Preparedness Monitoring Board (GPMB) which has proposed a UN framework as a political instrument setting principles, rules, and creating an institutional process for coordination and accountability. The immediate precedent is the Sendai Framework on disaster risk reduction. “Personally, I think the latter is a more realistic way forward and it doesn't exclude a treaty down the line if a political framework can build momentum and confidence in that direction,” Burci says.  

Some of the features of such a framework could include: sustainable funding, special rules for medicines and vaccines to aim at an equitable allocation, creating an institutional forum that would allow (or even compel) countries to consult and hopefully coordinate their measures, triggering special arrangements on trade, transportation etc when a pandemic is declared, creating a mechanism for settling disputes, Burci adds.

To be sure, a number of these issues are being addressed within WHO in the form of resolutions in the coming weeks including on steps towards sustainable financing, or even efforts to get countries to share pathogens for example.

HEALTH SECURITY AND PATHOGENS

As expected, the Board this week adopted the decision towards a resolution for strengthening WHO’s health emergency preparedness and response capacities.

But there has been a clear demand and emphasis from some member states on sharing pathogen samples. In his speech, at the opening of the meeting, DG Tedros even asked countries to join a new voluntary mechanism to share pathogen samples through the BioHub – a new repository hosted by Switzerland.   

In November 2020, at the World Health Assembly, WHO announced a new repository for specimens at a secure facility in Switzerland, to facilitate the voluntary sharing of viruses and the rapid development of medical countermeasures.

As we reported last week, this is highly political especially the discussions around benefits sharing. Senior WHO officials told the Board that samples from the BioHub will be shared with Swiss labs. But there has not been much clarity on discussing benefits for those sharing the samples.  

Do note that in a related agenda item of the Board on the public health implications of implementation of the Nagoya Protocol, the Secretariat has sought a mandate to “continue its work in this area, with a specific focus on options to  provide additional transparency, equity, clarity and consistency in pathogen-sharing practices globally, and to increase capacity worldwide for both the sequencing of pathogen genomes and the analysis of those genomes.” Experts familiar with the dynamics of these discussions believe that WHO may not have the mandate to undertake these responsibilities, since the Nagoya Protocol flows from a separate legal instrument - the Convention on Biological Diversity.

The issue of pathogen sharing is inextricably linked to the wider discussion on global health security. Consider this.

In a statement at the Board on Strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005), the IFPMA said:

“…IFPMA welcomes and supports the ongoing work and interim findings of the Review Committee on the Functioning of the IHR during the COVID-19 Response. Many critical issues have arisen through the Committee’s review process and it would be impossible for us to address all of these in the short amount of time we have today. Therefore, we would like to focus on the cross-cutting issue of pathogen sharing, which is also addressed under agenda item 14.4 public health implications of Nagoya Protocol.

The COVID-19 pandemic has highlighted the importance of timely pathogen sharing in the context of public health emergencies. The criticality of fast, timely and unrestricted access to pathogen information in allowing the development of medical countermeasures and understanding the genomic epidemiology of the virus has been recognised by both the Committee’s interim report, under paragraph 42, and the Director-General’s report on the ‘Public Health Implications of Implementation of the Nagoya Protocol’, under paragraph 3.

Though the preamble to the Nagoya Protocol recognises the IHR and “the importance of ensuring access to human pathogens for public health preparedness and response purposes”, currently, the global ability to share pathogen samples and their related data in a timely manner is being impacted due to the inefficient and bureaucratically burdensome bilateral system envisaged under the same Protocol, most notably for seasonal influenza viruses. Navigating a system in which each country has different access requirements that must be negotiated bilaterally is simply not feasible when dealing with the emergence of a novel pathogen.

In light of this, IFPMA fully supports the Committee’s approach of “conducting an article-by-article analysis” and “considering how the Regulations could facilitate the rapid sharing of scientific findings and samples within the global scientific community under Article 6.”

FINANCING DISCUSSIONS AT THE BOARD

The meeting has also been decisive in terms of discussions on financing including an impassioned plea by the DG, declaring that independence is more important than money.

He was speaking in the context of responding to certain member states’ questions on transparency of new initiatives including the WHO Foundation.

This frustration expressing the lack of flexibility is clearly understandable. According to WHO, while its budget increased from US$ 1.4 billion in 1990–1991 to US$ 5.8 billion for 2020–2021, assessed contributions have remained more or less static at about US$ 1 billion.

Readers of Geneva Health Files are likely aware that the financing of WHO falls into two groups: flexible funding and earmarked voluntary contributions. The flexible funding includes assessed contributions, core voluntary contributions and other programme support costs.  (i.e. overheads charged on top of any voluntary contribution). WHO explains that “in terms of sustainability, only assessed contributions can be considered truly sustainable, as core voluntary contributions and programme support costs are non-earmarked voluntary contributions, thus not fully predictable in the medium and long term.” While the amount that every country pays in assessed contributions is calculated relative to the country’s wealth and population, voluntary contributions are subject to a range of other conditions – in many cases, for example, parliamentary approval – and are therefore less predictable, WHO adds.

Hence the growing optimism about new initiatives of strings-free resources such as those promised by the WHO Foundation. It remains to be seen whether member states will come on board for an Open-ended Intergovernmental Working Group on Sustainable Financing, as suggested by WHO.

TAILPIECE

Medicines law expert, Ellen ‘t Hoen, has suggested that despite a harsh assessment of vaccine nationalism articulated by Dr Tedros, “…he left the elephant in the room unmentioned: most pharmaceutical companies refuse to share the know-how and technology needed to produce vaccines on a large scale.” The DG not mention the Covid-19 Technology Access Pool (C-TAP), which has so far failed to take off. What’s more, experts have also pointed out that in his report to the Board on the response to COVID-19 there has been no mention of vaccines shortages faced by developing countries, or the challenges faced by the COVAX Facility, for example.

Despite its virtual format, the EB meeting has so far provided several indications on how some of these matters will be resolved in the months to come. The renewal of the U.S. commitment to WHO and to global health will undoubtedly provide greater resources and optimism. It also opens the door for a more contested space at WHO. Interesting times ahead.

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2. THE TRADE & HEALTH UPDATE

WTO TRIPS TALKS

The next few weeks will determine the fate of the TRIPS Waiver proposal as it goes through several rounds of formal and informal consultations at the TRIPS Council, before being taken up at the General Council in March. The unabated rise in COVID-19 deaths and infections worldwide, also fuelled by mutations of SARS-Cov-2, concomitant with severe vaccine shortages lend an urgency to these discussions like never before.

At the TRIPS Council informal meeting earlier this week, as many as 30 members engaged in discussions around the TRIPS Waiver proposal as we reported on twitter on the 19th. While countries largely reiterated their previously stated positions, it appears the proponents of the proposal made greater headway in reaching out groups of countries. Next informal meeting is scheduled for February 4, when positions are expected to be stated on the record, for consideration by the General Council in early March.

The waiver proposal, sponsored by South Africa and India, seeks to allow all countries to not grant or enforce intellectual property protection for the duration of the pandemic, until widespread vaccination has been achieved. The proposal recognizes intellectual property, trade secrets, industrial designs, as barriers to sharing technology. The co-sponsors of the proposal now include Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt and Mali.

Sources familiar with the discussions said that the group of Least Developed Countries have also shown strong interest in co-sponsoring the proposal.

At the meeting, European Union, the United States, Switzerland, the United Kingdom and Japan continued to oppose the proposal. Some of these countries were of the opinion that the proposal is overly broad. And that it does not address problems of capacity or raw materials that are impeding sufficient supply. The countries continued to insist that the existing TRIPS system contains sufficient tools to address any IP-related problems. (Do note that countries including the U.S. opposed to reference to TRIPS flexibilities on a resolution on strengthening local production at WHO this week.)

A diplomatic source suggested a shift in the position of Brazil, since it had not taken the floor to voice its opposition to the proposal. “This could be significant. Clearly, like other countries, they are finding it difficult to secure access to vaccines to address the pandemic,” the source said.  

The position of wealthy countries is incongruous, a source familiar with the discussions told Geneva Health Files. “On the one hand they want to be seen as protaganists donating vaccines doses, on the other, they are blocking solutions to a raging pandemic,” the source said. It is not clear how long these countries will be able to reconcile these inconsistent position especially faced with rising mortalities from COVID-19 and unpredictable access to vaccines even in some richer countries.  

It is understood that China, Chile, Malaysia, Australia, Colombia and Canada continued to raise questions on how waiver proposal would work at national levels, according to sources.

It is also learnt that Afghanistan, Pakistan, Zimbabwe, Egypt, Mongolia, Chad, Indonesia, Nepal, Bangladesh, Sri Lanka, Cambodia and Venezuela spoke in support of the waiver proposal.

South Africa asked countries to move the discussion towards negotiating the text of the TRIPS waiver proposal in the coming weeks. It also offered to re-evaluate parts of the proposal with respect to its scope and the timeframes for its implementation, while asking other opposing countries to reconsider their positions.

Going forward, sources said that supporters of the proposal may consider adapting the waiver proposal to address the current urgency of vaccines shortages. “One suggestion could be to have a list-based approach where, for example, IP provisions will not apply to vaccines, diagnostics and therapeutics to fight COVID-19,” a source said. Another could be to getting faster issuance of compulsory licenses, or using the COVID-19 Technology Access Pool to spur tech transfer to boost the production of vaccines to meet demand, the source added.

It is not clear whether limiting the scope of the proposal would mean, focusing on waiving provisions on intellectual property, while setting aside other identified barriers to access to medicines, including copyrights, industrial designs and trade secrets (undisclosed information), for now.

While the proponents are keen to open up discussion on revisiting the text of certain provisions in the TRIPS agreement, it appears that ensuring access to medical products, including vaccines may have a certain immediacy and become an over-riding priority.

The use of interpretative text or a declaration to clarify certain sections of the TRIPS agreement is not ruled out in the future, the source said.

Whether proponents of the proposal get sufficient support from key groups of countries in the coming weeks, will remain to be seen. If a WTO member does not support this proposal, but reserves its opposition to it, the proponents will stand to gain, a source explained.

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