Public Hearings on a Pandemic Agreement Open Floodgates of Interest; WTO DG To Take Compromise Text on TRIPS Waiver to the Wider Membership
Newsletter Edition #131 [The Curated Edition]
It is human to give into optimism. So I will.
This week in Geneva witnessed refreshing participation from the public at the open hearings of the Intergovernmental Negotiating Body, where experts and interested stakeholders shared their visions on what a new instrument to govern future health emergencies should look like.
It is another matter whether, and to what extent these will be incorporated by the treaty-making process at WHO. Today we bring you an update on what these hearings were like and the symbolism of this kind of engagement.
Listening to the interventions by a rich diversity of stakeholders made me think that perhaps “this is what global health should be about” - shaped from anywhere by anyone. It also showed the ubiquitous impact of the current pandemic. However, these lofty expectations around the democratization of international law-making may be short-lived, given the paths these processes have so far traversed.
We also have a quick update on the TRIPS waiver discussions. It is expected that the wider WTO membership may soon review the compromise text on the TRIPS Waiver as the DG decides to take it further. Expect action.
Other news: sharing a link to a recent discussion on the how the G7 could accelerate the development and access to vaccines and therapeutics. Organized by the Global Health Hub Germany (and GIZ), I had the pleasure to moderate and learn from the panelists who were part of engagement groups feeding into the processes of the German G7 presidency.
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I. POLICY UPDATES
Public Hearings on a Pandemic Agreement Open Floodgates of Interest
An impressive range of stakeholders made their interests and concerns known at the public hearings this week conducted by the Intergovernmental Negotiating Body set up to establish a new pandemic agreement.
From feisty civil society activists to hard-as-knuckles lobbyists; from social justice champions to focused medical products manufacturers; from professors at American universities to healthcare workers; from representatives of the families of the deceased to wildlife experts; from anesthesiologists to anthropologists; from human rights scholars to teachers’ unions. These disparate group made forceful, incisive statements on what the pandemic meant to them, and how any new rules must address future health emergencies.
Such consultations are rare, and admittedly, the last such open hearings took place 22 years ago, a senior WHO official reminded the participants.
A diverse range of concerns were aired over two days of consultations including cautioning against conflicts of interest in treaty-making processes and highlighting the asymmetries of power. Some fear that these consultations could end up only as “checkbox” exercise. After opening up these discussions, the INB must now reform the direction of the treaty-making process, to move away from the top-down approach that it has been, and instead, to make it truly inclusive and ground-up.
Traditional stakeholders also took the opportunity to present their views to the public.
Here are excerpts from a few statements:
People’s Health Movement:
“We believe that the new pandemic instrument and International Health Regulations 2005 must complement each other in response to public health emergencies and not lead to a fragmented approach. The principles of IHR 2005 should be used as foundation to create a new pandemic instrument that will strive to increase international cooperation, solidarity among countries and not the securitisation of health.
The instrument must provide precedence to public health measures and include mechanisms to tackle trade and intellectual property barriers. The instrument must include global commitments to automatic suspension of TRIPS and pave way for mandatory open licensing. It should strive to create national and regional systems of publicly funded, administered and owned R&D and manufacturing hubs focusing on national and regional health needs.
Additionally the instrument must abide by the existing obligations of Convention on Biological Diversity and Nagoya Protocol that result in access and benefit sharing.
Though every country might risk being affected by a pandemic, national responses depend on the capacity and resources available to governments in an unequal world. Therefore, any new pandemic instrument should make provisions for financing for health, economic recovery and debt cancellation as a responsibility of the rich countries towards those subjected to the ills of neoliberal globalisation and colonialism.”
Gavi - The Vaccine Alliance
“….Also based on our 20 years of experience in advancing vaccine equity, Gavi would like to offer four suggestions towards the substantive elements of a new international instrument:
First, ensure rapid and agile contingency financing to support surge capacity and enable a network of global health agencies to orchestrate a rapid and robust global response during crisis, guided by principles of equity and global solidarity.
Second, maintain the key and rapidly scalable innovations from COVAX , such as adapted regulatory frameworks, fair allocation mechanism, as well as the necessary compensation, liability and indemnification legal safety nets.
Third, diversify and expand manufacturing capacity in emerging economies so as to increase global vaccine supply security, including pandemic vaccines when the need arises, whilst managing its impact on routine immunisation.
Fourth, strengthen investments in routine immunisation and primary health care, with a focus on health system access by the most marginalised communities who are most at risk from outbreaks due to gender, geographic, and socioeconomic barriers…”
Georgetown University Medical Center
“International Law as a System: Critical Considerations for the Pandemic Treaty
The pandemic treaty is an opportunity for us to develop greater coherence and coordination in the international law for pandemics. While it may be tempting to focus the treaty as narrowly as possible, this would be a mistake. The pandemic treaty is an opportunity to actively breakdown the siloes that left us so vulnerable to both the risks and impacts of pandemics. Through our Elements of a Pandemic Treaty project we have identified twelve elements for a cohesive and evidence based treaty for the pandemic era, two of which I will flag today.
The first is a planetary health approach in the drafting of the treaty. In the next decade, climate change will overtake land use as the biggest driver of pandemics and is predicted to create hundreds of thousands of potential opportunities for viral cross-species transmission. The Treaty text must recognize the role climate change will play in outbreak emergence, and can do so in preambular language as well as in operative provisions that embed State Parties’ obligations under other international treaties like the UNFCCC. Examples of this are common in international law, including Article 57 of the IHR and Article 4 of the Nagoya Protocol.
Secondly, there is currently no international legal obligation to share non-influenza pathogen samples and genetic sequences necessary for pandemic preparedness and response. At the same time, there will not be a successful or acceptable pandemic treaty without addressing the global injustice of the inequitable sharing of benefits from their use, including vaccines. The pandemic treaty is an opportunity to address this urgent issue, including as a protocol to a Framework Pandemic Convention negotiated in parallel, and in a manner consistent with art4(4) of the Nagoya Protocol….”
Third World Network
“…In COVID-19 pandemic we have witnessed unconscionable disparity in access to health products, technologies and know-how to respond to the pandemic, which underscores the urgent imperative for an access and benefit sharing framework negotiated by Members in the WHO.
Previously, we have observed similar inequities in the context of influenza pandemic leading to the adoption of the PIP Framework which provides an overarching structure for access to influenza viruses of pandemic potential, including genetic sequence information, fair and equitable benefit sharing, transparency, and oversight. Notably, it includes binding contractual agreements between WHO and manufacturers to commit to access to antivirals, vaccines and diagnostics during a pandemic and monetary benefits that has supported capacity building in developing countries. WHO Experts have labelled the Framework a “bold and innovative tool” that has led to greater confidence and predictability in the global capacity to respond to an influenza pandemic”.
This Framework is built on the fair and equitable benefit-sharing objective of the Convention of Biological Diversity, further elaborated by the Nagoya Protocol.
We urgently need an access and benefit-sharing instrument for other human pathogens of pandemic potential including genetic sequence information (GSI). This we see the single most relevant need of the hour in pandemic prevention, preparedness and response (PPPR) regime. One health approach, stress on the prevention, and fast-tracking of sharing of information should not frustrate this objective. The absence of such an ABS framework has undermined a prompt equitable public health response in the current pandemic….”
Knowledge Ecology International
“Norms for Terms in Funding Contracts
COVID-19 has shown that the terms of contracts to fund the development of new countermeasures to address an emerging pandemic (“funding agreements”) largely determine what state actors can and cannot do to rapidly expand access. The pandemic has further confirmed countries’ tendencies toward nationalism, their willingness to expend unprecedented sums of money toward the development and procurement of countermeasures, and the impropriety of monopolies under these circumstances.
A treaty on pandemic preparedness and response should recognize this reality, and should commit governments to implement terms in future funding agreements that would guarantee the ability to perform a technology transfer of all of the inputs needed to enable generic manufacture of any useful countermeasures (a “deep technology transfer”). Such a deep technology transfer would authorize governments to issue third-party licenses to background and foreground patents, data, knowhow, cell lines, copyrights, regulatory filings and authorizations, and any other input needed to facilitate generic production. Such terms should be implemented at the outset of any pandemic, when governments award massive subsidies and bear the risk of failure, because it is not yet apparent which technology will be useful. There should be no qualifications for governments performing this deep technology transfer.
The treaty should further commit governments to full transparency of the funding agreements, by obligating them to post the agreements on a publicly accessible website with no or minimal redactions, and to share the contracts with a WHO hosted public repository.
Independent Clinical Trials
In the current pandemic, much of the funding for the initial clinical trials came from governments, but the terms of the funding came with inadequate or no conditions on pricing, equitable access or technology transfer to scale manufacturing.
There have also been controversies over the trial designs.
Some vaccine hesitancy is related to the lack of trust in vaccine manufacturers as the source of data on safety and efficacy.
Many of the government-funded trials were controlled by the developers, and few featured useful head-to-head comparisons of safety and efficacy.
Public sector funding for trials of new vaccines declined after some vaccines received initial emergency use authorization (EUA), despite the public interest in evaluating new vaccines.
Clinical trials are expensive and important. Governments should collaborate to fund and set norms for transparent and independent clinical trials of vaccines and other countermeasures. Preferences should be given to funding trials that provide head-to-head comparisons of countermeasures, and include products that: have strong technology transfer obligations; provide concrete and credible plans to enable decentralized manufacturing including in developing countries; can be manufactured and sold for lower prices, and can be administered and are effective in resource-poor settings…”
WTO DG To Take Compromise Text on TRIPS Waiver to the Wider Membership
Ngozi Okonjo-Iweala is expected to take the compromise text on the TRIPS Waiver to the wider WTO membership, sources told Geneva Health Files this week. It is learned that some members of the Quad (the US, the EU, India and South Africa) have not signed off on the text.
The leaked compromise text between the four members of the Quad group has struggled to get endorsement and ownership from the US, India and South Africa. It is understood it is only the European Union, that has so far lent support to the current version of the compromise text on the TRIPS waiver proposal. (The current text resembles EU’s original proposal on clarifying rules around compulsory licensing)
While internal consultations continue within countries at the national level, the reasons for not supporting the text vary between these key members. The reasons for not endorsing the text are strategic for the proponents of the Waiver given the deep concessions compared to their original proposal.
As we reported earlier, some WTO members and other stakeholders have been pushing for this text to be presented as a facilitator’s text for consideration by the wider membership. After weeks of impasse during which the proponents of the waiver were allegedly asked to sign off on the compromise text, the DG is now expected to take this text to the wider membership, without such a sign off, diplomatic sources said. She had steered the discussions among this small group of members since December 2021.
So far, discussions on this compromise text has not been considered formally within the WTO. No TRIPS Council meetings have been scheduled, by the time this story went to print. The WTO ministerial is less than three months away, and an outcome on the TRIPS Waiver continues to be seen as a short-term panacea to save the relevance of the WTO. (See Politico: WTO faces ‘slow motion train wreck’ amid Ukraine war chaos)
Drowned by the Ukrainian crisis, the policy attention to the pandemic is already waning, not only at the WTO. Observers point to the glut in the production of vaccines, further complicated by a range of factors including vaccine hesitancy and logistical challenges in immunization programs in many countries. (Earlier this week, Airfinity, the life science analytics firm downgraded global COVID-19 vaccine revenue forecast)
However, considering that, nearly 3 billion people remain unvaccinated against COVID-19, and the need for therapeutics and diagnostics has not diminished, the relevance of the TRIPS Waiver continues to remain important, activists say.
Some point to the on-going developments with respect to the challenges in using TRIPS flexibilities (the EU’s preferred policy approach as opposed to the waiver). Last month, Knowledge Ecology International, reported about Pfizer’s March 18, 2022 opposition to the KEI request for a compulsory license in Dominican Republic for Paxlovid.
What next for the waiver proposal, and for the WTO?
The coming weeks will witness how these negotiations will progress at the WTO. After months of these discussions taking place, outside of the usual, formal processes of the WTO, the compromise text is now likely to be debated among the 164 members.
Sources also suggested that without a formal forum to discuss the compromise text it is difficult for other WTO members to make their positions known. “It is not clear to what extent, other co-sponsors of the waiver proposal, will take this forward.”
Some delegates indicated that if the compromise text “dies a natural death”, there would be scope for improvement on the current text or negotiation on the original waiver proposal. But the appetite for WTO members, especially that of many powerful ones, for engaging in lengthy discussions on the waiver, may be low, given also the political exigencies around the Ukrainian crisis.
It is learned that China has protested vociferously on being excluded from the implementation of a waiver as understood in the criteria suggested by the current compromise text.
For the proponents, the efforts will be to fight eligibility criteria that seeks to narrow the scope of implementation'; pushing to bring in therapeutics and diagnostics into the product scope of any waiver; and, to challenge the requirement for listing of patents as described in the current text, sources familiar with deliberations told us.
Developing countries are keen to have an outcome on the waiver proposal, failing which they would make conditional their support for the wider WTO response to the pandemic, diplomatic sources indicated. This is even as some opponents to the waiver seek to link the waiver discussions to issues such as food security.
Geneva-based sources also suggested that the small group approach used in these waiver discussions are now being suggested as an approach for negotiations on other WTO matters including on fisheries and agriculture. The small group deliberations have been criticized for being opaque and non-inclusive.
Whatever the outcome, time is running out. And it has also shown the reluctance of many countries to address the issues of equity in any meaningful manner at the WTO.
“If the DG wants to save the WTO, she must bring the compromise text in her role as a facilitator”, one developing country diplomat told us.
And in the event the compromise text is dead in the water, activists around the world may be relieved, since many see the current text as setting a bad precedent.
Tailpiece: Industry Groups Beat up Waiver Proposal
In one of the most strident criticisms till date, on the alleged ineffectiveness and the limitations of the TRIPS Waiver, pharma industry group, IFPMA brought together CEOs of large companies, to articulate the contempt for the proposal at a briefing earlier this week.
Drawing attention to a glut in vaccine production, and alleging high vaccine hesitancy in developing countries as reasons for low vaccination rates in some parts of the world, industry leaders repeatedly attacked the idea of a TRIPS Waiver. Some even called it “toxic”.
Thomas Cueni, Director General of IFPMA said that he was stunned that countries continue to debate the TRIPS Waiver.
The timing of the outrage from the industry on the waiver proposal is hard to understand, given that even after 18 months of deliberations, what is now being discussed is a significantly reduced form of the original proposal.
As these negotiations come down to the wire in the coming weeks, such expressions of outrage will continue to feed headlines.
II. PODCAST CORNER
Global Health Matters podcast episode 12
As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality? In the case of COVID-19, as of early March 2022, 74% of those in high-income countries have been fully vaccinated, compared with just 11% of people in low-income countries. Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? How has intellectual property rights affected development of vaccines across Africa? In this episode, host Garry Aslanyan speaks with the following guests:
Fatima Hassan - Human rights lawyer, activist and founder of the Health Justice Initiative
Judit Rius Sanjuan - Policy Specialist, Health Technologies, Innovation and Access, UNDP
Petro Terblanche - Managing Director, Afrigen Biologics
Garry Aslanyan is the host and moderator of the Global Health Matters podcast. You can contact him at: email@example.com
This podcast promotion is sponsored by the Global Health Matters podcast.
If you wish to promote relevant information for readers of Geneva Health Files, for a modest fee, get in touch with us at firstname.lastname@example.org.
III. WHAT WE FOUND INTERESTING
My new colleague Megha Kaveri, has put this together for you:
WHO Deleted India’s Air Pollution Data from its New Air Quality Database – Why? Health Policy Watch
Billions required to prevent next pandemic, warns epidemic expert - Financial Times
The Unbelievable Stupidity of Ending Global Covid Aid - New York Times
In the Rush to Return to ‘Normal,’ What Happens to the Vulnerable? - New York Times
Why the WHO took two years to say COVID is airborne - Nature (news feature)
Chief executives of mRNA vaccine groups earned $100mn in pandemic pay - Financial Times
The WTO TRIPS Waiver and Essential Security Rights in 2022 - South Centre
WHO sexual abuse allegations: 6 months on - The Lancet
A changing balance for TRIPS? - South Centre
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