An informal meeting was convened at the TRIPS Council today (December 3) to discuss the TRIPS waiver proposal. Discussions on the TRIPS waiver proposal is expected to continue in the TRIPS Council in 2021. We will come back with a fuller report on this next week, here are some details which emerged from today’s meeting. It is understood that the African Group may decide to co-sponsor the proposal after consultations with the capitals. Kenya, Sri Lanka, Jamaica and Argentina are understood to have expressed their support to the waiver proposal at the informal meeting today. South Africa and India have … Continue reading TRIPS COUNCIL INFORMAL MEETING ON TRIPS WAIVER PROPOSAL

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Regulatory discoherence: The case of remdesivir

THE NEED FOR REGULATORY COHERENCE: LESSONS FROM REMDESIVIR The story of Gilead’s drug remdesivir, one of the earliest candidates of repurposed medicines that showed promise for the treatment of COVID-19, should hopefully have lessons for regulatory authorities the world over. In reporting this story with my colleagues in the cross-border investigations team working on this project, we spoke to a number of experts from different parts of the world, in trying to understand how regulatory processes work. And what approvals from regulatory authorities mean for governments, for clinicians, for people and for companies. Image credit: Photo by Thirdman from Pexels Continues… To read … Continue reading Regulatory discoherence: The case of remdesivir

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TRIPS waiver discussions: moving the needle

TRIPS WAIVER: THE NEEDLE HAS MOVED, BUT THE FIGHT IS ON EU bloc and others, push for TRIPS flexibilities, a defining departure from the past Countries are making slow but sure progress in discussing a proposal to temporarily waive certain obligations under the TRIPS agreement at the WTO. After an informal meeting of the TRIPS Council last week, countries are now having bilateral discussions seeking clarifications from co-sponsors of the proposal including South Africa and India. The waiver proposal seeks to allow all countries to not grant or enforce intellectual property protection for the duration of the pandemic, until widespread … Continue reading TRIPS waiver discussions: moving the needle

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Q&A: Ellen Johnson Sirleaf, Co-Chair, the Independent Panel on Pandemic Preparedness and Response

In recent reforms-related discussions at WHO, some countries want independent teams to have access to outbreak sites going forward. Geopolitical pressures and a highly politicized environment has made global health security a defining agenda as a result of the pandemic. In an interview with one of the co-chairs of the Independent Panel on Pandemic Preparedness and Response (IPPPR), we tried to get a sense of the challenges that this panel faces. Q&A: Former President of Liberia, Ellen Johnson Sirleaf, Co-Chair of the Independent Panel on Pandemic Preparedness and Response Ellen Johnson Sirleaf [Image Credit: The Elders] [GHF] 1.       What are the … Continue reading Q&A: Ellen Johnson Sirleaf, Co-Chair, the Independent Panel on Pandemic Preparedness and Response

“Solidarity is not fairness”

The World Health Assembly draws all member states of World Health Organization to discuss health challenges, review actions, debate proposals and set future goals. It entrusts the secretariat to consult and engage with countries and other actors to coordinate vast areas of global health policy. This complex mechanism, some say, is now under threat. In this story, we will see why process matters and how it eventually impacts member states participation during the worst health emergency in a century. In addition, concomitant developments this week, dominated global health agenda. This crowded out the Assembly. Events that unfolded outside of the … Continue reading “Solidarity is not fairness”

The U.S. & Brazil team up to map W.H.O. reform

The U.S. and Brazil have teamed up to lay out a governance reform proposal for WHO in the context of the urgencies that COVID-19 has wrought upon. The timing of such a proposal is bemusing given the uncertainties around American engagement at WHO. It is expected that this proposal, along with others, will be discussed at the margins of the upcoming World Health Assembly next week, Zsuzsanna Jakab, Deputy Director-General, World Health Organization said at an event today. While there are some convergences with the earlier proposal put forth by Germany and France (such as on independent access to outbreak areas), on certain issues … Continue reading The U.S. & Brazil team up to map W.H.O. reform

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The World Health Assembly During a Lockdown

The 73rd World Health Assembly resumes virtually next week at a time when large parts of Europe including Switzerland are locked down. What’s more the Director General of WHO, Tedros Adhanom Ghebreyesus is currently in self-quarantine after coming in contact with COVID-19 confirmed case. It is as somber a milieu that one could be faced with, when 194 countries come together to work through health challenges in the midst of this pandemic. And yet, despite the limitations, a fairly productive week awaits the global health community. It is understood countries continue to discuss with WHO on the ways of engagement including special … Continue reading The World Health Assembly During a Lockdown

Philosophers seek to make space in pandemic response

Sridhar Venkatapuram, is an Associate Professor at the Global Health Institute, King’s College London. He has spearheaded the Independent Resource Group for Global Health Justice (IRG-GHJ “URGE”), along with other philosophers and experts to address the some of the biggest questions of the times we are now living in. You can also watch this recent event where these experts lucidly explain what they intend to do in getting organizations to discuss complex global justice matters and the ethical issues that this pandemic has thrown up. He spoke to Geneva Health Files at length on how issues around allocation and distribution of medical products, for … Continue reading Philosophers seek to make space in pandemic response

WHO PQ listing for Remdesivir

A SHORT BLOG: Questions are beginning to emerge as to why WHO proceeded to give a prequalification listing to Remdesivir, when it was aware of the results of its Solidarity Therapeutics trial on the drug’s lack of impact on the treatment for COVID-19. At the bi-weekly presser (on 16.10) last week, WHO’s top officials discussed briefly the independent processes of the prequalification process for Remdesivir (officially announced on the 15th) and the results of the Solidarity trial (highlighted on the 16th.)(See Soumya Swaminathan and Mariangela Simão address this question, half way into the briefing) It is also understood that the results from the Solidarity trial … Continue reading WHO PQ listing for Remdesivir

A peek into COVAX machine

INSIDE COVAX: CONTRACTS & GOVERNANCE A closer look at the model contracts issued by the COVAX Facility and how it will be governed Gavi’s COVAX Facility is gearing into operations mode, from acquiring an approved legal status, to building its governance structure; issuing contracts to participating countries to negotiating deals with vaccine manufacturers; the COVID-19 vaccine machine is here. Contentious issues including liability provisions for participating countries and cost-sharing for vaccines doses for low and middle-income countries continue to hashed out behind the scenes. More than 180 countries are set to have joined the Facility. This story is based on a review … Continue reading A peek into COVAX machine

Inflection Point? TRIPS Waiver proposal

THE TRIPS WAIVER PROPOSAL – AN IDEA WHOSE TIME HAS COME? Picture this, more than half a year into the pandemic of COVID-19, upwards of 38 million infections, a million and more lives lost; vaccine nationalism embraced by politicians of all stripes; hedged bets on numerous bilateral deals; short-termist planning for vaccines for a pandemic that might last years; economies in dire straits; limited manufacturing capacities; inadequate supply of all medical products; all this on the back of rising infections and mortality, with millions still susceptible. We are here. And now consider this, a new legal measure which in one … Continue reading Inflection Point? TRIPS Waiver proposal

“Consult us more”: Countries to WHO

COUNTRIES WANT WHO TO CONSULT MORE: EXECUTIVE BOARD MEETING Countries praise WHO efforts on addressing the pandemic, but want more consultation A number of countries called on WHO for greater consultations on the decisions around the response to the pandemic at the Special Executive Board [EB] meeting earlier this week. From demands on consultations on the allocation framework that will determine access to COVID-19 health products, to the governance structure of the Gavi-led COVAX Facility, countries seemed to suggest that they have been left out of these consultation processes. To be sure, in a repeat of the World Health Assembly in May 2020, countries … Continue reading “Consult us more”: Countries to WHO

COVID-19 Diagnostics: The Full Picture

The pandemic has revealed the entrenched inequities in the world, and the access to diagnostics for COVID-19 is also illustrative of this. As per latest announcements here in Geneva, 80% of the world’s population – living in low- and middle-income countries – will initially receive only 20% of two kinds of antigen-based rapid diagnostic tests, while the remaining 20% – those in high and upper middle-income countries – can essentially procure 80% of these tests. Undoubtedly, it is welcome that 120 million tests for the pandemic will be made available to low and middle income countries over a period of six months. … Continue reading COVID-19 Diagnostics: The Full Picture

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Gavi’s Discomfort With Civil Society on Vaccines

The hesitation of letting the door open to include civil society organizations, to effectively contribute to defining discussions on vaccines for the pandemic, especially for a massive immunization agency, is perplexing. Gavi – The Vaccine Alliance has vaccinated more than 820 million children, is backed by the most powerful funders of global health, and has received nearly $2 billion in pledges every year for the last few years[1]. Why is one of the biggest agencies in global health, wary of activists? Geneva Health Files tried to understand the reasons behind Gavi’s insistence on excluding Civil Society Organizations (CSOs) on COVID-19 … Continue reading Gavi’s Discomfort With Civil Society on Vaccines

Reading the AstraZeneca-Oxford Trial. What’s at stake?

Given the scientific, economic, political, commercial and moral compulsions around vaccines for the pandemic, the adverse event in a clinical trial of a leading vaccine candidate has been a humbling moment for citizens, governments, companies and hopefully, politicians. The goal of this expert interview is to help us read the recent pause in a leading clinical trial (AZD1222) following a suspected adverse event and the subsequent news of the resumption of the trial in the UK. A lot has been published already on this trial, already in phase III, but a few aspects worth underscoring. First, that Pascal Soriot, CEO of … Continue reading Reading the AstraZeneca-Oxford Trial. What’s at stake?

German-French Proposal For WHO Could Skew Balance Of Power In Donors’ Favor

The reform proposal led by Germany and France to strengthen WHO’s emergencies response and bolster global health security, could result in a balance of power tilting in favour of donor countries, diplomatic sources in Geneva say. Questions are being raised on whether the proposal truly seeks to empower WHO, or if it is also an attempt to fill the leadership vacuum caused by the retreat of the U.S. from the multilateral institution.   The proposal, being perceived in some quarters, as a genuine effort to strengthen multilateralism in global health, may be focusing too much on global health security; and risks … Continue reading German-French Proposal For WHO Could Skew Balance Of Power In Donors’ Favor

The story of Geneva Health Files

Geneva Health Files sent out the first edition of its newsletter on Substack. Here it is: Dear Subscribers, I am pleased and honored to be writing my first post to you. Welcome to the Geneva Health Files community.   An introduction is due for many new readers. I am an Indian journalist who has been working in Switzerland for the last decade. I publish Geneva Health Files, a website that tracks the governance of global health. Geneva Health Files was born and launched in the midst of the on-going pandemic. Here’s a story of how we got here. Global Health … Continue reading The story of Geneva Health Files

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The Covax Exchange: Gavi’s plans to let countries trade in vaccines

On Gavi’s table: plans to let countries trade “vaccine credits” like stocks Vaccines for COVID-19 are not yet a reality, but plans are afoot to enable trading in stocks of potential vaccines. Gavi says the plan will allow countries to exchange vaccines doses with each other, allowing each economy to optimise to their own needs. In order to get a firm commitment from rich countries to commit to buying vaccines from Gavi’s Covax Facility, the immunization agency is working on a plan for a “Covax Exchange” – where countries can trade their ‘vaccine credits’, according to sources. This is ostensibly … Continue reading The Covax Exchange: Gavi’s plans to let countries trade in vaccines

Sign up! Geneva Health Files Newsletter

Dear Readers, Thank you for your continued support to Geneva Health Files. We have been encouraged by your interest in keeping track of how key decisions in global health are being shaped in Geneva. Soon, we are starting a weekly newsletter. This will bring you deep dives on key global health issues, and relevant, curated content, delivered directly to your inbox. Given fast-moving developments on policies and politics in global health, we have decided to share our stories in a newsletter format so that you do not miss out on important analyses. Early results from our on-going survey on readership, show that … Continue reading Sign up! Geneva Health Files Newsletter

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“Policy Coherence” in the pandemic?

What the trilateral report on public health, IP and trade, says on the pandemic? A range of policy options drawn from different disciplines, is shaping the response to the pandemic, particularly in making medical products more accessible. From the use of flexibilities in copyrights for text and data mining to help drug discovery, to the use of competition policy to improve access to testing; from temporarily relaxing procurement rules, to easing regulatory processes; among many others. Many may lament that the pandemic is yet to witness any meaningful sharing of information and technologies. And yet, these limitations are in part … Continue reading “Policy Coherence” in the pandemic?

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WHO on the checks & balances for COVID-19 vaccines

As Russia approves a vaccine to fight against SARS-Cov-2, it is useful to note what global authorities, including WHO have said about the checks and balances in vaccine development in the context of COVID-19. Here is what Dr Soumya Swaminathan, WHO Chief Scientist has had to say about the processes around vaccine development in a recent conversation online. This was first broadcast by WHO on July 24, 2020, as an interaction on social media, moderated by Dr Margaret Harris. The following has been lightly edited for length and clarity. [There have been developments since, see Draft landscape of COVID-19 candidate … Continue reading WHO on the checks & balances for COVID-19 vaccines

The re-emergence of the WTO as a key forum for global health

ANALYSIS OF THE TRIPS COUNCIL MEETING JULY 30,2020 The coronavirus pandemic is slowly, but surely casting the World Trade Organization as a significant platform that could witness systematic efforts at the multilateral level to ensure better access to health products. This could be in the form of more formal deliberations amongst members to find ways to neutralise barriers to intellectual property, and not just patents, but other types of constraints that have affected access to diagnostics and health technologies. This pandemic has already brought into sharp focus, the inability to quickly provide essential diagnostics and medical products as a result … Continue reading The re-emergence of the WTO as a key forum for global health

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Trade in the time of the pandemic

THE TRADE IN MEDICAL PRODUCTS: THE STATE OF PLAY With every passing week in the prevailing pandemic, there is an urgency to understand and provide for the access to medical products and services. But what constitutes the trade in these crucial products? Who sells, who buys, how does it flow and what happens if it doesn’t? Geneva Health Files looks closely at the story of international trade that makes available medicines and medical services within existing constraints. The pandemic has shown how the restrictions in these pathways, puts the most vulnerable communities at risk of lacking access to both. The … Continue reading Trade in the time of the pandemic

The Three Month Mark: Geneva Health Files

Geneva Health Files completes three months – here’s what was covered Here is a recap of the stories since May 2020: Key global health coverage that included exclusive reporting and analyses on COVID19 Response Resolution, COVID-19 Tech Pool, the WHO Allocation Framework, Gavi’s Covax Facility and matters at WTO. July 2020 Resigning to supply constraints: WHO’s Allocation Framework – WHO’s Allocation Framework on COVID19 health products – GAVI COVAX FACILITY: Questions on access, pricing & governance – COVID-19 Omnibus Resolution at the UN – June 2020 COVID-19 Tech Platform – Countries pass up opportunity for a … Continue reading The Three Month Mark: Geneva Health Files

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Elections at the World Trade Organization

Rising protectionism sparks keen interest in saving the multilateral trading system   As home to World Health Organization, Geneva is already at the centre of pandemic-related policy making. Last week saw yet another flurry of activity, on the shores of Lac Léman – at the World Trade Organization. Face-masked officials accompanied interested candidates who were there to present their case to become the next chief of the international trade body. At a time when WTO’s leadership is needed most, when world merchandise trade could fall by a third, the current WTO Chief Roberto Azevêdo will step down at the end … Continue reading Elections at the World Trade Organization

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Giving in to supply constraints: WHO’s Allocation Plan

New Details on WHO’s Draft Allocation Framework – A Deep Dive With more than 13 million cases of COVID19 in mid-July 2020, and rising, WHO has an unenviable and difficult task at hand, to map and decide who gets vaccines and medicines first. As expected, as it works its way on devising an allocation framework (first reported here), it is inevitably having to wrestle with politically contentious decisions in the backdrop of rising vaccine nationalism and countries striking up bilateral deals with drug companies. It will have to decide, and soon, if it will tackle head on – the elephant … Continue reading Giving in to supply constraints: WHO’s Allocation Plan

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COVID-19 Omnibus Resolution at the UN

Institutional responses to the pandemic continue to be shaped by international organizations in an effort to improve coordination and streamline processes to deal with COVID-19 in an uneven world characterised by weak health systems, differing approaches to science and varying commitments to address human rights issues. Under the aegis of the UN General Assembly, countries are working on a draft omnibus resolution on the COVID-19 pandemic. Typically, an “omnibus resolution” longer than usual resolutions, relating to all aspects of a particular issue, containing more information and seeking specific action from governments. While not binding, UNGA resolutions do serve as a … Continue reading COVID-19 Omnibus Resolution at the UN

WHO-led Research & Innovation Forum on COVID-19: July 2

WHO convened a Global Research and Innovation Forum on COVID-19 this week, bringing together 1300 experts virtually including researchers, funders and developers, to discuss the state of the science and to take stock of the six-month old pandemic which has resulted in more than half a million deaths, infected upwards of 10 million people in more than 200 countries, and has devastated lives and livelihoods. The forum was convened in order lay out the existing knowledge gaps, map emerging research priorities and decide on the critical research questions that need to be addressed going forward. The conference follows the first … Continue reading WHO-led Research & Innovation Forum on COVID-19: July 2

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GAVI COVAX FACILITY: Questions on access, pricing & governance

A first look at Gavi’s COVID-19 Global Access COVAX Facility (Preliminary Technical design) Gavi – The Vaccine Alliance, is putting together a plan to devise the supply of COVID19 vaccines when they become available, to those who need it. The question of how should the world work towards equitable access, is an incredibly complex one. Gavi’s plan, does not answer this question, yet. The keys to this question,  may lie in how the politics of vaccines plays out in the coming weeks and months. Gavi’s plan, a work in progress, raises worrying questions on its ability to ensure equitable access, … Continue reading GAVI COVAX FACILITY: Questions on access, pricing & governance