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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

“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

“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

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