A Year in the Life of GPP: What’s actually happening, and how do we know it’s working?

The Good Participatory Practice (GPP) Guidelines have been shaping and improving HIV prevention research since 2007. They provide a global reference guide for ethical and effective stakeholder engagement, helping ensure the priorities of trial participants and their communities are centered in clinical trials and broader research agendas.   

One year ago, AVAC published the Good Participatory Practice (GPP) Body of Evidence, an online clearinghouse of tools, best practices and analyses showcasing the power of GPP. Here, we bring you a report from the year since – how this clearinghouse of resources continues to demonstrate the value of GPP, and concrete examples from 2024 of GPP’s impact on major research agendas and mechanisms. Read on for highlights. 

Critical Learnings from GPP: The Body of Evidence Webinar Series

Throughout 2024, AVAC and partners facilitated a series of webinars in collaboration with The Global Health Network, Wellcome Trust, and WHOfeaturing resources housed in the Body of Evidence. These conversations expanded the traditional understanding of GPP – highlighting that GPP is not just about trial implementation; that its practices evolve from product discovery to delivery and are important at every step of the way; and that monitoring and evaluation are complex and critical nuances are required to ensure its meaningful application. Look out for a final webinar on elevation of GPP in global clinical trials guidance in 2025. The full recordings and presentations are on the AVAC website.  

View the webinar series
A Few of our Favorite Moments from the Webinar

Our great leader Nelson Mandela said, ‘everything that is done for me, without me, is done against me,’ and we really must see our community members as having a role beyond that of as just a potential trial participant but to engage them right from the beginning, from the protocol design, from all our planning pre-study, the conduct of the study, and most important to the dissemination of the results – whether they be positive or negative. — Dr. Michelle Temeris, University of Capetown

How can we craft research questions so that when we have an answer at the end of the day it’s really something meaningful and impactful to communities? We can answer scientific questions that might be interesting to a researcher but at the end of the day that doesn’t get us very far if it’s not also equally impactful for community. — Sarah Read, US National Institute of Allergy and Infectious Diseases 

Thinking about community engagement moving forward we need to think about building relationships over time and beyond particular studies. We need to make sure that we’re not only giving accurate information but we’re also listening and responding to issues that are being raised in the course of our interactions. — Sassy Molyneux, KEMRI-Wellcome Trust, University of Oxford

One really important perspective would be to monitor the impact that engagement has on the trial, the way it’s run. That would be a really important aspect of monitoring and evaluation – to make note of the real changes that community stakeholders can have on the way trials are selected in the first place but also modified to make them appropriate. — Alun Davies, Global Health Network

GPP in Action: Influencing Research Programs

Advocates’ Consultation on Merck’s Monthly Pill Program

In recent years HIV prevention efficacy trial design has become one of the hottest topics. As the HIV prevention toolbox improves, researchers, statisticians, and regulators grapple with the best way to incorporate these options into efficacy trials. The key to all of this, they say? Community.  

ImageEnter GPP! In June, AVAC convened a community and advocates’ consultation with Merck around their program testing MK-8527 as a monthly pill for PrEP. With an efficacy program on the horizon, Merck set out to consult with communities – before any other stakeholder – about issues like choice of a comparator arm, the evolving standard of prevention, and how a trial could best reflect the reality of implementation in peoples’ countries, communities, and own lives. Consultation members consolidated feedback that is now being fed into Merck’s protocol development. Priorities included a design that would get to an efficacy answer most efficiently, but that would incorporate contextual issues of prevention choice as possible. Participants concluded that a monthly pill would be an important addition to the prevention toolkit, and thus support for the research program. But they also expressed ongoing frustration around community support for research that does not translate into access for their communities.  

Watch this space for further updates on the MK-8527 program, as engagement continues through protocol development, trial planning, implementation, and beyond!   

Pediatric Adolescent Virus Elimination (PAVE) Community Advisory Board (CAB)

Communities have been a key stakeholder advancing HIV cure research from the bench to early phase clinical trials. GPP has been the guiding principle as engagement has moved further upstream.   

The Pediatric Adolescent Virus Elimination (PAVE) Community Advisory Board (CAB) is an example of this impact as the only group dedicated to advancing an HIV cure in pediatric populations. Through its digital Voices Project featuring young people with HIV, clinicians, caregivers and researchers, the CAB has raised awareness of the research among youth in Sub-Saharan Africa who engaged with ministries of health to push for the inclusion of children in research. They also worked with PAVE investigators to simplify and convey complex scientific and ethical issues inherent in cure research.  

As research moves from the bench to the clinic, the CAB and community partners, will continue to play a strategic role in shaping future protocol designs and addressing community support needs.  

Elevating GPP: WHO’s New Clinical Trials Guidance

In September, 2024, the World Health Organization published their new Guidance for Best Practices for Clinical Trials. The guidelines state that centering patient, participant, and community engagement will lead to more efficient and equitable trials. Input from AVAC and partners, including Wellcome Trust, The Global Health Network, University of Oxford, and others helped ensure the new guidance centered the importance of community engagement in creating more equitable and actionable clinical trials research. 

Save the Date

On December 13, 2024, WHO is hosting a webinar, WHO launches new clinical trials guidance – What do I need to know? Registration is free, and during the webinar WHO will highlight key areas of change in the guidance for everyone involved in clinical trials.  

Register

Since AVAC and UNAIDS launched the GPP guidelines in 2007, the science and politics have grown ever more complex – and GPP implementers have continued to adapt, evolve and engage. We are committed to continuing our efforts to curate insights and resources, including further building out the Body of Evidence, and to support our collective advocacy for ethical and effective stakeholder engagement throughout clinical trials, research agendas and implementation in the months and years to come. 

Introducing the Gears of Lenacapavir Rollout and The People’s Research Agenda

This World AIDS Day, the HIV/AIDS response stands at a crossroads, with injectable lenacapavir set to transform HIV prevention. But as the new UNAIDS report highlights, it also comes at the same time as restrictive policies, economic instability, and geopolitical challenges threaten to frustrate access and rollback so much of the progress that has been achieved over the past two decades. 

AVAC’s 2025 advocacy agenda prioritizes collaboration and strategies for equitable and accelerated product introduction that maximize the public health potential of new prevention options and simultaneously sustains investment in critical research and development. AVAC’s newest publication, The Gears of Lenacapavir for PrEP Rollout, provides a clear pathway for the speed, scale and equity needed to translate exciting science into public health impact, while our recent The People’s Research Agenda (PRA) meets this high-stakes moment for HIV prevention with a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed in the future. 

Despite the challenges, 2025 holds immense potential for ensuring the equitable rollout of new options and the accelerated development of a pipeline of additional options, the combination of which can help move the field closer to ending HIV/AIDS.  

For the latest information on injectable lenacapavir for PrEP, be sure to join us for our webinar Tuesday, December 3. And read more below about both the Gears of LEN for PrEP Rollout and The People’s Research Agenda. 

The Gears of Lenacapavir for PrEP Rollout: Driving Speed, Scale, and Equity

Lenacapavir’s rollout is not just about making a new drug available as quickly as possible; it is about ensuring that it reaches the people who need it most, as swiftly and equitably as possible. Gilead has announced its readiness to manufacture up to 10 million doses for 2026, but this potential hinges on coordinated action by governments, donors, and civil society. The roadmap outlines the essential gears driving this effort, from robust demand generation and procurement strategies to equitable distribution and community-driven implementation. Crucially, the roadmap emphasizes lessons learned from previous PrEP interventions: that availability alone is not enough. With global HIV targets still unmet and disparities persisting, this effort demands decisive action and long-term planning.

Download the infographic

The People’s Research Agenda: A Community-Driven Vision

The People’s Research Agenda (PRA) brings the voices of affected communities to the forefront of HIV prevention research and product development. With limited resources, the stakes for decisions about which products to develop and eventually deliver become even higher for funders, communities, policy makers and governments. The PRA offers a bold vision for aligning scientific innovation with community needs. By amplifying the perspectives of those most affected by the epidemic, the PRA is a tool for driving accountability among funders, developers, and policymakers. As a living, adaptable framework, it ensures that evolving needs and challenges in the prevention landscape remain at the center of decision-making.

A Call to Action

The rollout of lenacapavir and the implementation of the PRA come at a critical moment in the global HIV/AIDS response. Achieving their full potential will require sustained collaboration, strategic investments, and unwavering commitment to equity. Together, we can transform this pivotal moment into lasting progress.

Advocacy: Now more than ever

We are in a period of profound uncertainty, remarkable progress and tremendous concern—for the state of the world, for the state of global health and HIV, and for the specific work that AVAC and our partners do. We’ve seen incredible advances in biomedical prevention in 2024 with the introduction of the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB) for PrEP and the spectacular clinical trial results of injectable lenacapavir—the combination of which could transform lives if rolled out with speed, scale and equity.  

For many of us, the unfolding developments in the United States, which continue to ripple across the global health community, are sparking anxiety around whether we can sustain the progress the field has made over decades while continuing to develop effective HIV prevention options and ensure access to those options for everyone who needs and wants them.  

At AVAC, we see strength in staying focused on developing what we need and delivering what we have. We are doubling down on delivering high-quality, impactful work, supported by ongoing collaboration with our partners to meet our mission in a shifting environment.

Your help is instrumental to the success of this work. If you appreciate our insights, resources, infographics, coalition-building, and evidence- and rights-based advocacy, please consider making a contribution to ensure that this work can continue.

As we recognize World AIDS Day this weekend and next week’s #GivingTuesday, a global day dedicated to giving back, we ask you to consider supporting AVAC so that we and our partners can continue to deliver the effective and impactful advocacy that is needed now more than ever. This means continuing to put people and communities at the center of our work, ensuring that the global response is connected to the real needs of affected people.

Many thanks in advance for your partnership and support.

Advancing Choice and Equity: New tools and a changing landscape

As a new US presidential administration takes shape, our commitment to championing choice, science, and rights remains unwavering. This critical moment demands intentional strategies to protect progress in HIV prevention and global health equity while staying true to our mission and values.

Given the concerning rise of health misinformation on X (formerly Twitter), we must find new ways to share accurate, science-based information. Starting this week, we’ll begin to transition our presence to BlueSky, an open-source alternative to X, alongside Instagram and Facebook. Learn more about Blue Sky here and be sure to follow us.

Read on for the latest insights on CAB for PrEP and new resources on PrEP delivery, STI R&D, and the political challenges and the priorities in 2025 and beyond.

Trials to Impact: The Latest Insights on CAB for PrEPAn Advocate’s Guide to Research in Pregnant and Lactating Populations

The Biomedical Prevention Implementation Collaborative (BioPIC) is leading an integrated and adaptable strategy to deliver new HIV prevention products, with a particular focus on longer-acting PrEP methods. The BioPIC’s Adaptable Product Introduction Framework, emphasizes the need to conduct early-stage activities alongside Phase III clinical trials, and conducts Think Tanks to pinpoint evidence gaps and share insights from modeling and implementation studies. This work is driving more effective, people-centered product delivery. Read more on recent CAB for PrEP insights and visit the Evidence Gap Tracker.

READ THE INSIGHTS

Resources on PrEP Delivery, STI R&D, and More!

Video Recording and English Audio / Ukrainian Audio / Portuguese Audio / Spanish Audio / Slides / Resources

Recording / Alison Footman Slides / Mandisa Mdingi Slides / Cécile Ventola Slides / Birgitta Gleeson Slides

KFF’s Jen Kates and AVAC’s Suraj Madoori lay out the challenges and the priorities in 2025 and beyond. 

In the days, months and years ahead under a new US Presidential Administration, advocacy for choice, freedom, science, and rights will require intentional strategies to protect hard fought gains in HIV treatment and prevention and in global health generally, and to safeguard policies and programs that advance it. And there will be major implications for the global AIDS response.

LISTEN TO THE PODCAST

An Advocate’s Guide to Research in Pregnant and Lactating Populations

Check out our updated graphic in this advocates’ guide, which shares background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

READ MORE

Trials to Impact

The Latest Insights on CAB for PrEP

The Biomedical Prevention Implementation Collaborative (BioPIC) is leading an integrated and adaptable strategy to deliver new long-acting HIV prevention products, including injectable cabotegravir (CAB) for PrEP. The HIV prevention products that exist today hold the potential to curb incidence, but their impact relies on stronger coordination to ensure they reach those who need them most. BioPIC unites a group of over 100 diverse stakeholders—civil society, donors, researchers, policymakers, implementers, and normative agencies like WHO and UNAIDS—across more than 20 countries to address these challenges. To support this, BioPIC introduced the Adaptable Product Introduction Framework, emphasizing the need to conduct early-stage activities alongside phase III clinical trials, and conducts Think Tanks to pinpoint evidence gaps and share insights from modeling and implementation studies. This work is driving more effective, people-centered product delivery, and is described in this article with colleagues at WHO: Shaping and coordinating the implementation science agenda for injectable cabotegravir for PrEP: the role of the Biomedical Prevention Implementation Collaborative (BioPIC).

To ensure lessons around early CAB for PrEP implementation are consolidated and captured, AVAC developed the CAB for PrEP Priority Evidence Gap Tracker, which tracks progress against addressing the highest priority CAB for PrEP evidence gaps identified in BioPIC Think Tanks. As data from the open label extension studies of the two CAB for PrEP Phase III trials, HPTN 083 and 084, as well as early implementation studies and modelling studies, has begun to emerge, AVAC has continued to update the tracker, with some of the latest major insights summarised below.

Rapid testing is the right choice for CAB for PrEP initiation and continuation

CAB is from a class of antiretrovirals called integrase strand transfer inhibitors (INSTIs), the same class as dolutegravir (DTG), a common first-line HIV treatment. There is a risk that people using CAB for prevention could develop resistance to INSTIs, which could compromise the effectiveness of DTG as treatment. Preventing the development of INSTI resistance is, therefore, a high priority for CAB for PrEP implementers. Resistance may develop if a person living with HIV (but unaware of their status) initiates CAB for PrEP or continues to use it after a breakthrough infection, so implementers need to feel confident in the results of HIV tests used at initiation and continuation visits. During the initial stages of programmatic rollout of CAB, there were questions as to whether rapid HIV tests were sensitive enough to be used for this purpose, or if more expensive, lab-based RNA testing would be required. After reviewing emerging evidence, WHO confirmed that rapid diagnostic tests can be used for CAB for PrEP initiation and continuation. Moreover, the HPTN 083 study team concluded that RNA testing performed poorly as a screening tool for CAB for PrEP continuation, as it led to false positives.

CAB for PrEP is safe to use during pregnanc

The HPTN 084 trial of CAB for PrEP amongst cisgender women included a requirement for participants to use contraception while enrolled in the trial, and participants who did become pregnant were immediately discontinued from CAB for PrEP. This meant that at the end of the trial, researchers were unable to conclude whether CAB for PrEP was safe and effective to use during pregnancy. The open label extension phase of the trial removed these restrictions, and with this new data, the HPTN 084 team has been able to confirm that CAB for PrEP is safe and well-tolerated in pregnancy. Delay in confirming this has led to confusion amongst implementers and variation across countries in whether CAB for PrEP is permitted for use in pregnancy, highlighting the importance of including pregnant and lactating people in clinical trials from the start, as has been done in the PURPOSE 1 trial of lenacapavir.

Offering choice increases PrEP uptake

For the first time, PrEP users in an increasing number of countries have the ability to choose from an array of options, including oral PrEP, CAB for PrEP, and the dapivirine vaginal ring.  The SEARCH study, in Kenya and Uganda, looked at the impact of choice on PrEP coverage, by comparing two groups of PrEP users: one offered the choice of oral PrEP or post-exposure prophylaxis (PEP), and the second offered oral PrEP, PEP, or CAB for PrEP.  Researchers found a highly significant impact, with PrEP coverage reaching 70% in the group whose options included CAB for PrEP, compared to 13% in the group offered only oral PrEP or PEP. 56% of users in the group offered CAB for PrEP took it up, and 42% of those who chose CAB for PrEP were not using any HIV prevention method at the time, demonstrating that adding more options can bring in more users as people are able to find products that better suit their preferences. Even more importantly, HIV incidence in the group offered CAB for PrEP was 0, compared to 1.8% in the other group. In addition to demonstrating the impact of choice in product, the SEARCH study demonstrated the impact of choice in delivery channel, by successfully offering a variety of HIV prevention options via outpatient facilities, antenatal clinics, and community health workers going door-to-door.

What’s next?

There are currently 31 ongoing CAB for PrEP implementation studies, all looking at different aspects of CAB for PrEP delivery among different populations across geographies. As interim insights continue to emerge from these studies, AVAC will continue to track them.  Check back regularly on the PrEPWatch Events page for webinars where these insights will be shared.

Resources

Think Tanks

The Votes Are In

What’s next for the US’ role in global health and HIV prevention?

In the days, months and years ahead under a new US presidential administration, advocacy for choice, freedom, science, and rights will require intentional strategies to protect hard fought gains in HIV treatment and prevention and in global health generally, and to safeguard policies and programs that advance it. What to do?

For a start, listen to AVAC’s newest PxPulse podcast. Jen Kates, Senior Vice President, Director of Global Health & HIV Policy at KFF, a nonpartisan health policy research organization and AVAC’s Director of Policy, Suraj Madoori lay out the challenges and the priorities in 2025 and beyond.

As the field prepares for new US leadership, advocates must take stock, identify allies, work in solidarity and seize opportunities. In the months and years to come, AVAC will be there, offering tools, analysis, and perspectives to support our collective work to advance HIV prevention and equity in global health.  

The Trump administration will likely have a fundamentally different worldview about US engagement in global health and in development. One that is much more isolationist, much more transactional. Why should the US be engaged in these programs? What is in it for us? And I think the challenges that will come up there, is where or will the US continue to play a leadership role diplomatically, financially, because the US is the largest funder of all global health programs.

Jennifer Kates
SVP and Director of Global Health & HIV Policy at KFF

There’s such a vibrant advocacy community outside the United States who want to engage their own governments in mobilizing domestic resources for HIV, who want to share their stories to Congress about the impact of PEPFAR and other lifesaving programs. That is a lot of untapped advocacy and a lot of North-South collaboration that will be so important to get us through at least the next two years into the midterms, if not the entire four years of this new administration.

Suraj Madoori
Director: Policy & Advocacy, AVAC

This Week at AVAC: US election, new LEN resources, STI pipeline and PrEP service delivery

As we continue to grapple with the results of the US presidential election and what this means for our work and for global health evidence- and rights-based policies and programs generally, we wanted to share a range of new tools and resources you may find helpful in your advocacy for choice, science and rights.

Injectable Lenacapavir for PrEP

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Additional LEN Resources

Webinars on the STI Pipeline, Advances in Research Ethics, and Money for the DVR and More!

Register

In Case You Missed It

Recording / Slides / DVR Early Market Access Vehicle page

And stay tuned for a new PxPulse podcast featuring Jen Kates of KFF and AVAC’s Suraj Madoori, The Votes Are In: What’s next for the US’ role in global health and HIV prevention. The podcast hits airways November 14.

Today — in the US and around the world

There are no words that can adequately, or appropriately, describe the state of the world right now and how AVAC and I are feeling about it. I expect it is a similar sentiment for all of us — irrespective of where we live and vote. 

AVAC was founded 30 years ago — in a very different time, with very different political and economic dynamics and epidemiologic realities. But from that beginning, AVAC has always championed an evidence- and rights-based, equitable response to the HIV epidemic — honoring choice and dignity for all.  

And we will not stop — not until we are done, and most definitely not now! 

We will all need time to process these US election results and strategize how we navigate through them in the days and years ahead — as individuals, as a network of partners, as citizens of the world, and — most importantly — as advocates for choice, freedom, science, and rights.  

There will, undoubtedly, be major implications for global health and the global AIDS response. We look forward to working with our partners in protecting hard-fought gains and in assessing the potential impact on PEPFAR and Global Fund support; on USAID, NIH, CDC and the FDA; on the US relationship to WHO and other UN agencies; and on evidence- and rights-based policies and programs generally.  

We will be in touch soon with an initial analysis, starting with the release of a podcast next week with Jen Kates from KFF and our own Suraj Madoori as we begin to unpack it all. And we look forward to working with all of you in reviewing it and making it actionable. 

Thank you; stay tuned; and stay strong. 

Mitchell J. Warren
Executive Director
AVAC

STIWatch Newsletter, November 2024

The past few months have brought exciting developments in the field of Sexually Transmitted Infections (STIs). The World Health Organization released the global priorities for STIs, which included the need to develop low-cost, rapid, STI point-of-care tests, vaccines, and communication strategies to increase STI awareness, prevention, service engagement. But we continue to see a soaring rise in STI incidence and an underfunded infrastructure for researching new treatment, prevention and testing tools. It’s up to the global community to ensure that research and development continues to see funding for better, faster, less expensive tools to reduce the toll of STIs. Read on for resources and insights to guide your advocacy.  

Conference updates

The annual conference of the International AIDS Society in July highlighted the troubling trend in the soaring rise in STI incidence. A preconference, Mobilize for Action on Sexually Transmitted Infections addressed the urgent need to confront the global spike in STI rates, particularly syphilis, gonorrhea, chlamydia, and trichomoniasis. Dr. Jeanne Marrazzo, director of NIAID, when discussing the number of global deaths from syphilis, which is treatable, said, “I think some of the more staggering statistics here, in addition to the sheer number of new infections, is the fact that we had in 2022 over 200,000 syphilis-associated deaths, which to me is practically medieval.” The meeting hosted a rigorous debate exploring the question of implementing DoxyPEP, given there’s no efficacy data for cisgender women in light of fears of creating drug resistant strains of STIs from wider use of doxycycline. Strong arguments were made on both sides, but this controversy is one of the reasons AVAC recently published an Advocate’s Guide to Doxycycline to Prevent STIs. 

The STI Prevention Conference in Atlanta, Georgia convened attendees in-person for the first time in four years and discussed the rise in syphilis rates, emerging gonorrhea treatments, STI funding and policy initiatives, and doxycycline post-exposure prophylaxis (DoxyPEP). Notably, much discussion centered on NIAID’s support for a biorepository to advance diagnostic development. This biorepository would streamline access to necessary specimens to support the research and development of new diagnostics. 

Save the date

New resources

Discover STIWatch.org!

STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts. 

STI Clinical Trials Dashboard

This dashboard provides information about trials focused on vaccines, diagnostics, and the use of doxycycline post-exposure prophylaxis (DoxyPEP) to detect, treat, and prevent chlamydia, gonorrhea, hepatitis B, herpes simplex virus (HSV), human papillomavirus, syphilis, trichomoniasis infections, and Mycoplasma genitalium.

Webinar Summary

Regulatory Pathways to Promote Access to STI Diagnostics. This webinar co-hosted with World Health Organization (WHO) supported researchers, product developers and the global advocacy community in identifying and discussing ways to bring new STI diagnostics to market with speed, equity and scale.

What We’re Reading

  • Special Issue: Sexually Transmitted Diseases. This leading journal celebrated 50 years by publishing a series of editorials that review the careers of some of the leading experts in the field. These stories are both inspiring and enlightening, highlighting the decades of efforts and growth in addressing STIs. AVAC’s own, Alison Footman, PhD, wrote about her experiences in the STI field and how instrumental mentorship has been in her career growth.
     
  • Gonorrhea point-of-care diagnostics technology and market landscape. This landscape report provides an overview of gonorrhea point-of-care diagnostics that can be offered closer to patients and communities and limit time to results and ultimately treatment. Gonorrhea touches on multiple public health priorities including the need to reduce STI rates, growing antimicrobial resistance, and its impact on sexual and reproductive outcomes and HIV transmission. 
     
  • FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis. The US Food and Drug Administration approved the first syphilis self-test. This is a monumental step in expanding syphilis testing options as infections have increased drastically over the past five years. Self-tests can provide people with the option to learn their syphilis status and seek additional testing and treatment options from a healthcare provider. 

Partner Spotlight

AVAC partners have been busy moving the needle to improve STI prevention, testing, and treatment options in their respective countries. The Latu Human Rights Foundation partnered with HEP Initiative Zambia on a symposium to foster ideas on how to better address viral hepatitis and integrate hepatitis B interventions into other government funded health programs.

To learn more about AVAC’s STI Program, visit STIWatch.org and avac.org/sti. Email sti@avac.org for questions or additional information. And to sign up for specific updates on STIs, click here.

Analysis on the Pandemic Agreement

Guest post by Spark Street Advisors

Last week relevant stakeholders were invited to a meeting with the Bureau for an Intergovernmental Negotiating Body (INB) for a pandemic agreement.  

The jury is out on whether or not negotiating states come to a consensus by mid-November, which is the deadline for calling a Special Session of the World Health Assembly (WHA) before the end of 2024. If they don’t meet this deadline, negotiations would de facto continue through May 2025, when the WHA is next scheduled to meet.

Beginning on the 4th of November, the INB will begin their 12th session in Geneva, which will be make or break. They continue to discuss the latest version of the draft, last published on Friday 20th September.

In preparation for these meetings, a group of stakeholders, including Resolve to Save Lives, AIDS Health Care Foundation Global Public Health Institute at the University of Miami, AVAC, the Independent Panel Secretariat, and Spark Street Advisors, have prepared an analysis of the current text. We are available to discuss our analysis.

In summary, the current text is very weak, and there is little time left to agree more than 100 paragraphs which still remain TBC. Core issues, including Pathogen Access and Benefit Sharing, Financing, and One Health, remain unresolved. And there is no clear path to accountability. 

We will keep you updated when the formal negotiations resume. Until then, the INB continues to have informal drafting group meetings, including on Chapter I and specific articles. The openings and closing of the INB12 will be public, with daily briefings with stakeholders. The Bureau has also promised to circulate a revised version of the text prior to the opening.