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By Nirmalya Syam and Muhammad Zaheer Abbas, PhD

On December 22, 2023, the U.S. Health and Human Services Department Office for Global Affairs requested comments “on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response.”

See comments submitted by Public Citizen and civil society below:

Misinformation, waning interest and entrenched positions threaten the World Health Organization’s (WHO) two pandemic-related negotiations aimed at strengthening future pandemic responses, according to a briefing given to the WHO executive board meeting on Monday. Draft agreements from the two processes – to establish a pandemic accord and to update the International Health Regulations (IHR) – are due to be presented to the World Health Assembly in May. But agreement will only be reached if member states are prepared to compromise and push back against “fake news, lies and conspiracy theories”, said WHO Director General Dr Tedros Adhanom Ghebreyesus. A global misinformation campaign is pushing the notion that the pandemic agreement and changes to the IHR will “cede sovereignty to WHO and give the WHO Secretariat the power to impose lockdowns or vaccine mandates on countries”, said Tedros. “We cannot allow this milestone in global health to be sabotaged by those who spread lies, either deliberately or unknowingly.

… As an international medical humanitarian organisation that provides medical care to people during crises, Médecins Sans Frontières/Doctors Without Borders (MSF) has responded to many infectious disease outbreaks, epidemics and pandemics over the last 50 years. These experiences have shown that timely, equitable and affordable access to medical products such as medicines, vaccines and diagnostic tests is crucial for an effective response to health emergencies. Based on our experiences, we believe that governments must take the following steps to ensure that the global pandemic accord safeguards access to medical products. … [1. Prioritise global equitable access and medical humanitarian needs in international stockpiling and allocation efforts; 2. Address intellectual property challenges for the protection of the right to health and access to medicines; 3. Ensure medical products that benefit from public contributions are accessible to people who need them; 4. Safeguard transparency, accountability and the public’s right to information by restricting confidentiality and trade secrets; 5.

As we approach the final months of member-state negotiations over a World Health Organization Pandemic Accord, due to come before the World Health Assembly in May, the efforts to forge a consensus have witnessed modest progress. However, the original divide between developed and developing countries on key issues such as finance, access and benefit sharing, transfer of health technologies, and ‘One Health’  approaches to pandemic prevention, continue to cast a long shadow over the process. Some critics worry that an accord, if and when one is achieved by the 2024 deadline, may be less meaningful in terms of substance and impact, because of the compromises required to reach an agreement. This issue of the Governing Pandemics Snapshot, the latest in the Geneva Graduate Institute series, recaps highlights of the past six months of negotiations. 

An analysis by Sangeeta Shashikant 

As Geneva was winding down for the Christmas break last December, the European Union (EU) circulated a six-page proposal on access and benefit-sharing to World Health Organization (WHO) Members. The proposal comes at a very late stage of the negotiations on the pandemic instrument and is expected to spark significant concerns. The EU proposal, which deviates from international norms established by the Convention on Biological Diversity (CBD) and its Nagoya Protocol is expected to exacerbate inequity, discourage the timely sharing of specimens and sequences by WHO Members, undermine national sovereignty, and erode the intergovernmental character of the WHO. The multilateral benefit sharing proposed by the EU is wholly inadequate and terribly flawed. This critique examines in detail the critical aspects that underscore the deficiencies in the EU's proposal and its possible ramifications on international collaboration during public health emergencies.

The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th ^WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyzes the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an

But pending discussions and consensus on key proposals including those focused on introducing equity-related considerations to the IHR, more time has been sought to conclude the negotiations on amending these rules. In addition, critical issues such as definition of a pandemic; a tiered alert system for declaring health emergencies; and on financing mechanisms; are being addressed both in the forum to amend the IHR, and in parallel discussions towards a new Pandemic Agreement. Unless these key issues are addressed within the overall scope of governing health emergencies including also pandemics, changes to IHR cannot be approved in isolation, diplomatic sources explained to us this past week.

In today’s edition we bring you the state of play in the discussions towards a new Pandemic Agreement, where countries are tackling the toughest issues in global health in the shortest possible time.

The process could take two paths, a shorter, easier one that might lead to the final deadline in May 2024, albeit without much change in status quo. A second, more challenging one, with a longer timeline, but one that might lead to few but potentially significant changes in the governance of health emergencies particularly for response measures. It is beginning to appear that political expediency could very likely push the first approach.

WHO member states struggled to understand and define the process of conducting negotiations during the first segment of the seventh meeting on the Intergovernmental Negotiating Body this week. This is even as they made slow and laborious progress in trying to improve a proposal for the negotiating text of a draft Pandemic Agreement, with their own proposals. This meeting will resume to conclude in early December and informal consultations will be conducted in the interim period.

Countries also decided to create subgroups on certain provisions in a bid to make quicker progress in attempting to narrow down vast divergences in positions on key issues including on technology transfer, intellectual property matters, financing and access and benefits-sharing among others.

While officially no country has as yet sought additional time for concluding the negotiations by the current deadline of May 2024, scores of delegations we spoke to, privately admitted that an extension would be inevitable in due course.