The mpox outbreak – characterised by the all-too-familiar lack of vaccines for Africa – provided added impetus to the global negotiations for a pandemic agreement, which resumed at the World Health Organization (WHO) headquarters in Geneva on Monday. 

Ethiopia, speaking for Africa, said that mpox, recently declared a public health emergency of international concern, “calls for a more focused approach to address the outstanding elements in the draft pandemic agreement to ensure that it’s balanced and addresses the gaps that perpetuate past inequalities and inequities, particularly in the developing countries”. 

“We cannot maintain the status quo,” stressed Ethiopia.

Mpox “illustrates the importance of a pandemic agreement that will effectively cover and address the full [pandemic prevention, preparedness and response] cycle”, added the European Union (EU).

Warm-ups

While the Intergovernmental Negotiating Body (INB) last met in July, four warm-up “interactive dialogues” were held last week addressed by experts and aimed at clarifying the big topics ahead of the negotiations. These focused on the pathogen access and benefit-sharing (PABS) system, One Health and what legal architecture is most appropriate for adopting the agreement.

PABS – how to share information about dangerous pathogens speedily and in a way that parties benefit if they share the information – is the heart of the agreement for many countries.

Ethiopia, speaking for the Africa region, stressed that PABS is “an integral part of the pandemic agreement, and its success will determine the fate of the entire agreement and its coming into force”.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) appealed for flexibility in the agreement.

“We believe it is possible to reach an agreement that addresses the needs of countries while enabling the private sector to innovate and respond effectively to future pandemics,” said the IFPMA’s Greg Kumer.

“Each pathogen of pandemic potential is unique, and so too will be the response of each company. The agreement must recognize the diversity within the biopharmaceutical industry as each company has different strengths based on its size, location, technology, platform and manufacturing capabilities,” said Kumer.

“We call for a framework that allows companies to choose from a menu of options to maximize their impact.”

He also called for for “creativity and proactive engagement” to “tackle critical challenges such as improving demand forecasting, ensuring surge financing for procurement in low income countries and addressing regulatory barriers”. 

Legal architecture

Aside from negotiating the content of the agreement, member states are debating how it should be adopted to ensure maximum effect. They are deciding whether to adopt it in terms of Article 19 or Article 21 of the WHO Constitution.

Under Article 19, the agreement would be a treaty-like “operative instrument” that, once adopted by the World Health Assembly (WHA) by a two-thirds majority, states would need to sign and ratify – potentially delaying adoption by years.

Under Article 21, the WHA has the authority to adopt regulations on “procedures designed to prevent the international spread of disease”. Once adopted by the WHA, member states would be bound by the regulations unless they opt out.

However, Knowledge Ecology International warned: “An Article 19 treaty will carry more legal authority for many member states, which has advantages, but in some forms and for some countries, the ratification of a treaty will be challenging, and may take considerable time.”

WHO’s Chief Legal Officer Steven Solomon also explained that the agreement itself had the potential to set up other structures – such as on PABS and One Health. These could either be annexes or protocols, and these too could be incorporated under Articles 19 or 21.

Decisions would need to be made based on what the approval mechanisms are internationally and domestically, said Solomon.

“Will the governance for the instruments be the same? Will there be complementary governance processes? If so, how will that complementarity and coordination be developed? And then the third consideration is, of course, implementability,” stressed Solomon.

US Ambassador Pamela Hamamoto stated her country’s preference for PABS to be adopted under Article 21 to enable “the broadest participation and allow for rapid adoption”. 

“Some experts [at the interactive dialogue] cautioned that if the pandemic agreement were adopted under Article 19, pursuing a PABS instrument under Article 21 could present complexities for aligning parties to both instruments and coordinating entry into force,” she added.

The Pandemic Action Network’s (PAN) Aggrey Aluso urged member states not to opt for protocols of annexes but to keep PABS, technology transfer, intellectual property and One Health as “robust in the text of the final agreement”.

“We think relegating issues to separate protocols only would further fragment the global PPR ecosystem and undercut the global solidarity and universality needed for meaningful change,” stressed Aluso.

Next two weeks

Addressing the opening, South Africa urged member states “to guard against losing the caring spirit and solidarity that existed at the beginning of this process. It is that commitment to humanity and the principles of solidarity in addressing equity that will carry us to change the current status quo.”

The rest of this INB, until its conclusion on 20 September ,will be conducted in closed negotiation sessions.