A WHO pandemic instrument: substantive provisions required to address global shortcomings

COVID-19 resulted in at least 14·8 million excess deaths globally between 2021 and 2022 and derailed progress towards achievement of the Sustainable Development Goals.¹ During the COVID-19 pandemic there have been capacity gaps in national pandemic prevention, preparedness, and response (PPR) strategies, failures of international collaboration and solidarity, and underlying inequities and inequalities.² The impacts of the COVID-19 pandemic disproportionately affected people living in vulnerable situations.³ Inequitable access to medical countermeasures across nations, particularly in Africa, led to poor access to vaccines, diagnostics, and treatments, exacerbated by vaccine nationalism.4, 5 The negotiation in 2023 by the Intergovernmental Negotiating Body (INB) for a convention, agreement, or other international instrument on PPR and the process of amending the International Health Regulations (2005) (IHR) has been undertaken to address these shortcomings. The World Health Assembly in May, 2024 is expected to adopt the new instrument and the amendments to the IHR. The Zero Draft of the instrument released on Feb 1, 2023,⁶ involved inputs from member states, UN agencies, the public, and other stakeholders through deliberations in the first three INB meetings,⁷ as well as written submissions. There has been further discussion on the Zero Draft at the fourth INB meeting and at the fifth meeting on April 3–6, 2023. A progress report on INB work will be reported to the World Health Assembly in May, 2023. The content of the final instrument will be negotiated and decided by countries.

We, as members of the Bureau of the INB, highlight certain elements in the Zero Draft⁶ and potential different views among members of the INB. The Zero Draft proposes a definition of pandemic as “the global spread of a pathogen or variant that infects human populations with limited or no immunity through sustained and high transmissibility from person to person, overwhelming health systems with severe morbidity and high mortality, and causing social and economic disruptions, all of which require effective national and global collaboration and coordination for its control”.⁶ This definition prompted much discussion at INB meetings. Should a pandemic be a situation that upscales from the Public Health Emergency of International Concern (PHEIC), as declared by the WHO Director-General upon recommendations by the Emergency Committee of the IHR? A PHEIC means an extraordinary event that constitutes a public health risk to member states through the international spread of disease and that potentially requires a coordinated international response. However, in practice, a PHEIC is declared when an event fits two of the following four criteria: there are serious public health impacts from the event; the event is unusual or unexpected; there is substantial risk of international spread; and the event is likely to disrupt international travel or lead to trade restrictions. At some point during the negotiation, the INB has yet to discuss and propose the modalities and terms for “declaring a pandemic” by the WHO Director-General, which may need to take into account and interlink with relevant IHR provisions and mechanisms.

In the Zero Draft, One Health has been proposed due to the nexus between environmental factors, animal and human health, and the incorporation of measures that can prevent disease outbreaks. Gaps in integrated One Health surveillance⁸ of pathogens with pandemic potential hamper risk assessment of pandemic threats and the initiation of research and development on potential pharmaceutical countermeasures. There are advocates for deep prevention through a One Health approach,⁹ which means focusing on preventing the outbreak of the disease from occurring through upstream and midstream prevention. The global watchlist of pathogens with high spillover potential support the development of new virus countermeasures.¹⁰ Comprehensive One Health integrated surveillance contributes to effective primary prevention of a pandemic and specific preparation for countermeasures.

Accelerating availability of effective, safe, quality medical countermeasures is essential in a public health emergency to save lives and reduce disease spread and severity. National regulatory authorities will need to explore and implement expedited pathways to ensure availability of such medical countermeasures in the market. A facilitated regulatory pathway for medical countermeasures during a pandemic has been proposed¹¹ through which time-limited authorisation is possible when there are limited human data and completion of clinical development is mandatory. This scenario requires considerable at-risk investment of commercial scale manufacturing before clinical proof of concept to ensure large-scale manufacturing earlier in development. Investment in large-scale production capacity will ensure global demand for these medical products. For such facilitated regulatory pathways, national regulatory authorities conduct earlier assessment with authorisation potentially granted based on preclinical efficacy and human safety data or with minimal human efficacy and safety data. Further, market licence is approved under exceptional circumstances, such as Emergency Use Authorization or Emergency Use Listing, and limited to the duration of declared public health emergency. These expedited pathways implemented by national regulatory authorities ensure timely availability of pandemic-related products in their countries.

There are crucial issues where members of the INB hold different opinions. The Zero Draft proposes that although all countries have a common responsibility to strengthen their PPR capacity, some countries that hold more resources than others should bear a commensurate degree of differentiated responsibility in supporting countries with less capacity.¹² This approach may include, for example, the training of the public health workforce and epidemiologists alongside strengthening zoonotic surveillance and genomic sequencing capacity. Some views were expressed at the fourth meeting of the INB that this concept of common but differentiated responsibility, which has been applied to climate actions in the United Nations Framework Convention on Climate Change (UNFCCC),¹³ may not be applicable to the context of global health.

In the Zero Draft of the pandemic instrument, it was proposed that strengthening the manufacturing capacity of pandemic response products in low-income and middle-income countries, through transfer of technology and know-how, would fill the gap in global production capacity (located largely in high-income countries), which falls short of being able to supply 8 billion people during a global event.¹⁴ Improved manufacturing capacity to match global demand may not be a contentious issue, but transfer of technology and know-how can be a major issue, likely in relation to pharmaceutical industries.

INB discussions have been ongoing on a waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights for COVID-19 vaccines that was raised at the World Trade Organization (WTO) 12th Ministerial Conference in June, 2022.¹⁵ In keeping with the global debates on this issue,16, 17 some argued at the fourth INB meeting that these issues should be dealt with by other competent organisations, such as the WTO and World Intellectual Property Organization, whereas others suggested that the issues can, and should be, dealt with as part of this instrument, as proposed in Articles 7 and 8 of the Zero Draft.⁶

The Zero Draft also proposes timely sharing of pathogens with pandemic potential and genomic sequence data. A global mechanism on pathogen access and benefit sharing between providers and users is also proposed, drawing on learnings from the implementation of the Pandemic Influenza Preparedness (PIP) Framework, which has been a successful access and benefit sharing mechanism designed for pandemic influenza biological materials and partnership contribution.¹⁸

Equity, a fundamental guiding principle, is incorporated in legal provisions in the Zero Draft, and this includes, as part of access and benefit sharing, that WHO should have access to 20% of “pandemic-related products”, including diagnostics, vaccines, personal protective equipment, and therapeutics.⁶ This approach would ensure initial early responses to countries affected by a pandemic. In 2022, the 15th UN Biodiversity Conference (COP 15) to the Convention of Biological Diversity (CBD) agreed on establishing a multilateral fund for the equitable sharing of benefits between providers and users of genetic resources and the digital sequence information, with the adoption of goal C, and target 13 to ensure such sharing.¹⁹ This decision has a bearing on the INB discussion on pathogen access and benefit sharing schemes as proposed in the Zero Draft, since access and benefit sharing under the CBD umbrella can be a reference for INB negotiation.

The Zero Draft also proposes adequate reporting, regulations, and oversight for biosecurity and biosafety to ensure that gain-of-function research,²⁰ which genetically alters organisms to increase their pathogenicity and transmissibility, does not lead to disease outbreaks, either by human error or intentional release of such pathogens. Current INB discussion suggests support for introducing stricter regulations of laboratories where such research is done.²¹

An oversight mechanism of adherence by state parties to their commitments in a pandemic instrument is important to ensure improved PPR capacity.²² Studies show that existing international agreements do not usually ensure needed compliance monitoring. A meta-analysis, which assessed 53 legally binding international agreements that did not include accountability mechanisms, showed that these treaties that aim to foster global cooperation failed to produce their intended effects.²³

As INB Bureau members, we reiterate our integrity and impartiality in facilitating INB negotiation among the 194 countries that are integral to the process. Together, through mutual trust within INB and between INB and the Bureau, and our shared visions, we are confident that the INB will be able to reach consensus on the new instrument that provides concrete, timely, and equitable means of preventing, preparing for, and responding to future pandemics.

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All authors are members of the Bureau of the Intergovernmental Negotiating Body (INB). We declare no other competing interests. This Comment neither represents the position of each Bureau member's country of origin nor prejudges the ongoing INB discussion or conclusions.