Call for benefit sharing from Mpox and COVID-19 pathogens

Covid-19

Kochi, 7 June (Nithin Ramakrishnan) – World Health Organization Member States – Indonesia, Namibia, India and Bangladesh – have made a strong call for fair and equitable sharing of benefits arising from the use of Mpox and COVID-19 pathogens and genetic sequence data.

They stressed that these are to be shared in accordance with standing recommendations made by the WHO under the International Health Regulations (IHR) 2005 (amended 2024).

These interventions came during discussions on Agenda Item 16 at the 78th World Health Assembly (WHA78), held in Geneva from 19 to 27 May 2025 at the United Nations Office in Geneva.

Agenda Item 16 on Health Emergency Preparedness and Response covered multiple issues, including the ongoing WHO Pandemic Agreement. Sub-items 16.1 and 16.3 specifically focused on WHO’s work to strengthen the global health emergency architecture and on the implementation of the IHR 2005, respectively.

The former deals with initiatives and work by the WHO Secretariat, grouped under the title “strengthening the global architecture for health emergency prevention, preparedness, response and resilience”, and the latter with the implementation of the IHR 2005.

Sub-item 16.3 involved a report from the WHO Director-General on the extension of standing recommendations for Mpox and COVID-19. Under Article 16 of the IHR 2005, the Director-General may issue such recommendations to help prevent or reduce international disease spread and avoid unnecessary disruption to global travel.

Under Article 53 of the IHR 2005, standing recommendations should be submitted for the consideration of the health assembly. Although these recommendations were submitted for the consideration of last year’s WHA77, this time the Director-General report on implementation of the IHR 2005 (A78/11) says the recommendations are submitted to the Health Assembly “for information”. Thus the standing recommendation for Mpox and COVID-19 was submitted as information documents A78/INF./6 and A78/INF./7 respectively.

Standing recommendation to share pathogen genetic data through public databases and lab networks

Under the standing recommendations for Mpox and COVID-19, States Parties to the IHR 2005 are advised to share pathogens and genetic sequence data (GSD). However, there is no parallel recommendation on the fair sharing of benefits – such as vaccines, therapeutics and diagnostics – arising from that data. Nor is there guidance on using national access and benefit sharing (ABS) laws or ensuring post-trial access to clinical research.

For instance, Recommendation B.7 of the Mpox standing recommendations urges States Parties to “collaborate with other countries so that genomic sequencing is available in, or accessible to, all countries. Share genetic sequence data and metadata through public databases.”

Similarly, the COVID-19 Recommendation C.8 advises countries to “maintain public reporting of sequences with metadata and support the establishment of the WHO Global Coronavirus Laboratory Network (CoViNet), including to support future selection of strains for updated vaccines.”

Yet, both recommendations are silent on how countries might leverage ABS laws to secure access to resulting health products or ensure that participation in networks like CoViNet leads to equitable outcomes.

The Mpox recommendation merely “encourage” States to work toward access. Paragraph G reads: “States Parties are encouraged to work towards ensuring equitable access to safe, effective and quality-assured countermeasures for Mpox, including through resource mobilization mechanisms“.

The COVID-19 guidance follows the same approach. It “encourages” States to pursue equitable access through mechanisms such as technology transfer, manufacturing expansion, and resource mobilization.

Moreover, the Mpox recommendation call for clinical trials (Recommendation D.12) but provides no guidance on post-trial access as well. It reads: “States Parties are encouraged to conduct clinical trials of medical countermeasures, including diagnostics, vaccines and therapeutics, in different populations, in addition to monitoring their safety, effectiveness and duration of protection“.

Member States demand sharing from shared data and use of laboratory networks.

Namibia, noting specifically the above recommendations on public reporting of genetic sequences and use of CoVinet, said that the “standing recommendations do not explicitly address the benefit sharing on post-trial access on equal footing”.

Namibia added that “We are not sure whether these recommendations are accompanied by guidance or obligation to ensure benefit sharing from the use of sequencing data, given their importance in WHO legal reforms”.

Accordingly Namibia sought clarity from the Secretariat: “We request the Secretariat to please clarify whether terms and conditions of pathogen and sequence data sharing through the CoVinet include commitments to share the vaccines, therapeutics and diagnostics developed via this network and if so, what those commitments entail”.

Indonesia advocated for strengthening health systems to ensure swift and effective response to emerging threats and strategic investments in robust early warning systems, targeted support for populations in vulnerable situations to mitigate health disparities during emergencies, sustained capacity building, technical assistance and knowledge sharing amongst Member states. In so doing, Indonesia called for enhanced global cooperation to ensure equitable access to essential medical countermeasures including vaccines, diagnostics and therapeutics.

The Indonesian delegation then stated: “We take note of the Director-General’s standing recommendations on Mpox which includes sharing GSD through public databases and conducting clinical trials for countermeasures. We believe these recommendations should be complemented with recommendations to ensure or facilitate benefit sharing arising from use of GSD as well as post-trial access”.

India and Bangladesh also joined the call for benefit sharing. Bangladesh requested from the Secretariat the status of response to Mpox in the backdrop of vaccine shortage. It also requested WHO to continue its efforts for adequate supplies of vaccines, diagnostics and therapeutics to the countries in need, as standing recommendations on COVID-19 pandemic are in effect till 30 April 2026.

Referring to the recommendations B7 and D12 on Mpox and C8 on CPVOD-19, Bangladesh called for “sharing of dividend” (benefits) and “post-clinical trial access commitments”.

Responding to the related agenda item 16.1 India stated, “Platforms like e-GISRS and BioHub require enhanced coordination and cooperation among the member states for fulfilling its mandate by ensuring equitable access to benefits, particularly to [low and middle income countries] and [middle income countries] in a transparent manner”.

[e-GISRS is the expanded Global Influenza Surveillance and Response System. The WHO BioHub System is a mechanism for WHO Member States to voluntarily share novel biological materials with epidemic or pandemic potential.]

India further made a call “to strengthen preparedness, investments in core [health emergency prevention, preparedness, response and resilience] capabilities such as strong collaborative surveillance backed by digital platforms, technology transfer and regional manufacturing hubs, and emergency coordination are essential”.

Namibia also acknowledged the critical importance of a robust and responsive health emergency system and appreciated the progress in expanding surveillance capabilities including integrated early warning systems and genomics surveillance. However, Namibia also urged strongly for WHO and Member States to adopt ABS measures to ensure equitable access to health products.- Third World Network