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TWN Info Service on Intellectual Property and Health WHO: Document reveals questionable practices in pathogen-sharing arrangements in WHO-managed networks Geneva, 11 February (K.M. Gopakumar, Lauren Paremoer and Sangeeta Shashikant): A concept note circulated by the World Health Organization (WHO) Secretariat during the Fifth Meeting of the Intergovernmental Working Group (IGWG) – the negotiating body for the Pathogen Access and Benefit Sharing (PABS) System – sheds light on questionable practices within WHO-managed laboratory networks operating across multiple pathogen and disease fields. Annex 1 of the concept note provides a non-exhaustive list of 15 laboratory networks established between 1952 and 2024. The earliest listed is the Global Influenza Surveillance and Response System (GISRS), established in 1952, while the most recent is CoViNet – the Coronavirus Network, established in 2024. Annex 2 lists laboratories involved in WHO’s R&D Blueprint on priority pathogens. The concept note is accompanied by an Excel document containing additional details on these laboratory networks. The note was developed in response to repeated requests from WHO Member States during the PABS negotiations for clarification on what constitutes the WHO-Coordinated Laboratory Network (WCLN) and its role in pathogen sharing under the PABS System. In particular, Member States sought transparency regarding which networks and laboratories handle pathogens and how they operate. According to the concept note, “there are at least 15 laboratory and similar networks coordinated across different WHO programmes. The specific roles, responsibilities, and activities conducted by these different WHO pathogen-specific laboratory networks reflect the technical areas they cover as well as the nature of their member laboratories. Some pathogen-specific networks include WHO collaborating centres, which have the capacity to do advanced characterization, including pathogen propagation”. Annex 1 indicates that cross-border pathogen and data sharing occurs within these networks for a range of purposes as follows – raising important questions about compliance with international and national rules on access and benefit sharing (ABS), oversight by WHO Members, transparency and implications for the Global South:
Undermining rules on access and benefit sharing? The Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit Sharing recognize the sovereign rights of States over their biological resources. Access to such resources is subject to the prior informed consent of the providing Party and to mutually agreed terms that establish the conditions for access, including provisions to ensure fair and equitable sharing of benefits arising from their utilization. The Nagoya Protocol further elaborates and operationalizes these rights by setting out detailed obligations on access procedures, benefit-sharing arrangements, compliance and monitoring. Building on these international norms, WHO’s Pandemic Influenza Preparedness (PIP) Framework was negotiated and adopted in 2011 to address the stark inequities in access to vaccines and other pharmaceutical products that developing countries experienced during the H5N1 and H1N1 influenza emergencies. The PIP Framework operationalized ABS principles at the multilateral level by establishing a structured system to facilitate the cross-border transfer of influenza viruses with pandemic potential and the sharing of their sequence information, while explicitly linking such access to binding benefit-sharing commitments. Over 14 years of implementation, it has generated at least US$349 million in partnership contributions from industry users and concluded multiple agreements with pharmaceutical companies to reserve supplies of vaccines and antivirals for use during a pandemic. By contrast, the concept note identifies at least 15 WHO-coordinated laboratory networks engaged in pathogen-sharing arrangements, yet mostly without an ABS mechanism comparable to the PIP Framework. The note itself clarifies: “Not all the networks and laboratories listed in the Table at Annex 1 will necessarily become part of the WCLN; only those laboratories and networks that handle pathogens that are relevant to the scope of the PABS System will be invited to join, and WCLN will grow as needs are identified.” This makes clear that even if certain laboratory networks dealing with pathogens of pandemic potential are incorporated into the PABS System, numerous other pathogen-sharing arrangements will remain outside any structured benefit-sharing framework. In effect, significant cross-border exchanges of biological materials and sequence information may continue without corresponding equity safeguards. The document therefore raises serious concerns about the coherence of WHO practice with the broader ABS framework established under the CBD and Nagoya Protocol. Notably, at least seven of these laboratory networks were established after the adoption of the PIP Framework in 2011, suggesting that parallel pathogen-sharing systems have expanded without being anchored in an equivalent multilateral benefit-sharing mechanism. Lack of oversight by WHO Members During an informal dialogue on the PABS Annex, the WHO Secretariat indicated that the only laboratory network subject to formal Member State oversight is the GISRS, by virtue of the PIP Framework. WHO’s governing World Health Assembly (WHA) oversees implementation of the PIP Framework, including the functioning of the GISRS. By contrast, the other WHO-coordinated laboratory networks appear to operate with limited or no direct oversight by the WHA. The list of networks and laboratories provided in the concept note further suggests a fragmented and largely ad hoc governance landscape. Diplomatic sources have indicated that, based on their interactions with WHO, there appears to be limited institutional visibility within the Organization itself regarding the full scope, structure and activities of these networks. Reporting to the WHA on the establishment, governance arrangements and operational activities of individual networks also appears to be minimal or non-existent. Taken together, this raises broader concerns about transparency, accountability and the degree of Member State supervision over WHO-coordinated pathogen-sharing arrangements beyond the PIP Framework. Non-transparent The concept note reveals a lack of transparency in the functioning of WHO’s pathogen-sharing arrangements. First, the concept note does not provide an exhaustive list of laboratory networks engaged in pathogen sharing. It states that “Currently, there are at least 15 laboratory and similar networks coordinated across different WHO programmes”, suggesting that many more such WHO-managed laboratory networks exist. Second, out of the 15 laboratory networks listed in the concept note, only some have terms of reference (ToR): the GISRS; CoViNet; the Global Polio Laboratory Network (GPLN); the Arbovirus Diagnosis Laboratory Network of the Americas (RELDA); the Global TB Laboratory Initiative (GLI); and the Global Outbreak Alert and Response Network (GOARN) DiSC. For the Emerging & Dangerous Pathogens Laboratory Network (EDPLN), the ToR seem to be for the AFRO (Africa) and EMRO (Eastern Mediterranean) regions, while the PulseNet Network for Latin America and the Caribbean (covering foodborne disease and emerging pathogens) has draft ToR. Of these, only the ToR of the GISRS are legally binding (according to the Excel document prepared by the Secretariat) as compliance with the ToR is required by Standard Material Transfer Agreement 1, a contract between the provider of pathogen material and the receiving GISRS laboratory. Based on the information circulated by WHO, no ToR were indicated for the remaining networks: the Global Yellow Fever Laboratory Network; PAHOGen (multi-pathogen genomic surveillance in the Americas); the Latin American Resistance Network (ReLaVRA+); the Global Antimicrobial Resistance & Use Surveillance (GLASS); and the International Pathogen Surveillance Network (IPSN). Some delegates who were briefed by WHO said WHO indicated that for some of the networks, it was unable to retrieve the ToR. While WHO’s document did not indicate any ToR for the IPSN, its ToR are available on its website. Information circulated by WHO does not provide any clarity on the specific participants of the networks but revealed that many of these networks involve vast numbers. A quick search reveals the membership of these networks to be wide-ranging, involving various types of non-state actors including business associations. For example, the GOARN involves more than 300 technical partner institutions within this arrangement, including those engaged in commercial activities such as patenting. For instance, the Chan Zuckerberg Biohub, while presenting itself as a non-profit, engages in patenting its discoveries and technologies, often in collaboration with partner universities, with the aim to bring them to market. The IPSN membership (according to the ToR on its website) consists of representatives from governmental organizations, intergovernmental organizations, non-governmental organizations, academic institutions, private sector business associations and philanthropic foundations. Its website further states that it engages with 366 active partner organizations which include 268 formal member organizations. Data extraction from the South Annex 2 of the Secretariat concept note lists laboratories involved in WHO’s R&D Blueprint for priority pathogens. The list covers 29 priority pathogens belonging to 12 pathogen families. Laboratories in the European region (EURO) received the most mentions (29) in the document, and thus are clearly the most active in receiving/handling/use of a wide range of priority pathogens. This is followed by laboratories in the Pan American Health Organization (PAHO) region (20 mentions), the Western Pacific region (WPRO) (17 mentions), the African region (AFRO) (12 mentions), the South-East Asia region (SEARO) (7 mentions) and the Eastern Mediterranean region (EMRO) (7 mentions). This geographical imbalance suggests a model of data extraction from the South to the North through WHO networks. According to the concept note, “Some pathogen-specific networks include WHO collaborating centres, which have the capacity to do advanced characterization, including pathogen propagation.” However, the Secretariat does not reveal the location of these laboratories possessing the capacity for advanced characterization. The concept note clearly demonstrates that, despite WHO’s formal commitments to equitable access to diagnostics, therapeutics and vaccines, its current practices risk entrenching inequities and enabling forms of data extractivism whereby pathogens and associated data are shared across borders without corresponding guarantees of fair and equitable benefit sharing. WHO has proposed that the WCLN be structured as a “Network of networks”, a move that appears designed to preserve the existing architecture of its numerous laboratory networks and affiliated institutions. However, constructing the WCLN for the PABS System on the basis of a fragmented, non-transparent and weakly accountable set of arrangements risks weakening the transparency, coherence and effectiveness of the PABS System, and undermining overall implementation of access and benefit sharing. |
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