Boehringer Ingelheim VPH TADtalk Global Newsletter Issue 1

Horsington et al.

10.3389/fvets.2023.127143

Researchers, especially those in academic settings, face the complexity of navigating the Nagoya Protocol. This complexity can impact efforts to develop diagnostics, therapeutics, and vaccines. Transnational collaborations may be hindered by ABS terms, and researchers in provider countries may face reduced collaboration opportunities. Provider countries, often in Africa and Asia, are impacted as their farmers and livestock keepers rely on FMD vaccines from external international companies. The Nagoya Protocol’s constraints may result in reduced access to new vaccines, affecting livestock productivity and hindering disease control efforts. Tools and products resulting from the utilization of genetic resources can directly improve livestock productivity. However, the Nagoya Protocol’s constraints may reduce access to these tools, jeopardizing international cooperation for vaccine development.

FIGURE 2 Feedback loop (pink arrows) for the utilisation of FMD resources highlighting the main actors in this process. NB: the shipment of samples to international FMD reference Laboratories does not typically involve the National NFP and their engagement in the process usually only occurs prior to utilisation of the samples once samples have been tested and characterised. Any measures to simplify the process to access FMD samples from endemic countries need to provide legal certainty and thereby ensure that global surveillance activities relating to FMD are not unintentionally impeded.

Figure 2 :Feedback loop (pink arrows) for the utilisation of FMD resources highlighting the main actors in this process. NB: the shipment of samples to international FMD reference Laboratories does not typically involve the National NFP and their engagement in the process usually only occurs prior to utilisation of the samples once samples have been tested and characterised. Any measures to simplify the process to access FMD samples from endemic countries need to provide legal certainty and thereby ensure that global surveillance activities relating to FMD are not unintentionally impeded.

involves transnational collaborations with researchers in countrie from which the materials have been sourced. Significant time and valuable resources in these institutions may be required to agree AB terms associated with projects that might yield limited benefits. In addition, researchers in provider countries may be disadvantaged through reduced collaboration opportunities, whether through reluctance from external scientists, or as a result of their own lack o motivation stemming from insufficient advice, information, and assistance when negotiating ABS exchanges (17).

activities and faster growing markets (26). This has a negative impact on global vaccine security with overall fewer FMD vaccines being produced and the absence of investment into updated high-quality and antigenically relevant vaccines. Similar constraints exist for other commercial actors such as diagnostic companies and pharmaceutical companies that may wish to utilise FMDV materials for new tests or therapeutics (Figure 2). The observation that there have not been any major epizootics to date involving countries blocking access to strains of FMDV for which current vaccines are ineffective does not diminish the need to be prepared for when such a situation arises.

2.4 Provider countries

2.3 Research projects and researchers

A perhaps overlooked group of stakeholders that is also impacted b restrictions on FMD research and development are farmers and livestoc keepers in the provider countries. Tools and products arising from th utilisation of genetic resources can directly improve livestock productivit in those countries that have provided the material (Figure 2). Fo example, most countries in Africa and Asia do not currently have th capacity to manufacture FMD vaccines at sufficient volumes and qualit required to have long-term impacts on disease control. Therefore, man endemic countries rely on FMD vaccines from external internationa companies, which are often located in the Global North. Even wher

4. An international FMDV repository could simplify access to viruses for utilization, such as for vaccine strain development, by ensuring ABS compliance in advance.

The article suggests that exempting FMDV completely out of the scope of the Nagoya protocol is not appropriate/feasible in the short term. It conflicts with CBD’s objectives. Instead, the authors propose the following: 1. Awareness about the Nagoya Protocol and related ABS frameworks is crucial. Efforts should focus on provider countries’ perspectives and improving communication between government officials in sourcing countries.

Beyond the utilisation of materials by commercial companies, the Nagoya Protocol presents a highly complex framework for scientists who work in the academic sector (including universities, governmental institutes, and not-for-profit organisations). Access to viruses, samples and data is often central to efforts to facilitate the development of prototype diagnostics, therapeutics, and vaccines and is also widely exploited to establish novel tools to understand the evolution, mechanisms of replication and infection, pathogenesis, immune responses, and host-cell interactions of FMDV. This work typically

07 5. Any solution requires political support and funding. Short-term focus could be on facilitating FMD material exchange between willing partners, while long-term solutions are sought at the international level. In conclusion, the Nagoya Protocol poses significant challenges to FMD stakeholders, affecting global surveillance, vaccine development, academic research, and livestock productivity in provider countries. A comprehensive science-policy dialogue is essential for a better understanding and effective implementation of the Nagoya Protocol. The impacts on FMD stakeholders underscore the need for clarity, streamlined processes, and global cooperation to ensure the fair and equitable sharing of benefits while addressing the complexities associated with ABS measures. Frontiers | Application of the Nagoya Protocol to veterinary pathogens: concerns for the control of foot-and-mouth disease (frontiersin.org)

Frontiers in Veterinary Science

frontiersin.or

2. Standardized terms for WOAH/FAO FMD Reference Labs would help share FMD viruses and comply with national ABS requirements. The approach could learn from the Global Influenza Surveillance and Response System (GISRS) experience.

3. A specialized multilateral ABS instrument, like the WHO Pandemic Influenza Preparedness (PIP) or the International Treaty on Plant Genetic Resources for Food and Agriculture, could be a long-term solution. It could reduce transaction costs and provide legal certainty.

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