Boehringer Ingelheim VPH TADtalk Global Newsletter Issue 1

Diagnostic/reference laboratories, which play a crucial role in the global surveillance of FMD, encounter uncertainties related to the long-term storage, distribution, and use of diagnostic samples due to the Nagoya Protocol. While immediate diagnostic activities fall outside the protocol’s scope, the long-term aspects may face restrictions. The laboratories often lack expertise on the Nagoya Protocol, and the complexities of Access and Benefit-Sharing (ABS) obligations may complicate their collaborative relationships. Vaccine manufacturers are also significantly affected by the Nagoya Protocol. The sourcing of pathogens for vaccine development falls within the protocol’s scope, obliging manufacturers to navigate ABS requirements. This can lead to delays in vaccine development, especially in endemic areas where FMDV evolves rapidly. These delays can have far-reaching effects, impacting livelihoods, food security, and FMD-free areas. Unrealistic expectations about monetary benefits may deter vaccine manufacturers, affecting global vaccine security.

Horsington et al.

10.3389/fvets.2023.1271434

Figure 1: Countries that are parties to the Nagoya Protocol (A) and countries where FMD is present within seven endemic virus pools (1–7) located in Asia, Africa and South America (B). Grey color defines countries that maintain an FMD-free status (with or without vaccination), dark red represents countries without any FMD-free status, while lighter red denotes countries with at least one FMD- free zone (as defined by WOAH in March 2023). FIGURE 1 Countries that are parties to the Nagoya Protocol (A) and countries where FMD is present within seven endemic virus pools (1–7) located in Asia, Africa and South America (B) . Grey colour defines countries that maintain an FMD-free status (with or without vaccination), dark red represents countries without any FMD-free status, while lighter red denotes countries with at least one FMD-free zone (as defined by WOAH in March 2023).

While pathogens clearly represent genetic resources as defined in the Nagoya Protocol, provisions to recognise specific and unique characteristics of pathogens, and clarification or further guidance on

Legislation on the sourcing and use of genetic resources includes administrative procedures and enforcement policies that vary from country to country. In its simplest form, a foreign researcher/company

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