The World Reference Laboratory for Foot-and-Mouth Disease (WRLFMD) plays a key role in international surveillance and control of FMD by receiving, characterising, cataloguing and sharing genetic materials from around the world. In doing so, we are committed to full compliance with the Nagoya Protocol on Access and Benefit-Sharing.
The Nagoya Protocol is an international agreement that gives countries the right to control access to their genetic resources and to ensure that any benefits arising from their use are shared fairly.

Our Approach to Compliance

  1. Responsible Use
    The WRLFMD uses genetic resources for purposes such as disease surveillance, diagnostics (including test validation), and outbreak response. These activities do not involve "utilisation" as defined under the Nagoya Protocol (i.e., research and development on the genetic or biochemical composition of the material).

  2. Respect for Country of Origin
    In most cases, materials are sent to us voluntarily by local reference laboratories or research organisations in the country of origin as part of collaborative efforts to support disease surveillance and response. As a result, we may not always be involved in the initial decision to share the material.

    Nevertheless, we will make every effort to understand and comply with any conditions set by the provider organisation and will honour all restrictions or terms communicated to us, in line with the spirit of the Nagoya Protocol.

  3. Controlled Sharing
    We may share materials with other designated reference laboratories, strictly for disease surveillance and control purposes and within the terms of the original terms from the provider. On receipt of a request to share material, the WRLFMD will work with the third party to determine whether the intended use falls within or outside of the scope of the Nagoya Protocol.

    If a third party wishes to use genetic resources for research or product development (such as creating new vaccines; see examples below), we will only transfer the material if:
    • They have obtained the required permissions (such as Prior Informed Consent and Mutually Agreed Terms) from the country of origin; and
    • Their proposed use complies with the access terms under which the material was originally shared with the WRLFMD.

  4. Due Diligence and Record-Keeping
    We maintain clear documentation for all materials received and distributed. This includes tracking permissions, conditions of use, and provider and recipient details. Materials are shared under strict Material Transfer Agreements which define their permitted use, and make clear that the recipient of material must comply with any applicable access and benefit sharing legislation.

Our Commitment

We support global efforts to control diseases while fully respecting the rights of countries over their genetic resources. Our practices aim to promote transparency, trust, and collaboration in line with the spirit and requirements of the Nagoya Protocol.

Examples

Specific examples of activities that are restricted by the Nagoya Protocol. This list was prepared by the international FMD community (www.foot-and-mouth.org) as part of a review to highlight the impacts of the Nagoya Protocol (Horsington et al., 2023).

Uses of material that require PIC (Prior Informed Consent) and MAT (Mutually Agreed Terms) before the WRLFMD will supply to a third party:
Any genetic resource that is the subject of utilisation

This includes:

  • A field strain of FMDV used to develop a vaccine seed stock;
  • An FMD virus being developed to become a component of a therapeutic agent;
  • An FMD virus being developed to become a research tool or to generate new knowledge);
  • An FMD virus being developed to become an integral component of a diagnostic test (i.e., required for the test to function);
  • Production of recombinant FMDV proteins for research or commercial purposes that utilise specific genetic information derived from field viruses (depending on the legal status of digital sequence information [DSI] in the relevant national ABS regulation of the source country);
  • Contract research that includes any of the above examples.

Material may be supplied by the WRLFMD to third parties to cover the following activities:
Any genetic resource that is not the subject of utilisation (i.e., no research and/or development is taking place, (depending on [i] a review of the specific request and [ii] accommodation of any conditions set by the provider organisation).

This may include:

  • Material used for taxonomy or identification of a resource. For instance, confirmatory testing or sequencing of samples received by a FMD reference laboratory;
  • Antigenic characterisation of field strains (vaccine matching);
  • FMD viruses used as challenge strains in animal trials;
  • Materials used as a positive or negative controls for diagnostic tests (i.e., as a measured analyte);
  • Samples used as components in a proficiency testing panel;
  • Long-term archiving of materials.

Reference

Horsington J, Abbeloos E, Kassimi LB, Boonsuya Seeyo K, Capozzo AV, Chepkwony E, Eblé P, Galdo-Novo S, Gizaw D, Gouverneur L, Grazioli S, Heath L, Hudelet P, Hyera JMK, Ilott M, King A, Lefebvre DJ, Mackay D, Metwally S, Mwiine FN, Nfon CK, Park MK, Pituco EM, Rosso F, Simon F, Ularamu HG, Vermeij P, Vosloo W, King DP (2023). Application of the Nagoya Protocol to veterinary pathogens: concerns for the control of foot-and-mouth disease. Frontiers in Veterinary Science, 10:1271434. doi: 10.3389/fvets.2023.1271434.