To undertake due diligence researchers should follow these steps.
1) Determine whether or not the material is subject to the Nagoya protocol:
- Is it a genetic resource?
- Is the genetic resource non-human? (Human material is exempt)
- Check whether the genetic resource is not already covered by existing legal agreements i.e. the International Treaty on Plant Genetic Resources for Food and Agriculture.
- Is the genetic resource found within an area of national jurisdiction? For instance, high seas are not in scope.
- If the answer to any of the above is no, proceed to step 6. Otherwise proceed to step 2.
2) Determine whether the genetic resources will be ‘utilised’ by you or a third party:
- Is the genetic resource being used for research and development?
- If not, proceed to step 6.
3) If so, determine the timing of access and utilisation:
- Was the genetic resource accessed directly (or indirectly) and utilised after 12th October 2014?
- If not, proceed to step 6.
4) If so, determine whether the country of origin has ratified the Nagoya Protocol?
- Using the ABS Clearing House, determine whether the country of origin has ratified the Nagoya Protocol
- If unsure, contact that country’s named ABS National Focal Point (NFP) designated under the Protocol to confirm whether access measures are in place. If the NFP fails to respond after reasonable attempts have been made to contact them, you must decide for yourselves whether or not to access or utilise the genetic resource in question. Keep a record of your efforts to obtain guidance from the NFP.
- If you determine that access and use of the materials is not covered by applicable measures, proceed to step 6.
- If you have confirmed there are access measures or are unsure, it is necessary to undertake further due diligence – please proceed to step 5.
5) Undertaking due diligence:
The due diligence steps required vary depending on how the genetic resource was accessed.
For direct access (i.e. using genetic resources obtained directly from the country of origin by the researcher):
- Using the ABS Clearing House, determine whether the access measures include requirements to obtain ‘prior informed consent’ (PIC) and ‘mutually agreed terms’ (MAT) for the genetic resource.
- If unsure, contact that country’s named ABS National Focal Point designated under the Protocol to confirm.
- If required, apply for PIC. This involves submitting the required information (which will vary) to the identified entry points and stakeholders of the provider country (e.g. may include the Competent National Authorities, local communities and different levels of government) and may be time consuming.
- If materials or knowledge associated with genetic materials are obtained from indigenous or local communities, it is best practice to negotiate mutually agreed terms for access even if this is not required in the national legislation.
- Check whether you need other permits (e.g. export control, access to protected areas etc.)
- After PIC is obtained, it is necessary for the University to negotiate MAT with the Competent National Authority.
- The Competent National Authority in the provider country issues a national permit or its equivalent to the user and publishes a record on the ABS Clearing House website.
- The ABS Clearing House generates an Internationally Recognised Certificate of Compliance (IRCC)
- Comply with these terms throughout research. If this is not possible, the PIC and MAT must be renegotiated.
For indirect access (i.e. the genetic resource is accessed from a third party e.g. collaborator, private/registered collection, botanical garden etc):
- Inquire about the best way to obtain the genetic resource for your project from the intermediary (this may vary depending on if the intermediary is a registered collection, collaborator, ex situ facility etc.)
- Confirm whether PIC and MAT were established by the intermediary when the resources were originally accessed (or seek records confirming that PIC and MAT were not required)
- Obtain PIC and MAT from the intermediary. This will likely be in the form of an IRCC, but may alternatively be in the form of equivalent information.
- Confirm that the transfer and your intended utilization are covered by PIC and MAT conditions.
- If not, apply for new or modified PIC and MAT from the provider country.
For transfer: (i.e. giving the genetic resource to a third party):
- Transferring genetic resources must be in accordance with requirements set out in PIC and MAT.
- The transfer should include:
- the internationally recognised certificate of compliance (IRCC) associated with their access to the genetic resource (or equivalent information)
- access permits and MAT, if applicable, and
- The transferred information must be kept by the new holder and included in any subsequent transfers.
6) If you determine that your work is not within the scope of the Nagoya Protocol:
- Please keep a record of your actions that determined the genetic resource was not within the scope as a ‘due diligence’ record.
- No further action is required to ensure compliance with the Protocol or regulation.
- Researchers should be aware, however, that some nations may have their own ABS legislation unrelated to the Nagoya Protocol and would need to be followed.