Nagoya Protocol

Compliance

Researchers who wish to gain access to genetic resources must exercise
due diligence, i.e., follow a process to verify that all biological material that
is collected (or transferred) and used for research
[1] complies with the legal requirements for ABS.

Be sure to contact the appropriate person at your research institution before taking any steps in Access & Benefit-Sharing!

  • 1. Determine whether the Nagoya Protocol will apply to the material.

    Consult the Checklist for Researchers, which provides a step-by-step guide to
    determine this. If you establish that the protocol does not apply, proceed to step 7 below.

  • 2. Gather information about the country providing the material.

    Use the Checklist for Researchers, referring to the ABS Clearing-House website
    to determine whether the provider country has ratified the protocol and has laws or regulations to
    regulate the genetic resource you wish to use.

  • 3. Undertake ‘due diligence’ if necessary.

    The required due diligence steps depend on how the genetic resource was obtained. The Checklist for Researchers summarizes the steps below.
    For
    direct access, where the genetic resources are obtained directly by the researcher
    from the country of origin:

    • Determine using the ABS Clearing-House whether the access measures include requirements to
      obtain ‘prior informed consent’ (PIC) and ‘mutually agreed terms’ (MAT) for the
      genetic resource (e.g., China requires PIC and MAT, Japan currently does not).
    • If in doubt, contact the national ABS focal point of that country, via the appropriate person at your
      research institution.
    • Apply for PIC if necessary. This involves submitting the required information (which will vary)
      to the identified access points and stakeholders of the provider country. This may include competent
      national authorities, local communities, and different levels of government and can be time-consuming.
    • If material or knowledge associated with genetic material is obtained from indigenous or local
      communities, it is recommended to negotiate ‘mutually agreed terms’ (MAT) for access,
      even if this is not required by national legislation.
    • Check whether you need other permits (e.g., for export, access to protected areas
      etc.)
    • Once PIC is obtained, your research institution will negotiate MAT with the competent national
      authority. (In practice, this often happens simultaneously with the PIC application.)
    • The competent national authority in the country providing the material issues a permit to the
      user and publishes a confirmation thereof on the ABS Clearing-House website.
    • The ABS Clearing-House generates an internationally recognized certificate of compliance (IRCC).
    • Adhere to these terms during the research. If this is not possible, the PIC and MAT must be
      renegotiated.

    For indirect access, where the genetic resources are obtained through a third party, for example, a
    private/registered collection, botanical garden etc.:

    • Inquire with the intermediary about the best way to obtain the genetic resource for your project.
      This may vary depending on whether the third party is a collection, collaborator, ex-situ
      facility [2] etc.
    • Check whether PIC and MAT were obtained by the intermediary when the resources were first
      accessed, or gather information to confirm that PIC and MAT were not required.
    • Obtain PIC and MAT from the intermediary. This will likely take the form of an IRCC, but can
      also take the form of equivalent information. [3]
    • Confirm that the transfer and the intended use are covered by the PIC and MAT conditions.
    • If not, apply for a new or modified PIC and MAT from the provider country.
  • 4. Submit a due diligence declaration if necessary.

    If you use genetic resources covered by the Nagoya Protocol, you must submit a due diligence declaration.
    Consult the Checklist for Researchers for more information.

  • 5. Keep proper records.

    Due diligence records, i.e., IRCC or equivalent information [3], must be kept for at least 20 years after the end of
    the utilization.

  • 6. Transfer

    Passing the genetic resource on to a third party.
    The transfer of genetic resources must comply with the requirements stipulated in PIC and MAT.
    The transfer must include:

    • the internationally recognized certificate of compliance (IRCC) or equivalent information
      [3]
    • access permits and MAT, if applicable

    The transferred information must be kept by the new holder and included in any subsequent transfers.

  • 7. If you determine that your work does not fall within the scope of the Nagoya Protocol:

    Keep a record of what you did to conclude that the genetic resource fell outside the
    scope, by way of ‘due diligence’. No further action is required.

    You must, however, be aware that some countries may have their own ABS legislation that is not
    linked to the Nagoya Protocol and that this must be followed.


[1] The EU guidelines on the protocol clarify that “research” should be defined as “the systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions” and “research and development” as “creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of knowledge to devise new applications”.

[2] If genetic resources are obtained after October 12, 2014, from an ex situ collection in the country of origin, they fall within the scope, regardless of when they were added to the collection.

[3] Equivalent information must include the date and place of access to the genetic resource; a description of the genetic resource, including unique identifiers where available; the source from which the genetic resource was directly obtained; the presence or absence of rights and obligations relating to access and benefit-sharing, including subsequent applications and commercialization; access permits, where applicable; mutually agreed terms, including benefit-sharing arrangements, where applicable.