Practical considerations and obligations

When could it impact?

There are several points at which Nagoya may become relevant:

• applying for a research grant or being awarded a research grant
  • you may be required to demonstrate compliance
• planning overseas fieldwork, or planned sample collection
• seeking project approval (departmental)
• buying genetic resources
• providing or accessing genetic resources to/from other researchers, universities, or other third parties
• patenting inventions or discoveries or seeking to commercialise technologies

Keeping records

It is important to maintain clear records of any collections or transactions made, to be available for inspection by the regulator.  It may be that you are required to declare compliance with the Nagoya Protocol and carried out necessary due diligence, so keeping good records is essential.  Records must also be retained for a period of 20 years following the end of use of the genetic resource.  Information that should be kept is:

• the date and place the genetic resources and associated traditional knowledge were acquired
• a description of the items and any identifiers
• the source from which the items were obtained, where applicable
• any rights and obligations , and terms and conditions governing access and benefit sharing
• the receipt of the materials into the College

This information will also need to be transferred to subsequent users, internal or external to College.

What to do

Always check whether the material you are accessing is subject to the Nagoya Protocol, if so:

For direct access, i.e. sample collection directly from country of origin:

1. Check the Access and Benefit-Sharing Clearing-House website (ABSCH) to see which national laws, procedures apply, and how to make contact.
2. Make all reasonable efforts to gain prior, explicit informed consent.  You must seek agreement of appropriate terms and conditions to govern your access. This may be Mutually Agreed Terms (MAT), or possibly (less likely) in the form of a Materials Transfer Agreement (MTA).  The provider country should issue a permit and publish a record on the ABSCH website, which will then trigger an internationally recognised certificate of compliance. Depending on the local government arrangements this may be time consuming.
3. Check whether any other authorisations or permits are needed (e.g. export licence, specific access)
4. Keep records for 20 years, which may be audited by the regulator.
5. Once the MTA concerning the genetic resource or traditional knowledge is fully executed and the materials are in receipt of the College. In addition, to confirmation of the receipt of the materials, the PI is required to complete a 'Due Diligence Form Nagoya Declaration'. This form is available for download in the 'Usefull Links' section i.e. the green box on the left of this page. This form is to be submitted to Defra, and a copy to the Research Office.

For indirect access, i.e. obtaining material from a collaborator, repository etc.

1. Confirm whether informed consent and a MAT were established at the original point of collection or access, and ensure these allow a transfer to you for the purposes envisaged - ask for evidence of these, possibly the registered certificate of compliance
2. If these are available an appropriate MTA can then be put in place with the third party.
3. If they are not available, it may not be possible to agree the transfer.  The alternative is to apply informed consent and a MAT with the original providing country. 

The Research Office Material Transfer Agreements (MTAs) team will be able to help with this.

If you are transferring material subject to the Nagoya Protocol:

1. Ensure the purpose for which it is being provided is in line with the original access and benefits-sharing arrangement, and informed consent
2. Ensure an appropriate agreement is in place, e.g. MTA, and the any conditions attached are passed on.
3. Maintain records for 20 years.

Faculty research services teams will be able to help with this.