Nagoya Protocol - FAQs

Should I get approval under the Nagoya Protocol prior to applying for funding or ethical approval?

The time required for getting approval under the Nagoya Protocol varies by country and we would advise starting as soon as the requirement is recognised.  We also advise that applications for funding can be submitted but that work should not start until approval is received.

You may submit an application for ethical approval on your research prior to receiving approval - if approved, this will be conditional upon satisfying the terms of the Nagoya Protocol.

Are countries that are party to the Nagoya Protocol implementing exactly the same ABS measures?

National laws and regulations implementing the Nagoya Protocol must meet certain minimum standards. For example, countries are required to take measures to ensure the prior informed consent of indigenous peoples and local communities for access to genetic resources or associated traditional knowledge over which they have established rights. However, national implementation may go beyond these minimum standards. For example, national laws or regulations may also define benefit sharing, rather than leaving it up to negotiations. As a result, ABS requirements and procedures may differ from the Nagoya Protocol. You need to check the ABS Clearinghouse and/or contact the National Focal Point to be certain of your obligations.

What should I do if the national authority in the provider country doesn't respond to my enquiries?

If instructions regarding ABS measures are unclear or if you need a response to continue your application process, you will have to wait for a response. It might be worth looking for relevant contacts outside of the ABS Clearing House.  You should keep a record of your attempts to get a response - this is part of the due diligence process.

Contact nagoyaprotocol@abdn.ac.uk for advice.

Is the ABS permit the only research permit I need?

The ABS agreement with the provider country may not be all that you will need. Different departments of the provider country government will be responsible for different aspects of access to genetic resources. You will also need to check if you need e.g. access to protected areas, ethical permissions or similar is required.

Do I have to pay a fee to access material in other countries?

Some national authorities charge administrative fees when you apply for access. You should check with your funder whether these fees can be paid under your grant agreement.

If I collaborate with colleagues from another country, how do we navigate Nagoya regulations?

If the provider country is party to the protocol, prior informed consent (PIC) and mutually agreed terms (MAT) must be obtained for both countries. You can further only transfer material between the UK and another country if the MAT allow so. As resident in the UK, you will further have to submit Due Diligence Declarations at checkpoints (if applicable) to the Office for Product Safety and Standards. Equivalently, collaborators will have to follow national obligations if their country is party to the Nagoya protocol.

Is taxonomic research in scope of the Nagoya Protocol?

The identification, taxonomic description, characterisation or description of a genetic resource, incl. with DNA sequencing, is not considered utilisation. This applies e.g. to species identification when investigating eDNA samples, microbial communities etc.

Is phylogenetic or population genetic research in scope of the Nagoya Protocol?

Research identifying variation in identity of species within and between populations or between species or higher taxa is considered similar to taxonomic identification. If the function of genes or DNA sequences is neither investigated nor of interest, and no insight into links between genotype and traits is created, the research is out of scope of the Nagoya Protocol.

Are digital genetic sequences considered derivatives?

Currently Digital Sequence Information (DSI) are not in scope of the Nagoya Protocol, but their inclusion is under discussion. The provider country’s ABS legislation may contain DSI associated terms, conditions, and obligations and so users might be subject to bilateral obligations.

Is research on imported laboratory animals or strains in scope?

What is a laboratory strain?

• They are living organisms;
• They are typically mass produced and often provided by commercial providers;
• They are genetically defined and have low heterozygosity;
• They are distinct from any parent material used in their development as a result of mutation, breeding, selection etc.;
• They are commonly used in research as models.

Use of an established laboratory strain as a model and platform for testing is not considered to be utilisation and therefore not in scope of the Nagoya protocol. 

Laboratory strains created before 12 October 2014 fall outside the scope for temporal reasons.

Creating a new or modified laboratory strain could be Nagoya Protocol relevant, depending on the national laws of the provider country of the parent material. A newly created strain remains within scope until it becomes publicly available to others for research purposes. If the strain has become a new laboratory strain and is shared by laboratories/researchers, its further use then falls out of scope.

Is utilisation of genetic resources from wild organisms in scope if these are considered model organisms?

If the genetic material of these organisms is not obtained from an established and genetically defined lab strain (usually from mass production or a commercial breeder), then they are in scope of the Nagoya Protocol.

Is my research out of scope if I am not sequencing DNA?

There are ways of “utilising” genetic resources that do not include sequencing of DNA but still could create new insight of (potential or real) benefit to the further process of product development. E.g. Microsatellite research identifying genotypes that are linked to higher productivity or other traits.

What kind of traditional knowledge is in scope?

Traditional knowledge is only in scope of the Nagoya protocol if it is associated with accessing genetic resources, e.g. locals telling you where to find organisms of interest, explaining how to trigger an organism to produce derivatives etc

Are materials obtained as commodity in scope?

If genetic resources were deliberately brought to the UK from a provider country, including as traded good, they are in scope of the Nagoya protocol. Derivatives need to be linked to their original genetic resource to be in scope of the Nagoya Protocol, so e.g. an essential oil bought in a shop would not be in scope.

There are ways of “utilising” genetic resources that don’t include sequencing of DNA, for example qPCR or microsatellite analysis, that are still in scope of the Nagoya protocol. More information on “utilisation” and some exemptions can be found here.

If you will only receive amplicons/fragments that are not functional units of heredity, the material is out of scope.

The time required for getting approval under the Nagoya Protocol varies by country and we would advise starting as soon as the requirement is recognised.  We also advise that applications for funding can be submitted but that work should not start until approval is received.

You may submit an application for ethical approval on your research prior to receiving approval - if approved, this will be conditional upon satisfying the terms of the Nagoya Protocol.

If the genetic material of these organisms is not obtained from an established and genetically defined lab strain (usually from mass production or a commercial breeder), then they are in scope of the Nagoya Protocol.

What is a laboratory strain?

• They are living organisms;
• They are typically mass produced and often provided by commercial providers;
• They are genetically defined and have low heterozygosity;
• They are distinct from any parent material used in their development as a result of mutation, breeding, selection etc.;
• They are commonly used in research as models.

Use of an established laboratory strain as a model and platform for testing is not considered to be utilization and therefore not in scope of the Nagoya protocol. 

Laboratory strains created before 12 October 2014 fall outside the scope for temporal reasons.

Creating a new or modified laboratory strain could be Nagoya Protocol relevant, depending on the national laws of the provider country of the parent material. A newly created strain remains within scope until it becomes publicly available to others for research purposes. If the strain has become a new laboratory strain and is shared by laboratories/researchers, its further use then falls out of scope.

National laws and regulations implementing the Nagoya Protocol must meet certain minimum standards. For example, countries are required to take measures to ensure the prior informed consent of indigenous peoples and local communities for access to genetic resources or associated traditional knowledge over which they have established rights. However, national implementation may go beyond these minimum standards. For example, national laws or regulations may also define benefit sharing, rather than leaving it up to negotiations. As a result, ABS requirements and procedures may differ from the Nagoya Protocol. You need to check the ABS Clearinghouse and/or contact the National Focal Point to be certain of your obligations.

If your research is out of scope, you don’t need to prove it. However, since you are obligated to do due diligence to demonstrate that it is out of scope, it is good practice to keep a record of the process. You can use our checklist for researchers to do that.

If instructions regarding ABS measures are unclear or if you need a response to continue your application process, you will have to wait for a response. It might be worth looking for relevant contacts outside of the ABS Clearing House.  You should keep a record of your attempts to get a response - this is part of the due diligence process.

Contact nagoyaprotocol@abdn.ac.uk for advice.

The ABS agreement with the provider country may not be all that you will need. Different departments of the provider country government will be responsible for different apects of access to genetic resources. You will also need to check if you need e.g. access to protected areas, ethical permissions or similar is required.

Currently it is under discussion if Digital Sequence Information (DSI) will be in scope of the Nagoya Protocol by default. However, a few countries already include them in their national regulations and you will have to follow the ABS procedure to use DSI obtained from those countries.

Some national authorities charge administrative fees when you apply for access. You should check with your funder whether these fees can be paid under your grant agreement.

The identification and classification of organisms is not considered to be a form of utilization under Regulation (EU) No 511/2014 as long as the research does not investigate the genetic or biochemical composition of the organism.