The Protocol has three main objectives:

• the conservation of biological diversity
• the sustainable use of the components of biological diversity
• the maintenance of fair and equitable sharing of benefits arising from the use of genetic resources.

The Protocol was implemented in the EU by Regulation (EU) No 511/2014 that entered force in October 2015[1] . The legislation is implemented and enforced in the UK by the Office for Product Safety and Standards within the Department of Business, Energy and Industrial Strategy (BEIS).

Nagoya Protocol checklist for researchers - Researchers are advised to start with this to understand if it applies to them

Due Diligence forms

What does the Protocol apply to?

1. Genetic Resources (GR):  any material of plant, animal, microbial or other origin (excluding human) containing functional units of heredity (e.g. genes and DNA) which is of actual or potential value; or their derivatives, e.g. proteins, lipids, enzymes or RNA.
2. Traditional Knowledge: knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the genetic resource

In the context of the Protocol, ‘utilisation’ means to conduct research and development (R&D) on the genetic and / or biochemical composition of genetic resources, including through application of biotechnology. This includes basic and applied research and genetic modification.

It applies to resources sourced from states that are signatories to the Protocol. However, local access legislation and conditions (i.e. a requirement for permits) are also likely apply to those who are not signatories. Details can be found on the website of the Access and Benefit Access Sharing Clearing House .

What is excluded from the Nagoya Protocol?

• human genetic resources, digital sequence data or synthetic gene segments synthesised without access to the physical genetic resource
• Genetic resources already governed by specialised international agreements that are consistent with the Protocol, e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture; the WHO Pandemic Influenza Preparedness Framework
• Genetic resources that are traded commodities
• Genetic resources used for the maintenance of a collection for conservation purposes
• Genetic resources used as a testing or reference tool in research, i.e. the genetic resource is not the object of the research, but serves to confirm or verify the desired features of another experiment or study).

What do I do if I find that the Nagoya Protocol applies?

(Please see the Nagoya Protocol checklist for researchers)

It is strongly advised that a due diligence form is kept as evidence of having considered whether the Protocol applies when planning research with a copy sent to rgoffice@sussex.ac.uk.

** Contact the Research Governance Officer (rgoffice@sussex.ac.uk) to discuss the next steps **

1. Undertake due diligence regarding access to the genetic resource by consulting the the Access and Benefit-Sharing (ABS) Clearing-House website prior to commencing research.

2. Comply with relevant access measures (obtain ‘prior informed consent’ (PIC) from the Competent National Authority 

3.  Secure Material Transfer Agreement (MTA) (if required)

4.  Submit due diligence declarations at the required stages of the research cycle;

5.  Keep appropriate records for 20 years (typically extending beyond the research activity);

6.  Provide copies of relevant information if you are transferring the genetic resource to another user. An up to date Material Transfer Agreement will be required in such a case.

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The following research activities are 'in scope'

• Research on a genetic resource leading to the isolation of a biochemical compound used as a new ingredient incorporated into a pharmaceutical product
• Creation or improvement of yeasts, resulting from human action through an R&D process, to be used in manufacturing process
• Genetic modification creation of a genetically modified plant containing a gene from another species
• All non-human samples containing genetic material are potentially in scope, e.g. including pathogens/parasites arising from human samples (e.g. blood) are considered in scope if the purpose of the research is focussed on the pathogen/parasite

The following research activities are 'out of scope'

•      The maintenance and management of a collection for conservation purposes

•      The handling and storing of biological material and describing its phenotype

•      Sourcing or accessing genetic resources as testing tools (GR is not the object of the research)

Required 'trigger points'

• applying for a research grant (e.g. you may be asked to describe ABS considerations or have agreements in place)
• being awarded a research grant (e.g. you may be required to demonstrate ABS approvals compliance at the outset or within a specified period)
• applying to your head of department for permission to undertake fieldwork
• going to obtain or purchase genetic resources
• seeking to lodge material in collections (at Oxford or museums, laboratories, libraries, gardens or herbaria in other locations) (eg you will almost certainly be asked to show ABS compliance and records)
• seeking to provide or give access to genetic resources to: other researchers, other units in the University, or external organisations
• seeking to patent certain discoveries (where it is suspected that genetic resources from another country have been used).
• seeking to sell or in other ways commercialise resources or products based on genetic resources

* Compliance should be achieved before samples come to the University *