The Nagoya Protocol and Access and Benefit Sharing ('ABS')

• Overview 
• Definitions and scope
• How do I comply: A checklist for researchers 
• Further resources 
• Contact us 

Overview 

Each country has rights over the genetic resources that exist within its borders, such as animals, plants, and organisms, as well as the traditional knowledge associated with them. The Nagoya Protocol is an international agreement to ensure fair and equitable Access and Benefit Sharing (ABS) concerning the use of genetic resources. 

ABS principles aim to reduce the inequalities between those providing genetic resources and those that use them, and many countries have established specific ABS legislation. In the UK, the Protocol came into force on 12 October 2015. 

Researchers are legally obliged to comply with the Nagoya Protocol. Potential consequences of non-compliance include financial penalties, confiscation of materials, loss of reputation, prohibition of further work, not being able to publish or having to retract publications.

Definitions and scope

Genetic material: Any material of plant, animal, microbial or other origin containing functional units of heredity 

Genetic resource: Genetic material of actual or potential value

Derivative: A naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity

Traditional knowledge associated with genetic resources: Traditional Knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources

User: A natural or legal person who utilises genetic resources or associated traditional knowledge

Access: Acquisition of genetic resources or of traditional knowledge associated with genetic resources in a party to the Nagoya Protocol

Utilisation of genetic resources: To conduct research and development on the genetic and/ or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention

What is within the scope of the legislation 

• Research into the genetic and/ or biochemical composition of the organism,
  for example, research and/ or development relating to gene function and inheritable traits; and
• Research relevant to the potential value of the organism, for example, research involving a genetic resource leading to the isolation of a biochemical compound used as a new ingredient incorporated into a pharmaceutical product, for example, genetic modification - the creation of a genetically modified organism containing a gene from another species.

What is NOT within the scope of the legislation 

• Genetic resources for which access and benefit-sharing are governed by specialised international instruments (such as the International Treaty on Plant Genetic Resources for Food and Agriculture);   
• Human genetic resources. However, the legislation might apply to genetic resources derived from human microbiota;
• Descriptive research, for example, describing a species/taxonomy;  
• Ecological research, for example, research into how an organism interacts with its environment;  
• Maintenance and management of a collection for conservation purposes; and  
• Genetic resources as testing/reference tools (when the specific genetic resource is not the subject of the research).

How do I comply: A checklist for researchers

As a researcher you must determine whether the Nagoya Protocol applies to the material, exercise due diligence to show that relevant country requirements have been met, and keep appropriate records.

To be within the scope of the Nagoya Protocol, ALL of the following criteria must be met, and the necessary permissions must be acquired before accessing the material or importing it to Queen Mary:

1. Material: is the material within the scope of the Nagoya Protocol?
   • Genetic resources not already governed by an international specialised instrument (e.g. ITPGRFA or the PIP framework) and/ or traditional knowledge associated with genetic resources.
2. Country: has the provider country ratified the Nagoya Protocol and established measures to regulate the genetic material?
   • Check the ABS Clearing House, which is a website that facilitates the implementation of the Nagoya Protocol.
   • Transfer of material from third parties: you must check where the material originates from, and ensure subsequent transfers align with the provider country's requirements. It may be necessary to obtain new permissions.
3. Date of access: Will the resources be accessed after 12 October 2015?
   • Resources accessed before 12 October 2015 are not in scope.
4. Intended use: Will the resources be utilised?
   • Utilisation is defined as conducting research and development on the genetic and/ or biochemical composition of genetic resources, including through the application of biotechnology).
   • You can find more information in the governmental Guidance on the UK ABS Regulations.
5. Place of utilisation: Will the resources be utilised in the UK?

If you answered ‘Yes’ to ALL the above points:

• Your work is within the scope of the Nagoya Protocol and you must follow the provider country requirements and obtain all relevant permissions before you import the resources. Please contact the JRMO International team at vp-trustedresearch@qmul.ac.uk
• If your research is externally funded you may be required to submit a due diligence declaration to the UK Department for Environment, Food and Rural Affairs (Defra).
• Due diligence records must be stored for a minimum of 20 years after the end of utilisation.

If you answered ‘No’ to one of the questions:

• Your work is not within the scope of the Nagoya Protocol.
• Keep records of your actions that determined the genetic resource was not in scope.

Please note: Some countries may have ABS legislation outside the scope of the compliance measures in force in the UK and the Nagoya Protocol which must still be adhered to when accessing resources or associated knowledge from these countries.

Further resources 

• UK Government guidance on the UK ABS Regulations: an overview of the Nagoya Protocol including guidance and best practice.
• The ABS Clearing House: an international website that facilitates the implementation of the Nagoya Protocol and exchanges information on access and benefit-sharing.
• Nagoya Protocol on Access and Benefit-sharing (a Protocol to the Convention on Biological Diversity). This includes the text of the Nagoya Protocol and factsheets. 

Contact us 

For further advice and support please contact the JRMO International team at vp-trustedresearch@qmul.ac.uk.