Nagoya Protocol

Source: https://www.bath.ac.uk/guides/nagoya-protocol/ Parent: https://www.bath.ac.uk/topics/research-integrity-and-ethics/

This guidance outlines the university's due diligence process to demonstrate compliance with the Nagoya Protocol.

Background

The Nagoya Protocol came into being in 2010, offering more detail to the Access and Benefit Sharing (ABS) principles from the Convention of Biological Diversity in a legally binding way.

The objective of the Nagoya Protocol is the “fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and sustainable use of its components".

From 1 January 2021, UK stakeholders involved in accessing genetic resources from Parties to the Nagoya Protocol are required to follow new UK processes for:

• Submitting a due diligence declaration
• Applying for best practice recognition
• Registering a collection in the UK

When sourcing or using resources in scope of the Protocol, it is the responsibility of the Principal Investigator (PI) or, in the case of a student project, the Supervisor, to ensure that genetic resources, and traditional knowledge associated with those resources, have been accessed in accordance with applicable access and benefit sharing laws implemented by the source country.

See a University of Bath due diligence checklist.

When does the Nagoya Protocol and related due diligence apply?

If

• The research involves genetic resource that is in scope of the protocol; and
• The utilisation of the genetic resource is in scope of the protocol; and
• The country from which the genetic resource has ratified the protocol and established applicable access measures.

then the Nagoya Protocol and related due diligence apply to your work.

Are there any exceptions to the Protocol?

The following material does not fall within the scope of the Nagoya Protocol:

• Human genetic material
• Genetic resources already governed by specialised international agreements that are consistent with the Protocol such as the International Treaty on Plant Genetic Resources for Food and Agriculture, or the WHO Pandemic Influenza Preparedness Framework.
• Genetic resources as traded commodities.
• Genetic resources that are used for maintenance of a collection for conservation purposes (i.e., not for research purposes)
• Genetic resources which are being used as tool in research but are not the object of the research.

Definitions

Genetic resource any material or 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 of RNA

Traditional knowledge knowledge, know-ho and practice of indigenous and local communities relevant for the utilisation of genetic resources

Utilisation to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through application of biotechnology. This includes basic and applied research.

References

• Regulations: the Nagoya Protocol on access and benefit sharing (ABS)
• Access and benefit sharing initiative
• Convention on Biodiversity
• Durham University
• University of Cambridge

Nagoya Protocol Checklist

To download the Nagoya Protocol checklist click here