Nagoya Protocol and Access Benefit Sharing

The Nagoya Protocol is an international agreement that came into effect in October 2014 and provides a framework for the fair and equitable sharing of benefits arising from the utilisation of genetic resources. It is translated into UK law under The Nagoya Protocol (Compliance) Regulations 2015 and is enforced by the Office for Product Safety and Standards (OPSS). The OPSS carry out institutional audits to monitor user compliance with the legislation.

The Genetic Resource (see definitions section below) must have a perceived or actual value to humanity, examples of such value include, but are not limited to, the development of medicines, cosmetics, improved crop protection or support of industrial processes.

If your research project involves accessing Genetic Resource that is relevant to the Nagoya Protocol you must follow the process described below.

Academics and researchers have a legal obligation to ensure that their research, conducted after 12 October 2014, is conducted in compliance with the Nagoya Protocol. This involves carrying out due diligence checks to ensure that Genetic Resources and associated Traditional Knowledge have been accessed in accordance with the access and benefit sharing laws of the country from where the genetic resource is collected, as detailed in the process section below.

The Project Assurance Research Integrity (PARI) team are responsible for oversight of activity at Keele and conducting internal audits related to the processes that must be followed to ensure compliance with the UK legislation.

There are five key stages to the process. You must keep records of all decision-making and due diligence.

Step 1 - Determine whether the Nagoya Protocol is relevant for the material being accessed. Make sure you record your decision-making process even if the result is that the material is not in scope of the Nagoya Protocol. The OFPSS can ask to see records of the decision-making process.

Step 2 – Use the Access and Benefit-Sharing Clearing-House to work out what national laws are relevant in the country of origin. Again, keep a record of when you accessed the Access and Benefit-Sharing Clearing-House as part of your due diligence process. Also use the Access and Benefit-Sharing Clearing House to find out what procedures are in place that you will need to follow and who to contact in the country of origin. It may be best to contact the National Focal Point to double-check your understanding of the local laws and whether the Nagoya Protocol is relevant, as some countries, for example Brazil, are only ratifying the Nagoya Protocol towards the end of 2020. Even if the Nagoya Protocol is not relevant because the source country is not a part of the framework, the country may have its own ABS laws that must be followed.

Also, check if other permits e.g. for access to protected areas or export control are required.

Step 3 – Make all reasonable efforts to gain prior informed consent (PIC) from the authorities of the country of origin. This involves agreeing the terms and conditions of access using Mutually Agreed Terms (MAT) if required by the local laws of country of origin. You will need to contact the Project Assurance Contracts team who will draft and arrange the approval the MAT in association with the Competent National Authority of the country of origin. An Internationally Recognised Certificate of Compliance (IRCC) is generated by the Access and Benefit-Sharing Clearing-House once PIC and MAT are in place.

Step 4 – Submit a Due Diligence Declaration – there are two checkpoints defined in the EU regulations when a due diligence declaration must be submitted.

Checkpoint 1 – when the first instalment of funding is received from the funder and all of the Genetic Resource has been obtained.

Checkpoint 2 – at the stage of final development of a product.

The DECLARE portal is used for making declarations of due diligence – you will need to create an account before logging in.

Step 5 - Keep records for 20 years. The IRCC or equivalent due diligence evidence must be kept for 20 years after the end of utilisation. If you leave Keele University a copy of your records must be provided to the Project Assurance Research Integrity team

If you have any queries, please email the PARI team (research.governance@keele.ac.uk).

The OFPSS gave a recent webinar that runs through the basics of the Nagoya Protocol.

University of Cambridge have useful information on how to access the Access and Benefit-Sharing Clearing-House.

User guide and FAQs for DECLARE Nagoya Protocol portal.