The Nagoya Protocol: Access and Benefit Sharing
What is the Nagoya Protocol?
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity is a supplementary agreement to the UN’s Convention on Biological Diversity and was adopted in 2010 and came into force on the 12th October 2014. It recognises the rights of countries to regulate access and utilization of their genetic resources and associated traditional knowledge through national legislation. Countries can negotiate the sharing of any benefits arising from the utilization of these resources, whether monetary or otherwise, such as training or other collaboration. This benefit sharing has the potential to positively influence biodiversity and its sustainable use.
Within the UK, the Competent Authority for Access and Benefit Sharing (ABS) is Regulatory Delivery, who are responsible for advising, supporting and enforcing the EU ABS Regulation.
What is the scope of the Nagoya Protocol?
Generally, to be in scope of the Nagoya Protocol a genetic resource (in our case usually the CCAP strain) must be:
- accessed on or after October 12th 2014
- accessed from a country of origin that is a Party to the Nagoya Protocol, exercises sovereign rights (i.e. the ‘high seas’ are out of scope), and has applicable access legislation in place.
- utilised for ‘Research and Development’ (The exact meaning of this phrase is currently a subject of debate, it will be clarified when the sector guidance documents of the European Commission have been finalised.)
Documentation and Due Diligence
Users must exercise due diligence to ensure that genetic resources and traditional knowledge have been accessed in accordance with access and benefit sharing requirements of the providing country.
The first step is to check if the Country of Origin is party to the Nagoya Protocol and if they have access legislation in place. This information can be found via the ABSCH (Access and Benefit Sharing Clearing House) database.
There are three specific documents/pieces of information that can assist with due diligence:
- PIC (Prior Informed Consent): this is a permit for accessing the genetic resource and/or associated traditional knowledge and is often administered by the relevant Competent National Authority.
- MAT (Mutually Agreed Terms): these are negotiated with the Competent National Authority, or a community, in the country of origin, prior to the access/collection of the material.
- IRCC (Internationally Recognised Certificate of Compliance): when a competent national authority publishes information on the access permission and MAT to the ABSCH, this will be in the form of an IRCC. The first IRCC was issued by India in October 2015, agreeing terms and granting access to ethno-medicinal knowledge of the Siddi community of Gujarat to a researcher affiliated with the University of Kent in the United Kingdom. As of early 2017 there are 51 published IRCCs from four countries.
These documents will prove that the material was legally accessed and may also determine permitted uses and terms of benefit sharing. Copies of the documents must be transferred along with the material to any subsequent users. The documents will be placed on the ABSCH (note that only non-confidential material is published).
What does this mean for depositors?
Any strains deposited with CCAP must be accompanied by our fully completed and signed accession form and, if in scope of the provider country legislation, also evidence of PIC and any available MAT or an IRCC.
What does this mean for users wishing to purchase strains?
If a strain comes under the scope of provider country legislation there will be information in the strain data in our online catalogue.
Copies of any associated documents and permissions will be available and would be transferred with the strain if purchased. These would outline how the strain can be utilized under the terms of the MAT/provider country legislation, and any information on benefit sharing.
The user can contact the Competent National Authority of the country of origin if any clarification or amendments are required.
Strains that are not subject to legislation under the Nagoya protocol
As stated in our Terms and Conditions of Sale: If the recipient desires to use the Material (or modifications) for defined commercial purpose(s), it is incumbent upon the recipient, in advance of such use and providing that the Country of Origin is a signatory to the CBD, to negotiate in good faith with the depositor or appropriate authority in the Country of Origin, the terms of any benefit sharing in compliance with the CBD.
- The CBD: The Nagoya Protocol
- ABS Clearing House
- Regulatory Delivery and ABS
- EU Regulation No. 511/2014 and the Implementing Regulation (EU) 2015/1866
EU 511/2014 English / other languages
EU 2015/1866 English / other languages
- EMBRC Guide to ABS Compliance: Recommendations To Marine Biological Resources, Collections’ And Users’ Institutions
- MIRRI (Microbial Resource Research Infrastructure) ABS Best Practice Manual