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 (‘the Protocol’) is an international agreement to ensure the fair and equitable access and benefit sharing (ABS) in using genetic resources. It came into force on 12th October 2014.
The Nagoya Protocol applies to genetic resources that are covered by the Convention on Biological Diversity (the CBD), and to the benefits arising from their utilization. The protocol also covers traditional knowledge associated with genetic resources that are covered by the CBD and the benefits arising from its utilization.
For users of genetic resources and traditional knowledge associated with genetic resources this entails inter alia the obligation to verify if the genetic resources have been accessed in compliance with applicable legislation or regulatory requirements (due diligence obligation), and whether benefits arising from the utilization of genetic resources have to be fairly and equitably shared upon mutually agreed terms.
What are genetic resources?
Genetic resources include any material of plant, animal, microbial or other origin containing functional units of heredity which is of actual or potential value, or derivatives.
Traditional knowledge refers to knowledge, know-how and practice of indigenous and local communities relevant for the utilization of the genetic resources accessed under the protocol.
It does not cover:
- human genetic resources
- genetic resources covered by specialized ABS treaties that are supportive of the Convention of Biological Diversity, for instance, the International Treaty on Plant Genetic Resources for Food and Agriculture.
What is meant by the use of genetic resources?
Utilization of genetic resources means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. If there is no such utilization, the requirements of the EU ABS Regulation do not apply in Austria. For example, the collection and identification, as well as the description of observed characteristics and the archiving of genetic resources do not constitute utilization in the meaning of the EU ABS Regulation. For these activities, it is therefore not necessary to take the measures set out in the EU ABS Regulation.
If you are not sure which/if ABS rules apply in your case, you can contact the National Focal Point (NFP) of the Providing Country of the genetic resources listed on the ABS Clearing House website.
Due diligence declaration
Article 7 of the EU ABS Regulation requires all recipients of research funding involving the utilization of genetic resources and traditional knowledge associated with genetic resources to submit a due diligence declaration. Such a due diligence declaration has also to be submitted at the stage of final development of a product. These due diligence declarations at the stage of research funding or at the stage of final development of a product demonstrate that the users have exercised due diligence in accordance with the obligations laid down.
Annex II to the Implementing Regulation (EU) 2015/1866 provides a template for a due diligence declaration which is to be submitted through the web tool DECLARE.
Website of the Austrian ABC Clearing House
INFORMATION SHEET FOR USERS OF GENETIC RESOURCES INCLUDING CHECKLIST
Due diligence obligation
For the purpose of demonstrating compliance with the due diligence obligation, the activity or process falling within the scope of the EU ABS Regulation has to be documented in accordance with Article 4 (3) of the EU ABS Regulation. The information and relevant documents have to be kept for 20 years after the end of the period of utilization. This is part of the due diligence obligations of users. Any additional information such as relevant correspondence should also be documented and kept, and transfers of genetic resources to subsequent users also have to be documented.
Prior Informed Consent and Mutually Agreed Terms
Access obligations, usually in the form of a Prior Informed Consent (PIC) permit, will be granted by the Provider Country of the genetic resource to the user (i.e. researcher) of the genetic resource prior to the acquisition of such resource. The Providing Country refers to the Country where the genetic resource is found in situ and where it will be initially accessed from.
Mutually Agreed Terms (MAT), are contractual obligations between the Providing Country of the genetic resource and the user of the genetic resource. MAT will establish monetary and/or non-monetary benefit-sharing measures and also establish what can be done (i.e. commercial or non-commercial research) with the genetic resource, who will be the user of such resource, for how long, if the resources can be transferred to other scientists, etc.
Once the user of a genetic resource obtains a PIC and a MAT from the Providing Country of the genetic resource, the Providing Country might extend an Internationally Recognized Certificate of Compliance (IRCC) to show the legality of access and the establishment of MATs and can decide to publish it on the ABS Clearing House website.
Consequences for non-compliance with the Nagoya Protocol
Austria can impose regulatory offenses of up to 50,000 EUR if found non-compliant with the regulation.
In Countries like Brazil and India researchers have gone to jail for violating national laws. Malaysia might decide to ban a group of researchers from entering the Country after not being able to prove they legally acquired a new species of tarantula which they recently published on a peer-reviewed journal.
Checklist for Researchers
What kind of material are you using? (material scope)
What are you using it for? (utilization scope)
When did you access this material? (temporal scope)
Where did you get the material from? (geographical scope)
The material contains DNA/RNA and derivatives (protein, metabolites etc.)
The research investigates the genetic and biochemical composition of the material.
The material was obtained on or after 12 October 2014.
The country providing the material was a Nagoya Protocol Party at the time of access.
In this case you are within the SCOPE of EU ABS Regulation.