Ensuring sustainable use of bioresources in science
The Nagoya Protocol (NP) is a supplementary agreement to the Convention on Biological Diversity (CBD). Since its entry into force on 12 October 2014, it provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising from the use of biological resources (1) (referred to as 'genetic resources' in the Nagoya Protocol) with the country of origin. It applies to research and development on the genetic and/or biochemical composition of biological resources.
The objective of the NP is to contribute to the conservation and sustainable use of biodiversity by providing a framework to the signatory countries for regulating access to their biological resources (2), sharing the benefit for their utilisation, and adopting compliance measures to control the effective enforcement of Access and benefit-sharing (ABS).
What is Access and Benefit Sharing (ABS)?
Access and Benefit Sharing (ABS) refers to the way in which biological resources may be accessed, and how the benefits that result from their utilisation in research and development are shared with the country of origin. Since the date of entry into force of the NP, users of biological resources have the obligation to comply with ABS requirements when obtaining samples from countries that have ratified the NP and adopted 'access legislation' (3).
Based on the CBD principle of sovereignty of a country over its biological resources, regulating access to its biological resources for research and development is the sole decision of a country party to the NP.
How does ABS affect your research?
In the European Union, before starting R&D activities on biological resources, independently of their country of origin, you must exercise your 'due diligence'. That means that you must check your right to use the resources and seek, keep, and transfer to subsequent users relevant information related to the resources.
In practice, when you acquire a biological resource in situ or ex situ, you must determine if you have to comply with ABS requirements by consulting the ABS Clearing-House (ABSCH) or by contacting the National Focal Point. If the country is party to the Nagoya Protocol (3), and there is an access legislation in place, contact the Competent National Authority to obtain an access permit (Prior Informed Consent, PIC) and establish Mutually Agreed Terms (MAT) before you can use the resource for your research or R&D.
The EU together with its member states, has established different 'due diligence' checkpoints where you must declare that you have taken the necessary steps to lawfully use the resource. At the stage of research funding (including Horizon Europe funding) and at the stage of final development of a product, you may use the DECLARE platform. Take into account that in certain countries you may be required to use a national platform to declare due diligence (eg France and Spain).
Finally, you should keep relevant information and documents relative to ABS (or proof of efforts to acquire them) for 20 years after the end of the period of utilisation as proof that you have exercised due diligence when obtaining your biological resources.
Negotiating PIC & MAT with the country of origin
At the access point, the country party to the NP with access legislation in place must give you a permit to use the resource under specific terms. The PIC/MAT determines how you may use the material obtained, under which conditions, and if you are allowed to transfer the resource.
Therefore, to facilitate further research on the resource, when negotiating with the providing country, EMBRC recommends that you request that the MAT include the rights to deposit the samples in an open, ABS-compliant scientist collection. The deposit of the biological resource in a collection is usually considered as non-monetary benefit sharing for the country of origin.
EMBRC & ABS: support to users & goals
In order to help you access and use marine biological resources, EMBRC is working to ensure that all organisms obtained through its biological resource centres and culture collections are compliant with ABS rules and accompanied by the appropriate documentation. We are incorporating the ABS EU regulation n°511/2014 in our activities and identifying resources that are in scope of the EU ABS regulation. Unique identifiers are being associated to each resource and a set of data relative to ABS requirements added in our databases. In addition, a passport system is being developed to allow you to acquire a biological resource with all the relevant information necessary to support your due diligence claims.
Through the implementation of such best practices (see our ABS guides), EMBRC aims to:
- Supply only biological resources with documentation providing evidence that the genetic resources were accessed in accordance with ABS EU regulation requirements;
- Facilitate the ABS due diligence of its users;
- Provide a safeguard system to the countries of origin whereby their biological resources are tracked from access to transfer;
- Create an ABS community of practice;
- Seek recognition of EMBRC procedures and tools as best practices under the EU ABS Regulation;
- Sustain long-term partnerships between collections and providing countries.
ABS is not a permit for sampling at sea
Be aware that your research on marine biological resources may also fall under the United Nations Convention of the Law of the Sea that regulates access to maritime zones and biodiversity and marine research conducted at sea. If the research occurs within the Exclusive Economic Zone of a country (4), you must also comply with different and complementary rules to the ones explained above.
Quick links: additional ABS resources
Footnotes
[1] Some Parties to the CBD have also adopted access regulations without ratifying NP (Brazil, Australia). For those, access compliance is also required, but NP specific domestic enforcement measures are not applicable (ie. the EU ABS regulation tracking mechanism - ABS documents archiving and due diligence declaration - does not apply, nor do national sanctions under NP compliance measures).
[2] 'Digital Sequence Information' (DSI), such as DNA sequence data downloadable from public databases / genebanks, is currently under discussion in the CBD and should lead to a framework soon.
[3] Some Parties to the CBD have also adopted access regulations without ratifying NP (Brazil, Australia). For those countries, access compliance is also required, but NP-specific domestic enforcement measures are not applicable (ie the EU ABS regulation tracking mechanism - ABS documents archiving and due diligence declaration - does not apply, nor do national sanctions under NP compliance measures).
[4] You may still access and freely use marine biological resources from the high seas. However, the framework applicable to biodiversity beyond national jurisdiction will change in the near future with the adoption of a supplementary instrument to the UNCLOS by the UN.
