What are genetic resources and why does benefit sharing matter?
Genetic resources are any plant, animal or microbial materials that contain genetic information. They are often used in research, innovation and product development, for example, in medicines, agriculture, environmental technologies and industrial processes.
Many uses of genetic resources draw on traditional knowledge from Indigenous Peoples and local communities. This knowledge can guide how resources are found, used and conserved.
Countries have sovereign rights over the genetic resources found on their territory. When research or commercial development brings benefits, those benefits should be shared fairly with the country providing the resources, and, where relevant, with knowledge holders. This is called Access and Benefit Sharing, or ABS.
If you plan to use genetic resources or related traditional knowledge from another country, you need to consider ABS from the outset, so that:
- Access is granted legally by the provider country
- Benefits (money, technology, training, data, etc.) are shared in a fair and agreed-upon way
What is the international context?
The Convention on Biological Diversity (CBD) sets fair and equitable benefit sharing as one of its three main objectives. Its Kunming–Montreal Global Biodiversity Framework (KMGBF) is a global action plan to halt and reverse nature loss by 2030. ABS is part of KMGBF Goal C and Target 13.
The 196 countries that adopted the Framework are translating this global plan into national actions for implementation on the ground. You can find more details about the framework here.
The Nagoya Protocol is a supplementary agreement to the CBD. It has been in force since 2014. It sets clear, legally binding rules on:
- How researchers and companies can obtain access to genetic resources and related traditional knowledge
- How the benefits from their use should be shared
Your key tool for implementation is the Access and Benefit Sharing Clearing House (ABSCH). It provides:
- Information on national ABS regimes
- Contacts for competent authorities and focal points
- Explanation and guidance on ABS
- And more
The Parties, including the EU and its Member States, have reported for the first time on how they implement the Nagoya Protocol through National Reports, which you can consult to understand the policy context in the EU.
What do you need to do to comply with the EU ABS Regulation?
The EU has applied the Nagoya Protocol since 12 October 2014. The EU ABS Regulation (Regulation (EU) No 511/2014) aligns EU law with Nagoya compliance requirements.
The Regulation applies to users in the EU who utilise genetic resources and associated traditional knowledge for research and development on their genetic or biochemical composition. It specifically covers resources and knowledge accessed after 12 October 2014 from countries that are Parties to the Nagoya Protocol and have applicable access and benefit-sharing rules.
A 2015 Implementing Regulation contains measures on specific aspects, in particular on monitoring user compliance, registered collections and best practices. The three registered collections and the best practices are recognised through a Commission Decision.
If you are a user in the EU and you utilise genetic resources in this way, you must exercise due diligence.
To show that you comply with your obligations, you must submit a Due Diligence Declaration at certain stages of the research and development chain. You do this through the web-based DECLARE system, which sends your declaration to the relevant Designated Competent Authority in the EU country concerned. A user guide and audio-visual manual explain how to use DECLARE.
You may find it difficult to decide whether you must submit a declaration. The European Commission has therefore published a guidance document on the scope and core obligations of the EU ABS Regulation, updated in 2020 and building on a 2016 document.
There are also:
- A glossary of key ABS terms
- Questions and answers on ABS
- A guide for researchers and scientists on the Nagoya Protocol and the EU Regulation
Designated Competent Authorities in EU countries implement the Regulation at the national level. To understand any additional access rules in a specific EU country, check that country’s profile in the international ABS Clearing-House.
How can expert groups help ensure consistent implementation across the EU?
The European Commission has created two expert groups to support a uniform application of the EU ABS Regulation.
The Expert Group on Access and Benefit Sharing under the Nagoya Protocol is a platform for cooperation between EU countries and the Commission. It works to ensure that users face similar ABS rules and expectations across the EU.
The ABS Consultation Forum brings together EU countries and selected stakeholders, such as business associations and NGOs. It discusses key work strands and helps coordinate implementation and communication.
If your organisation needs to align internal policies or sector practices with EU ABS rules, you can follow the work of these expert groups and forums to understand emerging interpretations and expectations.
How is the EU ABS Regulation monitored and evaluated over time?
Under Article 16 of the EU ABS Regulation, the Commission must report on how the Regulation is applied and how effective it is.
The first Implementation Report, adopted on 24 January 2019, covered the first years of application (Oct 2014 – Aug 2017, and two years for some specific provisions), using national reports from all 28 EU countries at that time.
After this report, the Commission published:
- An analysis of what the compliance obligations mean in practice for users of genetic resources in the EU
- A study by Prof. Geelhoed (Edinburgh Law School) on utilisation practices and challenges among upstream actors, such as collections and university researchers
The second national EU ABS reports cover Sep 2017–Dec 2025 and will inform a full evaluation of the Regulation.
The evaluation now underway looks at effectiveness, efficiency, coherence, relevance and EU added value. It pays particular attention to:
- The growing use of digital sequence information (DSI)
- Developments in other international treaties and agreements, including BBNJ, ITPGRFA, GRATK and the WHO Pandemics Agreement
A public call for evidence has already collected input from stakeholders, which will feed into the evaluation. The exercise is planned to finish in 2027.
Which EU research and innovation projects can you learn from or collaborate with?
ABS is not only about meeting legal requirements. It can also drive conservation, sustainable use of biodiversity and fairer partnerships, especially when supported by strong non-commercial research.
Since ratifying the Nagoya Protocol, the EU has funded several projects on genetic resources under Horizon 2020 (2014–2020) and Horizon Europe (2021–2027). These projects explore ABS from different angles:
- This MSCA grant runs from 2023 to 2027 and trains a new generation of early-stage scientists to take marine microbial natural products from the seabed to the bedside. Among other things, the training will equip the scientists with relevant skills in access and benefit sharing, intellectual property and entrepreneurship.
- This Horizon Europe project runs from 2022 to 2026 and will, among other things, establish new modalities in access and benefit sharing that balance sustainable and equitable use of marine genetic resources with intellectual property protection. The project will also develop and provide an integrated bioinformatics platform to explore the marine microbiome potential; apply the platforms to identify and develop natural products derived from marine microbes; and maximise equitable access to ocean microbiome resources and increase awareness of the marine microbiome to a diverse range of stakeholders.
- This Horizon Europe project runs from 2022 to 2026 and will aim to discover several hundreds of enzymes, rhodopsins, resistance genes, antimicrobials and anti-microfouling agents, thanks to a hybrid workflow of in silico and microfluidics-based functional discovery, resulting in the commercialization ≥400 enzymes for biocatalysis and ≥2 new solutions for plastic/polymer degradation, increasing the revenue of our industrial partners by 10-15%. The project will also develop a policy brief on ABS and DSI in marine microbiome research.
- This MSCA grant ran from 2020 to 2022 and assessed 1) the factors that determine the attribution of benefits; 2) the short and long-term impact of access and benefit sharing on local communities, socio-economic conditions, social status, the retention of traditional knowledge and resource sustainability; and 3) the role of women in access and benefit sharing.
- This Horizon 2020 project ran from 2016 to 2020 and aimed at enhancing the use of genetic collections and upgrading animal gene bank management. Among other things, the project conducted a review on Access and Benefit Sharing, which provided a guideline on how to interpret the Nagoya Protocol for gene banks.
If you are a researcher, policymaker or practitioner, you can use these project outputs to design better ABS practices, capacity-building activities and policy tools in your own work.
If you have specific questions about the Nagoya Protocol or the EU ABS Regulation, or you need clarification for a project, policy or compliance system, you can contact the European Commission at ENV-F3-NAGOYA-ABS
ec [dot] europa [dot] eu (ENV-F3-NAGOYA-ABS[at]ec[dot]europa[dot]eu) for further guidance.