Access and benefit sharing of genetic resources

Table Of Contents

Overview #

Access and Benefit-Sharing (ABS) is an international legal and ethical framework that governs access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation. ABS aims to ensure that countries providing biological resources receive appropriate benefits from their use in scientific research, innovation, and commercial development, while promoting biodiversity conservation and sustainable use.

The cornerstone of the ABS framework is the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, a supplementary agreement to the Convention on Biological Diversity (CBD). The Protocol entered into force in 2014 and provides the first comprehensive international framework governing access to genetic resources, benefit-sharing, and user compliance. It aims at sharing the benefits arising from the utilisation of genetic resources in a fair and equitable way.

The Convention on Biological Diversity established three mutually reinforcing objectives:

  • conservation of biological diversity;
  • sustainable use of its components;
  • fair and equitable sharing of benefits arising from the utilisation of genetic resources.

The Nagoya Protocol operationalises the third objective by establishing mechanisms through which users of genetic resources obtain prior authorisation from provider countries and share monetary and non-monetary benefits generated through research and development.

The Nagoya Protocol does not explicitly cover human genetic material, and if research is done on human DNA, RNA and derivatives, this is out of the scope of the Nagoya Protocol. However, when research focuses on materials associated with humans, such as pathogens, microbiota or microorganisms, this research might be in scope.

Thus, when a biobank, in addition to its usual activities of receiving, processing, storing and distributing samples, performs sequencing of human pathogens, the Nagoya Protocol might apply, impacting how biological materials are accessed and exchanged.

For this reason, navigating the Protocol’s provisions with confidence can be complex for researchers, biobanks and institutions.

What are genetic resources? #

Under the Convention on Biological Diversity, genetic resources are defined as any material of plant, animal, microbial or other non-human origin containing functional units of heredity (DNA or RNA) and having actual or potential value.

Examples also include biological material preserved in ex situ collections, such as culture collections and biobanks.

The Protocol also applies to derivatives, namely naturally occurring biochemical compounds resulting from genetic expression or metabolism, including proteins, enzymes, lipids, resins, essential oils, milk, honey and other metabolites, even where they no longer contain DNA or RNA.

Scope #

The Nagoya Protocol does not apply to human genetic resources. Consequently, research involving human DNA, RNA and their derivatives falls outside its scope.

However, important exceptions are highly relevant for biomedical research:

  • microorganisms associated with humans;
  • pathogens;
  • microbiota;
  • environmental microorganisms collected from human-associated environments.

Research involving these materials may fall within the Protocol and therefore trigger ABS obligations.

The three pillars of ABS #

The Protocol is based on three interconnected pillars:

1. Access #

Provider countries have sovereign rights over their genetic resources and determine the legal conditions for access.

Researchers generally need to obtain Prior Informed Consent (PIC); permits or authorisations where required; Mutually Agreed Terms (MAT) governing benefit-sharing.

Importantly, access legislation is established at national level, meaning each country decides whether and how to regulate access. Consequently, ABS requirements differ between jurisdictions.

2. Benefit-sharing #

Benefits arising from the utilisation of genetic resources should be shared fairly with provider countries. Benefits may be monetary (royalties; joint intellectual property arrangements, etc.) or Non-monetary (sharing research results; joint publications; technology transfer; infrastructure development; collaborative research).

3. Compliance #

Countries where genetic resources are used are responsible for ensuring that users comply with provider-country legislation. Within the European Union, compliance is governed by Regulation (EU) No 511/2014, which establishes due diligence obligations for all users of genetic resources.

Importance for biobanks and researchers #

Biobanks play an increasingly important role in ABS implementation. Good practices include:

  • documenting the legal origin of samples;
  • storing ABS permits and associated documentation;
  • transferring relevant information to subsequent users;
  • recording restrictions attached to biological materials;
  • supporting users in fulfilling due diligence obligations.

Researchers frequently encounter challenges because ABS legislation differs across countries; several national legal systems may apply within one project; national requirements evolve over time; compliance documentation may be difficult to obtain retrospectively.

Researchers thus are recommended to:

  • early plan and communicate with provider-country authorities
  • seek all relevant ABS documentation;
  • verify whether provider-country legislation applies;
  • retain documentation for the legally required period;
  • submit due diligence declarations where required.

Importantly to note: Material Transfer Agreements (MTAs) do not replace ABS permits.

Compliance with national provider-country legislation remains necessary even where EU obligations do not apply.

National authorities perform compliance checks that may include document reviews, inspections and verification of due diligence procedures.

Key ethical, legal and societal implications #

  • Fairness and global equity: The Nagoya Protocol addresses historical concerns regarding the unequal exploitation of biodiversity, particularly where biological resources originating in biodiversity-rich countries have generated scientific or commercial value without corresponding benefits for provider countries or Indigenous communities. Benefit-sharing seeks to promote distributive justice by recognising the contributions of provider countries to global scientific research.
  • Biodiversity conservation. ABS is not solely a legal mechanism for regulating research. It is also intended to contribute directly to biodiversity conservation and sustainable use of biological resources.
  • Responsible research and research integrity. Compliance with ABS requirements supports responsible research practices by ensuring lawful acquisition of biological materials; traceability throughout the research lifecycle; reproducibility of scientific research.
  • Due diligence by researchers: they must verify national legislation from the provider country and seek and store all the needed documentations.
  • Trust: ABS contributes to broader societal objectives by promoting trust between researchers and provider countries and supporting international research partnerships; The Protocol also recognises that biodiversity has cultural, ecological and economic value extending beyond scientific research.

Legal and ethical international and EU sources #

International #

European Union #

BBMRI-ERIC resources #

External resources #

Relevant literature #

  • Beato MS, Veneroso V. The Nagoya Protocol on access and benefit sharing: The neglected issue of animal health. Front Microbiol. 2023 Feb 14;14:1124120. doi: 10.3389/fmicb.2023.1124120. PMID: 36865778; PMCID: PMC9971722.
  • Kamau EC, Winter G (eds.). Common Pools of Genetic Resources: Equity and Innovation in International Biodiversity Law. 2013, Routledge, https://doi.org/10.4324/9780203590881
  • Beumer K, Roskam A. Friends with benefits: What constitutes a ‘benefit’ in Access and Benefit Sharing (ABS) for plant genetic resources? Agric Human Values. 2026;43(1):38. doi: 10.1007/s10460-026-10849-x. Epub 2026 Feb 3. PMID: 41647309; PMCID: PMC12868051.
  • Ljungqvist GV, Weets CM, Stevens T, Robertson H, Zimmerman R, Graeden E, et al. Global patterns in access and benefit-sharing: a comprehensive review of national policies. BMJ Public Health. 2025;3:e001800. https://doi.org/10.1136/bmjph-2024-001800
ELSI, Nagoya Protocol
Updated on 20 August, 2026