[For the Dutch version, see the ABS Focal Point website.]
[Voor de Nederlandse versie, zie de website van het ABS Focal Point.]

Welcome to the ninth ABS Focal Point newsletter! In this newsletter we take a look at the recently updated ABS Clearing-House website, give a brief overview of upcoming international discussions on ABS and digital sequence information (DSI), read what the EU ABS Regulation says about laboratory strains and human microbiota and pathogens, and look forward to an upcoming update of our interactive ABS help tool.

This newsletter contains:

• A guide to the ABS Clearing-House.
• CBD meetings (including on DSI) to be held in March.
• EU ABS Regulation: human microbiota and pathogens.
• Laboratory strains and the EU ABS Regulation.
• Coming soon: ABS help tool update.

A guide to the ABS Clearing-House

CBD meetings (including on DSI) to be held in March

Various previously postponed meetings in the framework of the Convention on Biological Diversity (CBD) and the Nagoya Protocol will now be held from 14-29 March in Geneva, Switzerland. These meetings will include discussions on how to deal with access to and benefit-sharing from the use of digital sequence information (DSI).

The meetings were originally scheduled for 2021 but were postponed to 2022, because physical meetings were not possible due to the COVID-19 pandemic and negotiations could not take place online. The meetings will now be held from 14-29 March in Geneva, Switzerland. More information can be found on the website of the CBD. The results of the Geneva meetings will feed into the Fifteenth meeting of the Conference of the Parties to the CBD (COP-15), which, after a formal virtual opening in October 2021, will now probably take place in the third quarter of 2022.

The Geneva meetings will include the resumed session of the Third Meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework (OEWG-3), in which further discussions will take place on how to deal with access to and benefit-sharing from the use of digital sequence information (DSI). For more information, see the previous articles Policy options for Access and Benefit-Sharing (ABS) and Digital Sequence Information and Progress on Digital Sequence Information (DSI).

In preparation for the DSI discussions during OEWG-3, areas of potential convergence and apparent divergence of opinions on how to deal with DSI have been identified. A multi-criteria framework is proposed to assess the different policy options, with the criteria focusing on effectiveness, efficiency, good governance and coherence. A new option (‘1 per cent levy on retail sales of genetic resources’), proposed by the African Union, has been added to the policy options identified earlier. In summary, the following policy options are currently under consideration, also keeping open the possibility to combine various options (e.g. Option 4 with another option).

• Option 0: Status Quo.
• Option 1: DSI on genetic resources fully integrated into domestic ABS measures.
• Option 2: Standard mutually agreed terms (MAT).
• 2.1: Standard MAT/licence at the national level.
• 2.2: Standard MAT/licence at the international level.
• Option 3: No prior informed consent (PIC), no mutually agreed terms (MAT).
• 3.1: Payment for access to DSI on genetic resources.
• 3.2: Other payments and contribution.
• Option 4: Enhanced technical and scientific capacity and cooperation.
• Option 5: No benefit-sharing from digital sequence information on genetic resources.
• Option 6: 1 per cent levy on retail sales of genetic resources.

More information on what will be discussed on DSI during the Geneva meetings can be found in this meeting document, with its annex I describing the policy options, and its annex II and III the possible criteria and subcriteria to assess these options. Much information on the DSI discussion is provided in the webinars organised by the CBD Secretariat in 2020 and 2021.

As indicated before, the Dutch ABS Competent National Authority (Ms Kim van Seeters; k.vanseeters@minlnv.nl) is interested in hearing the experiences of Dutch stakeholders with DSI and their opinions on the proposed DSI policy options.

EU ABS Regulation: human microbiota and pathogens

Human genetic resources are outside the scope of the Convention on Biological Diversity (CBD), Nagoya Protocol and EU ABS Regulation, but human microbiota and pathogens occurring on or in humans are not considered to be human genetic resources and may be in scope of the EU ABS Regulation. What do you need to keep in mind when using genetic resources associated with humans?

Human microbiota

In the context of the EU ABS Regulation, the term ‘human microbiota’ is used to refer to all microorganisms (such as bacteria, fungi, and viruses) residing on or in the human body, and ‘microbiome’ to the collective genomes of those microorganisms (i.e. the collective genetic resources). The microbial diversity is unique to each human individual and may change during the lifetime of this person.

While associated with human beings and essential for the well-being and survival of the human individual, the human microbiome represents genetic resources of non-human nature. The human microbiota is thus to be considered separate from human genetic resources, since it comprises distinct and different organisms. However, because of the symbiotic interaction between the microbiota and the human body, which results in a unique composition of microbiota in each individual, special conditions apply under the EU ABS Regulation to the use of human microbiota.

When studies focus on the microbiota from an individual human as a whole, and do not focus on individual taxa, such studies are considered to be out of scope of the EU ABS Regulation. However, when research and development activities are carried out on individual taxa isolated from a sample of the human microbiota, this isolate no longer represents the unique microbial composition characteristic of an individual human, and the studies are considered to be within scope of the EU ABS Regulation.

For example, a pharmaceutical company studies the composition of the gut microbiota in human faecal samples that are obtained from individuals, to explore the relationship between the microbiota and mental health. As the gut’s microbiota is unique for every individual, this study is out of scope of the EU ABS Regulation. In another study, the gut bacterium Lactobacillus rhamnosus is isolated from several samples and tested for its ability to inhibit attachment of Escherichia coli to human colon cells. As this study is focussed on an individual taxon, rather than the human microbiota, it is considered to be in scope of the EU ABS Regulation.

For more information, see section 2.3.1.7 of the EU Guidance.

Human pathogens and pests

When pathogenic organisms or pests present on a human are introduced unintentionally to a place in the EU, they fall outside the scope of the EU ABS Regulation, as there was or is no intention of introducing or distributing the harmful organisms as genetic resources. This is the case, for example, when travellers who are unknowingly infected with a virus travel to an EU country. However, if the pathogens or pests are established in situ in an EU country following introduction, utilisation of these genetic resources may be in scope of that country’s ABS legislation. For more information, see section 2.3.1.5 of the EU Guidance.

In case of a pandemic influenza virus, the genetic resource may be covered by the Pandemic Influenza Preparedness (PIP) Framework. Because the PIP Framework is recognised by the EU as a specialised ABS instrument, there are no obligations related to the EU ABS Regulation when the genetic resource is covered by the PIP Framework. Read ‘Minimising your administrative burden: specialised ABS instruments’ for more detailed information.

Laboratory strains and the EU ABS Regulation

Laboratory strains are key resources for research. Viruses, microbes, plants and animals are modified by laboratories to create laboratory strains that meet specific scientific needs. Are the creation and utilisation of laboratory strains in scope of the EU ABS Regulation?

A laboratory strain is a strain of living organisms or viruses that has particular properties that make it unique and is available for mass production and transfer to third parties. The strains generally have low or no genetic heterozygosity for traits of interest, are often inbred or clonal and are characterised by a genetic and/or biochemical composition that has been intentionally created or conserved. In addition, laboratory strains can be managed under a record of laboratory maintenance over several generations, with a publicly traceable history regarding ancestry and/or pedigree.

Laboratory strains of rats and mice, for example, are commonly used for disease modeling in biomedical studies, with thousands of different strains being available for a range of diseases and traits. Laboratory strains have also been developed in microbial species (e.g. Escherichia coli strains), plant species (e.g. Arabidopsis plants) and viruses (e.g. of the Herpes simplex virus).

Creating a new laboratory strain

New strains can be created from genetic material by intentional genetic modification or by selecting and conserving mutations that occurred uninentionally during sub-culturing, prolonged storage or as a result of preservation technologies.

The creation of a new strain (which may over time become a new laboratory strain) based on material in scope of the EU ABS Regulation is itself in scope of the EU ABS Regulation, as utilisation (research and development on the genetic and/or biochemical composition) of genetic resources takes place to create the new strain.

A newly created strain based on material in scope of the EU ABS Regulation remains in scope of the EU ABS Regulation as long as it is not publicly available to others for research and development purposes. Before the strain is made publicly available to others, the developer of the laboratory strain needs to submit a due diligence declaration.

Utilisation of a laboratory strain

After a strain has become a laboratory strain and is made publicly available to others, its further use is out of scope of the EU ABS Regulation. However, contractual agreements agreed in PIC and MAT concerning benefit-sharing resulting from further use of newly developed laboratory strains need to be respected.

For more information on laboratory strains, see section 7.5 of Annex II of the EU Guidance. 

Laboratory strains as testing and reference tools

When a genetic resource is used as a testing or reference tool, the material is not the object of the research in itself, but only serves to confirm or verify the desired features of other products developed or under development. This means that using laboratory strains as testing and reference tools is not considered to be utilisation in the meaning of the EU ABS Regulation. Examples are the use of laboratory animals to test their reaction to medical products, pathogens for testing the resistance of plant varieties, or bacteria for testing the effectiveness of compounds that are candidates for new antibiotics.

For more information about testing and reference tools, read the article ‘Utilisation: taxonomic identification and testing and reference tools’.