Recently, the European Commission published a revised Guidance on the EU ABS Regulation. In this series of articles, we take a closer look at the revised Guidance and highlight a number of topics regarding utilisation of genetic resources that might be of particular interest to our readers. In this article: taxonomic identification and testing and reference tools.
In the sense of the Nagoya Protocol and the EU ABS Regulation (Regulation (EU) 511/2014), utilisation of genetic resources is: “to conduct research and/or development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.”
The Guidance states that both basic and applied research may be considered utilisation. As a type of ‘litmus test’, users should ask themselves whether what they are doing with the genetic resources creates new insight into genetic and/or biochemical characteristics of the genetic resource which is of (potential) benefit to the further process of product development. If this is the case, the activity goes beyond mere description, should be considered research, and therefore falls under the term ‘utilisation’.
Not all activities with genetic resources are considered to be utilisation. As requested by users of genetic resources, the Guidance provides further specification of the concept of ‘utilisation’. Particularly relevant in this respect are section 2.3.3 and Annex II of the Guidance. Annex II follows the logic of the value chain as closely as possible, from acquisition, via storing, management of collections, identification and characterisation, to product development, product testing and placing of a product on the market. Many examples (cases) are given, drawn from different sectors and often based on feedback from stakeholders that identified issues and challenges in the interpretation of the Regulation.
Taxonomic identification of genetic resources, by morphological or molecular analysis, including through use of DNA sequencing, is not considered to constitute utilisation in the meaning of the EU ABS Regulation, as it does not involve the discovery of specific genetic and/or biochemical properties. Taxonomic studies, where they do not look into genetic properties (functionality), are thus not within scope of the EU ABS Regulation.
Discovery, description and publication of new species would also not qualify as utilisation in the meaning of the EU ABS Regulation, as long as this is done without additional research on the genetic and/or biochemical composition of the genetic resources to discover or making use of the properties (functions) of the genes.
However, if the identification or taxonomic description of an organism is combined with research on its specific genetic and/or biochemical composition, specifically the function of the genes, this would qualify as utilisation in terms of the EU ABS Regulation.
For more information and practical examples on taxonomic identification, see section 220.127.116.11 of the Guidance and section 6.1 of the Guidance’s Annex II.
Testing and reference tools
The application of genetic resources as testing or reference tools is not considered to constitute utilisation in the meaning of the EU ABS Regulation. At that stage 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.
At an earlier stage, however, research and development may have been carried out on those genetic resources with the aim of turning them into (better) testing or reference tools, and this research and development would be within the scope of the Regulation.
Examples of testing and reference tools are laboratory animals used to test their reaction to medical products, pathogens used for testing the resistance of plant varieties, pathogens used for testing biocontrol agents, rats used in toxicological studies aimed at testing synthesised compounds, and bacteria used for testing the effectiveness of compounds that are candidates for new antibiotics against those bacteria.
For more information and practical examples on testing and reference tools, see section 18.104.22.168 of the Guidance and sections 7.1 and 7.2 of the Guidance’s Annex II.