Microbial genetic resources: implementing the Nagoya Protocol in France

Since 2016, when the Nagoya Protocol was transposed into French law, users of genetic resources collected on French territory, including Institut Pasteur researchers, have found themselves concerned and impacted by its often restrictive application. Although the use of genetic resources derived from microorganisms was exempted from the Protocol's obligations in France, this has no longer been the case since 2022. This situation quickly confined the “users” of these resources to constrained and often over-restricted frameworks. Very recently, teams from the Biological Resource Center of Institut Pasteur (CRBIP) have helped to unblock this situation, so that researchers and microbial biobanks can once again publish the names of new prokaryotic species of French origin, and have these names validated by the international committee in charge of their nomenclature. An opportunity to protect genetic resources without hampering research into microbial diversity.

The Nagoya Protocol (NP), an international text adopted in 2010 at the end of the United Nations Conference on Biological Diversity (CBD) and which came into force in 2014, establishes the principle that each country is “sovereign” over the genetic resources (GR) collected on its territory. As such, the country is legitimate to control access to its GR and when granting such access, to demand a fair and equitable return of the benefits and/or advantages arising from the use of said GR: this is what is known as Acces and Benefit Sharing (ABS) whether monetary, scientific or even linked to intellectual property.

Each country is free to set up its own ABS system, the main principles of which are laid down in the NP. However, national or regional regulations governing the application of the NP are often too restrictive. This situation, combined with a lack of clarity as to how these regulations are to be applied, sometimes leads to the under- or non-use of microorganisms collected in different countries.

France, unlike the majority of European countries, decided to regulate access to genetic resources (GR) through Law n°2016-1087 of August 8, 2016, granting however an exception for microorganisms then not subject to the PN. This exception ended in September 2022 and, since that date, anyone, French or foreign, wishing to access microbial resources collected on French soil must therefore pursue ABS procedures to comply with NP obligations.
 

Microbial biobanks, for their part, find themselves indirectly concerned by the application of the NP because, even if their vocation is not to “use” microbial GR themselves in research projects, they are in charge of collecting, preserving and taxonomically characterizing them with regard to their identity and phylogeny. They also redistribute authenticated strains to researchers. Biobanks thus play the role of “intermediary”. Biobanks are also often called upon to publish on the taxonomy of new species, as are researchers working on prokaryotic taxonomy and nomenclature. For the name of any new species to be valid, it must be published in the leading scientific journal “International Journal of Systematic and Evolutionary Microbiology (IJSEM)”. This is the necessary prerequisite for the communication of new taxa within the scientific community, initiating further in-depth studies of these strains, which can lead to a variety of discoveries and applications, including applications for human health.   

Due to a lack of clarity in French regulations, deemed too restrictive regarding access to and use of microorganisms of French origin, the journal IJSEM had blocked the publication of any new species of French origin. Some foreign collections also began to hesitate about receiving deposits of French strains. Faced with this situation, the CRBIP teams undertook a communication and explanation campaign to facilitate the use of microorganisms without hindering legislation. The teams exchanged information with the French Ministry of Ecological Transition and Territorial Cohesion (France's focal point for ABS), and with the International Committee for the Systematics of Prokaryotes (ICSP), the body responsible for drawing up the rules of prokaryotic nomenclature included in the International Code of Nomenclature of Prokaryotes (ICNP). They also approached the editors of the journal IJSEM. Thanks to this triple intervention, researchers are once again able to publish and communicate on new species of French origin, and have them validated according to the ICNP code. To complete this approach, CRBIP, with collaborators from INRAE, published an article in the IJSEM journal to clarify the application of PN in France. 

One of the major roles of microbial biobanks, as research infrastructures, is to facilitate the task of researchers as “users”, in particular by communicating the details of the administrative procedures to be carried out before launching research work.  This is a real challenge if scientists are to make the best possible use of microbial resources for their work, while fulfilling their obligations under the NP and French and European regulations.

The CRBIP initiative has helped to support several Institut Pasteur researchers. It has helped to clarify French ABS regulations and the exceptions to their application, which will also benefit French and international researchers, biobanks, industry and policy makers. 

 
If you have any questions about the Nagoya Protocol, or would like to find out more on the subject, please do not hesitate to contact the CRBIP teams: crbip-pmo@pasteur.fr.
 
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