Regulating access can restrict participation in reporting new species and taxa

To the Editor — Publication of a novel microbial taxon requires adherence to the rules of the International Code of Nomenclature of Prokaryotes (ICNP), which are at odds with biodiversity laws that regulate access to genetic resources. Unfortunately, enabling access to isolates, which is a valuable goal, can restrict the ability of researchers based in countries that are signatories of the Convention on Biological Diversity and the Nagoya Protocol to exert their right to publish papers naming new microorganisms.

Names are important for all organisms, including bacteria and archaea. The International Committee on Systematics of Prokaryotes (ICSP; https://www.the-icsp.org/) assigns each microorganism a unique name and regulates naming by applying ICNP rules (the Code). The contribution of the ICSP is shown by the total number of named bacterial and archaeal species, which is in excess of 21,000 (ref. ¹).

The ICNP Code comprises 65 rules and 45 recommendations². Rule 30(3b) recommends that a viable culture of a newly described taxon must be deposited in at least two publicly accessible culture collections in different countries, including the country of origin, from which subcultures must be available². In addition to this, rule 30(4) places emphasis on restriction-free access and rejects culture deposits that have restricted access clauses for reasons including exclusivity or intellectual property rights. The ICNP Code demands that a certificate of deposition certifying that the cultures are present, viable and available at the time of publication, issued by the culture collections, must be submitted as evidence with a manuscript describing a new microorganism. The International Journal of Systematic and Evolutionary Microbiology is the official journal of record for novel prokaryotic taxa and mandates that a certificate of deposition is provided with all taxonomic descriptions. Unrestricted availability of type cultures is required for researchers to generate data to substantiate any scientific claims. Accessing cultures directly from the culture collection has been a standard practice, and making cultures readily available is considered as exercising due diligence. However, a significant change has occurred in the last two decades, with a few countries regulating access to cultures to claim sovereign rights over genetic resources in their territory.

The Convention on Biological Diversity (https://www.cbd.int/) is an international agreement to conserve biological diversity and use its components sustainably and to provide a legal framework to enable appropriate access to genetic resources. Ratification of the Nagoya Protocol, which deals with fair and equitable access and benefit sharing (ABS) for genetic resources, further demonstrates the fear of exploitation, particularly in the countries that are rich in biodiversity³. Anticipating the potential for losses in national biodiversity due to uncontrolled access to organisms, 130 countries became party to the Nagoya Protocol, which regulates access to all genetic resources and offers a legal system for access through the Access and Benefit-Sharing Clearing-House (https://absch.cbd.int/). The primary goals of the ABS Clearing-House are to provide users, including researchers and businesses, with the information needed to access genetic resources for commercial and non-commercial purposes and to assist national biodiversity authorities to record information on the utilization of genetic resources from their country once they have been accessed. However, the process of access and benefit-sharing differed considerably among the parties of the Nagoya Protocol⁴. A majority of the governments have not even issued a single Internationally Recognized Certificate of Compliance (IRCC), and only 23 governments actively issue them^4,5. Of the total 2,908 IRCCs issued and published, 1,993 were issued by the ABS Clearing-House of India. On the one hand, businesses and researchers involved in research and product development for commercialization have made most of the applications to the Indian ABS Clearing-House. On the other hand, academic researchers, who will probably not derive commercial benefit from the genetic resource, regard the access protocols of the ABS as an obstacle delaying their research projects because they require prior approval^6,7, which is not needed for simpler access procedures, such as those for accessing cultures from a bioresource centre or from a collaborator. Obtaining genetic resources from countries with controlled access without prior approval or under informal collaboration has been considered illegal exploitation of genetic resources and can attract fines and other penalties⁸.

The main conflict between biodiversity laws and the Code is that biodiversity laws regulate the access of genetic resources, whereas the Code requires restriction-free access. The problem worsens with misinterpretation of these rules. For example, during consideration of our recent submission to another journal, the journal initially rejected the following statement in the certificate of accession: “The culture will be freely accessible for research, teaching and quality control. Access to this culture is regulated by the Biodiversity laws of the country of origin, for all other purposes except the one, mentioned earlier”. The journal editor rejected this certificate by commenting “Unfortunately due to certain restrictions and in keeping in line with the requirements of the Bacteriological Code, we cannot accept proof of deposit for certificates with any restrictions”. The culture collection suggested that the authors sign a material transfer agreement that includes “the DEPOSITOR waives its own rights under any patents, intellectual property, or other proprietary rights with respect to the results to be obtained by use of the BIOLOGICAL RESOURCE”. After receiving this material transfer agreement, the culture collection issued a new certificate stating “...microorganism has been deposited and will be available to the public without restriction after publication by the author(s) of the scientific paper.” The journal editor then accepted this proof of deposit. Researchers from countries that are party to the Nagoya Protocol find themselves trapped because they do not want to bypass biodiversity regulations by making cultures freely accessible or waive rights under any patent or intellectual property agreement or other proprietary rights if they obtain results from the genetic resource, but, at the same time, they want to exercise their right to publish a description of a new taxon.

I propose that the problems imposed by policies designed to increase accessibility to genetic resources could be resolved by revising the ICNP rules to accommodate the many researchers working in countries that are signatories of the Convention on Biological Diversity and the Nagoya Protocol. This could be achieved by redefining ‘restriction-free access’ in rule 30(4) of the Code and by keeping regulated access to cultures under international legislation, like the Convention on Biological Diversity, the Nagoya Protocol and quarantine laws, free from restriction. I also hope that the national ABS Clearing-Houses will come up with more flexible procedures to facilitate the exchange of genetic resources between researchers, particularly for research, teaching and quality control purposes.