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Two recent publications offer practical guidance on regulatory compliance and access and benefit-sharing within the increasingly complex web of international regulations governing microbial research
Research takes place within a complex legal framework. The Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH, together with an international consortium, has now published two timely articles on this topic in the renowned journal “Sustainable Microbiology”. DSMZ researchers Davide Faggionato and Melania Muñoz-García are the lead authors of the articles, with Amber H. Scholz, Head of the DSMZ Department of Science Policy & Internationalisation, serving as corresponding author. The first article, “Policy in practice: How to do the Nagoya Protocol”, cleans up common misconceptions and offers researchers from around the world practical guidance/help on the ethical and legally compliant use of biological resources.
Microorganisms are the driving force behind biotechnological innovations
Microorganisms are central to biodiversity, ecosystem functioning, and biotechnological innovation. Research into microbial genetic resources is, however, increasingly shaped by a complex web of international and national legal frameworks. The two articles tackle this challenge from complementary perspectives: one publication offers a step-by-step guide to compliance with the Nagoya Protocol, the other provides an overview of the broader regulatory environment governing microbial resources, including rules on access and benefit-sharing, intellectual property, biological safety, ethics, and sector-specific agreements.
No more “Take what you want!”
The days of colonial research expeditions are long gone. Since the Nagoya Protocol came into force, access to genetic resources is bound by clear rules: the sovereign rights of the countries of origin must be respected and profits are to be shared fairly. “Many scientists still confuse the Nagoya Protocol with the Kyoto Climate Protocol,” explains Dr Amber H. Scholz. “The only thing they have in common is their Japanese origin. Life scientists need to be aware of the Nagoya Protocol.” Breaches of ABS (Access and Benefit-Sharing) rules can have drastic legal consequences.
Legal certainty as the basis for excellence
Without proof of compliance, manuscripts are now at risk of being rejected by journals or having funding withdrawn. The current publications serve as a blueprint for avoiding these pitfalls. They provide information and a step-by-step guide for practical application – from obtaining prior informed consent to establishing mutually agreed terms.
Contribution to global justice
By adhering to these rules, microbiology contributes directly to UN Sustainable Development Goal 15.6 (“Promote fair and equitable sharing of the benefits arising from the utilization of genetic resources and promote appropriate access to such resources, as internationally agreed”). The aim is to conduct research at eye level, promoting the protection of biodiversity and fair cooperation with the Global South. The authors of the articles thus emphasize their role as competent partners for science and industry in fair and equitable biological research.
Complex legal framework of microbiological research
The second article (“Policy Briefing: from access to use – untangling the international legal frameworks that govern microbial resources”) widens the scope beyond the Nagoya Protocol, explaining that microbiologists often have to navigate a complex web of regulations: the Convention on Biological Diversity, the Nagoya Protocol, digital sequence information, the BBNJ High Seas Treaty, the International Treaty on Plant Genetic Resources for Food and Agriculture, CITES, the International Plant Protection Convention, the WHO Framework for Pandemic Preparedness, the WHO Pandemic Agreement and the new WIPO Treaty on Intellectual Property, Genetic Resources and connected traditional knowledge. In the article, the authors argue that researchers and policymakers need a comprehensive overview of how these frameworks overlap and complement one another, rather than viewing them in isolation, and that they should possibly be harmonized or simplified in the future.
Promoting fairer international cooperation
While primarily targeting microbiologists, the two publications also seek to engage the broader life sciences community, advancing research that is legally sound, equitable, and driven by international collaboration. They regard regulatory compliance not as a purely administrative burden, but as a part of responsible science that respects the countries of origin, Indigenous Peoples and local communities, as well as the overarching goals of biodiversity protection and sustainable use of genetic resources. For further information, the researchers at the Department of Science Policy & Internationalisation at the Leibniz Institute DSMZ are available at https://research.dsmz.de/group/SPI/general-info. For information on the Nagoya Protocol, please use the project´s web site led by the DSMZ: https://nagoyaprotocol-hub.de/.
Press contact: PhDr. Sven-David Müller, Head of Public Relations, Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH, Phone: ++49 (0)531/2616-300, Mail: press@dsmz.de
About the Leibniz Institute DSMZ
The Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures is the world's most diverse collection of biological resources (bacteria, archaea, protists, yeasts, fungi, bacteriophages, plant viruses, genomic bacterial DNA as well as human and animal cell lines). Microorganisms and cell cultures are collected, investigated and archived at the DSMZ. As an institution of the Leibniz Association, the DSMZ with its extensive scientific services and biological resources has been a global partner for research, science and industry since 1969. The DSMZ was the first registered collection in Europe (Regulation (EU) No. 511/2014) and is certified according to the quality standard ISO 9001:2015. As a patent depository, it offers the only possibility in Germany to deposit biological material in accordance with the requirements of the Budapest Treaty. In addition to scientific services, research is the second pillar of the DSMZ. The institute, located on the Science Campus Braunschweig-Süd, accommodates more than 94,400 bioresources and has around 210 employees. www.dsmz.de
The Leibniz Association
The Leibniz Association connects 96 independent research institutions that range in focus from natural, engineering and environmental sciences to economics, spatial and social sciences and the humanities. Leibniz Institutes address issues of social, economic and ecological relevance. They conduct basic and applied research, including in the interdisciplinary Leibniz Research Alliances, maintain scientific infrastructure, and provide research-based services. The Leibniz Association identifies focus areas for knowledge transfer, particularly with the Leibniz research museums. It advises and informs policymakers, science, industry and the general public. Furthermore, a special focus is placed on technologically relevant research and active technology transfer: Leibniz Institutes bring innovative developments into targeted application and promote the implementation of new technologies in society through cooperation with business and industry. Leibniz institutions collaborate intensively with universities – including in the form of Leibniz ScienceCampi – as well as with industry and other partners at home and abroad. They are subject to a transparent, independent evaluation procedure. Because of their importance for the country as a whole, the Leibniz Association Institutes are funded jointly by Germany’s central and regional governments. The Leibniz Institutes employ around 21,400 people, including 12,200 researchers. The financial volume amounts to 2,3 billion euros. www.leibniz-gemeinschaft.de
Faggionato D, Muñoz-García M, Kostic T, Ferrari ML, Vonaesch P, Poyet M, Portier P, Ryan MJ, Djeddour D, Stumptner C, Varese GC, Zuzuarregui A, Groussin M, Schloter M, Finn RD, Haas AS, Probert I, Verkley G, Overmann J, Scholz AH. Policy Briefing: from access to use—untangling the international legal frameworks that govern microbial resources. Sustainable Microbiology. Volume 3, Issue 1, 2026, qvag005. https://doi.org/10.1093/sumbio/qvag005
Faggionato D, Muñoz-García M, Kostic T, Ferrari ML, Vonaesch P, Poyet M, Portier P, Ryan MJ, Djeddour D, Stumptner C, Varese GC, Zuzuarregui A, Groussin M, Schloter M, Finn RD, Haas AS, Probert I, Verkley G, Overmann J, Scholz AH. Policy in practice: How to do the Nagoya Protocol: common misconceptions, challenges and best practices for access and benefit-sharing compliance. Sustainable Microbiology. Volume 3, Issue 1, 2026, qvag007. https://doi.org/10.1093/sumbio/qvag007
The team at the DSMZ’s Science Policy & Internationalisation Department
Source: Michael Hübner
Copyright: DSMZ
Main Building Leibniz Institute DSMZ, Braunschweig/Germany
Source: Michael Hübner
Copyright: DSMZ
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