What is the Nagoya Protocol?
It’s an international treaty that aims to promote conservation of biodiversity by making sure that countries rightfully benefit from their own biological (genetic) resources. Its full name is the ‘Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity’. Essentially, genetic material is property of the country of origin. As you may have guessed, this applies to phages.
When did it come into effect?
The Nagoya Protocol was adopted in 2010, and took effect in 2014. The UN Convention on Biological Diversity was signed in 1992, and the Nagoya Protocol was meant to be a harmonized way of implementing part of what came out of the Convention on Biological Diversity.
What does this mean?
Essentially, the collection and use of biological/genetic resources needs to be approved by the country of origin. This means it can be illegal to even take samples from a country and not report it to that country, even if the samples will only be used for research, and even if they will merely be classified and stored.
How does reporting work?
Reporting can take many forms, and differs from country to country. Each country gets to make up its own terms and enforce everything themselves. So if you’re planning to sample from a given country, you should use this tool to look up that country’s Nagoya requirements before sampling.
This sounds like a lot of paperwork
It can be. Some feel that the Nagoya Protocol hinders biological research and development of products from biological entities (ahem: phages).
“In principle, every scientist is obligated to personally determine what applies in a country and which permits need to be obtained,” Professor Jörg Overmann, Managing Director of the DSMZ, says. “The Nagoya Protocol has made it considerably more difficult for science to work with bacteria or fungi cultures, which are among the most utilizable resources in the life sciences. Many underestimate the additional effort of obtaining Nagoya-related permission.” — 2018 DSMZ Press Release
The DSMZ’s progress toward streamlining Nagoya compliance
The DSMZ, a publicly-funded culture collection in Germany (which includes phages; see our previous Capsid & Tail post on phage banks here), has actually taken steps to make compliance with the Nagoya Protocol easier for people who deposit and order phages from their repository.
Fun fact: the DSMZ is the only organization in the European Union to appear as a “Registered Collection” in regards to Nagoya Protocol compliance. This means the DSMZ has demonstrated that it can handle the Nagoya requirements and that people who obtain samples from them can be confident that the agreements they sign with the DSMZ are sufficient to comply with Nagoya. You can read more here in this paper authored by the DSMZ director, Jörg Overmann or in this 2018 DSMZ press release.
Criticism of the Nagoya Protocol (as it applies to microbiology)
The Nagoya Protocol arose out of concern for larger species going extinct, paired with concern that developing countries (considered hotspots of biological diversity) would be taken advantage of by industrialized countries seeking to commercialize their genetic resources. Jörg Overmann and Amber Hartman Scholz of the DSMZ made a few key arguments regarding why the Nagoya doesn’t make as much sense for microbes.
In brief, they argue that microbial diversity is so vast and microbes are so distributed and cosmopolitan that microbial diversity hotspots aren’t necessarily located in developing countries (they state that 1 g of soil from North America or Europe contains 5 times as many microbial species as have been validly described in total). They also point out that microbes are in essentially unlimited supply, and not at risk of going extinct. From an economic perspective, they argue that microbes and their DNA aren’t inherently very valuable; rather, it takes so much work to isolate and characterize them that the bulk of their value lies with the research done and not with the genetic material itself.
All in all, the authors argue that the Nagoya Protocol should be carefully applied when it comes to restricting access to microbial resources, and that countries who apply the directives of the protocol with microbe-specific principles in mind will enjoy profound benefits compared to those who don’t.
How many countries have ratified the Nagoya Protocol?
Over 100 countries have ratified it, and are thus “party to” the Nagoya Protocol.
Examples of countries who are party to the Nagoya Protocol:
- The European Union
- Many countries in Africa
- Many countries in Asia
- Many countries in South America
- India
Examples of countries that are NOT party to the Nagoya Protocol:
- USA
- Canada
- Australia
- Georgia
- Many countries in the Middle East
A caveat: countries that haven’t ratified Nagoya may still impose restrictions
Even countries who haven’t signed the Nagoya Protocol may have their own laws surrounding what can be done with biological or genetic resources sampled from their country. Brazil is an example of this. This means that seeing that a country is NOT on the Nagoya list doesn’t mean you’re home-free to sample from that country.
So what should I do?
If you work with phages, bacterial strains, DNA samples, or any other genetic resource, make sure you know the Nagoya Protocol status and requirements of the country of origin of your samples. Get in touch with the contact person or department responsible for overseeing Nagoya Protocol compliance (these are listed on the ABS Clearinghouse website) and find out what you need to do to legally isolate and process your samples.
Where can I find out more?
Acknowledgements
A special thanks to Dr. Christine Rohde of the DSMZ for raising the issue of the Nagoya Protocol when it comes to phage research and phage exchange, and for directing me to many of these relevant resources!
Do you have firsthand experience with the Nagoya Protocol?
If so, please email us at [email protected]. We’re keen to hear about how it impacts phage researchers and phage companies in the real world. We want to support phage sharing and international research, development, and collaboration, and a better understanding of how the Nagoya Protocol impacts you will help us create resources to help you and others navigate it as efficiently as possible.
