The Nagoya Protocol Creates Disadvantages for Many Countries when Applied to Microorganisms
The international agreement is unlikely to generate revenues for developing countries, but instead threatens collaborative microbiological research
The currently restrictive implementation of the Nagoya Protocol threatens to hinder basic microbiological research and is likely to achieve the exact opposite of the Protocol’s stated goals. Instead of facilitating the “fair and equitable sharing of benefits arising from the utilization of genetic resources” the Protocol’s enforcement might actually exclude developing countries and their scientists from international research and collaboration, according to Professor Jörg Overmann and Dr. Amber Hartman Scholz of the Leibniz Institute DSMZ - German Collection of Microorganisms and Cell Cultures. Their analysis of the situation was recently published in Trends in Microbiology, a well renowned journal in the field.
This discrepancy is related to certain basic concepts of the Nagoya Protocol that do not apply to microorganisms. For example, there are no geographical hotspots of microbial diversity, as there are for higher plants and animals. “Most bacteria are true cosmopolites; they are found practically everywhere in the world,” says DSMZ Managing Director Overmann. An unintended result of the Protocol is that scientists will avoid countries with impractical regulations for sampling and studying microorganisms. Thus, Overmann and Scholz expect that there will be less international collaboration and knowledge transfer to developing countries, not more, as intended by the Protocol.
The situation is exacerbated by unrealistic perceptions regarding the commercial value of microbial resources. “There seems to be the notion that many bacteria harbor a million-dollar substance,” says Overmann. “This makes many countries protect their resources like gold mines, strictly regulating any access to them.” Statistically, however, about only 1 in 100,000 bacterial strains will provide the basis for a pharmaceutical product, while isolating and characterizing a single strain with novel properties can cost up to 10,000 euros. Even large pharmaceutical companies now avoid the financial risk of spending up to a billion euros to isolate a single suitable microorganism.
Instead, it usually falls to basic microbiological research to discover novel microorganisms and to study and understand their characteristics. However, strict regulations imposed by the Nagoya Protocol more and more often hinder just this type of basic research. “The Protocol is based on a far too broad definition of the term ‘use’,” says Overmann. Under the Protocol, "use" pertains not only to commercial uses, but to all forms of basic research, including the depositing of strains in public collections. Microbiological research, however, usually does not come with commercial interests attached, and in those rare cases in which a strain is commercially used, depositing the strains in public collections would actually guarantee the traceability of the resource, enabling subsequent negotiations with the country of origin.
To date, 80 countries have ratified the Nagoya Protocol. Overmann and Scholz hope that the countries ratifying the Protocol next will implement it in more balanced ways, allowing all parties involved to be able to benefit. “Countries that take a rigid stance on this issue, misinterpreting scientific curiosity as commercial interests or even biopiracy, will miss out on opportunities for their own research and development,” according to Overmann. They will experience severe disadvantages compared with countries striving for trust-based, scientifically informed, collaborative, and efficient approaches to implementing the Nagoya Protocol. The latter countries, Overmann thinks, will benefit from research and development, and will experience significant competitive advantages in both science and bio-economics, promoting their own future development.
The Leibniz Institute DSMZ is one of the world’s leading biological resource centers, archiving viable samples of bacterial diversity. It provides authentic, quality-controlled samples to researchers worldwide who order more than 40,000 products annually from DSMZ. DSMZ serves as a depository for microorganisms. Newly characterized bacterial species must be deposited in two public collections before they can be officially described. The public collections then make them available to the scientific community, enabling the verification of published research results. In addition to its depository function, DSMZ runs its own comprehensive microbiological research program.
The Nagoya Protocol is an international supplementary agreement to the UN’s Convention on Biological Diversity (CBD). Its goal is to regulate the “access to genetic resources and the fair and equitable sharing of benefits arising from their utilization,” briefly referred to as Access and Benefit Sharing (ABS). Specifically, this means that any biological resource, including plants, animals and parts thereof, microorganisms, but also DNA, will be the property of the country from which they originate. The only exemption from this rule covers human samples. Collecting, exporting, and using such resources require appropriate permits issued by the respective country of origin. The Nagoya Protocol entered into force on October 12, 2014, and a corresponding German law entered into force on July 1, 2016.
Article: Microbiological Research Under the Nagoya Protocol: Facts and Fiction: http://www.cell.com/trends/microbiology/fulltext/S0966-842X%2816%2930164-0
Deposit of biological material at the DSMZ: Compliance with the Nagoya Protocol