CBD Issues Study On Challenges For Benefit-Sharing Of Digital Genetic Information

The UN Convention on Biological Diversity has issued the results of a fact-finding study on genetic resources digital genetic information. The study particularly examined terminology and how digital genetic information are influencing its protocol on access and benefit sharing of genetic resources. The study called for policymakers to stay abreast of the profound developments shaping research today, and underlined challenges such as the identification of contributors and users, the provenance of sequences, and what the study defined as a “grey area” between non-commercial and commercial research.

A number of organisations have started to look into the consequences of the use of digital genetic information, rather than biological samples, on their treaties and protocols.

The Fact-Finding and Scoping Study [pdf] on Digital Sequence Information on Genetic Resources in the Context of the Convention on Biological Diversity and the Nagoya Protocol was published on 10 January.

According to the document, digital sequence information “may characterize genetic material found in nature, that is designed, mutated, or degenerated, or that is purely hypothetical.” Most digital sequence information is the product of sequencing technologies, which have become faster, cheaper and more accurate over the years, it says.

Digital sequence information is found in almost every branch of the life sciences and modern biology today, according to the study. Digital sequence information contributes to understanding the molecular basis of life, evolution, and how genes might be manipulated to provide new therapies and cures for disease, industrial products, and energy sources. The information may be accessed from private governmental, research institution collections, companies which synthesize sequence information, and from public, private and government databases.

The latter are the largest repositories of digital sequence information, according to the study. In the late 1970s, public databases were set up, such as GenBank, based at the National Center for Biotechnology Information in the United states, it says.

Some databases attach conditions to the use of digital sequence information, including notifications on databases and websites, conditions of use notices, clickthrough agreements, open source material transfer agreements (MTAs), and user agreements, the study found.

Open source agreements are designed to promote innovation and avoid the high transaction and legal costs associated with traditional MTAs or other forms of licensing agreements, according to the study.

Users agreements, said the study, are used by “some targeted databases and research institutions, and some include provisions that support ABS [access and benefit-sharing],” giving as an example the database access agreement developed by the Global Initiative on Sharing All Influenza Data (GISAID). This access agreement issues licences for the use of data and includes benefit sharing, the study found. See an Intellectual Property Watch story on GISAID here.

Challenges for Benefit Sharing

The study found that a range of challenges is in the way of benefit sharing, linked in particular to the difficulties of monitoring and identifying contributors, users, and the provenance of sequences, the problems regarding the determination of value, and the “increasing grey area between non-commercial and commercial research.”

Solutions to meet those challenges might include “a trend towards identifying the provenance of digital sequence information, the inclusion of meta-data with sequences, and unique identifiers for researchers,” the study says, adding that potential tools like user notices and agreements “might also provide models and guidance for possible benefit sharing approaches.”

“It behooves ABS policymakers to stay abreast of the profound developments shaping research today,” the study concludes. “Sequencing platforms have become faster, cheaper and more accurate in recent years, producing massive quantities of sequence information. Researchers can now edit and synthesize genes. Affordable and portable devices allow researchers to sequence physical samples, and upload them to the internet or databases.”

Non-Monetary Benefit Sharing

According to the study, some new forms of non-monetary benefit sharing have emerged, including wider access to databases, knowledge and technology, technology transfer, capacity building and collaboration.

Some consider that wider access to databases is not enough to compensate for access to genetic resource information, particularly because of the potential loss of control over national patrimony, and “underestimating the significant monetary and non monetary benefits that accrue to countries from hosting the databases and to users who access the information contained in these databases,” the study says. Another reason is the lack of sufficient molecular research capacity or biotechnology infrastructure in countries rich in biodiversity, to make use of global database systems.

WHO, FAO also Working on Issue

The issue of benefit sharing in the context of genetic sequence data is also ongoing at the World Health Organization, in the Pandemic Influenza Preparedness (PIP) Framework. And discussions are taking place on the consequences on the sharing of influenza viruses of the implementation of 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 (IPW, WHO, 10 November 2017).

According to the study, the CBD Conference of the Parties requested the CBD secretariat to commission the study, in particular to clarify terminology and concepts, and to assess the extent and the terms and conditions of the use of digital sequence information on genetic resources in context of the CBD and the Nagoya Protocol.

The study complements work undertaken as part as other international policy processes, it says, including the United Nations General Assembly process on the conservation and sustainable use of marine biodiversity, the WHO PIP Framework, and the UN Food and Agriculture Organisation’s International Treaty on Plant Genetic Resources for Food and Agriculture.

 

Image Credits: Flickr – Ron Mader