International Regulation of Digital Sequence Information

E. Nickson
Nickson Research and Consulting
May 1, 2020

Efforts are underway by governments to develop rules to regulate access to digital sequence information (DSI) under several international environmental treaties including the Convention on Biological Diversity (CBD), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), and the United Nations Convention on the Law of the Seas (UNCLOS).  Arguments based on the third objective of the CBD, the fair and equitable sharing of benefits derived from the utilization of genetic resources (ABS), call for a global system to regulate access to sequence data to ensure that monetary benefits are paid to “rightful owners” of the original genetic resource(s).  While the term DSI is still undefined, the broadest interpretation includes nucleotide sequences of DNA and RNA, amino acid sequences of proteins, and even metabolites and metabolic pathways.  The most common understanding of DSI embraces the sequences of nucleotide found in DNA and RNA like those found in public databases organized under the International Nucleotide Sequence Data Consortium (INSDC).

Parties to the CBD were scheduled to meet in China in October 2020[1] to resume negotiations on rules that would generate monetary benefits as a result of accessing DSI from any public database and from sequencing any genetic resources obtain from in situ and ex situ sources.  The concern expressed by advocates of regulation is that researchers are increasingly using DSI and developing commercial products.  Exempting “non-commercial” research has been proposed, but the idea is problematic from a regulatory perspective.  Because DSI is not a genetic resource as defined in the CBD, some believe this creates a loophole and escape of valuable information from benefit sharing obligations.  Many scientists close to this issue believe that the current benefits derived from publicly available DSI are vastly underestimated.  Importantly, the harm, including increase administrative costs, that would result is not justified by the projections of monetary benefits that could be generated by any regulatory system.

It is in the interest of the research community to be aware of these negotiations and the potential impact they will have on acquiring publicly available information that is currently free of charge and sharing sequence data as it is done today.  You may consider contacting your National Focal Point for ABS under the CBD and Nagoya Protocol to get more information and voice your opinion:  https://www.cbd.int/doc/lists/nfp-abs.pdf

[1] The CBD meetings have been postponed until 2021.