Access and Benefit Sharing and Digital Sequence Information: Unravelling the Knot

Scientific and technological advances in recent decades have significantly altered the nature of bio-based research and development (R&D). The rise of genomics, i.e. the study and editing of entire genomes rather than individual genes, has been accompanied by the birth of bioinformatics, which develops and uses methods and software tools to extract knowledge from biological material. Enabled by advances in computing power and tools that can generate and analyse large quantities of genotypic, phenotypic and environmental data, these developments have allowed for a ‘tsunami of genomic information being generated … [with] the potential to be shared with any other laboratory in real time’. Research on sequence data arising from biological and genetic resources has thus taken place alongside research on physical samples of such resources for several decades already. The normative and regulatory frameworks governing them, however, have developed in parallel and largely ignoring each other, alongside a third one: The intellectual property frameworks. The main framework for the collection, storage and sharing of genomic data is the International Nucleotide Sequence Data Collaboration (INSDC), an international collaboration between public databases in the United States, Europe and Japan, which includes sequence data associated with genetic resources both within and outside5 the scope of the United Nations Convention on Biological Diversity (CBD). Going back to the late 1970s, the INSDC provides the connecting infrastructure for the more than 700 public databases of sequence data around the world. It also makes a significant piece of the normative puzzle governing research on sequence data arising from biological and genetic resources. The INSDC adheres to a policy of free and unrestricted access with no use restrictions and with the note that data will be permanently accessible