LAUSR

To the Editor — In 2014, the United Nations Convention on Biological Diversity’s Nagoya Protocol entered into force, creating a legal framework to regulate access to genetic resources within national jurisdictions based on prior informed consent and mutually agreed terms of benefit sharing between ‘provider’ and ‘user’ countries. Although the protocol covers all terrestrial and marine life within national jurisdictions, international waters lie outside its reach. In March of 2018 the United Nations began working to address this loophole, and the liberal access regime to marine genetic resources is changing. Here we discuss the implications for bioprospecting efforts and the biotech industry in general going forward. Marine life has adapted to thrive even in the ocean’s most inhospitable conditions, where extremes of pressure, temperature and absence of light have selected species with a unique range of secondary metabolites1. These natural products have attracted growing commercial interest from the biotech sector, supporting a rich marine biodiscovery pipeline2. As yet, the Nagoya Protocol does not apply to some 64% of the ocean. This vast area beyond national jurisdiction covers roughly half the Earth’s surface and contains habitats ranging from hydrothermal vent communities to remote seamounts and the hadal depths of ocean trenches. No legislation exists either to limit access to genetic resources found here or to require the sharing of benefits arising from their use. In December 2017, however, the United Nations General Assembly agreed in Resolution 72/249 that this gap should be addressed. Accordingly, last September, states began negotiating a new international treaty on biodiversity in areas beyond national jurisdiction, which will address access and benefit-sharing obligations with regard to marine genetic resources from such areas. Another key consideration is that the Nagoya Protocol currently does not extend to genetic sequence data (referred to in this context as “digital sequence information”), much of which is shared in public databases. Technological advances are swiftly reducing sequencing costs, and biotech innovations are enabling commercial use of genetic sequence data with little or no physical sample material3. One result has been the exponential growth of databases such as GenBank, which has doubled in size every 18 months since 19824. Another result has been concern among biodiverse countries that public sharing of genetic sequence data constitutes a loss of national patrimony, spurring calls to include these data under the Nagoya Protocol5. Despite intensive negotiations, legal certainty about the future access and benefit sharing regime for digital sequence information remained elusive at the Conference of the Parties to the Convention on Biological Diversity that took place in November. Instead, the parties agreed to form an expert group to continue discussions, solicit views from governments and others, and commission a series of studies assessing issues, such as the extent and nature of public and private databases of digital sequence information6. How and when these regulatory gaps are closed could have profound consequences for the marine biotech industry. The reach of the Nagoya Protocol into digital sequence information sharing could have even broader implications for the biotech industry as a whole and for public health during infectious disease outbreaks. One possibility is that researchers using gene sequences that are currently freely accessible in public databases may soon need to seek permission from the government of the country of origin of those sequences and to conclude corresponding benefit sharing agreements before use. Likewise, new access and benefit sharing obligations could soon apply to vast ex situ collections of samples gathered from areas beyond national jurisdiction. In both cases, a period of legal uncertainty can be expected at least until 2020, when the negotiations on biodiversity in areas beyond national jurisdiction are scheduled to conclude and when the Parties to the Convention on Biological Diversity will reconvene for their next Conference. Access and benefit sharing negotiations have tended to focus on bioethics, often with insufficient participation by the scientific community or the private sector7. The Nagoya Protocol, for instance, makes no distinction between commercial and noncommercial research, and has drawn growing criticism for hindering taxonomic and biodiversity research8 while also coinciding with a drop in patent applications associated with marine genes9. Engagement by the biotech community is needed to ensure an outcome to the pending negotiations that promotes equity without creating undue barriers for commercial or noncommercial research. ❐