This article first appeared on AIPLA Biotech Buzz on 12 August 2019. For further information please go to www.aipla.org.
The Conference of the Parties to the Convention on Biological Diversity (the "Convention") and the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol on Access and Benefit-Sharing (the "Nagoya Protocol"), both held in December 2016, each adopted decisions to consider any potential implications of the use of digital sequence information ("DSI") on genetic resources ("GRs") in which they recognized the need for a coordinated and non-duplicative approach under the Convention and the Nagoya Protocol (decisions XIII/16 and NP-2/14, respectively).
Following these two decisions, the Secretariat to the Convention invited the submission of views and information through notification 2017-37. Whilst the USA is not a party to the Convention or the Nagoya Protocol, it did submit a response to the consultation as a non-party, as did 14 Convention contracting states and 38 organisations and stakeholders¹.
The main thrust of the response from the USA was that genetic sequence data is neither genetic material nor a GR and that unimpeded and rapid access to and use of such data are essential to furthering the three objectives of the Convention, namely:
1. The conservation of biological diversity;
2. The sustainable use of the components of biological diversity; and
3. The fair and equitable sharing of the benefits arising out of the utilization of GRs.
The USA also noted that it understood the term “digital sequence information on genetic resources” to mean the genetic sequence data ("GSD") that describe the order in which nucleotides are situated in a chain relative to one another in DNA or RNA molecules contained in genetic material of actual or potential value.
Consultation did not end there. In November 2018, the Conference of the Parties to the Convention adopted decision 14/20 to establish a science and policy based process on DSI. On 5 February 2019, pursuant to decision 14/20, the secretariat to the Convention in a notification invited parties to the Convention, other Governments, indigenous peoples and local communities, relevant organizations and stakeholders to submit views and information:
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To clarify the concept, including relevant terminology and scope, of DSI on GRs and if and how domestic measures on access and benefit-sharing ("ABS") consider DSI on GRs;
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On benefit-sharing arrangements from commercial and non-commercial use of DSI on GRs.
Pursuant to decision 14/20, the secretariat to the Convention also invited parties to the Convention, other Governments and indigenous peoples and local communities to submit information on their capacity-building needs regarding the access, use, generation and analysis of DSI on GRs, in particular for the three objectives of the Convention with a deadline for submissions of June 1 2019.
This time, 18 Convention contracting states and 19 organisations and stakeholders submitted responses². Once again, the USA was the only non-party to the Convention to file a response. It repeated some of the submissions made in the first response and made the following additional key points:
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Ready access to publicly available information on GRs spurs innovation and provides other broad benefits for society;
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The scientific norm of rapidly sharing information fosters international collaboration and is a form of benefit-sharing – the greater the amount of GSD shared broadly, the greater the potential benefit for society;
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As best practice, GSD are publicly available via international data repositories and in journals;
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The US Government supports the timely exchange of data; and
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Regulations that restrict or delay access to and sharing of GSD would likely lead to a significant reduction in data-sharing which could negatively impact efforts to promote the sustainable use and conservation of biodiversity and stifle research.
The UK BioIndustry Association also filed responses to both consultations. This author helped to draft the second response which included the following key arguments consistent with those made by the USA:
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DSI should not be included within the scope of the objectives of the CBD and the objective of the Nagoya Protocol on both legal and practical grounds.
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Addressing ongoing compliance and implementation challenges of the Nagoya Protocol should be the main focus of the Parties to the Protocol and of the Secretariat to the CBD. The potential inclusion of DSI at this stage would complicate matters further, exacerbating the significant and complex issues and challenges.
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The inclusion of DSI would do more harm than good by, amongst other things, presenting additional compliance challenges and problems which could seriously stifle innovation, particularly for SMEs.
The debate as to the implications of the use of DSI on GRs is ongoing with any firm action yet to be taken internationally. Besides the work being done under the umbrella of the Convention and the Nagoya Protocol, DSI and its implications are also being discussed under various other international instruments including the International Treaty on Plant Genetic Resources for Food and Agriculture, the WHO Pandemic Influenza Preparedness Framework and the UN Convention on the Law of the Sea. Whilst the broad debate over DSI is to be welcomed, this author warns against the potential risk of negative unintended consequences to science and innovation if DSI is brought within the scope of the Convention and the Nagoya Protocol.
¹ https://www.cbd.int/abs/dsi-gr/ahteg.shtml. The Secretariat to the Convention subsequently prepared a main synthesis document of all submissions: https://www.cbd.int/doc/c/49c9/06a7/0127fe7bc6f3bc5a8073a286/dsi-ahteg-2018-01-02-en.pdf
² https://www.cbd.int/abs/dsi-gr/2019-2020/submissions.shtml
Nothing herein should be construed as legal advice or legal representation.