Abstract
There is disagreement whether international agreements over genetic resources (GR) under the Convention on Biological Diversity, including the Nagoya Protocol, cover Digital Sequence Information (DSI). DSI is data on the composition of GR, which may be downloaded from databases and used by entities who have no contractual relationship with the country of origin of the original GR from which the data were derived, and with no applicable legal requirement to agree on benefit-sharing with that country. Proposals for inclusion of DSI under the CBD are intended as changing this situation and increasing benefit-sharing. However, inclusion of DSI under the CBD is contested, and there is a legal basis for both inclusion and exclusion, so any eventual decision must be based on policy agreement by parties. To date there has been little explicit basis for a definition of DSI; here a distinction between ‘inclusive’ and ‘exclusive’ definitions is discussed, the latter using the scope of the CBD to support the concept to include only Nucleotide Sequence Data. Irrespective of inclusion under the CBD countries are including DSI in national ABS legislation, through inclusion in PIC and MAT on newly accessed GR, stating sovereign rights over DSI already generated, and through article 5 (1) of the Nagoya Protocol. These approaches are discussed, and the need for further consideration of the practical implications of article 5 (1). Ultimately a strong focus of future discussions should be benefit-sharing and the ethical position of users.
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Notes
- 1.
Medaglia (2020).
- 2.
The term ‘components of biological diversity’ used in CBD article 4 on jurisdictional scope (see above) can be understood through the uses of terms set out in article 2 of the CBD, in particular ‘biological diversity’, ‘biological resources’, ‘genetic material’ and ‘genetic resources’.
- 3.
- 4.
NCBI (2019).
- 5.
- 6.
Lawson et al. (2020).
- 7.
Bagley (2015).
- 8.
Lawson et al. (2020).
- 9.
- 10.
SCBD (2018a).
- 11.
Spranger (2017).
- 12.
Sollberger (2018).
- 13.
- 14.
- 15.
SCBD (2002).
- 16.
Sollberger (2018).
- 17.
Spranger (2017).
- 18.
Australian Government (2019).
- 19.
- 20.
Soplín and Muller (2009).
- 21.
SCBD (2016).
- 22.
- 23.
Laird and Wynberg (2018).
- 24.
SCBD (2018c).
- 25.
SCBD (2018d).
- 26.
- 27.
- 28.
SCBD (2020).
- 29.
Medaglia (2020).
- 30.
SCBD (2018a).
- 31.
- 32.
ICC submission in SCBD (2018a).
- 33.
Commission on Genetic Resources for Food and Agriculture (2019a).
- 34.
SCBD (2018g).
- 35.
Bagley et al. (2020).
- 36.
Tvedt and Schei (2013).
- 37.
SCBD (2018e).
- 38.
WHO (2018).
- 39.
Welch et al. (2017).
- 40.
Manzella (2016).
- 41.
United Nations (2019).
- 42.
- 43.
Houssen et al. (2020).
- 44.
- 45.
SCBD (2019).
- 46.
- 47.
- 48.
Bygrave (2014).
- 49.
Lyal (2020).
- 50.
CETAF, NHM-RBGK-RBGE, SPHNC, ICC in SCBD (2019).
- 51.
SCBD (2018c).
- 52.
SCBD (2019).
- 53.
Houssen et al. (2020).
- 54.
- 55.
Ruiz Muller (2018).
- 56.
The concept of ‘natural information’ as a basis for benefit sharing has been expounded also by Vogel (1994) and Vogel et al. (2011) and others. The concept is far broader than ‘genetic resources’, and in the context of the CBD is used in concert with ‘Bounded openness’, which is the conceptual foundation which stresses that natural information flows freely for R&D, until commercial success of an innovation at which time the innovation protected by intellectual property is obligated to share monetary benefits (Vogel et al. 2018; Ruiz Muller 2018). In this model the scope of DSI is unimportant, and could include information on any derivative; the important condition is that there should be benefit sharing at the commercial end of a process that makes use of a biological resource.
- 57.
SCBD (2019).
- 58.
African Group of Negotiators submission in SCBD (2019), p. 2.
- 59.
SCBD (2019).
- 60.
Houssen et al. (2020).
- 61.
SCBD (2020).
- 62.
SCBD (2019).
- 63.
SCBD (2018c).
- 64.
An ORF is a continuous stretch of codons that contain a start codon.
- 65.
Houssen et al. (2020).
- 66.
SCBD (2020).
- 67.
- 68.
DNA and RNA—nucleic acids—are made up of long chains of connected ‘nucleotides’. The four types of nucleotides in DNA and RNA are Adenine, Thymine (Uracil in RNA), Guanine, and Cytosine, which are usually abbreviated to A, T, U, G and C. The order in which these nucleotides occur in a strand of DNA or RNA is the Nucleotide Sequence.
- 69.
CETAF submission in SCBD (2019).
- 70.
This is a more restricted concept than NSD, excluding information on sequence assembly etc., but the differences in detail are not significant for the purposes of this paper.
- 71.
ICC submission in SCBD (2019).
- 72.
- 73.
Submissions to the CBD in SCBD (2019) from South Africa, Malawi, Canada, EU and its Member States, Japan, Republic of Korea, Switzerland, USA.
- 74.
SCBD (2020).
- 75.
SCBD (2019).
- 76.
- 77.
WIPO (2018).
- 78.
SCBD (2019).
- 79.
- 80.
SCBD (2019).
- 81.
Deplazes-Zemp (2018).
- 82.
- 83.
SCBD (2017a).
- 84.
SCBD (2017b).
- 85.
Onions (Ed) (1973).
- 86.
- 87.
Sollberger (2018).
- 88.
E.g. European Seed Association in SCBD (2017a).
- 89.
Spranger (2017).
- 90.
Chartered Institute of Patent Attorneys in SCBD (2017a).
- 91.
E.g. Brazil in SCBD (2017a).
- 92.
- 93.
Schei and Tvedt (2010).
- 94.
United Nations (1969).
- 95.
- 96.
Deplazes-Zemp (2018).
- 97.
- 98.
Dawkins (2008).
- 99.
Rossi (2014).
- 100.
Goldman and Landweber (2016).
- 101.
Goldman and Landweber (2016).
- 102.
Bagley (2015).
- 103.
CBD COP decision 14/20, para 5.
- 104.
Bagley et al. (2020).
- 105.
SCBD (2019).
- 106.
Bagley et al. (2020).
- 107.
Bagley et al. (2020).
- 108.
Bagley et al. (2020).
- 109.
Bagley et al. (2020).
- 110.
African Group of Negotiators in SCBD (2019).
- 111.
Bagley et al. (2020).
- 112.
Submission by CETAF in SCBD (2017b).
- 113.
da Silva and de Oliveira (2018).
- 114.
‘Access’ in Brazilian legislation, is equivalent to ‘utilization’ in the Nagoya Protocol use of terms.
- 115.
da Silva and de Oliveira (2018).
- 116.
Commission on Genetic Resources for Food and Agriculture (2019b).
- 117.
For a detailed discussion of the Brazilian case see Mozini in this volume.
- 118.
Government of Malawi (2019).
- 119.
Ethiopia in AU submission to CBD in SCBD (2019).
- 120.
Argentina comment on Laird & Wynberg in SCBD (2017a).
- 121.
Polatin-Ruben and Wright (2014).
- 122.
Spranger (2017).
- 123.
Karsch-Mizrachi et al. (2017).
- 124.
Bagley et al. (2020).
- 125.
SCBD (2019).
- 126.
Laird and Wynberg (2018).
- 127.
Bagley et al. (2020).
- 128.
- 129.
Greiber et al. (2012).
- 130.
SCBD (2019).
- 131.
Laird and Wynberg (2018).
- 132.
SCBD (2017b).
- 133.
Wilkinson et al. (2016).
- 134.
To better understand the use of these databases, the reader is invited to look at the real-time map of use of one of the INSDC databases, EBI-EMBL, at www.ebi.ac.uk/about/our-impact (accessed 24 June 2020).
- 135.
Brunak et al. (2002), also at http://www.insdc.org/policy.html (accessed 24 June 2020).
- 136.
Rohden et al. (2020).
- 137.
GISAID EpiFlu™ Database Access Agreement, para 2(d) “Subject to applicable law, You agree not to distribute Data to any third party other than Authorized Users as contemplated by this Agreement.” (accessed 24 June 2020). GISAID was set up to service the WHO PIP framework not the CBD.
- 138.
Under Chatham House Rules, so unattributable.
- 139.
- 140.
ABS Capacity Development Initiative (2019).
- 141.
- 142.
SCBD (2019).
- 143.
For details see Winter in this volume.
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Acknowledgments
I would like to thank many people who have shared or contributed ideas, particularly Kate Davies, Peter Geire, Evanson Chege Kamau, Paul Kersey, Alicja Kozlowska, Thomas Greiber, Dirk Neumann, Anne Nivart, Alan Paton and China Williams. Marcelin Tonye Mahop, Gerd Winter and Evanson Chege Kamau provided very helpful comments and suggestions on an earlier version of this chapter. Interpretations and opinions are entirely my own unless stated otherwise.
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Lyal, C.H.C. (2022). Digital Sequence Information on Genetic Resources and the Convention on Biological Diversity. In: Chege Kamau, E. (eds) Global Transformations in the Use of Biodiversity for Research and Development. Ius Gentium: Comparative Perspectives on Law and Justice, vol 95. Springer, Cham. https://doi.org/10.1007/978-3-030-88711-7_21
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