Joanne van Harmelen December 7 2022 Legal nature of personal genomic sequence data in South Africa: property rights dimension ENSafrica | Healthcare & Life Sciences - South Africa Joanne van Harmelen Healthcare & Life Sciences IntroductionIs personal genomic sequence data property?Who owns personal genomic sequence data?Are there alternatives to private ownership of personal genomic sequence data?IntroductionThis article is part of a series that provides a comprehensive and integrated analysis of the various legal dimensions applicable to the most basic kind of human genomic data, "personal genomic sequence data" – that is, the genomic sequence data (often referred to as the "raw" genomic data) of a particular person (in contradistinction from aggregated genomic sequence data of multiple persons).(1) In particular, this article focuses on the most under-investigated legal dimension of personal genomic sequence data: its common law property rights dimension.Is personal genomic sequence data property?In South Africa's common law, the criteria for something to qualify as "property" are that it must:(2)be useful and valuable;not merely be part of something else;not be part of a human body; andbe capable of human control.These criteria may apply to personal genomic sequence data as follows:That personal genomic sequence data is useful and valuable (academically and commercially) is manifest.Personal genomic sequence data exists separately from the DNA from which such data was derived. Furthermore, although personal genomic sequence data is recorded on one or more electronic devices, personal genomic sequence data is not bound to any particular device and can be moved from one recording device to another. Personal genomic sequence data is not merely part of something else.Although personal genomic sequence data is derived from DNA, which in turn is derived from the human body, personal genomic sequence data is generated outside of the human body and exists outside of it.Humans can decide, among other things:on which device personal genomic sequence data is recorded;who has access to the data;how the data is processed; andfor what purpose the data is processed.Thus, personal genomic sequence data can indeed be controlled by humans.Accordingly, personal genomic sequence data – understood not in the abstract, but as a specific instance of personal genomic sequence data – qualifies as property.Who owns personal genomic sequence data?Personal genomic sequence data is not generated out of nothing – it requires technical expertise, the necessary laboratory infrastructure and human biological material from which DNA can be extracted. Various individuals and institutions (and indirectly the state and other funders) may therefore contribute elements to the creation of personal genomic sequence data. There may be a number of aspirant owners. Since the default position in South African law is contractual freedom – in the sense that persons are free to enter into contracts and that these contracts are legal and binding(3) – those who contribute to the creation of personal genomic sequence data can determine, through contract, who the owner of the personal genomic sequence data would be, and on what terms.That said, this default position of contractual freedom is significantly constrained through statute law in the context of research. In particular, the South African National Health Act 61 of 2003 (NHA) provides, in section 60(4), that it is an offence for a person who has donated tissue to receive any form of financial or other reward for such donation, except for the reimbursement of reasonable costs incurred by them. Having one's genomic data generated as a new legal object and becoming the owner thereof may be considered a reward. If so, it would be unlawful to enter into a contract with a research participant, where the contract provides that the research participant would be the owner of the personal genomic sequence data (that is to be generated using the DNA derived from the tissue that is to be donated by such a research participant). Accordingly, if becoming the owner of genomic data qualifies as a reward for the purposes of section 60(4), the only candidates for ownership determined through contract would be the research institution(s) involved and, if there are private or public funders, such funders.In the absence of a contract, it is not certain which of the modes of acquisition of ownership that exist in South African law would apply. The most likely candidate would be "occupatio" (appropriation), which entails that a person acquires ownership in respect of an object that belongs to no one by intending to be its owner and taking physical control of it. As such, it would require a construction that, after its creation, personal genomic sequence data is property that belongs to no one. A potential obstacle to conceiving of data in this way could be the requirement of physical control, given that personal genomic sequence data is not a corporeal object. It may be recorded on physical devices, but the data and the recording device are not to be confused – they are distinct objects. In any event, the data may be recorded in the cloud, meaning that the researchers who did the sequencing may not even know the physical location of the computer servers where the data are recorded – much less have physical control over such servers.The requirement of physical control may be outdated in today's world where so many valuable assets have a digital rather than a physical existence, and where these digital assets are effectively controlled via digital device interfaces. For example, effective control may be held in the form of access codes, encryption keys or passwords (or a combination of such measures). South African common law is dynamic and has readily recognised such forms of control in other contexts. It may therefore be suggested that the intention to be the owner, plus effective control of personal genomic sequence data as a digital object, should suffice to acquire ownership through appropriation. This clearly favours the research institution that conducts the sequencing, as it will be in effective control of the data. If a research institution outsources the sequencing to a service provider, and assuming that the institution intends to claim ownership of the data, the institution should ensure that its contract with its service provider contains carefully crafted ownership provisions.When considering who owns personal genomic sequence data, certain scholars(4) make the mistake of thinking that if someone has certain rights in respect of personal genomic sequence data that are typically entailed by ownership, such as the right to use, that such a person is the owner. However, this is to confuse a consequence with a criterion. Having the right to use something is a typical consequence of acquiring ownership in it, but it is not always the case and is by no means a criterion for ownership.Are there alternatives to private ownership of personal genomic sequence data?Private ownership is not the only option for personal genomic sequence data. If personal genomic sequence data is released into the public domain (unencrypted and without a non-fungible token), it would arguably become the common heritage of humankind. Another possibility is that the state can – through statutory intervention – make all personal genomic sequence data public property. This would entail that the state hold personal genomic sequence data in trust for the benefit of its subjects and regulate its use accordingly. This possibility has featured in recent policy proposals.(5)But what about empowering individuals? Through statutory intervention, the ownership of personal genomic sequence data can be made to initially vest in the individual data subject. This policy option appears better aligned with the recognition by South Africa's Constitution of each individual as an autonomous moral agent. At a practical level, technology may offer tools for individual persons to manage their personal genomic data. For example, smartphone apps that use blockchain infrastructure can be used to enable individual data self-governance and incentive-based data sharing in a privacy-preserving environment.(6) This would radically democratise control of personal genomic sequence data.For further information on this topic please contact Joanne van Harmelen at ENSafrica by telephone (+27 21 410 2500) or email ([email protected]). The ENSafrica website can be accessed at www.ensafrica.com.Endnotes(1) This series on the legal nature of personal genomic sequence data is a summarised version of "The multidimensional legal nature of personal genomic sequence data: A South African perspective" by Thaldar et al (2022).(2) Thaldar, D W, and Shozi, B (2021), "The legal status of human biological material used for research", S Afr Law J 138, 881–907.(3) Barkhuizen v Napier, 2007 (7) BCLR 691 (CC).(4) For example, Hand, D J (2018), "Aspects of data ethics in a changing world: Where are we now?" Big Data 6 (3), 176–190.(5) See:Academy of Science of South Africa (ASSAf) and Department of Science and Technology (DST) (2018), "Human genetics and genomics in South Africa: Ethical, legal and social implications"; andDraft National Data and Cloud Policy GN 306 of GG 44389, 2021.(6) See:Jin, X L, Zhang, M, Zhou, Z and Yu, X (2019), "Application of a blockchain platform to manage and secure personal genomic data: A case study of LifeCODE.ai in China", J Med Internet Res, 21 (9), e13587;Shabani, M (2019), "Blockchain-based platforms for genomic data sharing: A de-centralized approach in response to the governance problems?", J Am Med Inf Assoc 26 (1), 76–80; andCarlini, F, Carlini, R, Palma, S D, Pareschi, R, and Zappone, F (2020), "The Genesy model for a blockchain-based fair ecosystem of genomic data", Front. Blockchain 3, 1–13.