This article provides a comprehensive analysis of the various dimensions in South African law applicable to personal genomic sequence data. This analysis includes property rights, personality rights, and intellectual property rights. Importantly, the under-investigated question of whether personal genomic sequence data are capable of being owned is investigated and answered affirmatively. In addition to being susceptible of ownership, personal genomic sequence data are also the object of data subjects’ personality rights, and can also be the object of intellectual property rights: whether on their own qua trade secret or as part of a patented invention or copyrighted dataset. It is shown that personality rights constrain ownership rights, while the exploitation of intellectual property rights is constrained by both personality rights and ownership rights. All of these rights applicable to personal genomic sequence data should be acknowledged and harmonized for such data to be used effectively.
Human germline editing holds much promise for improving people’s lives, but at the same time this novel biotechnology raises ethical and legal questions. The South African ethics regulatory environment is problematic, as it prohibits all research on, and the clinical application of, human germline editing. By contrast, the South African legal regulatory environment allows a regulatory path that would, in principle, permit research on human germline editing. However, the legal regulation of the clinical application of human germline editing is uncertain. As such, the current ethical and legal positions in South Africa are in need of reform. Five guiding principles – aligned with the values of the Constitution – are proposed to guide ethical and legal policy reform regarding human germline editing in South Africa: (1) Given its potential to improve the lives of the people of South Africa, human germline editing should be regulated, not banned. (2) Human germline editing clinical applications should only be made accessible to the public if they are proven to be safe and effective. (3) Non-therapeutic human germline editing may be permissible, and should be regulated in the same way as therapeutic human germline editing. (4) The decision on whether to use germline gene editing on a prospective child, should, subject to Principle 2, be left to the prospective parents. (5) Concerns about exacerbating social inequalities should be addressed by measures to increase access. In conclusion, recommendations are made to policymakers and scientists contemplating research in this field.
Whether human biological material (‘HBM’) in the research context is susceptible of ownership is contested, yet under-investigated. This situation leads to legal uncertainty for local scientists and their international collaborators. This article presents a comprehensive analysis of the topic — investigating both common law and statutory law — and concludes that HBM in the research context is indeed susceptible of ownership. First, since the common law is dynamic, it should recognise the reality that HBM has become useful in the research context and should therefore treat HBM in this context as susceptible of being owned. This aligns with the general trend in comparative foreign case law. Secondly, since relevant statutes consistently use the legal-technical term ‘donation’ to denote a situation where HBM is provided by a research participant to a research institution for the purposes of research, the transfer of ownership in the donated HBM from the research participant to the research institution is a statutory requirement. This necessarily implies that HBM in the research context is indeed susceptible of ownership and, moreover, that HBM in the research context is owned by research institutions and not research participants.
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