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.
With recent advancements in systems engineering and artificial intelligence, autonomous agents are increasingly being called upon to execute tasks that have normative relevance. These are tasks that directly—and potentially adversely—affect human well-being and demand of the agent a degree of normative-sensitivity and -compliance. Such norms and normative principles are typically of a social, legal, ethical, empathetic, or cultural (‘SLEEC’) nature. Whereas norms of this type are often framed in the abstract, or as high-level principles, addressing normative concerns in concrete applications of autonomous agents requires the refinement of normative principles into explicitly formulated practical rules. This paper develops a process for deriving specification rules from a set of high-level norms, thereby bridging the gap between normative principles and operational practice. This enables autonomous agents to select and execute the most normatively favourable action in the intended context premised on a range of underlying relevant normative principles. In the translation and reduction of normative principles to SLEEC rules, we present an iterative process that uncovers normative principles, addresses SLEEC concerns, identifies and resolves SLEEC conflicts, and generates both preliminary and complex normatively-relevant rules, thereby guiding the development of autonomous agents and better positioning them as normatively SLEEC-sensitive or SLEEC-compliant.
The Protection of Personal Information Act 4 of 2013 (hereafter POPIA) has the potential to disrupt health research in South Africa. While the legal status quo is that broad consent by research participants is acceptable, POPIA requires specific consent for any processing of research participants' health and genetic information. However, POPIA offers mechanisms such as an exemption from specified measures which can potentially be used to ameliorate its impact. It is proposed that the health research sector should seek to utilise these mechanisms – in particular, a sector-wide exemption of all health research projects from the requirement of specific consent by research participants, subject to the conditions that: (a) a health research project must be approved by a health research ethics committee, and that (b) either specific, broad or tiered consent must be obtained for a health research project. Importantly, it would be counter-productive to approach such an application for exemption from the perspective of inconvenience for health researchers. Instead, an application for exemption must be approached from a human rights platform, and must be supported by solid evidence. Such evidence should include the results of empirical studies of South African research participants' preferences.
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.
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