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.
This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.
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.
Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.
The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. Whiledeveloping such a DTA template is certainly a worthwhile project, questions regarding the project’s practical execution should be addressed,including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that anempowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approachfollowed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entailgovernment making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowermentapproach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community andmaking the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisionsare analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certaintyregarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractualconstraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role asresponsible parties, where relevant, cannot be contracted out via a DTA.
This article investigates how comics can be used to adequately communicate the correct process of contract cancellation and whether comics can enhance understanding of the legal process. A survey of pre-owned vehicle buyers of various levels of education in Pretoria, South Africa found that when comics are used to communicate contract cancellation, a significant increase in the comprehension of the legal cancellation process occurs. The results may influence how contracting parties may choose to communicate complex legal issues in future, specifically to consumers with little formal education or when parties are confronted with severe language barriers, which is highly relevant in a country such as South Africa with eleven official languages and generally low levels of education. The article argues that representatives tasked with explaining contractual content to contracting parties should consider making use of comics to aid them in their communication process to ensure proper understanding and execution of terms and conditions, which in turn may lead to fewer disputes and avoid expensive litigation.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.