COVID-19 exposed flaws in the law regulating the sharing of data and human biological material (HBM). This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter alia, the promulgation of a revised version of the South African Material Transfer Agreement (SA MTA) by the Minister of Health. This would remove uncertainty regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a health research perspective.

Despite the fact that the Constitution explicitly protects the right to freedom of scientific research, this right features neither in the preamble to any legislation, nor in any reported case law. If the right to freedom of scientific research remains in obscurity, South Africa could slip into totalitarian control of the scientific enterprise, to the detriment not only of scientists, but also of society in general. The right to freedom of scientific research should play a more central role in policy-making. This is not only because it is an enumerated constitutional right, but also because it is important in its own right, as it serves purposes that are at the core of our constitutional value-system: promoting individual autonomy, facilitating the search for truth, and supporting democracy. The right to freedom of scientific research is unique in protecting not only the exchange of scientific thoughts and information, but also in particular the physical activities entailed by scientific research, such as performing experiments. The notion that government should somehow seek to regulate every new scientific development is erroneous, as freedom should be the default position in science-related policy, and should only be limited by regulation if, and to the extent that, it is constitutionally justified.

This paper reports the results of a public engagement study on heritable human genome editing (HHGE) carried out in South Africa, which was conducted in accordance with a study protocol that was published in this journal in 2021. This study is novel as it is the first public engagement study on HHGE in Africa. It used a deliberative public engagement (DPE) methodology, entailing inter alia that measures were put in place to ensure that potential participants became informed about HHGE, and that deliberations between the participants were facilitated with the aim of seeking consensus. A diverse group of 30 persons was selected to participate in the DPE study, which took place via Zoom over three consecutive weekday evenings. The main results are: Provided that HHGE is safe and effective, an overwhelming majority of participants supported allowing the use of HHGE to prevent genetic health conditions and for immunity against TB and HIV/Aids, while significant majorities opposed allowing HHGE for enhancement. The dominant paradigm during the deliberations was balancing health benefits (and associated improvements in quality of life) with unforeseen health risks (such as loss of natural immunity). The seriousness of a health condition emerged as the determining factor for the policy choice of whether to allow an application of HHGE. More generally, equal access to HHGE qua healthcare service featured as an important value, and it was uncontested that the South African government should allocate resources to promote scientific research into HHGE. These results are aligned with the policy principles for regulating HHGE in South Africa suggested by Thaldar et al. They call for urgent revision of South African ethics guidelines that currently prohibit research on HHGE, and for dedicated HHGE legal regulations that provide a clear and comprehensive legal pathway for researchers who intend to conduct HHGE research and clinical trials.