Altering the human genome : mapping the genome editing regulatory system in South Africa

Abstract

Novel therapeutic strategies using genome editing technologies, such as CRISPR-Cas9 are revolutionising the way in which diseases can be prevented and treated in the future. Consequently, a global debate has emerged around the ethical and legal implications relating to the use of such technology in research, therapy, and human reproduction. This has brought to the forefront questions regarding the extent to which current policies respond to these issues. In this article we provide a "map" of South African policy relating to genome editing, and illustrate how current ethical guidelines and law regulate its use. We find that the South African legal and policy framework is marred with inconsistencies and incompleteness, and that an opportunity exists for the normative and regulatory framework governing this field of research and therapeutic application in South Africa to be reviewed and reformed. In this article we present certain recommendations – with the goal of informing and supporting health policy and decision-making regarding the regulation of genome editing in South Africa. We suggest that by adopting a pragmatic regulatory approach such recommendations serve to address public concern, reflect appropriate international perspectives, and provide a firm foundation for the development of genome editing regulation in South Africa.