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 paper, 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 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 paper 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.
Highlights
Recent developments in genome editing techniques, such as CRISPRCas[9], are transforming biological therapeutic medicine
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 have presented an introduction to the nascent science of Clustered Regularly-Interspaced Short Palindromic Repeats (CRISPR)-based genome editing, which is poised to transform the field of precision medicine in the foreseeable future
Summary
Recent developments in genome editing techniques, such as CRISPRCas[9], are transforming biological therapeutic medicine These technologies enable precisely targeted alterations to genomic sequences in living cells. This involves cleaving a section of DNA at a targeted location and altering the genomic sequence by inserting new DNA at a specific site Such technologies, used in conjunction with precision medicine, can provide personalised preventative, diagnostic and therapeutic interventions to an individual in a predictive and precise manner.[1]. We aim to provide clarity on how activities related to genome editing are currently regulated; to identify gaps in the law and ethical guidance in this area; and to lay a solid foundation for ethically responsible policy development in genome editing that resonates with the values of the Constitution of the Republic of South Africa, 1996 (hereafter, the Constitution). We suggest that deliberative public engagement allows for the determination of values that are deeply embedded in our society and which ought to inform regulatory policymaking
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