WHO in 2019 established the Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, which has recently published a Draft Governance Framework on Human Genome Editing. Although the Draft Framework is a good point of departure, there are four areas of concern: first, it does not sufficiently address issues related to establishing safety and efficacy. Second, issues that are a source of tension between global standard setting and state sovereignty need to be addressed in a more nuanced fashion. Third, it fails to meaningfully engage with the extent to which the conceptualisation of human dignity may justifiably vary between jurisdictions. Fourth, the meaning of harm to the interests of a future person requires clarity. Provided these four areas of concern can be addressed, the future of the global governance of human genome editing may hold promise.
Tuberculosis (TB) continues to be the top killer disease in South Africa; there is little hope of a very efficient treatment in the near future. It is therefore becoming increasingly clear that the long-term solution to TB requires more than simply adding to the current arsenal of TB drugs. A treatment that provides quicker and long-lasting results is needed. Public health innovations such as genome editing present a promising therapeutic paradigm shift in terms of TB immunisation or treatment. The diversity of the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 genome-editing technology holds promise in its ability to alter the genome and to control gene expression. While the promotion of CRISPR research is a crucial public health intervention, the realm of patent laws clashes with promoting public health needs, which may delay the speedy use of this technology for disease treatment. For that reason, in this article, I discuss the South African CRISPR patent landscape and its impact on the proposed applications of genome editing technology in public health. I explore the complexities raised by the CRISPR patent landscape and how that may lead to high prices for these CRISPR therapies – thereby limiting patients’ access. I conclude by proposing recommendations on how we can efficiently bridge the disconnect between the existing CRISPR patents and access to CRISPR therapeutics as a public health benefit.
Over the past few years, developments in the science of precise editing of human genomes using CRISPR-Cas9 have led many countries that lack specific laws in this area, such as South Africa (SA), to contemplate legal reform. Thaldar et al. recently published five principles to guide legal reform in SA on heritable genome editing. In a similar vein, concerns about the global impact of human germline genome editing have led to calls for a global regulatory mechanism. This is what the World Health Organization has tried to achieve with the recently published ‘Draft governance framework for human genome editing’. In this article, we compare the policies proposed by the draft framework to the current SA legal position, as well as the five guiding principles. The article concludes that SA law is in need of reform in order to meet the global standards that the draft framework seems to be moving towards.
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