Dr Christopher Rudge1
1University Of Sydney Law School
Somatic cell genome editing (SCGE) now allows targeted, precise and nonheritable changes to be made to human DNA. While SCGE may have many applications in the future, current clinical trials indicate its potential to treat or even cure several monogenic diseases of the blood (hemoglobinopathies). This paper will offer a primer on somatic cells, outline their connection with genetic disease, and summarise the bioethical issues raised by therapeutic uses of SCGE.
Focusing on sickle-cell disease, the paper will compare SCGE with the current best treatment. It will describe how SCGE involves editing a patients’ cells with a programmable nuclease (CRISPR) in a medium before reintroducing those edited cells into the patients’ body. It will also consider what regulatory hurdles might prevent this treatment being introduced in Australia. The paper will then describe the current best treatment: the ‘bone marrow transplant’ (also known as an allogeneic hematopoietic stem cell transplantation). These transplants are legally unproblematic and involve replacing a patient’s sickle-affected stem cells with ‘healthy’ cells provided by a ‘matched’ donor.
In its final part, the paper will identify how four bioethical principles may be used to evaluate and compare these treatments, and in turn may inform proposals as to their regulatory treatment. While several studies have considered the bioethics of bone marrow transplants, vanishingly few have given serious consideration to the bioethics of SCGE. If time permits, the paper will also note several recommendations for governing SCGE published in 2021, including those recommended by the World Health Organization.
Biography:
Dr Christopher Rudge is a lecturer at Sydney Law School and a member of Sydney Health Law at the University of Sydney. Chris is also a chief investigator in the MRFF project ‘Improving decisions about access to stem cell interventions’ and this paper is presented with the support of that project. This work also derives from Chris’ postdoctoral research fellowship (2021) in the University of Tasmania’s Centre for Law and Genetics as a part of a Genomic Health Futures Mission project titled ‘Genome Editing: Formulating an Australian Community Response.’