Legal Governance of Genome-Editing Technologies for Human Gene and Cell Therapies in Singapore
This chapter provides an analysis of the legal governance that applies to genome-editing technologies for human biomedical research and (somatic and germline) cell therapies in Singapore. Genome-editing technologies refer to a group of techniques that include CRISPR/Cas9, which is a technological tool by which gene locus can be altered to create a specific genetic modification at that precise locus. For the purposes of this chapter, reference to gene-editing technologies includes techniques that could modify the genetic composition of a human cell. The ability to apply such techniques to human somatic and germline cells can eventually offer therapeutic opportunities to treat severe hereditary diseases by repairing the disease-causing gene(s). With a few exceptions, gene-editing technologies remain technically challenging and complex to implement safely and effectively at the time of writing, mainly because of fundamental limitations in the ability to precisely control how genetic material can be altered or introduced into cells. In other words, safety continues to be the foremost of concerns if such technologies are to be administered as clinical practice. Apart from concerns about physical wellbeing, gene-editing technologies have also raised concerns that relate to eugenics as they can be applied for non-therapeutic purposes or otherwise for the purposes of genetic enhancement. This chapter discusses the legal responses in Singapore to these and related concerns as legal governance of an emergent biomedical technology. Legal governance refers not only to statutory laws and regulations, but also to ethical principles, recommendations and good practices that either have regulatory effect or represent the legal or regulatory ends of legal requirements that apply to the use of genome-editing technologies in Singapore.