The Regulation of Human Germline Genome Modification in Singapore

Abstract

In Singapore, genome editing techniques may be applied in research but not for therapeutic (or clinical) purposes. Broadly speaking, the legal, regulatory and ethical provisions that apply to genome editing are drawn from five (at times overlapping) regulatory regimes: (i) research involving human embryos and stem cells; (ii) research involving assisted reproduction centers (and assisted reproduction services); (iii) research involving non-human animals; (iv) human biomedical research other than clinical trials; and (v) clinical trials. A human embryo may be created solely for the purposes of research (to study a genome editing technique, for instance), provided certain conditions are met and requisite approvals are obtained. Any such research should not extend beyond fourteen days from the time that the embryo was created. These requirements apply mutatis mutandis to the use of genome editing techniques to modify the genome of human oocytes and embryos. Owing to a moratorium that has been imposed, human germline genetic modification is not allowed in the clinical setting. However, it is less clear if such procedures could be applied in a clinical trial. This chapter provides an analysis of the regulatory framework and its application, as well as how it is expected to change in the foreseeable future.