BAC Consults on Ethical, Legal and Social Issues Arising from Human Nuclear Genetic Editing (HNGE)

The Bioethics Advisory Committee (“BAC“) has launched a public consultation on the ethical, legal, and social issues arising from Human Nuclear Genome Editing (“HNGE“). The public consultation runs from 3 June 2024 to 13 August 2024.

Background

The human genome, made of deoxyribonucleic acid (“DNA“), contains all the information needed for an individual to develop and function. HNGE is a technology that can modify the DNA of living cells, such as human cells, to correct defects or enhance traits. It may be broadly classified into: (i) non-heritable gene editing; (ii) heritable gene editing for clinical applications; and (iii) gene editing in embryos or germline cells for research.

It is reported that advances in HNGE hold great promise in improving health conditions, such as treating genetic diseases, enhancing personalised medicine, and increasing resistance to infections. While HNGE technologies have the potential to enhance human health, they also raise important ethical, legal and social issues. It is against this backdrop that BAC developed the consultation paper and launched this public consultation.

Key Issues

The key issues raised in the Consultation Paper include the following:

(a) Mosaicism, off-target effects, and on-target undesirable modifications. While HNGE technologies could potentially correct or remove mutations that may lead to adverse health conditions, they could also lead to unintended biological outcomes such as chromosomal mosaicism in embryos, and undesirable modifications arising from off-target mutations and deletions. Mosaicism is a condition that occurs when a person has two or more sets of cells that differ genetically from one another.

Ethical considerations include: (i) balancing the potential benefits of HNGE technologies against the risks associated with mosaicism and off-target effects; (ii) ensuring that patients or participants undergoing non-heritable gene editing interventions are fully informed of the risks associated with such applications; and (iii) whether clinical applications of heritable gene editing should be allowed to treat disease or infertility given potential unintended consequences for future generations.

(b)  Safety and long-term effects of HNGE. As HNGE is still in its early phase of development, there are concerns regarding the safety and long-term side effects of HNGE on affected individuals.

Ethical considerations include coming up with measures to deal with the challenges relating to HNGE, and alleviate the long-term consequences associated with non-heritable gene editing.

(c)  Procurement and use of human embryos and oocytes in HNGE research. Procuring oocytes with the desired genotype from individuals can enable researchers to study gene mutations in embryos for a given disease-causing gene, or assess the treatment for a specific gene mutation.

Ethical considerations include (i) health risks for donors during the oocyte extraction procedure; and (ii) balancing the potential benefits of gene editing research on human embryos and oocytes against potential privacy breach.

(d)  Equitable access and allocation of resources. HNGE has many potential benefits for human health. As with other new modalities in medicine, HNGE technologies could be prohibitively expensive and could give rise to the possibility of creating new inequalities and discrimination.

Ethical considerations include ensuring equitable access to HNGE technologies across different socio-economic groups and regions.

Feedback on the issues can be sent by: (i) email (bioethics_singapore@moh.gov.sg); (ii) post (Biomedical Ethics Coordinating Office, 1 Maritime Square, #09-66 HarbourFront Centre, Singapore 099253); or (iii) an online channel through this feedback form.

Gregory Vijayendran, SC from the Commercial Litigation Practice is a Deputy Chair of BAC and a member of the HNGE Review Group.

Click on the following links for more information (available on the BAC website at www.bioethics-singapore.gov.sg):

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