UK fertility watchdog considers laws for gene editing and lab-grown eggs

This is one of two articles published on the same day in the Guardian that suggests an emerging strategy to modify the UK’s Human Fertilisation and Embryology Act. Based on notable contributions from Robin Lovell-Badge, a leading figure in global discussions about the future of genome editing, this article discusses expected impending recommendations from the Human Fertilisation and Embryology Authority (HFEA) to update the 1990 Act.

Four radical new fertility treatments just a few years away from clinics

This is one of two articles published on the same day in the Guardian that suggests an emerging strategy to modify the UK’s Human Fertilisation and Embryology Act. This article identifies recent developments in life science research—specifically, genome editing, synthetic embryos, mitochondrial transfer, and lab-grown gametes—and suggests that revisions to the 1990 Act would need to account for progress in these areas. The article argues that scientific progress in each of these domains necessitates “future-proofing” legislation so that these technologies can be translated into the clinic.

Report of the IBC on updating its reflection on the Human Genome and Human Rights

Following a UNESCO meeting in Paris, the International Bioethics Committee (IBC) released this report, which clarifies its stance on recent research related to human genomics. It includes special considerations for heritable genome editing and specifically calls for a moratorium on such applications. The reasoning the IBC provides is that such interventions raise “serious concerns,” including threats to human dignity and the prospect of eugenic applications.

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention)

This treaty is more commonly known as the “Oviedo Convention,” after the city in Spain where it was ratified. The Oviedo Convention is based on the European Convention of Human rights and is the only legally binding international instrument for protecting human rights in biology and medicine, covering both clinical and research settings and giving special consideration to human dignity. It lays out the rights of patients and research subjects for Europe, focusing largely on individual rights of informed consent and privacy but also mandating consideration of equitable access to health care.

Intervention on the Human Genome: Re-examination Process of Article 13 of the Oviedo Convention - Conclusions and Clarifications

In 2021, the Council of Europe determined that it was necessary to clarify the provisions of the Oviedo Convention pertaining to human genome editing. These clarifications were designed to clear up ambiguity surrounding the applicability of Article 13 of the Oviedo Convention to research and in particular, the use of the terms “preventive, diagnostic and therapeutic.” The clarifications approved by the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) specify that Article 13’s restrictions apply to human genome editing for both clinical and research purposes.

Statement by the Organizing Committee of the Second International Summit on Human Genome Editing

This statement was released by the organizing committee of the Second International Summit on Human Genome Editing in Hong Kong in 2018, immediately following the revelation of He Jiankui’s heritable genome editing experiments. Though a scandal was emerging, the statement does not repeat the language from the first summit statement about the need for “broad societal consensus” to proceed with heritable genome editing. Instead, it says that its clinical use “remains irresponsible at this time” and beings the work of anticipating a path forward.

Statement from the Organising Committee of the Third International Summit on Human Genome Editing

This statement was released by the organizing committee of the Third International Summit on Human Genome Editing in London in 2023. It continues the trend from the second summit statement of laying out a path to clinical applications of human genome editing. One of the ways in which the organizers accomplish this is by making a distinction between heritable genome editing for reproductive purposes and germline genome editing for research purposes.

On Human Gene Editing - International Summit Statement

This statement followed the first three-day International Summit on Human Gene Editing convened by the National Academies of Sciences and Medicine. It summarizes the Organizing Committee’s conclusions, including the conclusion that “it would be irresponsible to proceed with any clinical use of germline editing." It identifies the need for “broad societal consensus” before such research should be pursued and suggests that the subject should be revisited regularly.

Human Genome Editing: Science, Ethics, and Governance

The National Academies of Sciences and Medicine convened a committee to summarize the important considerations for the future of human gene editing, including both somatic and germline editing. They lump these considerations into three categories: the scientific, the medical, and the ethical. They note that public engagement is especially important in the case of germline editing.

Genome editing: an ethical review

This report from the independent UK Nuffield Council on Bioethics takes a broad view of the practical and ethical significance of genome editing. It responds in part to the development of CRISPR/Cas9 and examines applications of genome editing well beyond the human. It divides its analysis into several different “fields of activity” in which CRISPR/Cas9 and genome editing more broadly have anticipated impacts.

A Voluntary Moratorium?

In this brief piece, then-Editor-in-Chief of Molecular Therapy draws on the occurrence of multiple adverse events in clinical trials of retrovirus-mediated gene therapies to address the question of whether a voluntary moratorium is necessary. Verma argues that it is not, on the grounds that it is difficult to identify the root causes of the adverse events and that a moratorium would be unfair to potential gene therapy patients.