Joint Statement of Ethics Councils from France, Germany and the United Kingdom on the Ethics of Human Germline Intervention

The ethics councils of three major European nations—France, Germany, and the UK—jointly authored this statement on the ethics of human germline genome editing. The statement identifies momentum toward allowing the clinical use of heritable genome editing but argues that this use would require “a level of public ethical reflection that is not yet met by current initiatives.” Accordingly, the three ethics bodies call for broad societal debate and deliberation and argue that this deliberation must focus more on ethical questions and principles.

Human Fertilisation and Embryology Act 1990, c. 37

The Human Fertilisation and Embryology Act was passed in British Parliament in 1990 and has since become a model of the regulation of human reproductive technologies. The legislation sought to maintain the status of the human embryo reached through deliberations in the previous decade, taking into account the 1987 white paper “Human Fertilisation and Embryology: a Framework for Legislation” and the 1984 Warnock Report (see Michael Mulkay [1987] for an account of the events between the Warnock Report’s release and its enshrinement into law).

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.

Human Fertilisation and Embryology: a Framework for Legislation (Cm.: 259)

This report follows the recommendation of the Warnock Report (1984) in creating an independent government body to regulate and oversee assisted reproduction. In the following years, given the diversity of views on the subject, the government made a series of public consultations. By the time the consultation period ended in June 1987, the British Government reaffirmed its intention to have legislation on assisted reproduction, a task for the British parliament.

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.

‘Where to draw the line?’ Mary Warnock, embryos and moral expertise

This chapter puts into perspective the sociopolitical context in which the Warnock committee in the UK was formed and the public division it was called to address, as well as key topics that informed the committee’s deliberations. The committee was unusual in broadening its membership to lay people, besides scientists and doctors; the author highlights Mary Warnock’s individual role in shaping bioethical thought in the UK, through her commitment to applied ethics, the need for external oversight, and her trajectory in civil service in previous committees.

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.

Report of the Committe of Inquiry into Human Fertilisation and Embryology (Warnock Report)

Known as the Warnock Report, this document primarily deals with issues surrounding in-vitro fertility treatments in the UK. However, it also includes recommendations on related matters of research on human gametes and embryos. One of the many consequential features of the Warnock Report was its advocacy of a fourteen-day limit on the culture of human embryos, the “14-day rule” that eventually made its way into UK law.

Agricultural Biotechnology: The U.S.-EU Dispute

In a US Congressional Research Service report, Charles Hanrahan recounts a dispute between the United States (along with Argentina and Canada) and the EU over the subject of genetically modified crops. The EU had kept a de facto moratorium on the import of genetically engineered foodstuffs, which the US argued was in violation of World Trade Organization rules and was causing economic harm to the United States both directly and through the global influence of EU policy.

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.

Human Embryo Culture: Discussions concerning the statutory time limit for maintaining human embryos in culture in the light of some recent scientific developments

The UK’s independent Nuffield Council of Bioethics convened an expert workshop to respond to the question of whether the 14-day rule should be reevaluated in the wake of new technological developments. The Council explains the logic underlying the initial establishment of the rule and the UK’s specific legal mechanisms providing licensed exceptions for research on embryos younger than two weeks.

Genome editing and human reproduction: social and ethical issues

The UK’s independent Nuffield Council on Bioethics prepared this 2018 report in response to recent developments in biological genome editing techniques. The report provides background, speculation on future directions of the technology, an analysis of a range of ethical considerations, and recommendations for governance of human germline genome editing. The report broadly determines that the important ethical considerations limit the range of applications for germline editing.

Self-organization of the human embryo in the absence of maternal tissues

This study led by Magdalena Zernicka-Goetz at the University of Cambridge reports the development of an “in vitro system to culture human embryos through implantation stages” (2016:700) in the absence of maternal tissues, which were previously thought to be required to mimic the implantation of an embryo in an uterus. The scientists adapted a protocol for mouse embryo culture, using an extracellular matrix. Implantation is a milestone in human development, thought to induce remodeling of the embryo and gastrulation.

The next frontier for human embryo research

Writing in Nature, science writer Elizabeth Svoboda describes the recent technological developments that have potential to provide new knowledge about the early stages of human development and lead to the production of a new range of therapeutic interventions. These developments test the limits of embryo research by extending its feasibility and producing a new range of “near-human embryonic structures” (2021:S16) that become objects of uncertain standing.

Do Human Cells Have Rights?

In a lecture given at Ormond College, Melbourne in July 1986, Mary Warnock provides a summary of the questions and moral dilemmas faced by the committee that she presided over, the Committee of Inquiry into Human Fertilization and Embryology. Warnock provides an overview of the moral reasoning behind the protection or use of human embryos in research, followed by an overview of how some of these arguments played out in the committee. These include the establishment of the appearance of a primitive streak and the 14-day rule as a cutoff for embryo policy.

Creating the ‘ethics industry’: Mary Warnock, in vitro fertilization and the history of bioethics in Britain

The author examines Mary Warnock’s role leading her namesake committee in the UK during the 1980s to show how bioethics gained traction and became institutionalized in Britain. British bioethics responded to concerns that were different from those in the US, particularly the need to exert external oversight and scrutiny of scientific activities. Wilson’s account suggests that this oversight was necessary for research to continue.

The Embryo Research Debate: Science and the Politics of Reproduction

This book provides an account of the events and public debate that took place between the commissioning of the Warnock Committee in 1982, to the 1990 passage of legislation that approved embryo research under certain conditions. In the 1980s, Britain experienced lively debates about whether human embryo research should be permitted and even considered a complete ban. The book traces the efforts of groups with different ideological and moral commitments to determine the future of embryo research in the UK, from initial mistrust and disapproval to permissibility.