July 27, 2019, by Brigitte Nerlich

Heritable Genome Editing: National and international governance challenges and policy options

This blog post has been co-authored with Achim Rosemann (University of Exeter). A shorter and slightly different version has been published by the BioMed Central ‘On Society’ Blog.


Germline gene editing has become a hot topic in science and in society, after one Chinese scientist edited embryos in 2018, an experiment that a Russian scientist now wants to repeat. The report we are about to present to you in this blog post is therefore rather topical.


The Hastings Center has just published a report about germline editing based on work carried out by Achim Rosemann in collaboration with (in alphabetical order) Adam Balen, Sarah Hartley, Christine Hauskeller, Nick Lee, Margaret Sleeboom-Faulkner, Xinqing Zhang, and myself. It is entitled “Heritable Genome Editing in a Global Context: National and International Policy Challenges”.

This is not just another report on genome/germline editing of which there are many, some of which are summarised in the report. It is comparable to a number of these reviews but brings new empirical evidence to bear on issues of policy and practice. And it appeared after a watershed moment in the debate about genome and germline editing, namely the news broadcast at the end of November 2018, that two babies had been born whose genomes had been edited by a research team in China. This news galvanised thinking about whether and how it was possible to regulate germline editing nationally and internationally.

Heritable genome editing and its uses

Germline editing or heritable genome editing involves using genome-editing techniques in a human germ cell or embryo, thus introducing changes to the ‘germline’ that can be passed on to future generations.

As outlined in the report, the bioethicist and policy analyst Tetsuya Ishii has listed three possible uses of this technology: (1) the prevention of monogenetic conditions, such as Huntington Disease; (2) the maximisation of reproductive choices during IVF, including hair or skin colour, and (3) genetic enhancement, such as muscularity or memory. Currently regulations only deal with clinical trials of (1) and (3) is rather speculative.

There are various issues and problems related to these potential uses which are outlined in the report before coming to the novel contribution it makes.

Involving stakeholders

This report contributes to emerging systematic investigations of the possible effects of international regulatory differences, and of the challenges likely to arise for national governments once clinical applications become available at a global scale.

Its unique contribution lies in presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing and on possible policy options, based on findings from a multistakeholder study conducted between October 2016 and January 2018, funded by the Wellcome Trust.

The work included a thorough literature review, interviews and a workshop, which involved leading UK scientists, in-vitro fertilisation clinicians, and representatives from regulatory bodies, patient organisations, and other civil societal organisations, as well as fertility companies.

The report has two parts. Part one explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options generated during the workshop in relation to the challenges discussed in part one.

Governance challenges

Part one of the report covers two overarching themes. The first theme deals with issues related to the situation and well-being of fertility patients and babies whose genomes are edited, with a focus on germline gene therapy tourism and the emergence of commercial (including illegal and rogue) clinics, many of which are situated in a grey zone between rigorous science and quackery.

The second theme deals with issues for researchers, fertility clinics, and corporations that aim to develop, apply and commercialise this technology in the context of international research or commercial partnerships. It deals in particular with the surfacing of premature, irresponsible, or rogue applications; the potential emergence of transnational germline therapy tourism; and the possibility of genetic enhancement as shared global challenges.

Challenges facing the UK in particular are related to UK researchers and corporations operating abroad to avoid regulatory restrictions or the involvement of UK researchers in overseas heritable genome editing research trials.

Policy options

Part two of the report focuses on policy challenges, such as the maximisation of patient safety, the creation of responsible forms of clinical translation and ethically robust forms of international research and corporate collaborations.

Workshop participants developed six broad policy options, namely, proactive regulation, broad public engagement, international guidelines, scientific sanctions, public and patient education, and the regulation of advertisements. The opportunities for such policies (especially in the UK with its mature regulatory landscape), as well as the challenges they face are discussed in detail.

Where to go from here?

The report has already stimulated critical discussion about the selection of stakeholders in public engagement and the need to open up deliberation beyond experts and decision makers. We hope that further reflection will follow soon. In order to further debates on the ethical governance of heritable gene editing, we suggest three lines of future research:

  1. Engage with the difficulties of public engagement

The stakeholder views presented in this report provide insights into possible future developments, challenges, and risks when human germline gene editing is translated from the laboratory into clinical practice. They demonstrate the complexity of this task at national and international levels, including the issue of public engagement.

Medium-term, public engagement with multiple stakeholders at an international level will be important. This would allow the comparison of expectations and assumptions from different countries and would initiate a conversation of the development of potential future solutions to challenges identified in this report.

A challenge is that public engagement is far from universal and has primarily emerged in wealthy, liberal democratic states. While calls for more inclusive forms of scientific governance exist also in other countries, including in China, Russia and other (semi)authoritarian states, the purposes, audiences and existing forms of public engagement do widely vary.

This situation is likely to make the organization of international engagement more difficult. Moreover, findings from public deliberation are likely to be considered more relevant in some countries, compared to others.

  1. Explore the implications of different regulatory regimes

Differences in regulation, regulatory priorities and the contexts in which regulatory controls are implemented can be expected to have a significant impact on the ways in which global risks of germline editing are managed and the types of clinical applications that are likely to emerge.

More research is needed to examine the implications of different regulatory regimes, and the social and institutional contexts in which they are situated, in order to anticipate at which point and under which conditions irresponsible and unsafe clinical and commercial applications could surface, and how these could affect parents, their babies, future generations and human societies at large.

Such research needs to examine the cultural, socio-economic and political factors that influence regulatory processes in different countries, in order to identify roadblocks to the development and implementation of international governance responses to germline editing.

While a start in this direction has been made (for example here, here, here and here) more detailed, comparative research on these processes is needed.

  1. Discuss the challenges and limitations of international harmonisation

With the birth of the first two genetically modified babies in late 2018, demands for the comprehensive global governance of germline gene editing have increased. The development of globally harmonised regulatory standards is widely seen as a solution to control and prevent problematic clinical applications.

However, there are important challenges to determine inclusive and ethically justified harmonized global regulations. Harmonization is based on agenda setting and consensus formation. As studies from other technology areas show, this process conventionally excludes many views and stakeholders from the outset. Viewpoints of the scientific and economic elites that initiate and structure harmonization processes are often more influential than the opinions of other stakeholders. Scientists, regulators, ethicists and citizens from poorer countries, for example, rarely have much influence on the creation of harmonized standards.

Current debates on the global harmonization of guidelines for germline are at present primarily led by experts from the USA, Europe and China, with much less input of stakeholders elsewhere. This raises concerns. Not only can insufficient participation result in a lack of motivation to adopt harmonized standards and ineffective implementation, but perspectives from many countries and world regions are presently not part of the debate.

These inequalities need to be addressed. A platform that is sensitive to entrenched interests and that enables more representative and pluralistic approaches to the development of internationally harmonized regulations for germline editing is much needed.


This work has benefitted from research support provided by the Wellcome Trust (204799/Z/16/Z). We thank the participants of this project for their participation and input.

Image: 3D Illustration of an artificial insemination or in-vitro fertilization of an egg cell, ovum or zygote (via Getty Images)

Posted in biotechnologyPublic educationpublic engagement with sciencepublic participationsynthetic biology