The Hastings Centre has just published a report about heritable germline editing in a global context 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 Brigitte Nerlich.
The report presents views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing and on possible policy options. It brings new empirical evidence to bear on issues of policy and practice. 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. The need to do so has become even more urgent now, after a Russian scientist announced that he wants to repeat that experiment.
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:
- the prevention of monogenetic conditions, such as Huntington Disease;
- the maximization of reproductive choices during IVF, including hair or skin colour;
- 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.
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 commercialize this technology in the context of international research or commercial partnerships. It focuses in particular on the emergence of premature, irresponsible, or rogue applications; the potential development of transnational germline therapy tourism; and the possibility of genetic enhancement as shared global challenges.
Challenges facing the UK in particular are related to researchers and corporations operating abroad to avoid regulatory restrictions or their involvement in overseas heritable genome editing research trials.
Part two focuses on policy challenges, such as the maximization of patient safety, the creation of responsible forms of clinical translation and ethically robust forms of international research and corporate collaborations.
Stakeholders 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.
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.
Public engagement is far from universal and has primarily emerged in wealthy, liberal democratic societies – audiences and existing forms of public do widely vary across countries.
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 problems identified in this report. However, there are two important challenges with this proposal.
A first challenge is that public engagement is far from universal and has primarily emerged in wealthy, liberal democratic societies. 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 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.
A second challenge lies in an inherent tension between recent calls for the rapid development of international regulatory standards for the clinical translation of germline editing, and demands for broad and inclusive public engagement. Public engagement takes time and seeks to “open up” debate with the aim to elicit multiple opinions, values and concerns. The rushed development of international standards on the other hand “closes down” diversity of views, and pre-empts a broad, public debate before it started.
For example, the appeal to develop a “rigorous, responsible translation pathway” toward germline editing, as put forward by the organizing committee of the Second International Summit on Human Genome Editing in Hong Kong, was issued without systematic examination of public views.
This reflects value judgments and a consensus (that the medical use of germline editing is desirable and should be endorsed) that have not emerged from public engagement, but from deliberation among a small group of stakeholders, mainly from the USA, Europe, and China. What about people and societies elsewhere? Should their opinions remain unheard?
In short, a more inclusive, global dialogue is urgently needed.
Acknowledgements: 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.