13 October 2016
The Nuffield Council on Bioethics published its review on the ethics of genome editing on 30 September, highlighting reproductive editing and editing of livestock as areas of immediate ethical concern; the report also recommended that a range of other issues, including xenotransplantation and cell-based therapies, should be addressed in the near future or kept under review.
The review focuses on the full spectrum of uses for genome editing such as in human health, food production and in releasing genetically altered species into the wild. In our response to the call for evidence for this inquiry the PHG Foundation focused on areas pertinent to human health, namely somatic genome editing for therapeutic use and germline (reproductive) editing. However, a common theme linking the ethical challenges of these different uses of genome editing are a focus on what the technology can be used for, rather than the technology in and of itself.
Currently the most contentious application for genome editing, and one of the issues the Nuffield Council has concluded requires urgent discussion, is the use of genome editing in reproductive technologies. Many of the questions surrounding germline editing focus on whether and how it adds value given the alternatives available such as pre-implantation genetic diagnosis (PGD) or gamete donation. While the review concurred with the prevailing view that it is morally and ethically challenging to justify germline editing, the discussions should start in earnest because they are likely to be heated and protracted. Moreover, if the eventual conclusion is that these technologies are indeed ethically permissible, then they should be made available as soon as possible thereafter. In the first instance, the variety of opinions and depth of public feeling over the issue indicate that intensive debate is warranted.
If the eventual conclusion is that these technologies are indeed ethically permissible, then they should be made available as soon as possible thereafter.
In terms of prioritising ethical discussions of the issues, putting germline editing in the category requiring urgent discussion makes sense given the challenges ahead. Likewise, other therapeutic uses of genome editing, ethically speaking, are in the least urgent 'keep under review' category. However, in terms of practical implementation, conversations about these other therapeutic uses should not wait, as therapeutic uses are moving closer to the clinic and some are already in early phase clinical trials. The cumulative impact on healthcare of these approaches could be quite large, as these techniques could potentially be used to treat a large number of rare conditions with current unmet clinical need. While these techniques are not without their risks, these risks affect the patient’s genotype only as any genetic changes made are not passed on to the next generation.
The issues that affect genome editing mirror those of regenerative medicines in general such as stem cells or other gene therapies. For example, issues include how to regulate these therapies and measure safety and efficacy in therapies that might use a patient's own tissue and therefore be personalised in terms of the biological material used (but not necessarily the technique). These issues are challenging, but surmountable. Therefore, an open and collaborative discussion is needed now, particularly if there are concerns in other areas, such as intellectual property rights associated with techniques and technologies, which could derail implementation. We are at an advantage in that many of the ethical challenges have been debated with respect to stem cell and gene therapies, so we can use this base of knowledge to build ethical frameworks and develop regulation, not just for therapeutic genome editing, but for regenerative medicines as a whole.
At the PHG Foundation, we will continue to focus on the regulatory challenges that could have an impact on the implementation of novel therapies
Additional challenges arise due to the speed of research progress using genome editing technologies and a potential blurring of the boundaries between research and treatments, for example if novel products continue to be used on a compassionate one-off basis in situations where patients have no further options. In these situations there is a danger that regulation might not keep pace with technological advances and we should ensure that any strategies and regulations that are developed for their management are proportionate.
At the PHG Foundation, we will continue to focus on the regulatory challenges that could have an impact on the implementation of novel therapies into the clinic. We think that efforts should continue to develop centralised coordination and oversight of regenerative medicines. This should support the streamlining of regulatory processes, how data are shared and stored and how 'lessons learned' are shared from clinical trials. An overarching vision is needed to drive forward the development of the most promising therapies, regardless of the technology used.
This report by the Nuffield Council is only the first step in outlining the areas of discussion and the ethical and moral challenges we face over the use of genome editing. The next steps outlined by the Council are to carry out reviews on the areas they have highlighted as being of urgent importance: genome editing in human reproduction and genome editing in livestock. We must continue the frank and open discussions that have already begun and continue to ensure that the issues surrounding the implementation of these technologies in medical treatments are included in these discussions.