The application of Genome Editing in humans

Recognising the importance of the significant advances that have taken place over the last few years in the science and application of genome editing, aided by the development of new techniques such as CRISPR/Cas9, the Federation of European Academies of Medicine (FEAM) has prepared the attached statement “The application of Genome Editing in humans”. We acknowledge that the rapid development of this technology and its potential to deliberately introduce modifications to the human germline, has also been responsible for driving forwards the current ethical and regulatory debate over the possibility of its future application in the clinic. FEAM hopes that this position paper, which has been endorsed by our Member Academies across Europe, will make a useful contribution to this ongoing debate. The preparation of this paper arose from a FEAM Workshop on current developments in the European landscape for Human Genome Editing, held in Paris in 2016.

A number of key issues are raised in the paper:

• It is essential that there is continued European funding for basic biomedical research in genome editing. The importance of the funding for research into some aspects of genome editing that is already being provided by the European Commission under the EU H2020 programme (and previously by the 7th Framework Programme) is recognised. However, FEAM would welcome further consideration by the European Commission, at some point in the future, of its restrictions on funding research involving germline cells and early human embryos. This would allow the EC to take advantage of promising research in this field, and considerable relevant expertise that exists across Europe.
• It is recognised that the EU regulatory context for genome editing is varied and that significantly divergent views are held at the national level on the acceptability of some areas of research, particularly concerning the potential genome editing of the germline, and more specifically regarding the use of embryos in research. Nevertheless FEAM considers that there is a need for ongoing review of the European regulatory framework. It is important that there is regulatory oversight across Europe that encompasses current developments in the science of genome editing and is also able to deal with future advances in this rapidly developing field.
• Recent advances in the techniques for the genome modification of non-reproductive (somatic) cells are opening up the real possibility of achieving therapeutic genome editing in diseased tissues and cells. We consider it essential for the potential benefit and risks of all proposed genome medications in somatic cells to be rigorously evaluated within an appropriate regulatory framework established by the European Medicines Agency and National Agencies. Through an effective, harmonised, or at least cooperative regulatory environment and through the provision of appropriate levels of funding for collaborative research, there is a real opportunity for the European biomedical community to take the lead in this field, for the benefit of Europe’s patients and those from other countries.
• There has been much speculation over the potential for the future clinical applications using human germline modification. There is clear agreement within FEAM’s Member Academies that much more needs to be known about the potential risks to both the individual and future generations, and the relative advantages and alternative approaches to treatment that are available, before clinical applications of potentially heritable germline genome editing should be initiated.
• There is a clear need for increased public engagement on the application of genome editing and more needs to be done in the development of an agreed lexicon and common definitions across Europe. This could help patients, policy makers and the wider public in different countries better understand the application of the science of genome editing and the different positions and opinions being developed. Much good work is taking place in some countries exploring what patients and laypeople think and know about genome editing and its implications, and how best to discuss genome editing in public. FEAM and its Member Academies will seek to engage and support such initiatives where appropriate, but we call upon the European Commission to take a lead in promoting such best practice across the EU.

The European biomedical community is currently playing a leading global role in seeking to further apply genome editing technology for the ultimate benefit of patients. FEAM and its Member Academies will continue to monitor the ethical, legal and technological aspects of this transformational technology to help ensure its continued development.

October 2017