A new report by the European Academies' Science Advisory Council on genome editing gives advice to European policy-makers on groundbreaking research involving genome editing and plants, animals, microbes and patients. In this report, "Genome Editing: Scientific opportunities, public interests, and policy options in the EU", EASAC emphasises that policy-makers must ensure that the regulation of applications is evidence-based, takes into account likely benefits as well as hypothetical risks, and is proportionate and sufficiently flexible to cope with future advances in the science.
Present knowledge gaps and uncertainties mean that more basic research will be necessary. EASAC expects that research advances will fill many of the current knowledge gaps and that progressive refinement of genome editing tools will further increase their efficiency and specificity, thereby reducing off-target effects. EASAC anticipates that the fast pace of change in research and innovation will continue.
EASACís new report addresses several areas in which genome editing occurs, including plants, animals, micro-organisms, human cell genome editing as well as gene drive applications for vector control. EASAC also makes recommendations regarding cross-cutting issues, including engaging with the public.
A few highlights from EASACís conclusions include:
∑ Regarding plants, EASAC advises EU regulators to regulate the specific agricultural trait/product rather than the technology by which it is produced.
∑ As genome editing pertains to animals, livestock breeding in agriculture should also be governed by the same principle as proposed for plant breeding Ė to regulate the trait rather than the technology and be open and explicit about what is being done.
∑ With regard to the modification of animals to serve as a source for xenotransplantation, EASAC urges European regulators to prepare for the new opportunities coming into range.
∑ For gene drive applications, for example to help in control of disease vectors, EASAC supports proposals for a phased approach to research that will enable responsible development and allow sufficient time to consider what changes might be needed in regulatory frameworks.
∑ Genome editing in microbes does not raise new issues for regulatory frameworks and is currently subject to the established rules for contained use and deliberate release of GMOs. Given the wide range of potential applications, including pharmaceuticals and other high value chemicals, biofuels, biosensors, bioremediation and the food chain, it is important to consider these in the EU strategy for innovation in the bioeconomy.
∑ Regarding human cell genome editing, intensive basic and clinical research is needed and should proceed subject to appropriate legal and ethical rules and standardised practices. Clinical use of somatic cell gene editing should be rigorously evaluated within existing and evolving regulatory frameworks. Clinical use of germline interventions (that would be heritable) poses difficult issues and it would be irresponsible to proceed until and unless the relevant scientific, ethical, safety and efficacy issues have been resolved and there is broad societal consensus.
EASAC urges the policy community as well as scientists to continue their efforts to promote public engagement with the important research advances and their societal implications. It is important for both policy-makers and scientists to build trust with the public. Public engagement will also require greater investment in social science to better understand how to improve.
Global justice is also a crucial element to consider. There may be risk of increasing inequity and tension between those who have access to the benefits of genome editing applications and those who do not, although the widespread adoption of the technique might facilitate the sharing of benefits. It is also vital for EU policy-makers to appreciate the consequences, sometimes inadvertent, of EU policy decisions on those outside the EU.
Read the EASAC report here.
EASAC is formed by the national science academies of the EU Member States, Norway and Switzerland, to collaborate in giving advice to European policy-makers. EASAC provides a means for the collective voice of European science to be heard. Through EASAC, the academies work together to provide independent, expert, evidence-based advice about the scientific aspects of European policies to those who make or influence policy within the European institutions.
Dr. Robin Fears
Phone: +44 1279 504270
Secondary press contact:
Ms. Molly Hurley-Depret
Phone: +352 691 112 882
This report will be publicly launched in Brussels on 4 May 2017. More information can be found here.
Notes to Editors
Please find below the full text of EASACís recommendations regarding genome editing.
EASACSís recommendations to the EU are as follows:
The increasing precision now possible in plant breeding represents a big change from conventional breeding approaches relying on random, uncontrolled chemical or radiation induced mutagenesis and meiotic recombination. In supporting the conclusions from previous EASAC work on new plant breeding techniques:
Research on animals is already subject to stringent regulation. While most genome-edited animals are currently being generated for basic or biomedical research, the technology also provides opportunities for livestock and aquaculture. It should be appreciated that in addition to potential increases in production, genome editing brings possibilities to enhance animal health and welfare. With regard to specific applications:
Gene drive to modify populations in the wild
Gene drive applications for vector control and other modifications of target populations in the wild offer significant potential opportunities to help address major public health and conservation challenges. As outlined recently by the US National Academies, a phased approach to research can enable responsible development and offers sufficient time for considering what amendments are needed to current regulatory frameworks to enable the sound evaluation of a gene-drive based technology. EASAC supports the recommendations by the US National Academies on gene drive approaches:
Human cell genome editing
EASAC endorses the emerging conclusions from other collective academy work (International Summit on Gene Editing and FEAM) and the initiatives of EASAC member academies:
General recommendations for cross-cutting issues
It is also vital for EU policy-makers to appreciate the consequences, sometimes inadvertent, of EU policy decisions on those outside the EU. There is evidence that previous decisions in the EU (for example, on GMOs) have created difficulties for scientists, farmers and politicians in developing countries. Reforming current regulatory frameworks in the EU and creating the necessary coherence between EU domestic objectives and a development agenda based on partnership and innovation is important for developing countries as well as for Europe.