Regulatory, Legal and Ethical Issues in Gene Drive for Non-Human Population Control (Invite only workshop)

Gene drives force a gene to spread through a population much more rapidly and to a greater extent than is predicted by standard evolutionary processes, even if it is lowers the fitness of the organism that carries it. This can be applied to replace or even eradicate populations and there is immediate interest in spreading disease­resistance through vector populations, such as the mosquitoes that transmit malaria or dengue and zika virus. Many conversations are currently on­going about regulation and responsible use of these technologies, in which the UK has a stake as a key exporter of related technologies and a potential user for control of pest populations.

This meeting addressed concerns of UK policy makers in terms of national and international regulations and specifically examined whether gene drive fits within existing regulations on deliberate release of GM organisms or if it is functionally different and therefore requires additional legal measures to be put in place.

Focus of workshop

The workshop discussed:

•  In regard to deficiencies noted in EU and UK regulation – what changes to risk assessment are appropriate in order to e.g. make comparison with alternative methods of control; incorporate consideration of benefits.
•  In regard to concerns about lack of international guidance and the problems this can cause, how might the UK provide leadership in this regard, e.g. through dissemination of best practice in research, application and regulatory responses.
•  In addition to the current discussion about mechanisms for safety and risk management, consideration of drivers for unsafe practice – such as: economic competitiveness; lack of understanding; shortage of funds partway through; public demand for rapid application; fear of public resistance – and how to address these.
•  Steps to developing sustained science­policy engagement to support appropriate responses to new applications of genetic technologies on a case­by­case basis. 
Specifically, the workshop will ask if there is a need for regulation beyond the scope of existing GM regulations and other relevant areas of legislation.

Workshop Briefing paper available here: CSER Gene Drive Briefing Paper

The workshop was co-organised with Cambridge University’s Synthetic Biology Strategic Research Initiative, and the Centre for Law, Medicine and the Life Sciences. It was supported in part by a grant from the Hauser-Raspe Foundation.