BIA urges the Government to take a science-based approach to regulation of gene editing and GMOs

The BioIndustry Association (BIA) has urged the Government to adopt a science-based and innovation-friendly regulatory framework for gene editing and genetically modified organisms (GMOs).

The BIA made the comments in a submission to the Department for Environment, Food and Rural Affairs (Defra), which has been consulting on the regulation of genetic technologies. A key focus of the consultation was on the Court of Justice of the European Union (CJEU)’s judgement to regulate gene edited products as GMOs. The BIA called on the Government to diverge from the judgement. 

In its response, the BIA also said that the Government should put in place an exemption scheme for medicines containing or consisting of GMOs undergoing clinical trials. This would ensure the UK remains a globally competitive location for clinical development and allow rapid patient access to these potentially curative medicines. Significant experience with gene delivery systems in the manufacture of medicines provides demonstrable evidence of the lack of increased risk of harm to human health or the environment posed by organisms produced by gene editing.

Steve Bates OBE, CEO of the BioIndustry Association, said: “Gene editing and GMOs have enormous potential to help us tackle health and environmental problems. Defra’s consultation on the regulation of genetic technologies is a clear opportunity to ensure the UK is at the forefront of these technologies and upholds its position as an attractive destination for foreign investment and top global talent to conduct their research.

“Given the CJEU’s judgment to regulate gene edited products as GMOs, it should be noted that the wider GMO regulations on the UK’s statute are burdensome and ineffective. Without addressing the underlying problems of these regulations, the UK will not be able to reap the benefits of gene editing and GMOs, whether in healthcare or tackling climate change. By adopting a science-based regulatory system which regulates the product instead of the process and has the confidence of the public, the UK would enable more start-ups to be created from our excellent science base, attract global investment, help deliver on the Government’s levelling up agenda and ambition to make the UK a global life sciences cluster.”


Notes to Editors 

1. Defra’s consultation document is available here.

2. To read the BIA’s response, follow this link.

3. Please contact Jack Fellows, Communications and Media Manager for further information.